FDB MedKnowledge U.S.

Documentation

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 FDB MedKnowledge U.S. Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
About This Document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Copyright . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Documentation Release Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
About FDB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
About FDB MedKnowledge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Product Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
FDB Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Implementation Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Information Update Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Product Configuration US-CA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Product Layout US-CA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Product Delivery US-CA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Data Definition Language Policy US-CA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Custom Services US-CA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Identifiers, Attributes, and Pricing Top-Level ERD . . . . . . . . . . . . . . . . . . . . . . . . . 102
MedKnowledge Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
MedKnowledge Identifiers and Attributes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Multiple Access Points MAPs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Good Vocabulary Practice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Advantages to Using MAPs in Application Development . . . . . . . . . . . . . . . . . . . . 107
Formulation-based MAPs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Name-based MAPs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Other Useful MAPs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
MAPs Master Tables ERDs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Clinical Formulation and Ingredient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
CFID Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
CFID Concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Clinical Formulation and Ingredient Data Editorial Policies . . . . . . . . . . . . . . . . . . . 143
MAPs Enhancements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
MAPs Freeness and Storage Condition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Alternative Strength . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
Dosage Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
Routes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181
Retrieving the Ingredients for a Specified Clinical Formulation . . . . . . . . . . . . . 182
Retrieving Related Drug Products Based on a Preferred Route and Ingredients List
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184
Navigating to a Routed Medication, Routed Dosage Form, and Medication . . . 189

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 Using the Clinical Formulation Identifier, Clinical Route, and Packaging Information
to Group Products for Purchasing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191
Finding a Replacement Ingredient Identifier . . . . . . . . . . . . . . . . . . . . . . . . . . . 195
Determining if a Given Drug Contains Ethyl Alcohol Ethanol . . . . . . . . . . . . . . . 197
Determining if a Given Drug Contains Metabolically Active Sugars . . . . . . . . . 203
Identifying Storage Condition Requirements for a Given Medication . . . . . . . . 205
Clinical Formulation and Ingredient Data ERD and Technical Specifications . . . . . 207
Alternative Clinical Formulation Identifier (GCN_SEQNO) to Ingredient Strength
Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210
Clinical Formulation Attribute Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212
Clinical Formulation Identifier (GCN_SEQNO) to Dosage Form Link Table . . . 213
Clinical Formulation Identifier (GCN_SEQNO) to Representative Route Table . 214
Clinical Formulation Identifier (GCN_SEQNO) to Route Relationship Table . . . 215
Clinical Formulation Ingredient Strength Component Table . . . . . . . . . . . . . . . 216
Clinical Formulation ID Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218
Clinical Formulation Ingredient Strength Type Description Table . . . . . . . . . . . 220
Dosage Form Attribute Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221
Dosage Form Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222
Dosage Form Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223
Dosage Form Master to Clinical Formulation Identifier (GCN_SEQNO) Dosage
Form Code Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224
Dosage Form Master to OrderKnowledge Dosage Form Link Table . . . . . . . . . 225
Dosage Form to Attribute Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226
Dosage Form Type Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227
Drug Category Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228
Drug Strength Component Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229
GCN_SEQNO/Inactive Ingredient Relation Table . . . . . . . . . . . . . . . . . . . . . . . 230
GCN_SEQNO-GCN Relation Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231
GCN_SEQNO Study Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232
HIC_SEQN-HIC_SEQN Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233
HIC-Chemical Abstracts Service Registry Number Relation Table . . . . . . . . . . 234
HICL_SEQNO-HIC3 Relation Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235
HICL_SEQNO-HIC Relation Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236
Hierarchical Base Ingredient Code Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 237
Hierarchical Ingredient Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . 238
Hierarchical Ingredient Code Organ System Table . . . . . . . . . . . . . . . . . . . . . . 239
Hierarchical Ingredient Code Pharmacological Class Table . . . . . . . . . . . . . . . 240
Ingredient List Identifier (HICL_SEQNO) to Route Relationship Table . . . . . . . 241
Ingredient List Identifier Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 242
Ingredient Replacement History Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243
Ingredient Status Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244
Ingredient Strength Unit of Measure Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . 245

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 Patient Parameter Required Description Table . . . . . . . . . . . . . . . . . . . . . . . . . 246
Related Route Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247
Routed Generic Clinical Formulation Identifier Link Table . . . . . . . . . . . . . . . . . 248
Routed Generic NDC Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 249
Routed Generic Status Code Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250
Routed Generic Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
Route Hierarchy Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 252
Route Labeled Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253
Route of Administration Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 254
Route of Administration Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 255
Strength Concentration Type Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 257
Strength Status Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258
Unit of Measure Conversion Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 259
Unit of Measure Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 260
Unit of Measure Type Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 263
Units Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 264
Packaged Product US . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 265
General Information-PP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 266
Packaged Product Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 267
Packaged Product Concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 273
Packaged Product Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 301
Packaged Product Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 334
Converting an 11-Digit NDC to a 10-Digit NDC . . . . . . . . . . . . . . . . . . . . . . . . . 335
Finding a Replacement or Previous NDC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 337
Finding the Product Labeler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 338
Retrieving a List of Therapeutic Substitutions . . . . . . . . . . . . . . . . . . . . . . . . . . 339
Determining HigherLower-cost Alternative Status . . . . . . . . . . . . . . . . . . . . . . . 360
Filtering Data with Product Attributes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 363
Determining Whether a Drug has a Biosimilar or Interchangeable Relationship with
Another Drug . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 370
Retrieving a Product's Active Ingredients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 371
Retrieving a Product's Inactive Ingredients . . . . . . . . . . . . . . . . . . . . . . . . . . . . 372
Determining the FDB Product ID and Associated Product Information Given an
External Product Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 373
Identifying Re-used External Product Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . 375
Packaged Product ERD and Technical Specifications US . . . . . . . . . . . . . . . . . . . 377
Alternative NDC Ingredient Strength Link Table . . . . . . . . . . . . . . . . . . . . . . . . 379
External Product Code Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 381
External Product Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 382
FDA Application Relationship Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 383
FDA Application Relationship Type Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 384
FDA Drug Application Type Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 385

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 First Databank Product Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 386
First Databank Product Status Description Table . . . . . . . . . . . . . . . . . . . . . . . 387
Labeler Identifier Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 388
NDC Attribute Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 389
NDC Attribute Type Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 390
NDC Attribute Value Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 391
NDC-HIC_SEQN Inactive Ingredient Relation Table . . . . . . . . . . . . . . . . . . . . . 392
NDC Inactive Ingredients Reviewed Master Table . . . . . . . . . . . . . . . . . . . . . . 393
NDC Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 394
NDC to FDA Drug Application Number Table . . . . . . . . . . . . . . . . . . . . . . . . . . 398
NDC to FDA NDA-ANDA Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 399
NDC to Route Relationship Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 400
Orange Book Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 401
Orange Book Code Relation Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 402
Packaged Product (NDC) to Dosage Form Link Table . . . . . . . . . . . . . . . . . . . 403
Packaged Product Package Type Description Table . . . . . . . . . . . . . . . . . . . . . 404
Medication Name Concepts MED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 405
MED General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 406
Medication Name Concepts Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 416
MED Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 422
Navigating to a Routed Medication Route Dosage Form and Medication . . . . . 423
Retrieving Active Products for a Medication . . . . . . . . . . . . . . . . . . . . . . . . . . . 425
Retrieving Related Active Ingredients for a Medication Name Concept . . . . . . 432
Retrieving Related Inactive Ingredients for a Medication Name Concept . . . . . 433
Retrieving Inactive Ingredient Statistics for a Medication Name Concept . . . . . 435
Retrieving the Generically Named Companion for a Medication Name Concept ..
437
Finding a Replacement MED Concept at Any Level of Specificity . . . . . . . . . . . 438
Retrieving and Displaying the Representative Brand Medication Names for a
Generically Named Medication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 440
Retrieving Pharmaceutically Equivalent Products When Searching by a Branded
Product No Longer Marketed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 451
Implementing Change Management of Stored MEDIDs . . . . . . . . . . . . . . . . . . 464
Identifying a Drug To Administer That May Have Multiple Alternative Ingredient
Strengths . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 470
Presenting a Prescribable MEDID Using a Search Term Type Code . . . . . . . . 474
MED ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 480
Alternative Medication Identifier (MEDID) to Ingredient Strength Link Table . . . 487
MAPs Attribute Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 489
Attribute Type Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 490
Attribute Value Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 491
Dosage Form Master to MED Dosage Form Link Table . . . . . . . . . . . . . . . . . . 492

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 MED Dosage Forms Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 493
MED GCN_SEQNO Assignment Code Description Table . . . . . . . . . . . . . . . . . 494
MED GCN_SEQNO to Medication ID Cross-Reference Table . . . . . . . . . . . . . 495
MED MED Concept Generic MED Relation Table . . . . . . . . . . . . . . . . . . . . . . . 496
MED MED Concept HICL_SEQNO Relation Table . . . . . . . . . . . . . . . . . . . . . . 497
MED MED Concept ID Type Description Table . . . . . . . . . . . . . . . . . . . . . . . . . 498
MED Medication Attribute Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 499
MED Medication Identifier (MEDID) to Dosage Form Link Table . . . . . . . . . . . 500
MED Medication Identifier (MEDID) to Route Relationship Table . . . . . . . . . . . 501
MED Medication ID Search Term Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 502
MED Medication Name Attribute Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 503
MED Medication Name ID/Inactive Ingredient Relation Table . . . . . . . . . . . . . . 504
MED Medication Name ID Inactive Ingredient Study Master Table . . . . . . . . . . 505
MED Medication Name Replacement History Table . . . . . . . . . . . . . . . . . . . . . 506
MED Medication Name Source Code Description Table . . . . . . . . . . . . . . . . . . 507
MED Medication Name Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 508
MED Medication Name to Route Relationship Table . . . . . . . . . . . . . . . . . . . . . 509
MED Medication Name Type Code Description Table . . . . . . . . . . . . . . . . . . . 510
MED Medication Replacement History Table . . . . . . . . . . . . . . . . . . . . . . . . . . 511
MED Medication Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 512
MED MEDID Inactive Ingredient Relation Table . . . . . . . . . . . . . . . . . . . . . . . . 514
MED MEDID Inactive Ingredient Study Master Table . . . . . . . . . . . . . . . . . . . . 515
MED Move Reason Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 516
MED NDC Generic MEDID Move History Reason Table . . . . . . . . . . . . . . . . . . 517
MED NDC Generic MEDID Relation History Table . . . . . . . . . . . . . . . . . . . . . . 518
MED NDC MEDID Move History Reason Table . . . . . . . . . . . . . . . . . . . . . . . . 520
MED NDC MEDID Relation History Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 521
MED NDC to Generic Medication ID Cross-Reference Table . . . . . . . . . . . . . . 523
MED NDC to Medication ID Cross-Reference Table . . . . . . . . . . . . . . . . . . . . . 524
MED Reference DESI2 Indicator Description Table . . . . . . . . . . . . . . . . . . . . . 525
MED Reference DESI Indicator Description Table . . . . . . . . . . . . . . . . . . . . . . 526
MED Reference Federal DEA Class Code Description Table . . . . . . . . . . . . . . 527
MED Reference Federal Legend Indicator Description Table . . . . . . . . . . . . . . 528
MED Reference Generic Comparative Price Code Description Table . . . . . . . . 529
MED Reference Generic Medication Name Code Description Table . . . . . . . . 530
MED Reference Generic Price Spread Code Description Table . . . . . . . . . . . . 531
MED Reference Generic Therapeutic Equivalence Code Description Table . . . 532
MED Reference Innovator Indicator Description Table . . . . . . . . . . . . . . . . . . . 533
MED Reference Multi-Source Code Description Table . . . . . . . . . . . . . . . . . . . 534
MED Routed Dosage Form Medication ID Inactive Ingredient Relation Table . 535
MED Routed Dosage Form Medication Identifier (MEDID) to Route Relationship
Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 536

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 MED Routed Dosage Form Medication ID Inactive Ingredient Study Master Table
537
MED Routed Dosage Form Medication Replacement History Table . . . . . . . . . 538
MED Routed Dosage Form Medication Table . . . . . . . . . . . . . . . . . . . . . . . . . . 539
MED Routed Dosage Form Medication to Dosage Form Link Table . . . . . . . . . 540
MED Routed Medication ID/Inactive Ingredient Relation Table . . . . . . . . . . . . . 541
MED Routed Medication ID Inactive Ingredient Study Master Table . . . . . . . . . 542
MED Routed Medication Replacement History Table . . . . . . . . . . . . . . . . . . . . 543
MED Routed Medication Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 544
MED Routed Medication to Dosage Form Link Table . . . . . . . . . . . . . . . . . . . . 545
MED Routed Medication to Route Relationship Table . . . . . . . . . . . . . . . . . . . . 546
MED Route Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 547
MED Status Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 548
Routed Dose Form Med Attribute Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 549
Routed Med Attribute Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 550
Search Term Type Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 551
Tall Man Plus 2.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 552
Tall Man Plus Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 553
TApplications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 556
Retrieving Tall Man Lettering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557
Listing Confusion Group Drug Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 561
Tall Man Plus ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . 564
Tall Man GNN Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 567
Tall Man GNN Type Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 568
Tall Man Group ID Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 569
Tall Man Medication ID Confusion Group Table . . . . . . . . . . . . . . . . . . . . . . . . 570
Tall Man Medication ID Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 571
Tall Man Medication Name Confusion Group Table . . . . . . . . . . . . . . . . . . . . . 572
Tall Man Medication Name Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 573
Tall Man Name Type Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 574
Tall Man NDC Confusion Group Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 575
Tall Man NDC Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 576
Tall Man Routed Dosage Form Medication Confusion Group Table . . . . . . . . . 577
Tall Man Routed Dosage Form Medication Name Table . . . . . . . . . . . . . . . . . . 578
Tall Man Routed Medication Confusion Group Table . . . . . . . . . . . . . . . . . . . . 579
Tall Man Routed Medication Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 580
Tall Man Source Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 581
FDB Medical Lexicon (FML) 2.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 582
General Information FML 2.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 583
FDB Medical Lexicon Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 589
FML Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 591
Finding DXID Descriptions and Synonyms . . . . . . . . . . . . . . . . . . . . . . . . . . . . 592

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 Finding DXIDs Based on an Input Search String . . . . . . . . . . . . . . . . . . . . . . . . 594
Finding DXIDs Based on a Patients Gender . . . . . . . . . . . . . . . . . . . . . . . . . . . 596
Building a Disease Navigation Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 597
Finding a Replacement DxID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 600
ICD Code Applications FML 2.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 601
Using FML with Other Modules FML 2.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 609
FML ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 611
FML Clinical Module Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 613
FML Disease Duration Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 614
FML Disease Identifier (DxID) Navigation Table . . . . . . . . . . . . . . . . . . . . . . . . 615
FML Disease Identifier (DxID) Replacement History Table . . . . . . . . . . . . . . . . 616
FML Disease Identifier (DxID) Search Table . . . . . . . . . . . . . . . . . . . . . . . . . . . 617
FML Disease Identifier (DxID) Status Code Description Table . . . . . . . . . . . . . 618
FML Disease Identifier (DxID) Synonym Table . . . . . . . . . . . . . . . . . . . . . . . . . 619
FML Disease Identifier (DxID) Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 620
FML ICD All Descriptions Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 621
FML ICD Billable Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 622
FML ICD Billable History Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 623
FML ICD Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 624
FML ICD Code Type Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 625
FML ICD Description Source Description Table . . . . . . . . . . . . . . . . . . . . . . . . 626
FML ICD Search Exclusion Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 627
FML ICD Search Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 628
FML ICD Status Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 629
FML Navigation Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 630
FML Synonym Name Type Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . 631
FML Synonym Status Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 632
First Databank Medical Test Lexicon (MTL) 1.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 633
General Information MTL 1.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 634
First Databank Medical Test Lexicon Editorial Policies . . . . . . . . . . . . . . . . . . . . . . 639
MTL Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 641
How to Use the FDB Cross-Reference to LOINC . . . . . . . . . . . . . . . . . . . . . . . 642
Finding Replacement Identifiers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 644
Finding a Synonym Name for a LAB_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 645
Identifying Laboratory Tests in a Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 647
Using MTL with the Drug-Lab Interference Module . . . . . . . . . . . . . . . . . . . . . . 649
MTL ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 650
MTL Analyte Identifier Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 652
MTL External Vocabulary Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 653
MTL External Vocabulary Type Description Table . . . . . . . . . . . . . . . . . . . . . . . 654
MTL First Databank Identifier Type Description Table . . . . . . . . . . . . . . . . . . . . 655
MTL Laboratory Test Identifier (LAB_ID) Replacement History Table . . . . . . . . 656

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 MTL Laboratory Test Identifier (LAB_ID) Status Code Description Table . . . . . 657
MTL Laboratory Test Identifier (LAB_ID) Synonym Identifier Table . . . . . . . . . 658
MTL Laboratory Test Identifier (LAB_ID) Synonym Name Type Description Table .
659
MTL Laboratory Test Identifier (LAB_ID) Synonym Status Description Table . . 660
MTL Laboratory Test Identifier (LAB_ID) Table . . . . . . . . . . . . . . . . . . . . . . . . . 661
MTL Methodology Identifier Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 662
MTL Panel Identifier Replacement History Table . . . . . . . . . . . . . . . . . . . . . . . . 663
MTL Panel Identifier Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 664
MTL Panel ID Status Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . 665
MTL Panel to LAB_ID Association Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 666
MTL Specific Laboratory Test Identifier Table . . . . . . . . . . . . . . . . . . . . . . . . . . 667
MTL Specific Laboratory Test ID Replacement History Table . . . . . . . . . . . . . . 668
MTL Specific Laboratory Test ID Status Code Description Table . . . . . . . . . . . 669
MTL Specimen Identifier Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 670
First Databank Cross-Reference Module (XRF) 1.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . 671
First Databank Cross-Reference Module General Information and Concepts . . . . 672
XRF Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 679
Retrieving a Clinical Quantity for a MEDID . . . . . . . . . . . . . . . . . . . . . . . . . . . . 680
Retrieving NClt codes contained within the NCPDP Quantity Unit of Measure
Terminology Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 687
Cross-Reference Module ERD and Technical Specifications . . . . . . . . . . . . . . . . . 690
Clinical Quantity MEDID Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 692
Clinical Quantity NDC Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 693
Cross-Reference DACN to DAM_AGCSP Table . . . . . . . . . . . . . . . . . . . . . . . . 694
Cross-Reference DAM_AGCSP to HIC_SEQN Table . . . . . . . . . . . . . . . . . . . . 695
Cross-Reference GCDF to NCPDP SCRIPT Quantity Qualifier Table . . . . . . . 696
Cross-Reference MED Dosage Forms to NCPDP SCRIPT Quantity Qualifier Table
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 697
Cross-Reference POEM Dosage Form to NCPDP SCRIPT Quantity Qualifier Table
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 698
Cross-Reference Source Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . 699
NCPDP SCRIPT Quantity Qualifier Master Table . . . . . . . . . . . . . . . . . . . . . . . 700
Daily Product Update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 701
Drug Product Pricing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 703
Drug Product Pricing Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 704
Pricing Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 705
Pricing Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 706
Pricing Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 717
Drug Product Pricing Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 718
Applications Drug Product Pricing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 719
Finding the Price for a Given NDC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 720

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 Finding the Price and Associated Pricing Attributes of an NDC for a Given Price Type
722
Identification of the NADAC Classification for Rate Setting Value that CMS has
Assigned . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 726
Determining Why a Federal Price is $0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 728
Identifying the NDC Deletion Reason . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 731
Drug Product Pricing ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . 733
Currency Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 735
National Drug Code Price Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 736
NDC Deletion Reason Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 737
NDC Price Type Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 739
Price Type Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 740
Pricing Unit of Measure Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 741
Product Price Attribute Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 742
Product Price Attribute Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 743
Product Price Attribute Type Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . 744
Product Price Attribute Value Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . 745
Product Price Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 746
AHFS DI Monographs (AHFS DI) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 747
AHFS DI Monographs General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 748
AHFS DI Monographs Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 750
AHFS DI Monographs ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . 777
AHFS DI Specific to General Monograph Table . . . . . . . . . . . . . . . . . . . . . . . . . . . 778
AHFS Full-Text Monograph Section Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 779
AHFS Full-Text Monograph Text Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 780
AHFS Full-Text Monograph Titles Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 781
Prioritized AHFS DI Monograph GCN_SEQNO Table . . . . . . . . . . . . . . . . . . . . . . 782
Clinical Screening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 783
Dosing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 784
Dosing Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 785
Dosing Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 786
Dosing Inclusion Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 788
Dosing Rule Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 790
Dosing Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 825
DRCM Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 826
Dosage Range Checking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 827
Converting Units During Dosage Range Checking . . . . . . . . . . . . . . . . . . . . . . 863
Performing Dosage Range Checking Using a DxID or ICD Code . . . . . . . . . . . 871
Performing Dosage Range Checking for a Patient with Renal Impairment . . . . 885
Accessing a Renal Adjustment Monograph . . . . . . . . . . . . . . . . . . . . . . . . . . . . 902
Customer-Compiled Warning Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 908
Utilizing FDB Preassembled Warning Messages . . . . . . . . . . . . . . . . . . . . . . . . 928

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 Generating DRCM Warning Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 944
Considerations for Screening Drugs That Have a Frequency of Less Than Once Per
Day Greater Than Once Per Month . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 949
Min-Max Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 952
MMAD, MMGD, MMAR, and MMGR Applications . . . . . . . . . . . . . . . . . . . . . . . 953
PDM Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 966
NEOM Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 980
Performing Dosage Range Checking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 981
Considerations for Using NEOM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1008
DRCM ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1018
Dosing Age Source Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1020
DRCM Age Exclusion Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1021
DRCM Calculation Required Type Code Description Table . . . . . . . . . . . . . . . 1023
DRCM Dose Calculation Code Description Table . . . . . . . . . . . . . . . . . . . . . . . 1024
DRCM Dose Type Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1025
DRCM Dosing Adjustment Type Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1026
DRCM Exclusion Reason Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1027
DRCM Exclusion Status Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1028
DRCM Exclusion Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1029
DRCM Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1030
DRCM Math Process Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . 1033
DRCM Monograph Format Code Description Table . . . . . . . . . . . . . . . . . . . . . 1034
DRCM Monograph Section Code Description Table . . . . . . . . . . . . . . . . . . . . . 1035
DRCM Neonatal and Adult Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1036
DRCM Renal Adjustment Monograph Line Table . . . . . . . . . . . . . . . . . . . . . . . 1039
DRCM Renal Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1040
DRCM Route Conversion Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1043
DRCM Route Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1044
DRCM Severity Level Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1045
DRCM Unit Conversion Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1046
DRCM Unit Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1047
MinMax ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1048
MinMax Dosing Age Source Description Table . . . . . . . . . . . . . . . . . . . . . . . . . 1053
MMAD Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1054
MMAR Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1055
MMGD Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1056
MMGR Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1057
PDM Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1058
PDM Unit Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1060
PDM Weight-Age Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1061
NEOM ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1063
NEOM Calculation Required Type Code Description Table . . . . . . . . . . . . . . . 1064

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 NEOM Dose Calculation Code Description Table . . . . . . . . . . . . . . . . . . . . . . . 1065
NEOM Dose Type Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1066
NEOM Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1067
NEOM Math Process Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . 1070
NEOM Route Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1071
NEOM Route Conversion Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1072
NEOM Unit Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1073
NEOM Unit Conversion Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1074
Drug Alergy Module (DAM) 4.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1075
Drug Allergy Module Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1076
Overview DAM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1077
Definitions DAM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1078
DAM Inclusion Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1081
DAM Data Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1083
DAM Rule Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1087
Maintenance DAM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1093
References DAM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1095
Appendix A: FDB Reported Inactives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1096
Appendix B: Former Potentially Inactive Ingredients Available for Profiling Purposes
Only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1105
DAM Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1108
Drug Allergy Screening Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1109
Screening an NDC for an Ingredient Allergen (Scenario A) . . . . . . . . . . . . . . . . 1112
Screening an NDC for a MED_NAME_ID Allergen (Illustration of Scenario B) . 1117
Screening an NDC for a DAM_ALRGN_GRP Allergen (Illustration of Scenario C) .
1123
Screening a MEDID for an Ingredient Allergen - Illustration of Scenario D . . . . 1129
Customizing the Allergen Pick List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1138
Recording Patient Allergy Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1141
Retrieving a Replacement Specific Allergen Group . . . . . . . . . . . . . . . . . . . . . . 1147
Displaying Inactive Ingredients for a Product . . . . . . . . . . . . . . . . . . . . . . . . . . . 1149
Drug Allergy Module ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . 1151
DAM Allergen Group Cross-Sensitivity Link Table . . . . . . . . . . . . . . . . . . . . . . . 1153
DAM Concept Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1154
DAM Cross-Sensitive Allergen Group Code Description Table . . . . . . . . . . . . . 1155
DAM Cross-Sensitive Allergen Group Code History Table . . . . . . . . . . . . . . . . 1156
DAM Cross-Sensitive Allergen Group Code Status Code Description Table . . 1157
DAM Ingredient Allergen Group Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1158
DAM Ingredient Cross-Sensitivity Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . 1159
DAM Patient Profile Allergen Pick List Table . . . . . . . . . . . . . . . . . . . . . . . . . . . 1160
DAM Pick List Concept ID Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . 1161
DAM Specific Allergen Group Code Description Table . . . . . . . . . . . . . . . . . . . 1162

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 DAM Specific Allergen Group Code History Table . . . . . . . . . . . . . . . . . . . . . . . 1163
DAM Specific Allergen Group Code Status Code Description Table . . . . . . . . . 1164
Drug Allergy Concept Attributes Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1165
Drug Allergy Screening HICL_SEQNO HIC Relation Table . . . . . . . . . . . . . . . . 1166
Drug-Disease Contraindications Module (DDCM) 2.0 . . . . . . . . . . . . . . . . . . . . . . . . . 1167
Drug-Disease Contraindications Module Editorial Policies . . . . . . . . . . . . . . . . . . . 1168
DDCM Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1174
Retrieving a List of Drug Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1175
DDCM Comparing Patient ICD Codes to Prospective Drug Therapy - Using the
Exclusion Table to Reduce Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1178
DDCM Comparing Patient DxIDs to Prospective Drug Therapy . . . . . . . . . . . . 1184
DDCM Checking Inferred Patient Diagnoses for Drug-Disease Contraindications
Associated with Prospective Drug Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1189
DDCM ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1193
DDCM Drug Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1194
DDCM GCN_SEQNO - Drug-Disease Code Relation Table . . . . . . . . . . . . . . . 1195
DDCM Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1196
DDCM Routed Generic Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1197
DDCM Routed Medication Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1198
DDCM Severity Level Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1199
Drug-Lab Interference Module (DLIM ) 2.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1200
Drug-Lab Interference Module Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . 1201
DLIM Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1202
DLIM Inclusion Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1203
DLIM Data Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1207
DLIM Rule Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1214
DLIM Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1216
DLIM References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1217
DLIM Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1218
DLIM Determining the Clinical Review Status of a Drug . . . . . . . . . . . . . . . . . . 1219
DLIM Screening a Drug for Possible Laboratory Test Interferences . . . . . . . . . 1221
Screening a Laboratory Test for Possible Drug Interferences . . . . . . . . . . . . . . 1226
DLIM Displaying an Alternative Laboratory Test Method When an Interference Is
Found . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1230
DLIM Monograph Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1234
DLIM ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1243
DLIM Clinically Reviewed Status Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1245
DLIM Documentation Level Code Description Table . . . . . . . . . . . . . . . . . . . . . 1246
DLIM Drug Group Identifier Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1247
DLIM Drug Identifier Type Code Description Table . . . . . . . . . . . . . . . . . . . . . . 1248
DLIM GCN_SEQNO to Drug Group Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1249
DLIM Interference Type Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . 1250

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 DLIM Laboratory Interference Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . . 1251
DLIM Monograph Identifier Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1252
DLIM Monograph Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1253
DLIM Monograph Text Type Description Table . . . . . . . . . . . . . . . . . . . . . . . . . 1254
DLIM Routed Generic Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1255
DLIM Routed Medication Identifier to Drug Group Table . . . . . . . . . . . . . . . . . . 1256
DLIM Status Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1257
Duplicate Therapy Module (DPT) 1.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1258
Duplicate Therapy Module Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1259
DPT Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1264
DPT Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1265
Detecting Therapeutic Class Duplications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1266
Comparing Duplicate Therapy Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . 1270
Implementing the DPT Duplication Allowance . . . . . . . . . . . . . . . . . . . . . . . . . . 1271
Generating Messages, Warnings, and Reports . . . . . . . . . . . . . . . . . . . . . . . . . 1272
DPT ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1275
DPT Class Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1276
DPT GCN_SEQNO Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1277
DPT Routed Generic Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1278
DPT Routed Medication ID Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1279
Inactive Ingredients Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1280
Indications Module (INDM) 2.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1286
Indications Module Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1287
INDM Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1296
Retrieving a Drug's List of Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1297
Retrieving Drugs Indicated for a Selected Condition - Using the Exclusion Table to
Refine the Treatment Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1301
Checking Inferred Patient Diagnoses for Drug-Disease Contraindications
Associated with Prospective Drug Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1313
Detecting Possible Drug-Related Iatrogenic Diseases . . . . . . . . . . . . . . . . . . . 1317
INDM ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1321
INDM Drug Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1322
INDM GCN_SEQNO Indications Code Relation Table . . . . . . . . . . . . . . . . . . . 1323
INDM Labeled Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1324
INDM Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1325
INDM Predictor Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1326
INDM Routed Generic Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1327
INDM Routed Medication Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1328
Interactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1329
Drug-Drug Interaction Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1330
DDIM General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1331
Drug-Drug Interaction Module Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . 1342

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 DDIM Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1346
DDIM ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1379
Drug-Drug Interaction Module for Consumers DDIM-C . . . . . . . . . . . . . . . . . . . . . 1399
DDIM-C General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1400
Drug-Drug Interaction Module for Consumers Editorial Policies . . . . . . . . . . . . 1404
Application: Displaying Drug-Drug Interaction Messages for Consumers . . . . . 1405
DDIM-C ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1410
Drug-Food Interaction Module (DFIM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1413
DFIM General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1414
Drug-Food Interaction Module Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . 1417
Application: Displaying Drug-Food Interaction Messages . . . . . . . . . . . . . . . . . 1419
DFIM Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1425
Drug-Food Interaction Module for Consumers (DFIM-C) 1.0 . . . . . . . . . . . . . . . . . 1431
General Information DFIM-C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1432
Drug-Food Interaction for Consumers Module Editorial Policies . . . . . . . . . . . . 1435
Application: Displaying Drug-Food Interaction Messages for Consumers . . . . . 1437
DFIM-C ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1445
Intravenous Module (IVM) 1.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1447
General Information IVM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1448
Intravenous Module Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1451
IVM Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1453
IVM Application Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1454
IVM Application Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1456
IVM Programming Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1461
IVM ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1471
GCN_SEQNO Intravenous Module Component Code Relation Table . . . . . . . 1473
Intravenous Module Admixture Component Code Relation Table . . . . . . . . . . . 1474
Intravenous Module Admixture Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . 1475
Intravenous Module Component Description Table . . . . . . . . . . . . . . . . . . . . . . 1476
Intravenous Module Manufacturer Description Table . . . . . . . . . . . . . . . . . . . . 1477
Intravenous Module Remarks Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1478
Intravenous Module Study Group Admixture Relation Table . . . . . . . . . . . . . . . 1479
Intravenous Module Study Group Master Table . . . . . . . . . . . . . . . . . . . . . . . . 1480
Intravenous Module Study Group Test Component Relation Table . . . . . . . . . 1481
Intravenous Module Study Group Test Master Table . . . . . . . . . . . . . . . . . . . . 1482
Intravenous Module Study Group Test Remarks Relation Table . . . . . . . . . . . . 1483
Intravenous Module TPN Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . 1484
Intravenous Module TPN Ingredient Description Table . . . . . . . . . . . . . . . . . . . 1485
Precaution Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1486
Geriatric Precautions Module (GERI) 2.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1487
Geriatric Precautions Module Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . 1488
GERI Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1497

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 GERI ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1507
Lactation Precautions Module (LACT) 1.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1514
Lactation Precautions Module Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . 1515
Lactation Precautions Module Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1528
Lactation Precautions Module ERD and Technical Specifications . . . . . . . . . . . 1534
Pediatric Precautions Module (PEDI) 2.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1542
Pediatric Precautions Module Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . 1543
Application: Screening a Drug for Pediatric Precautions . . . . . . . . . . . . . . . . . . 1552
Pediatric Precautions Module ERD and Technical Specifications . . . . . . . . . . . 1557
Pregnancy Precautions Module (PREG) 2.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1563
Pregnancy Precautions Module Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . 1564
Pregnancy Precautions Module Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . 1578
Pregnancy Precautions Module ERD and Technical Specifications . . . . . . . . . 1588
Side Effects Module (SIDE) 2.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1600
Side Effects Module Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1601
SIDE Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1602
SIDE Inclusion and Exclusion Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1603
SIDE Data Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1605
SIDE Rule Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1608
SIDE Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1610
SIDE Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1611
SIDE Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1612
Retrieving a List of Side Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1613
Detecting Additive Side Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1617
Comparing Side Effects to Current Patient Conditions . . . . . . . . . . . . . . . . . . . 1621
SIDE ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1623
SIDE GCN_SEQNO-Drug Side Effect Code Relation Table . . . . . . . . . . . . . . . 1624
SIDE Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1625
SIDE Routed Generic Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1626
SIDE Routed Medication Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1627
SIDE Side Effects Drug Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1628
Counseling Messages Module (CMM) 1.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1629
Counseling Messages Module Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1630
Applications CMM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1635
Sample Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1636
CMM ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1638
Counseling Message Module French Language Message Text Table . . . . . . . . . . 1640
Counseling Message Module Message Text Table . . . . . . . . . . . . . . . . . . . . . . . . 1641
Counseling Message Module Spanish Language Message Text Table . . . . . . . . . 1642
GCN_SEQNO Counseling Message Module Counseling Message Relation Table . . .
1643
GCN_SEQNO Counseling Message Module French Language Counseling Message

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 Relation Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1644
GCN_SEQNO Counseling Message Module Spanish Language Counseling Message
Relation Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1645
Drug Images Module 2.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1646
Drug Images General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1647
Drug Images Module Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1649
Drug Images Module Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1650
Displaying and|or Printing Images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1651
Placing Images on Patient Education Monographs . . . . . . . . . . . . . . . . . . . . . . . . . 1653
Using Images in Interactive Computer Applications . . . . . . . . . . . . . . . . . . . . . . . . 1656
Drug Images Module ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . 1658
Image Drug Manufacturer Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1659
Image Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1660
Image Unique Drug Image Journal Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1661
Image Unique Drug Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1662
Drug Imprints Module 2.1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1663
General Information Drug Imprints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1664
Drug Imprints Module Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1668
Drug Imprints ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1671
Imprint Basic Descriptor Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1673
Imprint Descriptor Category Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1674
Imprint Descriptor Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1675
Imprint Dosage Form Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1676
Imprint Drug Manufacturer Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1677
Imprint Property Descriptor Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1678
Imprint Property Imprint Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1679
Imprint Property Text Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1680
Imprint Text Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1681
Imprint Unique Drug Imprint Image Journal Table . . . . . . . . . . . . . . . . . . . . . . . . . 1682
Imprint Unique Drug Imprint Journal Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1683
Imprint Unique Drug Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1684
FDB High Risk Medication Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1685
FDB High Risk Medication Module Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . 1686
High Risk Medication Module Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1687
High Risk Medication Module Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1689
Inclusion Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1691
Data Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1696
Rule Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1700
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1704
High Risk Medication Module Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1706
High Risk Medication Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1707
Determining Whether a Given Drug has a REMS . . . . . . . . . . . . . . . . . . . . . . . . . . 1708

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 Displaying All REMS Related Actions for a Given Drug . . . . . . . . . . . . . . . . . . . . . 1710
Retrieving REMS Content for a Given Drug at the Time of Dispensing . . . . . . . . . 1715
Displaying Historical Information for a Replaced REMS . . . . . . . . . . . . . . . . . . . . . 1722
Displaying All Boxed Warning (BXW) Content for a Given Drug . . . . . . . . . . . . . . . 1724
High Risk Medication Module ERD and Technical Specifications . . . . . . . . . . . . . . . . 1741
Clinical Formulation to Risk Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1743
MEDID to Risk Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1744
NDC to Risk Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1745
Orderable Med to Risk Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1746
Risk Action Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1747
Risk Actor Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1748
Risk Additional Text Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1749
Risk Category (BXW) Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1750
Risk Infobyte (BXW) Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1751
Risk Infobyte (BXW) Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1752
Risk Infobyte (BXW) Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1753
Risk Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1754
Risk Med Cycle Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1755
Risk Mitigation (REMS) Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1756
Risk Monograph Format Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1757
Risk Monograph Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1758
Risk Monograph Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1759
Risk Monograph Type Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1760
Risk Previous-Replacement Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1761
Risk Status Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1762
Risk Type Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1763
Routed Generic to Risk Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1764
Routed Med to Risk Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1765
FDB Interoperability Module 1.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1766
FDB Interoperability Module Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1767
Interoperability Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1768
Interoperability Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1771
Interoperability Inclusion Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1780
Interoperability Data Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1795
Interoperability Rule Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1806
Interoperability Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1820
Interoperability Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1823
Interoperability Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1824
General Interoperability Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1826
Considerations When Implementing RxNorm Vocabulary Data . . . . . . . . . . . . 1827
Retrieving the Description Text of the Source Identifiers . . . . . . . . . . . . . . . . . . 1828
Medication Interoperability Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1829

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 Retrieving External Vocabulary Identifiers for a Given FDB Concept . . . . . . . . 1830
Retrieving a Single RxNorm Vocabulary Identifier for a Given NDC . . . . . . . . . 1832
Retrieving FDB Identifiers for an RxNorm Vocabulary Identifier . . . . . . . . . . . . 1834
Retrieving Description Text for the External Vocabulary and Vocabulary Type
Identifiers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1837
Retrieving RxNorm Ingredients for a Generically Named MED Medication Name ID
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1839
Selecting RXCUIs for Outbound e-Prescriptions . . . . . . . . . . . . . . . . . . . . . . . . 1842
Retrieving RxNorm Vocabulary Identifiers for a Replaced MEDID . . . . . . . . . . 1844
Retrieving RxNorm Vocabulary Identifiers for an Unassociated MEDID . . . . . . 1847
Retrieving a Replaced RXCUIs Replacement Value . . . . . . . . . . . . . . . . . . . . . 1852
Clinical Screening Interoperability Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1853
Finding Tall Man Descriptions for FDB Concepts Retrieved from RxNorm
Vocabulary Identifiers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1854
Using a Tall Man Description in a Continuity of Care Document-CCD . . . . . . . 1857
Finding Additional Synonyms for an RxNorm Semantic Branded Drug-SBD . . 1860
Retrieving FDB Concepts for a Given Externally Reported RxNorm-based
Medication Concept . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1861
Immunization Interoperability Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1877
Retrieving CVX Code Identifiers for a Given FDB Concept . . . . . . . . . . . . . . . . 1878
Retrieving CVX and MVX Codes Associated to an NDC for Registry Transmission
1886
Retrieving Note Text for a CVX Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1889
Submitting a Manufacturer for a Repackaged NDC to an Immunization Registry . .
1891
Allergen Interoperability Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1893
Navigating from a UNII Code to an Associated Ingredient . . . . . . . . . . . . . . . . 1894
Retrieving an External Allergen Interoperable Concept for a Given FDB Allergen
Concept . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1898
Retrieving FDB Allergen Interoperable Concepts for a Given External Allergen
Concept . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1902
Retrieving an HL7 Object Identifier (OID) for a Given Interoperable Concept Type
1905
Documenting Food or Environmental Allergies Using SNOMED CT Concepts . 1908
Problem|Reaction (SNOMED) Interoperability Applications . . . . . . . . . . . . . . . . . . 1916
Retrieving an Active SNOMED CT Clinical Finding Using the Term Description Field
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1917
Retrieving an Active SNOMED CT Description for a Given SNOMED CT Concept
Identifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1919
Retrieving an Active SNOMED CT Description for a Given SNOMED CT
Description Identifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1921
Retrieving Active Child SNOMED CT Concept Identifiers . . . . . . . . . . . . . . . . . 1922

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 Retrieving Active Parent SNOMED CT Concept Identifiers . . . . . . . . . . . . . . . . 1924
Retrieving a Single Description for a SNOMED CT Concept Identifier . . . . . . . 1926
Retrieving a SNOMED CT Concept Identifiers Associated DXIDs . . . . . . . . . . 1929
Clinical Quality Measures (CQM) Value Set Applications . . . . . . . . . . . . . . . . . . . . 1931
Presenting RXCUI Changes for Clinical Quality Measures . . . . . . . . . . . . . . . . 1932
Structured & Codified Sig Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1934
Retrieving an External Interoperable Concept for a Given FDB Interoperable
Concept . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1935
Retrieving an External HL7 Concept for a Given Frequency and Interval ID . . . 1938
Retrieving a UCUM Code for a Given FDB Master Unit of Measure Identifier . . 1941
Interoperability ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1943
Clinical Module Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1949
CPT to CVX Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1950
CVX to MVX Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1951
CVX Usage Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1952
DXID to SNOMED CT Best Fit History Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1953
DXID to SNOMED CT Best Fit Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1954
External Allergen to FDB Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1955
External Vocabulary CVX Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1956
External Vocabulary Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1957
External Vocabulary Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1958
External Vocabulary Link Type Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . 1959
External Vocabulary MVX Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1960
External Vocabulary Note Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1961
FDB to External Allergen Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1962
HL7 Standard Code Set CVX-VIS Mapping Table . . . . . . . . . . . . . . . . . . . . . . . . . 1963
HL7 Standard Code Set Mapping CVX to Vaccine Groups Table . . . . . . . . . . . . . 1964
IMK Status Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1965
Master FDB Unit of Measure to UCUM Link Table . . . . . . . . . . . . . . . . . . . . . . . . . 1966
Navigation Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1967
NDC to CVX-MVX Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1968
NLM SNOMED CT Concept Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1970
NLM SNOMED CT Concept Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1971
NLM SNOMED CT Language Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1972
NLM SNOMED CT Relationship Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1973
RXCUI Ultimate Replacement Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1974
RxNorm Concept Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1975
RxNorm Concept Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1976
RxNorm Concept Source Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1977
RxNorm to FDB Clinical Screening Exception Table . . . . . . . . . . . . . . . . . . . . . . . 1978
RxNorm to FDB Clinical Screening Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1979
SIG FDB to External Vocabulary Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1980

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 SIG Frequency Interval Event Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1981
SIG Frequency Interval Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1982
SNOMED CT Concept Type Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1983
SNOMED CT to DXID Search Exclusion History Table . . . . . . . . . . . . . . . . . . . . . 1984
SNOMED CT to DXID Search Exclusion Table . . . . . . . . . . . . . . . . . . . . . . . . . . . 1985
SNOMED CT to DXID Search History Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1986
SNOMED CT to DXID Search Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1987
SNOMED CT to FDB Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1988
SNOMED CT Type Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1989
SNOMED CT Value Set Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1990
SNOMED CT Value Set Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1991
Source Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1992
USHIK History Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1993
USHIK Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1995
Vaccine Information Statement (VIS) Lookup Table . . . . . . . . . . . . . . . . . . . . . . . . 1997
Vocabulary Data Version Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1998
Vocabulary Replacement History Description Table . . . . . . . . . . . . . . . . . . . . . . . . 1999
Vocabulary Replacement History Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2000
Vocabulary Type Definition Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2001
Vocabulary Type to HL7 OID Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2002
FDB State and Federal Controlled Substances Module . . . . . . . . . . . . . . . . . . . . . . . . . . 2003
FDB State and Federal Controlled Substance Module Editorial Policies . . . . . . . . . . . 2004
SFCSM Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2005
SFCSM Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2006
SFCSM Data Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2008
SFCSM Inclusion Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2020
SFCSM Rule Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2021
SFCSM Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2023
SFCSM Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2024
SFCSM Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2025
Finding the More Restrictive State or Federal Narcotic or Non-Narcotic Schedule for an
NDC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2026
Finding the State Schedule for an NDC that is Not Federally Controlled . . . . . . . . 2029
Finding the NCPDP SCRIPT 10.6 DEA Code for an EPCS Transaction . . . . . . . . 2031
Identifying the NDCs That Require Reporting to a PDMP . . . . . . . . . . . . . . . . . . . . 2033
Finding the More Restrictive State or Federal Schedule for an NDC . . . . . . . . . . . 2034
Finding the More Restrictive State or Federal Schedule for a Controlled Substance
Concept . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2038
Finding the State Schedule for a Controlled Substance Concept that is Not Federally
Controlled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2042
Identifying the Controlled Substance Concepts That Require Reporting to a PDMP . .
2045

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 Identifying Controlled Substance Concepts with Multiple Values from Related NDCs .
2047
Finding the More Restrictive State of Federal Narcotic or Non-Narcotic Schedule for a
Concept . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2052
State and Federal Controlled Substances Module ERD and Technical Specifications 2057
Controlled Substance Attribute Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . 2059
Controlled Substance Attribute Type Description Table . . . . . . . . . . . . . . . . . . . . . 2060
Controlled Substance Attribute Value Description Table . . . . . . . . . . . . . . . . . . . . . 2061
Controlled Substance Concept Source Description Table . . . . . . . . . . . . . . . . . . . 2062
Controlled Substance Concept Type Description Table . . . . . . . . . . . . . . . . . . . . . 2063
Controlled Substance Drug Concept (MEDID or RXCUI) Attribute Table . . . . . . . . 2064
Controlled Substance NDC Attribute Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2065
Controlled Substance Schedule to NCPDP SCRIPT DEA Code Link Table . . . . . . 2066
Federal Controlled Substance Drug Concept (MEDID or RXCUI) Link Table . . . . . 2067
Federal Controlled Substance NDC Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2068
NCPDP SCRIPT DEA Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2069
State and Territory Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2070
State Controlled Substance Difference Code Description Table . . . . . . . . . . . . . . . 2071
State Controlled Substance Difference Code Drug Concept (MEDID or RXCUI) Table
2072
State Controlled Substance Difference Code NDC History Table . . . . . . . . . . . . . . 2073
State Controlled Substance Difference Code NDC Table . . . . . . . . . . . . . . . . . . . . 2074
State Controlled Substance Drug Concept (MEDID or RXCUI) Attribute Table . . . 2075
State Controlled Substance Drug Concept (MEDID or RXCUI) Link Table . . . . . . . 2076
State Controlled Substance NDC Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2077
State PDMP Drug Concept (MEDID or RXCUI) Attribute Table . . . . . . . . . . . . . . . 2078
State PDMP Drug Concept (MEDID or RXCUI) Link Table . . . . . . . . . . . . . . . . . . . 2079
State PDMP Drug Source Concept (MEDID or RXCUI) Table . . . . . . . . . . . . . . . . 2080
State PDMP Drug Source Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2081
State PDMP Drug Source NDC Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2082
State PDMP List Type Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2083
State PDMP NDC Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2084
Medicaid Module 1.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2085
Medicaid Module General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2086
Medicaid Module ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . 2091
Federal Financing Participation Data Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2092
Medicaid Copay Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2093
Medicaid Coverage Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2094
Medicaid Data Price Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2095
Medicaid Data Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2096
Medicaid Maximum Quantity Code Description Table . . . . . . . . . . . . . . . . . . . . . . 2099
Medicaid Minimum Quantity Code Description Table . . . . . . . . . . . . . . . . . . . . . . . 2100

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 Medicaid Prior Authorization Code Description Table . . . . . . . . . . . . . . . . . . . . . . . 2101
Medicaid Refill Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2102
Medicare Module-HCPCS Select . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2103
Medicare Module - HCPCS Select Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . 2104
Medicare Module-HCPCS Select Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2105
Medicare Module-HCPCS Select Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2107
Medicare Module-HCPCS Select-Medicare Concepts . . . . . . . . . . . . . . . . . . . . . . 2110
Medicare Module-HCPCS Select Inclusion Criteria . . . . . . . . . . . . . . . . . . . . . . . . 2113
Medicare Module-HCPCS Select Data Elements . . . . . . . . . . . . . . . . . . . . . . . . . . 2117
Medicare Module-HCPCS Select Rule Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2118
Medicare Module-HCPCS Select Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2121
Medicare Module-HCPCS Select Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2123
Medicare Module-HCPCS Select Medicare Part B Applications . . . . . . . . . . . . . . . . . 2124
Retrieving Candidate HCPCS Codes for an NDC . . . . . . . . . . . . . . . . . . . . . . . . . . 2125
Retrieving Information About a HCPCS Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2126
Retrieving the Description of an HCPCS Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2128
Retrieving the Current Part B Price for an NDC . . . . . . . . . . . . . . . . . . . . . . . . . . . 2129
Retrieving a Historical Part B Price for an NDC . . . . . . . . . . . . . . . . . . . . . . . . . . . 2131
Retrieving Current or Previous NOC Pricing for an NDC . . . . . . . . . . . . . . . . . . . . 2133
Retrieving an NDC Linked to a HCPCS Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2135
Medicare Module-HCPCS Select ERD and Technical Specifications . . . . . . . . . . . . . 2137
Medicare Coverage Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2138
Medicare HCPC Part B Price Data File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2139
Medicare Region Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2141
Medicare Region Reference Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2142
FDB Medicare Part D Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2143
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2144
FDB Medicare Part D Module Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2146
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2147
Concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2148
FDB Medicare Part D Data Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2153
FDB Medicare Part D Module Additional Editorial Policies . . . . . . . . . . . . . . . . . . . 2155
FDB Medicare Part D Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2162
Determining Claim Eligibility Using Specific NDC SPL NSDE Attributes . . . . . . . . 2163
Determining the Acetaminophen Quantity Contained in One Dosage Unit . . . . . . . 2165
Determining the Morphine Equivalent Strength in Milligrams Contained in One Dosage
Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2167
Identifying NDCs that Should Adhere to the CMS Short Cycle Dispensing Rules . 2169
Identifying Concepts for CMS Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2170
Identifying Medication Therapy Management Categories for NDCs on a Patient Claim
History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2179
Identifying CMS Concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2180

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 Identifying NDCs for Screening Opioid and Concurrent Drug Therapy Risk . . . . . . 2185
FDB Medicare Part D Module ERD and Technical Specifications . . . . . . . . . . . . . . . . 2187
First Databank Inclusion Reason Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2190
Medicare FDB Product ID Measure Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2191
Medicare FDB Product ID Product Attribute Table . . . . . . . . . . . . . . . . . . . . . . . . . 2192
Medicare Measure Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2193
Medicare Measure Timeframe Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2194
Medicare NDC Product Attribute Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2195
Medicare NDC Product Measure Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2196
Medicare Product Attribute Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2197
Medicare Product Attribute Type Description Table . . . . . . . . . . . . . . . . . . . . . . . . 2198
Medicare Product Attribute Value Description Table . . . . . . . . . . . . . . . . . . . . . . . . 2199
Patient Education Module (PEM) 2.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2200
Patient Education Module Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2201
PEM Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2211
Displaying the Patient Education Standard Monograph . . . . . . . . . . . . . . . . . . . . . 2212
Displaying the ASHP MedTeach Monograph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2217
Implementing a PEM-XML Stylesheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2228
Changing Icons in the PEM-XML Icon Monograph Stylesheet . . . . . . . . . . . . . . . . 2229
PEM ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2230
GCN_SEQNO-Patient Education Code Relation Table . . . . . . . . . . . . . . . . . . . . . 2232
GCN_SEQNO-Patient Education French Monograph Code Relation Table . . . . . . 2233
GCN_SEQNO-Patient Education Monograph Code Relation Table . . . . . . . . . . . . 2234
GCN_SEQN-Patient Education Spanish Monograph Code Relation Table . . . . . . 2235
Patient Education (ASHP MedTeach) Monograph Text Table . . . . . . . . . . . . . . . . 2236
Patient Education French Language Standard Monograph Text Table . . . . . . . . . 2237
Patient Education Master Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2238
Patient Education Spanish Language Standard Monograph Text Table . . . . . . . . 2240
Patient Education Standard Monograph Text U.S. Brand Names Table . . . . . . . . 2241
PEM French Mono Routed Generic Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2242
PEM Mono Routed Generic Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2243
PEM Routed Generic Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2244
PEM Spanish Mono Routed Generic Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2245
Prescriber Order Entry Module (POEM) 2.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2246
General Information POEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2247
Prescriber Order Entry Module Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2269
POEM Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2274
Retrieving Default Dosage Order String Text . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2275
Retrieving Dosage Order String Text . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2277
Creating Custom Dosage Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2281
Calculating Prescription Quantity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2290
Retrieving Dosage Orders for Related Disease States . . . . . . . . . . . . . . . . . . . . . . 2307

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 POEM ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2312
Dosage Form Master to POEM Dosage Form Link Table . . . . . . . . . . . . . . . . . . . . 2314
POEM Administration Rate Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2315
POEM Calculation Required Type Code Description Table . . . . . . . . . . . . . . . . . . 2316
POEM Clinical Context Type Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . 2317
POEM Clinical Context Value Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . 2318
POEM Code Definition Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2319
POEM Context Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2320
POEM Country Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2321
POEM Dose Type Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2322
POEM GCN_SEQNO POEM Source Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2323
POEM GCN_SEQNO Standard Order Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2324
POEM Language Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2325
POEM Order Set Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2326
POEM Order String Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2327
POEM Order String to Text Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2329
POEM Route Description Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . 2330
POEM Text String Location Code Description Table . . . . . . . . . . . . . . . . . . . . . . . 2331
POEM Text Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2332
POEM Text Type Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2333
POEM Unit Code Type Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2334
Prioritized Label Warnings Module (LBLW) 1.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2335
General Information LBLW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2336
Prioritized Label Warnings Module Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . 2339
Applications LBLW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2340
Considerations for Using Prioritized Label Warnings . . . . . . . . . . . . . . . . . . . . . . . 2341
Retrieving Prioritized Label Warnings for a Drug . . . . . . . . . . . . . . . . . . . . . . . . . . 2342
Prioritized Label Warnings ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . 2343
French Prioritized Label Warning Code Description Table . . . . . . . . . . . . . . . . . . . 2344
GCN_SEQNO Prioritized Label Warning Code Relation Table . . . . . . . . . . . . . . . 2345
Prioritized Label Warning Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . 2346
Prioritized Label Warning Vendor Description Table . . . . . . . . . . . . . . . . . . . . . . . . 2347
Prioritized Label Warning Vendor Type Relation Table . . . . . . . . . . . . . . . . . . . . . 2348
Spanish Prioritized Label Warning Code Description Table . . . . . . . . . . . . . . . . . . 2349
MedGuides Module 1.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2350
MedGuides Module Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2351
Applications MedGuides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2357
Retrieving a PDF MedGuide for a Prescribed Packaged Product . . . . . . . . . . . . . . 2358
Retrieving an XML MedGuide for a Prescribed Packaged Product . . . . . . . . . . . . 2360
MedGuides ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2362
NDC to PDF MedGuides Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2363
NDC to XML MedGuides Link Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2364

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 Therapeutic Classification Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2365
First Databank Enhanced Therapeutic Classification System (ETC) 1.0 . . . . . . . . . . . 2366
First Databank Enhanced Therapeutic Classification System Editorial Policies . . . 2367
ETC Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2374
Building a Formulary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2375
Presenting Product Substitution Candidates . . . . . . . . . . . . . . . . . . . . . . . . . . . 2382
Performing Comparative Product Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2386
Reporting Ingredient-Based Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2388
Displaying or Selecting the Default ETC Class from Various Drug Concept Levels
2390
ETC ERD and Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2395
ETC Change Type Code Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2397
ETC HIC3 to ETC Cross Reference Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2398
ETC Search Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2399
ETC Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2400
ETC to GCN_SEQNO Assignment Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2403
ETC to GCN_SEQNO Change History Table . . . . . . . . . . . . . . . . . . . . . . . . . . 2404
ETC to HIC_SEQN Assignment History Table . . . . . . . . . . . . . . . . . . . . . . . . . . 2406
ETC to HIC_SEQN Assignment Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2407
ETC to HICL_SEQNO Assignment History Table . . . . . . . . . . . . . . . . . . . . . . . 2408
ETC to HICL_SEQNO Assignment Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2409
ETC to MedID Assignment Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2410
ETC to MedID Change History Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2411
ETC to Med Name ID Assignment History Table . . . . . . . . . . . . . . . . . . . . . . . . 2413
ETC to Med Name ID Assignment Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2414
ETC to NDC Assignment Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2415
ETC to NDC Change History Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2416
Therapeutic Classification Data ERD and Technical Specifications . . . . . . . . . . . . . . . 2418
AHFS Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2420
ATC Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2421
GCN_SEQNO AHFS Code Relation Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2422
GCN_SEQNO ATC Relation Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2423
Generic Therapeutic Class Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2424
Hierarchical Ingredient Code Specific Therapeutic Class Table . . . . . . . . . . . . . . . 2425
Standard Therapeutic Class Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2426
Universal System of Classification (USC) 1.0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2427
USC Description Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2428
USC GCN_SEQNO Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2429
USC NDC Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2430
Herbal Products Inclusion List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2431
Legacy Versions of Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2434
DRCM Neonatal and Adult Master Table v1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2435

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 Ingredient List Identifier Description Table v1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2438
Legacy Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2439
Pregnancy Precautions Module 1.0 Editorial Policies . . . . . . . . . . . . . . . . . . . . . . . . . 2440
Data Dictionary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2448
A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2450
ACTIVELY_USED_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2452
AD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2453
ADI_EFFTC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2454
ADI_EFFTXT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2455
ADI_MONOSN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2456
AHFS8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2461
AHFS_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2462
AHFS_GENM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2463
AHFS_MONO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2464
AHFS_MONOT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2465
AHFS_PAN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2466
AHFS_PNA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2467
AHFS_REL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2468
AHFS_SECT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2469
AHFS_SECTL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2470
AHFS_SECTT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2471
AHFS_SPECM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2472
AHFS_TEXT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2473
AHFS_TEXTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2474
ALT_STR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2475
ALT_STR_UOM_MSTR_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2476
ALT_STRENGTH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2477
ALT_STRENGTH_TYP_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2478
ALT_STRENGTH_UOM_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2479
AMACDE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2480
ANDA_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2481
APPL_NBR1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2482
APPL_NBR2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2483
APPL_NO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2484
APPL_RELATION_END_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2485
APPL_RELATION_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2486
APPL_RELATION_START_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2487
APPL_RELATION_TYPE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2488
APPL_RELATION_TYPE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2489
APPL_TYPE_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2490
APPL_TYPE_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2491
APPL_TYPE_ID1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2492

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 APPL_TYPE_ID2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2493
ASHPCDE3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2494
ASHPCDE_SN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2496
ATC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2498
ATC_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2499
ATC_VER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2500
ATTRIBUTE_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2501
ATTRIBUTE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2502
ATTRIBUTE_GROUP_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2503
ATTRIBUTE_SN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2504
ATTRIBUTE_TYPE_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2505
ATTRIBUTE_TYPE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2506
ATTRIBUTE_TYPE_LENGTH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2507
ATTRIBUTE_TYPE_PRECISION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2508
ATTRIBUTE_VALUE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2509
ATTRIBUTE_VALUE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2510
AVAILABLE_PRECAUTION_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2511
B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2512
BBDC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2513
BN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2514
BROADER_DXID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2515
C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2516
CAS9_TBL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2519
CDC_CVX_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2521
CDC_CVX_VACCINE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2522
CDC_DATA_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2523
CDC_SHORT_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2524
CDC_UNCERTAIN_FORM_CVX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2525
CDC_VACCINE_GROUP_NAME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2526
CDC_VACCINE_STATUS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2527
CDC_VIS_DOCUMENT_NAME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2528
CDC_VIS_DOCUMENT_TYPE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2529
CDC_VIS_EDITION_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2530
CDC_VIS_EDITION_STATUS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2531
CDC_VIS_FULLY_ENCODED_TEXT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2532
CDC_VIS_GDTI_DOCUMENT_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2533
CDC_VIS_LAST_UPDATED_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2534
CL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2535
CLIN_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2536
CLIN_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2537
CLIN_DRUG_GROUP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2538
CLIN_DRUG_GRP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2539

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 CLINICAL_RT_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2540
CLNQTY_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2541
CLNQTY_PKG_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2542
CLNQTY_SUBUNIT_QTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2543
CLNQTY_SUBUOM_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2544
CMMC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2545
CMMC_RN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2547
CMMCF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2549
CMMCS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2550
CMPAT1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2553
CMPAT2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2555
CMRPH1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2557
CMRPH2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2558
CMS_REPORTING_YEAR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2559
COADMIN_DOSING_TEXT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2560
COMPARISON_UOM_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2561
CONCEPT_FEDERAL_CS_END_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2562
CONCEPT_FEDERAL_CS_START_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2563
CONCEPT_STATE_CS_END_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2564
CONCEPT_STATE_CS_START_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2565
CONCEPT_STATE_PDMP_END_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2566
CONCEPT_STATE_PDMP_START_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2567
CONTINUOUS_RT_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2568
CS_ATTRIBUTE_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2569
CS_ATTRIBUTE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2570
CS_ATTRIBUTE_GROUP_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2571
CS_ATTRIBUTE_SN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2572
CS_ATTRIBUTE_TYPE_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2573
CS_ATTRIBUTE_TYPE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2574
CS_ATTRIBUTE_TYPE_LENGTH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2575
CS_ATTRIBUTE_TYPE_PRECISION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2576
CS_ATTRIBUTE_VALUE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2577
CS_ATTRIBUTE_VALUE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2579
CS_ATTRIBUTE_VALUE_SN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2581
CS_CONCEPT_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2582
CS_CONCEPT_SOURCE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2583
CS_CONCEPT_SOURCE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2584
CS_CONCEPT_TYPE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2585
CS_CONCEPT_TYPE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2586
CSP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2587
CURR_MEDID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2588
CURR_MEDID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2589

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 CURR_MEDID_NAME_SOURCE_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2590
CURR_MEDID_NEW_STATUS_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2591
CURR_MEDID_OLD_STATUS_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2592
CURRENCY_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2593
CURRENCY_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2594
D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2595
DACN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2601
DADDNC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2603
DAM_AGCSP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2604
DAM_ALRGN_GRP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2605
DAM_ALRGN_GRP_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2607
DAM_ALRGN_GRP_REPL_EFF_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2608
DAM_ALRGN_GRP_STATUS_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2609
DAM_ALRGN_GRP_STATUS_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2610
DAM_ALRGN_HIC_SEQN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2611
DAM_ALRGN_XSENSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2612
DAM_ALRGN_XSENSE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2614
DAM_ALRGN_XSENSE_REPL_EFF_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2615
DAM_ALRGN_XSENSE_STATUS_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2616
DAM_ALRGN_XSENSE_STATUS_CD_DSC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2617
DAM_CONCEPT_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2618
DAM_CONCEPT_ID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2619
DAM_CONCEPT_ID_TYP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2620
DAM_CONCEPT_ID_TYP_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2621
DAM_CONCEPT_STATUS_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2622
DAM_CONCEPT_STATUS_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2623
DAM_ENVIRON_AGENT_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2624
DAM_FOOD_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2625
DAM_GRP_POTENTIALLY_INACTV_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2626
DAM_MED_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2627
DAM_NON_ALRGN_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2628
DAM_PICKLIST_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2629
DAM_XSENSE_POTENTIAL_INCTV_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2630
DCC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2631
DCC_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2633
DCNV_CNVF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2635
DCNV_MTHI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2636
DCNV_MTHI_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2637
DCNV_PUI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2638
DDC_MONOSN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2639
DDC_SEVSN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2644
DDC_SEVTXT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2645

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 DDI_ABSI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2646
DDI_AGD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2647
DDI_AGSN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2649
DDI_CASEI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2651
DDI_CODEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2652
DDI_DC_DAYS_SCREEN_AMOUNT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2654
DDI_DES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2655
DDI_DISPLAY_ACTION_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2656
DDI_DISPLAY_ACTION_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2657
DDI_EXCEPT_ADD_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2658
DDI_IVASI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2659
DDI_MFGI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2660
DDI_MONOX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2661
DDI_NDC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2666
DDI_NDC_HICSEQN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2667
DDI_PGEDI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2668
DDI_PHARMACODYNAMIC_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2669
DDI_PHARMACOKINETIC_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2670
DDI_REVI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2671
DDI_SL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2672
DDI_SLSN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2673
DDI_SLTXT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2674
DDI_TREE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2675
DDI_TRIALI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2676
DDXCN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2677
DDXCN_DRUG_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2680
DDXCN_REF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2681
DDXCN_SL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2682
DDXCN_SL_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2683
DDXCN_SN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2684
DEA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2686
DES2DTEC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2687
DESDTEC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2688
DESI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2689
DESI2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2690
DF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2691
DGNAME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2692
DISC_RT_ADMIN_TEXT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2693
DISC_RT_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2694
DLIM_DOC_LEVEL_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2695
DLIM_DOC_LEVEL_CODE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2696
DLIM_DRUG_GRP_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2697

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 DLIM_DRUG_GRP_ID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2699
DLIM_DRUG_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2700
DLIM_DRUG_ID_TYP_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2701
DLIM_DRUG_ID_TYP_CODE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2702
DLIM_INTER_TYP_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2703
DLIM_INTER_TYP_CODE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2704
DLIM_MONOGRAPH_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2705
DLIM_MONOGRAPH_TITLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2706
DLIM_STATUS_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2707
DLIM_STATUS_CODE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2708
DLIM_TEXT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2709
DLIM_TEXT_SEQNO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2710
DLIM_TXT_TYP_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2711
DLIM_TXT_TYP_CODE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2712
DNAME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2713
DOSAGE_FORM_ATTRIBUTE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2714
DOSAGE_FORM_ATTRIBUTE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2715
DOSAGE_FORM_DESC_LONG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2716
DOSAGE_FORM_DESC_SHORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2717
DOSAGE_FORM_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2718
DOSAGE_FORM_RETIRE_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2719
DOSAGE_FORM_TYPE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2720
DOSAGE_FORM_TYPE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2721
DOSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2722
DOSE_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2724
DOSING_ADJ_TYPE_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2725
DOSING_ADJ_TYPE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2726
DOSING_AGE_SOURCE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2727
DOSING_AGE_SOURCE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2728
DOSING_MODULE_UNIT_ABBREV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2729
DOSTPI_DES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2731
DPT_ALLOWANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2732
DPT_CLASS_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2733
DPT_CLASS_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2734
DPU_LN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2736
DPU_REPNDC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2737
DR2_CRCLTH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2738
DR2_CRCLU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2739
DR2_DOSTPI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2740
DR2_HEPIMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2741
DR2_HIAGED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2742
DR2_HIDOSD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2743

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 DR2_HIDOSU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2744
DR2_HIDOTX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2745
DR2_HIFREQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2746
DR2_LOAGED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2747
DR2_LODOSD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2748
DR2_LODOSU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2749
DR2_LODOTX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2750
DR2_LOFREQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2751
DR2_MX1DOS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2752
DR2_MX1DSU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2753
DR2_MXDOSD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2755
DR2_MXDOSU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2756
DR2_MXDOTX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2758
DR2_MXLIFD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2759
DR2_MXLIFU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2760
DR2_RENIMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2761
DR2_RT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2762
DR2_SL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2764
DR2_SL_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2765
DR2_SL_MESSAGE_TEXT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2766
DR2_THAFHI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2767
DR2_THAFLO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2768
DR2_THAFU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2769
DR2_UNITS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2770
DRC_MONO_FORMAT_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2772
DRC_MONO_FORMAT_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2773
DRC_MONO_SECTION_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2774
DRC_MONO_SECTION_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2775
DRCM_SCREEN_RT_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2776
DUPDC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2777
DXID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2778
DXID_DESC56 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2780
DXID_DESC100 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2781
DXID_DISEASE_DURATION_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2782
DXID_DISEASE_DURATION_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2783
DXID_STATUS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2784
DXID_STATUS_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2785
DXID_SYN_DESC56 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2786
DXID_SYN_DESC100 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2787
DXID_SYN_NMTYP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2788
DXID_SYN_NMTYP_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2789
DXID_SYN_STATUS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2790

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 DXID_SYN_STATUS_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2791
DXID_SYNID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2792
E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2793
ERX_QTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2797
ERX_SCRIPT_POTUNIT_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2798
ERX_SCRIPT_UOM_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2799
ETC_CHANGE_TYPE_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2801
ETC_CHANGE_TYPE_CODE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2802
ETC_COMMON_USE_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2803
ETC_DEFAULT_USE_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2804
ETC_DRUG_CONCEPT_LINK_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2805
ETC_EFFECTIVE_DATE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2806
ETC_FORMULARY_LEVEL_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2807
ETC_HIERARCHY_LEVEL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2808
ETC_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2809
ETC_NAME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2811
ETC_PARENT_ETC_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2813
ETC_PRESENTATION_SEQNO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2814
ETC_PRODUCT_RELATED_ETC_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2815
ETC_RETIRED_DATE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2816
ETC_RETIRED_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2817
ETC_REVISION_SEQNO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2818
ETC_SEARCH_ETC_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2819
ETC_SORT_NUMBER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2820
ETC_ULTIMATE_CHILD_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2821
ETC_ULTIMATE_PARENT_ETC_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2822
EVD_CPT_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2823
EVD_CPT_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2824
EVD_CPT_CVX_LAST_UPDATE_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2825
EVD_CPT_CVX_NOTE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2826
EVD_CPT_STATUS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2827
EVD_CVX_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2828
EVD_CVX_CD_ADD_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2829
EVD_CVX_CD_DESC_LONG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2830
EVD_CVX_CD_DESC_SHORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2831
EVD_CVX_CD_NONVACCINE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2832
EVD_CVX_CD_OBS_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2833
EVD_CVX_CD_USAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2834
EVD_CVX_CD_USAGE_DESC_LONG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2836
EVD_CVX_CD_USAGE_DESC_SHORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2837
EVD_CVX_CODE_STATUS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2838
EVD_CVX_LAST_UPDATE_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2839

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 EVD_DATA_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2840
EVD_DATA_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2841
EVD_DATA_VERSION_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2842
EVD_EXT_CHANGE_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2843
EVD_EXT_PREV_VOCAB_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2844
EVD_EXT_PREV_VOCAB_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2845
EVD_EXT_REP_VOCAB_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2846
EVD_EXT_SEQ_SN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2847
EVD_EXT_ULT_REP_VOCAB_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2848
EVD_EXT_VOCAB_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2849
EVD_EXT_VOCAB_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2850
EVD_EXT_VOCAB_NOTE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2852
EVD_EXT_VOCAB_TYPE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2853
EVD_EXT_VOCAB_TYPE_ID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2855
EVD_FDB_EXCLUDE_RXCUI_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2856
EVD_FDB_VOCAB_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2857
EVD_FDB_VOCAB_TYPE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2858
EVD_FDB_VOCAB_TYPE_ID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2860
EVD_LINK_TYPE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2861
EVD_LINK_TYPE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2862
EVD_MVX_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2863
EVD_MVX_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2864
EVD_MVX_CD_STATUS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2865
EVD_MVX_LAST_UPDATE_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2866
EVD_PRESCRIBABLE_RXCUI_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2867
EVD_RXN_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2868
EVD_RXN_CODE_NO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2869
EVD_RXN_CONCEPT_DESC_KEY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2870
EVD_RXN_CONCEPT_SOURCE_KEY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2871
EVD_RXN_RXCUI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2872
EVD_RXN_RXCUI_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2873
EVD_RXN_RXCUI_SCREENED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2874
EVD_RXN_RXCUI_STATUS_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2875
EVD_RXN_RXCUI_UNSCREENED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2876
EVD_RXN_RXCUI_UNSCREENED_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2877
EVD_RXN_SAB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2878
EVD_RXN_SEQ_SN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2879
EVD_RXN_STR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2880
EVD_RXN_SUPPRESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2881
EVD_RXN_TTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2882
EVD_SEQ_SN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2883
EVD_SHARED_RXCUI_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2885

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 EVD_SOURCE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2886
EVD_SOURCE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2887
EVD_VACCINE_NAME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2888
EVD_VOCAB_TYPE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2889
EVD_VOCAB_TYPE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2891
EXCLUSION_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2893
EXCLUSION_HIAGED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2894
EXCLUSION_LOAGED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2895
EXCLUSION_MESSAGE_TEXT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2896
EXCLUSION_REASON_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2897
EXCLUSION_REASON_TEXT_LONG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2898
EXCLUSION_REASON_TEXT_SHORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2899
EXCLUSION_STATUS_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2900
EXCLUSION_STATUS_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2901
EXT_PRODUCT_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2902
EXT_PRODUCT_CD_DATA_TYPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2903
EXT_PRODUCT_CD_DEFINITION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2905
EXT_PRODUCT_CD_END_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2907
EXT_PRODUCT_CD_FIELD_LENGTH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2908
EXT_PRODUCT_CD_START_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2910
EXT_PRODUCT_CD_TYPE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2911
EXT_PRODUCT_CD_TYPE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2912
F . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2913
FD_SL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2915
FDB_DAM_PICKLIST_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2916
FDB_INCLUSION_REASON_DEF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2917
FDB_INCLUSION_REASON_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2918
FDB_INCLUSION_REASON_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2919
FDB_PRODUCT_FIRST_DELIVERY_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2920
FDB_PRODUCT_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2921
FDB_PRODUCT_OBSOLETE_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2922
FDB_PRODUCT_STATUS_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2923
FDB_PRODUCT_STATUS_DEFINITION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2924
FDB_PRODUCT_STATUS_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2925
FDB_VOCAB_ID_MULTI_SET_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2926
FDBDX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2927
FDCCDE_SN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2928
FDCDE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2931
FDCDE_SN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2933
FDCTXT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2936
FDMSG1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2939
FDMSG2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2940

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 FDTXT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2941
FEDERAL_CS_END_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2944
FEDERAL_CS_SCHEDULE_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2945
FEDERAL_CS_START_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2946
FFP_DATEC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2947
FFP_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2948
FFP_TYP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2949
FML_CLIN_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2950
FML_CLIN_CODE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2951
FML_NAV_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2952
FML_NAV_CODE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2953
FMLDXREPDT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2954
FMLPRVDXID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2955
FMLREPDXID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2956
FREQ_INT_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2957
FREQ_INT_TEXT_SHORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2958
FROM_UOM_MSTR_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2959
G . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2960
GCDF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2962
GCDF_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2964
GCN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2966
GCN_SEQNO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2968
GCNSEQ_GI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2971
GCRT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2972
GCRT2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2973
GCRT_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2974
GENDER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2975
GENERIC_MED_CONCEPT_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2976
GENERIC_MEDID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2977
GENERIC_MEDID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2979
GERI_BEERS_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2980
GERI_CARD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2981
GERI_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2982
GERI_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2983
GERI_END . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2984
GERI_HEDIS_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2985
GERI_HEP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2986
GERI_NARRATIVE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2987
GERI_NEUR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2988
GERI_PULM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2989
GERI_RNL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2990
GERI_SL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2991

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 GERI_SL_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2992
GERI_STOPP_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2993
GMI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2994
GNI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2995
GNN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2996
GNN60 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2998
GPI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3000
GPIDC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3001
GSI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3002
GTC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3003
GTC_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3005
GTI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3007
H . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3008
HCFA_APPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3011
HCFA_DC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3012
HCFA_DESC1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3013
HCFA_DESI1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3014
HCFA_FDA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3016
HCFA_MRKC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3018
HCFA_PS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3019
HCFA_TRMC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3020
HCFA_TYP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3021
HCFA_UNIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3022
HCPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3023
HCPC_PBC1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3024
HCPC_PBC2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3025
HCPC_PBC3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3026
HCPC_PBC4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3027
HCPC_PBC5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3028
HCPC_PBC6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3029
HCPC_PBC7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3030
HCPC_PBC8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3031
HCPC_PBP1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3032
HCPC_PBP2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3033
HCPC_PBP3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3034
HCPC_PBP4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3035
HCPC_PBP5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3036
HCPC_PBP6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3037
HCPC_PBP7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3038
HCPC_PBP8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3039
HIC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3040
HIC1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3042

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 HIC1_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3044
HIC1_SEQN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3045
HIC2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3047
HIC2_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3048
HIC2_ROOT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3049
HIC2_SEQN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3050
HIC3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3051
HIC3_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3054
HIC3_GRPN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3055
HIC3_RELNO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3056
HIC3_ROOT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3057
HIC3_SEQN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3058
HIC4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3060
HIC4_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3061
HIC4_POTENTIALLY_INACTV_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3062
HIC4_ROOT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3063
HIC4_SEQN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3064
HIC_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3065
HIC_POTENTIALLY_INACTV_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3066
HIC_REL_NO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3067
HIC_REPL_EFF_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3068
HIC_ROOT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3069
HIC_SEQN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3070
HICL_SEQNO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3072
HIGH_CURRENT_WEIGHT_GRAMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3073
HL7_FI_ADD_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3074
HL7_FI_EFFECTIVE_TIME_TYPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3075
HL7_FI_EVENT_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3076
HL7_FI_EVENT_SN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3077
HL7_FI_HIGH_EVENT_OFFSET_TIME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3078
HL7_FI_HIGH_EVENT_OFFSET_UOM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3079
HL7_FI_HIGH_VALUE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3080
HL7_FI_INACTIVE_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3081
HL7_FI_INSTITUTION_SPECIFIED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3082
HL7_FI_LOW_EVENT_OFFSET_TIME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3083
HL7_FI_LOW_EVENT_OFFSET_UOM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3084
HL7_FI_LOW_VALUE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3085
HL7_FI_PERIOD_TYPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3086
HL7_FI_PERIOD_VALUE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3087
HL7_FI_UOM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3088
HL7_OID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3089
HL7_OID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3091

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 HOME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3093
HOSP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3094
I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3095
IACIDENTN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3099
IACTEXTN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3100
IAMIDENTN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3101
IAMREFCAT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3102
IAMREFCATD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3103
IAMTEXTN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3104
ICD_BILLABLE_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3105
ICD_BILLABLE_IND_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3106
ICD_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3107
ICD_CD_TYPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3108
ICD_CD_TYPE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3109
ICD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3110
ICD_DESC_SOURCE_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3111
ICD_DESC_SOURCE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3112
ICD_FIRST_BILLABLE_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3113
ICD_FIRST_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3114
ICD_LAST_BILLABLE_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3115
ICD_LAST_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3116
ICD_STATUS_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3117
ICD_STATUS_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3118
IMGDFID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3119
IMGFILENM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3122
IMGID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3123
IMGMFGID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3124
IMGMFGNAME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3125
IMGNDC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3126
IMGSTOPDT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3127
IMGSTRTDT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3128
IMGUNIQID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3129
IMK_ADD_DATE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3130
IMK_EXT_VOCAB_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3131
IMK_EXT_VOCAB_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3132
IMK_EXT_VOCAB_STATUS_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3133
IMK_FDB_VOCAB_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3134
IMK_FDB_VOCAB_NO_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3136
IMK_FDB_VOCAB_STATUS_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3138
IMK_INACTIVE_DATE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3139
IMK_PARTIAL_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3140
IMK_PREFERRED_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3141

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 IMK_RELATED_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3142
IMK_SCT_VALUE_SET_COMMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3143
IMK_SCT_VALUE_SET_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3144
IMK_SCT_VALUE_SET_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3145
IMK_VOCAB_STATUS_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3146
IMK_VOCAB_STATUS_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3147
INACTV_NOT_PRES_CNT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3148
INACTV_PRES_CNT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3149
INDCTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3150
INDCTS_DRUG_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3152
INDCTS_LBL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3153
INDCTS_SN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3154
INDLBLDESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3155
ING_STATUS_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3156
ING_STATUS_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3157
INGREDIENT_SORT_ORDER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3158
INGREDIENT_STR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3159
INGREDIENT_UOM_MSTR_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3160
INNOV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3161
INPCKI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3162
INTERMITTENT_RT_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3163
INTERVAL_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3164
IPI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3165
IPTBSCDESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3166
IPTBSCDID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3168
IPTCATDESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3169
IPTCATID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3170
IPTDESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3171
IPTDESCID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3172
IPTDFDESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3173
IPTDFID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3176
IPTIMGID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3179
IPTISTOPDT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3180
IPTISTRTDT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3181
IPTLBLID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3182
IPTLINENO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3183
IPTMFGID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3184
IPTMFGNAME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3185
IPTNDC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3186
IPTPROPID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3187
IPTSIDE1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3188
IPTSIDE2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3189

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 IPTSTOPDT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3190
IPTSTRTDT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3191
IPTTEXT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3192
IPTTEXTID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3193
IPTUNIQID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3194
IVMADCNT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3195
IVMADMIX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3196
IVMCCNT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3197
IVMCOMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3198
IVMCOMPDSC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3199
IVMMFG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3200
IVMMFGD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3201
IVMREMARK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3202
IVMRMK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3203
IVMRMKSEQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3204
IVMRMKSN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3205
IVMRMKTYP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3206
IVMRSLT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3207
IVMSGRP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3208
IVMSTR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3209
IVMSTRU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3210
IVMTESTSN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3211
IVMTPNCNT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3212
IVMTPNDSC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3213
IVMTPNINGR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3214
IVMTTYPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3215
IVMVOL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3216
IVMVOLU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3217
L . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3218
LAB_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3220
LABEL_NAME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3221
LACT_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3222
LACT_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3223
LACT_EXCRT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3224
LACT_EXCRT_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3225
LACT_EXCRTSN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3226
LACT_LCTN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3227
LACT_LCTN_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3228
LACT_LCTNSN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3229
LACT_PRCTN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3230
LACT_SL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3231
LACT_SL_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3232

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 LACT_SLSN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3233
LBL_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3234
LBL_DESCF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3235
LBL_DESCS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3237
LBL_PRTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3238
LBL_TEXTSN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3239
LBL_TXTSNF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3240
LBL_TXTSNS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3242
LBL_WARN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3243
LBLAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3244
LBLGNDR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3245
LBLINFO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3246
LBLMSG1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3247
LBLMSG2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3248
LBLPREG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3249
LBLRID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3250
LBLRIND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3252
LBLW_VCODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3253
LBLW_VDESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3254
LBLW_VTYPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3256
LINK_ADD_DATE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3258
LINK_ADD_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3259
LINK_FIRST_ACTIVE_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3260
LINK_INACTIVE_DATE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3261
LINK_INACTIVE_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3262
LINK_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3263
LINK_LAST_ACTIVE_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3264
LISTING_SEQ_NO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3265
LN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3266
LN25 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3267
LN25I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3268
LN60 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3269
LOW_CURRENT_WEIGHT_GRAMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3270
M . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3271
MAINT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3278
MC_MEASURE_DEFINITION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3279
MC_MEASURE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3280
MC_MEASURE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3282
MC_MEASURE_TIMEFRAME_DEF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3284
MC_MEASURE_TIMEFRAME_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3285
MC_MEASURE_TIMEFRAME_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3286
MC_PRODUCT_ATTR_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3288

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 MC_PRODUCT_ATTR_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3289
MC_PRODUCT_ATTR_SN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3291
MC_PRODUCT_ATTR_TYPE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3292
MC_PRODUCT_ATTR_TYPE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3293
MC_PRODUCT_ATTR_TYPE_LENGTH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3294
MC_PRODUCT_ATTR_TYPE_PRECISION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3295
MC_PRODUCT_ATTR_VALUE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3296
MC_PRODUCT_ATTR_VALUE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3297
MC_PRODUCT_ATTR_VALUE_SN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3298
MCR_BC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3300
MCR_BCDESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3301
MCR_COV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3302
MCR_COVD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3304
MCR_DATEC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3305
MCR_REF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3306
MCR_REFSN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3307
MCR_REGION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3308
MDPT_DATEC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3309
MDPT_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3310
MDPT_PRICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3311
MDPT_TYP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3312
MDT_BC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3313
MDT_BCDTE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3314
MDT_BU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3315
MDT_CODE1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3316
MDT_COP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3317
MDT_COPD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3318
MDT_COV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3319
MDT_COVD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3320
MDT_FEE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3321
MDT_FI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3322
MDT_FIDTE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3323
MDT_FREQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3324
MDT_GBC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3325
MDT_GBCDTE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3326
MDT_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3327
MDT_LTC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3328
MDT_MAX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3329
MDT_MAXC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3330
MDT_MAXCD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3331
MDT_MIN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3332
MDT_MINC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3333

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 MDT_MINCD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3334
MDT_PA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3335
MDT_PAD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3336
MDT_PS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3337
MDT_QBU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3338
MDT_RFL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3339
MDT_RFLD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3340
MDT_SLC10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3341
MDT_SUB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3342
MED_CONCEPT_HICL_SRC_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3343
MED_CONCEPT_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3344
MED_CONCEPT_ID_TYP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3345
MED_CONCEPT_ID_TYP_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3346
MED_CONCEPT_OBSDATEC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3347
MED_DOSAGE_FORM_ABBR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3348
MED_DOSAGE_FORM_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3350
MED_DOSAGE_FORM_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3352
MED_GCNSEQNO_ASSIGN_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3354
MED_GCNSEQNO_ASSIGN_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3355
MED_MEDID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3356
MED_MEDID_REPL_EFF_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3358
MED_NAME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3359
MED_NAME_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3360
MED_NAME_ID_REPL_EFF_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3362
MED_NAME_SOURCE_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3363
MED_NAME_SOURCE_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3364
MED_NAME_TYPE_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3365
MED_NAME_TYPE_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3366
MED_PREV_MEDID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3367
MED_PREV_NAME_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3368
MED_PREV_ROUTED_DF_MED_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3369
MED_PREV_ROUTED_MED_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3370
MED_REF_DEA_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3371
MED_REF_DEA_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3374
MED_REF_DESI2_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3375
MED_REF_DESI2_IND_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3377
MED_REF_DESI_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3378
MED_REF_DESI_IND_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3380
MED_REF_FED_LEGEND_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3381
MED_REF_FED_LEGEND_IND_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3383
MED_REF_GEN_COMP_PRICE_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3384
MED_REF_GEN_COMP_PRICE_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3385

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 MED_REF_GEN_DRUG_NAME_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3386
MED_REF_GEN_DRUG_NAME_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3389
MED_REF_GEN_SPREAD_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3390
MED_REF_GEN_SPREAD_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3391
MED_REF_GEN_THERA_EQU_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3392
MED_REF_GEN_THERA_EQU_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3395
MED_REF_INNOV_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3396
MED_REF_INNOV_IND_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3398
MED_REF_MULTI_SOURCE_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3399
MED_REF_MULTI_SOURCE_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3401
MED_REPL_MEDID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3402
MED_REPL_NAME_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3403
MED_REPL_ROUTED_DF_MED_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3404
MED_REPL_ROUTED_MED_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3405
MED_ROUTE_ABBR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3406
MED_ROUTE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3408
MED_ROUTE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3410
MED_ROUTED_DF_MED_ID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3412
MED_ROUTED_DF_MED_ID_REP_EF_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3413
MED_ROUTED_MED_ID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3414
MED_ROUTED_MED_ID_REPL_EFF_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3415
MED_STATUS_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3416
MED_STATUS_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3419
MED_STRENGTH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3422
MED_STRENGTH_UOM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3423
MEDGUIDE_DIRECTORY_NAME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3424
MEDGUIDE_FILE_NAME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3425
MEDGUIDE_TITLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3426
MEDGUIDE_VERSION_DATE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3427
MEDICAL_SUPPLY_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3428
MEDID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3429
MEDID_SN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3431
MFG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3432
MINI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3433
MMA_MND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3434
MMA_MNDU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3435
MMA_MNU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3436
MMA_MNUF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3437
MMA_MXD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3438
MMA_MXDU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3439
MMA_MXU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3440
MMA_MXUF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3441

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 MMAR_MND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3442
MMAR_MNDU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3443
MMAR_MNU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3444
MMAR_MNUF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3445
MMAR_MXD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3446
MMAR_MXDU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3447
MMAR_MXU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3448
MMAR_MXUF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3449
MMG_MND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3450
MMG_MNDU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3451
MMG_MNU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3452
MMG_MNUF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3453
MMG_MXD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3454
MMG_MXDU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3455
MMG_MXU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3456
MMG_MXUF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3457
MMGR_MND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3458
MMGR_MNDU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3459
MMGR_MNU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3460
MMGR_MNUF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3461
MMGR_MXD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3462
MMGR_MXDU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3463
MMGR_MXU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3464
MMGR_MXUF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3465
MONOX_END_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3466
MONOX_TITLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3467
MOVE_REASON_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3468
MOVE_REASON_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3470
MTL_ANALYTE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3471
MTL_ANALYTE_ID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3472
MTL_EXTRN_VOCAB_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3473
MTL_EXTRN_VOCAB_TYP_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3474
MTL_EXTRN_VOCAB_TYP_CODE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3475
MTL_FDB_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3476
MTL_FDB_ID_TYP_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3477
MTL_FDB_ID_TYP_CODE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3478
MTL_LAB_ID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3479
MTL_LAB_ID_REPL_EFF_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3480
MTL_LAB_ID_STATUS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3481
MTL_LAB_ID_STATUS_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3482
MTL_LAB_ID_SYN_CODE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3483
MTL_LAB_ID_SYN_NMTYP_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3484

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 MTL_LAB_ID_SYN_NMTYP_CODE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3485
MTL_LAB_ID_SYN_STATUS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3486
MTL_LAB_ID_SYN_STATUS_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3487
MTL_LAB_ID_SYNID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3488
MTL_METHOD_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3489
MTL_METHOD_ID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3490
MTL_PANEL_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3491
MTL_PANEL_ID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3492
MTL_PANEL_ID_REPL_EFF_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3493
MTL_PANEL_ID_STATUS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3494
MTL_PANEL_ID_STATUS_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3495
MTL_PREV_LAB_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3496
MTL_PREV_PANEL_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3497
MTL_PREV_SPEC_LAB_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3498
MTL_REPL_LAB_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3499
MTL_REPL_PANEL_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3500
MTL_REPL_SPEC_LAB_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3501
MTL_SPEC_LAB_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3502
MTL_SPEC_LAB_ID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3503
MTL_SPEC_LAB_ID_REPL_EFF_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3504
MTL_SPEC_LAB_ID_STATUS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3505
MTL_SPEC_LAB_ID_STATUS_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3506
MTL_SPECIMEN_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3507
MTL_SPECIMEN_ID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3509
N . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3511
NARDCDE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3515
NAV_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3516
NAV_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3517
NDA_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3518
NDC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3519
NDC_ATTRIBUTE_SN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3521
NDC_ATTRIBUTE_TYPE_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3523
NDC_ATTRIBUTE_TYPE_DSC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3527
NDC_ATTRIBUTE_VALUE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3530
NDC_ATTRIBUTE_VALUE_DSC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3533
NDC_DELETE_DATE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3537
NDC_DELETE_REASON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3538
NDCFI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3539
NDCGI1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3540
NDL_GDGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3541
NDL_LNGTH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3542
NEOM_CALC_REQ_TYPE_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3543

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 NEOM_CALC_REQ_TYPE_CODE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3544
NEOM_CONVERSION_FACTOR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3545
NEOM_CREATININE_CLR_THRESHOLD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3546
NEOM_CREATININE_CLR_UNIT_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3547
NEOM_DOSE_CALC_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3548
NEOM_DOSE_CODE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3549
NEOM_DOSE_TYPE_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3550
NEOM_DOSE_TYPE_CODE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3551
NEOM_GEST_BIRTH_AGE_REQ_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3552
NEOM_HALF_LIFE_UNIT_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3553
NEOM_HEPATIC_IMPAIRMENT_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3554
NEOM_HIGH_AGE_DAYS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3555
NEOM_HIGH_CURRENT_WEIGHT_GRAMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3556
NEOM_HIGH_DOSE_PER_DAY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3557
NEOM_HIGH_DOSE_UNIT_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3558
NEOM_HIGH_DURATION_OF_TX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3560
NEOM_HIGH_ELIM_HALF_LIFE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3561
NEOM_HIGH_FREQUENCY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3562
NEOM_HIGH_GEST_BIRTH_AGE_WEEKS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3563
NEOM_LOW_AGE_DAYS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3564
NEOM_LOW_CURRENT_WEIGHT_GRAMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3565
NEOM_LOW_DOSE_PER_DAY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3566
NEOM_LOW_DOSE_UNIT_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3567
NEOM_LOW_DURATION_OF_TX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3569
NEOM_LOW_ELIM_HALF_LIFE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3570
NEOM_LOW_FREQUENCY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3571
NEOM_LOW_GEST_BIRTH_AGE_WEEKS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3572
NEOM_MATH_PROCESS_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3573
NEOM_MATH_PROCESS_CODE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3574
NEOM_MAX_DOSE_PER_DAY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3575
NEOM_MAX_DOSE_UNIT_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3576
NEOM_MAX_DURATION_OF_TX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3578
NEOM_MAX_LIFE_DOSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3579
NEOM_MAX_LIFE_DOSE_UNIT_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3580
NEOM_MAX_SINGLE_DOSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3582
NEOM_MAX_SINGLE_DOSE_UNIT_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3583
NEOM_PRESCRIBED_UNIT_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3585
NEOM_RENAL_IMPAIRMENT_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3586
NEOM_RESULT_UNIT_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3587
NEOM_ROUTE_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3589
NEOM_ROUTE_CODE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3591
NEOM_UNIT_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3593

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 NEOM_UNIT_CODE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3594
NEOM_WEIGHT_REQ_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3596
NEXT_SCREENING_DOSE_AGE_TEXT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3597
NEXT_SCREENING_DOSE_TEXT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3598
NLM_ACCEPTABILITY_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3599
NLM_ACTIVE_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3600
NLM_CASE_SIGNIFICANCE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3601
NLM_CHARACTERISTIC_TYPE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3602
NLM_CONCEPT_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3603
NLM_DEFINITION_STATUS_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3604
NLM_DESCRIPTION_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3605
NLM_DESTINATION_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3606
NLM_EFFECTIVE_TIME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3607
NLM_LANGUAGE_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3608
NLM_LANGUAGE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3609
NLM_MODIFIER_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3610
NLM_MODULE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3611
NLM_REFERENCED_COMPONENT_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3612
NLM_REFSET_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3613
NLM_RELATIONSHIP_GROUP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3614
NLM_RELATIONSHIP_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3615
NLM_SOURCE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3616
NLM_TERM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3617
NLM_TYPE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3618
NPT_DATEC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3619
NPT_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3620
NPT_PRICEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3623
NPT_TYPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3624
NTE_SINGLE_DOSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3627
NTE_SINGLE_DOSE_UNIT_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3628
O . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3630
OBC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3631
OBC3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3633
OBC_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3636
OBC_EXP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3638
OBC_SN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3640
OBSDTEC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3641
OBSOLETE_DATE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3642
ORD_MED_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3643
OUTPCKI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3644
OVW_CLINICAL_RT_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3645
OVW_DOSAGE_FORM_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3646

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 OVW_UOM_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3647
P . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3648
PACKAGE_TYPE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3655
PARAM_INCORP_UOM_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3656
PARENT_RISK_ACTION_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3657
PARENT_RT_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3658
PATIENT_PARAM_REQ_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3659
PATIENT_PARAM_REQ_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3660
PD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3661
PDM_AGEDSC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3663
PDM_F05WT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3664
PDM_F25WT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3665
PDM_F50WT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3666
PDM_F75WT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3667
PDM_F95WT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3668
PDM_M05WT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3669
PDM_M25WT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3670
PDM_M50WT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3671
PDM_M75WT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3672
PDM_M95WT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3673
PDM_MNAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3674
PDM_MND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3675
PDM_MNDU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3676
PDM_MNU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3677
PDM_MNUF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3678
PDM_MXAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3679
PDM_MXD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3680
PDM_MXDU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3681
PDM_MXU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3682
PDM_MXUF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3683
PDM_NTED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3684
PDM_NTEDU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3685
PDM_NTEU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3686
PDM_NTEUF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3687
PDM_UNDESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3688
PDM_UNIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3690
PEC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3692
PEDI_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3694
PEDI_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3695
PEDI_MAXAG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3696
PEDI_MINAG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3697
PEDI_NARRATIVE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3698

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 PEDI_SL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3699
PEDI_SL_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3700
PEDIATRIC_DOSE_TEXT_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3701
PEMAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3702
PEMGNDR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3703
PEMONO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3704
PEMONOE_SN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3706
PEMONOFRA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3707
PEMONOS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3711
PEMTXTA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3713
PEMTXTE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3715
PEMTXTEI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3716
PHMXCDE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3718
PKG_TYPE_LONG_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3719
PKG_TYPE_SHORT_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3720
PLBLR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3721
PNDC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3722
POEADMINSQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3723
POEADRT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3724
POEADRTUNT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3725
POECALCREQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3726
POECALCRTC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3727
POECALCRTC_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3728
POECLINID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3729
POECLINTYP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3730
POECLINTYP_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3731
POECLINVAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3732
POECLINVAL_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3733
POECOCDE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3734
POECOCDE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3735
POEDESC1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3736
POEDESC2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3737
POEDESC3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3738
POEDISPQTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3739
POEDOSETYP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3740
POEDOSETYP_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3741
POEHIGHD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3742
POEHIGHDFA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3743
POEHIGHDFU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3744
POEHIGHDR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3746
POEHIGHDRU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3747
POEHIGHDU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3748

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 POEHIGHF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3750
POEHIGHI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3751
POEHIGHIU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3752
POELANGCDE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3753
POELANGCDE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3754
POELOWD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3755
POELOWDFA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3756
POELOWDFU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3757
POELOWDR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3759
POELOWDRU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3760
POELOWDU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3761
POELOWF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3763
POELOWI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3764
POELOWIU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3765
POEM_RT_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3766
POEMAXRANG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3767
POEMINRANG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3768
POEMLCNVRS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3769
POEOSETID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3770
POEOSTRID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3771
POEOSTRSEQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3773
POEPERDAYC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3774
POERANGUNT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3775
POEROUTE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3776
POEROUTE_D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3778
POEROUTE_D_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3779
POESHIGHF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3780
POESHIGHI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3781
POESHIGHIU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3782
POESLOWF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3783
POESLOWI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3784
POESLOWIU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3785
POETEXTCDE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3786
POETEXTTYP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3788
POETEXTTYP_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3789
POETXLINE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3790
POETXTNUM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3792
POETXTSTRL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3793
POETXTSTRL_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3794
POEUNITCDE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3795
POEUNITTYP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3796
POEUNITTYP_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3797

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 PPI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3798
PRED_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3799
PREDDESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3800
PREFERRED_DOSAGE_FORM_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3801
PREG_BOXED_WARNING_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3802
PREG_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3803
PREG_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3805
PREG_MONO_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3806
PREG_MONO_LINE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3807
PREG_MONO_SECTION_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3808
PREG_MONO_SECTION_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3809
PREG_MONO_SN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3810
PREG_PRCTN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3811
PREG_REFERENCE_ACCESSED_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3812
PREG_REFERENCE_AUTHOR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3813
PREG_REFERENCE_EDITION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3814
PREG_REFERENCE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3815
PREG_REFERENCE_ISSUE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3816
PREG_REFERENCE_ISSUE_DT_TXT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3817
PREG_REFERENCE_LOCATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3818
PREG_REFERENCE_NAME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3819
PREG_REFERENCE_PAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3820
PREG_REFERENCE_PUBMED_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3821
PREG_REFERENCE_SUPPLEMENT_NBR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3822
PREG_REFERENCE_TITLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3823
PREG_REFERENCE_TYPE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3824
PREG_REFERENCE_TYPE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3825
PREG_REFERENCE_URL_TEXT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3826
PREG_REFERENCE_VOLUME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3827
PREG_SL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3828
PREG_SLD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3831
PREG_SLSN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3834
PREV_DAM_ALRGN_GRP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3837
PREV_DAM_ALRGN_XSENSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3838
PREV_HIC_SEQN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3839
PREV_MEDID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3840
PREV_MEDID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3841
PREV_MEDID_NAME_SOURCE_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3842
PREV_MEDID_NEW_STATUS_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3843
PREV_MEDID_OLD_STATUS_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3844
PREV_RISK_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3845
PRICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3846

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 PRICE_ATTRIBUTE_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3847
PRICE_ATTRIBUTE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3848
PRICE_ATTRIBUTE_GROUP_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3849
PRICE_ATTRIBUTE_SN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3850
PRICE_ATTRIBUTE_TYPE_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3851
PRICE_ATTRIBUTE_TYPE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3852
PRICE_ATTRIBUTE_TYPE_LENGTH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3853
PRICE_ATTRIBUTE_TYPE_PRECISION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3854
PRICE_ATTRIBUTE_VALUE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3855
PRICE_ATTRIBUTE_VALUE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3856
PRICE_ATTRIBUTE_VALUE_SN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3857
PRICE_EFFECTIVE_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3858
PRICE_QTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3859
PRICE_TYPE_DEFINITION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3860
PRICE_TYPE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3865
PRICE_TYPE_LONG_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3870
PRICE_TYPE_SHORT_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3876
PRICE_UOM_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3881
PRICE_UOM_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3882
PRODUCTION_DATE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3883
PRODUCTS_RESEARCHED_CNT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3884
PROXY_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3885
PS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3886
PS_EQUIV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3887
R . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3889
RANGE_MAX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3893
RANGE_MIN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3894
RATE_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3895
RATIO_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3896
RELATED_DXID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3897
RELATED_HIC_SEQN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3898
RELATION_INACTIVE_DATE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3899
REN_FOOTNOTE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3900
REN_HIAGED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3901
REN_HICRCL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3902
REN_HIDOSD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3903
REN_HIDOSU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3904
REN_HIFREQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3905
REN_LOAGED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3906
REN_LOCRCL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3907
REN_LODOSD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3908
REN_LODOSU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3909

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 REN_LOFREQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3910
REN_MONO_FORMAT_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3911
REN_MONO_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3912
REN_MONO_LINE_NUMBER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3913
REN_MONO_LINE_TEXT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3914
REN_MONO_SECTION_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3915
REN_MX1DOS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3916
REN_MX1DSU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3917
REN_MXDOSD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3918
REN_MXDOSU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3919
REN_NTE_SINGLE_DOSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3920
REN_NTE_SINGLE_DOSE_UNIT_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3921
REN_SORT_ORDER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3922
REPACK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3923
REPL_DAM_ALRGN_GRP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3924
REPL_DAM_ALRGN_XSENSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3925
REPL_HIC_SEQN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3926
REPL_RISK_EFF_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3927
REPL_RISK_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3928
REPLACEMENT_FDB_PRODUCT_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3929
REPNDC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3930
REPRESENTATIVE_RT_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3931
RESULT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3932
RISK_ACTION_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3933
RISK_ACTION_ID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3934
RISK_ACTOR_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3935
RISK_ACTOR_ID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3936
RISK_ADDL_TEXT_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3937
RISK_ADDL_TEXT_ID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3938
RISK_CATEGORY_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3939
RISK_CATEGORY_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3940
RISK_CATEGORY_CD_DESC_SHORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3941
RISK_END_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3942
RISK_GRP_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3943
RISK_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3944
RISK_INFOBYTE_END_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3946
RISK_INFOBYTE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3947
RISK_INFOBYTE_ID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3948
RISK_INFOBYTE_SEQNO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3949
RISK_INFOBYTE_START_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3950
RISK_INFOBYTE_VERSION_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3951
RISK_LINK_SEQNO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3952

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 RISK_MED_CYCLE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3953
RISK_MED_CYCLE_ID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3954
RISK_MITIGATION_SEQNO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3955
RISK_MONO_FORMAT_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3956
RISK_MONO_FORMAT_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3957
RISK_MONO_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3958
RISK_MONO_LINE_SEQNO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3959
RISK_MONO_TXT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3960
RISK_MONO_TYP_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3961
RISK_MONO_TYP_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3962
RISK_START_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3963
RISK_STATUS_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3964
RISK_STATUS_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3965
RISK_TYP_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3966
RISK_TYP_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3967
RISK_URL_TXT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3968
RISK_VERSION_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3969
ROUTED_DOSAGE_FORM_MED_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3970
ROUTED_GEN_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3972
ROUTED_GEN_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3973
ROUTED_GEN_STATUS_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3975
ROUTED_GEN_STATUS_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3976
ROUTED_MED_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3977
ROUTES_DES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3979
RT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3981
RT_ADVERB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3982
RT_DESC_LONG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3983
RT_DESC_SHORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3984
RT_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3985
RT_LABELED_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3986
RT_LABELED_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3987
S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3988
SCRIPT_DEA_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3991
SCRIPT_DEA_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3992
SCRIPT_DEA_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3993
SCRIPT_DEA_OBSOLETE_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3994
SCRIPT_DEA_SUBSET_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3995
SCRIPT_QQ_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3996
SCRIPT_QQ_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4001
SCRIPT_QQ_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4006
SCT_CONCEPT_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4007
SCT_CONCEPT_ID_TYPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4008

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 SCT_CONCEPT_ID_TYPE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4009
SCT_DESCRIPTION_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4010
SCT_TERM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4011
SCT_TYPE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4012
SCT_TYPE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4013
SEARCH_DXID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4014
SEARCH_ICD_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4015
SEARCH_SCT_CONCEPT_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4016
SEARCH_TERM_TEXT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4017
SEARCH_TERM_TYPE_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4018
SEARCH_TERM_TYPE_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4019
SHIPPER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4020
SHLF_PCK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4021
SIDE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4022
SIDE_A_DDI_CODEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4024
SIDE_A_GCN_SEQNO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4025
SIDE_A_ROUTED_GEN_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4026
SIDE_A_ROUTED_MED_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4027
SIDE_B_DDI_CODEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4028
SIDE_B_GCN_SEQNO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4029
SIDE_B_ROUTED_GEN_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4030
SIDE_B_ROUTED_MED_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4031
SIDE_DRUG_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4032
SIDE_FREQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4033
SIDE_HYPER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4034
SIDE_LABCD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4035
SIDE_PHYS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4036
SIDE_SEV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4037
SIDE_SN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4038
SIDE_VISCD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4039
SPCHAR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4040
STATE_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4041
STATE_CS_DIFF_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4042
STATE_CS_DIFF_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4043
STATE_CS_END_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4044
STATE_CS_SCHEDULE_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4045
STATE_CS_START_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4046
STATE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4047
STATE_PDMP_DRUG_SOURCE_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4048
STATE_PDMP_DRUG_SOURCE_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4049
STATE_PDMP_END_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4050
STATE_PDMP_LIST_TYPE_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4051

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 STATE_PDMP_LIST_TYPE_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4052
STATE_PDMP_START_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4053
STPK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4054
STR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4055
STR60 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4056
STR_CONC_TYPE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4057
STR_CONC_TYPE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4058
STR_SEQ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4059
STRENGTH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4060
STRENGTH_STATUS_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4061
STRENGTH_STATUS_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4062
STRENGTH_TYP_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4063
STRENGTH_TYP_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4064
STRENGTH_UOM_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4065
STRNUM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4066
STRUN50 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4067
SYR_CPCTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4068
SYSTEMIC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4069
STATE_CS_DIFF_CD_START_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4070
STATE_CS_DIFF_CD_END_DT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4071
T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4072
TC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4073
TC_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4074
TIME_UOM_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4075
TIME_UOM_MSTR_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4076
TIME_VALUE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4077
TM_ALT_GNN_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4078
TM_ALT_MED_NAME_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4079
TM_ALT_MEDID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4080
TM_ALT_NDC_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4082
TM_ALT_ROUTED_DF_MED_ID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4084
TM_ALT_ROUTED_MED_ID_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4086
TM_GNN_TYPE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4087
TM_GNN_TYPE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4088
TM_GROUP_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4089
TM_GROUP_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4090
TM_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4092
TM_NAME_TYPE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4093
TM_NAME_TYPE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4094
TM_SOURCE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4095
TM_SOURCE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4096
TO_UOM_MSTR_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4097

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 TOP50GEN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4098
TOP200 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4099
TOTAL_PRODUCTS_CNT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4100
TRADENAME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4101
TXTCDE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4102
TXTCDEC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4103
U . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4104
UCUM_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4106
UD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4107
UNII_CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4108
UNIT_DESC_ABBREV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4109
UNIT_DESC_EXPANDED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4111
UNITS_CTYP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4113
UNITS_CTYP_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4114
UNITS_DCC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4115
UNITS_DCC_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4116
UNITS_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4117
UNITS_RUI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4119
UOM_ABBR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4121
UOM_CONVERSION_FACTOR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4122
UOM_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4123
UOM_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4124
UOM_MSTR_ABBR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4125
UOM_MSTR_COMPONENT1_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4126
UOM_MSTR_COMPONENT2_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4127
UOM_MSTR_COMPONENT3_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4128
UOM_MSTR_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4129
UOM_MSTR_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4130
UOM_MSTR_PLURAL_ABBR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4131
UOM_MSTR_PLURAL_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4132
UOM_MSTR_PLURAL_PREFERRED_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4133
UOM_MSTR_PREFERRED_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4134
UOM_PLURAL_STDS_ORG_ABBR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4135
UOM_PLURAL_STDS_ORG_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4136
UOM_PREFERRED_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4137
UOM_STDS_ORG_ABBR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4138
UOM_STDS_ORG_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4139
UOM_TYPE_CD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4140
UOM_TYPE_CD_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4141
USC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4142
USC_DESC40 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4143
USHIK_CATEGORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4144

Copyright 2017 First Databank, Inc. Last Updated: August 2017

 USHIK_CODE_SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4145
USHIK_CODE_SYSTEM_VERSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4146
USHIK_CONCEPT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4147
USHIK_CONCEPT_DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4148
USHIK_ELIGIBILITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4149
USHIK_MEASURE_IDENTIFIER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4150
USHIK_MEASURE_TITLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4151
USHIK_NQF_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4152
USHIK_QUALITY_DATA_ELEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4153
USHIK_VALUE_SET_NAME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4154
USHIK_VALUE_SET_OID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4155
USHIK_VALUE_SET_VERSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4156
USHIK_VERSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4157
USPCDE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4158
UU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4159
V . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4160
VALID_CNS_RT_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4161
VOLNUM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4162
VOLUME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4163
VOLUME_UOM_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4164
VOLUME_UOM_MASTER_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4165
VOLUME_UOM_MSTR_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4166
VOLUN50 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4167
W . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4168
WEIGHT_REQ_IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4169
X . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4170
XRF_SOURCE_DESC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4171
XRF_SOURCE_ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4172

Copyright 2017 First Databank, Inc. Last Updated: August 2017

FDB MedKnowledge U.S. Documentation August 2017

FDB MedKnowledge U.S. Documentation

Contents
Getting Started
MedKnowledge Editorial Policies
MedKnowledge Identifiers and Attributes
Daily Product Update
Drug Product Pricing
AHFS DI Monographs (AHFS DI) 1.0
Clinical Screening
Counseling Messages Module (CMM) 1.0
Drug Images Module 2.0
Drug Imprints Module 2.1
FDB High Risk Medication Module
FDB Interoperability Module 1.0
FDB State and Federal Controlled Substances
Module
Medicaid Module 1.0
Medicare ModuleHCPCS Select
FDB Medicare Part D Module
Patient Education Module (PEM) 2.0
Prescriber Order Entry Module (POEM) 2.0
Prioritized Label Warnings Module (LBLW)
1.0
MedGuides Module 1.0
Therapeutic Classification Systems
Herbal Products Inclusion List
Legacy Versions of Tables

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Legacy Editorial Policies

Data Dictionary

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FDB MedKnowledge U.S. Documentation August 2017

Getting Started
This section contains the following topics:

About This Document

Copyright
Conventions
Documentation Release Notes
About FDB
About FDB MedKnowledge
Product Profile
FDB Disclaimer
Implementation Requirements
Information Update Options
Product Configuration
Product Layout
Product Delivery
Data Definition Language Policy
Custom Services
Identifiers, Attributes, and Pricing Top-Level ERD

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FDB MedKnowledge U.S. Documentation August 2017

About This Document

This section contains the following topics:

Copyright

Conventions

Documentation Release Notes

Copyright 2017 First Databank, Inc. 65

FDB MedKnowledge U.S. Documentation August 2017

Copyright
2017 First Databank, Inc. Part of the Hearst Health network.
All trademarks mentioned herein are the properties of their respective
owners.

The FDB MedKnowledge Documentation and the database supplied with it

may not be reproduced in any form or by any means, in whole or in part,
without written consent from the publisher. Any unauthorized use of this
copyright material will be subject to legal action.

All reproduction, quotation, broadcasting, software, and publication rights

reserved. No part of this program may be reproduced or transmitted in any
form or any means, electronic or mechanical, including photocopy, recording
on any information storage and retrieval system, without the express, written
consent of Hearst Corporation.
Corporate Office
Adobe Acrobat Reader is a registered trademark of Adobe Systems
First Databank, Inc.
Incorporated.
Part of the Hearst Health
AHFS Drug Information is a registered trademark of the American Society network
of Health-System Pharmacists. 701 Gateway Boulevard,
American Society of Health-System Pharmacists (ASHP) is a registered Suite 600, South San
trademark of the American Society of Health-System Pharmacists. Francisco, CA 94080
800.633.3453,
The monographs used in AHFS DI Monographs are from AHFS Drug
650.588.5454
Information, provided by the American Society of Health-System
Fax 650.246.2829
Pharmacists (ASHP).
www.fdbhealth.com
American Hospital Formulary Service (AHFS) Drug Information is a
Other locations
copyright of the American Society of Health-System Pharmacists.
Indianapolis, Indiana;
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange
Exeter, England
Book) is a copyright of the U.S. Department of Health and Human Services,
Customer Service:
Food and Drug Administration.
800.633.3453
Applied Therapeutics: The Clinical Use of Drugs is a copyright of Applied
Therapeutics, Inc.

Averys Diseases of the Newborn is a copyright of the WB Saunders

Company.

Clin-Alert is a registered trademark and copyright of Clin-Alert, Inc.

CPT is a registered trademark of the American Medical Association.

Current Medical Diagnosis and Treatment is a copyright of McGraw

Hill/Appleton & Lange.

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FDB MedKnowledge U.S. Documentation August 2017

Dorlands Illustrated Medical Dictionary is a copyright of WB Saunders

Company.

Drug Test Interactions Handbook is a copyright of Raven Press.

Drugs in Pregnancy and Lactation is a copyright of Lippencot, Williams, and

Wilkins.

Effects of Drugs on Clinical Laboratory Tests is a copyright of the American

Association of Clinical Chemistry.

Facts and Comparisons is a copyright of Wolters Kluwer.

FDA Medwatch is a copyright of the U.S. Department of Health and Human

Services, Food and Drug Administration.

FDB MedKnowledge is a trademark of First Databank, Inc.

Geriatric Dosage Handbook is a copyright of Lexi-Comp, Inc.

Goodman and Gilmans The Pharmacological Basis of Therapeutics is a

copyright of the McGraw-Hill Companies, Inc.

HL7 is a registered trademark of Health Level Seven, Inc.

The Harriet Lane Handbook is a copyright of Mosby, Inc.

Handbook on Injectable Drugs is a copyright of American Society of

Health-System Pharmacists, Inc.

Harrisons Principles of Internal Medicine is a copyright of the McGraw-Hill

Companies.

Health Level Seven is a registered trademark of Health Level Seven, Inc.

The Hospital For Sick Children Handbook of Pediatrics is a copyright of WB

Saunders Company.

IMS Health Incorporated, Plymouth Meeting, Pa. Copyright 2002. All rights
reserved.

International Classification of Diseases, 9th Revision, Clinical Modification

is a copyright under the Uniform Copyright Convention.

Jacobs & DeMott Laboratory Test Handbook with Keyword Index is a

copyright of Lexi-Comp, Inc.

The LOINC codes, LOINC Users Guide, and LOINC database are
copyright 1995-2003, Regenstrief Institute, Inc. and the Logical
Observation Identifiers Names and Codes (LOINC) Committee. All rights
reserved.

LOINC is a registered trademark of Regenstrief Institute, Inc.

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FDB MedKnowledge U.S. Documentation August 2017

Martindale: The Extra Pharmacopoeia is a copyright of the Royal

Pharmaceutical Society of Great Britain.

MedDRA is a registered trademark of the International Federation of

Pharmaceutical Manufacturers Associations (IFPMA).

MedEffect is a trademark of Health Canada.

MedKnowledge is a trademark of First Databank, Inc.

Med Teach is a trademark of the American Society of Health-System

Pharmacists.

Medic Alert is a registered trademark of the Medic Alert Foundation.

The Medical Letter is a registered trademark of The Medical Letter, Inc.

The Medical Letter On Drugs and Therapeutics is a copyright of The

Medical Letter, Inc.

Medications and Mothers Milk is a copyright of Thomas W. Hale, Ph.D.

Medicine for Children is a copyright of the Royal College of Paediatrics and

Child Health and the Neonatal and Paediatric Pharmacists Group.

The Merck Manual of Diagnosis and Therapy is a copyright of Merck & Co.,
Inc.

The Merck Index is a copyright of Merck & Co., Inc.

Merriam-Websters Medical Desk Dictionary is a copyright of

Merriam-Webster, Inc.

Metathesaurus is a registered trademark of the United States National

Library of Medicine.

Microsoft Access is a copyright of Microsoft Corporation.

Microsoft SQL Server is a trademark of Microsoft Corporation.

Microsoft and Windows are registered trademarks of Microsoft

Corporation.

Mosbys Drug Consult is a copyright of Elsevier Science.

National Library of Medicine is a registered trademark of the United States

National Library of Medicine.

NCPDP is a registered trademark of the National Council for Prescription

Drug Programs.

Nelson Textbook for Pediatrics is a copyright of WB Saunders Company.

Neonatal-Perinatal Medicine: Diseases of the Fetus and Infant is a

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FDB MedKnowledge U.S. Documentation August 2017

copyright of Mosby, Inc.

Neonatal Formulary 3: The Northern Neonatal Network is a copyright of

BMJ Books.

Neonatalogy: Management, Procedures, On-Call Problems, Diseases, and

Drugs is a copyright of McGraw Hill.

NLM is a registered trademark of the United States National Library of

Medicine.

Oracle is a registered trademark of Oracle Corporation and/or its affiliates.

Pediatric Dosage Handbook is a copyright of Lexi-Comp, Inc.

The Pediatric Drug Handbook is a copyright of Mosby, Inc.

Pharmacotherapy: A Pathophysiologic Approach is a copyright of Appleton

and Lange.

Physicians Desk Reference (PDR) is a registered trademark and copyright

of Micromedex.

Priniciples and Practice of Infectious Diseases is a copyright of Churchill

Livingstone, Inc.

Product Information File (PIF) is a trademark of First Databank.

Redbook: Report of the Committee on Infectious Diseases is a copyright of

the American Academy of Pediatrics.

Rudolphs Pediatrics is a copyright of McGraw Hill.

SNOMED-RT is a registered trademark of SNOMED International.

Stedmans Medical Dictionary is a copyright of Lippencot, Williams &

Wilkins.

Sybase is a registered trademark of Sybase, Inc.

Textbook of Neonatology is a copyright of Churchill Livingstone, Inc.

UMLS is a registered trademark of the United States National Library of

Medicine.

Universal System of Classification (USC) is maintained by IMS Health

Incorporated.

USP DI is a registered trademark of The United States Pharmacopeial

Convention, Inc., used herein under license to MICROMEDEX.

USP DI, Volume 1: Drug Information for the Health Care Professional is a
copyright of MICROMEDEX Thomson Healthcare.

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FDB MedKnowledge U.S. Documentation August 2017

Williams Obstetrics is a copyright of the McGraw-Hill Companies.

XML Bible is a copyright of Hungry Minds.

XML 101 is a copyright of INT Media Group.

Product and company names mentioned herein may be the trademarks of

their respective owners.

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FDB MedKnowledge U.S. Documentation August 2017

Conventions
This document is divided into the sections listed below.

MedKnowledge Descriptive Information and Modules

The MedKnowledge Descriptive Information is presented first, followed by the MedKnowledge modules. The
MedKnowledge Descriptive Information and modules include the following sections for each item:

Overviewsprovide descriptive information about each module or section.

Editorial Policiesprovide information about the policies that guide the development and maintenance of
the data in each module or section.
Applicationsprovide information about the practical application of data contained in each module or
section.
Technical Specificationsprovide table/entity information and specifications for each module or section.

Data Dictionary
The Data Dictionary provides an alphabetical listing of the column names with a definition for each. These column
names are not categorized by module; however, a link is provided in the Technical Specification Tables from the
column name to the Data Dictionary.

Technical Specifications
The Technical Specifications provides an alphabetical listing of the tables in each module. Each specification
includes the purpose of the table and a list of all the columns in the table, with links to the Data Dictionary.

P indicates a Primary key; F indicates a Foreign key; PF indicates a Primary and Foreign key.

Entity Relationship Diagrams

The Entity Relationship Diagrams provide a graphical representation of table/entity relationships within each
module.

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FDB MedKnowledge U.S. Documentation August 2017

Documentation Release Notes

This page provides recent revision information about FDB MedKnowledge Documentation. Added, updated, or
removed sections are listed in the Changes column, and they are in order according to applicable production
date.

Production Date Changes

August 24, 2017 Updated Prescriber Order Entry Module (POEM) 2.0 G
eneral Information to include expanded editorial policies.

August 17, 2017 Updated the following pages to show all available valid
values:

MC_MEASURE_TIMEFRAME_ID
MC_MEASURE_TIMEFRAME_DESC
MC_MEASURE_TIMEFRAME_DEF

July 20, 2017 Updated the following pages to reflect the addition of the
"Designation By Labeler" NDC attribute
(NDC_ATTRIBUTE_TYPE_CD = 62):

Added "Designation By Labeler" to Packaged Product C

oncepts section.
Updated NDC_ATTRIBUTE_TYPE_CD and NDC_ATT
RIBUTE_TYPE_DSC with new NDC attribute type code
62.
Updated NDC_ATTRIBUTE_VALUE and NDC_ATTRIB
UTE_VALUE_DSC with NDC attribute values for new
NDC attribute type code 62.
Updated CL with relevant note.
Updated NDC_ATTRIBUTE_VALUE and NDC_ATTRIBUT
E_VALUE_DSC with values for NDC attribute type codes 5
1-55 (Preservative Free, Sugar Free, Latex Free, Alcohol
Free, and Storage Condition (Refrigeration) Codes).

July 12, 2017 Updated MedGuides Module 1.0 Inclusion Criteria editori
al policies to reflect changes in the assignment of
FDA-approved class MedGuides.
Updated the FDB Medicare Part D Module application Ide
ntifying CMS Concepts to reflect policies regarding Measure
14 interactions.

June 22, 2017 Updated the following pages in the FDB Interoperability
Module to support updated allergen concept mappings for
inbound allergen targets and the addition of an extra year of
Clinical Quality Measure (CQM) Value Sets history:

Inclusion Criteria
Rule Sets
Maintenance
USHIK History Table

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June 1, 2017 Updated Clinically Significant Inactive Ingredients List in the

Inactive Ingredients Editorial Policies to remove Sodium
Salicylate and Triethanolamine in accordance with the
corresponding data update.
Updated CL valid values descriptions per internal policy
review.
Updated Unit Dose Indicator (UD) section of Packaged
Product Editorial Policies per internal policy review.

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FDB MedKnowledge U.S. Documentation August 2017

May 24, 2017 Updated Medicaid Module General Information to include

Maryland and Tennessee in the list of states that are
published Average Acquisition Cost (AAC) prices.
Updated Clinically Significant Inactive Ingredients List in the
Inactive Ingredients Editorial Policies to include coconut in
accordance with the corresponding data update.
Updated the Tall Man Plus 2.0 Module for the latest
enhancements as follows:

Added the following pages:

Tall Man GNN Table
Tall Man GNN Type Table
Added the following Data Dictionary entries:
TM_ALT_GNN_DESC
TM_GNN_TYPE_DESC
TM_GNN_TYPE_ID
Updated the following Data Dictionary entries:
GNN
GNN60
Updated the following pages:
Retrieving Tall Man Lettering Application
Tall Man Plus Editorial Polices
ERD and Technical Specifications
Updated the following pages in the Clinical Formulation and
Ingredient Data Module to support mixed case format:

Concepts
ERD and Technical Specifications
Ingredient List Identifier Description Table
Retrieving the Ingredients for a Specified Clinical
Formulation
Retrieving Related Drug Products Based on a
Preferred Route and Ingredients List
Updated the following pages in the Packaged Product
Module to support mixed case format:

Therapeutic Substitution Retrieval Method A

Therapeutic Substitution Retrieval Method B
Therapeutic Substitution Retrieval Method C
Updated the following page in the Drug Allergy Module
(DAM) 4.0 Module to support mixed case format:

Customizing the Allergen Pick List

Made Editorial Policies for PREG v1 available in the Legacy
Editorial Policies section.

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May 11, 2017 Updated the following section in the First Databank
Cross-Reference Module (XRF) 1.0 to reflect the removal
of Private Label NDCs from the Clinical Quantity NDC Table
(RCQNDC0_CLNQTY_NDC).

First Databank Cross-Reference Module General

Information and Concepts
Updated the Dosage Range Check Module (DRCM)
documentation to reflect the upgrade to the new version of
the DRCM Neonatal and Adult Master Table (RDRCNMA2_
MSTR) as follows:

Added new version of the DRCM Neonatal and Adult

Master Table (RDRCNMA2_MSTR).
Moved old version of the DRCM Neonatal and Adult
Master Table v1 (RDRCNMA1_MSTR).
Updated ERD on DRCM ERD and Technical
Specifications page.
Added the following data dictionary entries:
WEIGHT_REQ_IND
LOW_CURRENT_WEIGHT_GRAMS
HIGH_CURRENT_WEIGHT_GRAMS
Updated the following data dictionary entries to reflect
column length expansion:
DR2_LOFREQ
DR2_HIFREQ
Updated example depicted in the following data
dictionary entries:
NTE_SINGLE_DOSE
Updated Dosage Range Checking application and the
following examples:
ExampleDose Range Checking for an Adult
Patient
ExampleDose Range Checking for a Neonatal
Patient
ExampleDose Range Checking of Non-patient
Parameters
ExampleDose Range Checking of a Continuous
Infusion
ExampleDose Range Checking of an Intermittent
Infusion
Performing Dosage Range Checking Using a DxID
or ICD Code
Updated the Rules for Data Elements within the Dosing
Editorial Policies to reflect the table upgrade and
current editorial policies.
Additionally, replaced all references throughout
documentation to "RDRCNMA1_MSTR" table to
reference "RDRCNMA2_MSTR" table.

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April 20, 2017 Updated Unit Dose (UD) section of Packaged Product
Editorial Policies with a clarification per internal editorial
review.

April 17, 2017 Added a note to the NDC to FDA NDA/ANDA Table in the P
ackaged Product module to reflect the FDB assignment of
the Label Name-60 (LN60) to the FDA Trade Name (TRAD
ENAME) when the proprietary name from the NSDE File
exceeds 125 characters.

April 16, 2017 Updated the following Data Dictionary entries per internal
editorial review:

TOP200
TOP50GEN

April 6, 2017 Added the following pages for the latest enhancements to
the Drug Product Pricing module:

Identifying the NDC Deletion Reason

NDC Deletion Reason Table
NDC_DELETE_DATE
NDC_DELETE_REASON
REPLACEMENT_FDB_PRODUCT_ID
Updated the following page for the latest enhancements to
the Drug Product Pricing module:

ERD and Technical Specifications

Updated Clinically Significant Inactive Ingredients List in the
Inactive Ingredients Editorial Policies to include cinnamon
and remove both potassium chloride and potassium
phosphate in accordance with the corresponding data
update.
Global update: IHTSDO recently adopted the name
SNOMED International, so all references to IHTSDO within
this documentation have been updated accordingly. View
the associated press release from SNOMED International h
ere.

February 16, 2017 Updated the "Record Counts" section of the Product
Delivery to reflect the addition of the "No Limit" pricing
history within the National Drug Code Price
(RNP2_NDC_PRICE) table.
Clarified information about the CPT to CVX Link Table on
the following pages:

CPT to CVX Link Table

Data elements

January 26, 2017 Updated the following sections to reflect changes to the
FUL, WAAMP, NADACB, NADACG Pricing History:

NPT_TYPE
NPT_DESC

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January 26, 2017 Added the following to the Packaged Product Technical
Specifications:

Packaged Product ERD and Technical Specifications

Packaged Product Package Type Description Table
Added the following columns to support new table:

PACKAGE_TYPE_ID
PKG_TYPE_LONG_DESC
PKG_TYPE_SHORT_DESC
ACTIVELY_USED_IND

Identifying CMS Concepts

Inclusion Criteria
NOT_MARKETED_INDICATOR

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About FDB
Company Profile
FDB provides drug knowledge that helps healthcare professionals make precise medication-related decisions.
With thousands of customers worldwide, FDB enables our information system developer partners to deliver a
wide range of valuable, useful, and differentiated solutions. As the company that virtually launched the medication
decision support category, we offer more than three decades of experience in transforming drug knowledge into
actionable, targeted, and effective solutions that improve patient safety and healthcare outcomes. For a complete
look at our solutions and services please visit www.fdbhealth.com.

Contact First Databank

Contact FDB using any of the following methods:

Customer Service
Data-related problems, media-related problems, questions, or requests should be directed to:

Customer Service
First Databank, Inc.
Part of the Hearst Health network
701 Gateway Boulevard, Suite 600, South San Francisco, CA 94080

800.633.3453
Hours: 6:00 AM to 5:00 PM, PST
Voice Mail available 24 hours a day
Fax: 650.246.2829, available 24 hours a day
Email: [email protected]

Sales
For sales and licensing, questions should be directed to:

First Databank, Inc.

Part of the Hearst Health network
701 Gateway Boulevard, Suite 600, South San Francisco, CA 94080

800.633.3453
Voice Mail available 24 hours a day
Email: [email protected]

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FDB MedKnowledge U.S. Documentation August 2017

About FDB MedKnowledge

This section contains the following topics:

Product Profile
FDB Disclaimer
Implementation Requirements
Information Update Options
Product Configuration
Product Layout
Product Delivery
Data Definition Language Policy
Custom Services
Identifiers, Attributes, and Pricing Top-Level ERD

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FDB MedKnowledge U.S. Documentation August 2017

Product Profile
FDB MedKnowledge is one of the healthcare industrys most widely used sources of up-to-date drug
information utilized at the point of care. Encompassing every drug approved by the FDA, it combines descriptive
drug information, unique identifiers and pricing data with an extensive array of clinical decision-support modules.
MedKnowledge helps pharmacists, physicians, nurses and other medical professionals avoid medication errors,
prevent adverse drug events, reduce drug-related expenses and improve the quality of patient care.

To meet a wide range of needs, MedKnowledge is offered in convenient product bundles: Core, Enhanced, or
Premium product bundles. The Core bundle provides the data and screening capabilities that reside at the heart
of MedKnowledge, including descriptive and pricing information and drug allergy screening. The Enhanced
bundle augments the core capabilities by offering additional descriptive information and screening capabilities
within modules. Premium modules are sold separately and provide supplementary data specific for your needs.
Plus, several premium modules offer drug information written specifically for the consumer.

See below for a comprehensive list of the data and modules available within package bundles or as premium
modules.

MedKnowledge is designed for system developers, clinicians, and business analysts, and provides drug
processing data to government and private healthcare programs and systems that require drug product
information in an electronic medium.

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FDB Disclaimer
FDB assumes no responsibility for errors that may appear in the MedKnowledge Documentation or the
referenced databases. FDB also assumes no liability with respect to accuracy of codes or data herein.

FDB shall not be liable for any loss or damage claimed to have resulted from the use of the MedKnowledge
Documentation. The customer shall hold FDB harmless from any such claims and shall indemnify FDB for any
expenses incurred if any such claims are made.

In no event shall FDB be liable to the customer for special, indirect, incidental, or consequential damages.

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Implementation Requirements
The Licensing Agreement forMedKnowledgestates that this product must be implemented according to the
requirements specified in this document.

When implementingMedKnowledge,you must include the following:

Customer Disclaimer Notice

Copyright Statement

Customer Disclaimer Notice

The following disclaimer must be presented on a screen display and listed on all printed reports and
monographs you provide to end users unless a specific disclaimer is provided for the individual product. You
are advised to review the definitions, functionality, and limitations of each FDB module. The following is the
exact wording of the customer disclaimer notice:
Disclaimer Wording

The information contained in the First Databank (FDB) databases is intended to supplement the
knowledge of physicians, pharmacists, and other healthcare professionals regarding drug therapy
problems and patient counseling information. This information is advisory only and is not intended to
replace sound clinical judgment in the delivery of healthcare services.

FDB disclaims all warranties, whether expressed or implied, including any warranty as to the quality,
accuracy, and suitability of this information for any purpose.

Copyright 2017 First Databank, Inc.

Les informations contenues dans les bases de donnes de First Databank (FDB) sont destines
complter les connaissances des mdecins, pharmaciens et autres professionnels de la sant concernant
les problmes des traitements mdicamenteux et les informations dassistance aux patients. Ces
informations sont titre consultatif uniquement et ne sont pas destines remplacer un jugement mdical
fond pour la prestation de soins de sant.

FDB dcline toutes garanties, explicites ou implicites, y compris les garanties de qualit, exactitude et
adquation de ces informations tout usage.

Copyright 2017 First Databank, Inc.

La informacin contenida en las bases de datos de First Databank (FDB) es intencionada a suplementar
el conocimiento de mdicos, farmacuticos y otros profesionales de la salud con respecto a los
problemas de terapa de droga e informacin educativa al paciente. Esta informacin es solamente
educativa y no est intencionada en reemplazar el juicio clnico de los servicios de cuidados de salud.

FDB rechaza todas las garantas, ya sea expresadas o implicadas, incluyendo cualquier garanta de
calidad, exactitud y conveniencia de esta informacin para cualquier propsito.

Derechos reservados 2017 First Databank, Inc.

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Copyright Statement

The copyright statement must be presented on a screen display and listed on all printed reports and
monographs you provide to end users.
Copyright Statement

Copyright 2017 First Databank, Inc.

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Information Update Options

This section provides details concerning the following:

Types of Information Updates Provided

Frequency and Distribution Methods
Issues Related to Updates

Types of Information Updates Provided

FDB provides the following types of information updates:

Database (Full-file)
Database Update (Incremental)

A database contains full replacement files for all the data tables within a customer configuration.

A database update contains incremental files consisting of only the changes since the last update.

Frequency and Distribution Methods

Updated data is available on either a monthly or weekly frequency.Most MedKnowledge Descriptive and Pricing
files are available on a daily frequency.Monthly and weekly updates are typically produced on a Thursday and
distributed on or before the following Wednesday.Daily updates are produced and distributed daily.These
production schedules may be adjusted due to holidays when FDB is closed.To verify the date your frequency was
built, reference the NDDF_PRODUCT_INFO file. See Product Info for more information.FDB distributes
information updates with the following frequencies and options:

Monthly FrequencyFDB produces both a database (full-file) and an update (incremental) file once a
month. Customers choose to apply either the database or the update file. Updates are distributed as a
download file using File Transfer Protocol (FTP).
Weekly FrequencyFDB produces both a database (full-file) and an update (incremental) file once a
week. Customers choose to apply either the database or the update file. Updates are distributed as a
download file using File Transfer Protocol (FTP).

Daily FrequencyFDB produces a subset of the MedKnowledge database as the Daily Product Update,
which contains incremental files that are distributed every Monday through Friday as an FTP download on
the day they are produced. See Daily Product Update for more information.

Daily Product Update customers might also receive clinical data on a weekly or monthly frequency. Processing
files on different frequencies appropriately requires special consideration and care. See Daily Product Update
within the Issues Related to Updates section for more information.

Issues Related to Updates

FDB offers updates containing incremental changes as an alternative to a replacement database. The updates
are designed to provide a more efficient information update process that is especially helpful to customers
receiving data via FTP and/or customers distributing data to a large number of sites. Updates are an option for

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each of the FDB products and can greatly reduce the volume of data received by customers.

Transaction Codes

Transaction codes are provided with updates and are used to indicate whether a record has been added,
changed, or deleted.

Each table is provided as a separate file with the transaction code appended to the beginning of each record.
Transaction code values are as follows:

Transaction Codes Table

Code Description

A Add

C Change

D Delete

Transaction codes are displayed as a prefix to each record. The record length for each update file is one more
than that of the database. The file is sorted by its primary key as defined in the Technical Specifications section of
each module.

Empty Files

When there are no update transactions for a table, the update file is still sent as an empty file.

DDL Treatment

Data Definition Language (DDL) does not reflect transaction codes.

FDB does not include the transaction code in the DDL. All DDL is supplied in the tables documented format,
excluding delimiters and transaction codes.

Daily Product Update

If you receive and process Daily Product Update files, it is important to process them in daily order. If you receive
and process updates weekly in addition to your daily files, you must be extra careful to ensure you apply these
updates in the proper order.

The weekly update is produced once a week (typically on Thursday). See Frequency and Distribution Methods.
Based on your delivery method, you might receive the weekly update on subsequent days of the week. For
example, if a weekly update is produced on Thursday, you might receive it on the following Friday, Saturday,
Monday, Tuesday, or Wednesday. To keep your data in sync, FDB recommends postponing the processing of the
Daily Product Update files produced after the weekly update until after the weekly update is received and applied.
For example, a weekly update is produced on Thursday but is not received until Monday of the following week. In
the meantime, two daily updates are received on Friday and Monday. On Monday when the weekly update is
received, the weekly update is applied first followed by the application of the daily updates for Friday and
Monday, in daily order.

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Please refer to the production dates in the NDDF_PRODUCT_INFO file to determine the proper order for
processing the files. See Product Info for more information.

Failure to follow this update method may bring your data out-of-sync, causing data integrity issues for your
database.

Monthly Incremental Update

If you receive and process monthly incremental updates, it is important to note that you may need to perform full
database loads under certain circumstances. In the event that FDB must perform a mid-month rebuild of the data,
we cannot produce an incremental update file for the mid-month release or for the subsequent months data. As a
result, customers will be required to perform two consecutive full database loads to ensure data integrity.

In the event that customers need to perform a full load, the incremental update file will be empty except for the
following message:

"Please process total database only for this product release."

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Product Configuration
Both the database and update are delivered with the following standard configuration:

ASCII Character Set (Code Page)

Compressed Data Files
Variable or Fixed-length Data Format
Decimals
File and Record Terminators

A description of each of these is provided in this section.

ASCII Character Set (Code Page)

The product delivery is in ASCII for all platforms. For ASCII, there are many different types of character sets
(code pages). For standard characters like a-z, A-Z, and 0-9, there are no variations within ASCII. However, for
special characters like the not sign and for accented characters there are wide variations. The following table lists
the ASCII character sets (code pages) supported by FDB:

Supported Character Sets (Code Pages)

Character Set Supported Code Page Description

ASCII ISO-8859-1 Western European set for French and

Spanish modules

ASCII 437 Default

Compressed Data Files

Products are shipped in the requested character set in a compressed format. FDB uses PK Zip to compress the
data files and all files can be uncompressed using PK Zip version 2.04 or later.

Variable or Fixed-length Data Format

Data is available in either a fixed-length or variable-length data field format.

Options for formats and delimiters include the following:

Fixed-length, no delimiter
Variable-length, pipe delimiter
Fixed length, pipe delimiter

ExampleFixed-length Records with Delimiters and without Transaction Codes

The following example of records from a database file illustrates that the data field delimiters are provided in a
fixed position.

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ExampleFixed-length Records with Delimiters and Transaction Codes

The following example of records from an update file illustrates that the delimiters are provided in a fixed position
with the transaction code at the beginning of the record.

If the data uses delimiters, then the transaction code will also have delimiters.

Decimals
Files delivered in the delimited data format have explicit decimal points. This supports the Data Definition
Language (DDL) provided with the data which assumes decimal precision. Explicit decimal points occur in both
RELD and RELDV.

Data delivered in the non-delimited data format contains implicit decimal points. The position of the decimal point
should be determined by the precision of the number and the amount of digits to the right of the number. For
example, a non-delimited Drug Product Pricing file contains the NPT_PRICEX field with format 9(6)V9(5). In this
example, the decimal would be inserted in the seventh position of the 11-digit number. Implicit decimal points
occur in the REL format.

File and Record Terminators

No special terminator characters are used. Records are terminated with standard end-of-line characters. Files are
terminated with standard end-of-file characters.

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Product Layout
The following list presents the documentation for products in the order in which the products appear in the data
delivery. Click the product name to see the documentation for that product.

MedKnowledge Product Delivery

Counseling Messages Module (CMM) 1.0

Dosage Range Check Module (DRCM) 3.1- see Dosing Modules

Drug Allergy Module (DAM) 4.0

Drug-Disease Contraindications Module (DDCM) 2.0

Drug-Drug Interaction Module (DDIM)

Drug-Drug Interaction Module for Consumers (DDIM-C) 3.3

Drug-Food Interaction Module (DFIM)

Drug-Food Interaction Module for Consumers (DFIM-C) 1.0

Drug-Lab Interference Module (DLIM) 2.0

Duplicate Therapy Module (DPT) 1.0

Indications Module (INDM) 2.0

Intravenous Module (IVM) 1.0

Medicaid Module 1.0

Medicare Module HCPCS Select

Min/Max Dose Modules 2.0 - see Dosing Modules

MedKnowledge Descriptive and Pricing

MedKnowledge Basics: Clinical Formulation and Ingredient Data

MedKnowledge Basics: Packaged Product

MedKnowledge Basics: Drug Product Pricing

MedKnowledge Basics: Miscellaneous Therapeutic Classification Data

First Databank Enhanced Therapeutic Classification System (ETC) 1.0

FDB Medical Lexicon (FML) 2.0

Medication Name Concepts (MED) 3.0

First Databank Medical Test Lexicon (MTL) 1.0

First Databank Cross-Reference Module (XRF) 1.0

Tall Man Plus 2.0

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Neonatal and Infant Dosage Range Check Module (NEOM) 1.1 - see Dosing Modules

Patient Education Module (PEM) 2.0

Precaution Modules

Prescriber Order Entry Module (POEM) 2.0

Prioritized Label Warnings Module (LBLW) 1.0

Side Effects Module (SIDE) 2.0

Universal System of Classification (USC) 1.0

AHFS DI Product Delivery

AHFS DI Monographs (AHFS DI) 1.0

Drug Images and Imprints Product Delivery

Drug Images Module 2.0

Drug Imprints Module 2.1

High Risk Medication Product Delivery

FDB High Risk Medication Module

Interoperability Product Delivery

FDB Interoperability Module 1.0

MedGuides Product Delivery

MedGuides Module 1.0

State and Federal Controlled Substances Product Delivery

FDB State and Federal Controlled Substances Module

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Product Delivery
This section provides the following information about a standard product delivery:

Record Counts
Product Info
Source Files From FDB
Delivery and Support of up to Three Versions
Directory Structure
File Naming Conventions

Record Counts
The file RECORD_COUNTS.TXT appears at the root level of the stream folder. The RECORD_COUNTS.TXT file
contains a name and number of records for each table in the MedKnowledge product. You can use this file in your
data load routine to confirm that the number of loaded records for each table matches the number of records
indicated in the record count file.

Some tables contain a different number of records depending on the number of obsolete years included. For
those tables, a separate count appears for each possible number of obsolete years. Use the record count that
has the number of obsolete years you have chosen to receive appended to the end of the filename; you can
ignore the other counts. The following counts are available for the RNDC14_NDC_MSTR table:

RNDC1YRthe number of records for National Drug Codes (NDC) up to one year obsolete
RNDC3YRthe number of records for NDCs up to three years obsolete
RNDCALLthe number of records for all NDCs

The following counts are available for the RNP2_NDC_PRICE table:

RNP1YRthe number of records for NDCs up to one year obsolete

RNP3YRthe number of records for NDCs up to three years obsolete
RNPALLthe number of records for all NDCs

The following option is also available for the RNP2_NDC_PRICE table:

RNPNOLMTpopulated with all pricing history

The RNPNOLMT provides all the historic price histories published by FDB, without limitations on
the number of price histories provided, in an effort to present customers with the most complete
pricing information available. For customers using the 1YR, 3YR or ALL pricing file we recommend
to sync with the pricing history and then, with the next production run, receive the new stream for
RNP2 No Limit.

Product Info

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The file NDDF_PRODUCT_INFO appears at the root level of the stream folder. The NDDF_PRODUCT_INFO file
contains a single record with the production date. The date appears in the form CCYYMMDD. You can use this
file in your data load routine to ensure that you load the correct file.

Customers who receive data on a weekly frequency receive both full database and update files. For these
customers, the NDDF_PRODUCT_INFO.TXT file contains the production date for the full database and the
NDDF_PRODUCT_INFO.UPD file contains the production date for the update files.

Customers who receive data on other frequencies can find the production date in the
NDDF_PRODUCT_INFO.TXT file, regardless of whether the data is a full database or update files.

Source Files From FDB

Source files containing the product consist of one or more compressed ZIP files. The following diagram illustrates
the directory structure for source files.

DB for a database
UPD for an update
DDL for the data definition language files

Since every customer receives the same data for a module, decisions and actions concerning
customization are made by the customer.

For customers who are interested in receiving most descriptive and pricing information on a daily basis,
FDB offers the Daily Product Update, for an additional fee.

The Daily Product Update provides FDBs descriptive and pricing data on a daily frequency as a
download file using FTP. Contact Customer Service for more information about the Daily Product Update.

Delivery and Support of up to Three Versions

FDB provides up to three versions of a module in the download. After the fourth version becomes available, the
oldest version is dropped from the download. Providing up to three versions through FTP provides the customer
ample opportunity to migrate to the newest version. Once a version is dropped from the delivery, it will no longer
be supported.

Example 1

A customer originally purchases Drug Allergy Module (DAM) 2.0. After a period of time, another version of DAM is

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released such as DAM 2.1. Both versions would still be provided on the FTP download.

Example 2

A customer originally purchases DAM 2.0. After a longer period of time, three additional versions of DAM are
released, such as DAM 2.1, DAM 3.0, and DAM 4.0. Only the three newest versions (DAM 2.1, DAM 3.0, and
DAM 4.0) would be provided on the FTP download. In this example the customer must migrate from DAM 2.0 to a
newer version of the DAM module.

Directory Structure
A ZIP file, when uncompressed, creates one of three directories at the root level. The directory name indicates
that the underlying directory structure contains one the following:

Data Definition Language (DDL) information for a number of commercial database programs
Database (DB) with total replacement data for modules
Update (UPD) with incrementally updated data for modules

Below the root level, the UPD and DB directory structures and file names are identical. The DDL structure is
similar, but not identical. For information on paths within DDL, see Data Definition Language Policy.

For locating data files from the root level, there are at least two other directories that form part of the path name to
any file. These two directories reflect the following:

Product Description
Version

These two directories are present in all paths for DDL, DB, and UPD data. A typical path is of the form:
\[root]\[product description]\[version]\[data file]

For example, here is the path to a master table:

\NDDF Plus DB\Dosage Range Check\DRCM 3.0\RDRCMA2_MSTR

A few products, such as MedKnowledge Descriptive and Pricing, have other directories below Version that reflect
multiple components of the product. A typical DB or UPD path for those is of the form: \[root]\[product
description]\[version]\[component name]\[data file]

The following figure represents a partial view of the actual file system extracted from a ZIP file. Notice the
component name in the path to the file RNP2_NDC_PRICE.

\NDDF Plus DB\NDDF Descriptive and Pricing\NDDF Basics 1.0\Pricing\RNP2_NDC_PRICE

This is a total replacement (DB) file. If the files had been extracted from the ZIP file containing incremental data,
the path would be identical except the root directory would be \NDDF Plus UPD\.

Partial directory structure for a data delivery

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File Naming Conventions

Names of the data files provided in both DB and UPD use the following convention:

R{mmmm}{tt}{v}_{nnnnnn}

The file name format for all product deliveries is as follows:

Name Component Definition

R Indicates a relational data file

{mmmm} Two to four character module acronym

{tt} Two character table identifier

{v} One digit version number

_{nnnnnn} Variable length intuitive table name

Dosage Range Check Master Table: RDRCMA2_MSTR

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Data Definition Language Policy

This section provides information about the Data Definition Language (DDL) files.

DDL files are created to assist in establishing the fundamental database structures within a relational database
management system. DDL files help reduce the time-consuming task of defining the tables needed to store FDB
knowledge products in a relational database.

Supported DDL Platforms

FDBs objective is to support the most common database platforms. The following database platforms are
supported with the DDL files:
Oracle
SQL Server
Sybase
RDB
ANSI 92 SQL (for compliant databases that are not explicitly supported)

DDL Properties
Please refer to the following tables for a description of the DDL properties both supported and not supported by
FDB.

Supported DDL Properties

Supported DDL Property Description

Column Naming The column name and its length adheres to standards that
are mutually compatible with all supported database
platforms. Column names are 30 characters or less.

Mandatory Fields When indicated by the design and supported by the target
database, constraints for mandatory columns (not null
constraints) are supplied for the appropriate columns for the
tables within a module. The constraint name, when needed,
adheres to standards that are mutually compatible with all
supported database platforms.

Primary Key Index Creation When supported by the target database, primary key
indexes are provided for primary key columns for the tables
within a module. The index name adheres to standards that
are mutually compatible with all supported database
platforms.

Table Creation The Create Table statement always appears for each
table delivered in the module. The table name and its length
adheres to standards that are mutually compatible with all
supported database platforms. Table name lengths are 30
characters or less.

Unsupported DDL Properties

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Unsupported DDL Property Description

Data Loading Coding and scripts to assist in loading the flat file databases
into the structures established by the DDL are not supplied.

Foreign Key Creation Creation of foreign keys is not supported. This allows you to
load your tables in any order they choose.

Indexes Indexes are not directly created. Primary keys may

indirectly result in the creation of an index; however, this is
database specific. Foreign key indexes are also not
created.

Permission Information Items such as users, grants, and privileges are not defined
in the DDL.

Reserve There is no reserved space.

Table Sizing Information Items such as data volume, storage

requirements, and number of records are not defined in the
DDL.

Transaction Code Transaction codes, delimiters, and the like are not
supported within the DDL.

Considerations for Using the FDB DDL

Consider the following issues when loading data in accordance with the FDB DDL.
Numeric and Date Field Policies
Valid Blanks May Become Null

Numeric and Date Field Policies

This issue applies to all customers.

In 2010, FDB began to provide null values within new MedKnowledge date and numeric fields when there is no
value. Date and numeric fields released prior to 2010 contain zeros when there is no value, for example, the
Obsolete Date (OBSDTEC) column within the NDC Table (RNDC14_NDC_MSTR). For existing problems with
zero padded date fields, include a NULLIF statement in your load routine to convert these values for all date
fields.

Please note that nulls are represented as spaces/blanks in REL and RELD since they are fixed-width
files.

Valid Blanks May Become Null

This issue applies to customers who receive data in the RELDV format, as well as customers who receive data in
the REL and RELD formats whose loading software interprets hard-coded blanks as null values.

For some columns a blank is a valid entry, but will appear in as a null in your system after you load the data. To
correct this issue, after you load the data, convert the nulls to blanks in the following fields:

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DESI
DESI2
HCFA_DESI1
HCFA_DC
LBLRIND
MAINT
MDT_FI
MED_REF_DESI2_IND
PPI

Product and Physical File Organization

The following are brief explanations of the product organization and the physical file organization of the DDL:

Organized and Delivered by ModuleEach module supplies those table definitions that make up the
module. The DDL name for each module reflects the module name and database type. For example,
Drug_Drug_Interaction_SYBASE.sql.
Organized by Target Database SupportedFor a given target database and module, all DDL statements
for tables, primary key indexes, and constraints appear in one file, with the exception of Oracle. In the case
of Oracle, the DDL is provided in a control file (.sql), table file (.tab), a constraint file (.con) and an index file
(.ind).

The following diagram displays a partial layout of the DDL directories.

Partial directory structure for DDL

Testing and Validation

The DDL files are tested on the following database platforms at FDB:

Oracle

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SQL Server

Maintenance
The DDL files are built as described in the documentation. Updates are in response to enhancements to current
modules and introduction of new modules.

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Custom Services
If the standard delivery needs to be modified, FDB offers a variety of fee-based services for customizing the way
in which data is provided.

For questions or inquiries concerning customization, please contact the FDB Sales Department at 800-633-3453.

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Identifiers, Attributes, and Pricing Top-Level ERD

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MedKnowledge Editorial Policies

Click a link below to access the editorial policies for a particular MedKnowledge module:

Error rendering macro 'sv-contentbylabel' : null

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MedKnowledge Identifiers and Attributes

Multiple Access Points (MAPs)
Clinical Formulation and Ingredient Data
Packaged Product
Medication Name Concepts (MED)
Tall Man Plus 2.0
FDB Medical Lexicon (FML) 2.0
First Databank Medical Test Lexicon (MTL) 1.0
First Databank Cross-Reference Module (XRF) 1.0

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Multiple Access Points MAPs

First Databank (FDB) offers a variety of drug concepts and their identifiers to support a range of applications
using the data in MedKnowledge. These identifiers represent drug products, ingredients, and formulations, and
are referred to as Multiple Access Points (MAPs).

Good Vocabulary Practice

Advantages to Using MAPs in Application Development
Formulation-based MAPs
Name-based MAPs
Other Useful MAPs
MAPs Master Tables ERDs

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Good Vocabulary Practice

MAPs are designed to conform to good vocabulary practice, characterized by the following features:

Stable Identifiersstable numeric identifiers will always represent the same concept, ensuring stability in
customer data. For example, the ingredient code (HIC_SEQN) for diphenhydramine HCl is 3369, and this
number will always represent only diphenhydramine HCl.
Dumb Numbersnumeric identifiers carry no significance beyond their literal values; there is no encoded
information, therefore, there is no need to update the value when changes occur to the concept it
represents. For example, HIC_SEQN 3369 has no encoded information, it is simply a numeric identifier
representing the ingredient diphenhydramine HCl.
Single-Purposedeach identifier represents only one concept, enhancing its stability. For example, the
ingredient diphenhydramine HCl is classified as both an antihistamine and a sedative/hypnotic; the
ingredient code (HIC_SEQN) for diphenhydramine HCl is 3369 in both cases, because it represents only
the ingredient and not the therapeutic classification or any other concept; it is single-purposed.

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Advantages to Using MAPs in Application Development

Drug information applications must allow healthcare professionals to navigate to the drug of interest easily and
rapidly. MAPs concepts allow flexiblility and provide advantages in the following areas of application
development:

Optimizing Pick ListsMAPs provide only the level of information needed for a particular list, eliminating
unnecessary scrolling through information that is too detailed (for example, multiple entries of the same
medication name with varying strengths versus one entry using only the medication name).
Documenting patient-reported medicationsMAPs provide the ability to assign patient-reported
medications to a general concept level (the manner in which they are usually reported) and still link to
clinical information.
Providing access to clinical informationMAPs make it possible to choose the level of specificity
required for the information needed.
Connecting to formulary dataMAPs make it possible to build formularies at the most appropriate level
of specificity.

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Formulation-based MAPs
The following formulation-based MAPs represent drug products at the clinical formulation level:

GCN_SEQNOThe Clinical Formulation ID (GCN_SEQNO) represents the clinical formulation, which is

the combination of active ingredient(s), route, dosage form, and strength.
HICL_SEQNOThe Ingredient List Identifier (HICL_SEQNO, formerly the Hierarchical Ingredient Code
List Sequence Number) represents the list or set of ingredients in a product. The HICL_SEQNO includes
active ingredients.
HIC_SEQNThe Hierarchical Ingredient Code Sequence Number (HIC_SEQN) is a stable identifier
representing a unique active ingredient.
ROUTED_GEN_IDThe Routed Generic Identifier (ROUTED_GEN_ID) is a numeric identifier that
identifies a combination of the list or set of active ingredients and route of administration ( GCRT).

Refer to the following diagram for more information:

ExampleFormulation-based MAPs representing Augmentin Oral Suspension

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Name-based MAPs
The following name-based MAPs represent drug products at various levels of name-specificity:

MEDIDThe Medication Identifier (MEDID) is a stable identifier that represents the unique combination of
product or generic name, route, dosage form, strength and strength unit-of-measure.
ROUTED_DOSAGE_FORM_MED_IDThe Routed Dosage Form Medication Identifier
(ROUTED_DF_MED_ID) is a stable identifier that represents the product or generic name, route, and
dosage form.
ROUTED_MED_IDThe Routed Medication Identifier (ROUTED_MED_ID) is a stable identifier that
represents the product or generic name and route of administration.
MED_NAME_IDThe Medication Name Identifier (MED_NAME_ID) is a stable identifier that represents a
unique product or generic name. Refer to the following diagram for more information.

Name-based MAPs representing Azulfidine Oral Table

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Other Useful MAPs

ETC_IDThe ETC Identifier (ETC_ID) is a permanent numeric identifier that represents a unique
therapeutic classification.
DXIDThe FML Disease Identifier (DXID) is a permanent numeric identifier that represents medical
diagnoses, disease states, and health-related conditions or procedures. It is used in conjunction with the
FDB Disease Decision Support and Dosing modules.
NDCThe National Drug Code (NDC) is the code assigned to all drug products regulated by the FDA. It
represents a packaged product. The NDC may also represent a UPC, HRI, or PIN.

Refer to the following diagram for more information:

All MAPs representing Lotrimin Topical Cream

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MAPs Master Tables ERDs

Route Master ERD
Dosage Form Master ERD
Alternative Strength ERD
Unit of Measure ERD

Route Master ERD

Dosage Form Master ERD

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Alternative Strength ERD

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Unit of Measure ERD

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Clinical Formulation and Ingredient Data

General Information
Clinical Formulation and Ingredient Data Editorial Policies
MAPs Enhancements
MAPs Freeness and Storage Condition
Alternative Strength
Dosage Form
Routes
Applications
ERD and Technical Specifications

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General Information
The General Information section contains high-level information about the module.

Definitions
Concepts

Overview
The Clinical Formulation and Ingredient section provides a detailed explanation of First Databanks (FDBs)
clinical drug formulation identifier, the Clinical Formulation ID (GCN_SEQNO), along with the ingredient set, route
of administration, dosage form, and drug strength data.

FDB is not a laboratory and is not equipped to do a laboratory analysis of pharmaceutical products. FDB
depends on the pharmaceutical manufacturer to provide all relevant information accurately and
completely in the package insert. FDB relies on the information in the package insert when determining
how to enter a particular drug into the knowledge base.

Drug knowledge is aggregated at the Clinical Formulation ID (GCN_SEQNO), Routed Medication ID (

ROUTED_MED_ID), and the Routed Generic ID (ROUTED_GEN_ID) levels in the FDB knowledge base.
Under certain circumstances, aggregated drug knowledge may not apply to all related packaged
products; more specific information may be found within product labels.

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Definitions
This section defines important terms related to the module that users should understand. Some industry terms
that have a specific connotation in regards to the module are also defined.

Dosage Form
Inactive Ingredient
Ingredient Set
Piggyback Solution Products
Route of Administration
Strength of Drug

Dosage Form

The physical presentation of a drug, such as tablet, capsule, or liquid. It may also incorporate the delivery and
release mechanism of the drug.

A Dosage Form Code (GCDF) is associated to each Clinical Formulation ID (GCN_SEQNO) to identify that
component of the clinical formulation.For example, Acetaminophen-Codeine 300 mg-15 mg Tablet Oral
(GCN_SEQNO = 4163) has a GCDF value of TA with a description of Tablet.

Refer to Dosage Form in the Concepts section for more information.

Inactive Ingredient

An ingredient that does not serve a therapeutic function. The Clinical Formulation ID ( GCN_SEQNO) aggregates
drug products that share the same active ingredients in their formulation. Inactive ingredients are not taken into
consideration when grouping drug products with like ingredient lists.

Refer to Inactive Ingredients in the Concepts section for more information.

Ingredient Set

A set of active ingredients in a clinical formulation.

The set of active ingredients in a Clinical Formulation ID (GCN_SEQNO) is represented by the Ingredient List
Identifier (HICL_SEQNO).

Refer to Ingredient List Identifier (HICL_SEQNO) in the Concepts section for more information.

Piggyback Solution Products

Products that contain the drug already in solution and are specifically intended for intravenous piggyback (IVPB)
administration.

Refer to Piggyback Solution Products in the Concepts section for more information.

Route of Administration

Refers to the normal site or method by which a drug is administered in the body, such as oral, injection, or topical.

A Route of Administration Code (GCRT) is associated to each Clinical Formulation ID (GCN_SEQNO) to identify

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that component of the clinical formulation.For example, Acetaminophen-Codeine 300 mg-15 mg Tablet Oral
(GCN_SEQNO = 004163) has a value of 1 with a description of Oral.

Refer to Route of Administration in the Concepts section for more information.

Strength of Drug

The strength of a clinical formulation refers to the potency of the drug and is most commonly expressed in a
metric quantity, such as 500 mg, however, other unit expressions are possible if consistent with product labeling
and good clinical judgment.

A Drug Strength Description (STR) is associated to each Clinical Formulation ID (GCN_SEQNO) to identify that
component of the clinical formulation.For example, the STR for Acetaminophen-Codeine 300 mg-15 mg Tablet
Oral (GCN_SEQNO = 004163) is 300 mg-15 mg, meaning 300 mg of Acetaminophen and 15 mg of Codeine.

Refer to Strength in the Concepts section for more information.

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Concepts
This section describes concepts and database elements that are important for understanding the module.

Clinical Formulation Identifier (GCN_SEQNO)

Clinical Formulation ID and Packaged Drug Products
Ingredient List Identifier (HICL_SEQNO)
Generic Names
Ingredient List (HICL_SEQNO)
Ingredient Identifier (HIC_SEQN)
Base Ingredient Identifier (HIC4_SEQN)
Specific Therapeutic Classification Identifier (HIC3_SEQN)
Pharmacological Classification Identifier (HIC2_SEQN)
Organ System Identifier (HIC1_SEQN)
Ingredient List Relationships
Ingredient to Ingredient Diagram
Ingredient Classification Diagram
Inactive Ingredients
Inactive Ingredient columns and tables
The Potentially Inactive Indicator Columns
GCN_SEQNO/Inactive Ingredient Relation Table
GCN_SEQNO Study Table
Route of Administration
Oral Routes
Injection Routes
Parenteral/Non-injection Routes
Further Information on Routes
Dosage Form
Strength
Conventions for Strength Units
Character and Special Symbol Conventions
Single Ingredient Products
Multi-Ingredient Products
Piggyback Solution Products
Apothecary to Metric Conversion
Routed Generic
ROUTED_GEN_ID
ROUTED_GEN_STATUS_CD

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Clinical Formulation Identifier (GCN_SEQNO)

FDBs primary clinical formulation identifier is the Clinical Formulation ID ( GCN_SEQNO). It represents a
pharmaceutical formulation that is based on a unique combination of active ingredients, route of administration,
dosage form, and strength. The Clinical Formulation ID (GCN_SEQNO) is used to group together drug products
with like active ingredient sets, routes of administration, dosage forms, and strength and provides an excellent
method for:

navigating to clinical modules

developing a list of candidates for substitution in the dispensing environment
formulary building
purchasing and price analysis
prescribing

The components for the drug formulation, identified by the Clinical Formulation ID ( GCN_SEQNO), are stored in
the following columns:

Ingredient List Identifier (HICL_SEQNO)The Ingredient List Identifier represents the list or set of active
ingredients in a drug formulation. Inactive ingredients are generally not included in the ingredients list.
Some exceptions exist to facilitate the application of clinical information. These exceptions are not
common.
Route of Administration (GCRT)The Route of Administration Code provides the normal site or method by
which the drug is administered, such as oral, injection, or topical. A text description of the GCRT is
provided in the Route Description (RT) column.
Dosage Form (GCDF)The Dosage Form Code represents the dosage form of the clinical formulation,
such as tablet or capsule. A text description of the GCDF column is provided in the Dosage Form
Description (GCDF_DESC) column.
Strength (STR)The Drug Strength Description most commonly describes the drug potency in metric
units. Other unit expressions are possible if consistent with product labeling and good clinical judgment.

The Clinical Formulation ID (GCN_SEQNO) aggregates drug products that share a like active ingredient set,
route of administration, dosage form, and strength of drug but are marketed by multiple manufacturers, for
example, the pharmaceutical formulation ofAcetaminophen-Codeine 300 mg-15 mg Tablet Oral has a Clinical
Formulation ID (GCN_SEQNO) value of 004163.This formulation may be manufactured, packaged, and sold in
hundreds of variations ranging from bottles of 500 to blister packs. The information found in FDBs clinical
modules (such as drug-drug interactions, duplicate therapy occurrences, drug allergy checking, side effects, etc.)
is identical for all of the different packages of the same pharmaceutical formulation. The Clinical Formulation ID (
GCN_SEQNO) simplifies drug navigation by eliminating extraneous information and focusing on the core
components of the pharmaceutical formulation.

A unique Clinical Formulation ID (GCN_SEQNO) is assigned to each different combination of active ingredient(s),
route of administration, dosage form, and strength for a clinical formulation. The Clinical Formulation ID

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(GCN_SEQNO) Example Table below illustrates that there are many Clinical Formulation IDs (GCN_SEQNOs)
for the ingredient Nitroglycerin to accommodate each unique combination of ingredient, route of administration,
dosage form, and strength. The data for each column along with its corresponding description is provided below:

Clinical Formulation ID (GCN_SEQNO) Example Table

GCN_SEQN Ingredient Description Route Route Dosage Dosage Strength

O List (HIC_DESC (GCRT) Description Form Form (STR60)
Identifier ) (RT) (GCDF) Description
(HICL_SEQ (GCDF_DE
NO) SC)

000464 000159 nitroglycerin T TRANSDER OA OINTMENT( 2%

M GM)

000465 000159 nitroglycerin T TRANSDER PV PATCH, 0.4 mg/hour

M TRANSDER
MAL 24
HOURS

000466 000159 nitroglycerin T TRANSDER PV PATCH, 0.6 mg/hour

M TRANSDER
MAL 24
HOURS

000476 000159 nitroglycerin S SUBLINGUA TU TABLET, 0.6 mg

L SUBLINGUA
L

064720 000159 nitroglycerin A INTRAVEN HV VIAL 50 mg/10 mL

(SKV,MDV
(5 mg/mL)
OR
ADDITIVE(M
L)

Note that a difference in any of the components warrants the creation of another Clinical Formulation ID (
GCN_SEQNO). For example, Clinical Formulation IDs (GCN_SEQNOs) 000465 and 000466 (on the
above table) differ only in the strength value (0.4 mg/hour and 0.6 mg/hour), yet each is a unique clinical
formulation and are therefore given a unique Clinical Formulation ID (GCN_SEQNO).

There is one exception to the rule that Clinical Formulation IDs (GCN_SEQNOs) are created based upon the
unique combination of a formulations active ingredient set, route of administration, dosage form, and strength. In
special cases when supporting clinical data warrants it, the specific therapeutic classification (HIC3_SEQN) is
used to differentiate between identical clinical formulations. In these rare circumstances, pharmaceutically
equivalent formulations are given different Clinical Formulation IDs (GCN_SEQNOs) because each formulation
has been assigned to a different therapeutic classification.

For example, two Clinical Formulation IDs ([GCN_SEQNOs] 003703 and 011583) have DIPHENHYDRAMINE
HCL (HICL_SEQNO 004480) as their primary ingredient, as well as the same dosage form, strength, and route.

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However the specific therapeutic class (HIC3_SEQN) of each formulation is different because this clinical
formulation has indications in more than one therapeutic class.

GCN_SEQNO HIC3_SEQN HIC3_DESC Indications

003703 000257 SEDATIVE-HYPNOTICS,N Insomnia

ON-BARBITURATE

011583 003218 ANTIHISTAMINES - 1ST Parkinsonism,

GENERATION Extrapyramidal Disease,
Allergic Conjunctivitis,
Allergic Rhinitis, Nasal
Congestion, Pruritus,
Dermatographism, Urticaria,
Vertigo, Insomnia, Sneezing,
Cough, Nausea and
Vomiting, Nausea, Vomiting,
and Anaphylaxis

FDB recommends using the First Databank Enhanced Therapeutic Classification System (ETC) 1.0 to
categorize clinical formulations that serve multiple therapeutic needs. ETC allows one Clinical Formulation ID
(GCN_SEQNO) to be listed into multiple therapeutic classes.

Clinical Formulation ID and Packaged Drug Products

The Clinical Formulation ID (GCN_SEQNO) has a one-to-many relationship with packaged drug productsas
represented by NDCs (refer to the Packaged Product Packaged Product Editorial Policies for more information).A
given Clinical Formulation ID (GCN_SEQNO) may be linked to many packaged drug products; however, a
packaged drug product can have only one Clinical Formulation ID (GCN_SEQNO).

The following table shows five of the many packaged drug products that share the Clinical Formulation ID
(GCN_SEQNO) 009260. Note that the Clinical Formulation ID (GCN_SEQNO) can refer to more than one
National Drug Code (NDC), more than one manufacturer, and more than one kind of package.

GCN_SEQNO NDC Label Name (LN) Manufacturer Package Size Package

(MFG) (PS) Description (PD)

009260 55289007540 ERYTHROMYCIN PD-RX PHARM 40 BOTTLE

250 MG FILMTAB

009260 55289007556 ERYTHROMYCIN PD-RX PHARM 56 BOTTLE

250 MG FILMTAB

009260 60429007040 ERYTHROMYCIN GSMS, INC 40 BLIST PACK

250 MG FILMTAB

009260 66267009020 ERYTHROMYCIN NUCARE 20 BOTTLE

250 MG FILMTAB PHARMACE

009260 66267009028 ERYTHROMYCIN NUCARE 28 BOTTLE

250 MG FILMTAB PHARMACE

Examples of Formulation Differences

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The following tables illustrate differences in the way a drug is formulated and assigned a Clinical Formulation ID (
GCN_SEQNO):

ExampleSimilar products with different ingredients (pain relief)

GCN_SEQNO NDC LN

012080 00045060404 CHILD'S MOTRIN 100 MG/5 ML

(ibuprofen)

004481 56062037526 CHLD ACETAMINOPHEN 160 MG/5

ML (acetaminophen)

ExampleSimilar products with different ingredients (lowering cholesterol)

GCN_SEQNO NDC LN

006416 00071073720 LOPID 600 MG TABLET (gemfibrozil)

013675 00185094098 CHOLESTYRAMINE PACKET

(cholestyramine/sucrose)

016579 68115077790 ZOCOR 40 MG TABLET (simvastatin)

ExampleSame ingredient products with different dosage forms

GCN_SEQNO NDC LN

008995 00093310701 AMOXICILLIN 250 MG CAPSULE

(amoxicillin trihydrate capsule)

008998 00093415573 AMOXICILLIN 250 MG/5 ML SUSP

(amoxicillin trihydrate suspension)

ExampleSame ingredient products with different strength

GCN_SEQNO NDC LN

0021694 00078017605 LESCOL 20 MG CAPSULE (fluvastatin

sodium 20 MG)

0021695 00078023405 LESCOL 40 MG CAPSULE (fluvastatin

sodium 40 MG)

ExampleSame ingredient products with different route

GCN_SEQNO NDC LN

004371 00574703412 ASPIRIN 300 MG SUPPOSITORY

(aspirin rectal)

004376 00113041678 ASPIRIN 325 MG COATED TABLET

(aspirin oral)

Ingredient List Identifier (HICL_SEQNO)

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The Ingredient List Identifier (HICL_SEQNO) is a permanent numeric identifier that identifies a unique
combination of active ingredients, irrespective of the manufacturer, package size, dosage form, route of
administration, or strength.For example, HICL_SEQNO 021800 identifies the following set of active ingredients:

abacavir sulfate
lamivudine
zidovudine
Because the HICL_SEQNO uniquely identifies a specific list of active ingredients (such as Codeine Phosphate
and Acetaminophen), it can be associated to multiple Clinical Formulation IDs ( GCN_SEQNO), thus decreasing
processing time, eliminating redundancy, and ensuring that the list of active ingredients is consistent and correct
for each associated Clinical Formulation ID (GCN_SEQNO).

Individual ingredients are represented by the following:

Hierarchical Ingredient Code Sequence Number (HIC_SEQN)a dumb number used to permanently
identify a distinct ingredient and its specific therapeutic classification, such as HIC_SEQN 000590 for
Digitalis Leaf
Hierarchical Ingredient Code (HIC)a smart number used to identify an ingredient and its specific
therapeutic classification. FDB recommends using the HIC_SEQN instead of the HIC as a primary
identifier since the HIC_SEQN is a permanent, dumb number.
Hierarchical Ingredient Code Description (HIC_DESC)a description of the ingredient identified by the
HIC_SEQN (such as Digitalis Leaf).

Inactive ingredients (HIC_SEQNs) are not commonly included in the HICL_SEQNO. They are associated
at the NDC level through the NDC/HIC_SEQN Inactive Ingredient Relation Table, or at the MED concept
level through the The Inactive Ingredient Relation Tables (see Medication Name Concepts Concepts
for more information).

Refer to "Inactive Ingredients" in this Concepts section for more information about inactive ingredients.

The HICL_SEQNO has a one-to-many relationship with the Clinical Formulation ID (GCN_SEQNO). That is, one
HICL_SEQNO may be attached to just one or to many Clinical Formulation IDs (GCN_SEQNOs).

Generic Names

Long and short generic names for a HICL_SEQNO can be obtained through the Generic Name - Short Version (
GNN) and Generic Name - Long Version, (GNN60) columns of the Ingredient List Identifier Description Table
(RHICLSQ2_HICLSEQNO_MSTR).The table below illustrates the difference between the GNN and GNN60
descriptions.

Sample Valid Values Table

HICL_SEQNO GNN GNN60

1820 aspirin aspirin

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2073 albuterol sulfate albuterol sulfate

35285 pseudoeph/DM/guaifen/acetamin pseudoephedrine/dextromethorphan/g

uaifenesin/acetaminophen

1168 mag hydrox/aluminum hyd/simeth magnesium hydroxide/aluminum

hydroxide/simethicone

12233 betaine betaine

22000 bimatoprost bimatoprost

25663 DM/acetaminophen/doxylamine dextromethorphan

HBr/acetaminophen/doxylamine

Ingredient List (HICL_SEQNO)

The ingredient list, referenced by the HICL_SEQNO, is commonly referred to as the HICL. Each active ingredient
in the list is sequenced according to its clinical importance relative to other ingredients. The relative importance of
an active ingredient is based on its clinical and therapeutic use. The HICL can be assembled using the
HICL_SEQNO/HIC Relation Table (RHICL1_HIC_HICLSEQNO_LINK).

There is not a column named HICL in the standard relational product. HICL is simply a reasonable
abbreviation for the concept of a HIC List that has a unique identifier (its HICL_SEQNO).

Inactive ingredients are not included in the HICL.

Included in this section is information about the following concepts related to the Ingredient List Identifier. Two
diagrams are included to help illustrate the relationship of the ingredients and its identifiers. The following topics
are discussed in this section:

Ingredient Identifier (HIC_SEQN)

The Hierarchical Ingredient Code Sequence Number (HIC_SEQN) is a stable numeric identifier that represents a
distinct active or inactive ingredient, including salts and esters. The HIC_SEQN is a dumb number, assigned by
FDB. For example, as shown in the Ingredient to Ingredient Diagram below, HIC_SEQN 000724 will always
represent the ingredient Guaifenesin.

Potentially inactive ingredients have HIC_SEQN values, but they are not always included in product
HICL_SEQNOs. See the Inactive Ingredients, page 66 section for information on the inactive ingredient
functionality supplied by FDB.

Occasionally, a HIC_SEQN must be replaced. This usually happens when two HIC_SEQN values represent the
same ingredient. Replaced HIC_SEQN values receive an Ingredient Status Code ( ING_STATUS_CD) value of 1
(Replaced) and are listed in the Ingredient Replacement History Table (RHICRH0_ING_HIST, page 157) with a
reference to the current HIC_SEQN value. For example, HIC_SEQN 000626 and HIC_SEQN 001350 both
represent Lidocaine. To replace HIC_SEQN 000626 with HIC_SEQN 001350, HIC_SEQN 000626 received an
ING_STATUS_CD value of 1 and is listed in the RHICRH0_ING_HIST table with a reference to HIC_SEQN
001350.

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Replaced HIC_SEQN values are never deleted from the database. Replaced HIC_SEQN values can be removed
from active use, such as in pick lists, but remain in the database to produce important user messages, such as
allergy warnings and drug interaction alerts.

HIC_DESC

HIC_SEQNs for active and inactive ingredients have a HIC_DESC text description. For example, the HIC_DESC
for HIC_SEQN 001653 is dextromethorphan hydrobromide, as shown in the Ingredient to Ingredient Diagram,
page 65 later in this section.

HIC_REL_NO

The sequence of active ingredients in an ingredient list is identified by the HIC_REL_NO. The sequence of
ingredient names in multi-ingredient products is determined by the following blend of legacy and new priorities:

The order of ingredients used by FDB is guided by the order of ingredients and strengths presented in
product labeling by the innovator on FDB-approved drug products in the U.S. drug market. FDB presents
this order of ingredients as it is the most readily recognized for U.S. drug products.

The order of ingredients used by FDB for OTC formulations varies depending on the type of formulation.
For antihistamine-decongestant type cough and cold formulations for example FDB has a policy for the
order based on the pharmacology of the ingredient. Older formulations, regardless of type may follow the
legacy, "historic" market driven priority described below.

Historic market driven prioritya legacy prioritization system based on historic market driven needs. For
example, expectorants and related cough-cold ingredients were historically placed early in the ingredient
list to facilitate recognition as cough/cold formulations relative to billing and payor methods of using a
variety of basic classifications (i.e., HIC3/GC3, TC, GTC) to determine reimbursement. For example, the
active ingredients assigned to HICL_SEQNO 000222 are stored and identified in the following order:
Guaifenesin, Dextromethorphan Hydrobromide, and Pseudoephedrine.

Inactive ingredients identified in the Inactive Ingredient table do not have HIC_REL_NOs.

Hierarchical Ingredient Code (HIC)

The Hierarchical Ingredient Code (HIC) is a six-character smart identifier that represents an active or inactive
ingredient and its specific therapeutic classification. The HIC provides links to the following information about the
ingredient:

Base Ingredient
Therapeutic Classification
Pharmacological Classification
Organ System

FDB recommends using the HIC_SEQN instead of the HIC as a primary identifier since the HIC_SEQN is
a permanent, dumb number.

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For a more comprehensive and robust classifications that provide greater levels of specificity, FDB recommends
using the First Databank Enhanced Therapeutic Classification System (ETC) 1.0 rather than the HIC to
identify an active ingredients therapeutic classification.

Base Ingredient Identifier (HIC4_SEQN)

The HIC4_SEQN is a permanent numeric identifier that represents a base ingredient without salts or esters. For
example, the description for HIC4_SEQN 00074 is and always will be Guaifenesin.Potentially inactive ingredients
have HIC4_SEQN values as well, but they are not included in product HICL_SEQNOs. See the Inactive
Ingredients, page 66 section for information on the various inactive ingredient functionality supplied by FDB.
If a HIC4_SEQNs ingredient is retired because it is a duplicate ingredient, a replacement history is kept for that
HIC4_SEQN and the following events occur in order to uphold the requirements of a dumb number:

A new HIC4_SEQN value is created and assigned to the changed ingredient

The old HIC4_SEQN value is given an Ingredient Status Code ( ING_STATUS_CD) value of 1 (Replaced)
The old HIC4_SEQN value is listed in the Ingredient Replacement History Table (RHICRH0_ING_HIST)
with a reference to the new HIC4_SEQN value

An ingredient may be retired without replacement.

Specific Therapeutic Classification Identifier (HIC3_SEQN)

The HIC3_SEQN is a permanent numeric identifier that represents the specific therapeutic classification of a
given active ingredient (HIC_SEQN). The HIC3_SEQN is a dumb number, assigned by FDB, that will never
change. For example, the text description for HIC3_SEQN 000160 is and will always be Expectorants.

Pharmacological Classification Identifier (HIC2_SEQN)

The HIC2_SEQN is a permanent numeric identifier that represents the pharmacological classification of a given
active ingredient (HIC_SEQN). The HIC2_SEQN is a dumb number, assigned by FDB, that will never change. For
example, the text description for HIC2_SEQN 000030 is and will always be Affect Primarily Trachea/Bronchi.

Organ System Identifier (HIC1_SEQN)

The HIC1_SEQN is a permanent numeric identifier that represents the organ system of a given active ingredient (
HIC_SEQN). The HIC1_SEQN is a dumb number, assigned by FDB, that will never change. For example, the text
description of HIC1_SEQN 000002 is and will always be Respiratory System.

Ingredient List Relationships

The Hierarchical Ingredient Code (HIC) represents one active ingredient in the list of active ingredients identified
by the Ingredient List Identifier (HICL_SEQNO). All six characters of a HIC uniquely identify an active ingredient
and its specific therapeutic classification.

HIC Character/Position Description Table

Column Name Description Example: HIC H6CAHB

(Dextromethorphan Hydrobromide)

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HIC1_SEQN Identifies the organ system H = NERVOUS SYSTEM (EXCEPT

AUTONOMIC)

HIC2_SEQN Identifies the pharmacological H6 = DRUGS ACTING PRINCIPALLY

classification ON THE MIDBRAIN

HIC3_SEQN Identifies the therapeutic classification H6C = ANTITUSSIVES,

NON-NARCOTIC

HIC4_SEQN Identifies the base ingredient H6CA = DEXTROMETHORPHAN

HIC_SEQN Identifies the ingredient and the salt (if H6CAHB = DEXTROMETHORPHAN
applicable) HYDROBROMIDE

The 5th and 6th characters of a HIC identify the salt/ester for a base ingredient, such as hydrochloride, sodium,
sulfate, phosphate, or hydrobromide (if there is one). All six positions of the HIC are required to identify the
ingredient, with the first four identifying the base ingredient and its specific therapeutic classification.

For each level of an ingredients Hierarchical Ingredient Code ( HIC), there is an associated sequence number
(such as HIC1_SEQN) identifying that level. The root of one sequence number links to the sequence number of
the next hierarchical level. For example, the HIC_ROOT links to the HIC4_SEQN, the HIC4_ROOT links to the
HIC3_SEQN, and so on as described in the table below. It is important to follow the path of root and associated
sequence number to obtain hierarchical information about an active ingredient, because the sequence numbers
are permanent identifiers that never change meaning.

HIC Sequence Numbers and Associated Roots

HIC Identifier Description with Root Associated to

Example

HIC HIC_SEQN Ingredient - HIC_ROOT HIC4_SEQN

Dextromethorphan
Hydrobromide

HIC4 HIC4_SEQN Base Ingredient - HIC4_ROOT HIC3_SEQN

Dextromethorphan

HIC3 HIC3_SEQN Specific Therapeutic HIC3_ROOT HIC2_SEQN

Classification -
Antitussives,
Non-Narcotic

HIC2 HIC2_SEQN Pharmacological HIC2_ROOT HIC1_SEQN

Classification - Drugs
Acting Principally on
the Midbrain

HIC1 HIC1_SEQN Organ System - (n/a) (n/a)

Nervous System
(Except Autonomic)

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Refer to Ingredient to Ingredient Diagram and Ingredient Classification Diagram below for an illustration of
ingredient identifier relationships.

Ingredient to Ingredient Diagram

The following diagram graphically illustrates the relationship between the Hierarchical Ingredient Code Sequence
Number (HIC_SEQN) and the Ingredient List Identifier:

Ingredient Classification Diagram

The following diagram graphically illustrates the relationship between an active ingredient and its therapeutic
classification:

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Inactive Ingredients

FDB relies on notification by the manufacturer and a process of NDC review to keep its inactive ingredient
information current. For this reason inactive ingredient information is subject to change at any time without notice.

Manufacturers should notify FDB as soon as possible whenever a products inactive ingredients change.

Inactive Ingredient columns and tables

The following columns are provided in the Clinical Formulation and Ingredients module:

HIC Potentially Inactive Indicator (HIC_POTENTIALLY_INACTV_IND)

HIC4 Potentially Inactive Indicator (HIC4_POTENTIALLY_INACTV_IND)

The following tables are provided in the Clinical Formulation and Ingredients module:

GCN_SEQNO/Inactive Ingredient Relation Table (RGCNINH0_GCNSEQNO_INACTV_LINK)

GCN_SEQNO Study Table (RGCNINS0_STUDY_TABLE)
HIC_SEQN/HIC_SEQN Link Table (RHICHCR0_HIC_HIC_LINK)
Ingredient Replacement History Table (RHICRH0_ING_HIST)

The following sections provide detailed descriptions of these columns and tables:

The Potentially Inactive Indicator Columns

It is unsafe to categorize a particular ingredient as strictly inactive in all contexts. Ingredients that have the
potential to be inactive are called potentially inactive ingredients. The HIC Potentially Inactive Indicator (
HIC_POTENTIALLY_INACTV_IND) and the HIC4 Potentially Inactive Indicator (
HIC4_POTENTIALLY_INACTV_IND) identify potentially inactive ingredients.

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Both active and inactive ingredients pose allergy risks to allergic patients.

If an ingredient has a Potentially Inactive Indicator value of 0 (zero), the ingredient is considered active in every
context. If an ingredient has a Potentially Inactive Indicator value of 1, the ingredient is considered potentially
inactive. See the Inactive Ingredient Screening section in the Drug Allergy Screening Overview for important
information about inactive ingredients and allergy screening. If a potentially inactive ingredient appears in a
products HICL_SEQNO, the ingredient participates as an active ingredient in that product. Similarly, if the
ingredient is related to the products NDC in the NDC/HIC_SEQN Inactive Ingredient Relation Table
(RNDCINH0_NDC_INACTV_LINK), the ingredient participates as an inactive ingredient in that product.

Sorting on this field should not be performed. All ingredients with a potentially inactive indicator of 1 are
not inactive ingredients; they have the potential to be active ingredients in some formulations as well.

GCN_SEQNO/Inactive Ingredient Relation Table

The GCN_SEQNO/Inactive Ingredient Relation Table (RGCNINH0_GCNSEQNO_INACTV_LINK) provides

packaged product counts for a given Clinical Formulation ID (GCN_SEQNO)/HIC_SEQN combination. The
following two count values are associated with each of these combinations:

Inactive Ingredient Present Count (INACTV_PRES_CNT)

Inactive Ingredient Not Present Count (INACTV_NOT_PRES_CNT)

These count values report the number of NDCs linked to the given Clinical Formulation ID ( GCN_SEQNO) that
either have or do not have the inactive ingredient HIC_SEQN in their formulation. The counts only include NDCs
that have already been reviewed for inactive ingredients as reflected in the NDC Inactive Ingredients Reviewed
Master Table (RNDCINR0_INACTV_REVIEWED). These counts may change with continued FDB inactive
ingredient research.

These counts reflect active products, and products that have been retired or replaced for less than or equal to one
year.

GCN_SEQNO Study Table

The GCN_SEQNO Study Table (RGCNINS0_STUDY_TABLE) provides packaged product counts for the given
Clinical Formulation ID (GCN_SEQNO). The following two count values are associated with each Clinical
Formulation ID (GCN_SEQNO):

Total Products Count (TOTAL_PRODUCTS_CNT)

Products Researched for Inactive Ingredients Count (PRODUCTS_RESEARCHED_CNT)

These count values report the number of NDCs linked to the given Clinical Formulation ID (GCN_SEQNO) that
have been researched by FDB for inactive ingredient information, and the total number of NDCs linked to the
Clinical Formulation ID (GCN_SEQNO). These counts may change with continued FDB inactive ingredient

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research.

These counts reflect active products, and products that have been retired or replaced for less than or equal to one
year.

Route of Administration

The route of administration refers to the normal site or method by which a drug is administered to the body, such
as oral, injection, or topical. A Route of Administration Code (GCRT) is associated to each Clinical Formulation ID
(GCN_SEQNO) to identify that component of the clinical formulation.For example, Codeine Phos/Acetaminophen
15-325 MG Tablet Oral (GCN_SEQNO = 4164) has a GCRT value of 1 with a description of Oral.
FDB maintains a robust list of routes with which to describe formulations. Only one route may be assigned to any
Clinical Formulation ID (GCN_SEQNO). These routes fall into the following categories:

Oral Routes
Injection Routes
Parenteral/Non-injection Routes

Oral Routes

Oral routes include, but are not limited to, the following:

Oral Routes

Route Code Route Description Route Definition

1 ORAL ingested drug product

L TRANSLINGUAL drug product applied onto the tongue

B BUCCAL drug product held or adhered to inside

of cheek

S SUBLINGUAL drug product held under the tongue

4 MUCOUS MEMBRANE drug product applied topically to mouth

(TOPICAL MOUTH & THROAT) or throat, such as mouth washes and
throat rinses; administered directly to
the mouth and/or pharynx

D DENTAL drug products that go in the mouth,

such as toothpaste, tablets, gels and
other products used for dental
preparations; administered to the teeth

Injection Routes

Although there is a general route code for injection (unspecified parenteral), there are also routes that require
specific injection sites. In cases where packaged drug products can be injected in more than one manner the
preferred route is assigned.

For example, a product is primarily administered subcutaneously but according to its clinical information it can
also be administered intramuscularly. In this case, the preferred route of Subcutaneous would be applied for the

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formulation.

Injection Routes

Route Code Route Description Route Definition

A INTRAVENOUS (ONLY) Injection in a vein

C INTRAMUSCULAR (ONLY; Injection in a muscle

REPOSITORY; ETC.)

G SUBCUTANEOUS Injection made under the skin

2 INJECTION (UNSPECIFIED Parenteral drug administration by

PARENTERAL ROUTES) intravenous, intramuscular, or
subcutaneous injection

Parenteral/Non-injection Routes

Parenteral/non-injection routes are for packaged drug products introduced to the body other than by way of the
intestines. Following is a list of some of the parenteral/non-injection routes used by FDB:

Parenteral/Non-injection

Route Code Route Description Route Definition

E EPIDURAL (ONLY) Administered outside the dura mater

F PERFUSION The pumping of a fluid through an

organ or tissue

H INHALATION Medication to be taken in by inhaling

I INTRACAVERNOSAL Administration within the dilatable

spaces of the corporus cavernosa of
the penis

J INTRAARTERIAL Administered into, or involving entry by

way of an artery

K INTRAARTICULAR Administered by entering a joint

N IMPLANTATION Administered by the insertion or

grafting into the body

O INTRATHECAL Introduced into the space under the

arachnoid membrane of the brain or
spinal cord

P INTRAPERITONEAL Administered by entering the

peritoneum

Q INTRAVESICAL Administered within the bladder

R IRRIGATION (BLADDER, WOUNDS, Administration to bathe or flush open

ETC.) wounds or body cavities

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T TRANSDERMAL Supplying a medication in a form for

absorption through the skin into the
bloodstream

U URETHRAL Administered through the urethra

V VAGINAL Administered through the vagina

W INTRAOCULAR Administered by entering the eyeball

X INTRAPLEURAL Administered by entering the pleura or

pleural cavity

3 RECTAL Administered through the rectum

5 TOPICAL (HAIR, NAILS AND SKIN) Administration to a particular spot on

the outer surface of the body, including
hair, nails, and skin

6 OPHTHALMIC (INCLUDES EYE-EAR Administration to the external eye

PREPS)

7 NASAL Administration to or by way of the nose

8 OTIC Administration to or by way of the ear

9 INTRADERMAL Administered by entering the skin

Further Information on Routes

The route code M is for MISCELL. (NON-DRUG OR COMBO ROUTE DRUG). For additional information about
clinical routes of administration, refer to Clinical Route in the Rules for Data Elements section in the Dosing
Modules documentation or the Prescriber Order Entry Module (POEM) 2.0 documentation.

Dosage Form

The dosage form of a clinical formulation describes the physical presentation of a drug, such as tablet, capsule, or
liquid. It may also incorporate the delivery and release mechanism of the drug. A Dosage Form Code ( GCDF) is
associated to each Clinical Formulation ID (GCN_SEQNO) to identify that component of the formulation.

Determination of a dosage form for a new formulation is done by assessing:

Delivery method
Release mechanism
Clinical uniqueness, including, but not limited to, side effects, indications, contraindications and conditions
which may impact patient education and label warnings

Most formulations can be adequately described with FDBs existing dosage forms; however, new dosage forms
are added when the clinical uniqueness of a novel dosage form has been established.

The U.S. Food and Drug Administration does not specify as many unique dosage forms as FDB; FDB supports all
dosage forms identified by the Food and Drug Administration and observes similar naming conventions when
possible. FDB also supplies additional dosage forms.

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For example, FDB provides over 25 different dosage forms for tablets.

Tablet Dosage Forms

Dose Form Code (GCDF) Dose Form Description

TA TABLET

TV TABLET, BUCCAL

TY TABLET, BUCCAL EXTENDED RELEASE

TC TABLET, CHEWABLE

TE TABLET, DELAYED RELEASE (ENTERIC COATED)

TJ TABLET, DISPERSIBLE

UL TABLET, RAPID DISSOLVE

UD TABLET, DOSE PACK

TF TABLET, EFFERVESCENT

TN TABLET, GRANULE-LIKE OR PACKETS

TH TABLET, HYPODERMIC

UJ TABLET, LINGUAL DELAYED RELEASE

UB TABLET, MULTIPHASIC RELEASE

TR TABLET, PARTICLES/CRYSTALS IN

UA TABLET, SEQUENTIAL

TB TABLET, SOLUBLE

TU TABLET, SUBLINGUAL

TQ TABLET, EXT.RELEASE,PARTICLES/CRYSTALS

TS TABLET, EXTENDED RELEASE

UE TABLET, EXTENDED RELEASE SEQUENTIAL

TM TABLET, EXTENDED RELEASE 12HR

TI TABLET, EXTENDED RELEASE 24HR

UF TABLET, EXTENDED RELEASE 8HR

TO TABLET, EXTENDED RELEASE 12HR SEQUENTIAL

Strength

The strength of a drug formulation refers to the potency of the drug and is most commonly expressed in a metric
quantity, such as 500 mg, however other unit expressions are possible if consistent with product labeling and

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good clinical judgment. A Drug Strength Description (STR) is associated to each Clinical Formulation ID (
GCN_SEQNO) to identify that component of the formulation.

Strength descriptions follow Good Vocabulary Practice (GVP) and accepted industry standards whenever
possible, though space limitations create isolated exceptions. Identical products have identical strength
descriptions.

When possible, strength units are identified. In some cases it may not be possible to identify the units, such as
when a multi-ingredient products strengths exceed the maximum length.

ExampleA Multi-ingredient Product Strengths Exceeds the Maximum Length of Ten Bytes

The packaged drug product, Augmentin, contains a combination of multiple strengths for its multiple ingredients
and a volume 250 mg-62.5 mg per 5 mL, that exceeds ten bytes. Thus its strength is reported as 250-62.5/5, and
no UNIT is displayed.

Conventions for Strength Units

The following conventions apply to all rendering of strength units.

For single ingredients, decimals must have a leading zero (0.25MG). There are no zeroes trailing the
decimal point (1MG, not 1.0MG). For multi-ingredients, the strength value might not contain the leading
zero (.0375MG/24) due to space constraints.
All abbreviations for grams are G.
When units are identical, the units are stated after the second strength (for example, 800-160MG).
When the units are mixed, both or none are stated, depending on space.

Character and Special Symbol Conventions

Slashes (/) are to designate concentrations only (for example, 250MG/5ML).

Hyphens (-) are to designate strengths only. For example, 250MG-125 is the strength of Oyst-Cal-D 250
milligram-125 units.

Single Ingredient Products

Single ingredient products can be divided into five categories for the purposes of designating strength
descriptions:

Tablets, Capsules, Suppositories, Packets, and similar dose forms.

Pure Substance
Oral Liquid Preparations
Topical Preparations
Single-dose and Multi-dose Injections

Single Ingredient Products: Tablets, Capsules, Suppositories Packets, and Similar Dosage Forms

The value represented in the strength field is that strength which is used for dosing. Depending on the drug, it
may be either the base strength, the base plus salt (total) strength, the elemental strength, or the weight of the

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ingredient component when a more specific description doesn't apply (for example 32 mg of grape leaf extract
does not fit one of the previously mentioned strength types). At times strengths are represented in more than one
way and we may represent it both ways, if needed, to ensure recognition. Sometimes the strength is stated as the
base and sometimes it is stated as the base plus salt and elemental strength. In the table below the first example
product contains phenylephrine hydrochloride and its strength is expressed in terms of phenylephrine
hydrochloride. The second example shows a product containing telbivudine whose strength is in terms of
telbivudine only. The third example shows a product containing ferrous sulfate where 325 mg is the strength of
the base plus salt and 65 mg is the amount of iron in the ingredient.

Dosage Form and Strength in Single-Ingredient Drugs Examples

Example of Strength Generic Name Dosage Form Strength Strength - 60

1) Of base plus salt PHENYLEPHRINE STRIP 2.5MG 2.5 mg

HCL

2) Of the base only TELBIVUDINE TABLET 600MG 600 mg

3) Of base plus salt FERROUS SULFATE TABLET 325(65)MG 325 mg (65 mg Iron)
and elemental
strength

Single Ingredient Products: Pure Substance

If a bulk chemical or dosage form is a pure substance, its strength number is displayed as 100%. If a bulk
chemical does not have a strength, the strength is either not available or is pending clarification.

In the table below, the first example is 100% acetaminophen and the fifth example (prednisone) is either not
available or is pending clarification.

Pure Substance Strength Example

Generic Name Dosage Form Strength Strength - 60

ACETAMINOPHEN POWDER (GM) 100% 100 %

LITHIUM CARBONATE POWDER (GM) 99% 99 %

SOMATROPIN POWDER (GM) 13% 13% (1gram/7.7 gram)

MISOPROSTOL POWDER (GM) 1% 1%

PREDNISONE POWDER (GM) (No strength displayed) (No strength displayed)

Single Ingredient Products: Oral Liquid Preparations

The strength of oral liquid preparations is expressed in terms of the amount of active ingredient in five milliliters
(/5ML), as illustrated below. The exception is for unique strength preparations that are usually administered or
measured by drops, where the strength is expressed in terms of the amount of active ingredient in one milliliter
(/ML).

Oral Liquid Preparations Strength Example

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Generic Name Dosage Form Strength Strength - 60

AMPICILLIN TRIHYDRATE SUSPENSION, 125MG/5ML 125 mg/5 mL

RECONSTITUTED, ORAL
(ML)

AMPICILLIN TRIHYDRATE SUSPENSION, 250MG/5ML 250 mg/5 mL

RECONSTITUTED, ORAL
(ML)

AMOXICILLIN DROP RECONSTITUTED, 50MG/ML 50 mg/mL

TRIHYDRATE ORAL (ML)

Single Ingredient Products: Topical Preparations

The strength for topical preparations is listed either as a percentage or the amount of active ingredient in one
gram (/G).

Topical Preparations Examples

Generic Name Dosage Form Strength Strength - 60

HYDROCORTISONE OINTMENT(GM) 1% 1%

ESTROGENS, CREAM 0.625MG/G 0.625 mg/gram

CONJUGATED

Single Ingredient Products: Single-dose and Multi-dose Injections

Pre-diluted multi-dose injections commonly have a strength representation of per mL (e.g., 10 mg/mL).
Single-dose containers are preferentially represented as the total milligrams per the total volume per container.
Single dose syringes, amps, or vials with volumes of less a mL are represented as the volume necessary to
deliver the appropriate dose (e.g., Fondaparinux Sodium 7.5 mg/0.6 mL Sub-Q Disp Syringe. (See Piggyback
Solution Products in this section for examples of single-dose and multi-dose strength examples). If a formulation
represents a drug product which comes pre-diluted, strength is expressed as the amount per volume. When the
preparation must be reconstituted before administration no volume is indicated. The table below references two
examples: the first is a ready-to-use product, and the second product must be reconstituted prior to use.

Single-dose and Multi-dose Injections Strength Example

Generic Name Dosage Form Strength Strength - 60

PENICILLIN G PROCAINE INJECTION 300K U/ML 300,000 unit/mL

PENICILLIN G POTASSIUM INJECTION 20MMU 20 million unit

At this time, FDB avoids applying "U" or "UNIT" directly next to the strength expression (for example,
300K U/ML) to prevent confusion with the strength number (for example, confusing 300U with 3,000). The
abbreviation for unit ("U") is not ISMP compliant and is therefore not used or allowed in the ISMP

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compliant strength field, STR60. Over time, the abbreviated "U" expression will also be removed from the
old, short 10-character STR field. The "IU" expression (meaning international units) is not used because it
has the potential to be mistaken for "IV" (meaning intravenous).

Multi-Ingredient Products

With products containing more than one active ingredient, the Drug Strength Description ( STR) column
information is displayed differently than single ingredient products.

If a clinical formulation has two active ingredients, the strength value is listed as a hyphenated pair. The strength
values are listed in the same sequence as they appear in the generic name. Clinical Formulations with long
strengths or with more than one or two ingredients may require strength abbreviations that exclude one or more
ingredient strengths or units of measure based on space limitations in the STR (10-character strength field). For
example:

Multi-Ingredient Tablet Strength Example

Generic Name (GNN) Dosage Form Drug Strength Description Drug Strength
(STR) Description - 60 (STR-60)

sulfamethoxazole/trimethopri TABLET 800-160MG 800 mg-160 mg

m

methenam/sod TABLET 81.6-.12MG 81.6 mg-40.8 mg-10.8

phos/mblue/hyoscy mg-0.12 mg

The STR must be unique for a specific Ingredient List, Route, Strength, and Dosage Form. We have limited space
in STR in which to describe the differences between similar products. Drug Strength Description - 60 ( STR60) is a
more complete and ISMP-compliant strength field, which is recommended if a careful comparison of strengths is
desired. The legacy length limitations of the older STR column require that we choose the ingredient strengths,
which are represented to make the overall formulation unique. Therefore, the STR is not a complete listing of the
strengths of the associated products. If one ingredients strength in a multi-ingredient drug differs from the other
ingredients, then the strength value of the ingredient with a different strength is listed.

For multi-ingredient liquids, the strengths of all active ingredients are listed. If it is not possible to list all strengths
then the strengths that are most important are listed, such as codeine. For example:

Multi-Ingredient Liquid Strength Example

Generic Name (GNN) Dosage Form Description Drug Strength Drug Strength Description
(STR) - 60 (STR-60)

brompheniramine/p-eph/cod LIQUID 3.3-6.3/5 1.33 mg-3.33 mg-6.33 mg/5

eine mL

phenylephrine/DM/acetamin LIQUID 5-325MG/15 5 mg-10 mg-325 mg-200

op/GG mg/15 mL

Older, legacy Clinical Formulations with active drugs in the ingredient lists, but blank strength fields require review
to verify that associated products contain the same drug content and should not be assumed to be

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pharmaceutically equivalent.

Note that OTC vitamins are not uncommonly grouped based on general similarities but may differ in exact vitamin
content and vitamin strength.

Piggyback Solution Products

Products that contain the drug already in solution and are specifically intended for intravenous piggyback (IVPB)
administration (Dosage Form code of HP) have their strengths stated in terms of the total amount of drug per total
volume. This permits the strengths to be expressed in the format normally used for these products in settings
such as hospitals or home health care. Since these IVPB products have different amounts of total drugs in
different package sizes (drug/volume), they have different Clinical Formulation IDs (GCN_SEQNOs), which
makes it easier to distinguish between them. For example:

Piggyback Solution Strength Example

Label Name Strength Strength - 60

FLAGYL I.V. RTU 500 MG/100 ML 500MG/0.1L 500 mg/100 mL

METRONIDAZOLE 500 MG/100ML 500MG/0.1L 500 mg/100 mL

GENTAMICIN SULFATE IN NS 80MG/100ML 80 mg/100 mL

THEOPHYLLINE 200MG IN D5W 200MG/50ML 200 mg/50 mL

METRONIDAZOLE 500MG/0.1L 500 mg/100 mL

TIMENTIN 3.1G GALAXY CONT 3.1G/0.1L 3.1 gram/100 mL

Volume is expressed in terms of liters (L) when space constraints in the STR field prohibit the usual statement of
milliliters (ML).

Apothecary to Metric Conversion

The following table lists standard FDB conversions from apothecary to metric units. These standard conversions
are used when strengths or weights are given only in apothecary units.

Apothecary to Metric Conversion Table

Weight Apothecary Metric Liquids Apothecary Metric

1 POUND 480 G 1 PINT 480 ML

1 OUNCE 30 G 8 FL. OZ 240 ML

12 GRAINS 750 MG 1 FL. OZ 30 ML

10 GRAINS 600 MG 10 MINIMS 0.6 ML

7.5 GRAINS 500 MG 1 MINIM 0.06 ML

6 GRAINS 400 MG

5 GRAINS 300 MG

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4 GRAINS 250 MG

3 GRAINS 200 MG

2.5 GRAINS 150 MG

Aspirin is an exception to these conversions. Five grains of aspirin is equivalent to 325MG by

long-standing tradition.

Routed Generic

The routed generic is a formulation-based concept that enables clinical screening at the routed generic level. See
Formulation-based MAPs for more information.

The Routed Generic concept includes the following list of identifiers and codes:

ROUTED_GEN_ID

The Routed Generic Identifier (ROUTED_GEN_ID) is an eight-character numeric identifier that represents a
unique combination of the Ingredient List Identifier (HICL_SEQNO) and Route of Administration Code (GCRT).
The ROUTED_GEN_ID may be linked to zero to many NDCs and one to many Clinical Formulation IDs
(GCN_SEQNOs). However, an NDC or Clinical Formulation ID (GCN_SEQNO) can only have one
ROUTED_GEN_ID.

The ROUTED_GEN_ID will always represent the same HICL_SEQNO and GCRT, but if that combination of
HICL_SEQNO and GCRT is no longer relevant, the ROUTED_GEN_ID might not appear in the data.

Packaged products associated to the ROUTED_GEN_ID through the Routed Generic NDC Link Table
(RRTGNND0_ROUTED_GEN_NDC_LINK) should parallel the packaged products associated to the
ROUTED_GEN_ID through the Routed Generic Clinical Formulation Identifier Link Table
(RRTGNGC0_RTD_GEN_GCNSEQNO_LNK).

A Clinical Formulation ID (GCN_SEQNO) can be associated to a ROUTED_GEN_ID even if the Clinical

Formulation ID (GCN_SEQNO) is not associated to any active NDCs.

The ROUTED_GEN_ID and its description (ROUTED_GEN_DESC) reside in the Routed Generic Table
(RRTGN0_ROUTED_GEN_MSTR).

ROUTED_GEN_STATUS_CD

The Routed Generic Identifier Status Code (ROUTED_GEN_STATUS_CD) is a one-character, programmatically

derived code that indicates the availability of products on the market that match the Routed Generic. The
ROUTED_GEN_STATUS_CD is determined by the status of associated NDCs.

The following rules apply:

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ROUTED_GEN_STATUS_CODE Routed Generic Status Code Rule Description

0 Activeat least one associated NDC is not obsolete.

3 Inactiveall associated NDCs are obsolete.

9 Unassociatedno NDCs are associated.

The ROUTED_GEN_STATUS_CD and its description (ROUTED_GEN_STATUS_CD_DESC) reside in the

Routed Generic Status Code Table (RRTGNSD0_RTD_GEN_STATUS_DSC).

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Clinical Formulation and Ingredient Data Editorial Policies

The policies and criteria that apply to the scope and processes of Clinical Formulation and Ingredient Data are
provided in the following sections:

Scope
Editorial Process

Scope
FDBs primary formulation identifier is the Clinical Formulation ID (GCN_SEQNO). It represents a pharmaceutical
drug formulation that is based on a unique combination of active ingredients, route of administration, dosage
form, and strength. The Clinical Formulation ID (GCN_SEQNO) is used to group together drug products with like
active ingredient sets, routes of administration, dosage forms, and strength and provides an excellent method for:

navigating to clinical modules

developing a list of candidates for substitution in the dispensing environment
formulary building
purchasing and price analysis
prescribing

Links to Data and Clinical Modules

The Clinical Formulation ID (GCN_SEQNO) provides a direct link to all of the following FDB data and clinical
modules:

MedKnowledge Descriptive and Pricing

Packaged Product
Drug Product Pricing
Medication Name Concepts (MED)
Therapeutic Classification Data ERD and Technical Specifications
First Databank Enhanced Therapeutic Classification System (ETC)

Modules

Dosing
Drug Allergy Module (DAM) 4.0
Drug-Disease Contraindications Module (DDCM) 2.0
Drug-Lab Interference Module (DLIM ) 2.0
Duplicate Therapy Module (DPT) 1.0
Inactive Ingredients Editorial Policies
Indications Module (INDM) 2.0
Interactions
Intravenous Module (IVM) 1.0

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Precaution Modules
Side Effects Module (SIDE) 2.0

Counseling Messages Module (CMM) 1.0

Patient Education Module (PEM) 2.0

Precaution Modules

Prescriber Order Entry Module (POEM) 2.0

Prioritized Label Warnings Module (LBLW) 1.0

Side Effects Module (SIDE) 2.0
Universal System of Classification (USC) 1.0

Routed Formulation Links to Data and Clinical Modules

The Routed Generic Concept is included in Clinical Formulation and Data, with the goals of providing links to
clinical data appropriate to the routed formulation level of specificity, and enabling users to screen orders with
MedKnowledge clinical information. The routed generic is a formulation-based concept that represents a single
instance of a unique combination of an Ingredient List Identifier (HICL_SEQNO) and route of administration (
GCRT). One Routed Formulation Identifier (ROUTED_GEN_ID) is assigned to each combination of
HICL_SEQNO and GCRT. Each ROUTED_GEN_ID is associated with one-or-more Clinical Formulation IDs (
GCN_SEQNO) and zero-or-more NDCs.

The ROUTED_GEN_ID provides a direct link to all of the following FDB data and clinical modules:

Packaged Product

Dosing
Drug Allergy Module (DAM) 4.0
Drug-Disease Contraindications Module (DDCM) 2.0
Drug-Lab Interference Module (DLIM ) 2.0
Duplicate Therapy Module (DPT) 1.0
Inactive Ingredients Editorial Policies
Indications Module (INDM) 2.0
Interactions
Intravenous Module (IVM) 1.0
Precaution Modules
Side Effects Module (SIDE) 2.0

Editorial Process
The following section describes the processes and criteria the clinical editors use to add or review database
elements.

External Triggers for Clinical Review

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The external triggers that prompt the clinical editors to add or review data are the following:

MedEffects Alerts from Health Canada

MedWatch Safety Alerts

Internal Triggers for Clinical Review

The internal trigger that prompts the clinical editors to add or review data is a new Clinical Formulation ID (
GCN_SEQNO).

The Clinical Formulation Ingredient Strength Component Table

The Clinical Formulation Ingredient Strength Component Table (RGCNSTR0_INGREDIENT_STRENGTH)

provides detailed strength data for each ingredient in a clinical formulation. While a valuable asset, there are
limitations in placesome market imposedto the amount and types of strength data the table contains. This
section will address how information is obtained for this table and the type of limitations in place.

The labeling for drugs that are approved by the FDA generally have the most complete strength information.
However, the labeling for many OTC drugs and related products, including herbal formulations, are not routinely
reviewed by the FDA. FDB Clinical Staff receive product labeling for a product from drug manufacturers which
includes, but is not limited to, the package insert.

For drugs approved by the FDA, labeling commonly includes a variety of strength information. The strength type
(e.g. Base, Base plus Salt, Elemental, etc.) used in dosing a new medication varies but is most commonly based
on the strength or strengths used in studies submitted to the FDA as part of the drug approval process. As
strength type can vary, it is important to review product labeling to make the determination for preparations where
this value has been shown to vary based on differences in labeling practices.

Some of the limitations in place when assessing and using the manufacturer-supplied information include:

Manufacturers do not always clearly indicate which component of the drug their strength information is
based on.
Non-FDA source drugs (over the counter drugs or drugs not reviewed by the FDA) commonly do not
clearly indicate what strength information is based on in product labeling.
For some drugs, such as herbals, it is not appropriate to indicate a strength type for plant parts or plant
part extracts.

Strength Type Code

The Strength Type Code (STRENGTH_TYP_DESC) indicates how the ingredient strength is expressed. For
example, the ingredient Finasteride occurs as a base drug without salt components to increase solubility.
Therefore, its strength type is Base.

Drugs which have been manufactured with salts to improve solubility or exist as salt naturally may have strengths
that represent either the Base strength or the total Base plus Salt strength depending on the ingredient. Not
uncommonly, FDA reviewed products which contain salts describe the strength of the ingredient both ways in
product labeling, but typically use only one of the strength types to routinely describe dosing strength. For
example, the ingredient Tenofivir disoproxil fumarate is present in the product Atripla in a strength of 300 mg per

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tablet. The 300 mg strength is the dosing strength, but the strength of tenofivir disoproxil without the fumarate
component is 245 mg. In this case, the 300 mg strength is represented as the primary or first strength in
ingredient-strength data as it is the strength used for dosing and has a strength type of Base plus Salt, while the
245 mg strength has a strength type of Base.

However, there are several instances where strength type cannot be specified. There are three scenarios for why
strength type may not be specified in the data:

Strength type is not defined or is not obvious in manufacturer-supplied information.

Herbals are involved.
FDB clinical editors have determined that the strength type is not applicable. For example, there would not
be an applicable strength type for a bandage dressing.
Not Specified at this time pending review of product labeling and primary literature.

When it is determined that a strength type cannot be specified, it is assigned a strength type code of zero, which
is defined as Not Specified.

Strength Ranges

It is possible to have range information columns (RANGE_MAX and RANGE_MIN) associated to a product with
the strength column (STRENGTH) left as blank. This occurs when product labeling does not specify a specific
mid-point for the range but does supply minimum and maximum range information.

Dosing: Base Ingredient vs. Base Ingredient Plus Salt

Dosing is not always based on the base ingredient and this is not always obvious. This point can be illustrated
with an example using the drug Pseudoephedrine.

This example will involve the use of two drugs:

Pseudoephedrine Hydrochloride 60 mg Oral Tablet(Clinical Formulation ID 005090)

Pseudoephedrine Sulfate 60 mg Oral Tablet(Clinical Formulation ID 016620)

As shown, each drug is listed as a 60 mg oral tablet. At first glance, the 60 mg designations are like amounts of
Pseudoephedrine which would seem to suggest that the dosing strength is of the base, but in actuality these
strengths are based on the base plus salt amounts.

The sulfate salt is a much larger salt than the hydrochloride salt. As such, the ratio of active base to salt
molecules differ for these two drugs. Pseudoephedrine Hydrochloride has a 1:1 ratio of drug to salt and
Pseudoephedrine Sulfate has a 2:1 ratio of drug to salt.

The molecular weights also differ:

The molecular weight of Pseudoephedrine is 165.23.

The molecular weight of Pseudoephedrine Hydrochloride is 201.69 (1:1 ratio of drug to salt, 81.92% of
which is Pseudoephedrine, so approximately 49.15 mg of a 60 mg dose).
The molecular weight of Pseudoephedrine Sulfate is 428.54 (2:1 ratio of drug to salt, 77.1% of which is
Pseudoephedrine, so approximately 46.27 mg of a 60 mg dose).

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The analysis shows that there are different amounts of active ingredient in each drug. The difference is
approximately a 4% difference in the active amount of Pseudoephedrine per tablet: a 1.4 mg difference between
30 mg tablets, a 2.8 mg difference between 60 mg tablets (used in the above example), and a 5.75 mg difference
between 120 mg tablets. While the actual difference in the active drug content is therefore relatively small, this
example illustrates how misleading like milligram amounts can be in determining the appropriate strength-type
representation. The fact that the two drugs are delivering different amounts of the active ingredient is not apparent
from the strength printed on product inserts.

Units of Measure

The vast majority of strengths are associated with units of measure. Rarely, Range strength data can occur
without unit data in some circumstances. (Refer to the Strength Ranges section above for more information.)

Iron Product Strength Field Policy

This section will discuss iron product policies and the strength issues unique to representing iron formulation
strengths.

The policy for representation of strength for Iron formulations is consistent with the policy for other drug
formulations. When multiple drug strength representations are possible, the strength represented first in the
STR60 strength field, is represented first in the ingredient strength data. For example, in the Clinical Formulation
40119 Ferrous Gluconate, the STR60 reads: 240 mg (27 mg Iron). The 240 mg is the total strength and is
represented first in the ingredient strength data. The active component of iron formulations is the elemental iron
value (for both desired activity and for potential toxicity) and in this example, 27 mg is the alternative strength
representing the elemental value. There are large differences in the elemental iron content delivered based on
difference in the weight of the associated iron salt in the formulation (i.e., sulfate, fumarate, gluconate, etc.) and
although some single ingredient oral iron preparations are still commonly ordered by the total weight, (for
example, 325 mg Ferrous Sulfate), only the elemental weight is comparable. Therefore, when totaling the iron
delivered by formulations with differing iron salts or differing strength representations (e.g., elemental versus base
plus salt), it is necessary to total the strength values associated with the "elemental" strength-type to get an
accurate and clinically relevant total iron calculation.

Strength Policy for Prenatal Vitamins

For Prenatal Vitamins, the elemental strength of the iron is listed. However, in other vitamin supplements, listing
either the elemental amount of iron or the total weight of the iron plus the salt may be inconsistent based on
differences in product labeling.

Strength Policy for Parenteral Forms of Iron

Parenteral Iron products are represented using only the elemental strength.

Some examples:

Parenteral Forms of Iron Example Table

Clinical Formulation GNN STR60 Dosage Form Route

ID (GCN_SEQNO)

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001609 IRON DEXTRAN 50 mg/mL VIAL INJECTION

COMPLEX

042074 SOD FERRIC GLUC 62.5 mg/5 mL AMPUL (ML) INTRAVEN

COMPLX/SUCROSE

046700 FERROUS 40 mg/mL VIAL INTRAMUSC

GLUCONATE/VIT B
COMP

047038 IRON SUCROSE 100 mg/5 mL VIAL INTRAVEN

COMPLEX

Strength Policy for Pediatric Iron Drops

Pediatric Iron products with Drops dosage forms are represented using only the elemental strength. For
example, Clinical Formulation ID (GCN_SEQNO) 001641 Ferrous Sulfate Drops Oral 15 mg/0.6 mL Elemental
(75 mg/0.6 mL). The primary strength is the Elemental strength (which is commonly used in dosing pediatric
drops) and 75 mg represents the total Ferrous Sulfate (Base plus Salt) weight.

Iron Strength Representation Variations and Exceptions

The current policy of representing the total weight for single ingredient, oral iron solid dosage forms and non-drop
liquid forms is guided by existing prescriber perceptions and product strength recognition. Physicians commonly
look for 325 mg of iron sulfate, so this is the most prominent strength, but when possible, we have enhanced the
strength to also include the elemental iron strength content in an effort to display both and to prevent creating
duplicates based on one or the other strength representation. Currently, there is no single, perfect solution for all
forms of iron or products containing iron given the variability in labeling and the need for recognition of traditional
strengths by a variety of healthcare personnel. Therefore, when totaling the iron delivered by formulations with
differing iron salts or differing strength representations (e.g., elemental versus base plus salt), it is necessary to
total the strength values associated with the "elemental" strength-type to get an accurate and clinically relevant
total iron calculation.

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MAPs Enhancements
Concepts
Parent Route of Administration
Clinical Route of Administration
Discretionary Clinical Route
Dosage Form Attributes
Dosage Form Types
NDC Ingredient Strength
Representative Route
Roll-up
Route Hierarchy
Strength Concentration Type
Unit of Measure
Inclusion Criteria
Inclusion
Rule Sets
Maintenance
Triggers for Clinical Review
Resources

Concepts
This section defines important terms related to FDB Multiple Access Points (MAPs) that users should
understand. See the technical specifications for more information.

Parent Route of Administration

A general navigational term intended for use in order entry systems that, when chosen by a clinician, can lead to
a list of more specific routes of administration represented by the associated clinical routes for the clinician to
choose. For example, the parent route of injection may group intravenous (IV), intramuscular (IM), and
subcutaneous (Sub-Q) clinical routes for a specific product, providing a custom, NDC-specific listing of route by
which the product may be administered.

Clinical Route of Administration

The route or routes by which a drug product may be administered. Clinical Routes include labeled and unlabeled
routes of administration. Labeled routes are derived from labeling of the associated products. Clinical Routes are
collected at the NDC and may be applied directly at the product chosen for dispensing level. However, Clinical
Routes are also provided at other navigational levels, to facilitate the ordering process at the desired level. For
example, Routed Medication ceftriaxone injection is associated with intravenous (IV) and intramuscular (IM)
routes of administration for display to, and selection by, the clinician.

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Discretionary Clinical Route

Discretionary clinical routes are composites of multiple routes (for example, PO/PR or IV/IM) that play a part in
the dosing safety module, so that, given the patients clinical status, the person giving the medication can choose
the best route at the time of administration. Composite routes of this type are not included in the selection of
routes directly associated with Parent Routes.

Dosage Form Attributes

Dosage attributes are dosage form components by which dosage forms and extension drug formulations may be
delineated or grouped. For example, it is possible to search for and locate all oral liquid formulations with a
specific ingredient list by limiting the search to dosage forms with an attribute of liquid and a route of oral.
Attributes provide varying degrees of granularity, ranging from broad: liquid or solid dosage forms (for example,
tablets or capsules), to more specific: capsule, tablet, and include distinguishing subtleties such as rate of
release: immediate release or extended release; where released: delayed release [aka enteric coated] is beyond
the acidic stomach, and dosing frequencies associated with extending release formulations (8 hour, 12 hour, 24
hour).

Dosage Form Types

The Final Dosage Form is a dosage form that describes the administrable dosage from the perspective of the
administering clinician and may be a more concise representation of a dosage form than that necessary to
distinguish that dosage form from another in an electronic database.

For example, a Capsule, ER 24 hr at the Clinical Formulation Identifier (GCN_SEQNO) or Medication Identifier
(MEDID) has a final dosage form description of simply capsule, extended release. It provides a streamlined
version of the description, and is perhaps easier to read and understand, but retains the extended release
component so that a knowledge nurse would know or could be alerted that this capsule should not be crushed or
chewed since it is extended release.

In another example, a product with a dosage form of Solution & Solution Reconstituted, Sequential at the
Clinical Formulation Identifier (GCN_SEQNO) simply has solution as the Final Dosage Form, removing
description components that suggest the need for reconstitution in the pharmacy prior to dispensing.

The Alternative Dosage Form has a different intended use than the Final Dosage Form. It is intended to provide
customers with additional options for dosage form descriptions that are used to build drug descriptions for display.

For example, FDB uses the dosage form tablet to represent products labels as tablets, but it also represents gel
coated tablet formulations commonly described on product labeling as caplets. The Alternative Dosage Form of
caplet is associated with NDCs labeled with the term caplet should a customer prefer to build a drug
description using caplet rather than tablet. The Alternative Dosage Form may also be used to group similar drug
products with the same Alternative Dosage Form.

NDC Ingredient Strength

The product-specific and ingredient-specific strength information is limited to injectable products at this time. The
data is most useful for liquid injectable products because these formulations have volume information that is used
to calculate the total amount and total volume of a drug. However, dry, lyophilized vials and ampules (and other

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packaging types for drugs requiring reconstitution) are also included for completeness. Dry vials and ampules
have a single strength value per ingredient represented by both strength types.

For example, for a dry 1 gram vial, the normalized strength and total strength values are simply populated with
the same strength and strength unit of measure (UOM) values of 1 gram.

Representative Route

The representative route is intended for inclusion in generating a display of the Clinical Formulation in dispensing
environments where a single description is preferable. The route was previously obtained by getting the Route of
Administration Code (GCRT) for a specific GCN_SEQNO from any version of the Clinical Formulation ID Table
(RGCNSEQ4_GCNSEQNO_MSTR) and retrieving the routed description from any version of the legacy route
table, for example, the RROUTED3_ROUTE_DESC. Due to space limitations, the GCRT, a one-character code,
is out of room for growth. The representative route (REPRESENTATIVE_RT_ID) in the Clinical Formulation
Identifier (GCN_SEQNO) to Representative Route Table (RPEIGRR0_GCNSEQNO_REP_RT) is the go-forward
single route for the GCN_SEQNO.

For example, the Clinical Formulation Identifier (GCN_SEQNO) legacy route for infant lung surfactants is the
legacy, nonspecific route of inhalation, while the new representative route is intratracheal.

Brand Name Clinical Formulation Identifier Clinical Formulation Description

CUROSURF 27956 poractant alfa 120 mg/1.5 mL (80

mg/mL) intratracheal Vial

INFASURF 43195 Calfactant 35 mg/mL intratracheal Vial

SURFAXIN 69982 lucinactant 34 mg/mL intratracheal Vial

SURVANTA 16280 beractant 25 mg/mL intratracheal Vial

Roll-up

The summation of data at the Clinical Formulation Identifier and at other important concepts will commonly be
referred to as a roll-up of data from the associated source NDCs. Please note that rolled up data is no longer
NDC-specific; therefore, labeled and unlabeled source information no longer applies and is only present in the
NDC to Route Relationship Table (RPEINR0_NDC_RT_RELATION).

Route Hierarchy

The Route Hierarchy table should not be used alone for determining which clinical routes are appropriate for
selecting products and appropriate routes for safe administration. When navigating to medications, the route
relationship tables should be used to ensure that appropriate product selection and routes of administration are
selected.

Strength Concentration Type

There are two strength types. The first, normalized, represents the concentration per one milliliter (per 1 mL or
/mL). For example, a product vial which contains 60 mg/3 mL has a normalized concentration of 20 mg per 1 mL

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or 20 mg/mL. The normalized concentration is useful for a) programming pumps and related administration
devices; b) for locating similar injectable products based on the same ingredient list, route, and normalized
concentration; and c) dosing calculations.

The second strength type is total package. The total package strength type reflects the total Dosage Form
Attribute Identifier (DOSE). This represents the packaging entity upon which the total package strength is based.
The goal of specifying this component is to remove ambiguity and provide clarity regarding the product
component upon which this total package strength is based. This attribute is present in the Alternative Clinical
Formulation Identifier (GCN_SEQNO) to Ingredient Strength Link Table (RPEIGS0_GCNSEQNO_STR_LINK).

The total package is also useful in programming pumps and performing dosing calculations. Providing the total
package strength decreases the risks associated with performing calculations at the patients bedside using the
normalized concentration and the package size. Total package strength can be useful as a safety check when
choosing the correct product size relative to the desired dose to help avoid dosing errors.

Unfortunately, potent drugs may be labeled using only the normalized concentration (per mL), requiring clinicians
to notice and account for the difference by reviewing the package size, determining the appropriate volume, and
drawing up only the desired amount. Vials that show the same normalized concentration on product labeling may
be mistaken for one another, adding to the risk that an incorrect total dose may be withdrawn and injected. For
this reason, the FDA now mandates that all Heparin products reflect total strength and normalized strength on
product labeling. This is not the case for many other injectable products. Using the total package strength data
could also reduce cost by helping to ensure that the appropriate product size is chosen for dosing.

Unit of Measure

The units of measures included in the Unit of Measure Master Table (RPEIUM0_UOM_MSTR) shall not be limited
by type in the manner other unit of measure tables are filtered. For example, units of measure shall be included
for quantities, strength, concentration, and time.

Inclusion Criteria
The MAPs enhancements encompass NDCs from First Databanks (FDB) MedKnowledge database.

Inclusion

NDCs which are active or have been obsolete for less than three years are considered the most likely to be still
present on the market and therefore have been reviewed for accuracy and completeness, but components of this
data have varying rules for inclusion.

For example, the NDC-to-Alternative Route and Alternative Dosage Form data applies to all NDCs, whereas the
NDC-to-Ingredient Strength data is limited to injectable medications.

Non-injectable drugs are out of policy at this time.

Rule Sets
This section provides rules that the clinical team uses to create or maintain Multiple Access Points (MAPs)
enhancements, both general rules and rules specific to data elements.

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The following data is collected at the product level and is product-specific: Alternative Dosage Form (Final and
Alternate); Alternative Strengths (Total and Normalized) for injectable products are calculated based on product
package size and strength values from the associated Clinical Formulation Identifier (GCN_SEQNO); Parent and
Clinical product Routes are obtained from product labeling (Labeled) and from the sources described in the
References Section (Unlabeled).

Triggers for content review are evaluated for applicability to expanded Maps content. (See the MAPs
Enhancements Maintenance section for more information.)

Maintenance
This section contains information regarding the ongoing maintenance of the module's data.

Triggers for Clinical Review

FDA-approved documentation from manufacturers or distributors

Introduction of new drug products to the U.S. market
Customer or manufacturer clinical inquiries are reviewed daily and the database is updated weekly as
appropriate
FDA MedWatch Medical Product Safety Information Alerts
Notification of changes from documented sources listed in the Resources section below
MedEffects Alerts from Health-Canada (except Non-U.S. product alerts exclusive to Canada)

Resources
This section lists sources used by First Databank (FDB) to compile the information contained in the alternative
Route module relative to Labeled and Unlabeled Routes.

FDB utilizes many reference sources including, but not limited to, the primary medical literature (for example,
published journal articles), medical reference texts, published expert treatment guidelines, and manufacturers
product package inserts. FDB uses current source editions or versions when coding and updating data, as well as
when researching questions about data. However, FDB does not conduct a formal data review for every new
release of source editions or versions. Additional sources include:

AHFS Drug Information. Published by American Society of Health System Pharmacists.

Primary Medical Literature.
Product labeling:
Manufacturer websites
FDA sources:
Daily Med: Structured Product Labels (SPL). Available at:
http://dailymed.nlm.nih.gov/dailymed/rsshome.cfm.
FDA Approved Drug Products. Available at:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/
National Drug Code Directory. Available at:
http://www.accessdata.fda.gov/scripts/cder/ndc/default.cfm.

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Treatment Guidelines

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MAPs Freeness and Storage Condition

Concepts
Ethyl Alcohol Free
Latex Free
Preservative Free
Roll-up
Storage Conditions
Sugar Free
Inclusion Criteria
Latex Free
Ethyl Alcohol Free
Sugar Free
Preservative Free
Storage Conditions (Refrigeration Code)
Data Elements
Clinical Formulation Attribute Table (RPRPEIGA0_GCNSEQNO_ATTRIBUTE)
Med Medication Attribute Table (RPEIMA0_MED_ATTRIBUTE)
NDC Attribute Table (RNDCAT0_NDC_ATTRIBUTE)
Routed Dosage Form Med Attribute Table (RPEIRA0_RT_DF_MED _ATTRIBUTE)
Routed Med Attribute Table (RPEIRMA0_RTD_MED _ATTRIBUTE)
Routed Med Name Attribute Table (RPEINA0_MED_NAME_ATTRIBUTE)

Concepts
This section defines concepts related to FDB Multiple Access Points (MAPs) Freeness and Storage
Condition enhancements. See the technical specifications for more information.

Ethyl Alcohol Free

Denotes the absence of Ethyl Alcohol (ethanol) from a drug product.

Latex Free

Denotes the absence of latex (natural rubber) from a drug and its packaging. This designation extends to drug
packaging and containers utilizing latex that may be brought into contact with the patient or healthcare provider
through administration (i.e. injectable drug containers utilizing a latex seal).

Preservative Free

Identifies products intended for administration in pediatrics, the eye, or the CNS that do not contain preservative
ingredients. Preservative-Free products formulated for CNS or pediatric administration may be either entirely

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preservative-free or contain preservative ingredients concentrations below levels effective for preservative use
(for example trace thimerosol) or at levels recognized as safe for administration into the CNS (for example, low
concentrations of sodium calcium EDTA).

Roll-up

The summation of data from the NDC up to the Med Name (and other medication concepts in between) will
commonly be referred to as a roll-up of data. Each less specific medication concept includes value(s) from the
more specific medication concept below it. The follow diagram illustrates a "roll-up" for a given drug:

Examplemorphine (PF) 1 mg/mL injection solution

Storage Conditions

Identifies the storage condition that, based on product labeling, maximizes product shelf life upon receipt from the
manufacturer or distributor.

Sugar Free

Denotes the absence of metabolically active sugars that affect blood glucose levels.

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Inclusion Criteria
Latex Free

The presence of latex in a medication product or packaging can have serious, potentially life-threatening adverse
effects in patients with latex allergies.

FDB categorizes products as latex free when product labeling contains specific representations indicating that no
components of the product contain latex or natural rubber. Products made from components using synthetic
rubbers are identified as latex free.

For injectable products containing parts typically made from rubber (vial stoppers) where the material used is not
specified in product labeling, FDB requires written confirmation from the manufacturer stating the product is free
of latex containing components before it can be identified as latex free.

FDB will categorize the latex status of products as follows:

Latex Free: Product does not contain latex (natural rubber) that may come in contact with the drug,
patient, or healthcare provider
Contains Latex: Product contains latex (natural rubber)
Undetermined: The presence of latex cannot be determined due to one of the following reasons:
Non injectables:
Product lacks an SPL or is repackaged
Watermarked products (where a labeler has marketed multiple versions of the same NDC)
Products marked as obsolete prior to 9/1/2011
Ambiguous labeling
Injectables: FDB evaluates latex content for all injectable products, including repackaged
injectables, regardless of SPL status, based on product labeling and manufacturer confirmation.
Injectable products will be marked Undertermined if:
Product labeling is ambiguous and FDB is unable to confirm latex status with the
manufacturer
Injectable products are marked obsolete prior to 9/1/2011

Synthetic or butyl rubber is not known to cause hypersensitivity reactions and is

excluded from consideration.

Ethyl Alcohol Free

The presence of alcohol in a medication can have serious adverse effects in some patients, including:

Elevated blood sugar due to metabolizing

Adverse drug interactions
Pediatric and neonatal patient harm

Independent of any marketing or labeling claims made by the manufacturer, FDB categorizes products as follows:

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Ethyl Alcohol Free: Product does not contain ethyl alcohol as a listed active or inactive ingredient.
Contains Ethyl Alcohol: Product contains ethyl alcohol as a listed active or inactive ingredient.
Undetermined: the presence of ethyl alcohol cannot be determined due to one of the following reasons
Product lacks an SPL or is repackaged
Watermarked products (where a labeler has marketed multiple versions of the same NDC)
Products marked as obsolete prior to 9/1/2011
Ambiguous labeling

FDB only reviews products for the presence of Ethyl Alcohol and does not review products
for other types of alcohol such as Butyl, Ispopropyl or Benzyl alcohols.

Alcohol is used in glazes and printing inks in tablets and capsules and frequently appears in
the list of inactive ingredients for a product: because of the insignificant amount used and
evaporation, FDB will consider these products alcohol-free.

This indicator cannot be used to determine Alcohol as it relates to flammability (storage and
handling of the product).

Sugar Free

The presence in a medication of the metabolically active sugars listed below can affect blood glucose levels,
causing serious adverse effects in patients with conditions such as diabetes.

Independent of any marketing or labeling claims made by the manufacturer, FDB will categorize products as
follows:

Sugar Free: Product does not contain any of the identified metabolically active sugars in its listed active or
inactive ingredients that can affect blood glucose levels.
Contains Sugar: Product contains the identified metabolically active sugars in its listed active or inactive
ingredients that can affect blood glucose levels.
Undetermined: The presence of metabolically active sugars cannot be determined due to one of the
following
Product lacks an SPL or is repackaged
Watermarked products (where a labeler has marketed multiple versions of the same NDC)
Products marked as obsolete prior to 9/1/2011
Ambiguous labeling

The following is a list of metabolically active sugars that can affect blood glucose levels:

Corn syrup
Dextrose

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Fructose
Inverted Sugar
Isomalt
Lactose
Maltitol
Maltose
Mannitol
Sorbitol
Sucrose
Trehalose

Preservative Free

The presence of preservative ingredients at effective preservative concentrations can have serious adverse
effects in patients depending on the age of the patient or the site of administration. For example:

In the CNS, preservatives in preservative concentrations may cause:Increased risk of adverse neurologic
events via neurotoxicity, local or muscle cramping due to sequestration of calcium (for example, sodium
EDTA).
Arachnoiditis (meningeal inflammation), local tissue injury, and related adverse effects.

In pediatric patients, preservatives such as Benzyl alcohol and paraben-containing compounds have been
implicated in pediatric and neonatal patient harm metabolic acidosis, encephalopathy, and respiratory depression
with gasping syndrome and death in neonates.

In eye products, preservatives can precipitate or worsen dry eye syndromes due to inflammatory effects of the
preservative on local tissue and should therefore be minimized or avoided in patients with existing dry eye
conditions.

FDB categorizes products as follows:

Preservative Free: Identifies products intended for administration in pediatrics, the eye, or the CNS that
do not contain preservative ingredients. Preservative-Free products formulated for CNS or pediatric
administration may be either entirely preservative-free or contain preservative ingredients concentrations
below levels effective for preservative use (for example trace thimerosol) or at levels recognized as safe
for administration into the CNS (for example, low concentrations of sodium calcium EDTA).
Not Applicable:
Contains preservatives
Preservative Status is unknown Product does not meet inclusion criteria (injectable formulations or
eye formulations)
Absence of an SPL
Product obsolete prior to 2010 and in labeling unavailable.

FDB uses the USP listing of preservatives and screens product labeling preservatives that have significant

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adverse effects as discussed above. Common preservatives include:

Methyl parabens
Thimerosol
EDTA (Ethylenediaminetetraacetic acid)
Sulfites

The presence of benzyl alcohol is always classified as a preservative, regardless of manufacturer

designation.

Sulfites and EDTA, can be considered preservatives depending on concentration.

Storage Conditions (Refrigeration Code)

Based on product labeling, FDB will identify the manufacturer recommended pharmacy storage condition to
maximize shelf life. This content covers storage requirements upon receipt from the
manufacturer/distributor/wholesaler.

Each NDC will be assigned one of the following values:

Store at room temperature upon receipt from the MFG

Refrigerate upon receipt from the manufacturer
Freeze upon receipt from the manufacturer
Undetermined (NDCs will be assigned an undetermined storage condition for the following reasons):
Product lacks an SPL or is repackage
Watermarked products (where a labeler has marketed multiple versions of the same NDC)
Products marked as obsolete prior to 9/1/2011
Ambiguous labeling

This content does not cover storage/temperature requirements for:

Shipping/transportation
Dispensing to patients
Distribution to nursing units/facilities/automated dispensing devices
Reconstitution/compounding
Administration

Storage Condition content is only populated at the NDC level and is not rolled up at the MEDID,
clinical formulation, etc.

Data Elements
The following data elements are associated with Freeness and Storage Conditions concepts. The freeness

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attribute tables will use roll-up logic to relate attributes to the Clinical Formulation, MEDID, Routed Dosage Form
Med, Routed Med, and Med Name levels from related NDCs.

Clinical Formulation Attribute Table (RPRPEIGA0_GCNSEQNO_ATTRIBUTE)

Contains freeness information summarized to the Clinical Formulation level. Clinical formulations may have one
or several freeness values.

Med Medication Attribute Table (RPEIMA0_MED_ATTRIBUTE)

Contains freeness information summarized to the MEDID level. MEDIDs may have one or several freeness
values.

NDC Attribute Table (RNDCAT0_NDC_ATTRIBUTE)

Contains freeness information and medication storage condition information at the NDC level. NDCs will have a
single value for each freeness and a single value for medication storage condition.

NDC_ATTRIBUTE_TYPE_CD
NDC_ATTRIBUTE_TYPE_DSC

ExampleNDC_ATTRIBUTE_TYPE_CD and associated columns

NDC_ATTRIBUTE_ NDC_ATTRIBUTE_ NDC_ATTRIBUTE_ NDC_ATTRIBUTE_

TYPE_CD TYPE_DSC VALUE VALUE_DSC

51 Preservative Free Code 1 Preservative Free

51 Preservative Free Code 2 Not Applicable

52 Sugar Free Code 1 Sugar Free

52 Sugar Free Code 2 Contains Sugar

52 Sugar Free Code 3 Undetermined

53 Latex Free Code 1 Latex Free

53 Latex Free Code 2 Contains Latex

53 Latex Free Code 3 Undetermined

54 Alcohol Free Code 1 Ethyl Alcohol Free

54 Alcohol Free Code 2 Contains Ethyl Alcohol

54 Alcohol Free Code 3 Undetermined

55 Storage Condition 1 Store at room temperature

(Refrigeration Code) upon receipt from MFG

55 Storage Condition 2 Refrigerate upon receipt

(Refrigeration Code) from manufacturer

55 Storage Condition 3 Freeze upon receipt from

(Refrigeration Code) manufacturer

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55 Storage Condition 4 Undetermined

(Refrigeration Code)

Routed Dosage Form Med Attribute Table (RPEIRA0_RT_DF_MED _ATTRIBUTE)

Contains freeness information summarized to the Routed Dosage Form Med level. Routed Dosage Form Meds
may have one or several freeness values.

Routed Med Attribute Table (RPEIRMA0_RTD_MED _ATTRIBUTE)

Contains information regarding freeness information summarized to the Routed Med level. Routed Meds may
have one or several freeness values.

Routed Med Name Attribute Table (RPEINA0_MED_NAME_ATTRIBUTE)

Contains freeness information rolled-up to the Med Name level. Med Names may not have one or several
freeness values.

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Alternative Strength
Overview
Inclusion Criteria
Data Elements
Alternative Strength Components and Descriptions
Rule Sets
Maintenance
Triggers for Clinical Review
Resources

Overview
The First Databank Alternative Strength data delivers at an NDC level two key new strength values for injectable
drug products: the Total Strength and Normalized Strength for ingredients associated with a product. These
product-specific strength values may be displayed or implemented as part of an enhanced patient safety plan for
integrated dose checking at the point of care.

This product-specific information is also aggregated at the Clinical Formulation Identifier (GCN_SEQNO), and at
the Medication Identifier (MEDID) in the First Databank (FDB) knowledge base. Aggregated drug knowledge may
not apply to all associated packaged products, and more specific information may be found at individual NDCs.
However, NDC information aggregated at GCN_SEQNO or MEDID concepts may be useful to clinicians by
displaying aggregated attributes to aid in locating the subset of NDCs with desired attributes.

Inclusion Criteria
This section provides the criteria that govern the inclusion of data in the module as well as information pertaining
to limitations or exclusions where appropriate.

All injectable Clinical Formulations (GCN_SEQNO) associated with products in the United States are candidates
for inclusion. This module has a primary focus of providing new information for liquid injectable drugs. Injectable
drugs that come in a dry form (for example, lyophilized powders) are also included to increase the number of
injectable drugs represented in the data. Initial data population has focused on injectable drug products that are
active (not obsolete) or less than three years obsolete, though injectable products obsolete longer than three
years were included when practical.

Data Elements
This section contains additional information about particularly important tables and codes contained within the
module, as well as concepts about the data that the reader must understand in order to understand the module.

Alternative Strength Components and Descriptions

Alternative NDC Ingredient Strength Link Table (RPEINS0_NDC_STR_LINK)

This table provides Total and Normalized strength data for active ingredients associated with an injectable NDC.

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Related tables have NDC Total and Normalized strength data rolled up to Clinical Formulation Identifier
(GCN_SEQNO) and the Med Medication Identifier (MEDID).

Alternative Clinical Formulation Identifier (GCN_SEQNO) to Ingredient Strength Link Table

(RPEIGS0_GCNSEQNO_STR_LINK)

This table provides Total and Normalized strength data for active ingredients rolled up to the Clinical Formulation
Identifier (GCN_SEQNO) from associated injectable products.

Alternative Medication Identifier (MEDID) to Ingredient Strength Link Table (RPEIMS0_MED_STR_LINK)

This table provides Total and Normalized strength data for active ingredients rolled up to the Med Medication
Identifier (MEDID) from associated injectable products.

Strength Concentration Type Table (RPEIST0_STR_CONC_TYPE)

This table provides the description for the strength type within these two ingredient strength tables: Total or
Normalized strength data representations.

For example, a 5 mL vial of midazolam has a normalized concentration of 1 mg/mL and therefore has a total
package strength of 5 mg/5 mL.

STR_CONC_TYPE_ID STR_CONC_TYPE_DESC

2 Normalized

3 Total Package

Strength Concentration Type

Normalized Drug Concentration

Total Package Strength and Total Volume

Normalized Drug Concentration

The Normalized Drug Concentration is the amount of drug per one milliliter (mL) of diluent: in an 80 mg/2 mL vial,
the normalized concentration is 40 mg/mL. All liquid injectable NDCs associated with a Clinical Formulation
(GCN_SEQNO) will share the same normalized concentration. The normalized concentration is useful for finding
Clinical Formulations (GCN_SEQNO) with the same ingredient list and normalized concentration that which may
differ by total volume or by packaging-type dosage forms, e.g., when the same drug in the same normalized
concentration is packaged in ampules rather than in vials.

The core design of this strength data is very nearly the same as that in the Clinical Formulation Ingredient
Strength Component Table (RGCNSTR0_INGREDIENT_STRENGTH), which is Clinical Formulation Identifier
(GCN_SEQNO)-centric. Both are based on the drug strength per ingredient to facilitate ingredient-specific dose
checking and total dose calculations.

Total Package Strength

Total Package Strength is the amount of an injectable ingredient per vial, ampule, or syringe (not per case). The
total amount per individual container is useful as it eliminates the need for manual calculation of the total amount

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of drug (for example, the total per vial) at the point of care. For example, product labeling on a vial may reflect the
concentration per mL, and separately on the label, the total volume in the vial without identifying the total
amount of drug per vial. Medication dosing errors have occurred based on a misconception that the normalized
concentration (the amount per mL) displayed on product labeling was the total amount of drug in the vial.

For example, to administer a loading dose of heparin of 70 units/kg to a 72 kg male (approximately 5,000 units), a
clinician using a 5 mL vial labeled as 5,000 units per mL would need to draw up 1 mL to administered the correct
dose. If, however, if the clinician misinterprets the vial label to mean that the vial contained a total of 5,000 units
and withdrew that vials entire 5 mL volume in a syringe, the result would be unintentional delivery of 25,000 units
as a single I.V. bolus. However, when scanned during programming of an infusion pump, the vials NDC could
alert the system to the concentration and total syringe volume and facilitate an alert to the administering clinician
that the total dose exceeds the prescribed dose and avert a medication dosing error.

With the aggregated data at the Clinical Formulation or Medication Identifier, more than one row of Total Package
Strength data indicates that associated NDCs differ by total volume per product.

Ingredient Alternate Strength Type Code

The Ingredient Alternate Strength Type Code (ALT_STRENGTH_TYP_CODE) definition is provided in the
MedKnowledge documentation, along with the Ingredient Alternate Strength Unit of Measure Identifier (
ALT_STRENGTH_UOM_ID) definition.

Ingredient Alternate Strength Unit of Measure Identifier

The Ingredient Alternate Strength unit of Measure (ALT_STRENGTH_UOM_ID) identifies the unit of measure of
the alternative strength of an ingredient. Use the value in this column to retrieve the description of the unit of
measure from the Ingredient Strength Unit of Measure Table (RSTRUOM0_STRENGTH_UOM).

Ingredient Strength Type Code

The Ingredient Strength Type Code (STRENGTH_TYP_CODE) indicates how the ingredient strength is
expressed.

Occasionally, strength type cannot be determined and is given a zero code. Strength type is not specified when
any of the following occurs:

Strength type is not defined or is not made obvious in manufacturer-supplied information.

The ingredient is Herbal.
It is determined by FDB clinical editors as inappropriate to specify strength type.
Not specified at this time pending review of product labeling and primary literature.

The description text is provided by the Strength Type Description ( STRENGTH_TYP_DESC) column within the
Clinical Formulation Ingredient Strength Type Description Table (RSTRTD0_STRENGTH_TYP_DESC, page
130).

Ingredient Strength Type Description

The Clinical Formulation Ingredient Strength Type Description Table (RSTRTD0_STRENGTH_TYP_DESC)

provides text descriptions for Ingredient Strength Type Codes (STRENGTH_TYP_DESC) and Ingredient

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Alternate Strength Type Codes (ALT_STRENGTH_TYP_CODE).

Ingredient Strength Status Code

The Ingredient Strength Status Code (STRENGTH_STATUS_CODE) provides the status of an ingredient. The
description text is provided by the Strength Status Description (STRENGTH_STATUS_DESC).

Strength Status Description

The Strength Status Description (STRENGTH_STATUS_DESC) provides text descriptions for Ingredient Strength
Status Codes (STRENGTH_STATUS_CODE).

Dosage Form Attribute

The Dosage Form Attribute Identifier (DOSE) and Dosage Form Attribute Description (
DOSAGE_FORM_ATTRIBUTE_DESC) provide context for the Total Strength value and remove ambiguity by
clarifying what this strength is relative to. For example, for a total strength of 400 mg/4 mL, a dosage form
attribute of vial indicates 400 mg/4 mL per vial.

Common Exceptions

For dry or lyophilized drug powders in vials or amps and injectable liquids (solutions or suspensions) without a
defined or fixed product volume, there are exceptions in how drug strength data is populated for injectable drugs
billed as an each. As these drugs do not have a volume unit of measure, calculation of a Normalized Drug
Concentration is not possible.

Rather than leave the Normalized Drug Concentration blank for these injectable drugs, which could inhibit the
comparison of strength values across Clinical Formulations (for example, comparison of the strength values
between an ampule and a vial), the module populates the strength number and strength unit of measure (UOM)
values of the Normalized Drug Concentration with available strength and strength UOM values, leaving the
volume number and volume UOM. NDC 00069448203 is a 1 gram vial of ceftriaxone powder. HIC_SEQNO 2734
is ceftriaxone sodium (from the RHICD3 ingredient file).

NDC HIC_SEQN STR_CONC_TYPE_ID

00069448203 2734 2

00069448203 2734 3

Note that the Volume and Volume UOM columns are blank for dry powders:

INGREDIENT_STR INGREDIENT_UOM_MSTR VOLUME VOLUME_UOM_MSTR_ID

_ID

1 368

1 368

Using the Strength Type Description and UOM description from the Unit of Measure Master Table
(RPEIUM0_UOM_MSTR):

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UOM_MSTR_ID UOM_MSTR_DESC

368 gram

and the Strength Concentration Type from the Strength Concentration Type Table
(RPEIST0_STR_CONC_TYPE):

STR_CONC_TYPE_ID STR_CONC_TYPE_DESC

2 Normalized

3 Total Package

The NDC strength may be represented in a more end-user friendly display:

NDC INGREDIENT STR_CONC_TYPE_ INGREDIENT_STR UOM_MSTR_DESC

DESC

00069448203 ceftriaxone sodium Normalized 1 gram

00069448203 ceftriaxone sodium Total Package 1 gram

Note that the Volume and Volume UOM columns are blank for dry powders:

VOLUME VOLUME_UOM_MSTR_ID

Rule Sets
This section provides rules that the clinical team uses in regard to creating the module's data, both general rules
and rules specific to data elements.

Strength data is collected at the product level and is product-specific. Strength data is delivered at the product
level for injectable products and in separate Clinical Formulation Identifiers (GCN_SEQNO) and Medication
Identifier (MEDID) tables, product strength data is rolled up to the associated Clinical Formulation Identifier
(GCN_SEQNOs) and Medication Identifiers (MEDIDs) so that customers working at these concepts may access
the strength data for the associated products.

Alternative Strengths (Total and Normalized) for injectable products are most commonly calculated based on
product package size and strength values from the associated Clinical Formulation Identifier (GCN_SEQNO).
However, Total Package Strength values are based on the designated Dosage Form Attribute as described
above.

Triggers for content review are evaluated for applicability to expanded MAPs content.

Maintenance
This section contains information regarding the ongoing maintenance of the module's data.

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Triggers for Clinical Review

FDA-approved documentation from manufacturers or distributors

Introduction of new drug products to the U.S. market
Customer or manufacturer clinical inquiries are reviewed daily and the database is updated weekly as
appropriate
FDA MedWatch Medical Product Safety Information Alerts
Notification of changes from documented sources listed in the Resources section below
MedEffects Alerts from Health-Canada (except Non-U.S. product alerts exclusive to Canada)

Resources
This section lists sources used by First Databank (FDB) to compile the information contained in the alternative
Route module relative to Labeled and Unlabeled Routes.

FDB utilizes many reference sources including, but not limited to, the primary medical literature (for example,
published journal articles), medical reference texts, published expert treatment guidelines, and manufacturers
product package inserts. FDB uses current source editions or versions when coding and updating data, as well as
when researching questions about data. However, FDB does not conduct a formal data review for every new
release of source editions or versions.

Additional sources include:

AHFS Drug Information. Published by American Society of Health System Pharmacists.

Primary Medical Literature.
Treatment Guidelines
Product labeling:
Manufacturer websites
FDA sources:
Daily Med: Structured Product Labels (SPL). Available at:
http://dailymed.nlm.nih.gov/dailymed/rsshome.cfm
FDA Approved Drug Products. Available at:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/
National Drug Code Directory. Available at:
http://www.accessdata.fda.gov/scripts/cder/ndc/default.cfm

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Dosage Form
Dosage Form Attributes
Overview
Inclusion
Data Elements
Rule Sets
Maintenance
Resources
Final and Alternative Dosage Form
Overview
Inclusion
Data Elements
Rule Sets
Maintenance
Resources

Dosage Form Attributes

Overview

Dosage Form Attributes are dosage form components by which Master Dosage Forms may be identified,
delineated, or grouped. Using the Master Dosage to MedID or GCNSEQNO relationship tables, the same
grouping rules may be applied. Similarly it is possible to group associated drug products by using dosage form
attributes as components of the search. For example, it is possible to search for and locate Medication Concepts
which are oral liquid formulations with a specific ingredient list by limiting the search to dosage forms with an
attribute of liquid and a route of oral.

Attributes provide varying degrees of granularity, ranging from broad: solid oral dosage forms (for example,
tablets or capsules), to more specific: capsule, tablet, and include distinguishing subtleties such as rate of
release: immediate release or extended release; dosing frequencies associated with extended release
formulations (8 hour, 12 hour, 24 hour), and related types of release, for example, delayed release (includes
enteric coated) denotes dosage forms which are designed for release beyond the acidic stomach for acid labile
drugs.

Inclusion

This section provides the criteria that govern the inclusion of data in the module as well as information pertaining
to limitations or exclusions where appropriate.

All master dosage forms are included and have dosage form attribute associations.

Data Elements

This section contains additional information about particularly important tables and codes contained within the

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module, as well as concepts about the data that the reader must understand in order to understand the module.

Dosage Form Attributes Data Components and Descriptions

Dosage Form Attribute Table (RPEIDFA0_DOSAGE_FORM_ATTRIBUTE)

Master Dosage Form to Attribute Link Table (RPEIAL0_DF_ATTRIBUTE_LINK)

Dosage Form Attribute Table (RPEIDFA0_DOSAGE_FORM_ATTRIBUTE)

This table contains descriptions of dosage form attributes (components) by which dosage forms, and by extension
drug formulations, may be delineated or grouped.

Master Dosage Form to Attribute Link Table (RPEIAL0_DF_ATTRIBUTE_LINK)

This table links a dosage form to its dosage form attributes. For example, the dosage form of capsule has
dosage forms attributes of 1) capsule, 2) solid dosage form (oral). A dosage form may have one to many Dosage
Form Attributes.

Rule Sets

All Master Dosage Forms are included and have been associated with Dosage Form Attributes.

Maintenance

This section contains information regarding the ongoing maintenance of the module's data

Triggers for Clinical Review

FDA-approved documentation from manufacturers or distributors

Introduction of new drug products to the U.S. market
Customer or manufacturer clinical inquiries are reviewed daily and the database is updated weekly as
appropriate
FDA MedWatch Medical Product Safety Information Alerts
Notification of changes from documented sources listed in the Resources section below
MedEffects Alerts from Health-Canada (except Non-U.S. product alerts exclusive to Canada)

Resources

This section lists sources used by First Databank (FDB) to compile the information contained in the alternative
Route module relative to Labeled and Unlabeled Routes.

FDB utilizes many reference sources including, but not limited to, the primary medical literature (for example,
published journal articles), medical reference texts, published expert treatment guidelines, and manufacturers
product package inserts. FDB uses current source editions or versions when coding and updating data, as well as
when researching questions about data. However, FDB does not conduct a formal data review for every new
release of source editions or versions. Additional sources include:

AHFS Drug Information (published by American Society of Health System Pharmacists)

Primary Medical Literature
Product labeling:

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Manufacturer websites
FDA sources:
Daily Med: Structured Product Labels (SPL). Available at:
http://dailymed.nlm.nih.gov/dailymed/rsshome.cfm
FDA Approved Drug Products. Available at:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/
National Drug Code Directory. Available a:
http://www.accessdata.fda.gov/scripts/cder/ndc/default.cfm
Treatment Guidelines

Final and Alternative Dosage Form

Overview

First Databank has established a variety of dosage form concepts over time that share descriptive similarities but
may differ in how they are used based on module-specific or drug identifier-specific applications and the
requirements that each must fulfill in that use setting. For example, Clinical Formulation ID (GCN_SEQNO)
dosage form, the GCDF is a key component of GCN_SEQNO uniqueness which has legacy associations to
NCPDP billing units while MEDID dosage form do not have billing associations. Similarly, the dosage forms in
OrderKnowledge support a unique descriptive need in that modules data. The First Databank Master Dosage
Form Table introduces a pivotal dosage form concept, the Master Dosage Form intended to facilitate navigation
between similarly named dosage forms in FDB data sets by helping to bridge the relationship between differing
numeric and alpha-numeric identifiers. The Master Dosage Form is also used directly to populate two new
dosage form data sets, the Final Dosage Form and the Alternative Dosage Form.

Inclusion

This section provides the criteria that govern the inclusion of data in the Final and Alternative Dosage Form tables
as well as information pertaining to limitations or exclusions where appropriate.

All products in the U.S. are included. Initial data population has focused on drug products that are active (not
obsolete) or less than three years obsolete, although products obsolete for longer than 3 years were included
when practical.

Data Elements

This section contains additional information about particularly important tables and codes contained within the
module, as well as concepts about the data that the reader must understand in order to understand the module.

Dosage Form Types

Final Dosage Form

The Final Dosage Form is a dosage form that describes the administrable dosage from the perspective of the
administering clinician and may be a more concise representation of a dosage form than that necessary to
distinguish that dosage form from another in an electronic database.

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For example, a Capsule, ER 24 hr at the Clinical Formulation Identifier (GCN_SEQNO) or Medication Identifier
(MEDID) has a final dosage form description of simply capsule, extended release. It provides a streamlined
version of the description and is perhaps easier to read and understand but retains the extended release
component so that a knowledge nurse would know or could be alerted that this capsule should not be crushed or
chewed because it is extended release.

In another example, a product with a dosage form of Solution & Solution Reconstituted, Sequential at the
Clinical Formulation Identifier (GCN_SEQNO) simply has solution as the Final Dosage Form, removing
descriptions components that suggest the need for reconstitution in the pharmacy prior to dispensing.

Alternative Dosage Form

The Alternative Dosage Form has a different intended use than the Final Dosage Form. It is intended to provide
customers with additional options for dosage form descriptions that can be used to build drug descriptions for
display. For example, FDB uses the dosage form tablet to represent products labeled as tablets, but FDB also
uses tablet to represent gel coated tablet formulations commonly described on product labeling as caplets. The
Alternative Dosage Form of caplet is associated with NDCs labeled with the term caplet should a customer
prefer to build a drug description using a dosage form description of caplet rather than tablet in the description.
The Alternative Dosage Form may also be used as an additional query component to locate and group related
drug products with the same Alternative Dosage Form.

Dosage Form Components and Descriptions

Packaged Product (NDC) to Dosage Form Link Table (RPEIND0_NDC_DF_LINK)

This table provides a link between a product and its Final Dosage Form or between a product and Alternative
Dosage Forms.

Clinical Formulation Identifier (GCN_SEQNO) to Dosage Form Link Table (RPEIGD0_GCNSEQNO_DF_LINK)

This table provides a product Final Dosage Form or Alternative Dosage Forms rolled-up to the GCNSEQNO.

Med Medication Identifier (MEDID) to Dosage Form Link Table (RPEIMD0_MED_DF_LINK)

This table provides a product Final Dosage Form or Alternative Dosage Forms rolled-up to the Med Medication ID
(MEDID).

MED Routed Dosage Form Medication to Dosage Form Link Table (RPEIRD0_RTD_DF_MED_DF_LINK)

This table provides a product Final Dosage Form or Alternative Dosage Forms rolled-up to the Routed Dosage
Form MED.

MED Routed Medication to Parent and Clinical Routes Table (RPEIRMD0_RTD_MED_DF_LINK)

This table provides a product Final Dosage Form or Alternative Dosage Forms rolled-up to the Routed Med.

Dosage Form Master to Clinical Formulation Identifier (GCN_SEQNO) Dosage Form Code Link
Table (RPEIGL0_GEN_DF_MSTR_LINK)

This table Relates dosage forms in the Dosage Form Master table to dosage forms in the Dosage Form
Description table (RDOSED2_DOSE_DESC) of the Clinical Formulation Identifier (GCN_SEQNO).

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Dosage Form Master to MED Dosage Form Link Table (RPEIML0_MED_DF_MSTR_LINK)

This table relates dosage forms in the Dosage Form Master table to dosage forms in the Medication Concepts
dosage form table (RMIDFD1_DOSE_FORM).

Rule Sets

Product Final and Alternative Dosage Forms are collected at the product level and are product-specific at that
level. Dosage Form data is rolled-up to less specific drug concepts (e.g. GCN_SEQNO, MEDID, Routed Dosage
Form Med, and Routed Med as described above) so that customers working at these concepts may access the
data for associated products without navigating to the product level.

Aggregated drug knowledge may not apply to all associated packaged products, and more specific information
may be found at individual NDCs. However, product information aggregated at the concepts listed above may be
useful to clinicians by displaying aggregated attributes to aid in locating the subset of NDCs with desired
attributes.

Triggers for content review are evaluated for applicability to expanded MAPs content. (See the MAPs
Enhancements Maintenance section for more information.)

Maintenance

This section contains information regarding the ongoing maintenance of the module's data.

Triggers for Clinical Review

FDA-approved documentation from manufacturers or distributors

Introduction of new drug products to the U.S. market
Customer or manufacturer clinical inquiries are reviewed daily and the database is updated weekly as
appropriate
FDA MedWatch Medical Product Safety Information Alerts
Notification of changes from documented sources listed in the Resources section below
MedEffects Alerts from Health-Canada (except Non-U.S. product alerts exclusive to Canada)

Resources

This section lists sources used by First Databank (FDB) to compile the information contained in the alternative
Route module relative to Labeled and Unlabeled Routes.

FDB utilizes many reference sources including, but not limited to, the primary medical literature (for example,
published journal articles), medical reference texts, published expert treatment guidelines, and manufacturers
product package inserts. FDB uses current source editions or versions when coding and updating data, as well as
when researching questions about data. However, FDB does not conduct a formal data review for every new
release of source editions or versions.

Additional sources include:

AHFS Drug Information (published by American Society of Health System Pharmacists)

Primary Medical Literature

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Treatment Guidelines
Product labeling:
Manufacturer websites
FDA sources:
Daily Med: Structured Product Labels (SPL). Available at:
http://dailymed.nlm.nih.gov/dailymed/rsshome.cfm
FDA Approved Drug Products. Available at:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/
National Drug Code Directory. Available at:
http://www.accessdata.fda.gov/scripts/cder/ndc/default.cfm

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Routes
Overview
Inclusion Criteria
Data Elements
Alternative Route Components and Descriptions
Route Relation Table Elements
Rule Sets
Maintenance
Triggers for Clinical Review
Resources

Overview
The First Databank Product Route Relation data delivers, at an NDC level, two useful route values for all
products: the Parent Route and the Clinical Route. The Parent Route for a product is intended for implementation
as a general navigational Route term (e.g. injection) associated with more granular and product-specific Clinical
Routes (e.g. intravenous, intramuscular, etc.) for use in order entry processes such as physician order entry and
pharmacy order fulfillment at the point of care.

Product-specific route data is also aggregated for use at the following concepts: Clinical Formulation ID (
GCN_SEQNO), Ingredient List ID (HICL_SEQNO), Medication ID (MEDID), Routed Dosage Form MedID, Routed
MedID, and Med Name.

Aggregated drug knowledge may not apply to all associated packaged products, and more specific information
may be found at individual NDCs. However, product information aggregated at the concepts listed above may be
useful to clinicians by displaying aggregated attributes to aid in locating the subset of NDCs with desired
attributes.

Inclusion Criteria
This section provides the criteria that govern the inclusion of data in the module as well as information pertaining
to limitations or exclusions where appropriate.

All products in the U.S. are included. Initial data population has focused on drug products that are active (not
obsolete) or less than three years obsolete, although products obsolete longer than 3 years were included when
practical.

Data Elements
This section contains additional information about particularly important tables and codes contained within the
module, as well as concepts about the data that the reader must understand in order to understand the module.

Alternative Route Components and Descriptions

Alternative Route Components and Descriptions appear in the following tables.

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NDC to Route Relationship Table (RPEINR0_NDC_RT_RELATION)

Clinical Formulation Identifier (GCN_SEQNO) to Route Relationship Table
(RPEIGR0_GCNSEQNO_RT_RELATION)
Ingredient List Identifier (HICL_SEQNO) to Route Relationship Table
(RPEIHR0_HICLSEQNO_RT_RELATION)
MED Medication Identifier (MEDID) to Route Relationship Table (RPEIMRR0_MED_RT_RELATION)
MED Routed Dosage Form Medication Identifier (MEDID) to Route Relationship Table
(RPEIRR0_RTD_DF_MED_RT_RELATION)
MED Routed Medication to Route Relationship Table (RPEIRMR0_RTD_MED_RT_RELATION)
MED Medication Name to Route Relationship Table (RPEIMNR0_MED_NAME_RT_RELATION)
Route Hierarchy Table (RPEIRH0_RT_HIERARCHY)
Route Labeled Description Table (RPEIRL0_RT_LABELED_DESC)
Clinical Formulation Identifier (GCN_SEQNO) to Representative Route Table
(RPEIGRR0_GCNSEQNO_REP_RT)

NDC to Route Relationship Table (RPEINR0_NDC_RT_RELATION)

This table provides one or more product-specific, general Parent Routes and one or more clinically relevant and
specific Clinical Routes for integration in drug ordering processes such as physician order entry and pharmacy
order fulfillment.

Related tables have product-specific routes rolled-up to the following concepts: Clinical Formulation ID (
GCN_SEQNO), Ingredient List ID (HICL_SEQNO), Medication ID (MEDID), Routed Dosage Form MedID, Routed
MedID, and Med Name. These association tables are included below.

Clinical Formulation Identifier (GCN_SEQNO) to Route Relationship Table (RPEIGR0_GCNSEQNO_RT_RELATION)

This table provides one or more product Parent Routes and the associated Clinical Routes for each parent route
for integration in drug ordering processes such as physician order entry and pharmacy order fulfillment
rolled-up to the GCN_SEQNO.

Ingredient List ID (HICL_SEQNO) to Route Relationship Table (RPEIHR0_HICLSEQNO_RT_RELATION)

This table provides one or more product Parent Routes and the associated Clinical Routes for each parent route
for integration in drug ordering processes such as physician order entry and pharmacy order fulfillment
rolled-up to the Ingredient List ID (HICL_SEQNO).

Med Medication Identifier (MEDID) to Route Relationship Table (RPEIMRR0_MED_RT_RELATION)

This table provides one or more product Parent Routes and the associated Clinical Routes for each parent route
for integration in drug ordering processes such as physician order entry and pharmacy order fulfillment
rolled-up to the Medication ID (MEDID).

MED Routed Dosage Form Medication Identifier (MEDID) to Route Relationship

Table (RPEIRR0_RTD_DF_MED_RT_RELATION)

This table provides one or more product Parent Routes and the associated Clinical Routes for each parent route

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for integration in drug ordering processes such as physician order entry and pharmacy order fulfillment
rolled-up to the Routed Dosage Form Med (ROUTED_DOSAGE_FORM_MED_ID).

Med Routed Medication to Route Relationship Table (RPEIRMR0_RTD_MED_RT_RELATION)

This table provides one or more product Parent Routes and the associated Clinical Routes for each parent route
for integration in drug ordering processes such as physician order entry and pharmacy order fulfillment
rolled-up to the Routed Med (ROUTED_MED_ID).

MED Medication Name to Route Relationship Table (RPEIMNR0_MED_NAME_RT_RELATION)

This table provides one or more product Parent Routes and the associated Clinical Routes for each parent route
for integration in drug ordering processes such as physician order entry and pharmacy order fulfillment
rolled-up to the Med Name (MED_NAME_ID).

Route Hierarchy Table (RPEIRH0_RT_HIERARCHY)

This table provides Parent Routes and associated Clinical Routes without the context of specific drug concepts.
This table should not be used independent of the drug concept to route relationship tables.

Route Relation Table Elements

Parent Route
Clinical Route
Route Labeled Identifier
Labeled
Unlabeled
Relation Inactive Date

Parent Route

The Parent Route (PARENT_RT_ID) for a product is intended for implementation as a general navigational term,
such as injection, where there is a need for a broad choice as a component of the pathway to choosing a more
specific route of administration.

Clinical Route

The Clinical Route (CLINICAL_RT_ID) for a product is intended for implementation as a site-specific choice for
ordering clinicians.

Combining use of Parent and Clinical Routes for Navigational use or Display of Clinical Route Choices in Drug Order
Entry

Implementation of the Parent Route (PARENT_RT_ID) as an initial choice which is associated with and facilitates
display of more granular and site-specific Clinical Routes (CLINICAL_RT_ID ) for ordering clinicians to choose
from.

This design is intended to overcome the historic limitation of the single, representative route associated with a
Clinical Formulation ID (GCN_SEQNO) or Medication Concept (MEDID) and provide viable product-specific route
osculations for implementation in a physician order entry or pharmacy order fulfillment environments.

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Delivery of Clinical Routes at a variety of drug concept levels in designed to facilitate implementation at the
desired level of physician order entry, profiling and display. Clinical Route to drug concept associations may also
be used to assemble locally customized pre-built order strings.

Delivery of Clinical Routes at the product level is intended to facilitate order fulfillment by guiding product choice
based on their associated labeled and unlabeled Clinical Routes.

Route Labeled Description Table (RPEIRL0_RT_LABELED_DESC)

This table provides relation between a Route Label Indicator and its description. This table includes a list of
values that denote whether a listed route has been derived from the labeling of the associated product or
products (Labeled), or from other sources meeting the FDB policy for inclusion (Unlabeled).

Route Labeled Description

Route Labeled Descriptions are Labeled and Unlabeled.

RT_LABELED_ID RT_LABELED_DESC

1 Labeled

2 Not Labeled

Route Labeled Identifier

The Route Labeled Identifier (RT_LABELED_ID) appears only in the NDC to Route Relation table
(RPEINR0_NDC_RT_RELATION) as Clinical Routes in this table are product-specific. The Route Labeled
Identifier of Labeled denotes that the Clinical Route is represented in product labeling as defined by the FDA.
Unlabeled routes are potential routes of administration which are not represented in product labeling. See the
References section for FDB sources of unlabeled routes. As Route data in the other Route Relation tables may
be rolled-up from more than one product, the Route Labeled Identifier is not applied in the associated concept
tables.

Relation Inactive Date

The Relation Inactive Date (RELATION_INACTIVE_DATE) is Clinical Route-specific obsolete date. When null, it
indicates that at least one active product is associated and is the source of the Clinical Route rolled-up to the
concept in focus (e.g. MEDID, GCN_SEQNO, etc.). When the Relation Inactive Date is populated with an
obsolete date, it represents the date at which the last active source product became obsolete. As the Relation
Inactive Date is based on whether or not all associated products are obsolete its data value is not stable and may
change back to null if an active product is newly associated or if an obsolete product changes status and
becomes active (non-obsolete).

Clinical Formulation Identifier (GCN_SEQNO) to Representative Route Table (RPEIGRR0_GCNSEQNO_REP_RT)

The Representative Route Identifier (REPRESENTATIVE_RT_ID) identifies a single representative route for a
given Clinical Formulation ID (GCN_SEQNO).

Representative Route Identifier

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The representative route is intended for inclusion in generating a display of the Clinical Formulation ID (
GCN_SEQNO) in dispensing environments or formulary listings where a single description may be preferable.
The route was previously obtained by getting the Route of Administration Code ( GCRT) for a specific
GCN_SEQNO from any version of the Clinical Formulation ID (GCN_SEQNO) master table (the most recent
version is the RGCNSEQ4_ GCNSEQNO_MSTR) and retrieving the Route description from a version of the
legacy route table (e.g. RROUTED3_ROUTE_DESC). The legacy route code, the GCRT, is a one-character code
which has been exhausted. Therefore there is no longer room for adding new routes of administration. The
Representative route in the Clinical Formulation Identifier (GCN_SEQNO) to Representative Route Table
(RPEIGRR0_GCNSEQNO_REP_RT) is the go-forward single route for the Clinical Formulation ID (
GCN_SEQNO). For example, the Clinical Formulation Identifier (GCN_SEQNO) legacy route for infant lung
surfactants is the legacy, nonspecific route of inhalation, while the new representative route is intratracheal.

Brand Name Clinical Formulation ID Clinical Formulation Description

CUROSURF 27956 poractant alfa 120 mg/1.5 mL (80

mg/mL)

INFASURF 43195 Calfactant 35 mg/mL intratracheal Vial

SURFAXIN 69982 lucinactant 34 mg/mL intratracheal Vial

SURVANTA 16280 beractant 25 mg/mL intratracheal Vial

Rule Sets
This section provides rules that the clinical team uses in regard to creating the module's data, both general rules
and rules specific to data elements.

Product and Clinical Routes are collected at the product level and are product-specific at that level. Route data is
rolled-up to less specific drug concepts
(e.g. MEDID, RT_DF_MED, RT_MED, MED_NAME, GCN_SEQNO, HICL_SEQNO) so that customers working at
these concepts may access the route data for associated products without navigating to the product level.

Aggregated drug knowledge may not apply to all associated packaged products, and more specific information
may be found at individual NDCs. However, product information aggregated at the concepts listed above may be
useful to clinicians by displaying aggregated attributes to aid in locating the subset of NDCs with desired
attributes.

Maintenance
This section contains information regarding the ongoing maintenance of the module's data.

Triggers for Clinical Review

FDA-approved documentation from manufacturers or distributors

Introduction of new drug products to the U.S. market
Customer or manufacturer clinical inquiries are reviewed daily and the database is updated weekly as
appropriate

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FDA MedWatch Medical Product Safety Information Alerts

Notification of changes from documented sources listed in the Resources section below
MedEffects Alerts from Health-Canada (except Non-U.S. product alerts exclusive to Canada)

Resources
This section lists sources used by First Databank (FDB) to compile the information contained in the alternative
Route module relative to Labeled and Unlabeled Routes.

FDB utilizes many reference sources including, but not limited to, the primary medical literature (for example,
published journal articles), medical reference texts, published expert treatment guidelines, and manufacturers
product package inserts. FDB uses current source editions or versions when coding and updating data, as well as
when researching questions about data. However, FDB does not conduct a formal data review for every new
release of source editions or versions. Additional sources include:

AHFS Drug Information (published by American Society of Health System Pharmacists)

Primary Medical Literature
Treatment Guidelines
Product labeling:
Manufacturer websites
FDA sources:
Daily Med: Structured Product Labels (SPL). Available at:
http://dailymed.nlm.nih.gov/dailymed/rsshome.cfm
FDA Approved Drug Products. Available at:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/
National Drug Code Directory. Available at:
http://www.accessdata.fda.gov/scripts/cder/ndc/default.cfm

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Applications
This section provides information about the practical application of data contained in this module.

Retrieving the Ingredients for a Specified Clinical Formulation

Retrieving Related Drug Products Based on a Preferred Route and Ingredients List

Navigating to a Routed Medication, Routed Dosage Form, and Medication

Using the Clinical Formulation Identifier, Clinical Route, and Packaging Information to Group Products for
Purchasing

Finding a Replacement Ingredient Identifier

Determining if a Given Drug Contains Ethyl Alcohol (Ethanol)

Determining if a Given Drug Contains Metabolically Active Sugars

Identifying Storage Condition Requirements for a Given Medication

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Retrieving the Ingredients for a Specified Clinical Formulation

This example illustrates how to retrieve a clinical formulation ingredient list using the Clinical Formulation ID (
GCN_SEQNO) of a product.

Some columns are provided for description purposes only; if they are not important to the success of the
application their source tables may not be specified.

A products clinical formulation is made up of a list of active ingredients. The following application provides the
steps for assembling the active ingredient list for FIORINAL WITH CODEINE #3 (GCN_SEQNO 041844):

1. Retrieve the Ingredient List Identifier (HICL_SEQNO) for the given Clinical Formulation ID (GCN_SEQNO)
from the Clinical Formulation ID Table (RGCNSEQ4_GCNSEQNO_MSTR). Each Clinical Formulation ID (
GCN_SEQNO) has a corresponding HICL_SEQNO that represents the list of ingredients for its clinical
formulation. For example:

GCN_SEQNO HICL_SEQNO GNN60

004120 001699 codeine

phosphate/butalbital/aspirin/caffeine

The Generic Name - Long Version (GNN60) column is shown for descriptive reasons only and is
not necessary to this step. The GNN60 column is in the Ingredient List Identifier Description Table
(RHICLSQ2_HICLSEQNO_MSTR).

Retrieve the Ingredient Code Sequence Numbers (HIC_SEQN) for the given HICL_SEQNO using the
HICL_SEQNO/HIC Relation Table (RHICL1_HIC_HICLSEQNO_LINK). The example product has more
than one active ingredient, so the output has more than one row:

HICL_SEQNO HIC_SEQN

001699 001551

001699 000600

001699 001587

001699 001423

Finally, retrieve each Hierarchical Ingredient Code Description (HIC_DESC) using the Hierarchical
Ingredient Code Description Table (RHICD5_HIC_DESC).

HIC_SEQN HIC_DESC

001551 codeine phosphate

000600 caffeine

001587 aspirin

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001423 butalbital

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Retrieving Related Drug Products Based on a Preferred Route and Ingredients List
This application illustrates how to retrieve a list of packaged products that have the same active ingredients and
route of administration as a given product but with a variation of strengths and dosage forms.

Some columns are provided for description purposes only; if they are not important to the success of the
application their source tables may not be specified.

1. Retrieve the Clinical Route Identifier (CLINICAL_RT_ID) from the NDC to Route Relationship Table
(RPEINR0_NDC_RT_RELATION) where the National Drug Code (NDC) value equals the given NDC.

Text descriptions for Clinical Route Identifier (CLINICAL_RT_ID) values can be retrieved from the
Route of Administration Master Table (RPEIRM0_RT_MSTR).

2. Retrieve the associated Clinical Formulation ID (GCN_SEQNO) from the NDC Table
(RNDC14_NDC_MSTR) where the National Drug Code (NDC) value equals the given NDC.

3. Retrieve the Ingredient List Identifier (HICL_SEQNO) from the Clinical Formulation Identifier
(GCN_SEQNO) to Representative Route Table (RGCNSEQ4_GCNSEQNO_MSTR) where the Clinical
Formulation ID (GCN_SEQNO) equals the value retrieved in the previous step.

The Generic Name - Long Version (GNN60) value for a given Ingredient List Identifier (
HICL_SEQNO) can be retrieved from the Ingredient List Identifier Description Table
(RHICLSQ2_HICLSEQNO_MSTR.)

4. Retrieve the Clinical Formulation ID (GCN_SEQNO) from the Clinical Formulation Identifier
(GCN_SEQNO) to Representative Route Table (RGCNSEQ4_GCNSEQNO_MSTR) where the Ingredient
List Identifier (HICL_SEQNO) equals the values retrieved in the previous step.

The Dosage Form Description (DOSE) for a given Clinical Formulation ID (GCN_SEQNO) value
can be retrieved from the Dosage Form Description Table (RDOSED2_DOSE_DESC).

The results of this query will probably be numerous.

5. Filter the values retrieved from step 4 in the Clinical Formulation Identifier (GCN_SEQNO) to Route
Relationship Table (RPEIGR0_GCNSEQNO_RT_RELATION), retaining only results where the Clinical
Route ID (CLINICAL_RT_ID) equals the values retrieved in step 1 and the Relation Inactive Date (
RELATION_INACTIVE_DATE) column value is null.

6. Retrieve all associated National Drug Code (NDC) and Label Name-60 (LN60) values from the NDC Table
(RNDC14_NDC_MSTR) where the Clinical Formulation ID (GCN_SEQNO) equals the values retrieved in
the previous step.

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The results of this query will probably be numerous.

7. Filter the NDCs retrieved in the previous step, retaining only the NDCs that have the same alternative
routes as the routes in step 1. This filtering results in a list of packaged products that have the same active
ingredients and route of administration as the given product but with a variation of strengths and dosage
forms.

The results of this query will probably be numerous. Limit results to include only Clinical Routes of
IV, IM, and Sub-Q.

ExampleRetrieving Related Drug Products Based on a Preferred Route and Ingredients List

For purposes of demonstrating this application, the following scenario is used: The following application provides
the steps for assembling a list of related drug products for morphine 15 mg/mL Vial (NDC 00641607125).

1. Retrieve the Clinical Route ID (CLINICAL_RT_ID) from the NDC to Route Relationship Table
(RPEINR0_NDC_RT_RELATION) where the National Drug Code (NDC) equals 00641607125.

NDC CLINICAL_RT_ID

00641607125 186

00641607125 194

00641607125 217

Text descriptions for Clinical Route Identifier (CLINICAL_RT_ID) values can be retrieved from the
Route of Administration Master Table (RPEIRM0_RT_MSTR).

186 = Intramuscular (IM)

189 = Intraperitoneal (IV)
194 = Intravenous (Sub-Q)

2. Retrieve the associated Clinical Formulation ID (GCN_SEQNO ) from the NDC Table
(RNDC14_NDC_MSTR) where the National Drug Code (NDC) equals 00641607125.

NDC GCN_SEQNO

00641607125 4077

3. Retrieve the Ingredient List Identifier (HICL_SEQNO) from the Clinical Formulation Identifier
(GCN_SEQNO) to Representative Route Table (RGCNSEQ4_GCNSEQNO_MSTR) where the Clinical
Formulation ID (GCN_SEQNO ) equals the value retrieved in the previous step (4077).

GCN_SEQNO HICL_SEQNO

4077 1694

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The Generic Name - Long Version (GNN60) value for a given Ingredient List Identifier (
HICL_SEQNO) can be retrieved from the Ingredient List Identifier Description Table
(RHICLSQ2_HICLSEQNO_MSTR):

1694 = morphine sulfate

4. Retrieve the Clinical Formulation Identifiers (GCN_SEQNO) from the Clinical Formulation Identifier
(GCN_SEQNO) to Representative Route Table (RGCNSEQ4_GCNSEQNO_MSTR) where the Ingredient
List Identifier (HICL_SEQNO) equals the value retrieved in the previous step (1694). Variations of drug
form and strength are possible and have been included below to illustrate the differences.

HICL_SEQNO GCN_SEQNO STR60 GCDF DOSE

1694 4061 0.5 mg/mL HH AMPUL

1694 4062 1 mg/mL HH AMPUL

1694 4067 1 mg/mL HQ DISP SYRIN

1694 4077 15 mg/mL HV VIAL

1694 58973 10 mg TH TABLET HYP

1694 69903 150 mg CN CAPSULE,

EXTENDED
RELEASE PELLETS

The Dosage Form Description (DOSE) for a given Clinical Formulation Identifiers (GCN_SEQNO)
value can be retrieved from the Dosage Form Description Table (RDOSED2_DOSE_DESC).

The results of this query will probably be numerous. The results shown in this step represent a
small sample of the full result set.

5. Filter the values retrieved from step 4 in the Clinical Formulation Identifier (GCN_SEQNO) to Route
Relationship Table (RPEIGR0_GCNSEQNO_RT_RELATION), retaining only results where the Clinical
Route ID (CLINICAL_RT_ID) equals the values retrieved in step 1 and the Relation Inactive Date (
RELATION_INACTIVE_DATE) column value is null.

GCN_SEQNO CLINICAL_RT_ID RELATION_INACTIVE_DATE

4077 186

4077 194

4077 217

6. Retrieve all associated National Drug Code (NDC) and Label Name 60 (LN60) values from the NDC Table
(RNDC14_NDC_MSTR) where the Clinical Formulation Identifier (GCN_SEQNO) equals the values

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6.

retrieved in the previous step (4077). The retrieved results will represent drug products that have the same
ingredients and route of administration as the given product but vary in strength and/or dosage form.

GCN_SEQNO NDC LN60

4077 00641607201 MORPHINE 300 MG/20 ML VIAL

4077 00641607101 MORPHINE 15 MG/ML VIAL

4077 00641607125 MORPHINE 15 MG/ML VIAL

4077 00641607201 MORPHINE 300 MG/20 ML VIAL

4077 00641607101 MORPHINE 15 MG/ML VIAL

4077 00641607125 MORPHINE 15 MG/ML VIAL

4077 00641607201 MORPHINE 300 MG/20 ML VIAL

4077 00641607101 MORPHINE 15 MG/ML VIAL

4077 00641607125 MORPHINE 15 MG/ML VIAL

4077 00641607201 MORPHINE 300 MG/20 ML VIAL

4077 00641607101 MORPHINE 15 MG/ML VIAL

4077 00641607125 MORPHINE 15 MG/ML VIAL

4077 00641607201 MORPHINE 300 MG/20 ML VIAL

4077 00641607101 MORPHINE 15 MG/ML VIAL

4077 00641607125 MORPHINE 15 MG/ML VIAL

4077 00641607201 MORPHINE 300 MG/20 ML VIAL

4077 00641607101 MORPHINE 15 MG/ML VIAL

4077 00641607125 MORPHINE 15 MG/ML VIAL

The results of this query will probably be numerous. The values above represent only an example
of the retrieved results.

7. Filter the values retrieved from the previous step in the NDC to Route Relationship Table
(RPEINR0_NDC_RT_RELATION) where:
The National Drug Code (NDC) equals the values retrieved in the previous step
The Clinical Route ID (CLINICAL_RT_ID) equals the values retrieved in step 1 (186, 194, 217)

NDC CLINICAL_RT_ID

00641607101 186

00641607125 186

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00641607201 186

00641607101 194

00641607125 194

00641607201 194

00641607101 217

00641607125 217

00641607201 217

The filtered results provide packaged products that have the same active ingredients and
route of administration as the given product but with a variation of strengths and dosage
forms.

The results of this query will probably be numerous. The results shown in this step
represent a small sample of the full result set. These sample results have been limited to
include only Clinical Routes of IV, IM, and Sub-Q.

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Navigating to a Routed Medication, Routed Dosage Form, and Medication

This application illustrates how to navigate using Medication Name Concepts.

1. Retrieve the MED Medication Name ID (MED_NAME_ID) from the MED Medication Name Table
(RMINMID1_MED_NAME) where the MED Medication Name (MED_NAME) equals the given drug.

2. Retrieve the Routed Medication ID (ROUTED_MED_ID) and MED Routed Medication Description (
MED_ROUTED_MED_ID_DESC) values from the MED Routed Medication Table
(RMIRMID1_ROUTED_MED) where the MED Medication Name (MED_NAME_ID) equals the value
retrieved in the previous step and the MED Medication Status Code ( MED_STATUS_CD) value equals 0
(active).

3. Retrieve the associated Clinical Route Identifier (CLINICAL_RT_ID) from the MED Routed Medication to
Route Relationship Table (RPEIRMR0_RTD_MED_RT_RELATION) where the MED Routed Medication
Identifier (ROUTED_MED_ID) equals the value retrieved in the previous step.

The RT_DESC_LONG column is found in the Route of Administration Master Table

(RPEIRM0_RT_MSTR).

4. Retrieve the MED Routed Dosage Form Med ID ( ROUTED_DOSAGE_FORM_MED_ID) and from the
MED Routed Dosage Form Medication Table (RMIDFID1_ROUTED_DOSE_FORM_MED) where the MED
Routed Medication ID (ROUTED_MED_ID) equals the value retrieved in step 2 and the MED Medication
Status Code (MED_STATUS_CD) value equals 0 (active).

5. Retrieve the Medication Identifier (MEDID) and MED Medication Description (MED_MEDID_DESC) values
from the MED Medication Table (RMIID1_MED) where the MED Routed Dosage Form Med ID (
ROUTED_DOSAGE_FORM_MED_ID) equals the value retrieved in the previous step and the MED
Medication Status Code (MED_STATUS_CD) value equals 0 (active).

ExampleNavigating to a Routed Medication, Routed Dosage Form, and Medication

For purposes of demonstrating this application, the following scenario is used: A pharmacist receives an order for
gentamicin 100 mg intravenouspiggyback every 12 hours.

1. Retrieve the MED Medication Name ID (MED_NAME_ID) from the MED Medication Name Table
(RMINMID1_MED_NAME) where the MED Medication Name (MED_NAME) equals gentamicin.

MED_NAME MED_NAME_ID

gentamicin 1484

2. Retrieve the Routed Medication ID (ROUTED_MED_ID) and MED Routed Medication Description (
MED_ROUTED_MED_ID_DESC) values from the MED Routed Medication Table
(RMIRMID1_ROUTED_MED) where the MED Medication Name (MED_NAME_ID) equals the value
retrieved in the previous step (1484) and the MED Medication Status Code (MED_STATUS_CD) value
equals 0 (active).

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MED_NAME_ID ROUTED_MED_ID MED_ROUTED_MED_ID MED_STATUS_CD

_DESC

1484 1496 gentamicin Inj 0

1484 8337 gentamicin Opht 0

1484 75145 gentamicin Top 0

3. Retrieve the associated Clinical Route Identifier (CLINICAL_RT_ID) from the MED Routed Medication to
Route Relationship Table (RPEIRMR0_RTD_MED_RT_RELATION) where the Routed Medication ID (
ROUTED_MED_ID) equals the value retrieved in the previous step. In this example, the Routed
Medication Identifier (ROUTED_MED_ID) value 1496 (gentamicin Inj [Injection]) is utilized:

ROUTED_MED_ID CLINICAL_RT_ID RT_DESC_LONG

1496 194 intravenous

The RT_DESC_LONG column is found in the Route of Administration Master Table

(RPEIRM0_RT_MSTR).

4. Retrieve the MED Routed Dosage Form Med ID ( ROUTED_DOSAGE_FORM_MED_ID) and MED Routed
Dosage Form Medication Description (MED_ROUTED_DF_MED_ID_DESC) from the Routed Dosage
Form Medication Table (RMIDFID1_ROUTED_DOSE_FORM_MED,
RMIDFID2_ROUTED_DOSE_FORM_MED page 271) where the MED Routed Medication ID (
ROUTED_MED_ID) equals the value retrieved in step 2 (1496) and the MED Medication Status Code (
MED_STATUS_CD) value equals 0 (active).

ROUTED_MED_ID MED_STATUS_CD ROUTED_DOSAGE_FO MED_ROUTED_DF_MED

RM_MED_ID _ID_DESC

1496 0 1563 gentamicin Injection

5. Retrieve the Medication Identifier (MEDID) and MED Medication Description (MED_MEDID_DESC) values
from the MED Medication Table (RMIID1_MED) where the MED Routed Dosage Form Med ID (
ROUTED_DOSAGE_FORM_MED_ID) equals the value retrieved in the previous step (1563) and the MED
Medication Status Code (MED_STATUS_CD) value equals 0 (active).

ROUTED_DOSAGE_FO MED_STATUS_CD MEDID MED_MEDID_DESC

RM_MED_ID

1563 0 171012 gentamicin 10 mg/mL

Injection

1563 0 278441 gentamicin 40 mg/mL

Injection

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Using the Clinical Formulation Identifier, Clinical Route, and Packaging Information to Group
Products for Purchasing
The Clinical Formulation Identifier (GCN_SEQNO) is very useful for retrieving and comparing similar packaged
products. This application describes how to compare extremely similar products on a price-per-package basis. To
enhance comparisons for purchasing and clinical decision-making, use the NDC to Route Relationship Table
(RPEINR0_NDC_RT_RELATION) to find the clinical route(s), select a clinical route, and filter routes so that
results have the same clinical route based on a given NDC.

Some columns are provided for description purposes only; if they are not important to the success of the
application their source tables may not be specified.

This application uses more constraints than other examples, but does not involve as many steps. There
are different types of pricing, but this application concentrates only on the Consolidated Price Type 2
price. When appropriate, use a different price type, for example Consolidated Price Type 1 or
Wholesale Acquisition Cost (WAC) Package Price instead.

1. Retrieve the Clinical Route ID (CLINICAL_RT_ID) from the NDC to Route Relationship Table
(RPEINR0_NDC_RT_RELATION) where the National Drug Code (NDC) equals the given NDC.

2. Retrieve the Label Name (LN), Clinical Formulation Identifier (GCN_SEQNO), Package Size (PS), Unit
Dose Indicator (UD), Unit of Use Indicator (UU), and Package Description (PARENT_RT_ID) values from
the NDC Table (RNDC14_NDC_MSTR) where the National Drug Code (NDC) value equals the given
NDC.

3. Retrieve all associated NDCs from the NDC Table (RNDC14_NDC_MSTR) where the Label Name (LN),
Clinical Formulation Identifier (GCN_SEQNO), Package Size (PS), Unit Dose Indicator (UD), Unit of Use
Indicator (UU), and Package Description (PARENT_RT_ID) values are equal to the values retrieved in the
previous step and the Obsolete Date (OBSDTEC) value equals 0 (active).

4. Retrieve the NDC Price Table Price (NPT_PRICEX) for each NDC retrieved in the previous step from
the National Drug Code Price Table (RNP2_NDC_PRICE) where the NDC Price Table Price Type Code
(NPT_TYPE) value equals 17.

17 is the code for the Consolidated Price 2 Unit Price - Current price plus up to seven price
histories available price type (as opposed to Average Wholesale Price or other price types) in the
NDC Price Table Price Type Code (NPT_TYPE).

5. Filter the list of NDCs retrieved from the previous step in the NDC to Route Relationship Table
(RPEINR0_NDC_RT_RELATION) where the Clinical Route ID (CLINICAL_RT_ID) equals the value
chosen in step 1.
This filtering results in a list of extremely similar products that can be compared on a price-per-package
basis. The comparison is enhanced by providing products that have the same clinical route.

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The results of this query will probably be numerous.

The Manufacturer (MFG) name for a given NDC can be retrieved from the Labeler Identifier
Description Table (RLBLRID3_LBLR_DESC) where the Labeler Identifier (LBLRID) value equals
the Labeler Identifier (LBLRID) value in the NDC Table (RNDC14_NDC_MSTR) for the given
DCN.

ExampleUsing the Clinical Formulation Identifier (GCN_SEQNO), Clinical Route, and Packaging Information to
Group Products for Purchasing

For purposes of demonstrating this application, the following scenario is used: A provider wants to
compare the price of nafcillin 1 gram Solution for Injection (NDC 55150012215) that can be given by intravenous
(IV) administration with other candidate market products. To enhance comparisons for purchasing and clinical
decision-making, the provider wants to find the alternative routes based on the given NDC.

1. Retrieve the Clinical Route ID (CLINICAL_RT_ID) from the NDC to Route Relationship Table
(RPEINR0_NDC_RT_RELATION) where the National Drug Code (NDC) equals 55150012215.

NDC CLINICAL_RT_ID

55150012215 186

55150012215 189

55150012215 194

Text descriptions for Clinical Route Identifier (CLINICAL_RT_ID) values can be retrieved from the
Route of Administration Master Table (RPEIRM0_RT_MSTR):

186 = Intramuscular (IM)

189 = Intraperitoneal (IV)
194 = Intravenous (Sub-Q)

2. Retrieve the Label Name (LN), Clinical Formulation Identifier (GCN_SEQNO), Package Size (PS), Unit
Dose Indicator (UD), Unit of Use Indicator (UU), and Package Description (PARENT_RT_ID) values from
the NDC Table (RNDC14_NDC_MSTR) where the National Drug Code (NDC) value equals 55150012215.

NDC LN GCN_SEQN PS UD UU PD
O

55150012215 NAFCILLIN 1 8966 1 0 0 VIAL

GM VIAL

3. Retrieve all associated NDCs from the NDC Table (RNDC14_NDC_MSTR) where the Label Name (LN),
Clinical Formulation Identifier (GCN_SEQNO), Package Size (PS), Unit Dose Indicator (UD), Unit of Use
Indicator (UU), and Package Description (PARENT_RT_ID) values are equal to the values retrieved in the

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previous step and the Obsolete Date (OBSDTEC) value equals 0 (active).

NDC LN GCN_SEQ PS UD UU PD OBSDTEC

NO

0078131248 NAFCILLIN 8966 1 0 0 VIAL 0

5 1 GM VIAL

0078131249 NAFCILLIN 8966 1 0 0 VIAL 0

5 1 GM VIAL

0078191248 NAFCILLIN 8966 1 0 0 VIAL 0

5 1 GM VIAL

0078191249 NAFCILLIN 8966 1 0 0 VIAL 0

5 1 GM VIAL

2502101391 NAFCILLIN 8966 1 0 0 VIAL 0

0 1 GM VIAL

6332303271 NAFCILLIN 8966 1 0 0 VIAL 0

0 1 GM VIAL

The resulting packaged products are identical to the given NDC in most ways.

4. Retrieve the NDC Price Table Price (NPT_PRICEX) for each NDC retrieved in the previous step from
the National Drug Code Price Table (RNP2_NDC_PRICE) where the NDC Price Table NDC Price Type
Code (NPT_TYPE) value equals 17.

NDC NPT_TYPE NPT_PRICEX

00781312495 17 14.599

00781912485 17 14.59

00781912495 17 14.599

25021013910 17 11.25

55150012215 17 14.5

63323032710 17 11.91

17 is the code for the Consolidated Price 2 Unit Price - Current price plus up to seven price
histories available price type (as opposed to Average Wholesale Price or other price types) in the
NDC Price Table Price Type Code (NPT_TYPE).

The Manufacturer (MFG) name for a given NDC can be retrieved from the Labeler Identifier
Description Table (RLBLRID3_LBLR_DESC) where the Labeler Identifier (LBLRID) value equals
the Labeler Identifier (LBLRID) value in the NDC Table (RNDC14_NDC_MSTR) for the given
DCN.

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5. Filter the list of NDCs retrieved from the previous step in the NDC to Route Relationship Table
(RPEINR0_NDC_RT_RELATION) where the Clinical Route ID (CLINICAL_RT_ID) equals 194
(Intravenous).

NDC CLINICAL_RT_ID

00781312495 194

00781912485 194

00781912495 194

25021013910 194

55150012215 194

63323032710 194

This filtering results in a list of extremely similar products that can be compared on a price-per-package
basis. The comparison is enhanced by providing products that have the same clinical route.

The results of this query will probably be numerous. The results shown in this step represent a
small sample of the full result set.

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Finding a Replacement Ingredient Identifier

This application illustrates how to retrieve a replacement value for a replaced ingredient identifier.

1. Select the Ingredient Status Code (ING_STATUS_CD) values from the Hierarchical Ingredient Code
Description Table (RHICD5_HIC_DESC) where the Hierarchical Ingredient Code Sequence Number (
HIC_SEQN) column equals the HIC_SEQN value of a given ingredient.

2. If the ING_STATUS_CD value equals 1 (indicating replaced), select the following columns from the
Ingredient Replacement History Table (RHICRH0_ING_HIST) where the Previous Hierarchical Ingredient
Code Sequence Number (PREV_HIC_SEQN) column equals the replaced HIC_SEQN value from step 1.
Replacement Hierarchical Ingredient Code Sequence Number (REPL_HIC_SEQN)
Hierarchical Ingredient Code Sequence Number Replacement Effective Date ( HIC_REPL_EFF_DT)

In this step, the previous Ingredient Number column is populated with the replaced
HIC_SEQN value queried in step 1 to retrieve its related replacement Ingredient Number.

3. Repeat steps 1 and 2 using the replacement HIC_SEQN values retrieved in the previous step until the
ING_STATUS_CD value is 0 (indicating active) or 2 (indicating retired).

ExampleFinding a Replacement Ingredient Code

For purposes of demonstrating this application, the following scenario is used: Upon selection of lidocaine
(obsolete) (HIC_SEQN 626), a healthcare system first checks its status to determine if it has been replaced
before attempting to locate its replacement value.

1. Select the Ingredient Status Code (ING_STATUS_CD) values from the Hierarchical Ingredient Code
Description Table (RHICD5_HIC_DESC) where the Hierarchical Ingredient Code Sequence Number (
HIC_SEQN) column equals the HIC_SEQN value of a given ingredient.

HIC_SEQN HIC_DESC ING_STATUS_CD

626 lidocaine (obsolete) 1

2. If the ING_STATUS_CD value equals 1 (indicating replaced), select the following columns from the
Ingredient Replacement History Table (RHICRH0_ING_HIST) where the Previous Hierarchical Ingredient
Code Sequence Number (PREV_HIC_SEQN) column equals the replaced HIC_SEQN value from step 1.
Replacement Hierarchical Ingredient Code Sequence Number (REPL_HIC_SEQN)
Hierarchical Ingredient Code Sequence Number Replacement Effective Date ( HIC_REPL_EFF_DT)

PREV_HIC_SEQN REPL_HIC_SEQN HIC_REPL_EFF_DT

626 1350 19990216

3. Repeat steps 1 and 2 using the replacement HIC_SEQN values retrieved in the previous step until the
ING_STATUS_CD value is 0 (indicating active) or 2 (indicating retired).

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HIC_SEQN HIC_DESC ING_STATUS_CD

1350 lidocaine 0

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Determining if a Given Drug Contains Ethyl Alcohol Ethanol

This application illustrates how to determine if a given drug contains ethyl alcohol (ethanol).

This application may also be performed at the Med Medication Name ( MED_NAME), MED Routed
Medication ID (ROUTED_MED_ID), MED Routed Dosage Form Medication ID (
ROUTED_DOSAGE_FORM_MED_ID), or National Drug Code (NDC) level.

For purposes of demonstrating this application, the following scenario is used: A pharmacist is filling an
order for fluoxetine 20 mg/5 mL oral (MEDID 156099) for a patient who is currently on metronidazole. Due to the
potential for disulfiram drug reaction, the pharmacist must determine if a ethyl alcohol (ethanol) free product is
available for dispensing.

1. Retrieve the Attribute Code (ATTRIBUTE_CODE) and Attribute Value (ATTRIBUTE_VALUE) values from
the MED Medication Attribute Table (RPEIMA0_MED_ATTRIBUTE) where the MEDID equals 156099
(fluoxetine 20 mg/5 mL oral) and the LINK_INACTIVE_DATE is null:

MEDID ATTRIBUTE_CODE ATTRIBUTE_VALUE

156099 51 2

156099 52 2

156099 53 1

156099 54 1

156099 54 2

2. Retrieve the Attribute Description (ATTRIBUTE_DESC) and Attribute Type Code (

ATTRIBUTE_TYPE_DESC) values from the Attribute Description Table (RPEIAD0_ATTRIBUTE_DESC)
where the ATTRIBUTE_CODE equals the value(s) retrieved in the previous step.

ATTRIBUTE_CODE ATTRIBUTE_DESC ATTRIBUTE_VALUE

51 Preservative Free Code 2

52 Sugar Free Code 2

53 Latex Free Code 1

54 Alcohol Free Code 1

54 Alcohol Free Code 2

At this level, users may filter results to complete the desired action. For this example, the user will
select the ATTRIBUTE_CODE 54 (Alcohol Free Code) to complete this application.

3. Retrieve the Attribute Value Description (ATTRIBUTE_VALUE_DESC) values from the Attribute Value
Description Table (RPEIAV0__ATTRIBUTE_VALUE_DESC) where the ATTRIBUTE_CODE and

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3.

ATTRIBUTE_VALUE equals the filtered values retrieved in steps 1 and 2.

ATTRIBUTE_CODE ATTRIBUTE_VALUE ATTRIBUTE_VALUE_DESC

54 1 Ethyl Alcohol (Ethanol) Free

54 2 Contains Ethyl Alcohol (Ethanol)

4. Display results to user. In this scenario, the pharmacist sees that an ethyl alcohol (Ethanol) free packaged
product is available for the ordered medication and may proceed (step 5).

MEDID ATTRIBUTE_CODE ATTRIBUTE_DESC ATTRIBUTE_VALU ATTRIBUTE_VALU

E E_DESC

156099 54 Alcohol Free Code 1 Ethyl Alcohol

(Ethanol) Free

156099 54 Alcohol Free Code 2 Contains Ethyl

Alcohol (Ethanol)

5. Select the National Drug Code (NDC) values from the MED NDC to Medication ID Cross-Reference Table
(RMINDC1_NDC_MEDID) where the MEDID equals the MEDID value of the prescribed medication (
156099).

MEDID NDC

156099 00121472105

156099 60505035201

156099 00093610812

156099 54838052340

156099 00121072105

156099 60432016204

156099 00406066701

156099 00472002104

156099 00121072104

156099 49884069937

6. Select the National Drug Code (NDC) values from the MED NDC to Generic Medication ID
Cross-Reference Table (RMEDNGM0_NDC_GEN_MEDID) where the MEDID equals the MEDID value of
the prescribed medication (156099).

MEDID NDC

156099 00093610812

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156099 00121072104

156099 00121072105

156099 00121472105

156099 00472002104

156099 00406066701

156099 00777512058

156099 00777512058

156099 50962050005

156099 50962050060

156099 54569359600

156099 54838052340

156099 60505035201

156099 60432016204

The results returned in this step may contain duplicate NDC values. Remove any duplicate NDC
values before proceeding.

7. Filter the results retrieved in the previous step using the NDC Table (RNDC14_NDC_MSTR), where the
Obsolete Date (OBSDTEC) equals 0 (Active).

NDC OBSDETC

00093610812 0

00121072104 0

00121072105 0

00121472105 0

54838052340 0

60505035201 0

An Obsolete Date (OBSDTEC) value equal to 0 (Active) is also associated to NDCs up to three
years obsolete (for example, >20120115).

8. Retrieve the NDC Attribute Type Code (NDC) and NDC Attribute Value (NDC_ATTRIBUTE_VALUE)
values from the NDC Attribute Table (RNDCAT0_NDC_ATTRIBUTE) where the NDCs equal values
filtered from the previous step.

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NDC NDC_ATTRIBUTE_TYPE_CD NDC_ATTRIBUTE_VALUE

00093610812 53 2

00093610812 54 1

00093610812 55 1

00121072104 53 1

00121072104 54 1

00121072104 55 1

00121072105 53 1

00121072105 54 1

00121072105 55 4

00121072105 53 1

00121072105 54 1

00121072105 55 1

54838052340 53 1

54838052340 54 2

54838052340 55 1

60505035201 53 3

60505035201 54 3

60505035201 55 4

Results may be numerous. This example represents only a sample of the returned values.

9. Retrieve the NDC Attribute Type Description (NDC_ATTRIBUTE_TYPE_DSC) values from the NDC
Attribute Value Description Table (RNDCTD0_NDC_ATTRIBUTE_TYP_DSC) where the
NDC_ATTRIBUTE_CODE equals the value(s) retrieved in the previous step.

NDC NDC_ATTRIBUTE_TYPE_CD NDC_ATTRIBUTE_VALUE

00093610812 53 Alcohol Free Code

00093610812 54 Latex Free Code

00093610812 55 Storage Condition (Refrigeration

Code)

00121072104 53 Alcohol Free Code

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00121072104 54 Latex Free Code

00121072104 55 Storage Condition (Refrigeration

Code)

00121072105 53 Alcohol Free Code

00121072105 54 Latex Free Code

00121072105 55 Storage Condition (Refrigeration

Code)

00121072105 53 Alcohol Free Code

00121072105 54 Latex Free Code

00121072105 55 Storage Condition (Refrigeration

Code)

54838052340 53 Alcohol Free Code

54838052340 54 Latex Free Code

54838052340 55 1Storage Condition (Refrigeration

Code)

60505035201 53 Alcohol Free Code

60505035201 54 Latex Free Code

60505035201 55 Storage Condition (Refrigeration

Code)

Results may be numerous. This example represents only a sample of the returned values.

10. Retrieve and display the NDC Attribute Value Description (NDC_ATTRIBUTE_VALUE_DSC) value(s) from
the NDC Attribute Value Description Table (RNDCVD0_NDC_ATTRIBUTE_VALU_DSC) where the
NDC_ATTRIBUTE_TYPE_CD and NDC_ATTRIBUTE_VALUE equals the values retrieved in steps 9 and
10.

NDC NDC_ATTRIBUTE_VALU NDC_ATTRIBUTE_VALU NDC_ATTRIBUTE_VAL

E_DSC E UE_DSC

00093610812 Alcohol Free Code 2 Contains Ethyl Alcohol

(Ethanol)

00121072104 Alcohol Free Code 1 Ethyl Alcohol (Ethanol)

Free

00121072105 Alcohol Free Code 1 Ethyl Alcohol (Ethanol)

Free

00121072105 Alcohol Free Code 1 Ethyl Alcohol (Ethanol)

Free

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54838052340 Alcohol Free Code 2 Contains Ethyl Alcohol

(Ethanol)

60505035201 Alcohol Free Code 3 Undetermined

11. The pharmacist can view which packaged products are Ethyl Alcohol (Ethanol) Free and dispense an
ethanol free NDC available in their pharmacy inventory.

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Determining if a Given Drug Contains Metabolically Active Sugars

This application illustrates how to determine if a given drug contains ethyl alcohol (ethanol).

This application may also be performed at the Med Medication Name (MED_NAME), MED Routed
Medication ID (ROUTED_MED_ID), MED Routed Dosage Form Medication ID (
ROUTED_DOSAGE_FORM_MED_ID), or National Drug Code (NDC) level.

For purposes of demonstrating this application, the following scenario is used: A physician is prescribing
guaifenesin-dextromethorphan (MEDID 199757) for a diabetic patient and needs to determine if a product that
does not contain metabolically active sugars is available.

1. Retrieve the Attribute Code (ATTRIBUTE_CODE) and Attribute Value (ATTRIBUTE_VALUE) values from
the MED Medication Attribute Table (RPEIMA0_MED_ATTRIBUTE) where the MEDID equals 199757
(guaifenesin-dextromethorphan) and the LINK_INACTIVE_DATE is null.

MEDID ATTRIBUTE_CODE ATTRIBUTE_VALUE

199757 51 2

199757 52 1

199757 52 2

199757 52 3

199757 53 1

199757 53 3

199757 54 1

199757 54 3

2. Retrieve the Attribute Description (ATTRIBUTE_DESC) and Attribute Type Code (

ATTRIBUTE_TYPE_DESC) values from the Attribute Description Table (RPEIAD0_ATTRIBUTE_DESC)
where the ATTRIBUTE_CODE equals the value(s) retrieved in the previous step.

At this level, users may filter results to complete the desired action. For this example, the user will
select the ATTRIBUTE_CODE 52 (Sugar Free Code) to complete this application.

ATTRIBUTE_CODE ATTRIBUTE_DESC ATTRIBUTE_VALUE

51 Preservative Free Code 2

52 Sugar Free Code 1

52 Sugar Free Code 2

52 Sugar Free Code 3

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53 Latex Free Code 1

53 Latex Free Code 3

54 Alcohol Free Code 1

54 Alcohol Free Code 3

At this level, users may filter results to complete the desired action. For this example, the user will
select the ATTRIBUTE_CODE 52 (Sugar Free Code) to complete this application.

3. Retrieve the Attribute Value Description (ATTRIBUTE_VALUE_DESC) values from the Attribute Value
Description Table (RPEIAV0_ATTRIBUTE_VALUE_DESC) where the ATTRIBUTE_CODE and
ATTRIBUTE_VALUE equals the filtered values retrieved in steps 1 and 2.

ATTRIBUTE_CODE ATTRIBUTE_VALUE ATTRIBUTE_VALUE_DESC

52 1 Sugar Free

52 2 Contains Sugar

52 3 Undetermined

4. Display results to user. In this scenario, at least one sugar free product is available and the physician
prescribes the medication with a note to the pharmacy to fill with a sugar free formulation.

MEDID ATTRIBUTE_CODE ATTRIBUTE_DESC ATTRIBUTE_VALU ATTRIBUTE_VALU

E E_DESC

199757 52 Sugar Free Code 1 Sugar Free

199757 52 Sugar Free Code 2 Contains Sugar

199757 52 Sugar Free Code 3 Undetermined

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Identifying Storage Condition Requirements for a Given Medication

This application illustrates how to determine storage condition requirements for a given medication at the time of
receiving.

For purposes of demonstrating this application, the following scenario is used: A pharmacist receives a
package of Doxorubicin Liposome 50mg/25ml (NDC 47335005040) and must determine the storage requirements
for the product.

1. Retrieve the NDC Attribute Type Code (NDC_ATTRIBUTE_TYPE_CD) and NDC Attribute Value (
NDC_ATTRIBUTE_VALUE) values from the NDC Attribute Table (RNDCAT0_NDC_ATTRIBUTE) where
the NDC equals 47335005040.

NDC NDC_ATTRIBUTE_TYPE_CD NDC_ATTRIBUTE_VALUE

47335005040 53 1

47335005040 54 1

47335005040 55 2

47335005040 58 01

47335005040 59 20141118

These example results represent only a subset of the NDC Attributes for NDC 47335005040.

2. Retrieve the NDC Attribute Type Description (NDC_ATTRIBUTE_TYPE_DSC) values from the NDC
Attribute Type Description Table (RNDCTD0_NDC_ATTRIBUTE_TYP_DSC) where the
NDC_ATTRIBUTE_CODE and NDC_ATTRIBUTE_VALUE equal the values retrieved in the previous step.

NDC_ATTRIBUTE_TYPE_CD NDC_ATTRIBUTE_VALUE NDC_ATTRIBUTE_TYPE_DSC

53 1 Latex Free Code

54 1 Alcohol Free Code

55 2 Storage Condition (Refrigeration

Code)

58 01 Covered Outpatient Drug (COD)

Status

59 20141118 Covered Outpatient Drug (COD)

Status Effective Date

At this level, users may filter results to complete the desired action. For this example, the user will
select the NDC_ATTRIBUTE_TYPE_CD 55 (Storage Condition [Refrigeration Code]) to complete
this application.

3.

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3. Retrieve the NDC Attribute Value Description (NDC_ATTRIBUTE_VALUE_DSC) value(s) from the NDC
Attribute Value Description Table (RNDCVD0_NDC_ATTRIBUTE_VALU_DSC) where the
NDC_ATTRIBUTE_TYPE_CD and NDC_ATTRIBUTE_VALUE equals the values retrieved in steps 1 and
2.

NDC_ATTRIBUTE_TYPE NDC_ATTRIBUTE_TYPE NDC_ATTRIBUTE_VALU NDC_ATTRIBUTE_VALU

_CD _DSC E E_DSC

55 Storage Condition 2 Refrigerate upon receipt

(Refrigeration Code) from manufacturer

4. Display results to user. In this scenario, at least one sugar free product is available and the physician
prescribes the medication with a note to the pharmacy to fill with a sugar free formulation.

NDC NDC_ATTRIBUTE_ NDC_ATTRIBUTE_ NDC_ATTRIBUTE_ NDC_ATTRIBUTE_

TYPE_CD TYPE_DSC VALUE VALUE_DSC

47335005040 55 Storage Condition 2 Refrigerate upon

(Refrigeration Code) receipt from
manufacturer

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Clinical Formulation and Ingredient Data ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

Clinical Formulation and Ingredient Data Tables

Clinical Formulation and Ingredient Data ERD

Clinical Formulation and Ingredient Data Tables

Alternative Clinical Formulation Identifier (GCN_SEQNO) to Ingredient Strength Link Table
Clinical Formulation Attribute Table
Clinical Formulation Identifier (GCN_SEQNO) to Dosage Form Link Table
Clinical Formulation Identifier (GCN_SEQNO) to Representative Route Table
Clinical Formulation Identifier (GCN_SEQNO) to Route Relationship Table
Clinical Formulation ID Table
Clinical Formulation Ingredient Strength Component Table
Clinical Formulation Ingredient Strength Type Description Table
Dosage Form Attribute Table
Dosage Form Description Table
Dosage Form Master Table
Dosage Form Master to Clinical Formulation Identifier (GCN_SEQNO) Dosage Form Code Link Table
Dosage Form Master to OrderKnowledge Dosage Form Link Table
Dosage Form to Attribute Link Table
Dosage Form Type Table
Drug Category Description Table
Drug Strength Component Table
GCN_SEQNO/Inactive Ingredient Relation Table
GCN_SEQNO/GCN Relation Table
GCN_SEQNO Study Table
HIC_SEQN/HIC_SEQN Link Table
HIC/Chemical Abstracts Service Registry Number Relation Table
HICL_SEQNO/HIC3 Relation Table
HICL_SEQNO/HIC Relation Table
Hierarchical Base Ingredient Code Table
Hierarchical Ingredient Code Description Table
Hierarchical Ingredient Code Organ System Table
Hierarchical Ingredient Code Pharmacological Class Table
Ingredient List Identifier (HICL_SEQNO) to Route Relationship Table

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Ingredient List Identifier Description Table

Ingredient Replacement History Table
Ingredient Status Code Description Table
Ingredient Strength Unit of Measure Table
Patient Parameter Required Description Table
Related Route Table
Routed Generic Clinical Formulation Identifier Link Table
Routed Generic NDC Link Table
Routed Generic Status Code Table
Routed Generic Table
Route Hierarchy Table
Route Labeled Description Table
Route of Administration Description Table
Route of Administration Master Table
Strength Concentration Type Table
Strength Status Code Description Table
Unit of Measure Conversion Table
Unit of Measure Master Table
Unit of Measure Type Description Table
Units Description Table

Clinical Formulation and Ingredient Data ERD

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Alternative Clinical Formulation Identifier (GCN_SEQNO) to Ingredient Strength Link Table

Table Name RPEIGS0_GCNSEQNO_STR_LINK

Revision Activity add. 7-1-2013

Purpose Relates a Clinical Formulation Identifier (GCN_SEQNO) to

the Normalized and Total Package strengths per ingredient,
rolled up (see Roll-up in the MAPs Enhancements
Concepts section) from the associated NDCs to provide
additional useful total package information about associated
products without navigating to the product level.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation
Identifier

PF HIC_SEQN Hierarchical N 6 9(6)

Ingredient Code
Sequence Numbe
r (Stable Identifier)

PF STR_CONC_TYP Strength N 8 9(8)

E_ID Concentration
Type Identifier

P STR_SEQ Strength N 4 9(4)

Sequence

STRENGTH_STA Ingredient N 1 9(1)

TUS_CODE Strength Status
Code

INGREDIENT_ST Ingredient N 20 9(13).9(6)

R Strength

P INGREDIENT_UO Ingredient Strengt N 8 9(8)

M_MSTR_ID h Unit of Measure
Master Identifier

STRENGTH_TYP Ingredient N 1 9(1)

_CODE Strength Type
Code

VOLUME Total Volume N 20 9(13).9(6)

P VOLUME_UOM_ Ingredient Volume N 8 9(8)

MASTER_ID Unit of Measure
Master Identifier

ALT_STR Alternative N 20 9(13).9(6)

Ingredient
Strength

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F ALT_STR_UOM_ Alternative N 8 9(8)

MSTR_ID Ingredient
Strength Unit of
Measure Master
Identifier

ALT_STRENGTH Alternate N 1 9(1)

_TYP_CODE Ingredient
Strength Type
Code

TIME_VALUE Ingredient N 6 9(3).9(3)

Strength Time
Value

F TIME_UOM_MST Ingredient N 8 9(8)

R_ID Strength Time
Unit of Measure
Master Identifier

RANGE_MAX Ingredient N 20 9(13).9(6)

Strength Range
Maximum

RANGE_MIN Ingredient N 20 9(13).9(6)

Strength Range
Minimum

F DOSAGE_FORM Dosage Form N 8 9(8)

_ATTRIBUTE_ID Attribute Identifier

INGREDIENT_SO Ingredient Sort N 4 9(4)

RT_ORDER Order

LINK_INACTIVE_ Link Inactive Date N 8 9(8)

DATE

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Clinical Formulation Attribute Table

Table Name RPEIGA0_GCNSEQNO_ATTRIBUTE

Revision Activity add. 02-17-2015

Purpose Contains freeness information summarized to the Clinical

Formulation (GCN_SEQNO) level. Clinical formulations may
have one or several assigned attributes.
Clinical Formulations to their associated attribute values are
determined by roll-up logic from the related NDCs.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF ATTRIBUTE_CO Attribute Code N 8 9(8)

DE

P ATTRIBUTE_SN Attribute N 4 9(4)

Sequence
Number

ATTRIBUTE_VAL Attribute Value AN 100 X(100)

UE

LINK_INACTIVE_ Link Inactive Date N 8 9(8)

DATE

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Clinical Formulation Identifier (GCN_SEQNO) to Dosage Form Link Table

Table Name RPEIGD0_GCNSEQNO_DF_LINK

Revision Activity add.7-1-2013

Purpose Contains associations between a Clinical Formulation

Identifier (GCN_SEQNO) and the Final Dosage Form and
Alternative Dosage Forms rolled up (see Roll-up in the MAP
s Enhancements Concepts section) from directly associated
packaged products (NDCs/UPCs).

The Link Inactive Date is populated with the date the last
associated active (non-obsolete) packaged product
becomes obsolete. Note that drug products may continue to
be present in the retail market for up to three years from the
obsolete date.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation
Identifier

PF DOSAGE_FORM Dosage Form N 8 9(8)

_ID Identifier

PF DOSAGE_FORM Dosage Form N 8 9(8)

_TYPE_ID Type Identifier

LINK_INACTIVE_ Link Inactive Date N 8 9(8)

DATE

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Clinical Formulation Identifier (GCN_SEQNO) to Representative Route Table

Table Name RPEIGRR0_GCNSEQNO_REP_RT

Revision Activity add.7-1-2013

Purpose Contains the association of a Clinical Formulation Identifier

(GCN_SEQNO) to a single representative route.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation
Identifier (Stable
Identifier)

F REPRESENTATI Representative N 8 9(8)

VE_RT_ID Route Identifier

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Clinical Formulation Identifier (GCN_SEQNO) to Route Relationship Table

Table Name RPEIGR0_GCNSEQNO_RT_RELATION

Revision Activity add. 7-1-2013

Purpose Contains the association of a Clinical Formulation

(GCN_SEQNO) to its Parent and Clinical Routes.
Each Clinical Formulation Identifier may have zero to many
Parent and Clinical Route associations. Route relationships
delivered at the Clinical Formulation are the sum of all
Parent and Clinical Route associations from NDCs directly
associated with that Clinical Formulation.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation
Identifier (Stable
Identifier)

PF PARENT_RT_ID Parent Route N 8 9(8)

Identifier

PF CLINICAL_RT_ID Clinical Route N 8 9(8)

Identifier

RELATION_INAC Relation N 8 9(8)

TIVE_DATE Inactive Date

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Clinical Formulation Ingredient Strength Component Table

Table Name RGCNSTR0_INGREDIENT_STRENGTH

Revision Activity Add.03-31-2005

Purpose Provides detailed strength data for each ingredient in a

clinical formulation.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF HIC_SEQN Ingredient N 6 9(6)

Identifier (Stable
ID)

F STRENGTH_STA Ingredient N 1 9(1)

TUS_CODE Strength Status
Code

STRENGTH Clinical N 20 9(13).9(6)

Formulation
Ingredient
Strength

F STRENGTH_UO Clinical N 8 9(8)

M_ID Formulation
Ingredient
Strength Unit of
Measure
Identifier

F STRENGTH_TYP Ingredient Strengt N 1 9(1)

_CODE h Type Code

VOLUME Clinical N 20 9(13).9(6)

Formulation
Ingredient
Volume

F VOLUME_UOM_I Clinical N 8 9(8)

D Formulation
Ingredient
Volume Unit of
Measure
Identifier

ALT_STRENGTH Ingredient N 20 9(13).9(6)

Alternate Strength
Type Code

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F ALT_STRENGTH Clinical N 8 9(8)

_UOM_ID Formulation
Ingredient
Alternate Strength
Unit of Measure
Identifier

F ALT_STRENGTH Ingredient N 1 9(1)

_TYP_CODE Strength Type
Code

TIME-VALUE Clinical N 7 9(3).9(3)

Formulation
Ingredient Time

F TIME_UOM_ID Clinical N 8 9(8)

Formulation
Ingredient
Time Unite of
Measure Identifier

RANGE_MAX Clinical N 20 9(13).9(6)

Formulation
Ingredient Range
Maximum

RANGE_MIN Clinical N 20 9(13).9(6)

Formulation
Ingredient Range
Minimum

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Clinical Formulation ID Table

Table Name RGCNSEQ4_GCNSEQNO_MSTR

Revision Activity rev.07-29-2004

Purpose Provides attributes of a Clinical Formulation ID

(GCN_SEQNO) drug formulation.

Key Column Name Column Format Length Picture

Description

P GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

F HIC3 Hierarchiacal AN 3 X(3)

Specific
Therapeutic Class
Code (Stable ID)

F HICL_SEQNO Ingredient List N 6 9(6)

Identifier (formerly
the Hierarchical
Ingredient Code
LIst Sequence
Number) (Stable
ID)

F GCDF Dosage Form AN 2 X(2)

Code
(2-character)

F GCRT Route of AN 1 X(1)

Administration
Code
(1-character)

F STR Drug Strength AN 10 X(10)

Description

F GTC Therapeutic Class N 2 9(2)

Code, Generic

F TC Therapeutic Class N 2 9(2)

Code, Standard

F DCC Drug Category AN 1 X(1)

Code

GCNSEQ_GI GCN_SEQNO-Le AN 1 X(1)

vel
Multi-Source/Singl
e Source Indicator

GENDER Gender-Specific AN 1 X(1)

Drug Indicator

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F HIC3_SEQN Hierarchical N 6 9(6)

Specific
Therapeutic Class
Code Sequence
Number (Stable
ID)

F STR60 Drug Strength AN 60 X(60)

Description - 60

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Clinical Formulation Ingredient Strength Type Description Table

Table Name RSTRTD0_STRENGTH_TYP_DESC

Revision Activity add.03-31-2005

Purpose Provides descriptions for the strength type.

Key Column Name Column Format Length Picture

Description

P STRENGTH_TYP Strength Type N 1 9(1)

_CODE Code

STRENGTH_TYP Strength Type AN 100 X(100)

_DESC Description

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Dosage Form Attribute Table

Table Name RPEIDFA0_DOSAGE_FORM_ATTRIBUTE

Revision Activity add. 7-1-2013

Purpose Contains descriptions of dosage form components by which

dosage forms, and by extension drug formulations, may be
delineated or grouped.
For example, it is possible to search for and locate all oral
liquid formulations with a specific ingredient list by limiting
the search to dosage forms with an attribute of liquid and a
route of oral.

Key Column Name Column Format Length Picture

Description

p DOSAGE_FORM Dosage Form N 8 9(8)

_ATTRIBUTE_ID Attribute Identifier

DOSAGE_FORM Dosage Form AN 100 X(100)

_ATTRIBUTE_DE Attribute
SC Description

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Dosage Form Description Table

Table Name RDOSED2_DOSE_DESC

Revision Activity rev. 7-29-2004

Purpose Relates the various dosage form codes to their

descriptions/abbreviations.

Key Column Name Column Format Length Picture

Description

P GCDF Dosage Form AN 2 X(2)

Code
(2-character)

DOSE Dosage Form AN 10 X(10)

Description

GCDF_DESC Dosage Form AN 40 X(40)

Code Description

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Dosage Form Master Table

Table Name RPEIDM0_DOSAGE_FORM_MSTR

Revision Activity add. 7-1-2013

Purpose Provides a normalized master list of dosage forms compiled

from module specific dosage form tables and any additional
alternative dosage forms.

Key Column Name Column Format Length Picture

Description

P DOSAGE_FORM Dosage Form N 8 9(8)

_ID Identifier

DOSAGE_FORM Dosage Form AN 40 X(40)

_DESC_SHORT Description Short

DOSAGE_FORM Dosage Form AN 75 X(75

_DESC_LONG Description Long

DOSAGE_FORM Dosage Form N 8 9(8)

_RETIRE_DT Retirement Date

UOM_MSTR_ID Unit of Measure N 8 9(8)

Master Identifier

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Dosage Form Master to Clinical Formulation Identifier (GCN_SEQNO) Dosage Form Code Link Table

Table Name RPEIGL0_GEN_DF_MSTR_LINK

Revision Activity add. 7-1-2013

Purpose Relates dosage forms in the Dosage Form Master Table to

dosage forms in the Dosage Form Description Table of the
Clinical Formulation Identifier (GCN_SEQNO).

Key Column Name Column Format Length Picture

Description

PF DOSAGE_FORM Dosage Form N 8 9(8)

_ID Identifier

PF GCDF Dosage Form AN 2 X(2)

Code

PREFERRED_D Preferred Dosage N 1 9(1)

OSAGE_FORM_I Form Indicator
ND

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Dosage Form Master to OrderKnowledge Dosage Form Link Table

Table Name RPEIOL0_DF_MSTR_LINK

Revision Activity add. 7-1-2013

Purpose Relates dosage forms in the Dosage Form Master table to

dosage forms in the OrderKnowledge Dosage Form table.

Key Column Name Column Format Length Picture

Description

PF DOSAGE_FORM Dosage Form N 8 9(8)

_ID Identifier

PF OVW_DOSAGE_ OrderKnowledge N 4 9(4)

FORM_ID Dosage Form
Identifier

PREFERRED_D Preferred Dosage N 1 9(1)

OSAGE_FORM_I Form Indicator
ND

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Dosage Form to Attribute Link Table

Table Name RPEIAL0_DF_ATTRIBUTE_LINK

Revision Activity add. 7-1-2013

Purpose Links a dosage form to its dosage form attributes.

For example, the dosage form of solution has a dosage
form attribute of liquid. A dosage form may have one to
many Dosage Form Attributes. See Dosage Form Attribute
Table.

Key Column Name Column Format Length Picture

Description

PF DOSAGE_FORM Dosage Form N 8 9(8)

_ID Identifier

PF DOSAGE_FORM Dosage Form N 8 9(8)

_ATTRIBUTE_ID Attribute Identifier

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Dosage Form Type Table

Table Name RPEIDT0_DOSAGE_FORM_TYPE

Revision Activity add. 7-1-2013

Purpose Provides the description for packaged product-specific

dosage form types.
For example, Final Dosage Form or Alternative Dosage
Form.

Key Column Name Column Format Length Picture

Description

P DOSAGE_FORM Dosage Form N 8 9(8)

_TYPE_ID Type Identifier

DOSAGE_FORM Dosage Form AN 100 X(100)

_TYPE_DESC Type Description

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Drug Category Description Table

Table Name RDCCD0_DRUG_CAT_DESC

Revision Activity add. 5-12-1992

Purpose Relates the Drug Category Code to its text description

Key Column Name Column Format Length Picture

Description

P DCC Drug Category AN 1 X(1)

Code

DCC_DESC Drug Category AN 40 X(40)

Code Description

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Drug Strength Component Table

Table Name RSTR1_STRNGTH_DESC

Revision Activity rev. 11-18-2004

Purpose Provides attributes of a drug's potency.

Key Column Name Column Format Length Picture

Description

P STR60 Drug Strength AN 60 X(60

Description - 60

STRNUM Drug Strength N 12 9(8).9(3)

Number

VOLNUM Drug Strength N 8 9(4).9(3)

Volume Number

STRUN50 Drug Strength AN 50 X(50)

Units - 50

VOLUN50 Drug Strength AN 50 X(50)

Volume Units - 50

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GCN_SEQNO/Inactive Ingredient Relation Table

Table Name RGCNINH0_GCNSEQNO_INACTV_LINK

Revision Activity add.07-29-2004

Purpose Links packaged product counts to the Clinical Formulation

ID (GCN_SEQNO). The counts represent currently active
products that either have or do not have the specified
HIC_SEQN in their formulation. Packaged products are only
considered if they have been checked for inactive
Ingredients. Counts change as inactive Ingredient research
continues.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF HIC_SEQN Hierarchical N 6 9(6)

Ingredient Code
Sequence
Number (Stable
ID)

INACTIV_NOT_P Inactive Ingredient N 6 9(6)

RES_CNT Not Present Count

INACTV_PRES_ Inactive Ingredient N 6 9(6)

CNT Present Count

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GCN_SEQNO-GCN Relation Table

Table Name RGCN0_GCN_GCNSEQNO_LINK

Revision Activity original

Purpose Links a unique drug formulation to a slightly broader clinical

formulation.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF GCN Formulation ID N 5 9(5)

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GCN_SEQNO Study Table

Table Name RGCNINS0_STUDY_TABLE

Revision Activity add.07-29-2004

Purpose Provides packaged product counts for the Clinical

Formulation ID (GCN_SEQNO). Counts are based on active
NDCs. Counts change as Inactive Ingredient research
continues.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

TOTAL_PRODUC Total Products N 6 9(6)

TS_CNT Count

PRODUCTS_RE Products N 6 9(6)

SEARCHED_CNT Researched for
Inactive
Ingredients Count

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HIC_SEQN-HIC_SEQN Link Table

Table Name RHICHCR0_HIC_HIC_LINK

Revision Activity add.07-29-2004

Purpose Links related Ingredients.

Key Column Name Column Format Length Picture

Description

PF HIC_SEQN Hierarchical N 6 9(6)

Ingredient Code
Sequence
Number (Stable
ID)

P RELATED_HIC_S Related N 6 9(6)

EQN Hierarchical
Ingredient Code
Sequence
Number

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HIC-Chemical Abstracts Service Registry Number Relation Table

Table Name RHICCAS1_HIC_CAS_LINK

Revision Activity rev.07-29-2004

Purpose Links an active ingredient to its chemical ingredient.

Key Column Name Column Format Length Picture

Description

PF HIC_SEQN Hierarchical N 6 9(6)

Ingredient Code
Sequence
Number

P CAS9_TBL Chemical N 9 9(9)

Abstracts Service
Registry Number

HIC Hierarchical AN 6 X(6)

Ingredient Code
(Stable ID)

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HICL_SEQNO-HIC3 Relation Table

Table Name RHIC3L2_HIC3_HICLSEQNO_LINK

Revision Activity rev.05-01-1999

Purpose Links an ingredient list to a parent therapeutic class.

Key Column Name Column Format Length Picture

Description

PF HICL_SEQNO Ingredient List N 6 9(6)

Identifier (formerly
the Hierarchical
Ingredient Code
List Sequence
Number) (Stable
ID)

PF HIC3_SEQN Hierarchical N 6 9(6)

Specific
Therapeutic Class
Code Sequence
Number (Stable
ID)

F HIC3 Hierarchical AN 3 X(3)

Specific
Therapeutic Class
Code

HIC3_RELNO Hierarchical N 1 9(1)

Specific
Therapeutic Class
Code Relative
Number

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HICL_SEQNO-HIC Relation Table

Table Name RHICL1_HIC_HICLSEQNO_LINK

Revision Activity rev.09-01-1997

Purpose Links individual ingredients to an ingredient list.

Key Column Name Column Format Length Picture

Description

PF HICL_SEQNO Ingredient List N 6 9(6)

Identifier (formerly
the Hierarchical
Ingredient Code
List Sequence
Number) (Stable
ID)

PF HIC_SEQN Hierarchical N 6 9(6)

Ingredient Code
Sequence
Number (Stable
ID)

HIC_REL_NO Hierarchical N 1 9(1)

Ingredient Code
Relative Number

F HIC Hierarchical AN 6 X(6)

Ingredient Code

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Hierarchical Base Ingredient Code Table

Table Name RHIC4D2_HIC_BASE_ING_DESC

Revision Activity rev.07-29-2004

Purpose Provides attributes of a base ingredient.

Key Column Name Column Format Length Picture

Description

P HIC4_SEQN Hierarchical Base N 6 9(6)

Ingredient Code
Sequence
Number(Stable
ID)

HIC4 Hierarchical Base AN 4 X(4)

Ingredient Code

HIC4_DESC Hierarchical Base AN 50 X(50)

Ingredient Code
Description

HIC4_ROOT Hierarchical Base N 6 9(6)

Ingredient Parent
HIC3 Sequence
Number

F HIC4_POTENTIA Hierarchical Base N 1 9(1)

LLY_INACTIV_IN Ingredient Code
D Sequence
Number
Potentially
Inactive Indicator

F ING_STATUS_C Ingredient Status N 1 9(1)

D Code

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Hierarchical Ingredient Code Description Table

Table Name RHICD5_HIC_DESC

Revision Activity rev.07-29-2004

Purpose Relates the HIC_SEQN to its text description and provides

attributes of that relationship.

Key Column Name Column Format Length Picture

Description

P HIC_SEQN Hierarchical N 6 9(6)

Ingredient Code
Sequence
Number (Stable
ID)

HIC Hierarchical AN 6 X(6)

Ingredient Code

HIC_DESC Hierarchical AN 50 X(50)

Ingredient Code
Description

HIC_ROOT Hierarchical N 6 9(6)

Ingredient Parent
HIC4 Sequence
Number

F HIC_POTENTIAL Hierarchical N 1 9(1)

LY_INACTIV_IND Ingredient Code
Sequence
Number
Potentially
Inactive Indicator

F ING_STATUS_C Ingredient Status N 1 9(1)

D Code

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Hierarchical Ingredient Code Organ System Table

Table Name RHIC1D2_HIC_ORGAN_SYS_DESC

Revision Activity rev.10-03-2002

Purpose Provides attributes of an organ class.

Key Column Name Column Format Length Picture

Description

P HIC1_SEQN Hierarchical N 6 9(6)

Organ System
Code Sequence
Number (Stable
ID)

HIC1 Hierarchical AN 1 X(1)

Organ System
Code

HIC1_DESC Hierarchical AN 50 X(50)

Organ System
Code Description

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Hierarchical Ingredient Code Pharmacological Class Table

Table Name RHIC2D3_HIC_RX_CLASS_DESC

Revision Activity rev.10-03-2002

Purpose Provides attributes of a pharmacological class.

Key Column Name Column Format Length Picture

Description

P HIC2_SEQN Hierarchical N 6 9(6)

Pharmacological
Class Code
Sequence
Number (Stable
ID)

HIC2 Hierarchical AN 2 X(2)

Pharmacological
Class Code

HIC2_DESC Hierarchical AN 50 X(50)

Pharmacological
Class Code
Description

HIC2_ROOT Hierarchical N 6 9(6)

Pharmacological
Class Code
Parent HIC1
Sequence
Number

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Ingredient List Identifier (HICL_SEQNO) to Route Relationship Table

Table Name RPEIHR0_HICLSEQNO_RT_RELATION

Revision Activity add.7-1-2013

Purpose Contains the association of an Ingredient List Identifier

(HICL_SEQNO) to its Parent and Clinical Routes.
Each Ingredient List may have zero to many related Parent
and Clinical Routes. Ingredient List to route relationships
are rolled-up (see Roll-up in the MAPs Enhancements
Concepts section) from associated NDCs.

Key Column Name Column Format Length Picture

Description

PF HICL_SEQNO Ingredient List N 6 9(6)

Identifier

PF PARENT_RT_ID Parent Route N 8 9(8)

Identifier

PF CLINICAL_RT_ID Clinical Route N 8 9(8)

Identifier

RELATION_INAC Relation Inactive N 8 9(8)

TIVE_DATE Date

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Ingredient List Identifier Description Table

Table Name RHICLSQ2_HICLSEQNO_MSTR

Revision Activity rev.05-24-2017 (previous:11-01-1996)

Purpose Relates the HICL_SEQNO to the generic drug ingredient list

(long and short version in mixed case format).

Key Column Name Column Format Length Picture

Description

P HICL_SEQNO Ingredient List N 6 9(6)

Identifier (Stable
ID)

GNN Generic Name - AN 30 X(30)

Short Version

GNN60 Generic Name - AN 60 X(60)

Long Version

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Ingredient Replacement History Table

Table Name RHICRH0_ING_HIST

Revision Activity add.07-29-2004

Purpose Tracks the ingredient's replacement history.

Key Column Name Column Format Length Picture

Description

P REPL_HIC_SEQ Replacement N 6 9(6)

N Hierarchical
Ingredient Code
Sequence
Number

P PREV_HIC_SEQ Previous N 6 9(6)

N Hierarchical
Ingredient Code
Sequence
Number

HIC_REPL_EFF_ Hierarchical N 8 9(8)

DT Ingredient Code
Sequence
Number
Replacement
Effective Date

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Ingredient Status Code Description Table

Table Name RHICSCD0_ING_STAT_CD_DESC

Revision Activity add.07-29-2004

Purpose Provides the description of the Ingredient Status Code.

Key Column Name Column Format Length Picture

Description

P ING_STATUS_C Ingredient Status N 1 9(1)

D Code

ING_STATUS_C Ingredient Status AN 50 X(50)

D_DESC Code Description

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Ingredient Strength Unit of Measure Table

Table Name RSTRUOM0_STRENGTH_UOM

Revision Activity add.03-31-2005

Purpose Provides abbreviations and descriptions of the strength unit

of measure.

Key Column Name Column Format Length Picture

Description

P UOM_ID Strength Unit of N 8 9(8)

Measure Identifier

UOM_DESC Strength Unit of AN 50 X(50)

Measure
Description

UOM_ABBR Strength Unit of AN 10 X(10)

Measure
Abbreviation

UOM_PREFERR Strength Unit of AN 50 X(50)

ED_DESC Measure
Preferred
Description

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Patient Parameter Required Description Table

Table Name RPEIPP0_PATIENT_PARAM_REQ_DESC

Revision Activity add.7-1-2013

Purpose Lists the potential patient parameters included in a unit of

measure in the Unit of Measure Master Table.
For example, patient's weight in kilograms or patient's body
surface area.

Key Column Name Column Format Length Picture

Description

P PATIENT_PARA Patient Parameter N 4 9(4)

M_REQ_CD Required Code

PATIENT_PARA Patient Parameter AN 50 X(50)

M_REQ_CD_DES Code Description
C

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Related Route Table

Table Name RPEIRER0_RELATED_RT

Revision Activity add.7-1-2013

Purpose Contains the mapping between continuous routes to related

intermittent routes.

Key Column Name Column Format Length Picture

Description

PF CONTINUOUS_R Continuous Route N 8 9(8)

T_ID Identifier

PF INTERMITTENT_ Intermittent Route N 8 9(8)

RT_ID Identifier

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Routed Generic Clinical Formulation Identifier Link Table

Table Name RRTGNGC0_RTD_GEN_GCNSEQNO_LNK

Revision Activity original

Purpose Links a clinical formulation to a routed generic.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation
Identifier (Stable
ID)

F ROUTED_GEN_I Routed Generic N 8 9(8)

D Identifier

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Routed Generic NDC Link Table

Table Name RRTGNND0_ROUTED_GEN_NDC_LINK

Revision Activity original

Purpose Links a routed generic to a packaged product.

Key Column Name Column Format Length Picture

Description

PF NDC Package Product AN 11 X(11)

Identifier

F ROUTED_GEN_I Routed Generic N 8 9(8)

D Identifier

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Routed Generic Status Code Table

Table Name RRTGNSD0_RTD_GEN_STATUS_DSC

Revision Activity original

Purpose Links a routed generic status code to its description.

Key Column Name Column Format Length Picture

Description

P ROUTED_GEN_S Routed Generic AN 1 X(1)

TATUS_CD Status Code

ROUTED_GEN_S Routed Generic AN 30 X(30)

TATUS_CD_DES Status Code
C Description

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Routed Generic Table

Table Name RRTGN0_ROUTED_GEN_MSTR

Revision Activity original

Purpose Provides the description and attributes of the routed

generic.

Key Column Name Column Format Length Picture

Description

P ROUTED_GEN_I Routed Generic N 8 9(8)

D Identifier

ROUTED_GEN_D Routed Generic AN 100 X(100)

ESC Identifier
Description

F GCRT Clinical AN 1 X(1)

Formulation
Identifier Route

F HICL_SEQNO Ingredient List N 6 9(6)

Identifier Route
(Stable ID)

F ROUTED_GEN_S Routed Generic AN 1 X(1)

TATUS_CD Identifier Status
Code

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Route Hierarchy Table

Table Name RPEIRH0_RT_HIERARCHY

Revision Activity add.7-1-2013

Purpose Presents a listing of all potential Parent Routes to Clinical

Routes outside of the context of a specific drug product.
For example, this table contains the linkage of an
"injectable" parent route to the clinical route of "epidural"
without a specific product in focus.

Key Column Name Column Format Length Picture

Description

PF PARENT_RT_ID Parent Route N 8 9(8)

Identifier

PF CLINICAL_RT_ID Clinical Route N 8 9(8)

Identifier

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Route Labeled Description Table

Table Name RPEIRL0_RT_LABELED_DESC

Revision Activity add.7-1-2013

Purpose Provides the description for values that describe the source
of clinical routes associated to a product.
This table includes a list of values that denote whether a
listed route has been derived from the labeling of the
associated product or products (Labeled), or from other
sources meeting the FDB policy for inclusion (Unlabeled).

Key Column Name Column Format Length Picture

Description

P RT_LABELED_ID Route Labeled N 8 9(8)

Identifier

RT_LABELED Route Labeled AN 50 X(50)

DESC Description

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Route of Administration Description Table

Table Name RROUTED3_ROUTE_DESC

Revision Activity rev.07-29-2004

Purpose Relates the various routes of administration codes to their

descriptions/abbreviations.

Key Column Name Column Format Length Picture

Description

P GCRT Route of AN 1 X(1)

Administration
Code
(1-character)

RT Route Description AN 10 X(10)

GCRT2 Route of AN 2 X(2)

Administration
Code
(2-character)

GCRT_DESC Route Code AN 40 X(40)

Interpretation

SYSTEMIC Systemic Route AN 1 X(1)

Indicator

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Route of Administration Master Table

Table Name RPEIRM0_RT_MSTR

Revision Activity add.7-1-2013

Purpose Presents a unified, normalized master list of routes from the

separate route tables and any additional new routes which
may not have fit within the scope of the previous route
tables.
The RPEIRM0_RT_MSTR table contains foreign keys to all
the separate route tables where the data sets will overlap.

Key Column Name Column Format Length Picture

Description

P RT_ID Route Identifier N 8 9(8)

RT_DESC_SHOR Route Short AN 50 X(50)

T Description

RT_DESC_LONG Route Long AN 50 X(50)

Description

RT_ADVERB Route Adverb AN 50 X(50)

F DR2_RT DRCM Route of AN 3 X(3)

Administration
Indicator

F DRCM_SCREEN DRCM Screen AN 3 X(3)

_RT_ID Route Identifier

F POEM_RT_ID POEM Route N 4 9(4)

Identifier

F MED_ROUTE_ID MED Route N 5 9(5)

Identifier

F OVW_CLINICAL_ OrderKnowledge N 8 9(8)

RT_ID Clinical Route
Identifier

F GCRT Generic Clinical AN 1 X(1)

Route Identifier

DISC_RT_IND Discretionary N 1 9(1)

Route Indicator

DISC_RT_ADMIN Discretionary AN 80 X(80)

_TEXT Route
Administration
Text

VALID_CNS_RT_ Valid Central N 1 9(1)

IND Nervous System
Route Indicator

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Strength Concentration Type Table

Table Name RPEIST0_STR_CONC_TYPE

Revision Activity add.7-1-2013

Purpose Denotes the strength type of an alternative strength

assigned to an NDC or rolled up (see Roll-up in the MAPs
Enhancements Concepts section) to the Clinical
Formulation Identifier (GCN_SEQNO) or Medication
Identifier (MEDID).
For example, a 5 mL vial of midazolam has a Normalized co
ncentration of 1 mg/mL and therefore has a Total Package
strength of 5mg/5mL.

Key Column Name Column Format Length Picture

Description

P STR_CONC_TYP Strength N 8 9(8)

E_ID Concentration
Type Identifier

STR_CONC_TYP Strength AN 100 X(100)

E_DESC Concentration
Type Description

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Strength Status Code Description Table

Table Name RSTRSCD0_STRENGTH_STATUS_DESC

Revision Activity add.03-31-2005

Purpose Provides descriptions of the strength statuses.

Key Column Name Column Format Length Picture

Description

P STRENGTH_STA Ingredient N 1 9(1)

TUS_CODE Strength Status
Code

STRENGTH_STA Strength Status AN 100 X(100)

TUS_DESC Description

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Unit of Measure Conversion Table

Table Name RPEIUC0_UOM_CONVERSION

Revision Activity add.7-1-2013

Purpose Contains the factor by which to multiply a value to convert

the value form one unit of measure to another.

Key Column Name Column Format Length Picture

Description

P FROM_UOM_MS From Master Unit N 8 9(8)

TR_ID of Measure
Identifier

TO_UOM_MSTR_ To Master Unit of N 8 9(8)

ID Measure Identifier

UOM_CONVERSI Unit Conversion N 17 9(10).9(6)

ON_FACTOR Factor

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Unit of Measure Master Table

Table Name RPEIUM0_UOM_MSTR

Revision Activity add.7-1-2013

Purpose Serves as the centralized location for all units of measure

including linkages out to other unit of measure tables in
other modules.

Key Column Name Column Format Length Picture

Description

P UOM_MSTR_ID Unit of Measure N 8 9(8)

Master Identifier

UOM_MSTR_DE Unit of Measure AN 80 X(80)

SC Master
Description

UOM_MSTR_PLU Unit of Measure AN 80 X(80)

RAL_DESC Master Plural
Description

UOM_MSTR_AB Unit of Measure AN 80 X(80)

BR Master
Abbreviation

UOM_MSTR_PLU Unit of Measure AN 80 X(80)

RAL_ABBR Master Plural
Abbreviation

UOM_MSTR_PR Unit of Measure AN 80 X(80)

EFERRED_DESC Master Preferred
Description

UOM_MSTR_PLU Unit of Measure AN 80 X(80)

RAL_PREFERRE Master Plural
D_DESC Preferred
Description

UOM_STDS_OR Unit of Measure AN 80 X(80)

G_DESC Long Standards
Organization
Description

UOM_PLURAL_S Unit of Measure AN 80 X(80)

TDS_ORG_DESC Long Plural
Standards
Organization
Description

UOM_STDS_OR Unit of Measure AN 80 X(80)

G_ABBR Short Standards
Organization

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UOM_PLURAL_S Unit of Measure AN 80 X(80)

TDS_ORG_ABBR Short Plural
Standards
Organization
Description

UOM_MSTR_CO Unit of Measure N 8 9(8)

MPONENT1_ID Master
Component 1
Identifier

UOM_MSTR_CO Unit of Measure N 8 9(8)

MPONENT2_ID Master
Component 2
Identifier

UOM_MSTR_CO Unit of Measure N 8 9(8)

MPONENT3_ID Master
Component 3
Identifier

UOM_TYPE_CD Unit of Measure N 4 9(4)

Type Code

RATIO_IND Ratio Indicator N 1 9(1)

RATE_IND Rate Indicator N 1 9(1)

DOSE_IND Dose Indicator N 1 9(1)

INTERVAL_IND Interval Indicator N 1 9(1)

PATIENT_PARA Patient Parameter N 4 9(4)

M_REQ_CD Required Code

PARAM_INCORP Parameter N 8 9(8)

_UOM_ID Incorporated Unit
of Measure
Identifier

PEDIATRIC_DOS Pediatric Dose N 1 9(1)

E_TEXT_IND Text Indicator

COMPARISON_U Least Common N 8 9(8)

OM_ID Denominator Unit
of Measure
Identifier

DR2_UNITS Dose Range AN 2 X(2)

Check Module
(DRCM) Units
Code

POEUNITCDE POEM Unit Code N 4 9(4)

UOM_ID Strength Unit of N 8 9(8)

Measure Identifier

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OVW_UOM_ID OrderKnowledge N 8 9(8)

Unit of Measure
Identifier

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Unit of Measure Type Description Table

Table Name RPEIUT0_UOM_TYPE_DESC

Revision Activity add.7-1-2013

Purpose Lists the potential categories a unit of measure may be

classified.
For example, quantity, concentration, and time are Unit of
Measure Types.

Key Column Name Column Format Length Picture

Description

P UOM_TYPE_CD Unit of Measure N 4 9(4)

Type Code

UOM_TYPE_CD_ Unit of Measure AN 50 X(50)

DESC Type Code
Description

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Units Description Table

Table Name RUNITSD0_UNITS_DESC

Revision Activity add.09-30-2004

Purpose Relates the units description fields from the Min/Max,

DRCM, NEOM, POEM, IVM modules to the TJC-compliant
units descriptions.

Key Column Name Column Format Length Picture

Description

P DOSING_MODUL Dosing Module AN 30 X(30)

E_UNIT_ABBREV Unit Abbreviation

UNIT_DESC_AB Unit Description AN 30 X(30)

BREV Abbreviation

UNIT_DESC_EX Units Description AN 60 X(60)

PANDED Expanded

The DOSING_MODULE_UNIT_ABBREV column might contain abbreviations considered inappropriate

by The Joint Commission (TJC) and the Institute for Safe Medication Practices (ISMP). For TJC- and
ISMP-compliant unit descriptions, use the UNIT_DESC_EXPANDED or UNIT_DESC_ABBREV columns.

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Packaged Product

General Information
Packaged Product Editorial Policies
Applications
ERD and Technical Specifications

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General Information
The General Information section contains high-level information about the module.

Definitions
Concepts

Overview
Packaged Product data contains essential information about the packaged product (NDC). This information
includes elements that describe:

product packaging
manufacturing
distribution
generic classification indicators
candidates for therapeutic substitution identifiers
FDA application status information
other descriptive elements

Drug knowledge is aggregated at the Clinical Formulation ID (GCN_SEQNO), Routed Medication ID (

ROUTED_MED_ID), and the Routed Generic ID (ROUTED_GEN_ID) levels in the First Databank (FDB)
knowledge base. Under certain circumstances, aggregated drug knowledge may not apply to all related
packaged products; more specific information may be found within product labels.

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Packaged Product Definitions

This section defines important terms related to the module that users should understand. Some industry terms
that have a specific connotation in regards to the module may also be defined.

Abbreviated New Drug Application (ANDA)

Biologic License Application (BLA)
Comprehensive NDC Structured Product Labeling Data Elements (NSDE) File
FDA Device Registration
Food and Drug Administration Old National Code Directory
Food and Drug Administration Modernization Act (FDAMA)
Health Related Item (HRI)
Inner NDCs
National Council for Prescription Drug Programs (NCPDP)
National Drug Code (NDC)
New Drug Application (NDA)
Outer NDCs
Over-the-Counter (OTC) Monograph
Packaged Product
Product Identification Number (PIN)
Universal Product Code (UPC)
Additional Sources

Abbreviated New Drug Application (ANDA)

A document submitted by pharmaceutical companies to the Food and Drug Administration (FDA) for a license to
market a generic or duplicate version of a drug that has already been granted approval under a New Drug
Application (NDA). Once approved, the pharmaceutical company is assigned a code representing their
Abbreviated New Drug Application (ANDA). Drug products approved under an ANDA are considered by the FDA
to have a generic status.

Biologic License Application (BLA)

A document submitted by manufacturers to the Food and Drug Administration (FDA) to request approval to
market a biologic product. According to the FDA, biological products include a wide range of products such as
vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant
therapeutic proteins. These products are regulated for human use by the FDAs Center for Biologics Evaluation
and Research (CBER).

Comprehensive NDC Structured Product Labeling Data Elements (NSDE) File

Beginning September 1, 2012, CMS is using the FDAs Comprehensive NDC Structured Product Labeling Data
Elements (NSDE) File to edit Prescription Drug Events (PDEs). They will use the NSDE file to determine a drugs
coverage under Medicare Part D and to make marketing category determinations for the Coverage Gap Discount

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Program. For these purposes, CMS will use the following data elements from the NSDE file:

11-digit NDC (Item Code)

Marketing Category
Marketing Start Date
Marketing End Date

See "NSDE File Policy" in the Packaged Product Editorial Policies for more information.

FDA Device Registration

A document submitted by manufacturers to the Food and Drug Administration (FDA) to acquire approval to
market a medical device. Depending on the device, the submitted application could be a Pre-market Notification
(510k) or a Pre-market Approval (PMA) document. According to the FDA:
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as
safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not
subject to PMA. Submitters must compare their device to one or more similar legally marketed devices and make
and support their substantial equivalency claims.
The PMA is the most stringent type of device marketing application required by FDA. The applicant must receive
FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by
FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its
intended use(s). See
http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapp
for more information.

Food and Drug Administration Old National Code Directory

The FDA publishes a list of NDC numbers and information for all drugs manufactured, prepared, propagated,
compounded, or processed by drug establishments for commercial distribution called the National Drug Code
Directory. There is a New NDC Directory and an Old NDC Directory.

The Old NDC Directory is based on the older paper-based Drug Registration and Listing System (DRLS). When
the FDA stopped accepting hardcopy/paper submissions of drug registration and listing information (and only
accept electronic submissions), the New NDC Directory was created. In April 2013, FDB discontinued its use of
the New NDC Directory and instead now references the FDAs Comprehensive NDC Structured Product Labeling
Data Elements (NSDE) File
(http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm240580.htm).

A final edition of the Old NDC Directory was published on June 1, 2012. However, as the Old NDC Directory
potentially contains NDCs that cannot be found in the newer eLIST and eDRLS (FDA internal software systems)
based versions of the New NDC Directory, FDB continues to reference the Old Directory. See
http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm for more information.

Food and Drug Administration Modernization Act (FDAMA)

This act was enacted November 21, 1997 to amend the Federal, Food, Drug, and Cosmetic Act relating to the
regulation of food, drugs, devices, and biological products.

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Health Related Item (HRI)

The Health Related Item (HRI) is a unique 10-digit numeric code assigned to medical devices by the Food and
Drug Administration (FDA) and the manufacturer or distributor. Each segment of the HRI number has meaning,
as defined in the following table:

HRI Definition

4-6 Digit Segments Definition Assigned By

First 4 digits Indicates the labeler code representing FDA Drug Listing Branch
a manufacturer, distributor, or
repackager

Last 6 digits Indicates the product Manufacturer or Distributor

This code is found in the 11-digit National Drug Code (NDC) column and is identified via the NDC Format
Indicator (NDCFI). See "Identifying the Original 10-digit NDC" in the Concepts for more information.

The HRI is also known as the National Health Related Items Code (NHRIC).

Inner NDCs

Inner NDCs are NDCs on inner packaging that differ from the NDC on the outside of the package. For example,
an inner NDC may be found on an individual vial when that product is only sold in boxes of multiple vials and the
outer packaging has a different NDC number. Some inner NDCs may not be priced for individual sale.

National Council for Prescription Drug Programs (NCPDP)

The National Council for Prescription Drug Programs (NCPDP) is an ANSI-accredited standards development
organization for the pharmacy services industry.

National Drug Code (NDC)

The NDC is a unique 10-digit numeric code assigned to a drug product by the Food and Drug Administration
(FDA) and the manufacturer or distributor. It identifies the manufacturer/distributor, drug, dosage form, strength,
and package size, as defined in the following table:

If assigned a 4-digit labeler code, an NDC will have a 4-4-2 format.

If assigned a 5-digit labeler code, an NDC will have either a 5-3-2 or 5-4-1 format.

An NDC can have one of the following formats depending on the labeler code assigned by the FDA to the
manufacturer or distributor:

NDC Definition

Digit Segments Definition Assigned By

First 4 or 5 digits Indicates the labeler code representing FDA Drug Listing Branch
a manufacturer, distributor, or
repackager

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Second 3 or 4 digits Indicates the drug product Manufacturer or Distributor

Last 1 or 2 digits Indicates the product packaging Manufacturer or Distributor

This code is found in the 11-digit National Drug Code (NDC) column and is identified via the NDC Format
Indicator (NDCFI). See "Identifying the Original 10-digit NDC" in the Concepts for more information.

New Drug Application (NDA)

A document submitted by pharmaceutical companies to the Food and Drug Administration (FDA) for approval to
market a drug that has never been approved for a license to be marketed in the United States. Once approved,
the pharmaceutical company is assigned a code representing their NDA. Drug products approved under an NDA
are considered by the FDA to have a brand status.

Outer NDCs

Outer NDCs are NDCs on packaging that can contain one or more inner NDCs. An outer NDC can be linked to
one or more inner NDCs. In MedKnowledge, an NDC is only referred to as an Outer NDC if the Inner NDC is a
different number from the NDC on the outside of the package.

Over-the-Counter (OTC) Monograph

Over-the-counter (OTC) monographs cover acceptable ingredients, doses, formulations, and labeling for OTC
drugs. Drug products that conform to an FDA OTC monograph are given FDA marketing approval.

Packaged Product

A packaged product is the drug, supply, or device in the container received from the labeler.

Product Identification Number (PIN)

The Product Identification Number (PIN) is a unique 11-digit numeric code assigned to products by the
manufacturer or distributor.

The Product Identification Number (PIN) used in the United States is in no way related to the Provincial
Identification Number (PIN), which is used in Canada.

Universal Product Code (UPC)

The GS1 (formerly known as Uniform Code Council or UCC) administers the Universal Product Code (UPC) Bar
Code, which is used to identify retail products, including healthcare items, in the United States and Canada. In an
effort to standardize identification codes worldwide, the GS1 (http://www.gs1us.org/) has partnered with EAN
(European Article Number) International.

On February 24, 2004, the Food and Drug Administration (FDA) published a final rule, titled Bar Code Label
Requirements for Human Drug Products and Biological Products. This rule requires that a machine-readable,
linear bar code must be placed on the immediate packaging for all prescription drug products and
over-the-counter (OTC) products commonly ordered in hospitals. The bar code must meet European Article
Number/Uniform Code Council (EAN.UCC) or Health Industry Business Communications Council (HIBCC)

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standards. The FDA rule applies to drug manufacturers, repackagers, relabelers, and private label distributors.
The linear bar code for drugs must contain the NDC, a unique identifier of the drug.

A 12-digit UPC number is encoded in the linear bar code and consists of a qualifier digit, which identifies the type
of product; a 10-digit core code, which is the NDC; and a check digit, which confirms that the bar code was
scanned correctly.

Each segment of the UPC number has meaning, as defined in the following table:

UPC Definition

5-5 Digit Segments Definition Assigned By

First 5 digits Indicates the name of the GS1

manufacturer or distributor

Last 5 digits Indicates the product Manufacturer or Distributor

Additional Sources

The following table provides additional website sources for more information about selected definitions listed
above.

Additional Sources

Definition More Information

Abbreviated New Drug Application (ANDA) http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Ho

wDrugsareDevelopedandApproved/ApprovalApplications/d
efault.htm

Biologic License Application (BLA) http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Ho

wDrugsareDevelopedandApproved/ApprovalApplications/d
efault.htm

Comprehensive NDC Structured Product Labeling Data http://www.fda.gov/ForIndustry/DataStandards/StructuredPr

Elements (NSDE) File oductLabeling/ucm240580.htm

FDA Device Registration http://www.fda.gov/MedicalDevices/DeviceRegulationandG

uidance/HowtoMarketYourDevice/PremarketSubmissions/P
remarketNotification510k/default.htm
and
http://www.fda.gov/medicaldevices/deviceregulationandguid
ance/howtomarketyourdevice/premarketsubmissions/prema
rketapprovalpma/default.htm

Food and Drug Administration Old National Code http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.

Directory htm

Food and Drug Administration Modernization Act (FDAMA) http://www.fda.gov/regulatoryinformation/legislation/significa

ntamendmentstothefdcact/fdama/ucm2005642.htm

National Council for Prescription Drug Programs (NCPDP) http://www.ncpdp.org/standards.aspx

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New Drug Application (NDA) http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Ho

wDrugsareDevelopedandApproved/ApprovalApplications/d
efault.htm

Over-the-Counter (OTC) Monograph http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Ho

wDrugsareDevelopedandApproved/ApprovalApplications/d
efault.htm

Universal Product Code (UPC) http://www.gs1us.org/

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Packaged Product Concepts

The sections below describe the concepts and database elements that are important for understanding the NDC
column and how it is used and defined within Packaged Product:

NDC Column
Converting a 10-digit NDC to NCPDP 11-digit Format
Identifying the Original 10-digit NDC
Customer Challenges
Packaged Product Attributes
NDC Table
NDC Attribute Table
Fiscal Utility Indicator (FUI)
Inner NDC Attribute
Over-the-counter (OTC) Monograph Information
Reason Not Priced Attribute
NDC Attribute Indicators
FDA Drug Application Status Information
Orange Book Code
Current Source Reason Codes for Consolidated Price 1 and 2
Marketing Category and Associated Dates
Repackaged NDCs
Re-used NDCs
Non-Responsive Manufacturers
Morphine Equivalence Code Attributes
Designation by Labeler
Inactive Ingredient Information
Packaged Product and Supporting Data Uses
Pricing Applications
Claims Adjudication
Therapeutic Substitution Candidate Identification and List Generation

NDC Column

The NDC column contains the following formats that are collectively referred to by FDB as the NDC:

National Drug Code (NDC)

Health Related Item (HRI)
Universal Product Code (UPC)
Product Identification Number (PIN)

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Hereafter in the documentation, NDC indicates an NDC, HRI, UPC, or PIN. The NDC Format Indicator (
NDCFI) must be used in conjunction with the NDC column to determine if the product is represented by
an NDC, HRI, UPC, or PIN.

The NDC column displays codes in an 11-digit 5-4-2 format. The hyphens are implied in the database.

The NDC, HRI, and UPC external identifiers are supplied by the manufacturer or distributor as 10-digit NDCs.

FDB refers to the UPC as the core 10-digit code in a 12-digit UPC code (commonly seen in the United
States), 13-digit EAN, or 14-digit GTIN. The core 10-digit code is assigned to products by the GS1 (
http://www.gs1us.org/) and the manufacturer or distributor and has the following format: 5-5.

To bring these identifiers in accordance with the National Council for Prescription Drug Programs (NCPDP)
standard, FDB converts them to 11-digit codes. The 11-digit formatted NDC was developed by NCPDP to ensure
a standard format for billing and reimbursement of prescription claims based on 11 digits and is pervasive in the
industry.

PINs, which are assigned by the manufacturer or distributor, are not addressed by the NCPDP standard and do
not need to be converted as they are already in an 11-digit 5-4-2 format. However, since they are not structured
with logic or built-in meaning, PINs may not be readable using bar code standards. To help determine the NDC
type per product, FDB provides the NDC Format Indicator (NDCFI).

Converting a 10-digit NDC to NCPDP 11-digit Format

To convert a 10-digit NDC to a National Council for Prescription Drug Programs (NCPDP) 11-digit formatted
NDC, FDB adds a zero to either the first, sixth, tenth, or eleventh position of the code.

The following table shows how an original 10-digit external identifier in its original format is converted to an
11-digit 5-4-2 format, based on the NDC Format Indicator ( NDCFI) value and the type of external identifying code.
The table below provides examples where the zero was added when necessary to convert the 10-digit NDC to an
NCPDP 11-digit formatted NDC:

NDC Column Format Rendering

External Code Original Format NDC Column Converted Converted?

Format

NDC 4-4-2 (9999-9999-99) 5-4-2 (09999999999) yes

NDC 5-3-2 (99999-999-99) 5-4-2 (99999099999) yes

NDC 5-4-1 (99999-9999-9) 5-4-2 (99999999909) yes

UPC 5-5 (99999-99999) 5-4-2 (99999099999) yes

UPC 5-5 (99999-99999) 5-4-2 (99999999909) yes

UPC 5-5 (99999-99999) 5-4-2 (99999999990) yes

HRI 4-6 (9999-999999) 5-4-2 (09999999999) yes

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PIN 5-4-2 (99999-9999-99) 5-4-2 (99999999999) [no no

added zero]

Since 2000, FDB converts Universal Product Code (UPC) codes to 11 digits by inserting a zero in the
sixth position, in order to comply with NCPDP guidelines. UPC products added to the MedKnowledge
database prior to 2000 may have been converted into one of three 11-digit formats: a zero inserted either
in the sixth, tenth, or eleventh position of the code.

Converting the NCPDP 11-digit formatted NDC to a 10-digit NDC is just a matter of removing the zero, as shown
in the Identifying the section below.

Identifying the Original 10-digit NDC

Converting the National Council for Prescription Drug Programs (NCPDP) 11-digit formatted NDC to a 10-digit
NDC is a matter of identifying the placement of and removing the zero, as shown in the Converting an 11-Digit
NDC to a 10-Digit NDC application. Because the NDC Format Indicator (NDCFI) identifies both the type of
external identifying code (NDC, HRI, UPC, or PIN) in the National Drug Code ( NDC) column and the way in which
the external identifying code has been converted into the 11-digit 5-4-2 format, it can be used to find the original
10-digit code, particularly in situations when an NDC has a zero in the sixth position. Without the NDCFI, it would
be impossible to make a distinction between NDCs and UPCs once they were converted to the 11-digit code.

Hyphens are implied in the database.

The table below defines each format and demonstrates where the zero is added for each format type:

Format Indicator Table

NDC Format External Code Original Format Converted 5-4-2 Zero Position
Indicator Format

0 PIN 5-4-2 (99999-9999-99) 5-4-2 (99999999999) no zero added

1 NDC 4-4-2 (9999-9999-99) 5-4-2 (09999999999) zero added to 1st

position

2 NDC 5-3-2 (99999-999-99) 5-4-2 (99999099999) zero added to 6th

position

3 NDC 5-4-1 (99999-9999-9) 5-4-2 (99999999909) zero added to 10th

position

4 (only format used for UPC 5-5 (99999-99999) 5-4-2 (99999099999) zero added to 6th
UPCs since 2000) position

5 (has not been used UPC 5-5 (99999-99999) 5-4-2 (99999999909) zero added to 10th
since 2000) position

6 (has not been used UPC 5-5 (99999-99999) 5-4-2 (99999999990) zero added to 11th
since 2000) position

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7 HRI 4-6 (9999-999999) 5-4-2 (09999999999) zero added to 1st

position

Customer Challenges

NDCs encoded in bar codes are 10 digits and NDCs reported to the FDA are 10 digits. FDB formats 10-digit
NDCs into an 11-digit number, according to National Council for Prescription Drug Programs (NCPDP) standards.

FDB customers use the NCPDP 11-digit formatted NDC to access packaged product data in the MedKnowledge
database by scanning a products bar code. However, in order for NCPDP 11-digit formatted NDCs to be read
within the EAN.UCC UPC standard, they must be converted to 10-digit NDCs.

The NCPDP 11-digit formatted NDCs and the converted 10-digit NDCs should be placed in a cross-reference file
so that when the bar code is scanned, the system reads the 10-digit NDC from the bar code, retrieves the
associated NCPDP 11-digit formatted NDC from the cross-reference file, and then uses the NCPDP 11-digit
formatted NDC to access FDB data for that product. See the Converting an 11-Digit NDC to a 10-Digit NDC
application for more information on how to convert an NCPDP 11-digit formatted NDC to 10 digits.

The 11-digit formatted NDC was developed to ensure a standard format for billing and reimbursement of
prescription claims based on 11 digits. The use of this NCPDP 11-digit formatted NDC is pervasive in the
industry.

FDB refers to the external identifiers (NDC, HRI, UPC, and PIN) that populate the NDC column as the
NDC.
PINs, which are assigned by the manufacturer or distributor, are already 11 digits and may not be
readable using bar code standards.

Nine-Digit Caution

FDB strongly recommends using the full 11-digit code to identify drug products to help ensure distinction
between drug products. Using only the first nine digits to identify drug products is a detrimental limitation
that may lead to serious flaws in system implementation. While the Food and Drug Administration (FDA)
requires that the first nine digits for an NDC be unique to the product, no such requirement exists for
UPCs and HRIs. On rare occasions, a manufacturer or distributor might use the same first nine digits to
indicate two distinct drug products.

Packaged Product Attributes

Attributes for the packaged product (NDC) are found within the following tables:

NDC Table (RNDC14_NDC_MSTR)

NDC Attribute Table (RNDCAT0_NDC_ATTRIBUTE)
NDC to FDA NDA/ANDA Table (RAPPLSL0_FDA_NDC_NDA_ANDA)
NDC to FDA Drug Application Number Table (RAPPLNA0_FDA_NDC_APPL)

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The tables above are supported by the following description and relation tables:

FDA Drug Application Type Table (RAPPLTD0_FDA_APPL_TYPE)

NDC Attribute Type Description Table (RNDCTD0_NDC_ATTRIBUTE_TYP_DSC)
NDC Attribute Value Description Table (RNDCVD0_NDC_ATTRIBUTE_VALU_DSC)
Labeler Identifier Description Table (RLBLRID3_LBLR_DESC)
Orange Book Code Description Table (ROBCD0_OBC_DESC)
Orange Book Code Relation Table (ROBCNDC0_OBC_NDC)

See the following sections for more information.

NDC Table

At its core, the packaged product attributes within the NDC Table (RNDC14_NDC_MSTR) provide packaging,
distribution, and manufacturer information as illustrated below (the following explanations pertain to the first and
last products shown in the example):

ExamplePackaged products and selected columns

NDC Label Name Package Size Drug Form Package Labeler Manufacturer
(LN) (PS) Code (DF) Description Identifier Name (MFG)
(PD) (LBLRID)

66267096300 IBUPROFEN 100 1 BOTTLE A66267 NUCARE

800 MG PHARM.
TABLET

70030013143 SORE 177 2 SQUEEZ BTL A00113 PERRIGO CO.

THROAT
SPRAY

54868198600 GUAIFENESIN 480 2 BOTTLE A54868 PHYSICIANS

DM SYRUP TC.

Example Interpretation

The first product (Ibuprofen 800 mg Tablet) has a Package Size ( PS) of 100 tablets (Drug Form Code [DF]
= 1 [each]), is packaged in bottles (Package Description [PARENT_RT_ID]), and is distributed by A66267
(Labeler Identifier [LBLRID]) Nucare Pharmaceuticals (MFG).
The last product (Guaifenesin DM Syrup) has a package size (PS) of 480 mL (DF= 2 [milliliters (liquids)]),
is packaged in bottles (PD), and is distributed by A54868 (LBLRID) Physician TC (MFG).

NDC Attribute Table

The NDC Attribute Table (RNDCAT0_NDC_ATTRIBUTE) provides additional NDC attributes to supplement the
data provided within the NDC Table (RNDC14_NDC_MSTR) and the FDA NDA/ANDA Application tables.

NDC Attributes

NDC_ATTRIBUTE_T NDC_ATTRIBUTE_T Format Length Picture

YPE_CD YPE_DSC

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1 Fiscal Utility Indicator N 2 9(2)

(FUI) - This value is
not currently being
populated.

2 Fiscal Utility Indicator N 8 9(8)

(FUI) Effective Date -
This value is not
currently being
populated.

3 Fiscal Utility Indicator N 13 9(13)

(FUI) Median Price -
This value is not
currently being
populated.

4 Fiscal Utility Indicator N 8 9(8)

(FUI) Median Price
Effective Date - This
value is not currently
being populated.

5 Orange Book Code AN 3 X(3)

(OBC3)

6 NDA Approval Date N 8 9(8)

7 FDB Maintained NDA N 8 9(8)

Approval Date

8 NDA Application AN 25 X(25)

Number

9 FDB Maintained NDA AN 25 X(25)

Application Number

10 ANDA Approval Date N 8 9(8)

11 FDB Maintained N 8 9(8)

ANDA Approval Date

12 ANDA Application AN 25 X(25)

Number

13 FDB Maintained AN 25 X(25)

ANDA Application
Number

14 Other Application AN 25 X(25)

Number

15 FDB Maintained Other AN 25 X(25)

Application Number

16 Not Defined AN 25 X(25)

Application Number

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17 FDB Maintained Not AN 25 X(25)

Defined Application
Number

18 Authorized Generic AN 1 X(1)

19 BLA Approval Date N 8 9(8)

20 FDA Device N 8 9(8)

Registration Approval
Date

21 Reference Listed Drug AN 1 X(1)

(RLD)

22 BLA Application AN 25 X(25)

Number

23 FDA Device AN 25 X(25)

Registration

24 OTC Monograph AN 25 X(25)

Number

25 OTC Monograph N 8 9(8)

Publish Date

28 NDC Found in AN 1 X(1)

Available Approved
Sources

29 FDA Registered NDC AN 1 X(1)

30 FDB Maintained FDA AN 1 X(1)

Registered NDC

31 Not Defined Approval N 8 9(8)

Date

32 FDB Maintained Not N 8 9(8)

Defined Approval Date

33 Reason Not Priced N 2 9(2)

34 Inner NDC AN 11 X(11)

35 Consolidated Price 1 - N 1 9(1)

Current Source
Reason Code

36 Consolidated Price 2 - N 1 9(1)

Current Source
Reason Code

37 NDA FDA Source N 3 9(3)

Code

38 ANDA FDA Source N 3 9(3)

Code

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39 Not Defined FDA N 3 9(3)

Source Code

40 Other FDA Source N 3 9(3)

Code

41 FDA Current NSDE N 8 9(8)

Marketing Start Date

42 FDA Current and N 8 9(8)

Archived NSDE
Marketing Start Date

43 FDA Current NSDE N 8 9(8)

Marketing End Date

44 FDA Current and N 8 9(8)

Archived Marketing
End Date

45 FDA Current NSDE AN 50 X(50)

Marketing Category

46 FDA Current and AN 50 X(50)

Archived Marketing
Category

47 Repackaged Original AN 11 X(11)

NDC

48 Re-Used NDC Date of N 8 9(8)

Add

49 Latest Price N 8 9(8)

Verification Date

50 Obsolete Reason N 3 9(3)

Code

51 Preservative Free AN 5 X(5)

Code

52 Sugar Free Code AN 5 X(5)

53 Latex Free Code AN 5 X(5)

54 Alcohol Free Code AN 5 X(5)

55 Storage Condition AN 5 X(5)

(Refrigeration Code)

56 FDA Repackaged AN 9 X(9)

Original Core9

57 NADAC Classification AN 50 X(50)

for Rate Setting

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58 CMS Covered AN 4 X(4)

Outpatient Drug
(COD) Status

59 CMS Covered N 8 9(8)

Outpatient Drug
(COD) Status
Effective Date

60 CMS Reactivation N 8 9(8)

Date

61 Morphine Equivalence N 1 9(1)

Code

The NDC Attribute Table (RNDCAT0_NDC_ATTRIBUTE) table contains the NDC Attribute Type Code (
NDC_ATTRIBUTE_TYPE_CD) to identify the attributes associated to an NDC, the NDC Attribute Value (
NDC_ATTRIBUTE_VALUE) to provide the numeric or text value of the NDC attribute, and the NDC Attribute
Sequence Number (NDC_ATTRIBUTE_SN), which links multiple attribute values together without indicating an
order of importance and maintains relationships between related attribute types.

Related NDC Attributes

NDC_ATTRIBUTE_TYPE_ NDC_ATTRIBUTE_TYPE_ Related Related

CD DSC NDC_ATTRIBUTE_TYPE_CD NDC_ATTRIBUTE_TYPE_
DSC

8 NDA Application Number 6 NDA Approval Date

37 NDA FDA Source Code

9 FDB Maintained NDA 7 FDB Maintained NDA

Application Number Approval Date

12 ANDA Application Number 10 ANDA Approval Date

38
ANDA FDA Source Code

13 FDB Maintained ANDA 11 FDB Maintained ANDA

Application Number Approval Date

14 Other Application Number 40 Other FDA Source Code

16 Not Defined Application 31 Not Defined Approval Date

Number 39 Not Defined FDA Source
Code

17 FDB Maintained Not Defined 32 FDB Maintained Not Defined

Application Number Approval Date

22 BLA Application Number 19 BLA Approval Date

23 FDA Device Registration 20 FDA Device Registration

Approval Date

24 OTC Monograph Number 25 OTC Monograph Publish

Date

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45 FDA Current NSDE 41 FDA Current NSDE

Marketing Category 43 Marketing Start Date
FDA Current NSDE
Marketing End Date

46 FDA Current and Archived 42 FDA Current and Archived

NSDE Marketing Category NSDE Marketing Start Date
44
FDA Current and Archived
NSDE Marketing End Date

Date column values associated to a given attribute are optional and may not be available.
Source code values associated to a given attribute will always be available.

Some NDC_ATTRIBUTE_TYPE_CDs may have multiple values. The NDC_ATTRIBUTE_SN value can be used
to link the multiple values together as exemplified in the tables below.

ExampleNDC_ATTRIBUTE_SN Linking Multiple Attribute Values

NDC NDC_ATTRIBUTE_T NDC_ATTRIBUTE_T NDC_ATTRIBUTE_S NDC_ATTRIBUTE_V

YPE_CD YPE_DSC N ALUE

00074372713 5 Orange Book Code 1 AB2

(OBC3)

00074372713 5 Orange Book Code 2 AB1

(OBC3)

ExampleNDC_ATTRIBUTE_SN Maintaining Relationships Between Related Attribute Type Records

NDC NDC_ATTRIBUT NDC_ATTRIBUT NDC_ATTRIBUT NDC_ATTRIBUT NDC_ATTRIBUT

E_TYPE_CD E_TYPE_DSC E_SN E_VALUE E_VALUE_DSC

00603499821 12 ANDA Application 1 087463

Number

00603499821 12 ANDA Application 2 040105

Number

00603499821 12 ANDA Application 3 077712

Number

00603499821 10 ANDA Approval 1 19831207

Date

00603499821 10 ANDA Approval 2 19960730

Date

00603499821 10 ANDA Approval 3 20070131

Date

00603499821 38 ANDA FDA 1 2 Old FDA NDC Dir

Source Code

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00603499821 38 ANDA FDA 2 1 SPL

Source Code

00603499821 38 ANDA FDA 3 2 Old FDA NDC Dir

Source Code

00603499821 13 FDB Maintained 1 087463

ANDA
Application
Number

00603499821 13 FDB Maintained 2 040105

ANDA
Application
Number

00603499821 13 FDB Maintained 3 077712

ANDA
Application
Number

00603499821 11 FDB Maintained 1 19831207

ANDA
Approval Date

00603499821 11 FDB Maintained 2 19960730

ANDA
Approval Date

00603499821 11 FDB Maintained 3 20070131

ANDA
Approval Date

ExampleNDC_ATTRIBUTE_SN Used to Avoid Truncating Attribute Values Exceeding Maximum Field Length

NDC NDC_ATTRIBUTE_T NDC_ATTRIBUTE_T NDC_ATTRIBUTE_S NDC_ATTRIBUTE_V

YPE_CD YPE_DSC N ALUE

00093018701 45 FDA Current NSDE 1 APPROVED DRUG

Marketing Category PRODUCT
MANUFACTURED
EXCLUSIVELY FOR

00093018701 45 FDA Current NSDE 2 PRIVATE LABEL

Marketing Category DISTRIBUTOR

Fiscal Utility Indicator (FUI)

The Fiscal Utility Indicator (FUI) information within the NDC Attribute Table (RNDCAT0_NDC_ATTRIBUTE) will
identify a products price as below, equal to, or above a median selected unit price. This unit price is still to be
determined by FDB. As a result, the FUI values are not currently being populated and will not appear as attributes
for an NDC.

Inner NDC Attribute

If an NDC links to one or more inner NDCs, the Inner NDC attribute ( NDC_ATTRIBUTE_TYPE_CD = 34) appears

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with each inner NDC as a value of the attribute. If an NDC links to more than one inner NDC, additional inner
NDCs each have different NDC Attribute Sequence Number (NDC_ATTRIBUTE_SN) values.

Over-the-counter (OTC) Monograph Information

The over-the-counter (OTC) monograph information within the NDC Attribute Table
(RNDCAT0_NDC_ATTRIBUTE) enables the identification of Food and Drug Administration (FDA)-approved OTC
products by providing the OTC monograph number and publish date of products marketed under the Center for
Drug Evaluation and Research (CDER) regulations. The table below lists the NDC Attribute Type Code (
NDC_ATTRIBUTE_TYPE_CD) values for the OTC Monograph information alongside the formats of their
associated NDC Attribute Values (NDC_ATTRIBUTE_VALUE).

NDC_ATTRIBUTE_T NDC_ATTRIBUTE_T Format Length Picture

YPE_CD YPE_DSC

24 OTC Monograph AN 25 X(25)

Number

25 OTC Monograph N 8 9(8)

Publish Date

FDB editorially assigns the OTC monograph values to a National Drug Code (NDC) when FDA-approved
monograph information is received from the manufacturer. An NDC without values for the
NDC_ATTRIBUTE_TYPE_CDs listed above indicates that the product is not an FDA-approved OTC product or
that the manufacturer has not supplied FDB with the required information.

When a drug product is associated to multiple monograph numbers, the NDC Attribute Sequence Number (
NDC_ATTRIBUTE_SN) is used to link the values together without indicating an order of importance. See NDC
Attribute Table above for more information on the NDC_ATTRIBUTE_SN column.

Reason Not Priced Attribute

In certain limited circumstances, some NDCs included within the Packaged Product data do not have published
prices. If an NDC does not have a published price, the Reason not Priced attribute (
NDC_ATTRIBUTE_TYPE_CD = 33) appears in the affected NDC record. The related NDC Attribute Value
Description (NDC_ATTRIBUTE_VALUE_DSC) provides the reason why there is no published price for the NDC.

NDC Attribute Indicators

The attributes listed below are from the NDC Attribute Table (RNDCAT0_NDC_ATTRIBUTE) and will only appear
when the condition is true for a given National Drug Code (NDC). for example, an NDC is registered with the
FDA. If the condition is false, the value will not appear as an attribute for the NDC.
Authorized Generic
Reference Listed Drug (RLD)
NDC Found in Available Approved Sources
FDA Registered NDC

Authorized Generic

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The Authorized Generic (NDC_ATTRIBUTE_TYPE_CD = 18) attribute identifies generic drug products that are
marketed under the brand pharmaceutical companys approval and New Drug Application (NDA). FDB editorially
assigns a value of 1 when a written confirmation is received from the brand pharmaceutical company that the
product is an authorized generic.

Reference Listed Drug (RLD)

The Reference Listed Drug (RLD) (NDC_ATTRIBUTE_TYPE_CD = 21) attribute identifies Food and Drug
Administration (FDA)-approved drug products used in new Abbreviated New Drug Application (ANDA) to show
bioequivalence. FDB acquires this information from the FDA and programmatically links MedKnowledge NDCs to
the RLD data. The data is not editorially adjusted in any way.

See Reference Listed Drug (RLD) Policy1 in the Editorial Process section for more information on how FDB
assigns the RLD status values.

In June 2011, FDB announced a content freeze for the RLD due to changes made by the FDA to the
National Drug Code (NDC) Directory. This content remains frozen until further notice.

NDC Found in Available Approved Sources

The NDC Found In Available Approved Sources (NDC_ATTRIBUTE_TYPE_CD = 28) is a programmatically

calculated value that identifies drug products marketed under one of the following applications:

Biologic License Application (BLA) (NDC_ATTRIBUTE_TYPE_CD = 22)

FDA Device Registration (NDC_ATTRIBUTE_TYPE_CD = 23)
New Drug Application (NDA) (NDC_ATTRIBUTE_TYPE_CD = 9)
Abbreviated New Drug Application (ANDA) (NDC_ATTRIBUTE_TYPE_CD = 13)
Over-the-Counter (OTC) Monograph (NDC_ATTRIBUTE_TYPE_CD = 24)

FDB references the FDB-maintained NDA and ANDA values (NDC_ATTRIBUTE_TYPE_CD = 9 and 13). See
FDA Drug Application Status Information for more information.

FDA Registered NDC

The FDA Registered NDC (NDC_ATTRIBUTE_TYPE_CD = 29) and the FDB Maintained FDA Registered NDC (
NDC_ATTRIBUTE_TYPE_CD = 30) attributes identify Food and Drug Administration (FDA)-registered drug
products.

Some registered products, such as medical foods, may not be included on the FDA registered list and may not
appear as a registered National Drug Code (NDC) in MedKnowledge. See FDA Registered NDC Policy in the
Editorial Policy section for more information on how FDB maintains the FDA Registered NDC values.

FDA Drug Application Status Information

The Food and Drug Administration (FDA) drug application attributes enable the creation of application rules to
categorize drug products for assigning brand, generic, or not covered status, or creating co-pays and
reimbursements. The FDA drug application information is provided within the following tables:

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NDC Attribute Table (RNDCAT0_NDC_ATTRIBUTE)

NDC to FDA NDA/ANDA Table (RAPPLSL0_FDA_NDC_NDA_ANDA)
NDC to FDA Drug Application Number Table (RAPPLNA0_FDA_NDC_APPL)
FDA Drug Application Type Table (RAPPLTD0_FDA_APPL_TYPE)

The RNDCAT0_NDC_ATTRIBUTE table provides the following application approval numbers and OTC
Monograph numbers, as well as approval dates for National Drug Codes ( NDC) approved under an NDA, ANDA,
Not Defined, BLA, Device Registration, and publish date for the OTC Monograph.

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)
Biologic License Application (BLA)
FDA Device Registration
Otherthe drug product was listed under the FDAs Other category. The FDA assigns this type to a drug
product when 1) an approved application number was not provided with the listing submission, 2) it does
not need one, or 3) the drug product is unapproved by the FDA.
Not Definedthe drug product was approved and assigned an application number by the FDA that doesnt
fit the FDAs numbering schema for the assignment of a particular status. (See Interpreting and Publishing
the FDA Drug Application Data in the Editorial Policies for more information.)
Over the Counter (OTC) Monograph

The NDA/ANDA tables identify whether a drug product was approved by the FDA under an NDA, ANDA, Other,
or Not Defined application. This data also contains the FDAs Listing Sequence Number and Trade Name to
enable access to additional FDA data.

The implementation of this information depends on your business needs and the attributes that are required to
meet those needs. For more information see:
NDC to FDA Application Number and NDA/ANDA Information
FDA Status Information Within the NDC Attribute Table

NDC to FDA Application Number and NDA/ANDA Information

This section defines the attributes within the NDC to FDA NDA/ANDA Table
(RAPPLSL0_FDA_NDC_NDA_ANDA) and the NDC to NDC to FDA Drug Application Number Table
(RAPPLNA0_FDA_NDC_APPL).

Application status indicators (NDA_IND and ANDA_IND) identify whether an NDC was approved by the Food and
Drug Administration (FDA) under an NDA and/or an ANDA. NDCs, such as kits with multiple items or combo
packs, may have NDA and ANDA approval.

The FDA Listing Sequence Number (LISTING_SEQ_NO) provides the unique, FDA-generated identification
number for a product. This number can be used to access additional FDA descriptive elements (for example,
manufacturer, ingredients, strength, and strength unit of measure) and the National Library of Medicines (NLMs)

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RxNorm database. The FDA Trade Name (TRADENAME) column contains the FDA description for an NDC. The
LISTING_SEQ_NO and TRADENAME column values are FDA-specific and cannot be obtained or validated by
any other source. Therefore, these columns contain null values within FDB-supplemented NDA or ANDA records.

The FDA Drug Application Number (APPL_NO) provides the NDA or ANDA number(s) assigned to an NDC by
the FDA. One NDC may be assigned multiple application numbers. This number can be used to access additional
information from FDA databases such as Drugs@FDA and Orange Book.

APPL_NO records associated to NDCs within the RAPPLNA0_FDA_NDC_APPL table are identical to
those found within the NDC Attribute Table (RNDCAT0_NDC_ATTRIBUTE), where
NDC_ATTRIBUTE_TYPE_CD = 9, 13, 15, and 17. See FDA Status Information Within the NDC Attribute
Table for more information.

The Application Type Code (APPL_TYPE_CD) identifies the application type for an NDC. The type values
include:

NDA
ANDA
Other
Not Defined

These application types can also be identified within the RNDCAT0_NDC_ATTRIBUTE table, which provides the
NDA, ANDA, Other, Not Defined, BLA and device registration application numbers. See FDA Status Information
Within the NDC Attribute Table for more information.

FDA Status Information Within the NDC Attribute Table

The NDC Attribute Table (RNDCAT0_NDC_ATTRIBUTE) provides the following Food and Drug Administration
(FDA) application numbers and approval dates, along with the source from where FDB obtained the FDA
application data (where applicable):

NDA with approval date and source

ANDA with approval date and source
BLA with approval date
Device Registration with approval date
Other and source
Not Defined with approval date and source

FDA drug application data values within the RNDCAT0_NDC_ATTRIBUTE table are maintained
and distributed by the FDA or are maintained by FDB. See the FDA Drug Application Data Policy
in the Editorial Policies for more information on the rules used to build and maintain the FDA drug
application data.

The table below lists the NDC Attribute Type Code (NDC_ATTRIBUTE_TYPE_CD) values for the FDA drug

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application information alongside the format of their associated NDC Attribute Value (NDC_ATTRIBUTE_VALUE
):

NDC_ATTRIBUT NDC_ATTRIBUT Attribute Attribute Value Attribute Value Attribute Value

E_TYPE_CD E_TYPE_DSC Definition Format Length Picture

6 NDA Approval Date when an N 8 9(8)

Date NDA application
was approved by
the FDA for a
given NDC

7 FDB Maintained FDB-maintained N 8 9(8).

NDA Approval date when an
Date NDA application
was approved by
the FDA for a
given NDC

8 NDA Application FDA-approved AN 25 X(25)

Number NDA application
number for a
given NDC.

9 FDB Maintained FDB-maintained AN 25 X(25)

NDA Application FDA-approved
Number NDA application
number for a
given NDC.

10 ANDA Approval Date when an N 8 9(8)

Date ANDA application
was approved for
a given NDC.

11 FDB Maintained FDB-maintained N 8 9(8)

ANDA Approval date when an
Date ANDA application
was approved for
a given NDC.

12 ANDA Application FDA-approved AN 25 X(25)

Number ANDA application
number for a
given NDC.

13 FDB Maintained FDB-maintained AN 25 X(25)

ANDA Application FDA-approved
umber ANDA application
number for a
given NDC.

14 Other Application FDA-approved AN 25 X(25)

Number Other application
number for a
given NDC.

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15 FDB Maintained FDB-maintained AN 25 X(25)

Other Application FDA-approved
Number Other application
number for a
given NDC.

16 Not Defined FDA-approved AN 25 X(25)

Application Not Defined
Number application
number for a
given NDC.

17 FDB Maintained FDB-maintained AN 25 X(25)

Not Defined FDA-approved
Application Not Defined
Number application
number for a
given NDC.

19 BLA Approval Date when a BLA N 8 9(8)

Date application was
approved for a
given NDC.

20 FDA Device Date when a N 8 9(8)

Registration device registration
Approval Date was approved for
a given NDC.

22 BLA Application FDA-approved AN 25 X(25)

Number BLA application
number for a
given NDC.

23 FDA Device FDA-approved AN 25 X(25)

Registration device registration
Number number for a
given NDC.

31 Not Defined Date when a Not N 8 9(8)

Approval Date Defined
application was
approved for a
given NDC.

32 FDB Maintained FDB-maintained N 8 9(8)

Not Defined FDA-approved
Approval Date Not Defined
application
number for a
given NDC.

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37 NDA FDA Source Identifies the N 3 9(3)

Code source of the
FDA-approved
NDA application
number for a
given NDC.

38 ANDA FDA Identifies the N 3 9(3)

Source Code source of the
FDA-approved
ANDA application
number for a
given NDC.

39 Not Defined FDA Identifies the N 3 9(3)

Source Code source of the Not
Defined FDA
application
number for a
given NDC.

40 Other FDA Source Identifies the N 3 9(3)

Code source of the
Other FDA
application
number for a
given NDC.

Orange Book Code

The FDAs Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) identifies drug
products approved on the basis of safety and effectiveness, and provides therapeutic equivalence evaluations for
approved multi-source prescription drug products. These therapeutic equivalence evaluations are represented by
codes in the Orange Book.

FDB provides Orange Book Code information within the NDC Table (RNDC14_NDC_MSTR), NDC Attribute
Table (RNDCAT0_NDC_ATTRIBUTE), and the Orange Book Code Relation Table (ROBCNDC0_OBC_NDC).

The RNDC14_NDC_MSTR table associates the following Orange Book Code attributes to an NDC:

Orange Book Code (OBC)

Expanded Orange Book Code (OBC_EXP)
Orange Book Code; three-byte version (OBC3)

ExampleOBC Information within the RNDC14_MSTR Table

NDC LN OBC OBC3 OBC3_EXP

00002032902 V-CILLIN K 250 MG AB AB AB

TABLET

55829010110 ACETAMINOPHEN ZB ZB ZB
325 MG TABLET

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The ROBCNDC0_OBC_NDC table relates pharmaceutical attributes and the OBC3 to a given NDC.

ExampleOB3 Information within the ROBCNDC0_OBC_NDC Table

NDC OBC3 GCN GCN_SEQNO GTI

00002032902 AB 39053 8879 3

55829010110 ZB 16964 4489 4

The RNDCAT0_NDC_ATTRIBUTE table associates single and multiple (when available) OBC3 values to a given
NDC. The table below lists the OBC3 NDC Attribute Type Code ( NDC_ATTRIBUTE_TYPE_CD) alongside the
format of its associated NDC Attribute Value (NDC_ATTRIBUTE_VALUE):

NDC_ATTRIBUTE_T NDC_ATTRIBUTE_T Format Length Picture

YPE_CD YPE_DSC

5 Orange Book Code AN 3 X(3)

(OBC3)

When a drug product is associated to multiple OBC3 values, the NDC Attribute Sequence Number (
NDC_ATTRIBUTE_SN) is used to link the values together without indicating an order of importance.

Please note that an NDCs OBC3 value linked to NDC_ATTRIBUTE_SN = 1 in the RNDCAT0_NDC_ATTRIBUTE
table is identical to that NDCs OBC3 value within the RNDC14_NDC_MSTR table.

ExampleOBC3 Information within the RNDCAT0_NDC_ATTRIBUTE Table

NDC NDC_ATTRIBUTE_TYPE_ NDC_ATTRIBUTE_SN NDC_ATTRIBUTE_VALUE

CD

00074372713 5 1 AB1

00074372713 5 2 AB2

See Orange Book Code Policy in the Editorial Policy section for more information on the Orange Book Code
policies.

Current Source Reason Codes for Consolidated Price 1 and 2

Consolidated Price 1 (WSD) and Consolidated Price 2 (SWD) represent consolidated prices published by FDB.
The source reason code (NDC_ATTRIBUTE_TYPE_CD of 35 or 36) used in conjunction with the NDC attribute
value (NDC_ATTRIBUTE_VALUE of 1, 2, or 3) identifies whether the current price represents Direct Price (DIR),
Suggested Wholesale Price (SWP), or Wholesale Acquisition Cost (WAC), as shown in the table below.

NDC_ATTRIBUTE_TYPE_ NDC_ATTRIBUTE_TYPE_ NDC_ATTRIBUTE_VALUE NDC_ATTRIBUTE_VALUE

CD DSC _DSC

35 Consolidated Price 1 - 1 Current Price Reflects DIR

Current Source Reason
Code

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35 Consolidated Price 1 - 2 Current Price Reflects SWP

Current Source Reason
Code

35 Consolidated Price 1 - 3 Current Price Reflects WAC

Current Source Reason
Code

36 Consolidated Price 1 - 2 Current Price Reflects DIR

Current Source Reason
Code

36 Consolidated Price 1 - 2 Current Price Reflects SWP

Current Source Reason
Code

36 Consolidated Price 1 - 2 Current Price Reflects WAC

Current Source Reason
Code

Marketing Category and Associated Dates

Beginning September 1, 2012, CMS is using the FDAs Comprehensive NDC Structured Product Labeling Data
Elements (NSDE) File to edit Prescription Drug Events (PDEs). They will use the NSDE file to determine a drugs
coverage under Medicare Part D and to make marketing category determinations for the Coverage Gap Discount
Program. For these purposes, CMS will use the following data elements from the NSDE file:

11-digit NDC (Item Code)

Marketing Category
Marketing Start Date
Marketing End Date

To assist our customers with their handling of Medicare Part D claims, FDB provides the following NDC Attribute
Types:

NDC_ATTRIBUT NDC_ATTRIBUT Attribute Attribute Value Attribute Value Attribute Value

E_TYPE_CD E _TYPE_DSC Definition Format Length Picture

41 FDA Current Provides the N 8 9(8)

NSDE Marketing Marketing Start
Start Date Date for NDCs
that are present
on the NSDE file.

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42 FDA Current and Provides the N 8 9(8)

Archived NSDE Marketing Start
Marketing Start Date for NDCs
Date currently on the
NSDE file or
reflects the last
recorded
Marketing Start
Date should the
NDC be removed
from the NSDE
file

43 FDA Current Provides the N 8 9(8)

NSDE Marketing Marketing End
End Date Date for NDCs
that are present
on the NSDE file.

44 FDA Current and Provides the N 8 9(8)

Archived Marketing End
Marketing End Date for NDCs
Date currently on the
NSDE file or
reflects the last
recorded
Marketing End
Date should the
NDC be removed
from the NSDE
file.

45 FDA Current Provides the AN 50 X(50)

NSDE Marketing Marketing
Category Category for
NDCs that are
present on the
NSDE file.

46 FDA Current and Provides the AN 50 X(50)

Archived Marketing
Marketing Category for
Category NDCs currently on
the NSDE file or
reflects the last
recorded
Marketing
Category should
the NDC be
removed from the
NSDE file.

Repackaged NDCs

The following attribute types provide more information about repackaged NDCs:

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Repackaged Original NDC

FDA Repackaged Original Core9

NDC_ATTRIBUT NDC_ATTRIBUT Attribute Attribute Value Attribute Value Attribute Value

E_TYPE_CD E_TYPE_DSC Definition Format Length Picture

47 Repackaged Provides the AN 11 X(11)

Original NDC original NDC of a
drug that has
been repackaged.
FDB delivers this
data as provided
by the
manufacturer or
the SPL.

56 FDA Repackaged Provides the AN 9 X(9)

Original Core9 original Core 9
(i.e.,
manufacturer,
ingredient, and
strength) of a drug
that has been
repackaged. FDB
delivers this data
as provided on the
SPL.

FDB recommends using either NDC Attribute Type Code 47 for Repackaged Original NDC (11 digit NDC
from manufacturer or the SPL) or type code 56 for FDA Repackaged Original Core9 (9 digit NDC from the
SPL) instead of using the Repackaged Indicator (REPACK) to identify repackaged NDCs.

Re-used NDCs

The Re-Used Date of Add attribute type provides more information about re-used NDCs.

NDC_ATTRIBUT NDC_ATTRIBUT Attribute Attribute Value Attribute Value Attribute Value

E_TYPE_CD E_TYPE_DSC Definition Format Length Picture

48 Re-Used NDC Provides the date N 8 9(8)

Date of Add on which an NDC
was first published
as re-used by
First Databank.
Prior to this date,
the NDC
represented a
different product
in FDBs
database.

Non-Responsive Manufacturers

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FDB previously had a policy to obsolete NDCs for non-responsive manufacturers. FDB has made proactive
attempts to determine the current status of these drugs.

For drugs that FDB was able to determine are still on the market, FDB has removed the obsolete date.
For drugs whose status FDB has been unable to determine, FDB will continue to list the product as
obsolete.

To help our customers identify these drugs, FDB provides a new obsolete reason code of Unable to contact
mfg/mfg no longer in business. Additionally, FDB provides a Latest Price Verification Date to allow customers to
see when FDB was last able to obtain pricing verification from the manufacturer for an NDC. These attributes are
shown in the table below:

NDC_ATTRIBUT NDC_ATTRIBUT Attribute Attribute Attribute Value Attribute Value

E_TYPE_CD E_TYPE_DSC Definition Value Format Length Picture

49 Latest Price Provides the most N 8 9(8)

Verification Date recent date on
which a list price
for an NDC was
verified by the
manufacturer.

50 Obsolete Reason Identifies the N 3 9(3)

Code NDCs that were
set to obsolete by
FDB under our
previous policy to
obsolete NDCs for
non-responsive
manufacturers.

For clarity, FDB identifies the last date of contact with the manufacturer through the Latest Price Verification Date
(NDC_ATTRIBUTE_TYPE_CD = 49). In the event of renewed manufacturer contact, the obsolete designation for
non-responsive manufacturers will be removed for active products and the Obsolete Reason Code will be
removed for all products.

The Obsolete Reason Code (NDC_ATTRIBUTE_TYPE_CD = 50) has only one attribute value associated with it (
NDC_ATTRIBUTE_VALUE = 101). This value is assigned to those NDCs currently on the database for which it
had proved impossible to obtain verification of product data from a manufacturer.

NDC_ATTRIBUTE_TYPE_ NDC_ATTRIBUTE_TYPE_ NDC_ATTRIBUTE_TYPE_ NDC_ATTRIBUTE_TYPE_

CD DSC CD DSC

50 Obsolete Reason Code 101 Unable to contact mfg/mfg

no longer in business

Products which FDB was able to confirm have been taken off the market, either by manufacturer reporting or due
to an FDA withdrawal from the market, will continue to be marked as obsolete but with no Obsolete Reason
Code.

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Morphine Equivalence Code Attributes

The FDB Medicare Part D Module identifies the quantity of equivalent morphine an NDC contains to assist in
calculating the total daily morphine load dispensed to a patient. The module multiplies the quantity, in grams, of
the opioid in an NDC-specified packaged product by an industry-defined and CMS-endorsed conversion factor to
produce an equivalent morphine quantity. Adding the equivalent morphine amounts of all the opioids a patient
takes in a day results in a daily total that can be compared to thresholds employed in customer-specific
intervention activities.

Given the focus of the Module on Medicare Part D population, the drugs covered are primarily those used in an
ambulatory outpatient setting. Drugs whose Medicare Part D conversion values are not available, e.g., injectable
formulations of some opioids, and opioids that are unavailable in a solid dosage form, are not included in the
Module. In such cases the total daily morphine load calculation will need to take these non-covered drugs into
account. To do so, customers can select product records with NDC Attribute Code 61 - "Morphine Equivalence
Code". Then, for these selected records, products with an Attribute Value of 1- "Opioid: Morphine Equivalent
Dose is Available", will have an associated record in the Part D Module to indicate the morphine equivalent
quantity. Those selected records with an Attribute Value of 2 - "Opioid: Morphine Equivalent Dose is Not
Available", will identify those opioid drugs that have no morphine equivalent in the FDB Medicare Part D Module
and must be addressed independently.

For more information about Morphine Equivalence Dosing, see Determining the Morphine Equivalent Strength in
Milligrams Contained in One Dosage Unit in the Applications and Morphine Equivalent Dose in the FDB
Medicare Part D Module Editorial Policies.

Designation by Labeler

FDB assigns all dietary supplements and all medical foods irrespective of their ingredient content, including folic
acid, a Class value of O (products with no federal legal prescription requirement) in the NDC Table
(RNDC14_NDC_MSTR). The "Designation by Labeler" NDC Attribute Type (NDC_ATTRIBUTE_TYPE_CD = 62)
in the NDC Attribute Table (RNDCAT0_NDC_ATTRIBUTE) provides customers additional information for these
products by identifying representations made by their manufacturers as to the prescription status of the products.
This attribute consequently supplements the Drug Class (CL) attribute, which references the federal legal
standard, with statements that appear on product package labels.

Associated Attribute Values for "Designation by Labeler" Attribute Type

NDC_ATTRIBUTE_TYPE_CD NDC_ATTRIBUTE_VALUE NDC_ATTRIBUTE_VALUE_DSC

62 1 Designated As Prescription

62 2 Prenatal Dietary Supplement

62 3 Pediatric Dietary Supplement

62 4 Dietary Supplement

62 5 Medical Food

Inactive Ingredient Information

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The NDC Table (RNDC14_NDC_MSTR) has two supporting tables that supply inactive ingredient information:

NDC/HIC_SEQN Inactive Ingredient Relation Table (RNDCINH0_NDC_INACTV_LINK)

NDC Inactive Ingredients Reviewed Master Table (RNDCINR0_INACTV_REVIEWED)

See Inactive Ingredient Information for more information about inactive ingredients.

Packaged Product and Supporting Data Uses

Packaged product data functions as an electronic catalog, providing the foundation for a variety of applications in
pharmacy and healthcare information systems. Example uses of packaged product data are provided in this
section.

The example uses in this section provide a limited sample of the ways in which packaged product data
can be used; it is not a comprehensive list of the applications of this data.

Pricing Applications

Packaged product data provides companion data for FDBs Drug Product Pricing for pricing applications. The
following example displays products with their label names, package sizes, and Wholesale Acquisition Cost
(WAC) unit prices. The data is retrieved from the NDC Table (RNDC14_NDC_MSTR), NDC Price Type
Description Table (RNP2_NDC_PRICE), and the NDC Price Type Description Table
(RNPTYPD0_NDC_PRICE_TYPE_DESC).

ExamplePackage size and Wholesale Acquisition Cost (WAC) Unit Price for selected products

NDC Label Name Package Size Drug Form NDC Price NDC Price NDC Price
(LN) (PS) Code (DF) (NPT_PRICEX Type Code Type Code
) (NPT_TYPE) Description
(NPT_DESC)

00046086799 PREMARIN 00000100.000 1 000000.88700 09 WHN

0.625 MG
TABLET

00310027139 SEROQUEL 00000100.000 1 000005.52130 09 WHN

100 MG
TABLET

00093519973 PENICILLIN 00000100.000 2 000000.02220 09 WHN

VK 250 MG/5
ML LIQ

00005010432 HIBTITER 00000000.500 2 000045.71200 09 WHN

VACCINE VIAL

Example Interpretation

The following explanations pertain to the first and last products shown in the example:

The first product (Premarin 0.625 mg Tablet) has a package size ( PS) of 100 tablets, the billing unit (DF) is
one tablet (each), and the Wholesale Acquisition Cost (WAC) Unit Price ( NPT_TYPE and NPT_DESC) is

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approximately $0.89 per tablet (NPT_PRICEX).

The last product (Hibtiter Vaccine Vial) has a package size (PS) of 0.5 mLs, the billing unit ( DF) is one mL,
and the Wholesale Acquisition Cost (WAC) Unit Price (NPT_TYPE / NPT_DESC) is approximately $45.71
per unit, or $22.86 per package (0.5 units is the package size).

Claims Adjudication

Packaged product data provides attributes such as the generic classification indicators (NDCGI1, GMI, GNI,
NDA_IND, ANDA_IND, and GTI) and repackager identification (REPACK) that are useful in claims adjudication.
The following table shows multi-source/single source indicators, pricing indicators, and repackaged indicators for
selected products:

ExampleRepackaging indicators for selected products

NDC Label Name (LN) Multi-Source/Sin NDA Indicator ANDA Indicator Repackager
gle Source (NDA_IND) (ANDA_IND) Indicator
Indicator (REPACK)
(NDCGI1)

54569107100 CHILDS 1 1 0 1
SUDAFED 15
MG/5 ML LIQ

54569107701 KWELL 1% 1 1 0 1
LOTION

50111036201 CHLORTHALIDO 1 1 0 0
NE 25 MG
TABLET

49669152001 FLUOSOL 20% 2 1 0 0

EMULSION BAG

Example Interpretation

The following explanations pertain to the first and last products shown in the example:
The first product (Childs Sudafed 15 mg/5 mL Liquid) is distributed by more than one labeler (multiple-source,
NDCGI1 = 1), has an NDA (NDA_IND = 1), and is distributed by a repackager (REPACK = 1).
The last product (Fluosol 20% Emulsion Bag) is distributed by only one labeler (single-source, NDCGI1 = 2), has
an NDA (NDA_IND = 1), and the distributor is not a repackager (REPACK = 0).

Therapeutic Substitution Candidate Identification and List Generation

Packaged product data provides attributes, such as the Orange Book Code ( OBC) that are useful in applications
that identify candidates for therapeutic substitution. OBCs denote the therapeutic equivalence of products that
share the same Clinical Formulation ID (GCN_SEQNO), as determined by the Food and Drug Administrations
(FDA) Drug Products with Therapeutic Equivalence Evaluations (Orange Book). See Orange Book Code for more
information.

The following table shows equivalency ratings for selected products:

ExampleEquivalency ratings for selected products (continued)

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NDC Label Name (LN) Clinical Formulation Orange Book Code Description
ID (GCN_SEQNO) (OBC)

00024153524 PHISOHEX 3% 007250 AT Topical products

CLEANSER therapeutically
equivalent in same
dosage form.

00074454102 LEUCOVORIN CAL 044540 AP Injectable aqueous

10 MG/ML VIAL solutions including dry
powders,
concentrated solutions
or ready-to-use
solutions are
considered
pharmaceutically and
therapeutically
equivalent if they
produce the same
concentration and are
labeled similarly

00006778066 AQUA-MEPHYTON 002301 BP Active ingredients and

10 MG/ML AMPUL dosage forms with
potential
bioequivalence
problems.

Example Interpretation

The following explanations pertain to the first and last products shown in the example:

The first product (PhisoHex 3% Cleanser) is considered by the FDA to be therapeutically equivalent (OBC
= AT) to other NDCs with Clinical Formulation ID (GCN_SEQNO) 007250.
The last product (Aqua-Mephyton 10 mg/mL Ampule) is not considered therapeutically equivalent ( OBC =
BP) to other NDCs with Clinical Formulation ID (GCN_SEQNO) 002301.

The uses described above are provided for illustrative purposes only and are not intended to instruct or to
direct the use of the packaged product data.

The Clinical Formulation ID (GCN_SEQNO) can be used to generate a list of candidates for substitution. When
used in combination with other drug product data, it can also be used to manipulate drug product lists, support
substitution practices in pharmacies, manage formularies, and conduct purchasing and pricing analysis.

Nutritional formulations (such as baby formulas, specialized foods, and related nutritional foods, most
non-prescription multivitamins, etc.) and medical supplies are often broadly grouped and categorized in
association with a Clinical Formulation ID (GCN_SEQNO). They are categorized as such so that they
may be included in the database for purposes of commerce only and commonly have not been rigorously
evaluated for pharmaceutical equivalence as is the case for prescription drug items.

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The Clinical Formulation ID (GCN_SEQNO) groups packaged products from different manufacturers and
distributors.

Partial List of Drug Products included in Clinical Formulation ID (GCN_SEQNO) 009258

Label Name (LN) Manufacturer/Distributor

ERYTHROMYCIN EC 250 MG CAP ABBOTT LABS

ERYTHROMYCIN EC 250 MG CAP STAT RX USA

ERYTHROMYCIN EC 250 MG CAP PALMETTO STATE

ERYTHROMYCIN EC 250 MG CAP QUALITY CARE

ERYTHROMYCIN EC 250 MG CAP PHARMA PAC

ERYTHROMYCIN EC 250 MG CAP A-S MEDICATION

ERYTHROMYCIN EC 250 MG CAP PHYSICIANS TC.

ERYTHROMYCIN EC 250 MG CAP PD-RX PHARM

ERYTHROMYCIN EC 250 MG CAP SOUTHWOOD PHARM

Although the Clinical Formulation ID (GCN_SEQNO) can be used to develop a list of candidates for substitution,
these candidates are only pharmaceutically equivalent; it is not sufficient to determine therapeutic substitutability.

Any substitution process using the Clinical Formulation ID (GCN_SEQNO) must:

Include a check against Orange Book Codes

Provide for compliance with State Boards of Pharmacy regulations
Respect state formulary codes (if any)
Provide opportunity for the exercise of best clinical judgment of the dispensing pharmacist.

Please access the FDA Center for Drug Evaluation and Research Approved Drug Products with
Therapeutic Equivalence Evaluations website at the following location for more information on the
Therapeutic Equivalence Evaluations Codes:
http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm071436.pdf.

Keep in mind, however, that the Orange Book lists drugs by whoever holds the approved application. This is
usually the manufacturer, but not always. Therefore, generic distributors not holding approved applications will not
receive an A rating. Final product selection must always be up to the pharmacists best clinical judgment. See
Orange Book Code Policy for more information on the OBC ratings.

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Packaged Product Editorial Policies

FDB receives information from manufacturers, distributors, government sources and publications, research, and
other sources. The policies and criteria that apply to the scope, processes, and sources of the packaged product
data are provided in the following sections:

Scope
Editorial Process
Sources

Scope
The following section describes the criteria the clinical editors use to include database content.

Use with FDB Modules

Packaged product data often works as companion data in applications that utilize other FDB modules. The NDC,
linked to the Clinical Formulation ID (GCN_SEQNO) and the MED Medication ID (MEDID), provides access to
and from modules. Additionally, some modules directly utilize the NDC (such as the Drug Images Module, Drug
Imprints Module, Medicare Module, Medicaid Module, and MedGuides Module).

Editorial Process
The following section describes the process and criteria used to add or review database elements. Major topics
covered in this section are the following:
External Triggers for Clinical Review
Internal Triggers for Clinical Review
Database Product Inclusion
Government Information
CMS (formerly HCFA) Codes
Why Products Have a HCFA Termination Date and a Reactivation Date
DESI Codes
FDA Drug Application Data Policy
NSDE File Policy
Reference Listed Drug (RLD) Policy
Orange Book Code Policy
FDA Registered NDC Policy
Labeler Information
Labeler Identifier (LBLRID)
Manufacturer Name (MFG)
Repackaged Indicator (REPACK)
Private Labeler Indicator (PLBLR)
Innovator Indicator (INNOV)

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Packaging Information
Brand Name (BN)
Label Name (LN)
Package Description (PD)
Drug Form Code (DF) and Package Size (PS)
Metric Package Sizes
Package Size Equivalent Value (PS_EQUIV)
Shelf Pack (SHLF_PCK)
Case Pack (CSP)
Shipper Quantity (SHIPPER)
Unit Dose Indicator (UD)
Unit of Use Indicator (UU)
Standard Package Indicator (STPK)
Generic Classification Indicators
Multi-Source/Single Source Indicator (NDCGI1)
Generic Manufacturer Indicator (GMI)
Generic Name Indicator (GNI)
Therapeutic Equivalence Indicator (GTI)
Inactive Ingredient Information
NDC Inactive Ingredients Reviewed Master Table
NDC/HIC_SEQN Inactive Ingredient Relation Table
Obsolete and Replaced NDCs
Re-use of NDCs

External Triggers for Clinical Review

The external triggers that prompt the clinical editors to add or review data are the following:

FDA-approved documentation from manufacturers or distributors

MedEffects Alerts from Health Canada
MedWatch Safety Alerts

Internal Triggers for Clinical Review

The internal trigger that prompts the clinical editors to add or review data is a new Clinical Formulation ID (
GCN_SEQNO).

Database Product Inclusion

This section provides information detailing the criteria that guided the inclusion of the Packaged Product data as
well as information pertaining to limitations or exclusions when appropriate.

FDB will add to the database:

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Approved prescription drugs*

Over-the-counter drugs that comply with FDA regulations*
Registered Outsourcing Facility products that comply with FDA regulations and have been requested by
FDB customers
Medical foods, nutritional supplements and bulk ingredients for compounding that comply with FDA
regulations
Select FDA cleared medical devices commonly dispensed in pharmacies

*In general these products must be listed with the FDA

FDB will not add homeopathic preparations, compounding kits, cosmetics, veterinary products or
software/applications.

FDB will evaluate products for inclusion on the database based on their FDA approval, and listing status and their
clinical use. FDB reserves the right to decline to add products to the database that are not compliant or have an
insufficient basis for assessing their safety and efficacy.

The addition of any product to the database is contingent dependent upon the products labeler providing
sufficient information to identify the product specifically, including a product label.

FDB can add products in advance of their launch, but no more than 28 days prior to the price effective date.

Government Information

This section details the policies FDB uses to provide data from the Food and Drug Administration (FDA) or the
Centers for Medicare and Medicaid Services (CMS).

These FDA and CMS indicators are obtained from the FDAs Comprehensive NDC Structured Product Labeling
Data Elements (NSDE) File (
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm240580.htm), the FDAs old NDC
Directory, and the CMS website. These indicators are provided for only those drugs included in MedKnowledge.
No such information will be provided for the products of manufacturers that have failed to comply with FDA and
CMS filing requirements. While FDB does not edit the content of the data as published by the FDA or CMS or
independently validate their linkages, we will exclude incorrect linkages that are uncovered in routine data
processing.

Data compiled and maintained by CMS or the FDA may be applied to a MedKnowledge NDC that has
been re-used by the manufacturer. Until FDB receives updated information, data may be linked to CMS
and FDA-maintained data. See the Re-use of NDCs section for more information.

CMS (formerly HCFA) Codes

Starting with the third quarter 2014, CMS has discontinued the publication of the DESI field (Drug Safety
Efficacy Study Implementation Rating).
Accordingly, as of October 30, 2014, FDB has discontinued the maintenance of the following
DESI-related columns:

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HCFA_DESI1
HCFA_DESC1
DESI
DESDTEC
DESI2
DES2DTEC

CMS announced that a new COD (Covered Outpatient Drug) Status field will replace the DESI field. FDB
will output the CMS Covered Outpatient Drug (COD) Status Code and associated effective date as NDC
Attribute Type Codes (NDC_ATTRIBUTE_TYPE_CD) 58 and 59.
Additionally, CMS has introduced the Reactivation Date field. FDB will output this field as NDC Attribute
Type Code (NDC_ATTRIBUTE_TYPE_CD) 60.

The NDC Table (RNDC14_NDC_MSTR) contains drug information from the Centers for Medicare and Medicaid
Services (CMS). This information is compiled and maintained by CMS. FDB downloads the data directly from the
CMS download,
http://www.medicaid.gov/medicaid-chip-program-information/by-topics/benefits/prescription-drugs/downloads/xxx-6-qtrly-8qs-dr
, on a quarterly basis, and provides the following data in the RNDC14_NDC_MSTR.

HCFA FDA Therapeutic Equivalency Code (HCFA_FDA)provides manufacturer-specified Orange Book

equivalency codes.
HCFA Unit Indicator (HCFA_UNIT)provides CMSs standard unit of measure for determining rebate
quantities.
HCFA Units Per Package (HCFA_PS)provides CMSs number of units per package.
HCFA FDA Approval Date (HCFA_APPC)provides the date on which Food and Drug Administration
(FDA)-approved products were introduced in the marketplace after 9/30/90 (the HCFA Rebate program
start date). Products introduced prior to this date contain 19900930 in this column in lieu of the actual
approval date.
HCFA Market Entry Date (HCFA_MRKC)provides the date on which the manufacturer introduced
products to the marketplace after 9/30/90 (the HCFA Rebate program start date). Products introduced prior
to this date contain 19900930 in this column in lieu of the actual market entry date.
HCFA Termination Date (HCFA_TRMC)provides the shelf-life expiration date of the last batch/lot of
product produced.
HCFA Drug Type Code (HCFA_TYP)provides the prescription or over-the-counter status of a specified
product.
HCFA Drug Category (HCFA_DC)provides single source, multi-source, or innovator status.

Although still found in the RNDC14_NDC_MSTR table, as of October 30, 2014, the following columns are no
longer maintained by FDB.

HCFA DESI Drug Indicator (HCFA_DESI1)provides the DESI status code.

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HCFA DESI Effective Date (HCFA_DESC1)provides the date on which DESI status was applied or
removed.

Two new NDC Attribute Type Codes (NDC_ATTRIBUTE_TYPE_CD) have been added to replace these HCFA
DESI codes:

CMS Covered Outpatient Drug (COD) Status (58)provides the COD status code.
CMS Covered Outpatient Drug (COD) Status Effective Date (59)provides the date on which COD status
was applied or removed.

The HCFA DESI Effective Date and CMS Covered Outpatient (COD) Status Effective Date coincides with
the CMS publish date.

A new NDC Attribute Type Code (NDC_ATTRIBUTE_TYPE_CD) has been added to reflect the new CMS
reactivation date field:

CMS Reactivation Date (60)provides the date of reactivation, as provided by CMS.

CMS defines the reactivation date as the date a terminated product is reintroduced to the market.

Why Products Have a HCFA Termination Date and a Reactivation Date

CMS introduced a new Reactivation Date field beginning with the 3rd quarter 2014 CMS rebate drug product data
file. This is the date on which a terminated product is re-introduced to the market. Products with a reactivation
date are currently active and available even though they appear with a termination date.

CMS has informed FDB that termination dates are retained as history to show the time period during which the
NDCs were initially active. Reactivated NDCs will continue to have termination dates on the quarterly rebate file
until the manufacturer submits a new termination date for the reactivated NDCs. Once the manufacturer has
submitted a new termination date for the reactivated NDC, then the reactivation date will become blank and the
new termination date will appear on the termination date field. For every product with a termination date,
customers should check if there is a reactivation date before concluding that the product is no longer on the
market.

For additional information regarding the Medicaid Drug Rebate Program, see this website:
http://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Benefits/Prescription-Drugs/Medicaid-Drug-Rebate-P

FDB publishes the Termination Date and the Reactivation Date as they are listed on CMS rebate drug product
data file. FDB does not edit, modify or change any of the values on the CMS rebate file.

The HCFA Termination Date is available as HCFA_TRMC on the RNDC14_NDC_MSTR table.

The CMS Reactivation Date is available as NDC_ATTRIBUTE_TYPE_CD = 60 on the

RNDCAT0_NDC_ATTRIBUTE Table.

For example: NDC 00406888501, Amphetamine Salts 15 mg Tablet, is an active NDC. It has a HCFA_TRMC of
07/31/2007 on the RNDC14_NDC_MSTR table and a Reactivation Date of 12/23/2013 on the

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RNDCAT0_NDC_ATTRIBUTE table.

RNDC14_NDC_MSTR

NDC LN HCFA_TRMC

00406888501 AMPHETAMINE SALTS 15 MG 20070731

TABLET

RNDCAT0_NDC_ATTRIBUTE and RNDCTD0_NDC_ATTRIBUTE_TYP_DSC

NDC NDC_ATTRIBUTE_VALUE NDC_ATTRIBUTE_TYPE_ NDC_ATTRIBUTE_TYPE_

CD DSC

00406888501 20131223 60 CMS Reactivation Date

Other CMS (formerly HCFA) attributes are available in the Drug Product Pricing data set. These attributes
include Federal Financing Participation Rebate Indicators.

DESI Codes

Starting with the third quarter 2014, CMS has discontinued the publication of the DESI field (Drug Safety
Efficacy Study Implementation Rating).

Accordingly, as of October 30, 2014, FDB has discontinued the maintenance of the following
DESI-related columns:

HCFA_DESI1
HCFA_DESC1
DESI
DESDTEC
DESI2
DES2DTEC

CMS announced that a new COD (Covered Outpatient Drug) Status field will replace the DESI field. FDB
will output the CMS Covered Outpatient Drug (COD) Status Code and associated effective date as NDC
Attribute Type Codes (NDC_ATTRIBUTE_TYPE_CD) 58 and 59.

Prior to the third quarter of 2014, the NDC Table (RNDC14_NDC_MSTR) provides drug information from the
Food and Drug Administration (FDA) Drug Product Efficacy Study and Implementation program (DESI). The DESI
codes (DESI, DESI2, and HCFA_DESI1, columns) denote a drug product as declared by the DESI program or
Centers for Medicare and Medicaid Services (CMS) to be less than effective. Drugs subject to DESI status
include the following product types:

Pre-1962 drug products; these products pre-date the FDAs requirement that a product demonstrate
efficacy, and therefore, were not declared effective by that regulatory agency before public availability.

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New drug products that contain certain pre-1962 ingredients; for example, certain cough and cold
preparations containing guaifenesin (a pre-1962 ingredient).

CMS worked with the FDA to determine and publish DESI status on a regular basis; in 1990, CMS appended the
listing of DESI drugs to include ingredients that are similar and related to the FDAs original DESI list and that do
not demonstrate efficacy (as deemed by CMS). The HCFA_DESI1 column is populated with values from CMS.
Effective November 2007, FDB began populating the DESI and DESI2 columns based upon the products
HCFA_DESI1 value. However, starting October 14, 2014, FDB stopped maintaining the HCFA DESI fields. CMS
announced that a new COD (Covered Outpatient Drug) Status field will replace the DESI field.

The HCFA_DESI1 values were applied using the following criteria:

HCFA_DESI1 Description DESI/DESI2 Status

0 NDC not or no longer on CMS list (no No change to existing DESI or DESI2
information submitted by value
manufacturer)

2 Safe and Effective or Non-DESI If DESI = 1, change DESI to 0

If DESI2 = 1, change DESI2 to 0

3 DESI/IRS Drugs Under Review (no If DESI = 1, change DESI to 0

Notice of Opportunity for a Hearing If DESI2 = 1, change DESI2 to 0
[NOOH] issued)

4 Less than effective DESI/IRS Drugs for If DESI = 1, change DESI to 0

Some Indications
If DESI2 = 1, change DESI2 to 0

5 Less than effective DESI/IRS Drugs for If both DESI and DESI2 are not
All Indications already 1, change DESI to 1
DESI2 remains unchanged

6 Less than effective DESI/IRS Drugs If both DESI and DESI2 are not
Removed from the Market already 1, change DESI to 1
DESI2 remains unchanged

The HCFA DESI Effective Date (HCFA_DESC1) coincides with the CMS publish date.

FDA Drug Application Data Policy

This section details the policies FDB uses to provide the Food and Drug Administration (FDA) drug application
information.

The FDA drug application information is provided within the following tables:

Controlled Substance NDC Attribute Table (RNDCAT0_NDC_ATTRIBUTE)

NDC to FDA NDA/ANDA Table (RAPPLSL0_FDA_NDC_NDA_ANDA)
NDC to FDA Drug Application Number Table (RAPPLNA0_FDA_NDC_APPL)
FDA Drug Application Type Table (RAPPLTD0_FDA_APPL_TYPE)

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The tables are populated when updated information is available from the Food and Drug Administration (FDA).
However, changes in the data occur when an FDA-maintained record is edited or supplemented by FDB.

Going forward within this module, any reference to FDA drug application data as provided by the FDA is
from either of these two sources: FDAs Comprehensive NDC Structured Product Labeling Data
Elements (NSDE) File (
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm240580.htm) or the old
FDA NDC Directory.

Assembling the FDA Drug Application Data

FDB uses the following process to assemble the FDA drug application data:

1. FDB Clinical Editors supplement or edit the FDA drug application data as FDA-approved information is
received from the manufacturers.

2. FDB accesses FDA related external sources daily to determine whether updates have been applied for
each NDC:

a. The FDAs Comprehensive NDC Structured Product Labeling Data Elements (NSDE) File (
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm240580.htm).
Any application number found on the SPL has its FDA Source (Attribute Type Codes 37 -
40) identified as such.
Approval date assigned to an application number if the application number approval date is
listed on the Electronic Orange Book (EOB) Query data file (located at
http://www.fda.gov/Drugs/InformationOnDrugs/ucm129689.htm).
Application type (i.e. NDA, ANDA) is identified within the SPL.

b. The old FDA National Drug Code Directory (old NDC Directory at
http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm) is referenced next.
Any application number found only on the old FDA NDC Directory has its FDA Source
identified as such.
The approval date is assigned to an application number if the application number approval
date is listed on the Electronic Orange Book (EOB) Query data file (located at
http://www.fda.gov/Drugs/InformationOnDrugs/ucm129689.htm).
If the application number is listed, the application type is identified by referencing the
Electronic Orange Book (EOB) Query data file (located at
http://www.fda.gov/Drugs/InformationOnDrugs/ucm129689.htm). If the application number is
not listed, the application type is determined as shown in the FDA Drug Application Numbers
and Types table below.

3. Once the most recent database release is found, the data is loaded into FDBs internal database
structures.

4. FDB assembles the FDA 11-digit NDC values.

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5. As part of the MedKnowledge daily build, FDBs NDC values are compared to the assembled FDA
11-digit NDC values retrieved from the FDA.

6. FDB NDCs that match the FDA assembled NDCs are published with the updated FDA data according to
FDBs editorial policy.

See the following for more information on the policies used to perform each of these steps:
Comparing Assembled FDA NDC Values to FDB NDC Values
Interpreting and Publishing the FDA Drug Application Data
FDA Drug Application Numbers and Types
Application Approval Dates
Populating and Updating FDB-Supplemented Data

Comparing Assembled FDA NDC Values to FDB NDC Values

This section defines illustrates how FDB compares FDA assembled values to link the FDA data to FDB NDCs.

ExampleComparing Assembled FDA 11-digit NDC Values to FDB NDC Values

FDA LBLCODE FDA PRODCODE FDA PKGCODE FDB NDC Matched NDC

000904 1349 70 00904-1349-60 00904-1349-61

00904-1349-61 00904-1349-70
00904-1349-70 00904-1349-80
00904-1349-80

010019 *092 03 10019-0092-03 10019-0092-03

10019-0092-04 10019-0092-04

023490 5013 *3 23490-5013-01 23490-5013-01

23490-5013-02 23490-5013-02
23490-5013-03 23490-5013-03
23490-5013-04 23490-5013-04

050201 1300 ** 50201-1300-02 50201-1300-02

50201-1300-04 50201-1300-04
50201-1300-06 50201-1300-06

058016 *135 ** 58016-0135-00 58016-0135-00

58016-0135-02 58016-0135-02
58016-0135-30 58016-0135-30
58016-0135-60 58016-0135-60
58016-0135-90 58016-0135-90

Interpreting and Publishing the FDA Drug Application Data

This section defines how FDB interprets the FDA drug application number values and publishes the FDA drug
application data within MedKnowledge.

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In order to provide a complete data set, FDB accesses external sources daily to assemble the FDA drug
application data. First, the FDAs Comprehensive NDC Structured Product Labeling Data Elements (NSDE) File (
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm240580.htm) is referenced. Then,
the old FDA National Drug Code Directory
(http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm) is referenced to add information not available in
the NSDE File.

FDA-maintained drug application data is published within the NDC Attribute Table
(RNDCAT0_NDC_ATTRIBUTE). FDB programmatically assigns data created and maintained by the FDA to the
NDC Attribute Value (NDC_ATTRIBUTE_VALUE) column for the following NDC Attribute Type Codes (
NDC_ATTRIBUTE_TYPE_CD):

6 (NDA Approval Date)

8 (NDA Application Number)
10 (ANDA Approval Date)
12 (ANDA Application Number)
14 (Other Application Number)
16 (Not Defined Application Number)
31 (Not Defined Approval Date)

NDCs that are re-used may be linked to FDA data related to the former product until FDB receives
updated information from the FDA.

The FDA Source Code fields (NDC Attribute Type Code values 37-40 NDC_ATTRIBUTE_TYPE_CD]) for each
type of application indicate whether an application number was obtained via the NSDE file or the old NDC
Directory. The source code NDC_ATTRIBUTE_TYPE_CD values are as follows:

37 (NDA FDA Source Code)

38 (ANDA FDA Source Code)
39 (Not Defined FDA Source Code)
40 (Other FDA Source Code)

The following NDC Attribute Values (NDC_ATTRIBUTE_VALUE) that identify the specific FDA source are linked
to the NDC Attribute Type Code (NDC_ATTRIBUTE_TYPE_CD) values listed above:

1 (SPL)
2 (Old FDA NDC Dir)
3 (Old FDA NDC Dir - not OBC verified)

FDBs frequency of reporting of the FDA application data is dependent on the FDAs publication schedule.

FDB interprets the FDA drug application number values according to general guidance from the FDA as defined
below.

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FDA Drug Application Numbers and Types

Application Number Application Number Type

Other Other

1-29,999 NDA

30,000-49,999 ANDA

50,000-59,000 NDA

60,000-89,999 ANDA

90,000-99,999 ANDA

Application numbers that are equal to or greater than 100,000 will be identified as Not Defined.

The FDA has also provided the following chart:

Type Number Series NDA and ANDA Series Description

NDA 0002 to 22xxx Since 1938 FFD&CA. Thru low 12000

= pre-1962. Associated with 40xxxx
and 80xxx ANDAs.

NDA 0002 to 22xxx High 12xxx to today = post 1962.

Associated with 70xxx ANDAs.

NDA 50xxx Old antibiotic applications (pre

FDAMA). Associated with 60xxx ANDA
under 507 & 505(j) post FDAMA. Post
FDAMA antibiotics are in integrated
into the 20xxx series.

ANDA 40xxx 505(j) based in pre 1962 RLDs.

ANDA 60xxx thru 64xxx Antibiotic Abbreviated New

Drug Applications (AADA).

ANDA 65xxx 505(j) based on pre-FDAMA.

ANDA 70xxx Post-1962 RLDs.

ANDA 80xxx Pre-1962 RLDs.

ANDA 90xxx Series Description is unknown at this

time.

Many reported FDA table values do not provide a numeric application number. The value OTHER is commonly
reported. Per FDA documentation, OTHER has the following definition:

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'OTHER' in this field signifies that this product may not be approved for both safety and efficacy under an NDA or ANDA,
may be subject to the Drug Efficacy Study Implementation (DESI), and/or may be one for which FDA currently lacks
sufficient data to provide information. DESI is a retrospective evaluation of the efficacy of drugs that had been approved on
safety grounds alone between 1938 and 1962, and drugs identical, related, or similar to those drugs. This evaluation was
necessitated by the 1962 amendments to the FD&C Act, which added the requirement that a drug be evaluated for
efficacy, not only for safety, for FDA approval.

NDCs with an application number value of OTHER are not assigned an approval date by the FDA as the
product may not be approved for both safety and efficacy.

Other application numbers continue to be extracted only from the old FDA NDC Directory. FDB is not
extracting Other application numbers from the FDAs Comprehensive NDC Structured Product Labeling
Data Elements (NSDE) File (
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm240580.htm).

Concerning error reporting, the FDA can be contacted at [email protected].

Application Approval Dates

Approval dates retrieved from the FDAs Electronic Orange Book (EOB) Query Data Files are assigned for NDA,
ANDA, and Not Defined application approvals. When assigned, FDB applies the earliest date associated to each
application number within the FDA data. Any applications approved prior to January 1, 1982 are assigned a
default approval date of December 31, 1981, indicating that the application was approved prior to 1982.

Populating and Updating FDB-Supplemented Data

This section defines the policies FDB uses to populate and update the FDB-supplemented FDA drug application
information.

FDB-supplemented FDA drug application data is published within the NDC to FDA NDA/ANDA Table
(RAPPLSL0_FDA_NDC_NDA_ANDA), NDC to FDA Drug Application Number Table
(RAPPLNA0_FDA_NDC_APPL), and for the following NDC Attribute Type Codes (NDC_ATTRIBUTE_TYPE_CD
) within the NDC Attribute Table (RNDCAT0_NDC_ATTRIBUTE):

7 (FDB Maintained NDA Approval Date)

9 (FDB Maintained NDA Application Number)
11 (FDB Maintained ANDA Approval Date)
13 (FDB Maintained ANDA Application Number)
15 (FDB Maintained Other Application Number)
17 (FDB Maintained Not Defined Application Number)
19 (BLA Approval Date)
20 (FDA Device Registration Approval Date)
22 (BLA Application Number)
23 (FDA Device Registration)

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32 (FDB Maintained Not Defined Approval Date)

FDA Drug Application Number (APPL_NO) values associated to NDCs within the NDC to FDA Drug
Application Number Table (RAPPLNA0_FDA_NDC_APPL) are identical to those found within the
RNDCAT0_NDC_ATTRIBUTE table where NDC_ATTRIBUTE_TYPE_CD = 9, 13, 15, and 17.

All attributes listed above are populated when updated information is available from the Food and Drug
Administration (FDA). However, this information can be edited or supplemented by FDB. As the FDA expressly
recognizes, the FDAs Comprehensive NDC Structured Product Labeling Data Elements (NSDE) File (
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm240580.htm) and old NDC
Directory can contain errors or omissions. While FDB does not independently corroborate each entry, we will,
when we receive a copy of an FDA-approved application from a manufacturer, use that information to supplement
or edit the information when necessary. If the obtained FDA files exclude application information previously
distributed, FDB continues to publish the information; however the data can no longer be used to access
additional descriptive information from the FDA.

FDB maintained application numbers for repackaged NDCs mirror what is available from FDA sources
only. Consequently, if an application number for a repackaged NDC is removed by the FDA, it will no
longer appear in the FDB maintained fields. Additionally, listing sequence numbers tied to repackaged
NDCs are updated accordingly.

FDA Device Registration Information

The FDA Device Registration attribute (NDC Attribute Type Code NDC_ATTRIBUTE_TYPE_CD = 23]) provides
Pre-market Notification (510k) and Pre-market Approval (PMA) numbers when applicable for a given NDC.
Approval numbers are 6-characters in length and are preceded with either a K (indicating 510k approval) or a P
(indicating PMA approval).

Publication of FDB-supplemented FDA Drug Application Information

FDA-maintained application data values are published with the FDB-supplemented information using the following
process:

1. After downloading the updated FDA application data into our internal data structures, FDB compares the
current FDB data file with the newly-acquired FDA information to identify FDB NDCs with application
number updates.

Within MedKnowledge, NDCs that are re-used may be linked to FDA data belonging to the former
product.

2. FDB uses the following rules to determine the FDA application number updates to apply:
If the FDA only provides the application number value of Other for an NDC that already contains a
valid application number, the Other value is not assigned to the FDB NDC.

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Any NDCs previously assigned a BLA or device registration application number and subsequently
receives FDA application data is sent for editorial review.
If the FDA data provides an NDA application number for an NDC not previously assigned an NDA
application number, the NDC is sent for editorial review.
All remaining FDA application number updates are applied.

Approval dates retrieved from the FDAs Electronic Orange Book (EOB) Query Data Files are assigned for NDA,
ANDA, and Not Defined application approvals. When assigned, FDB applies the earliest date associated to each
application number within the FDA data. Any applications approved prior to January 1, 1982 are assigned a
default approval date of December 31, 1981, indicating that the application was approved prior to 1982.

FDB-maintained approval date information (NDC_ATTRIBUTE_TYPE_CD = 7, 11, and 32) is published with the
supplemented and edited information using the following criteria:

For a given NDC, if the current FDB-maintained NDA or ANDA Approval Date value is not populated and a
value is provided within the FDA application data, the value received from the FDA is assigned.
Any other combinations are editorially reviewed.

NSDE File Policy

Beginning September 1, 2012, CMS is using the FDAs Comprehensive NDC Structured Product Labeling Data
Elements (NSDE) File to edit Prescription Drug Events (PDEs). They will use the NSDE file to determine a drugs
coverage under Medicare Part D and to make marketing category determinations for the Coverage Gap Discount
Program. For these purposes, CMS will use the following data elements from the NSDE file:

11-digit NDC (Item Code)

Marketing Category
Marketing Start Date
Marketing End Date

To assist our customers with their handling of Medicare Part D claims, FDB provides the following NDC Attribute
Type fields:

FDA Current NSDE Marketing Start DateProvides the Marketing Start Date for NDCs that are present on
the NSDE file.
FDA Current NSDE Marketing End DateProvides the Marketing End Date for NDCs that are present on
the NSDE file.
FDA Current NSDE Marketing CategoryProvides the Marketing Category for NDCs that are present on
the NSDE file.

The FDA has indicated that they will not be removing NDCs from the NSDE file when they reach their Marketing
End Date. However, on other data sources provided by the FDA, NDCs are removed when they hit their
Marketing End Date. As a precaution for our customers, should an NDC be removed from the NSDE file, FDB will

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continue to provide the Marketing Start Date, Marketing End Date, the Marketing Category within the following
NDC Attribute Type fields so that customers can continue to complete inquiries and process current or historic
claims for that NDC:

FDA Current and Archived Marketing Start DateProvides the Marketing Start Date for NDCs currently on
the NSDE file or reflects the last recorded Marketing Start Date should the NDC be removed from the
NSDE file.
FDA Current and Archived Marketing End DateProvides the Marketing End Date for NDCs currently on
the NSDE file or reflects the last recorded Marketing End Date should the NDC be removed from the
NSDE file.
FDA Current and Archived Marketing CategoryProvides the Marketing Category for NDCs currently on
the NSDE file or reflects the last recorded Marketing Category should the NDC be removed from the NSDE
file.

See Marketing Category and Associated Dates in the Concepts section for more information about these NDC
Attribute Type fields.

Reference Listed Drug (RLD) Policy

Within the Reference Listed Drug (NDC_ATTRIBUTE_TYPE_CD = 21) attribute in the NDC Attribute Table
(RNDCAT0_NDC_ATTRIBUTE), FDB identifies prescription products designated by the FDA as a product upon
which an applicant relies in seeking approval of its Abbreviated New Drug Application (ANDA)).

In June 2011, FDB announced a content freeze for the RLD due to changes made by the FDA to the
National Drug Code (NDC) Directory. This content remains frozen until further notice.

FDB provides the RLD information as maintained by the FDA and does not editorially adjust the data in any way.
FDBs reporting of the RLD data is dependent on the FDAs publication schedule of the FDA drug application data
and Orange Book Code data. Errors are reported to the FDA per the contact information defined in the
Interpreting and Publishing the FDA Drug Application Data section.

The process below defines how FDB relates the FDA data to FDB NDCs.

1. FDB checks for information daily when updated information is available from the FDA, FDB downloads the
information from the FDAs Electronic Orange Book (EOB) Query Data Files located at
http://www.fda.gov/Drugs/InformationOnDrugs/ucm129689.htm.

2. FDB NDCs meeting the following criteria are then compared to assembled FDA 11-digit NDC values from
the FDA to identify which MedKnowledge records meet the criteria.
have an FDA-assigned Therapeutic Equivalence Code
are of type RX
have an NDC Format Indicator (NDCFI) = 1, 2, 3
are active or less than 3 years obsolete

An FDB NDC may be linked to multiple NDA and ANDA application numbers. An NDC is identified as an RLD

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only when all NDA and ANDA application numbers linked to the NDC are identified by the FDA as a Reference
Listed Drug.

NDCs that are obsolete for over 3 years retain their RLD value if the NDC continues to be listed as an
RLD by the FDA.

Within MedKnowledge, NDCs that are re-used may be linked to FDA data related to the former product
until FDB receives updated information from the FDA.

Orange Book Code Policy

This section details the policies FDB uses to assign the Orange Book Code (OBC) information. See Orange Book
Code in the Concepts section for more conceptual information on these attributes.

FDB editorially assigns OBC values only to prescription products. Prescription products that change to OTC
status maintain their OBC value.

If the product package insert states that the manufacturer of the product is different from the labeler, FDB
applies the appropriate OBC as represented by the manufacturer on the FDA OBC Web site.

Repackagers/Redistributors

FDB permits linkage of repackaged products to the National Drug Code (NDC) Orange Book Code value
(OBC/OBC3), images, and imprints if:

The repackaged product has a Structured Product Labeling (SPL) that identifies the source NDC being
repackaged AND
FDB has the image/imprint of the source NDC (NDC Attribute Type Code 56) on file, and
FDB has the OBC/OBC3.

FDB links images, imprints, and OBC/OBC3 values to qualifying repackaged products newly added to the
database. Those qualifying repackaged NDCs currently in the database will be linked over time with expected
resulting increases in the size of image, imprint, and OBC files.

If a source NDC has multiple images (watermarked) linked to it, FDB cannot determine which image/imprint
should be used for the repackaged product, and so no image/imprint will be associated to the repackaged NDC.
If FDB becomes aware that the image for a source NDC has changed, FDB will remove the source NDC's
image/imprint and OBC/OBC3 values from the repackaged product.

OBC Codes

Products that are evaluated in the Orange Book are assigned A codes to indicate therapeutic equivalence or B
codes to indicate non-equivalence. FDB assigns the OBC to all products in the database that share the same
Clinical Formulation ID (GCN_SEQNO) and the first nine digits of the NDC with the product evaluated in the
Orange Book.

When a drug product is associated to multiple OBC3 values within the NDC Attribute Table

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(RNDCAT0_NDC_ATTRIBUTE), the NDC Attribute Sequence Number (NDC_ATTRIBUTE_SN) is used to link

the values together without indicating an order of importance. Please note that an NDCs OBC3 value linked to
NDC_ATTRIBUTE_SN = 1 in the RNDCAT0_NDC_ATTRIBUTE table is identical to that NDCs OBC3 value
within the RNDC14_NDC_MSTR table.

Not all products are evaluated or assigned an equivalency rating in the Orange Book; FDB includes ZA, ZB, and
ZC codes in the OBC columns for these products. These Z ratings are described below.

For a complete listing of valid values for the OBC column, refer to the Orange Book Code definition in the Data
Dictionary; see also Orange Book Code; 3-Byte Version, and Expanded Orange Book Code in the Data
Dictionary.
For information on using the Orange Book Codes, see Retrieving a List of Therapeutic Substitutions in the
Applications section.

Code ZA

FDB assigns a ZA code to pharmaceutical entities evaluated by the FDA for whom the particular labelers product
was not evaluated, and therefore, is not in the Orange Book. The Orange Book lists drugs by the approved
application-holder. This is usually, but not necessarily, the manufacturer. It is not possible to track the ultimate
labeler of the products because they are not required to immediately notify the FDA when they change source.
Therefore, generic distributors who do not hold approved applications will not receive A or B ratings, but will be
assigned a ZA by FDB.

Code ZB

FDB assigns a ZB code to all non-prescription pharmaceutical entities and those prescription pharmaceutical
entities that are not evaluated in the Orange Book.

Code ZC

FDB assigns a ZC code to products in the Orange Book that do not have a therapeutic equivalency rating. There
are prescription products in the Orange Book that are not assigned equivalency ratings. These are single source
items. Occasionally, a single source product will have an equivalency code if a company has several applications
for the same drug. If a product goes from multi-source to single source, expect the equivalency rating to change.
This could mean going from a B rating to a Z rating.

Considerations for the Z Codes

In general, no conclusions can be made regarding the equivalency of products with any of the Z ratings. Consider
the following:

The FDA does not evaluate drugs that were on the market prior to 1938. For example, guaifenesin is not
evaluated in the Orange Book.
Within a given Clinical Formulation ID (GCN_SEQNO) there may be both A and B ratings. This means that
just because one manufacturer has an equivalent rating, not all manufacturers of the same product will
have an equivalent rating.
The Orange Book has special situations which alter the meaning of some of the data. In order to use the
Orange Book accurately, a knowledge of these special situations is imperative. For example, there are

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actually two sustained-release theophylline products that are listed in the Orange Book as equivalent.
Sustained-release products often have bioequivalence problems. Bioavailability studies followed
administration of the particular theophylline products every 12 hours. One of these products is marketed for
once daily dosing. This could be misleading unless there is an understanding that several of the
equivalency evaluations depend on specific manufacturers labelling instructions.

The Orange Book is not the ultimate answer to generic substitution of therapeutically equivalent products.
Users are strongly encouraged to carefully read the Orange Book introduction and take into consideration
all the limitations. Refer to the FDA website, http://www.FDA.gov, for more information.

FDA Registered NDC Policy

This section details the policies FDB uses to provide the Food and Drug Administration (FDA) registered NDC
information.

The following NDC attributes within the NDC Attribute Table (RNDCAT0_NDC_ATTRIBUTE) indicate if a given
NDC is registered with the FDA (see "FDA Registered NDC" in the Concepts section for more information on
these attributes):

FDA Registered NDC (NDC_ATTRIBUTE_TYPE_CD = 29)

FDB Maintained FDA Registered NDC (NDC_ATTRIBUTE_TYPE_CD = 30)

Both attributes listed above are populated when updated information is available from the FDA. However,
differences in the data occur when FDB-maintained information (NDC_ATTRIBUTE_TYPE_CD = 30) is edited or
supplemented by FDB upon receipt of information from the manufacturer. The FDA Registered NDC
(NDC_ATTRIBUTE_TYPE_CD = 29) information is dependent on the FDAs publication schedule.

Within MedKnowledge, NDCs that are re-used may be linked to FDA data related to the former product
until FDB receives updated information from CMS.

FDB uses the following method to populate the FDA Registered NDC attribute values:

1. FDB accesses the FDAs Comprehensive NDC Structured Product Labeling Data Elements (NSDE) File,
located at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm240580.htm, and
the FDAs old NDC Directory, located at http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm,
daily to determine if updates have been published. When updated information is available, FDB downloads
the data from the FDA and loads it into FDBs internal structures.

2. MedKnowledge NDCs are then compared to assembled FDA 11-digit NDC values.

3. FDA information for matching NDCs are published according to the following:

a. The FDA Registered NDC (NDC_ATTRIBUTE_TYPE_CD = 29) values for all matching NDCs are
updated according the information received from FDA.

b. The current FDB Maintained FDA Registered NDC (NDC_ATTRIBUTE_TYPE_CD = 30) values are

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b.

compared to the data received by the FDA and are assigned according to the following criteria:
For a given NDC, if the current MedKnowledge FDB Maintained FDA Registered NDC value
= False (indicating that the NDC is not registered with the FDA) and the newly downloaded
FDA data = True (indicating that the NDC is registered with the FDA), the MedKnowledge
FDB Maintained FDA Registered NDC value is changed to True.
Any other combinations are editorially reviewed.

Labeler Information

FDB provides data in the NDC Table (RNDC14_NDC_MSTR) that identifies product manufacturers, distributors,
and repackagers, hereafter collectively referred to as labelers. The FDA drug division assigns a five-digit labeler
code to a drug labeler (non-drug product labelers are not assigned a labeler code by the FDA drug division). This
five-digit code comprises the first five digits of the NDC. FDB uses the five-character labeler code as the basis for
the six-character alphanumeric Labeler Identifier (LBLRIDh represents the following types of companies:

Manufacturera company that manufactures the drug product. A manufacturer may manufacture and
distribute the product with their company name on the label. These products usually carry NDCs that
contain the manufacturing companys labeler code as the first five digits of the NDC. Alternately, a
manufacturer may only manufacture the product and send it to a distributor for distribution.
Distributora company that does not manufacture the product, but receives it from the manufacturer,
labels it with their own name, markets, and sells the product. These products usually carry NDCs that
contain the distributor company labeler code as the first five digits of the NDC.
Repackagera company that buys bulk products from a manufacturer or distributor, changes the package
quantity, and re-labels the product with their own name. These products usually carry NDCs that contain
the repackaging company labeler code as the first five digits of the NDC.

Although the first five digits of the NDC usually represent the product labeler, this is not always true. A product
that has been sold to another company may continue to carry an NDC with the original labelers five-digit code.
For example, Darvon-N was acquired by AAI Pharma (five-digit labeler code 66591) from Eli Lilly and Co.
(five-digit labeler code 00002). The NDC for Darvon-N 100 mg bottle of 100 tablets remained 0002-0353-02 (with
Lillys five-digit labeler code) for a period of time after the acquisition, but FDBs Labeler Identifier ( LBLRID) was
changed to A66591 for AAI Pharma. Therefore, the five-digit labeler code (first five digits of the NDC) must not be
used to determine the product labeler. Instead, the six-character alphanumeric LBLRID must be used, as
described in Finding the Product Labeler.

Labeler Identifier (LBLRID)

The Labeler Identifier (LBLRID) column in the NDC Table is a six-character alphanumeric code that is assigned to
a product by FDB and represents the product labeler (a manufacturer, distributor, or repackager). The first
character of LBLRID is alphabetic and represents a division within a company. The last five characters are
numeric and represent the parent company. Products that are distributed from different divisions of the same
company usually will have unique alphabetic characters preceding the shared numeric code.

The LBLRID should not be confused with the five-digit labeler code that is assigned to a company by the

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FDA and that comprises the first five digits of an NDC. The LBLRID is independent of the NDC.

Manufacturer Name (MFG)

The Manufacturer Name (MFG) column provides a text description (name) for an LBLRID. This column includes
names of manufacturers, distributors, and repackagers.

ExampleLBLRID and MFG for sample NDCs

NDC LBLRID MFG

50111035903 A50111 SIDMAK LABS

00069026035 A00069 PFIZER LABS

00113031026 A00113 PERRIGO CO.

00074129901 C00074 ROSS CONSUMER

00074010150 D00074 ROSS PHARM

58948012865 A00113 PERRIGO CO.

Repackaged Indicator (REPACK)

The Repackaged Indicator (REPACK) column identifies a product as repackaged or not repackaged, and in turn,
identifies the labeler as a repackager. FDB assigns REPACK to all products distributed by companies that
repackage products, usually into dispensable quantities.

Products with a REPACK of 1 may be listed in the NDC Table with brand or generic names, based on the
information provided by the repackaging company.

The following example shows two products, the first is distributed by a repackager, while the second product is
not:

ExampleREPACK product

NDC LN LBLRID MFG REPACK

50962005003 ACETAMINOPHEN A50962 XACTDOSE,INC. 1

160 MG/5 ML SOL

00781637716 ACETAMINOPHEN A00781 GENEVA PHARM. 0

160 MG/5 ML SOL

FDB recommends using either NDC Attribute Type Code 47 for Repackaged Original NDC (11 digit NDC
from manufacturer or the SPL) or type code 56 for FDA Repackaged Original Core9 (9 digit NDC from the
SPL) instead of using the Repackaged Indicator (REPACK) to identify repackaged NDCs.

Original NDCs for Repackaged Products

FDB also provides the original NDCs of repackaged products, if available from the manufacturer or the SPL.

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See "Repackaged NDCs" in the Concepts section for more information.

Private Labeler Indicator (PLBLR)

The Private Labeler Indicator (PLBLR) column identifies products labeled for exclusive distribution by specific
businesses; these are usually store-brand non-prescription products sold at retail pharmacies.

ExamplePLBLR products

NDC LN LBLRID MFG PLBLR

50428261925 CVS CHLD A50428 CVS 1

IBUPROFEN 100
MG/5 ML

12333099431 LONGS SUPER A12333 LONGS DRUG 1

TUSSIN CF SYR STORE

00363054808 ALLERGY A11917 WALGREEN CO 1

MULTI-SYMPTOM
CAPLET

Innovator Indicator (INNOV)

The Innovator Indicator (INGREDIENT_SORT_ORDER) is a one-character alphanumeric column that identifies

products that have an NDA, a Biologic License Application (BLA), or are the earliest product registered within a
Clinical Formulation ID (GCN_SEQNO).

When a Clinical Formulation ID (GCN_SEQNO) includes NDCs that have an NDA or Biologic License Application
(BLA), all such NDCs will be designated as INNOV, even if there are more than one within a Clinical Formulation
ID (GCN_SEQNO). However, when there are no NDCs with an NDA in a Clinical Formulation ID (GCN_SEQNO),
the INNOV will be assigned to the first product to be registered in that Clinical Formulation ID (GCN_SEQNO).

Prior to the 1984 Hatch-Waxman amendments to the Food, Drug and Cosmetic Act, there was no
Abbreviated New Drug Act option available for the approval of generic products, and all approvals were
NDAs. The follow-on NDAs were informally designated as paper NDAs since their approval was based,
not on independent testing, but on already published studies and literature. Under these circumstances,
pre-1984 approved paper NDA drugs cannot be considered as innovators and accordingly they will not
be assigned an Innovator indicator.

Repackaged products, medical supplies, private labeler products, bulk products and non-drug items are
excluded from this determination. They are assigned an INNOV value of 0.

ExampleInnovator and non-innovator product

NDC LN LBLRID MFG APPL_NO APPL_TYPE_ INNOV

CD_DESC

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00085051704 DIPROLENE A00085 SCHERING 019555 New Drug 1

AF 0.05% CORP. Application
CREAM (NDA)

55045303901 DIPROLENE A55045 DRX 019555 New Drug 0

AF 0.05% Application
CREAM (NDA)

Explanation of Example

NDC 00085051704 (Diprolene AF 0.05% Cream) is manufactured by Schering Corporation as an innovator

product

Packaging Information

This section provides information on columns in the NDC Table that provide packaging indicators, package
descriptions, brand and label names, and other packaging data.

Brand Name (BN)

The Brand Name (BN) column generally provides the name that appears on the package label provided by the
manufacturer. This column is populated for all products, brand and generic, as follows:

The BN for brand products may be edited to fit space requirements. For example, ROBITUSSIN COUGH &
CHEST CONGESTION would be revised to ROBITUSSIN-COUGH-CHEST-CONG.
The BN for generic products may be edited to fit space requirements and/or for editorial consistency. For
example, BUTALBITAL-CAFFEINE-ACETAMINOPHEN-CODEINE would be revised to
BUTALBITAL-CAFF-APAP-CODEINE.
If the manufacturers name is the first and not the only term on the package label name, it will be deleted
from the BN, so that similar products can be alpha organized. For example, BAYER ASPIRIN would be
revised to ASPIRIN.

ExampleBN values for selected products

NDC BN

54738010801 AMOXICILLIN

49483000810 FERROUS SULFATE

00247120320 KEFLEX

FDB offers the Medication Name (MED_NAME), a longer and mixed case alternative to the BN. Refer to
Medication Name Concepts (MED) 3.0 for more information.

Label Name (LN)

The Label Name (LN) column is a 30-character alphanumeric column that contains a combination of the product
name (from the package label), the dosage form description, and the strength description.

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LN is a narrative, free-form column subject to interpretation. Absolute consistency is not possible, but the field is
generally consistent within a product series. If the concatenated LN value exceeds 30 bytes, the label name must
be shortened. In most cases this affects the dosage form. Truncation should not affect product recognition,
especially when the LN is used in conjunction with the NDC for product differentiation.

Editing LN Due to Space Limitations

If the label name must be shortened, FDB uses the following guidelines to prioritize the process:

1. Dosage form description is shortened.

2. Dosage form description is not included unless necessary to differentiate products.

3. Product name is shortened using economy of characters.

4. Strength description is omitted only when it is not essential to differentiate products.

Editorial license is used to best describe a label name within the given space constraints to minimize confusion
with other label names.

If the product name must be abbreviated, the following guidelines are used:

Abbreviations at the beginning of the LN column are avoided because in an alphabetical listing these
products will be misfiled; for example, DP-Hydramine is not used for diphenhydramine.
Abbreviated names are spelled phonetically, such as:
NORMAL = NRML
DISC = DSC (not DIS)

The information in the LN column might include abbreviations considered inappropriate by The Joint
Commission (TJC) and Institute for Safe Medication Practices (ISMP). To comply with TJC and ISMP
requirements, use the Label Name-60 (LN60) column instead of the LN column for medication orders and
patient records.

Salt-ester information is included in the LN when it is important; for example, it is included with hydroxyzine,
erythromycin, and pseudoephedrine, because these ingredients have more than one salt/ester formulation. In
most instances, however, salts are not included if they are not significant.

ExampleLN values for selected products

NDC LN

54738010801 AMOXICILLIN 250 MG CAPSULE

49483000810 FERROUS SULFATE 325 MG TAB

00247120320 KEFLEX 250 MG PULVULE

Package Description (PD)

The Package Description (PD) column provides the text description of the container that is in direct contact with

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the product. FDB obtains the package description from the product package insert, and the following rules are
used for consistency:

Abbreviations are used to keep package description terms within 10 characters (for example, SQUEEZ
BTL is used for squeeze bottle).
Terms may be combined to describe certain packages, such as AMPUL/KIT.

EamplePD values for selected products

NDC LN PD

00069314019 ZITHROMAX 200 MG/5 ML SUSP BOTTLE

00069315014 ZITHROMAX I.V. 500 MG VIAL VIAL

00069305107 ZITHROMAX 1 GM POWDER PACKET

PACKET

00056017470 COUMADIN 10 MG TABLET BOTTLE

00056016975 COUMADIN 1 MG TABLET BLIST PACK

For a complete listing of the package descriptions used by FDB, see PD in the Data Dictionary.

Drug Form Code (DF) and Package Size (PS)

FDB assigns the Drug Form Code (DF) and the Package Size (PS) in accordance with billing unit standards from
the National Council for Prescription Drug Programs (NCPDP).

According to the NCPDP Billing Unit Standard, the billing unit is defined as grams, milliliters, or eaches. This
standard ensures that all payers and providers use the same billing unit for all financial transactions. For more
information about the billing unit standard, refer to the NCPDP website ( http://www.NCPDP.org), where a billing
unit standard overview is available.

Drug Form Code (DF)

The DF column represents the type of billing unit to be used for a product.

Package Size (PS)

The PS is the number of billing units (DF) in the labeled quantity from which the pharmacist dispenses; for
example, 100 tablets, 1000 capsules, or 20 mL vial.

FDB reports metric decimal packages sizes; the MedKnowledge database allows three places after the decimal,
for example 1.5 mLs would be output as 00000001.500.

ExampleDF and PS assignment criteria for selected products

NDC LN DF PS

00074714819 SYNTHROID 200 MCG 1 (each) 1000 (number of billing units

TABLET in the trade container)

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00074536505 SODIUM CHLORIDE 0.9% 2 (milliliters) 5 (number of billing units

FLUSH expressed in milliliters)

59366274501 BENZOYL PEROXIDE 5% 3 (grams) 60 (number of billing units

GEL expressed in grams)

FDB defines trade container as the smallest self-contained package (unbreakable) as provided by the labeler. For
example, the product may only be sold in cases of 12 bottles of 100 tablets each, but the smallest unbreakable
container is a bottle of 100 tablets.

Metric Package Sizes

FDB always uses the actual metric package size as supplied by the manufacturer or distributor. If the actual
metric package size is unavailable, the following conversions are used, per National Council for Prescription Drug
Programs (NCPDP) standards:

1 Fluid Ounce = 30ML

1 Pint = 480ML
1 Ounce = 30GM
1 Pound = 454GM

Package Size Equivalent Value (PS_EQUIV)

The Package Size Equivalent Value (PS_EQUIV) column provides the non-metric or most commonly used
package size for non-injectable products whose actual package size measurements are metric or non-standard.
PS_EQUIV makes it easier to group together records with essentially equal package sizes.

PS_EQUIV is generated programmatically for products with a DF of 2 or 3.

ExamplePS_EQUIV package size

PS Range PS_EQUIV Description

00000476.000 00000470.000 to 00000480.000 480 mL = 16 fl. oz. = 1 pint

00000480.000

Example Interpretation

A Package Size (PS) of 476 mL would be converted to a PS_EQUIV of 480 mL (one pint), which is the more
commonly used size.

If the PS value does not fall within a normalized range, the PS_EQUIV column will contain the PS value (PS is
the default). For a complete list of the normalized ranges and corresponding valid values for this column, refer to
PS_EQUIV in the Data Dictionary.

Shelf Pack (SHLF_PCK)

The Shelf Pack (SHLF_PCK) column provides the number of bundled salable units in the shipping container.
Note that this information is entered only if provided by the manufacturer.

Case Pack (CSP)

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The Case Pack (CSP) column provides the number of salable units in the shipping container. FDB uses this
number as a divisor to calculate the single package price when case pricing for the NDC is reported to FDB;
customers can use it as a multiplier to determine the case price from the single package price. When case pricing
for the NDC is not reported, the default for the column is 1.

Shipper Quantity (SHIPPER)

The Shipper Quantity (SHIPPER) column provides the number of salable units in the minimum order quantity
available from the distributor; it is usually a multiple of the Shelf Pack ( SHLF_PCK) or Case Pack (CSP). Note
that this information is entered only if provided by the manufacturer.

The following example shows the Package Size (PS), SHLF_PCK, CSP, and Shipper Quantity (SHIPPER) for
selected products.

ExamplePS, SHLF_PCK, CSP, and SHIPPER for selected products

NDC LN PD PS/DF SHLF_PCK CSP SHIPPER

08881602141 MONOLET Packet 200/1 (each) 5 1 25

LANCETS

00074405712 MORPHINE Ampul 10/2 (MLs) 1 1 5

0.5 MG/ML
AMPUL P/F

08881511235 MONOJECT Syringe 500/1 (each) 1 1 1

TB SAFETY
SYRN 1 ML

00091361011 MONOKET 10 Bottle 100/1 (each) 1 2 12

MG TABLET

00126029002 PREVIDENT Jar 56/3 (grams) 12 12 144

1.1% GEL

Explanation of Example

The first product (Monolet Lancets) has a PS of 200 lancets, is distributed as five packets of 200 lancets per case
(SHLF_PCK), with a minimum order quantity of 25 packets (SHIPPER).

Unit Dose Indicator (UD)

The Unit Dose Indicator (UD) column identifies products that are packaged in individual unit doses. Products may
be labeled as unit dose by the manufacturer. Each individual unit dose label may contain the NDC number or
barcode but must contain the product name, dosage form, strength, and manufacturer. This indicator does not
apply to injectable products, suppositories, patches or powder packets.

Effective March 2017, ODT (orally disintegrating tablet) products may be marked as Unit Dose if they
meet the criteria above.

ExampleDose Unit Products

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NDC LN PD PS DF UD

00615450943 GLYBURIDE 2.5 BLIST PACK 00001000.000 1 (each) 1

MG TABLET

53404045113 BICODYL 5 MG BOTTLE 00000100.000 1 (each) 1

TABLET EC

00157018352 METHYLPREDNI PACKAGE 00000021.000 1 (each) 1

SOLONE 4 MG
TAB

Explanation of Example

The first product (Glyburide 2.5 mg Tablet) is a blister pack (Package Description ( PD) with a Package Size (PS)
of 1000 tablets.

Unit of Use Indicator (UU)

The Unit of Use Indicator (UU) column identifies oral products with solid dosage forms that are packaged per
course of therapy.

FDB applied the UU flag to products such as birth control pills, starter packs, dose packs and
combination packs. The UU flag will not be marked for products where the Case Pack ( CSP) is greater
than 1. FDB has revised its definition of the Unit of Use Indicator to assist customers with the short cycle
dispensing requirements.

ExampleUnit of Use Products

NDC LN PD PS UU

00781-5022-07 METHYLPREDNISOL DISPENSING PACK 00000021.000 1

ONE 4 MG DOSEPK

54569-4497-00 ZITHROMAX 250 MG BOTTLE 00000006.000 1

Z-PAK

16714-0340-01 LEVONEST-28 Blister Pack 00000028.000 1

TABLET

Explanation of Example

The first product (Deltasone 5 mg Tablet) is a packet (Package Description [ PD]) of 21 tablets (Package Size [PS
]).

Standard Package Indicator (STPK)

The Standard Package Indicator (STPK) column indicates whether the product package size is the standard
package size. FDB uses the following criteria to assign STPK:

Standard package size for non-unit dose, non-prepack tablets and capsules is 100.
Standard package size for liquids is 473 mL or 480 mL (one pint).

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There is no standard package size for grams.

ExampleSTPK for Selected NDCs

NDC LN PS DF STPK

54569095850 FOLIC ACID 1 MG 00000100.000 1 (each) 1

TABLET

52747040490 HEMOCYTE-F ELIXIR 00000480.000 2 (ML) 1

19458961701 ECK ISOPROPYL 00000946.000 2 (ML) 0

RUBBING ALCOHOL

Explanation of Example

The first and second products have standard package sizes (100 tablets and 480 mLs, respectively), while the
third product has a non-standard package size of 946 mLs

Generic Classification Indicators

The NDC Table provides the following classification indicators to assist in the determination of generic status:

Multi-Source/Single Source Indicator (NDCGI1)

Generic Manufacturer Indicator (GMI)
Generic Name Indicator (GNI)
Therapeutic Equivalence Indicator (GTI)

FDB does not recommend one indicator over another, but provides several indicators to meet a variety of
needs. This section explains the criteria FDB uses to assign these indicators to products.

Multi-Source/Single Source Indicator (NDCGI1)

The Multi-Source/Single Source Indicator (NDCGI1) column is an NDC-level single-source or multi-source

indicator. The NDCGI1 specifies whether a products clinical formulation (i.e., its particular active ingredient,
dosage form, route of administration and strength) is only available from a single labeler or from multiple labelers.

Products that have the same clinical formulation are not necessarily therapeutically equivalent. In many states
equivalent Orange Book ratings are required before a pharmacist can dispense an OBC rated equivalent
formulation. Refer to the Therapeutic Equivalence Indicator (GTI) to determine whether a drug designated as
multi-source is A-rated by the FDA (meaning the drug has therapeutically equivalent alternatives), or B-rated by
the FDA (meaning the drug does not have therapeutically equivalent alternatives).

Name brand and generically named products whose clinical formulation is only available from a single labeler
have an NDCGI1 value of 2. Products whose clinical formulation is available from more than one labeler have an
NDCGI1 value of 1.

Once the clinical formulation for a product with only one source (NDCGI1 = 2) becomes available from an
additional labeler, the products NDCGI1 value changes to 1. This change in NDCGI1 takes place upon the
effective date of the price. For example:

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There is no other drug with the same clinical formulation as fictional drug product Alpha, and therefore Alpha has
an NDCGI1 value of 2. Another manufacturer introduces the drug product Beta, which has the same clinical
formulation as Alpha (i.e., the two drugs are pharmaceutically equivalent). Upon the effective date of Betas price,
product Alpha is assigned an NDCGI1 value of 1, and product Beta is also assigned an NDCGI1 value of 1.

Repackaged (REPACK = 1) and private labeler products (PLBL = 1) are defaulted to an NDCGI1 value of
1.

All medical supplies are assigned an NDCGI1 value of 1, indicating multi-source.

FDB does not recommend the Multi-Source/Single Source Indicator NDCGI1 over any other Generic
Classification Indicator for purposes of determining generic status, but provides several indicators to
meet a variety of needs.

Generic Manufacturer Indicator (GMI)

The Generic Manufacturer Indicator (GMI) column specifies whether a product is distributed by a brand
manufacturer, a generic manufacturer, a niche manufacturer, or labelers that are not otherwise classified,
including labelers that distribute BOTH brand and generically named products.

Manufacturers specify the value for this field. If the manufacturer does not provide the necessary information, the
product is assigned a GMI status of Indeterminate (Labelers that are not otherwise classified, including labelers
that distribute BOTH brand and generically named products). The GMI value of 0 (Non-drug item) is assigned to
manufacturers generally classified as medical supply or bulk chemical manufacturers. If the drug product is a
non-drug item, a value of 0 is also assigned regardless of the manufacturers general classification. The GMI
value of 3 (alternative - niche) is no longer applied (to new products).

FDB does not recommend the Generic Manufacturer Indicator GMI over any other Generic Classification
Indicator for purposes of determining generic status, but provides several indicators to meet a variety of
needs.

Generic Name Indicator (GNI)

The Generic Name Indicator (GNI) column specifies whether a product is a brand-named product or a generically
named product, using the product name as the criteria. A GNI value of 0 is assigned to all non-drug items, such
as medical supplies and bulk chemicals.

When discussing drug products with respect to their manufacturers, generically named drug products are
products without a proprietary name. Typically in the United States, these products are named consistent
with the United States Adopted Names (USAN).
FDB does not recommend the GNI over any other Generic Classification Indicator for purposes of
determining generic status, but provides several indicators to meet a variety of needs.

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Therapeutic Equivalence Indicator (GTI)

The Therapeutic Equivalence Indicator (GTI) column indicates a drug products Orange Book Code rating (or lack
of an Orange Book rating), which provides therapeutic equivalence information. The GTI is generated based upon
an algorithm utilizing the Orange Book Code and the HCFA FDA Therapeutic Equivalency Code ( HCFA_FDA). A
GTI value of 0 is assigned to all non-drug items, such as medical supplies and bulk chemicals.

The GTI provides therapeutic equivalence information.

The Orange Book is the leading authority for basing substitution decisions at the pharmacy level. The
FDA has stated that the Orange Book is advisory only; many states use its data to regulate product
selection.
A-rated Orange Book Codes are defined by the FDA as drug products that FDA considers to be
therapeutically equivalent to other pharmaceutically equivalent products.
B-rated Orange Book Codes are defined by the FDA as drug products that FDA at this time, considers
not to be therapeutically equivalent to other pharmaceutically equivalent products.
For specific information on the FDA and the Orange Book Code definitions, see section 1.7 Therapeutic
Equivalence Evaluation Codes, found at
http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm071436.pdf.

FDB does not recommend the GTI over any other Generic Classification Indicator for purposes of
determining generic status, but provides several indicators to meet a variety of needs.

Inactive Ingredient Information

Changes to product inactive ingredients are not regulated by the FDA, so FDB relies on notification by the
manufacturer and a process of NDC review to keep its inactive ingredient information current. For this reason
inactive ingredient information is subject to change at any time without notice.

Manufacturers should notify FDB as soon as possible whenever a products inactive ingredients change.

Additionally, NDC-level inactive ingredient information is provided for purposes other than the inclusion of NDCs
on patient profiles. FDB strongly discourages the inclusion of NDCs on patient profiles for purposes of allergy
information and/or screening. Instead a Med Name (MED_NAME_ID), an individual Ingredient Identifier (
HIC_SEQN) or a DAM Specific Allergen Group Code (DAM_ALRGN_GRP) should be used for this purpose.

The following tables are provided in the Packaged Product module:

NDC Inactive Ingredients Reviewed Master Table

NDC/HIC_SEQN Inactive Ingredient Relation Table

NDC Inactive Ingredients Reviewed Master Table

The NDC Inactive Ingredients Reviewed Master Table (RNDCINR0_INACTV_REVIEWED) table is a list of all

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NDCs reviewed by FDB for inactive ingredients. FDB continually researches NDCs for inactive ingredient
information, and as each product is examined, it is placed in this list. This list is dynamic, and FDB reserves the
right to add or remove NDCs from this table at any time. Customers should not depend on NDCs staying in this
table on a permanent basis.

Inactive ingredient content can change in a manner that will not be immediately reflected in our database.
Consequently, if a patient's allergen profile contains a potentially harmful inactive ingredient or allergen
group, the inactive ingredient file should not be used as the exclusive source of this information, and
prospective drugs should be manually screened for potentially harmful inactive ingredients. The same
precaution should be observed for drug-drug interactions in which inactive ingredients participate. The
package insert and product labeling remain the authoritative sources for inactive ingredient information.

No inactive ingredient information should be assumed about NDCs not present in this table. Active and inactive
NDCs may both appear in the table; an NDCs current market status does not affect its eligibility to appear in this
table. NDCs that have been replaced are not intended to remain in the table and shall be removed promptly.

NDCs that already appear in this table are rechecked for inactive ingredients periodically.

NDC/HIC_SEQN Inactive Ingredient Relation Table

The NDC/HIC_SEQN Inactive Ingredient Relation Table (RNDCINH0_NDC_INACTV_LINK) table links NDCs to
their related inactive ingredients. An NDC must be present in the RNDCINR0_INACTV_REVIEWED table to
appear in this table. If an NDC has more than one inactive ingredient it will have multiple rows in this table. The
data in this table is continually changing, and it should not be used to generate a list of all inactive ingredients.

In rare cases where an ingredient participates in the HICL_SEQNO, it could be listed in the Clinical
Formulations Ingredient List (HICL_SEQNO) and in the RNDCINH0_INACTV_LINK table. When this
occurs, the ingredient will only appear in the HICL_SEQNO and not in the RNDCINH0_INACTV_LINK
table to minimize redundancy.

Obsolete and Replaced NDCs

NDCs become obsolete when a manufacturer or labeler has informed FDB, in writing, that an NDC is
discontinued, no longer marketed, no longer produced, no longer distributed, or otherwise made unavailable to
the marketplace. The Obsolete Date (OBSDTEC) column contains the date on which the product met one of
those criteria. Obsolete NDCs remain in FDBs internal database, and customers generally receive 3 years of
obsolete NDCs but may select to receive all obsolete NDCs if they wish. See "Record Counts" in the About FDB
MedKnowledge section for more information.

The obsolete date is unrelated to the expiration date present on a products label.

FDB recognizes that courts and other governmental institutions may issue orders or directives with
respect to the manufacturer, distribution, and/or sale of pharmaceutical products. Under appropriate

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circumstances, FDB accepts such an order or directive in lieu of notification from a pharmaceutical
manufacturer or labeler.

Occasionally NDCs are changed or replaced by the labeler. In this case, the original record remains in the
database, and the Replacement NDC (REPNDC) column is populated with the new NDC. The new NDC has its
own record, and its Previous NDC column (PNDC) contains the old NDC. An NDC must be obsolete in order for a
REPNDC to be assigned. The brand name, formulation, and package size may differ between the old and new
NDC.

The following example shows an Obsolete Date, and Replacement and Previous NDCs for Brevital Sodium 5 gm
Vial:

NDC LN REPNDC PNDC OBSDTEC

00002144501 BREVITAL SODIUM 5 52604144501 19960401

GM VIAL

52604144501 BREVITAL SODIUM 5 00002144501

GM VIAL

FDB occasionally deletes NDCs from the MedKnowledge database, in cases where a labeler re-uses an
NDC, or if an NDC can no longer be validated.

Re-use of NDCs

The re-use of NDCs is allowed by the FDA, five years after the expiration date of the last lot for the former
product. The re-use of NDCs is problematic but beyond the control of FDB. The following is FDBs policy for the
deletion and re-use of NDCs and other product identifiers such as UPCs, NHRIs, and PINs:

1. Announce the re-use of product identifiers of commercially available products in the Editorial Highlights the
Monday prior to the deletion. Products include prescription, OTC, Private Label, bulk chemical, and
repackaged products.

2. Delete the product identifier on Thursday after the announcement and add with the new information on
Friday after the weekly Thursday database.

3. The date on which an NDC was first published as re-used by First Databank can be determined using the
Re-Used NDC Date of Add attribute (NDC_ATTRIBUTE_TYPE_CD = 48).

The timeline for FDBs policy of deletion and re-use of an NDC is shown.

Event Time line

Announce Deletion Monday

Delete NDC Thursday

Add NDC Back Friday

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File with New NDC Distributed Daily Update FrequencyFriday

Weekly Update FrequencyFollowing Thursday

Products must be obsolete for one weekly database update before the delete and reuse NDC process
can occur.

Please be aware that FDB does not editorially adjust the FDA-maintained data. The following attributes within the
NDC Attribute Table (RNDCAT0_NDC_ATTRIBUTE), may contain data linked to the former product until FDB
receives updated information from the FDA:

FDA Drug Application Types, Numbers, and Approval Dates (NDC_ATTRIBUTE_TYPE_CD = 6, 8, 10, 12,
14, 16, and 31).
FDA Registered NDC (NDC_ATTRIBUTE_TYPE_CD = 29).
Reference Listed Drug (RLD) (NDC_ATTRIBUTE_TYPE_CD = 21).

Sources
This section lists sources used by FDB to compile the information contained in the module.

FDB utilizes many reference sources including, but not limited to, the primary medical literature (for example,
published journal articles), medical reference texts, published expert treatment guidelines, and manufacturer
product package inserts. FDB uses current source editions or versions when coding and updating data, as well as
when researching questions about data. However, a formal data review does not occur for every new release of
source editions or versions. Additional sources include:

Centers for Medicare and Medicaid Services. Available at: http://www.cms.gov.

Electronic Orange Book. Available at: http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm.
U.S. Food and Drug Administration. FDA MedWatch. [Newsletter].
U.S. Food and Drug Administration. MedWatch: The FDA Safety Information and Adverse Event Reporting
Program. Available at: http://www.fda.gov/Safety/MedWatch/default.htm
U.S. Food and Drug Administration. Comprehensive NDC SPL Data Elements File (NSDE) Available at:
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm240580.htm
U.S. Food and Drug Administration. The Old National Drug Code Directory. Available at:
http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm

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Packaged Product Applications

Packaged product has a variety of uses in information systems and applications. The following applications are
provided as a guide to basic data navigation and filtering:

Converting an 11-Digit NDC to a 10-Digit NDC

Finding a Replacement or Previous NDC
Finding the Product Labeler
Retrieving a List of Therapeutic Substitutions
Determining Higher/Lower-cost Alternative Status
Filtering Data with Product Attributes
Determining Whether a Drug has a Biosimilar or Interchangeable Relationship with Another Drug
Retrieving a Product's Active Ingredients
Retrieving a Product's Inactive Ingredients
Determining the FDB Product ID and Associated Product Information Given an External Product Code
(Such as an NDC)
Identifying Re-used External Product Codes (Such as an NDC)

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Converting an 11-Digit NDC to a 10-Digit NDC

This application illustrates the general steps involved in converting an NCPDP (National Council for Prescription
Drug Programs) 11-digit formatted National Drug Code (NDC) to 10-digits for the purpose of scanning a products
bar code to retrieve FDB data.

This application assumes that you have a basic understanding of bar code technology, including how to read a
bar code. For information on EAN.UCC or HIBCC bar code standards, see http://www.uc-council.org or
http://www.hibcc.org.

When reading bar codes, keep the following issues in mind:

The 10-digit code embedded in the bar code may not be the products NDC. This is especially true for
over-the-counter products.
The number encoded in the bar code may not be a UPC number and may not follow the UCC (GS1)
standard.
The NDC on the immediate packaging being dispensed to or administered to the patient may be different
than the NDC on the shelf pack. When this occurs, the NDC on the immediate packaging may not be
available from FDB.

Also, please read the Universal Product Code (UPC) and Customer Challenges Concepts sections to ensure you
are familiar with all related background information regarding bar codes and their requirements.

1. Select the NDC Format Indicator (NDCFI) value from the NDC Table (RNDC14_NDC_MSTR) where the
NDC column equals the NDC of the NCPDP 11-digit formatted NDC to convert.

2. Remove the 0 from the appropriate position noted by the NDCFI value, as shown in the table below:

If the NDCFI is.. remove 0 from this position.

1 or 7 1st

2 or 4 6th

3 or 5 10th

6 11th

3. If necessary, repeat the process for each NCPDP 11-digit formatted NDC in FDBs NDC table, and create
a cross-reference file containing NCPDP 11-digit formatted NDCs and the associated 10-digit NDCs. You
must create the cross-reference file every time you receive an update to the NDC Table.

On rare occasions, after you remove the 0, you may end up with some duplicate 10-digit NDCs in
your conversion file.

You must decide whether you will show both NDCs to the user or whether you will remove the
duplicates so that the user receives a no matches found message.

ExampleConverting an 11-Digit NDC to 10-Digits

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A pharmacy wants to scan bar codes to retrieve FDB data. The process begins with the drug product Ibuprofen
200 mg tablet (NDC 11917005673).

1. Select the NDC Format Indicator (NDCFI) value from the NDC Table (RNDC14_NDC_MSTR) where the
NDC column equals the NDC of the NCPDP 11-digit formatted NDC to convert.

NDC NDCFI

11917005673 4

In this example, the NDCFI value is 4, indicating that the NDC value is a UPC identifier.

2. Remove the 0 from the appropriate position noted by the NDCFI value, as shown in the table below:

if the NDCFI is... remove 0 from this position.

1 or 7 1st

2 or 4 6th

3 or 5 10th

6 11th

In this example, the NDCFI value is 4, indicating that the 0 from the 6th position should be removed. The
converted NDC is 1191705673.

3. If necessary, repeat the process for each NCPDP 11-digit formatted NDC in FDBs NDC table, and create
a cross-reference file containing NCPDP 11-digit formatted NDCs and the associated 10-digit NDCs. You
must create the cross-reference file every time you receive an update to the NDC Table.

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Finding a Replacement or Previous NDC

A products NDC may change if that product is sold to another labeler. When FDB is notified of an NDC change, a
new NDC record is added to the database. This application describes how to retrieve the old or new NDC using
the following application:

1. Select the Replacement NDC (REPNDC) and the Previous NDC (PNDC) values from the NDC Table
(RNDC14_NDC_MSTR) where the NDC column equals the NDC value of the product.
If the REPNDC column is populated, the given NDC has been replaced by the REPNDC. The
REPNDC column contains the new NDC, which will also be found in the NDC column in its own
record.
If the PNDC column is populated, the given NDC is a replacement for the PNDC. The PNDC column
contains the old NDC, which will also be found in the NDC column in its own record.

The following example displays the NDCs, REPNDCs, and PNDCs for Brevital Sodium 5 gm vial:

NDC LN REPNDC PNDC

00002144501 BREVITAL SODIUM 5 GM 52604144501

VIAL

52604144501 BREVITAL SODIUM 5 GM 00002144501

VIAL

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Finding the Product Labeler

This application illustrates how to identify a product's labeler.

1. Select the Labeler Identifier (LBLRID) value from the NDC Table (RNDC14_NDC_MSTR) where the NDC
column equals the NDC value of the product.

2. Select the Manufacturer Name (MFG) value from the Labeler Identifier Description Table
(RLBLRID3_LBLR_DESC) where the LBLRID column equals LBLRID value from the previous step.

The Labeler ID (LBLRID) and Manufacturer Name (MFG) columns represent manufacturers,
distributors, and repackagers.

ExampleFinding the Product Labeler

A pharmacist wants to identify the labeler for Brevital (NDC 52604144501).

1. Select the Labeler Identifier (LBLRID) value from the NDC Table (RNDC14_NDC_MSTR) where the NDC
column equals the NDC value of the product.

NDC LBLRID

52604144501 A61570

2. Select the Manufacturer Name (MFG) value from the Labeler Identifier Description Table
(RLBLRID3_LBLR_DESC) where the LBLRID column equals LBLRID value from the previous step.

LBLRID MFG

A61570 MONARCH PHRM

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Retrieving a List of Therapeutic Substitutions

This section contains the following three applications:

Therapeutic Substitution Retrieval Method A

Therapeutic Substitution Retrieval Method B
Therapeutic Substitution Retrieval Method C

These applications illustrate the following for determining therapeutically equivalent products:

Determine whether the product is a multi-source product

Retrieve a list of candidates for substitution
Retrieve a list of therapeutically equivalent products using Orange Book codes

FDB does not recommend the use of one element/method over another, but provides the information
needed to create a methods that meet business requirements.

Equivalency codes from the FDAs Orange Book indicate the FDAs assessment of therapeutic equivalence. The
use of Orange Book codes to determine therapeutic equivalence depends on State regulations. Please note that
the final decision to substitute must also include a review of State Board of Pharmacy regulations relative to drug
substitution and the dispensing pharmacists best professional judgement. Please read the Therapeutic
Substitution Candidate Identification and List Generation section in Concepts for more information.

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Therapeutic Substitution Retrieval Method A

To retrieve therapeutically equivalent products using method A, complete the following steps:

1. Select the Multi-Source/Single Source Indicator (NDCGI1) value from the NDC Table
(RNDC14_NDC_MSTR) where the National Drug Code (NDC) column equals the NDC value of the
product.
If the NDCGI1 = 1, the product is multi-source; proceed to step 2 to retrieve the products
candidates for substitution.
If the NDCGI1 = 2, the product is single-source and will not have any candidates for substitution; do
not proceed.

2. Select the Clinical Formulation ID (GCN_SEQNO) value from the RNDC14_NDC_MSTR table where the
NDC column equals the NDC value of the product.

3. Select the following values from the RNDC14_NDC_MSTR table where the GCN_SEQNO column equals
the Clinical Formulation ID (GCN_SEQNO) values from the previous step and the Obsolete Date (
OBSDTEC) column equals 0:
Note that one Clinical Formulation ID (GCN_SEQNO) may be linked to many NDCs.
NDC
Packaged Description (PD)
Labeler Identifier (LBLRID)

4. Select the Manufacturer Name column (MFG) from the Labeler Identifier Description Table
(RLBLRID3_LBLR_DESC) where the LBLRID column equals the LBLRID values from step 4. This step is
listed for the purposes of illustration.

5. Select the NDC Attribute Sequence Number (NDC_ATTRIBUTE_SN) values from the NDC Attribute Table
(RNDCAT0_NDC_ATTRIBUTE) where the following:
NDC column equals the NDC values from step 3
NDC Attribute Type Code (NDC_ATTRIBUTE_TYPE_CD) column equals 5 (Orange Book Code [
OBC3]), 7 (FDB Maintained NDA Approval Date), 9 (FDB Maintained NDA Application Number),
11(FDB Maintained ANDA Approval Date), 13 (FDB Maintained ANDA Application Number).
NDC Attribute Value (NDC_ATTRIBUTE_VALUE) column equals A*
This step results in products that are considered therapeutically equivalent by FDA standards and
provides the drug application number and date the products were approved under, when available.
Note that the use of the Orange Book Code to determine therapeutic equivalence depends on your
State regulations.

6. Check to make sure the items in the therapeutic substitution list are in compliance with the State Boards of
Pharmacy regulations.

7. Check for any state formulary codes and ensure compliance with them.

8. Provide opportunity for the exercise of best clinical judgment of the dispensing pharmacist.

ExampleTherapeutic Substitution Retrieval Method A

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A pharmacist wants to generate a list of therapeutically equivalent products before dispensing a prescription for
Synthroid 137 MCG Tablet (NDC 00378182301).

1. Select the Multi-Source/Single Source Indicator (NDCGI1) value from the NDC Table
(RNDC14_NDC_MSTR) where the National Drug Code (NDC) column equals the NDC value of the
product.
If the NDCGI1 = 1, the product is multi-source; proceed to step 2 to retrieve the products
candidates for substitution.
If the NDCGI1 = 2, the product is single-source and will not have any candidates for substitution; do
not proceed.

NDC LN NDCGI1

00378182301 LEVOTHYROXINE 137 MCG 1

TABLET

2. Select the Clinical Formulation ID (GCN_SEQNO) value from the RNDC14_NDC_MSTR where the NDC
column equals the NDC value of the product.

NDC LN GCN_SEQNO

00378182301 LEVOTHYROXINE 137 MCG 20176

TABLET

The remaining step results show only small subsets of the actual results for this NDC.

3. Select the following values from the RNDC14_NDC_MSTR table where the Obsolete Date column (
OBSDTEC) equals 0 and the GCN_SEQNO column equals the Clinical Formulation ID (GCN_SEQNO)
values from the previous step.
Note that one Clinical Formulation ID (GCN_SEQNO) may have many NDCs.
NDC
Packaged Description (PD)
Labeler Identifier (LBLRID)

GCN_SEQNO OBSDTEC NDC GNN60 PD LBLRID

20176 0 00074372713 levothyroxine BOTTLE A00074

sodium

20176 0 00378182301 levothyroxine BOTTLE A00378

sodium

20176 0 00378182310 levothyroxine BOTTLE A00378

sodium

20176 0 00456133100 levothyroxine BOTTLE A00456

sodium

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20176 0 00456133101 levothyroxine BOTTLE A00456

sodium

20176 0 00527163801 levothyroxine BOTTLE A00527

sodium

20176 0 00527163810 levothyroxine BOTTLE A00527

sodium

20176 0 00781519101 levothyroxine BOTTLE D00781

sodium

20176 0 21695075530 levothyroxine BOTTLE A21695

sodium

20176 0 35356031200 levothyroxine BOTTLE A49999

sodium

The GNN60 column is shown for descriptive reasons only and is not necessary to this step.
The GNN60 column is in the Ingredient List Identifier Description Table
(RHICLSQ2_HICLSEQNO_MSTR).

4. Select the Manufacturer Name column (MFG) from the Labeler Identifier Description Table
(RLBLRID3_LBLR_DESC) where the LBLRID column equals the LBLRID values from step 4. This step is
listed for the purpose of illustration.

LBLRID MFG

A00074 ABBOTT LABS

A00378 MYLAN

A00378 MYLAN

A00456 FOREST PHARMACE

A00456 FOREST PHARMACE

A00527 LANNETT CO. INC

A00527 LANNETT CO. INC

D00781 SANDOZ

A21695 PHYSICIAN PARTN

A49999 QUALITY CARE

5. Select the NDC Attribute Sequence Number (NDC_ATTRIBUTE_SN) values from the NDC Attribute Table
(RNDCAT0_NDC_ATTRIBUTE) where the following:
NDC column equals the NDC values from step 3
NDC Attribute Type Code (NDC_ATTRIBUTE_TYPE_CD) column equals 5 (Orange Book Code

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[OBC3]), 7 (FDB Maintained NDA Approval Date), 9 ( FDB Maintained NDA Application Number),
11 (FDB Maintained ANDA Approval Date), 13 ( FDB Maintained ANDA Application Number), 15
(FDB Maintained Other Application Number), and 17 (FDB Maintained Not Defined Application
Number)
NDC Attribute Value (NDC_ATTRIBUTE_VALUE) column equals A*
This step results in products that are considered therapeutically equivalent by FDA standards and
provides the drug application number and date the products were approved under, when available.
Note that the use of the Orange Book Code to determine therapeutic equivalence depends on your
State regulations.

NDC GNN60 NDC_ATTRIB NDC_ATTRIB NDC_ATTRIB NDC_ATTRIB

UTE_TYPE_C UTE_TYPE_D UTE_SN UTE_VALUE
D SC

00074372713 levothyroxine 5 Orange Book 1 AB2

sodium Code (OBC3)

00074372713 levothyroxine 5 Orange Book 2 AB1

sodium Code (OBC3)

00074372713 levothyroxine 7 FDB 1 20020724

sodium Maintained
NDA Approval
Date

00074372713 levothyroxine 9 FDB 1 021402

sodium Maintained
NDA
Application
Number

00378182301 levothyroxine 5 Orange Book 1 AB2

sodium Code (OBC3)

00378182301 levothyroxine 5 Orange Book 2 AB1

sodium Code (OBC3)

00378182301 levothyroxine 5 Orange Book 3 AB3

sodium Code (OBC3)

00378182301 levothyroxine 5 Orange Book 4 AB4

sodium Code (OBC3)

00378182301 levothyroxine 11 FDB 1 20020605

sodium Maintained
ANDA Approval
Date

00378182301 levothyroxine 13 FDB 1 076187

sodium Maintained
ANDA
Application
Number

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00378182310 levothyroxine 5 Orange Book 1 AB2

sodium Code (OBC3)

00378182310 levothyroxine 5 Orange Book 2 AB1

sodium Code (OBC3)

00378182310 levothyroxine 5 Orange Book 3 AB3

sodium Code (OBC3)

00378182310 levothyroxine 5 Orange Book 4 AB4

sodium Code (OBC3)

00378182310 levothyroxine 11 FDB 1 20020605

sodium Maintained
ANDA Approval
Date

00378182301 levothyroxine 13 FDB 1 076187

sodium Maintained
ANDA
Application
Number

6. Check to make sure the items in the therapeutic substitution list are in compliance with the State Boards of
Pharmacy regulations.

7. Check for any state formulary codes and ensure compliance with them.

8. Provide opportunity for the exercise of best clinical judgment of the dispensing pharmacist.

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Therapeutic Substitution Retrieval Method B

To retrieve therapeutically equivalent products using method B, complete the following steps:

1. Select the Multi-Source/Single Source Indicator (NDCGI1) value from the NDC Table
(RNDC14_NDC_MSTR) where the National Drug Code (NDC) column equals the NDC value of the
product.
If the NDCGI1 = 1, the product is multi-source; proceed to step 2 to retrieve the products
candidates for substitution.
If the NDCGI1 = 2, the product is single-source and will not have any candidates for substitution; do
not proceed.

2. Select the Clinical Formulation ID (GCN_SEQNO) value from the RNDC14_NDC_MSTR table where the
NDC column equals the NDC value of the product.

3. Select the NDC values from the RNDC14_NDC_MSTR table where the Obsolete Date column (OBSDTEC
) equals 0 and the GCN_SEQNO column equals the Clinical Formulation ID (GCN_SEQNO) values from
the previous step.
Note that one Clinical Formulation ID (GCN_SEQNO) may have many NDCs.

4. Select the Orange Book Code (OBC) values from the RNDC14_NDC_MSTR table where the OBC column
equals A* and the NDC column equals the NDC values from the previous step.
This step results in products that are considered therapeutically equivalent by FDA standards. Note that
the use of the Orange Book Code to determine therapeutic equivalence depends on your State
regulations.

5. Select the Packaged Description (PD) and Labeler Identifier (LBLRID) from the RNDC14_NDC_MSTR
table where the NDC column equals the NDC values from the previous step.

6. Select the Manufacturer Name column (MFG) from the Labeler Identifier Description Table
(RLBLRID3_LBLR_DESC) where the NDC column equals the NDC values from the previous step.
This step is listed for the purposes of illustration.

7. Select the following values from the NDC to FDA Drug Application Number Table
(RAPPLNA0_FDA_NDC_APPL) where the NDC column equals the NDC values from the previous step:
FDA Drug Application Number (APPL_NO)
FDA Drug Application Type Code (APPL_TYPE_CD)

8. Check to make sure the items in the therapeutic substitution list are in compliance with the State Boards of
Pharmacy regulations.

9. Check for any state formulary codes and ensure compliance with them.

10. Provide opportunity for the exercise of best clinical judgment of the dispensing pharmacist.

ExampleTherapeutic Substitution Retrieval Method B

A pharmacist wants to generate a list of therapeutically equivalent products before dispensing a prescription for
PACERONE 200 MG TABLET (NDC 00245014760).

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1. Select the Multi-Source/Single Source Indicator (NDCGI1) value from the NDC Table
(RNDC14_NDC_MSTR) where the National Drug Code (NDC) column equals the NDC value of the
product.
If the NDCGI1 = 1, the product is multi-source; proceed to step 2 to retrieve the products
candidates for substitution.
If the NDCGI1 = 2, the product is single-source and will not have any candidates for substitution; do
not proceed.

NDC LN NDCGI1

00245014760 PACERONE 200 MG TABLET 1

2. Select the Clinical Formulation ID (GCN_SEQNO) value from the RNDC14_NDC_MSTR table where the
National Drug Code (NDC) column equals the NDC value of the product.

NDC LN GCN_SEQNO

00245014760 PACERONE 200 MG TABLET 000266

The remaining step results show only small subsets of the actual results for this NDC.

3. Select the NDC values from the RNDC14_NDC_MSTR table where the Obsolete Date column (OBSDTEC
) equals 0 and the GCN_SEQNO column equals the Clinical Formulation ID (GCN_SEQNO) values from
the previous step.
Note that one Clinical Formulation ID (GCN_SEQNO) may have many NDCs. The results of this process
are summarized below.

GCN_SEQNO NDC OBSDTEC GNN60

000266 00093913306 0 amiodarone HCl

000266 00093913352 0 amiodarone HCl

000266 00185014405 0 amiodarone HCl

000266 00185014409 0 amiodarone HCl

000266 00185014460 0 amiodarone HCl

000266 00904655661 0 amiodarone HCl

000266 51672402504 0 amiodarone HCl

000266 63739038710 0 amiodarone HCl

000266 65862073205 0 amiodarone HCl

000266 65862073260 0 amiodarone HCl

000266 68084037101 0 amiodarone HCl

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000266 68084037111 0 amiodarone HCl

000266 68382022705 0 amiodarone HCl

000266 68382022714 0 amiodarone HCl

000266 00245014701 0 amiodarone HCl

000266 00245014715 0 amiodarone HCl

000266 00245014760 0 amiodarone HCl

000266 00245014789 0 amiodarone HCl

000266 00245014790 0 amiodarone HCl

The GNN60 column is shown for descriptive reasons only and is not necessary to this step. The
GNN60 column is in the Ingredient List Identifier Description Table
(RHICLSQ2_HICLSEQNO_MSTR).

4. Select the Orange Book Code (OBC) values from the RNDC14_NDC_MSTR table where the OBC column
equals AB and the NDC column equals the NDC values from the previous step.

NDC LN OBC

00093913306 AMIODARONE HCL 200 MG AB

TABLET

00093913352 AMIODARONE HCL 200 MG AB

TABLET

00185014405 AMIODARONE HCL 200 MG AB

TABLET

00185014409 AMIODARONE HCL 200 MG AB

TABLET

00185014460 AMIODARONE HCL 200 MG AB

TABLET

00904655661 AMIODARONE HCL 200 MG AB

TABLET

51672402504 AMIODARONE HCL 200 MG AB

TABLET

63739038710 AMIODARONE HCL 200 MG AB

TABLET

65862073205 AMIODARONE HCL 200 MG AB

TABLET

65862073260 AMIODARONE HCL 200 MG AB

TABLET

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68084037101 AMIODARONE HCL 200 MG AB

TABLET

68084037111 PACERONE 200 MG TABLET AB

68382022705 PACERONE 200 MG TABLET AB

68382022714 PACERONE 200 MG TABLET AB

00245014701 PACERONE 200 MG TABLET AB

00245014715 PACERONE 200 MG TABLET AB

00245014760 PACERONE 200 MG TABLET AB

00245014789 PACERONE 200 MG TABLET AB

00245014790 PACERONE 200 MG TABLET AB

This step results in products that are considered therapeutically equivalent by FDA standards. The use of
the Orange Book Code to determine therapeutic equivalence depends on your State regulations.

5. Select the Packaged Description (PD) and Labeler Identifier (LBLRID) from the RNDC14_NDC_MSTR
table where the NDC column equals the NDC values from the previous step.

NDC LN PD LBLRID

00093913306 AMIODARONE HCL 200 BOTTLE B00093

MG TABLET

00093913352 AMIODARONE HCL 200 BOTTLE B00093

MG TABLET

00185014405 AMIODARONE HCL 200 BOTTLE D00781

MG TABLET

00185014409 AMIODARONE HCL 200 BOTTLE D00781

MG TABLET

00185014460 AMIODARONE HCL 200 BOTTLE D00781

MG TABLET

00904655661 AMIODARONE HCL 200 BLIST PACK A00904

MG TABLET

51672402504 AMIODARONE HCL 200 BOTTLE A51672

MG TABLET

63739038710 AMIODARONE HCL 200 BLIST PACK B63739

MG TABLET

65862073205 AMIODARONE HCL 200 BOTTLE A65862

MG TABLET

65862073260 AMIODARONE HCL 200 BOTTLE A65862

MG TABLET

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68084037101 AMIODARONE HCL 200 BLIST PACK A62584

MG TABLET

68084037111 PACERONE 200 MG BLIST PACK A62584

TABLET

68382022705 PACERONE 200 MG BOTTLE A68382

TABLET

68382022714 PACERONE 200 MG BOTTLE A68382

TABLET

00245014701 PACERONE 200 MG BLIST PACK A00245

TABLET

00245014715 PACERONE 200 MG BOTTLE A00245

TABLET

00245014760 PACERONE 200 MG BOTTLE A00245

TABLET

00245014789 PACERONE 200 MG BLIST PACK A00245

TABLET

00245014790 PACERONE 200 MG BOTTLE A00245

TABLET

6. Select the Manufacturer Name column (MFG) from the Labeler Identifier Description Table
(RLBLRID3_LBLR_DESC) where the LBLRID column equals the LBLRID values from the previous step.
This step is listed for the purpose of illustration.

LN PD LBLRID MFG

AMIODARONE HCL 200 BOTTLE B00093 TEVA USA

MG TABLET

AMIODARONE HCL 200 BOTTLE B00093 TEVA USA

MG TABLET

AMIODARONE HCL 200 BOTTLE D00781 SANDOZ

MG TABLET

AMIODARONE HCL 200 BOTTLE D00781 SANDOZ

MG TABLET

AMIODARONE HCL 200 BOTTLE D00781 SANDOZ

MG TABLET

AMIODARONE HCL 200 BLIST PACK A00904 MAJOR PHARMACEU

MG TABLET

AMIODARONE HCL 200 BOTTLE A51672 TARO PHARM USA

MG TABLET

AMIODARONE HCL 200 BLIST PACK B63739 MCKESSON PACKAG

MG TABLET

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AMIODARONE HCL 200 BOTTLE A65862 AUROBINDO PHARM

MG TABLET

AMIODARONE HCL 200 BOTTLE A65862 AUROBINDO PHARM

MG TABLET

AMIODARONE HCL 200 BLIST PACK A62584 AHP

MG TABLET

PACERONE 200 MG BLIST PACK A62584 AHP

TABLET

PACERONE 200 MG BOTTLE A68382 ZYDUS PHARMACEU

TABLET

PACERONE 200 MG BOTTLE A68382 ZYDUS PHARMACEU

TABLET

PACERONE 200 MG BLIST PACK A00245 UPSHER SMITH

TABLET

PACERONE 200 MG BOTTLE A00245 UPSHER SMITH

TABLET

PACERONE 200 MG BOTTLE A00245 UPSHER SMITH

TABLET

PACERONE 200 MG BLIST PACK A00245 UPSHER SMITH

TABLET

PACERONE 200 MG BOTTLE A00245 UPSHER SMITH

TABLET

7. Select the following values from the NDC to FDA Drug Application Number Table
(RAPPLNA0_FDA_NDC_APPL) where the NDC column equals the NDC values from the previous step:
FDA Drug Application Number (APPL_NO)
FDA Drug Application Type Code (APPL_TYPE_CD)

NDC LN APPL_NO APPL_TYPE_CD

00093913306 AMIODARONE HCL 200 074739 2

MG TABLET

00093913352 AMIODARONE HCL 200 074739 2

MG TABLET

00185014405 AMIODARONE HCL 200 075315 2

MG TABLET

00185014409 AMIODARONE HCL 200 075315 2

MG TABLET

00185014460 AMIODARONE HCL 200 075315 2

MG TABLET

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00904655661 AMIODARONE HCL 200 079029 2

MG TABLET

51672402504 AMIODARONE HCL 200 075424 2

MG TABLET

63739038710 AMIODARONE HCL 200 075135 2

MG TABLET

65862073205 AMIODARONE HCL 200 204742 2

MG TABLET

65862073260 AMIODARONE HCL 200 204742 2

MG TABLET

68084037101 AMIODARONE HCL 200 079029 2

MG TABLET

68084037111 PACERONE 200 MG 079029 2

TABLET

68382022705 PACERONE 200 MG 079029 2

TABLET

68382022714 PACERONE 200 MG 079029 2

TABLET

00245014701 PACERONE 200 MG 075135 2

TABLET

00245014715 PACERONE 200 MG 075135 2

TABLET

00245014760 PACERONE 200 MG 075135 2

TABLET

00245014789 PACERONE 200 MG 075135 2

TABLET

00245014790 PACERONE 200 MG 075135 2

TABLET

This step provides FDA drug application numbers and their type.

8. Check to make sure the items in the therapeutic substitution list are in compliance with the State Boards of
Pharmacy regulations.

9. Check for any state formulary codes and ensure compliance with them.

10. Provide opportunity for the exercise of best clinical judgment of the dispensing pharmacist.

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Therapeutic Substitution Retrieval Method C

To retrieve therapeutically equivalent products using method C, complete the following steps:

1. Select the Multi-Source/Single Source Indicator (NDCGI1) value from the NDC Table
(RNDC14_NDC_MSTR) where the National Drug Code (NDC) column equals the NDC value of the
product.
If the NDCGI1 = 1, the product is multi-source; proceed to step 2 to retrieve the products
candidates for substitution.
If the NDCGI1 = 2, the product is single-source and will not have any candidates for substitution; do
not proceed.

2. Select the Clinical Formulation ID (GCN_SEQNO) value from the RNDC14_NDC_MSTR table where the
NDC column equals the NDC value of the product.

3. Select the NDC values from the RNDC14_NDC_MSTR table where the Obsolete Date column (OBSDTEC
) equals 0 and the GCN_SEQNO column equals the Clinical Formulation ID (GCN_SEQNO) values from
the previous step.
Note that one Clinical Formulation ID (GCN_SEQNO) may have many NDCs.

4. Select the following values from the ROBCNDC0_OBC_NDC table where the OBC3 column equals AB,
the GTI equals 3, and the NDC column equals the NDC values from the previous step:
Orange Book Code; 3-byte version (OBC3)
Therapeutic Equivalence Indicator (GTI)
This step results in products that are considered therapeutically equivalent by FDA standards. Note
that the use of the Orange Book Code to determine therapeutic equivalence depends on your State
regulations.

5. Select the Packaged Description (PD) and Labeler Identifier (LBLRID) from the RNDC14_NDC_MSTR
table where the NDC column equals the NDC values from the previous step.

6. Select the Manufacturer Name column (MFG) from the Labeler Identifier Description Table
(RLBLRID3_LBLR_DESC) where the LBLRID column equals the LBLRID values from step 4.
This step is listed for the purposes of illustration.

7. Select the following values from the NDC to FDA Drug Application Number Table
(RAPPLNA0_FDA_NDC_APPL) where the NDC column equals the NDC values from the previous step:
FDA Drug Application Number (APPL_NO)
FDA Drug Application Type Code (APPL_TYPE_CD)

8. Check to make sure the items in the therapeutic substitution list are in compliance with the State Boards of
Pharmacy regulations.

9. Check for any state formulary codes and ensure compliance with them.

10. Provide opportunity for the exercise of best clinical judgment of the dispensing pharmacist.

ExampleTherapeutic Substitution Retrieval Method C

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A pharmacist wants to generate a list of therapeutically equivalent products before dispensing a prescription for
PACERONE 200 MG TABLET (NDC 00245014701).

1. Select the Multi-Source/Single Source Indicator (NDCGI1) value from the RNDC14_NDC_MSTR table
where the National Drug Code (NDC) column equals the NDC value of the product.
If the NDCGI1 = 1, the product is multi-source; proceed to step 2 to retrieve the products
candidates for substitution.
If the NDCGI1 = 2, the product is single-source and will not have any candidates for substitution; do
not proceed.

NDC LN NDCGI1

00245014701 PACERONE 200 MG TABLET 1

2. Select the Clinical Formulation ID (GCN_SEQNO) value from the RNDC14_NDC_MSTR table where the
NDC column equals the NDC value of the product.

NDC LN GCN_SEQNO

00245014701 PACERONE 200 MG TABLET 000266

The remaining step results show only small subsets of the actual results for this NDC.

3. Select the NDC values from the RNDC14_NDC_MSTR table where the Obsolete Date column (OBSDTEC
) equals 0 and the GCN_SEQNO column equals the Clinical Formulation ID (GCN_SEQNO) values from
the previous step.
Note that one Clinical Formulation ID (GCN_SEQNO) may have many NDCs.

GCN_SEQNO NDC GNN60 OBSDTEC

000266 65862073205 amiodarone HCl 0

000266 00185014405 amiodarone HCl 0

000266 00185014460 amiodarone HCl 0

000266 51672402504 amiodarone HCl 0

000266 00093913352 amiodarone HCl 0

000266 00185014409 amiodarone HCl 0

000266 00904655661 amiodarone HCl 0

000266 68382022714 amiodarone HCl 0

000266 68084037111 amiodarone HCl 0

000266 00093913306 amiodarone HCl 0

000266 68382022705 amiodarone HCl 0

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000266 63739038710 amiodarone HCl 0

000266 68084037101 amiodarone HCl 0

000266 65862073260 amiodarone HCl 0

000266 00245014701 amiodarone HCl 0

000266 00245014715 amiodarone HCl 0

000266 00245014789 amiodarone HCl 0

000266 00245014790 amiodarone HCl 0

00266 00245014760 amiodarone HCl 0

The GNN60 column is shown for descriptive reasons only and is not necessary to this step. The
GNN60 column is in the Ingredient List Identifier Description Table (
RHICLSQ2_HICLSEQNO_MSTR).

4. Select the following values from the ROBCNDC0_OBC_NDC table where the OBC3 column equals AB,
the GTI equals 3, and the NDC column equals the NDC values from the previous step:
Orange Book Code; 3-byte version (OBC3)
Therapeutic Equivalence Indicator (GTI)
This step results in products that are considered therapeutically equivalent by FDA standards. Note
that the use of the Orange Book Code to determine therapeutic equivalence depends on your State
regulations.

NDC LN OBC3 GTI

65862073205 AMIODARONE HCL 200 AB 3

MG TABLET

00185014405 AMIODARONE HCL 200 AB 3

MG TABLET

00185014460 AMIODARONE HCL 200 AB 3

MG TABLET

51672402504 AMIODARONE HCL 200 AB 3

MG TABLET

00093913352 AMIODARONE HCL 200 AB 3

MG TABLET

00185014409 AMIODARONE HCL 200 AB 3

MG TABLET

00904655661 AMIODARONE HCL 200 AB 3

MG TABLET

68382022714 AMIODARONE HCL 200 AB 3

MG TABLET

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68084037111 AMIODARONE HCL 200 AB 3

MG TABLET

00093913306 AMIODARONE HCL 200 AB 3

MG TABLET

68382022705 AMIODARONE HCL 200 AB 3

MG TABLET

63739038710 AMIODARONE HCL 200 AB 3

MG TABLET

68084037101 AMIODARONE HCL 200 AB 3

MG TABLET

65862073260 AMIODARONE HCL 200 AB 3

MG TABLET

00245014701 PACERONE 200 MG AB 3

TABLET

00245014715 PACERONE 200 MG AB 3

TABLET

00245014789 PACERONE 200 MG AB 3

TABLET

00245014790 PACERONE 200 MG AB 3

TABLET

00245014760 PACERONE 200 MG AB 3

TABLET

5. Select the Packaged Description (PD) and Labeler Identifier (LBLRID) from the NDC Table
(RNDC14_NDC_MSTR) where the NDC column equals the NDC values from the previous step.

NDC LN PD LBLRID

65862073205 AMIODARONE HCL 200 BOTTLE A65862

MG TABLET

00185014405 AMIODARONE HCL 200 BOTTLE D00781

MG TABLET

00185014460 AMIODARONE HCL 200 BOTTLE D00781

MG TABLET

51672402504 AMIODARONE HCL 200 BOTTLE A51672

MG TABLET

00093913352 AMIODARONE HCL 200 BOTTLE B00093

MG TABLET

00185014409 AMIODARONE HCL 200 BOTTLE D00781

MG TABLET

00904655661 AMIODARONE HCL 200 BLIST PACK A00904

MG TABLET

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68382022714 AMIODARONE HCL 200 BOTTLE A68382

MG TABLET

68084037111 AMIODARONE HCL 200 BLIST PACK A62584

MG TABLET

00093913306 AMIODARONE HCL 200 BOTTLE B00093

MG TABLET

68382022705 AMIODARONE HCL 200 BOTTLE A68382

MG TABLET

63739038710 AMIODARONE HCL 200 BLIST PACK B63739

MG TABLET

68084037101 AMIODARONE HCL 200 BLIST PACK A62584

MG TABLET

65862073260 AMIODARONE HCL 200 BOTTLE A65862

MG TABLET

00245014701 PACERONE 200 MG BLIST PACK A00245

TABLET

00245014715 PACERONE 200 MG BOTTLE A00245

TABLET

00245014789 PACERONE 200 MG BLIST PACK A00245

TABLET

00245014790 PACERONE 200 MG BOTTLE A00245

TABLET

00245014760 PACERONE 200 MG BOTTLE A00245

TABLET

6. Select the Manufacturer Name column (MFG) from the Labeler Identifier Description Table
(RLBLRID3_LBLR_DESC) where the LBLRID column equals the LBLRID values from step 5.
This step is listed for the purpose of illustration.

LN PD LBLRID MFG

AMIODARONE HCL 200 BOTTLE A65862 AUROBINDO PHARM

MG TABLET

AMIODARONE HCL 200 BOTTLE D00781 SANDOZ

MG TABLET

AMIODARONE HCL 200 BOTTLE D00781 SANDOZ

MG TABLET

AMIODARONE HCL 200 BOTTLE A51672 TARO PHARM USA

MG TABLET

AMIODARONE HCL 200 BOTTLE B00093 TEVA USA

MG TABLET

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AMIODARONE HCL 200 BOTTLE D00781 SANDOZ

MG TABLET

AMIODARONE HCL 200 BLIST PACK A00904 MAJOR PHARMACEU

MG TABLET

AMIODARONE HCL 200 BOTTLE A68382 ZYDUS PHARMACEU

MG TABLET

AMIODARONE HCL 200 BLIST PACK A62584 AHP

MG TABLET

AMIODARONE HCL 200 BOTTLE B00093 TEVA USA

MG TABLET

AMIODARONE HCL 200 BOTTLE A68382 ZYDUS PHARMACEU

MG TABLET

AMIODARONE HCL 200 BLIST PACK B63739 MCKESSON PACKAG

MG TABLET

AMIODARONE HCL 200 BLIST PACK A62584 AHP

MG TABLET

AMIODARONE HCL 200 BOTTLE A65862 AUROBINDO PHARM

MG TABLET

PACERONE 200 MG BLIST PACK A00245 UPSHER SMITH

TABLET

PACERONE 200 MG BOTTLE A00245 UPSHER SMITH

TABLET

PACERONE 200 MG BLIST PACK A00245 UPSHER SMITH

TABLET

PACERONE 200 MG BOTTLE A00245 UPSHER SMITH

TABLET

PACERONE 200 MG BOTTLE A00245 UPSHER SMITH

TABLET

7. Select the following values from the NDC to FDA Drug Application Number Table
(RAPPLNA0_FDA_NDC_APPL) where the NDC column equals the NDC values from the previous step:
FDA Drug Application Number (APPL_NO)
FDA Drug Application Type Code (APPL_TYPE_CD)

NDC LN APPL_NO APPL_TYPE_CD

65862073205 AMIODARONE HCL 200 204742 2

MG TABLET

00185014405 AMIODARONE HCL 200 075315 2

MG TABLET

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00185014460 AMIODARONE HCL 200 075315 2

MG TABLET

51672402504 AMIODARONE HCL 200 075424 2

MG TABLET

00093913352 AMIODARONE HCL 200 074739 2

MG TABLET

00185014409 AMIODARONE HCL 200 075315 2

MG TABLET

00904655661 AMIODARONE HCL 200 079029 2

MG TABLET

68382022714 AMIODARONE HCL 200 079029 2

MG TABLET

68084037111 AMIODARONE HCL 200 079029 2

MG TABLET

00093913306 AMIODARONE HCL 200 074739 2

MG TABLET

68382022705 AMIODARONE HCL 200 079029 2

MG TABLET

63739038710 AMIODARONE HCL 200 075135 2

MG TABLET

68084037101 AMIODARONE HCL 200 079029 2

MG TABLET

65862073260 AMIODARONE HCL 200 204742 2

MG TABLET

00245014701 PACERONE 200 MG 075135 2

TABLET

00245014715 PACERONE 200 MG 075135 2

TABLET

00245014789 PACERONE 200 MG 075135 2

TABLET

00245014790 PACERONE 200 MG 075135 2

TABLET

00245014760 PACERONE 200 MG 075135 2

TABLET

This step provides FDA drug application numbers and their type.

8. Check to make sure the items in the therapeutic substitution list are in compliance with the State Boards of
Pharmacy regulations.

9. Check for any state formulary codes and ensure compliance with them.

10.

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10. Provide opportunity for the exercise of best clinical judgment of the dispensing pharmacist.

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Determining HigherLower-cost Alternative Status

This application illustrates the general steps involved in creating a method for determining the higher lower-cost
alternative status of products. There are several possible methods for making this determination, including
importing or assigning additional values or using applications that take several data elements into consideration.
Your business requirements should determine the methods and elements built into the logic you create.

FDB does not recommend the use of one element method over another, but provides the information
needed to create a method that meets business requirements.

The examples following the application provide sample methods for applying plan-specific logic.

The methods described in this section are provided for illustrative purposes only and are not intended to
instruct or to direct the use of the packaged product data.

Determining Status Using the NDA, ANDA, BLA, and Authorized Generic Attributes
Determining Status Using the NDA_IND and ANDA_IND Indicators
Determining Status Using the GNI and NDCGI1 Indicators
Determining Status Using the NDA_IND, ANDA_IND and GNI Indicators

The following application assumes familiarity with the various drug concepts and their identifiers and how to
access clinical information. See Multiple Access Points (MAPs) for more information.

1. Create plan-specific logic that meets your business needs for determining a products higher-cost or
lower-lost alternative status.

2. Familiarize yourself with NDC data elements and attributes, such as:
FDA Drug Application Status Information
Innovator Indicator (INNOV)
Authorized Generic
Generic Manufacturer Indicator (GMI)
Generic Name Indicator (GNI)
Therapeutic Equivalence Indicator (GTI)
Multi-Source/Single Source Indicator (NDCGI1)
HCFA Drug Category (HCFA_DC)

3. Create one or more methods that apply the logic to the data. These methods may include importing or
assigning one or more data elements or additional values.

Determining Status Using the NDA, ANDA, BLA, and Authorized Generic Attributes

A pharmacist wants to determine if a claim for Sertraline HCL 50 MG Tablet (NDC 18837024830) should be
assigned a higher-cost or lower-cost alternative status.

1. Select the following NDC Attribute Type Code (NDC_ATTRIBUTE_TYPE_CD) values from the NDC

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1.
Attribute Table (RNDCAT0_NDC_ATTRIBUTE) where the NDC column equals the NDC value of the
product.
7 (FDB Maintained NDA Approval Date)
9 (FDB Maintained NDA Application Number)
11 (FDB Maintained ANDA Approval Date)
13 (FDB Maintained ANDA Application Number)
18 (Authorized Generic)
19 (BLA Approval Date)
22 (BLA Application Number)
The Label Name (LN) values are retrieved using the NDC Table (RNDC14_NDC_MSTR).

NDC LN NDC_ATTRIBUTE_TYP NDC_ATTRIBUTE_VA

E_CD LUE

18837024830 SERTRALINE HCL 50 7 19911230

MG TABLET

18837024830 SERTRALINE HCL 50 9 019839

MG TABLET

18837024830 xSERTRALINE HCL 50 18 1

MG TABLET

This product was approved under an NDA but is identified as an Authorized Generic. Using the
plans logic, this product is assigned a lower-cost alternative status.

Determining Status Using the NDA_IND and ANDA_IND Indicators

A pharmacist wants to determine if a claim for Lescol 20 mg capsule (NDC 00078017605) should be assigned a
higher-cost or lower-cost alternative status.

1. Select the NDA Status Indicator (NDA_IND) and ANDA Status Indicator (ANDA_IND) values from the NDC
to FDA NDA/ANDA Table (RAPPLSL0_FDA_NDC_NDA_ANDA) where the NDC column equals the NDC
value of the product.

NDC LN NDA_IND ANDA_IND

00078017605 LESCOL 20 MG 1 0
CAPSULE

A return NDA_IND value of 1 indicates that this product was approved under an NDA. Using the plans
logic, this product is assigned a higher-cost alternative status.

Determining Status Using the GNI and NDCGI1 Indicators

A pharmacist wants to determine if a claim for Enbrel 25 mg/0.5 ml syringe (NDC 58406045501) should be
assigned a higher-cost or lower-cost alternative status.

1. Select the Generic Name Indicator (GNI) value from the NDC Table (RNDC14_NDC_MSTR) where the

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1.

NDC column equals the NDC value of the product.

NDC GNI Description

58406045501 2 Brand named

2. Select the Multi-Source/Single Source Indicator (NDCGI1) value from the RNDC14_NDC_MSTR table
where the NDC column equals the NDC value of the product.

NDC NDCGI1 Description

58406045501 2 Single source

The product is identified as a single-source, brand-named product. Using the plans logic, this product is
assigned a higher-cost alternative status.

Determining Status Using the NDA_IND, ANDA_IND and GNI Indicators

A pharmacy needs to determine if a claim for Sertraline 20 mg/ml oral conc (NDC 59762494001) should be
assigned a higher-cost or lower-cost alternative status.

1. Select the NDA Status Indicator (NDA_IND) and ANDA Status Indicator (ANDA_IND) values from the NDC
to FDA NDA/ANDA Table (RAPPLSL0_FDA_NDC_NDA_ANDA) where the NDC column equals the NDC
value of the product.

NDC LN NDA_IND ANDA_IND

00078017605 SERTRALINE 20 MG/ML 1 0

ORAL CONC

2. Select the Generic Name Indicator (GNI) value from the NDC Table (RNDC14_NDC_MSTR) where the
NDC column equals the NDC value of the product.

NDC GNI Description

00078017605 1 Genetically named

The product is identified as having an NDA approval status and a generically named status. Using the
plans logic, this product is assigned a lower-cost alternative status.

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Filtering Data with Product Attributes

This application illustrates how to use product attribute types to filter packaged product data. See NDC Attribute
Table for more information about NDC Attribute Types.

ExampleIdentifying All Active Prescription Products Excluding Repackagers and DESI Products
ExampleIdentifying Non-drug Items Using the GNI
ExampleIdentifying Non-drug Items Approved Under a Device Registration
ExampleFinding the Original NDC of a Repackaged Product
ExampleIdentifying Re-used NDCs
ExampleFinding the Marketing Category and Associated Dates for a Product

ExampleIdentifying All Active Prescription Products Excluding Repackagers and DESI Products

For inventory purposes, a pharmacist wants to identify all active prescription products commonly found in chain
pharmacies, excluding repackagers, institutional, and DESI products.

Starting with the third quarter 2014, CMS has discontinued the publication of the DESI field (Drug Safety
Efficacy Study Implementation Rating).

Accordingly, as of October 30, 2014, FDB has discontinued the maintenance of the following
DESI-related columns:

HCFA_DESI1
HCFA_DESC1
DESI
DESDTEC
DESI2
DES2DTEC

CMS announced that a new COD (Covered Outpatient Drug) Status field will replace the DESI field. FDB
will output the CMS Covered Outpatient Drug (COD) Status Code and associated effective date as NDC
Attribute Type Codes (NDC_ATTRIBUTE_TYPE_CD) 58 and 59.

CMS Covered Outpatient Drug (COD) Status (58)-provides the COD status code
CMS Covered Outpatient Drug (COD) Status Effective Date (59)-provides the date on which COD
status was applied or removed.

1. Select the National Drug Code (NDC) and the Label Name (LN) columns from the NDC Table
(RNDC14_NDC_MSTR) where the:
Class (CL) column equals the value of F, indicating the product requires a prescription for
dispensing, and
Obsolete Date (OBSDTEC) column equals the value of 0, indicating the NDC is active, and
Repackaged Indicator (REPACK) column equals the value of 0 (indicates that the product is not

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repackaged), and
Institutional Product Indicator (IPI) column equals the value of 0, indicating that the product is not
sold only to selected customers.

NDC LN CL OBSDTEC REPACK IPI

00002325030 STRATTERA F 0 0 0
80 MG
CAPSULE

00013265702 GENOTROPIN F 0 0 0
MINIQUICK 1.8
MG

49884098501 NATEGLINIDE F 0 0 0
120 MG
TABLET

00574709012 HYDROCORTI F 0 0 0
SONE AC 25
MG SUPP

51079062181 GRANULEX F 0 0 0
SPRAY

00516005110 POTABA 500 F 0 0 0

MG CAPSULE

00245071260 TOPIRAGEN F 0 0 0
50 MG TABLET

2. For the returned values, select the NDC Attribute Type Code ( NDC_ATTRIBUTE_TYPE_CD) and NDC
Attribute Value (NDC_ATTRIBUTE_VALUE) columns from the NDC Attribute Table (
RNDCAT0_NDC_ATTRIBUTE) where the:
NDC_ATTRIBUTE_TYPE_CD column values equal 58 (CMS Covered Outpatient Drug (COD)
Status)
NDC_ATTRIBUTE_VALUE column values are not equal to COD Status 05 (DESI 5) and COD
Status 06 (DESI 6)
NDC values equal the values from the RNDC14_NDC_MSTR table in the previous step

NDC LN NDC_ATTRIBUTE_TYP NDC_ATTRIBUTE_VA

E_CD LUE

00002325030 STRATTERA 80 MG 58 03
CAPSULE

00013265702 GENOTROPIN 58 03
MINIQUICK 1.8 MG

49884098501 NATEGLINIDE 120 MG 58 01

TABLET

51079062181 GRANULEX SPRAY 58 12

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The values returned are all active prescription drugs. Continue to the next step to retrieve additional
active prescription drugs.

3. For the returned records from the first step that did not have any NDC_ATTRIBUTE_VALUE values for
NDC_ATTRIBUTE_TYPE_CD equals 58, retrieve the following from the RNDC14_NDC_MSTR table:
DESI Drug Indicator (DESI) column equals the values of blank or 0, indicating the product is
considered effective by the FDAs DESI program
DESI 2 Drug Indicator (DESI2) column equals the values of blank or 0, indicating the product is
considered effective by the FDAs DESI program
HCFA DESI Code (HCFA_DESI1) column equals the values of 0, 2, 3, or 4 indicating the product is
considered effective by the FDAs DESI program

NDC LN DESI DESI2 HCFA_DESI1

00245071260 TOPIRAGEN 50 2
MG TABLET

The values returned are all active prescription drugs.

ExampleIdentifying Non-drug Items Using the GNI

For claim adjudication, a pharmacy wants to determine if Safety Lancet (NDC 08463803028) is a non-drug item.

1. Select the Generic Name Indicator (GNI) value from the NDC Table (RNDC14_NDC_MSTR) where the
NDC column equals the NDC value of the product.

NDC GNI Description

08463803028 0 Non-drug item, such as medical

supplies and bulk chemicals

In this example, the GNI value of 0 indicates the product is a non-drug item.

ExampleIdentifying Non-drug Items Approved Under a Device Registration

While defining formulary rules for Medical Supplies & DME - Glucose Monitoring Test Supplies ( ETC_ID), an
insurance payer ensures that products not covered under Medicare Part D are excluded from the formulary. For
information on building formulary rules, see the ETC application, Building a Formulary.

1. Select the National Drug Code (NDC) values from the ETC to NDC Assignment Table
(RETCNDC0_ETC_NDC) where the ETC Identifier (ETC_ID) column equals the ETC_ID value
representing the therapeutic classification under review.
The Label Name (LN) values are retrieved using the NDC Table (RNDC14_NDC_MSTR).
A sample of results are shown below.

ETC_ID NDC LN

1158 85325000001 CARESENS N BLOOD GLUCOSE

SYST

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1158 85325000004 CARESENS N BLOOD GLUCOSE

SYST

1158 85325000011 CARESENS N BLOOD GLUCOSE

SYST

1158 85325000015 ACURA PLUS STARTER KIT

1158 85325000016 ACURA PLUS METER KIT

1158 85325000017 ACURA PLUS METER KIT

1158 85325000020 CARESENS N BLOOD GLUCOSE

SYST

1158 85925000004 CARESENS N BLOOD GLUCOSE

SYST

1158 85925000011 CARESENS N BLOOD GLUCOSE

SYST

1158 85925000020 CARESENS N BLOOD GLUCOSE

SYST

1158 86227028105 SURE COMFORT 28G LANCETS

1158 86227028205 SURE COMFORT 28G LANCETS

1158 86227030105 SURE COMFORT 30G LANCETS

1158 86227030205 SURE COMFORT 30G LANCETS

1158 86227052205 SURE COMFORT LANCING PEN

1158 87701039908 GNP SUPER THIN LANCETS

1158 87701039909 BL SUPER THIN LANCETS

1158 87701044671 GNP THIN LANCETS

1158 87701052519 BL LANCING SYSTEM DEVICE

2. Select the NDC Attribute Value (NDC_ATTRIBUTE_VALUE) from the NDC Attribute Table
(RNDCAT0_NDC_ATTRIBUTE) where the NDC column equals the NDCs from the previous state and the
NDC Attribute Type Code (NDC_ATTRIBUTE_TYPE_CD) equals 23.
A sample of results are shown below.

NDC LN NDC_ATTRIBUTE_TYPE NDC_ATTRIBUTE_VALU

_CD E

08524001802 SMARTEST PERSONA 23 K083468

GLUCOSE METER

08524002802 SMARTEST PERSONA 23 K093712

STARTER KIT

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08617187301 CARESENS N BLOOD 23 K083468

GLUCOSE SYST

08617192303 SMART CARESENS N 23 K994387

GLUCOSE SYSTM

85325000001 CARESENS N BLOOD 23 K940986

GLUCOSE SYST

85925000011 CARESENS N BLOOD 23 K090398

GLUCOSE SYST

98939000256 FORA G71A BLOOD 23 K093712

GLUCOSE SYSTEM

98939000265 FORA G71A BLOOD 23 K090398

GLUCOSE SYSTEM

98939000267 FORA G71A BLOOD 23 K090057

GLUCOSE SYSTEM

In this example, all retrieved NDCs with a device registration number are removed from the formulary.

ExampleFinding the Original NDC of a Repackaged Product

A physician dispenses a repackaged product, Carisoprodol 350 mg Table (NDC 42549068240), to a patient and
needs to get the list price from the original NDC of the product for billing purposes.

1. Select the National Drug Code (NDC), NDC Attribute Type Code (NDC_ATTRIBUTE_TYPE_CD), NDC
Attribute Sequence Number (NDC_ATTRIBUTE_SN) and NDC Attribute Value (
NDC_ATTRIBUTE_VALUE) columns from the NDC Attribute Table (RNDCAT0_NDC_ATTRIBUTE) where
the NDC column equals 42549068240 and NDC_ATTRIBUTE_TYPE_CD column equals 47, indicating
that the product has an original NDC.

NDC NDC_ATTRIBUTE_TYPE NDC_ATTRIBUTE_SN NDC_ATTRIBUTE_VALU

_CD E

42549068240 47 1 62756044604

2. Select the National Drug Code (NDC), NDC Price TablePrice (NPT_PRICEX), NDC Price
TableEffective Date (NPT_DATEC), and the NDC Price TablePrice Type Code (NPT_TYPE) columns
from the NDC Price Type Description Table (RNP2_NDC_PRICE) where the NDC column equals
62756044604 and the NPT_TYPE that correspond to the desired price type based on your business
needs.

ExampleIdentifying Re-used NDCs

The owner of a pharmacy is reviewing re-used products and would like to obtain the date on which each re-used
NDC was added to the FDB data as re-used, if applicable.

1. Select the NDC Attribute Type Code (NDC_ATTRIBUTE_TYPE_CD), NDC Attribute Sequence Number (
NDC_ATTRIBUTE_SN), and NDC Attribute Value (NDC_ATTRIBUTE_VALUE) columns from the NDC

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1.

Attribute Table (RNDCAT0_NDC-ATTRIBUTE) where the NDC_ATTRIBUTE_TYPE_CD column equals

the value of 48, which provides the date on which an NDC was first published as re-used by FDB.

Prior to the date provided by NDC Attribute Type 48 (Re-Used NDC Date of Add), the NDC
represented a different product in FDBs database.

Below is an example of re-used NDCs and their Re-Used NDC Date of Add values.

NDC NDC_ATTRIBUTE_TYPE_CD
NDC_ATTRIBUTE_SN NDC_ATTRIBUTE_VALUE

00071015740 48 1 20070906

08290305125 48 1 20040827

08290305125 48 2 20050121

58016066224 48 1 20020426

58016066400 48 1 20020430

58016036230 48 1 20020312

58016036230 48 2 20040415

58016036230 48 3 20060512

If an NDC is re-used more than once, each occurrence is sequenced in ascending order by date
using the NDC_ATTRIBUTE_SN.

ExampleFinding the Marketing Category and Associated Dates for a Product

A pharmacy system is processing Medicare Part D claims for Prescription Drug Events (PDEs) and needs to
access the marketing category determinations and associated dates for NDC 00002322730 (Strattera 10 mg
Capsule). This information is found on the FDAs Comprehensive NDC Structured Product Labeling Data
Elements (NSDE) file.

1. Select the NDC Attribute Type Code (NDC_ATTRIBUTE_TYPE_CD), NDC Attribute Sequence Number (
NDC_ATTRIBUTE_SN), and NDC Attribute Value (NDC_ATTRIBUTE_VALUE) columns from the NDC
Attribute Table (RNDCAT0_NDC_ATTRIBUTE) where the NDC column equals 00002322730 and the
NDC_ATTRIBUTE_TYPE_CD column equals any of the following values:
41 (FDA Current NSDE Marketing Start Date)
42 (FDA Current and Archived NSDE Marketing Start Date)
43 (FDA Current NSDE Marketing End Date)
44 (FDA Current and Archived NSDE Marketing End Date)
45 (FDA Current NSDE Marketing Category)
46 (FDA Current and Archived NSDE Marketing Category)

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The FDA Current and Archived attribute types (NDC_ATTRIBUTE_TYPE_CD = 42, 44, 46)
reflects the last recorded Marketing Start Date, Marketing End Date, and Marketing
Category should the NDC be removed from the FDAs NSDE file.

NDC NDC_ATTRIBUTE_TYP NDC_ATTRIBUTE_SN NDC_ATTRIBUTE_VA

E_CD LUE

00002322730 41 1 20030110

00002322730 42 1 20030110

00002322730 45 1 NDA

00002322730 46 1 NDA

This NDC does not have a Marketing End Date attribute type
(NDC_ATTRIBUTE_TYPE_CD = 43 or 44) listed in the results because the product has not
reached its marketing end date.

If the content in the NDC_ATTRIBUTE_VALUE field exceeds the maximum field length of
50 characters for that column, the NDC_ATTRIBUTE_SN is used to avoid truncating the
content.

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Determining Whether a Drug has a Biosimilar or Interchangeable Relationship with Another Drug
This application illustrates how to determine whether a drug is biosimilar to or interchangeable with another drug.

1. Retrieve the NDC Attribute Value (NDC_ATTRIBUTE_VALUE) from the NDC Attribute Table
(RNDCAT0_NDC_ATTRIBUTE) where the NDC value equals the NDC of the drug and the NDC Attribute
Type Code (NDC_ATTRIBUTE_TYPE_CD) value equals 22 (BLA Application Number).
If a value is returned, it is the BLA Application Number. Use this value in step 2.
If no value is returned, the drug does not have a BLA and the application ends

2. Query the FDA Application Relationship Table (RAPLR0_APPL_RELATION) where the Reference Drug (
APPL_NBR1) value equals the BLA Application Number retrieved in step 1.
If a record is returned, then the drug in focus has a biosimilar or interchangeable relationship with
another drug. Continue to step 4.
If no record is returned, then continue to step 3.

The text description for the FDA Application Relationship Type ID (

APPL_RELATION_TYPE_ID) is provided by the FDA Application Relationship Type
Description (APPL_RELATION_TYPE_DESC) in the FDA Application Relationship Type
Table (RAPLRT0_APPL_RELATION_TYPE).

The FDA Application Type IDs (APPL_TYPE_ID1 and APPL_TYPE_ID2) identify the type of
FDA drug application. Text descriptions for these columns are as follows:

1 = BLA 351A
2 = BLA 351K

3. Query the FDA Application Relationship Table (RAPLR0_APPL_RELATION) where the Related Drug (
APPL_NBR2) value equals the BLA Application Number retrieved in step 1.
If a record is returned, then the drug in focus has a biosimilar or interchangeable relationship with
another drug. Continue to step 4.
If no record is returned, then the drug in focus does not have a biosimilar or interchangeable
relationship with another drug.

4. Retrieve the NDC from the NDC Attribute Table (RNDCAT0_NDC_ATTRIBUTE) where the NDC Attribute
Type Code (NDC_ATTRIBUTE_TYPE_CD) value equals 22 (BLA Application Number) and the NDC
Attribute Value (NDC_ATTRIBUTE_VALUE) equals the APPL_NBR1 or APPL_NBR2 value retrieved in
the previous step. Display the results to the end user.

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Retrieving a Product's Active Ingredients

This application illustrates how to find an NDC's active ingredients.

1. Select the Clinical Formulation ID (GCN_SEQNO) value form the NDC Table (RNDC14_NDC_MSTR)
where the NDC column equals the NDC of the product.

2. Retrieve the ingredients related to the Clinical Formulation ID ( GCN_SEQNO) from step 1. See Retrieving
the Ingredients for a Specified Clinical Formulation for the process steps.

ExampleRetrieving a Product's Active Ingredients

A prescriber wants to find all active ingredients that are associated with the packaged product Prozac weekly 90
mg capsule (NDC 00002300475).

1. Select the Clinical Formulation ID (GCN_SEQNO) value from the NDC Table (RNDC14_NDC_MSTR)
where the NDC column equals the NDC of the product.

NDC GCN_SEQNO

00002300475 047571

2. Retrieve the ingredients related to the Clinical Formulation ID ( GCN_SEQNO) from step 1. See Retrieving
the Ingredients for a Specified Clinical Formulation for the process steps.

GCN_SEQNO HICL_SEQNO HIC_SEQN HIC_DESC

047571 001655 001514 fluoxetine HCL

In this example, the active ingredient in Prozac is Fluoxetine HCL.

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Retrieving a Product's Inactive Ingredients

This application illustrates how to find an NDC's inactive ingredients. A product's inactive ingredients serve
non-therapeutic functions, such as lending color or flavor to the product.

1. Check the NDC Inactive Ingredients Reviewed Master Table (RNDCINR0_INACTV_REVIEWED) to

determine if the NDC has undergone inactive ingredient review by FDB.
If the NDC does not appear in this table, alert the user that inactive ingredient information is not
available.
If the NDC appears in this table, continue to the next step.

2. Select the Hierarchial Ingredient Code Sequence Number (HIC_SEQN) values from the NDC/HIC_SEQN
Inactive Ingredient Relation Table (RNDCINH0_NDC_INACTV_LINK) where the NDC column equals the
NDC of the product.

ExampleRetrieving a Product's Inactive Ingredients

A prescriber wants to find all inactive ingredients that are associated with the packaged product Prozac weekly 90
mg capsules (NDC 00002300475).

1. Check the NDC Inactive Ingredients Reviewed Master Table (RNDCINR0_INACTV_REVIEWED) to

determine if the NDC has undergone inactive ingredient review by FDB.
If the NDC does not appear in this table, alert the user that inactive ingredient information is not
available.
If the NDC apears in this table, continue to the next step.
In this example, the NDC appears in the table. The process continues to the next step.

2. Select the Hierarchcal Ingredient Code Sequence Number (HIC_SEQN) values from the NDC/HIC_SEQN
Inactive Ingredient Relation Table (RNDCINH0_NDC_INACTV_LINK) where the NDC column equals the
NDC of the product.

NDC HIC_SEQN HIC_DESC

00002300475 002549 gelatin

00002300475 002598 sucrose

00002300475 009246 FD&C no.2 (indigotine)

00002300475 008998 triethyl citrate

The associated ingredient descriptions (HIC_DESC) were retrieved from the Hierarchical
Ingredient Code Description Table (RHICD5_HIC_DESC).

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Determining the FDB Product ID and Associated Product Information Given an External Product
Code
The purpose of this application is to demonstrate how customers can:

Retrieve an FDB Product ID given any External Product Code ( EXT_PRODUCT_CD) (such as an NDC)
Access certain core information about any such product such as the Label Name ( LABEL_NAME), Clinical
Formulation ID (GCN_SEQNO), or Labeler ID (LBLRID) for any product even if the product code has been
reused.

This application illustrates how to retrieve the LABEL_NAME, GCN_SEQNO, LBLRID, First Databank Product
First Delivery Date (FDB_PRODUCT_FIRST_DELIVERY_DT), and the FDB Product Obsolete Date (
FDB_PRODUCT_OBSOLETE_DT) for a given NDC.

1. Retrieve the EXT_PRODUCT_CD under evaluation with the associated External Product Code Type
Identifier (EXT_PRODUCT_CD_TYPE_ID) from the External Product Code Table
(RPRDPC0_EXT_PRODUCT_CD) where the Product Status Code (FDB_PRODUCT_STATUS_CD)
equals 0 (Active).

2. Retrieve the First Databank Product Identifier (FDB_PRODUCT_ID) associated with the
EXT_PRODUCT_CD and EXT_PRODUCT_CD_TYPE_ID where the desired Date of Use is equal to or
after the External Product Code Start Date (EXT_PRODUCT_CD_START_DT) and is before the External
Product Code End Date (EXT_PRODUCT_CD_END_DT), or where the EXT_PRODUCT_CD_END_DT is
null.

3. Use the FDB_PRODUCT_ID from step 2 to continue navigation to the First Databank Product Master
Table (RPRD0_PRODUCT) to retrieve the GCN_SEQNO, the LBLRID, the LABEL_NAME (i.e. LN60), the
FDB_PRODUCT_FIRST_DELIVERY_DT, or the FDB_PRODUCT_OBSOLETE_DT.

The FDB_PRODUCT_FIRST_DELIVERY_DT is identical to the Date of AddNDC column (DADDNC) in

the NDC Table (RNDC14_NDC_MSTR), and the FDB_PRODUCT_OBSOLETE_DT is identical as the
Obsolete Date (OBSDTEC) column in the RNDC14_NDC_MSTR Table.

For EXT_PRODUCT_CDs that have an EXT_PRODUCT_CD_TYPE_ID of 1, NDC11 (NCPDP

Formatted), the EXT_PRODUCT_CD will be identical to the NDC on the RNDC14_NDC_MSTR Table.

ExampleDetermining the FDB Product ID and Associated Product Information Given an External Product Code
(Such as an NDC)

For the purpose of demonstrating this application, the following scenario is used: A user is attempting to
determine the First Databank Product Identifier (FDB_PRODUCT_ID) using the External Product Code (
EXT_PRODUCT_CD) of 63304079010 and knows the specific date of use for the given product.

1. Retrieve the EXT_PRODUCT_CD under evaluation (in this case, a value of 63304079010) with the
associated External Product Code Type Identifier (EXT_PRODUCT_CD_TYPE_ID) from the External
Product Code Table (RPRDPC0_EXT_PRODUCT_CD) (in this case, the EXT_PRODUCT_TYPE_ID

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equals a value of 1).

2. Retrieve the First Databank Product Identifier (FDB_PRODUCT_ID) associated with the
EXT_PRODUCT_CD and the EXT_PRODUCT_TYPE_ID retrieved in step 1, where the desired Date of
Use (in this case, a date of 20130601) is greater than or equal to the External Product Code Start Date (
EXT_PRODUCT_CD_START_DT) and is less than the External Product Code End Date (
EXT_PRODUCT_CD_END_DT) or where the EXT_PRODUCT_CD_END_DT is null.
In this case, an FDB_PRODUCT_ID value of 313504 is retrieved.

EXT_PRODUCT_C EXT_PRODUCT_C EXT_PRODUCT_C EXT_PRODUCT_C FDB_PRODUCT_ID

D D_START_DT D_END_DT D_TYPE_ID

63304079010 20061220 Null 1 313504

3. Use the FDB_PRODUCT_ID from step 3 (in this case, a value of 313504) to continue navigation to the
First Databank Product Master Table (RPRD0_PRODUCT) to retrieve the Clinical Formulation Identifier (
GCN_SEQNO) (in this case, a value of 16577), the Labeler Identifier (LBLRID) (in this case a value of
A63304), the Label Name (LABEL_NAME) (in this case, SIMVASTATIN 10 MG TABLET), the First
Databank Product First Delivery Date (FDB_PRODUCT_FIRST_DELIVERY_DT) (in this case, a value of
20061220), and the FDB Product Obsolete Date (FDB_PRODUCT_OBSOLETE_DT) (in this case, a value
20130630).

FDB_PRODUC GCN_SEQNO LBLRID LABEL_NAME FDB_PRODUC FDB_PRODUC

T_ID T_FIRST_DELI T_OBSOLETE_
VERY_DT DT

313504 16577 A63304 SIMVASTATIN 20061220 20130630

10 MG TABLET

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Identifying Re-used External Product Codes

The purpose of this application is to demonstrate how customers can:

Identify the External Product Codes (EXT_PRODUCT_CD) (NDCs) that have been reused.
Access certain core historical information about any such product whether it has been reused or not, such
as the Label Name (LABEL_NAME), Clinical Formulation ID (GCN_SEQNO), or Labeler ID (LBLRID).

This application illustrates how to retrieve the LABEL_NAME, GCN_SEQNO, LBLRID, First Databank Product
First Delivery Date (FDB_PRODUCT_FIRST_DELIVERY_DT), and the FDB Product Obsolete Date (
FDB_PRODUCT_OBSOLETE_DT) for a given NDC.

1. Retrieve the First Databank Product Identifier (FDB_PRODUCT_ID) from the External Product Code Table
(RPRDPC0_EXT_PRODUCT_CD) for the product in question using the application Determining the FDB
Product ID and Associated Product Information Given an External Product Code (Such as an NDC) where
the External Product Code (EXT_PRODUCT_CD) equals the product code in question.

2. If multiple FDB_PRODUCT_IDs are returned, the EXT_PRODUCT_CD has been reused.

3. Retrieve the FDB_PRODUCT_ID associated with the EXT_PRODUCT_CD and

EXT_PRODUCT_CD_TYPE_ID where the desired Date of Use is equal to or after the External Product
Code Start Date (EXT_PRODUCT_CD_START_DT) and is before the External Product Code End Date (
EXT_PRODUCT_CD_END_DT), or where the EXT_PRODUCT_CD_END_DT is null.

4. Use the FDB_PRODUCT_ID from step 3 to continue navigation to the First Databank Product Master
Table (RPRD0_PRODUCT) to retrieve the GCN_SEQNO, the LBLRID, the LABEL_NAME (i.e. LN60), the
FDB_PRODUCT_FIRST_DELIVERY_DT, or the FDB_PRODUCT_OBSOLETE_DT.

The FDB_PRODUCT_FIRST_DELIVERY_DT is identical to the Date of AddNDC column (DADDNC) in

the NDC Table (RNDC14_NDC_MSTR), and the FDB_PRODUCT_OBSOLETE_DT is identical to the
Obsolete Date (OBSDTEC) column in the RNDC14_NDC_MSTR Table.

For EXT_PRODUCT_CDs that have an EXT_PRODUCT_CD_TYPE_ID of 1, NDC11 (NCPDP

Formatted), the EXT_PRODUCT_CD will be identical to the NDC on the RNDC14_NDC_MSTR Table.

ExampleIdentifying Re-used External Product Codes (Such as an NDC)

For the purpose of demonstrating this application, the following scenario is used: A user is attempting to
determine whether an NDC (or External Product Code [EXT_PRODUCT_CD]) 58016036230 has been re-used.
The user knows the specific date of use for the given product.

1. Retrieve the EXT_PRODUCT_CD under evaluation with the associated External Product Code Type
Identifier (EXT_PRODUCT_CD_TYPE_ID) from the External Product Code Table
(RPRDPC0_EXT_PRODUCT_CD) (in this case, an EXT_PRODUCT_CD value of 58016036230 and the
EXT_PRODUCT_TYPE_ID equals a value of 1).

2. Retrieve the First Databank Product Identifier (FDB_PRODUCT_ID) associated with the

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2.
EXT_PRODUCT_CD (in this case 58016036230) and the EXT_PRODUCT_TYPE_ID (in this case, 1)
where the desired Date of Use (in this case, a date of 20050601) is greater than or equal to the External
Product Code Start Date (EXT_PRODUCT_CD_START_DT) and is less than the External Product Code
End Date (EXT_PRODUCT_CD_END_DT) or where the EXT_PRODUCT_CD is a value of 20060511.
In this case, an FDB_PRODUCT_ID value of 272140 is retrieved.

EXT_PRODUCT_C EXT_PRODUCT_C EXT_PRODUCT_C EXT_PRODUCT_C FDB_PRODUCT_ID

D D_START_DT D_END_DT D_TYPE_ID

58016036230 20040415 20060511 1 272140

3. Use the FDB_PRODUCT_ID from step 2 (in this case, a value of 272140) to continue navigation to the
First Databank Product Master Table (RPRD0_PRODUCT) to retrieve the Clinical Formulation Identifier (
GCN_SEQNO) (in this case, a value of 390) the Labeler Identifier (LBLRID) (in this case a value of A58016
), the Label Name (LABEL_NAME) (in this case, ZESTRIL 10 MG TABLET), the First Databank Product
First Delivery Date (FDB_PRODUCT_FIRST_DELIVERY_DT) (in this case a value of 20040415), the
External Product Code (EXT_PRODUCT_CD) (in this case 58016036230), and the FDB Product Obsolete
Date (FDB_PRODUCT_OBSOLETE_DT) (in this case a value 20060511).

FDB_PRODUC GCN_SEQNO LBLRID LABEL_NAME FDB_PRODUC FDB_PRODUC

T_ID T_FIRST_DELI T_OBSOLETE_
VERY_DT DT

272140 390 A58016 ZESTRIL 10 MG 20040415 20060511

TABLET

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Packaged Product ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

Packaged Product Tables

Packaged Product ERD

Packaged Product Tables

Alternative NDC Ingredient Strength Link Table
External Product Code Table
External Product Code Description Table
FDA Application Relationship Table
FDA Application Relationship Type Table
FDA Drug Application Type Table
First Databank Product Master Table
First Databank Product Status Description Table
Labeler Identifier Description Table
NDC Attribute Table
NDC Attribute Type Description Table
NDC Attribute Value Description Table
NDC/HIC_SEQN Inactive Ingredient Relation Table
NDC Inactive Ingredients Reviewed Master Table
NDC Table
NDC to FDA Drug Application Number Table
NDC to FDA NDA/ANDA Table
NDC to Route Relationship Table
Orange Book Code Description Table
Orange Book Code Relation Table
Packaged Product (NDC) to Dosage Form Link Table
Packaged Product Package Type Description Table

Packaged Product ERD

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Alternative NDC Ingredient Strength Link Table

Table Name RPEINS0_NDC_STR_LINK

Revision Activity add. 7-1-2013

Purpose Relates an NDC to its Normalized and Total Package

strength values for each ingredient.
This table includes the same strength components - such
as strength number, unit of measure (UOM), and time - as
the analogous Clinical Formulation Ingredient Strength
Component Table.
This table is also populated with NDC-specific normalized
and total package strength data. See the Strength
Concentration Type Table for descriptions of these strength
types.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

PF HIC_SEQN Hierarchical N 6 9(6)

Ingredient Code
Sequence
Number (Stable
Identifier)

PF STR_CONC_TYP Strength N 8 9(8)

E_ID Concentration
Type Identifier

STRENGTH_STA Ingredient N 1 9(1)

TUS_CODE Strength Status
Code

INGREDIENT_ST Ingredient N 20 9(13).9(6)

R Strength

F INGREDIENT_UO Ingredient N 8 9(8)

M_MSTR_ID Strength Unit of
Measure Master
Identifier

STRENGTH_TYP Ingredient N 1 9(1)

_CODE Strength Type
Code

VOLUME Total Ingredient N 20 9(13).9(6)

Volume

F VOLUME_UOM_ Ingredient Volume N 8 9(8)

MSTR_ID Unit of Measure
Master Identifier

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ALT_STR Alternative N 20 9(13).9(6)

Ingredient
Strength

F ALT_STR_UOM_ Alternative N 8 9(8)

MSTR_ID Ingredient
Strength Unit of
Measure Master
Identifier

ALT_STRENGTH Alternate N 1 9(1)

_TYP_CODE Ingredient
Strength Type
Code

TIME_VALUE Ingredient N 6 9(3).9(3)

Strength Time
Value

F TIME_UOM_MST Ingredient N 8 9(8)

R_ID Strength Time
Unit of Measure
Master Identifier

RANGE_MAX Ingredient N 20 9(13).9(6)

Strength Range
Maximum

RANGE_MIN Ingredient N 20 9(13).9(6)

Strength Range
Minimum

F DOSAGE_FORM Dosage Form N 8 9(8)

_ATTRIBUTE_ID Attribute Identifier

INGREDIENT_SO Ingredient Sort N 4 9(4)

RT_ORDER Order

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External Product Code Table

Table Name RPRDPC0_EXT_PRODUCT_CD

Revision Activity add. 04-07-2014

Purpose Provides one or more industry standard product codes

(such as an NDC or GTIN) and the time frame in which this
product code was used to identify the FDB Product
Identifier.

Key Column Name Column Format Length Picture

Description

PF FDB_PRODUCT_ First Databank N 11 9(11)

ID Product Identifier

PF EXT_PRODUCT_ External Product N 8 9(8)

CD_TYPE_ID Code Type
Identifier

P EXT_PRODUCT_ External Product N 8 9(8)

CD_START_DT Code Start Date

EXT_PRODUCT_ External Product AN 100 X(100)

CD Code

EXT_PRODUCT_ External Product N 8 9(8)

CD_END_DT Code End Date

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External Product Code Description Table

Table Name RPRDPCD0_EXT_PRODUCT_CD_DESC

Revision Activity add. 04-07-2014

Purpose Provides a full text description, definition, and the meta data
needed to properly define an External Product Code Type
Identifier.

Key Column Column Format Length Picture

Description

P EXT_PRODUCT_ External Product N 8 9(8)

CD_TYPE_ID Code Type
Identifier

EXT_PRODUCT_ External Product AN 50 X(50)

CD_DESC Code Description

EXT_PRODUCT_ External Product AN 20 X(20)

CD_DATA_TYPE Code Data Type

EXT_PRODUCT_ External Product N 8 9(8)

CD_FIELD_LENG Code Field Length
TH

EXT_PRODUCT_ External Product AN 2000 X(2000)

CD_DEFINITION Code Definition

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FDA Application Relationship Table

Table Name RAPLR0_APPL_RELATION

Revision Activity add. 03-19-2015

Purpose Relates one FDA application type to another FDA

application type and identifies the time period during which
this relationship was approved.

Key Column Name Column Format Length Picture

Description

P APPL_RELATION FDA Application N 8 9(8)

_ID Relationship ID

F APPL_RELATION FDA Application N 4 9(4)

_TYPE_ID Relationship Type
ID

APPL_NBR1 Application AN 20 X(20)

Number 1

APPL_TYPE_ID1 FDA Application N 4 9(4)

Type ID 1

APPL_NBR2 FDA Application AN 20 X(20)

Number 2

APPL_TYPE_ID2 FDA Application N 4 9(4)

Type ID 2

APPL_RELATION FDA Application N 8 9(8)

_START_DT Relationship Start
Date

APPL_RELATION FDA Application N 8 9(8)

_END_DT Relationship End
Date

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FDA Application Relationship Type Table

Table Name RAPLRT0_APPL_RELATION_TYPE

Revision Activity add. 03-19-2015

Purpose Relates the FDA Application Relationship Type ID to its text

description.

Key Column Name Column Format Length Picture

Description

P APPL_RELATION FDA Application N 4 9(4)

_TYPE_ID Relationship Type
ID

APPL_RELATION FDA Application AN 40 X(40)

_TYPE_DESC Relationship Type
Description

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FDA Drug Application Type Table

Table Name RAPPLTD0_FDA_APPL_TYPE

Revision Activity add. 02-28-07

Purpose Provides the text description for an FDA Drug Application

Type Code.

Key Column Name Column Format Length Picture

Description

P APPL_TYPE_CD FDA Drug N 4 9(4)

Application Type
Code

APPL_TYPE_CD FDA Drug AN 50 X(50)

_DESC Application Type
Code

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First Databank Product Master Table

Table Name RPRD0_PRODUCT

Revision Activity add. 04-07-2014

Purpose Provides attributes of a First Databank Product Identifier,

including status, clinical formulation, label name and the
date range when these data elements are being actively
maintained in FDB content. The date format is
YYYYMMDD.

Key Column Name Column Format Length Picture

Description

P FDB_PRODUCT_ First Databank N 11 9(11)

ID Product Identifier

F FDB_PRODUCT_ First Databank AN 8 X(8)

STATUS_CD Product Status
Code

F GCN_SEQNO Clinical N 6 9(6)

Formulation ID

F LBLRID Labeler Identifier AN 6 X(6)

LABEL_NAME Label Name AN 255 X(255)

FDB_PRODUCT_ First Databank N 8 9(8)

FIRST_DELIVER Product First
Y_DT Delivery Date

FDB_PRODUCT_ First Databank N 8 9(8)

OBSOLETE_DT Product Obsolete
Date

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First Databank Product Status Description Table

Table Name RPRDSD0_PRODUCT_STATUS_DESC

Revision Activity add. 04-07-2014

Purpose Provides a full text status description and definition for the
First Databank Product Status Code.

Key Column Name Column Format Length Picture

Description

P FDB_PRODUCT_ First Databank AN 8 X(8)

STATUS_CD Product Status
Code

FDB_PRODUCT_ First Databank AN 50 X(50)

STATUS_DESC Product Status
Description

FDB_PRODUCT_ First Databank AN 2000 X(2000)

STATUS_DEFINI Product Status
TION Definition

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Labeler Identifier Description Table

Table Name RLBLRID3_LBLR_DESC

Revision Activity rev.07-29-2004

Purpose Relates the Labeler Identifier to its text description and

provides attributes of that association.

Key Column Name Column Format Length Picture

Description

P LBLRID Labeler Identifier AN 6 X(6)

MFG Manufacturer AN 15 X(15)

Name

LBLRIND Labeler Indicator AN 1 X(1)

Code

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NDC Attribute Table

Table Name RNDCAT0_NDC_ATTRIBUTE

Revision Activity add. 12-09-2010

Purpose Provides NDC attributes.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

PF NDC_ATTRIBUT NDC Attribute N 4 9(4)

E_TYPE_CD Type Code

P NDC_ATTRIBUT NDC Attribute N 4 9(4)

E_SN Sequence
Number

NDC_ATTRIBUT NDC Attribute AN 50 X(50)

E_VALUE Value

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NDC Attribute Type Description Table

Table Name RNDCTD0_NDC_ATTRIBUTE_TYP_DSC

Revision Activity add. 12-09-2010

Purpose Provides a description of an NDC attribute type code.

Key Column Name Column Format Length Picture

Description

P NDC_ATTRIBUT NDC Attribute N 4 9(4)

E_TYPE_CD Type Code

NDC_ATTRIBUT NDC Attribute AN 100 X(100)

E_TYPE_DSC Type Code
Description

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NDC Attribute Value Description Table

Table Name RNDCVD0_NDC_ATTRIBUTE_VALU_DSC

Revision Activity add. 12-09-2010

Purpose Provides descriptions of coded values for NDC attributes

that have an additional set of values.

Key Column Name Column Format Length Picture

Description

PF NDC_ATTRIBUT NDC Attribute N 4 9(4)

E_TYPE_CD Type Code

P NDC_ATTRIBUT NDC Attribute AN 50 X(50)

E_VALUE Value

NDC_ATTRIBUT NDC Attribute AN 50 X(50)

E_VALUE_DSC Value Description

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NDC-HIC_SEQN Inactive Ingredient Relation Table

Table Name RNDCINH0_NDC_INACTV_LINK

Revision Activity add. 07-29-2004

Purpose Links each reviewed packaged product to one or more

Inactive Ingredient HIC_SEQN. Packaged products without
Inactive Ingredients are not listed in this table.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

PF HIC_SEQN Hierarchical N 6 9(6)

Ingredient Code
Sequence
Number (Stable
ID)

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NDC Inactive Ingredients Reviewed Master Table

Table Name RNDCINR0_INACTV_REVIEWED

Revision Activity add.07-29-2004

Purpose Provides all packaged products that have been checked for
Inactive Ingredients, whether or not they actually contain
inactive ingredients.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

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NDC Table

Table Name RNDC14_NDC_MSTR

Revision Activity rev.11-18-13

Purpose Provides attributes of a packaged product.

Key Column Name Column Format Length Picture

Description

P NDC National Drug AN 11 X(11)

Code

F LBLRID Labeler Identifier AN 6 X(6)

F GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PS Package Size N 12 9(8).9(3)

DF Drug Form Code AN 1 X(1)

AD Additional AN 20 X(20)
Descriptor

LN Label Name AN 30 X(30)

BN Brand Name AN 30 X(30)

PNDC Previous National AN 11 X(11)

Drug Code

REPNDC Replacement AN 11 X(11)

National Drug
Code

NDCFI NDC Format AN 1 X(1)

Indicator

DADDNC Date of N 8 9(8)

AddNDC

DUPDC Date of N 8 9(8)

UpdateNDC

DESI DESI Drug AN 1 X(1)

Indicator

DESDTEC DESI Status N 8 9(8)

Change Effective
Date

DESI2 DESI2 Drug AN 1 X(1)

Indicator

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DES2DTEC DESI2 Status N 8 9(8)

Change Effective
Date

DEA Drug Enforcement AN 1 X(1)

Administration
Code

CL Class AN 1 X(1)

GPI This column is not AN 1 X(1)

currently being
used.

HOSP Hospital Selection AN 1 X(1)

Indicator

INNOV Innovator AN 1 X(1)

Indicator

IPI Institutional AN 1 X(1)

Product Indicator

MINI Mini Selection AN 1 X(1)

Indicator

MAINT Maintenance Drug AN 1 X(1)

Indicator

OBC Orange Book AN 2 X(2)

Code

OBSDTEC Obsolete Date N 8 9(8)

PPI Patient Package AN 1 X(1)

Insert Indicator

STPK Standard Package AN 1 X(1)

Indicator

REPACK Repackaged AN 1 X(1)

Indicator

TOP200 Top 200 Drugs AN 3 X(3)

Indicator

UD Unit Dose AN 1 X(1)

Indicator

CSP Case Pack N 7 9(7)

NDL_GDGE Needle Gauge N 6 9(2).9(3)

NDL_LNGTH Needle Length N 6 9(2).9(3)

SYR_CPCTY Syringe Capacity N 6 9(2).9(3)

SHLF_PCK Shelf Pack N 7 9(7)

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SHIPPER Shipper Quantity N 7 9(7)

HCFA_FDA FDA Therapeutic AN 2 X(2)

Equivalency Code

HCFA_UNIT HCFA Unit AN 3 X(3)

Indicator

HCFA_PS HCFA Units Per N 12 9(8).9(3)

Package

HCFA_APPC HCFA FDA N 8 9(8)

Approval Date

HCFA_MRKC HCFA Market N 8 9(8)

Entry Date

HCFA_TRMC HCFA N 8 9(8)

Termination Date

HCFA_TYP HCFA Drug Type AN 1 X(1)

Code

HCFA_DESC1 HCFA DESI N 8 9(8)

Effective Date

HCFA_DESI1 HCFA DESI Code AN 1 X(1)

UU Unit of Use AN 1 X(1)

Indicator

PD Package AN 10 X(10)
Description

LN25 This column is not AN 25 X(25)

currently being
used.

LN25I Label Name - AN 1 X(1)

25/Generic Name
Use Indicator

GPIDC This column is not N 8 9(8)

currently being
used.

BBDC This column is not N 8 9(8)

currently being
used.

HOME Home Health AN 1 X(1)

Selection Indicator

INPCKI Inner Package AN 1 X(1)

Indicator

OUTPCKI Outer Package AN 1 X(1)

Indicator

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OBC_EXP Expanded Orange AN 2 X(2)

Book Code

PS_EQUIV Package Size N 12 9(8).9(3)

Equivalent Value

PLBLR Private Labeler AN 1 X(1)

Indicator

TOP50GEN Top 50 Generics AN 2 X(2)

OBC3 Orange Book AN 3 X(3)

Code; three-byte
version

GMI Generic AN 1 X(1)

Manufacturer
Indicator

GNI Generic Name AN 1 X(1)

Indicator

GSI This column is not AN 1 X(1)

currently being
used.

GTI Therapeutic AN 1 X(1)

Equivalence
Indicator

NDCGI1 Multi-Source/Singl AN 1 X(1)

e Source Indicator
(NDC-Level)

HCFA_DC HCFA Drug AN 1 X(1)

Category

LN60 Label Name - 60 AN 60 X(60)

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NDC to FDA Drug Application Number Table

Table Name RAPPLNA0_FDA_NDC_APPL

Revision Activity add. 02-28-07

Purpose Links an NDC to its FDA drug application numbers.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

P APPL_NO FDA Drug AN 25 X(25)

Application
Number

F APPL_TYPE_CD FDA Drug N 4 9(4)

Application Type
Code

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NDC to FDA NDA-ANDA Table

Table Name RAPPLSL0_FDA_NDC_NDA_ANDA

Revision Activity add. 02-28-07

Purpose Links an NDC to its FDA NDA/ANDA application status,

FDA trade name, and FDA unique identifier.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

NDA_IND NDA Status N 1 9(1)

Indicator

ANDA_IND ANDA Status N 1 9(1)

Indicator

LISTING_SEQ_N FDA Listing N 7 9(7)

O Sequence
Number

TRADENAME FDA Trade Name AN 125 X(125)

When the proprietary name from the external source exceeds 125 characters, the Label Name-60 ( LN60)
will be assigned to the "TRADENAME."

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NDC to Route Relationship Table

Table Name RPEINR0_NDC_RT_RELATION

Revision Activity add. 07-01-2013

Purpose Contains the association of an NDC to its Parent and

Clinical Routes and whether the Clinical Route(s) in the
relationship are included on product labeling.
Each NDC may have zero to many related parent and
clinical routes.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

PF PARENT_RT_ID Parent Route N 8 9(8)

Identifier

PF CLINICAL_RT_ID Clinical Route N 8 9(8)

Identifier

F RT_LABELED_ID Route Labeled N 8 9(8)

Identifier

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Orange Book Code Description Table

Table Name ROBCD0_OBC_DESC

Revision Activity original

Purpose Relates the Orange Book Code to its text description.

Key Column Name Column Format Length Picture

Description

P OBC Orange Book AN 2 X(2)

Code

P OBC_SN Orange Book Text N 2 9(2)

Sequence
Number

OBC_DESC Orange Book AN 60 X(60)

Code Description

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Orange Book Code Relation Table

Table Name ROBCNDC0_OBC_NDC

Revision Activity original

Purpose Relates pharmaceutical and therapeutic equivalency

attributes to one another.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

OBC3 Orange Book AN 3 X(3)

Code; three-byte
version

GCN Formulation ID N 5 9(5)

GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

GTI Therapeutic AN 1 X(1)

Equivalence
Indicator

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Packaged Product (NDC) to Dosage Form Link Table

Table Name RPEIND0_NDC_DF_LINK

Revision Activity add.07-01-2013

Purpose Contains the associations between a packaged product and

its Final Dosage Form or Alternative Dosage Forms.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

PF DOSAGE_FORM Dosage Form N 8 9(8)

_ID Identifier

PF DOSAGE_FORM Dosage Form N 8 9(8)

_TYPE_ID Type Identifier

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Packaged Product Package Type Description Table

Table Name RPRDPKD0_PACKAGE_DESC

Revision Activity add.01-26-2016

Purpose Provides the description of the container that is in direct

contact with the product.

Key Column Name Column Format Length Picture

Description

P PACKAGE_TYPE Package N 8 9(8)

_ID Description
Identifier

PKG_TYPE_LON Package Type AN 50 X(50)

G_DESC Long Description

PKG_TYPE_SHO Package Type AN 10 X(10)

RT_DESC Short Description

ACTIVELY_USED Actively Used AN 1 X(1)

_IND Indicator

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Medication Name Concepts

Medication Name Concepts (MED) 3.0
General Information
Medication Name Concepts Editorial Policies
MED Applications
ERD and Technical Specifications

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MED General Information

Overview
Concepts
MED_NAME_ID
ROUTED_MED_ID
ROUTED_DOSAGE_FORM_MED_ID
MEDID
MED_CONCEPT_ID
MED_CONCEPT_HICL_SRC_CD
GENERIC_MED_CONCEPT_ID
MED_NAME_SOURCE_CD
MEDID Reference Attributes
MED Concept/HICL_SEQNO Relation Table
Inactive Ingredient Columns and Tables
Roll-up
Inactive Ingredient Relation Tables
Inactive Ingredient Present/Not Present Count Columns
Total Products/Products Researched Count Columns
Medication Name Concept History Tables
Search Term Columns and Tables

Overview
Medication name concepts represent unique product trade and generic names. Healthcare providers typically use
medication name concepts with variable levels of specificity, depending on the application and the amount of
information available at the time. For example, when dispensing a prescription medication in the United States, a
packaged product is selected for dispensing and the related National Drug Code (NDC) or other numerical
product identifier is used for processing a claim with a payer. In contrast, when interviewing a patient to obtain a
medical history, all that may be available is the product name, route of administration (for example, oral), and
the dosage form (for example, tablet). In both situations, the healthcare professional needs to capture the
medication concept and perform a drug utilization review (DUR) to identify possible drug allergies, interactions, or
contraindications.

Drug knowledge is aggregated at the Clinical Formulation ID (GCN_SEQNO), Routed Medication ID (

ROUTED_MED_ID), and the Routed Generic ID (ROUTED_GEN_ID) levels in the First Databank (FDB)
knowledge base. Under certain circumstances, aggregated drug knowledge may not apply to all related
packaged products; more specific information may be found within product labels.

Concepts

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Medication Name Concepts (MED) provides descriptive names with stable numerical identifiers and related
attributes relative to the level of specificity of the identifier. For example, if the product name and route of
administration are all that is available, then the Routed Medication concept would be the appropriate medication
name concept. This medication name concept can then provide links to the clinical data appropriate to that level
of specificity. Although a great deal of clinical screening can be done at the routed medication level, a more
specific concept provides a greater number of associated attributes (such as route, dosage form, strength), and
therefore, greater specificity and more clinical detail.

The medication name concepts are:

Medication Name
Routed Medication
Routed Dosage Form Medication
Medication

Each concept builds upon the previous, moving from general to more specific by adding more information at each
level (when necessary).

ExampleMedication Name Concepts

Concept Example

Medication Name ampicillin

Routed Medication ampicillin Oral

Routed Dosage Form Medication ampicillin Oral Susp

Medication ampicillin 250 mg/5 mL Oral Susp

MED_NAME_ID

The MED Medication Name ID (MED_NAME_ID) represents the most general concept. It is a permanent numeric
identifier that represents a unique product or generic name and is used primarily for navigational purposes when
presenting name concepts to the end user. One MED Medication Name ID ( MED_NAME_ID) is linked to
zero-to-many MED Routed Medication IDs (ROUTED_MED_ID).

ROUTED_MED_ID

The MED Routed Medication ID (ROUTED_MED_ID) is a permanent numeric identifier that represents the
product or generic name and route of administration. It is used for navigational purposes or to profile patient
medications when the dosage form is unknown or not required. It is also used for entry into some clinical
modules. One ROUTED_MED_ID is linked to zero-to-many MED Routed Dosage Form Medication IDs (
ROUTED_DOSAGE_FORM_MED_ID).

ROUTED_DOSAGE_FORM_MED_ID

The MED Routed Dosage Form Medication ID (ROUTED_DOSAGE_FORM_MED_ID) is a permanent numeric

identifier that represents the product or generic name, route of administration, and dosage form. It is used for
navigational purposes, for profiling patient medications when the strength is unknown, or for ordering

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prescriptions in an in-patient setting when the dosage form strength is not required. For example, when
prescribing Oral amoxicillin Capsules, 500 mg every morning in an in-patient setting, the prescriber is not
concerned about whether it is administered as one 500 mg capsule, two 250 mg capsules, or four 125 mg
capsules. One ROUTED_DOSAGE_FORM_MED_ID is linked to zero-to-many Medication IDs (MEDID).

The description of the Routed Dosage Form Medication ID contains the route and dosage form only when
necessary to resolve ambiguity, provide clarification, or to aid in patient safety.

MEDID

The MED Medication ID (MEDID) represents the most specific name concept. It is a permanent numeric identifier
that represents the unique combination of product or generic name, route of administration, dosage form,
strength, and strength unit-of-measure. Examples of its use include outpatient prescribing and patient medication
profiling. In contrast to the in-patient setting, outpatient prescribing must be specific as to dosage form and
strength. For example, when prescribing Oral amoxicillin Capsules, 500 mg every morning the dose required
could be achieved using different strengths. The prescription could be written using oral amoxicillin 500 mg, 250
mg, or 125 mg tablets. Each prescription would use a different MEDID to identify the specific dosage form and
strength of the drug that should be dispensed to the patient. Attributes of the MEDID provide drug information and
access to clinical and patient education modules.

The description of the Medication ID contains the route, dosage form, and strength only when necessary
to resolve ambiguity, provide clarification, or to aid in patient safety.

MED_CONCEPT_ID

The MED Concept ID (MED_CONCEPT_ID) column is located in the following two tables:

The MED Concept/HICL_SEQNO Relation Table (RMEDMHL0_MED_HICLSEQNO_LINK), which links a

given MED concept to its associated list of ingredients (HICL_SEQNO)
The MED Concept/Generic MED Relation Table (RMEDMGL0_MED_GENERIC_MED_LINK), which links
a given MED concept to its generically named companion ( GENERIC_MED_CONCEPT_ID)

The MED_CONCEPT_ID represents one of the following MED identifiers:

MED_NAME_ID
ROUTED_MED_ID
ROUTED_DOSAGE_FORM_MED_ID
MEDID

The MED Concept ID Type (MED_CONCEPT_ID_TYP) identifies which of these four concepts the corresponding
MED_CONCEPT_ID value reflects.

MED_CONCEPT_HICL_SRC_CD

The MED Concept HICL_SEQNO Source Code (MED_CONCEPT_HICL_SRC_CD) identifies the source of the

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associated MED concepts HICL_SEQNO. The MED_CONCEPT_HICL_SRC_CD is necessary because a given

MED_CONCEPT_ID may have HICL_SEQNO data based on its Clinical Formulation ID ( GCN_SEQNO) or on a
specific NDC.

To check the obsolete status of the MED Concept/HICL_SEQNO association consult the MED Concept Obsolete
Date (MED_CONCEPT_OBSDATEC) column. If all NDCs or Clinical Formulation IDs (GCN_SEQNOs) linked to
both the MED Concept and HICL_SEQNO are now obsolete and no longer on the market, the
MED_CONCEPT_OBSDATEC reflects the most recent obsolete date. If this column does not contain a date then
products are still on the market to support the association, and therefore the association is not considered out of
date.

General MED Concepts (like MED Name) are likely to return multiple HICL_SEQNO. Systems should be
able to accommodate multiple HICL_SEQNO results.

GENERIC_MED_CONCEPT_ID

The Generically Named MED Concept ID (GENERIC_MED_CONCEPT_ID) identifies a MED concepts

generically named companion. This generically named companion exists at the same level of abstraction as its
branded companion, but it does not reflect brand information. For example, Prozacs generically named
companion is fluoxetine.

Each of the example concepts (Prozac and fluoxetine) has a MED_NAME_ID listed in the MED Medication Name
Table (RMINMID1_MED_NAME), and these two MED_NAME_IDs are associated with each other in the MED
MED Concept/Generic MED Relation Table (RMEDMGL0_MED_GENERIC_MED_LINK). The following diagram
illustrates the relationship between Prozac and its generically named companion:

This example illustrates the association between the MEDID for Tylenol Junior 160 mg Oral Tab and its
generically named companion, as listed in the MED Medication Table (RMIID1_MED). In this example the
MED_CONCEPT_ID_TYPs value is 3 instead of 1, as the value of 3 means the associated MED_CONCEPT_ID
is a Medication, not a Medication Name:

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To obtain the GENERIC_MED_CONCEPT_IDs text description (MED_NAME) use the appropriate MED table. In
the example above the MED Concept ID Type (MED_CONCEPT_ID_TYP_DESC) value was 3, so the
Medication table was used. The four possible values for MED_CONCEPT_ID_TYP are listed below:

If MED_CONCEPT_ID_TYP = 1, use RMINMID1_MED_NAME

If MED_CONCEPT_ID_TYP = 2, use RMIRMID1_ROUTED_MED
If MED_CONCEPT_ID_TYP = 7, use RMIDFID1_ROUTED_DOSE_FORM_MED
If MED_CONCEPT_ID_TYP = 3, use RMIID1_MED

If a MED Concept links to itself in the RMEDMGL0_MED_GENERIC_MED_LINK table, the MED Concept does
not have a different generically named companion because it is a generically named companion. For example,
the following listing exists for the generically named companion acetaminophen 160 mg Oral Tab:

See Retrieving a MED Concepts Generically Named Companion for more information.

MED_NAME_SOURCE_CD

The MED Medication Name Source Code (MED_NAME_SOURCE_CD) provides information about the origin of
the MEDID. It designates that the name concept was created to represent a Clinical Formulation, a product, or
both. The value is programmatically determined based upon the relationship between the MEDID and the Clinical
Formulation ID (GCN_SEQNO) and/or the MEDID and the IDC. Retired MEDIDs and MEDIDs that have never
been associated to a formulation concept will have a MED_NAME_SOURCE_CD of 9 (Unassociated).

MEDID Reference Attributes

The MEDID has 10 reference attributes that provide information about the active NDCs that are associated
directly to the brand MEDIDs or indirectly to the generic MEDIDs. These reference values are:

MED Reference Federal Legend Indicator (MED_REF_FED_LEGEND_IND)derived from the NDC Class
(CL) value
MED Reference Federal DEA Class Code (MED_REF_DEA_CD)derived from the NDC Drug
Enforcement Administration Code (DEA) value
MED Reference Multi-Source Code (MED_REF_MULTI_SOURCE_CD)derived from the
Multi-Source/Single Source Indicator (NDCGI1) value

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MED Reference Generic Medication Name Code (MED_REF_GEN_DRUG_NAME_CD)derived from the

NDC Generic- Named Drug Indicator (GNI) value
MED Reference Generic Comparative Price Code (MED_REF_GEN_COMP_PRICE_CD)This attribute
is no longer supported. All records show a value of 9, indicating No Value.
MED Reference Generic Price Spread Code (MED_REF_GEN_SPREAD_CD)This attribute is no longer
supported. All records show a value of 9, indicating No Value.
MED Reference Innovator Indicator (MED_REF_INNOV_IND)derived from the NDC Innovator Indicator (
INGREDIENT_SORT_ORDER) value
MED Reference Generic Therapeutic Equivalence Code (MED_REF_GEN_THERA_EQU_CD)derived
from the NDC Therapeutic Equivalence Indicator (GTI) value
MED Reference DESI Indicator (MED_REF_DESI_IND)derived from the NDC FDA DESI Drug Indicator
(DESI) value
MED Reference DESI2 Indicator (MED_REF_DESI2_IND)derived from the NDC FDA DESI2 Drug
Indicator (DESI2) value

Changes to the related attributes of obsolete NDCs do not impact the reference attributes of the associated
MEDIDs. Retired MEDIDs and MEDIDs that have never been associated (directly or indirectly) to NDCs will have
reference attributes of 9 (No Value).

MED Concept/HICL_SEQNO Relation Table

The MED MED Concept/HICL_SEQNO Relation Table (RMEDMHL1_MED_HICLSEQNO_LINK) provides linkage

between medication concept identifiers (Medication ID, Routed Dosage Form Medication ID, Routed Medication
ID, and Medication Name ID) and their list of ingredients. The medication concepts contained within the table
have one of the following statuses:

Active
Inactive
Replaced
Unassociated

The only type of medication concept that does not appear within RMEDMHL0_MED_HICLSEQNO_LINK table
are those marked with a status of Retired.

A small number of Replaced concepts do not appear in the RMEDMHL0_MED_HICLSEQNO_LINK table

as they have been determined to be too broad to be useful in allergy checking (for example, Bulk
Chemicals Liquid), or they are medical supplies that would not normally participate in allergy checking.

Inactive Ingredient Columns and Tables

The following columns are provided in the MED module:

Inactive Ingredient Not Present Count (INACTV_NOT_PRES_CNT)

Inactive Ingredient Present Count (INACTV_PRES_CNT)

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Products Researched for Inactive Ingredients Count (PRODUCTS_RESEARCHED_CNT)

Total Products Count (TOTAL_PRODUCTS_CNT)

The following tables are provided in the MED module:

MED MEDID/Inactive Ingredient Relation Table (RMEDIN0_MEDID_INACTV_LINK)

MED Routed Dosage Form Medication ID/Inactive Ingredient Relation Table
(RMEDDIN0_RDFMID_INACTV_LINK)
MED Medication Name ID/Inactive Ingredient Relation Table (RMEDNIN0_MNID_INACTV_LINK)
MED Routed Medication ID/Inactive Ingredient Relation Table (RMEDRIN0_RMID_INACTV_LINK)
MED MEDID Inactive Ingredient Study Master Table (RMEDIS0_MEDID_STUDY_TABLE)
MED Routed Dosage Form Medication ID Inactive Ingredient Study Master Table
(RMEDDIS0_ROUTED_DF_STUDY_TABLE)
MED Medication Name ID/Inactive Ingredient Study Master Table
(RMEDNIS0_MED_NAME_STUDY_TABLE)
MED Routed Medication ID Inactive Ingredient Study Master Table
(RMEDRIS0_ROUTED_MED_STDY_TBL)

The following sections provide detailed descriptions of these columns and tables.

Roll-up

The summation of data at the Clinical Formulation Identifier and at other important concepts will commonly be
referred to as a roll-up of data from the associated source NDCs. Please note that rolled up data is no longer
NDC-specific; therefore, labeled and unlabeled source information no longer applies and is only present in the
NDC to Route Relationship Table (RPEINR0_NDC_RT_RELATION).

Inactive Ingredient Relation Tables

These tables link the MED Concepts to the inactive ingredients in their formulations:

RMEDIN0_MEDID_INACTV_LINK
RMEDDIN0_RDFMID_INACTV_LINK
RMEDNIN0_MNID_INACTV_LINK
RMEDRIN0_RMID_INACTV_LINK

If any NDCs of a MED Concept include an inactive ingredient, its respective table links its HIC_SEQN to the MED
Concept. Additionally the product count for this MED Concept changes. The MED/Ingredient associations reflect
active products, and products that have been retired or replaced for less than or equal to one year.

Inactive Ingredient Present/Not Present Count Columns

The INACTV_PRES_CNT and INACTV_NOT_PRES_CNT columns reside in the Inactive Ingredient Relation
tables. These columns report the number of NDCs linked to the given MED Concept that either have or do not
have the associated inactive ingredient HIC_SEQN in their formulation. The counts only include NDCs that have
already been reviewed for inactive ingredients as reflected in the NDC Inactive Ingredients Reviewed Master

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Table (RNDCINR0_INACTV_REVIEWED). These counts may change with continued FDB inactive ingredient
research.

These counts reflect active products, and products that have been retired or replaced for less than or equal to one
year.

See the application for Retrieving Inactive Ingredient Statistics for a Medication Name Concept for an example of
how to use these columns.

Total Products/Products Researched Count Columns

The TOTAL_PRODUCTS_CNT and PRODUCTS_RESEARCHED_CNT reside in the following four MED tables:

RMEDNIS0_MED_NAME_STUDY_TABLE
RMEDIS0_MEDID_STUDY_TABLE
RMEDDIS0_ROUTED_DF_STUDY_TABLE
RMEDRIS0_ROUTED_MED_STDY_TBL

These count values report the number of NDCs linked to the given MED Concept that have been researched by
FDB for inactive ingredient information, and the total number of NDCs linked to the MED Concept. These counts
may change with continued FDB inactive ingredient research.

These counts reflect active products, and products that have been retired or replaced for less than or equal to one
year.

See the application for Retrieving a MED Concepts Inactive Ingredient Statistics for an example of how to use
these columns.

Medication Name Concept History Tables

MED History tables support the stability of the Medication Name Concepts by providing replaced concept
identifier history information., as well as NDC and MED Medication ID ( MEDID) relationship change history
information.

The following Medication Name Concept identifier history tables indicate when a given identifier has been
replaced; and provide the replacement identifier.

MED Medication Name Replacement History Table (RMINMRH1_MED_NAME_HIST)

MED Routed Dosage Form Replacement History Table (RMIDFRH1_ROUTED_DOSE_FORM_HIST)
MED Routed Medication Replacement History Table (RMIRMRH1_ROUTED_MED_HIST)
MED Medication Replacement History Table (RMIRH1_MED_HIST)

The NDC/MEDID relationship change history tables support change management of stored MEDIDs in healthcare
systems by providing details of the changes that occur within the MED NDC to Medication ID Cross-Reference
Table (RMINDC1_NDC_MEDID) and the MED NDC to Generic Medication ID Cross-Reference Table
(RMEDNGM0_NDC_GEN_MEDID). The MEDIDs contained within these tables have one of the following status
types:

Active

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Inactive
Replaced
Retired
Unassociated

When concepts are modified (e.g., become replaced, retired, unassociated, etc.) or when NDC/MEDID
relationships change, drug products stored in healthcare systems, such as patient profiles and medication
dispensing systems, can become orphaned or obsolete. The following tables provide the means to create reports
or tools that mitigate the affects of changes, and define the reason(s) and dates for the changes:

MED NDC/MEDID Relation History Table (RMEDNMH0_NDC_MEDID_HIST)

MED NDC/Generic MEDID Relation History Table (RMEDNGH0_NDC_GEN_MEDID_HIST)
MED NDC/MEDID Move History Reason Table (RMEDNMR0_NDC_MEDID_REASON)
MED NDC/Generic MEDID Move History Reason Table (RMEDNGR0_NDC_GEN_MEDID_REASON)
MED Move Reason Description Table (RMEDMRD0_MOVE_REASON_DESC)

All records within the NDC/MEDID relationship change history tables are static and reflect the data as it was at
the time of the change indicated by the Production Date (PRODUCTION_DATE).

The reason information provides the reason code and description. Each change in the history table will have at
least one reason code that provides context around why the change took place. Please be aware that more than
one reason code may be assigned to a given change record.

Search Term Columns and Tables

The following tables are provided in the MED module for search terms:

MED Medication ID Search Term Table RMEDST0_MEDID_SEARCH_TERM

Search Term Type Description Table RMEDSTD0_SEARCH_TERM_TYPE_DESC

The MED Medication ID Search Term Table table links the MEDID to a SEARCH_TERM_TYPE_CD and
SEARCH_TERM_TEXT, which are the columns needed to build advanced search term functionality. The Search
Term Type Description Table is a description table that provides the description
(SEARCH_TERM_TYPE_CD_DESC) of the search term type codes (SEARCH_TERM_TYPE_CD). This table is
used to find the definitions of the codes.

The following columns are provided in the MED module for search terms:

MEDID
MED_MEDID_DESC
MEDICAL_SUPPLY_IND
SEARCH_TERM_TYPE_CD
SEARCH_TERM_TYPE_CD_DESC
SEARCH_TERM_TEXT

The three search term columns (SEARCH_TERM_TYPE_CD, SEARCH_TERM_TYPE_CD_DESC, and

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SEARCH_TERM_TEXT) are used for advanced search term functionality, including the ability to allow end users
to search for a MEDID by:

Description
Alternative names
Abbreviations and acronyms
Obsolete brand names
Medication description
Generic medication for a brand medication
Brand medication for a generic medication
Alternate brand for brand

The MEDICAL_SUPPLY_IND can be used to identify if a MEDID is for a medical supply or not. Developers can
use this column to enhance search result usability by filtering out or only exclusively displaying medical supplies.

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Medication Name Concepts Editorial Policies

This section provides information detailing the criteria that guided the inclusion of the data contained within the
module as well as information pertaining to limitations or exclusions when appropriate to the discussion.

Scope
Editorial Process
MAPs Enhancements

Scope
Medication Name Concepts provide name concepts at varying levels of specificity. These levels are brand or
generic name, route, dosage form, and strength. The medication name concepts are represented by permanent
numeric identifiers and are used for name navigation. The permanency of the numeric identifiers are supported
through the use of concept identifier history tables. In addition, changes in the relationship between NDCs and
MEDIDs are recorded within the relation change history tables.

Limitations

A MED Generic MEDID (GENERIC_MEDID) may be linked to more than one Clinical Formulation ID (
GCN_SEQNO). For example, at the Clinical Formulation ID (GCN_SEQNO) level, gentamicin sulfate injection 10
mg/ml exists in two unique Clinical Formulation IDs (GCN_SEQNOs) because packaging units of vial and ampul
are reflected in the dosage form. However, these Clinical Formulation IDs (GCN_SEQNOs) are associated with
only one MEDID. This MEDID represents the core, shared components of these Clinical Formulation IDs
(GCN_SEQNOs) namely ingredients, strength, and route and the true dosage form (solution): gentamicin sulfate
Injection Solution 10 mg/ml. Therefore, this one MEDID is linked to two Clinical Formulation IDs (GCN_SEQNOs).
Salts do not appear in the medication name concept descriptions when only one salt form of the medication name
exists. For example, acebutolol HCl is the only available form of acebutolol, so the medication name description
becomes acebutolol. Alternately, both albuterol and albuterol sulfate forms exist, so those medication name
descriptions exist.

Additionally, medication name concept descriptions have the following guidelines:

Route is not described when the dosage form is available in only one route
Dosage Form descriptions that are clinically familiar are added
Abbreviations that are unclear, misleading, or redundant are clarified, repositioned, or are removed
Salt descriptions are not present when a combination of the name, route, and dosage form uniquely
identify the medication concept

Starting July 21, 2005, the following improvements to the medication name concept descriptions were
implemented in the MED data:

Type of Change MEDID Current Medication New Medication

Description Description

Remove route, enhance 00244361 Biaxin XL 500 mg Oral Tb24 Biaxin XL 500 mg 24 hr Tab
dosage form

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Remove route, enhance 00224912 clarithromycin 500 mg Oral clarithromycin 500 mg 24 hr

dosage form Tb24 Tab

Remove route, enhance 00179043 Verelan PM 100 mg Oral Verelan PM 100 mg 24 hr

dosage form C24P Cap

Remove route and salt, 00263969 verapamil HCl 100 mg Oral verapamil 100 mg 24 hr Cap
enhance dosage form C24P

Enhance dosage form 00428868 Ancef 500 mg IV PgBk Ancef 500 mg IV Piggy Back

Enhance dosage form, 00225377 cefazolin sodium 500 mg IV cefazolin 500 mg IV Piggy
remove salt PgBk Back

Remove route 00176166 Sectral 200 mg Oral Cap Sectral 200 mg Cap

Remove route and salt 00275110 acebutolol HCl 200 mg Oral acebutolol 200 mg Cap
Cap

Remove route, enhance 00473583 Allegra-D 24 Hour 180 Allegra-D 24 Hour 180
dosage form, remove mg-240 mg Oral Tb24 mg-240 mg Tab
redundant time abbreviation

Remove route, enhance 00473577 fexofenadine-pseudoephedri fexofenadine-pseudoephedri

dosage form ne 180 mg-240 mg Oral ne 180 mg-240 mg 24 hr
Tb24 Tab

Remove route 00454012 Alpha Keri Top Oil Alpha Keri Oil

Remove route and 00195152 Bath Oil Top Oil Bath Oil
redundant dosage form
abbreviation

Remove route 00233477 Teczem 180-5 mg Oral Tb24 Teczem 180-5 mg 24 hr Tab

Remove route and salt, 00267075 enalapril mal-diltiazem enalapril-diltiazem 5 mg-180

enhance dosage form malate 5 mg-180 mg Oral mg 24 hr Tab
Tb24

Remove route, enhance 00256685 Volmax 4 mg Oral TbOm Volmax 4 mg Tab

dosage form

Remove route, enhance 00288817 albuterol sulfate 4 mg Oral albuterol sulfate 4 mg Tab
dosage form. Salt not TbOm
removed.

Remove route and 00151208 METADATE ER 20 mg Oral METADATE ER 20 mg Tab

misleading SR abbreviation, TbSR
enhance dosage form

Remove route and 00292315 Ritalin SR 20 mg Oral TbSR Ritalin SR 20 mg Tab

redundant SR abbreviation,
enhance dosage form

Remove route and salt, 00247696 methylphenidate HCl 20 mg methylphenidate SR 20 mg

enhance dosage form, clarify Oral TbSR Tab
SR abbreviation

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Remove route, enhance 00174864 METADATE CD 20 mg Oral METADATE CD 20 mg Cap

dosage form MP30

Remove route and salt, 00452571 methylphenidate HCl 20 mg methylphenidate SR 20 mg

enhance dosage form Oral MP30 multiphase Cap 30-70

Remove route, enhance 00445259 Ritalin LA 20 mg Oral MP50 Ritalin LA 20 mg Cap

dosage form

Remove route and salt, 00452573 methylphenidate HCl 20 mg methylphenidate 20 mg

enhance dosage form Oral MP50 multiphase Cap 50-50

Editorial Process
The following section describes the processes and criteria the clinical editors use to add or review database
elements.

External Triggers for Clinical Review

The external triggers that prompt the clinical editors to add or review data are the following:

MedWatch Safety Alerts

MedEffects Alerts from Health Canada

Internal Triggers for Clinical Review

The internal trigger that prompts the clinical editors to add or review data is a new Clinical Formulation ID
(GCN_SEQNO).

Inactive Ingredient Columns and Tables

FDB relies on notification by the manufacturer and a process of NDC review to keep its inactive ingredient
information current. For this reason inactive ingredient information is subject to change at any time without notice.

Manufacturers should notify FDB as soon as possible whenever a product changes in any way.

Inclusion Criteria/Exclusion Criteria

All major prescription and non-prescription drug products and devices sold in the United States are included in
Medication Name Concepts except for those products and devices companies have chosen not to list in the
knowledge base.

Retirement and Replacement

Medication name concept identifiers are permanent identifiers, which provide stability to the customer file. In the
event that an identifier is replaced, a link will be provided from the old identifier to its replacement identifier.

Medication name concept identifiers may be retired from use when judged by FDB editorial staff as no longer
having validity.

There are two ways FDB clinicians indicate that a medication concept is no longer optimal for use within the FDB
data. The first involves marking the concept with a Retired status and, as the status suggests, retiring it from

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use.

The second method involves marking the concept with a status of Replaced and creating a pointer in the
medication history leading from the replaced concept (also known as the previous concept) to the concept
replacing the previous concept. This replacement history is most critical in the context of using the medication
concepts as part of allergen profiling and tracking.

Replacement is always the preferred method for medication retirement.

Retirement or replacement cannot be reversed.

NDC/MEDID Relationships and Change History Maintenance

The MED NDC to Medication ID Cross-Reference Table (RMINDC1_NDC_MEDID) links each brand-named NDC
to its appropriate, brand-specific MEDID. The MED NDC to Generic Medication ID Cross-Reference Table
(RMEDNGM0_NDC_GEN_MEDID) links each NDC (brand or generically-named) to its appropriate,
generically-named MEDID.

The NDC/MEDID relationship change history tables support change management of stored MEDIDs in healthcare
systems by providing details of the relationship changes that have occurred between NDCs and their associated
MEDIDs, such as when an NDCs association to a given MEDID is removed or moves to another MEDID. When
an NDC/MEDID relationship changes, one of the following occurs:

When a relationship change occurs within the RMINDC1_NDC_MEDID table, a record of the change will
appear within the MED NDC/MEDID Relation History Table (RMEDNMH0_NDC_MEDID_HIST).
When a relationship change occurs within the RMEDNGM0_NDC_GEN_MEDID table, a record of the
change will appear within the MED NDC/Generic MEDID Relation History Table
(RMEDNGH0_NDC_GEN_MEDID_HIST).

See Medication Name Concept History Tables in the General Information section for more information.

NDC/MEDID relationship change history files contain a summary of all changes between NDCs and MEDIDs that
occurred beginning June 24, 2010. Changes are added on a weekly basis. Monthly files contain a summary of the
weekly changes that occurred within that months production cycle.

Newly-added NDCs, which have no previous association to a MEDID, fall outside of the scope of these tables. If
an NDC is added to the NDC Table (RNDC14_NDC_MSTR) for the first time, no change history record will
appear in these tables.

Descriptive information for a given change reflects the data as it was on the date of the change. This information
will remain static despite subsequent updates made to the description information per our standard editorial
process should an enhancement occur at a later date. Therefore, the descriptive information in the change history
files can differ from current MEDID descriptions.

For example, an NDC moves from MEDID A to MEDID B in January. In May, MEDID Bs description changes per
our standard editorial process. The description value that appeared in the history table in January for MEDID B
remains static and does not change.

MEDID Search Terms and Targets

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These search terms and targets optimize medication prescription writing in ambulatory settings. End users
wishing to browse and select MEDID targets that span the inpatient setting should navigate against the MED
Medication Table (RMIID1_MED). For example, routes of intravenous are not included as MEDID targets for the
ambulatory setting.

In the ambulatory setting, drugs frequently are selected by their name, strength, and dosage form as the starting
point for prescribing. MEDID search targets are provided for medications likely to be prescribed in an outpatient
setting. Orderable medication concepts that span orders typical of an inpatient setting may be used by developers
for navigation and selection of additional medications and orders that may be unique to administration within a
physician's office or ordered for administration within a home care setting.

By policy, MEDID search terms are constrained to medications likely to be prescribed and dispensed in an
ambulatory setting.

Clinicians that desire to support clinic-administered medication order entry need to use the inpatient capabilities of
OrderKnowledge.

Developers using this in tandem with OrderKnowledge in an ambulatory setting need to consider the deployment
of end-user controlled MEDID search settings that enable suppression for MEDID values and dispensable orders
that span characteristics like:

Exclude IM Route
Exclude Continuous Subcutaneous Route
Exclude Parameter Based Sigs (for example, weight-based, body surface area based)
Exclude non-prescription (MEDID attribute MED_REF_FED_LEGEND_IND) = 2 or 9
Exclude Medical Supplies
MEDID search values will be deleted from the table when the MEDID no longer spans at least one active
dispensable order.

MAPs Enhancements
This section defines concepts related to FDB Multiple Access Points (MAPs) enhancements. See MAPs
Enhancements for more information.

Alternative Strengths

The First Databank Alternative Strength data delivers at an NDC level two key new strength values for injectable
drug products: the Total Strength and Normalized Strength for ingredients associated with a product. These
product-specific strength values may be displayed or implemented as part of an enhanced patient safety plan for
integrated dose checking at the point of care.

Dosage Form Attributes

Dosage Form Attributes are dosage form components by which Master Dosage Forms may be identified,
delineated, or grouped. It is possible to group associated drug products by using dosage form attributes as

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components of the search. For example, it is possible to search for and locate Medication Concepts which are
oral liquid formulations with a specific ingredient list by limiting the search to dosage forms with an attribute of
liquid and a route of oral.

Routes

The First Databank Product Route Relation data delivers, at an NDC level, two useful route values for all
products: the Parent Route and the Clinical Route. The Parent Route for a product is intended for implementation
as a general navigational Route term (e.g. injection) associated with more granular and product-specific Clinical
Routes (e.g. intravenous, intramuscular, etc.) for use in order entry processes such as physician order entry and
pharmacy order fulfillment at the point of care.

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MED Applications
This section provides information about the practical applications of Medication Name Concept data.

Navigating to a Routed Medication, Routed Dosage Form, and Medication

Retrieving Active Products for a Medication

Retrieving Related Active Ingredients for a Medication Name Concept

Retrieving Related Inactive Ingredients for a Medication Name Concept

Retrieving Inactive Ingredient Statistics for a Medication Name Concept

Retrieving the Generically Named Companion for a Medication Name Concept

Finding a Replacement MED Concept at Any Level of Specificity

Retrieving and Displaying the Representative Brand Medication Names for a Generically Named Medication

ExampleUsing the MED_MEDID_DESC in Your Display to Illustrate That a Single Concept May Have
Multiple Recognizable Innovator Brands
ExampleUsing the MED_MEDID_DESC in Your Display to Distinguish Between Similarly Named but
Clinically Different Medications
ExampleUsing the MED_NAME in Your Display to Distinguish Between Similarly Named but Clinically
Different Medications

Retrieving Pharmaceutically Equivalent Products When Searching by a Branded Product No Longer Marketed

ExampleRetrieving Pharmaceutically Equivalent Products When Attempting to Order a Branded Product

No Longer Marketed
ExampleRetrieving all Pharmaceutically Equivalent Products When Dispensing a Prescribed Branded
Product No Longer Marketed

Implementing Change Management of Stored MEDIDs

ExampleMonitoring NDC/MEDID Changes Within a Dispensing Environment

ExampleCreating a Weekly MEDID Change History Report

Identifying a Drug To Administer That May Have Multiple Alternative Ingredient Strengths

Presenting a Prescribable MEDID Using a Search Term Type Code

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Navigating to a Routed Medication Route Dosage Form and Medication

This application illustrates how to navigate using Medication Name Concepts.

1. Retrieve the MED Medication Name ID (MED_NAME_ID) from the MED Medication Name Table
(RMINMID1_MED_NAME) where the MED Medication Name (MED_NAME) equals the given drug.

2. Retrieve the Routed Medication ID (ROUTED_MED_ID) and MED Routed Medication Description (
MED_ROUTED_MED_ID_DESC) values from the MED Routed Medication Table
(RMIRMID1_ROUTED_MED) where the MED Medication Name (MED_NAME_ID) equals the value
retrieved in the previous step and the MED Medication Status Code ( MED_STATUS_CD) value equals 0
(active).

3. Retrieve the associated Clinical Route Identifier (CLINICAL_RT_ID) from the MED Routed Medication to
Route Relationship Table (RPEIRMR0_RTD_MED_RT_RELATION) where the MED Routed Medication
Identifier (ROUTED_MED_ID) equals the value retrieved in the previous step.

The RT_DESC_LONG column is found in the Route of Administration Master Table

(RPEIRM0_RT_MSTR).

4. Retrieve the MED Routed Dosage Form Med ID ( ROUTED_DOSAGE_FORM_MED_ID) and from the
MED Routed Dosage Form Medication Table (RMIDFID1_ROUTED_DOSE_FORM_MED) where the MED
Routed Medication ID (ROUTED_MED_ID) equals the value retrieved in step 2 and the MED Medication
Status Code (MED_STATUS_CD) value equals 0 (active).

5. Retrieve the Medication Identifier (MEDID) and MED Medication Description (MED_MEDID_DESC) values
from the MED Medication Table (RMIID1_MED) where the MED Routed Dosage Form Med ID (
ROUTED_DOSAGE_FORM_MED_ID) equals the value retrieved in the previous step and the MED
Medication Status Code (MED_STATUS_CD) value equals 0 (active).

ExampleNavigating to a Routed Medication, Routed Dosage Form, and Medication

For purposes of demonstrating this application, the following scenario is used: A pharmacist receives an
order for gentamicin 100 mg intravenouspiggyback every 12 hours.

1. Retrieve the MED Medication Name ID (MED_NAME_ID) from the MED Medication Name Table
(RMINMID1_MED_NAME) where the MED Medication Name (MED_NAME) equals gentamicin.

MED_NAME MED_NAME_ID

gentamicin 1484

2. Retrieve the Routed Medication ID (ROUTED_MED_ID) and MED Routed Medication Description (
MED_ROUTED_MED_ID_DESC) values from the MED Routed Medication Table
(RMIRMID1_ROUTED_MED) where the MED Medication Name (MED_NAME_ID) equals the value
retrieved in the previous step (1484) and the MED Medication Status Code (MED_STATUS_CD) value
equals 0 (active).

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MED_NAME_ID ROUTED_MED_ID MED_ROUTED_MED_ID MED_STATUS_CD

_DESC

1484 1496 gentamicin Inj 0

1484 8337 gentamicin Opht 0

1484 75145 gentamicin Top 0

3. Retrieve the associated Clinical Route Identifier (CLINICAL_RT_ID) from the MED Routed Medication to
Route Relationship Table (RPEIRMR0_RTD_MED_RT_RELATION) where the Routed Medication ID (
ROUTED_MED_ID) equals the value retrieved in the previous step. In this example, the Routed
Medication Identifier (ROUTED_MED_ID) value 1496 (gentamicin Inj [Injection]) is utilized:

ROUTED_MED_ID CLINICAL_RT_ID RT_DESC_LONG

1496 194 Intravenous

The RT_DESC_LONG column is found in the Route of Administration Master Table

(RPEIRM0_RT_MSTR).

4. Retrieve the MED Routed Dosage Form Med ID ( ROUTED_DOSAGE_FORM_MED_ID) and MED Routed
Dosage Form Medication Description (MED_ROUTED_DF_MED_ID_DESC) from the MED Routed
Dosage Form Medication Table (RMIDFID1_ROUTED_DOSE_FORM_MED) where the MED Routed
Medication ID (ROUTED_MED_ID) equals the value retrieved in step 2 (1496) and the MED Medication
Status Code (MED_STATUS_CD) value equals 0 (active).

ROUTED_MED_ID MED_STATUS_CD ROUTED_DOSAGE_FO MED_ROUTED_DF_MED

RM_MED_ID _ID_DESC

1496 0 1563 gentamicin Injection

5. Retrieve the Medication Identifier (MEDID) and MED Medication Description (MED_MEDID_DESC) values
from the MED Medication Table (RMIID1_MED) where the MED Routed Dosage Form Med ID (
ROUTED_DOSAGE_FORM_MED_ID) equals the value retrieved in the previous step (1563) and the MED
Medication Status Code (MED_STATUS_CD) value equals 0 (active).

ROUTED_DOSAGE_FO MED_STATUS_CD MEDID MED_MEDID_DESC

RM_MED_ID

1563 0 171012 gentamicin 10 mg/mL

Injection

1563 0 278441 gentamicin 40 mg/mL

Injection

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Retrieving Active Products for a Medication

This application illustrates how to retrieve active products that are associated to branded and/or generically
named MED Medication IDs (MEDIDs). When developing your application, please keep that your business needs
might also require the retrieval of obsolete products up to a specified number of years, such as one or three
years.

The steps are listed below:

1. Select the National Drug Code (NDC) values from the MED NDC to Medication ID Cross-Reference Table
(RMINDC1_NDC_MEDID) where the MED Medication ID (MEDID) column equals the MEDID value of the
prescribed medication.

2. Select the MEDID values from the MED NDC to Generic Medication ID Cross-Reference Table
(RMEDNGM0_NDC_GEN_MEDID) where the NDC column equals the NDC values from the previous step.

3. Select the NDC values from the RMEDNGM0_NDC_GEN_MEDID table where the MEDID column equals
the MEDID values from the previous step.

4. Remove duplicates from the list of NDCs returned in the previous step.

5. Filter the list of NDCs from the previous step using the NDC Table (RNDC14_NDC_MSTR) where the
Obsolete Date (OBSDTEC) equals 0 (indicating Active), and, if preferred, obsolete less than a specified
date.

6. Select the Clinical Formulation ID (GCN_SEQNO) values from the RNDC14_NDC_MSTR table where the
NDC column equals the NDC values from the previous step.

The following examples illustrate this application from a prescribing perspective. Therefore, the example
scenarios consider brand substitution and pharmaceutical equivalence.

ExampleRetrieving Products Associated to a MED Medication ID (MEDID)

ExampleRetrieving Active Products for a Do not Substitute Prescription

ExampleRetrieving Products Associated to a MED Medication ID (MEDID)

For purposes of demonstrating this application, the following scenario is used: A physician prescribes the
branded medication, Prinivil 10 mg Tab (MED Medication ID [ MEDID] 00150320), allowing substitution. The
system retrieves a list of active products and products that are up to three years obsolete to present as potential
candidates to fill the prescription. Prior to beginning this application, the system stores the prescribed
medications Clinical Formulation ID (GCN_SEQNO) value of 000390 for use later in the process.

1. Select the National Drug Code (NDC) values from the MED NDC to Medication ID Cross-Reference Table
(RMINDC1_NDC_MEDID) where the MEDID column equals the MEDID value of the prescribed
medication.
A sample of the results is shown below:

MEDID NDC

00150320 00006010628

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00150320 00006010631

00150320 00006010654

00150320 00006010658

00150320 00006010672

00150320 00006010682

00150320 00006010686

00150320 00006010687

00150320 00006010694

00150320 54569175200

00150320 54569175201

00150320 54569175202

00150320 54569175203

00150320 54569175206

00150320 54569858300

2. Select the MEDID values from the MED NDC to Generic Medication ID Cross-Reference Table
(RMEDNGM0_NDC_GEN_MEDID) where the NDC column equals the NDC values from the previous step.

A sample of the results is shown below:

NDC MEDID MED_MEDID_DESC

00006010628 00244899 lisinopril 10 mg Tab

00006010631 00244899 lisinopril 10 mg Tab

00006010654 00244899 lisinopril 10 mg Tab

00006010658 00244899 lisinopril 10 mg Tab

00006010672 00244899 lisinopril 10 mg Tab

00006010682 00244899 lisinopril 10 mg Tab

00006010686 00244899 lisinopril 10 mg Tab

00006010687 00244899 lisinopril 10 mg Tab

00006010694 00244899 lisinopril 10 mg Tab

54569175200 00244899 lisinopril 10 mg Tab

54569175201 00244899 lisinopril 10 mg Tab

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54569175202 00244899 lisinopril 10 mg Tab

54569175203 00244899 lisinopril 10 mg Tab

54569175206 00244899 lisinopril 10 mg Tab

54569858300 00244899 lisinopril 10 mg Tab

3. Select the NDC values from the RMEDNGM0_NDC_GEN_MEDID table where the MEDID column equals
the MEDID values from the previous step.

A sample of the results is shown below:

MEDID NDC

00244899 00006010628

00244899 00006010628

00244899 00006010628

00244899 00006010631

00244899 00006010631

00244899 00006010631

00244899 00006010631

00244899 00006010631

4. Remove duplicates from the list of MEDIDs returned in the previous step.

A sample of the results is shown below:

MEDID NDC

00244899 00006010628

00244899 00006010631

00244899 00006010654

00244899 00006010658

00244899 00006010672

00244899 00006010682

00244899 00006010686

00244899 00006010687

5. Filter the list of NDCs from the previous step using the NDC Table (RNDC14_NDC_MSTR), where the
Obsolete Date (OBSDTEC) equals 0 (indicating Active) or up to three years obsolete (for example, >
20090301).

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5.

A sample of the results is shown below.

NDC LN60 OBSDTEC

00006010654 PRINIVIL 10 MG TABLET 0

00143126701 LISINOPRIL 10 MG TABLET 0

00143126710 LISINOPRIL 10 MG TABLET 0

00172375910 LISINOPRIL 10 MG TABLET 0

00172375960 LISINOPRIL 10 MG TABLET 0

00172375970 LISINOPRIL 10 MG TABLET 0

00172375980 LISINOPRIL 10 MG TABLET 0

00185010101 LISINOPRIL 10 MG TABLET 0

00185010110 LISINOPRIL 10 MG TABLET 0

00310013111 ZESTRIL 10 MG TABLET 0

00378207401 LISINOPRIL 10 MG TABLET 0

00378207410 LISINOPRIL 10 MG TABLET 0

00591040701 LISINOPRIL 10 MG TABLET 0

00591040710 LISINOPRIL 10 MG TABLET 0

00603421102 LISINOPRIL 10 MG TABLET 0

6. Select the Clinical Formulation ID (GCN_SEQNO) values from the RNDC14_NDC_MSTR table where the
NDC column equals the NDC values from the previous step.

A sample of the results is shown below.

NDC LN60 GCN_SEQNO

00006010654 PRINIVIL 10 MG TABLET 000390

00143126701 LISINOPRIL 10 MG TABLET 000390

00143126710 LISINOPRIL 10 MG TABLET 000390

00172375910 LISINOPRIL 10 MG TABLET 000390

00172375960 LISINOPRIL 10 MG TABLET 000390

00172375970 LISINOPRIL 10 MG TABLET 000390

00172375980 LISINOPRIL 10 MG TABLET 000390

00185010101 LISINOPRIL 10 MG TABLET 000390

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00185010110 LISINOPRIL 10 MG TABLET 000390

00310013111 ZESTRIL 10 MG TABLET 000390

00378207401 LISINOPRIL 10 MG TABLET 000390

00378207410 LISINOPRIL 10 MG TABLET 000390

00591040701 LISINOPRIL 10 MG TABLET 000390

00591040710 LISINOPRIL 10 MG TABLET 000390

00603421102 LISINOPRIL 10 MG TABLET 000390

In this example, all products have the same Clinical Formulation ID (GCN_SEQNO) as the prescribed
product (stored prior to this application) and are pharmaceutically equivalent. Therefore, all returned NDCs
are displayed to the end-user to select from.

ExampleRetrieving Active Products for a Do not Substitute Prescription

For purposes of demonstrating this application, the following scenario is used: A physician prescribes
Vytorin 10-20 10 mg-20 mg Tab (MED Medication ID [MEDID] 00471146) without allowing substitution. The
system retrieves a list of active products and products up to three years obsolete to present as potential
candidates to fill the prescription.The system retrieves a list of active products and products that are up to three
years obsolete to present as potential candidates to fill the prescription. Prior to beginning this application, the
system stores the prescribed medications Clinical Formulation ID (GCN_SEQNO) value of 057863 for use later in
the process.

Retrieve All Products Associated to the Medication

1. Select the National Drug Code (NDC) values from the MED NDC to Medication ID Cross-Reference Table
(RMINDC1_NDC_MEDID) where the MEDID column equals the MEDID value of the prescribed
medication.

MEDID NDC

00471146 12280038530

00471146 12280038530

00471146 12280038530

00471146 12280038530

00471146 12280038530

00471146 12280038530

00471146 12280038530

00471146 12280038530

00471146 12280038530

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00471146 12280038530

00471146 12280038530

00471146 12280038530

00471146 12280038530

00471146 12280038530

00471146 12280038530

In this example, the prescription does not allow substitution when filling this prescription. Therefore, the
application skips steps 2 through 4.

2. Select the MEDID values from the MED NDC to Generic Medication ID Cross-Reference Table
(RMEDNGM0_NDC_GEN_MEDID) where the NDC column equals the NDC values from the previous step.

3. Select the NDC values from the RMEDNGM0_NDC_GEN_MEDID table where the MEDID column equals
the MEDID values from the previous step.

4. Remove duplicates from the list of MEDIDs returned in the previous step.

5. Filter the list of NDCs using the NDC Table (RNDC14_NDC_MSTR) where the Obsolete Date (OBSDTEC)
equals 0 (indicating Active) or up to three years obsolete (for example, 20090301).

NDC OBSDTEC

12280038530 20090401

12280038590 20090401

21695032530 0

49999095730 0

51138036430 0

54569576600 0

54868518700 0

54868518701 0

54868518702 0

55289098021 0

66582031228 0

66582031231 0

66582031254 20110928

66582031282 0

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66582031287 0

In this example, no records are removed.

6. Select the Clinical Formulation ID (GCN_SEQNO) values from the RNDC14_NDC_MSTR table where the
NDC column equals the NDC values from the previous step.

NDC GCN_SEQNO

12280038530 057863

12280038590 057863

21695032530 057863

49999095730 057863

51138036430 057863

54569576600 057863

54868518700 057863

54868518701 057863

54868518702 057863

55289098021 057863

66582031228 057863

66582031231 057863

66582031254 057863

66582031282 057863

66582031287 057863

In this example, all products have the same Clinical Formulation ID (GCN_SEQNO) as the prescribed
product (stored prior to this application) and are pharmaceutically equivalent. Therefore, all returned NDCs
are displayed to the end-user to select from.

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Retrieving Related Active Ingredients for a Medication Name Concept

MED Concept IDs (MED_CONCEPT_ID) usually reference multiple packaged products (NDC). This application
illustrates how to find the active ingredients associated to a given MED_CONCEPT_ID.

For purposes of demonstrating this application, the following scenario is used: A patient is prescribed two
Routed Medications (ROUTED_MED_ID): benazepril Oral (ROUTED_MED_ID 00004682), and prednisone Oral
(ROUTED_MED_ID 00006007). Allergy screening software must retrieve all active ingredients associated to the
ROUTED_MED_ID to ensure that the patient is not administered an ingredient that will induce an allergic
reaction.

1. Determine the proper MED Concept ID Type (MED_CONCEPT_ID_TYP) value for the MED Concept or
MED Concepts in question by using the MED MED Concept ID Type Description Table
(RMEDCD0_MED_CONCEPT_TYP_DESC).
In this case benazepril Oral and prednisone Oral are both ROUTED_MED_IDs, therefore they use a
MED_CONCEPT_ID_TYP value of 2.

2. Use the MED MED Concept/HICL_SEQNO Relation Table (RMEDMHL0_MED_HICLSEQNO_LINK) and

the MED_CONCEPT_ID_TYP value of 2 to find each MED_CONCEPT_IDs associated Ingredient List
Identifier (HICL_SEQNO), MED Concept HICL_SEQNO Source Code (MED_CONCEPT_HICL_SRC_CD),
and MED Concept Obsolete Date (MED_CONCEPT_OBSDATEC). For example:

MED_CONCEPT_I MED_CONCEPT_I HICL_SEQNO MED_CONCEPT_H MED_CONCEPT_O

D D_TYP ICL_SRC_CD BSDATEC

00004682 2 006113 0

00004682 2 006113 1

00005341 2 001742 1

If a record has a value listed for its MED_CONCEPT_OBSDATEC, the

MED_CONCEPT_ID/HICL_SEQNO association is expired and should only be used if the end user
knows he or she has a packaged product that was produced prior to the obsolete date.

3. For each HICL_SEQNO, find its related active ingredients (HIC_SEQN) using the HICL_SEQNO/HIC
Relation Table (RHICL1_HIC_HICLSEQNO_LINK). Each HIC_SEQNs text description is provided for
illustrative purposes. For example:

HICL_SEQNO HIC_SEQN HIC_DESC

00004682 003598 benazepril HCl

00005341 001559 oxycodone HCl

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Retrieving Related Inactive Ingredients for a Medication Name Concept

MED Concept IDs (MED_CONCEPT_ID) usually reference multiple packaged products (NDC). These products
undergo constant review by FDB clinical editors for inactive ingredient data, and this application illustrates how to
find the inactive ingredients that are currently associated to a given MED_CONCEPT_ID.

For purposes of demonstrating this application, the following scenario is used: A patient is prescribed two
Routed Medications (ROUTED_MED_ID): benazepril Oral (ROUTED_MED_ID 00004682), and prednisone Oral
(ROUTED_MED_ID 00006007). Allergy screening software must retrieve all inactive ingredients associated to the
ROUTED_MED_ID to ensure that the patient is not administered an ingredient that will induce an allergic
reaction.

1. Using the ROUTED_MED_ID values of 00004682 and 00005341, retrieve the related ingredient codes (
HIC_SEQN) from the MED Routed Medication ID/Inactive Ingredient Relation Table
(RMEDRIN0_RMID_INACTV_LINK).
These ingredient codes represent all inactive ingredients that appear in reviewed products that belong to
the given ROUTED_MED_ID. The descriptions for the ROUTED_MED_IDs (found in the MED Routed
Medication Table) have been included for illustrative purposes only. For example:

ROUTED_MED_ID MED_ROUTED_MED_ID_DESC HIC_SEQN

00004682 benazepril Oral 002432

00004682 benazepril Oral 002436

00004682 benazepril Oral 002437

00004682 benazepril Oral 002438

00004682 benazepril Oral 002478

00004682 benazepril Oral 003887

00004682 benazepril Oral 004425

00004682 benazepril Oral 009252

00004682 benazepril Oral 009865

00006007 prednisone Oral 000738

00006007 prednisone Oral 001090

2. Retrieve the Hierarchical Ingredient Code Descriptions (HIC_DESC) for the HIC_SEQN values using the
Hierarchical Ingredient Code Description Table (RHICD5_HIC_DESC).
Notice that prednisone Oral had inactive ingredients that also appeared in benazepril Oral, so the following
table contains fewer entries than the one in the previous step. For example:

HIC_SEQN HIC_DESC

002432 lactose

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002436 magnesium stearate

002437 zinc stearate

002438 cellulose

002478 castor oil

003887 stearic acid

004425 hydroxypropylcellulose

009252 FD & C no.6(sunset yellow fcf)

009865 polysorbate 80

3. Follow the steps in the Retrieving a MED Concepts Inactive Ingredient Statistics application if you wish to
view or display statistical information about these associations.

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Retrieving Inactive Ingredient Statistics for a Medication Name Concept

MED Concept IDs (MED_CONCEPT_ID) usually reference multiple packaged products (NDC). These products
undergo constant review by FDB clinical editors for inactive ingredient data, and this application illustrates how to
find the following statistical information for a given MED_CONCEPT_ID:

How many products are associated to the MED_CONCEPT_ID

How many products that belong to the MED_CONCEPT_ID have been researched for inactive ingredient
information
Which inactive ingredients have thus far been associated to the MED_CONCEPT_ID
How many of the researched products for that MED_CONCEPT_ID contain a given inactive ingredient

For purposes of demonstrating this application, the following scenario is used: A prescriber wishes to
prescribe the Medication Name amoxicillin (MED_NAME_ID 00001519) to a patient. The Computerized Order
Entry (COE) system screens the Med Name against the patients allergy profile, which indicates that the patient is
allergic to the potentially inactive ingredient silicon dioxide (HIC_SEQN value of 005872). Statistical information
about the medication would help the prescriber determine if a different medication would be preferred, based on
the likelihood that the patient will be allergic to a prescribed amoxicillin medication.

Specifically, this application will complete this statement: X percent of the products that belong to the Medication
Name amoxicillin have been researched for inactive ingredient information, and Y percent of the researched
products contain the ingredient silicon dioxide.

1. Use the MED_NAME_ID for amoxicillin (00001519) to retrieve the Total Products Count (
TOTAL_PRODUCTS_CNT) and Products Researched Count (PRODUCTS_RESEARCHED_CNT) values
from the MED Medication Name ID/Inactive Ingredient Study Master Table
(RMEDNIS0_MED_NAME_STUDY_TABLE). For example:
Of the 141 products that belong to this MED_CONCEPT_ID, 43 of them have been researched; roughly
30.5%.

If the PRODUCTS_RESEARCHED_CNT equals 0, no products associated to this MED_NAME_ID

have been researched. The end-user should be notified that no inactive ingredient data exists for
this medication, and the remainder of this application does not apply.

2. Use the MED_NAME_ID and the HIC_SEQN value for silicon dioxide (005872) to retrieve the Inactive
Ingredient Present Count (INACTV_PRES_CNT) and Inactive Ingredient Not Present Count (
INACTV_NOT_PRES_CNT) values from the MED Medication Name ID/Inactive Ingredient Relation Table
(RMEDNIN0_MNID_INACTV_LINK). For example:

MED_NAME_ID HIC_SEQN INACTV_PRES_CNT INACTV__NOT_PRES_C

NT

00001519 005872 000035 000008

Of the 43 products researched by FDB (found in the previous step), 35 contain the inactive ingredient
silicon dioxide; roughly 81.4%. Based on the data retrieved by this query, the statement at the beginning of

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this application can be completed as follows:

30.5% of the products that belong to the Medication Name amoxicillin have been researched for inactive ingredient
information, and 81.4% of the researched products contain the ingredient silicon dioxide.

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Retrieving the Generically Named Companion for a Medication Name Concept

This application illustrates how to use the MED MED Concept/Generic MED Relation Table to find a given MED
Concepts generically named companion.

For purposes of demonstrating this application, the following scenario is used: A prescriber wishes to find
the generically named companion of the medication Robitussin Night Relief Oral Liquid at the MED Medication ID
(MEDID) level. This products MEDID is 00199158.

1. Retrieve the products associated MED Concept ID Type (MED_CONCEPT_ID_TYP) and Generically
Named MED Concept ID (GENERIC_MED_CONCEPT_ID) values from the
RMEDMGL0_MED_GENERIC_MED_LINK table using the MEDID value 00199158. Filter the results to
include only those records that have a MED_CONCEPT_ID_TYP value of 3, because this MED Concept is
a MEDID.

MED_CONCEPT_ID MED_CONCEPT_ID_TYP GENERIC_MED_CONCEPT_ID

00199158 3 00239791

2. Retrieve the GENERIC_MED_CONCEPT_IDs description using the MED Medication Table

(RMIID1_MED). This is Robitussin Night Relief Oral Liquids generically named companion.

MED_CONCEPT_ID MED_MEDID_DESC

00239791 phenylephrine-pyrilamine-DM-acetaminophen Oral

Liquid

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Finding a Replacement MED Concept at Any Level of Specificity

This application illustrates how to retrieve a replacement MED Concept value at any level of specificity.

1. Depending on the FDB concept type, perform one of the following:

Select the MED Medication Status Code (MED_STATUS_CD) values from the MED Medication
Name Table (RMINMID1_MED_NAME) where the MED Medication Name ID (MED_NAME_ID)
column equals the MED_NAME_ID value of a given medication name.
Select the MED Medication Status Code (MED_STATUS_CD) values from the MED Routed
Medication Table (RMIRMID1_ROUTED_MED) where the MED Routed Medication ID (
ROUTED_MED_ID) column equals the ROUTED_MED_ID value of a given routed medication.
Select the MED Medication Status Code (MED_STATUS_CD) values from the MED Routed
Dosage Form Medication Table (RMIDFID1_ROUTED_DOSE_FORM_MED) where the MED
Routed Dosage Form Medication ID (ROUTED_DOSAGE_FORM_MED_ID) column equals the
ROUTED_DOSAGE_FORM_MED_ID value of a given routed dosage form medication.
Select the MED Medication Status Code (MED_STATUS_CD) values from the MED Medication
Table (RMIID1_MED) where the MED Medication ID (MEDID) column equals the MEDID value of a
given medication.

2. If the MED_STATUS_CD value from the previous step equals 1 (indicating replaced), select the MED
Replacement Medication Name ID (MED_REPL_NAME_ID) values from the MED Medication Name
Replacement History Table (RMINMRH1_MED_NAME_HIST) where the MED Previous Medication Name
ID (MED_PREV_NAME_ID) column equals one of the following:
the replaced MED_NAME_ID value from step 1
the replaced ROUTED_MED_ID value from step 1
the replaced ROUTED_DOSAGE_FORM_MED_ID value from step 1
the replaced MEDID value from step 1

In this step, the previous Medication Name Identifier column is populated with the replaced MED
Concept value queried in step 1 to retrieve its related replacement Medication Name Identifier.

3. Repeat steps 1 and 2 using the replacement Medication Name concept values retrieved in the previous
step until the MED_STATUS_CD equals 0 (indicating Active), 3 (indicating Inactive), or 9 (indicating
Unassociated).

ExampleFinding a Replacement MEDID

For purposes of demonstrating this application, the following scenario is used: Upon selection of
Corrective Laxative 100-65 mg Tab (MEDID 151200) for prescribing, a healthcare system first checks its status to
determine if it has been replaced. After determining that it has been replaced, the system retrieves its related
replacement value.

1. Select the MED Medication Status Code (MED_STATUS_CD) values from the MED Medication Table
(RMIID1_MED) where the MED Medication ID (MEDID) column equals the MEDID value of a given

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1.

medication.

MEDID MED_STATUS_CD MED_STATUS_CD_DESC

00151200 1 Replaced

Retrieve the MED Medication Status Code Description (MED_STATUS_CD_DESC) values from
the MED Status Code Description Table (RMISCD1_STATUS_DESC).

2. Select the MED Replacement Medication ID (MED_REPL_MEDID) values from the MED Medication
Replacement History Table (RMIRH1_MED_HIST) where the MED Previous Medication ID (
MED_PREV_MEDID) column equals the replaced MEDID value from step 1.

MED_PREV_MEDID MED_REPL_MEDID

00151200 00434238

3. Repeat step 1 and 2 using the MED_REPL_MEDID values retrieved in the previous step until the
MED_STATUS_CD equals 0 (indicating Active), 3 (indicating Inactive), or 9 (indicating Unassociated).

MEDID MED_STATUS_CD MED_STATUS_CD_DESC

00434238 3 Inactive

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Retrieving and Displaying the Representative Brand Medication Names for a Generically Named
Medication
When displaying generically named concepts, it may be useful to display a representative brand name to
distinguish between concepts with similar components (name, route, dosage form, and strength). This application
is useful to aid in visual recognition and to distinguish between similarly described generic representations of drug
formulations. This functionality is useful in a number of settings:

for the display of generic drug terms to healthcare providers

when messaging drug descriptive data from a provider to a pharmacy
for display in lay or professional drug information systems
for display in a list of patient medications

This application illustrates how to retrieve a representative brand name for a generically named concept, when
the MED Medication Description (MED_MEDID_DESC) is known.

The following examples demonstrate the application:

ExampleUsing the MED_MEDID_DESC in Your Display to Illustrate That a Single Concept May Have
Multiple Recognizable Innovator Brands
ExampleUsing the MED_MEDID_DESC in Your Display to Distinguish Between Similarly Named but
Clinically Different Medications
ExampleUsing the MED_NAME in Your Display to Distinguish Between Similarly Named but Clinically
Different Medications

Part 1: Retrieve the MEDID of the generically named medication.

1. Select the MED Medication ID (MEDID) values from the MED Medication Table (RMIID1_MED) where the
MED Medication Description (MED_MEDID_DESC) column equals the MED_MEDID_DESC of the
generically named concept.

2. Verify that the MEDID value for the generically named concept appears in the MED GCN_SEQNO to
Medication ID Cross-Reference Table (RMIGC1_MEDID_GCNSEQNO_LINK) to ensure that the MEDID is
associated with the generically named concept.
If the MEDID does not appear in the RMIGC1_MEDID_GCNSEQNO_LINK table, alert the user that
the MEDID is not associated with the generically named concept.
If the MEDID appears in this table, continue to the next step.

Part 2: Retrieve the MEDID of the innovator brand medications associated with the generically named medication.

Select the MEDID values from the MED Medication Table (RMIID1_MED)

where:

the GENERIC_MEDID column equals the MEDID value of the generically named medication retrieved in
Part 1, and

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the MED Reference Innovator Indicator (MED_REF_INNOV_IND) equals 1 (indicating the product is an
innovatorfirst product introduced into the market and/or first NDA)
This step retrieves all brand nameinnovator medications associated with the generically named medication
concept.There may be more than one innovator for a generic concept.

Part 3: Retrieve the MED_NAME of the brand medications.

1. Select the MED Routed Dosage Form Medication ID (ROUTED_MED_ID) values from the MED
Medication Table (RMIID1_MED) where the MEDID column equals the MEDID values from Part 2.

2. Select the MED Routed Medication ID (ROUTED_MED_ID) values from the MED Routed Dosage Form
Medication Table (RMIDFID1_ROUTED_DOSE_FORM_MED RMIDFID2_ROUTED_DOSE_FORM_MED)
where the ROUTED_DOSAGE_FORM_MED_ID column equals the ROUTED_DOSAGE_FORM_MED_ID
values from the previous step.

3. Select the MED Medication Name ID (MED_NAME_ID) values from the MED Routed Medication Table (
RMIRMID1_ROUTED_MED) where the ROUTED_MED_ID column equals the ROUTED_MED_ID values
from the previous step.

4. Select the MED Medication Name (MED_NAME) values from the MED Medication Name Table (
RMINMID1_MED_NAME) where the MED_NAME_ID column equals the MED_NAME_ID values from the
previous step.

Part 4: Display the generically named medication and the associated brand medication names.

Display the MED_NAME of the associated brand medication from Part 3 in parentheses next to the generically
named medication. Depending on your business needs, you may choose to display either the
MED_MEDID_DESC or the MED_NAME of the generically named medication. See the application examples for
these display options.

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Example - Using the MED_MEDID_DESC in Your Display to Illustrate That a Single Concept May Have Multiple
Recognizable Innovator Brands

For purposes of demonstrating this application, the following scenario is used: A healthcare system would
like to display the brand medication names associated with the generically named medication nifedipine 20 mg
Cap (MED_MEDID_DESC). A single concept may have multiple recognizable innovator brands.

For this example, the healthcare system displays the MED_MEDID_DESC of the generically named medication
along with the MED_NAMEs of the innovator brands.

Part 1: Retrieve the MEDID of the generically named medication.

Retrieve the MEDID of the generically named medication.

1. Select the MED Medication ID (MEDID) values from the MED Medication Table (RMIID1_MED) where the
MED Medication Description (MED_MEDID_DESC) column equals the MED_MEDID_DESC of the
generically named concept.

MED_MEDID_DESC MEDID

nifedipine 20 mg Cap 00174042

2. Verify that the MEDID value for the generically named concept appears in the MED GCN_SEQNO to
Medication ID Cross-Reference Table (RMIGC1_MEDID_GCNSEQNO_LINK) to ensure that the MEDID is
associated with the generically named concept.
If the MEDID does not appear in the RMIGC1_MEDID_GCNSEQNO_LINK table, alert the user that
the MEDID is not associated with the generically named concept.
If the MEDID appears in this table, continue to the next step.

In this example, the MEDID appears in the RMIGC1_MEDID_GCNSEQNO_LINK table. The application
continues to the next step.

Part 2: Retrieve the MEDID of the innovator brand medications associated with the generically named medication.

Select the MEDID values from the MED Medication Table (RMIID1_MED) where:

the GENERIC_MEDID column equals the MEDID value of the generically named medication retrieved in
Part 1, and
the MED Reference Innovator Indicator (MED_REF_INNOV_IND) equals 1 (indicating the product is an
innovatorfirst product introduced into the market and/or first NDA)

This step retrieves all brand name innovator medications associated with the generically named medication
concept. There may be more than one innovator for a generic concept.

GENERIC_MEDID MED_REF_INNOV_IND MEDID MED_MEDID_DESC

00174042 1 00229689 Adalat 20 mg Cap

00174042 1 00170576 Procardia 20 mg Cap

Part 3: Retrieve the MED_NAME of the brand medications.

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1. Select the MED Routed Dosage Form Medication ID (ROUTED_DOSAGE_FORM_MED_ID) values from
the MED Medication Table (RMIID1_MED) where the MEDID column equals the MEDID values from Part
2.

The MED Routed Dosage Form Medication Description (MED_ROUTED_DF_MED_ID_DESC) column is

found within the MED Routed Dosage Form Medication Table (RMIDFID1_ROUTED_DOSE_FORM_MED
RMIDFID2_ROUTED_DOSE_FORM_MED).

MEDID MED_MEDID_DESC ROUTED_DOSAGE_FO MED_ROUTED_DF_MED

RM_MED_ID _ID_DESC

00229689 Adalat 20 mg Cap 00010057 Adalat Cap

00170576 Procardia 20 mg Cap 00012431 Procardia Cap

2. Select the MED Routed Medication ID (ROUTED_MED_ID) values from the

RMIDFID1_ROUTED_DOSE_FORM_MED table where the ROUTED_DOSAGE_FORM_MED_ID column
equals the ROUTED_DOSAGE_FORM_MED_ID values from the previous step.

ROUTED_DOSAGE_FORM_MED_ ROUTED_MED_ID MED_ROUTED_MED_ID_DESC

ID

00010057 00008964 Adalat Oral

00012431 00010981 Procardia Oral

3. Select the MED Medication Name ID (MED_NAME_ID) values from the MED Routed Medication Table (
RMIRMID1_ROUTED_MED) where the ROUTED_MED_ID column equals the ROUTED_MED_ID values
from the previous step.

ROUTED_MED_ID MED_ROUTED_MED_ID_DESC MED_NAME_ID

00008964 Adalat Oral 00008444

00010981 Procardia Oral 00010307

4. Select the MED Medication Name (MED_NAME) values from the MED Medication Name Table (
RMINMID1_MED_NAME) where the MED_NAME_ID column equals the MED_NAME_ID values from the
previous step.

MED_NAME_ID MED_NAME

00008444 Adalat

00010307 Procardia

Part 4: Display the generically named medication and the associated brand medication names.

Display the MED_NAME for the brand medication name from Part 3 in parentheses next to the
MED_MEDID_DESC for the generically named medication from Part 1:

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nifedipine 20 mg Cap (Adalat, Procardia)

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Example - Using the MED_MEDID_DESC in Your Display to Distinguish Between Similarly Named but Clinically
Different Medications

For purposes of demonstrating this application, the following scenario is used: A healthcare system would
like to display the brand medication names associated with the following generically named medications:

metformin ER 1,000 mg 24 hr Tab Ctrl Rel (MED_MEDID_DESC)

metformin ER 1,000 mg 24 hr Tab, GR (MED_MEDID_DESC)
When clinically different medications have similar generic presentations, display of the brand name(s) can clarify
the choice because the clinical differences of the displayed Brands are known to the clinician.

For this example, the healthcare system displays the MED_MEDID_DESC of the generically named medication
along with the MED_NAME of the associated brand medication.

Part 1: Retrieve the MEDID of the generically named medication.

1. Select the MED Medication ID (MEDID) values from the MED Medication Table (RMIID1_MED) where the
MED Medication Description (MED_MEDID_DESC) column equals the MED_MEDID_DESC of the
generically named concept.

MED_MEDID_DESC MEDID

metformin ER 1,000 mg 24 hr Tab Ctrl Rel 00467970

metformin ER 1,000 mg 24 hr Tab, GR 00546006

2. Verify that the MED Medication ID (MEDID) value for the generically named concept appears in the MED
GCN_SEQNO to Medication ID Cross-Reference Table (RMIGC1_MEDID_GCNSEQNO_LINK) to ensure
that the MEDID is associated with the generically named concept.
If the MEDID does not appear in the RMIGC1_MEDID_GCNSEQNO_LINK table, alert the user that
the MEDID is not associated with the generically named concept.
If the MEDID appears in this table, continue to the next step.

In this example, the MEDID appears in the RMIGC1_MEDID_GCNSEQNO_LINK table. The application
continues to the next step.

Part 2: Retrieve the MEDID of the innovator brand medications associated with the generically named medication.

Select the MEDID values from the MED Medication Table (RMIID1_MED)

where:

the GENERIC_MEDID column equals the MEDID value of the generically named medication retrieved in
Part 1, and
the MED Reference Innovator Indicator (MED_REF_INNOV_IND) equals 1 (indicating the product is an
innovatorfirst product introduced into the market and/or first NDA)
This step retrieves all brand nameinnovator medications associated with the generically named medication
concept.There may be more than one innovator for a generic concept.

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GENERIC_MEDID MED_REF_INNOV_IND MEDID MED_MEDID_DESC

00467970 1 00467985 Fortamet 1,000 mg 24 hr

Tab Ctrl Rel

00546006 1 00555263 Glumetza 1,000 mg 24 hr

Tab

Part 3: Retrieve the MED_NAME of the brand medications.

1. Select the MED Routed Dosage Form Medication ID (ROUTED_DOSAGE_FORM_MED_ID) values from
the MED Medication Table (RMIID1_MED) where the MEDID column equals the MEDID values from Part
2.

The MED Routed Dosage Form Medication Description (MED_ROUTED_DF_MED_ID_DESC) column is

found within the MED Routed Dosage Form Medication Table (RMIDFID1_ROUTED_DOSE_FORM_MED
RMIDFID2_ROUTED_DOSE_FORM_MED).

MEDID MED_MEDID_DESC ROUTED_DOSAGE_FO MED_ROUTED_DF_MED

RM_MED_ID _ID_DESC

00467985 Fortamet 1,000 mg 24 hr 00106221 Fortamet 24 hr Tab Ctrl

Tab Ctrl Rel Rel

00555263 Glumetza 1,000 mg 24 hr 00164069 Glumetza 24 hr Tab

Tab

Select the MED Routed Medication ID (ROUTED_MED_ID) from the RMIDFID1_ROUTED_DOSE_FORM_MED

table where the ROUTED_DOSAGE_FORM_MED_ID column equals the ROUTED_DOSAGE_FORM_MED_ID
values from the previous step.

ROUTED_DOSAGE_FORM_MED_ID ROUTED_MED_ID MED_ROUTED_MED_ID_DESC

00106221 0089227 Fortamet Oral

00164069 00144868 Glumetza Oral

Select the MED Medication Name ID (MED_NAME_ID) values from the MED Routed Medication Table
(RMIRMID1_ROUTED_MED) where the ROUTED_MED_ID column equals the ROUTED_MED_ID values from
the previous step.

ROUTED_MED_ID MED_ROUTED_MED_ID_DESC MED_NAME_ID

00089227 Fortamet Oral 00075552

00144868 Glumetza Oral 00110597

Select the MED Medication Name (MED_NAME) values from the MED Medication Name Table
(RMINMID1_MED_NAME) where the MED_NAME_ID column equals the MED_NAME_ID values from the
previous step.

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MED_NAME_ID MED_NAME

00075552 Fortamet

00110597 Glumetza

Part 4: Display the generically named medication and the associated brand medication names.

1. Display the MED_NAME values in parentheses next to the MED_MEDID_DESC for the generically named
medication from step 1:

metformin ER 1,000 mg 24 hr Tab Ctrl Rel (Fortamet)

metformin ER 1,000 mg 24 hr Tab, GR (Glumetza)

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Example - Using the MED_NAME in Your Display to Distinguish Between Similarly Named but Clinically Different
Medications

For purposes of demonstrating this application, the following scenario is used: A healthcare system needs
to display medications in a pick list used by physicians for selecting orders. The following generically named
medications have similar extended release dosage form expressions. To help physicians distinguish between
similarly named, but clinically different medications in the pick list, key brand names can be retrieved and
displayed next to the generically named medication (MED_NAME). The innovator flag is used to limit the list of
names toinnovator brand names to simplify and clarify the choices.

metformin ER 1,000 mg 24 hr Tab Ctrl Rel (MED_MEDID_DESC)

metformin ER 1,000 mg 24 hr Tab, GR (MED_MEDID_DESC)
For this example, the healthcare system displays the MED_NAME of the generically named medication along with
the MED_NAME of the associated brand medication.

Part 1: Retrieve the MEDID of the generically named medication.

1. Select the MED Medication ID (MEDID) values from the MED Medication Table (RMIID1_MED) where the
MED Medication Description (MED_MEDID_DESC) column equals the MED_MEDID_DESC of the
generically named concept.

MED_MEDID_DESC MEDID

metformin ER 1,000 mg 24 hr Tab Ctrl Rel 00467970

metformin ER 1,000 mg 24 hr Tab, GR 00546006

2. Verify that the MED Medication ID (MEDID) value for the generically named concept appears in the MED
GCN_SEQNO to Medication ID Cross-Reference Table (RMIGC1_MEDID_GCNSEQNO_LINK) to ensure
that the MEDID is associated with the generically named concept.
If the MEDID does not appear in the RMIGC1_MEDID_GCNSEQNO_LINK table, alert the user that
the MEDID is not associated with the generically named concept.
If the MEDID appears in this table, continue to the next step.

In this example, the MEDID appears in the RMIGC1_MEDID_GCNSEQNO_LINK table. The application
continues to the next step.

Part 2: Retrieve the MEDID of the innovator brand medications associated with the generically named medication.

1. Select the MEDID values from the MED Medication Table (RMIID1_MED)

where:
the GENERIC_MEDID column equals the MEDID value of the generically named medication
retrieved in Part 1, and
the MED Reference Innovator Indicator (MED_REF_INNOV_IND) equals 1 (indicating the product is
an innovatorfirst product introduced into the market and/or first NDA)
This step retrieves all brand nameinnovatormedications associated with the generically named medication

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concept. There may be more than one innovator for a generic concept.

GENERIC_MEDID MED_REF_INNOV_IND MEDID MED_MEDID_DESC

00467970 1 00467985 Fortamet 1,000 mg 24 hr

Tab Ctrl Rel

00546006 1 00555263 Glumetza 1,000 mg 24 hr

Tab

Part 3: Retrieve the MED_NAME of the brand medications.

1. Select the MED Routed Dosage Form Medication ID (ROUTED_DOSAGE_FORM_MED_ID) values from
the MED Medication Table (RMIID1_MED) where the MEDID column equals the MEDID values from Part
2.
The MED Routed Dosage Form Medication Description (MED_ROUTED_DF_MED_ID_DESC) column is
found within the MED Routed Dosage Form Medication Table (RMIDFID1_ROUTED_DOSE_FORM_MED
RMIDFID2_ROUTED_DOSE_FORM_MED).

MEDID MED_MEDID_DESC ROUTED_DOSAGE_FO MED_ROUTED_DF_MED

RM_MED_ID _ID_DESC

00467985 Fortamet 1,000 mg 24 hr 00106221 Fortamet 24 hr Tab Ctrl

Tab Ctrl Rel Rel

00555263 Glumetza 1,000 mg 24 hr 00164069 Glumetza 24 hr Tab

Tab

2. Select the MED Routed Medication ID (ROUTED_MED_ID) from the

RMIDFID1_ROUTED_DOSE_FORM_MED table where the ROUTED_DOSAGE_FORM_MED_ID column
equals the ROUTED_DOSAGE_FORM_MED_ID values from the previous step.

ROUTED_DOSAGE_FORM_MED_ ROUTED_MED_ID MED_ROUTED_MED_ID_DESC

ID

00106221 00089227 Fortamet Oral

00164069 00144868 Glumetza Oral

3. Select the MED Medication Name ID (MED_NAME_ID) values from the MED Routed Medication Table
(RMIRMID1_ROUTED_MED) where the ROUTED_MED_ID column equals the ROUTED_MED_ID
values from the previous step.

ROUTED_MED_ID MED_ROUTED_MED_ID_DESC MED_NAME_ID

00089227 Fortamet Oral 00075552

00144868 Glumetza Oral 00110597

4. Select the MED Medication Name (MED_NAME) values from the MED Medication Name Table

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4.
(RMINMID1_MED_NAME) where the MED_NAME_ID column equals the MED_NAME_ID values from the
previous step.

MED_NAME_ID MED_NAME

00075552 Fortamet

00110597 Glumetza

Part 4: Display the generically named medication and the associated brand medication names.

1. Display the MED_NAME of the associated brand medication from Part 3 in parentheses next to the
MED_NAME of the generically named medication. To retrieve the MED_NAME for the generically named
medication, use the MEDID for the generically named medication from Part 1 and follow the steps in Part
3.

metformin (Fortamet)
metformin (Glumetza)

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Retrieving Pharmaceutically Equivalent Products When Searching by a Branded Product No Longer

Marketed
This application illustrates how to retrieve and display active products or products less than three years obsolete
that are associated to drug products that are no longer marketed. The implementation of this application enables
system users to enter the brand name of a drug that is no longer on the market and retrieve a list of
pharmaceutically equivalent products.

Part 1 of this application determines if the prescribed medication is directly associated to any active clinical
formulations. If active clinical formulations are found, the application ends. Otherwise, the application proceeds to
Part 2, which retrieves all related brand and generically-named MEDIDs and navigates through the Clinical
Formulation ID (GCN_SEQNO) to return all active products and products less than three years obsolete. Part 3
optionally displays the MED Medication ID (MEDID) descriptions for your returned products. The need for this
step is determined by your business needs.

The following examples illustrate this application:

ExampleRetrieving Pharmaceutically Equivalent Products When Attempting to Order a Branded Product

No Longer Marketed
ExampleRetrieving all Pharmaceutically Equivalent Products When Dispensing a Prescribed Branded
Product No Longer Marketed

Part 1: Determine if the prescribed medication is directly associated to any active products.

Select the MEDID and MED Medication Status Code (MED_STATUS_CD) values from the MED Medication
Table (RMIID1_MED) where the MED Medication Description (MED_MEDID_DESC) column contains the name
of the prescribed medication.

If MED_STATUS_CD values equal 3 (inactive), proceed to the next step.

If MED_STATUS_CD values equal 0 (active), proceed to the Retrieving a Medications Active Products
application.
If a MED_STATUS_CD value equals 1 (Replaced), 2 (Retired), or 9 (Unassociated), this application ends.

Part 2: Retrieve all active or less than three years obsolete products associated to the brand and generically-named
MEDIDs related to the prescribed medication.

1. If more than one MEDID is returned, select a specific MEDID for the prescribed medication from the list
retrieved in Part 1.

2. Select the National Drug Code (NDC) values from the MED NDC to Medication ID Cross-Reference Table
(RMINDC1_NDC_MEDID) where the MEDID column equals the MEDID value from the previous step.

3. Select the MEDID values from the MED NDC to Generic Medication ID Cross-Reference Table
(RMEDNGM0_NDC_GEN_MEDID) where the NDC column equals the NDC values from the previous
step.

4. Select the Clinical Formulation ID (GCN_SEQNO) values from the MED GCN_SEQNO to Medication ID
Cross-Reference Table (RMIGC1_MEDID_GCNSEQNO_LINK) where the MEDID column equals the MED
Generic Medication Identifier (GENERIC_MEDID) values from the previous step.

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5. Select the NDC values from the RNDC14_NDC_MSTR where the GCN_SEQNO column equals the
Clinical Formulation ID (GCN_SEQNO) values from the previous step and the Obsolete Date (OBSDTEC)
column equals 0 (Active) or less than three years obsolete.

Part 3: Optionally, retrieve associated MEDIDs and their descriptions.

1. Select the MEDID values from the RMINDC1_NDC_MEDID table where the NDC column equals the NDC
values from the previous step.

2. Select the MED_MEDID_DESC values from the RMIID1_MED tables where the MEDID column equals the
MEDID values from the previous step.

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Example - Retrieving Pharmaceutically Equivalent Products When Attempting to Order a Branded Product No Longer
Marketed

For purposes of demonstrating this application, the following scenario is used: A physician wishes to
prescribe the brand medication, Thorazine 25 mg/ml injection without allowing substitution. After receiving a
search for *Thorazine*, the application performs the following steps:

Part 1: Determine if the selected medication is directly associated to any active product.

1. Select the MED Medication ID (MEDID) and MED Medication Status Code (MED_STATUS_CD) values
from the MED Medication Table (RMIID1_MED) where the MED Medication Description (
MED_MEDID_DESC) column contains the name of the prescribed medication.
If MED_STATUS_CD values equal 3 (inactive), proceed to the next step.
If MED_STATUS_CD values equal 0 (active), retrieve the active product. See Retrieving a
Medications Active Products application for more information.
If a MED_STATUS_CD value equals 1 (Replaced), 2 (Retired), or 9 (Unassociated), this application
ends.

MED_MEDID_DESC MEDID MED_STATUS_CD

Thorazine 30 mg Cap 00187513 3

Thorazine 100 mg Tab 00189655 3

Thorazine 100 mg Rectal 00198144 3

Suppository

Thorazine 150 mg Cap 00206457 3

Thorazine 10 mg Tab 00211746 3

Thorazine 25 mg/mL Injection 00212404 3

Thorazine 75 mg Cap 00231800 3

Thorazine 50 mg Tab 00237911 3

Thorazine 25 mg Rectal 00245966 3

Suppository

Thorazine 10 mg/5mL Syrup 00265559 3

Thorazine 200 mg Tab 00291422 3

Thorazine 25 mg Tab 00298294 3

Thorazine 30 mg/mL Oral 00435464 3

Concentrate

Thorazine 100 mg/mL Oral 00435465 3

Concentrate

In this example, the MED_STATUS_CD value for the returned MEDIDs is 3 (indicating inactive).

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The system displays a message to the end-user stating that this medication is no longer available
and that an equivalent medication must be used or a new medication prescribed. In this example,
the physician elects to use a pharmaceutically-equivalent product. The system continues with the
application.

Part 2: Retrieve all active or less than three years obsolete products associated to the brand and generically-named
MEDIDs related to the prescribed medication.

1. If more than one MEDID is returned, select a specific MEDID for the prescribed medication from the list
retrieved in Part 1.

You can sort large lists to simplify the MEDID selection for the user. For example, the list below is sorted
by route, strength, then dosage form.

MED_MEDID_DESC MEDID MED_STATUS_CD

Thorazine 25 mg/mL Injection 00212404 3

Thorazine 10 mg/5mL Syrup 00265559 3

Thorazine 10 mg Tab 00211746 3

Thorazine 100 mg/mL Oral 00435465 3

Concentrate

Thorazine 100 mg Tab 00189655 3

Thorazine 150 mg Cap 00206457 3

Thorazine 200 mg Tab 00291422 3

Thorazine 25 mg Tab 00298294 3

Thorazine 30 mg/mL Oral 00435464 3

Concentrate

Thorazine 30 mg Cap 00187513 3

Thorazine 50 mg Tab 00237911 3

Thorazine 75 mg Cap 00231800 3

Thorazine 100 mg Rectal 00198144 3

Suppository

Thorazine 25 mg Rectal Suppository 00245966 3

In this example, MEDID 00212404 (Thorazine 25 mg/mL Injection) is selected.

2. Select the National Drug Code (NDC) values from the MED NDC to Medication ID Cross-Reference Table
(RMINDC1_NDC_MEDID) where the MEDID column equals the MEDID value from the previous step.

MEDID MED_MEDID_DESC NDC

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00212404 Thorazine 25 mg/mL Injection 00007506011

00212404 Thorazine 25 mg/mL Injection 00007506020

00212404 Thorazine 25 mg/mL Injection 00007506025

00212404 Thorazine 25 mg/mL Injection 00007506101

00212404 Thorazine 25 mg/mL Injection 00007506111

00212404 Thorazine 25 mg/mL Injection 00007506120

00212404 Thorazine 25 mg/mL Injection 00007506125

00212404 Thorazine 25 mg/mL Injection 00007506201

00212404 Thorazine 25 mg/mL Injection 00007506212

00212404 Thorazine 25 mg/mL Injection 00007506220

00212404 Thorazine 25 mg/mL Injection 54569207400

00212404 Thorazine 25 mg/mL Injection 54569208900

3. Select the MEDID values from the MED NDC to Generic Medication ID Cross-Reference Table
(RMEDNGM0_NDC_GEN_MEDID) where the NDC column equals the NDC values from the previous
step.

NDC LN60 MEDID MED_MEDID_DESC

00007506011 THORAZINE 25 MG/ML 00252140 chlorpromazine 25 mg/mL

AMPUL Injection

00007506020 THORAZINE 25 MG/ML 00252140 chlorpromazine 25 mg/mL

AMPUL Injection

00007506025 THORAZINE 25 MG/ML 00252140 chlorpromazine 25 mg/mL

AMPUL Injection

00007506101 THORAZINE 25 MG/ML 00252140 chlorpromazine 25 mg/mL

AMPUL Injection

00007506111 THORAZINE 25 MG/ML 00252140 chlorpromazine 25 mg/mL

AMPUL Injection

00007506120 THORAZINE 25 MG/ML 00252140 chlorpromazine 25 mg/mL

AMPUL Injection

00007506125 THORAZINE 25 MG/ML 00252140 chlorpromazine 25 mg/mL

AMPUL Injection

00007506201 THORAZINE 25 MG/ML 00252140 chlorpromazine 25 mg/mL

VIAL Injection

00007506212 THORAZINE 25 MG/ML 00252140 chlorpromazine 25 mg/mL

VIAL Injection

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00007506220 THORAZINE 25 MG/ML 00252140 chlorpromazine 25 mg/mL

VIAL Injection

54569207400 THORAZINE 25 MG/ML 00252140 chlorpromazine 25 mg/mL

AMPUL Injection

54569208900 THORAZINE 25 MG/ML 00252140 chlorpromazine 25 mg/mL

AMPUL Injection

In this example, all NDCs are associated to the MEDID value of 00252140.

4. Select the Clinical Formulation ID (GCN_SEQNO) values from the MED GCN_SEQNO to Medication ID
Cross-Reference Table (RMIGC1_MEDID_GCNSEQNO_LINK) where the MEDID column equals the MED
Generic Medication Identifier (GENERIC_MEDID) values from the previous step. A sample of the results
are shown below.

NDC MEDID GCN_SEQNO

00007506011 00252140 003788

00007506011 00252140 003790

00007506020 00252140 003788

00007506020 00252140 003790

00007506025 00252140 003788

00007506025 00252140 003790

00007506101 00252140 003788

00007506101 00252140 003790

00007506111 00252140 003788

00007506111 00252140 003790

In this example, two Clinical Formulation ID (GCN_SEQNO) values (003788 and 003790) are returned.

5. Select the NDC values from the NDC Table (RNDC14_NDC_MSTR) where the GCN_SEQNO column
equals the Clinical Formulation ID (GCN_SEQNO) values from the previous step and the Obsolete Date (
OBSDTEC) column equals 0 (indicating Active) or less than three years obsolete. A sample of the results
are shown below:

GCN_SEQNO NDC LN60 OBSDTEC

003788 00641139731 CHLORPROMAZINE 25 0

MG/ML AMP

003788 00641139735 CHLORPROMAZINE 25 0

MG/ML AMP

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003788 00641139831 CHLORPROMAZINE 25 0

MG/ML AMP

003788 00641139835 CHLORPROMAZINE 25 0

MG/ML AMP

003788 00641139731 CHLORPROMAZINE 25 0

MG/ML AMP

003788 00641139735 CHLORPROMAZINE 25 0

MG/ML AMP

003788 00641139831 CHLORPROMAZINE 25 0

MG/ML AMP

003788 00641139835 CHLORPROMAZINE 25 0

MG/ML AMP

In this example, only active NDCs associated to the Clinical Formulation ID (GCN_SEQNO) value of
003788 are retrieved from the RNDC14_NDC_MSTR table. Because the prescribed brand medication is
no longer available and the physician has selected Do not Substitute, the system continues with the
application.

Part 3: Optionally, retrieve associated MEDIDs and descriptions.

1. Select the MEDID values from the RMINDC1_NDC_MEDID table where the NDC column equals the NDC
values from the previous step. A sample of the results are shown below:

NDC MEDID

00641139731 00252140

00641139735 00184992

00641139831 00202830

00641139835 00202830

00641139731 00202830

00641139735 00202830

00641139831 00202830

00641139835 00202830

2. Select the MED_MEDID_DESC values from the RMIID1_MED tables where the MEDID column equals the
MEDID values from the previous step.

A distinct sample of results is shown below:

MEDID MED_MEDID_DESC

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00202830 chlorpromazine 25 mg/mL Injection

The system uses the retrieved MEDID in the order.

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Example - Retrieving all Pharmaceutically Equivalent Products When Dispensing a Prescribed Branded Product No
Longer Marketed

For purposes of demonstrating this application, the following scenario is used: A pharmacist receives an
order for Compazine 10 mg orally 3 to 4 times per day prn nausea and vomiting. After receiving a search for
*Compazine*, the application performs the following steps:

Part 1: Determine if the selected medication is directly associated to any active product.

1. Select the MED Medication ID (MEDID) and MED Medication Status Code (MED_STATUS_CD) values
from the MED Medication Table (RMIID1_MED) where the MED Medication Description (
MED_MEDID_DESC) column contains the name of the prescribed medication.
If MED_STATUS_CD values equal 3 (inactive), proceed to the next step.
If MED_STATUS_CD values equal 0 (active), proceed to the Retrieving a Medications Active
Products application.
If a MED_STATUS_CD value equals 1 (Replaced), 2 (Retired), or 9 (Unassociated), this application
ends.

MED_MEDID_DESC MEDID MED_STATUS_CD

Compazine 10 mg Cap 166383 3

Compazine 10 mg Tab 184992 3

Compazine 5 mg Rectal 209848 3

Suppository

Compazine 5 mg/5 mL Syrup 222048 3

Compazine 5 mg Tab 233726 3

Compazine 25 mg Rectal 241584 3

Suppository

Compazine 5 mg/mL Injection 263644 3

Compazine 2.5 mg Rectal 264073 3

Suppository

Compazine 15 mg Cap 278041 3

Compazine 5 mg/mL Syringe 444955 3

Compazine 10 mg/2 mL (5 568635 3

mg/mL) Injection

In this example, the MED_STATUS_CD value for the returned MEDIDs is 3 (indicating inactive).
The system continues with the application.

Part 2: Retrieve all active or less than three years obsolete products associated to the brand and generically-named
MEDIDs related to the prescribed medication.

1.

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1. If more than one MEDID is returned, select a specific MEDID for the prescribed medication from the list
retrieved in Part 1.

You can sort large lists to simplify the MEDID selection for the user. For example, the list below is sorted
by route, strength, then dosage form.

MED_MEDID_DESC MEDID MED_STATUS_CD

Compazine 10 mg/2 mL (5 mg/mL) 568635 3

Injection

Compazine 5 mg/mL Injection 263644 3

Compazine 5 mg/mL Syringe 444955 3

Compazine 10 mg Cap 166383 3

Compazine 10 mg Tab 184992 3

Compazine 15 mg Cap 278041 3

Compazine 5 mg/5 mL Syrup 222048 3

Compazine 5 mg Tab 233726 3

Compazine 2.5 mg Rectal 264073 3

Suppository

Compazine 25 mg Rectal 241584 3

Suppository

Compazine 5 mg Rectal Suppository 209848 3

In this example, MEDID 184992 (Compazine 10 mg tab) is selected.

2. Select the National Drug Code (NDC) values from the MED NDC to Medication ID Cross-Reference Table
(RMINDC1_NDC_MEDID) where the MEDID column equals the MEDID value from the previous step.

A sample of the results are shown below:

MEDID MED_MEDID_DESC NDC

184992 Compazine 10 mg Tab 00007336720

184992 Compazine 10 mg Tab 00007336721

184992 Compazine 10 mg Tab 00007336730

184992 Compazine 10 mg Tab 00247049702

184992 Compazine 10 mg Tab 00247049703

184992 Compazine 10 mg Tab 00247049704

184992 Compazine 10 mg Tab 00247049706

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184992 Compazine 10 mg Tab 00247049710

3. Select the MEDID values from the MED NDC to Generic Medication ID Cross-Reference Table
(RMEDNGM0_NDC_GEN_MEDID) where the NDC column equals the NDC values from the previous
step.

A sample of the results are shown below:

NDC LN60 MEDID MED_MEDID_DESC

00007336720 COMPAZINE 10 MG 202830 prochlorperazine maleate

TABLET 10 mg Tab

00007336721 COMPAZINE 10 MG 202830 prochlorperazine maleate

TABLET 10 mg Tab

00007336730 COMPAZINE 10 MG 202830 prochlorperazine maleate

TABLET 10 mg Tab

00247049702 COMPAZINE 10 MG 202830 prochlorperazine maleate

TABLET 10 mg Tab

00247049703 COMPAZINE 10 MG 202830 prochlorperazine maleate

TABLET 10 mg Tab

00247049704 COMPAZINE 10 MG 202830 prochlorperazine maleate

TABLET 10 mg Tab

00247049706 COMPAZINE 10 MG 202830 prochlorperazine maleate

TABLET 10 mg Tab

00247049710 COMPAZINE 10 MG 202830 prochlorperazine maleate

TABLET 10 mg Tab

00247049712 COMPAZINE 10 MG 202830 prochlorperazine maleate

TABLET 10 mg Tab

00247049715 COMPAZINE 10 MG 202830 prochlorperazine maleate

TABLET 10 mg Tab

00247049720 COMPAZINE 10 MG 202830 prochlorperazine maleate

TABLET 10 mg Tab

In this example, all NDCs are associated to the MEDID value of 00202830.

4. Select the Clinical Formulation ID (GCN_SEQNO) values from the MED GCN_SEQNO to Medication ID
Cross-Reference Table (RMIGC1_MEDID_GCNSEQNO_LINK) where the MEDID column equals the MED
Generic Medication Identifier (GENERIC_MEDID) values from the previous step.

A sample of the results are shown below:

NDC MEDID GCN_SEQNO

00007336720 202830 003846

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00007336721 202830 003846

00007336730 202830 003846

00247049702 202830 003846

00247049703 202830 003846

00247049704 202830 003846

00247049706 202830 003846

00247049710 202830 003846

00247049712 202830 003846

00247049715 202830 003846

00247049720 202830 003846

In this example, only one Clinical Formulation ID (GCN_SEQNO) value (003846) is returned. Please be
aware that a clinical formulation can be associated to more than one MEDID. Therefore, more than one
Clinical Formulation ID (GCN_SEQNO) values can be retrieved at this point. See ExampleRetrieving
Pharmaceutically Equivalent Products When Attempting to Order a Branded Product No Longer Marketed
for more information.

5. Select the NDC values from the NDC Table (RNDC14_NDC_MSTR) where the GCN_SEQNO column
equals the Clinical Formulation ID (GCN_SEQNO) values from the previous step and the Obsolete Date (
OBSDTEC) column equals 0 (Active) or less than three years obsolete. A sample of the results are shown
below:

GCN_SEQNO NDC LN60 OBSDTEC

003846 00247049715 COMPAZINE 10 MG 20090617

TABLET

003846 00247049720 COMPAZINE 10 MG 20090617

TABLET

003846 00378511001 PROCHLORPERAZINE 0

10 MG TAB

003846 00555052202 PROCHLORPERAZINE 20090528

10 MG TAB

003846 00781502101 PROCHLORPERAZINE 0

10 MG TAB

003846 10135036801 PROCHLORPERAZINE 0

10 MG TAB

003846 21695057205 PROCHLORPERAZINE 0

10 MG TAB

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003846 21695057230 PROCHLORPERAZINE 0

10 MG TAB

In this example, the application ends as the system selects the dispensed product based on the
pharmacies formulary.

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Implementing Change Management of Stored MEDIDs

The NDC/MEDID relation change history tables enable the creation of reports or programmatic maintenance
tools to assist healthcare professionals in maintaining links to stored medication concepts.

The following examples demonstrate the application:

ExampleMonitoring NDC/MEDID Changes Within a Dispensing Environment

ExampleCreating a Weekly MEDID Change History Report

The examples in this application were created using sample data and may not exist within the current
data.

1. Select the desired values from either the MED NDC/MEDID Relation History Table
(RMEDNMH0_NDC_MEDID_HIST) or the MED NDC/Generic MEDID Relation History Table
(RMEDNGH0_NDC_GEN_MEDID_HIST) where the Production Date (PRODUCTION_DATE) column
equals the production date value containing the association changes you wish to review:
National Drug Code (NDC)
Production Date (PRODUCTION_DATE)
Previously Associated Medication ID (PREV_MEDID)
Previously Associated Medication ID Name Source Code ( PREV_MEDID_NAME_SOURCE_CD)
Previously Associated Medication ID Old Status Code (PREV_MEDID_OLD_STATUS_CD)
Previously Associated Medication ID New Status Code (PREV_MEDID_NEW_STATUS_CD)
Previously Associated Medication ID Description (PREV_MEDID_DESC)
Currently Associated Medication ID (CURR_MEDID)
Currently Associated Medication ID Name Source Code (CURR_MEDID_NAME_SOURCE_CD)
Currently Associated Medication ID Old Status Code (CURR_MEDID_OLD_STATUS_CD)
Currently Associated Medication ID New Status Code (CURR_MEDID_NEW_STATUS_CD)
Currently Associated Medication ID Description (CURR_MEDID_DESC)

2. Select the Move Reason Code (MOVE_REASON_CD) from one of the following tables where the NDC
column equals the NDC value and the PRODUCTION_DATE column equals the PRODUCTION_DATE
value of the previous step.
MED NDC/MEDID Move History Reason Table (RMEDNMR0_NDC_MEDID_REASON)
MED NDC/Generic MEDID Move History Reason Table
(RMEDNGR0_NDC_GEN_MEDID_REASON)

3. Select the Move Reason Code Description (MOVE_REASON_CD_DESC) from the MED Move Reason
Description Table (RMEDMRD0_MOVE_REASON_DESC) where the MOVE_REASON_CD column
equals the MOVE_REASON_CD values from the previous step.

4. Use the retrieved values according to your business needs. This could include adding the values to reports

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4.
or using them programmatically to replace or add values within patient profiles as shown in the examples.

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Example - Monitoring NDC-MEDID Changes Within a Dispensing Environment

A hospital system has decided to implement a safety measure to ensure that patients are only dispensed drugs
that appear on their profile (expressed as MEDID values). The validation process utilizes the relationship between
an NDC and its associated MEDID in the MED NDC to Medication ID Cross-Reference Table
(RMINDC1_NDC_MEDID) and the MED NDC to Generic Medication ID Cross-Reference Table
(RMEDNGM0_NDC_GEN_MEDID) to stop the dispensing process when an NDC does not map to a MEDID
stored on a patient profile.

In addition, the validation process creates a report to note changes made to the NDC/MEDID relationships since
the systems last update. This process assists healthcare professionals in maintaining MEDIDs that appear on
patient profiles but have been modified, for example, an NDC/MEDID relationship changes or the MEDID
becomes replaced, retired, unassociated, etc.

In this example, an NDC 00517481025 (nitroglycerin 5 mg/mL vial) relationship to MEDID 00199016 (nitroglycerin
5 mg/mL IV) is changed to MEDID 00557118 (nitroglycerin 50 mg/10mL (5 mg/mL) IV) in the May 7, 2009 data
update. Upon receipt of this update, a report is generated, which lists the NDC/MEDID relationship changes. The
systems last data update was made on April 21, 2009.

1. Select the following columns from the MED NDC/MEDID Relation History Table
(RMEDNMH0_NDC_MEDID_HIST) where the Production Date (PRODUCTION_DATE) column is greater
than the date of the system databases last update.
Previously Associated Medication ID (PREV_MEDID)
Currently Associated Medication ID (CURR_MEDID)
Currently Associated Medication ID Description (CURR_MEDID_DESC)

This step retrieves any relationship changes that have occurred since the last update. In this example, the
system database was last updated on April 21, 2009 and one relationship change was retrieved.

NDC PRODUCTION_DA PREV_MEDID CURR_MEDID CURR_MEDID_DE

TE SC

00517481025 20090507 00199016 0057118 nitroglycerin 50

mg/10 mL (5 mg/mL)
IV

2. Select the Move Reason Code (MOVE_REASON_CD) from the MED NDC/MEDID Move History Reason
Table (RMEDNMR0_NDC_MEDID_REASON) where the NDC column equals the NDC value and the
PRODUCTION_DATE column equals the PRODUCTION_DATE value of the previous step.

NDC PRODUCTION_DATE MOVE_REASON_CD

00517481025 20090507 9

3. Select the Move Reason Code Description (MOVE_REASON_CD_DESC) from the MED Move Reason
Description Table (RMEDMRD0_MOVE_REASON_DESC) where the MOVE_REASON_CD column
equals the MOVE_REASON_CD values from the previous step.

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MOVE_REASON_CD MOVE_REASON_CD_DESC

9 Product associated with a MedID representing the total

drug strength & total volume

4. The validation system adds the PREV_MEDID, CURR_MEDID, and MOVE_REASON_CD_DESC to a

report, which is presented to an end-user who determines if further action is required.

PREV_MEDID CURR_MEDID CURR_MEDID_DESC MOVE_REASON_CD_DE

SC

00199016 00557118 nitroglycerin 50 mg/10 mL Product associated with a

(5 mg/mL) IV MedID representing the
total drug strength & total
volume

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Example - Creating a Weekly MEDID Change History Report

To ensure a stored MEDID always links to NDCs for dispensing, a healthcare professional requests a weekly
report so they can select replacement MED Medication IDs (MEDID) for those that no longer link to NDCs. A
weekly report is generated illustrating the previous and current MEDID values and their attributes.

1. Select the Previously Associated Medication ID (PREV_MEDID) and the Currently Associated Medication
ID (CURR_MEDID) values from the MED NDC/MEDID Relation History Table
(RMEDNMH0_NDC_MEDID_HIST)

where the:
Production Date (PRODUCTION_DATE) equals the date of the most recent FDB build.
Previously Associated Medication ID New Status Code (PREV_MEDID) equals 1 (Replaced), 2 (
Retired), or 9 (Unassociated).

The table below contains a sample of returned values:

PRODUCTION_ PREV_MEDID_ PREV_MEDID PREV_MEDID_ CURR_MEDID CURR_MEDID_

DATE NEW_STATUS DESC DESC
_CD

20100916 0 00448318 Commit 2 mg 00561655 Nicorette 2 mg

Buccal Lozenge Buccal Lozenge

20100916 0 00448318 Commit 2 mg 00561655 Nicorette 2 mg

Buccal Lozenge Buccal Lozenge

20100916 0 00448319 Commit 4 mg 00561656 Nicorette 4 mg

Buccal Lozenge Buccal Lozenge

20100916 0 00448319 Commit 4 mg 00561656 Nicorette 4 mg

Buccal Lozenge Buccal Lozenge

20100916 1 00467732 Remedy 4-in-1 00557714 Remedy

Cleanser Lotion Cleansing Body
1.5 % Topical
Cleanser

20100916 1 00467732 Remedy 4-in-1 00557714 Remedy

Cleanser Lotion Cleansing Body
1.5 % Topical
Cleanser

20100916 0 00209027 Slow-Mag 64 mg 00562168 Slow-Mag 71.5

Tab mg Tab, Delayed
Release

20100916 3 00225977 Sore Throat 00550558 Sore Throat

Lozenges 32.5 Lozenges 6
mg mg-10 mg

20100916 3 00225977 Sore Throat 00550558 Sore Throat

Lozenges 32.5 Lozenges 6
mg mg-10 mg

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20100916 0 00218992 Tice BCG 50 mg 00294151 BCG vaccine,

Intravesical Susp live (PF) 50 mg
Percutaneous
Suspension

2. Filter the records retrieved in step 1 to remove any duplicates, if needed.

3. The retrieved CURR_MEDID values represent candidates for replacement of the PREV_MEDID.

PRODUCTION_ PREV_MEDID_ PREV_MEDID PREV_MEDID_DESC

CURR_MEDID CURR_MEDID_DESC
DATE NEW_STATUS
_CD

20100916 0 00448318 Commit 2 mg 00561655 Nicorette 2 mg

Buccal Lozenge Buccal Lozenge

20100916 0 00448319 Commit 4 mg 00561656 Nicorette 4 mg

Buccal Lozenge Buccal Lozenge

20100916 1 00467732 Remedy 4-in-1 00557714 Remedy

Cleanser Lotion Cleansing Body
1.5 % Topical
Cleanser

20100916 0 00209027 Slow-Mag 64 mg 00562168 Slow-Mag 71.5

Tab mg Tab, Delayed
Release

20100916 3 00225977 Sore Throat 00550558 Sore Throat

Lozenges 32.5 Lozenges 6
mg mg-10 mg

20100916 0 00218992 Tice BCG 50 mg 00294151 BCG vaccine,

Intravesical Susp live (PF) 50 mg
Percutaneous
Suspension

4. Build a report using the information retrieved from the previous step.

Your users might find it useful to include the NDCs

present in the change records to support their decision-making process.

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Identifying a Drug To Administer That May Have Multiple Alternative Ingredient Strengths
This application illustrates how a clinician can identify and dispense medications using a consistent strength using
the alternative strength tables added as part of the MAPs enhancements.

1. Retrieve the MED Medication Name Identifier (MED_NAME_ID) from the MED Medication Name Table
(RMINMID1_MED_NAME) where the Med Medication Name (MED_NAME) equals the medication name
specified in the order.

2. Retrieve the MED Routed Medication Identifier (ROUTED_MED_ID) from the MED Routed Medication
Table (RMIRMID1_ROUTED_MED) where the Med Medication Name Identifier (MED_NAME_ID) equals
the value retrieved in the previous step and MED Route Identifier ( MED_ROUTE_ID) equals the route
specified in the order.

Text descriptions for MED Route Identifier (ROUTED_MED_ID) values are located in the MED
Route Description (MED_ROUTE_DESC).

3. Retrieve the MED Routed Dosage Form Medication ID ( ROUTED_DOSAGE_FORM_MED_ID) from the
MED Routed Dosage Form Medication Table (RMIDFID1_ROUTED_DOSE_FORM_MED) where the Med
Routed Medication ID (ROUTED_MED_ID) equals the value retrieved in the previous step.

4. Retrieve the Med Medication ID (MEDID) from the MED Medication Table (RMIID1_MED) where the Med
Routed Dosage Form Medication ID (ROUTED_DOSAGE_FORM_MED_ID) equals the value retrieved in
the previous step and strength is equal to the strength specified in the order.

5. Retrieve the related National Drug Codes (NDC) from the MED NDC to Medication ID Cross-Reference
Table (RMINDC1_NDC_MEDID) where the Med Medication ID (MEDID) equals the value retrieved in the
previous step.

6. Retrieve the following values from the Alternative NDC Ingredient Strength Link Table
(RPEINS0_NDC_STR_LINK) where the National Drug Code (NDC) equals the values retrieved in the
previous step:
Ingredient Strength (INGREDIENT_STR)
Ingredient Strength Unit of Measure Master Identifier (INGREDIENT_UOM_MSTR_ID)
Clinical Formulation Ingredient Volume (VOLUME)
Ingredient Volume Unit of Measure Master Identifier (VOLUME_UOM_MSTR_ID)

7. Retrieve the Unit of Measure Master Description (UOM_MSTR_DESC) from the Unit of Measure Master
Table (RPEIUM0_UOM_MSTR) where the Ingredient Strength Unit of Measure Master Identifier (
INGREDIENT_UOM_MSTR_ID) equals the value retrieved in the previous step.

8. Retrieve the Unit of Measure Master Description (UOM_MSTR_DESC) from the Unit of Measure Master
Table (RPEIUM0_UOM_MSTR) where the Ingredient Volume Unit of Measure Master Identifier (
VOLUME_UOM_MSTR_ID) equals the value retrieved in step 6.

9. Display NDCs that have an alternative strength equal to the strength specified in the order so that the

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9.

clinician can select an appropriate NCD to dispense.

ExampleIdentify Drug To Administer That May Have Multiple Alternative Ingredient Strengths

For purposes of demonstrating this application, the following scenario is used: For purposes of
demonstrating this application, the following scenario is used: A nurse tries to open an automated dispensing
cabinet to administer prochlorperazine edisylate 5 mg/mL Injection (MEDID 00242041) to a patient.

1. Retrieve the MED Medication Name Identifier (MED_NAME_ID) from the MED Medication Name Table
(RMINMID1_MED_NAME) where the Med Medication Name (MED_NAME) equals the given medication
name (prochlorperazine edisylate).

MED_NAME MED_NAME_ID

prochlorperazine edisylate 00004314

2. Retrieve the MED Routed Medication Identifier (ROUTED_MED_ID) from the MED Routed Medication
Table (RMIRMID1_ROUTED_MED) where the Med Medication Name Identifier (MED_NAME_ID) equals
the value retrieved in the previous step (0004314) and the MED Route Identifier ( MED_ROUTE_ID)
equals 9 (Injection).

MED_NAME_ID MED_ROUTE_ID ROUTED_MED_ID

00004314 9 00004410

Text descriptions for MED Route Identifier (MED_ROUTE_ID) values are located in the MED
Route Description (MED_ROUTE_DESC).

3. Retrieve the MED Routed Dosage Form Medication ID ( ROUTED_DOSAGE_FORM_MED_ID) from the
MED Routed Dosage Form Medication Table (RMIDFID1_ROUTED_DOSE_FORM_MED) where the Med
Routed Medication ID (ROUTED_MED_ID) equals the value retrieved in the previous step (00004410).

ROUTED_MED_ID ROUTED_DOSAGE_FORM_MED_ID

00004410 00004778

4. Retrieve the Med Medication ID (MEDID) from the MED Medication Table (RMIID1_MED) where the Med
Routed Dosage Form Medication ID (ROUTED_DOSAGE_FORM_MED_ID) equals the value retrieved in
the previous step (00004778) and strength equals the given strength (5 mg/mL).

ROUTED_DOSAGE_FO MED_STRENGTH MED_STRENGTH_UOM MEDID

RM_MED_ID

00004778 5 mg/mL 00242041

5. Retrieve the related National Drug Codes (NDC) from the MED NDC to Medication ID Cross-Reference
Table (RMINDC1_NDC_MEDID) where the Med Medication ID (MEDID) equals the value retrieved in the
previous step (00242041).

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MEDID NDC

00242041 55390007710

00242041 54868026100

The results of this query will probably be numerous. The results shown in this step represent a
small sample of the full result set.

6. Retrieve the following values from the Alternative NDC Ingredient Strength Link Table
(RPEINS0_NDC_STR_LINK) where the National Drug Code (NDC) equals the values retrieved in the
previous step:
Ingredient Strength (INGREDIENT_STR)
Ingredient Strength Unit of Measure Master Identifier (INGREDIENT_UOM_MSTR_ID)
Clinical Formulation Ingredient Volume (VOLUME)
Ingredient Volume Unit of Measure Master Identifier (VOLUME_UOM_MSTR_ID)

NDC 55390007710

INGREDIENT_STR 5

INGREDIENT_UOM_MSTR_ID 367

VOLUME 1

VOLUME_UOM_MSTR_ID 380

7. Retrieve the Unit of Measure Master Description (UOM_MSTR_DESC) from the Unit of Measure Master
Table (RPEIUM0_UOM_MSTR) where the Ingredient Strength Unit of Measure Master Identifier (
INGREDIENT_UOM_MSTR_ID) equals the value retrieved in the previous step.

INGREDIENT_UOM_MSTR_ID UOM_MSTR_DESC

367 mg

8. Retrieve the Unit of Measure Master Description (UOM_MSTR_DESC) from the Unit of Measure Master
Table (RPEIUM0_UOM_MSTR) where the Ingredient Volume Unit of Measure Master Identifier (
VOLUME_UOM_MSTR_ID) equals the value retrieved in step 6 (380).

VOLUME_UOM_MSTR_ID UOM_MSTR_DESC

380 mL

9. Display NDCs that have an alternative strength of 5 mg/mL. In this example, NDC 55390007710
(PROCHLORPERAZINE 5 MG/ML VIAL) has a normalized strength of 5 mg per 1 mL and a packaged
strength of 10 mg per 2 mL and is displayed as an option for dispensing. When the clinician selects NDC

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55390007710 (PROCHLORPERAZINE 5 MG/ML VIAL), the automated dispensing cabinet will allow the
drawer corresponding to NDC 55390007710 to be opened so that the medication can be administered to
the patient.

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Presenting a Prescribable MEDID Using a Search Term Type Code

Searching for a prescribable medication can be one of the first steps in selecting an ambulatory order. The
MEDID may be associated to a medication or a medical supply.

The MED Medication ID Search Term Table (RMEDST0_MEDID_SEARCH_TERM) and the Search Term Type
Description Table (RMEDSTD0_SEARCH_TERM_TYPE_DESC) can be used by prescribers who know a brand
name for a medication but prefer to prescribe using the generic name or by prescribers who know the
abbreviation for a product and want to find a prescribable medication name. In these and other situations, the
following Search Term Type Codes (SEARCH_TERM_TYPE_CD) can be utilized:

Description (SEARCH_TERM_TYPE_CD = 0)
Alternative names (SEARCH_TERM_TYPE_CD = 1)
Abbreviations and acronyms (SEARCH_TERM_TYPE_CD = 2)
Obsolete brand names (SEARCH_TERM_TYPE_CD = 3)
Medication description (SEARCH_TERM_TYPE_CD = 4)
Generic medication for a brand medication (SEARCH_TERM_TYPE_CD = 5)
Brand medication for a generic medication (SEARCH_TERM_TYPE_CD = 6)
Alternate brand for a brand (SEARCH_TERM_TYPE_CD = 7)

Perform the following general steps to select a prescribable MEDID using the search function. Example
applications by search term type with selected search result returns displayed for illustrative purposes are
presented below.

Rather than prompt the end user, a developer can also set default and exhaustive search settings.

1. Retrieve the MED Medication ID (MEDID) and MED Medication Description (MED_MEDID_DESC) from
the MED Medication ID Search Term Table (RMEDST0_MEDID_SEARCH_TERM) where the:
Search Term Text (SEARCH_TERM_TEXT) value equals the value of the search term you are
searching for
Search Term Type Code (SEARCH_TERM_TYPE_CD) equals the value of the search term type
code you are filtering by
Medical Supply Indicator (MEDICAL_SUPPLY_IND) equals 0 (MEDID is not considered a medical
supply)

Not including medical supplies in the results reduces the number of returns to the end user. If no
selection is made, all MEDID (medical supplies and non medical supplies) will be returned.

Entering a SEARCH_TERM_TYPE_CD reduces the number of returns to the end user. If a

SEARCH_TERM_TYPE_CD is not selected, results for all types of search term types matching the
search string criteria will be returned. Limiting the search to SEARCH_TERM_TYPE_CD = 4
provides a direct search against the MEDID description itself. Developers may want to use this as

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the default setting, and expand to other search types when the end-user desires an exhaustive
search.

The SEARCH_TERM_TEXT field is built to accept uppercase letters, so the system must convert
the user's input to uppercase letters.

To increase precision, your system should allow for a prescriber to use compound wildcard string
searches.

2. Display the results to the end user for selection.

Using SEARCH_TERM_TYPE_CD 2 (Abbreviations and Acronyms)

For purposes of demonstrating this application, the following scenario is used: A prescriber wants to look up
hydrochlorothiazide using its abbreviation, HCTZ.

1. Retrieve the MED Medication ID (MEDID) and MED Medication Description (MED_MEDID_DESC) from
the MED Medication ID Search Term Table (RMEDST0_MEDID_SEARCH_TERM) where the:
Search Term Text (SEARCH_TERM_TEXT) value equals HCTZ
Search Term Type Code (SEARCH_TERM_TYPE_CD) equals 2 (Abbreviations and Acronyms)
Medical Supply Indicator (MEDICAL_SUPPLY_IND) equals 0 (MEDID is not considered a medical
supply)

MEDID MED_MEDID_DE SEARCH_TERM_ SEARCH_TERM_ MEDICAL_SUPPL

SC TEXT TYPE_CD Y_IND

176024 hydrochlorothiazide HCTZ 2 0

50 mg tablet

208944 Microzide 12.5 mg HCTZ 2 0

capsule

253304 hydrochlorothiazide HCTZ 2 0

12.5 mg capsule

269382 hydrochlorothiazide HCTZ 2 0

25 mg tablet

549792 hydrochlorothiazide HCTZ 2 0

12.5 mg tablet

2. Display the results to the end user for selection.

Using SEARCH_TERM_TYPE_CD 3 (Obsolete Brand Name)

For purposes of demonstrating this application, the following scenario is used: A prescriber is familiar with Esidrix,
which is the brand name of an obsolete product, but the prescriber needs a MEDID for a current product.

1. Retrieve the MED Medication ID (MEDID) and MED Medication Description (MED_MEDID_DESC) from

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1.
the MED Medication ID Search Term Table (RMEDST0_MEDID_SEARCH_TERM) where the:
Search Term Text (SEARCH_TERM_TEXT) value equals ESIDRIX
Search Term Type Code (SEARCH_TERM_TYPE_CD) equals 3 (Obsolete Brand Names)
Medical Supply Indicator (MEDICAL_SUPPLY_IND) equals 0 (MEDID is not considered a medical
supply)

MEDID MED_MEDID_DE SEARCH_TERM_ SEARCH_TERM_ MEDICAL_SUPPL

SC TEXT TYPE_CD Y_IND

176024 hydrochlorothiazide ESIDRIX 3 0

50 mg tablet

208944 Microzide 12.5 mg ESIDRIX 3 0

capsule

253304 hydrochlorothiazide ESIDRIX 3 0

12.5 mg capsule

269382 hydrochlorothiazide ESIDRIX 3 0

25 mg tablet

549792 hydrochlorothiazide ESIDRIX 3 0

12.5 mg tablet

2. Display the results to the end user for selection.

Using SEARCH_TERM_TYPE_CD 4 (Medication Description)

This is the recommended default search type to use when searching for a medication description. For purposes of
demonstrating this application, the following scenario is used: A prescriber wants to look up atorvastatin.

1. Retrieve the MED Medication ID (MEDID) and MED Medication Description (MED_MEDID_DESC) from
the MED Medication ID Search Term Table (RMEDST0_MEDID_SEARCH_TERM) where the:
Search Term Text (SEARCH_TERM_TEXT) value equals ATORVASTATIN
Search Term Type Code (SEARCH_TERM_TYPE_CD) equals 4 (Medication Description)
Medical Supply Indicator (MEDICAL_SUPPLY_IND) equals 0 (MEDID is not considered a medical
supply)

MEDID MED_MEDID_DE SEARCH_TERM_ SEARCH_TERM_ MEDICAL_SUPPL

SC TEXT TYPE_CD Y_IND

154892 atorvastatin 40 mg ATORVASTATIN 4 0

tablet 40 MG TABLET

163181 atorvastatin 20 mg ATORVASTATIN 4 0

tablet 20 MG TABLET

158585 atorvastatin 80 mg ATORVASTATIN 4 0

tablet 80 MG TABLET

170427 atorvastatin 10 mg ATORVASTATIN 4 0

tablet 10 MG TABLET

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2. Display the results to the end user for selection.

Using SEARCH_TERM_TYPE_CD 4 (Medication Description) to Find a Medical Supply

This is the recommended default search type to use when searching for a medication description. For purposes of
demonstrating this application, the following scenario is used: A prescriber wants to prescribe a blood-glucose
meter for a patient.

1. Retrieve the MED Medication ID (MEDID) and MED Medication Description (MED_MEDID_DESC) from
the MED Medication ID Search Term Table (RMEDST0_MEDID_SEARCH_TERM) where the:
Search Term Text (SEARCH_TERM_TEXT) value equals %GLUCOSE%METER%
Search Term Type Code (SEARCH_TERM_TYPE_CD) equals 4 (Medication Description)
Medical Supply Indicator (MEDICAL_SUPPLY_IND) equals 1 (MEDID is considered a medical
supply)

MEDID MED_MEDID_DE SEARCH_TERM_ SEARCH_TERM_ MEDICAL_SUPPL

SC TEXT TYPE_CD Y_IND

557274 Sure Edge Blood SURE EDGE 4 1

Glucose Meter BLOOD GLUCOSE
METER

557700 Prodigy Voice PRODIGY VOICE 4 1

Glucose Meter kit GLUCOSE METER
KIT

562707 UltraTRAK Glucose ULTRATRAK 4 1

Meter GLUCOSE METER

562996 EasyMax L Blood EASYMAX L 4 1

Glucose Meter BLOOD GLUCOSE
METER

575587 Reveal Blood REVEAL BLOOD 4 1

Glucose Meter kit GLUCOSE METER
KIT

2. Display the results to the end user for selection.

Using SEARCH_TERM_TYPE_CD 5 (Generic Medication for a Brand Medication)

For purposes of demonstrating this application, the following scenario is used: A prescriber has a patient with
prescription benefits limited to generic medications if a generic is available. The prescriber uses the brand name
medication Zebutal to search for the MEDID of the corresponding generic medication.

1. Retrieve the MED Medication ID (MEDID) and MED Medication Description (MED_MEDID_DESC) from
the MED Medication ID Search Term Table (RMEDST0_MEDID_SEARCH_TERM) where the:
Search Term Text (SEARCH_TERM_TEXT) value equals ZEBUTAL
Search Term Type Code (SEARCH_TERM_TYPE_CD) equals 5 (Generic Medication for a Brand
Medication)

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Medical Supply Indicator (MEDICAL_SUPPLY_IND) equals 0 (MEDID is not considered a medical

supply)

MEDID MED_MEDID_DE SEARCH_TERM_ SEARCH_TERM_ MEDICAL_SUPPL

SC TEXT TYPE_CD Y_IND

226661 butalbital-acetamin ZEBUTAL 50 5 0

ophen-caffeine 50 MG-500 MG-40
mg-500 mg-40 mg MG CAPSULE
capsule

2. Display the results to the end user for selection.

Using SEARCH_TERM_TYPE_CD 6 (Brand Medication for a Generic Medication)

For purposes of demonstrating this application, the following scenario is used: A prescriber wants to look up
brand name medications available for the generic name medication levothyroxine. This medication comes in
numerous strengths, so, to increase precision, your system should allow for a prescriber to use compound
wildcard string searches.

1. Retrieve the MED Medication ID (MEDID) and MED Medication Description (MED_MEDID_DESC) from
the MED Medication ID Search Term Table (RMEDST0_MEDID_SEARCH_TERM) where the:
Search Term Text (SEARCH_TERM_TEXT) value equals LEVOT%175%
Search Term Type Code (SEARCH_TERM_TYPE_CD) equals 6 (Brand Medication for a Generic
Medication)
Medical Supply Indicator (MEDICAL_SUPPLY_IND) equals 0 (MEDID is not considered a medical
supply)

MEDID MED_MEDID_DE SEARCH_TERM_ SEARCH_TERM_ MEDICAL_SUPPL

SC TEXT TYPE_CD Y_IND

189604 Levoxyl 175 mcg LEVOTHYROXINE 6 0

tablet 175 MCG TABLET

213415 Synthroid 175 mcg LEVOTHYROXINE 6 0

tablet 175 MCG TABLET

268570 Levothroid 175 LEVOTHYROXINE 6 0

mcg tablet 175 MCG TABLET

273579 Unithroid 175 mcg LEVOTHYROXINE 6 0

tablet 175 MCG TABLET

2. Display the results to the end user for selection.

Using SEARCH_TERM_TYPE_CD 7 (Alternate Brand for Brand)

For purposes of demonstrating this application, the following scenario is used: A prescriber is searching for
alternative brand name medications for the brand name medication Levothroid using a partial brand name and a
partial strength in the search string. This medication comes in numerous strengths, so, to increase precision, your
system should allow for a prescriber to use compound wildcard string searches.

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1. Retrieve the MED Medication ID (MEDID) and MED Medication Description (MED_MEDID_DESC) from
the MED Medication ID Search Term Table (RMEDST0_MEDID_SEARCH_TERM) where the:
Search Term Text (SEARCH_TERM_TEXT) value equals LEVOT%75%
Search Term Type Code (SEARCH_TERM_TYPE_CD) equals 7 (Alternate Brand for a Brand)
Medical Supply Indicator (MEDICAL_SUPPLY_IND) equals 0 (MEDID is not considered a medical
supply)

MEDID MED_MEDID_DE SEARCH_TERM_ SEARCH_TERM_ MEDICAL_SUPPL

SC TEXT TYPE_CD Y_IND

189604 Levoxyl 175 mcg LEVOTHROID 175 7 0

tablet MCG TABLET

193374 Levoxyl 75 mcg LEVOTHROID 75 7 0

tablet MCG TABLET

213415 Synthroid 175 mcg LEVOTHROID 175 7 0

tablet MCG TABLET

253625 Synthroid 75 mcg LEVOTHROID 75 7 0

tablet MCG TABLET

2. Display the results to the end user for selection.

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MED ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

Medication Name Concepts Tables

Medication Name Concepts ERD
MED NDC/MEDID Relationship Change History Table ERD
Medication Name Concepts Inactive Ingredients ERD
Medication Name Concepts Descriptive Tables ERD
MEDID Search Term ERD
Medication Name Concepts Freeness and Storage Concepts Tables ERD

Medication Name Concepts Tables

Alternative Medication Identifier (MEDID) to Ingredient Strength Link Table
Attribute Description Table
Attribute Type Description Table
Attribute Value Description Table
Dosage Form Master to MED Dosage Form Link Table
MED Dosage Forms Table
MED GCN_SEQNO Assignment Code Description Table
MED GCN_SEQNO to Medication ID Cross-Reference Table
MED MED Concept/Generic MED Relation Table
MED MED Concept/HICL_SEQNO Relation Table
MED MED Concept ID Type Description Table
MED Medication Attribute Table
MED Medication Identifier (MEDID) to Dosage Form Link Table
MED Medication Identifier (MEDID) to Route Relationship Table
MED Medication ID Search Term Table
MED Medication Name Attribute Table
MED Medication Name ID/Inactive Ingredient Relation Table
MED Medication Name ID/Inactive Ingredient Study Master Table
MED Medication Name Replacement History Table
MED Medication Name Source Code Description Table
MED Medication Name Table
MED Medication Name to Route Relationship Table
MED Medication Name Type Code Description Table

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MED Medication Replacement History Table

MED Medication Table
MED MEDID/Inactive Ingredient Relation Table
MED MEDID Inactive Ingredient Study Master Table
MED Move Reason Description Table
MED NDC/Generic MEDID Move History Reason Table
MED NDC/Generic MEDID Relation History Table
MED NDC/MEDID Move History Reason Table
MED NDC/MEDID Relation History Table
MED NDC to Generic Medication ID Cross-Reference Table
MED NDC to Medication ID Cross-Reference Table
MED Reference DESI2 Indicator Description Table
MED Reference DESI Indicator Description Table
MED Reference Federal DEA Class Code Description Table
MED Reference Federal Legend Indicator Description Table
MED Reference Generic Comparative Price Code Description Table
MED Reference Generic Medication Name Code Description Table
MED Reference Generic Price Spread Code Description Table
MED Reference Generic Therapeutic Equivalence Code Description Table
MED Reference Innovator Indicator Description Table
MED Reference Multi-Source Code Description Table
MED Routed Dosage Form Medication ID/Inactive Ingredient Relation Table
MED Routed Dosage Form Medication Identifier (MEDID) to Route Relationship Table
MED Routed Dosage Form Medication ID Inactive Ingredient Study Master Table
MED Routed Dosage Form Medication Replacement History Table
MED Routed Dosage Form Medication Table
MED Routed Dosage Form Medication to Dosage Form Link Table
MED Routed Medication ID/Inactive Ingredient Relation Table
MED Routed Medication ID Inactive Ingredient Study Master Table
MED Routed Medication Replacement History Table
MED Routed Medication Table
MED Routed Medication to Dosage Form Link Table
MED Routed Medication to Route Relationship Table
MED Route Table
MED Status Code Description Table
Routed Dose Form Med Attribute Table
Routed Med Attribute Table

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Search Term Type Description Table

Medication Name Concepts ERD

MED NDC/MEDID Relationship Change History Table ERD

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Medication Name Concepts Inactive Ingredients ERD

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Medication Name Concepts Descriptive Tables ERD

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MEDID Search Term ERD

Medication Name Concepts Freeness and Storage Concepts Tables ERD

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Alternative Medication Identifier (MEDID) to Ingredient Strength Link Table

Table Name RPEIMS0_MED_STR_LINK

Revision Activity add.7-1-2013

Purpose Relates a Medication Identifier (MEDID) to the Normalized

and Total Package strengths per ingredient, rolled up from
the associated NDCs to provide additional useful total
package information about associated products without
navigating to the product level.

Key Column Name Column Format Length Picture

Description

PF MEDID MED Medication N 8 9(8)

Identifier (Stable
Identifier)

PF HICL_SEQNO Hierarchical N 6 9(6)

Ingredient Code
Sequence
Number (Stable
Identifier)

PF STR_CONC_TYP Strength N 8 9(8)

E_ID Concentration
Type Identifier

P STR_SEQ Strength N 4 9(4)

Sequence

STRENGTH_STA Ingredient N 1 9(1)

TUS_CODE Strength Status
Code

INGREDIENT_ST Ingredient N 20 9(13).9(6)

R Strength

P INGREDIENT_UO Ingredient N 8 9(8)

M_MSTR_ID Strength Unit of
Measure Master
Identifier

STRENGTH_TYP Ingredient N 1 9(1)

_CODE Strength Type
Code

VOLUME Total Volume N 20 9(13).9(6)

P VOLUME_UOM_ Ingredient Volume N 8 9(8)

MSTR_ID Unit of Measure
Master Identifier

ALT_STR Alternative N 20 9(13).9(6)

Ingredient
Strength

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F ALT_STR_UOM_ Alternative N 8 9(8)

MSTR_ID Ingredient
Strength Unit of
Measure Master
Identifier

ALT_STRENGTH Alternate N 1 9(1)

_TYP_CODE Ingredient
Strength Type
Code

TIME_VALUE Ingredient N 7 9(3).9(3)

Strength Time
Value

F TIME_UOM_MST Ingredient N 8 9(8)

R_ID Strength Time
Unit of Measure
Master Identifier

RANGE_MAX Ingredient N 20 9(13).9(6)

Strength Range
Maximum

RANGE_MIN Ingredient N 20 9(13).9(6)

Strength Range
Minimum

F DOSAGE_FORM Dosage Form N 8 9(8)

_ATTRIBUTE_ID Attribute Identifier

INGREDIENT_SO Ingredient Sort N 4 9(4)

RT_ORDER Order

LINK_INACTIVE_ Link Inactive Date N 8 9(8)

DATE

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MAPs Attribute Description Table

Table Name RPEIAD0_ATTRIBUTE_DESC

Revision Activity add.02-17-2015

Purpose Relates a freeness Attribute to its text description.

Key Column Name Column Format Length Picture

Description

PF ATTRIBUTE_CO Attribute Code N 8 9(8)

DE

F ATTRIBUTE_DES Attribute AN 100 X(100)

C Description

F ATTRIBUTE_TYP Attribute Type N 8 9(8)

E_CODE Code

F ATTRIBUTE_GR Attribute Group N 8 9(8)

OUP_CODE Code

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Attribute Type Description Table

Table Name RPEIAT0_ATTRIBUTE_TYPE_DESC

Revision Activity add.02-17-2015

Purpose Relates a freeness Attribute Type to its text description.

Key Column Name Column Format Length Picture

Description

PF ATTRIBUTE_TYP Attribute Type N 8 9(8)

E_CODE Code

ATTRIBUTE_TYP Attribute Type AN 100 X(100)

E_DESC Description

ATTRIBUTE_TYP Attribute Type N 8 9(8)

E_LENGTH Length

ATTRIBUTE_TYP Attribute Type N 8 9(8)

E_PRECISION Precision

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Attribute Value Description Table

Table Name RPEIAV0_ATTRIBUTE_VALUE_DESC

Revision Activity add.02-17-2015

Purpose Relates a freeness Attribute Type to its text description.

Key Column Name Column Format Length Picture

Description

PF ATTRIBUTE_CO Attribute Code N 8 9(8)

DE

P ATTRIBUTE_VAL Attribute Code AN 100 X(100)

UE

ATTRIBUTE_VAL Attribute Value AN 100 X(100)

UE_DESC Description

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Dosage Form Master to MED Dosage Form Link Table

Table Name RPEIML0_MED_DF_MSTR_LINK

Revision Activity add.7-1-2013

Purpose Relates dosage forms in the Dosage Form Master Table to

dosage forms in the MED Dosage Forms Table (RMIDFD1_
DOSE_FORM).

Key Column Name Column Format Length Picture

Description

PF DOSAGE_FORM Dosage Form N 8 9(8)

_ID Identifier

PF MED_DOSAGE_F MED Dosage N 5 9(5)

ORM_ID Form Identifier

PREFERRED_D Preferred Dosage N 1 9(1)

OSAGE_FORM_I Form Indicator
ND

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MED Dosage Forms Table

Table Name RMIDFD1_DOSE_FORM

Revision Activity rev.04-25-2002

Purpose Relates the Medication Dosage Form ID to its text

description and abbreviation.

Key Column Name Column Format Length Picture

Description

P MED_DOSAGE_F MED Dosage N 5 9(5)

ORM_ID Form ID

MED_DOSAGE_F MED Dosage AN 4 X(4)

ORM_ABBR Form Abbreviation

MED_DOSAGE_F MED Dosage AN 30 X(30)

ORM_DESC Form Description

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MED GCN_SEQNO Assignment Code Description Table

Table Name RMIGCND1_GCNSEQNO_ASSGN_DESC

Revision Activity rev.04-25-2002

Purpose Relates the GCN_SEQNO Assignment Code to its text

description.

Key Column Name Column Format Length Picture

Description

P MED_GCNSEQN MED AN 1 X(1)

O_ASSIGN_CD GCN_SEQNO
Assignment Code

MED_GCNSEQN MED AN 60 X(60)

O_ASSIGN_CD_ GCN_SEQNO
DESC Assignment Code
Description

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MED GCN_SEQNO to Medication ID Cross-Reference Table

Table Name RMIGC1_MEDID_GCNSEQNO_LINK

Revision Activity add.07-01-2002

Purpose Links a Clinical Formulation ID (GCN_SEQNO) to a

Medication ID.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

F MEDID MED Medication N 8 9(8)

ID (Stable ID)

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MED MED Concept Generic MED Relation Table

Table Name RMEDMGL0_MED_GENERIC_MED_LINK

Revision Activity add.07-29-2004

Purpose Links a MED Concept to its generically named companion.

Key Column Name Column Format Length Picture

Description

P MED_CONCEPT_ MED Concept ID N 8 9(8)

ID

PF MED_CONCEPT_ MED Concept ID N 1 9(1)

ID_TYP Type

P GENERIC_MED_ Generically N 8 9(8)

CONCEPT_ID Named MED
Concept

MED_CONCEPT_ MED Concept N 8 9(8)

OBSDATEC Obsolete Date

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MED MED Concept HICL_SEQNO Relation Table

Table Name RMEDMHL0_MED_HICLSEQNO_LINK

Revision Activity Add.07-29-2004

Purpose Links a medication concept identifier (Medication ID,

Routed Dosage Form Medication ID, Routed Medication ID,
and Medication Name ID) to its list of ingredients. The
medication concepts contained within the table have a
status of Active, Inactive, Replaced, or Unassociated.
The only type of medication concept that does not appear
within this table are those marked with a status of Retired.
Note: A small number of Replaced concepts do not appear
in the MED Concept/HICL_SEQNO Relation Table as they
have been determined to be too broad to be useful in
allergy checking (for example, Bulk Chemicals Liquid), or
they are medical supplies that would not normally
participate in allergy checking.

Key Column Name Column Format Length Picture

Description

P MED_CONCEPT_ MED Concept ID N 8 9(8)

ID

PF MED_CONCEPT_ MED Concept ID N 1 9(1)

ID_TYP Type

PF HICL_SEQNO Ingredient List N 6 9(6)

Identifier (formerly
the Hierarchical
Ingredient Code
List Sequence
Number) (Stable
ID)

P MED_CONCEPT_ MED Concept N 1 9(1)

HICL_SRC_CD HICL_SEQNO
Source Code

MED_CONCEPT_ MED Concept N 8 9(8)

OBSDATEC Obsolete Date

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MED MED Concept ID Type Description Table

Table Name RMEDCD0_MED_CONCEPT_TYP_DESC

Revision Activity add.07-29-2004

Purpose Provides the description of the MED Concept ID.

Key Column Name Column Format Length Picture

Description

P MED_CONCEPT_ MED Concept ID N 1 9(1)

ID_TYP Type

MED_CONCEPT_ MED Concept ID AN 50 X(50)

ID_TYP_DESC Type Description

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MED Medication Attribute Table

Table Name RPEIMA0_MED_ATTRIBUTE

Revision Activity add.02-17-2015

Purpose Contains information regarding freeness information

summarized to the Med Medication ID (MEDID) level.
MEDIDs may have one or several assigned attributes.
MEDIDs to their associated attribute values are determined
by roll-up logic from the related NDCs.

Key Column Name Column Format Length Picture

Description

PF MEDID MED Medication N 8 9(8)

ID

PF ATTRIBUTE_CO Attribute Code N 8 9(8)

DE

P ATTRIBUTE_SN Attribute N 4 9(4)

Sequence
Number

ATTRIBUTE_VAL Attribute Value AN 100 X(100)

UE

LINK_INACTIVE_ Link Inactive Date N 8 9(8)

DATE

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MED Medication Identifier (MEDID) to Dosage Form Link Table

Table Name RPEIMD0_MED_DF_LINK

Revision Activity add. 7-1-2013

Purpose Contains associations between a Medication Identifier

(MEDID) and the Final Dosage Form and Alternative
Dosage Forms rolled up from directly associated packaged
products (NDCs/UPCs).
The Link Inactive Date is populated with the date the last
associated active (non-obsolete) packaged product
becomes obsolete.

Key Column Name Column Format Length Picture

Description

PF MEDID MED Medication N 8 9(8)

Identifier (Stable
Identifier)

PF DOSAGE_FORM Dosage Form N 8 9(8)

_ID Identifier

PF DOSAGE_FORM Dosage Form N 8 9(8)

_TYPE_ID Type Identifier

LINK_INACTIVE_ Link Inactive Date N 8 9(8)

DATE

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MED Medication Identifier (MEDID) to Route Relationship Table

Table Name RPEIMRR0_MED_RT_RELATION

Revision Activity add. 7-1-2013

Purpose Contains the association of a Medication Identifier (MEDID)

to its Parent and Clinical Routes.
Each MEDID may have zero to many parent and clinical
routes associations. MEDID parent and clinical route
relationships are rolled up from associated NDCs.

Key Column Name Column Format Length Picture

Description

PF MEDID MED Medication N 8 9(8)

Identifier (Stable
Identifier)

PF PARENT_RT_ID Parent Route N 8 9(8)

Identifier

PF CLINICAL_RT_ID Clinical Route N 8 9(8)

Identifier

RELATION_INAC Relation Inactive N 8 9(8)

TIVE_DATE Date

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MED Medication ID Search Term Table

Table Name RMEDST0_MEDID_SEARCH_TERM

Revision Activity add.06-19-2014

Purpose Provides search terms used to find orders by medication

and the associated dispensable drug MED Medication ID
(MEDID). MEDID search values will be deleted from the
table when the MEDID is no longer deemed a prescribable
medication. The data in this table is contained in both
OrderKnowledge and MedKnowledge.

Key Column Name Column Format Length Picture

Description

P MEDID MED Medication N 8 9(8)

ID

PF SEARCH_TERM_ Search Term N 4 9(4)

TYPE_CD Type Code

P SEARCH_TERM_ Search Term Text AN 150 X(150)

TEXT

MED_MEDID_DE MED Medication AN 70 X(70)

SC Description

MEDICAL_SUPP Medical Supply N 1 9(1)

LY_IND Indicator

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MED Medication Name Attribute Table

Table Name RPEINA0_MED_NAME_ATTRIBUTE

Revision Activity add.02-17-2015

Purpose Contains freeness information rolled-up to the Medication

Name level. Med Names may have one or several assigned
attributes.
Med Medication Names to their associated attribute values
are determined by roll-up logic from the related Routed
Medications.

Key Column Name Column Format Length Picture

Description

PF MED_NAME_ID MED Medication N 4 9(4)

Name ID

PF ATTRIBUTE_CO Attribute Code N 8 9(8)

DE

P ATTRIBUTE_SN Attribute N 4 9(4)

Sequence
Number

ATTRIBUTE_VAL Attribute Value AN 100 X(100)

UE

LINK_INACTIVE_ Link Inactive Date N 8 9(8)

DATE

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MED Medication Name ID/Inactive Ingredient Relation Table

Table Name RMEDNIN0_MNID_INACTV_LINK

Revision Activity add.07-29-2004

Purpose Links an inactive ingredient and packaged product counts to

the Medication Name ID. The counts represent the number
of currently active products that either have or do not have
the specified inactive HIC_SEQN in their formula. Packaged
products are only considered if they have been checked for
Inactive Ingredients. Counts change as Inactive Ingredient
research continues.

Key Column Name Column Format Length Picture

Description

PF MED_NAME_ID MED Medication N 8 9(8)

Name ID (Stable
ID)

PF HIC_SEQN Hierarchical N 6 9(6)

Ingredient Code
Sequence
Number (Stable
ID)

INACTV_NOT_P Inactive Ingredient N 6 9(6)

RES_CNT Not Present Count

INACTV_PRES_ Inactive Ingredient N 6 9(6)

CNT Present Count

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MED Medication Name ID Inactive Ingredient Study Master Table

Table Name RMEDNIS0_MED_NAME_STUDY_TABLE

Revision Activity add.07-29-2004

Purpose Provides packaged product counts for the Medication Name

ID. Counts are based on active NDCs. Counts are subject
to change as Inactive Ingredient research continues.

Key Column Name Column Format Length Picture

Description

PF MED_NAME_ID MED Medication N 8 9(8)

Name ID

TOTAL_PRODUC Total Products N 6 9(6)

TS_CNT Count

PRODUCTS_RE Products N 6 9(6)

SEARCHED_CNT Researched for
Inactive
Ingredients Count

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MED Medication Name Replacement History Table

Table Name RMINMRH1_MED_NAME_HIST

Revision Activity rev.04-25-2002

Purpose Tracks the replacement history of the medication name.

Key Column Name Column Format Length Picture

Description

PF MED_REPL_NAM MED N 8 9(8)

E_ID Replacement
Medication Name
ID

PF MED_PREV_NA MED Previous N 8 9(8)

ME_ID Medication Name
ID

MED_NAME_ID_ MED Medication N 8 9(8)

REPL_EFF_DT Name
Replacement
Effective Date

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MED Medication Name Source Code Description Table

Table Name RMINAMD1_NAME_SRC_DESC

Revision Activity rev.04-25-2002

Purpose Relates the Medication Name Source Code to its text

description.

Key Column Name Column Format Length Picture

Description

P MED_NAME_SO MED Medication AN 1 X(1)

URCE_CD Name Source
Code

MED_NAME_SO MED Medication AN 90 X(90)

URCE_CD_DESC Name Source
Code Description

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MED Medication Name Table

Table Name RMINMID1_MED_NAME

Revision Activity rev.04-25-2002

Purpose Provides attributes of the medication name.

Key Column Name Column Format Length Picture

Description

P MED_NAME_ID MED Medication N 8 9(8)

Name ID (Stable
ID)

MED_NAME MED Medication AN 30 X(30)

Name

F MED_NAME_TYP MED Medication AN 1 X(1)

E_CD Name Type Code

F MED_STATUS_C MED Medication AN 1 X(1)

D Status Code

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MED Medication Name to Route Relationship Table

Table Name RPEIMNR0_MED_NAME_RT_RELATION

Revision Activity add. 7-1-2013

Purpose Contains the association of a Medication Name to its Parent

and Clinical Routes.
Each Medication Name may have zero to many Parent and
Clinical Route associations. Medication Name to route
relationships are rolled up from associated NDCs.

Key Column Name Column Format Length Picture

Description

PF MED_NAME_ID MED Medication N 8 9(8)

Name Identifier

PF PARENT_RT_ID Parent Route N 8 9(8)

Identifier

PF CLINICAL_RT_ID Clinical Route N 8 9(8)

Identifier

RELATION_INAC Relation Inactive N 8 9(8)

TIVE_DATE Date

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MED Medication Name Type Code Description Table

Table Name RMINMD1_MED_NAME_TYPE_DESC

Revision Activity rev.04-25-2002

Purpose Relates the Medication Name Type Code to its text

description.

Key Column Name Column Format Length Picture

Description

P MED_NAME_TYP MED Medication AN 1 X(1)

E_CD Name Type Code

MED_NAME_TYP MED Medication AN 30 X(30)

E_CD_DESC Name Type Code
Description

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MED Medication Replacement History Table

Table Name RMIRH1_MED_HIST

Revision Activity rev.04-25-2002

Purpose Tracks the replacement history of the medication.

Key Column Name Column Format Length Picture

Description

PF MED_REPL_MED MED N 8 9(8)

ID Replacement
Medication ID

PF MED_PREV_ME MED Previous N 8 9(8)

DID Medication ID

MED_MEDID_RE MED N 8 9(8)

PL_EFF_DT Replacement
Effective Date

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MED Medication Table

Table Name RMIID1_MED

Revision Activity rev.06-26-2008

Purpose Provides the attributes of a medication.

Key Column Name Column Format Length Picture

Description

P MEDID MED Medication N 8 9(8)

ID (Stable ID)

F ROUTED_DOSA MED Routed N 8 9(8)

GE_FORM_MED Dosage Form
_ID Medication ID
(Stable ID)

MED_STRENGT MED Strength AN 15 X(15)

H

MED_STRENGT MED Strength AN 15 X(15)

H_UOM Unit of Measure

MED_MEDID_DE MED Medication AN 70 X(70)

SC Description

F GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

F MED_GCNSEQN MED AN 1 X(1)

O_ASSIGN_CD GCN_SEQNO
Assignment Code

F MED_NAME_SO MED Medication AN 1 X(1)

URCE_CD Name Source
Code

F MED_REF_FED_ MED Reference AN 1 X(1)

LEGEND_IND Federal Legend
Indicator

F MED_REF_DEA_ MED Reference AN 1 X(1)

CD Federal DEA
Class Code

F MED_REF_MULT MED Reference AN 1 X(1)

I_SOURCE_CD Multi-Source
Code

F MED_REF_GEN_ MED Reference AN 1 X(1)

DRUG_NAME_C Generic
D Medication Name
Code

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F MED_REF_GEN_ This column is not AN 1 X(1)

COMP_PRICE_C currently being
D used.

F MED_REF_GEN_ This column is not AN 1 X(1)

SPREAD_CD currently being
used.

F MED_REF_INNO MED Reference AN 1 X(1)

V_IND Innovator
Indicator

F MED_REF_GEN_ MED Reference AN 1 X(1)

THERA_EQU_CD Generic
Therapeutic
Equivalence Code

F MED_REF_DESI MED Reference AN 1 X(1)

_IND DESI Indicator

F MED_REF_DESI MED Reference AN 1 X(1)

2_IND DESI2 Indicator

F MED_STATUS_C MED Medication AN 1 X(1)

D Status Code

GENERIC_MEDI MED Generic N 8 9(8)

D Medication
Identifier

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MED MEDID Inactive Ingredient Relation Table

Table Name RMEDIN0_MEDID_INACTV_LINK

Revision Activity add.07-29-2004

Purpose Links an inactive ingredient and packaged product counts to

the Medication ID. The counts represent the number of
currently active products that either have or do not have the
specified inactive HIC_SEQN in their formula. Packaged
products are only considered if they have been checked for
Inactive Ingredients. Counts change as Inactive Ingredient
research continues.

Key Column Name Column Format Length Picture

Description

PF MEDID MED Medication N 8 9(8)

ID (Stable ID)

PF HIC_SEQN Hierarchical N 6 9(6)

Ingredient Code
Sequence
Number (Stable
ID)

INACTV_NOT_P Inactive Ingredient N 6 9(6)

RES_CNT Not Present Count

INACTV_PRES_ Inactive Ingredient N 6 9(6)

CNT Present Count

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MED MEDID Inactive Ingredient Study Master Table

Table Name RMEDIS0_MEDID_STUDY_TABLE

Revision Activity add.07-29-2004

Purpose Provides packaged product counts for the Medication ID.

Counts are based on active NDCs. Counts are subject to
change as Inactive Ingredient research continues.

Key Column Name Column Format Length Picture

Description

PF MEDID MED Medication N 8 9(8)

ID (Stable ID)

TOTAL_PRODUC Total Products N 6 9(6)

TS_CNT Count

PRODUCTS_RE Products N 6 9(6)

SEARCHED_CNT Researched for
Inactive
Ingredients Count

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MED Move Reason Description Table

Table Name RMEDMRD0_MOVE_REASON_DESC

Revision Activity add. 07-08-2010

Purpose Relates the Move Reason Code to its text description.

Key Column Name Column Format Length Picture

Description

P MOVE_REASON Move Reason N 4 9(4)

_CD Code

MOVE_REASON Move Reason AN 100 X(100)

_CD_DESC Code Description

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MED NDC Generic MEDID Move History Reason Table

Table Name RMEDNGR0_NDC_GEN_MEDID_REASON

Revision Activity add.07-08-2010

Purpose Provides the reason for why association changes have

occurred within the MED NDC to Generic Medication ID
Cross-Reference Table (RMEDNGM0_NDC_GEN_MEDID).

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

P PRODUCTION_D Production Date N 8 9(8)

ATE

PF MOVE_REASON Move Reason N 4 9(4)

_CD Code

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MED NDC Generic MEDID Relation History Table

Table Name RMEDNGH0_NDC_GEN_MEDID_HIST

Revision Activity add.07-08-2010

Purpose Provides the NDC/Generic MEDID association changes that

occur within the MED NDC to Generic Medication ID
Cross-Reference Table (RMEDNGM0_NDC_GEN_MEDID).

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

P PRODUCTION_D Production Date N 8 9(8)

ATE

F PREV_MEDID Previously N 8 9(8)

Associated
Medication ID

F PREV_MEDID_N Previously AN 1 X(1)

AME_SOURCE_ Associated
CD Medication ID
Name Source
Code

F PREV_MEDID_O Previously AN 1 X(1)

LD_STATUS_CD Associated
Medication ID Old
Status Code

F PREV_MEDID_N Previously AN 1 X(1)

EW_STATUS_CD Associated
Medication ID
New Status Code

PREV_MEDID_D Previously AN 70 X(70)

ESC Associated
Medication ID
Description

F CURR_MEDID Currently N 8 9(8)

Associated
Medication ID

F CURR_MEDID_N Currently AN 1 X(1)

AME_SOURCE_ Associated
CD Medication ID
Name Source
Code

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F CURR_MEDID_O Currently AN 1 X(1)

LD_STATUS_CD Associated
Medication ID Old
Status Code

F CURR_MEDID_N Currently AN 1 X(1)

EW_STATUS_CD Associated
Medication ID
New Status Code

CURR_MEDID_D Currently AN 70 X(70)

ESC Associated
Medication ID
Description

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MED NDC MEDID Move History Reason Table

Table Name RMEDNMR0_NDC_MEDID_REASON

Revision Activity add.07-08-2010

Purpose Provides the reason for why association changes have

occurred within the MED NDC to Medication ID
Cross-Reference Table (RMINDC1_NDC_MEDID).

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

P PRODUCTION_D Production Date N 8 9(8)

ATE

PF MOVE_REASON Move Reason N 4 9(4)

_CD Code

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MED NDC MEDID Relation History Table

Table Name RMEDNMH0_NDC_MEDID_HIST

Revision Activity add.07-08-2010

Purpose Provides the NDC/MEDID association changes that occur

within the MED NDC to Medication ID Cross-Reference
Table (RMINDC1_NDC_MEDID).

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

P PRODUCTION_D Production Date N 8 9(8)

ATE

F PREV_MEDID Previously N 8 9(8)

Associated
Medication ID

F PREV_MEDID_N Previously AN 1 X(1)

AME_SOURCE_ Associated
CD Medication ID
Name Source
Code

F PREV_MEDID_O Previously AN 1 X(1)

LD_STATUS_CD Associated
Medication ID Old
Status Code

F PREV_MEDID_N Previously AN 1 X(1)

EW_STATUS_CD Associated
Medication ID
New Status Code

PREV_MEDID_D Previously AN 70 X(70)

ESC Associated
Medication ID
Description

F CURR_MEDID Currently N 8 9(8)

Associated
Medication ID

F CURR_MEDID_N Currently AN 1 X(1)

AME_SOURCE_ Associated
CD Medication ID
Name Source
Code

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F CURR_MEDID_O Currently AN 1 X(1)

LD_STATUS_CD Associated
Medication ID Old
Status Code

F CURR_MEDID_N Currently AN 1 X(1)

EW_STATUS_CD Associated
Medication ID
New Status Code

CURR_MEDID_D Currently AN 70 X(70)

ESC Associated
Medication ID
Description

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MED NDC to Generic Medication ID Cross-Reference Table

Table Name RMEDNGM0_NDC_GEN_MEDID

Revision Activity add.07-08-2010

Purpose Links a drug product to its distinct pharmaceutically named

Medication ID.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

F MEDID MED Medication N 8 9(8)

ID (Stable ID)

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MED NDC to Medication ID Cross-Reference Table

Table Name RMINDC1_NDC_MEDID

Revision Activity rev.04-25-2002

Purpose Links a drug product to its brand Medication ID.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

F MEDID MED Medication N 8 9(8)

ID (Stable ID)

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MED Reference DESI2 Indicator Description Table

Table Name RMIDE2D1_REF_DESI2_IND_DESC

Revision Activity rev.04-25-2002

Purpose Relates the Reference DESI2 Indicator to its text

description.

Key Column Name Column Format Length Picture

Description

P MED_REF_DESI MED Reference AN 1 X(1)

2_IND DESI2 Indicator

MED_REF_DESI MED Reference AN 60 X(60)

2_IND_DESC DESI2 Indicator
Description

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MED Reference DESI Indicator Description Table

Table Name RMIDESD1_REF_DESI_IND_DESC

Revision Activity rev.04-25-2002

Purpose Relates the Reference DESI Indicator to its text description.

Key Column Name Column Format Length Picture

Description

P MED_REF_DESI MED Reference AN 1 X(1)

_IND DESI Indicator

MED_REF_DESI MED Reference AN 60 X(60)

_IND_DESC DESI Indicator
Description

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MED Reference Federal DEA Class Code Description Table

Table Name RMIDEAD1_REF_FED_DEA_DESC

Revision Activity rev.04-25-2002

Purpose Relates the Reference Federal DEA Class Code to its text
description.

Key Column Name Column Format Length Picture

Description

P MED_REF_DEA_ MED Reference AN 1 X(1)

CD Federal DEA
Class Code

MED_REF_DEA_ MED Reference AN 60 X(60)

CD_DESC Federal DEA
Class Code
Description

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MED Reference Federal Legend Indicator Description Table

Table Name RMILGND1_REF_FED_LGND_DESC

Revision Activity rev.04-25-2002

Purpose Relates the Reference Federal Legend Indicator to its text

description.

Key Column Name Column Format Length Picture

Description

P MED_REF_FED_ MED Reference AN 1 X(1)

LEGEND_IND Federal Legend
Indicator

MED_REF_FED_ MED Reference AN 60 X(60)

LEGEND_IND_D Federal Legend
ESC Indicator
Description

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MED Reference Generic Comparative Price Code Description Table

Table Name RMIGPCD1_REF_GEN_PRC_DESC

Revision Activity rev.04-25-2002(discontinued)

Purpose Relates the Reference Generic Comparative Price Code to

its text description.
Please note that this table is no longer supported within
MedKnowledge. All records contain a 9 (no value) price
code value and a description value of This column is not
supported.

Key Column Name Column Format Length Picture

Description

P MED_REF_GEN_ MED Reference AN 1 X(1)

COMP_PRICE_C Generic
D Comparative Price
Code

MED_REF_GEN_ MED Reference AN 90 X(90)

COMP_PRICE_C Generic
D_DESC Comparative Price
Code Description

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MED Reference Generic Medication Name Code Description Table

Table Name RMIGNCD1_REF_GEN_NAME_DESC

Revision Activity rev.04-25-2002

Purpose Relates the Reference Generic Medication Name Code to

its text description.

Key Column Name Column Format Length Picture

Description

P MED_REF_GEN_ MED Reference AN 1 X(1)

DRUG_NAME_C Generic
D Medication Name
Code

MED_REF_GEN_ MED Reference AN 90 X(90)

DRUG_NAME_C Generic
D_DESC Medication Name
Code Description

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MED Reference Generic Price Spread Code Description Table

Table Name RMIGSCD1_REF_GEN_PRC_SPRD_DESC

Revision Activity rev.04-25-2002(discontinued)

Purpose Relates the Reference Generic Price Spread Code to its

text description.
Please note that this table is no longer supported within
MedKnowledge. All records contain a 9 (no value) price
code value and a description value of This column is not
supported.

Key Column Name Column Format Length Picture

Description

P MED_REF_GEN_ MED Reference AN 1 X(1)

SPREAD_CD Generic Price
Spread Code

MED_REF_GEN_ MED Reference AN 90 X(90)

SPREAD_CD_DE Generic Price
SC Spread Code
Description

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MED Reference Generic Therapeutic Equivalence Code Description Table

Table Name RMIGECD1_REF_GEN_THERAP_DESC

Revision Activity rev.04-25-2002

Purpose Relates the Reference Generic Therapeutic Equivalence

Code to its text description.

Key Column Name Column Format Length Picture

Description

P MED_REF_GEN_ MED Reference AN 1 X(1)

THERA_EQU_CD Generic
Therapeutic
Equivalence Code

MED_REF_GEN_ MED Reference AN 90 X(90)

THERA_EQU_CD Generic
_DESC Therapeutic
Equivalence Code
Description

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MED Reference Innovator Indicator Description Table

Table Name RMIINND1_REF_INNOV_IND_DESC

Revision Activity rev.04-25-2002

Purpose Relates the Reference Innovator Indicator to its text

description.

Key Column Name Column Format Length Picture

Description

P MED_REF_INNO MED Reference AN 1 X(1)

V_IND Innovator
Indicator

MED_REF_INNO MED Reference AN 90 X(90)

V_IND_DESC Innovator
Indicator
Description

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MED Reference Multi-Source Code Description Table

Table Name RMIMLTD1_REF_MULTI_SRC_DESC

Revision Activity rev.04-25-2002

Purpose Relates the Reference Multi-Source Code to its text

description.

Key Column Name Column Format Length Picture

Description

P MED_REF_MULT MED Reference AN 1 X(1)

I_SOURCE_CD Multi-Source
Code

MED_REF_MULT MED Reference AN 90 X(90)

I_SOURCE_CD_ Multi-Source
DESC Code Description

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MED Routed Dosage Form Medication ID Inactive Ingredient Relation Table

Table Name RMEDDIN0_RDFMID_INACTV_LINK

Revision Activity add.07-29-2004

Purpose Links an inactive ingredient and packaged product counts to

the Routed Dosage Form Medication ID. The counts
represent the number of currently active products that either
have or do not have the specified inactive HIC_SEQN in
their formula. Packaged products are only considered if they
have been checked for Inactive Ingredients. Counts change
as Inactive Ingredient research continues.

Key Column Name Column Format Length Picture

Description

PF ROUTED_DOSA MED Routed N 8 9(8)

GE_FORM_MED Dosage Form
_ID Medication ID
(Stable ID)

PF HIC_SEQN Hierarchical N 6 9(6)

Ingredient Code
Sequence
Number (Stable
ID)

INACTV_NOT_P Inactive Ingredient N 6 9(6)

RES_CNT Not Present Count

INACTV_PRES_ Inactive Ingredient N 6 9(6)

CNT Present Count

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MED Routed Dosage Form Medication Identifier (MEDID) to Route Relationship Table

Table Name RPEIRR0_RTD_DF_MED_RT_RELATION

Revision Activity add. 7-1-2013

Purpose Contains the association of a Routed Dosage Form

Medication to its Parent and Clinical routes.
Each Routed Dosage Form Medication may have zero to
many Parent and Clinical Route associations. Routed
Dosage Form Medication to route relationships are rolled up
from associated NDCs.

Key Column Name Column Format Length Picture

Description

PF ROUTED_DOSA MED Routed N 8 9(8)

GE_FORM_MED Dosage Form
_ID Medication
Identifier (Stable
Identifier)

PF PARENT_RT_ID Parent Route N 8 9(8)

Identifier

PF CLINICAL_RT_ID Clinical Route N 8 9(8)

Identifier

RELATION_INAC Relation Inactive N 8 9(8)

TIVE_DATE Date

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MED Routed Dosage Form Medication ID Inactive Ingredient Study Master Table

Table Name RMEDDIS0_ROUTED_DF_STUDY_TABLE

Revision Activity add.07-29-2004

Purpose Provides packaged product counts for the Routed Dosage

Form Medication ID. Counts are based on active NDCs.
Counts are subject to change as Inactive Ingredient
research continues.

Key Column Name Column Format Length Picture

Description

PF ROUTED_DOSA MED Routed N 8 9(8)

GE_FORM_MED Dosage Form
_ID Medication ID
(Stable ID)

TOTAL_PRODUC Total Products N 6 9(6)

TS_CNT Count

PRODUCTS_RE Products N 6 9(6)

SEARCHED_CNT Researched for
Inactive
Ingredients Count

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MED Routed Dosage Form Medication Replacement History Table

Table Name RMIDFRH1_ROUTED_DOSE_FORM_HIST

Revision Activity rev.04-25-2002

Purpose Tracks the replacement history of the routed dosage form

medication.

Key Column Name Column Format Length Picture

Description

PF MED_REPL_ROU MED N 8 9(8)

TED_DF_MED_ID Replacement
Routed Dosage
Form Medication
ID

PF MED_PREV_RO MED Previous N 8 9(8)

UTED_DF_MED_I Routed Dosage
D Form Medication
ID

MED_ROUTED_ MED Routed N 8 9(8)

DF_MED_ID_RE Dosage Form
P_EF_DT Medication ID
Replacement
Effective Date

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MED Routed Dosage Form Medication Table

Table Name RMIDFID1_ROUTED_DOSE_FORM_MED

Revision Activity
rev.04-25-2002

Purpose Provides the attributes of the routed dosage form

medication.

Key Column Name Column Format Length Picture

Description

P ROUTED_DOSA MED Routed N 8 9(8)

GE_FORM_MED Dosage Form
_ID Medication ID
(Stable ID)

F ROUTED_MED_I MED Routed N 8 9(8)

D Medication ID
(Stable ID)

F MED_DOSAGE_F MED Dosage N 5 9(5)

ORM_ID Form ID

MED_ROUTED_ MED Routed AN 60 X(60)

DF_MED_ID_DE Dosage Form
SC Medication
Description

F MED_STATUS_C MED Medication AN 1 X(1)

D Status Code

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MED Routed Dosage Form Medication to Dosage Form Link Table

Table Name RPEIRD0_RTD_DF_MED_DF_LINK

Revision Activity add. 7-1-2013

Purpose Contains associations between a Routed Dosage Form

Medication and the Final Dosage Form and Alternative
Dosage Forms rolled up from directly associated packaged
products (NDCs/UPCs).
The Link Inactive Date is populated with the date the last
associated active (non-obsolete) packaged product
becomes obsolete.

Key Column Name Column Format Length Picture

Description

PF ROUTED_DOSA Routed Dosage N 8 9(8)

GE_FORM_MED Form Medication
_ID Identifier (Stable
Identifier)

PF DOSAGE_FORM Dosage Form N 8 9(8)

_ID Identifier

PF DOSAGE_FORM Dosage Form N 8 9(8)

_TYPE_ID Type Identifier

LINK_INACTIVE_ Link Inactive Date N 8 9(8)

DATE

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MED Routed Medication ID/Inactive Ingredient Relation Table

Table Name RMEDRIN0_RMID_INACTV_LINK

Revision Activity add.07-29-2004

Purpose Links an inactive ingredient and packaged product counts to

the Routed Medication ID. The counts represent the
number of currently active products that either have or do
not have the specified inactive HIC_SEQN in their formula.
Packaged products are only considered if they have been
checked for Inactive Ingredients. Counts change as Inactive
Ingredient research continues.

Key Column Name Column Format Length Picture

Description

PF ROUTED_MED_I MED Routed N 8 9(8)

D Medication ID
(Stable ID)

PF HIC_SEQN Hierarchical N 6 9(6)

Ingredient Code
Sequence
Number (Stable
ID)

INACTV_NOT_P Inactive Ingredient N 6 9(6)

RES_CNT Not Present Count

INACTV_PRES_ Inactive Ingredient N 6 9(6)

CNT Present Count

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MED Routed Medication ID Inactive Ingredient Study Master Table

Table Name RMEDRIS0_ROUTED_MED_STDY_TBL

Revision Activity add.07-29-2004

Purpose Provides packaged product counts for the Routed

Medication ID. Counts are based on active NDCs. Counts
are subject to change as Inactive Ingredient research
continues.

Key Column Name Column Format Length Picture

Description

PF ROUTED_MED_I MED Routed N 8 9(8)

D Medication ID
(Stable ID)

TOTAL_PRODUC Total Products N 6 9(6)

TS_CNT Count

PRODUCTS_RE Products N 6 9(6)

SEARCHED_CNT Researched for
Inactive
Ingredients Count

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MED Routed Medication Replacement History Table

Table Name RMIRMRH1_ROUTED_MED_HIST

Revision Activity rev.04-25-2002

Purpose Tracks the replacement history of the routed medication.

Key Column Name Column Format Length Picture

Description

PF MED_REPL_ROU MED N 8 9(8)

TED_MED_ID Replacement
Routed
Medication ID

PF MED_PREV_RO MED Previous N 8 9(8)

UTED_MED_ID Routed
Medication ID

MED_ROUTED_ MED Routed N 8 9(8)

MED_ID_REPL_E Medication ID
FF_DT Replacement
Effective Date

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MED Routed Medication Table

Table Name RMIRMID1_ROUTED_MED

Revision Activity rev.04-25-2002

Purpose Provides attributes of the routed medication.

Key Column Name Column Format Length Picture

Description

P ROUTED_MED_I MED Routed N 8 9(8)

D Medication ID
(Stable ID)

F MED_NAME_ID MED Medication N 8 9(8)

Name ID (Stable
ID)

F MED_ROUTE_ID MED Route ID N 5 9(5)

MED_ROUTED_ MED Routed AN 60 X(60)

MED_ID_DESC Medication
Description

F MED_STATUS_C MED Medication AN 1 X(1)

D Status Code

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MED Routed Medication to Dosage Form Link Table

Table Name RPEIRMD0_RTD_MED_DF_LINK

Revision Activity add. 7-1-2013

Purpose Contains associations between a Routed Medication and

the Final Dosage Form and Alternative Dosage Forms
rolled up from directly associated packaged products
(NDCs/UPCs).
The Link Inactive Date is populated with the date the last
associated active (non-obsolete) packaged product
becomes obsolete.

Key Column Name Column Format Length Picture

Description

PF ROUTED_MED_I Routed N 8 9(8)

D Medication
Identifier

PF DOSAGE_FORM Dosage Form N 8 9(8)

_ID Identifier

PF DOSAGE_FORM Dosage Form N 8 9(8)

_TYPE_ID Type Identifier

LINK_INACTIVE_ Link Inactive Date N 8 9(8)

DATE

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MED Routed Medication to Route Relationship Table

Table Name RPEIRMR0_RTD_MED_RT_RELATION

Revision Activity add. 7-1-2013

Purpose Contains the association of a Routed Medication to its

parent and clinical routes.
Each Routed Medication may have zero to many Parent
and Clinical Route associations. Routed Medication to route
relationships are rolled up from associated NDCs.

Key Column Name Column Format Length Picture

Description

PF ROUTED_MED_I MED Routed N 8 9(8)

D Medication
Identifier (Stable
Identifier)

PF PARENT_RT_ID Parent Route N 8 9(8)

Identifier

PF CLINICAL_RT_ID Clinical Route N 8 9(8)

Identifier

RELATION_INAC Relation Inactive N 8 9(8)

TIVE_DATE Date

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MED Route Table

Table Name RMIRTD1_ROUTE

Revision Activity rev.04-25-2002

Purpose Provides attributes of a medication route.

Key Column Name Column Format Length Picture

Description

P MED_ROUTE_ID MED Route ID N 5 9(5)

MED_ROUTE_AB MED Route AN 4 X(4)

BR Abbreviation

MED_ROUTE_DE MED Route AN 30 X(30)

SC Description

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MED Status Code Description Table

Table Name RMISCD1_STATUS_DESC

Revision Activity rev.04-25-2002

Purpose Relates the Medication Status Code to its text description.

Key Column Name Column Format Length Picture

Description

P MED_STATUS_C MED Medication AN 1 X(1)

D Status Code

MED_STATUS_C MED Medication AN 30 X(30)

D_DESC Status Code
Description

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Routed Dose Form Med Attribute Table

Table Name RPEIRA0_RT_DF_MED_ATTRIBUTE

Revision Activity add.02-17-2015

Purpose Contains freeness information summarized to the Routed

Dosage Form Medication ID level. Routed Dosage Form
Medications IDs may have one or several assigned
attributes.
Routed Dosage Form Medications and their associated
attribute values are determined by roll-up logic from the
related MEDIDs.

Key Column Name Column Format Length Picture

Description

PF ROUTED_DOSA Routed Dosage N 8 9(8)

GE_FORM_MED Form Med ID
_ID

PF ATTRIBUTE_CO Attribute Code N 8 9(8)

DE

P ATTRIBUTE_SN Attribute N 4 9(4)

Sequence
Number

ATTRIBUTE_VAL Attribute Value AN 100 X(100)

UE

LINK_INACTIVE_ Link Inactive Date N 8 9(8)

DATE

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Routed Med Attribute Table

Table Name RPEIRMA0_RTD_MED_ATTRIBUTE

Revision Activity add.02-17-2015

Purpose Contains freeness information summarized to the Med

Routed Medication ID level. Routed Medication IDs may
have one or several assigned attributes.
Routed Medication IDs and their associated attribute values
are determined by roll-up logic from the related Routed
Dose Form Medications.

Key Column Name Column Format Length Picture

Description

PF ROUTED_MED_I Routed N 8 9(8)

D Medication ID

PF ATTRIBUTE_CO Attribute Code N 8 9(8)

DE

P ATTRIBUTE_SN Attribute N 4 9(4)

Sequence
Number

ATTRIBUTE_VAL Attribute Value AN 100 X(100)

UE

LINK_INACTIVE_ Link Inactive Date N 8 9(8)

DATE

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Search Term Type Description Table

Table Name RMEDSTD0_SEARCH_TERM_TYPE_DESC

Revision Activity add.06-19-2014

Purpose Provides descriptions of the search term type codes. The

data in this table is contained in both OrderKnowledge and
MedKnowledge.

Key Column Name Column Format Length Picture

Description

P SEARCH_TERM_ Search Term N 4 9(4)

TYPE_CD Type Code

SEARCH_TERM_ Search Term AN 50 X(50)

TYPE_CD_DESC Type Code
Description

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Tall Man Plus 2.0

Tall Man Plus Editorial Policies
Applications
ERD and Technical Specifications

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Tall Man Plus Editorial Policies

The policies and criteria that apply to the inclusion criteria, processes, and references used in creation of the
module are provided in the following sections:

Overview
Inclusion Criteria
Data Elements
Maintenance

Overview
Tall Man Plus provides the healthcare professional with two tools to detect drugs that have been identified by the
FDA, ISMP, or FDB as having a high probability of being mistaken for other drugs because of similarities in either
their pronunciation or drug name description. The modules goal of limiting dispensing errors is achieved primarily
through the use of a Tall Man lettering scheme.

Tall Man lettering is the term given to an alternate casing of a drug name, where portions of the name appear in
all capital letters to visually distinguish it from a drug with a very similar name. For example, the Tall Man lettering
of acetazolamide is acetaZOLAMIDE, which distinguishes it from the drug acetohexamide. In turn, Tall Man
lettering for acetohexamide is acetoHEXAMIDE.

When appropriate, Tall Man lettering is provided for the following:

MED Concepts
Medication Name (MED_NAME_ID)
Routed Name (ROUTED_MED_ID)
Routed Dosage Form Name (ROUTED_DOSAGE_FORM_MED_ID)
Medication ID (MEDID)

Package Products (NDC)

Brand Name (BN)
Label Name (LN)
Label Name - 60 (LN60)
Ingredient List Identifier (HICL_SEQNO)
Generic Name - Short Version (GNN)
Generic Name - Long Version (GNN60)

Drug knowledge is aggregated at the Clinical Formulation ID (GCN_SEQNO), Routed Medication ID (

ROUTED_MED_ID), and the Routed Generic ID (ROUTED_GEN_ID) levels in the First Databank (FDB)
knowledge base.

Tall Man also lists confusion groups, which provide a method for identifying drugs that may be confused with

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other drugs. Drugs that may be confused with other drugs share the same confusion group to facilitate additional
safety checks prior to dispensing. For instance, if a user has chosen acetazolamide for dispensing from a pick list,
Tall Man confusion groups may be used to display a list of confused drug names that include acetohexamide prior
to confirmation of the drug order based on their association with the same confusion group.

Inclusion Criteria
This section provides information detailing the criteria that guided the inclusion of the data contained within the
module as well as information pertaining to limitations or exclusions when appropriate to the discussion.

Inclusion Criteria

Drug names qualify for Tall Man lettering based on review of recommendations from sources whose goals are to
reduce prescribing and administration errors. These sources include the Food and Drug Administration (FDA) and
the Institute for Safe Medication Practices (ISMP).

Additional recommendations are provided by FDB when these official sources appear to be deficient based on
experience and internal review. In all instances, the source of the recommendation appears with the name.

For ease of implementation, Tall Man lettering of a name is restricted to a single group with a single source. For
example, if the ISMP newly recommends ASPIRin, while FDB had previously suggested aspiRIN, the FDB
suggestion will be removed and the ISMP recommendation added.

Exclusion Criteria

Tall Man descriptions are associated to each level of the FDB Medication Name Concepts, Package Product or
Ingredient List Identifier names. Information is supplemented in these files only where recognition errors
frequently occur. For example, not all MEDIDs appear in the Tall Man Medication ID Table
(RTMMID1_TM_MED). For Packaged Products, not all NDCs appear in the Tall Man NDC Table
(RTMNID0_TM_NDC). For Ingredient List Identifiers, not all HICL_SEQNOs appear in the Tall Man GNN Table
(RTMNGN0_TM_GNN).

Only names that could potentially benefit from further scrutiny when being used for drug selection on screen
displays or in printed materials are part of Tall Man.

Not all drugs with frequently mistaken names have Tall Man lettering available. In some instances, only
suffixes differ. For example, Wellbutrin SR and Wellbutrin XL appear in Tall Man Plus linked together
as a group, but Tall Man lettering is not supplied. However, confusion group and editorial source
information is supplied, alerting the user that the risk of a mistake is higher than normal for this group. For
these drugs, the original description and the Tall Man alternative are exactly the same.

Data Elements
This section contains additional information about particularly important tables and codes contained within the
module, as well as concepts about the data that the reader must understand in order to understand the module.

Tall Man Group ID Description Table (RTMGRPD1_TM_GROUP_DESC)

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Each group of names deemed easily confused is given a common Tall Man Group Identifier ( TM_GROUP_ID).
These identifiers are also given a Tall Man Group Description (TM_GROUP_DESC), which may or may not have
Tall Man lettering. TM_GROUP_IDs and their descriptions are contained in the Tall Man Group ID Description
Table (RTMGRPD1_TM_GROUP_DESC).

One drug can be associated to more than one confusion group.

Tall Man Source Description Table (RTMSRCD1_TM_SOURCE_DESC)

To identify the source of the recommendations, either from a source outside of FDB (FDA, ISMP) or from within
FDB, Tall Man Editorial Source Identifiers (TM_SOURCE_ID) and their associated Tall Man Editorial Source
Descriptions (TM_SOURCE_DESC) are provided within the Tall Man Source Code Description Table
(RTMSRCD1_TM_SOURCE_DESC).

Tall Man Name Type Description Table (RTMDT0_TM_NAME_TYPE)

As Tall Man alternative casing can be found by Packaged Product (NDC), the Tall Man Name Type Description
Table (RTMDT0_TM_NAME_TYPE) was created to differentiate the Label Name (LN), Label Name - 60 (LN60),
or Brand Name (BN) Tall Man Alternative NDC Descriptions (TM_ALT_NDC_DESC). In the Tall Man Name Type
Description Table, the Tall Man Name Type ID (TM_NAME_TYPE_ID) column provides the numerical identifier of
the Tall Man Name Type Description (TM_NAME_TYPE_DESC) for LN, LN60, or BN.

Tall Man GNN Type Table (RTMNGT0_TM_GNN_TYPE)

As Tall Man alternate casing can be found by Ingredient List Identifier (HICL_SEQNO), the Tall Man GNN Type
Table (RTMNGT0_TM_GNN_TYPE) was created to differentiate the Generic Name - Short Version ( GNN) or
Generic Name - Long Version (GNN60) Tall Man Alternative GNN Descriptions (TM_ALT_GNN_DESC). In the
Tall Man GNN Type Table, the Tall Man GNN Type ID ( TM_GNN_TYPE_ID) column provides the numerical
identifier of the Tall Man GNN Type Description (TM_GNN_TYPE_DESC) for GNN or GNN60.

Maintenance
This section contains information regarding the ongoing maintenance of the module's data.

External Triggers for Clinical Review

The external triggers that prompt the clinical editors to add or to review data are the following:

Institute for Safe Medication Practices (ISMP) bulletins and publications

MedWatch Safety Alerts
Primary Literature Review, National Library of Medicine (NLM)
Introduction of new drug products to the U.S. market with potentially confused product or generic names

Internal Triggers for Clinical Review

The internal triggers that prompt the clinical editors to add or review data is a new Clinical Formulation ID
(GCN_SEQNO) and the brand and label names of the associated products.

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Applications
This section provides information about the practical application of data contained in this module.

Retrieving Tall Man Lettering

Listing Confusion Group Drug Descriptions

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Retrieving Tall Man Lettering

This application illustrates how to retrieve Tall Man lettering to display to the end user. The scenarios provided in
this section illustrate systems that use the Medication Name Concepts or Packaged Products.

If you are navigating from an FDB identifier other than a Medication Name Concept or Packaged Product,
see Multiple Access Points (MAPs).

Because of the exception-driven nature of this file and the need to consider other concept attributes,
substitution of this casing and usage should occur as a final step in processing. The various other
attributes of the concept (status, name sources, etc.) remain with the concept in their original files. For
example, the retired status of a medication name will not be replicated in Tall Man.

There is an optional step in this application that considers the editorial source. This is best utilized when your
organization wants to use substitute casing from specific sources.

1. Select the Tall Man Indicator (TM_IND) from one of the following tables:
Tall Man Medication ID Table (RTMMID1_TM_MED) where the MED Medication ID (MEDID)
column equals the MEDID value of the medication.
Tall Man Routed Dosage Form Medication Name Table (RTMDFID1_TM_ROUTED_DF_MED)
where the MED Routed Dosage Form Medication ID ( ROUTED_DOSAGE_FORM_MED_ID)
column equals the ROUTED_DOSAGE_FORM_MED_ID value of the medication.
Tall Man Routed Medication Table (RTMRMID1_TM_ROUTED_MED) where the MED Routed
Medication ID (ROUTED_MED_ID) column equals the ROUTED_MED_ID value of the medication.
Tall Man Medication Name Table (RTMNMID1_TM_MED_NAME) where the MED Medication
Name ID (MED_NAME_ID) column equals the MED_NAME_ID value of the medication.
Tall Man NDC Table (RTMNID0_TM_NDC) where the NDC (NDC) column equals the NDC value of
the medication. For this option, also select the Tall Man Name Type ID ( TM_NAME_TYPE_ID)
column from the Tall Man NDC Table where the TM_NAME_TYPE_ID equals the ID for the label or
brand name type that needs to be displayed.
Tall Man GNN Table (RTMNGN0_TM_GNN) where the Ingredient List Identifier (HICL_SEQNO)
column equals the HICL_SEQNO value of the medication. For this option, also select the Tall Man
GNN Type ID (TM_GNN_TYPE_ID) column from the Tall Man GNN Table where the
TM_GNN_TYPE_ID equals the ID for the Generic Name type (long or short version) that needs to
be displayed.
Proceed as follows:
If the TM_IND value from the previous step equals 1, Tall Man lettering is available. Continue to the
next step.
If the TM_IND value from the previous step equals 0 or if no record is returned, Tall Man lettering is
not available. The application ends.

2. Select one of the following description values from the table used in step 1.

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2.
Tall Man Altered Medication Description (TM_ALT_MEDID_DESC)
Tall Man Altered Routed Dosage Form Medication Description (
TM_ALT_ROUTED_DF_MED_ID_DESC)
Tall Man Altered Routed Medication Description (TM_ALT_ROUTED_MED_ID_DESC)
Tall Man Altered Medication Name Description (TM_ALT_MED_NAME_DESC)
Tall Man Altered NDC Description (TM_ALT_NDC_DESC)
Tall Man Altered GNN Description (TM_ALT_GNN_DESC)
Optionally, you can also select additional columns to filter the results. For example:
Tall Man Source ID (TM_SOURCE_ID) column from the Tall Man Source Code Description Table
(RTMSRCD1_TM_SOURCE_DESC) where the TM_SOURCE_ID equals the identifier of the
editorial source your organization wants to use for substitute casing.

3. Display the information to the end-user.

ExampleRetrieving Tall Man Lettering for a Given Medication Name Concept

For the purposes of demonstrating this application, the following scenario is used: A customer (vendor)
wants to reduce script filling errors by using Tall Man lettering from Institute for Safe Medication Practices (ISMP)
instead of the conventional casing of a drug name for printing and displaying orders. This example illustrates how
the customer retrieves the Tall Man lettering forClomipramine 75 mg Capsule (MEDID = 00173045).

1. Select the Tall Man Indicator (TM_IND) from the Tall Man Medication ID Table (RTMMID1_TM_MED)
where the MEDID column equals the MEDID value of the medication.
Proceed as follows:
If the TM_IND value from the previous step equals 1, Tall Man lettering is available. Proceed to the
next step.
If the TM_IND value from the previous step equals 0 or if no record is returned, Tall Man lettering is
not available. The application ends.

MEDID TM_IND

00173045 1

In this example, TM_IND equals 1, indicating that Tall Man lettering is available. The application
continues to the next step.

2. Select the Tall Man Altered Medication Description (TM_ALT_MEDID_DESC) values from the Tall Man
Medication ID Table where the MEDID column equals the MEDID value of the medication and the Tall Man
Source ID (TM_SOURCE_ID) column equals the TM_SOURCE_ID value of 1 (indicating ISMP & FDA) or
4 (indicating ISMP).
The Tall Man Editorial Source Description (TM_SOURCE_DESC) column is found within the Tall Man
Source Code Description Table (RTMSRCD1_TM_SOURCE_DESC) and was added for illustrative
purposes only.

MEDID TM_SOURCE_ID TM_SOURCE_DESC TM_ALT_MEDID_DESC

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00173045 1 FDA & ISMP - Confused clomiPRAMINE 75 mg

drug name groups from Cap
the FDA and ISMP (with or
without Tall Man casing)

In this example, the editorial source value equals 1 (indicating FDA & ISMP).

3. Display the information to the end-user. In this example, the information is entered as an entry in the
systems order form using the altered description, clomiPRAMINE 75 mg Cap. If no ISMP casing was
available, the application would enter the information using the original description of clomipramine 75 mg
Cap.

ExampleRetrieving Tall Man Lettering for a Given Packaged Product

For the purposes of demonstrating this application, the following scenario is used: To meet JCAHO (Joint
Commission on Accreditation of Healthcare Organizations) surveyors' expectations, a dispensing pharmacy in a
Long Term Care (LTC) nursing home setting alerts nurses if the product they are about to administer to the
patient has a look-alike/sound-alike/easily confused drug name. A pharmacist is dispensing
HYDROCODONE-ACETAMINOPHEN 7.5-325 TAB (NDC = 00406012401) and must print a prescription label
using the Label Name - 60 (Tall Man Name Type ID = 2) with appropriate Tall Man lettering applied.

1. Select the Tall Man Indicator (TM_IND,) and Tall Man Name Type ID (TM_NAME_TYPE_ID) columns from
the Tall Man NDC Table (RTMNID0_TM_NDC) where the NDC (NDC) equals the NDC value of the
medication and the Tall Man Name Type ID equals the ID for Label Name - 60 (2).
The Tall Man Name Type Description (TM_NAME_TYPE_DESC) column is found within the Tall Man
Name Type Description Table (RTMDT0_TM_NAME_TYPE) and was added for illustrative purposes only.
Proceed as follows:
If the TM_IND value from the previous step equals 1, Tall Man lettering is available. Proceed to the
next step.
If the TM_IND value from the previous step equals 0 or if no record is returned, Tall Man lettering is
not available. The application ends.

NDC TM_NAME_TYPE_ID TM_NAME_TYPE_DES TM_IND

C

00406012401 2 LN60 1

In this example, TM_IND equals 1, indicating that Tall Man lettering is available. The application
continues to the next step.

2. Select the Tall Man Altered NDC Description (TM_ALT_NDC_DESC) value from the Tall Man NDC Table
where the NDC and TM_NAME_TYPE_ID values are the same as the previous step.

NDC TM_NAME_TYPE_ID TM_ALT_NDC_DESC

00406012401 2 HYDROcodone-acetaminophen
7.5-325 MG TABLET

3.

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3. Display the information to the end-user.

In this example, the Tall Man Altered NDC Description HYDROcodone-acetaminophen 7.5-325 MG
TABLET is printed on the prescription label and given to a nurse for administration.

ExampleRetrieving Tall Man Lettering for a Given Generic Drug Name Associated with an Ingredient List Identifier

For the purposes of demonstrating this application, the following scenario is used: A customer (vendor)
wants to reduce errors due to drug name similarities by using Tall Man lettering from Institute for Safe Medication
Practices (ISMP) instead of the conventional casing of a medication name for printing and displaying orders. This
example illustrates how the customer retrieves the Tall Man lettering for hydrocodone bitartrate/acetaminophen
(HICL_SEQNO = 1730).

1. Select the Tall Man Indicator (TM_IND) and Tall Man GNN Type ID (TM_GNN_TYPE_ID) columns from
the Tall Man GNN Table (RTMNGN0_TM_GNN) where the Ingredient List Identifier (HICL_SEQNO)
equals the Ingredient List Identifier value of the medication and the Tall Man GNN Type ID equals the ID
for GNN60 (2).
The Tall Man Name GNN Type Description (TM_GNN_TYPE_DESC) column is found within the Tall Man
GNN Type Table (RTMNGT0_TM_GNN_TYPE) and was added for illustrative purposes only.
Proceed as follows:
If the TM_IND value from the previous step equals 1, Tall Man lettering is available. Proceed to the
next step.
If the TM_IND value from the previous step equals 0 or if no record is returned, Tall Man lettering is
not available. The application ends.

HICL_SEQNO TM_GNN_TYPE_ID TM_GNN_TYPE_DESC TM_IND

1730 2 GNN60 1

In this example, TM_IND equals 1, indicating that Tall Man lettering is available. The application
continues to the next step.

2. Select the Tall Man Altered GNN Description (TM_ALT_GNN_DESC) value from the Tall Man GNN Table
where the Ingredient List Identifier and and TM_GNN_TYPE_ID values are the same as the previous step.

HICL_SEQNO TM_NAME_TYPE_ID TM_ALT_NDC_DESC

1730 2 HYDROcodone
bitartrate/acetaminophen

3. Display the information to the end-user.

In this example, the Tall Man Altered GNN Description HYDROcodone bitartrate/acetaminophen is
displayed.

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Listing Confusion Group Drug Descriptions

This application illustrates how to retrieve a list of confusion groups that are frequently mistaken for each other
and display it to the end-user. The scenarios provided in this section illustrate systems that use the Medication
Name Concepts or Packaged Products.

If you are navigating from an FDB identifier other than a Medication Name Concept or Packaged Product,
see Multiple Access Points (MAPs).

1. Select the Tall Man Group Identifier (TM_GROUP_ID) from one of the following tables:
Tall Man Medication ID Confusion Group Table (RTMMICG0_TM_MED_CNFSN_GRP) where the
MED Medication ID (MEDID) column equals the MEDID value of the medication
Tall Man Routed Dosage Form Medication Confusion Group Table
(RTMDFCG0_TM_RTD_DF_CNFSN_GRP) where the MED Routed Dosage Form Medication ID (
ROUTED_DOSAGE_FORM_MED_ID) column equals the ROUTED_DOSAGE_FORM_MED_ID
value of the medication
Tall Man Routed Medication Confusion Group Table (RTMRMCG0_TM_RTD_MED_CNFSN_GRP)
where the MED Routed Medication ID (ROUTED_MED_ID) column equals the ROUTED_MED_ID
value of the medication
Tall Man Medication Name Confusion Group Table (RTMNMCG0_TM_MED_NAME_CNFSN_GRP)
where the MED Medication Name ID (MED_NAME_ID) column equals the MED_NAME_ID value of
the medication
Tall Man NDC Confusion Group Table (RTMNCG0_TM_NDC_CNFSN_GRP4) where the NDC (
NDC) column equals the NDC value of the medication.
Proceed as follows:
If a TM_GROUP_ID value is returned, the medication is associated to a confusion group. Continue
to the next step.
If no TM_GROUP_ID value is returned, the medication is not associated to a confusion group. The
application ends.

2. Select the Tall Man Group Description (TM_GROUP_DESC) column from the Tall Man Group ID
Description Table (RTMGRPD1_TM_GROUP_DESC).

3. Display a message to the end-user providing the retrieved information.

ExampleListing Confusion Groups for Medication Concepts

For the purposes of demonstrating this application, the following scenario is used: A user is ready to order
the drug, Clonazepam Oral using its associated MED Routed Medication ID (ROUTED_MED_ID) value of
00014403. Once the medication is ordered, the users ordering system checks to see if the routed medication is
associated to a confusion group(s). If an association is found, the system retrieves the confusion group name. A
message is then generated for the user to relate that these groups have a high risk of being mistaken when
ordering the medication.

1.

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1. Select the Tall Man Group Identifier (TM_GROUP_ID) from the Tall Man Routed Medication Confusion
Group Table (RTMRMCG0_TM_RTD_MED_CNFSN_GRP) where the ROUTED_MED_ID column equals
the ROUTED_MED_ID value of the medication.

ROUTED_MED_ID TM_GROUP_ID

00014403 00306

00014403 00343

Proceed as follows:
If one or more TM_GROUP_ID values are returned, the medication is associated to a confusion
group. Continue to the next step.
If no TM_GROUP_ID value is returned, the medication is not associated to a confusion group. The
application ends.
In this example, two TM_GROUP_IDs value are returned. The application continues to the next
step.

2. Select the Tall Man Group Description (TM_GROUP_DESC) column from the Tall Man Group ID
Description Table (RTMGRPD1_TM_GROUP_DESC).

ROUTED_MED_ID TM_GROUP_ID TM_GROUP_DESC

00014403 00306 clonazepam/lorazepam

00014403 00343 clonazepam/clonidine

3. Display a message to the end-user providing the retrieved information.

Clonazepam Oral has been determined to be part of an underlying group of drug names that are frequently
mistaken for one another and may have Tall Man casing available:
clonazepam/lorazepam
clonazepam/clonidine

ExampleListing Confusion Groups for Packaged Products

For the purposes of demonstrating this application, the following scenario is used: To meet JCAHO (Joint
Commission on Accreditation of Healthcare Organizations) surveyors' expectations, a dispensing pharmacy in a
Long Term Care (LTC) nursing home setting alerts nurses if the product they are about to administer to the
patient has a look-alike/sound-alike/easily confused drug name. A pharmacist is dispensing a Zyprexa 10 mg
tablet (NDC = 00002411730) and must check if the medication is associated to a confusion group(s).

1. Select the Tall Man Group Identifier (TM_GROUP_ID) from the Tall Man NDC Confusion Group Table
(RTMNCG0_TM_NDC_CNFSN_GRP4) where the NDC column equals the NDC (NDC) of the medication.

NDC TM_GROUP_ID

00002411730 121

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Proceed as follows:
If one or more TM_GROUP_ID values are returned, the medication is associated to a confusion
group. Continue to the next step.
If no TM_GROUP_ID value is returned, the medication is not associated to a confusion group. The
application ends.
In this example, one TM_GROUP_ID value is returned. The application continues to the next step.

2. Select the Tall Man Group Description (TM_GROUP_DESC) column from the Tall Man Group ID
Description Table (RTMGRPD1_TM_GROUP_DESC).

NDC TM_GROUP_ID TM_GROUP_DESC

00002411730 121 Zyprexa/Zyrtec

3. Display a message to the end-user providing the retrieved information.

Zyprexa has been determined to be part of an underlying group of drug names that are frequently mistaken for one
another and may have Tall Man casing available:
Zyprexa/Zyrtec

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Tall Man Plus ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

Tall Man Tables

Tall Man Plus Medication Name Concepts Lettering Tables ERD
Tall Man Plus Medication Name Concepts Confusion Group Tables ERD
Tall Man Plus NDC Tables ERD
Tall Man Plus GNN Tables ERD

Tall Man Tables

Tall Man GNN Table
Tall Man GNN Type Table
Tall Man Group ID Description Table
Tall Man Medication ID Confusion Group Table
Tall Man Medication ID Table
Tall Man Medication Name Confusion Group Table
Tall Man Medication Name Table
Tall Man Name Type Description Table
Tall Man NDC Confusion Group Table
Tall Man NDC Table
Tall Man Routed Dosage Form Medication Confusion Group Table
Tall Man Routed Dosage Form Medication Name Table
Tall Man Routed Medication Confusion Group Table
Tall Man Routed Medication Table
Tall Man Source Code Description Table

Tall Man Plus Medication Name Concepts Lettering Tables ERD

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Tall Man Plus Medication Name Concepts Confusion Group Tables ERD

Tall Man Plus NDC Tables ERD

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Tall Man Plus GNN Tables ERD

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Tall Man GNN Table

Table Name RTMNGN0_TM_GNN

Revision Activity add. 05-24-2017

Purpose When appropriate, provides Tall Man lettering of an

Ingredient Lists GNN as well as the sources of the
recommendations for inclusion.

Key Column Name Column Format Length Picture

Description

PF HICL_SEQNO Ingredient List N 6 9(6)

Identifier (Stable
ID)

PF TM_GNN_TYPE_I TM GNN Type ID N 5 9(5)

D

F TM_SOURCE_ID TM Editorial N 5 9(5)

Source ID

TM_IND TM Indicator N 1 9(1)

TM_ALT_GNN_D TM Altered GNN AN 60 X(60)

ESC

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Tall Man GNN Type Table

Table Name RTMNGT0_TM_GNN_TYPE

Revision Activity add. 05-24-2017

Purpose Relates the Tall Man GNN Type ID to its text description.

Key Column Name Column Format Length Picture

Description

PF TM_GNN_TYPE_I TM GNN Type ID N 5 9(5)

D

TM_GNN_TYPE_ TM GNN Type AN 30 X(30)

DESC Description

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Tall Man Group ID Description Table

Table Name RTMGRPD1_TM_GROUP_DESC

Revision Activity rev.12-01-2011

Purpose Relates the Group ID to its text description.

Key Column Name Column Format Length Picture

Description

P TM_GROUP_ID TM Group ID N 5 9(5)

TM_GROUP_DE TM Group AN 250 X(250)

SC Description

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Tall Man Medication ID Confusion Group Table

Table Name RTMMICG0_TM_MED_CNFSN_GRP

Revision Activity add.12-01-2011

Purpose Links medications to drug names that are frequently

confused with one another.

Key Column Name Column Format Length Picture

Description

P MEDID MED Medication N 8 9(8)

ID

P TM_GROUP_ID TM Group ID N 5 9(5)

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Tall Man Medication ID Table

Table Name RTMMID1_TM_MED

Revision Activity rev.12-01-2011

Purpose When appropriate, provides Tall Man lettering of a

Medication Concept as well as the sources of the
recommendations for inclusion.

Key Column Name Column Format Length Picture

Description

P MEDID MED Medication N 8 9(8)

ID

F TM_SOURCE_ID TM Editorial N 5 9(5)

Source ID

TM_IND TM Indicator N 1 9(1)

TM_ALT_MEDID_ TM Altered AN 70 X(70)

DESC Medication
Description

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Tall Man Medication Name Confusion Group Table

Table Name RTMNMCG0_TM_MED_NAME_CNFSN_GRP

Revision Activity add.12-01-2011

Purpose Links medication names to drug names that are frequently

confused with one another.

Key Column Name Column Format Length Picture

Description

P MED_NAME_ID MED Medication N 8 9(8)

Name ID

P TM_GROUP_ID TM Group ID N 5 9(5)

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Tall Man Medication Name Table

Table Name RTMNMID1_TM_MED_NAME

Revision Activity rev.12-01-2011

Purpose When appropriate, provides Tall Man lettering of a

Medication Name Concept as well as the sources of the
recommendations for inclusion.

Key Column Name Column Format Length Picture

Description

P MED_NAME_ID MED Medication N 8 9(8)

Name ID

F TM_SOURCE_ID TM Editorial N 5 9(5)

Source ID

TM_IND TM Indicator N 1 9(1)

TM_ALT_MED_N TM Altered AN 70 X(70)

AME_DESC Medication Name
Description

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Tall Man Name Type Description Table

Table Name RTMDT0_TM_NAME_TYPE

Revision Activity add. 08-22-2013

Purpose Relates the Tall Man Name Type ID to its text description.

Key Column Name Column Format Length Picture

Description

P TM_NAME_TYPE TM Name ID N 5 9(5)

_ID

TM_NAME_TYPE TM Name Type AN 30 X(30)

_DESC Description

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Tall Man NDC Confusion Group Table

Table Name RTMNCG0_TM_NDC_CNFSN_GRP

Revision Activity add. 08-22-2013

Purpose Links Packaged Products (NDCs) to drug names that are

frequently confused with one another.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

PF TM_GROUP_ID TM Group ID N 5 X(5)

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Tall Man NDC Table

Table Name RTMNID0_TM_NDC

Revision Activity add. 08-22-2013

Purpose When appropriate, provides Tall Man lettering of a

Packaged Product (NDC) as well as the sources of the
recommendations for inclusion.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

PF TM_NAME_TYPE TM Name Type ID N 5 9(5)

_ID

F TM_SOURCE_ID TM Editorial N 5 9(5)

Source ID

TM_IND TM Indicator N 1 9(1)

TM_ALT_NDC_D TM Altered NDC AN 60 X(60)

ESC Description

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Tall Man Routed Dosage Form Medication Confusion Group Table

Table Name RTMDFCG0_TM_RTD_DF_CNFSN_GRP

Revision Activity add.12-01-2011

Purpose Links routed dosage form medications to drug names that

are frequently confused with one another.

Key Column Name Column Format Length Picture

Description

P ROUTED_DOSA MED Routed N 8 9(8)

GE_FORM_MED Dosage Form
_ID Medication ID
(Stable ID)

P TM_GROUP_ID TM Group ID N 5 9(5)

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Tall Man Routed Dosage Form Medication Name Table

Table Name RTMDFID1_TM_ROUTED_DF_MED

Revision Activity rev.12-01-2011

Purpose When appropriate, provides Tall Man lettering of a Routed

Dosage Form Medication Concept as well as the sources of
the recommendations for inclusion.

Key Column Name Column Format Length Picture

Description

P ROUTED_DOSA MED Routed N 8 9(8)

GE_FORM_MED Dosage Form
_ID Medication ID
(Stable ID)

F TM_SOURCE_ID TM Editorial N 5 9(5)

Source ID

TM_IND TM Indicator N 1 9(1)

TM_ALT_ROUTE TM Altered AN 70 X(70)

D_DF_MED_ID_D Routed Dosage
ESC Form Medication
Description

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Tall Man Routed Medication Confusion Group Table

Table Name RTMRMCG0_TM_RTD_MED_CNFSN_GRP

Revision Activity add.12-01-2011

Purpose Links routed medications to drug names that are frequently

confused with one another.

Key Column Name Column Format Length Picture

Description

P ROUTED_MED_I MED Routed N 8 9(8)

D Medication ID

P TM_GROUP_ID TM Group ID N 5 9(5)

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Tall Man Routed Medication Table

Table Name RTMRMID1_TM_ROUTED_MED

Revision Activity rev.12-01-2011

Purpose When appropriate, provides Tall Man lettering of a Routed

Medication Concept as well as the sources of the
recommendations for inclusion.

Key Column Name Column Format Length Picture

Description

P ROUTED_MED_I MED Routed N 9 9(8)

D Medication ID
(Stable ID)

F TM_SOURCE_ID TM Editorial N 5 9(5)

Source ID

TM_IND TM Indicator N 1 9(1)

TM_ALT_ROUTE TM Altered AN 70 X(70)

D_MED_ID_DES Routed
C Medication
Description

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Tall Man Source Code Description Table

Table Name RTMSRCD1_TM_SOURCE_DESC

Revision Activity rev.12-01-2011

Purpose Relates the Editorial Source ID to its text description.

Key Column Name Column Format Length Picture

Description

P TM_SOURCE_ID TM Editorial N 5 9(5)

Source ID

TM_SOURCE_DE TM Editorial AN 120 X(120)

SC Source
Description

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FDB Medical Lexicon (FML) 2.0

General Information
FDB Medical Lexicon Editorial Policies
Applications
ERD and Technical Specifications

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General Information
The General Information section contains high-level information about the module.

Overview
Definitions
Concepts

Overview
The FDB Medical Lexicon (FML) is a collection of medical vocabulary concepts, called Disease Identifiers
(DXIDs), created by First Databank (FDB) for use with the Disease Decision Support and Dosing modules.

The technical design of FML provides a concept-based DXID semantic neighborhoodDXIDs linked to other
related DXIDs within the context of each Disease Decision Support or Dosing module. This is achieved using the
FML Disease Identifier (DXID) Search Table.When queried with an FML Clinical Module Code
(FML_CLIN_CODE), this table returns DXIDs specific to drug indications (INDM), contraindications (DDCM), side
effects (SIDE), or dosing information (NEOM and DRCM).

Drug knowledge is aggregated at the Clinical Formulation ID (GCN_SEQNO), Routed Medication ID (

ROUTED_MED_ID), and the Routed Generic ID (ROUTED_GEN_ID) levels in the FDB knowledge base.
Under certain circumstances, aggregated drug knowledge may not apply to all related packaged
products; more specific information may be found within product labels.

Definitions
This section defines important terms related to the module that users should understand. Some industry terms
that have a specific connotation in regards to the module are also defined.

ICD-9-CM

ICD-9-CM codes are an administrative HIPAA-compliant scheme representing patient problems and health
events. FML utilizes the codes and descriptions provided in the United States Department of Health and Human
Services' International Classification of Diseases, Clinical Modification, 9th Revision (ICD-9-CM). Updates of this
file are done annually. All new ICD code and ICD code description updates are included at the time of updating.

DXIDs may be associated to none or to many ICD Codes. This allows the Disease Decision Support Modules to
generate the most comprehensive and relevant set of alerts, and is useful when ICD Codes are known for a given
patient. Most, but not all, DXIDs/FDBDXs will be associated to at least one ICD Code in the FML ICD Search
Table. Many ICD Codes do not map to DXIDs/FDBDXs. The example below illustrates the relationship of DXID
599Diabetic Nephropathy to its associated ICD Code. Please note that not all ICD Codes will have links to
DXIDs.

ExampleICD Code to DXID relationships

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ICD_CD FML ICD Code FML Navigation DXID FML 56-character

Description Code Description
Description(Relation
ship)

250 DIABETES Broader 599 Diabetic Nephropathy

MELLITUS

250.4 DIAB W RENAL Equal 599 Diabetic Nephropathy

MANIFEST

250.40 DIAB RENAL MANIF Equal 599 Diabetic Nephropathy

TYPE II OR
UNSPECIFIED

250.41 DIAB RENAL MANIF Narrower 599 Diabetic Nephropathy

TYPE I

250.42 DM RENAL MANIF Narrower 599 Diabetic Nephropathy

TYPE II OR
UNSPECIFIED
UNCONTROLLED

250.43 DM RENAL MANF Narrower 599 Diabetic Nephropathy

TYP I
UNCONTROLLED

250.8 DIABETES W Broader 599 Diabetic Nephropathy

MANIFEST NEC

250.80 DIAB W MANIF NEC Broader 599 Diabetic Nephropathy

TYPE II

250.9 DIABETES W Broader 599 Diabetic Nephropathy

COMPLIC NOS

250.90 DIAB W COMPL NOS Broader 599 Diabetic Nephropathy

TYPE II

583.8 NEPHRITIS NOS W Broader 599 Diabetic Nephropathy

OTH LESIONS

583.81 NEPHRITIS NOS IN Broader 599 Diabetic Nephropathy

OTH DIS W OTH
LESION

583.89 NEPHRITIS NEC W Broader 599 Diabetic Nephropathy

OTH LESIONS

583.9 NEPHRITIS W Broader 599 Diabetic Nephropathy

UNSPEC LESIONS

ICD-10-CM

The International Classification of Diseases, 10th revision, Clinical Modification as written by the World Health
Organization (WHO) and the National Center for Healthcare Statistics (NCHS). CMS indicates the ICD-10 code
field is not case sensitive.

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ICD-10-PCS

The International Classification of Diseases, 10th revision, Procedure Classification System as written by the
World Health Organization (WHO) and the National Center for Healthcare Statistics (NCHS). CMS indicates the
ICD-10 code field is not case sensitive.

FML Disease Identifier (DxID) Search Table

The FML Disease Identifier (DxID) Search Table (RFMLDSR0_DXID_SEARCH[) allows users to retrieve the
specific DXIDs utilized within a given Disease Decision Support or Dosing module, via the FML Clinical Module
Code (FML_CLIN_CODE). For example, if Indications Module information is queried, only DXIDs relevant to that
module are retrieved. Each DXID is linked many-to-many to other DXIDs used within the same module, creating a
module-specific semantic neighborhood. The example below illustrates that Vascular Disease, Hypertension,
and Uncontrolled Severe Hypertension DXIDs are related to themselves and each other within the Indications
Module. Descriptions for the various identifiers and codes are also shown in this example.

ExampleDXID relationships in Indications Module

Search DXID Description Navigation Code Related DXID Description Clinical Module Code
Description (Relationship) Description

Vascular Disease Equal Vascular Disease Indications

Vascular Disease Broader Hypertension Indications

Vascular Disease Broader Hypertension, Uncontrolled, Indications

Severe

Hypertension Equal Hypertension Indications

Hypertension Narrower Vascular Disease Indications

Hypertension Broader Hypertension, Uncontrolled, Indications

Severe

Hypertension, Uncontrolled, Equal Hypertension, Uncontrolled, Indications

Severe Severe

Hypertension, Uncontrolled, Narrower Hypertension Indications

Severe

Hypertension, Uncontrolled, Narrower Vascular Disease Indications

Severe

ICD Description Tables

FDB provides both "long" and "short" ICD-10 descriptions from the National Center for Health Statistic (NCHS).
The FML ICD Code Description Table (RFMLINM1_ICD_DESC) uses the "long" description. If you prefer to
display the short description, navigate to the FML ICD All Descriptions Table (RFMLIAD0_ICD_ALL_DESC) and
select the record where the ICD Description Source Code (ICD_DESC_SOURCE_CD) equals 04.

FML ICD Search Exclusion Table

The FML ICD Search Exclusion Table (RFMLISX0_ICD_SEARCH_EXCLUSION) provides exclusion mappings to

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support more refined drug indications, drug-disease contraindications, and side effects screening. For example,
this reduces conflicting information in that a drugs indication cannot trigger a drug-disease contraindication alert.

Concepts
This section describes concepts and database elements that are important for understanding the module.

Billable ICD Codes

The FML ICD Billable History Table (RFMLIBH0_ICD_BILLABLE_HIST) provides information regarding the
billable dates and billable history of an ICD Code, allowing for both current and retrospective billing analysis of an
ICD code or group of ICD codes.

CLIN_DRUG_GROUP

The Clinical Module Drug Group field contains values from disease-based clinical modules and is used as a
search filter in the FML ICD Search Exclusion Table (RFMLISX0_ICD_SEARCH_EXCLUSION).

DXID

The FML Disease Identifier (DXID) is a permanent numeric identifier that represents medical diagnoses, disease
states, and health-related conditions or procedures. Each DXID is linked to several text descriptions (names),
including the preferred primary professional name and professional synonyms, layman names and synonyms,
and abbreviations. The DXID description (DXID_DESC100) may consist of pre-coordinated terms, such as
Hypercalcemia with Metastatic Breast Carcinoma or Klebsiella Nosocomial Pneumonia.

Link Relationships

Each FML Disease Identifier (DXID) is linked to an FML Disease Duration Code (
DXID_DISEASE_DURATION_CD) that represents a potential duration of the diagnosis represented by the values
Acute, Chronic, or both.

DXIDs are linked many-to-many to other DXIDs for navigation purposes and to generate appropriate module
alerts, creating the DXID semantic network in the FML Disease Identifier (DxID) Search Table
(RFMLDSR0_DXID_SEARCH).

DXIDs may also be associated to none or to many ICD-9 and ICD-10 codes to generate appropriate module
alerts using the FML ICD Search Table (RFMLISR1_ICD_SEARCH).

Each DXID is linked one-to-one to a First Databank Disease Code (FDBDX).

Navigation to and storage of DXID values for use in FDB applications is supported with the caveat that not all
conditions and procedures are represented. If using DXID values, it is necessary to implement the
Retire/Replacement History feature. DXID values are not a HIPAA-compliant code set for any part of a patient
record.

FML Navigation Codes (FML_NAV_CODE) are linked to each DXID association to represent Broader, Narrower,
Equal, or Related relationships solely for the purpose of supporting alert message construction, particularly for
the Drug-Disease Contraindications Module (DDCM). The primary table used in the query is the FML ICD
Search Table (RFMLISR1_ICD_SEARCH), and this table contains the Search ICD Code (SEARCH_ICD_CD),

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the Related DXID (RELATED_DXID), and the FML Navigation Code (FML_NAV_CODE). There are several
DDCM applications that detail how to construct the messages using this information:

Comparing Patient ICD Codes to Prospective Drug TherapyUsing the Exclusion Table to Reduct Alerts
Comparing Patient DxIDs to Prospective Drug Therapy
Checking Inferred Patient Diagnoses for Drug-Disease Contraindications Associated with Prospective Drug
Therapy

Default Screening Record

The FML Disease Identifier (DXID) value 4892 can be used as the default screening record in the DRCM. The
default screening record should be used when the patient condition is not available or if a reason for use record
(FDBDX or DXID) for a given age range is not available. When screening a drug order with DRCM and there are
no patient conditions available, you can use the default screening records exclusively for a given age range. The
default screening record is the most common in DRCM due to the fact that most drugs do not have
condition-specific dosing ranges. In cases when a drug does have condition-specific dosing, a specific DXID, not
default, is used.

Gender-Specific Record

Due to an FDA alert about gender-specific dosing levels for zolpidem, a widely prescribed drug indicated to treat
insomnia, FDB added new DXID values for female and male to use in the DRCM. The DXID values are as
follows:

DXID DXID_DESC100

14160 Female

14161 Male

If the gender is known, use the DXID values when performing dosage range checking for a medication that
contains zolpidem. The gender-specific record should be used instead of the default screening record for
zolpidem.

Currently, there are no indication-specific records linked to zolpidem.

If you do not have gender information, use the default screening record (4892).

The associated usage-specific records encompass single dose and maintenance dose types for adults aged
6570-23724 days. The High Daily Dose (DR2_HIDOSD) and Maximum Daily Dose (DR2_MXDOSD) values for
women correspond to the FDA recommended dosing levels for zolpidem. The gender-specific records are in
place of the default record, so any other indication-specific record would take preference over the gender-specific
records.

FML_NAV_CODE

The FML Navigation Code (FML_NAV_CODE) identifies whether an ICD Code or DXID is a narrower concept, a
broader concept, an equal concept, or a related concept, relative to another DXID.

For example, Pneumococcal Pneumonia is a narrower concept than Pneumonia, while Respiratory Disease is a

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broader concept than Pneumonia.

ICD_CD_TYPE value 04 is only available for ICD-10-CM/PCS codes and not for ICD-9-CM codes.

FML_CLIN_CODE

The FML Clinical Module Code (FML_CLIN_CODE) identifies the Disease Decision Support or Dosing module
that is being referenced.

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FDB Medical Lexicon Editorial Policies

The policies and criteria that apply to the scope and sources of the FML module are provided in the following
sections:

Scope
Sources

Scope
The FDB Medical Lexicon (FML) is a medical vocabulary developed by FDB for the specific purpose of relating
drug products to various diagnoses and health-related conditions, within the context of the Dosing Modules and
the following FDB Disease Decision Support modules:

Indications Module (INDM) 2.0

Drug-Disease Contraindications Module (DDCM) 2.0
Side Effects Module (SIDE) 2.0
Prescriber Order Entry Module (POEM) 2.0

FML utilizes the Disease Identifier (DxID) to represent unique diagnoses and health-related concepts. For
migration purposes, DxIDs relate one-to-one to First Databank Disease Codes (FDBDX). Cross-references are
made between DxIDs and ICD codes.

Limitations

The FDB Medical Lexicon includes only those medical concepts that are relevant to the use of drug products. It is
intended to support the FDB Disease Decision Support and Dosing modules. FML does not include all diseases
or procedures, and therefore, is not intended to directly support health record or electronic medical record
documentation applications. It does not contain all concepts that are expressed by the MedDRA or SNOMED
CT terminologies. Cross-references from the DxID to these other standard medical terminologies may be
available in the future based on customer need.

Sources
This section lists sources used by FDB to compile the information contained in the module.

The FDB Medical Lexicon concepts are created on an as needed basis when new drugs are added to the
Disease Decision Support knowledge bases. These concepts are created to accurately describe diagnoses,
diseases, drug indications procedures, side effect symptoms, etc. Each DXID description is verified using many
sources of information, including the following:

College of American Pathologists. SNOMED CT Terminology.

Ingenix, Hart A, Ford B. ICD-9-CM Expert for Hospitals.
Medline Plus Medical Encyclopedia (hosted by National Library of Medicine).
Available at: http://www.nlm.nih.gov/medlineplus/encyclopedia.html.
Merriam-Webster Medical Dictionary. Available online via National Library of Medicine. Available at:
http://www.nlm.nih.gov/medlineplus/mplusdictionary.html.

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New codes, descriptions, synonyms, and abbreviations are added on a continual as needed basis.

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FML Applications
This section provides information about the practical application of data contained in this module.

Finding DXID Descriptions and Synonyms

Finding DXIDs Based on an Input Search String

Finding DXIDs Based on a Patients Gender

Building a Disease Navigation Report

Finding a Replacement DxID

ICD Code Applications

Retrieving an ICD Codes Alternate Description

Retrieving an ICD Codes Associated DxIDs
Retrieving the Billable Dates for a Given ICD Code

Using FML with Other Modules

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Finding DXID Descriptions and Synonyms

This application illustrates how to retrieve the various text descriptions associated to a given Disease Identifier (
DXID) or set of input DXIDs (for example, a result set retrieved by another application). Each DXID may have the
following text descriptions:

Primary Professional Name: one and only one

Professional Synonym: zero, one, or many
Primary Layman Name: zero, one, or many
Layman Synonym: zero, one, or many
Abbreviation: zero, one, or many

Remember that an FML descriptions designation as a preferred term versus a synonym is subjective. If your
application allows end-users to choose one of these descriptions from a list, you should present them with every
available text description so they can select the term they prefer.

Each description type has a 56-character version and a 100-character version. The descriptions are
equivalent; one is simply constrained to 56-characters to accommodate systems that must use short
strings.

This application retrieves all descriptions associated to DXID 00000595.

1. For DxID 00000595s Primary Professional Name, find its associated FML 56-character Description
column (DXID_DESC56) and FML 100-character Description column (DXID_DESC100) in the FML
Disease Identifier (DxID) Table (RFMLDX0_DXID).

DXID DXID_DESC56 DXID_DESC100

00000595 Type 1 Diabetes Mellitus Type 1 Diabetes Mellitus

2. For DxID 00000595s Professional Synonyms, find its associated FML 56-character Synonym Description (
DXID_SYN_DESC56) and FML 100-character Synonym Description (DXID_SYN_DESC100) in the FML
Disease Identifier (DxID) Synonym Table (RFMLSYN0_DXID_SYN). Specify a value of 01 for the FML
Name Type Code (DXID_SYN_NMTYP) to signify that you wish to retrieve this DxIDs Professional
Synonyms.

DXID DXID SYN_NMTYP DXID_SYN_DESC56 DXID_SYN_DESC100

00000595 01 Juvenile Onset DM Juvenile Onset DM

00000595 01 Insulin-Dependent DM Insulin-Dependent DM

00000595 01 Insulin-Dependent Insulin-Dependent

Diabetes Mellitus Diabetes Mellitus

00000595 01 Ketosis-Prone Diabetes Ketosis-Prone Diabetes

Mellitus Mellitus

00000595 01 Ketosis-Prone Diabetes Ketosis-Prone Diabetes

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00000595 01 Juvenile Diabetes Juvenile Diabetes

00000595 01 Juvenile-Onset Diabetes Juvenile-Onset Diabetes

Mellitus Mellitus

00000595 01 Immune Mediated Immune Mediated

Diabetes Mellitus Diabetes Mellitus

00000595 01 Type I Diabetes Mellitus Type I Diabetes Mellitus

00000595 01 Diabetes Mellitus Type 1 Diabetes Mellitus Type 1

00000595 01 Ketosis-Prone DM Ketosis-Prone DM

00000595 01 Insulin Dependent Insulin Dependent

Diabetes Mellitus Diabetes Mellitus

00000595 01 Juvenile-Onset Diabetes Juvenile-Onset Diabetes

Because DxIDs can have multiple synonyms of a given type, the synonyms have been assigned a
unique FML Synonym Identifier (Stable ID) (DXID_SYNID), also present in the
RFMLSYN0_DXID_SYN table. You can use this value at your discretion to help keep track of the
different synonyms

3. For DxID 00000595s Primary Layman Names, perform the same query as step 2, but use a value of 02 for
the DXID_SYN_NMTYP code to signify that you wish to retrieve this DxIDs Primary Layman Names.

DXID DXID_SYN_NMTYP DXID_SYN_DESC56 DXID_SYN_DESC100

00000595 02 Type 1 Diabetes Mellitus Type 1 Diabetes Mellitus

4. For DxID 00000595s Layman Synonyms, perform the same query as step 2, but use a value of 03 for the
DXID_SYN_NMTYP code to signify that you wish to retrieve this DxIDs Layman Synonyms.

DXID DXID_SYN_NMTYP DXID_SYN_DESC56 DXID_SYN_DESC100

00000595 03 Insulin-Dependent Insulin-Dependent

Diabetes Diabetes

00000595 03 Type I Diabetes Type I Diabetes

5. For DxID 00000595s Abbreviations, perform the same query as step 2, but use a value of 04 for the
DXID_SYN_NMTYP code to signify that you wish to retrieve this DxIDs Abbreviations.

DXID DXID_SYN_NMTYP DXID_SYN_DESC56 DXID_SYN_DESC100

00000595 04 IDDM IDDM

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Finding DXIDs Based on an Input Search String

This application illustrates how to retrieve Disease Identifiers (DXID) whose descriptions partially match an input
text string. Each DXID has multiple descriptions that must be searched for all matching instances of the input
string.

This application finds all DXIDs whose descriptions contain the term hypertension.

1. Search the FML 56-character Description column (DXID_DESC56) and the FML 100-character Description
column (DXID_DESC100) in the FML Disease Identifier (DxID) Table (RFMLDX0_DXID) for all instances
of the phrase hypertension. Retrieve the associated DXID value for each description that returns a match.

2. Search the FML 56-character Synonym Description (DXID_SYN_DESC56) and the FML 100-character
Synonym Description (DXID_SYN_DESC100) in the FML Disease Identifier (DxID) Synonym Table
(RFMLSYN0_DXID_SYN) for all instances of the phrase hypertension. Retrieve the associated DXID
value for each description that returns a match.

3. Consolidate the two lists of DXIDs found in steps 1 and 2 by removing redundant DXID values. The
resulting 23 DXIDs appear below with descriptions for context. Note that the Primary Professional Name
for DXID 00001444, Hypertensive Cardio-Renal Disease, does not contain the phrase hypertension.
However, one of its synonym descriptions does.

DXID DXID_DESC100

00000507 Hypertension Secondary to Pheochromocytoma

00000508 Prevention of Hypertension in Pheochromocytoma

00001121 Benign Intracranial Hypertension

00001204 Ocular Hypertension

00001431 Malignant Essential Hypertension

00001432 Hypertension

00001433 Hypertension due to Scleroderma

00001434 Paroxysmal Hypertension

00001435 Severe Uncontrolled Hypertension

00001436 Mild Hypertension

00001440 Supine Hypertension

00001441 Hypertension due to Aortic Coarctation

00001442 Hypertension due to Arteriovenous Shunt

00001444 Hypertensive Cardio-Renal Disease

00001445 Perioperative Hypertension

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00001446 Intraoperative Hypertension

00001478 Pulmonary Hypertension

00001581 Chronic Heart Failure Not due to Hypertension

00002540 Pregnancy-Induced Hypertension

00004207 Intracranial Hypertension

00004739 Moderate Hypertension

00010527 Portal Hypertension

00010918 Hypertension with Left Ventricular Hypertrophy

Sorting based on DXID value is arbitrary. For example, you could sort the results to list those that
start with the users search string first.

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Finding DXIDs Based on a Patients Gender

This application illustrates how to retrieve Disease Identifiers (DXID) specific to a patients gender (i.e., female or
male). Users would search for a gender-specific DXID code when performing dosage range checking for
zolpidem, a widely prescribed drug indicated to treat insomnia, which has different dose ranges for female and
male patients.

This application uses the example of finding the DXID code for a female patient.

1. Search the FML 56-character Description column (DXID_DESC56) and the FML 100-character Description
column (DXID_DESC100) in the FML Disease Identifier (DxID) Table (RFMLDX0_DXID) for all instances
of the phrase female.

2. Retrieve the associated DXID value, and present the results to the user.

DXID DXID_DESC100

00014160 Female

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Building a Disease Navigation Report

This application builds a disease navigation report by retrieving all DxIDs relatedeither in a broader sense or in
a narrower senseto an input DxID. If you wish to use this process for a user-input search term, you must first
follow the process described in the application titled Finding DXIDs Based on an Input Search String. Please note
that this process is best carried out for a single DxID, as each DxID involved will generate its own navigation
report. If you must create disease navigation reports for more than one DxID, follow the steps below from start to
finish for each individual DxID.

This process only works for current DxIDs. Current DxIDs have an FML Disease Identifier Status Code (
DXID_STATUS) of 0.

This application builds a disease navigation report for DxID 00000598, Diabetic Coma.

Part 1: Retrieve all DxIDs that are broader than the input DxID

1. Retrieve each FML Broader DxID (BROADER_DXID) associated to DxID 00000598 using the FML
Disease Identifier (DxID) Navigation Table (RFMLNAV0_DXID_NAVIGATION).

DXID BROADER_DXID

00000598 00000604

00000598 00003033

2. For each BROADER_DXID value retrieved in the previous step, retrieve all associated BROADER_DXID
values using the RMFLNAV0_DXID_NAVIGATION table again.

DXID BROADER_DXID

00000604 00000655

00000604 00003278

00003033 00003037

3. Repeat step 2 for each set of newly-retrieved DxID values until no BROADER_DXID values remain (the
BROADER_DXID is zero-filled). The last FML Broader DxIDs retrieved represent the highest-level DxIDs.

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Part 2: Retrieve all DxIDs that are narrower than the input DxID

1. Retrieve DxIDs that are narrower than the input DxID by using the input DxID as the BROADER_DXID in
the RMFLNAV0_DXID_NAVIGATION table (effectively reversing the navigation used in part 1 above).

DXID BROADER_DXID

000000597 00000598

2. Use each DXID retrieved in the previous step as the BROADER_DXID, and retrieve all associated DXID
values from the RMFLNAV0_DXID_NAVIGATION table.

DXID BROADER_DXID

NO VALUES RETURNED 00000597

3. Repeat step 2 for each set of newly-retrieved DxID values until no narrower DXID values remain. The last
DxIDs retrieved represent the lowest-level DxIDs.

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4. Retrieve the descriptions for the DxIDs that appear in the navigation report using the method described in
Finding DXID Descriptions and Synonyms. The following example report uses each DxIDs Primary
Professional Name.

ExampleDisease navigation report for Diabetic Coma, DxID 00000598

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Finding a Replacement DxID

This application illustrates how to find a DxIDs replacement and the date the replacement took place. DxIDs that
have been replaced with a more current DxID value have an FML DxID Status Code ( DXID_STATUS) value of 1
in the FML Disease Identifier (DxID) Table (RFMLDX0_DXID). Follow these steps to retrieve a superseded
DxIDs replacement DxID value.

This application finds the replacement and replacement date for DxID 00001725.

1. Look up the replaced DxID using the FML Previous DxID ( FMLPRVDXID) in the FML Disease Identifier
(DxID) Replacement History Table (RFMLDRH0_DXID_HIST), and retrieve the associated
FML Replacement DxID (FMLREPDXID).

FMLPRVDXID DXID_DESC56 FMLREPDXID DXID_DESC56

00001725 Circulatory System 00001594 Disease of Cardiovascular

Disorders (DO NOT USE) System

The phrase (DO NOT USE) in the replaced DxID description is meant for legacy customers who
do not have retirement/replacement indicators.

2. Retrieve the FML DxID Replacement Date (FMLDXREPDT) which specifies when the FMLREPDXID
replaced the FMLPRVDXID.

FMLPRVDXID FMLREPDXID FMLDXREPDT DXID_DESC56

00001725 00001594 20040112 Disease of Cardiovascular

System

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ICD Code Applications

The FDB Medical Lexicon provides the ability to retrieve the names and DxIDs associated to ICD codes.

The FML ICD Search Table was not intended to be used for billing purposes. The FML Navigation Code
in the FML ICD Search Table is designed to point end-users to concepts that are equal to, broader than,
or narrower than the ICD code entered, enabling the end-user to find relevant decision support in the
related clinical modules.

Not all ICD codes are included in the FML ICD Search Table. The table only includes ICD-codes that are
associated to one or more DxID(s).

This section contains the following applications:

Retrieving an ICD Codes Alternate Description

Retrieving an ICD Codes Associated DxIDs
Retrieving the Billable Dates for a Given ICD Code

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Retrieving an ICD Codes Alternate Description

The FML ICD Code Description Table (RFMLINM1_ICD_DESC) defaults to the First Databank description for
ICD-9-CM codes and to the National Center for Health Statistics (NCHS) Long description for ICD-10-CM/PCS
codes. This application illustrates how to retrieve an alternate description for an ICD code from the FML ICD All
Descriptions Table (RFMLIAD0_ICD_ALL_DESC).

1. Retrieve the ICD Code Description (ICD_DESC) and ICD Description Source Code (
ICD_DESC_SOURCE_CD) from the FML ICD All Descriptions Table (RFMLIAD0_ICD_ALL_DESC) where
the ICD Code (ICD_CD) value equals the ICD Code in focus and the FML ICD Code Type ( ICD_CD_TYPE
) represents the type of ICD Code in focus.
In this example, ICD-10-CM code I87.321 (ICD_CD_TYPE = 05) is in focus.

ICD_CD ICD_CD_TYPE ICD_DESC ICD_DESC_SOURCE_C

D

I87.321 05 Chronic venous 03

hypertension (idiopathic)
with inflammation of right
lower extremity

I87.321 05 Chronic venous 04

hypertension w
inflammation of r lo

2. Use the FML ICD Source Code Description (ICD_DESC_SOURCE_DESC) to filter for the preferred
description. In this example, the NCHS Short description (ICD_DESC_SOURCE_CD = 04) is used.

ICD_CD ICD_CD_TYPE ICD_DESC ICD_DESC_SOURCE_C

D

I87.321 05 05 Chronic venous 04

hypertension w
inflammation of r lo

The FML ICD Source Code Description (ICD_DESC_SOURCE_DESC) is found in the FML ICD
Description Source Description Table (RFMLISD1_ICD_DESC_SOURCE_DESC).

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Retrieving an ICD Codes Associated DxIDs

This application illustrates how to retrieve an input ICD Codes associated DxIDs as a method of entry into any of
the FDB disease decision support or dosing modules.

This application retrieves the DxIDs associated to ICD-9-CM code 401.9 for use in the Drug-Disease
Contraindications Module (DDCM). For illustrative purposes, it also displays descriptive information about the
DxIDs relationship to the ICD Code (either broader, narrower, or equal).

1. Using the given ICD Code as the Search ICD Code (SEARCH_ICD_CD) and the ICD Code Type (
ICD_CD_TYPE), retrieve the following columns from the FML ICD Search Table
(RFMLISR1_ICD_SEARCH):
FML Related DxID column (RELATED_DXID)
FML Clinical Module Code column (FML_CLIN_CODE) - (used in step 2)
FML Navigation Code column (FML_NAV_CODE) - (used in step 3)

SEARCH_ICD_CD ICD_CD_TYPE RELATED_DXID FML_CLIN_CODE FML_NAV_CODE

... ... ... ... ...

401.9 01 00001431 01 02

401.9 01 00001431 02 02

401.9 01 00001431 03 02

401.9 01 00001431 04 02

... ... ... ... ...

The results shown in this step represent a small sample of the ICD Codes full result set.

2. Filter the results of step 1 on the FML_CLIN_CODE column, which identifies the RELATED_DXIDs
disease decision support or dosing module. After filtering for FML_CLIN_CODE value of 03 (DDCM
module), the resulting RELATED_DXID values are appropriate for use in DDCM. See the
FML_CLIN_CODE_DESC columns data dictionary description for information about the different
FML_CLIN_CODE values.

SEARCH_ICD_CD ICD_CD_TYPE RELATED_DXID FML_CLIN_CODE FML_NAV_CODE

401.9 01 00000505 03 02

401.9 01 00001432 03 01

401.9 01 00001435 03 02

401.9 01 00001436 03 02

401.9 01 00001441 03 02

401.9 01 00001442 03 02

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401.9 01 00001444 03 02

401.9 01 00001594 03 03

401.9 01 00002540 03 02

401.9 01 00002541 03 02

401.9 01 00002542 03 02

401.9 01 00002543 03 02

401.9 01 00004739 03 02

401.9 01 00013484 03 03

3. Retrieve the FML_NAV_CODEs FML Navigation Code Description (FML_NAV_CODE_DESC) using the
FML Navigation Description Table (RFMLNVD0_NAVIGATION_DESC). The FML_NAV_CODE field can
be used to assist in constructing Disease Contraindication Alert messages (recall that this examples
results have been filtered for the DDCM module). The following table shows this examples result set of
DxIDs and their descriptive text.

ExampleDxID values associated to ICD-9-CM 401.9 for use in the DDCM module

SEARCH_ICD_ ICD_CD_TYPE RELATED_DXI DXID_DESC56 FML_NAV_CO FML_NAV_CO

CD D DE DE_DESC

401.9 01 00001432 Hypertension 01 Equal

401.9 01 00000505 Pheochromocyto 02 Broader

ma

401.9 01 00001435 Severe 02 Broader

Uncontrolled
Hypertension

401.9 01 00001436 Mild 02 Broader

Hypertension

401.9 01 00001441 Hypertension 02 Broader

due to Aortic
Coarctation

401.9 01 00001442 Hypertension 02 Broader

due to
Arteriovenous
Shunt

401.9 01 00001444 Hypertensive 02 Broader

Cardio-Renal
Disease

401.9 01 00002540 Pregnancy-Induc 02 Broader

ed Hypertension

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401.9 01 00002541 Mild 02 Broader

Pre-Eclampsia

401.9 01 00002542 Severe 02 Broader

Pre-Eclampsia

401.9 01 00002543 Eclampsia of 02 Broader

Pregnancy

401.9 01 00004739 Moderate 02 Broader

Hypertension

401.9 01 00001594 Disease of 03 Narrower

Cardiovascular
System

401.9 01 00013484 Increased 03 Narrower

Cardiovascular
Event Risk

The FML_NAV_CODE is not meant to filter results, but for use in constructing alert messages. For
an illustrated example of how the FML_NAV_CODE should be used, see the DDCM modules
application Comparing Patient ICD Codes to Prospective Drug TherapyUsing the Exclusion
Table to Reduce Alerts.

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Retrieving the Billable Dates for a Given ICD Code

FML 2.0 provides billable dates for ICD codes that are currently billable, were previously billable, or will be billable
in accordance with the billable dates published annually by the Centers for Medicare and Medicaid Services
(CMS). This application illustrates how to retrieve the billable dates for an ICD Code, allowing for both current and
retrospective billing analysis of an ICD code or group of ICD codes.

To view the billable dates for a given ICD code:

1. Select the ICD First Billable Date and the ICD Last Billable Date from the FML ICD Billable History Table
for the given ICD code and ICD code type.

2. Filter and sort the resulting records. Perform analysis according to your business needs.
If you wish to determine whether the ICD Code is billable for a specified date of service, check
whether the billable date range of the ICD code encompasses the specified date.
If you are performing other historical billing analysis, filter and sort the resulting records and perform
analysis according to your business needs.

ExampleDetermining Whether an ICD Code is Billable

For purposes of demonstrating this application, the following scenario is used: A hospital billing clerk is
following up on an unpaid medical claim from date of service November 21, 2014 for a patient who was
diagnosed with Salmonella infection, unspecified (ICD_CD = A02.9). The clerk wants to check whether the
ICD-10-CM on the claim is billable for the given date of service.

1. Select the following from the FML ICD Billable History Table (RFMLIBH0_ICD_BILLABLE_HIST):
ICD First Billable Date (ICD_FIRST_BILLABLE_DT)
ICD Last Billable Date (ICD_LAST_BILLABLE_DT)
where:
ICD Code (ICD_CD) value equals A02.9
ICD Code Type (ICD_CD_TYPE) equals 05 (ICD10CM)

ICD_CD ICD_CD_TYPE ICD_FIRST_BILLABLE ICD_LAST_BILLABLE

_DT _DT

A02.9 05 20141001

ICD Codes that have an ICD_FIRST_BILLABLE_DT value may not have a

ICD_LAST_BILLABLE_DT value. This indicates that the code is still billable.

2. The date of service for the ICD-10-CM code occurs after the ICD_FIRST_BILLABLE_DT, and there is no
ICD_LAST_BILLABLE_DT listed. In this example, the ICD-10-CM code is billable.

ExampleViewing the Billable History of an ICD-10-CM Code

For purposes of demonstrating this application, the following scenario is used: A hospital is performing
retrospective billing analysis regarding their diabetes patients. The hospital billing staff pulls all patient records

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from the past five years that include any ICD-10-CM codes related to diabetes. They would like to check whether
those codes were billable in each year.

1. Query the FML ICD Code Description Table (RFMLINM1_ICD_DESC) for all ICD codes that are related to
diabetes and where the ICD Code Type (ICD_CD_TYPE) column equals the value of 05 (indicating
ICD-10-CM).

ICD_CD ICD_CD_TYPE ICD_DESC

E08.01 05 Diabetes mellitus due to underlying

condition with hyperosmolarity with
coma

E09.36 05 Drug or chemical induced diabetes

mellitus with diabetic cataract

E10.649 05 Type 1 diabetes mellitus with

hypoglycemia without coma

E11.36 05 Type 2 diabetes mellitus with

diabetic cataract

E11.621 05 Type 2 diabetes mellitus with foot

ulcer

E13.00 05 Other specified diabetes mellitus

E23.2 05 Diabetes insipidus

O24.419 05 Gestational diabetes mellitus in

pregnancy, unspecified control

P70.2 05 Neonatal diabetes mellitus

Z13.1 05 Encounter for screening for diabetes

mellitus

Z83.3 05 Family history of diabetes mellitus

The data above reflects a summary of this steps results.

2. Using the records found in the previous step, select the ICD First Billable Date (
ICD_FIRST_BILLABLE_DT) and the ICD Last Billable Date (ICD_LAST_BILLABLE_DT) from the FML ICD
Billable History Table (RFMLIBH0_ICD_BILLABLE_HIST).

ICD_CD ICD_CD_TYPE ICD_FIRST_BILLABLE_ ICD_LAST_BILLABLE_D

DT T

E08.01 05 20130101

E09.36 05 20061231

E10.649 05 20091231

E11.36 05 20061231

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E11.621 05 20130101

E13.00 05 20130101

E23.2 05 20130101

O24.419 05 20061231

P70.2 05 20130101

Z13.1 05 20130101

Z83.3 05 20130101

The data above reflect a summary of this steps results. Additionally, the example dates provided in this
application are for the purposes of demonstrating how to filter for historical analysis.

ICD Codes that have an ICD_FIRST_BILLABLE_DT value may not have a

ICD_LAST_BILLABLE_DT value. This indicates that the code is still billable.

3. Filter the resulting records for those ICD-10 codes that were billable within the past five years and perform
analysis according to your business needs.

ICD_CD ICD_CD_TYPE ICD_FIRST_BILLABLE_ ICD_LAST_BILLABLE_D

DT T

E08.311 20061231

E09.36 20061231

E10.649 20091231

E11.36 20061231

E11.649 20091231

O24.419 20061231

O24.429 20061231

O24.439 20061231

The data above reflect a summary of this steps results. Additionally, the example dates provided in this
application are for the purposes of demonstrating how to filter for historical analysis.

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Using FML with Other Modules

The following FDB Disease Decision Support and Dosing modules utilize the FML Disease Identifier (DxID)
Search Table and other data from the FDB Medical Lexicon:

Dosage Range Check Module (DRCM)

Neonatal and Infant Dosage Range Check Module (NEOM)
Indications Module (INDM)
Drug-Disease Contraindications Module (DDCM)
Side Effects Module (SIDE)
Prescriber Order Entry Module (POEM)

These related modules are listed below with hyperlinks to the respective applications.

Using FML in the Dosage Range Check Module (DRCM)

DRCM uses the FDB Medical Lexicon in the following application: Performing Dosage Range Checking Using a
DxID or ICD Code

Using FML in the Neonatal and Infant Dosage Range Check Module (NEOM)

NEOM uses the FDB Medical Lexicon in the following applications:

Performing Dosage Range Checking

Using FML in the Prescriber Order Entry Module (POEM)

POEM uses the FDB Medical Lexicon in the following applications:

Retrieving Dosage Orders for Related Disease States

Using FML in the Side Effects Module (SIDE)

SIDE uses the FDB Medical Lexicon in the following applications:

Detecting Additive Side Effects

Comparing Side Effects to Current Patient Conditions

Using FML in the Drug-Disease Contraindications Module (DDCM)

DDCM uses the FDB Medical Lexicon in the following applications:

Comparing Patient ICD Codes to Prospective Drug TherapyUsing the Exclusion Table to Reduce Alerts

Comparing Patient DxIDs to Prospective Drug Therapy

Checking Inferred Patient Diagnoses for Drug-Disease Contraindications Associated with Prospective Drug
Therapy

Using FML in the Indications Module (INDM)

INDM uses the FDB Medical Lexicon in the following applications:

Retrieving a Drugs List of Indications

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Retrieving Drugs Indicated for a Selected ConditionUsing the Exclusion Table to Refine the Treatment Options

Checking Inferred Patient Diagnoses for Drug-Disease Contraindications Associated with Prospective Drug
Therapy

Detecting Possible Drug-Related Iatrogenic Diseases

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FML ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

FDB Medical Lexicon Tables

FDB Medical Lexicon ERD

FDB Medical Lexicon Tables

FML Clinical Module Description Table
FML Disease Duration Description Table
FML Disease Identifier (DxID) Navigation Table
FML Disease Identifier (DxID) Replacement History Table
FML Disease Identifier (DxID) Search Table
FML Disease Identifier (DxID) Status Code Description Table
FML Disease Identifier (DxID) Synonym Table
FML Disease Identifier (DxID) Table
FML ICD All Descriptions Table
FML ICD Billable Description Table
FML ICD Billable History Table
FML ICD Code Description Table
FML ICD Code Type Description Table
FML ICD Description Source Description Table
FML ICD Search Exclusion Table
FML ICD Search Table
FML ICD Status Description Table
FML Navigation Description Table
FML Synonym Name Type Description Table
FML Synonym Status Description Table

FDB Medical Lexicon ERD

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FML Clinical Module Description Table

Table Name RFMLCMD0_CLIN_MOD_DESC

Revision Activity add.03-14-2002

Purpose Relates the Clinical Module Code to its text description.

Key Column Name Column Format Length Picture

Description

P FML_CLIN_COD FML Clinical AN 2 X(2)

E Module Code

FML_CLIN_COD FML Clinical AN 50 X(50)

E_DESC Module Code
Description

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FML Disease Duration Description Table

Table Name RFMLDDD0_DX_DURATION_DESC

Revision Activity add.03-14-2002

Purpose Relates the DxID Disease Duration Code to its text

description.

Key Column Name Column Format Length Picture

Description

P DXID_DISEASE_ FML Disease AN 1 X(1)

DURATION_CD Duration Code

DXID_DISEASE_ FML Disease AN 50 X(50)

DURATION_CD_ Duration Code
DESC Description

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FML Disease Identifier (DxID) Navigation Table

Table Name RFMLNAV0_DXID_NAVIGATION

Revision Activity add.03-14-2002

Purpose Links a disease state to a broader disease state.

Key Column Name Column Format Length Picture

Description

PF DXID FML Disease N 8 9(8)

Identifier (Stable
ID)

P BROADER_DXID FML Broader N 8 9(8)

DxID

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FML Disease Identifier (DxID) Replacement History Table

Table Name RFMLDRH0_DXID_HIST

Revision Activity add.03-14-2002

Purpose Tracks the replacement history for a disease state.

Key Column Name Column Format Length Picture

Description

PF FMLPRVDXID FML Previous N 8 9(8)

DxID

P FMLREPDXID FML Replacement N 8 9(8)

DxID

FMLDXREPDT FML DxID N 8 9(8)

Replacement
Date

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FML Disease Identifier (DxID) Search Table

Table Name RFMLDSR0_DXID_SEARCH

Revision Activity add.03-14-2002

Purpose Links disease states within a given Disease Decision

Support or Dosing module.

Key Column Name Column Format Length Picture

Description

PF SEARCH_DXID FML Search DxID N 8 9(8)

N

PF RELATED_DXID FML Related DxID N 8 9(8)

PF FML_CLIN_COD FML Clinical AN 2 X(2)

E Module Code

F FML_NAV_CODE FML Navigation AN 2 X(2)

Code

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FML Disease Identifier (DxID) Status Code Description Table

Table Name RFMLSCD0_DXID_STATUS_DESC

Revision Activity add.03-14-2002

Purpose Relates the DxID Status Code to its text description.

Key Column Name Column Format Length Picture

Description

P DXID_STATUS FML DxID Status AN 1 X(1)

Code

DXID_STATUS_D FML DxID Status AN 50 X(50)

ESC Code Description

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FML Disease Identifier (DxID) Synonym Table

Table Name RFMLSYN0_DXID_SYN

Revision Activity add.03-14-2002

Purpose Associates professional synonyms, primary layman names,

layman synonyms, and abbreviations to a disease state.

Key Column Name Column Format Length Picture

Description

P DXID_SYNID FML Synonym N 8 9(8)

Identifier (Stable
ID)

F DXID FML Disease N 8 9(8)

Identifier (Stable
ID)

F DXID_SYN_NMT FML Name Type AN 2 X(2)

YP Code

DXID_SYN_DES FML 56-character AN 56 X(56)

C56 Synonym
Description

DXID_SYN_DES FML AN 100 X(100)

C100 100-character
Synonym
Description

F DXID_SYN_STAT FML Synonym AN 1 X(1)

US Identifier Status
Code

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FML Disease Identifier (DxID) Table

Table Name RFMLDX0_DXID

Revision Activity add.03-14-2002

Purpose Associates a primary professional name(s) to a disease

state.

Key Column Name Column Format Length Picture

Description

P DXID FML Disease N 8 9(8)

Identifier (Stable
ID)

DXID_DESC56 FML 56-character AN 56 X(56)

Description

DXID_DESC100 FML AN 100 X(100)

100-character
Description

F DXID_STATUS FML DxID Status AN 1 X(1)

Code

F FDBDX First Databank AN 9 X(9)

Disease Code

F DXID_DISEASE_ FML Disease AN 1 X(1)

DURATION_CD Duration Code

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FML ICD All Descriptions Table

Table Name RFMLIAD0_ICD_ALL_DESC

Revision Activity add.11-01-2012

Purpose Provides all of the descriptions for a given ICD code.

Key Column Name Column Format Length Picture

Description

PF ICD_CD International AN 10 X(10)

Classification of
Diseases Code

PF ICD_CD_TYPE ICD Code Type AN 2 X(2)

PF ICD_DESC_SOU ICD Description AN 2 X(2)

RCE_CD Source Code

ICD_DESC International AN 500 X(500)

Classification of
Diseases Code
Description

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FML ICD Billable Description Table

Table Name RFMLIBD0_ICD_BILLABLE_DESC

Revision Activity add.11-01-2012

Purpose Relates the ICD Billable Indicator to its text description.

Key Column Name Column Format Length Picture

Description

P ICD_BILLABLE_I ICD Billable N 1 9(1)

ND Indicator

ICD_BILLABLE_I ICD Billable AN 50 X(50)

ND_DESC Indicator
Description

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FML ICD Billable History Table

Table Name RFMLIBH0_ICD_BILLABLE_HIST

Revision Activity add.11-01-2012

Purpose Provides the history of the billable status of the ICD Code.

Key Column Name Column Format Length Picture

Description

PF ICD_CD International AN 10 X(10)

Classification of
Diseases Code

PF ICD_CD_TYPE ICD Code Type AN 2 X(2)

P ICD_FIRST_BILL ICD First Billable N 8 9(8)

ABLE_DT Date

ICD_LAST_BILLA ICD Last Billable N 8 9(8)

BLE_DT Date

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FML ICD Code Description Table

Table Name RFMLINM1_ICD_DESC

Revision Activity rev.11-01-2012

Purpose Relates an ICD code to its text description and other

attributes.
First Databank (FDB) provides both long and short
ICD-10 descriptions from the National Center for Health
Statistic (NCHS), however this table uses the long
description. If you prefer to display the short description,
navigate to the FML ICD All Descriptions Table (RFMLIAD0
_ICD_ALL_DESC) and select the record where the ICD
Description Source Code (ICD_DESC_SOURCE_CD)
equals 04.

Key Column Name Column Format Length Picture

Description

P ICD_CD International AN 10 X(10)

Classification of
Diseases Code

PF ICD_CD_TYPE ICD Code Type AN 2 X(2)

ICD_DESC International AN 500 X(500)

Classification of
Diseases Code
Description

F ICD_DESC_SOU ICD Description AN 2 X(2)

RCE_CD Source Code

F ICD_STATUS_CD ICD Status Code AN 1 X(1)

AN

ICD_FIRST_DT ICD First Date N 8 9(8)

ICD_LAST_DT ICD Last Date N 8 9(8)

F ICD_BILLABLE_I ICD Billable N 1 9(1)

ND Indicator

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FML ICD Code Type Description Table

Table Name RFMLITD1_ICD_CD_TYPE_DESC

Revision Activity rev.11-01-2012

Purpose Relates the ICD Code Type to its text description.

Key Column Name Column Format Length Picture

Description

P ICD_CD_TYPE ICD Code Type AN 2 X(2)

ICD_CD_TYPE_D ICD Code Type AN 50 X(50)

ESC Description

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FML ICD Description Source Description Table

Table Name RFMLISD1_ICD_DESC_SOURCE_DESC

Revision Activity rev.11-01-2012

Purpose Relates the ICD Source Code to its text description.

Key Column Name Column Format Length Picture

Description

P ICD_DESC_SOU ICD Description AN 2 X(2)

RCE_CD Source Code

ICD_DESC_SOU ICD Source Code AN 50 X(50)

RCE_DESC Description

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FML ICD Search Exclusion Table

Table Name RFMLISX0_ICD_SEARCH_EXCLUSION

Revision Activity add.11-01-2012

Purpose Provides filtering for ICD Code search results to support

more refined clinical screening results.

Key Column Name Column Format Length Picture

Description

PF SEARCH_ICD_C Search ICD Code AN 10 X(10)

D

PF ICD_CD_TYPE ICD Code Type AN 2 X(2)

PF RELATED_DXID Related DxID N 8 9(8)

PF FML_CLIN_COD FML Clinical AN 2 X(2)

E Module Code

P CLIN_DRUG_GR Clinical Drug N 5 9(5)

OUP Group

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FML ICD Search Table

Table Name RFMLISR1_ICD_SEARCH

Revision Activity rev.11-01-2012

Purpose Links a disease state to a health-related condition.

Key Column Name Column Format Length Picture

Description

PF SEARCH_ICD_C Search ICD Code AN 10 X(10)

D

PF ICD_CD_TYPE FML ICD Code AN 2 X(2)

Type

PF RELATED_DXID Related DxID N 8 9(8)

PF FML_CLIN_COD FML Clinical AN 2 X(2)

E Module Code

F FML_NAV_CODE FML Navigation AN 2 X(2)

Code

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FML ICD Status Description Table

Table Name RFMLCSD0_ICD_STATUS_DESC

Revision Activity add.11-01-2012

Purpose Relates the ICD Status Code to its text description.

Key Column Name Column Format Length Picture

Description

P ICD_STATUS_CD ICD Status Code AN 1 X(1)

ICD_STATUS_DE ICD Status Code AN 50 X(50)

SC Description

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FML Navigation Description Table

Table Name RFMLNVD0_NAVIGATION_DESC

Revision Activity add.03-14-2002

Purpose Relates the Navigation Code to its text description.

Key Column Name Column Format Length Picture

Description

P FML_NAV_CODE FML Navigation AN 2 X(2)

Code

FML_NAV_CODE ML Navigation AN 50 X(50)

_DESC Code Description

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FML Synonym Name Type Description Table

Table Name RFMLSND0_SYN_NAME_TYPE_DESC

Revision Activity add.03-14-2002

Purpose Relates the DxID Synonym Name Type Code to its text
description.

Key Column Name Column Format Length Picture

Description

P DXID_SYN_NMT FML Name Type AN 2 X(2)

YP Code

DXID_SYN_NMT FML Name Type AN 50 X(50)

YP_DESC Code Description

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FML Synonym Status Description Table

Table Name RFMLSSD0_SYN_STATUS_DESC

Revision Activity add.03-14-2002

Purpose Relates the Synonym Identifier Status Code to its text

description.

Key Column Name Column Format Length Picture

Description

P DXID_SYN_STAT FML Synonym AN 1 X(1)

US Identifier Status
Code

DXID_SYN_STAT FML Synonym AN 50 X(50)

US_DESC Identifier Status
Code Description

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First Databank Medical Test Lexicon (MTL) 1.0

General Information
First Databank Medical Test Lexicon Editorial Policies
Applications
ERD and Technical Specifications

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General Information
The General Information section contains high-level information about the module.

Overview
Definitions
Analyte
Clinical Laboratory Test
Drug-Lab Interference
LOINC
Method
Panel
Reagent
Specimen
Concepts
LAB_ID
MTL_ANALYTE_ID
MTL_EXTRN_VOCAB_TYP_CODE
MTL_LAB_ID_SYNID
MTL_METHOD_ID
MTL_PANEL_ID
MTL_SPECIMEN_ID
MTL_SPEC_LAB_ID

Overview
First Databank Medical Test Lexicon (MTL) provides a laboratory test vocabulary for laboratory test names,
specimen types, and laboratory test method descriptions.

MTL uses Good Vocabulary Practice because it is a concept-based vocabulary with a synonym file. MTL
concepts have hierarchical relationships and are associated to dumb numbers that serve as stable identifiers.
These stable identifiers have a retirement and replacement history mechanism that will always link them to MTL
data.

Drug knowledge is aggregated at the Clinical Formulation ID (GCN_SEQNO), Routed Medication ID (

ROUTED_MED_ID), and the Routed Generic ID (ROUTED_GEN_ID) levels in the First Databank (FDB)
knowledge base. Under certain circumstances, aggregated drug knowledge may not apply to all related
packaged products; more specific information may be found within product labels.

Definitions
This section describes concepts and database elements that are important for understanding the module.

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Analyte

An analyte is any substance that is measured via a laboratory test.

For example, fasting glucose is the analyte in a blood glucose laboratory test. MTL_ANALYTE_ID represents an
analyte.

Clinical Laboratory Test

A clinical laboratory test is used to analyze or measure a chemical or biological substance from the body.

For example, a blood glucose test measures the amount of glucose (sugar) in the blood so that blood glucose
levels can be monitored for a diabetic patient.

Drug-Lab Interference

The term drug-lab interference in the context of FDB knowledge bases strictly refers to an analytic interference
causing erroneous or false clinical laboratory test results.

See Drug-Lab Interference Module (DLIM ) 2.0 for additional information.

LOINC

LOINC (Logical Observation Identifiers Names and Codes) is an external laboratory vocabulary that provides a
standard set of universal names and codes for identifying individual laboratory and clinical results.

MTL concepts are mapped to a subset of LOINC identifiers. The purpose of this mapping is to ensure that the
relevant subset of LOINC codes used in patient medical records can trigger FDBs Laboratory Decision Support
for DLIM.

Method

Method describes the reagent, equipment, or process used to measure or assess the presence of the analyte in a
laboratory test.

For example, a blood glucose laboratory test could use several different methods, such as the glucose oxidase
method or glucose dehydrogenase method. MTL_METHOD_ID represents a method.

Panel

A panel is a group of laboratory tests ordered together under a single description.

A Chem 7 Panel includes a random glucose test as well as blood urea nitrogen, chloride, creatinine, potassium,
and sodium tests. MTL_PANEL_ID represents a panel.

Reagent

A reagent is a substance used during a laboratory test procedure to produce a chemical reaction in order to
detect or measure other substances (analytes). Reagents sometimes help define specific lab test methods.

For example, the hexokinase enzyme used in a random glucose test is a reagent.

Specimen

A specimen is the bodily substance or fluid that contains the analyte that will be measured or assessed via a

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laboratory test. The specimen is obtained from a given patient and sent to the clinical laboratory for testing.
For example, in the blood glucose test example, blood is the specimen that contains the analyte, fasting glucose.
MTL_SPECIMEN_ID represents a specimen.

Concepts
This section describes concepts and database elements that are important for understanding the module.

LAB_ID

The Laboratory Test Identifier (LAB_ID) identifies the lab test abstraction that includes the analyte and specimen.
For example, LAB_ID 10 identifies a serum potassium laboratory test; serum is the specimen and potassium is
the analyte.

The Laboratory Test Identifier Description (MTL_LAB_ID_DESC) is structured in natural language word order for
ease of readability when displayed to the user. For example, Serum Potassium instead of Potassium, Serum is
displayed to the user.

The primary professional name is provided by default; however, professional synonyms, primary layman names,
layman synonyms, and abbreviations may be retrieved from the MTL Laboratory Test Identifier (LAB_ID)
Synonym Identifier Table (RMTLSYN0_LAB_ID_SYN).

LAB_IDs are created for and assigned to laboratory tests associated with MTL_SPEC_LAB_ID that are
necessary to support DLIM.

A LAB_ID is a stable identifier. It can be retired or replaced, but never deleted. The MTL Laboratory Test Identifier
(LAB_ID) Replacement History Table (RMTLLRH0_LAB_ID_HIST) provides the change history for a LAB_ID,
including the Previous Laboratory Test Identifier (MTL_PREV_LAB_ID) and the Replacement Laboratory Test
Identifier (MTL_REPL_LAB_ID).

MTL_ANALYTE_ID

The Analyte Identifier (MTL_ANALYTE_ID) identifies the substance measured via the laboratory test. For
example, MTL_ANALYTE_ID 228 identifies potassium, which is the analyte in a serum potassium test. A single
professional description is provided for each analyte.

MTL_EXTRN_VOCAB_TYP_CODE

The External Vocabulary Type Code (MTL_EXTRN_VOCAB_TYP_CODE) identifies the external laboratory
vocabulary that MTL links to. Specifically, MTL concepts (LAB_ID, MTL_PANEL_ID, or MTL_SPEC_LAB_ID) are
mapped to a subset of LOINC identifiers. The purpose of this mapping is to ensure that the relevant subset of
LOINC codes used in patient medical records can trigger FDBs Laboratory Decision Support for DLIM.

LOINC is characterized by the following:

LOINC is an external laboratory vocabulary that provides a standard set of universal names and codes for
identifying individual laboratory and clinical results.
LOINC can be used to document electronic medical records and to transfer results electronically.

MTL_LAB_ID_SYNID

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The Laboratory Test Identifier Synonym Identifier (MTL_LAB_ID_SYNID) identifies a synonym name for a
LAB_ID. Professional synonyms, primary layman names, layman synonyms, and abbreviations may be provided.

For example, Serum K+ is the professional synonym for a serum potassium test.

MTL_METHOD_ID

The Methodology Identifier (MTL_METHOD_ID) identifies the reagent, equipment, or process used to measure or
provide an assessment of the analyte. For example, MTL_METHOD_ID 22 identifies ion specific electrode, which
is a method that can be used in a serum potassium test.

A single professional description is provided for each method.

MTL data includes those specific methods that are known to be involved in drug-lab interferences, as well as
alternative methods useful today in clinical practice.

MTL_PANEL_ID

The Panel Identifier (MTL_PANEL_ID) associates a set of labs usually ordered together under a single name for
the convenience of the prescribers and to optimize the cost-effectiveness and completeness of testing. Ordering
or screening for a panel may be faster than ordering or screening each laboratory test in a panel. For example, a
Renal Function Profile (PANEL_ID 6) includes a serum potassium test (LAB_ID 10), serum chloride (LAB_ID 17),
serum creatinine (LAB_ID 32), and several others.

A PANEL_ID is a stable identifier. When a laboratory test (LAB_ID) is removed from a panel, the MTL_PANEL_ID
must be retired or replaced, but not deleted. The MTL Panel Identifier Replacement History Table
(RMTLPRH0_PANEL_ID_HIST) provides the change history for a PANEL_ID, including the Replacement Panel
Identifier (MTL_REPL_PANEL_ID) and the Previous Panel Identifier (MTL_PREV_PANEL_ID).

Other than universal CMS-approved panels, panels are not standardized from institution to institution, so a panel
at one institution wont necessarily identify the same set of labs in a panel at another institution.

If a clinical laboratory uses a panel that does not correspond to a PANEL_ID in MTL data, the individual
laboratory tests that make up the panel can be cross-referenced to the appropriate MTL data.

PANEL_IDs can be cross-referenced to the appropriate LOINC code for interoperability purposes.

MTL_SPECIMEN_ID

The Specimen Identifier (MTL_SPECIMEN_ID) identifies the bodily source of the analyte measured via the
laboratory test. For example, MTL_SPECIMEN_ID 3 identifies serum, which is the specimen in a serum
potassium test. Potassium is the analyte.

A single professional description is provided for each specimen.

MTL_SPEC_LAB_ID

The Specific Laboratory Identifier (MTL_SPEC_LAB_ID) identifies the laboratory test that includes the analyte,
the specimen, and the methodology used to measure the related laboratory test. The MTL_SPEC_LAB_ID
represents the analyte, specimen, and method. For example, MTL_SPEC_LAB_ID 350 identifies a serum
potassium test that uses an ion specific electrode as the method.

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An MTL_SPEC_LAB_ID is a stable identifier. It can be retired or replaced, but not deleted. The MTL Specific
Laboratory Test ID Replacement History Table (RMTLSRH0_SPECIFIC_LAB_ID_HIST) provides the change
history for a MTL_SPEC_LAB_ID, including the Previous Specific Laboratory Test Identifier (
MTL_PREV_SPEC_LAB_ID) and the Replacement Specific Laboratory Test Identifier (
MTL_REPL_SPEC_LAB_ID).

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First Databank Medical Test Lexicon Editorial Policies

The policies and criteria that apply to the scope, processes, and sources of the MTL module are provided in the
following sections:

Scope
Limitations
Editorial Process
Sources

Scope
First Databank Medical Test Lexicon (MTL) is a controlled vocabulary developed by FDB for the specific purpose
of supporting the population of drug-lab interference records in the Drug-Lab Interference Module (DLIM ) 2.0
. Therefore, customers such as hospitals, pharmacies, physicians, and clinical laboratories use MTL in
conjunction with DLIM to identify drugs that may falsely alter laboratory test results.

MTL concepts are mapped to a subset of LOINC (Logical Observation Identifiers Names and Codes) identifiers,
a comprehensive standard laboratory test result vocabulary. The purpose of this mapping is to ensure that the
relevant subset of LOINC codes used in patient medical records can trigger FDBs laboratory decision support
using DLIM.

Limitations
MTL does not provide a comprehensive listing of laboratory tests to be ordered or laboratory test results. In
addition, MTL may not provide all potential alternative test methods when interferences do occur.

MTL does not provide reference range values for laboratory tests and specimens.

Institutions should not use MTL identifiers to electronically code patient records. Institutions must use an external
vocabulary (such as LOINC) for this purpose. LOINC provides a standard set of universal names and codes for
identifying individual laboratory and clinical results, which allows for integration with existing systems using
LOINC. MTL identifiers, which are not as comprehensive as LOINC, are not intended to replace LOINC.

Editorial Process
The following section describes the processes and criteria the clinical editors use to add or review database
elements.

MTL includes commonly ordered laboratory tests that have analytic drug-related interferences associated with
them, as supported by good evidence. Lab tests used for Therapeutic Drug Monitoring (TDM) are included in
MTL. TDM tests are used to measure drug concentrations, for example serum digoxin.

Sources
This section lists sources used by FDB to compile the information contained in the module.

FDB utilizes many reference sources including, but not limited to, the primary medical literature (e.g., published
journal articles), medical reference texts, published expert treatment guidelines, and manufacturer product

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package inserts. FDB uses current source editions or versions when coding and updating data, as well as when
researching questions about data. However, a formal data review does not occur for every new release of source
editions or versions. Additional sources include:

FDA CLIA Database. Available at:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm124105.htm
.
Food and Drug Administration. MedWatch: The FDA Safety Information and Adverse Event Reporting
Program. Available at: http://www.fda.gov/Safety/MedWatch/default.htm.
Health Canada, Advisories for Health Professional. Available at:
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/index_e.html.
Jacobs DS, DeMott WR, Oxley DK, eds. Jacobs & DeMott Laboratory Test Handbook with Keyword Index.
Kaplan LA, Pesce AJ, Kazmierczak S, eds. Clinical Chemistry Theory, Analysis, Correlation.
Logical Observation Identifiers Names and Codes (LOINC) [database].
Product package inserts.
Salway JG, ed. Drug-Test Interactions Handbook.
Young D. Effects of Drugs on Clinical Laboratory Tests.

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MTL Applications
This section provides information about the practical application of data contained in this module.

How to Use the FDB Cross-Reference to LOINC

Finding Replacement Identifiers

Finding a Synonym Name for a LAB_ID

Identifying Laboratory Tests in a Panel

Using MTL with the Drug-Lab Interference Module

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How to Use the FDB Cross-Reference to LOINC

MTL concepts are mapped to a subset of LOINC identifiers. The purpose of this mapping is to ensure that lab
tests used in patient medical records can trigger FDBs Laboratory Decision Support for DLIM. This application
assists in integrating DLIM decision support into a health care lab system by illustrating how to map lab system
test codes (for example LOINC codes) to an associated Laboratory Test Identifier ( LAB_ID).

Lab system integration with MTL requires the creation of a mapping between MTL identifiers data and the lab
system's data dictionary. FDBs Cross-Reference to LOINC can be used to integrate the proprietary lab test
codes that may also be linked to LOINC.

There are benefits for mapping proprietary codes of multiple levels of abstraction (for example method
information) to the various MTL identifiers. Unnecessary alerts are avoided, and the mapping allows
applications to deliver institution-specific available alternate lab test methods as part of alert messages.

For purposes of demonstrating this application, the following scenario is used: A clinical laboratory
performs a fasting blood sugar test. The results of the test come back outside of the reference range so the lab
sends the results to the DLIM knowledge base for assessment (see Screening a Laboratory Test for Possible
Drug Interferences in DLIM). The test result can trigger DLIM decision support if the lab system's proprietary code
for fasting blood glucose is mapped to MTL identifiers. The FDB Cross-Reference to LOINC can be used as an
integration tool to facilitate the mapping.

1. Given a proprietary code for fasting blood glucose, find the associated LOINC code(s) in the lab system's
data dictionary. Use this LOINC code or codes to query the MTL External Vocabulary Link Table
(RMTLEVL0_EXT_VOCAB_LINK), using the External Vocabulary Code (MTL_EXTRN_VOCAB_CODE)
field, to retrieve the following: the associated First Databank Identifier (MTL_FDB_ID) with an External
Vocabulary Type Code (MTL_EXTRN_VOCAB_TYP_CODE) of 01 (LOINC) and a First Databank Identifier
Type Code (MTL_FDB_ID_TYP_CODE) of 01 (LAB_ID). In this example there are 11 LOINC codes that
map to a single Fasting Blood Glucose LAB_ID code of 1:

MTL_EXTRN_VOCAB_C MTL_EXTRN_VOCAB_T MTL_FDB_ID_TYP_COD MTL_FDB_ID

ODE YP_CODE E

14743-9 01 01 1

15074-8 01 01 1

2339-0 01 01 1

2340-8 01 01 1

2341-6 01 01 1

2345-7 01 01 1

32016-8 01 01 1

32318-8 01 01 1

5914-7 01 01 1

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6777-7 01 01 1

2. Retrieve the description of the newly found MTL_FDB_ID. In the example the MTL_FDB_ID is a LAB_ID
because its type code is 01, so use the MTL Laboratory Test Identifier (LAB_ID) Table
(RMTLLAB0_LAB_ID) to find the MTL Laboratory Test Identifier Description ( MTL_LAB_ID_DESC) value
for the LAB_ID of 1:

LAB_ID MTL_LAB_ID_DESC

1 Fasting Blood Glucose

3. Finally, use the MTL Specific Laboratory Test Identifier Table (RMTLSLT0_SPECIFIC_LAB_ID) to retrieve
all MTL Specific Laboratory Test Identifiers (MTL_SPEC_LAB_ID) associated with the LAB_ID found
earlier in step 1:

LAB_ID MTL_SPEC_LAB_ID

1 1

1 317

1 318

1 319

1 320

Once the MTL_SPEC_LAB_IDs are retrieved, these IDs can be manually associated with their appropriate
proprietary codes that include method information (i.e. manual mapping step necessary for this level of
abstraction of MTL identifiers).

LOINC codes infrequently include method information. When available, these more specific LOINC
codes map to the MTL Specific Laboratory Test Identifier (MTL_SPEC_LAB_ID). Use the LOINC
code as the MTL_EXTRN_VOCAB_CODE in the External Vocabulary Link Table (see Step 1
above). The MTL_EXTRN_VOCAB_TYP_CODE should be 01 (LOINC) and
MTL_FDB_ID_TYP_CODE should be 02 (MTL_SPEC_LAB_ID) instead of 01 as shown in the
example. Retrieve the associated MTL_FDB_ID.

LOINC does include panel information and when appropriate may link to the MTL Panel Identifier (
MTL_PANEL_ID), which has a MTL_FDB_ID_TYP_CODE of 03 (MTL_PANEL_ID).

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Finding Replacement Identifiers

MTL provides replacement identifiers for LAB_IDs, Panel Identifiers (MTL_PANEL_IDs), and Specific Laboratory
Test Identifiers (MTL_SPEC_LAB_IDs). This application demonstrates how to find the replacement identifier for a
LAB_ID using the following application, but the same procedure applies to MTL_PANEL_IDs and
MTL_SPEC_LAB_IDs.

For purposes of demonstrating this application, the following scenario is used: A laboratory technician
needs to find the replacement identifier for a laboratory test and the date it was replaced.

1. For a given laboratory test, retrieve the associated LAB_ID from the MTL Laboratory Test Identifier
(LAB_ID) Table (RMTLLAB0_LAB_ID).

2. If the Laboratory Test Identifier Status Code (MTL_LAB_ID_STATUS) is 1 (Replaced), use the initially
selected LAB_ID as the Previous Laboratory Test Identifier (MTL_PREV_LAB_ID) and retrieve the
associated Replacement Laboratory Test Identifier (MTL_REPL_LAB_ID) from the MTL Laboratory Test
Identifier (LAB_ID) Replacement History Table (RMTLLRH0_LAB_ID_HIST).

3. Display the MTL_REPL_LAB_ID and the Laboratory Test Identifier Replacement Effective Date (
MTL_LAB_ID_REPL_EFF_DT).

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Finding a Synonym Name for a LAB_ID

A synonym for a LAB_ID may be specified as a professional synonym, primary layman name, layman synonym,
or abbreviation(s).This application retrieves laboratory test synonym names upon input of a laboratory description
search term or a LAB_ID, using the following application.

For purposes of demonstrating this application, the following scenario is used: Search for synonyms for a
blood glucose laboratory test.

1. For a given laboratory test, query the Laboratory Test Identifier Table, using the Laboratory Test Identifier
Description (MTL_LAB_ID_DESC), and retrieve the associated LAB_ID with the MTL_LAB_ID_STATUS of
0 (Live), as shown in the following example:

MTL_LAB_ID_DESC LAB_ID MTL_LAB_ID_STATUS

Fasting Blood Glucose 1 0

The MTL_LAB_ID_DESC provides the Primary Professional Name.

2. Use the retrieved LAB_ID to find associated names and synonyms:

For Professional Synonym(s), use the MTL Laboratory Test Identifier (LAB_ID) Synonym Identifier
Table (RMTLSYN0_LAB_ID_SYN). Specify 01 for the Laboratory Test Identifier Synonym Name
Type Code (MTL_LAB_ID_SYN_NMTYP_CODE) and retrieve the Laboratory Test Identifier
Synonym Description (MTL_LAB_ID_SYN_CODE_DESC), as shown in the following example:

LAB_ID MTL_LAB_ID_SYN_NMTYP_CO MTL_LAB_ID_SYN_CODE_DES

DE C

1 01 Fasting Blood Glucose

For Primary Layman Name, use the Laboratory Test Identifier Synonym Identifier Table. Specify 02
for MTL_LAB_ID_SYN_NMTYP_CODE and retrieve the MTL_LAB_ID_SYN_CODE_DESC, as
shown in the following example:

LAB_ID MTL_LAB_ID_SYN_NMTYP_CO MTL_LAB_ID_SYN_CODE_DES

DE C

1 02 Fasting Glucose

For Layman Synonym(s), use the Laboratory Test Identifier Synonym Identifier Table. Specify 03 for
MTL_LAB_ID_SYN_NMTYP_CODE and retrieve the MTL_LAB_ID_SYN_CODE_DESC, as shown
in the following example:

LAB_ID MTL_LAB_ID_SYN_NMTYP_CO MTL_LAB_ID_SYN_CODE_DES

DE C

1 03 Fasting Blood Sugar

For Abbreviations, use the Laboratory Test Identifier Synonym Identifier Table. Specify 04 for the

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MTL_LAB_ID_SYN_NMTYP_CODE and retrieve the MTL_LAB_ID_SYN_CODE_DESC, as shown

in the following example:

LAB_ID MTL_LAB_ID_SYN_NMTYP_CO MTL_LAB_ID_SYN_CODE_DES

DE C

1 04 FBG

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Identifying Laboratory Tests in a Panel

This application retrieves a list of the individual laboratory tests in a panel, using the following application.

For purposes of demonstrating this application, the following scenario is used: A laboratory technician
searches for the components of a Renal Function Panel.

1. For a given panel, query the MTL Panel Identifier Table (RMTLPID0_PANEL_ID) using the Panel Identifier
Description (MTL_PANEL_ID_DESC), in this case Renal Function Profile, to retrieve the MTL_PANEL_ID
with a Panel Identifier Status Code (MTL_PANEL_ID_STATUS) of 0 (Live), as shown in the following
example:

MTL_PANEL_ID_DESC MTL_PANEL_ID MTL_PANEL_ID_STATUS

Renal Function Profile 6 0

2. Use the MTL_PANEL_ID to query the MTL Panel to LAB_ID Association Table
(RMTLPLB0_PANEL_LABID_LINK) and retrieve all associated LAB_IDs, as shown in the following
example:

MTL_PANEL_ID_DESC MTL_PANEL_ID LAB_ID

Renal Function Profile 6 6

Renal Function Profile 6 10

Renal Function Profile 6 17

Renal Function Profile 6 20

Renal Function Profile 6 32

Renal Function Profile 6 56

Renal Function Profile 6 238

3. Use the LAB_IDs to query the MTL Laboratory Test Identifier (LAB_ID) Table (RMTLLAB0_LAB_ID) and
retrieve the MTL_LAB_ID_DESC, as shown in the following example:

LAB_ID MTL_LAB_ID_DESC

6 Serum Sodium

10 Serum Potassium

17 Serum Chloride

20 Serum Blood Urea Nitrogen

32 Serum Creatinine

56 Serum Uric Acid

238 Random Serum Glucose

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Using MTL with the Drug-Lab Interference Module

The First Databank Medical Test Lexicon provides a controlled concept-based vocabulary for the Drug-Lab
Interference Module (DLIM). It has the following uses in DLIM:

Provides a LOINC mapping that can be used as an integration tool for lab systems that have LOINC codes
cross referenced to their proprietary lab test codes.
Provides permanent laboratory test identifiers that can be retired or replaced but not deleted.
Provides different name types for laboratory tests.
Provides identifiers and names for methods associated to specific laboratory tests.
Provides identifiers and names for bodily sources of substances measured via laboratory tests.
Provides identifiers and names representative of a set of laboratory tests (panels).

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MTL ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

MTL Tables
First Databank Medical Test Lexicon ERD

MTL Tables
MTL Analyte Identifier Table
MTL External Vocabulary Link Table
MTL External Vocabulary Type Description Table
MTL First Databank Identifier Type Description Table
MTL Laboratory Test Identifier (LAB_ID) Replacement History Table
MTL Laboratory Test Identifier (LAB_ID) Status Code Description Table
MTL Laboratory Test Identifier (LAB_ID) Synonym Identifier Table
MTL Laboratory Test Identifier (LAB_ID) Synonym Name Type Description Table
MTL Laboratory Test Identifier (LAB_ID) Synonym Status Description Table
MTL Laboratory Test Identifier (LAB_ID) Table
MTL Methodology Identifier Table
MTL Panel Identifier Replacement History Table
MTL Panel Identifier Table
MTL Panel ID Status Code Description Table
MTL Panel to LAB_ID Association Table
MTL Specific Laboratory Test Identifier Table
MTL Specific Laboratory Test ID Replacement History Table
MTL Specific Laboratory Test ID Status Code Description Table
MTL Specimen Identifier Table

First Databank Medical Test Lexicon ERD

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MTL Analyte Identifier Table

Table Name RMTLAID0_ANALYTE_ID

Revision Activity add.07-01-2003

Purpose Relates an Analyte Identifier to its primary professional text

description.

Key Column Name Column Format Length Picture

Description

P MTL_ANALYTE_I MTL Analyte N 8 9(8)

D Identifier

MTL_ANALYTE_I MTL Analyte AN 50 X(50)

D_DESC Identifier
Description

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MTL External Vocabulary Link Table

Table Name RMTLEVL0_EXT_VOCAB_LINK

Revision Activity add.07-01-2003

Purpose Presents mapping or cross-reference information from FDB

laboratory concepts to external vocabularies.

Key Column Name Column Format Length Picture

Description

PF MTL_EXTRN_VO MTL External AN 2 X(2)

CAB_TYP_CODE Vocabulary Type
Code

PF MTL_EXTRN_VO MTL External AN 20 X(20)

CAB_CODE Vocabulary Code

PF MTL_FDB_ID_TY MTL First AN 2 X(2)

P_CODE Databank
Identifier Type
Code

P MTL_FDB_ID MTL First N 8 9(8)

Databank
Identifier

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MTL External Vocabulary Type Description Table

Table Name RMTLVTD0_EXT_VOCAB_TYP_DESC

Revision Activity add.07-01-2003

Purpose Relates the External Vocabulary Type Code to its text

description.

Key Column Name Column Format Length Picture

Description

P MTL_EXTRN_VO MTL External AN 2 X(2)

CAB_TYP_CODE Vocabulary Type
Code

MTL_EXTRN_VO MTL External AN 50 X(50)

CAB_TYP_CODE Vocabulary Type
_DESC Code Description

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MTL First Databank Identifier Type Description Table

Table Name RMTLITD0_FDB_ID_TYP_DESC

Revision Activity add.07-01-2003

Purpose Relates the First Databank Identifier Type Code to its text
description.

Key Column Name Column Format Length Picture

Description

P MTL_FDB_ID_TY MTL First AN 2 X(2)

P_CODE Databank
Identifier Type
Code

MTL_FDB_ID_TY MTL First AN 50 X(50)

P_CODE_DESC Databank
Identifier Type
Code Description

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MTL Laboratory Test Identifier (LAB_ID) Replacement History Table

Table Name RMTLLRH0_LAB_ID_HIST

Revision Activity add.07-01-2003

Purpose Tracks the replacement history for a laboratory or

assessment concept.

Key Column Name Column Format Length Picture

Description

PF MTL_PREV_LAB MTL Previous N 8 9(8)

_ID Laboratory Test
Identifier

PF MTL_REPL_LAB_ MTL Replacement N 8 9(8)

ID Laboratory Test
Identifier

MTL_LAB_ID_RE MTL Laboratory N 8 9(8)

PL_EFF_DT Test Identifier
Replacement
Effective Date

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MTL Laboratory Test Identifier (LAB_ID) Status Code Description Table

Table Name RMTLLSD0_LAB_ID_STATUS_DESC

Revision Activity add.07-01-2003

Purpose Relates the Laboratory Test Identifier Status Code to its text
description.

Key Column Name Column Format Length Picture

Description

P MTL_LAB_ID_ST MTL Laboratory AN 1 X(1)

ATUS Test Identifier
Status Code

MTL_LAB_ID_ST MTL Laboratory AN 50 X(50)

ATUS_DESC Test Identifier
Status Code
Description

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MTL Laboratory Test Identifier (LAB_ID) Synonym Identifier Table

Table Name RMTLSYN0_LAB_ID_SYN

Revision Activity add.07-01-2003

Purpose Associates professional synonyms, primary layman names,

layman synonyms, and abbreviations to a laboratory or
assessment concept.

Key Column Name Column Format Length Picture

Description

P MTL_LAB_ID_SY MTL Laboratory N 8 9(8)

NID Test Identifier
Synonym
Identifier (Stable
ID)

F LAB_ID MTL Laboratory N 8 9(8)

Test Identifier
(Stable ID)

F MTL_LAB_ID_SY MTL Laboratory AN 2 X(2)

N_NMTYP_CODE Test Identifier
Synonym Name
Type Code

MTL_LAB_ID_SY MTL Laboratory AN 100 X(100)

N_CODE_DESC Test Identifier
Synonym
Description

F MTL_LAB_ID_SY MTL Laboratory AN 1 X(1)

N_STATUS Test Identifier
Synonym Status
Code

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MTL Laboratory Test Identifier (LAB_ID) Synonym Name Type Description Table

Table Name RMTLSND0_LAB_ID_SYN_NMTYP_DESC

Revision Activity add.07-01-2003

Purpose Relates the Laboratory Test Identifier Synonym Name Type

Code to its text description.

Key Column Name Column Format Length Picture

Description

P MTL_LAB_ID_SY MTL Laboratory AN 2 X(2)

N_NMTYP_CODE Test Identifier
Synonym Name
Type Code

MTL_LAB_ID_SY MTL Laboratory AN 50 X(50)

N_NMTYP_CODE Test Identifier
_DESC Synonym Name
Type Code
Description

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MTL Laboratory Test Identifier (LAB_ID) Synonym Status Description Table

Table Name RMTLSSD0_LABID_SYN_STATUS_DESC

Revision Activity add.07-01-2003

Purpose Relates the Laboratory Test Identifier Synonym Status

Code to its text description.

Key Column Name Column Format Length Picture

Description

P MTL_LAB_ID_SY MTL Laboratory AN 1 X(1)

N_STATUS Test Identifier
Synonym Status
Code

MTL_LAB_ID_SY MTL Laboratory AN 50 X(50)

N_STATUS_DES Test Identifier
C Synonym Status
Code Description

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MTL Laboratory Test Identifier (LAB_ID) Table

Table Name RMTLLAB0_LAB_ID

Revision Activity add.07-01-2003

Purpose Provides attributes of a specific laboratory or assessment

concept.

Key Column Name Column Format Length Picture

Description

P LAB_ID MTL Laboratory N 8 9(8)

Test Identifier
(Stable ID)

MTL_LAB_ID_DE MTL Laboratory AN 100 X(100)

SC Test Identifier
Description

F MTL_ANALYTE_I MTL Analyte N 8 9(8)

D Identifier

F MTL_SPECIMEN MTL Specimen N 5 9(5)

_ID Identifier

F MTL_LAB_ID_ST MTL Laboratory AN 1 X(1)

ATUS Test Identifier
Status Code

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MTL Methodology Identifier Table

Table Name RMTLMID0_METHODOLOGY_ID

Revision Activity add.07-01-2003

Purpose Relates the Methodology Identifier to its text description.

Key Column Name Column Format Length Picture

Description

P MTL_METHOD_I MTL Methodology N 5 9(5)

D Identifier

MTL_METHOD_I MTL Methodology AN 50 X(50)

D_DESC Identifier
Description

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MTL Panel Identifier Replacement History Table

Table Name RMTLPRH0_PANEL_ID_HIST

Revision Activity add.07-01-2003

Purpose Tracks replacement history for a specific group of laboratory

tests (panel).

Key Column Name Column Format Length Picture

Description

PF MTL_PREV_PAN MTL Previous N 5 9(5)

EL_ID Panel Identifier

PF MTL_REPL_PAN MTL Replacement N 5 9(5)

EL_ID Panel Identifier

MTL_PANEL_ID_ MTL Panel N 8 9(8)

REPL_EFF_DT Identifier
Replacement
Effective Date

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MTL Panel Identifier Table

Table Name RMTLPID0_PANEL_ID

Revision Activity add.07-01-2003

Purpose Relates the Panel Identifier to its text description and

provides attributes of that relationship.

Key Column Name Column Format Length Picture

Description

P MTL_PANEL_ID MTL Panel N 5 9(5)

Identifier (Stable
ID)

MTL_PANEL_ID_ MTL Panel AN 50 X(50)

DESC Identifier
Description

F MTL_PANEL_ID_ MTL Panel AN 1 X(1)

STATUS Identifier Status
Code

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MTL Panel ID Status Code Description Table

Table Name RMTLPSD0_PANEL_ID_STATUS_DESC

Revision Activity add.07-01-2003

Purpose Relates the Panel Identifier Status Code to its text

description.

Key Column Name Column Format Length Picture

Description

P MTL_PANEL_ID_ MTL Panel AN 1 X(1)

STATUS Identifier Status
Code

MTL_PANEL_ID_ MTL Panel AN 50 X(50)

STATUS_DESC Identifier Status
Code Description

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MTL Panel to LAB_ID Association Table

Table Name RMTLPLB0_PANEL_LABID_LINK

Revision Activity add.07-01-2003

Purpose Links a laboratory or assessment concept to a group of

laboratory tests (panel).

Key Column Name Column Format Length Picture

Description

PF MTL_PANEL_ID MTL Panel N 5 9(5)

Identifier (Stable
ID)

PF LAB_ID MTL Laboratory N 8 9(8)

Test Identifier
(Stable ID)

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MTL Specific Laboratory Test Identifier Table

Table Name RMTLSLT0_SPECIFIC_LAB_ID

Revision Activity add.07-01-2003

Purpose Relates the Specific Laboratory Test Identifier to its text

description and provides attributes of that relationship.

Key Column Name Column Format Length Picture

Description

P MTL_SPEC_LAB MTL Specific N 8 9(8)

_ID Laboratory Test
Identifier (Stable
ID)

F LAB_ID MTL Laboratory N 8 9(8)

Test Identifier
(Stable ID)

F MTL_METHOD_I MTL Methodology N 5 9(5)

D Identifier

MTL_SPEC_LAB MTL Specific AN 100 X(100)

_ID_DESC Laboratory Test
Identifier
Description

F MTL_SPEC_LAB MTL Specific AN 1 X(1)

_ID_STATUS Laboratory Test
Identifier Status
Code

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MTL Specific Laboratory Test ID Replacement History Table

Table Name RMTLSRH0_SPECIFIC_LAB_ID_HIST

Revision Activity add.07-01-2003

Purpose Tracks replacement history for a specific laboratory test and

methodology.

Key Column Name Column Format Length Picture

Description

PF MTL_PREV_SPE MTL Previous N 8 9(8)

C_LAB_ID Specific
Laboratory Test
Identifier

PF MTL_REPL_SPE MTL Replacement N 8 9(8)

C_LAB_ID Specific
Laboratory Test
Identifier

MTL_SPEC_LAB MTL Specific N 8 9(8)

_ID_REPL_EFF_ Laboratory Test
DT Identifier
Replacement
Date

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MTL Specific Laboratory Test ID Status Code Description Table

Table Name RMTLSCD0_SPEC_LAB_STATUS_DESC

Revision Activity add.07-01-2003

Purpose Relates the Specific Laboratory Test Identifier Status Code

to its text description.

Key Column Name Column Format Length Picture

Description

P MTL_SPEC_LAB MTL Specific AN 1 X(1)

_ID_STATUS Laboratory Test
Identifier Status
Code

MTL_SPEC_LAB MTL Specific AN 50 X(50)

_ID_STATUS_DE Laboratory Test
SC Identifier Status
Code Description

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MTL Specimen Identifier Table

Table Name RMTLSID0_SPECIMEN_ID

Revision Activity add.07-01-2003

Purpose Relates the Specimen Identifier to its professional text

description.

Key Column Name Column Format Length Picture

Description

P MTL_SPECIMEN MTL Specimen N 5 9(5)

_ID Identifier

MTL_SPECIMEN MTL Specimen AN 50 X(50)

_ID_DESC Identifier
Description

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First Databank Cross-Reference Module (XRF) 1.0

First Databank Cross-Reference Module General Information and Concepts
Applications
ERD and Technical Specifications

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First Databank Cross-Reference Module General Information and Concepts

The General Information section contains high-level information about the module.

Overview
Concepts
Allergy-to-Ingredient Cross-Reference
Allergy-to-Allergy Cross-Reference
FDB Dosage Form to NCPDP SCRIPT Quantity Qualifier Cross-Reference
Clinical Quantity Unit of Measure

Overview
The purpose of the First Databank Cross-Reference Module (XRF) is to provide navigation between similar drug
concepts from a subset of First Databank (FDB) concepts to applicable external vocabularies. Please refer to the
FDB Interoperability Module for guidance on navigation from a more extensive range of FDB concepts and
external interoperable vocabularies.

Cross-References are currently provided between Allergy Codes (DAM_AGCSP) and Ingredient Codes
(HIC_SEQN) from MedKnowledge. Additionally, cross-references are provided between allergy code types
(DACN and DAM_AGCSP).

The Clinical Quantity tables are provided to assist in eliminating the confusion that occurs between the prescriber
and the pharmacy when trying to determine the correct quantity to dispense. Confusion can occur even
when a correct value is sent on the e-Prescription. For example, standards allow for the quantity of 1 to be
submitted for a tube; but the ultimate payer policies may not permit or pay for a discretionary selection to be made
by the pharmacist (e.g., 30g tube verses a 15g tube). Similarly, identifying the number of doses contained in an
inhaler is problematic for the prescriber because inhalers often contain an each/ml/gram quantity but not how may
doses that represents. Use of a prescriber submitted whole number quantity for the associated Clinical Quantity
Description (CLNQTY_DESC) requested and the Clinical Quantity ERX Quantity (ERX_QTY) fields should help
prevent misunderstandings.

In support of e-prescribing, the First Databank Cross-Reference Module (XRF) Clinical Quantity Tables provide
mappings between National Drug Codes (NDC) or MED Medication IDs (MEDID) to the:

ERX NCPDP SCRIPT Quantity Qualifier Code (ERX_SCRIPT_POTUNIT_CD)

ERX NCPDP SCRIPT Quantity Qualifier Description (ERX_SCRIPT_UOM_DESC)
Clinical Quantity Description (CLNQTY_DESC)
ERX Quantity (ERX_QTY)

NCPDP SCRIPT Quantity Qualifier Cross-Reference tables map key FDB dosage forms and the NCPDP Quantity
Qualifier value sets as required in the DRU (Drug) Segments of the SCRIPT 8.1 (SCRIPT 8.1 is still included in
the data set but is no longer valid for e-prescribing) and SCRIPT 10.6 (DRU segment Field Number
020-I009-05-7994 Potency Unit Code).

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For e-prescribing, FDB does not recommend use of dosage form mappings as an effective means to
fetch the Potency Unit Code used in within the DRU-Drug Segment of the SCRIPT 10.6 prescription.
The continued use of FDB-based dosage form mappings (i.e., GCDF, MED Dosage Form, POEM
Dosage Form) to the NCPDP SCRIPT Quantity Qualifier Identifier (SCRIPT_QQ_ID) contained in the
NCPDP SCRIPT Quantity Qualifier Cross-Reference tables is discouraged. Use of the dosage form
based NCPDP SCRIPT Quantity Qualifier Cross-Reference tables can result in mapping to a Script
Quantity Qualifier Description value of "Unspecified". Although valid, not all SCRIPT_QQ codes may be
accepted by e-prescribing networks (e.g., unspecified). For current e-prescribing practices, FDB
recommends the use of the ERX NCPDP SCRIPT Quantity Qualifier Codes
(ERX_SCRIPT_POTUNIT_CD) contained in the Clinical Quantity Unit of Measure tables in this module.

The module is intended to be used only in conjunction with regularly licensed FDB products.

In the NCPDP SCRIPT Quantity Qualifier Cross-Reference table, the NCPDP Quantity Qualifier
references the SCRIPT version 10.6 DRU (Drug) Segment "Potency Units Code."

The First Databank Cross-Reference Module contains the following:

Allergy-to-Ingredient Cross-References: the Cross-Reference DAM_AGCSP to HIC_SEQN Cross Table.

This table provides navigation from the allergy code to the ingredient code for the FDB allergy products.
Allergy-to-Allergy Cross-Reference: the Cross-Reference DACN to DAM_AGCSP Table. This table
provides navigation between allergy codes.

The DAM_AGCSP is synonymous with the newer column that serves the same purpose, the
DAM_ALRGN_GRP.

Clinical Quantity Unit of Measure: the Clinical Quantity NDC Table and the Clinical Quantity MEDID Table,
which provide information used for select and electronic prescription submission at the National Drug Code
(NDC) level with distinct clinical quantity descriptions.

Concepts
This section describes concepts and database elements that are important for understanding the module.

Allergy-to-Ingredient Cross-Reference

Inclusion Criteria

In order to cross-reference allergy codes between products, it is necessary to navigate through ingredients. The
allergy-to-ingredient cross-reference files begin the navigation by cross-referencing allergy codes to their
respective ingredient codes, as shown in the following illustration.

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Allergy-to-ingredient cross-reference files include, but are not limited to, United States and Canadian ingredients
referenced in an allergy context. All allergy codes for each of the FDB allergy products will be included in the
respective allergy-to-ingredient cross-reference.

In the one-to-one relationship, one allergy code is linked to one ingredient code.

In the many-to-many relationship, many allergy codes are linked to many ingredient codes. The following table
illustrates many DAM_AGCSPs linked to many HIC_SEQNs.

ExampleMany-to-Many Relationship

DAM_AGCSP HIC_SEQN

177 Insulins 881 Insulin Isophane NPH, BF-PK

177 Insulins 882 Insulin Isophane, Beef

177 Insulins 883 Insulin Isophane, Beef Pure

900067 Protamine 881 Insulin Isophane NPH, BF-PK

900067 Protamine 882 Insulin Isophane, Beef

900067 Protamine 883 Insulin Isophane, Beef Pure

900124 Beef Containing Products 881 Insulin Isophane NPH, BF-PK

900124 Beef Containing Products 882 Insulin Isophane, Beef

900124 Beef Containing Products 883 Insulin Isophane, Beef Pure

Deletions

When an ingredient is deleted in the allergy-to-ingredient cross-reference files, all cross-reference records
containing that ingredient are also deleted.

Allergy-to-Allergy Cross-Reference

Inclusion Criteria

The allergy-to-allergy cross-reference file (Cross-Reference DACN to DAM_AGCSP Table) can be used to
convert Drug Allergy Code New (DACN) codes to DAM Allergy Group Code Specific (DAM_AGCSP) codes,
bypassing the need to convert to common ingredient codes.

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Since Drug Allergy Codes (DAC) are a subset of the Drug Allergy Codes New (DACN), DAC will be found
in the DACN tables.

In the one-to-one relationship, an allergy code in one product line is linked to exactly one allergy code in another
product. The following table illustrates that one DACN is linked to one DAM_AGCSP code.

ExampleOne-to-One Relationship

DACN DAM_AGCSP

80 Streptokinases 000335 DAM_AGCSP Thrombolytic Enzymes

In the one-to-many relationship, an allergy code in one product is linked to many allergy codes in another product.
The following table illustrates that one DACN is linked to many DAM_AGCSPs.

ExampleOne-to-Many Relationship

DACN DAM_AGCSP

01 Penicillins; Cephalosporins; Carbapenem 000476 Penicillins

01 Penicillins; Cephalosporins; Carbapenem 000476 Penicillins

01 Penicillins; Cephalosporins; Carbapenem 000477 Cephalosporins

01 Penicillins; Cephalosporins; Carbapenem 000488 Betalactams

01 Penicillins; Cephalosporins; Carbapenem 000490 Carbapenem

Limitations

The allergy-to-allergy cross-reference file will be supported only in combination with approved FDB products.

FDB Dosage Form to NCPDP SCRIPT Quantity Qualifier Cross-Reference

Inclusion Criteria/Exclusion Criteria

Mapping of the FDB dosage forms to the appropriate NCPDP Quantity Qualifier value is based on clinical editor
knowledge of the use of FDB dosage forms to provide the most appropriate and useful associations between FDB
dosage form descriptions and the NCPDP Quantity Qualifier.

SCRIPT 8.1 related codes (XRF_SOURCE_ID = 1) are considered to be obsolete, SCRIPT 10.6

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(XRF_SOURCE_ID = 2) related codes are reviewed and updated by an FDB clinical editor.

Only GCDFs that have a Clinical Formulation ID (GCN_SEQNO) are mapped to NCPDP Quantity Qualifier values
in the Cross-Reference GCDF to NCPDP SCRIPT Quantity Qualifier Table (RXRGDFQ0_GCDF_SCRIPT_QQ).

Only MED dosage forms linked to the MED Routed Dosage Form Medication ID (
ROUTED_DOSAGE_FORM_MED_ID) are mapped to NCPDP Quantity Qualifier values in the Cross-Reference
MED Dosage Forms to NCPDP SCRIPT Quantity Qualifier Table (RXRMDFQ0_MEDDOSFM_SCRIPT_QQ).

Limitations

These cross-reference files support situations when the prescribed quantity is dosage-form based (for example,
tablet or capsule). Cross-references are provided from FDB's Clinical Formulation (GCN_SEQNO) Dosage Form
(GCDF), from the Med Name Concept Dosage Form (MED_DOSAGE_FORM_ID), and from the POEM Unit
Code (POEUNITCDE) to its most appropriate matching form within the NCPDP Quantity Qualifier value sets.

When the prescribed quantity is not expressed as a true dosage form (for example, tablet or capsule), but rather
as a metric unit of measure (for example, milliliter [mL]):

Map milliliters to the 10.6 Standard value of C28254 (Milliliter).

Map grams to the 10.6 Standard value of C48155 (Gram).

Clinical Quantity Unit of Measure

Inclusion Criteria/Exclusion Criteria

The Clinical Quantity Unit of Measure tables assist in minimization of manual intervention required to convert the
prescribers intentions into a prescription in the pharmacists dispensing system. The tables limit the data content
to:

NDCs that are active or obsolete less than three years

NDCS that are not indicated as inner-packs
NDCs that are not indicated as non-unit doses (unless all associated NDCs are unit-dose)
NDCs that are associated to bulk chemicals
NDCs that are associated to "Sample" drugs
NDCs that are not indicated as private labeler

FDB will edit clinical quantity information on an ongoing basis as necessary.

Data Elements

The following tables are provided in the XRF module for clinical quantity unit of measure:

Clinical Quantity NDC Table (RCQNDC0_CLNQTY_NDC)

Clinical Quantity MEDID Table (RCQMED0_CLNQTY_MEDID)

The Clinical Quantity MEDID Table is used to associate a clinical quantity unit of measure to a known MEDID.
Use this table to build an interface that allows an end user to select a MEDID, a quantity to be dispensed, and the
clinical quantity (CLNQTY_DESC). This table also associates an electronic e-Prescribing quantity unit of measure

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(ERX_QTY) that can be delivered to the pharmacy. After a selection is made, the Clinical Quantity NDC Table is
used to associate a representative NDC to the MEDID and CLNQTY_DESC combination.

The following columns are provided in the XRF module for clinical quantity unit of measure:

NDC
MEDID
MEDID_SN
CLNQTY_SUBUNIT_QTY
CLNQTY_SUBUOM_DESC
CLNQTY_PKG_DESC
CLNQTY_DESC
ERX_QTY
ERX_SCRIPT_UOM_DESC
ERX_SCRIPT_POTUNIT_CD

The CLN_QTY columns contain the quantities and unit of measures familiar to prescribers. The CLNQTY_DESC
column is a concatenation of the CLNQTY_SUBUNIT_QTY, CLN_QTY_SUBUOM_DESC, and
CLNQTY_PKG_DESC columns. You can use the separate columns CLNQTY_SUBUNIT_QTY,
CLN_QTY_SUBUOM_DESC, and CLNQTY_PKG_DESC for programs that require more finite data selections.

The ERX columns contain the quantities and unit of measures used by pharmacies, which require unambiguous
medication package size information. The ERX_SCRIPT_UOM_DESC represents the text description of the
ERX_SCRIPT_POTUNIT_CD, which provides the SCRIPT potency unit code to be used for the electronic
prescription. The ERX_QTY is the numerical quantity of the ERX_SCRIPT_UOM_DESC used in electronic
prescribing.

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XRF Applications
This section provides information about the practical application of data contained in this module.

Retrieving a Clinical Quantity for a MEDID

Retrieving NClt codes contained within the NCPDP Quantity Unit of Measure Terminology Set

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Retrieving a Clinical Quantity for a MEDID

In cases when a prescriber system sends a prescription to a pharmacy for formulations packaged in fixed
quantities (for example, aerosol with adapter [that is, inhaler], dropper bottles, dial packs), confusion may result
when the quantity to be dispensed is ambiguous to the pharmacy. For example, the prescriber system may allow
a quantity of 1 to be submitted for an aerosol with adapter, even though the pharmacist may not be able to fulfill
the order without physician verification because of payer policies. By using clinical quantities, the software vendor
can allow the prescriber can still submit whole number quantities, and the system will send the associated billing
unit quantity to the pharmacy.

The prescriber should be shown the selected quantity and the actual representation of the quantity sent
on the electronic prescription.

This application assumes that the end user has selected the MED Medication ID ( MEDID) and MED Medication
Description (MED_MEDID_DESC) using vendor software.

1. Retrieve the Clinical Quantity Description (CLNQTY_DESC) value(s) from the Clinical Quantity MEDID
Table (RCQMED0_CLNQTY_MEDID) where the MEDID equals the value identified by the end user.

2. The system prompts the end user to select a CLNQTY_DESC and enter the whole number quantity to be
dispensed.

The quantity or quantity to be dispensed field will be provided by the vendor system.

3. Retrieve the ERX Quantity (ERX_QTY) and the ERX NCPDP SCRIPT Quantity Qualifier Code (
ERX_SCRIPT_POTUNIT_CD) from the RCQMED0_CLNQTY_MEDID table where the MEDID and
CLNQTY_DESC values equal the values from the previous step.

4. Multiply the quantity to be dispensed (as entered by the end user in step 2) by the ERX_QTY from the
previous step. This is the calculated ERX_QTY.

5. Display the MED_MEDID_DESC, user selected CLNQTY_DESC, and calculated ERX_QTY values for
approval by the end user.

6. Retrieve the representative NDC from the Clinical Quantity NDC Table (RCQNDC0_CLNQTY_NDC)
where the MEDID and CLNQTY_DESC values equal the values from the previous steps.

Software vendors may elect to use the representative NDC to retrieve the associated RXCUI and
TTY for e-prescription submission.

7. Provide the calculated ERX_QTY and the ERX_SCRIPT_POTUNIT_CD from the

RCQMED0_CLNQTY_MEDID table and the representative NDC from the RCQNDC0_CLNQTY_NDC
table to be used in the e-prescription.

Example: Aerosol with Adapter

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For purposes of demonstrating this application, the following scenario is used: An end user wants to prescribe a
Dulera aerosol with adapter to a patient. The MED Medication ID (MEDID) equals 561631 and MED Medication
Description (MED_MEDID_DESC) equals Dulera 200 mcg-5 mcg/actuation HFA aerosol inhaler.

1. Retrieve the Clinical Quantity Description (CLNQTY_DESC) value(s) from the Clinical Quantity MEDID
Table (RCQMED0_CLNQTY_MEDID) where the MEDID equals the value identified by the end user.

MEDID MEDID CLNQTY_DESC

561631 120 Inhalation Aerosol with Adapter

561631 60 Inhalation Aerosol with Adapter

2. The system prompts the end user to select a CLNQTY_DESC and enter the whole number quantity to be
dispensed.
In this example, the end user selects the 60 Inhalation Aerosol with Adapter and 3 as the quantity to be
dispensed.

3. Retrieve the ERX Quantity (ERX_QTY) and the ERX NCPDP SCRIPT Quantity Qualifier Code (
ERX_SCRIPT_POTUNIT_CD) from the RCQMED0_CLNQTY_MEDID table where the MEDID and
CLNQTY_DESC values equal the values from the previous step.

MEDID CLNQTY_DESC ERX_QTY ERX_SCRIPT_POTUNIT

_CD

561631 60 Inhalation Aerosol with 8.8 C48155

Adapter

4. Multiply the quantity to be dispensed (as entered by the end user in step 2) by the ERX_QTY from the
previous step. This is the calculated ERX_QTY.
In this example, the calculation would be:
3 x 8.8 = 26.4

5. Display the MED_MEDID_DESC, user selected CLNQTY_DESC, and calculated ERX_QTY values for
approval by the end user.
In this example, the output displayed to the end user would be:
Dulera 200 mcg-5 mcg/actuation HFA aerosol inhaler user selected as 3 x 60 Inhalation Aerosol with
Adapter (26.4 grams)

6. Retrieve the representative NDC from the RCQNDC0_CLNQTY_NDC table where the MEDID and
CLNQTY_DESC values equal the values from the previous steps.

MEDID CLNQTY_DESC NDC

561631 60 Inhalation Aerosol with Adapter 00085461005

7. Provide the calculated ERX_QTY and the ERX_SCRIPT_POTUNIT_CD from the

RCQMED0_CLNQTY_MEDID table and the representative NDC from the Clinical Quantity NDC Table
(RCQNDC0_CLNQTY_NDC) table to be used in the e-prescription.

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In this example, the output for electronic prescribing would be:

26.4 C48155 0008546100

Example Code

Example: Topical Cream

For purposes of demonstrating this application, the following scenario is used: An end user wants to prescribe
Elidel topical cream to a patient. The MED Medication ID (MEDID) equals 183153 and MED Medication
Description (MED_MEDID_DESC) equals Elidel 1% topical cream.

1. Retrieve the Clinical Quantity Description (CLNQTY_DESC) value(s) from the Clinical Quantity MEDID
Table (RCQMED0_CLNQTY_MEDID) where the MEDID equals the value identified by the end user.

MEDID CLNQTY_DESC

183153 30 gram Tube

183153 60 gram Tube

183153 100 gram Tube

2.

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2. The system prompts the end user to select a CLNQTY_DESC and enter the whole number quantity to be
dispensed.
In this example, the end user selects the 60 Gram Tube and 2 as the quantity to be dispensed.

3. Retrieve the ERX Quantity (ERX_QTY,) and the ERX NCPDP SCRIPT Quantity Qualifier Code (
ERX_SCRIPT_POTUNIT_CD) from the RCQMED0_CLNQTY_MEDID table where the MEDID and
CLNQTY_DESC values equal the values from the previous step.

MEDID CLNQTY_DESC ERX_QTY ERX_SCRIPT_POTUNIT

_CD

183153 60 gram Tube 60 C48155

4. Multiply the quantity to be dispensed (as entered by the end user in step 2) by the ERX_QTY from the
previous step. This is the calculated ERX_QTY.
In this example, the calculation would be:
2 x 60 = 120

5. Display the MED_MEDID_DESC, user selected CLNQTY_DESC, and calculated ERX_QTY values for
approval by the end user.
In this example, the output displayed to the end user would be:
Elidel 1% topical cream user selected user selected as 2 x 60 gram Tube (120 grams)

6. Retrieve the representative NDC from the Clinical Quantity NDC Table (RCQNDC0_CLNQTY_NDC)
where the MEDID and CLNQTY_DESC values equal the values from the previous steps.

MEDID CLNQTY_DESC NDC

183153 60 gram Tube 00187510102

7. Provide the calculated ERX_QTY and the ERX_SCRIPT_POTUNIT_CD from the

RCQMED0_CLNQTY_MEDID table and the representative NDC from the RCQNDC0_CLNQTY_NDC
table to be used in the e-prescription.
In this example, the output for electronic prescribing would be:
120 C48155 00187510102

Example Code

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Example: Syringe

For purposes of demonstrating this application, the following scenario is used: An end user wants to prescribe a
Lovenox subcutaneous syringe to a patient. The MED Medication ID (MEDID) equals 448434 and MED
Medication Description (MED_MEDID_DESC) equals Lovenox 30 mg/0.3 mL subcutaneous syringe.

1. Retrieve the Clinical Quantity Description (CLNQTY_DESC) value(s) from the Clinical Quantity MEDID
Table (RCQMED0_CLNQTY_MEDID) where the MEDID equals the value identified by the end user.

MEDID MEDID CLNQTY_DESC

448434 0.3 mL Syringe

2. The system prompts the end user to select a CLNQTY_DESC and enter the whole number quantity to be
dispensed.
In this example, the end user selects the 0.3 mL Syringe and 20 as the quantity to be dispensed.

3. Retrieve the ERX Quantity (ERX_QTY) and the ERX NCPDP SCRIPT Quantity Qualifier Code (
ERX_SCRIPT_POTUNIT_CD) from the RCQMED0_CLNQTY_MEDID table where the MEDID and

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3.

CLNQTY_DESC values equal the values from the previous step.

MEDID CLNQTY_DESC ERX_QTY ERX_SCRIPT_POTUNIT

_CD

448434 0.3 mL Syringe 0.3 C28254

4. Multiply the quantity to be dispensed (as entered by the end user in step 2) by the ERX_QTY from the
previous step. This is the calculated ERX_QTY.
In this example, the calculation would be:
20 x 0.3 = 6

5. Display the MED_MEDID_DESC, user selected CLNQTY_DESC, and calculated ERX_QTY values for
approval by the end user.
In this example, the output displayed to the end user would be:
Lovenox 30 mg/0.3 mL subcutaneous syringe user selected as 20 x 0.3 mL Syringe (6mL)

6. Retrieve the representative NDC from the Clinical Quantity NDC Table (RCQNDC0_CLNQTY_NDC)
where the MEDID and CLNQTY_DESC values equal the values from the previous steps.

MEDID CLNQTY_DESC NDC

448434 0.3 mL Syringe 00075062430

7. Provide the calculated ERX_QTY and the ERX_SCRIPT_POTUNIT_CD from the

RCQMED0_CLNQTY_MEDID table and the representative NDC from the RCQNDC0_CLNQTY_NDC
table to be used in the e-prescription.
In this example, the output for electronic prescribing would be:
6 C28254 00075062430

Example Code

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Retrieving NClt codes contained within the NCPDP Quantity Unit of Measure Terminology Set

ExampleRetrieving NClt codes from a MEDID

ExampleRetrieving NClt codes from an NDC
ExampleUsing XML Message Format

FDB recommends utilizing the Clinical Quantity MEDID Table and/or Clinical Quantity NDC Table to map to
the NCPDP terminology files codes available in the National Cancer Institute Thesaurus (NCIt) in place of the
SCRIPT_QQ values (and associated tables). The NCPDP Quantity Unit of Measure Terminology Set is used for
Potency Unit Code identification.

Both the Clinical Quantity MEDID and Clinical Quantity NDC tables contain the NCIt Description (found in the
FDB ERX_SCRIPT_UOM_DESC field) and NCIt Code (found in the FDB ERX_SCRIPT_POTUNIT_CD
field) corresponding to the associated NDC and/or MEDID. However, only the NCIt Code provided
in the ERX_SCRIPT_POTUNIT_CD field is required for identification of the potency unit code for the Medication
prescribed quantity composite used in e-prescribing.

The provided guidance is based on the SCRIPT Standard Implementation Guide v10.6 documentation
and the SCRIPT Implementation Recommendations Document. This application provides guidance to
FDB customers on the use of FDB data content within the National Council for Prescription Drug
Programs (NCPDP) SCRIPT v10.6 electronic prescribing standard when transmitting electronic
prescriptions between prescriber systems and pharmacy applications.

This application illustrates the use of the Clinical Quantity MEDID Table (RCQMED0_CLNQTY_MEDID) and
Clinical Quantity NDC Table (RCQNDC0_CLNQTY_NDC) to retrieve the NClt codes for use in the Medication
Quantity Composite. Within SCRIPT, the Quantity composite provides the count of tablets, milliliters, or number of
grams prescribed.

The NCIt code retrieved at the NDC level using Clinical Quantity NDC Table, should be identical to the
NCIt code retrieved when using the Clinical Quantity MEDID Table.

The following steps need to be completed to retrieve an associated NCIt code for a MEDID:

1. Retrieve the Clinical Quantity Description (CLNQTY_DESC) value(s) from the Clinical Quantity MEDID
Table (RCQMED0_CLNQTY_MEDID) where the MEDID equals the value identified for the prescribed
medication.

2. Select one Clinical Quantity Description (CLNQTY_DESC) value for the associated MEDID.

3. Retrieve the ERX NCPDP SCRIPT Quantity Qualifier Code (ERX_SCRIPT_POTUNIT_CD) also known as
NCIt code for the associated Clinical Quantity Description (CLNQTY_DESC) and MEDID combination.

ExampleRetrieving NClt codes from a MEDID

For purposes of demonstrating this application, the following scenario is used: An end user wants to prescribe a

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single Dulera aerosol with adapter inhaler to a patient and needs to determine the NClt code for ePrescribing. The
MED Medication ID (MEDID) equals 561631 and MED Medication Description (MED_MEDID_DESC) equals
Dulera 200 mcg-5 mcg/actuation HFA aerosol inhaler.

1. Retrieve the Clinical Quantity Description (CLNQTY_DESC) value and ERX NCPDP SCRIPT Quantity
Qualifier Code (ERX_SCRIPT_POTUNIT_CD) from the Clinical Quantity MEDID Table
(RCQMED0_CLNQTY_MEDID) where the MEDID equals the value identified by the end user.

MEDID CLINQTY_DESC ERX_QTY ERX_SCRIPT_UO ERX_SCRIPT_POT

M_DESC UNIT_CD
(NCPDP Preferred (NCIt Code)
Term)

561631 60 Inhalation Aerosol 8.8 Gram C48155

With Adapter

561631 120 Inhalation 13 Gram C48155

Aerosol With
Adapter

2. Select one Clinical Quantity Description (CLNQTY_DESC) value for the associated MEDID.

3. Retrieve the ERX NCPDP SCRIPT Quantity Qualifier Code (ERX_SCRIPT_POTUNIT_CD), also known as
NCIt code, for the associated Clinical Quantity Description (CLNQTY_DESC) and MEDID combination.

4. Provide the ERX_QTY and ERX_SCRIPT_POTUNIT_CD to be used in the ePrescription.

The ERX Quantity (ERX_QTY) used in the ePrescription is known as the "calculated" ERX_QTY. This is
determined by multiplying the quantity to be dispensed by the ERX_QTY. The quantity to be dispensed
should be entered as a whole number. In the example above, a single (1) inhaler is to be dispensed
therefore the calculation would be: 1 x 8.8 = 8.8 and the following would be displayed to the end user:
Dulera 200 mcg-5 mcg/actuation HFA aerosol inhaler user selected as 1 x 60 Inhalation Aerosol with
Adapter (8.8 grams). It is important to note that the System prompts the end user to select the quantity to
be dispensed and completes the calculation. Vendor systems may present the information differently.

The following steps need to be completed to retrieve an associated NCIt code for an NDC:

1. Retrieve the Clinical Quantity Description (CLNQTY_DESC) value from the Clinical Quantity NDC Table
(RCQMED0_CLNQTY_MEDID) where the NDC equals the value identified for the prescribed medication.

2. Select one Clinical Quantity Description (CLNQTY_DESC) value for the associated NDC.

3. Retrieve the ERX NCPDP SCRIPT Quantity Qualifier Code (ERX_SCRIPT_POTUNIT_CD), also known as
NCIt code, for the associated Clinical Quantity Description (CLNQTY_DESC) and NDC combination.

ExampleRetrieving NClt codes from an NDC

For purposes of demonstrating this application, the following scenario is used: An end user wants to prescribe a
single Dulera aerosol with adapter inhaler to a patient and needs to determine the NClt code for ePrescribing. The

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National Drug Code (NDC) equals 00085461005.

1. Retrieve NDC and the ERX NCPDP SCRIPT Quantity Qualifier Code (ERX_SCRIPT_POTUNIT_CD) from
the Clinical Quantity NDC Table (RCQMED0_CLNQTY_MEDID) table where the NDC equals the value
identified by the end user.

NDC CLINQTY_DESC ERX_QTY ERX_SCRIPT_UO ERX_SCRIPT_POT

M_DESC UNIT_CD
(NCPDP Preferred (NCIt Code)
Term)

00085461005 60 Inhalation Aerosol 8.8 Gram C48155

With Adapter

2. Provide the ERX_QTY and ERX_SCRIPT_POTUNIT_CD to be used in the ePrescription.

The ERX Quantity (ERX_QTY) used in the ePrescription is known as the "calculated" ERX_QTY.
This is determined by multiplying the quantity to be dispensed by the ERX_QTY. The quantity to
be dispensed should be entered as a whole number. In the example above, a single (1) inhaler is
to be dispensed therefore the calculation would be: 1 x 8.8 = 8.8 and the following would be
displayed to the end user: Dulera 200 mcg-5 mcg/actuation HFA aerosol inhaler user selected as 1
x 60 Inhalation Aerosol with Adapter (8.8 grams). It is important to note that the System prompts
the end user to select the quantity to be dispensed and completes the calculation. Vendor systems
may present the information differently.

ExampleUsing XML Message Format

<MedicationPrescribed>

<Quantity>

<Value>8.8</Value> FDB ERX Quantity

<CodeListQualifier>38</CodeListQualifier> (38 is the code for "quantity prescribed" by prescriber on a new

prescription order; 40 is the code the pharmacy uses for "remaining quantity", and 87 is the code to represent
"quantity actually dispensed" by pharmacist)

<PotencyUnitCode>C48155</PotencyUnitCode> FDB ERX NCPDP SCRIPT Quantity Qualifier Code

<UnitSourceCode>AC</UnitSourceCode> (AC is an NCPDP code used to represent a NCPDP Quantity Unit of

Measure Terminology)

</Quantity>

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Cross-Reference Module ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

XRF Tables
XRF ERDs

XRF Tables
Clinical Quantity MEDID Table
Clinical Quantity NDC Table
Cross-Reference DACN to DAM_AGCSP Table
Cross-Reference DAM_AGCSP to HIC_SEQN Table
Cross-Reference GCDF to NCPDP SCRIPT Quantity Qualifier Table
Cross-Reference MED Dosage Forms to NCPDP SCRIPT Quantity Qualifier Table
Cross-Reference POEM Dosage Form to NCPDP SCRIPT Quantity Qualifier Table
Cross-Reference Source Description Table
NCPDP SCRIPT Quantity Qualifier Master Table

XRF ERDs
Allergy and Ingredient Cross-Reference ERD

FDB Dosage Form to NCPDP SCRIPT Quantity Qualifier Cross-Reference ERD

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Clinical Quantity Unit of Measure ERD

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Clinical Quantity MEDID Table

Table Name RCQMED0_CLNQTY_MEDID

Revision Activity add.06-19-2014

Purpose Provides information used for select and electronic

prescription submission at the MED Medication ID (MEDID)
level with distinct clinical quantity descriptions.

Key Column Name Column Format Length Picture

Description

PF MEDID MED Medication N 8 9(8)

ID

P MEDID_SN MED Medication N 8 9(8)

Identifier
Sequence
Number

CLNQTY_SUBUN Clinical Quantity N 19 9(11).9(7)

IT_QTY Sub-Unit Quantity

CLNQTY_SUBUO Clinical Quantity AN 70 X(70)

M_DESC Sub-Unit
Description

CLNQTY_PKG_D Clinical Quantity AN 50 X(50)

ESC Package
Description

CLNQTY_DESC Clinical Quantity AN 255 X(255)

Description

ERX_QTY ERX Quantity N 19 9(11).9(7)

ERX_SCRIPT_U ERX NCPDP AN 50 X(50)

OM_DESC SCRIPT Quantity
Qualifier
Description

ERX_SCRIPT_P ERX NCPDP AN 10 X(10)

OTUNIT_CD SCRIPT Quantity
Qualifier Code

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Clinical Quantity NDC Table

Table Name RCQNDC0_CLNQTY_NDC

Revision Activity add.06-19-2014

Purpose Provides information used for select and electronic

prescription submission at the National Drug Code (NDC)
level with distinct clinical quantity descriptions.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

PF MEDID MED Medication N 8 9(8)

ID

CLNQTY_SUBUN Clinical Quantity N 19 9(11).9(7)

IT_QTY Sub-Unit Quantity

CLNQTY_SUBUO Clinical Quantity AN 70 X(70)

M_DESC Sub-Unit
Description

CLNQTY_PKG_D Clinical Quantity AN 50 X(50)

ESC Package
Description

CLNQTY_DESC Clinical Quantity AN 255 X(255)

Description

ERX_QTY ERX Quantity N 19 9(11).9(7)

ERX_SCRIPT_U ERX NCPDP AN 50 X(50)

OM_DESC SCRIPT Quantity
Qualifier
Description

ERX_SCRIPT_P ERX NCPDP AN 10 X(10)

OTUNIT_CD SCRIPT Quantity
Qualifier Code

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Cross-Reference DACN to DAM_AGCSP Table

Table Name RXRFDDX0_DACN_AGCSP

Revision Activity add.03-11-2003

Purpose Enables the conversion of DACN codes to DAM_AGCSP

codes.

Key Column Name Column Format Length Picture

Description

PF DACN Drug Allergy Code AN 2 X(2)

New

PF DAM_AGCSP DAM Specific N 6 9(6)

Allergen Group
Code

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Cross-Reference DAM_AGCSP to HIC_SEQN Table

Table Name RXRFAHX0_AGCSP_HICSEQN

Revision Activity add.08-01-2001

Purpose Enables the conversion of an allergy to an ingredient.

Key Column Name Column Format Length Picture

Description

PF DAM_AGCSP DAM Specific N 6 9(6)

Allergen Group
Code

PF HIC_SEQN Hierarchical N 6 9(6)

Ingredient Code
Sequence
Number (Stable
ID)

F HIC Hierarchical AN 6 X(6)

Ingredient Code

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Cross-Reference GCDF to NCPDP SCRIPT Quantity Qualifier Table

Table Name RXRGDFQ0_GCDF_SCRIPT_QQ

Revision Activity add.12-08-2011

Purpose Provides the cross-reference of GCDF to NCPDP SCRIPT

Quantity Qualifier.

Key Column Name Column Format Length Picture

Description

PF GCDF Dosage Form AN 2 X(2)

Code
(2-character)

PF SCRIPT_QQ_ID NCPDP SCRIPT N 8 9(8)

Quantity Qualifier
Identifier

FDB recommends utilizing the Clinical Quantity MEDID Table and/or Clinical Quantity NDC Table to map
to NCIt values. These tables are preferred over the SCRIPT_QQ values (and associated tables) and
provide a cross-reference to NClt codes contained within the NCPDP Quantity Unit of Measure
Terminology Set. Although valid, not all SCRIPT_QQ NClt codes may be accepted by ePrescribing
networks (e.g., unspecified).

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Cross-Reference MED Dosage Forms to NCPDP SCRIPT Quantity Qualifier Table

Table Name RXRMDFQ0_MEDDOSFM_SCRIPT_QQ

Revision Activity add.12-08-2011

Purpose Provides the cross-reference of MED dosage forms to

NCPDP SCRIPT Quantity Qualifier.

Key Column Name Column Format Length Picture

Description

PF MED_DOSAGE_F MED Dosage N 5 9(5)

ORM_ID Form ID

PF SCRIPT_QQ_ID NCPDP SCRIPT N 8 9(8)

Quantity Qualifier
Identifier

FDB recommends utilizing the Clinical Quantity MEDID Table and/or Clinical Quantity NDC Table to map
to NCIt values. These tables are preferred over the SCRIPT_QQ values (and associated tables) and
provide a cross-reference to NClt codes contained within the NCPDP Quantity Unit of Measure
Terminology Set. Although valid, not all SCRIPT_QQ NClt codes may be accepted by ePrescribing
networks (e.g., unspecified).

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Cross-Reference POEM Dosage Form to NCPDP SCRIPT Quantity Qualifier Table

Table Name RXRPDFQ0_POEMDOSFM_SCRIPT_QQ

Revision Activity add.12-08-2011

Purpose Provides the cross-reference of POEM dosage forms to

NCPDP SCRIPT Quantity Qualifier

Key Column Name Column Format Length Picture

Description

PF POEUNITCDE POEM Unit Code N 4 9(4)

PF SCRIPT_QQ_ID NCPDP SCRIPT N 8 9(8)

Quantity Qualifier
Identifier

FDB recommends utilizing the Clinical Quantity MEDID Table and/or Clinical Quantity NDC Table to map
to NCIt values. These tables are preferred over the SCRIPT_QQ values (and associated tables) and
provide a cross-reference to NClt codes contained within the NCPDP Quantity Unit of Measure
Terminology Set. Although valid, not all SCRIPT_QQ NClt codes may be accepted by ePrescribing
networks (e.g., unspecified).

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Cross-Reference Source Description Table

Table Name RXRNSRC0_SOURCE_DESC

Revision Activity add.12-08-2011

Purpose Relates the source identifier to its description.

Key Column Name Column Format Length Picture

Description

P XRF_SOURCE_I Cross Reference N 4 9(4)

D Source Identifier

XRF_SOURCE_D Cross Reference AN 100 X(100)

ESC Source
Description

FDB recommends utilizing the Clinical Quantity MEDID Table and/or Clinical Quantity NDC Table to map
to NCIt values. These tables are preferred over the SCRIPT_QQ values (and associated tables) and
provide a cross-reference to NClt codes contained within the NCPDP Quantity Unit of Measure
Terminology Set. Although valid, not all SCRIPT_QQ NClt codes may be accepted by ePrescribing
networks (e.g., unspecified).

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NCPDP SCRIPT Quantity Qualifier Master Table

Table Name RXRNCQQ0_QQ_MSTR

Revision Activity add.12-08-2011

Purpose Provides listing of all SCRIPT 10.6 Quantity Qualifier Values

and their attributes.

Key Column Name Column Format Length Picture

Description

P SCRIPT_QQ_ID NCPDP SCRIPT N 8 9(8)

Quantity Qualifier
Identifier

SCRIPT_QQ_CD NCPDP SCRIPT AN 10 X(10)

Quantity Qualifier
Code

SCRIPT_QQ_DE NCPDP SCRIPT AN 50 X(50)

SC Quantity Qualifier
Description

XRF_SOURCE_I Cross Reference N 4 9(4)

D Source Identifier

OBSOLETE_DAT NCPDP SCRIPT N 8 9(8)

E Quantity Qualifier
Obsolete Date

FDB recommends utilizing the Clinical Quantity MEDID Table and/or Clinical Quantity NDC Table to map
to NCIt values. These tables are preferred over the SCRIPT_QQ values (and associated tables) and
provide a cross-reference to NClt codes contained within the NCPDP Quantity Unit of Measure
Terminology Set. Although valid, not all SCRIPT_QQ NClt codes may be accepted by ePrescribing
networks (e.g., unspecified).

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Daily Product Update

Overview
Daily Product Update Data
Daily Product Update Directory Structure
Partial directory structure for the Daily Product Update:

Overview
The Daily Product Update provides all record changes (new or updated) made within a designated collection of
descriptive and pricing tables included in the product. See Information Update Options for more information on
the frequency and distribution methods and issues related to the Daily Product Update.

Daily Product Update Data

The Daily Product Update provides all record changes made within the following collection of descriptive and
pricing tables included within the product:

Clinical Formulation and Ingredient Data Tables

Pricing Tables
Miscellaneous Therapeutic Classification Data Tables
Packaged Product Tables
ETC Tables

Daily Product Update Directory Structure

The Daily Product Update is delivered via FTP. In your FTP folder, you will receive the Daily Product Update
folder with a file name that will be provided to you. This folder contains the following:

multiple folders containing the most current and historical Daily Product Update data with each folder name
identifying the production date of the data. For example, 11JUL.2008.[Drug Product Update folder name].
a Current folder containing the most current daily update.

Each folder above contains the following:

NDDF Plus DDL folder containing the Data Definition Language (DDL) information for a number of
commercial database programs.
NDDF Plus UPD folder containing the NDDF PLUS UPD.zip file (contains the incremental files).
Copyright.txt containing the First Databank (FDB) copyright information.
NDDF_PRODUCT_INFO.UPD file containing production dates for both the previous and the current
incremental files.

The NDDF PLUS UPD.zip file, when uncompressed, creates the NDDF Plus UPD directory. This directory

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contains the NDDF Descriptive and Pricing folder, which includes the following:

NDDF BASICS 3.0 folder containing the Drug Product Pricing, Packaged Product, Clinical Formulation and
Ingredient Data, and Miscellaneous Therapeutic Classification tables.
NDDF ETC 1.0 folder containing the First Databank Enhanced Therapeutic Classification System (ETC)
tables.

Partial directory structure for the Daily Product Update:

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Drug Product Pricing

Drug Product Pricing Editorial Policies
Applications
ERD and Technical Specifications

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Drug Product Pricing Editorial Policies

The policies and criteria that apply to the inclusion and maintenance of Drug Product Pricing are provided in the
following sections:

Overview
Explanation of Terms
Maintenance
Resources

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Pricing Overview
First Databank (FDB) pricing data contains pricing information for most drug, medical device, bulk chemical,
herbal, nutritional supplement, prescription product, and non-prescription product in our database. (See "NDCs
Without Prices" in the Explanation of Terms section for more information.) The term drug product as it appears
in this policy refers to medical devices, bulk chemicals, herbals, nutritional supplements, prescription products,
and non-prescription products.

FDB relies on manufacturers and other third parties to report or otherwise make available the values for
the price data fields in this policy and, as a result, such data fields are subject to the availability of the
relevant information. FDB reserves the right, in its sole discretion, to change this Drug Price Policy
without notice. Please refer to the following URL for updates to this policy:

http://www.fdbhealth.com/policies/drug-pricing-policy/

Drug knowledge is aggregated at the Clinical Formulation ID (GCN_SEQNO), Routed Medication ID (

ROUTED_MED_ID), and the Routed Generic ID (ROUTED_GEN_ID) levels in the FDB knowledge base.
Under certain circumstances, aggregated drug knowledge may not apply to all related drug products;
more specific information may be found within product labels.

Emerging Price Types

First Databank constantly monitors new price types and evaluates the opportunity to publish these in our
databases. First Databank plans to publish these price types as they become available, and at that time this
Pricing Policy will be modified to reflect these and any other new Price Types.

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Pricing Definitions
This section defines important terms related to the module that users should understand. Some industry terms
that have a specific connotation in regards to the module are also defined.

Average Acquisition Cost (AAC)

Case Pricing
Clinical Formulation ID (GCN_SEQNO)
Consolidated Price 1 and 2
Direct Price (DIR)
Formulation ID (GCN)
Federal Upper Limit (FUL)
Latest Price Verification Date
Manufacturer
National Average Drug Acquisition Cost for Brand Drugs (NADACB) and Generic Drugs (NADACG)
NDCs Without Prices
Obsolete Date (OBSDTEC)
Package Size (PS)
Suggested Wholesale Price (SWP)
Weighted Average of Average Manufacturer Prices (WAAMP)
Wholesale Acquisition Cost (WAC)

Average Acquisition Cost (AAC)

As published by FDB reports the average acquisition cost at which pharmacies within a state purchase a drug, as
defined, calculated and reported by the relevant state Medicaid program. Since all states do not report an AAC,
FDB publishes AACs for each state where it is available.

Case Pricing
The following price types for case pricing are available in the Product Price Table
(RPRDPP0_PRODUCT_PRICE):

PRICE_TYPE_ID PRICE_TYPE_SHORT_DE PRICE_TYPE_LONG_DES PRICE_TYPE_DEFINITION

SC C

27 DIRCP Direct Case Price The manufacturer's

published catalog or list
price to non-wholesalers as
reported to First Databank
by the manufacturer. The
Direct Case Price (DIRCP) is
the direct price of a single
case, where a case consists
of more than one package.

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28 SWPCP Suggested Wholesale Case The manufacturer's

Price suggested price from
wholesalers to their
customers (for example,
retailers, hospitals,
physicians and other buying
entities) as reported to First
Databank by the
manufacturer. The
Suggested Wholesale Case
Price (SWPCP) is the
suggested wholesale price
of a single case, where a
case consists of more than
one package.

29 WHNCP Wholesale Case Price The manufacturer's

published catalog or list
price for a drug product sold
to wholesalers as reported to
First Databank by the
manufacturer. The
Wholesale Acquisition Case
Price (WHNCP) is the
suggested wholesale
acquisition cost of a single
case by a wholesaler, where
a case consists of more than
one package.

Case prices are only available in the newer Product Price Table (RPRDPP0_PRODUCT_PRICE) and not
in the National Drug Code Price Table (RNP2_NDC_PRICE).

Only current case prices are provided; that is, prices that are effective on or prior to the FDB production
date on which the record is updated. No historical case prices are provided.

Clinical Formulation ID (GCN_SEQNO)

The Clinical Formulation ID (GCN_SEQNO) is specific to generic ingredient(s), drug strength(s), dosage form,
and route of administration. However, the classification of two products in the same GCN_SEQNO should not be
understood to mean that they are therapeutically equivalent. FDB does not determine therapeutic equivalency,
and recommends that a combination of the Clinical Formulation ID and the FDA's Approved Drug Products with
Therapeutic Equivalence Orange Book Code (OBC) be employed to group products for evaluation of
bioequivalence. While the FDA has stated that the Orange Book is advisory only, it constitutes the leading
authority for basing substitution decisions at the pharmacy level. However, state laws vary as to whether OBC
equivalence is required for therapeutic substitution, so it is necessary to identify the controlling law in the
jurisdiction in question. See the Applications for illustrated examples of using MedKnowledge to find candidates
for substitution.

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Consolidated Price 1 and 2

Consolidated Price 1 (WSD) and Consolidated Price 2 (SWD) represent consolidated prices published by FDB.

The output for Consolidated Price 1 (WSD) is based on the application of the following criteria:

1. If Wholesale Acquisition Cost (WAC) is available, WAC will be output.

2. If WAC is not available, Suggested Wholesale Price (SWP) will be output.

3. If neither WAC nor SWP are available, Direct Price (DIR) will be output.

The output for Consolidated Price 2 (SWD) is based on the application of the following criteria:

1. If SWP is available, SWP will be output.

2. If SWP is not available, WAC will be output.

3. If neither SWP nor WAC are available, Direct Price will be output.

MedKnowledge uses two different price type codes to represent WSD and SWD data, one based on unit price,
the other based on package price. Summarized here are the WSD and SWD price types as defined by the NDC
Price Table - Price Type Code column (NPT_TYPE).

These values are always non-zero and have an associated effective date.

NPT_TYPE NPT_DESC Expanded Description

15 WSD Consolidated Price 1 Unit Price

Current price plus up to two price
histories available.

16 WSDPKG Consolidated Price 1 Package Price

Current price plus up to two price
histories available.

17 SWD Consolidated Price 2 Unit Price

Current price plus up to two price
histories available.

18 SWDPKG Consolidated Price 2 Package Price

Current price plus up to two price
histories available.

The NDC Price Table - Effective Date (NPT_DATEC) value for each new price type will be the date of the
referenced price, such as Direct Price (DIR), Suggested Wholesale Price (SWP), or Wholesale Acquisition Cost
(WAC).

Direct Price (DIR)

Direct Price as published by FDB represents the manufacturers published catalog or list price for a drug product
to non-wholesalers as reported to FDB by the manufacturer. Direct Price does not represent actual transaction

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prices and does not include prompt pay or other discounts, rebates or reductions. FDB does not perform any
independent investigation or analysis of actual transaction prices for purposes of reporting Direct Price. FDB
relies on manufacturers to report or otherwise make available the values for the Direct Price data field.

MedKnowledge uses two different price type codes to represent Direct Price data, one based on unit price, the
other based on package price. Summarized here are the Direct Price price types as defined by the NDC Price
Table - Price Type Code column (NPT_TYPE):

These columns may have a zero price with an effective date if a manufacturer no longer provides a DIR for the
product.

NPT_TYPE NPT_DESC Expanded Description

05 DIR Direct Unit Price

06 DIRPKG Direct Package Price

Formulation ID (GCN)
The GCN is a five-digit code number that represents a clinical formulation specific to generic ingredient(s), drug
strength(s), and route of administration, and dosage form (with the exception of most medical supplies). For all
medical supplies and certain drugs there may be multiple Clinical Formulation IDs ( GCN_SEQNO) associated
with one GCN. FDB does not determine therapeutic equivalency, and recommends that a combination of the
Clinical Formulation ID and the FDA's Approved Drug Products with Therapeutic Equivalence Orange Book Code
(OBC) be employed to group products for evaluation of bioequivalence. While the FDA has stated that the
Orange Book is advisory only, it constitutes the leading authority for basing substitution decisions at the pharmacy
level. However, state laws vary as to whether OBC equivalence is required for therapeutic substitution, so it is
necessary to identify the controlling law in the jurisdiction in question.

See the Applications for illustrated examples of using MedKnowledge to find candidates for substitution.

Although GCN and GCN_SEQNO are, for the most part, parallel concepts, new and current customers are
encouraged to use the GCN_SEQNO instead of the GCN because of its greater specificity and its
uniqueness to ingredient(s), dosage form, route, strength, and medical supplies, which are discussed in
detail below. Additionally, as the number of clinical formulations grow, the GCN has the potential to reach a
maximum number of 99,999 records, whereas GCN_SEQNO will allow for expanded growth for a longer period of
time. Customers who utilize GCN should be aware that FDB does not expect a shortage of GCN numbers for new
formulations for the foreseeable future. For customers interested in migrating from GCN to GCN_SEQNO, FDB
offers a cross-walk file between the two data elements to enable migration and business between customers who
have either structure. The GCN_SEQNO/GCN Relation Table cannot be used to cross-walk medical supplies
except in the GCN_SEQNO to GCN direction. FDB recommends using the National Drug Code (NDC) for this
purpose.

Medical Supplies

An important difference between GCN and GCN_SEQNO is that in GCN all medical supplies that do not
contain clinically significant ingredients are given the same number: 94200. As an example, syringes of

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different sizes and GCN_SEQNO values would all have the same GCN:

GCN GCN_SEQNO GNN

94200 61017 syringe with cannula, disposable 12

mL

94200 67193 syringe with needle, insulin, safety, 0.5

mL

94200 61252 blood-glucose meter & wrist blood

pressure monitor

Medical supplies that contain clinically significant ingredients are given GCN values other than 94200. For
example, an intra-uterine device (IUD) (GCN = 33983) levonorgestrel is considered clinically significant and would
not be given a 94200 GCN value.

Federal Upper Limit (FUL)

The Centers for Medicaid and Medicare and the States employ the Federal Upper Limit price as a cost
containment measure. CMS calculates a FUL amount for all multiple source drugs for which the FDA has rated at
least three products pharmaceutically and therapeutically equivalent.

Under the Affordable Care Act of 2010 the methodology for calculating FULs was redefined to:

[N]o less than 175 percent of the weighted average (determined on the basis of utilization) of the most recently
reported monthly average manufacturer prices for pharmaceutically and therapeutically equivalent multiple source
drug products that are available for purchase by retail community pharmacies on a nationwide basis.

The Average Manufacturer Price (AMP) is defined as:

[T]he average price paid to the manufacturer for the drug in the United States by wholesalers for drugs
distributed to retail community pharmacies and retail community pharmacies that purchase drugs directly from the
manufacturer

Please note: CMS publishes the Weighted Average of the Average Manufacturer Prices for a group of
pharmaceutically and therapeutically equivalent product; CMS does not make the individual Average
Manufacturer Prices (AMP) publically available.

Regulations finalized in 2016 incorporated the National Average Drug Acquisition Cost (NADAC) into the FUL
calculation methodology: whenever 175% of the weighted average AMP for a drug is less than the
CMS-published NADAC price for the same drug, the NADAC value will be employed as its FUL.

For more information, see

https://www.medicaid.gov/medicaid-chip-program-information/by-topics/benefits/prescription-drugs/federal-upper-limits.html
.

FDB provides the following price type codes to accommodate the updated FUL content:

NPT_TYPE NPT_DESC Expanded Description

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23 FUL ACA Federal Upper Limit (FUL)

Current price plus up to three price
histories available.

19 WAAMP Weighted Average of Average

Manufacturer Prices (WAAMP)

PRICE_TYPE_ID PRICE_TYPE_SHORT_DE PRICE_TYPE_LONG_DES PRICE_TYPE_DEFINITION

SC C

23 FUL ACA Federal Upper Limit ACA Federal Upper Limit for
a drug product, as published
by CMS

19 WAAMP Weighted Average of The Weighted Average AMP

Average Manufacturer for a drug product, as
Prices (WAAMP) published by CMS

Understanding Federal Upper Limit Pricing (Price Type 23) provided by FDB:

Differences between using Product Prices Tables versus NDC Price Table

Significance to the left of the decimal. CMS FUL prices are significant to the 6th position to the right of
the decimal.
The Product Price Table can accommodate 7 positions to the right of the decimal, so the price is
exactly as stated by CMS.
NDC Price Table can only accommodate prices up to the 5th significant digit. The 6th digit
($4.471556) is truncated.
CMS Billing Units.
The Product Price Table (RPRDPP0_PRODUCT_PRICE) contains the Price Quantity and the
Pricing Unit of Measure Identifier (CMS billing units) for the FUL. The descriptions for the Pricing
Unit of Measure Identifiers are found in the Pricing Unit of Measure Table
(RPRDUOM0_PRICE_QTY_UOM).
CMS billing units are associated to existing Price Unit of Measures in the NDC Price table.

The following FDB Drug Form Codes are considered equivalent to the CMS Billing Unit noted
below:

FDB Drug Form Codes PRICE_UOM_ID CMS Billing Unit PRICE_UOM_ID

1 (Each) 1 AHF 49
CAP 45
SUP 46
TAB 47
TDP 48
EA 1

2 (mL) 2 ML 2

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3 (g) 3 GM 3

If CMS billing units do not translate to existing Price Unit of Measure in the NDC Price table; the
NDC is excluded.
The Product Price Table provides the CMS billing units as provided; regardless of the FDB Drug
Form Code.

NDC Price Agreement

FDB delivers ACA FUL prices for NDCs as published on CMS's FUL files. Values are not extrapolated to other
related NDCs in the same Clinical Formulation (GCN_SEQNO).

Not all NDCs on FDB's database will be associated with a federal price type (WAAMP, FUL, NADACG,
NADACB).

Zero Prices

A zero will be present in a federal price type (WAAMP, FUL, NADACG, NADACB) file in two cases. When CMS
drops a previously listed NDC from the file, FDB will indicate this change by reporting a zero value for that NDC.
FDB will also report a zero price when CMS publishes a new NDC with a zero value. In both cases the zero price
identifies an NDC for which there is no associated federal price type (WAAMP, FUL, NADACG, NADACB).

For FUL - the effective date of the FDB assigned zero-price is the 1 st of the following month.

Frequency of FUL Price Updates

Information will be updated and distributed upon release of CMS data (expectation is monthly). FDB can release
future date pricing if provided prior to the effective date.

Delivery File Transaction Codes

Update files are delivered with a code to indicate Deletions (D), Changes (C), or Additions (A). NDC rows are
coded for deletion for the following circumstances:

Row exceeds the maximum amount of histories maintained for the NDC; in this instance the oldest date is
rolled-off.
An NDC with an October 2013 obsolete date has gone past the obsolete date provided to the customer.
For the NDC with an October 2013 obsolete date shown in the example below, all four rows would be
deleted in October 2016 for customers receiving a three year file.

D 68084031711 23 20160401 00000115284

D 68084031711 23 20160401 00000126808

D 68084031711 23 20160401 00000102661

D 68084031711 23 20160401 00000000000

Latest Price Verification Date

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The Latest Price Verification Date identifies the last date of contact with the manufacture, allowing customers to
see when FDB was last able to obtain pricing verification from the manufacturer for an NDC. NDCs without prices
will not have a Latest Price Verification Date.

Manufacturer
For the purposes of this Drug Pricing Policy, the term manufacturer includes manufacturers, repackagers,
private labelers, and other suppliers.

National Average Drug Acquisition Cost for Brand Drugs (NADACB) and Generic Drugs (NADACG)
The National Average Drug Acquisition Cost for Brand Drugs, as published by CMS, for those drug products that
have been identified with a Classification for Rate Setting of B, B-ANDA, or B-BIO.

The National Average Drug Acquisition Cost for Generic Drugs, as published by CMS, for those drug products
that CMS has identified with a Classification for Rate Setting of G or contain a non-blank value in the
Corresponding Generic Drug NADAC Per Unit field.

Not all NDCs on FDB's database will be associated with a federal price type (WAAMP, FUL, NADACG,
NADACB).

CMS NADAC prices (NADACB and NADACG) are directly imported from the CMS Weekly NADAC Reference
file, which is updated every week. This file provides purchase prices of all covered outpatient drugs by retail
community pharmacies.

In the file received from CMS, if a B, B-ANDA, or B-BIO classification populates the field in the Classification for
Rate Setting column, then the NADAC price will be represented in NPT_TYPE 24. If that column field is
populated with a G classification, then the NADAC price will be represented in NPT_TYPE 25. Additionally any
NDC with a zero or greater value in the Corresponding Generic Drug NADAC Per Unit field will be represented
in NPT_TYPE 25. This data provides a more intuitive description of how CMS designates the NADAC prices.

Zero Prices

A zero will be present in a federal price type (WAAMP, FUL, NADACG, NADACB) file in two cases. When CMS
drops a previously listed NDC from the file, FDB will indicate this change by reporting a zero value for that NDC.
FDB will also report a zero price when CMS publishes a new NDC with a zero value. In both cases the zero price
identifies an NDC for which there is no associated federal price type (WAAMP, FUL, NADACG, NADACB).

For NADACB, NADACG the effective date of the FDB assigned zero-price is the date of the weekly
NADAC update (normally on Wednesdays).

The Centers for Medicaid Services (CMS) removed the draft status from NPT_TYPE 24 (NADACB) and
NPT_TYPE 25 (NADACG) on November 28, 2013.

These classifications can be found in the NDC Attribute Table (RNDCAT0_NDC_ATTRIBUTE) with an
NDC_ATTRIBUTE_TYPE_CD value of 57.

NDCs Without Prices

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Some NDCs included within the Packaged Product data do not have published prices. These NDCs can include
the following:

NDCs on inner packaging that are not individually priced. For example, an inner NDC may be found on an
individual vial when that product is only sold in boxes of multiple vials and the outer packaging has a
different NDC number.
The first generic version of a product that has not yet begun to ship and therefore does not yet have a
published price. This includes first generics that are also authorized generics and have a New Drug
Application (NDA) or an Abbreviated New Drug Application (ANDA) assigned.
New NDCs that are sourced from the SPL and meet all of the following criteria:
The NDC is a new FDA approved drug and listed on the SPL.
The drug form and other related attributes conform to National Council for Prescription Drug
Programs (NCPDP) standards.
FDB is unable to obtain a price from the manufacturer.
FDA approved vaccines that have not been launched and vaccines available only through the Federal
Repository that are not marketed to the general public but do have published CVX codes.
Sample products with an available Structured Product Label (SPL) and samples of diabetic related
supplies
Products associated with an Outsourcing Facility. FDB Defines an Outsourcing Facility as a facility that is
engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and
complies with all of the requirements of The United States Federal Food, Drug, and Cosmetic Act (FDCA)
section 503B.

Obsolete Date (OBSDTEC)

An eight-character numeric column containing the date or estimated date (as provided by the manufacturer or
FDA notification) on which a product's obsolete status begins. The date format is CCYYMMDD.

FDB applies an obsolete date to those products that are no longer maintained on MedKnowledge because they
are discontinued, no longer marketed, no longer produced, or otherwise made unavailable to the marketplace.
FDB also applies an obsolete date to products that provide an insufficient basis for an assessment of their safety
and efficacy or otherwise present regulatory compliance issues.

The obsolete date is unrelated to the expiration date present on a product's label.

Products that are no longer produced or have been discontinued by a manufacturer may still be available
for sale.

Package Size (PS)

The PS identifies the number of billing units (as specified by the labeled quantity) in the package the pharmacist
uses to dispense; for example, 100 tablets, 1000 capsules, or 20 ml vial. The package quantity complies with the

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National Council of Prescription Drug Programs (NCPDP) Billing Unit Standard.

Suggested Wholesale Price (SWP)

Suggested Wholesale Price (SWP) as published by FDB represents the manufacturers suggested price for a
drug product from wholesalers to their customers (i.e., retailers, hospitals, physicians and other buying entities) as
reported to FDB by the manufacturer. SWP is a suggested price and does not represent actual transaction prices.
FDB relies on manufacturers to report or otherwise make available the values for the SWP data field.

NPT_TYPE NPT_DESC Expanded Description

07 SWP Suggested Wholesale Price (SWP)

Unit Price

08 SWPPKG Suggested Wholesale Price (SWP)

Package Price

Weighted Average of Average Manufacturer Prices (WAAMP)

Weighted Average AMP for a drug product, as published by CMS.

Zero Prices

A zero will be present in a federal price type (WAAMP, FUL, NADACG, NADACB) file in two cases. When CMS
drops a previously listed NDC from the file, FDB will indicate this change by reporting a zero value for that NDC.
FDB will also report a zero price when CMS publishes a new NDC with a zero value. In both cases the zero price
identifies an NDC for which there is no associated federal price type (WAAMP, FUL, NADACG, NADACB).

For WAAMP - the effective date of the FDB assigned zero-price is the 1 st of the following month.

Not all NDCs on FDB's database will be associated with a federal price type (WAAMP, FUL, NADACG,
NADACB).

Wholesale Acquisition Cost (WAC)

Wholesale Acquisition Cost (WAC) (previously referred to as Net Wholesale Price) as published by FDB
represents the manufacturers published catalog or list price for a drug product to wholesalers as reported to FDB
by the manufacturer. WAC does not represent actual transaction prices and does not include prompt pay or other
discounts, rebates or reductions in price. FDB does not perform any independent investigation or analysis of
actual transaction prices for purposes of reporting WAC. FDB relies on manufacturers to report or otherwise make
available the values for the WAC data field.

MedKnowledge uses two different price type codes to represent WAC data, one based on unit price, the other
based on package price. Summarized here are the WAC price types as defined by the NDC Price Table - Price
Type Code column (NPT_TYPE):

NPT_TYPE NPT_DESC Expanded Description

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09 WHN Wholesale Acquisition Cost (WAC)

Unit Price

10 WHNPKG Wholesale Acquisition Cost (WAC)

Package Price

Please note that NPT_TYPEs 09 and 10 were formerly described as the Wholesale Net Price. Though
the database acronym of WHN did not change, the expanded description now reflects more commonly
used terminology.

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Pricing Maintenance
This section contains information regarding the ongoing maintenance of the module's data.

External Triggers for Clinical Review

Internal Triggers for Clinical Review
Wholesale Acquisition Cost (WAC) Policies
Direct Price (DIR) Policies
Suggested Wholesale Price (SWP)

External Triggers for Clinical Review

The external triggers that prompt the clinical editors to add or review data are the following:

MedEffects Alerts from Health Canada

MedWatch Safety Alerts

Internal Triggers for Clinical Review

The internal trigger that prompts the clinical editors to add or review data is a new Clinical Formulation ID
(GCN_SEQNO).

Wholesale Acquisition Cost (WAC) Policies

FDB does not perform any independent investigation or analysis of actual transaction prices for purposes of
reporting WAC. FDB relies on manufacturers to report or otherwise make available the values for the WAC data
field.

Direct Price (DIR) Policies

FDB does not perform any independent investigation or analysis of actual transaction prices for purposes of
reporting Direct Price. FDB relies on manufacturers to report or otherwise make available the values for the Direct
Price data field.

Suggested Wholesale Price (SWP)

FDB does not perform any independent investigation or analysis of actual transaction prices for purposes of
reporting the Suggested Wholesale Price (SWP). FDB relies on manufacturers to report or otherwise make
available the values for the SWP data field.

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Drug Product Pricing Resources

This section lists sources used by First Databank to compile the information contained in the module.

First Databank utilizes many reference sources including, but not limited to, the primary medical literature (e.g.,
published journal articles), medical reference texts, published expert treatment guidelines, and manufacturer
product package inserts. First Databank uses current source editions or versions when coding and updating data,
as well as when researching questions about data. However, a formal data review does not occur for every new
release of source editions or versions. Additional sources include:

Centers for Medicare & Medicaid Services. Medicare.gov: Federal Upper Limits. Available at
https://www.medicaid.gov/medicaid-chip-program-information/by-topics/benefits/prescription-drugs/federal-upper-limits.h

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Applications Drug Product Pricing

This section provides general information about the practical application of the data contained in Drug Product
Pricing Data.

Finding the Price for a Given NDC

Finding the Price and Associated Pricing Attributes of an NDC for a Given Price Type

Identification of the NADAC Classification for Rate Setting Value that CMS has Assigned

Determining the Basis Used for Assigning a Federal Price to Zero ($0)

Identifying the NDC Deletion Reason

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Finding the Price for a Given NDC

This application illustrates how to retrieve a price for a given NDC.

This table uses legacy pricing tables that provide limited information regarding the pricing of a drug
product. FDB encourages customers to take advantage of the newer Product Price tables. See the
Finding the Price and Associated Pricing Attributes of an NDC for a Given Price Type application for more
information about implementing this content.

1. Retrieve the Price Type Code (NPT_TYPE) value from the NDC Price Type Description Table
(RNPTYPD0_NDC_PRICE_TYPE_DESC) where the Price Type Code Description (NPT_DESC) equals
the product code in focus.

2. Retrieve the following columns from the National Drug Code Price Table (RNP2_NDC_PRICE):
Price (NPT_PRICEX)
Effective Date (NPT_DATEC)
where
The National Drug Code (NDC) column equals the NDC of the product.
The Price Type Code (NPT_TYPE) equals the value of the NPT_TYPE retrieve in the previous step.

If the CMS billing unit (PRICE_UOM_ID) is not equivalent to FDB, FUL (price type 23) and
WAAMP (price type 19) prices will not be output in the National Drug Code Price Table
(RNP2_NDC_PRICE). Customers will need to reference the FDB Product Pricing content
Product Price Table (RPRDPP0_PRODUCT_PRICE) in order to retrieve these prices and
determine which price is to be used.

ExampleFinding the FUL and WAAMP Prices for a Given NDC

For the purpose of demonstrating this application, the following scenario is used: A user is attempting to
determine the ACA Federal Upper Limit (FUL) and Weighted Average of Average Manufacturer (WAAMP)
prices for NDC 00591321254.

1. Retrieve the Price Type Code (NPT_TYPE) value from the NDC Price Type Description Table
(RNPTYPD0_NDC_PRICE_TYPE_DESC) where the Price Type Code Description (NPT_DESC) equals
00591321254.

NPT_DESC NPT_TYPE

FUL 23

WAAMP 19

2. Retrieve the following columns from the National Drug Code Price Table (RNP2_NDC_PRICE):
Price (NPT_PRICEX)

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2.

Effective Date (NPT_DATEC)

where
The National Drug Code (NDC) column equals 00591321254.
The Price Type Code (NPT_TYPE) equals 19 or 23.

NDC NPT_TYPE NPT_DESC NPT_DATEC NPT_PRICEX

00591321254 19 WAAMP 20160401 5.62254

00591321254 23 FUL 20160401 9.83945

If the CMS billing unit (PRICE_UOM_ID) is not equivalent to FDB, FUL (price type 23) and
WAAMP (price type 19) prices will not be output in the National Drug Code Price Table
(RNP2_NDC_PRICE). Customers will need to reference the FDB Product Pricing content
Product Price Table (RPRDPP0_PRODUCT_PRICE) in order to retrieve these prices and
determine which price is to be used.

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Finding the Price and Associated Pricing Attributes of an NDC for a Given
Price Type
This application acts as an aid in understanding the use of the First Databank Product Identifier (
FDB_PRODUCT_ID) and how it relates to retrieving pricing information for a given product. Users of this
information may wish to use the new pricing files because:

A larger and more specific price field is being provided (11.7)

Prices are being provided with explicit price unit of measures (such as package descriptions for package
prices), and
It is possible to retrieve and display reasons explaining why a particular price record has been set to zero.

This application illustrates how to retrieve the Price (PRICE), Price Quantity (PRICE_QTY), Price Unit of Measure
Identifier (PRICE_UOM_ID) or Currency Code (CURRENCY_CD), for a given NDC using the
FDB_PRODUCT_ID.

1. Retrieve the FDB_PRODUCT_ID from the External Product Code Table

(RPRDPC0_EXT_PRODUCT_CD) for the product in focus using the application Determining the FDB
Product ID and Associated Product Information Given an External Product Code where the External
Product Code (EXT_PRODUCT_CD) equals the product code in focus.

2. Retrieve the Price Type Identifier (PRICE_TYPE_ID) value from the Price Type Description Table
(RPRDPTD0_PRICE_TYPE_DESC) where the Price Type Short Description (
PRICE_TYPE_SHORT_DESC) or the Price Type Long Description (PRICE_TYPE_LONG_DESC) is
describing the price type being evaluated.

3. Retrieve the following price attributes columns from the Product Price Table
(RPRDPP0_PRODUCT_PRICE):
Price (PRICE)
Price Quantity (PRICE_QTY)
Price Unit of Measure Identifier (PRICE_UOM_ID)
Currency Code (CURRENCY_CD)
where:
The FDB_PRODUCT_ID value equals the value of the FDB_PRODUCT_ID retrieved in step 1.
The PRICE_TYPE_ID equals the value of the PRICE_TYPE_ID retrieved in step 2.
The Price Effective Date (PRICE_EFFECTIVE_DT) equals the latest date that occurs on or after the
time period under evaluation.

4. Retrieve the following columns from the Product Price Attribute Table (RPRDPA0_PRICE_ATTR):
Price Attribute Code (PRICE_ATTRIBUTE_CD)
Price Attribute Value (PRICE_ATTRIBUTE_VALUE)
where
The FDB_PRODUCT_ID equals the value of the FDB_PRODUCT_ID retrieved in step 1.

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The PRICE_TYPE_ID equals the value of the PRICE_TYPE_ID retrieved in step 2.

The PRICE_EFFECTIVE_DT equals the latest date that occurs on or after the time period under
evaluation.

5. Present the pricing record(s) to the user.

ExampleFinding the Associated Price and Pricing Attributes of Given Price Types (FUL & WAAMP)
for an NDC
For the purpose of demonstrating this application, the following scenario is used: A user wants to find the
ACA Federal Upper Limit (FUL) and Weighted Average of Average Manufacturer (WAAMP) prices for NDC
00904560961.

1. Retrieve the First Databank Product Identifier (FDB_PRODUCT_ID) value from the External Product Code
Table (RPRDPC0_EXT_PRODUCT_CD) where:
The NDC product code equals a value of 00904560961.
The External Product Code Type ID (EXT_PRODUCT_CD_TYPE_ID) equals a value of 1
(NDC11).
The External Product Code End Date (EXT_PRODUCT_CD_END_DT) is null.

EXT_PRODUCT_CD EXT_PRODUCT_CD_T FDB_PRODUCT_ID

EXT_PRODUCT_CD_END_DT
YPE_ID

00904560961 1 147606

In this example, an FDB_PRODUCT_ID value of 147606 is retrieved.

2. Retrieve the Price Type Identifier (PRICE_TYPE_ID) values from the Price Type Description Table
(RPRDPTD0_PRICE_TYPE_DESC) where the Price Type Short Description (
PRICE_TYPE_SHORT_DESC) and the Price Type Long Description (PRICE_TYPE_LONG_DESC) are
associated to the price type under evaluation.

PRICE_TYPE_SHORT_DESC PRICE_TYPE_LONG_DESC PRICE_TYPE_ID

WAAMP Weighted Average of Average 19

Manufacturer Prices

FUL ACA Federal Upper Limit 23

In this example, PRICE_TYPE_ID values of 19 and 23 are retrieved.

3. Retrieve the following price attributes columns from the Product Price Table
(RPRDPP0_PRODUCT_PRICE):
Price (PRICE)
Price Quantity (PRICE_QTY)
Price Unit of Measure Identifier (PRICE_UOM_ID)
Currency Code (CURRENCY_CD)
where:

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The FDB_PRODUCT_ID value equals 147606.

The PRICE_TYPE_ID equals 19 or 23.
The PRICE_EFFECTIVE_DT equals the latest date that occurs on or after the time period under
evaluation (in this example, 20160401).

FDB_PRODUCT_ID 147606 147606

PRICE_TYPE_ID 19 23

PRICE_EFFECTIVE_DT 20160401 20160401

PRICE 0.143106 0.250436

PRICE_QTY 1.0 1.0

PRICE_UOM_ID 46 46

PRICE_UOM_DESC Tablet Tablet

CURRENCY_CD USD USD

The text description for the price unit of measure shown above is provided by the
PRICE_UOM_DESC column in the Pricing Unit of Measure Table
(RPRDUOM0_PRICE_QTY_UOM).

4. Retrieve the following columns from the Product Price Attribute Table (RPRDPA0_PRICE_ATTR):
Price Attribute Code (PRICE_ATTRIBUTE_CD)
Price Attribute Sequence Number (PRICE_ATTRIBUTE_SN)
Price Attribute Value Sequence Number (PRICE_ATTRIBUTE_VALUE_SN)
Price Attribute Value (PRICE_ATTRIBUTE_VALUE)
where
The FDB_PRODUCT_ID equals 147606.
The PRICE_TYPE_ID equals 19 or 23.
The PRICE_EFFECTIVE_DT equals the latest date that occurs on or after the time period under
evaluation (in this example, 20160401).

FDB_PRODUCT_ID 147606

PRICE_TYPE_ID 23

PRICE_EFFECTIVE_DT 20160401

PRICE_ATTRIBUTE_CD 7

PRICE_ATTRIBUTE_DESC CMS ACA FUL Calculation Basis

PRICE_ATTRIBUTE_SN 1

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PRICE_ATTRIBUTE_VALUE 2

PRICE_ATTTRIBUTE_VALUE_DESC ACA FUL based on Weighted Average AMP

PRICE_ATTRIBUTE_VALUE_SN 1

In this example, the FUL price has a Price Attribute Code (PRICE_ATTRIBUTE_CD) of 7
associated to it.

The text description for the price attribute shown above is provided by the
PRICE_ATTRIBUTE_DESC column in the Product Price Attribute Type Description Table
(RPRDPAT0_PRICE_ATTR_TYPE_DESC).

The text description for the price attribute value shown above is provided by the
PRICE_ATTRIBUTE_VALUE_DESC column in the Product Price Attribute Value
Description Table (RPRDPAV0_PRICE_ATTR_VALUE_DESC).

5. Present the pricing record(s) to the user.

NDC 00904560961 00904560961

PRICE_TYPE_SHORT_DESC WAAMP FUL

PRICE 0.143106 0.250436

CURRENCY_CD USD USD

PRICE_QTY 1.0 1.0

PRICE_UOM_DESC Tablet Tablet

PRICE_EFFECTIVE_DT 20160401 20160401

PRICE_ATTRIBUTE_DESC CMS ACA FUL Calculation Basis

PRICE_ATTTRIBUTE_VALUE_DE ACA FUL based on Weighted

SC Average AMP

NDC: 00904560961
WAAMP Price: 0.143106 USD per 1.0 Tablet
Price Effective: 20160401

NDC: 00904560961
FUL Price: 0.250436 USD per 1.0 Tablet
Price Effective: 20160401
Additional Notes: CMS ACA FUL Calculation Basis: ACA FUL based on Weighted Average AMP

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Identification of the NADAC Classification for Rate Setting Value that CMS
has Assigned
This application explains how a particular price was classified by CMS.

The NADAC Classification for Rate Setting attribute (NDC_ATTRIBUTE_TYPE_CD = 57) is based on the CMS
definition within this NADAC application. Other CMS brand/generic definitions also exist using other data
elements published in MedKnowledge. Customers should fully understand which CMS application is being
considered for brand/generic applicationas well as for their own commercial use definitionswhen determining
if or how to use these brand/generic definitions.

FDB does not imply applicability of this definition for any other use of these attributes outside of NADAC.

Below is an illustration of how to identify the NADAC classification for rate setting value that CMS has assigned
using the NDC Attribute table:

1. For each National Drug Code (NDC) on the NDC Table (RNDC14_NDC_MSTR), identify NDCs assigned
the attribute code of 57 (NADAC Classification for Rate Setting) in the NDC Attribute Table
(RNDCAT0_NDC_ATTRIBUTE).

2. Select the appropriate NDC Attribute Value (NDC_ATTRIBUTE_VALUE) by its associated classification.
The NDC_ATTRIBUTE_VALUE will contain one of the following classifications:
BBrand
GGeneric
B-ANDANDC was considered brand and approved under an ANDA
B-BIOFDA-approved Biosimilar Drug

ExampleIdentifying a CMS Brand vs. a Generic Drug when NADAC Prices were Assigned

For the purpose of demonstrating this application, the following scenario is used: A user wants to
determine whether NDCs 00007488513 and 00023031304 have been classified as a brand or generic drug by
the CMS.

1. For each National Drug Code (NDC) on the NDC Table (RNDC14_NDC_MSTR) identify NDCs assigned
the NDC Attribute Type Code (NDC_ATTRIBUTE_TYPE_CD) value of 57 (NADAC Classification for Rate
Setting) in the NDC Attribute Table (RNDCAT0_NDC_ATTRIBUTE).

2. Retrieve the NDC Attribute Sequence Number (NDC_ATTRIBUTE_SN) from

RNDCAT0_NDC_ATTRIBUTE, in this case, a value of 1.

In this example, the NDC Attribute Values (NDC_ATTRIBUTE_VALUE) of B and B-ANDA are retrieved.

NDC NDC_ATTRIBUTE_ NDC_ATTRIBUTE_ NDC_ATTRIBUTE_ NDC_ATTRIBUTE_

TYPE_CD TYPE_DSC SN VALUE

00007488513 57 NADAC 1 B
Classification for
Rate Setting

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00555076802 57 NADAC 1 B-ANDA

Classification for
Rate Setting

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Determining Why a Federal Price is $0

This application demonstrates an instance where a federal price record has been set to zero and provides
additional details to aid customers in determining the reason a federal price was set to zero.

Each customer should then determine how a zero-price may be represented in their vendor system and
also understand how a payer (CMS, State Medicaid agencies, Medicare Part D, worker's compensation,
and all other payer types) will ultimately interpret this information, especially if a non-zero price exists in
prior history.

A zero will be present in a federal price type (WAAMP, FUL, NADACG, NADACB) file in two cases. When CMS
drops a previously listed NDC from the file, FDB will indicate this change by reporting a zero value for that NDC.
FDB will also report a zero price when CMS publishes an NDC with a zero value. In both cases the zero price
identifies an NDC for which there is no associated federal price type (WAAMP, FUL, NADACG, NADACB).

For NADACB and NADACG the effective date of the FDB assigned zero-price is the date of the weekly
NADAC update (normally on Wednesdays).
For FUL and WAAMP the effective date of the FDB assigned zero-price is the 1 st of the following month.

PRICE_TYPE_ID PRICE_TYPE_SHORT_DESC

19 WAAMP

23 FUL

25 NADACG

24 NADACB

Using FDB's External Product Code Tables, customers are able to view additional details to aid in determining the
reason a federal price was set to zero by querying the data in the associated Price Attribute tables.

When FDB assigns a zero price ($0), the FDB Price Note Code (Price Attribute Code = 3) is assigned,
indicating that the price was set to zero by FDB because the external product code is either no longer
listed on the external source file or a NADAC rate setting has changed for that external product code.
When CMS assigns a zero price ($0), the FDB Price Note Code is not assigned, indicating that CMS
assigned the zero ($0) price.

ExampleDetermining the Basis Used for Assigning an FUL to a Zero-Price

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For the purpose of demonstrating one such application, we will use a scenario where a payer wants to confirm the
reason NDC 68084031711 was given a current price of zero.

Refer to the Determining the FDB Product ID and Associated Product Information Given an External
Product Code (Such as an NDC) and Finding the Price and Associated Pricing Attributes of an NDC for a
Given Price Type applications for additional information.

1. Retrieve the associated FDB Product Identifier (FDB_PRODUCT_ID) from the External Product Code
Table (RPRDPC0_EXT_PRODUCT_CD) where:
The External Product Code (EXT_PRODUCT_CD) equals the NDC in question.
The External Product Code End Date (EXT_PRODUCT_CD_END_DT) is Null/Blank.
The External Product Code Type Identifier (EXT_PRODUCT_CD_TYPE_ID) value equals
"1" (NDC11 [NCPDP Formatted]).

FDB_PRODUCT_I EXT_PRODUCT_ EXT_PRODUCT_ EXT_PRODUCT_ EXT_PRODUCT_

D CD CD_ TYPE_ID CD_START_DT CD_END_DT

420195 68084031711 1 (NDC11 20091028

[NCPDP
Formatted])

2. Retrieve the FDB Product Identifier (FDB_PRODUCT_ID) and the Price Type Identifier ( PRICE_TYPE_ID)
and the Price Effective Date (PRICE_EFFECTIVE_DT) values from the Product Price Table
(RPRDPP0_PRODUCT_PRICE) where:
The FDB Product Identifier (FDB_PRODUCT_ID) equals the FDB Product Identifier
(FDB_PRODUCT_ID) value in step 1.
The Price Type Identifier (PRICE_TYPE_ID) value equals "23" (FUL).
The Price Effective Date (PRICE_EFFECTIVE_DT) is the most current date (e.g. MAX
[PRICE_EFFECTIVE_DT]).

FDB_PRODUCT_ID PRICE_TYPE_ID PRICE_EFFECTIVE_DT

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420195 23 (FUL) 20160701

3. Retrieve the FDB Product Identifier (FDB_PRODUCT_ID), the Price Type Identifier (PRICE_TYPE_ID),
Price Effective Date (PRICE_EFFECTIVE_DT), Price Attribute Code (PRICE_ATTRIBUTE_CD), Price
Attribute Sequence Number (PRICE_ATTRIBUTE_SN), Price Attribute Value Sequence Number (
PRICE_ATTRIBUTE_VALUE_SN) and the Price Attribute Value (PRICE_ATTRIBUTE_VALUE) from the
Product Price Attribute Table (RPRDPA0_PRICE_ATTR) where:
The FDB Product Identifier (FDB_PRODUCT_ID) equals the value of the FDB_PRODUCT_ID
retrieved in step 2 (420195).
The Price Type Identifier (PRICE_TYPE_ID) equals the value of the PRICE_TYPE_ID retrieved in
step 2 (23).
The Price Effective Date (PRICE_EFFECTIVE_DT) equals the value of the
PRICE_EFFECTIVE_DT retrieved in step 2 (20160701).
The Price Attribute Code (PRICE_ATTRIBUTE_CD) value equals "3" (FDB Price Note Code).

FDB_PROD PRICE_TYP PRICE_EFF PRICE_ATT PRICE_ATT PRICE_ATT PRICE_ATT

UCT_ID E_ID ECTIVE_DT RIBUTE_CD RIBUTE_SN RIBUTE_VA RIBUTE_VA
LUE_SN LUE

420195 23 20160701 3 (FDB Price 1 1 1

Note Code)

4. Use the PRICE_ATTRIBUTE_CD and the PRICE_ATTRIBUTE_VALUE retrieved in step 3 to retrieve each
Price Attribute Value Description (PRICE_ATTRIBUTE_VALUE_DESC) from the Product Price Attribute
Value Description Table (RPRDPAV0_PRICE_ATTR_VALUE_DESC) associated with this price record
where:
The PRICE_ATTRIBUTE_CD equals the value of the PRICE_ATTRIBUTE_CD in step 3.
The PRICE_ATTRIBUTE_VALUE equals the value of the PRICE_ATTRIBUTE_VALUE in step 3.

PRICE_ATTRIBUTE_CD PRICE_ATTRIBUTE_VALUE PRICE_ATTRIBUTE_VALUE_D

ESC

3 1 Price set to zero by FDB because

the external product code is either
no longer listed on the external
source file or a NADAC rate
setting has changed for that
external product code. For
example, if a NADAC rate setting
changes from a "G" to a "B", this
change will affect the price types
associated with that NDC. See
customer documentation manual
"NADAC Rate Setting Change"
for further details.

5. Display the PRICE_ATTRIBUTE_VALUE_DESC to explain the reason for the zero price.

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Identifying the NDC Deletion Reason

The purpose of this application is to demonstrate how customers can:

Identify if an NDC has been deleted or deleted and reused on the NDC Table (RNDC14_NDC_MASTER).
Access core information about the removed NDC including the FDB Product Identifier, Clinical Formulation
and MEDID descriptions, delete date and deletion reason of the deleted NDC. If the NDC is reused, then
the replacement FDB Product ID and replacement NDC attributes are provided.

The NDC Deletion Reason Table can be utilized as a supplement to the pricing files to help identify when
prices are being completely removed from the National Drug Code Price Table (RNP2_NDC_PRICE)
table.

This application illustrates how to identify if an NDC was deleted from Medknowledge and retrieve the date the
NDC was removed (NDC_DELETE_DATE), the deletion reason (NDC_DELETE_REASON) and the replacement
FDB Product ID (REPLACEMENT_FDB_PRODUCT_ID), if available, for a given NDC.

1. Use the NDC Deletion Reason Table (RNDCDR0_NDC_DELETION_REASON) to retrieve the NDC
deletion date (NDC_DELETE_DATE), deletion reason (NDC_DELETE_REASON) and associated product
information for the NDC in question.

ExampleIdentifying Deleted NDCs

For the purpose of demonstrating this application, the following scenario is used: A user wants to
determine if NDC 75137070401 was deleted.

1. Use the NDC Deletion Reason Table (RNDCDR0_NDC_DELETION_REASON) to determine if the NDC
was deleted and retrieve the NDC deletion date (NDC_DELETE_DATE), deletion reason (
NDC_DELETE_REASON) and associated product information for the NDC in question (in this case, NDC
75137070401).

Deleted NDC Attributes Replacement NDC Attributes

FDB_PRODUCT_ID 485683 769261

NDC 75137070401 75137070401

DADDNC 20140801 20161222

LBLRID A75137 A16864

MFG MEDTECH LABS MEDTECH/MOBERG

OBSDTEC 20161205 0

NDC_DELETE_DATE 20161205

NDC_DELETE_REASON MFG UPDATE - Ingredient and

Strength change due to
reformulation

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BN NEW SKIN NEW SKIN

LN60 NEW SKIN LIQUID SPRAY NEW SKIN LIQUID SPRAY

BANDAGE BANDAGE

GCN_SEQNO 72545 76918

GENERIC_MEDID 581999 592538

GENERIC_MEDID_DESC oxyquinoline 1 % topical spray benzethonium chloride 0.2 % topical

spray

MEDID 582198 592562

MED_MEDID_DESC New Skin (oxyquinoline) 1 % topical New Skin (benzethonium) 0.2 %

spray topical spray

REPLACEMENT_FDB_PRODUCT 769261
_ID

2. If the NDC was deleted from or deleted and reused on the NDC Table (RNDC14_NDC_MASTER), then
display the NDC_DELETE_REASON to explain the reason for the NDC deletion, as depicted in the
example above (MFG UPDATE - Ingredient and Strength change due to reformulation).

NDCs can be reused more than once. Choose the most current Date of Add (DADDNC) if multiple
entries are not required.

If the deletion reason is associated to a reused NDC, then the Replacement FDB Product ID (
REPLACEMENT_FDB_PRODUCT_ID) and replacement NDC attributes are provided.

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Drug Product Pricing ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

Drug Product Pricing Tables

Drug Product Pricing ERD

Drug Product Pricing Tables

Currency Code Description Table
National Drug Code Price Table
NDC Deletion Reason Table
NDC Price Type Description Table
Price Type Description Table
Pricing Unit of Measure Table
Product Price Attribute Description Table
Product Price Attribute Table
Product Price Attribute Type Description Table
Product Price Attribute Value Description Table
Product Price Table

For customers interested in receiving new NDC and pricing changes on a daily basis, First Databank
(FDB) offers the Daily Product Update for an additional fee. Refer to Information Update Options for more
information on delivery. If you are interested in receiving the Daily Product Update, contact Customer
Service.

Drug Product Pricing ERD

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Currency Code Description Table

Table Name RPRDCC0_CURRENCY_CD_DESC

Revision Activity add. 04-07-2014

Purpose Provides a full text description for a Currency Code.

Key Column Name Column Format Length Picture

Description

P CURRENCY_CD Currency Code AN 3 X(3)

CURRENCY_CD Currency Code AN 100 X(100)

_DESC Description

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National Drug Code Price Table

Table Name RNP2_NDC_PRICE

Revision Activity rev.08-01-2003

Purpose Links a drug product to a price.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

PF NPT_TYPE NDC Price Table - AN 2 X(2)

Price Type Code

P NPT_DATEC NDC Price Table - N 8 9(8)

Effective Date

NPT_PRICEX NDC Price Table - N 12 9(6).9(5)

Price

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NDC Deletion Reason Table

Table Name RNDCDR0_NDC_DELETION_REASON

Revision Activity add. 04-06-2017

Purpose Identifies NDCs that were deleted from Medknowledge, the

reason for the deletion and other relevant
attributes/identifiers including the FDB Product ID. When
the deleted NDC is reused, then the Replacement FDB
Product ID (REPLACEMENT_FDB_PRODUCT_ID) and
replacement NDC attributes are provided.

Key Column Name Column Format Length Picture

Description

PF FDB_PRODUCT_ First Databank N 11 9(11)

ID Product Identifier

NDC National Drug AN 11 X(11)

Code

DADDNC Date of N 8 9(8)

AddNDC

F LBLRID Labeler Identifier AN 6 X(6)

MFG Manufacturer AN 15 X(15)

Name

OBSDTEC Obsolete Date N 8 9(8)

NDC_DELETE_D Date NDC is N 8 9(8)

ATE removed from
Medknowledge

NDC_DELETE_R Reason why AN 200 X(200)

EASON NDC was
removed from
Medknowledge

BN Brand Name AN 30 X(30)

LN60 Label Name-60 AN 60 X(60)

F GCN_SEQNO Clinical N 6 9(6)

Formulation ID

F GENERIC_MEDI MED Generic N 8 9(8)

D Medication
Identifier

GENERIC_MEDI MED Generic AN 70 X(70)

D_DESC Medication
Description

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F MEDID MED Medication N 8 9(8)

ID

MED_MEDID_DE MED Medication AN 70 X(70)

SC Description

F REPLACEMENT_ FDB Product N 11 9(11)

FDB_PRODUCT_ Identifier
ID associated to
Reused NDC

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NDC Price Type Description Table

Table Name RNPTYPD0_NDC_PRICE_TYPE_DESC

Revision Activity add.05-01-1999

Purpose Relates the Price Type Code to its text description.

Key Column Name Column Format Length Picture

Description

P NPT_TYPE NDC Price Table - AN 2 X(2)

Price Type Code

NPT_DESC NDC Price Table - AN 6 X(6)

Price Type Code
Description

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Price Type Description Table

Table Name RPRDPTD0_PRICE_TYPE_DESC

Revision Activity add. 04-07-2014

Purpose Provides full text descriptions and a definition for a Price

Type.

Key Column Name Column Format Length Picture

Description

P PRICE_TYPE_ID Price Type N 3 9(3)

Identifier

PRICE_TYPE_SH Price Type Short AN 10 X(10)

ORT_DESC Description

PRICE_TYPE_LO Price Type Long AN 50 X(50)

NG_DESC Description

F NPT_TYPE NDC Price Table - AN 2 X(2)

Price Type Code

PRICE_TYPE_DE Price Type AN 2000 X(2000)

FINITION Definition

The NPT_TYPE is a legacy column provided for reference purposes only.

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Pricing Unit of Measure Table

Table Name RPRDUOM0_PRICE_QTY_UOM

Revision Activity add. 04-07-2014

Purpose Provides a full text description for a Pricing Unit of Measure

ID.

Key Column Name Column Format Length Picture

Description

P PRICE_UOM_ID Pricing Unit of N 8 9(8)

Measure Identifier

PRICE_UOM_DE Pricing Unit of AN 50 x(50)

SC Measure
Description

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Product Price Attribute Description Table

Table Name RPRDPAD0_PRICE_ATTR_DESC

Revision Activity add. 04-07-2014

Purpose Provides a full text description and the type code describing
the data type for a Price Attribute Code.

Key Column Name Column Format Length Picture

Description

P PRICE_ATTRIBU Price Attribute AN 8 X(8)

TE_CD Code

PRICE_ATTRIBU Price Attribute AN 100 X(100)

TE_DESC Description

F PRICE_ATTRIBU Price Attribute AN 8 X(8)

TE_TYPE_CD Type Code

PRICE_ATTRIBU Price Attribute AN 8 X(8)

TE_GROUP_CD Group Code

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Product Price Attribute Table

Table Name RPRDPA0_PRICE_ATTR

Revision Activity add. 04-07-2014

Purpose Provides additional attributes for a product price that

supplement the information provided within the Product
Price Table (RPRDPP0_PRODUCT_PRICE). The First
Databank Product Identifier, the Price Type Identifier, Price
Effective Date and Price Attribute Code form a composite
key for navigation to the associated product price.

Key Column Name Column Format Length Picture

Description

PF FDB_PRODUCT_ First Databank N 11 9(11)

ID Product Identifier

PF PRICE_TYPE_ID Price Type N 3 9(3)

Identifier

PF PRICE_EFFECTI Price Effective N 8 9(8)

VE_DT Date

PF PRICE_ATTRIBU Price Attribute AN 8 X(8)

TE_CD Code

P PRICE_ATTRIBU Price Attribute N 4 9(4)

TE_SN Sequence
Number

P PRICE_ATTRIBU Price Attribute N 4 9(4)

TE_VALUE_SN Value Sequence
Number

PRICE_ATTRIBU Price Attribute AN 255 X(255)

TE_VALUE Value

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Product Price Attribute Type Description Table

Table Name RPRDPAT0_PRICE_ATTR_TYPE_DESC

Revision Activity add. 04-07-2014

Purpose Provides the data type, optional length, and optional

precision for a Price Attribute Type Code.

Key Column Name Column Format Length Picture

Description

P PRICE_ATTRIBU Price Attribute AN 8 X(8)

TE_TYPE_CD Type Code

PRICE_ATTRIBU Price Attribute AN 100 X(100)

TE_TYPE_DESC Type Description

PRICE_ATTRIBU Price Attribute N 8 9(8)

TE_TYPE_LENG Type Length
TH

PRICE_ATTRIBU Price Attribute N 8 9(8)

TE_TYPE_PRECI Type Precision
SION

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Product Price Attribute Value Description Table

Table Name RPRDPAV0_PRICE_ATTR_VALUE_DESC

Revision Activity add. 04-07-2014

Purpose Provides full text descriptions of codified Price Attribute

Values.

Key Column Name Column Format Length Picture

Description

PF PRICE_ATTRIBU Price Attribute AN 8 X(8)

TE_CD Code

P PRICE_ATTRIBU Price Attribute AN 255 X(255)

TE_VALUE Value

PRICE_ATTRIBU Price Attribute AN 500 X(500)

TE_VALUE_DES Value Description
C

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Product Price Table

Table Name RPRDPP0_PRODUCT_PRICE

Revision Activity add. 04-07-2014

Purpose Provides the price and pricing characteristics such as

currency, quantity, and unit of measure used to accurately
define the price of a product.

Key Column Name Column Format Length Picture

Description

PF FDB_PRODUCT_ First Databank N 11 9(11)

ID Product Identifier

PF PRICE_TYPE_ID Price Type N 3 9(3)

Identifier

P PRICE_EFFECTI Price Effective N 8 9(8)

VE_DT Date

PRICE Price N 19 9(11).9(7)

PRICE_QTY Price Quantity N 19 9(11).9(7)

F PRICE_UOM_ID Pricing Unit of N 8 9(8)

Measure Identifier

F CURRENCY_CD Currency Code AN 3 X(3)

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AHFS DI Monographs (AHFS DI)

General Information
AHFS DI Monographs Editorial Policies
ERD and Technical Specifications

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AHFS DI Monographs General Information

The General Information section contains high-level information about the module.

Overview
American Society of Health-System Pharmacists (ASHP) Disclaimer

Overview
AHFS DI Monographs are professional-level full-text monographs that can be integrated into healthcare
information systems to provide a drug information resource at the point of care.

AHFS DI contains in-depth clinical drug descriptions for thousands of drug products. The American Society of
Health-System Pharmacists (ASHP) supplies the drug information contained in the AHFS DI Monographs.

Multiple monographs might link to a single Clinical Formulation ID (GCN_SEQNO), and multiple Clinical
Formulation IDs (GCN_SEQNOs) might link to a single monograph. Links between the Clinical Formulation ID
(GCN_SEQNO) and the monographs include a priority indicator. Use the priority indicator to display the most
important record first. Refer to the AHFS DI Monographs Data File Relationships ERD for a graphical
representation of these relationships.

If a single Clinical Formulation ID (GCN_SEQNO) links to multiple monographs, each link includes a priority
indicator determined by First Databank (FDB). The priority indicator contains a value 1 through 9, with 1 being the
highest priority. For example, the Clinical Formulation ID (GCN_SEQNO) for Tylenol with Codeine #3 links to
monographs for codeine and acetaminophen. The link to the monograph for codeine includes a lower number as
the priority indicator than the link to the monograph for acetaminophen because the information in the codeine
monograph is more important.

If a single monograph links to multiple Clinical Formulation IDs (GCN_SEQNOs), each link includes a priority
indicator determined by FDB. The priority indicator contains a value 1 through 6, with 1 being the highest priority.
For example, the AHFS DI monographs for Felodipine links to the following drugs:

Felodipine Tab CR 2.5 mg (priority 1)

Felodipine Tab CR 5 mg (priority 2)
Felodipine Tab CR 10 mg (priority 3)
Enalapril Maleate/Felodipine Tab CR 5/2.5 mg (priority 4)
Enalapril Maleate/Felodipine Tab CR 5/5 mg (priority 5)

If a single monograph links to more than five Clinical Formulation IDs (GCN_SEQNOs), the five most important
relationships receive a priority 1 through 5 and the remaining Clinical Formulation IDs (GCN_SEQNOs) receive a
priority of 6.

This section also provides disclaimers for the AHFS DI product.

Drug knowledge is aggregated at the Clinical Formulation ID (GCN_SEQNO), Routed Medication ID (

ROUTED_MED_ID), and the Routed Generic ID (ROUTED_GEN_ID) levels in the FDB knowledge base.

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Under certain circumstances, aggregated drug knowledge may not apply to all related packaged
products; more specific information may be found within product labels.

Please refer to FDB Disclaimer for details about FDBs disclaimer.

American Society of Health-System Pharmacists (ASHP) Disclaimer

When displaying the AHFS Drug Information monographs provided by the American Society of Health-System
Pharmacists (ASHP), the appropriate copyright and trademark notice and disclaimer must be presented on any
computer screen for a sufficient period of time to be read by an average person and/or listed on all printed
materials as shown below. The year must be changed to correspond to the date of the most recent update.

This AHFS Drug Information database is copyrighted by the American Society of Health-System
Pharmacists, Inc. 2016, ASHP, Bethesda, Maryland 20814. All Rights Reserved. Duplication must be
expressly authorized by ASHP, unless such duplication consists of printing or downloading portions of
the data inherent in the program for non-commercial use.

The American Society of Health-System Pharmacists, Inc. represents that the database provided
hereunder was formulated with a reasonable standard of care, and in conformity with professional
standards in the field. The American Society of Health-System Pharmacists, Inc. makes no
representations or warranties, express or implied, including, but not limited to, any implied warranty of
merchantability and/or fitness for a particular purpose, with respect to such database and specifically
disclaims all such warranties and representations. Users are advised that decisions regarding drug
therapy are complex medical decisions requiring the independent, informed decision of an appropriate
health care professional, and the database is provided for informational purposes only. The entire
monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and
side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or
recommend the use of any drug in the database. The information contained in the database is not a
substitute for medical care or treatment by a licensed health care provider.

In addition, you must display the content of the Copyright section at the end of a monograph as shown below
every time you display any portion of a monograph:

Selected Revisions September 2015, Copyright, October 2016, American Society of Health-System
Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

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AHFS DI Monographs Editorial Policies

AHFS Drug Information is a comprehensive collection of drug monographs for single-drug entities available in the
United States. It is a tested and proven source of comparative, unbiased, and evaluative drug information.

Most AHFS DI monographs contains information about single-drug entities. Trademarked preparation and brand
information is contained in a single monograph.

AHFS DI includes information about drug combinations in the monographs of the principal ingredients of the
combination. A separate monograph exists for a drug combination (for example Co-trimoxazole 8:40) if the
combination is important because of therapeutic rationale or frequency of use.

AHFS DI includes monographs with general statements on groups of drugs (such as Salicylates 28:08.04) if the
activities and uses of the drugs permit discussing the drugs as a class.
Information within each drug monograph is divided into sections and subsections.

Monograph Title and Synonyms

Introductory Description
Uses
Dosage and Administration
Cautions
Drug Interactions
Laboratory Test Interferences
Acute Toxicity
Chronic Toxicity
Pharmacology
Mechanism of Action
Spectrum
Resistance
Pharmacokinetics
Chemistry and Stability
Preparations
References
Copyright
Monograph Example

Not all sections or subsections are included in each monograph. The information is provided only when
applicable and necessary.

The presence or absence of a particular drug or use is not a judgment of merit by the AHFS DI.

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Monograph Title and Synonyms

The Monograph Title and Synonyms section lists the United States Adoptive Names (USAN) name or other name
for the drug(s) described. If multiple forms (for example, salts and esters) of the same drug are available, all forms
are described within the monograph. The title includes all forms if space permits. If too many forms exist to fit in
the title, the title includes the base only. If a single monograph includes information for several drug entities, the
title might be descriptive of the group, for example, Antacids 56:04.

The title also includes a graphic formula of the drug or prototype (if multiple drugs) in the style adopted by the
USAN Council and United State Pharmacopeia Convention.

Introductory Description
The Introductory Description section provides a brief chemical, structural, and pharmacologic/therapeutic
description of the drug.

Uses
The Uses section provides information on the following categories of a use of a drug:

Labeled uses. Labeled uses are approved by the US Food and Drug Administration (FDA) during labeling.
Unlabeled, of off-label, uses. Unlabeled uses are not approved by the FDA. Dagger identify unlabeled
uses within the text of the monographs.

The Uses section contains comparisons with other forms of therapy and limitations on use if appropriate. This
section often is divided by major indication.

Dosage and Administration

The Dosage and Administration section includes information about the following topics:

Reconstitution and Administration

Administration
Dosage
Dosage in Renal (and Hepatic) Impairment

Reconstitution and Administration

The Reconstitution and Administration subsection appears in the monograph in place of the Administration
subsection for injectable drugs and other dosage forms that require reconstitution. The Reconstitution and
Administration subsection provides the following information:

Instructions for reconstitution

Instructions for dilution of the dosage form
The rate of injection or infusion of the drug
Precautions associated with administration
The routes of administration

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The appropriate dosage form for each route, if necessary

Instructions for administering the drug, such as after meals or with food
Specialized methods of administration
Instructions for extemporaneous preparation of a dosage form that is not commercially available, for
example, preparation of a pediatric oral suspension from the contents of capsules

Administration
The Administration subsection appears in the monograph in place of the Reconstitution and Administration
subsection for dosage forms that do not require reconstitution. The Administration subsection provides the
following information:

The routes of administration

The appropriate dosage form for each route, if necessary
Instructions for administering the drug, such as after meals or with food
Specialized methods of administration
Instructions for extemporaneous preparation of a dosage form that is not commercially available, for
example, preparation of a pediatric oral suspension from the contents of capsules

Dosage
The Dosage subsection provides dosing information for a drug. Information in this subsection might be divided by
use. The Dosage subsection provides the following information:

Recommended and alternative dosage schedules for each dosage form and route of administration, age of
patient, and condition being treated
Dosage equivalencies
The initial, maintenance, and maximum dosages

Dosage in Renal (and Hepatic) Impairment

The Dosage in Renal (and Hepatic) Impairment subsection provides dosage information for children, geriatric or
debilitated patients, or patients with renal or hepatic impairment.

Cautions
The Cautions section includes information in the following subsections:

Adverse Effects
Precautions and Contraindications
Pediatric Precautions
Mutagenicity and Carcinogenicity
Pregnancy, Fertility, and Lactation

Adverse Effects

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The Adverse Effects subsection provides information about reasonably associated, undesirable effects of a drug
that might occur as part of its pharmacologic action or might be unpredictable in occurrence. The Adverse Effects
subsection is often divided by body system affected.

Precautions and Contraindications

The Precautions and Contraindications subsection provides the following information:

Special care practitioners and patients should take for safe and effective use of the drug
Serious adverse effects and potential safety hazards, limitations on use imposed by the hazards, and
actions to take if the hazards occur
Situations or conditions for which the drug should not be used because the risk clearly outweighs any
possible benefit

Additional sections of the drug monograph, such as Pediatric Precautions and Drug Interactions, also contain
precautions and contraindications.

Precautionary information for drugs changes frequently. Periodically review the manufacturers labeling.

Pediatric Precautions
The Pediatric Precautions subsection describes pediatric age groups for which adequate and well-controlled
studies have not established the safety or efficacy of the drug. This subsection also described the risks
associated with using the drug in children.

Geriatric Precautions
The Geriatric Precautions subsection includes precautions, warnings, and contraindications associated with the
drug in geriatric individuals. This subsection also provides some perspective regarding study and experience in
the geriatric population, including factors that might affect response and tolerance.

Not all monographs include a Geriatric Precautions subsection because of the lack of geriatric-specific
information and the current absence of FDA regulations requiring US drug manufacturers to specifically include
geriatric information in their labeling. For most monographs, geriatric information resides within the appropriate
major sections of the monograph.

Mutagenicity and Carcinogenicity

The Mutagenicity and Carcinogenicity subsection describes the mutagenic and carcinogenic potential of the drug.
The information in this subsection is derived from long-term animal studies, in vitro tests of mutagenic potential,
and pertinent evidence from human data.

Pregnancy, Fertility, and Lactation

The Pregnancy, Fertility, and Lactation subsection appears in monographs for drugs that are known to be
absorbed systemically and that are subject to FDA regulation for pregnancy labeling. This subsection provides the
following information:

A description of the safety of the drug in pregnant women. This subsection includes the FDAs pregnancy

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category, A, B, C, D, and X, if available.

A description of the safety and associated precautions of the drug in lactating women. This subsection
describes whether the drug is distributed into milk, if available, and the effects of the drug on lactation and
the nursing infant.
A list of the potential effects on the male and female reproduction capacity. This subsection describes
pertinent evidence from humans regarding effects of the drug on fertility.

Drug Interactions
The Drug Interactions section describes clinically important drug-drug and drug-food interactions, including
adverse and therapeutically useful interactions. This subsection describes the mechanism of the interaction,
associated clinical importance, precautions to observe, and management of the interaction.

Laboratory Test Interferences

The Laboratory and Test Interferences section includes information on common, well established drug/laboratory
test interferences. This subsection describes the mechanism of the interaction effects on test results and effects
on interpretation of these results. Alterations in the laboratory test results that reflect a pathologic effect of the
drug appear in the appropriate subsections of Cautions.

Acute Toxicity
The Acute Toxicity section provides the following information:

The toxic effects of the drug associated with intentional or accidental ingestion or administration of a large
dose
The single-dose amount of the drug that usually results in the symptoms of overdosage
The single-dose amount of the drug that is likely to be life-threatening
Manifestations, symptoms, laboratory findings, and potential complications of acute overdose
Plasma concentrations associated with toxicity, if well described.
Recommendations for management of acute toxicity, including those for supportive and symptomatic
treatment

Chronic Toxicity
The Chronic Toxicity section includes well described toxic effects of the drug with prolonged used. If information
on chronic toxicity is limited, the information appears in the appropriate subsection under Cautions. The Chronic
Toxicity subsection provides the following information:

The pathogens, manifestations, and treatment of chronic effects

A description of tolerance to the drug
A description of physical or psychologic dependence on the drug
Adverse effects associated with abrupt withdrawal of the drug
Appropriate measures for management

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Pharmacology
The Pharmacology section appears in monographs for drugs other than anti-infectives in place of the Mechanism
of Action, Spectrum, and Resistance sections. The Pharmacology section includes a brief statement of
pharmacologic activity and mechanism of action, often compared with similar drugs. This section includes
expanded descriptions of all pharmacologic activities and effects. Pharmacology often is subdivided by
pharmacologic effect (such as Anti-inflammatory, Analgesic) and body system affected (such as CNS, GI,
Hematologic).

Mechanism of Action
The Mechanism of Action section appears in monographs for anti-infectives in place of the Pharmacology section.
The Mechanism of Action section describes the mechanism of anti-infective activity for anti-infective agents.

Spectrum
The Spectrum section appears in monographs for anti-infectives in place of the Pharmacology section. The
Spectrum section describes the in vitro spectra of activity of anti-infectives. The subsection on Susceptibility
Testing describes factors such as pH, test media, and inoculum size that affect susceptibility tests. It also defines
susceptible and resistant organisms in terms of in vitro susceptibility test results.

In general, nomenclature for micro-organisms follows that presented in the current edition of Bergeys Manual for
Systematic Bacteriology (Williams & Wilkins) and the Approved Lists of Bacterial Names published in the
International Journal of Systematic Bacteriology. If available, in vitro susceptibility information is described
according to the National Committee for Clinical Laboratory Standards or the manufacturers labeling.

Resistance
The Resistance section appears in monographs for anti-infectives in place of the Pharmacology section. The
Resistance section provides the following information:

The mechanism of resistance of micro-organisms to anti-infective agents

The microbiologic tolerance to these agents
Cross-resistance with other anti-infective agents

Pharmacokinetics
The Pharmacokinetics section contains the following categories of information:

Absorption
Distribution
Elimination (biotransformation and excretion)

Absorption
The Absorption subsection includes the following information:

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The extent (bioavailability) and rate of absorption by usual routes of administration

Factors, such as product formulation and food, that might influence extent and rate of absorbtion
Comparative information on doses, dosage form, and routes of administration
Serum concentrations achieved
The period of time for onset, peak, and duration of pharmacologic and therapeutic effect, even if an
absorption phase does not occur, such as following IV administration
Ranges for therapeutic and toxic concentrations, for example, plasma and serum, of the drug, if
established

Distribution
The Distribution subsection provides the following information

The usual distribution of the drug into bodily tissue and fluids
The drugs propensity to cross the blood-brain barrier
The drugs propensity to cross to the placenta
The drugs propensity to distribute into milk
Protein-binding characteristics

Elimination
The Elimination subsection provides the following information:

Biotransformation and excretory characteristics of the drug

Elimination half-life and factors influencing it
Clearance, site, and extent of biotransformation
Metabolic products and their activities
Routes of elimination from the body (such as urine, feces, or bile) and factors affecting them
Effect of peritoneal dialysis and hemodialysis on elimination of the drug

Chemistry and Stability

The Chemistry and Stability section provides the following information:

A brief chemical, structural, or pharmacological description, often compared with similar drugs
Structure-activity relationships, if applicable
A physical description of all drug entities, including physical appearance, taste, odor, and solubility

Preparations
The Preparations section lists commercially available preparations of the drug. Preparations are described by
USAN or other nonproprietary name. Combination preparations are described under a separate heading (for
example, Aspirin Combinations) following the appropriate single-entity subsection (such as Aspirin).

Preparations are listed hierarchically by route of administration (alphabetically), dosage form (alphabetically), and

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strength (in order of increasing strength). If potency is described in terms other than those listed in the drug
heading (for example, potency of cefotaxime sodium is expressed in terms of cefotaxime), the labeled moiety
appears in parenthesis after the strength (such as 1 g [of cefotaxime]). Route of administration and dosage form
listings occasionally are modified (such as Injection, for IM use only, chewable, Capsules, extended-release).

A list of the proprietary names follows each preparation description. The list is alphabetical and includes the
corresponding manufacturers. Generally, multiple-source preparations that are available by nonproprietary name
do not include the manufacturers labels.

Pharmacy equivalent names (PENs) (such as co-careldopa for levodopa and carbidopa) appear in parenthesis
beside the combination heading if the PEN is established by United States Pharmacopeia (USP).

Generally, dosage forms used in the Preparations sections are the pharmaceutical dosage forms described in
USP. Several dosage forms (for example, elixir, extract, fluid extract, spirit, and tincture) appear only if the
preparation is official (USP or National Formulary [NF]). Solution generally describes all liquid preparations of
dissolved drug, regardless of solvent. If syrup is official (USP or NF), the dosage form is listed as solution, and
syrup is included only as part of the proprietary name.

This subsection include applicable legal descriptions, such as drugs subject to control under the Federal
Controlled Substances Act of 1970.

References
The References section includes the bibliography for cited references. Information included in AHFS Drug
Information does not include reference notations. All statements appearing in the publication are documented.

Reference groups within each monograph are indicated by a

Copyright
The Copyright section includes the copyright information for the monograph. You must display the content of the
Copyright section at the end every time you display any portion of the monograph.

Monograph Example
The following is an example of an AHFS monograph. This example is not representative of all monographs, nor is
it in the format or font that you might see within your systems setup. This example is for illustrative purposes only.

Fexofenadine Hydrochloride
Introduction

Fexofenadine, a second-generation antihistamine, is the active carboxylic acid metabolite of terfenadine.

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Uses
Fexofenadine shares the uses of other antihistamines, including the management of allergic rhinitis and chronic idiopathic
urticaria. For additional information on these and other uses of antihistamines, see Uses in the Antihistamines General
Statement 4:00.

Fexofenadine is the active carboxylic acid metabolite of terfenadine (no longer commercially available in the US).
Fexofenadine is thought to provide essentially all the therapeutic benefits of terfenadine while avoiding the serious
cardiotoxic and drug interaction risks of the parent drug, and therefore is considered a relatively safe alternative to
terfenadine. Although other relatively nonsedating (second generation) antihistamines that lack the cardiotoxic and drug
interaction potentials of terfenadine also are commercially available in the US, individual patients vary in their response to
antihistamines, and a specific antihistamine that provides dramatic relief without adverse effects to one patient may be
ineffective or poorly tolerated in another. Trial of various antihistamines may be necessary to determine which drug will
cause relief while causing minimal adverse effects.

Allergic Rhinitis
Fexofenadine alone or in fixed combination with pseudoephedrine hydrochloride is used to provide symptomatic relief of
seasonal allergic rhinitis (e.g., hay fever) in adults and children 6 years of age and older or in adults and children 12 years
and older, respectively. Fexofenadine provides symptomatic relief of rhinorrhea, sneezing, oronasopharyngeal itching, and
red, itching, watery eyes. Extended-release tablets containing fexofenadine hydrochloride in fixed combination with
pseudoephedrine hydrochloride also provide symptomatic relief of nasal congestion. However, it is recommended that the
fixed combination generally be used only when both the antihistaminic and nasal decongestant activity of the combination
preparation are needed concurrently.

Antihistamines are not curative and merely provide palliative relief; since seasonal allergic rhinitis may be a chronic,
recurrent condition, successful therapy often may require long-term intermittent use of these drugs.In the treatment of
seasonal allergic rhinitis, antihistamines are more likely to be beneficial when therapy is initiated at the beginning of the hay
fever season when pollen counts are low. Antihistamines are less likely to be effective when pollen counts are high, when
pollen exposure is prolonged, and when nasal congestion is prominent. Chronic nasal congestion and headache caused by
edema of the paranasal sinus mucosa are often refractory to antihistamine therapy. The drugs generally are not effective in
relieving symptoms of nasal obstruction.

Safety and efficacy of fexofenadine in the management of seasonal allergic rhinitis were established in several 2-week
multicenter, randomized, double-blind, placebo-controlled studies in patients with seasonal allergic rhinitis 1268 years of
age. In these studies, treatment with fexofenadine hydrochloride (administered in a dosage of 60 mg twice daily or 180 mg
once daily) was more effective than placebo in providing symptomatic relief of rhinorrhea, sneezing, oronasopharyngeal
itching, and itching, red, watery eyes. In addition, results of one 12-week clinical study in patients with seasonal allergic
rhinitis indicate that fexofenadine hydrochloride (given in a dosage of 60 mg twice daily) is at least as effective as
loratadine (given in a dosage of 12 mg daily) in providing relief of rhinorrhea and other subjective symptoms of such
rhinitis. The efficacy of fexofenadine reportedly is not affected by age, gender, or race.

Safety and efficacy of the extended-release fixed-combination preparation containing 60 mg of fexofenadine hydrochloride
and 120 mg of pseudoephedrine hydrochloride were established in a 2-week randomized, double-blind, active-controlled
study in patients 1265 years of age with seasonal allergic rhinitis. In this study, treatment with the fixed-combination
tablets twice daily was more effective than treatment with either drug alone in reducing the intensity of sneezing,
rhinorrhea, oronasopharyngeal itching, itchy/red/watery eyes, and nasal congestion. Clinical safety and efficacy studies
have not been conducted with the extended-release fixed-combination preparation containing 180 mg of fexofenadine
hydrochloride and 240 mg of pseudoephedrine hydrochloride. Efficacy of this preparation in the management of seasonal
allergic rhinitis is based on an extrapolation of the demonstrated efficacy of fexofenadine hydrochloride 180 mg and the
nasal decongestant properties of pseudoephedrine hydrochloride.

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Fexofenadine hydrochloride also is used to provide symptomatic relief in the treatment of seasonal allergic rhinitis in
children 6 years of age and older. Efficacy of fexofenadine hydrochloride for symptomatic treatment of seasonal allergic
rhinitis in children 6 years of age and older is based on a 2-week randomized, placebo-controlled study in children 611
years of age with seasonal allergic rhinitis and on extrapolation of the demonstrated efficacy of fexofenadine hydrochloride
in patients 12 years of age and older and on pharmacokinetic comparisons in adults and children. Results of the 2-week
multicenter, randomized, placebo-controlled study in 411 children 611 years of age with seasonal allergic rhinitis indicate
that fexofenadine hydrochloride (administered in dosages of 15, 30, or 60 mg twice daily) is more effective than placebo in
providing symptomatic relief of rhinorrhea, sneezing, oronasopharyngeal itching and red, itching, watery eyes; however, a
dose-response relationship has not been observed. In this study, fexofenadine hydrochloride dosages of 60 mg twice daily
did not appear to provide additional therapeutic benefit compared with fexofenadine hydrochloride dosages of 30 mg twice
daily. In addition, a 30-mg dose in children was reported to be comparable to a 60-mg dose in adults. Recommended
pediatric dosages are based on cross-study comparisons of the pharmacokinetics of fexofenadine in adults and children
and on safety profiles of the drug from studies in adults and children at recommended or higher doses.

Chronic Idiopathic Urticaria

Fexofenadine hydrochloride is used for the management of pruritus, erythema, and urticaria associated with chronic
idiopathic urticaria in adults and children 6 years of age and older.

Results of two 4-week multicenter, randomized, placebo-controlled studies in 726 patients with chronic idiopathic urticaria
1270 years of age indicate that fexofenadine hydrochloride (administered in dosages of 20, 60, 120, and 240 mg twice
daily) is more effective than placebo in decreasing manifestations of urticaria, relieving associated pruritus, and reducing
whealing. Symptom reduction was greater than and efficacy was maintained over the entire 4-week treatment period with
fexofenadine hydrochloride dosages of 60, 120, and 240 mg twice daily, but the 120- and 240-mg twice-daily dosages
provide no additional clinical benefit over that reported with the 60-mg twice-daily dosage.

Efficacy of fexofenadine hydrochloride for the management of chronic idiopathic urticaria in children 6 years of age and
older is based on extrapolation of the demonstrated efficacy of fexofenadine hydrochloride in adults and the likelihood that
the disease course, pathophysiology, and drug activity are substantially similar between the 2 populations.

Common Cold
Although antihistamines frequently are used for symptomatic relief in the common cold, evidence of effectiveness for the
drugs remains to be established. Antihistamines cannot prevent, cure, or shorten the course of the common cold, but may
provide some symptomatic relief. Conventional (prototypical, first generation) antihistamines (e.g., those with
anticholinergic activity) are considered effective in relieving rhinorrhea and sneezing associated with the common cold, but
evidence of efficacy in relieving oronasopharyngeal itching, lacrimation, or itching eyes associated with this condition
currently is lacking. Relatively nonsedating (second generation) antihistamines (e.g., terfenadine) do not appear to be
effective in relieving rhinorrhea associated with the common cold, suggesting that histamine is not a principal mediator of
this manifestation. The extent to which histamine contributes to other manifestations of the common cold currently is
unclear, but pathogenesis of the full constellation of symptoms that constitute the common cold appears to be complex,
involving a number of mediators and neurologic mechanisms. In several studies, terfenadine (the parent drug of
fexofenadine) was no more effective than placebo in providing symptomatic relief of the common cold.

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Dosage and Administration

Administration
Fexofenadine hydrochloride is administered orally. The manufacturer states that when fexofenadine hydrochloride is given
alone (i.e., not in fixed combination with pseudoephedrine hydrochloride) the drug may be given without regard to meals.
Since absorption and peak plasma concentrations of fexofenadine are decreased by concomitant administration of an
aluminum and magnesium hydroxides antacid (Maalox) (see Pharmacokinetics: Absorption and see Drug Interactions:
Antacids), the manufacturer recommends that the drug not be taken closely in time with an antacid containing aluminum
and magnesium. Since food appears to substantially affect the rate and extent of absorption of fexofenadine hydrochloride
when administered as the extended-release tablets of the drug in fixed combination with pseudoephedrine hydrochloride,
the manufacturer states that such extended-release tablets should be administered on an empty stomach with water. (See
Pharmacokinetics: Absorption and see Drug Interactions: Fruit Juices.) Extended-release tablets containing fexofenadine
hydrochloride in fixed combination with pseudoephedrine hydrochloride should be swallowed intact, and patients should be
instructed not to break, crush, or chew such tablets.

Dosage
Allergic Rhinitis
For symptomatic relief of seasonal allergic rhinitis, the usual dosage of fexofenadine hydrochloride for adults and children
12 years of age and older is 60 mg twice daily or 180 mg once daily. Fexofenadine hydrochloride dosages exceeding 60
mg twice daily (up to a dosage of 240 mg twice daily) do not appear to provide additional therapeutic benefit. When one of
the fixed combinations containing fexofenadine hydrochloride with pseudoephedrine hydrochloride is used for symptomatic
relief of allergic rhinitis in adults and children 12 years of age and older, the usual dosage of fexofenadine hydrochloride is
60 mg twice daily (as Allegra-D 12 Hour) or 180 mg once daily (as Allegra-D 24 Hour).

For symptomatic relief of seasonal allergic rhinitis, the usual dosage of fexofenadine hydrochloride for children 6 to
younger than 12 years of age is 30 mg twice daily.

Although peak plasma fexofenadine concentrations increased by 99% in healthy adults 65 years of age and older when
compared with those in younger adults, there appears to be no evidence of age-related differences in the mean elimination
half-lives between geriatric and younger adults. In addition, limited data indicate that the safety profile of the drug in adults
6068 years of age is similar to that in adults younger than 60 years of age. Therefore, dosage adjustment of fexofenadine
hydrochloride solely on the basis of age generally is not required for healthy geriatric patients. However, the possible need
for dosage adjustment in geriatric patients should be considered for those with decreased renal function since clearance of
the drug may be decreased and half-life prolonged in such patients. (See Dosage: Dosage in Renal and Hepatic
Impairment, in Dosage and Administration.)

Chronic Idiopathic Urticaria

For the management of chronic idiopathic urticaria, the usual dosage of fexofenadine hydrochloride for adults and children
12 years of age and older is 60 mg twice daily. The usual dosage for children 6 to younger than 12 years of age is 30 mg
twice daily.

Dosage in Renal and Hepatic Impairment

Adjustment of fexofenadine hydrochloride dosage may be necessary in patients with renal impairment. Peak plasma
fexofenadine concentrations increased by 87 or 111%, and elimination half-life increased by 59 or 72% in patients with
mild (e.g., creatinine clearance of 4180 mL/minute) or severe (creatinine clearance of 1140 mL/minute) renal
impairment, respectively, when compared with those observed in healthy individuals. In addition, peak plasma
fexofenadine concentration increased by 82% and elimination half-life increased by 31% in those on hemodialysis
(creatinine clearance of 10 mL/minute or less) compared with healthy individuals.

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The manufacturer states that adults and children 12 years of age and older with impaired renal function or those on
hemodialysis should receive an initial fexofenadine hydrochloride dosage of 60 mg daily (either given alone or in fixed
combination with 120 mg of pseudoephedrine hydrochloride [Allegra-D 12 Hour]). The fixed-combination preparation
containing 180 mg of fexofenadine hydrochloride and 240 mg of pseudoephedrine hydrochloride (Allegra-D 24 Hour)
generally should be avoided in patients with renal impairment because of a possible risk of accumulation of
pseudoephedrine.

Children 6 to younger than 12 years of age with impaired renal function should receive an initial fexofenadine hydrochloride
dosage of 30 mg daily.

Since the pharmacokinetics of fexofenadine do not appear to be altered in patients with hepatic impairment, the
manufacturer states that dosage adjustment is not necessary in such patients. The manufacturer of Allegra-D 12 Hour
and Allegra-D 24 Hour does not make specific recommendations for dosage adjustment in patients with hepatic
impairment, although it is not known if pharmacokinetics of pseudoephedrine are altered in patients with hepatic
impairment.

Cautions
Although fexofenadine is the active metabolite of terfenadine (the parent drug of fexofenadine; no longer commercially
available in the US), fexofenadine does not share the cardiotoxic and drug interaction potentials of terfenadine. In addition,
although experience with fexofenadine is far less extensive than with terfenadine, no new adverse effects, not already
associated with terfenadine, would be expected with fexofenadine since most patients receiving terfenadine have been in
fact exposed principally to fexofenadine as a result of extensive first-pass metabolism of the parent drug in the liver.
However, as with any drug, certain drug-induced adverse effects (e.g., those dependent on individual susceptibilities)
usually are not detected for several years after marketing, since the number of patients exposed during clinical trials is
small relative to the total number of individuals exposed to the drug during postmarketing surveillance.

In placebo-controlled studies, adverse effects reported in adults and children 12 years of age and older with chronic
idiopathic urticaria are similar to those in patients with seasonal allergic rhinitis. During controlled clinical studies in patients
12 years of age and older receiving oral fexofenadine hydrochloride dosages of 20240 mg twice daily or 120 or 180 mg
once daily, the incidence of fexofenadine-induced adverse effects was similar to that reported with placebo. The incidence
of adverse effects (e.g., drowsiness) was not affected by dose, age, gender, or race.Discontinuance of fexofenadine
therapy because of adverse events was reported in 2.2% of patients receiving the drug compared with 3.3% of those
receiving placebo.

Results of a clinical study indicate that adverse reactions reported to date with extended-release tablets containing
fexofenadine hydrochloride in fixed combination with pseudoephedrine hydrochloride have been similar to those reported
in patients receiving either drug as individual preparations. In one clinical trial, discontinuance of therapy was reported in
3.7, 0.5, or 4.1% of patients receiving the extended-release tablets containing fexofenadine hydrochloride (60 mg) in fixed
combination with pseudoephedrine hydrochloride (120 mg) twice daily, fexofenadine hydrochloride alone, or
pseudoephedrine hydrochloride alone, respectively. Many of the adverse effects (e.g., insomnia, headache, nausea, dry
mouth, dizziness, agitation, nervousness, anxiety, palpitation) occurring in patients receiving the commercially available
fixed combination were adverse effects that were reported mainly in patients receiving pseudoephedrine hydrochloride
alone.

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Nervous System Effects

In controlled clinical studies in patients 12 years of age and older with allergic rhinitis receiving oral fexofenadine
hydrochloride dosages of 60 mg twice daily or placebo, drowsiness or fatigue occurred in 1.3% of patients, compared with
0.9% of those receiving placebo. In these studies in patients receiving fexofenadine hydrochloride dosages of 180 mg once
daily (as conventional tablets) or placebo, headache was reported in 10.6 or 7.5% of patients, respectively. In controlled
studies in children 611 years of age with seasonal allergic rhinitis receiving fexofenadine hydrochloride dosages of 30 mg
twice daily or placebo, headache was reported in 7.2 or 6.6% of patients, respectively, while pain was reported in 2.4 or
0.4% of patients, respectively.In clinical trials in patients receiving the extended-release tablets containing fexofenadine
hydrochloride (60 mg) in fixed combination with pseudoephedrine hydrochloride (120 mg), headache occurred in 13% of
patients receiving the fixed combination, 11.5% of those receiving fexofenadine hydrochloride alone, and 17.4% of those
receiving pseudoephedrine hydrochloride alone. The incidence of headache was higher in patients receiving placebo than
in those receiving fexofenadine.

In studies of patients receiving the extended-release tablets containing fexofenadine hydrochloride (60 mg) in fixed
combination with pseudoephedrine hydrochloride (120 mg) twice daily, insomnia occurred in 12.6% of patients receiving
the combination, 3.2% of those receiving fexofenadine hydrochloride alone, and 13.3% of those receiving
pseudoephedrine hydrochloride alone. Dizziness or agitation occurred in 1.9 or 1.9% of patients receiving the combination,
respectively, 0 or 0% of those receiving fexofenadine hydrochloride alone, respectively, and 3.2 or 1.4% of those receiving
pseudoephedrine hydrochloride alone, respectively. In addition, nervousness or anxiety each occurred in 1.4% of patients
receiving the combination, 0.5 or 0% of those receiving fexofenadine hydrochloride alone, respectively, and 1.8 or 1.4% of
those receiving pseudoephedrine hydrochloride alone, respectively.

In controlled studies in adults and children 12 years of age and older with chronic idiopathic urticaria receiving
fexofenadine hydrochloride dosages of 60 mg twice daily or placebo, dizziness was reported in 2.2 or 0.6%, respectively,
while drowsiness was reported in 2.2% or 0% respectively.

Sleep disorder, insomnia, or paroniria has occurred in patients receiving fexofenadine hydrochloride.

GI Effects
During controlled clinical studies, nausea and dyspepsia were reported in 1.6 and 1.3%, respectively, of patients receiving
oral fexofenadine hydrochloride dosages of 60 mg twice daily versus 1.5 and 0.6%, respectively, of those receiving
placebo. In studies of patients receiving extended-release dosage forms of fexofenadine hydrochloride (60 mg) in fixed
combination with pseudoephedrine hydrochloride (120 mg), nausea or dry mouth occurred in 7.4 or 2.8% of patients
receiving the combination, respectively, 0.5 or 0.5% of those receiving fexofenadine hydrochloride alone, respectively, and
5 or 5.5% of those receiving pseudoephedrine hydrochloride alone, respectively. Dyspepsia or abdominal pain occurred in
2.8 or 1.4% of patients receiving the combination, respectively, 0.5 or 0.5% of those receiving fexofenadine hydrochloride
alone, respectively, and 0.9 or 0.5% of those receiving pseudoephedrine hydrochloride alone, respectively.

Cardiac Effects
Clinical data from over 2000 patients indicate that fexofenadine hydrochloride lacks the cardiotoxic potential of its parent
drug terfenadine. In 714 patients with seasonal allergic rhinitis, fexofenadine hydrochloride dosages of 60240 mg twice
daily were not associated with statistically significant mean increases in the QT interval corrected for rate (QTc) in
controlled clinical studies. In addition, in 231 healthy individuals, fexofenadine hydrochloride dosages of 240 mg given once
daily for 1 year also were not associated with statistically significant increases in the mean QTc. Even at dosages
exceeding these (e.g., up to 400 mg twice daily for 6 days in 40 patients, up to 690 mg twice daily for about 1 month in 32
patients, up to 800 mg given in a single dose in 87 patients), statistically significant mean increases in the QTc or other
ECG abnormalities have not been reported in healthy adults or patients with seasonal allergic rhinitis. In children 511
years of age, fexofenadine hydrochloride dosages of up to 60 mg twice daily were not associated with statistically
significant treatment- or dose-related increases in QTc in 2 placebo-controlled studies. In addition, no statistically
significant increases in the mean QTc interval have been reported in patients with seasonal allergic rhinitis receiving the
commercially available extended-release tablets containing 60 mg of fexofenadine hydrochloride in fixed combination with
120 mg of pseudoephedrine hydrochloride for about 2 weeks when compared with those receiving fexofenadine
hydrochloride (60 mg twice daily) or pseudoephedrine hydrochloride (120 mg twice daily) as individual drugs.

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In one patient with a preexisting increased QTc interval (494 msec) and cardiovascular abnormalities and risk factors,
additional prolongation of the QTc interval (to 532 msec) and syncope occurred 2 months after discontinuance of carvedilol
and initiation of fexofenadine hydrochloride 180 mg daily (without concomitant drug therapy). When fexofenadine
hydrochloride was discontinued (for 5 days) the QTc interval decreased to 489 msec, but the patient still experienced
serious ventricular arrhythmias 4 days after discontinuance of the drug. Upon rechallenge with the same dosage of
fexofenadine hydrochloride for 5 days, the QTc interval increased again to 512 msec, and the patient experienced
polymorphic ventricular tachycardia that rapidly progressed to ventricular fibrillation. Upon discontinuance of the drug, the
QTc interval decreased to 482 msec. Because additional increases in the QTc interval occurred with rechallenge of
fexofenadine hydrochloride, a causal relationship between these adverse cardiac effects and the drug was suggested. It
should be considered, however, that this patient had a QTc interval above normal limits while not receiving fexofenadine
hydrochloride, and the patient was prone to developing increased QTc intervals.

The clinicians reporting this case state that the possibility of fexofenadine-induced increases in QTc interval and potential
ventricular arrhythmias should be considered in susceptible patients pending further accumulation of
pharmacoepidemiologic data. However, the manufacturer questions a causal relationship in this case and, while the
possibility of an effect cannot be excluded completely, the manufacturer does not share the concern of the clinicians that
such a caution is needed in light of existing preclinical and clinical data showing no evidence of clinically important QT
prolongation with the drug, even at high dosages.

It has been suggested that the increased safety profile of fexofenadine compared with the parent drug results from the lack
of fexofenadine-induced cardiotoxicity in addition to only minimal metabolism of fexofenadine in the liver by the cytochrome
P-450 microsomal enzyme system. Evidence from animal models using fexofenadine have suggested that the apparent
lack of cardiotoxic effects of the drug may have resulted at least in part from lack of blockade of the potassium channel
involved in repolarization of cardiac cells (i.e., blockade of the delayed rectifier potassium current IK). Prolongations in the
QTc interval were not reported in dogs receiving oral fexofenadine hydrochloride dosages of 10 mg/kg daily for 5 days or in
rabbits receiving an IV fexofenadine hydrochloride dose of 10 mg/kg (resulting in plasma fexofenadine concentrations 28 or
63 times the therapeutic plasma concentrations in humans, respectively, based on a dosage of 60 mg of fexofenadine
hydrochloride given twice daily). In addition, no effect was observed on calcium-channel current, delayed
potassium-channel current, or action potential duration in guinea pig myocytes, sodium current in rat neonatal myocytes, or
on the delayed rectifier potassium channel cloned from human heart at fexofenadine concentrations up to 10-5M
(approximately equivalent to 32 times the therapeutic plasma concentrations in humans, based on a dosage of 60 mg of
fexofenadine hydrochloride given twice daily).

In studies of patients receiving the extended-release tablets containing fexofenadine hydrochloride (60 mg) in fixed
combination with pseudoephedrine hydrochloride (120 mg) twice daily, palpitation occurred in 1.9% of patients receiving
the combination, 0% of those receiving fexofenadine hydrochloride alone, and 0.9% of those receiving pseudoephedrine
hydrochloride alone.

Dermatologic and Sensitivity Reactions

Rash, urticaria, pruritus, and hypersensitivity reactions including angioedema, chest tightness, dyspnea, flushing, or
anaphylaxis have been reported rarely in patients receiving fexofenadine hydrochloride.

Other Adverse Effects

Viral infection (e.g., cold, influenza) or dysmenorrhea was reported in 2.5 or 1.5% of patients 12 years of age and older
receiving fexofenadine hydrochloride in dosages of 60 mg twice daily, respectively. In controlled clinical studies in adults
and children 12 years of age and older receiving fexofenadine hydrochloride dosages of 180 mg once daily or placebo,
upper respiratory tract infection was reported in 3.2 or 3.1% of patients, respectively, while back pain was reported in 2.8 or
1.4% of patients, respectively.

In studies of patients receiving the extended-release tablets containing fexofenadine hydrochloride (60 mg) in fixed
combination with pseudoephedrine hydrochloride (120 mg) twice daily, throat irritation or upper respiratory infection
occurred in 2.3 or 1.4% of patients receiving the combination, respectively, 1.8 or 0.9% of those receiving fexofenadine
hydrochloride alone, respectively, and 0.5 or 0.9% of those receiving pseudoephedrine hydrochloride alone, respectively.
In addition, back pain occurred in 1.9% of patients receiving the combination, 0.5% of those receiving fexofenadine
hydrochloride alone, and 0.5% of those receiving pseudoephedrine hydrochloride alone.

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In controlled studies in children 611 years of age with seasonal allergic rhinitis receiving fexofenadine hydrochloride 30
mg twice daily, upper respiratory tract infection, coughing, accidental injury, fever, and otitis media occurred in 4.3, 3.8, 2.9,
2.4, and 2.4% of children, respectively, while these adverse effects were reported in 1.7, 1.3, 1.3, 0.9, and 0%,
respectively, in those receiving placebo.

In controlled studies in adults and children 12 years and older with chronic idiopathic urticaria receiving fexofenadine
hydrochloride dosages of 60 mg twice daily or placebo, both back pain and sinusitis were reported in 2.2 or 1.1% of
patients, respectively.

Precautions and Contraindications

Although fexofenadine does not share the cardiotoxic potential of its parent drug terfenadine, fexofenadine has been
associated with increased QTc interval, syncope, and ventricular arrhythmia in at least one susceptible patient with
preexisting cardiovascular risk. (See Cautions: Cardiac Effects.) In addition, although drug interactions between
fexofenadine and certain drugs have been reported, fexofenadine does not share the drug interaction potential of
terfenadine. (See Drug Interactions.) If a fixed-combination preparation containing fexofenadine hydrochloride with
pseudoephedrine hydrochloride is used, the cautions, precautions, and contraindications associated with pseudoephedrine
must be considered.

Patients receiving preparations containing fexofenadine hydrochloride in fixed combination with pseudoephedrine
hydrochloride should be instructed to take the drug only as prescribed and not to exceed the prescribed dosage. Patients
also should be advised not to use other antihistamines or decongestants for self-medication. If nervousness, dizziness, or
sleepiness occurs during therapy, patients should be advised to discontinue use of the fixed-combination preparation and
consult a clinician. Patients also should be instructed to store the drug in a tightly closed container in a cool, dry place, and
away from children. Patients receiving the extended-release fixed-combination preparation containing 60 mg of
fexofenadine hydrochloride and 120 mg of pseudoephedrine hydrochloride (Allegra-D 12 Hour) should be informed that
the inert tablet ingredients occasionally may be eliminated in feces in a form that may resemble the original tablet.

Fexofenadine is contraindicated in patients who are hypersensitive to the drug or any ingredient in its formulation.

Pediatric Precautions
Safety and efficacy of fexofenadine hydrochloride have not been established in children younger than 6 years of age. The
safety of fexofenadine hydrochloride for symptomatic relief of seasonal allergic rhinitis in children 611 years of age is
based on 2 placebo-controlled studies in which dosages of 30 mg twice daily of the drug were administered for 2 weeks.
(See Uses) The safety of fexofenadine hydrochloride for the management of chronic idiopathic urticaria in children 611
years of age is based on cross-study comparisons of the pharmacokinetics of fexofenadine in adults and children and on
the safety profile of fexofenadine in both adults and children at recommended or higher dosages. Recommended pediatric
doses are based on cross-study comparisons of the pharmacokinetics of fexofenadine in adults and children and on safety
profiles of the drug from studies in adults and children at recommended or higher doses. In addition, fexofenadine
hydrochloride (20240 mg given twice daily for up to 2 weeks) has been used in adolescents 1216 years of age, and
adverse effects reported in this age group were similar to those reported in individuals older than 16 years of age.

Safety and efficacy of fexofenadine in fixed combination with pseudoephedrine hydrochloride have not been established in
children younger than 12 years of age, and use of such preparations (Allegra-D 12 Hour and Allegra-D 24 Hour) is not
recommended in this age group. In addition, it should be noted that the doses of fexofenadine hydrochloride and
pseudoephedrine hydrochloride in the fixed-combination preparations exceed those recommended for children younger
than 12 years of age.

Geriatric Precautions
Fexofenadine hydrochloride (20240 mg given twice daily for up to 2 weeks) has been used in patients 6068 years of
age, and adverse effects reported in this age group were similar to those reported in younger adults.

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Clinical studies of fexofenadine hydrochloride capsules and conventional tablets and of extended-release tablets
containing fexofenadine hydrochloride in fixed combination with pseudoephedrine hydrochloride did not include sufficient
numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger
patients. Although clinical experience generally has not revealed differences in responses between geriatric and younger
patients to the drug, it should be considered that fexofenadine is substantially excreted by the kidneys and the risk of
severe adverse reactions to the drug may be increased in patients with impaired renal function. Because geriatric patients
may have decreased renal function, the manufacturer states that monitoring renal function may be useful and dosage
should be selected with caution in these patients. In addition, it should be considered that geriatric patients receiving the
extended-release tablets containing fexofenadine hydrochloride in fixed combination with pseudoephedrine hydrochloride
may be especially sensitive to, and are more likely to have adverse effects from, administration of sympathomimetic
amines than younger patients. For further information about the effects of pseudoephedrine in geriatric patients, see
Cautions: Precautions and Contraindications in Pseudoephedrine 12:12.

Mutagenicity and Carcinogenicity

No evidence of mutagenicity was seen when fexofenadine was tested in vitro for bacterial reverse mutation, CHO/HGPRT
forward mutation, and rat lymphocyte chromosomal aberration assays. The drug also did not exhibit mutagenic potential in
vivo in the mouse bone marrow micronucleus test. Mutagenic studies have not been performed using the
fixed-combination tablets containing fexofenadine hydrochloride and pseudoephedrine hydrochloride.

No evidence of carcinogenesis was seen in mice and rats receiving oral terfenadine (the parent drug of fexofenadine; no
longer commercially available in the US) dosages up to 150 mg/kg daily for 18 and 24 months, respectively, resulting in
fexofenadine exposure levels calculated to be of 23 times the maximum recommended daily oral human dosage.
Carcinogenicity studies have not been performed using the fixed-combination tablets containing fexofenadine
hydrochloride and pseudoephedrine hydrochloride.

Pregnancy, Fertility, and Lactation

Pregnancy
Reproduction studies in mice receiving fexofenadine doses up to 3730 mg/kg (approximately 1015 times the maximum
recommended daily oral human dosage of fexofenadine hydrochloride in adults) have not revealed evidence of adverse or
teratogenic effects during gestation. Reproduction studies in rats and rabbits using oral terfenadine dosages up to 300
mg/kg resulting in fexofenadine exposure levels calculated to be about 34 and 2531 times, respectively, those resulting
from the maximum recommended daily oral human dosage of fexofenadine hydrochloride in adults have not revealed
evidence of teratogenicity. However, in rats, oral terfenadine dosages of 150 mg/kg, resulting in fexofenadine exposure
levels calculated to be about 34 times those resulting from the maximum recommended daily oral human dosage of
fexofenadine hydrochloride in adults (based on comparison of the AUC), were associated with decreased weight gain and
neonatal survival in the pups.

Reproduction studies in rats and rabbits using terfenadine and pseudoephedrine hydrochloride in a fixed-combination ratio
of 1:2 at dosages of 150/300 (corresponding to fexofenadine AUCs of about 34 times the maximum recommended adult
therapeutic value and to pseudoephedrine hydrochloride dosages about 10 times the maximum recommended human
adult daily oral dosage, on a mg/m2 basis) and 100/200 mg/kg daily (corresponding to fexofenadine AUCs of about 810
times the maximum recommended adult therapeutic value and to pseudoephedrine hydrochloride dosages about 15 times
the maximum recommended human adult daily oral dosage, on a mg/m2 basis), respectively, have revealed evidence of
reduced fetal weight; delayed ossification with wavy ribs also was observed in rats receiving the drug at these dosages.

There are no adequate and controlled studies to date using fexofenadine in pregnant women, and fexofenadine
hydrochloride alone or in fixed combination with pseudoephedrine hydrochloride should be used during pregnancy only
when the potential benefits justify the possible risks to the fetus.

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Fertility
Reproduction studies in male and female mice receiving fexofenadine doses up to 4438 mg/kg (approximately 1015 times
the maximum recommended daily oral human dosage of fexofenadine hydrochloride in adults) have not revealed evidence
of impaired fertility. Reproduction studies in rats using terfenadine dosages of 150 mg/kg (resulting in fexofenadine
exposure levels calculated to be about 34 times those resulting from the maximum recommended daily oral human
dosage of fexofenadine hydrochloride) revealed dose-related decreases in implantation and an increased incidence of
postimplantation losses. Reproduction studies to evaluate effects on fertility have not been performed using the
fixed-combination tablets containing fexofenadine hydrochloride and pseudoephedrine hydrochloride.

Lactation
It is not known if fexofenadine hydrochloride is distributed into breast milk; however, pseudoephedrine hydrochloride
distributes into breast milk. Since there are no adequate and controlled studies to date on the use of fexofenadine during
lactation in humans and because many drugs are excreted in human milk, the manufacturer states that fexofenadine alone
or in fixed combination with pseudoephedrine hydrochloride should be used with caution in nursing women, and a decision
should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

Drug Interactions
Drugs Affecting Hepatic Microsomal Enzymes
The increased safety profile of fexofenadine compared with the parent drug terfenadine (no longer commercially available
in the US) appears to result from the lack of cardiotoxicity in addition to minimal metabolism of fexofenadine in the liver by
the cytochrome P-450 (CYP) microsomal enzyme system. Evidence from animal models using fexofenadine has
suggested that the lack of cardiotoxic effects of the drug may result at least in part from lack of blockade of the potassium
channel involved in repolarization of cardiac cells (i.e., blockade of the delayed rectifier potassium current IK).

Anti-infective Agents
Increased concentrations of fexofenadine have been reported in 2 controlled drug interaction studies in healthy individuals
receiving 120 mg of fexofenadine hydrochloride twice daily concomitantly with erythromycin dosages of 500 mg every 8
hours or ketoconazole 400 mg once daily. In these studies, area under the plasma-concentration time curve (AUC) of
fexofenadine increased by 109 or 164% following concomitant administration with erythromycin or ketoconazole,
respectively, while peak plasma concentrations of fexofenadine increased by 82 or 135%, respectively. However, no
clinically important adverse effects or changes in the QT interval corrected for rate (QTc) were reported after concomitant
administration of erythromycin or ketoconazole with fexofenadine. Increases in fexofenadine plasma concentrations
observed during the drug interaction studies were within the range of plasma fexofenadine concentrations achieved with
fexofenadine alone in clinical trials.

Data from in vitro, in situ, and in vivo studies in animals indicate that erythromycin and ketoconazole enhance absorption of
concomitantly administered fexofenadine, possibly by affecting mechanisms of transport systems such as p-glycoprotein.
In vivo animal studies suggest that, in addition to enhancing fexofenadine absorption, ketoconazole decreases
fexofenadine GI secretion, while erythromycin also may decrease biliary excretion.

Fexofenadine did not alter the pharmacokinetics of erythromycin or ketoconazole. No statistically significant increases in
mean QTc interval have been reported in healthy adults or patients with seasonal allergic rhinitis receiving fexofenadine
hydrochloride dosages up to 400 mg twice daily (for 6 days) or 60240 mg twice daily (for 2 weeks), respectively, in
several controlled clinical studies.

Antacids
Administration of a single 120-mg dose (2 capsules of 60 mg) of fexofenadine hydrochloride within 15 minutes of
administration of an aluminum and magnesium hydroxides antacid (Maalox) decreased the AUC and peak plasma
concentration of fexofenadine by 41 and 43%, respectively. Therefore, the manufacturer states that fexofenadine (alone or
in fixed combination with pseudoephedrine hydrochloride) should not be taken closely in time with antacids containing
aluminum and magnesium.

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Fruit Juices
Fruit (grapefruit, orange, apple) juices may reduce bioavailability and systemic exposure of fexofenadine. In clinical studies,
the size of wheal and flare was substantially larger when fexofenadine hydrochloride was administered with grapefruit juice
or orange juice compared with water; based on literature reports, the same effects may be extrapolated to other fruit juices
such as apple juice. The clinical importance of these observations is unknown. Based on a population pharmacokinetic
analysis of combined data from the studies using concomitant grapefruit juice or orange juice with data from a
bioequivalence study, bioavailability of fexofenadine was reduced by 36%. Therefore, to maximize the effects of
fexofenadine, the manufacturer recommends that the drug be administered with water.

Pseudoephedrine
When fexofenadine hydrochloride is used concomitantly with pseudoephedrine hydrochloride, the pharmacokinetics of
either drug are not altered.

Monoamine Oxidase Inhibitors

Because monoamine oxidase (MAO) inhibitors potentiate the pressor effects of sympathomimetic drugs (e.g.,
pseudoephedrine), fixed-combination extended-release tablets containing fexofenadine hydrochloride and
pseudoephedrine hydrochloride are contraindicated in patients receiving an MAO inhibitor, or for 2 weeks after
discontinuance of an MAO inhibitor. For further information about drug interactions with pseudoephedrine, see
Pseudoephedrine Hydrochloride 12:12.

Laboratory Test Interferences

Although the effect of fexofenadine on antigen skin-testing procedures has not been fully elucidated, based on the effect of
terfenadine (no longer commercially available in the US) on intradermal histamine-induced whealing and pending further
accumulation of data, the manufacturer suggests that the antihistamine be discontinued at least 2448 hours prior to
performing these tests.

Acute Toxicity
Pathogenesis and Manifestations
Limited information is available on the acute toxicity of fexofenadine in humans; however, dizziness, drowsiness, and dry
mouth have been reported. Single fexofenadine hydrochloride doses up to 800 mg and fexofenadine hydrochloride
dosages of 690 mg twice daily for 1 month or fexofenadine hydrochloride dosages of 240 mg once daily for 1 year have
been well tolerated in adults. The median lethal dose in newborn rats was 438 mg/kg (2030 times the maximum
recommended human daily dose on a mg/m2 basis). No clinical signs of toxicity, gross pathologic findings, or fatalities
have been reported in mice and rats receiving oral fexofenadine hydrochloride doses up to 5 g/kg (110170 and 230340
times the maximum recommended daily oral dosage in adults, respectively, or 200 and 400 times the maximum
recommended daily oral dosage in children, respectively, based on body surface area). In addition, no evidence of toxicity
was observed in dogs receiving oral fexofenadine hydrochloride doses up to 2 g/kg (300450 times the maximum
recommended daily oral dosage in adults or 530 times the maximum recommended daily oral dosage in children, based on
body surface area).

Treatment
For the treatment of fexofenadine overdosage, usual measures to remove unabsorbed drug from the GI tract, and
supportive and symptomatic treatment should be initiated. Experience with terfenadine (no longer commercially available in
the US), the parent drug, indicates that fexofenadine is not effectively removed by hemodialysis. Management of
overdosage with the fixed combination of fexofenadine hydrochloride and pseudoephedrine hydrochloride should also
include measures for the management of pseudoephedrine overdosage.

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Pharmacology
Fexofenadine is a specific, selective, histamine H1-receptor antagonist. The pharmacology of fexofenadine resembles that
of other currently available antihistamines; however, the overall pharmacologic profile of fexofenadine, like that of
terfenadine (no longer commercially available in the US), differs from that of these other drugs. Fexofenadine is the active
carboxylic acid metabolite of terfenadine, and some of the available information on the pharmacologic activity of this
metabolite is derived from studies in which the parent drug terfenadine and not fexofenadine was employed. Although the
pharmacologic activity of fexofenadine generally is thought to mimic that of the parent drug, some differences in
pharmacologic actions between the parent drug and fexofenadine do exist (e.g., cardiotoxic potential).

Fexofenadine has been shown to inhibit histamine release from peritoneal mast cells in rats. Unlike terfenadine,
fexofenadine does not block the potassium channel involved in repolarization of cardiac cells (i.e., blockade of the delayed
rectifier potassium current IK). As a result, fexofenadine lacks the cardiotoxic potential of terfenadine. Fexofenadine also
does not possess appreciable anticholinergic, antidopaminergic, or a- or -adrenergic blocking effects at usual
antihistaminic doses in pharmacologic studies.

Unlike most other currently available antihistamines (e.g., chlorpheniramine, diphenhydramine, pyribenzamine) but like
cyproheptadine, terfenadine, the parent drug of fexofenadine, appears to have a dual effect on histamine H1-receptors. In
vitro studies indicate that terfenadine competitively antagonizes the actions of histamine at concentrations of about 1547
ng/mL, while a relatively irreversible antagonism occurs at higher concentrations (i.e., 150470 ng/mL). Experimental
evidence indicates that terfenadine exhibits a specific and selective antagonism of histamine H1-receptors and that the
drug slowly binds to the H1-receptor and forms a stable complex from which it subsequently slowly dissociates. These
findings suggest that the prolonged and generally irreversible nature of terfenadines antagonism of histamine results
principally from the drugs slow dissociation from the H1-receptors.

In vitro, terfenadine exhibits a similar affinity for histamine H1-receptors from brain and peripheral tissues; however, in vivo,
unlike first generation antihistamines, terfenadine and fexofenadine do not readily cross the blood-brain barrier and
therefore do not appear to interact appreciably with H1-receptors within the CNS at usual doses. In animals, high doses
(i.e., up to 1 g/kg orally or 100 mg/kg intraperitoneally) of terfenadine did not appear to cause appreciable CNS effects. The
incidence of CNS effects (e.g., sedation, EEG disturbances, impaired psychomotor performance) associated with
fexofenadine in clinical studies is similar to that with placebo and less than that with first generation antihistamines (e.g.,
chlorpheniramine, clemastine, diphenhydramine, triprolidine). (See Cautions: Nervous System Effects.) At therapeutic
dosages, terfenadine generally has little, if any, clinically important effect on the EEG, sleep time, sleep latency, or rapid
eye movement (REM) sleep.

Pharmacokinetics
The pharmacokinetics of fexofenadine hydrochloride in patients with seasonal allergic rhinitis and chronic idiopathic
urticaria are similar to those in healthy individuals. In addition, the pharmacokinetics of the drug in patients with hepatic
impairment are similar to those observed in healthy individuals. No clinically important gender-related differences were
observed in the pharmacokinetics of fexofenadine.

Absorption
Fexofenadine hydrochloride is rapidly absorbed from the GI tract following oral administration. Following oral administration
of two 60-mg fexofenadine hydrochloride capsules, peak plasma concentrations are achieved in about 2.6 hours. Following
oral administration of a single 60-mg capsule or 60- or 180-mg conventional tablet in healthy individuals, mean peak
plasma concentrations were 131, 142, and 494 ng/mL, respectively. In healthy men, peak plasma concentrations of 167
ng/mL were achieved within 1.42 hours following oral administration of 60-mg fexofenadine hydrochloride doses every 12
hours for 9 doses. In healthy individuals, steady-state peak plasma concentrations averaged 286 ng/mL following
administration of 60 mg of fexofenadine hydrochloride oral solution every 12 hours for 10 doses. Following multiple-dose
administration of fexofenadine 20, 60, 120, or 240 mg twice daily to healthy individuals, the steady-state peak plasma
concentration and area under the plasma-concentration time curve (AUC) of the drug were proportional to the dosage
administered.

The manufacturer states that the capsule formulation of fexofenadine hydrochloride is bioequivalent to the conventional
tablet formulation of the drug.

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Following oral administration of a single 60-mg dose of fexofenadine hydrochloride (given in fixed combination with 120 mg
of pseudoephedrine hydrochloride), mean peak plasma fexofenadine concentrations of 191 ng/mL are reached within 2
hours; following multiple-dose administration, steady-state, peak plasma fexofenadine concentrations of 255 ng/mL are
reached within 2 hours after a dose. Following single- or multiple-dose administration of the fixed-combination preparation
containing 180 mg of fexofenadine hydrochloride and 240 mg of pseudoephedrine hydrochloride, mean peak plasma
fexofenadine concentrations of 634 or 674 ng/mL, respectively, are achieved within 1.82 hours after administration.

Following oral administration of fexofenadine hydrochloride capsules in fasting children (mean age: 811.6 years) with a
history of allergic rhinitis with or without mild asthma, peak plasma fexofenadine concentrations of about 178 or 286 ng/mL
were attained in approximately 2.4 hours after a 30- or 60-mg dose, respectively. Following oral administration of a 60-mg
dose of fexofenadine hydrochloride, the AUC was 56% greater in children 712 years of age with allergic rhinitis than in
healthy adults. Plasma exposure in children receiving 30 mg of fexofenadine hydrochloride is similar to that of adults
receiving 60 mg of the drug. Limited data indicate that peak plasma fexofenadine concentrations in adolescents (1216
years of age) were similar to those in adults, while peak plasma concentrations in geriatric adults (65 years of age and
older) were 99% greater than in healthy individuals younger than 65 years of age. AUC also was higher in geriatric adults
(6580 years of age) than in younger adults (1945 years of age); however, these values were considered to be within
accepted limits. In addition, peak plasma concentrations of fexofenadine were 87 and 111% higher in patients with mild
(creatinine clearance of 4180 mL/minute) to severe (creatinine clearance of 1140 mL/minute) renal impairment,
respectively, compared with those observed in healthy adults. In patients undergoing dialysis (creatinine clearance of 10
mL/minute or less), peak plasma concentrations of fexofenadine were 82% higher than in healthy adults. Pharmacokinetics
of fexofenadine appear to be linear for oral dosages up to 120 mg twice daily.

Concomitant oral administration of fexofenadine hydrochloride with pseudoephedrine hydrochloride has little, if any, effect
on the bioavailability of either drug. The commercially available fixed combinations containing the drugs reportedly are
bioequivalent to concurrent oral administration of the drugs as individual preparations.

Food may decrease peak plasma concentrations of fexofenadine hydrochloride capsules by 17%; however, time to achieve
peak plasma concentrations of the drug does not appear to be affected. Furthermore, the pharmacokinetics of
fexofenadine were not substantially altered when the contents of the 60-mg capsule were mixed with applesauce prior to
administration. Therefore, the manufacturer states that fexofenadine hydrochloride capsules may be given without regard
to meals. Absorption and peak plasma concentrations of fexofenadine are decreased when the drug is administered within
15 minutes of an antacid containing aluminum and magnesium hydroxides. Administration of 120 mg (two 60-mg capsules)
of fexofenadine hydrochloride within 15 minutes of administration of an aluminum and magnesium hydroxides antacid
(Maalox) resulted in 41 and 43% decreases of AUC and peak plasma concentrations of fexofenadine, respectively. The
manufacturer states that fexofenadine hydrochloride should not be taken closely in time with antacids containing
magnesium and aluminum.

Administration of the extended-release tablets of fexofenadine hydrochloride in fixed combination with pseudoephedrine
hydrochloride concomitantly with food appears to substantially affect the rate and/or extent of absorption of fexofenadine
hydrochloride. When the fixed-combination preparation containing 60 mg of fexofenadine hydrochloride and 120 mg of
pseudoephedrine hydrochloride was administered with a high-fat meal, peak plasma concentrations and AUC of
fexofenadine decreased by 46 and 42%, respectively, while time to reach peak plasma concentrations of fexofenadine was
delayed by 50%. When the fixed-combination preparation containing 180 mg of fexofenadine hydrochloride and 240 mg of
pseudoephedrine hydrochloride was administered 30 minutes or 1.5 hours after a high-fat meal, peak plasma
concentrations and AUC of fexofenadine decreased by 54 and 42%, respectively. Fruit (grapefruit, orange, apple) juices
also may reduce bioavailability and systemic exposure of fexofenadine. (See Drug Interactions: Fruit Juices.) Food did not
appear to affect the rate or extent of absorption of pseudoephedrine following administration of the fixed-combination
preparations. Therefore, the manufacturer states that the extended-release tablets of fexofenadine hydrochloride in fixed
combination with pseudoephedrine hydrochloride should be administered on an empty stomach with water.

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Following oral administration of fexofenadine hydrochloride 60-mg capsules or extended-release tablets of the drug in fixed
combination with pseudoephedrine hydrochloride in a limited number of patients with seasonal allergic rhinitis, the onset of
antihistaminic action occurs within 13 hours. Following oral administration of single and twice-daily doses of 20 and 40 mg
of fexofenadine hydrochloride in healthy individuals, the antihistaminic effect of the drug (as determined by suppression of
the wheal and flare responses induced by intradermal administration of histamine) is apparent within 1 hour, maximal
within 23 hours, and persists for about 12 hours. Antihistaminic effect (as determined by suppression of the wheal and
flare responses induced by allergens) of the drug may persist for up to 2 days in ragweed-sensitive patients receiving
twice-daily doses of 60 mg of fexofenadine hydrochloride. There was no evidence of tolerance to these effects
(tachyphylaxis) after 28 days of therapy; however, the clinical importance of this finding is not known. Following oral
administration of a single 30- or 60-mg dose of fexofenadine in children (mean age: 712 years), the antihistaminic effect
(as determined by suppression of the wheal and flare responses induced by intradermal administration of histamine) is
apparent within 12 hours, maximal within 3 hours, and greater than 49 and 74% inhibition of wheal and flare area,
respectively, were maintained for 8 hours; the antihistaminic effect may persist up to 24 hours, depending on the dose of
the drug administered and the concentration of histamine used. Following oral administration of 60 mg of fexofenadine
hydrochloride in patients with seasonal allergic rhinitis who were exposed to ragweed pollen, symptomatic relief of allergic
reactions (excluding nasal congestion) was evident within 60 minutes and was maintained for about 12 hours.

Distribution
Distribution of fexofenadine into human body tissues and fluids has not been fully elucidated. Following oral administration
of fexofenadine hydrochloride in animals, the drug is distributed into the small and large intestines, stomach, pancreas,
liver, and kidney. Fexofenadine distributes more extensively into plasma than into blood or saliva. The drug does not
appear to cross the blood-brain barrier. It is not known if fexofenadine crosses the placenta or is distributed into breast
milk. Fexofenadine is 6070% bound to plasma proteins, principally albumin and a1-acid glycoprotein. Following oral
administration of single 30- or 60-mg doses of fexofenadine hydrochloride as capsules in fasting children (mean age:
811.6 years), the apparent volume of distribution was about 5.4 or 5.8 L/kg, respectively.

Elimination
Following oral administration of 60 mg of fexofenadine hydrochloride twice daily in healthy individuals, the mean elimination
half-life of the drug at steady state reportedly is about 14.414.6 hours; mean elimination half-life reportedly was similar in
geriatric adults (65 years of age or older) who received a single 80-mg oral dose of fexofenadine hydrochloride. In addition,
elimination half-life was about 18 hours in fasting children (mean age: 811.6 years) who received single oral 30- or 60-mg
doses of fexofenadine hydrochloride as capsules. In patients with mild (creatinine clearance of 4180 mL/minute) to severe
(creatinine clearance of 1140 mL/minute) renal impairment, mean elimination half-lives were 59 and 72% longer than
those observed in healthy individuals, respectively. In patients undergoing dialysis (creatinine clearance of 10 mL/minute or
less), elimination half-life was 31% longer than in healthy individuals. About 5% of a single oral dose of fexofenadine is
metabolized.

Negligible amounts of fexofenadine (about 0.51.5% of a dose) are metabolized in the liver by the cytochrome P-450
microsomal enzyme system to an inactive metabolite, while about 3.5% of a fexofenadine dose is metabolized by a second
metabolic pathway (unrelated to the cytochrome P-450 microsomal enzyme system) to the methyl ester derivative of
fexofenadine. The methyl ester metabolite of fexofenadine is found only in feces, and it has been suggested that the
intestinal flora probably are involved in this metabolism. Limited data indicate that oral clearance of the drug is 33% lower
in females than in males, although renal clearance of the drug appears to be similar in both genders. In addition, oral
clearance in geriatric adults (6580 years of age) was lower than in younger adults (1945 years of age). Following oral
administration of a 30- or 60-mg dose of fexofenadine hydrochloride capsules in fasting children (mean age: 811.6 years),
clearance rates averaged about 14.4 or 18.4 mL/minute per kg, respectively.

Fexofenadine is eliminated principally in feces; however, because the absolute bioavailability of fexofenadine hydrochloride
has not been established, it remains to be established whether fecal component represents unabsorbed drug or it is the
result of biliary excretion. The drug also is excreted in urine, and approximately 80 and 1112% of the drug is excreted in
feces and urine, respectively.

Chemistry and Stability

Chemistry

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Fexofenadine is a butyrophenone-derivative antihistamine. The drug is the active carboxylic acid metabolite of terfenadine
(no longer commercially available in the US) (i.e., terfenadine carboxylate), and unchanged terfenadine, not fexofenadine,
is thought to be principally responsible for the cardiotoxic potential of terfenadine. (See Drug Interactions: Drugs Affecting
Hepatic Microsomal Enzymes, in the Antihistamines General Statement 4:00.) Because distribution of fexofenadine into the
CNS is limited with a resultant decreased potential for adverse CNS effects compared with prototypical antihistamines,
fexofenadine has been referred to as a relatively nonsedating or second generation antihistamine.

Fexofenadine hydrochloride occurs as a white to off-white crystalline powder and is slightly soluble in water, having an
aqueous solubility of 2.2 mg/mL at 25C. The drug is freely soluble in alcohol, having a solubility of more than 300 mg/mL
at 25C. The pKa(s) of the drug are 4.25 and 9.53 at 25C. Fexofenadine hydrochloride occurs as a racemic mixture and
exists as a zwitterion in aqueous media at physiologic pH. Both enantiomers (R[+] and S[-]) have approximately equal
antihistaminic activity.

Allegra-D 12 Hour and Allegra-D 24 Hour tablets contain 60 or 180 mg of fexofenadine hydrochloride, respectively, in
an immediate-release layer and 120 or 240 mg of pseudoephedrine hydrochloride, respectively, in an extended-release
matrix layer that slowly releases the drug.

Stability
Fexofenadine hydrochloride capsules, conventional tablets, and the extended-release tablets containing fexofenadine
hydrochloride in fixed combination with pseudoephedrine hydrochloride should be stored at controlled room temperature
between 2025C; foil-backed blister packages containing the drug should be protected from excessive moisture.

Commercially available fexofenadine hydrochloride capsules have an expiration date of 18 or 24 months after the date of
manufacture when packaged in the manufacturers unopened blister packages or high-density polyethylene bottles,
respectively. Commercially available fexofenadine hydrochloride 30-mg conventional tablets have an expiration date of 18
months after the date of manufacture when packaged either in the manufacturers unopened blister packages or
high-density polyethylene bottles, whereas the commercially available fexofenadine hydrochloride 60-mg conventional
tablets have an expiration date of 30 months after the date of manufacture when packaged either in the manufacturers
unopened blister packages or high-density polyethylene bottles. In addition, fexofenadine hydrochloride 180-mg
conventional tablets have an expiration date of 18 or 30 months after the date of manufacture when packaged either in the
manufacturers unopened blister packages or high-density polyethylene bottles, respectively.

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Preparations
Fexofenadine Hydrochloride

Route Form Strength Brand

Oral Capsules 60 mg Allegra, Aventis

Tablets, film-coated 30 mg Allegra ( with povidone),

Aventis

60 mg Allegra ( with povidone),

Aventis

180 mg Allegra ( with povidone),

Aventis

Fexofenadine Combinations

Route Form Strength Brand

Oral Tablets, extended-release 60 mg with Allegra-D 12 Hour,

layer (pseudoephedrine Pseudoephedrine Aventis
hydrochloride only), Hydrochloride 120 mg
film-coated

180 mg with Allegra-D 24 Hour,

Pseudoephedrine Aventis
Hydrochloride 240 mg

References

Aventis. Allegra (fexofenadine hydrochloride) capsules and tablets prescribing information. Kansas City, MO; 2003 May.

Hoechst Marion Roussel, Inc. Product information form for American hospital formulary service: Allegra (fexofenadine
HCl). Kansas City, MO; 1996.

Sorkin EM, Heel RC. Terfenadine: a review of its pharmacodynamic properties and therapeutic efficacy. Drugs. 1985;
29:34-56. (IDIS 197286) (PubMed 2857636)

Borge PA. Problems in allergic rhinitis. Arzneimittelforschung. 1982; 32:1199-201. (PubMed 6891258)

Buckley CE, Klemawesch SJ, Lucas SK. Treatment of allergic rhinitis with a new selective H1 antihistamine: terfenadine. N
Engl J Med. 1985; 6:63-70.

Food and Drug Administration. Over-the-counter drugs: establishment of a monograph for OTC cold, cough, allergy,
bronchodilator and antihistaminic products. [21 CFR 341]. Fed Regist. 1976; 41:38312-424. (IDIS 66640)

Babe KS Jr, Serafin WE. Histamine, bradykinin and their antagonists. In: Hardman JG, Limbird LE, Molinoff PB et al, eds.
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Hoechst Marion Roussel, Kansas City, MO: Personal communication.

Antihistamines, nonsedating/macrolide antibiotics. In: Tatro DS, Olin BR, Hebel SK eds. Drug interaction facts. St. Louis:
JB Lippincott Co; 1997 (Oct):110d.

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FDB MedKnowledge U.S. Documentation August 2017

Food and Drug Administration. Hoechst Marion Roussel, Inc, and Baker Norton Pharmaceuticals, Inc; terfenadine;
proposal to withdraw approval of two new drug applications and one abbreviated new drug application; opportunity for a
hearing. [Docket No.96N-0512] Fed Regist. 1997; 62:1889-92.

Cruzan S. FDA proposes to withdraw Seldane approval. FDA Talk Paper. Rockville, MD: Food and Drug Administration;
1997 Jan 13.

Merrell Dow Pharmaceuticals Inc. Seldane (terfenadine) monograph. Cincinnati, OH; 1985.

Merrell Dow Pharmaceuticals Inc. Product information form for American hospital formulary service on Seldane.
Cincinnati, OH; 1985 Apr 1.

Cheng HC, Woodward JK. A kinetic study of the antihistaminic effect of terfenadine. Arzneimittelforschung. 1982;
32:1160-6. (PubMed 6129862)

Koch H. Terfenadine: specific peripheral H1-histamine receptor antagonist. Pharm Int. 1983; 4:252-3. (IDIS 177660)

Cheng HC, Woodward JK. Antihistaminic effect of terfenadine: a new piperidine-type antihistamine. Drug Dev Res. 1982;
2:181-96.

Wiech NL, Martin JS. Absence of an effect of terfenadine on guinea pig brain histamine H1-receptors in vivo determined by
receptor binding techniques. Arzneimittelforschung. 1982; 32:1167-70. (PubMed 6817763)

Rose C, Quach TT, Llorens C et al. Relationship between occupation of cerebral H1-receptors and sedative properties of
antihistamines: assessment in the case of terfenadine. Arzneimittelforschung. 1982; 32:1171-3. (PubMed 6129863)

Nicholson AN. Antihistamines and sedation. Lancet. 1983; 2:211-2. (IDIS 173746) (PubMed 6135040)

Norman PS. New developments in treating allergic rhinitis. Drug Ther. 1984; 14:117,126,127,130-2. (IDIS 189846)

Hoechst Marion Roussel. Seldane (terfenadine) tablets prescribing information. Kansas City, MO; 1997 Sep.

Anon. Treatment of seasonal and perennial rhinitis. Br Med J. 1981; 283:808-10. (IDIS 138581)

Douglas WW. Histamine and 5-hydroxytryptamine (serotonin)and their antagonists. In: Gilman AG, Goodman LS, Rall TW
et al, eds. Goodman and Gilmans the pharmacological basis of therapeutics. 7th ed. New York: Macmillan Publishing
Company; 1985:605-38.

Cirillo VJ, Tempero KF. The pharmacology and therapeutic use of H1 and H2 antihistamines. In: Miller RR, Greenblatt DJ,
eds. Drug therapy reviews. Vol 2. New York: Elsevier/North Holland Inc; 1979:24-47.

Church JA. Allergic rhinitis: diagnosis and management. Clin Pediatr (Philadelphia). 1980; 19:655-9. (IDIS 122291)

Food and Drug Administration. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter
human use; tentative final monograph for OTC antihistamine drug products. [21 CFR Part 341] Fed Regist. 1985;
50:2200-18. (IDIS 195256)

AMA Division of Drugs. AMA drug evaluations. 5th ed. Chicago: American Medical Association; 1983:1465-79.

Bernstein D, Schoenwetter W, Nathan R et al. Fexofenadine: a new nonsedating antihistamine is effective in the treatment
of seasonal allergic rhinitis. J Allergy Clin Immunol. 1996; 97:435.

Holgate S. Comparative trial of two non-sedative H1antihistamines, terfenadine and astemizole, for hay fever. Thorax.
1985; 40:399.

Anon. Fexofenadine hydrochloride: terfenadine carboxylate hydrochloride MDL- 16455A Allegra. Drugs Future. 1996;
21:1017-21.

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Nightingale SL. From the Food and Drug Administration: FDA proposes to withdraw terfenadine approval. JAMA. 1997;
277:370. (PubMed 9010159)

Simons FER, Bergman JN, Watson WTA et al. Allergens, IgE, mediators, inflammatory mechanisms: the clinical
pharmacology of fexofenadine in children. J Allergy Clin Immunol. 1996; 98:1062-4. (IDIS 378437) (PubMed 8977506)

Anon. Fexofenadine. Med Lett Drugs Ther. 1996; 38:95-6. (PubMed 8906132)

Day JH, Briscoe MP, Welsh A et al. Onset of action, efficacy and safety of a single dose of 60 mg and 120 mg
fexofenadine HCl for ragweed (RW) allergy using controlled antigen exposure in an enviromental exposure unit (EEU). J
Allergy Clin Immunol. 1996; 97:434.

Tinkelman D, Falliers C, Bronsky E et al. Efficacy and safety of fexofenadine HCl in fall seasonal allergic rhinitis. J Allergy
Clin Immunol. 1996; 97:435.

Crutcher JE, Kantner TR. The effectiveness of antihistamines in the common cold. J Clin Pharmacol. 1981; 21:9-15. (IDIS
128348) (PubMed 7012191)

West S, Brandon B, Stolley P et al. A review of antihistamines and the common cold. Pediatrics. 1975; 56:100-7. (PubMed
240145)

Howard JC Jr, Kantner TR, Lilienfield LS et al. Effectiveness of antihistamines in the symptomatic management of the
common cold. JAMA. 1979; 242:2414-7. (IDIS 108056) (PubMed 490852)

Food and Drug Administration. Over-the-counter drugs: establishment of a monograph for OTC cold, cough, allergy,
bronchodilator and antiasthmatic products. [DES No. 11935] Fed Regist. 1983; 48:56854-6.

Bryant BG, Cormier JF. Cold and allergy products. In: American Pharmaceutical Association. Handbook of nonprescription
drugs. 8th ed. Washington, DC: American Pharmaceutical Association; 1986:127-74.

Gaffey MJ, Gwaltney JM Jr, Sastre A et al. Intranasally and orally administered antihistamine treatment of experimental
rhinovirus colds. Am Rev Respir Dis. 1987; 136:556-60. (IDIS 245031) (PubMed 3307567)

Food and Drug Administration. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter
human use; final monograph for OTC antihistamine drug products. Final rule. 21 CFR Parts 201, 310, 341, and 369. Fed
Regist. 1992; 57:58356-8.

Simons FER, Simons KJ. The pharmacology and use of H1-receptor-antagonist drugs. N Engl J Med. 1994; 330:1663-70.
(IDIS 330632) (PubMed 7909915)

Burroughs Wellcome Co. Semprex-D (acrivastine and pseudoephedrine HCl) capsules. Research Triangle Park, NC;
1994 Apr.

Douglass JA, Dhami D, Gurr CE et al. Influence of interleukin-8 challenge in the nasal mucosa in atopic and nonatopic
subjects. Am J Respir Crit Care Med. 1994; 150:1108-13. (IDIS 338161) (PubMed 7921444)

Turner RB, Sperber SJ, Sorrentino JV et al. Effectiveness of clemastine fumarate for treatment of rhinorrhea and sneezing
associated with the common cold. Clin Infect Dis. 1997; 25:824-30. (IDIS 395789) (PubMed 9356796)

Doyle WJ, McBride TP, Skoner DP et al. A double-blind, placebo-controlled clinical trial of the effect of chlorpheniramine on
the response of the nasal airway, middle ear and eustachian tube to provocative rhinovirus challenge. Pediatr Infect Dis J.
1988; 7:229-38. (PubMed 3282216)

Food and Drug Administration. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter
human use; tentative final monograph for combination drug products. [21 FR Part 341] Fed Regist. 1988; 53:30522-64.

Turner RB. Elaboration of intereleukin 8 from fibroblast cells and human nasal epithelium in response to rhinovirus
challenge. Proceedings of ICAAC Orlando 1994. Abstract No. B43.

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FDB MedKnowledge U.S. Documentation August 2017

Berkowitz RB, Tinkelman DG. Evaluation of terfenadine for treatment of the common cold. Ann Allergy. 1991; 67:593-7.
(IDIS 294960) (PubMed 1750722)

Gaffey MJ, Kaiser DL, Hayden FG. Ineffectiveness of oral terfenadine in natural colds: evidence against histamine as a
mediator of common cold symptoms. Pediatr Infect Dis J. 1988; 7:223-8. (PubMed 2895909)

Proud D, Naclerio RM, Gwaltney JM et al. Kinins are generated in nasal secretions during natural rhinovirus colds. J Infect
Dis. 1990; 161:120-3. (PubMed 2295843)

Proud D, Gwaltney JM Jr., Hendley JO et al. Increased levels of interleukin-1 are detected in nasal secretions of volunteers
during experimental rhinovirus colds. J Infect Dis. 1994; 169:1007-13. (IDIS 329294) (PubMed 8169385)

Woodward JK, Munro NL. Terfenadine, the first non-sedating antihistamine. Arzneimittelforschung. 1982; 32:1154-6.
(PubMed 6129860)

Fink M, Irwin P. CNS effects of the antihistamines diphenhydramine and terfenadine (RMI 9918). Pharmakopsychiatr
Neuro Psychopharmakol. 1979; 12:35-44.

Lundberg PK. Assessment of drugs side effects: visual analogue scale versus checklist format. Percept Mot Skills. 1980;
50:1067-73. (PubMed 6774312)

Roehrs TA, Tietz EI, Zorick FJ et al. Daytime sleepiness and antihistamines. Sleep. 1984; 7:137-41. (IDIS 199927)
(PubMed 6146180)

Garteiz DA, Hook RH, Walker BJ et al. Pharmacokinetics and biotransformation studies of terfenadine in man.
Arzneimittelforschung. 1982; 32:1185-90. (PubMed 6817765)

Hey JA, del Prado M, Sherwood J et al. Comparative analysis of cardiotoxicity proclivities of second generation
antihistamines in an experimental model predictive of adverse clinical ECG effects. Arneim-Forsch. 1996; 46:153-8.

Rampe D, Wible B, Brown AM et al. Effects of terfenadine and its metabolites on a delayed rectifier K+ channel cloned
from human heart. Mol Pharmacol. 1993; 44:1240-5. (PubMed 8264561)

Smith MBH, Feldman W. Over-the-counter cold medications: a critical review of clinical trials between 1950 and 1991.
JAMA. 1993; 269: 2258-63. (IDIS 313601) (PubMed 8097268)

D Agostino RB, Weintraub M. Meta-analysis: a method for synthesizing research. Clin Pharmacol Ther. 1995; 58:605-16.
(PubMed 8529325)

Hoechst Marion Roussel, Kansas City, MO: Personal communication.

Nsouli SM. Treatment of allergic rhinitis fexofenadine (FF) versus loratadine (LR). Presented at the meeting of the
American College of Allergy, Asthma and Immunology. San Diego, CA: 1997 November 7-12. Abstract.

Hther KJ, Renftle G, Barraud N et al. Inhibitory activity of terfenadine on histamine-induced skin wheals in man. Eur J Clin
Pharmacol. 1977; 12:195-99. (PubMed 22436)

Merrell Dow, Cincinnati, OH: Personal communication.

Bateman DN, Woodhouse KW, Rawlins MD. Adverse reactions to N-acetylcysteine. Hum Toxicol. 1984; 3:393-8. (IDIS
199928) (PubMed 6436169)

Fleischer Kupec I. FDA approves Allegra D, manufacturer to withdraw Seldane from marketplace. FDA Talk Paper.
Rockville, MD: Food and Drug Administration; 1997 Dec 29.

Aventis. Allegra-D 12 Hour (fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg)
extended-release tablets prescribing information. Kansas City, MO; 2004 Dec.

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Pinto YM, van Gelder IC, Heeringa M et al. QT lengthening and life-threatening arrhythmias associated with fexofenadine.
Lancet. 1999; 353:980. (IDIS 421822) (PubMed 10459910)

Markham A, Wagstaff AJ. Comment on fexofenadine. Drugs. 1998; 55:269-74. (PubMed 9506246)

Galant SP. Comments on fexofenadine. Drugs. 1998; 55:275.

Simons FER. Comments on fexofenadine. Drugs. 1998; 55:275-6.

Sussman GL, Mason J, Compton D et al. The efficacy and safety of fexofenadine HCl and pseudoephedrine, alone and in
combination, in seasonal allergic rhinitis. J Allergy Clin Immunol. 1999; 104:100-6. (IDIS 432261) (PubMed 10400846)

Pratt CM, Mason J, Russell T et al. Cardiovascular safety of fexofenadine HCl. Am J Cardiol. 1999; 83:1451-1454. (IDIS
428538) (PubMed 10335761)

Giraud T. QT lengthening and arrhythmias associated with fexofenadine. Lancet. 1999; 353:2072. (IDIS 428826) (PubMed
10376646)

Pinto YM, van Gelder IC, Heeringa M at al. QT lengthening and arrhythmias associated with fexofenadine. Lancet. 1999;
353:2072-3. (IDIS 428826) (PubMed 10376646)

Rao N, Weilert DR, Grace MGA et al. Pharmacokinetics of terfenadine-acid metabolite, MDL 16,455, in healthy geriatric
subjects. Pharm Res. 1995 12 (Suppl 9):S-386. Abstract No. PPDM 8240.

Russell T, Arumugham T, Eller M et al. A comparison of MDL 16,455A pharmacokinetics by gender. Pharm Res. 1995 12
(Suppl 9): S-389. Abstract No. PPDM 8252.

Aventis. Allegra-D 24 Hour (fexofenadine hydrochloride 180 mg and pseudoephedrine hydrochloride 240 mg)
extended-release tablets prescribing information. Kansas City, MO; 2005 Jan.

Selected Revisions November 2007, Copyright, October 2006, American Society of Health-System Pharmacists, Inc.,
7272 Wisconsin Avenue, Bethesda, Maryland 20814.

Note that the Copyright section appears at the end of the monograph example. The content of the
Copyright section must be displayed at the end of the monograph every time any portion of the
monograph is displayed. See the American Society of Health-System Pharmacists (ASHP) Disclaimer for
more information.

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AHFS DI Monographs ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

AHFS DI Tables
AHFS DI ERD

AHFS DI Tables
AHFS DI Specific to General Monograph Table
Prioritized AHFS DI Monograph GCN_SEQNO Table
AHFS Full-Text Monograph Section Table
AHFS Full-Text Monograph Text Table
AHFS Full-Text Monograph Titles Table

AHFS DI ERD

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AHFS DI Specific to General Monograph Table

Table Name RAHDISG0_SPECGEN_LINK

Revision Activity add.12-02-2002

Purpose Associates a general statement to one or more specific

monographs.

Key Column Name Column Format Length Picture

Description

PF AHFS_SPECM AHFS Full-Text N 6 9(6)

Specific
Monograph
Number

PF AHFS_GENM AHFS Full-Text N 6 9(6)

General
Monograph
Number

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AHFS Full-Text Monograph Section Table

Table Name RAHDISD0_MONO_SECT_DESC

Revision Activity add.12-02-2002

Purpose Associates a specific monograph section with a specific

monograph.

Key Column Name Column Format Length Picture

Description

PF AHFS_MONO AHFS Full-Text N 6 9(6)

Monograph
Number

P AHFS_SECT AHFS Full-Text N 4 9(4)

Monograph
Section ID

PF AHFS_SECTL AHFS Full-Text N 1 9(1)

Monograph
Section Level

AHFS_SECTT AHFS Full-Text AN 70 X(70)

Monograph
Section Title

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AHFS Full-Text Monograph Text Table

Table Name RAHDIMD0_MONO_TEXT_DESC

Revision Activity add.12-02-2002

Purpose Associates specific text with a specific section of a

monograph.

Key Column Name Column Format Length Picture

Description

PF AHFS_MONO AHFS Full-Text N 9 9(6)

Monograph
Number

P AHFS_SECT AHFS Full-Text N 4 9(4)

Monograph
Section ID

P AHFS_TEXTS AHFS Full-Text N 4 9(4)

Monograph Text
Sequence
Number

AHFS_TEXT AHFS Full-Text AN 75 X(75)

Monograph Text

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AHFS Full-Text Monograph Titles Table

Table Name RAHDITD0_MONO_TITLES_DESC

Revision Activity add.12-02-2002

Purpose Associates a specific title with a specific monograph.

Key Column Name Column Format Length Picture

Description

P AHFS_MONO AHFS Full-Text N 6 9(6)

Monograph
Number

AHFS_MONOT AHFS Full-Text AN 70 X(70)

Monograph Title

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Prioritized AHFS DI Monograph GCN_SEQNO Table

Table Name RAHDIGC0_GCNSEQNO_LINK

Revision Activity add.12-02-2002

Purpose Links First Databanks (FDBs) Clinical Formulation ID

(GCN_SEQNO) to ASHPs Drug Information Monograph
Numbers.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

AHFS_PNA Priority Indicator AN 1 X(1)

from Clinical
Formulation ID
(GCN_SEQNO) to
AHFS

AHFS_PAN Priority Indicator AN 1 X(1)

from AHFS to
Clinical
Formulation ID
(GCN_SEQNO)

PF AHFS_MONO AHFS Full-Text N 6 9(6)

Monograph
Number

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Clinical Screening
Dosing
Drug Allergy Module (DAM) 4.0
Drug-Disease Contraindications Module (DDCM) 2.0
Drug-Lab Interference Module (DLIM ) 2.0
Duplicate Therapy Module (DPT) 1.0
Inactive Ingredients Editorial Policies
Indications Module (INDM) 2.0
Interactions
Intravenous Module (IVM) 1.0
Precaution Modules
Side Effects Module (SIDE) 2.0

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Dosing
Dosing Modules
Dosing Editorial Policies
DRCM Applications
Min/Max Applications
NEOM Applications
DRCM ERD and Technical Specifications
Min/Max ERD and Technical Specifications
NEOM ERD and Technical Specifications

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Dosing Editorial Policies

Overview
Inclusion Criteria
Rule Sets
Maintenance

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Dosing Overview
The Dosing Modules are designed to serve as a means of identifying potentially incorrect dosing that is the
product of error or miscommunication. Given the range of patient-specific factors relevant to the determination of
appropriate dosing, factors that are unknown to the developers of the dosing databases, the modules do not
purport to be and cannot be used as a means of identifying the right dosing for a patient. They instead serve to
identify potentially unsafe dosing and alert users to possible medication errors, thereby serving as a safety net
mechanism that can be applied programmatically.

With this goal in mind, the creators of the dosing modules review a range of defined sources of dosing
information, identified more particularly below, including manufacturer documentation, clinical literature and
regulatory announcements, to determine the low and high dosage amounts beyond which these sources can
identify no clinical support. This concept of identifying questionable levels rather than presenting a recommended
dosing order permits the module to provide appropriate warnings of potential medication errors while minimizing
the number of alerts that would be otherwise triggered by, for example, a literal adoption of a manufacturer
package insert.

Dosing range information is, as indicated, presented in categories based on age. However, the available clinical
literature does not generally provide dosing information that will correspond to all these age categories. Indeed,
package inserts commonly refer to usual or normal dosing without identifying the ages to which such dosing
will apply, and only occasionally identify pediatric or geriatric dosing. Likewise, even authoritative geriatric or
pediatric references will not regularly track the age ranges or fill them comprehensively. Under these
circumstances, the available choices for the dosing modules are to leave the respective age fields unfilled, or to
use as a proxy the dosing information that is available for other ages. Since the former policy would leave users
with essentially no dosing check for a substantial number of age categories, and particularly in view of the safety
net goal outlined above, the dosing modules will follow the latter course. That is, when there is no available
dosing information in the reviewed sources for a specified age group, and there is no evidence that the
medication is contraindicated for that age groups, the dosing modules will report either the value that has been
reported as the general, non-age specific dose or as the dosing for the adult age group. When doing so, they will
indicate to module users that such an incorporation of this sort of alternative dosing has occurred. For example, if
a product's package insert identifies only a normal dose of 250 mg twice daily, but makes no mention of geriatric
dosing, and none of the sources reviewed by the editors provide any further information, the editors will fill the
geriatric dose ranges with the same value used for adults and will indicate that it has done so by setting the age
source indicator's value to adult. In this way the goals of comprehensiveness and clarity are both served most
effectively.

The Min/Max Dose Modules 2.1 identify the usual dose range of a drug given by its most common route of
administration. The Adult and Geriatric Min/Max modules each have two different master tables, the Daily Dose
and Absolute Range of Daily Dosing tables. In the Absolute Range of Daily Dosing tables, the dosing range
specified for a Clinical Formulation ID is the usual range found in the literature regardless of the strength identified
by the Clinical Formulation ID or the ability of the underlying drug form to be divided, while in the Daily Dose
tables, the range specified takes both factors into account. For example, Clinical Formulation ID 46215 pertains to
fluoxetine 40 mg capsules. In the Adult Absolute Range of Daily Dosing table, the range coded is 20 - 80 mg/day,
and the Geriatric Absolute Range of Daily Dosing table the range coded is 10 - 80 mg/day. However, in these

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modules' corresponding Daily Dose tables, the fact that the Clinical Formulation ID strength is 40 mg and that the
relevant drug is a capsule that cannot be divided results in different values: because you can not practically
administer doses lower than 40 mg with this particular dosage form, the range coded for both the Adult and
Geriatric tables is 40 - 80 mg/day.

In the Dosage Range Check Module (DRCM), dose ranges coded in the DRCM Master Table
(RDRCMA2_MSTR) and the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) are for patients with
normal organ function only. Dose ranges coded in the DRCM Renal Master Table (RDRCRM0_RENAL_MSTR)
are for patients with renal impairment.

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Dosing Inclusion Criteria

This section provides information detailing the criteria that guided the inclusion of the data contained within the
modules as well as information pertaining to limitations or exclusions when appropriate to the discussion.

Drugs included in the Dosing Modules must be in the drug file and linked to a dispensable product available in the
United States, Canada, Hong Kong, or Australia.

The Min/Max modules cover only products available in the U.S. or Canada. Only active drugs will be coded for
addition to the database.

The Min/Max modules will code drugs only when their unit of measure for the dose can practically and accurately
be converted to the unit of measure employed by the modules (for example, grams can be converted to
milligrams, but mg/kg cannot be converted to grams or milligrams).

Exclusion Criteria

Certain therapeutic categories are excluded. These excluded categories consist of the following:

Large and small volume parenteral fluids, including dextrose in water, sodium chloride and other
electrolytes, amino acids for TPNs, lipids, sterile water for injection, and other diluents.
Dietary supplements, including those for enteral feeding, medical food, multivitamins.
All herbal products not of FDB's herbal list (see Herbal Products Inclusion List).
Anesthetic gases.
Drugs such as Digoxin Immune FAB and MESNA where the dose given is based upon the amount of a
second drug.
Medical supplies, including IV pumps, bandages, diabetic test kits, and contraceptive supplies, because
they do not have dosage ranges.
Kits and other individual products packaged together in a combination package, such as Helidac and
Prevpac, unless the kit is a single drug combined with a medical device, such as a syringe and/or a diluent.
Kits and Combo packs that contain more than one drug.
Antihemophilic Factors.
Radiographic/MRI/Ultrasound imaging agents.
Radioisotopes.
OTC Topical products that do not have significant systemic absorption. Exclusion Example: Emollients.
Drugs linked to the following Extended Therapeutic Classifications:
277 Cardioplegic Solutions
815 Topical Hemostatic Agents
1039 Diagnostic Reagents - In Vitro
1117 Chemicals - Pharmaceutical Adjuvants
1131 Medical Supplies - DME
1259 Peritoneal Dialysis solutions
3504 Diagnostic - Urine Tests

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3548 Alternative Therapy- Homeopathic Products

3755 Organ Preservation Solutions
3942 Allergenic Extracts
4500 FDB Class Obsolete - Not Used
4535 Musculoskeletal Therapy Agents - Joint Tissue Replacement
5964 Hemodialysis & Hemofiltrate Solutions
Obsolete products in a newly-included category. Products that are included and subsequently become
obsolete will retain their dosage ranges.

Clinical Formulation IDs for drugs excluded from DRCM are provided in the DRCM Exclusion Table
(RDRCEX0_EXCLUSIONS), along with a code identifying the reason they were excluded.

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Dosing Rule Sets

This section provides rules that the clinical team uses in regard to creating the module's data, both general rules
and rules specific to data elements.

Rules of General Applicability

Rules for Data Elements

Unless otherwise indicated, the rules apply to the data in all three modules:

The Dosage Range Check Module (DRCM) 3.1

Min/Max Dose Modules 2.0
Neonatal and Infant Dosage Range Check Module (NEOM) 1.1

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Dosing Rules of General Applicability

This section describes editorial policies that have a broad impact on the module data or by nature are less
specific than those policies in other sections.

DRCM and NEOM

Min/Max Modules
Coding of Age Ranges
Neonatal Doses (DRCM and NEOM only)

DRCM and NEOM

1. The DRCM Master Table (RDRCMA2_MSTR) is used to screen adults, as well as neonates and infants
born at full term only. Drug knowledge is aggregated in this table based on a unique record key which is
composed of the following data fields:

a. Clinical Formulation ID (GCN_SEQNO)

b. Clinical Route (DR2_RT)

c. Dose Type (DR2_DOSTPI)

d. Reason for Use (FDBDX or DXID)

e. Age Low (DR2_LOAGED)

f. Age High (DR2_HIAGED)

2. The DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) and the NEOM Master Table
(RNEOMMA1_MSTR) are used to screen neonates and infants, including those born prematurely. The
DRCM Neonatal and Adult Master Table is also used to screen adults. Drug knowledge is aggregated in
this table based on a unique record key which is composed of the following data fields:

a. Clinical Formulation ID (GCN_SEQNO)

b. Clinical Route (DR2_RT and NEOM_ROUTE_CODE)

c. Dose Type (DR2_DOSTPI and NEOM_DOSE_TYPE_CODE)

d. Reason for Use (FDBDX or DXID)

e. Age Low (DR2_LOAGED and NEOM_LOW_AGE_DAYS)

f. Age High (DR2_HIAGED and NEOM_HIGH_AGE_DAYS)

g. Gestational Age at Birth (GAB) Low (NEOM_LOW_GEST_BIRTH_AGE_WEEKS)

h. Gestational Age at Birth (GAB) High (NEOM_HIGH_GEST_BIRTH_AGE_WEEKS)

i. Current Weight Low (LOW_CURRENT_WEIGHT_GRAMS)

j. Current Weight High (HIGH_CURRENT_WEIGHT_GRAMS)

3. The DRCM Renal Master Table (RDRCRM0_RENAL_MSTR) is used to screen renally impaired adults

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3.

(including geriatric patients), children, and infants over 29 days old and born at full term only. Drug
knowledge is aggregated in this table based on a unique record key which is composed of the following
data fields:

a. Clinical Formulation ID (GCN_SEQNO)

b. Clinical Route (DR2_RT)

c. Dose Type (DR2_DOSTPI)

d. Reason for Use (FDBDX or DXID)

e. Age Low (REN_LOAGED)

f. Age High (REN_HIAGED)

g. Creatinine Clearance Low (REN_LOCRCL)

h. Creatinine Clearance High (REN_HICRCL)

i. DRCM Renal Sort Order (REN_SORT_ORDER)

4. When coding data for drugs administered by the ophthalmic, otic, or nasal routes, the range coded will be
for the administration of a drug to only one orifice, not both.

5. For drugs that are a combination of ingredients, the dosing range unit of measure (UOM) will be a dosage
form type of UOM.

6. When coding data for drugs administered by the intra-catheter route, the range coded will be for drug
administered to only one lumen (body site). (For example, a drug can be administered at the same time to
different lumens in a patient with more than one catheter, but the range coded for the drug will be for the
amount administered to only one lumen.)

7. For drugs that can be dosed as either elemental vs. base plus salt, or base vs. base plus salt, the dosing
range coded will match the Clinical Formulation ID (GCN_SEQNO) (also see section entitled Dosing
Ranges and Ingredient Strength).

Min/Max Modules

1. Adult and Geriatric Modules:

a. Drug knowledge is aggregated at the Clinical Formulation ID (GCN_SEQNO) in the following tables:
MMAD Master Table (RMMADMA1_ADULT_DOSE_MSTR)
MMAR Master Table (RMMARMA0_ADULT_RANGE_MSTR)
MMGD Master Table (RMMGDMA1_GERI_DOSE_MSTR)
MMGR Master Table (RMMGRMA1_GERI_RANGE_MSTR)

b. Age ranges are not tied to individual records, but to the module.
While there are no universally accepted definitions of Adult and Geriatric, the terms are
commonly understood to refer to, respectively, 18 - 64 years of age and 65 and over, and the
Min/Max module follows this convention.

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2. Pediatric Dosing Module (PDM or Pediatric Min/Max).

Drugs that are a combination of ingredients will be coded using the dosage form fields only.

a. Drug knowledge is aggregated in the PDM Master Table (RPDMMA1_PEDI_MSTR) based on a

unique record key which is composed of the following data fields:
Clinical Formulation ID (GCN_SEQNO)
Minimum Dosing Age (PDM_MNAGE)
Maximum Dosing Age (PDM_MXAGE)

3. For drugs that can be dosed as either elemental vs. base plus salt, or base vs. base plus salt, the dosing
range coded will match the Clinical Formulation ID (GCN_SEQNO). Please note that this policy is effective
during the first quarter of 2012. See #6 in DRCM and NEOM for information on the current policy.

4. For products whose dosing unit is "inhalation," "application," or "scoops" and the Clinical Formulation ID (
GCN_SEQNO) being coded spans more than one package size, the associated Minimum amount will be
based on the smallest package size and the Maximum amount will be based on the largest package size.
The amount coded will be based upon the total package size, not the quantity of the active ingredient.

LN PS LN PS GCN_SEQNO

ADVAIR HFA 115-21 8 ADVAIR HFA 115-21 12 61344

MCG INHALER MCG INHALER

PROAIR HFA 90 6.7 PROAIR HFA 90 18 28090

MCG INHALER MCG INHALER

SYMBICORT 6 SYMBICORT 10.2 62726

160-4.5 MCG 160-4.5 MCG
INHALER INHALER

VENTOLIN HFA 90 8 VENTOLIN HFA 90 18 28090

MCG INHALER MCG INHALER

5. When coding data for drugs administered by the ophthalmic, otic, or nasal routes, the range coded for the
Minimum Daily Dose will be for drug administered to only one orifice, and the Maximum Daily Dose will be
for two orifices.

a. When converting drops to mL, FDB uses 20 drops/mL for the conversion factor.

b. If the drug being coded expresses its dose range as "x - y mg/day," and it does not matter if it is
given in one orifice or two orifices (or the dose is to alternate between orifices), then the range
coded will be "x - y mg/day," and will not take into account the orifices (for example, desmopressin
nasal solution is an example of this type of drug).

Coding of Age Ranges

The following interpretations of the age category terminology found in the reference sources are employed in the
dosing modules, unless those sources provide a more specific and different age range; for example, DRCM,
NEOM, and Min/Max will regard a reference to dosing for a "child" as pertaining to the 1 to 12 age range, unless a
reference source cites dosing for "Children - ages 2 to 10," in which case the coding will track the reference.

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Age Category Table

Age Category Age In Years Age In Days

Neonate 0 to 0.082 0 to 29

Infant 0.083 to 0.99 30 to 364

Child 1 to 12 365 to 4744

Adolescent 13 to 17 4745 to 6569

Adult 18 to 64 6570 to 23724

Geriatric 65 to 110 23725 to 40150

Pediatric 1 to 17 365 to 6569

Adult and Adolescent 13 to 64 4745 to 23724

Adult and Geriatric 18 to 110 6570 to 40150

Young Child <6 365 to 2189

Age Category Gestational Age at Birth Weight at Birth

Premature Neonate or Infant <37 weeks <2000 Grams

Full Term Neonate or Infant 37 weeks 2000 Grams

The following table lists the five Min/Max Dose Modules and indicates the age group defined by the module and
the context for each.

Module Name Targeted Age Group Context

Pediatric Dose Module (PDM) Age in years: 0.083 to 17 years Daily Dosing
Age in days: 30 to 6569 days

Min/Max Adult Daily Dose Module Age in years: 18 to 64 years Daily Dosing
(MMAD)
Age in days: 6570 to 23724

Min/Max Adult Daily Range Module Age in years: 18 to 64 years Absolute Range of Daily Dosing
(MMAR)
Age in days: 6570 to 23724

Min/Max Geriatric Daily Dose Module Age in years: 65 to 110 years Daily Dosing
(MMGD)
Age in days: 23725 to 40150

Min/Max Geriatric Daily Range Module Age in years: 65 to 110 years Absolute Range of Daily Dosing
(MMGR)
Age in days: 23725 to 40150

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DRCM covers patients from 0 days to 110 years, while NEOM covers patients 0 to 364 days. The age for a
dosing record is coded in days.

Neonatal Doses (DRCM and NEOM only)

When dosing information specifically referencing "Neonates" or the associated age range is unavailable, the
dosing modules will not incorporate dosing information from any other age range and no information will be
provided.

Infant Doses

In order to code dosing for the "Infant" age range, the reference information must specifically state that the dose
is for infants or the associated age range.

Child Doses

When dosing information specifically referencing "Child" or "Children" or the associated age range is unavailable,
the dosing modules will not incorporate dosing information from an adult age range and no information will be
provided.

Adolescent Doses

In the absence of a specific citation to "Adolescents" or the associated age range, and if DRCM references do not
identify any information that the adult dose is contraindicated for adolescents, the adult dose range will be
reported (and identified as such) for the adolescent age range.

Geriatric Doses

In the absence of any specific citation "Geriatrics" or the associated age range, and if DRCM references do not
identify any information that the adult dose is contraindicated for geriatrics, the adult dose range will be reported
(and identified as such) for the geriatric age range. When coding a drug for the geriatric age range, the full age
range will be coded unless there is specific data that the drug's use has not been studied in patients above a
specified age.

Module users employing adult dosing information with respect to geriatric patients must remain conscious of the
potentially decreasing organ function and changes in body composition associated with the geriatric patient.As
set forth below, DRCM provides indicators that identify when patients with impaired renal or hepatic functioning
may require dosing adjustment by treating practitioners, as well as dosage ranges that are adjusted for renal
impairment.

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Dosing Rules for Data Elements

This section describes editorial policies that have a broad impact on the module data or by nature are less
specific than those policies in other sections.

Renal Impairment Indicator (DRCM/NEOM only)

Creatinine Clearance Threshold (DRCM/NEOM only)
Creatinine Clearance Threshold UOM Code (DRCM/NEOM only)
Creatinine Clearance Range (DRCM only)
Dosing Adjustment Type (DRCM Only)
Hepatic Flag
Clinical Formulation ID
Clinical Route
Clinical Generic Route
Dose Type
Reason for Use
Age Low
Age High
Gestational Age at Birth (GAB) Required Indicator
Gestational Age at Birth (GAB) Low
Gestational Age at Birth (GAB) High
Interaction of GAB and Age Range
Current Weight Required Flag
Current Weight Low
Current Weight High
Interaction of Current Weight and Age Range
Low Dose per Day (DRCM/NEOM) or Minimum Daily Dose (Min/Max)
High Dose per Day (DRCM and NEOM) or Maximum Daily Dose (Min/Max)
Max Dose per Day (DRCM and NEOM only)
Maximum Amount per Single Dose (DRCM and NEOM only)
Maximum Amount per Single Dose (DRCM and NEOM only)
Not-to-Exceed per Single Dose (DRCM and NEOM only)
Maximum Amount per Lifetime Dose (DRCM and NEOM only)
Dosing Ranges and Ingredient Strength
Not-to-Exceed per Day (Pediatric Min/Max only)
Dosing Not Established (Pediatric Min/Max only)
Dosing Not Recommended (Pediatric Min/Max only)
Interplay of Frequency and Dose

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Variance Policy
Units of Measure
Min/Max Units
TJC (formerly JCAHO) Compliance
Unit Conversions (DRCM/NEOM only)
Patient Parameter (DRCM/NEOM only)
Dose Calculation Code
Frequency of Administration (DRCM/NEOM only)
Duration of Therapy
Special Considerations for Antineoplastics
Special Considerations for Narcotic Analgesic
Half-Life (DRCM/NEOM only)
Dosing Age Source Identifier Code
Clinical Formulation Exclusion Code
Age Exclusions

Renal Impairment Indicator (DRCM/NEOM only)

The dosage ranges specified in NEOM are for patients with normal organ function. Some drugs may require
dosage adjustment when given to patients with renal impairment.

In DRCM, dosage ranges coded in the DRCM Master Table (RDRCMA2_MSTR) and the DRCM Neonatal and
Adult Master Table (RDRCNMA2_MSTR) are for patients with normal organ function only. Dosage ranges coded
in the DRCM Renal Master Table (RDRCRM0_RENAL_MSTR) are for patients with renal impairment.

DRC renal adjusted dosing excludes weight-based dosing.

The Renal Impairment Indicator is a Yes/No field in the dosing record. As such, it is specific to drug, patient age,
route of administration, and dose type.

The value is set to Y when a drug needs to have its dose adjusted in patients with renal dysfunction. The flag
will be set to Y even if the reference does not provide a creatinine clearance threshold at which to begin
adjusting the dose or if the reference information provides general warnings such as Use with caution in patients
with renal dysfunction.

If both the Renal and Hepatic Impairment Indicators are set to Y and the patient has both hepatic
impairment and renal impairment below the creatinine clearance threshold, dose range checking for renal
impairment with DRCM cannot be used. Developers may want to provide an advisory message to the end
user such as, Dosage range checking for <medication name> is not available in situations where the
patient exhibits both hepatic impairment and renal impairment (CrCl < 50).

The Renal Adjustment Indicator is represented in the following:

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DRCM Renal Impairment Assessment Indicator (DR2_RENIMP)

NEOM Renal Impairment Indicator (NEOM_RENAL_IMPAIRMENT_IND)

Creatinine Clearance Threshold (DRCM/NEOM only)

For those drugs that must have their dose adjusted based upon renal function, this field indicates the lowest
creatinine clearance to which the dosing record applies. Patients with a creatinine clearance value that is less
than or equal to the Creatinine Clearance Threshold should be screened using DRC Renal. It is set at a null value
if this data is not available and will be reflected in the database as 0.

Creatinine Clearance Threshold is represented in the following fields:

DRCM Creatinine Clearance Threshold (DR2_CRCLTH)

NEOM Creatinine Clearance Threshold (NEOM_CREATININE_CLR_THRESHOLD)

Creatinine Clearance Threshold UOM Code (DRCM/NEOM only)

This is the associated unit of measure (UOM) for the Creatinine Clearance Threshold in milliliters per minute
(mL/min) or milliliters per minute per 1.73 meters squared (mL/min/1.73 m2). When the creatinine clearance has a
0 value, the unit of measure is null.

The Creatinine Clearance Threshold UOM code is represented in the following fields:

DRCM Creatinine Clearance Units Indicator (DR2_CRCLU)

NEOM Creatinine Clearance Threshold Unit Code (NEOM_CREATININE_CLR_UNIT_CODE)

Creatinine Clearance Range (DRCM only)

For those drugs that must have their dose adjusted based upon renal function, the high and low creatinine
clearance values indicate the range to which the adjusted dosing record applies. Low and High Creatinine
Clearance values are measured in milliliters per minute (mL/min).

The creatinine clearance range is represented in the following fields within the DRCM Renal Master Table
(RDRCRM0_RENAL_MSTR):

DRCM Renal Low Creatinine Clearance mL/min (REN_LOCRCL)

DRCM Renal High Creatinine Clearance mL/min(REN_HICRCL)

Dosing Adjustment Type (DRCM Only)

The adjustment type field in DRCM indicates the method of adjustment applied to the dosing records of a drug
based upon renal impairment. The renally adjusted dosage ranges are a best estimate for the population of
renally impaired patients. Each patient should be closely monitored for signs of efficacy and for drug toxicity within
associated adjustment in the dose. Drug levels should be monitored if possible. When in doubt, consult a
nephrologist or pharmacist who is familiar with drug dosing for patients with renal impairment.

The supported adjustment types are shown in the following table:

DOSING_ADJ_TYPE_CD DOSING_ADJ_TYPE_DESC

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1 See footnote

2 Administration is not recommended in this level of organ

impairment

3 Adjust dose using multiplier

4 Adjust frequency

5 Adjust dose using multiplier and adjust frequency

6 Adjust dose to fixed amount

7 Adjust dose to fixed amount and adjust frequency

8 No adjustment necessary

9 See monograph

10 Default

11 No adjustment information

The dosing adjustment type is represented in the DRCM Dosing Adjustment Type Code (
DOSING_ADJ_TYPE_CD) field.

See footnote (DOSING_ADJ_TYPE_CD = 1)

The adjusted dosing range may not be codified. If dosing ranges are equal to 0, present the DRCM Renal
Adjustment Footnote Text (REN_FOOTNOTE) to the user so that they can screen orders manually based on the
information presented in the footnote. If dosing ranges are not equal to 0, proceed with renal dosage screening
and present the DRCM Renal Adjustment Footnote Text. All DRCM Renal Master records with a See footnote
DRCM Dosing Adjustment Type Code shall have a DRCM Renal Sort Order ( REN_SORT_ORDER) equal to 1.

Administration is not recommended in this level of organ impairment (DOSING_ADJ_TYPE_CD = 2)

The drug is not recommended for patients with the specified level of organ function. All DRCM Renal Master
records with an Administration is not recommended in this level of organ impairment DRCM Dosing Adjustment
Type Code shall have a DRCM Renal Sort Order (REN_SORT_ORDER) equal to 1.

Adjust dose using multiplier (DOSING_ADJ_TYPE_CD = 3)

The dosage range checking values provided have been adjusted to a percentage of the original range. All DRCM
Renal Master records with an Adjust dose using multiplier DRCM Dosing Adjustment Type Code shall have a
DRCM Renal Sort Order (REN_SORT_ORDER) greater than 1.

Adjust frequency (DOSING_ADJ_TYPE_CD = 4)

The dosage range checking values provided have been adjusted by changing the frequency at which a dose is
administered and associated low and high dosing values have been adjusted accordingly. All DRCM Renal
Master records with an Adjust frequency DRCM Dosing Adjustment Type Code shall have a DRCM Renal Sort
Order (REN_SORT_ORDER) greater than 1.

Adjust dose using multiplier and adjust frequency (DOSING_ADJ_TYPE_CD = 5)

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The dosage range checking values have been adjusted by a percentage of the original range, and associated low
and high frequency values have been adjusted. All DRCM Renal Master records with an Adjust dose using
multiplier and adjust frequency DRCM Dosing Adjustment Type Code shall have a DRCM Renal Sort Order (
REN_SORT_ORDER) greater than 1.

Adjust dose to fixed amount (DOSING_ADJ_TYPE_CD = 6)

The dosage range checking values have been adjusted to a fixed amount. All DRCM Renal Master records with
an Adjust dose to fixed amount DRCM Dosing Adjustment Type Code shall have a DRCM Renal Sort Order (
REN_SORT_ORDER) greater than 1.

Adjust dose to fixed amount and adjust frequency (DOSING_ADJ_TYPE_CD = 7)

The dosage range checking values have been adjusted to a fixed amount, and associated low and high frequency
values have been adjusted. All DRCM Renal Master records with an Adjust dose to fixed amount and adjust
frequency DRCM Dosing Adjustment Type Code shall have a DRCM Renal Sort Order ( REN_SORT_ORDER)
greater than 1.

No adjustment necessary (DOSING_ADJ_TYPE_CD = 8)

Dosage range checking values provided did not require an adjustment. Continue screening using the unadjusted
dosage range checking values available in the DRCM Renal Master Table (RDRCRM0_RENAL_MSTR). All
DRCM Renal Master records with a No adjustment necessary DRCM Dosing Adjustment Type Code shall have
a DRCM Renal Sort Order (REN_SORT_ORDER) equal to 1.

See monograph (DOSING_ADJ_TYPE_CD = 9)

It is not possible to codify the adjusted dosing range. Present an adjustment monograph to the user so they can
screen the order manually based upon the information in the monograph. See Accessing a Renal Adjustment
Monograph for more information regarding how to access a renal adjustment monograph. All DRCM Renal
Master records with a See monograph DRCM Dosing Adjustment Type Code shall have a DRCM Renal Sort
Order (REN_SORT_ORDER) equal to 1.

Default (DOSING_ADJ_TYPE_CD = 10)

A Default DRCM Dosing Adjustment Type Code shall be present when a medication, clinical route, reason for
use, age range, dose type and creatinine clearance range combination has one or more of the following DRCM
Dosing Adjustment Type Code (DOSING_ADJ_TYPE_CD) values:

Adjust dose using multiplier

Adjust frequency
Adjust dose using multiplier and adjust frequency

Every DRCM Renal Master record that has one of these DRCM Dosing Adjustment Type Code values will have a
corresponding record with a Default DRCM Dosing Adjustment Type Code. When a DRCM Renal Master record
has only one of the previously mentioned DRCM Dosing Adjustment Type Code values present, the dosage
range checking values for the record with the Default DRCM Dosing Adjustment Type Code will match the
dosage range checking values for the Adjust dose using multiplier, Adjust frequency, or Adjust dose using
multiplier and adjust frequency DRCM Dosing Adjustment Type Code record. If more than one DRCM Dosing

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Adjustment Type Code may be used to adjust the dosing range checking values, the dosage range checking
values for the Default DRCM Dosing Adjustment Type Code have been calculated by selecting the:

Lowest DRCM Renally Adjusted Low Dose Per Day value

Highest DRCM Renally Adjusted High Dose Per Day value
Highest DRCM Renally Adjusted Max Dose Per Day value
Highest DRCM Renally Adjusted Maximum Amount Per Single Dose value
Highest DRCM Renally Adjusted Not-to-Exceed Amount Per Single Dose value

The Default DRCM Dosing Adjustment Type Code presents a consistent, single response for renal dosage range
check screening. All DRCM Renal Master records with a Default DRCM Dosing Adjustment Type Code shall
have a DRCM Renal Sort Order (REN_SORT_ORDER) equal to 1.

No adjustment information (DOSING_ADJ_TYPE_CD = 11)

Dose range checking values cannot be adjusted for the level of renal impairment as referenced dose adjustment
information is unavailable at the given level of renal impairment. The No adjustment information DRCM Dosing
Adjustment Type Code may replace the use of other DRCM Dosing Adjustment Type Codes used currently to
communicate this information such as See footnote. All DRCM Renal Master records with a No adjustment
information DRCM Dosing Adjustment Type Code shall have a DRCM Renal Sort Order ( REN_SORT_ORDER)
equal to 1.

Hepatic Flag

The dosage ranges specified in the DRCM Master Table (RDRCMA2_MSTR) and the DRCM Neonatal and Adult
Master Table (RDRCNMA2_MSTR) are for patients with normal organ function. Some drugs require dosage
adjustment when given to patients with hepatic impairment.

The Hepatic Impairment Indicator is a Yes/No field in the dosing record. As such, it is specific to drug, patient age,
route of administration, and dose type.

The value is set to Y when a drug may need to have its dose adjusted in patients with hepatic dysfunction.
Underlying reference information here may be very specific (for example, doses that require adjustment only for a
cirrhosis indication), or may state the severity at which the dose needs to begin to be adjusted (for example, mild,
moderate, or severe failure, or a Child-Pugh score). However, the Hepatic Impairment Indicator has only Yes or
No values; that is, it cannot incorporate these sorts of multiple variables into a binary indicator. Consequently,
the flag for hepatic dysfunction will be set to Y when the supporting references identify any reason that the dose
may require adjustment or use with caution in patients with hepatic dysfunction.

If both the Renal and Hepatic Impairment Indicators are set to Y and the patient has both hepatic
impairment and renal impairment below the creatinine clearance threshold, dose range checking for renal
impairment with DRCM cannot be used. Developers may want to provide an advisory message to the end
user, such as, Dosage range checking for <medication name> is not available in situations where the
patient exhibits both hepatic impairment and renal impairment (CrCl < 50).

The Hepatic Flag is represented in the following:

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DRCM Hepatic Impairment Assessment Indicator (DR2_HEPIMP)

NEOM Hepatic Impairment Indicator (NEOM_HEPATIC_IMPAIRMENT_IND)

Clinical Formulation ID

The Clinical Formulation ID (also known as the GCN_SEQNO) identifies the drug the dosing record is intended to
screen. The Clinical Formulation ID is represented by the Clinical Formulation ID (Stable ID) ( GCN_SEQNO)
field.

Clinical Route

The route of administration coded is the route by which the drug will actually be administered; this is referred to as
the clinical route. This clinical route is not necessarily the route of the drug appearing in approved labeling.

Many of the clinical routes contain the word "continuous" in the description. Drugs coded by a continuous route
are meant for uninterrupted administration for at least 24 hours. A drug given over 3 hours on an every 6 hour
schedule (for example, administered for 3 hours then stopped for 3 hours, then given again for 3 hours, etc.) is
not considered to be continuous.

The Clinical Route is represented in the following:

DRCM Route of Administration Indicator (DR2_RT)

NEOM Route Code (NEOM_ROUTE_CODE)

Clinical Generic Route

The Clinical Generic Route codes link the Route of Administration Code (GCRT2) routes from MedKnowledge to
the DRCM Route of Administration Indicator (DR2_RT)/NEOM Route Code (NEOM_ROUTE_CODE) routes used
in DRCM and NEOM.

Dose Type

The dose type field in DRCM/NEOM indicates the type of dose being screened. Three types of dosing are
supported in DRCM/NEOM. The supported dose types are shown in the following table, along with their
2-character Dose Type Code:

Dose Type Code Dose Type Description

01 Loading Dose

02 Maintenance Dose

07 Single Dose

Dose Type is represented in the following:

DRCM Dose Type Indicator (DR2_DOSTPI)

NEOM Dose Type Code (NEOM_DOSE_TYPE_CODE)

Loading Dose

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An initial dose(s) given to rapidly achieve total body stores (that is, desired plasma level) of the drug.

Maintenance Dose

The maintenance dose is the amount of drug needed to replace what is lost by the body during the dosing
interval.

Single Dose

A Single Dose type record provides the range of a single dose for a drug. Continuous routes of administration
(such as Continuous Nebulization, DR2_RT = 072) do not have single dose type records in DRCM.

Reason for Use

Since pharmacies will not necessarily be aware of a drug's reason for use, dosing data is coded with a "Default
Screening Record."

The "Default Screening Record" dose ranges are set at the lowest of the low dose ranges to the highest of the
high dose ranges found in the DRCM enumerated references for the same age range, Dose Type, and route of
administration for the common uses of the drug.

Reason specific records are coded if the dosage range falls outside of the "Default Screening Record" range. If a
dosage range for a specific reason for use falls within the "Default Screening Record" range, only the "Default
Screening Record" record will be coded.

All DxIDs linked to a dosing record as a reason for use must be paired to the Clinical Formulation ID in the
Indications Module.

Age Low

The UOM for the age low is days. The value coded in the field represents the lowest patient age, in days, for
which the dosing record can be used to screen an order. For oral contraceptives/patches/injections and pre-natal
vitamins the low age will be set at ten years unless references specifically state otherwise.

Age Low is represented in the following:

DRCM Low Age in Days (DR2_LOAGED)

DRCM Renal Low Age in Days (REN_LOAGED)
NEOM Low Age in Days (NEOM_LOW_AGE_DAYS)

Age High

The UOM for the age high is days. The value coded in the field represents the highest patient age, in days, for
which the dosing record can be used to screen an order.

Age High is represented in the following fields:

DRCM High Age in Days (DR2_HIAGED)

DRCM Renal High Age in Days (REN_HIAGED)
NEOM High Age in Days (NEOM_HIGH_AGE_DAYS)

Gestational Age at Birth (GAB) Required Indicator

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This indicator is set to true if the GAB is required in order to determine the correct dosage range of the drug.

The GAB is used only in patients less than 1 year in age.

Gestational Age at Birth (GAB) Required Indicator is represented in the following field:

Neonatal Gestational Birth Age Required Indicator (NEOM_GEST_BIRTH_AGE_REQ_IND)

Gestational Age at Birth (GAB) Low

The UOM for the GAB low is weeks. The value coded in the field represents the lowest GAB for which the dosing
record can be used to screen an order. A "0" in this field implies that there is not a lower end to the gestational
age at birth range.

The GAB is used only in patients less than 1 year in age.

Gestational Age at Birth (GAB) Low is represented in the following field:

Neonatal Low Gestational Age at Birth in Weeks (NEOM_LOW_GEST_BIRTH_AGE_WEEKS)

Gestational Age at Birth (GAB) High

The UOM for the GAB high is weeks. The value coded in the field represents the highest GAB for which the
dosing record can be used to screen an order. A "0" in this field implies that there is not an upper end to the
gestational age at birth range.

The GAB is used only in patients less than 1 year in age.

Gestational Age at Birth (GAB) High is represented in the following field:

Neonatal High Gestational Age at Birth in Weeks (NEOM_HIGH_GEST_BIRTH_AGE_WEEKS)

Interaction of GAB and Age Range

In premature neonates, and especially in micro-premies (that is, <1000g birth weight and/or <32 gestational age
at birth), the fact that they have reached 30 days of age and are technically infants does not mean that they can
receive normal infant dosing. However, ex-utero, these infants may mature their organ and some enzymes
systems at a faster rate than they would in-utero. For this reason, drugs that require adjustments based upon the
patient's gestational age at birth may need to be transitioned to infant dosing (for full term infants) at some point
later than 30 days. The dosing records will use the GAB and Age fields in combination to allow for this transition
to infant dosing.

Currently, 23 weeks of gestation is the limit of viability. If 40 weeks is term, then the data could apply to a patient
that was up to 17 weeks premature. They will not be beyond their adjusted neonatal period until they are at term
+ 4 weeks, or a corrected gestational age of 44 weeks. 44 weeks - 23 weeks = 21 weeks * 7 days/week = 147
days for the post-natal age. Therefore, the use of the GAB will not be necessary for records coded for post-natal
ages beyond 147 days.

Current Weight Required Flag

Some drugs require the patient's current weight in order to determine the appropriate dosage range (above and
beyond the fact the UOM may use mg/kg like units). This flag is set to true if the patients weight is required to

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determine the correct dosage range.

Weight-based dosing is not available for Min/Max or renal dosing.

Current Weight Required Flag is represented in the following fields:

Weight Required Indicator (WEIGHT_REQ_IND)

Neonatal Weight Required Indicator (NEOM_WEIGHT_REQ_IND)

Current Weight Low

The UOM for the current weight low is grams. The value coded in the field represents the patient's lowest current
weight for which the dosing record can be used to screen an order. A "0" in this field implies that there is not a
lower end to the weight range.

Weight-based dosing is not available for Min/Max or renal dosing.

Current Weight Low is represented in the following fields:

Low Current Weight in Grams (LOW_CURRENT_WEIGHT_GRAMS)

Neonatal Low Current Weight in Grams (NEOM_LOW_CURRENT_WEIGHT_GRAMS)

Current Weight High

The UOM for the current weight high is grams. The value coded in the field represents the patient's highest
current weight for which the dosing record can be used to screen an order. A "0" in this field implies that there is
not an upper end to the weight range.

Weight-based dosing is not available for Min/Max or renal dosing.

Current Weight High is represented in the following fields:

High Current Weight in Grams (HIGH_CURRENT_WEIGHT_GRAMS)

Neonatal High Current Weight in Grams (NEOM_HIGH_CURRENT_WEIGHT_GRAMS)

Interaction of Current Weight and Age Range

In premature neonates, and especially in micro-premies (that is, <1000g birth weight and/or <32 weeks
gestational age at birth), the fact that they have reached 30 days of age and are technically infants does not
mean that they can receive normal infant dosing. However, ex-utero, these infants may mature their organ and
some enzymes systems at a faster rate than they would in-utero. For this reason, drugs that require adjustments
based upon the patient's current weight will need to be transitioned to infant dosing (for full term infants) at some
point later than 30 days. A combination of the Age fields and Current Weight fields will be used to code these
transitional doses.

To determine the cut-off-postnatal-age for a given weight, use the following table, which identifies the postnatal
age by which even a severely premature infant should exceed that weight. This means that dosing for that weight

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or less does not need to be coded beyond that age.

Weight in Grams High Cut-Off-Postnatal-Age (days)

1000 127

1200 182

1500 222

2000 273

2500 335

Using the above table, a newborn would be expected to weigh at least 1200 g by 183 days of age, so records for
babies <1200 g will not be coded beyond a post natal age of 182 days. Additionally, the table data contemplates
that Current Weight fields will not be necessary beyond 335 days of post natal age.

Premature infant dosing is not populated beyond 1 year of age. If neonatal dosing extends beyond age 29 days
and non-neonatal weight-based dosing is appropriate for ages 30-364 days, there will only be one weight-based
dosing record for the appropriate age range and weight range.

All weights for all ages are given in grams.

Example Records for methylnaltrexone SQ

Age Low 6570 6570 6570 6570

Age High 40150 40150 40150 40150

Weight Low (G) 0 38000 62000 114001

Weight High (G) 37999 61999 114000 0

Duration Low 1 1 1 1

Duration High

Duration Max

Frequency Low 0.43 0.43 0.43 0.43

Frequency High 1 1 1 1

Daily Low 0.061 3.268 4.902 0.061

Daily Low UOM mg/kg/day mg/day mg/day mg/kg/day

Daily High 0.15 8 12 0.15

Daily High UOM mg/kg/day mg/day mg/day mg/kg/day

Daily Max 0.15 8 12 0.15

Daily Max UOM mg/kg/day mg/day mg/day mg/kg/day

Single Max 0.15 8 12 0.15

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Single Max UOM mg/kg/day mg/day mg/day mg/kg

Not-to-Exceed (NTE) 8 8 12 0.15

Not-to-Exceed (NTE) mg mg mg mg/kg

UOM

Low Dose per Day (DRCM/NEOM) or Minimum Daily Dose (Min/Max)

The Low Dose per Day is the lowest effective dose specific to the patient age, reason for use, dose type, route of
administration, and creatinine clearance, as well as gestational age at birth and current weight that is given on a
daily basis.

When coding drugs that can be given on a PRN basis, the Low Dose per Day will be the equivalent of the lowest
effective single dose specific to the patient age, reason for use, dose type, and route of administration, as well as
gestational age at birth and current weight.

Some drugs require a lower dose, when therapy is first started, to allow the patient to become tolerant of potential
side effects of the drug. In these cases, the Low Dose per Day field will be coded with the lowest daily dose of
that initial phase of therapy.

Drugs which are combinations of ingredients are coded using dosage form UOMs only.

When coding the amount for the dosage form fields in the Min/Max modules (for example, MMA_MNU,
MMAR_MNU, MMG_MNU, MMGR_MNU, PDM_MNU), the value should be appropriate for the National Council
for Prescription Drug Programs (NCPDP) UOM associated with the drug.

Low Dose per Day is represented in the following:

DRCM Low Dose Per Day (DR2_LODOSD)

DRCM Renally Adjusted Low Dose Per Day (REN_LODOSD)
NEOM Low Dose per Day (NEOM_LOW_DOSE_PER_DAY)

Minimum Daily Dose is represented in the fields that provide minimum daily dose strength and minimum daily
dose units values in all five Min/Max Dose Modules (MMAD, MMGD, MMAR, MMGR, PDM).

High Dose per Day (DRCM and NEOM) or Maximum Daily Dose (Min/Max)

The high dose per day is the highest dose recommended on the label for common indications, specific to the
patient age, reason for use, dose type, route of administration, and creatinine clearance, as well as gestational
age at birth and current weight.

Drugs which are combinations of ingredients are coded using dosage form UOMs only.

When coding the amount for the dosage form fields in the Min/Max modules (for example, MMA_MXU,
MMAR_MXU, MMG_MXU, MMGR_MXU, and PDM_MXU), the value should be appropriate for the NCPDP UOM
associated with the drug.

High Dose per Day is represented in the following:

DRCM High Dose Per Day (DR2_HIDOSD)

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DRCM Renally Adjusted High Dose Per Day (REN_HIDOSD)

NEOM High Dose per Day (NEOM_HIGH_DOSE_PER_DAY)

Maximum Daily Dose is represented in the fields that provide maximum daily dose strength and maximum daily
dose units values in all five Min/Max Dose Modules (MMAD, MMGD, MMAR, MMGR, PDM).

Max Dose per Day (DRCM and NEOM only)

The Maximum Dose per Day is the largest dose identified as safe within the DRCM references specific to patient
age, reason for use, dose type, route of administration, and creatinine clearance, as well as gestational age at
birth and current weight. The maximum dose per day includes the outlier dosing.

Some drugs require a higher dose, when therapy is first started, to rapidly gain control of the patient's symptoms.
If this value is greater than the Max Dose per Day for normal maintenance therapy, the Max Dose per Day field
will be coded with the maximum dose of that initial phase of therapy.

Drugs which are combinations of ingredients are coded using dosage form UOMs only.

Where the data specifies the dose as 25 - 50 mg/kg/day IV to a maximum of 2000 mg/day, since either
description could be employed to identify maximum dosing, the Max Dose per Day field would be coded with
2000 mg/day and the High Dose per Day field would be coded with 50 mg/kg/day.

Max Dose per Day is represented in the following:

DRCM Maximum Dose Per Day (DR2_MXDOSD)

DRCM Renally Adjusted Maximum Dose Per Day (REN_MXDOSD)
NEOM Maximum Dose per Day (NEOM_MAX_DOSE_PER_DAY)

Maximum Amount per Single Dose (DRCM and NEOM only)

The Maximum Amount per Single Dose is the largest amount of drug that references indicate should be
administered at one time, specific to the patient age, reason for use, dose type, route of administration, and
creatinine clearance, as well as gestational age at birth and current weight.

Maximum Amount per Single Dose is represented in the following:

DRCM Maximum Dose Per Day (DR2_MXDOSD)

DRCM Renally Adjusted Maximum Dose Per Day (REN_MXDOSD)
NEOM Maximum Dose per Day (NEOM_MAX_DOSE_PER_DAY)

Maximum Amount per Single Dose (DRCM and NEOM only)

The Maximum Amount per Single Dose is the largest amount of drug that references indicate should be
administered at one time, specific to the patient age, reason for use, dose type, route of administration, and
creatinine clearance, as well as gestational age at birth and current weight.

Maximum Amount per Single Dose is represented in the following:

DRCM Maximum Amount Per Single Dose (DR2_MX1DOS)

DRCM Renally Adjusted Maximum Amount Per Single Dose (REN_MX1DOS)

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NEOM Maximum Single Dose (NEOM_MAX_SINGLE_DOSE)

Not-to-Exceed per Single Dose (DRCM and NEOM only)

The Not-to-Exceed (NTE) per Single Dose is the largest amount of drug that references indicate should be given
as a single dose specific to the patient age, reason for use, dose type, route of administration, and creatinine
clearance, as well as gestational age at birth and current weight.

In many cases, the Not-to-Exceed per Single Dose value and the Maximum Amount per Single Dose will be the
same. However, in situations where the dose for the drug is "x" mg/kg or "x" mg/m2 up to "y" mg/dose, the "x"
mg/kg or "x" mg/m2 value will be coded in the Maximum Amount per Single Dose field and the "y" mg/dose value
will be coded in the Not-to-Exceed per Single Dose field. There are also situations where the pediatric dose may
be expressed as "x" mg/kg or "x" mg/m2 without an NTE value, but the adult or adolescent Maximum Amount per
Single Dose is expressed as "z" mg/dose. In these situations again the "x" mg/kg or "x" mg/m2 value will be
coded in the Maximum Amount per Single Dose field and the "z" mg/dose Adult value will be coded in the
Not-to-Exceed per Single Dose field for the pediatric age ranges.

When screening a single dose, it must pass both the Maximum Amount per Single Dose and the Not-To-Exceed
per Single Dose fields in order to pass DRCM/NEOM screening.

Not to Exceed per Single Dose value is represented in the following:

Not-to-Exceed Amount Per Single Dose (NTE_SINGLE_DOSE)

DRCM Renally Adjusted Not-to-Exceed Amount Per Single Dose (REN_NTE_SINGLE_DOSE)

Maximum Amount per Lifetime Dose (DRCM and NEOM only)

The Maximum Lifetime Dose is the largest amount of drug that can be safely administered over a patient's
lifetime.

Maximum Amount per Lifetime Dose is represented in the following fields:

DRCM Maximum Lifetime Dose (DR2_MXLIFD)

NEOM Maximum Lifetime Dose (NEOM_MAX_LIFE_DOSE)

Dosing Ranges and Ingredient Strength

For some drugs, it is possible to express the strength of the dosage form in more than one way.

For example, the strength of a ferrous sulfate 325 mg (65 mg iron) tablet can be expressed as either 325 mg of
ferrous sulfate, or as 65 mg of elemental iron.

The dosing range for this product could then be either the range for the salt (that is, ferrous sulfate), or the range
for the elemental amount of iron. The DRCM range that will be coded will be based upon the amount stated first in
either the STR [that is, 325(65) mg], or the STR60 [that is, 325 mg (65 mg iron)] fields; this value will be the
strength specified in the STRENGTH and STRENGTH_UOM_ID columns (as opposed to the ALT_STRENGTH
and ALT_STRENGTH_TYP_CODE columns) in the Clinical Formulation Ingredient Strength Component Table.
In the example above, the range coded will be for the 325 mg base plus salt range.

This practice will be applied to all drugs, not just ferrous sulfate.

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Not-to-Exceed per Day (Pediatric Min/Max only)

If the reference source states that the Max dose (for example, PDM_MXD field) is of the form "x" mg/kg/day up to
a maximum of "y" mg/day, that "y" amount is expressed in this field.
Drugs which are combinations of ingredients are coded using dosage form UOMs only, so the amount coded
needs to be appropriate for the UOM.

Not-to-Exceed per Day is represented in the following fields:

PDM Not-to-Exceed Daily Dose Strength Quantity (PDM_NTED)

PDM Not-to-Exceed Daily Dose Units Quantity (PDM_NTEU)

Dosing Not Established (Pediatric Min/Max only)

If the reference source states that a drug has not been studied in pediatric patients, but there are no specific
warnings about using it in a pediatric age group, the drug will be output with the PDM field filled with "9," signifying
that the dosing is not established.

PDM field refers to any of the following fields:

PDM Minimum Daily Dose Strength Quantity (PDM_MND)

PDM Minimum Daily Dose Units Quantity (PDM_MNU)
PDM Maximum Daily Dose Strength Quantity (PDM_MXD)
PDM Maximum Daily Dose Units Quantity (PDM_MXU)
PDM Not-to-Exceed Daily Dose Strength Quantity (PDM_NTED)
PDM Not-to-Exceed Daily Dose Units Quantity (PDM_NTEU)

Dosing Not Recommended (Pediatric Min/Max only)

If the reference source states that a drug should not be used in a pediatric patient because of potential problems
with its use in the age group, the drug will be output with the PDM field filled with "0," to indicate that dosing of the
drug in this age group is not recommended.

PDM field refers to any of the following fields:

PDM Minimum Daily Dose Strength Quantity (PDM_MND)

PDM Minimum Daily Dose Units Quantity (PDM_MNU)
PDM Maximum Daily Dose Strength Quantity (PDM_MXD)
PDM Maximum Daily Dose Units Quantity (PDM_MXU)
PDM Not-to-Exceed Daily Dose Strength Quantity (PDM_NTED)
PDM Not-to-Exceed Daily Dose Units Quantity (PDM_NTEU)

Interplay of Frequency and Dose

When coding the Maximum Dose per Day field, the data will reflect the following relationships:

Maximum Dose per day (Maximum Amount per Single Dose * High Frequency of Administration)

Additionally, when dealing with frequencies of <1, the daily dose amounts are calculated in the following manner:

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If the Low Frequency is <1.

Low Dose per Day (DRCM/NEOM) or Minimum Daily Dose (Min/Max) = Low Dose amount * Low Frequency
* Low Variance. The value coded is rounded down at the second decimal point.

If the High Frequency is <1.

High Dose per Day (DRCM and NEOM) or Maximum Daily Dose (Min/Max) = High Dose amount * High
Frequency * High Variance. The value coded is rounded up at the second decimal point.

Max Dose per Day (DRCM and NEOM only) = Max Dose amount * High Frequency * High Variance. The
value coded is rounded up at the second decimal point.

Maximum Amount per Single Dose (DRCM and NEOM only) = Max Single Dose amount * High Variance.
The value coded is rounded up at the second decimal point.

Not-to-Exceed per Single Dose (DRCM and NEOM only). If the UOM for the Not-to-Exceed per Single Dose
(DRCM and NEOM only) AND Maximum Amount per Single Dose (DRCM and NEOM only) fields are the
same, then Not-to-Exceed per Single Dose (DRCM and NEOM only) = Not-to-Exceed per Single Dose
amount * High Variance. The value coded is rounded up at the second decimal point. If the UOM for the
Not-to-Exceed per Single Dose (DRCM and NEOM only) AND Maximum Amount per Single Dose (DRCM
and NEOM only) fields are different, the Not-to-Exceed per Single Dose field is not changed.

The calculations employ the values coded in the frequency fields and multiply them by the dose amount. (The
alternative of dividing the dose by the number of days for the dosing interval will result in rounding and precision
issues.)

Be sure to use the frequency values from the table in Frequency of Administration when calculating daily
dose from dose amount values with frequencies of <1.

In cases where the low frequency is <1, but the high frequency is 1, only the data coded in the Low Dose per
Day (DRCM/NEOM) or Minimum Daily Dose (Min/Max) field is adjusted for the frequency being less than one
dose per day.

The Maximum Amount per Lifetime dose (DRCM and NEOM only) field is not affected by a frequency <1.

Variance Policy

In situations where the low dose per day, high dose per day, and maximum dose per day are equal and the unit
of measure is of the form */kg or */m2, DRCM values are adjusted by the percentage identified by USP as the
manufacturing variance. In this manner, the frequency of alerts occasioned purely by rounding issues involving
calculated values and dosing amounts will be reduced, while the variance is kept within limits acknowledged as
potentially present in the underlying medication.

If more than one dosage form is present and those dosage forms have different variances in the USP, the
variance with the smallest range will be the one coded in the data.

Based on editorial guidelines, the range may be narrower than what is found in the USP. If the USP variance is

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>20%, either + or -, a value of 20% will be assigned.

If the USP does not report a range for the Clinical Formulation ID, DRCM will assign a variance of 5% for
solutions and 10% for other dosage forms.

Zero-Tolerance Record Definition: If for a given dosing record, the research indicates that if the Low Dose per
Day, High Dose per Day, and Max Dose per Day fields, or the Min Dose field and Max Dose field, should be
coded with the same value, this situation defines a Zero-Tolerance Record.

Doses coded for Zero-Tolerance Records that use patient parameter UOMs and records with frequencies <1 will
have a variance applied to the dosing range.

Patient parameter UOMs are those with the general format of */kg/* or */m2/* (such as, mg/kg/day or mg/m2/day).

When a Zero-Tolerance Record's data uses a UOM, for any of the fields, which has a patient parameter
requirement (for example, */kg/* or */m2/*), this will cause an excessive number of false hits against the record
because of the necessity to round the dose to a dispensable amount.

As an example, the child's dose for cyproheptadine is 0.25 mg/kg/day PO divided into 2 or 3 doses. This data
would result in the following information being coded for the age range:

Low Dose Low Dose High Dose High Dose Max Dose Max Dose Max Single Max Single
per Day per Day per Day per Day per Day per Day Dose Dose UOM
UOM UOM UOM

0.25 mg/kg/day 0.25 mg/kg/day 0.25 mg/kg/day 0.125 mg/kg

For a 13.5 kg child, the dose is 13.5 kg * 0.25 mg/kg/day = 3.375 mg/day in 2 or 3 doses. If the dose is rounded to
something dispensable, and is not exactly 3.375 mg/day in total, a warning will be generated.

The USP variance data is coded as a factor that can be used to mathematically expand the range. This variance
factor is applied to the dosing record if it is a zero tolerance record (as noted above) and the UOM is of the format
*/kg/day or */m2/day, or if the low or high frequency is less than once per day.

The low USP variance is a number between 0.8 - 1, and the high variance is a number between 1 - 1.2. In the
case for cyproheptadine, the low variance = 0.9 and the high variance = 1.1. These factors are then applied to the
dosing range as follows:

Low Daily Dose: 0.25 mg/kg/day * 0.9 = 0.225 mg/kg/day.

High Daily Dose and Max Daily Dose: 0.25 mg/kg/day * 1.1 = 0.275 mg/kg/day.

Max Single Dose: 0.125 mg/kg * 1.1 = 0.1375 mg/kg.

These calculations would result in the following dosing record:

Low Dose Low Dose High Dose High Dose Max Dose Max Dose Max Single Max Single
per Day per Day per Day per Day per Day per Day Dose Dose UOM
UOM UOM UOM

0.225 mg/kg/day 0.275 mg/kg/day 0.275 mg/kg/day 0.1375 mg/kg

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The second situation where the variance is applied is when the dosing frequency is less than once per day. There
are two variations of this situation. The first is when just the low frequency is <1, and the second is when both the
low and high frequencies are <1.

The following provides an example of when only the low frequency is <1:

Low Dose Low Dose High Dose High Dose Max Dose Max Dose Max Single Max Single
per Day per Day per Day per Day per Day per Day Dose Dose UOM
UOM UOM UOM

0.29 mg/day 4 mg/day 4 mg/day 1 mg

The low variance = 0.9 and the high variance = 1.1. However, because only the low frequency is <1, only the Low
Daily Dose should be adjusted by the variance. 0.9 * 0.29 mg/day = 0.261 mg/day.

These calculations would result in the following dosing record:

Low Dose Low Dose High Dose High Dose Max Dose Max Dose Max Single Max Single
per Day per Day per Day per Day per Day per Day Dose Dose UOM
UOM UOM UOM

0.261 mg/day 4 mg/day 4 mg/day 1 mg

The second situation is where both the low frequency and the high frequency are <1. For a clonidine patch to be
applied once every 7 days and left in place for the week, both the low and high frequency would be 0.14. The low
dose, high dose, and max dose are then calculated as 0.14 * 1 application/day = 0.14 applications per day.

Low Dose Low Dose High Dose High Dose Max Dose Max Dose Max Single Max Single
per Day per Day per Day per Day per Day per Day Dose Dose UOM
UOM UOM UOM

0.14 patch/day 0.14 patch/day 0.14 patch/day 1 patch

The low variance = 0.94 and the high variance = 1.05. Applying the variance the low dose becomes 0.94 * 0.14
patch/day = 0.132 patch /day. The high dose and max dose become 1.05 * 0.14 patch /day = 0.147 patch/day.
The Max Single Dose becomes 1 patch * 1.05 = 1.05 patch.

These manipulations would result in the following dosing record:

Low Dose Low Dose High Dose High Dose Max Dose Max Dose Max Single Max Single
per Day per Day per Day per Day per Day per Day Dose Dose UOM
UOM UOM UOM

0.132 patch/day 0.147 patch/day 0.147 patch/day 1.05 patch

Units of Measure

When coding the Low Dose per Day Unit, High Dose per Day Unit, and Maximum Dose per Day Unit fields for a
noncontinuous route of administration, the selected UOM must have a time component of day (for example
mg/day or mcg/kg/day are acceptable; mg, mcg/kg, mg/hr, mcg/min are not acceptable). The Max Single Dose

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and Not-to-Exceed per Single Dose units will not contain a time component (for example, mg and mcg/kg are
acceptable; mg/day or mcg/kg/day are not acceptable).

If the route for the record being coded is a continuous route of administration, the unit of measure for the Low
Dose per Day, High Dose per Day, Max Dose per Day, Max Single Dose, and Not-to-Exceed per Single Dose
units will contain a time component of "Hour," "Minute," or "Second," unless there is a cap on the total amount per
day that can be given as described above. If this cap does exist, the Max Dose per Day Unit's field time
component will be day (for example, mg/hr, mcg/min are acceptable; mg/day is not acceptable unless in the Max
Daily Dose field to indicate an absolute cap on the daily amount).

Multi-ingredient drugs use a dose-form (for example, tab-cap, suppos, etc.) UOM only.

Transdermal patches are coded with a UOM of "patch/day" or "patch" in DRCM and NEOM, and "each" or
"each/day" in the Min/Max modules.

The Maximum Lifetime Dose Unit is chosen based upon the data available in the literature. For the same drug, it
may be different for different age ranges. Like the Maximum Dose per Day Unit fields, the Maximum Lifetime
Dose Unit is chosen from the codes WITHOUT a time component (for example, mg or mg/m2 are acceptable;
mg/day is not).

Units of Measure are represented in the following fields:

DRCM Low Dose Units Code (DR2_LODOSU)

DRCM High Dose Units Code (DR2_HIDOSU)
DRCM Maximum Single Dose Units Code (DR2_MX1DSU)
DRCM Maximum Dose Units Code (DR2_MXDOSU)
DRCM Renally Adjusted Lose Dose Per Day Units Code (REN_LODOSU)
DRCM Renally Adjusted High Dose Per Day Units Code (REN_HIDOSU)
DRCM Renally Adjusted Maximum Single Dose Units Code (REN_MX1DSU)
DRCM Renally Adjusted Maximum Dose Per Day Units Code (REN_MXDOSU)
DRCM Renally Adjusted Not-to_Exceed Amount Per Single Dose Units Code (
REN_NTE_SINGLE_DOSE_UNIT_CODE)
NEOM Low Dose Unit Code (NEOM_LOW_DOSE_UNIT_CODE)
NEOM High Dose Unit Code (NEOM_HIGH_DOSE_UNIT_CODE)
NEOM Maximum Dose Unit Code (NEOM_MAX_DOSE_UNIT_CODE)
DRCM Maximum Lifetime Dose Units Code (DR2_MXLIFU)
NEOM Maximum Lifetime Dose Unit Code (NEOM_MAX_LIFE_DOSE_UNIT_CODE)

Min/Max Units

Units of measure available in the Min/Max modules:

Adult

The Adult Minimum/Maximum Daily Dose Units are available in the following fields:

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MMAD Minimum Daily Dose Strength Units (MMAR_MNDU)

MMAD Maximum Daily Dose Strength Units (MMA_MXDU)
MMAR Minimum Daily Dose Strength Units (MMAR_MNDU)
MMAR Maximum Daily Dose Strength Units (MMAR_MXDU)
Adult Minimum/Maximum Daily Dose Units

G GRAMS

MG MILLIGRAM

MCG MICROGRAM

MEQ MILLIEQUIVALENT

U UNITS

AP APPLICATORFUL

SC SCOOPS

IN INHALATIONS

MU UNITS X 1000

MMU UNITS X 1000000

GTT DROPS

The Adult Minimum/Maximum Daily Units Form are available in the following fields:

MMAD Minimum Daily Dose Units Form (MMA_MNUF)

MMAD Maximum Daily Dose Units Form (MMA_MXUF)
MMAR Minimum Daily Dose Units Form (MMAR_MNUF)
MMAR Maximum Daily Dose Units Form (MMAR_MXUF)
Adult Minimum/Maximum Daily Units Form

EA TABLETS, CAPSULES, SUPPOSITORIES, ETC.

ML LIQUIDS

IN METERED DOSE AEROSOLS FOR INHALATION

SC POWDERS WHICH ARE PRESCRIBED BY THE 'SCOOP'

AP VAGINAL CREAMS PRESCRIBED BY THE

'APPLICATORFUL'

G METERED DOSE AEROSOLS FOR INHALATION

Geriatric

The Geriatric Minimum/Maximum Daily Dose Units are available in the following fields:

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MMGR Minimum Daily Dose Strength Units (MMGR_MNDU)

MMGR Maximum Daily Dose Strength Units (MMGR_MXDU)
MMGD Minimum Daily Dose Strength Units (MMG_MNDU)
MMGD Maximum Daily Dose Strength Units (MMG_MXDU)
Geriatric Minimum/Maximum Daily Dose Units

G GRAM

MG MILLIGRAM

MCG MICROGRAM

MEQ MILLIEQUIVALENT

U UNITS

AP APPLICATORFUL

SC SCOOPS

IN INHALATIONS

MU UNITS X 1000

MMU UNITS X 1000000

GTT DROPS

The Geriatric Minimum/Maximum Daily Units Form are available in the following fields:

MMGR Minimum Daily Dose Units Form (MMGR_MNUF)

MMGR Maximum Daily Dose Units Form (MMGR_MXUF)
MMGD Minimum Daily Dose Units Form (MMG_MNUF)
MMGD Maximum Daily Dose Units Form (MMG_MXUF)
Geriatric Minimum/Maximum Daily Units Form

EA TABLETS, CAPSULES, SUPPOSITORIES, ETC.

ML LIQUIDS

G METERED DOSE AEROSOLS FOR INHALATION

Pediatric

The Pediatric Dose Quantity Units and Dose Units Form Code are available in the following fields:

PDM Minimum Daily Dose Strength Units (PDM_MNDU)

PDM Maximum Daily Dose Strength Units (PDM_MXDU)
PDM Maximum Daily Dose Units Form (PDM_MXUF)
PDM Minimum Daily Dose Units Form (PDM_MNUF)

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PDM Not-to-Exceed Daily Dose Strength Units (PDM_NTEDU)

PDM Not-to-Exceed Daily Dose Units Form (PDM_NTEUF)
Pediatric Dose Quantity Units and Dose Units Form Code

Code Description

01 EA/KG/DAY

02 EA/DAY

03 ML/KG/DAY

04 ML/DAY

05 G/KG/DAY

06 G/DAY

07 MCG/KG/D

08 MCG/D

09 MEQ/DAY

10 MG/KG/DAY

11 MG/DAY

12 IN/DAY

13 SC/DAY

14 AP/DAY

15 MEQ/KG/DAY

16 SC/KG/DAY

17 MG/KG/HR

18 MG/1.73M2/DAY

19 UNIT/KG/DAY

20 UNIT/DAY

21 ML/KG/HR

22 EA/KG/HR

23 ML/1.73M2/DAY

24 EA/1.73M2/DAY

25 G/KG/HR

26 G/HR

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27 MG/KG/DOSE

28 MG/DOSE

29 EA/HR

30 ML/HR

31 EA/KG/DOSE

32 ML/KG/DOSE

33 EA/DOSE

34 ML/DOSE

35 MU/DAY

36 MMU/DAY

37 MU/KG/DAY

38 MMU/KG/DAY

TJC (formerly JCAHO) Compliance

The Joint Commission Compliance fields are used to code the description for the unit that is compliant with The
Joint Commission (TJC) and Institute for Safe Medication Practices (ISMP) requirements. In the coding of this
description, DRCM does not use symbols or abbreviations in the Units Description Expanded (
UNIT_DESC_EXPANDED) field. The Unit Description Abbreviation (UNIT_DESC_ABBREV) field does use the "/"
character for per. Any abbreviations used in these fields are compliant with both TJC and ISMP.

Unit Conversions (DRCM/NEOM only)

The "Unit Conversion" fields are used to code how to convert from the unit being coded to a different unit.

There are four fields associated with the conversion:

1. DRCM Prescribed Unit Indicator (DCNV_PUI)/NEOM Prescribed Unit Code (

NEOM_PRESCRIBED_UNIT_CODE)
This is the code for the prescribed UOM or the unit from which a conversion will be made.

2. DRCM Results Unit Code (UNITS_RUI)/NEOM Result Unit Code (NEOM_RESULT_UNIT_CODE)

This is the code for the resulting UOM or the unit to which a conversion will be made.

3. DRCM Units Math Indicator (DCNV_MTHI)/NEOM Math Process Code (NEOM_MATH_PROCESS_CODE

)
This is the code identifying the mathematical operation (for example, multiplication or division) to be
performed on the dose amount to convert the units.

4. DRCM Units Conversion Factor (DCNV_CNVF)/NEOM Conversion Factor (

NEOM_CONVERSION_FACTOR)

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4.

This is the factor used with the mathematical operation to convert the dose amount.

Patient Parameter (DRCM/NEOM only)

This field must be coded for all units. Valid Values are:

Not Applicable
Patient Weight (Kg)
Body Surface Area (m2)

Units are permanent objects, and once published and delivered, they cannot be deleted. Editing will be
performed only for the purpose of error correction or clarification.

Patient Parameter is represented in the following fields:

DRCM Units Required Calculation Type Code (UNITS_CTYP)

NEOM Calculation Required Type Code (NEOM_CALC_REQ_TYPE_CODE)

Dose Calculation Code

Choose the "Dose in Dose Units" option if the UOM is a dosage form type of unit (for example, Tab-Cap, suppos).

Choose the "Dose in Dose Amount" option if the UOM is an amount type of unit (for example, mg, mg/kg,
mcg/m2/day).

Dose Calculation Code is represented in the following fields:

DRCM Units Dose Calculation Code (UNITS_DCC)

NEOM Dose Calculation Code (NEOM_DOSE_CALC_CODE)

Frequency of Administration (DRCM/NEOM only)

Frequency is expressed as the number of doses per day.

There are two frequency fields, the Low Frequency of Administration and the High Frequency of Administration
fields. These fields reflect the low and high number of administrations per day.

Dosage regimens may have doses administered less frequently than once per day. When this occurs, the
frequency coded will be a value <1.0. This determination is not always a matter of simple calculation, and must
take relevant circumstances into account. For example, an every other day regimen would initially suggest a
frequency of 0.5 (1 dose every 2 days = 12 = 0.5). However, such a dosing regimen should result in three doses
per week the first week and four doses per week the second week. Consequently, the low frequency is coded =
0.43 (that is, 37=0.43), and the high frequency is coded = 0.57 (that is, 47=0.57). Currently used frequencies
less than one are shown in the table below. Be sure to use these frequency values when calculating daily dose
from dose amount values. See Considerations for Screening Drugs That Have a Frequency of Less Than Once
Per Day/Greater Than Once Per Month.

Frequency Description

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0.71 5 times every 7 days

0.67 8 times every 12 days

0.60 3 times every 5 days

0.57 4 times every 7 days

0.50 1 time every 2 days

0.43 3 times every 7 days

0.33 1 time every 3 days

0.29 2 times every 7 days

0.25 1 time every 4 days

0.24 5 times every 21 days

0.21 3 times every 14 days

0.14 1 time every 7 days

0.10 1 time every 10 days

0.07 1 time every 14 days

0.05 1 time every 21 days

0.04 1 time every 28 days

0.03 1 time every 30 days

If the frequency is less than one dose every 30 days, the Maintenance Dose Type records will be coded like the
Single Dose Type records.

Frequency is represented in the following fields:

DRCM Low Frequency of Administration (DR2_LOFREQ)

DRCM High Frequency of Administration (DR2_HIFREQ)
DRCM Renally Adjusted Low Frequency of Administration (REN_LOFREQ)
DRCM Renally Adjusted High Frequency of Administration (REN_HIFREQ)
NEOM Low Frequency (NEOM_LOW_FREQUENCY)
NEOM High Frequency (NEOM_HIGH_FREQUENCY)

Duration of Therapy

All duration fields have days as their unit of measure.

Duration Low

This identifies the least amount of time during which a drug should be administered for the reason for use and
route of administration indicated. A minimum value of "1" will be coded in this field if the duration is less than one

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day. A value greater than 1 indicates the minimum amount of time (in days) for the course of therapy or between
changes in the dose.

Duration Low is represented in the following fields:

DRCM Low Duration of Therapy (DR2_LODOTX)

NEOM Low Duration of Therapy (NEOM_LOW_DURATION_OF_TX)

Duration High

This identifies the normal upper limits of time during which a drug should be administered for the reason for use
and route of administration indicated. A value of 0indicates that either the drug is intended for chronic use or the
high duration is undefined.

Duration High is represented in the following fields:

DRCM High Duration of Therapy (DR2_HIDOTX)

NEOM High Duration of Therapy (NEOM_HIGH_DURATION_OF_TX)

Maximum Recommended Duration

This is the maximum amount of time during which a drug should be administered, for the reason for use and route
of administration indicated. A value of 0indicates that either the drug is intended for chronic use or the high
duration is undefined.

A drug that is prescribed for multiple courses of limited duration therapy on one prescription (for example, when a
single prescription provides enough medication for four five-day courses of therapy) will have the Max Duration
field set at zero and the High Duration field coded at the length of one course of therapy (in the example, at "5").

Maximum Recommended Duration is represented in the following fields:

DRCM Maximum Duration of Therapy (DR2_MXDOTX)

NEOM Maximum Duration of Therapy (NEOM_MAX_DURATION_OF_TX)

Special Considerations for Antineoplastics

Coding for antineoplastic drugs takes into account the normal order sequence for chemotherapy; for example, a
drug may be ordered each day for five days in a cycle to be repeated every three weeks. With such an order
post-treatment lab values will be reviewed and, if appropriate, the order will be renewed.

Given such circumstances, the dosing modules code antineoplastics for a single cycle of therapy. In the example,
the maintenance dose for the drug would be coded at the daily dose with a high and maximum duration of five
days. If the drug was to be given for only one day every three weeks, the maintenance dose would be coded with
a high and maximum duration of one day.

Frequencies of administration that extend beyond one day are provided for chemotherapeutic agents when the
prescribed schedule is "standard" in nature (every other day, every third day, etc.).

Special Considerations for Narcotic Analgesic

In coding for opiates and opiate analogs, the dosing modules take into account the considerations of opiod

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tolerance relative to the strength of a particular clinical formulation. For example, an appropriate oral morphine
dose for a non-tolerant patient could be 180 mg/day, while in a tolerant patient the dose can be as high as 1600
mg per day. With oral morphine available in tablet strengths of 10 mg, 20 mg, 30 mg, 60 mg, 100 mg, and 200
mg, and given its usual duration of action, the 10, 20, and 30 mg tablets will be coded as if prescribed for a
non-tolerant patient, while the 60, 100, and 200 mg strengths will be coded as if prescribed for tolerant patients.

Examples of how these Clinical Formulation IDs (GCN_SEQNOs) are coded are set out in the following table:

Strength Low Dose per Day* (mg) High Dose per Day (mg) Maximum Dose per Day
(mg)

10 mg, 20 mg 10 180 240

30 mg 30 180 360

60 mg 60 360 720

100 mg 100 600 1000

200 mg 200 1200 1600

*Low dose coded as a single dose per day.

Injectable products, because they can be given to non-tolerant patients, will be coded as if prescribed for
non-tolerant patients regardless of their concentration.

Narcotics in Combination with a Nonsteroidal Antiinflammatory Drug (NSAID)

When a narcotic is combined with an NSAID type agent, the dose of the combined product will not exceed the
acceptable dose of the NSAID agent when used by itself, unless there is specific labeling for the combination that
allows for a higher dose.

Half-Life (DRCM/NEOM only)

The apparent half-life of the drug is provided when available. The half-life ranges specified in DRCM are for
patients with normal organ function.

The half-life fields are in the dosing record. As such, it is specific to drug and patient age range.

Where the available half-life data has not been expressed as a range, but only a single value, only the low half-life
field will be populated.

When the drug being screened contains a combination of ingredients, these fields are not coded.

Low Half-Life

This field is coded with the value for the low end of the drug's half-life range.

Low Half-Life is represented in the following fields:

DRCM Low Elimination Half-Life (DR2_THAFLO)

NEOM Low Elimination Half Life (NEOM_LOW_ELIM_HALF_LIFE)

High Half-Life

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This field is coded with the value for the high end of the drug's half-life range.

High Half-Life is represented in the following fields:

DRCM High Elimination Half-Life (DR2_THAFHI)

NEOM High Elimination Half Life (NEOM_HIGH_ELIM_HALF_LIFE)

Half-Life Units

There is a separate 2-byte field for the units.

Half-Life Units are represented in the following fields:

DRCM Units of Time Half-Life Indicator (DR2_THAFU)

NEOM Half Life Unit Code (NEOM_HALF_LIFE_UNIT_CODE)

Dosing Age Source Identifier Code

The Dosage Age Source Identifier field indicates if the dosing range coded for an age-specific record was based
on evaluation of references relating to a different age range. Valid values for this field are:

1. Derived from Adult

2. Source Reference for Age Range

3. Supporting reference may not be specific to age group

When dosing information for a drug is not specific as to the age ranges it encompasses or is absent for a
specified age range, and there is no indication that the drug should not be used for that age range, adult dosing
data may be applied for those ranges. The dosing record will indicate when this has been done by setting the
Dosing Age Source Identifier Code to the value for Derived from Adult. Adult dosing will not be extended to the
pediatric, infant, or neonatal age ranges with the exception of the Single Dose NTE value. See the
Not-to-Exceed per Single Dose (DRCM and NEOM only). When the dosage range for a pediatric, infant, or
neonatal patient has an adult single dose NTE value coded, the value code for the Age Source Identifier field will
still be set to Source Reference for Age Range.

The "Supporting reference may not be specific to age group" value is the default field set by the database when
this field was added, and will remain until the dosing record is reviewed and either sourced to age-specific
references or, in the case of adolescent and geriatric age ranges, sourced to adult dosing. Pediatric, infant, and
neonatal dosing will not be provided in the absence of age-specific references, and consequently all neonatal,
infant, and child records will ultimately be set at "Source Reference for Age Range"; that is, no other age range
information will be used for them, with the exception of the NTE value. Adult records will also always be set at
"Source Reference for Age Range." Adolescent and Geriatric records may be either "Source Reference for Age
Range" or "Derived from Adult."

When a record extends across more than one age group (for example 6570 - 40150 days, encompassing both
the adult and geriatric age ranges), these age ranges must also share the same Age Source Identifier code,
which in this case would be "Source Data for Age Range." If different Age Source Codes are required, the data
will be separated for each applicable age range based upon the Age Source Identifier code to be applied.

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Dosing Age Source Identifier Code is represented in the following field:

Dosing Age Source Identifier (DOSING_AGE_SOURCE_ID)

Clinical Formulation Exclusion Code

This code indicates why a Clinical Formulation ID (GCN_SEQNO) does not have data in the Dosage Range
Check Module (DRCM).

The Clinical Formulation Exclusion Code is represented in the following field:

Exclusion Code (EXCLUSION_CODE)

Age Exclusions

Previously, the exclusion of age ranges, gestational age at birth and current weight ranges from DRCM Neonatal
and Adult data left gaps in certain dosing records. The reason for the exclusion may have been due to such
criteria as medication contraindications, inappropriate therapies for a certain age, or missing information for
certain age ranges. In order to avoid confusion as to why no information existed for a particular dosing record, a
No Information Available alert was issued without an associated explanation.

The inclusion of the DRCM Age Exclusion Table (RDRCAE0_AGE_EXCLUSION) will enable clinicians to make
more informed clinical screening decisions by receiving appropriate and relevant alert texts that explain why age
and weight ranges have been excluded from certain screening results.

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Dosing Maintenance
This section contains information regarding the ongoing maintenance of dosing module data.

The Dosing Editors review a variety of sources to identify and update dosing data, including manufacturer product
information, regulatory agency notifications and clinical references. Such a review may be initiated by events such
as creation of a new Clinical Formulation ID, FDA approval for a new chemical entity, receipt of a
MedWatch/Health Canada Med Effects alert, change in manufacturer labeling, and/or customer inquiries.

Reference Data Evaluation

FDB clinical editors compare, review, and compile the clinical information contained within these and other clinical
data sources to identify the dosing content for a given age, clinical route, indication and dose type.

Sources

This section lists sources that may be used by FDB Editors to compile the dosing information considered for
inclusion within dosing modules.

Manufacturer Product Labeling (country-specific based on product approval/availability)

AAP Pediatric Care Online
AAP Redbook
American Hospital Formulary Service Drug Information (AHFS)
APhA Drug Information Handbook
APhA Geriatric Dosage Handbook
APhA Pediatric and Neonatal Dosage Handbook
British National Formulary
British National Formulary for Children
Drug Prescribing In Renal Failure
Harriet Lane Handbook
Martindale: The Complete Drug Reference
Natural Medicines Comprehensive Database
Neonatology-Gomella
Pediatric Dosing Expert Panel (PDEP), convened by FDB
Primary Medical Literature (when appropriate)
Specialty References/Textbooks
Specialty Guidelines, Consensus
The Renal Drug Handbook

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DRCM Applications
This section provides information about the practical application of data contained in the Dosage Range Check
Module (DRCM).

FDB offers a variety of drug concepts and their identifiers to support a range of drug information applications
using clinical data. These identifiers represent drug products, ingredients, and formulations and are referred to as
Multiple Access Points (MAPs). From a development point of view, familiarity with the Multiple Access Points
(MAPs) section is needed before attempting the applications contained in this section.

Dosage Range Checking

ExampleDose Range Checking for an Adult Patient

ExampleDose Range Checking for a Neonatal Patient
ExampleDose Range Checking of Non-patient Parameters
ExampleDose Range Checking of a Continuous Infusion
ExampleDose Range Checking of an Intermittent Infusion

Converting Units During Dosage Range Checking

Performing Dosage Range Checking Using a DxID or ICD Code

Performing Dosage Range Checking for a Patient with Renal Impairment

Accessing a Renal Adjustment Monograph

Customer-Compiled Warning Messages

Utilizing FDB Preassembled Warning Messages

Generating DRCM Warning Messages

Considerations for Screening Drugs That Have a Frequency of Less Than Once Per Day/Greater Than Once Per
Month

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Dosage Range Checking

Dosage range checking uses patient and medication data from the database and checks the prescription for:

frequency of administration
duration of therapy
dose per day
maximum single dose
maximum single dose not-to-exceed

DRCM can also display the elimination half-life and maximum lifetime dose for the prescribed drug.

Half-Life is an information-only data field and represents the elimination half-life for the drug. It does not
have any functionality in DRCM and is for display-only (fields DR2_THAFLO and DR2_THAFHI,
DR2_THAFU). The half-life value may be a single-value or range of values for patients with normal renal
function. The range of half-life values usually represents values from healthy patients, but may include
values for patients with the clinical condition(s), for which the drug is indicated, and normal renal
function. This half-life information does not include values for patients with renal and/or hepatic disease
who require dosage adjustment of the usual/normal dose.

When performing dosage range checking it may be necessary to convert the DRCM units to the
prescribed units. See the Converting Units During Dosage Range Checking application for more
information on converting units.

When performing dosage range checking on extemporaneously compounded drugs, each active
ingredient should be screened individually.

The DRCM Dose Units Code Description (UNITS_DESC) column is in the DRCM Unit Description Table
(RDRCUND0_UNITS_DESC).

The information in the UNITS_DESC column might include abbreviations considered inappropriate by
The Joint Commission (TJC) and Institute for Safe Medication Practices (ISMP). To retrieve the
corresponding TJC-compliant unit descriptions for the given unit in the UNITS_DESC column, query the
Units Description Table (RUNITSD0_UNITS_DESC) and use the description found in either the
UNIT_DESC_ABBR or UNIT_DESC_EXPANDED columns.

The following application assumes familiarity with the various drug concepts and their identifiers and how to
access clinical information. This application begins at the Clinical Formulation level with the Clinical Formulation
ID (GCN_SEQNO). See Multiple Access Points (MAPs) for more information.

The examples following the application demonstrate the following:

Dose Range Checking for an Adult Patient

Dose Range Checking for a Neonatal Patient

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Dose Range Checking of Non-patient Parameters

Dose Range Checking of a Continuous Infusion
Dose Range Checking of an Intermittent Infusion

Part 1: Collect Dose Range Checking Data

This part of the application collects the appropriate data for dosage range checking. In addition to the prescription
information, the patients renal impairment, creatinine clearance, weight, age in days, and lifetime administrations
of the medication may be required.

Dosage range checking can be performed when some information is unknown but the information retrieved will be
less specific. Default values may be used to return more specific screening information.

1. Select records from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in days,
and

e. DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in days,
and

f. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record).

2. Select the Dosing Age Source Identifier (DOSING_AGE_SOURCE_ID) from the RDRCNMA2_MSTR table
where the columns equal the dosing record collected in step 1.
According to your business needs:

a. Display the data source information to the end-user.

b. Determine if the collected dosing record can be used in screening based on its source.

3. Check the Weight Required Indicator (WEIGHT_REQ_IND):

a. If WEIGHT_REQ_IND equals 0, the current weight is not required to select the screening record.
Skip to step 5.

b. If WEIGHT_REQ_IND equals 1, the current weight is required to select the screening record.
If the weight of the patient is known, use the actual weight.
If the weight of the patient is unavailable, prompt the end-user to enter the weight. Optionally

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the institution could provide a default nomogram based weight, to proceed with screening.

4. Filter the records returned in the previous step where:

a. Low Current Weight in Grams (LOW_CURRENT_WEIGHT_GRAMS) is less than or equal to the

patients weight in grams, and

b. High Current Weight in Grams (HIGH_CURRENT_WEIGHT_GRAMS) is greater than or equal to

the patients weight in grams.

5. Check the NEOM Gestational Birth Age Required Indicator (NEOM_GEST_BIRTH_AGE_REQ_IND) if

screening for a neonatal patient:

a. If NEOM_GEST_BIRTH_AGE_REQ_IND equals 0, the gestational age at birth is not required to

select the screening record.

b. If NEOM_GEST_BIRTH_AGE_REQ_IND equals 1, the gestational age at birth is required to select

the screening record.

6. Filter the records returned in step 1 where the:

a. NEOM Low Gestational Age at Birth in Weeks (NEOM_LOW_GEST_BIRTH_AGE_WEEKS) column

is less than or equal to the patients gestational birth age in weeks, and

b. NEOM High Gestational Age at Birth in Weeks (NEOM_HIGH_GEST_BIRTH_AGE_WEEKS)

column is greater than or equal to the patients gestational birth age in weeks.

7. Select the DRCM Renal Impairment Assessment Indicator (DR2_RENIMP):

a. If DR2_RENIMP equals N, the order is acceptable and does not produce an alert. Skip to Part 2:
Dose Range Checking.

b. If DR2_RENIMP equals Y, alert the user that the dose may need to be adjusted for renal impairment
(sample message 5) and continue to step 8.

8. If the patient is a neonate (aged 0-29 days) or infant born prematurely (Gestational Age at Birth less than
37 weeks or Weight at Birth less than 2000 grams), skip to Part 2: Dose Range Checking. Otherwise,
continue to step 9.

See Coding of Age Ranges for more information regarding editorial policy criteria defining
neonates and infants.

9. Display the patients creatinine clearance (convert units if necessary) and the DRCM Creatinine Clearance
Threshold (DR2_CRCLTH) if necessary:

a. If DR2_CRCLTH equals 0, you may want to alert the user that creatinine clearance threshold
checking is unavailable. Continue to Part 2: Dose Range Checking.

b. If the patients creatinine clearance is unavailable, alert the user that a drug dosage adjustment
should be considered (sample message 6 appended to message 5). Continue to Part 2: Dose

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b.

Range Checking.

c. If the patients creatinine clearance is less than or equal to DR2_CRCLTH, a drug dosage
adjustment for renal impairment should be considered. Do not continue with this application.
Instead, perform the remainder of the dose checking process by following the instructions provided
in the application Performing Dosage Range Checking for a Patient with Renal Impairment

d. If the patients creatinine clearance is greater than DR2_CRCLTH, continue to Part 2: Dose Range
Checking.

Part 2: Dose Range Checking

This section compares the prescription information with the data retrieved in Part 1 and displays alerts when
needed. See Generating DRCM Warning Messages to view sample user alerts for each of the dose range
checks.

1. Compare the prescribed frequency of administration per day to DRCM Low Frequency of Administration (
DR2_LOFREQ) and DRCM High Frequency of Administration (DR2_HIFREQ):

a. If the prescribed frequency is equal to either DR2_LOFREQ or DR2_HIFREQ, or within the value
range, the order is acceptable and does not produce an alert.

b. If the prescribed frequency is less than DR2_LOFREQ, alert the user that the prescribed frequency
is less than the recommended minimum frequency for the drug (sample message 8).

c. If the prescribed frequency is greater than DR2_HIFREQ, alert the user that the prescribed
frequency exceeds the recommended maximum frequency for the drug (sample message 9).

2. Compare the prescribed duration of therapy in days to DRCM Low Duration of Therapy (DR2_LODOTX)
and DRCM High Duration of Therapy (DR2_HIDOTX):

a. If the prescribed duration of therapy is equal to either DR2_LODOTX or DR2_HIDOTX, or within the
value range, the order is acceptable and does not produce an alert. Skip to step 4.

b. If the prescribed duration of therapy is less than DR2_LODOTX, alert the user that the prescribed
duration is less than the recommended low duration for the drug (sample message 10). Skip to step
4.

c. If the prescribed duration of therapy is greater than DR2_HIDOTX, compare the recommended
maximum duration of therapy to the prescribed duration of therapy.

3. Compare the prescribed duration of therapy to DRCM Maximum Duration of Therapy (DR2_MXDOTX):

a. If DR2_MXDOTX equals 0, the maximum duration of therapy has no limit, the order is acceptable
and does not produce an alert.

b. If the prescribed duration of therapy is equal to or less than DR2_MXDOTX, alert the user that the
prescribed duration exceeds the recommended high duration for the drug but less is than the
recommended maximum duration of therapy (sample message 12).

c. If the prescribed duration of therapy is greater than DR2_MXDOTX, alert the user that the

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c.

prescribed duration exceeds the recommended maximum duration for the drug (sample message
13).

4. Compare the prescribed daily dose (convert units if necessary) to DRCM Low Dose per Day (
DR2_LODOSD) and DRCM High Dose per Day (DR2_HIDOSD):

a. If the prescribed daily dose is equal to either DR2_LODOSD or DR2_HIDOSD, within the value
range, the order is acceptable and does not produce an alert. Skip to step 6.

b. If the prescribed daily dose is less than DR2_LODOSD, alert the user that the prescribed dose is
less than the recommended low daily dose for the drug (sample message 1). Skip to step 6.

c. If the prescribed daily dose is greater than DR2_HIDOSD, compare the recommended maximum
daily dose to the prescribed daily dose.

5. Compare the prescribed daily dose (convert units if necessary) to DRCM Maximum Dose per Day (
DR2_MXDOSD):

a. If the prescribed daily dose is equal to or less than DR2_MXDOSD, alert the user that the
prescribed dose exceeds the recommended high daily dose for the drug but is less than the
recommended maximum daily dose (sample message 2).

b. If the prescribed daily dose is greater than DR2_MXDOSD, alert the user that the prescribed dose
exceeds the recommended maximum daily dose for the drug ( sample message 3).

6. Compare the prescribed single dose (convert units if necessary) to DRCM Maximum Amount per Single
Dose (DR2_MX1DOS) and the Not-to-Exceed Amount Per Single Dose (NTE_SINGLE_DOSE):

a. If the prescribed single dose is equal to or less than DR2_MX1DOS and NTE_SINGLE_DOSE, the
order is acceptable and does not produce an alert.

b. If the prescribed single dose is greater than either DR2_MX1DOS and/or NTE_SINGLE_DOSE,
alert the user that the prescribed dose exceeds the recommended maximum single dose for the
drug (sample messages 4a, 4b, or 4c).

7. Display the DRCM Maximum Lifetime Dose (DR2_MXLIFD):

a. If DR2_MXLIFD equals 0, the maximum lifetime dose is unavailable.

b. If DR2_MXLIFD does not equal 0, display the maximum lifetime dose value for the prescribed
medication (sample message 15).

Part 3: Optionally Display Additional Dose Adjustment Information

1. Select the DRCM Hepatic Impairment Assessment Indicator (DR2_HEPIMP):

a. If the value equals N, the order is acceptable and does not produce an alert.

b. If the value equals Y, alert the user that the dose may need to be adjusted for hepatic impairment (
sample message 7).

2. Display the DRCM Low Elimination Half-Life (DR2_THAFLO) and DRCM High Elimination Half-Life (

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2.

DR2_THAFHI) range (or value):

a. If DR2_THAFLO and DR2_THAFHI equals 0, the elimination half-life range (or value) is
unavailable.

b. If DR2_THAFLO or DR2_THAFHI does not equal 0, display the elimination half-life range (or value)
for the patient (sample message 14).

ExampleDose Range Checking for an Adult Patient

ExampleDose Range Checking for a Neonatal Patient
ExampleDose Range Checking of Non-patient Parameters
ExampleDose Range Checking of a Continuous Infusion
ExampleDose Range Checking of an Intermittent Infusion

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Example - Dose Range Checking for an Adult Patient

A patient has a prescription for a single dose (DR2_DOSTPI 07) of acetaminophen (Clinical Formulation ID
[GCN_SEQNO] 66887) 1000 mg/day intravenously (DR2_RT 052). The acetaminophen is indicated for
Postoperative acute pain (DXID 244). The patient is 18 years old (6,570 days) and weighs 104 pounds (47173 g).

See the Generating DRCM Warning Messages application for more information on the sample messages referred
to in this example.

Part 1: Collect Dosage Range Check Data

1. Select records from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in days,
and

e. DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in days,
and

f. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record).
In this example, the reason for use-specific record (DXID 244) is not available for an 18-year-old
patient. Therefore, the default screening record (DXID 4892) is used.

GCN_SEQNO 66887

DR2_RT 052

DR2_DOSTPI 07

DR2_LOAGED 4380

DR2_HIAGED 40150

DXID 4892

2. Select the Dosing Age Source Identifier (DOSING_AGE_SOURCE_ID) from the RDRCNMA2_MSTR table
where the columns equal the dosing record collected in step 1. According to your business needs:

a. Display the data source information to the end-user.

b. Determine by the source if the collected dosing record can be used in screening.

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b.

In this example, DOSING_AGE_SOURCE_ID equals 2, indicating that there is a supporting

reference for the age range.

3. Check the Weight Required Indicator (WEIGHT_REQ_IND):

a. If WEIGHT_REQ_IND equals 0, the current weight is not required to select the screening record.

b. If WEIGHT_REQ_IND equals 1, the current weight is required to select the screening record.
If the weight of the patient is known, use the actual weight.
If the weight of the patient is unavailable, prompt the end-user to enter the weight. Optionally
the institution could provide a default nonmogram based weight, to proceed with screening.
In this example, WEIGHT_REQ_IND equals 1, indicating that the current weight is required to select
the screening record. Using the retrieved record, the system proceeds with screening.

4. Filter the records returned in the previous step where:

a. Low Current Weight in Grams (LOW_CURRENT_WEIGHT_GRAMS) is less than or equal to the

patients weight in grams, and

b. High Current Weight in Grams (HIGH_CURRENT_WEIGHT_GRAMS) is greater than or equal to

the patients weight in grams.

5. Select the DRCM Renal Impairment Assessment Indicator (DR2_RENIMP):

a. If DR2_RENIMP equals N, the order is acceptable and does not produce an alert. Skip to Part 2:
Dose Range Checking.

b. If DR2_RENIMP equals Y, alert the user that the dose may need to be adjusted for renal impairment
(sample message 5).

This example has a positive return. The system alerts the user that the dose may need to be
adjusted for renal impairment.

6. If the patient is a neonate (aged 0-29 days) or infant born prematurely (Gestational Age at Birth less than
37 weeks or Weight at Birth less than 2000 grams), skip to Part 2: Dose Range Checking.

See Coding of Age Ranges for more information regarding editorial policy criteria defining
neonates and infants.

In this example, the patient is an adult. The system begins creatinine clearance threshold checking.

7. Display the patients creatinine clearance (convert units if necessary) and the DRCM Creatinine Clearance
Threshold (DR2_CRCLTH) if necessary:

a. If DR2_CRCLTH equals 0, you may want to alert the user that creatinine clearance threshold
checking is unavailable. Continue to Part 2: Dose Range Checking.

b. If the patients creatinine clearance is unavailable, alert the user that a drug dosage adjustment
should be considered (sample message 6 appended to message 5). Continue to Part 2: Dose
Range Checking.

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c. If the patients creatinine clearance is less than or equal to DR2_CRCLTH, a drug dosage
adjustment for renal impairment should be considered. Do not continue with this application.
Instead, perform the remainder of the dose checking process by following the instructions provided
in the application Performing Dosage Range Checking for a Patient with Renal Impairment.

d. If the patients creatinine clearance is greater than DR2_CRCLTH, continue to Part 2: Dose Range
Checking.

DR2_CRCLTH DR2_CRCLU Description Patients Creatinine

Clearance

50 01 ML/MIN ---

Concatenate the DR2_CRCLTH value of 50 with the DR2_CRCLU description of ML/MIN to display
the creatinine clearance threshold of 50 ML/MIN to the user.

In this example, the patients creatinine clearance is unavailable. The system alerts the user that a
drug dosage adjustment should be considered and screening continues to Part 2: Dose Range
Checking.

Part 2: Dose Range Checking

This section compares the prescription information with the data retrieved in Part 1 and displays alerts when
needed. See Generating DRCM Warning Messages to view sample user alerts for each of the dose range
checks.

1. Compare the prescribed frequency of administration per day to DRCM Low Frequency of Administration (
DR2_LOFREQ) and DRCM High Frequency of Administration (DR2_HIFREQ):

a. If the prescribed frequency is equal to either DR2_LOFREQ or DR2_HIFREQ, or within the value
range, the order is acceptable and does not produce an alert.

b. If the prescribed frequency is less than DR2_LOFREQ, alert the user that the prescribed frequency
is less than the recommended minimum frequency for the drug (sample message 8).

c. If the prescribed frequency is greater than DR2_HIFREQ, alert the user that the prescribed
frequency exceeds the recommended maximum frequency for the drug (sample message 9).

DR2_LOFREQ DR2_HIFREQ Prescribed Frequency

1 1 Single dose

In this example, the prescribed frequency of a one-time dose is within the DR2_LOFREQ and
DR2_HIFREQ value range of 1 per day to 1 per day. The system passes the order and continues
screening.

2. Compare the prescribed duration of therapy in days to DRCM Low Duration of Therapy (DR2_LODOTX)
and DRCM High Duration of Therapy (DR2_HIDOTX):

a. If the prescribed duration of therapy is equal to either DR2_LODOTX or DR2_HIDOTX, or within the

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a.

value range, the order is acceptable and does not produce an alert.

b. If the prescribed duration of therapy is less than DR2_LODOTX, alert the user that the prescribed
duration is less than the recommended low duration for the drug (sample message 10).

c. If the prescribed duration of therapy is greater than DR2_HIDOTX, compare the recommended
maximum duration of therapy to the prescribed duration of therapy.

DR2_LODOTX DR2_HIDOTX Prescribed duration

1 1 1 day

In this example, the prescribed frequency is equal to the DR2_LODOTX value of 1 day. The system
passes the order and continues screening.

3. Compare the prescribed daily dose (convert units if necessary) to DRCM Low Dose per Day (
DR2_LODOSD) and DRCM High Dose per Day (DR2_HIDOSD):

a. If the prescribed daily dose is equal to either DR2_LODOSD or DR2_HIDOSD, or within the value
range, the order is acceptable and does not produce an alert.

b. If the prescribed daily dose is less than DR2_LODOSD, alert the user that the prescribed dose is
less than the recommended low daily dose for the drug (sample message 1).

c. If the prescribed daily dose is greater than DR2_HIDOSD, compare the recommended maximum
daily dose to the prescribed daily dose.

The DRCM Dose Units Code Description (UNITS_DESC) column is from the DRCM Unit
Description Table (RDRCUND0_UNITS_DESC).

DR2_LODOSD 12.5

DR2_LODOSU 02

UNITS_DESC MG/KG/DAY

DR2_HIDOSD 15

DR2_HIDOSU 02

UNITS_DESC MGKG//DAY

Prescribed dose per day 590 mg/day

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the UNITS_DESC column.

DOSING_MODULE_UNIT_ABB UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

REV

MG/DAY mg/day milligram per day

In this example, 590 mg is prescribed as a one-time dose. The prescribed daily dose is equal to the

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DR2_LODOSD value of 12.5 mg/kg/day. The system passes the order and continues screening.

4. Compare the prescribed single dose (convert units if necessary) to DRCM Maximum Amount per Single
Dose (DR2_MX1DOS) and the Not-to-Exceed Amount Per Single Dose (NTE_SINGLE_DOSE):

a. If the prescribed single dose is equal to or less than DR2_MX1DOS and NTE_SINGLE_DOSE, the
order is acceptable and does not produce an alert.

b. If the prescribed single dose is greater than either DR2_MX1DOS and/or NTE_SINGLE_DOSE,
alert the user that the prescribed dose exceeds the recommended maximum single dose for the
drug (sample message 4a, 4b, or 4c).

DR2_MX1DOS DR2_MX1DSU NTE_SINGLE_DO NTE_SINGLE_DO Prescribed Single

SE SE_UNIT_CODE Dose

15 03 750 28 590 MG

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the UNITS_DESC column.

DOSING_MODULE_UNIT_ABB UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

REV

MG mg milligram

In this example, the prescribed dose of 590 mg is less than the DR2_MX1DOS and
NTE_SINGLE_DOSE values of 750 mg. The system passes the order and continues screening.

5. Display the DRCM Maximum Lifetime Dose (DR2_MXLIFD) value:

a. If DR2_MXLIFD equals 0, the maximum lifetime dose is unavailable.

b. If DR2_MXLIFD does not equal 0, display the maximum lifetime dose value for the prescribed
medication (sample message 15).

In this example, the maximum lifetime dose equals 0 and is unavailable for display.

Part 3: Optionally Display Additional Dose Adjustment Information

1. Select the DRCM Hepatic Impairment Assessment Indicator (DR2_HEPIMP) for the prescribed medication:

a. If the value equals N, the order is acceptable and does not produce an alert.

b. If the value equals Y, alert the user that the dose may need to be adjusted for hepatic impairment (
sample message 7).

This example has a negative return. The system passes the order and checks the display
availability of the elimination half-life values.

2. Display the DRCM Low Elimination Half-Life (DR2_THAFLO) and DRCM High Elimination Half-Life (
DR2_THAFHI) range (or value):

a. If DR2_THAFLO and DR2_THAFHI equals 0, the elimination half-life range (or value) is

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a.

unavailable.

b. If DR2_THAFLO or DR2_THAFHI does not equal 0, display the elimination half-life range (or value)
for the patient (sample message 14).

DR2_THAFLO DR2_THAFHI DR2_THAFU Description

1 5 02 Hours

In this example, the elimination half-life for the order does not equal 0 and is available for display.
The system displays the elimination half-life range as 1 hours - 5 hours.

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Example - Dose Range Checking for a Neonatal Patient

A physician orders a prescription for a loading dose (DR2_DOSTPI 01) of Digoxin 0.25 mg/mL (Clinical
Formulation ID [GCN_SEQNO] 15) 30 mcg intravenous (DR2_RT 052) given in 3 divided doses to be given as
follows: 15 mcg now followed by 7.5 mcg for 2 doses. The reason for use is not available. The patient is 10 days
old and weighs 1,500 grams (1.5 kg). The gestational age at birth was 29 weeks.

See the Generating DRCM Warning Messages application for more information on the sample warning messages
referred to in this example.

Part 1: Collect Dosage Range Check Data

1. Select records from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in days,
and

e. DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in days,
and

f. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record).

GCN_SEQNO 15 15

DR2_RT 052 052

DR2_DOSTPI 01 01

DR2_LOAGED 0 0

DR2_HIAGED 29 119

DXID 4892 4892

2. Select the Dosing Age Source Identifier (DOSING_AGE_SOURCE_ID) from the RDRCNMA2_MSTR table
where the columns equal the dosing record collected in step 1. According to your business needs:

a. Display the data source information to the end-user.

b. Determine by the source if the collected dosing record can be used in screening.

In this example, DOSING_AGE_SOURCE_ID equals 3, indicating that this supporting reference

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b.

may not be specific to the given age group.

3. Check the Weight Required Indicator (WEIGHT_REQ_IND):

a. If WEIGHT_REQ_IND equals 0, the current weight is not required to select the screening record.

b. If WEIGHT_REQ_IND equals 1, the current weight is required to select the screening record.

In this example, WEIGHT_REQ_IND equals 0 indicating that the current weight is not required to
select the screening record. The system checks the gestational age at birth required indicator.

4. Check the NEOM Gestational Birth Age Required Indicator (NEOM_GEST_BIRTH_AGE_REQ_IND):

a. If NEOM_GEST_BIRTH_AGE_REQ_IND equals 0, the gestational age at birth is not required to

select the screening record.

b. If NEOM_GEST_BIRTH_AGE_REQ_IND equals 1, the gestational age at birth is required to select

the screening record.

In this example, NEOM_GEST_BIRTH_AGE_REQ_IND equals 1. The system prompts the user to

enter the gestational age of the patient at birth in weeks.

5. Filter the records returned in step 1 where the:

a. NEOM Low Gestational Age at Birth in Weeks (NEOM_LOW_GEST_BIRTH_AGE_WEEKS) column

is less than or equal to the patients gestational birth age in weeks, and

b. NEOM High Gestational Age at Birth in Weeks (NEOM_HIGH_GEST_BIRTH_AGE_WEEKS)

column is greater than or equal to the patients gestational birth age in weeks.

GCN_SEQNO 15 15

DR2_RT 052 052

DR2_DOSTPI 01 01

DR2_LOAGED 0 0

DR2_HIAGED 29 119

DXID 4892 4892

NEOM_LOW_GEST_BIRTH_AG 37 0
E_WEEKS

NEOM_HIGH_GEST_BIRTH_A 0 36
GE_WEEKS

In this example, the weight range of 0 to 36 weeks is retrieved by the system after the user enters
the patients gestational age of the patient at birth of 29 weeks. Using the retrieved record, the
system begins screening.

6. Select the DRCM Renal Impairment Assessment Indicator (DR2_RENIMP):

a. If DR2_RENIMP equals N, the order is acceptable and does not produce an alert. Skip to Part 2:

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6.

a.
Dose Range Checking.

b. If DR2_RENIMP equals Y, alert the user that the dose may need to be adjusted for renal impairment
(sample message 5) and continue to step 7.

This example has a positive return. The system alerts the user that the dose may need to be
adjusted for renal impairment and continues to step 7.

7. If the patient is a neonate (aged 0-29 days) or infant born prematurely (Gestational Age at Birth less than
37 weeks or Weight at Birth less than 2000 grams), skip to Part 2: Dose Range Checking. Otherwise,
continue with creatinine clearance checking.

See Coding of Age Ranges for more information regarding editorial policy criteria defining
neonates and infants.

In this example, the patient is a neonate. The system continues screening the order (Part 2: Dose Range
Checking).

As the patient in this example is less than 30 days of age, adjusted dosage range checking values
for renal impairment will not be available in the DRCM Renal Master Table
(RDRCRM0_RENAL_MSTR).

Part 2: Dose Range Checking

This section compares the prescription information with the data retrieved in Part 1 and displays alerts when
needed. See Generating DRCM Warning Messages to view sample user alerts for each of the dose range
checks.

1. Compare the prescribed frequency of administration per day to DRCM Low Frequency of Administration (
DR2_LOFREQ) and DRCM High Frequency of Administration (DR2_HIFREQ):

a. If the prescribed frequency is equal to either DR2_LOFREQ or DR2_HIFREQ, or within the value
range, the order is acceptable and does not produce an alert.

b. If the prescribed frequency is less than DR2_LOFREQ, alert the user that the prescribed frequency
is less than the recommended minimum frequency for the drug (sample message 8).

c. If the prescribed frequency is greater than DR2_HIFREQ, alert the user that the prescribed
frequency exceeds the recommended maximum frequency for the drug (sample message 9).

DR2_LOFREQ DR2_HIFREQ Prescribed Frequency

1 3 3 per day

In this example, the prescribed frequency of 3 per day is equal to the DR2_HIFREQ value of 3 per
day. The system passes the order and continues screening.

2. Compare the prescribed duration of therapy in days to DRCM Low Duration of Therapy (DR2_LODOTX)

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2.

and DRCM High Duration of Therapy (DR2_HIDOTX):

a. If the prescribed duration of therapy is equal to either DR2_LODOTX or DR2_HIDOTX, or within the
value range, the order is acceptable and does not produce an alert.

b. If the prescribed duration of therapy is less than DR2_LODOTX, alert the user that the prescribed
duration is less than the recommended low duration for the drug (sample message 10).

c. If the prescribed duration of therapy is greater than DR2_HIDOTX, compare the recommended
maximum duration of therapy to the prescribed duration of therapy.

DR2_LODOTX DR2_HIDOTX Prescribed duration

1 2 1 day

In this example, the prescribed duration is equal to the DR2_LODOTX value of 1 day. The system
passes the order and continues screening.

3. Compare the prescribed daily dose (convert units if necessary) to DRCM Low Dose per Day (
DR2_LODOSD) and DRCM High Dose per Day (DR2_HIDOSD):

a. If the prescribed daily dose is equal to either DR2_LODOSD or DR2_HIDOSD, or within the value
range, the order is acceptable and does not produce an alert.

b. If the prescribed daily dose is less than DR2_LODOSD, alert the user that the prescribed dose is
less than the recommended low daily dose for the drug (sample message 1).

c. If the prescribed daily dose is greater than DR2_HIDOSD, compare the recommended maximum
daily dose to the prescribed daily dose.

The DRCM Dose Units Code Description (UNITS_DESC) column is from the DRCM Unit
Description Table (RDRCUND0_UNITS_DESC).

DR2_LODOSD 15

DR2_LODOSU 46

UNITS_DESC MCG/KG/DAY

DR2_HIDOSD 35

DR2_HIDOSU 46

UNITS_DESC MCG/KG/DAY

Prescribed dose per day 30 mcg/day

In this example, 15 mcg is prescribed once and 7.5 is prescribed twice over 1 day. Therefore, the
dose per day is 15 + (7.5 X 2) = 30 mcg/day.

Since the retrieved units are given in mcg/kg/day and the prescription is written in mcg/day, it is
necessary to convert the units of measure. See Converting Units During Dosage Range Checking

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for more information about converting units.

The following table shows the data after the conversion.

DR2_LODOSD 15

DR2_LODOSU 46

UNITS_DESC MCG/KG/DAY

DR2_HIDOSD 35

DR2_HIDOSU 46

UNITS_DESC MCG/KG/DAY

Prescribed dose per day 30 mcg/day

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the UNITS_DESC column.

DOSING_MODULE_UNIT_ABB UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

REV

MCG/DAY mcg/day microgram per day

In this example, the prescribed dose of 30 mcg/day is within the DR2_LODOSD and DR2_HIDOSD
value range. The system passes the order and continues screening.

4. Compare the prescribed single dose (convert units if necessary) to DRCM Maximum Amount per Single
Dose (DR2_MX1DOS) and the Not-to-Exceed Amount Per Single Dose (NTE_SINGLE_DOSE):

a. If the prescribed single dose is equal to or less than DR2_MX1DOS and NTE_SINGLE_DOSE, the
order is acceptable and does not produce an alert.

b. If the prescribed single dose is greater than either DR2_MX1DOS and/or NTE_SINGLE_DOSE,
alert the user that the prescribed dose exceeds the recommended maximum single dose for the
drug (sample message 4a, 4b, or 4c).

The DRCM Dose Units Code Description (UNITS_DESC) column is from the DRCM Unit
Description Table (RDRCUND0_UNITS_DESC).

DR2_MX1DOS DR2_MX1DSU NTE_SINGLE_DO NTE_SINGLE_DO Prescribed Single

SE SE_UNIT_CODE Dose

20 19 0.6 28 15 mcg

20 19 0.6 28 7.5 mcg

20 19 0.6 28 7.5 mcg

Since the retrieved units are given in mcg/kg and mg and the prescription is written in mcg, it is
necessary to convert the units of measure. See Converting Units During Dosage Range Checking

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for more information about converting units.

The following table shows the data after the conversion.

DR2_MX1DOS DR2_MX1DSU NTE_SINGLE_ NTE_SINGLE_ UNITS_DESC Prescribed

DOSE DOSE_UNIT_ Single Dose
CODE

30 33 600 33 MCG 15 mcg

30 33 600 33 MCG 7.5 mcg

30 33 600 33 MCG 7.5 mcg

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the UNITS_DESC column.

DOSING_MODULE_UNIT_ABB UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

REV

MCG mcg microgram

The prescribed single doses of 15 mcg, 7.5 mcg, and 7.5 mcg are less than the DR2_MX1DOS and
NTE_SINGLE DOSE values. The system passes the order and continues screening.

5. Display the DRCM Maximum Lifetime Dose (DR2_MXLIFD) value:

a. If DR2_MXLIFD equals 0, the maximum lifetime dose is unavailable.

b. If DR2_MXLIFD does not equal 0, display the maximum lifetime dose value for the prescribed
medication (sample message 15).

In this example, the maximum lifetime dose equals 0 and is unavailable for display.

Part 3: Optionally Display Additional Dose Adjustment Information

1. Select the DRCM Hepatic Impairment Assessment Indicator (DR2_HEPIMP):

a. If DR2_HEPIMP equals N, the order is acceptable and does not produce an alert.

b. If DR2_HEPIMP equals Y, alert the user that the dose may need to be adjusted for hepatic
impairment (sample message 7).
This example has a positive return. The system alerts the user that the dose may need to be
adjusted for hepatic impairment and checks the display availability of the elimination half-life values.

2. Display the DRCM Low Elimination Half-Life (DR2_THAFLO) and DRCM High Elimination Half-Life (
DR2_THAFHI) range (or value):

a. If DR2_THAFLO and DR2_THAFHI equal 0, the elimination half-life range (or value) is unavailable.

b. If DR2_THAFLO or DR2_THAFHI does not equal 0, display the elimination half-life range (or value)
for the patient. (sample message 14).

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DR2_THAFLO DR2_THAFHI DR2_THAFU Description

18 170 02 HOURS

In this example, the elimination half-life for the order does not equal 0. The system displays the
elimination half-life range as 18 hours - 170 hours.

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Example - Dose Range Checking of Non-patient Parameters

A patient has a prescription for a single dose (DR2_DOSTPI 07) of palivizumab (Clinical Formulation ID
[GCN_SEQNO] 59246) 100 mg/mL vial intramuscular (DR2_RT 040) 15 mg/kg once per day. No reason for use
is supplied. The patient is 1 years old (365 days) and weighs 22 pounds (10 kg).

See the Generating DRCM Warning Messages application for more information on the sample messages referred
to in this example.

Part 1: Collect Dosage Range Check Data

1. Select records from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in days,
and

e. DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in days,
and

f. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record).

GCN_SEQNO 59246

DR2_RT 040

DR2_DOSTPI 02

DR2_LOAGED 0

DR2_HIAGED 1094

DXID 4892

2. Select the Dosing Age Source Identifier (DOSING_AGE_SOURCE_ID) from the RDRCNMA2_MSTR table
where the columns equal the dosing record collected in step 1. According to your business needs:

a. Display the data source information to the end-user.

b. Determine by the source if the collected dosing record can be used in screening.

In this example, DOSING_AGE_SOURCE_ID equals 3, indicating that this supporting reference

may not be specific to the given age group.

3.

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3. Check the Weight Required Indicator (WEIGHT_REQ_IND):

a. If WEIGHT_REQ_IND equals 0, the current weight is not required to select the screening record.

b. If WEIGHT_REQ_IND equals 1, the current weight is required to select the screening record.
If the weight of the patient is known, use the actual weight.
If the weight of the patient is unavailable, prompt the end-user to enter the weight. Optionally
the institution could provide a default nonmogram based weight, to proceed with screening.

In this example, WEIGHT_REQ_IND equals 0, indicating that the current weight is not required to
select the screening record. Using the retrieved record, the system proceeds with screening.

4. Select the DRCM Renal Impairment Assessment Indicator (DR2_RENIMP):

a. If DR2_RENIMP equals N, the order is acceptable and does not produce an alert. Skip to Part 2:
Dose Range Checking.

b. If DR2_RENIMP equals Y, alert the user that the dose may need to be adjusted for renal impairment
(sample message 5) and continue with creatinine clearance checking.

This example has a negative return. The system passes the order and continues screening (Part 2:
Dose Range Checking).

Part 2: Dose Range Checking

This section compares the prescription information with the data retrieved in Part 1 and displays alerts when
needed. See Generating DRCM Warning Messages to view sample user alerts for each of the dose range
checks.

1. Compare the prescribed frequency of administration per day to DRCM Low Frequency of Administration (
DR2_LOFREQ) and DRCM High Frequency of Administration (DR2_HIFREQ):

a. If the prescribed frequency is equal to either DR2_LOFREQ or DR2_HIFREQ, or within the value
range, the order is acceptable and does not produce an alert.

b. If the prescribed frequency is less than DR2_LOFREQ, alert the user that the prescribed frequency
is less than the recommended minimum frequency for the drug (sample message 8).

c. If the prescribed frequency is greater than DR2_HIFREQ, alert the user that the prescribed
frequency exceeds the recommended maximum frequency for the drug (sample message 9).

DR2_LOFREQ DR2_HIFREQ Prescribed Frequency

1 1 1 per day

In this example, the prescribed frequency of 1 per day equals the DR2_LOFREQ and DR2_HIFREQ
values of 1. The system passes the order and continues screening.

2. Compare the prescribed duration of therapy in days to DRCM Low Duration of Therapy (DR2_LODOTX)
and DRCM High Duration of Therapy (DR2_HIDOTX):

a.

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a. If the prescribed duration of therapy is equal to either DR2_LODOTX or DR2_HIDOTX, or within the
value range, the order is acceptable and does not produce an alert.

b. If the prescribed duration of therapy is less than DR2_LODOTX, alert the user that the prescribed
duration is less than the recommended low duration for the drug (sample message 10).

c. If the prescribed duration of therapy is greater than DR2_HIDOTX, compare the recommended
maximum duration of therapy to the prescribed duration of therapy.

DR2_LODOTX DR2_HIDOTX Prescribed duration

1 1 1 day

In this example, the prescribed frequency is equal to the DR2_LODOTX and DR2_HIDOTX values
of 1 day. The system passes the order and continues screening.

3. Compare the prescribed daily dose (convert units if necessary) to DRCM Low Dose per Day (
DR2_LODOSD) and DRCM High Dose per Day (DR2_HIDOSD):

a. If the prescribed daily dose is equal to either DR2_LODOSD or DR2_HIDOSD, or within the value
range, the order is acceptable and does not produce an alert.

b. If the prescribed daily dose is less than DR2_LODOSD, alert the user that the prescribed dose is
less than the recommended low daily dose for the drug (sample message 1).

c. If the prescribed daily dose is greater than DR2_HIDOSD, compare the recommended maximum
daily dose to the prescribed daily dose.

The DRCM Dose Units Code Description (UNITS_DESC) column is from the DRCM Unit
Description Table (RDRCUND0_UNITS_DESC).

DR2_LODOSD 13.5

DR2_LODOSU 02

UNITS_DESC MG/KG/DAY

DR2_HIDOSD 16.5

DR2_HIDOSU 02

UNITS_DESC MG/KG/DAY

Prescribed dose per day 30 mg/kg

Since the retrieved and prescribed units are given in mg/kg/day, it is necessary to calculate the units
of measure. See Converting Units During Dosage Range Checking for more information.

The following table shows the data after the conversion.

DR2_LODOSD 135

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DR2_LODOSU 01

UNITS_DESC MG/DAY

DR2_HIDOSD 135

DR2_HIDOSU 01

UNITS_DESC MG/DAY

Prescribed dose per day 150 mg/kg

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the UNITS_DESC column.

DOSING_MODULE_UNIT_ABB UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

REV

MG/DAY mg/day milligram per day

The prescribed daily dose is less than the DR2_LODOSD value of 135 mg/day. The system passes
the order and continues screening.

4. Compare the prescribed single dose (convert units if necessary) to DRCM Maximum Amount per Single
Dose (DR2_MX1DOS) and the Not-to-Exceed Amount Per Single Dose (NTE_SINGLE_DOSE):

a. If the prescribed single dose is equal to or less than DR2_MX1DOS and NTE_SINGLE_DOSE, the
order is acceptable and does not produce an alert.

b. If the prescribed single dose is greater than either DR2_MX1DOS and/or NTE_SINGLE_DOSE,
alert the user that the prescribed dose exceeds the recommended maximum single dose for the
drug (sample message 4a, 4b, or 4c).

DR2_MX1DOS DR2_MX1DSU NTE_SINGLE_DO NTE_SINGLE_DO Prescribed Single

SE SE_UNIT_CODE Dose

16.5 03 16.5 03 15 mg/kg

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the UNITS_DESC column.

DOSING_MODULE_UNIT_ABB UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

REV

MG mg milligram

In this example, the prescribed dose of 15 mg/kg is less than the DR2_MX1DOS and
NTE_SINGLE_DOSE values of 16.5 mg/kg. The system passes the order and continues screening.

5. Display the DRCM Maximum Lifetime Dose (DR2_MXLIFD) value:

a. If DR2_MXLIFD equals 0, the maximum lifetime dose is unavailable.

b.

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b. If DR2_MXLIFD does not equal 0, display the maximum lifetime dose value for the prescribed
medication (sample message 15).

In this example, the maximum lifetime dose equals 0 and is unavailable for display.

Part 3: Optionally Display Additional Dose Adjustment Information

1. Select the DRCM Hepatic Impairment Assessment Indicator (DR2_HEPIMP) for the prescribed medication:

a. If the value equals N, the order is acceptable and does not produce an alert.

b. If the value equals Y, alert the user that the dose may need to be adjusted for hepatic impairment (
sample message 7).
This example has a negative return. The system passes the order and checks the display
availability of the elimination half-life values.

2. Display the DRCM Low Elimination Half-Life (DR2_THAFLO) and DRCM High Elimination Half-Life (
DR2_THAFHI) range (or value):

a. If DR2_THAFLO and DR2_THAFHI equals 0, the elimination half-life range (or value) is
unavailable.

b. If DR2_THAFLO or DR2_THAFHI does not equal 0, display the elimination half-life range (or value)
for the patient (sample message 14).

DR2_THAFLO DR2_THAFHI DR2_THAFU Description

18 20 03 Days

In this example, the elimination half-life for the order does not equal 0 and is available for display.
The system displays the elimination half-life range as 18 days - 20 days.

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Example - Dose Range Checking of a Continuous Infusion

A physician orders a prescription for a maintenance dose (DR2_DOSTPI 02) of Ondansetron HCL 4 mg/2 ml Vial
(Clinical Formulation ID [GCN_SEQNO] 61716) 10 mg/h continuous infusion (DR2_RT 006) for 36 hours every 21
days. The reason for use is not available (DXID 4892). The patient is 8 years old (2,920 days) and weighs 55 lbs
(25 kg).

Please note that DRCM does not screen administration information or course of treatment information
often included within infusion orders. For example, the every 21 days course of treatment requirement in
the order above.

See the Generating DRCM Warning Messages application for more information on the sample warning messages
referred to in this example.

Part 1: Collect Dosage Range Check Data

1. Select records from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in days,
and

e. DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in days,
and

f. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record).

GCN_SEQNO 61716

DR2_RT 006

DR2_DOSTPI 02

DR2_LOAGED 365

DR2_HIAGED 6569

DXID 4892

2. Select the Dosing Age Source Identifier (DOSING_AGE_SOURCE_ID) from the RDRCNMA2_MSTR table
where the columns equal the dosing record collected in step 1.

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2.

According to your business needs:

a. Display the data source information to the end-user.

b. Determine by the source if the collected dosing record can be used in screening.

In this example, DOSING_AGE_SOURCE_ID equals 3, indicating that this supporting reference

may not be specific to the given age group.

3. Check the Weight Required Indicator (WEIGHT_REQ_IND):

a. If WEIGHT_REQ_IND equals 0, the current weight is not required to select the screening record.

b. If WEIGHT_REQ_IND equals 1, the current weight is required to select the screening record.
If the weight of the patient is known, use the actual weight.
If the weight of the patient is unavailable, prompt the end-user to enter the weight. Optionally
the institution could provide a default nonmogram based weight, to proceed with screening.

In this example, WEIGHT_REQ_IND equals 0, indicating that the current weight is not required to
select the screening record. Using the retrieved record, the system proceeds with screening.

4. Select the DRCM Renal Impairment Assessment Indicator (DR2_RENIMP):

a. If DR2_RENIMP equals N, the order is acceptable and does not produce an alert. Skip to Part 2:
Dose Range Checking.

b. If DR2_RENIMP equals Y, alert the user that the dose may need to be adjusted for renal impairment
(sample message 5) and continue with creatinine clearance checking.

This example has a negative return. The system passes the order and continues screening (Part 2:
Dose Range Checking).

Part 2: Dose Range Checking

This section compares the prescription information with the data retrieved in Part 1 and displays alerts when
needed. See Generating DRCM Warning Messages to view sample user alerts for each of the dose range
checks.

1. Compare the prescribed duration of therapy in days to DRCM Low Duration of Therapy (DR2_LODOTX)
and DRCM High Duration of Therapy (DR2_HIDOTX):

a. If the prescribed duration of therapy is equal to either DR2_LODOTX or DR2_HIDOTX, or within the
value range, the order is acceptable and does not produce an alert.

b. If the prescribed duration of therapy is less than DR2_LODOTX, alert the user that the prescribed
duration is less than the recommended low duration for the drug (sample message 10).

c. If the prescribed duration of therapy is greater than DR2_HIDOTX, compare the recommended
maximum duration of therapy to the prescribed duration of therapy.
Because DRCM duration of therapy is expressed in full days, this example rounds up the prescribed
duration of 36 hours (1.5 days) and screens the duration at 2 days.

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DR2_LODOTX DR2_HIDOTX Prescribed duration

1 0 2 days

In this example, the prescribed duration of therapy is greater than the DR2_HIDOTX value of 0
days. The system compares the recommended maximum duration to the prescribed duration.

2. Compare the prescribed duration of therapy to DRCM Maximum Duration of Therapy (DR2_MXDOTX):

a. If DR2_MXDOTX equals 0, the maximum duration of therapy has no limit, the order is acceptable
and does not produce an alert.

b. If the prescribed duration of therapy is equal to or less than DR2_MXDOTX, alert the user that the
prescribed duration exceeds the recommended high duration for the drug but less than the
recommended maximum duration (sample message 12).

c. If the prescribed duration of therapy is greater than DR2_MXDOTX, alert the user that the
prescribed duration exceeds the recommended maximum duration for the drug (sample message
13).

DR2_MXDOTX Prescribed duration

0 2 days

In this example, DR2_MXDOTX equals 0, indicating that the maximum duration of therapy has no
limit. The system passes the order and continues screening.

3. Compare the prescribed daily dose (convert units if necessary) to DRCM Low Dose per Day (
DR2_LODOSD) and DRCM High Dose per Day (DR2_HIDOSD):

a. If the prescribed daily dose is equal to either DR2_LODOSD or DR2_HIDOSD, or within the value
range, the order is acceptable and does not produce an alert.

b. If the prescribed daily dose is less than DR2_LODOSD, alert the user that the prescribed dose is
less than the recommended low daily dose for the drug (sample message 1).

c. If the prescribed daily dose is greater than DR2_HIDOSD, compare the recommended maximum
daily dose to the prescribed daily dose.

The DRCM Dose Units Code Description (UNITS_DESC) column is from the DRCM Unit
Description Table (RDRCUND0_UNITS_DESC).

DR2_LODOSD 1

DR2_LODOSU 17

UNITS_DESC MG/H

DR2_HIDOSD 1

DR2_HIDOSU 17

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UNITS_DESC MG/H

Prescribed dose per day 10 mg/h

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the UNITS_DESC column.

DOSING_MODULE_UNIT_ABB UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

REV

MG/H mg/hour milligram per hour

In this example, the prescribed dose of 10 mg/h is greater than the DR2_HIDOSD value of 1 mg/h.
The system compares the prescribed daily dose to the recommended maximum daily dose.

4. Compare the prescribed daily dose (convert units if necessary) to DRCM Maximum Dose per Day (
DR2_MXDOSD):

a. If the prescribed daily dose is equal to or less than DR2_MXDOSD, alert the user that the
prescribed dose exceeds the recommended high daily dose for the drug but less than the
recommended maximum daily dose (sample message 2).

b. If the prescribed daily dose is greater than DR2_MXDOSD, alert the user that the prescribed dose
exceeds the recommended maximum daily dose for the drug ( sample message 3).

The DRCM Dose Units Code Description (UNITS_DESC) column is from the DRCM Unit
Description Table (RDRCUND0_UNITS_DESC).

DR2_MXDOSD DR2_MXDOSU UNITS_DESC Prescribed Dose per

Day

1.333 18 MG/KG/H 10 mg/h

Since the retrieved units are given in mg/kg/hour and the prescription is written in mg/hour, it is
necessary to convert the units of measure. See Converting Units During Dosage Range Checking
for more information about converting units.

DR2_MXDOSD UNITS_DESC Prescribed Dose per Day

33.325 MG/H 10 mg/h

In this example, the prescribed daily dose of 10 mg/h is less than the DR2_MXDOSD value of
33.325 mg/h. The system alerts the user that the prescribed daily dose exceeds the recommended
high daily dose but is less than the recommended maximum daily dose for the drug and continues
screening the order.

5. Compare the prescribed single dose (convert units if necessary) to DRCM Maximum Amount per Single
Dose (DR2_MX1DOS) and the Not-to-Exceed Amount Per Single Dose (NTE_SINGLE_DOSE):

a. If the prescribed single dose is equal to or less than DR2_MX1DOS and NTE_SINGLE_DOSE, the

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a.

order is acceptable and does not produce an alert.

b. If the prescribed single dose is greater than either DR2_MX1DOS and/or NTE_SINGLE_DOSE,
alert the user that the prescribed dose exceeds the recommended maximum single dose for the
drug (sample message 4a, 4b, or 4c).

The DRCM Dose Units Code Description (UNITS_DESC) column is from the DRCM Unit
Description Table (RDRCUND0_UNITS_DESC).

DR2_MX1DOS DR2_MX1DSU NTE_SINGLE_DO NTE_SINGLE_DO Prescribed Single

SE SE_UNIT_CODE Dose

1.333 18 1.333 18 10 mg/h

Since the retrieved units are given in mg/kg/hour and the prescription is written in mg/h, it is
necessary to convert the units of measure. See Converting Units During Dosage Range Checking
for more information about converting units.

DR2_MX1DOS NTE_SINGLE_DOSE UNITS_DESC Prescribed Dose per

Day

33.325 33.325 MG/H 10 mg/h

In this example, the prescribed dose of 10 mg/h is less than the DR2_MX1DOS and
NTE_SINGLE_DOSE value of 33.325 mg/hour. The system passes the order and continues
screening.

6. Display the DRCM Maximum Lifetime Dose (DR2_MXLIFD) value:

a. If DR2_MXLIFD equals 0, the maximum lifetime dose is unavailable.

b. If DR2_MXLIFD does not equal 0, display the maximum lifetime dose value for the prescribed
medication (sample message 15).

In this example, the maximum lifetime dose equals 0 and is unavailable for display.

Part 3: Optionally Display Additional Dose Adjustment Information

1. Select the DRCM Hepatic Impairment Assessment Indicator (DR2_HEPIMP):

a. If DR2_HEPIMP equals N, the order is acceptable and does not produce an alert.

b. If DR2_HEPIMP equals Y, alert the user that the dose may need to be adjusted for hepatic
impairment (sample message 7).

This example has a positive return. The system alerts the user that the dose may need to be
adjusted for hepatic impairment and checks the display availability of the elimination half-life values.

2. Display the DRCM Low Elimination Half-Life (DR2_THAFLO) and DRCM High Elimination Half-Life (
DR2_THAFHI) range (or value):

a. If DR2_THAFLO and DR2_THAFHI equal 0, the elimination half-life range (or value) is unavailable.

b.

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b. If DR2_THAFLO or DR2_THAFHI does not equal 0, display the elimination half-life range (or value)
for the patient. (sample message 14).

DR2_THAFLO DR2_THAFHI DR2_THAFU Description

2.5 6.2 02 Hour

In this example, the elimination half-life for the order does not equal 0. The system displays the
elimination half-life range as 2.5 hour - 6.2 hour and checks the display availability of the maximum
lifetime dose value.

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Example - Dose Range Checking of an Intermittent Infusion

A physician orders a prescription for a maintenance dose (DR2_DOSTPI 02) of Cefazolin 1 GM Vial (Clinical
Formulation ID [GCN_SEQNO] 9060) intravenous (DR2_RT 052) 1 G over 30 minutes every 8 hours times 3
doses. The reason for use is not available (DXID 4892 [default screening record]). The patient is 30 years old
(10,950 days) and weighs 130 lbs (59 kg).

Please note that DRCM does not screen administration information or course of treatment information
often included within infusion orders. For example, the over 30 minutes administration information
requirement in the order above.

See the Generating DRCM Warning Messages application for more information on the sample warning messages
referred to in this example.

Part 1: Collect Dosage Range Check Data

1. Select records from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in days,
and

e. DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in days,
and

f. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record).

GCN_SEQNO 9060

DR2_RT 052

DR2_DOSTPI 02

DR2_LOAGED 6570

DR2_HIAGED 23724

DXID 4892

2. Select the Dosing Age Source Identifier (DOSING_AGE_SOURCE_ID) from the RDRCNMA2_MSTR table
where the columns equal the dosing record collected in step 1.

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2.

According to your business needs:

a. Display the data source information to the end-user.

b. Determine by the source if the collected dosing record can be used in screening.

In this example, DOSING_AGE_SOURCE_ID equals 3, indicating that this supporting reference

may not be specific to the given age group.

3. Check the Weight Required Indicator (WEIGHT_REQ_IND):

a. If WEIGHT_REQ_IND equals 0, the current weight is not required to select the screening record.

b. If WEIGHT_REQ_IND equals 1, the current weight is required to select the screening record.
If the weight of the patient is known, use the actual weight.
If the weight of the patient is unavailable, prompt the end-user to enter the weight. Optionally
the institution could provide a default nonmogram based weight, to proceed with screening.

In this example, WEIGHT_REQ_IND equals 0, indicating that the current weight is not required to
select the screening record. Using the retrieved record, the system proceeds with screening.

4. Select the DRCM Renal Impairment Assessment Indicator (DR2_RENIMP):

a. If DR2_RENIMP equals N, the order is acceptable and does not produce an alert. Skip to Part 2:
Dose Range Checking.

b. If DR2_RENIMP equals Y, alert the user that the dose may need to be adjusted for renal impairment
(sample message 5).

This example has a positive return. The system alerts the user that the dose may need to be
adjusted for renal impairment and continues screening the order.

5. If the patient is a neonate (aged 0-29 days) or infant born prematurely (Gestational Age at Birth less than
37 weeks or Weight at Birth less than 2000 grams), skip to Part 2: Dose Range Checking. Otherwise,
continue to step 6.

See Coding of Age Ranges for more information regarding editorial policy criteria defining
neonates and infants.

In this example, the patient is an adult. The system begins creatinine clearance threshold checking (step
4).

6. Display the patients creatinine clearance (convert units if necessary) and the DRCM Creatinine Clearance
Threshold (DR2_CRCLTH) if necessary:

a. If DR2_CRCLTH equals 0, you may want to alert the user that creatinine clearance threshold
checking is unavailable. Continue to Part 2: Dose Range Checking.

b. If the patients creatinine clearance is unavailable, alert the user that a drug dosage adjustment
should be considered (sample message 6 appended to message 5). Continue to Part 2: Dose

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b.

Range Checking.

c. If the patients creatinine clearance is less than or equal to DR2_CRCLTH, a drug dosage
adjustment for renal impairment should be considered. Do not continue with this
application. Instead, perform the remainder of the dose checking process by following the
instructions provided in the application Performing Dosage Range Checking for a Patient with Renal
Impairment.

d. If the patients creatinine clearance is greater than DR2_CRCLTH, continue to Part 2: Dose Range
Checking.

DR2_CRCLTH DR2_CRCLU Description Patients Creatinine

Clearance

90 01 ML/MIN ---

Concatenate the DR2_CRCLTH value of 90 with the DR2_CRCLU description ML/MIN to display
the creatinine clearance threshold of 90 ML/MIN to the user.

In this example, the patients creatinine clearance is unavailable. The system alerts the user that a
drug dosage adjustment should be considered and continues screening the order (Part 2: Dose
Range Checking).

Part 2: Dose Range Checking

This section compares the prescription information with the data retrieved in Part 1 and displays alerts when
needed. See Generating DRCM Warning Messages to view sample user alerts for each of the dose range
checks.

1. Compare the prescribed frequency of administration per day to DRCM Low Frequency of Administration (
DR2_LOFREQ) and DRCM High Frequency of Administration (DR2_HIFREQ):

a. If the prescribed frequency is equal to either DR2_LOFREQ or DR2_HIFREQ, or within the value
range, the order is acceptable and does not produce an alert.

b. If the prescribed frequency is less than DR2_LOFREQ, alert the user that the prescribed frequency
is less than the recommended minimum frequency for the drug (sample message 8).

c. If the prescribed frequency is greater than DR2_HIFREQ, alert the user that the prescribed
frequency exceeds the recommended maximum frequency for the drug (sample message 9).

DR2_LOFREQ DR2_HIFREQ Prescribed Frequency

2 4 3 per day

In this example, the prescribed frequency of 3 per day is within the DR2_LOFREQ and
DR2_HIFREQ value range of 2 to 4 per day. The system passes the order and continues screening.

2. Compare the prescribed duration of therapy in days to DRCM Low Duration of Therapy (DR2_LODOTX)
and DRCM High Duration of Therapy (DR2_HIDOTX):

a.

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2.

a. If the prescribed duration of therapy is equal to either DR2_LODOTX or DR2_HIDOTX, or within the
value range, the order is acceptable and does not produce an alert.

b. If the prescribed duration of therapy is less than DR2_LODOTX, alert the user that the prescribed
duration is less than the recommended low duration for the drug (sample message 10).

c. If the prescribed duration of therapy is greater than DR2_HIDOTX, compare the recommended
maximum duration of therapy to the prescribed duration of therapy.

DR2_LODOTX DR2_HIDOTX Prescribed duration

1 14 1 day (24 hours)

In this example, the prescribed duration of therapy is equal to the DR2_LODOTX value of 1 day.
The system passes the order and continues screening.

3. Compare the prescribed daily dose (convert units if necessary) to DRCM Low Dose per Day (
DR2_LODOSD) and DRCM High Dose per Day (DR2_HIDOSD):

a. If the prescribed daily dose is equal to either DR2_LODOSD or DR2_HIDOSD, or within the value
range, the order is acceptable and does not produce an alert.

b. If the prescribed daily dose is less than DR2_LODOSD, alert the user that the prescribed dose is
less than the recommended low daily dose for the drug (sample message 1).

c. If the prescribed daily dose is greater than DR2_HIDOSD, compare the recommended maximum
daily dose to the prescribed daily dose.

The DRCM Dose Units Code Description (UNITS_DESC) column is from the DRCM Unit
Description Table (RDRCUND0_UNITS_DESC).

DR2_LODOSD 750

DR2_LODOSU 01

UNITS_DESC MG/DAY

DR2_HIDOSD 8000

DR2_HIDOSU 01

UNITS_DESC MG/DAY

Prescribed dose per day 3 g/day

Since the retrieved units are given in mg/day and the prescription is written in g/day, it is necessary
to convert the units of measure. See Converting Units During Dosage Range Checking for more
information about converting units.

The following table shows the data after the conversion.

DR2_LODOSD 0.75

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DR2_LODOSU 51

UNITS_DESC G/DAY

DR2_HIDOSD 8

DR2_HIDOSU 51

UNITS_DESC G/DAY

Prescribed dose per day 3 g/day

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the UNITS_DESC column.

DOSING_MODULE_UNIT_ABB UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

REV

G/DAY gram/day gram per day

In this example, the prescribed daily dose of 3 g/day is within the DR2_LODOSD and DR2_HIDOSD
value range of 0.75 g/day to 8 g/day. The system passes the order and continues screening.

4. Compare the prescribed single dose (convert units if necessary) to DRCM Maximum Amount per Single
Dose (DR2_MX1DOS) and the Not-to-Exceed Amount Per Single Dose (NTE_SINGLE_DOSE):

a. If the prescribed single dose is equal to or less than DR2_MX1DOS and NTE_SINGLE_DOSE, the
order is acceptable and does not produce an alert.

b. If the prescribed single dose is greater than either DR2_MX1DOS and/or NTE_SINGLE_DOSE,
alert the user that the prescribed dose exceeds the recommended maximum single dose for the
drug (sample message 4a, 4b, or 4c).

The DRCM Dose Units Code Description (UNITS_DESC) column is from the DRCM Unit
Description Table (RDRCUND0_UNITS_DESC).

DR2_MX1DOS DR2_MX1DSU NTE_SINGLE_DO NTE_SINGLE_DO Prescribed Single

SE SE_UNIT_CODE Dose

3 29 3 29 1g

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the UNITS_DESC column.

DOSING_MODULE_UNIT_ABB UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

REV

G gram gram

In this example, the prescribed dose of 1 g is less than the DR2_MX1DOS and
NTE_SINGLE_DOSE value of 3 g. The system passes the order and continues screening.

5.

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5. Display the DRCM Maximum Lifetime Dose (DR2_MXLIFD) value:

a. If DR2_MXLIFD equals 0, the maximum lifetime dose is unavailable.

b. If DR2_MXLIFD does not equal 0, display the maximum lifetime dose value for the prescribed
medication (sample message 15).

In this example, the maximum lifetime dose equals 0 and is unavailable for display.

Part 3: Optionally Display Additional Dose Adjustment Information

1. Select the DRCM Hepatic Impairment Assessment Indicator (DR2_HEPIMP):

a. If DR2_HEPIMP equals N, the order is acceptable and does not produce an alert.

b. If DR2_HEPIMP equals Y, alert the user that the dose may need to be adjusted for hepatic
impairment (sample message 7).
This example has a negative return. The system passes the order and checks the display
availability of the elimination half-life values.

2. Display the DRCM Low Elimination Half-Life (DR2_THAFLO) and DRCM High Elimination Half-Life (
DR2_THAFHI) range (or value):

a. If DR2_THAFLO and DR2_THAFHI equal 0, the elimination half-life range (or value) is unavailable.

b. If DR2_THAFLO or DR2_THAFHI does not equal 0, display the elimination half-life range (or value)
for the patient. (sample message 14).

DR2_THAFLO DR2_THAFHI DR2_THAFU Description

1.2 2.5 02 Hours

In this example, the elimination half-life for the order does not equal 0. The system displays the
elimination half-life range of 1.2 hours to 2.5 hours.

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Converting Units During Dosage Range Checking

This application converts one unit of measure to another. You should carry out the steps in this application if the
prescribed unit of measure differs from the unit of measure in the DRCM Neonatal and Adult Master Table during
the Dosage Range Checking application.

This application is broken into two parts. The decision process involved in the two parts:

Part 1converts weight-based or surface-area-based dosing information if necessary (for example,

converts from MG/KG to MG).
Part 2compares dosing information to the prescribed units of measure then converts dosing information
to the prescribed units of measure.

The Converting Units During Dosage Range Checking example following the application provides an illustration
on how to convert units during Dosage Range Checking:

The following application assumes familiarity with the various drug concepts and their identifiers and how to
access clinical information. This application begins at the Clinical Formulation level with the Clinical Formulation
ID (GCN_SEQNO). See Multiple Access Points (MAPs) for more information.

Part 1: Convert weight-based or surface-area-based dosing information

1. Select the following columns from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR):

a. Low Dose Per Day (DR2_LODOSD)

b. Low Dose Per Day Units Code (DR2_LODOSU)

c. High Dose Per Day (DR2_HIDOSD)

d. High Dose Per Day Units Code (DR2_HIDOSU)

e. Maximum Dose Per Day (DR2_MXDOSD)

f. Maximum Dose Per Day Units Code (DR2_MXDOSU)

g. Maximum Amount Per Single Dose (DR2_MX1DOS)

h. Maximum Amount Per Single Dose Units Code (DR2_MX1DSU)

i. Not-to-Exceed Amount Per Single Dose (NTE_SINGLE_DOSE)

j. Not-to-Exceed Amount Per Single Dose Units Code (NTE_SINGLE_DOSE_UNIT_CODE)

k. Maximum Lifetime Dose (DR2_MXLIFD)

l. Maximum Lifetime Dose Units Code (DR2_MXLIFU)

where:

a. the Clinical Formulation ID (GCN_SEQNO) column equals the GCN_SEQNO of the prescribed
medication, and

b. the DRCM Route of Administration Code (DR2_UNITS) column equals the route of administration

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b.

for the prescribed product, and

c. the DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in
days, and

d. the DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in
days, and

e. the FML Disease Indicator (DXID) column equals the DXID of the patient condition to be treated
with this prescription, and

f. the DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type of the prescribed
medication.

2. Select the DR2_UNITS column from the DRCM Unit Description Table (RDRCUND0_UNITS_DESC) using
the various unit code column values from the previous step to retrieve each doses Units Required
Calculation Type Code (UNITS_CTYP).

3. Depending on the value of the UNITS_CTYP for each dosing value, perform the appropriate action:

a. If the UNITS_CTYP column equals 0 Neither weight-based nor surface-area-based conversion is

necessary. Skip the remaining steps in Part 1 of this application, use the dosing values found in step
1, and proceed to Part 2.

b. If the UNITS_CTYP column equals 1 Multiply the value found in the dose column by the patients
weight.

c. If the UNITS_CTYP column equals 2 Multiply the value found in the dose column by the patients
body surface area.

4. Continue on to Part 2 using the converted values.

Part 2: Compares Dosing Information to the Prescribed Units of Measure Then Converts Dosing information to the
Prescribed Units of Measure

1. Select the DR2_UNITS column of the RDRCUND0_UNITS_DESC table using the various unit code
column values from step 1 of Part 1 to retrieve each doses Results Unit Code ( UNITS_RUI) value. The
descriptions for these values appear in the RDRCUND0_UNITS_DESC table.

2. Query the Dose Units Code Description (UNITS_DESC) column of the RDRCUND0_UNITS_DESC table
using each prescribed dose unit of measure to find their DR2_UNITS values.

The information in the DRCM Dose Units Code Description (UNITS_DESC) column might include
abbreviations considered inappropriate by the Joint Commission (TJC) and Institute for Safe
Medication Practices (ISMP). To retrieve the corresponding TJC-compliant unit descriptions for the
given unit in the UNITS_DESC column, query the Units Description Table
(RUNITSD0_UNITS_DESC).

3. Compare the DR2_UNITS values from step 2 to the UNITS_RUI values found in step 1 to see if the DRCM

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3.

units of measure match the prescribed units of measure.

a. If all values match, no unit conversion is necessary for the given data. Skip the remaining steps of
this application and continue the dosage range check operation.

b. If any values do not match, a unit conversion is necessary for dosage range checking. Continue on
to step 4.

4. Query the Prescribed Unit Indicator (DCNV_PUI) and UNITS_RUI columns of the DRCM Unit Conversion
Table (RDRCCVU0_UNITS_CONVERSION). Use the values from step 1 to query the DCNV_PUI column,
and use the values from step 2 to query the UNITS_RUI column.

Retrieve their Units Math Indicator (DCNV_MTHI) and Units Conversion Factor (DCNV_CNVF) columns.

5. Perform the conversions indicated by the previous step on the dosing values found in Part 1.

ExampleConverting Units During Dosage Range Checking

A 25-day-old patient who weighs 12 pounds (5.45 kg) has a prescription for a maintenance dose of amoxicillin
oral suspension (Clinical Formulation ID [GCN_SEQNO] 8997) 0.125 g oral twice daily. No reason for use is
supplied. The reason for using an unorthodox dosage of 0.125 g for this example will become apparent in Part 2
of the application.

Part 1: Convert weight-based or surface-area-based dosing information, if necessary

1. Select the following columns from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR):

a. Low Dose Per Day (DR2_LODOSD)

b. Low Dose Per Day Units Code (DR2_LODOSU)

c. High Dose Per Day (DR2_HIDOSD)

d. High Dose Per Day Units Code (DR2_HIDOSU)

e. Maximum Dose Per Day (DR2_MXDOSD)

f. Maximum Dose Per Day Units Code (DR2_MXDOSU)

g. Maximum Amount Per Single Dose (DR2_MX1DOS)

h. Not-to-Exceed Amount Per Single Dose (NTE_SINGLE_DOSE)

i. Not-to-Exceed Amount Per Single Dose Units Code (NTE_SINGLE_DOSE_UNIT_CODE)

j. Maximum Amount Per Single Dose Units Code (DR2_MX1DSU)

k. Maximum Lifetime Dose (DR2_MXLIFD)

l. Maximum Lifetime Dose Units Code (DR2_MXLIFU)

where:

a. the Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID value of
(GCN_SEQNO) 8997 (Amoxicillin 0.125 g), and

b.

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b. the DRCM Route of Administration Indicator (DR2_RT) column equals DR2_RT 064 (Oral), and

c. the DRCM Low Age in Days (DR2_LOAGED) column is 0, which less than 25 days, and

d. the DRCM High Age in Days (DR2_HIAGED) column is 29, which is greater than 25 days, and

e. the FML Disease Indicator (DXID) column equals DXID = 4892 (default screening record), and

f. the DRCM Dose Type Indicator (DR2_DOSTPI) column equals DR2_DOSTPI 02 (Maintenance).

GCN_SEQNO 8997

DR2_LODOSD 20

DR2_LODOSU 02

DR2_HIDOSD 30

DR2_HIDOSU 02

DR2_MXDOSD 30

DR2_MXDOSU 02

DR2_MX1DOS 15

DR2_MX1DOU 03

NTE_SINGLE_DOSE 1000

NTE_SINGLE_DOSE_UNIT_CODE 28

DR2_MXLIFD 0

DR2_MXLIFU

2. Select the DRCM Units Code (DR2_UNITS) column from the DRCM Unit Description Table
(RDRCUND0_UNITS_DESC) using the various unit code column values from the previous step to retrieve
each doses Units Required Calculation Type Code (UNITS_CTYP) column.

Note that DR2_MXLIFU has no value and therefore has no corresponding UNITS_CTYP value. Also, the
NTE_SINGLE_DOSE_UNIT_CODE has a non-patient parameter unit and therefore does not require
conversion.

Unit Column DR2_UNITS UNITS_DESC UNITS_CTYP

DR2_LODOSU 02 MG/KG/DAY 1

DR2_HIDOSU 02 MG/KG/DAY 1

DR2_MXDOSU 02 MG/KG/DAY 1

DR2_MX1DOU 03 MG/KG 1

NTE_SINGLE_DOSE_UNI 28 MG 0
T_CODE

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DR2_MXLIFU ... ... ...

3. Depending on the value of the UNITS_CTYP for each dosing value, perform the appropriate action:

a. If the UNITS_CTYP column equals 0 Neither weight-based nor surface-area-based conversion is

necessary. Skip the remaining steps in Part 1 of this application, use the dosing values found in step
1, and proceed to Part 2.

b. If the UNITS_CTYP column equals 1 Multiply the value found in the dose column by the patients
weight.

c. If the UNITS_CTYP column equals 2 Multiply the value found in the dose column by the patients
body surface area.

In this example, four dosing values have a UNITS_CTYP value of 1. Therefore, multiply the values
found in the DRCM Neonatal and Adult Master Table by the patients weight to arrive at a converted
unit of measure.

Low Dose Per Day

High Dose Per Day

Maximum Dose Per Day

Maximum Amount Per Single Dose

4. Continue on to Part 2 using the converted values.

Part 2: Convert dosing information to the prescribed units of measure, if necessary

1. Select the DR2_UNITS column of the RDRCUND0_UNITS_DESC table using the various unit code
column values from step 1 of Part 1 to retrieve each doses Results Unit Code ( UNITS_RUI) value. The
descriptions for these values appear in the RDRCUND0_UNITS_DESC table and appear below for
context.

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Unit Column DR2_UNITS UNITS_RUI UNITS_DESC

DR2_LODOSU 02 01 MG/DAY

DR2_HIDOSU 02 01 MG/DAY

DR2_MXDOSU 02 01 MG/DAY

DR2_MX1DOU 03 28 MG

NTE_SINGLE_DOSE_UNI 28 28 MG
T_CODE

DR2_MXLIFU ... ...

2. Select the Dose Units Code Description (UNITS_DESC) column of the RDRCUND0_UNITS_DESC table
using each prescribed dose unit of measure to find their DR2_UNITS values.

This example has two different prescription units of measure: 0.125G is expressed in grams (G), and
0.125G twice daily is expressed in grams/day (G/DAY).

UNITS_DESC DR2_UNITS

G 29

G/DAY 51

The information in the DRCM Dose Units Code Description (UNITS_DESC) column might include
abbreviations considered inappropriate by The Joint Commission (TJC) and Institute for Safe
Medication Practices (ISMP). To retrieve the corresponding TJC-compliant unit descriptions for the
given unit in the UNITS_DESC column, query the Units Description Table
(RUNITSD0_UNITS_DESC).

3. Compare the DR2_UNITS values from step 2 to the UNITS_RUI values found in step 1 to see if the DRCM
units of measure match the prescribed units of measure.

a. If all values match, no unit conversion is necessary for the given data. Skip the remaining steps of
this application and continue the dosage range check operation.

b. If any values do not match, a unit conversion is necessary for dosage range checking. Continue on
to step 4.

In the example case the prescribed values of 29 and 51 do not match any of the UNTS_RUI values
from step 1, so a unit conversion is required before dosage range checking can continue.

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4. Select the Prescribed Unit Indicator (DCNV_PUI) and UNITS_RUI columns of the DRCM Unit Conversion
Table (RDRCCVU0_UNITS_CONVERSION). Use the values from step 1 to query the DCNV_PUI column,
and use the values from step 2 to query the UNITS_RUI column.

Retrieve their Units Math Indicator (DCNV_MTHI) and Units Conversion Factor (DCNV_CNVF) columns.

The extra table below provides descriptions to illustrate the way this table works.

DCNV_PUI UNITS_RUI DCNV_MTHI DCNV_CNVF

01 51 2 1000

28 29 2 1000

Input Unit Resulting Unit Math Operation Factor of Operation

Milligrams/Day Grams/Day Divide 1000

(MG/DAY) (G/DAY)

Milligrams (MG) Grams (G) Divide 1000

5. Perform the conversions indicated by the previous step on the dosing values found in Part 1.

Low Dose Per Day

High Dose Per Day

Maximum Dose Per Day

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Maximum Amount Per Single Dose

Not-to-Exceed Amount Per Single Dose

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Performing Dosage Range Checking Using a DxID or ICD Code

For this application, refer to the FDB Medical Lexicon DxID and ICD Code Search Tables to perform dosage
range checking that is specific to a particular diagnosis or disease state. Applying these examples are dependent
upon the following:

Familiarity with the FDB Medical Lexicon (FML) 2.0 and the Disease Identifier (DxID).
Assignment of a DxID or ICD Code to a given disease state.

Part 1: Retrieve Related DxIDs

A patient with status epilepticus has a prescription for a single dose (DR2_DOSTPI = 07) of Diazepam 5 mg/mL
(Clinical Formulation ID [GCN_SEQNO] 3761) 0.75 mg intravenous (DR2_RT 052). The patient is 10 days old
and weighs 1,500 grams (1.5 kg). The gestational age at birth was 29 weeks.

This section consists of two subparts and describes how to retrieve related DxIDs using either an ICD Code or a
DxID. When following the application, follow the instructions for A or B, depending on which Disease Identifier
(DxID or ICD Code) is being used to retrieve related DxIDs. Do not perform both. For example, if using an ICD
Code to retrieve related DxIDs, perform Part 1A, then continue to Part 2.

Part 1A: Using an ICD Code to Retrieve Related DxIDs

1. Given the ICD Code, query the FML ICD Search Table (RFMLISR1_ICD_SEARCH) for FML Related
DxIDs (RELATED_DXID) and FML Navigation Codes (FML_NAV_CODE), specifying the following:
The ICD Code for the Search ICD Code (SEARCH_ICD_CD) column.
04 for the FML Clinical Module Code (FML_CLIN_CODE) column, which specifies the query is for
the Dosage Range Check Module.
The following table shows an example of retrieved data:

SEARCH_ICD_CD RELATED_DXID FML_CLIN_CODE FML_NAV_CODE

345.3 1099 04 01

345.3 1105 04 03

345.3 3053 04 03

Results with FML_NAV_CODE 01 indicate the RELATED_DXID is equal. In this example, one
RELATED_DXID is returned that is rated equal. In this example the patient has been diagnosed
with Status Epilepticus and DxID 1099 is a match. Refer to FDB Medical Lexicon (FML) 2.0 for
information on accessing DxID descriptions.

2. Query the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) and retrieve all records
associated to the prescribed Clinical Formulation ID (GCN_SEQNO) and the RELATED_DxID rated equal.
In this example, one record is returned.

GCN_SEQNO DXID

3761 1099

3.

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3. Depending on the query results, do one of the following:

If records are retrieved using the DxID rated equal, as they are in this example, continue to Collect
Dosage Range Check Data for more information about retrieving the appropriate record for dosage
range checking.
If no records are retrieved using the DxID rated equal, continue to Step 4.

4. If no records are retrieved using the DxID rated equal, query the RDRCNMA2_MSTR table for all records
associated to the prescribed Clinical Formulation ID (GCN_SEQNO) and the RELATED_DxIDs rated
broader (FML_NAV_CODE 02), narrower (FML_NAV_CODE 03), and related (FML_NAV_CODE 04).

5. Depending on the query results, do one of the following:

If records are retrieved using DxIDs rated broader and/or narrower, continue to Collect Dosage
Range Check Data for more information about retrieving the appropriate record for dosage range
checking.
Preface all DRCM message text using records retrieved with DxIDs rated broader, narrower, or
related with the following statement: Dosing range for [Dose ICD Code] is not available. Dosing
range information for the associated term [Related DxID name] has been used.
If no records are retrieved for DxIDs rated broader and/or narrower, continue to Step 6.

6. Query the RDRCNMA2_MSTR table and retrieve all records associated to the prescribed Clinical
Formulation ID (GCN_SEQNO) and the default screening record DxID of 4892. Continue to Collect
Dosage Range Check Data for more information about retrieving the appropriate record for dosage range
checking.

Preface all DRCM message text using records retrieved with the default screening record DxID of 4892
with the following statement: Dosing range for [Dose ICD Code] is not available. Dosing range information
for the default screening record DxID of 4892 has been used.

Part 1B: Using a DxID to Retrieve Related DxIDs

1. Given the DxID, query the FML Disease Identifier (DxID) Search Table (RFMLDSR0_DXID_SEARCH) for
RELATED_DXIDs and FML_NAV_CODEs, specifying the following:
The DxID for the SEARCH_DXID column.
04 for the FML_CLIN_CODE column, which specifies the query is for DRCM. The following table
shows an example of retrieved data:

SEARCH_DXID RELATED_DXID FML_CLIN_CODE FML_NAV_CODE

1099 1099 04 01

Results with FML_NAV_CODE 01 indicate the RELATED_DXID is equal. In this example, one
RELATED_DXID is returned that is rated equal. In this example, the patient has been diagnosed
with status epilepticus and DxID 1099 has the DXID_DESC_56 of Status Epilepticus (refer to FDB
Medical Lexicon (FML) 2.0 for information on accessing DxID descriptions) which matches the
scenario patients reason for use.

2.

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2. Query the RNEOMMA1_MSTR table and retrieve all records associated to the prescribed Clinical
Formulation ID (GCN_SEQNO) and the RELATED_DxID rated equal.

GCN_SEQNO DXID

3761 1099

3. Depending on the query results, do one of the following:

If records are retrieved using the DxID rated equal, as they are in this example, continue to Collect
Dosage Range Check Data for more information about retrieving the appropriate record for dosage
range checking.
If no records are retrieved using the DxID rated equal, continue to Step 4.

4. If no records are retrieved using the DxID rated equal, query the RDRCNMA2_MSTR table for all records
associated to the prescribed Clinical Formulation ID (GCN_SEQNO) and the RELATED_DXIDs rated
broader (FML_NAV_CODE 02) and/or narrower (FML_NAV_CODE 03).

5. Depending on the query results, do one of the following:

If records are retrieved using DxIDs rated broader and/or narrower, continue to Collect Dosage
Range Check Data for more information about retrieving the appropriate record for dosage range
checking.
Preface all DRCM message text using records retrieved with DxIDs rated broader and/or narrower
with the following statement: Dosing range for [Dose DxID name] is not available. Dosing range
information for the associated term [Related DxID name] has been used.
If no records are retrieved for DxIDs rated broader and/or narrower, continue to Step 6.

6. Query the RDRCNMA2_MSTR table and retrieve all records associated to the prescribed Clinical
Formulation ID (GCN_SEQNO) and the default screening record DxID of 4892. Continue to Collect
Dosage Range Check Data for more information about retrieving the appropriate record for dosage range
checking.

Preface all DRCM message text using records retrieved with the default screening record DxID of 4892
with the following statement: Dosing range for [Dose DxID name] is not available. Dosing range
information for the Default Screening Record DxID of 4892 has been used.

Part 2: Collect Dosage Range Check Data

1. Select records from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) where the:

a. GCN_SEQNO column equals the Clinical Formulation ID (GCN_SEQNO) value of the prescribed
medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d.

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d. DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in days,
and

e. DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in days,
and

f. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record).

GCN_SEQNO 3761

DR2_RT 052

DR2_DOSTPI 07

DR2_LOAGED 0

DR2_HIAGED 29

DXID 1099

2. Select the Dosing Age Source Identifier (DOSING_AGE_SOURCE_ID) from the RDRCNMA2_MSTR table
where the columns equal the dosing record collected in step 1. According to your business needs:

a. Display the data source information to the end-user.

b. Determine by the source if the collected dosing record can be used in screening.

In this example, DOSING_AGE_SOURCE_ID equals 3, indicating that this supporting reference

may not be specific to the given age.

3. Check the Weight Required Indicator (WEIGHT_REQ_IND):

a. If WEIGHT_REQ_IND equals 0, the current weight is not required to select the screening record.

b. If WEIGHT_REQ_IND equals 1, the current weight is required to select the screening record.
If the weight of the patient is known, use the actual weight.
If the weight of the patient is unavailable, prompt the end-user to enter the weight. Optionally
the institution could provide a default nonmogram based weight, to proceed with screening.

In this example, WEIGHT_REQ_IND equals 0, indicating that the current weight is not required to
select the screening record. The system continues screening.

4. Check the NEOM Gestational Birth Age Required Indicator (NEOM_GEST_BIRTH_AGE_REQ_IND) if

screening for a neonatal patient:

a. If NEOM_GEST_BIRTH_AGE_REQ_IND equals 0, the gestational age at birth is not required to

select the screening record.

b. If NEOM_GEST_BIRTH_AGE_REQ_IND equals 1, the gestational age at birth is required to select

the screening record.

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b.

In this example, NEOM_GEST_BIRTH_AGE_REQ_IND equals 0 indicating that the gestational age

at birth is not required to select the screening record. The system begins dose range checking using
the record retrieved in Part 1.

5. Select the DRCM Renal Impairment Assessment Indicator (DR2_RENIMP):

a. If DR2_RENIMP equals N, the order is acceptable and does not produce an alert. Skip to Part 3:
Dose Range Checking.

b. If DR2_RENIMP equals Y, alert the user that the dose may need to be adjusted for renal impairment
(sample message 5) and continue with creatinine clearance checking.

This example has a negative return. The system continues screening the order (Part 3: Dose Range
Checking).

Part 3: Dose Range Checking

This section compares the prescription information with the data retrieved in Part 2 and displays alerts when
needed. See Generating DRCM Warning Messages to view sample user alerts for each of the dose range
checks.

1. Compare the prescribed frequency of administration per day to DRCM Low Frequency of Administration (
DR2_LOFREQ) and DRCM High Frequency of Administration (DR2_HIFREQ):

a. If the prescribed frequency is equal to either DR2_LOFREQ or DR2_HIFREQ, or within the value
range, the order is acceptable and does not produce an alert.

b. If the prescribed frequency is less than DR2_LOFREQ, alert the user that the prescribed frequency
is less than the recommended minimum frequency for the drug (sample message 8).

c. If the prescribed frequency is greater than DR2_HIFREQ, alert the user that the prescribed
frequency exceeds the recommended maximum frequency for the drug (sample message 9).

DR2_LOFREQ DR2_HIFREQ Prescribed Frequency

1 1 1 per day

In this example, the prescribed frequency of 1 per day is equal to the DR2_LOFREQ and the
DR2_HIFREQ values of 1 per day. The system passes the order and continues screening.

2. Compare the prescribed duration of therapy in days to DRCM Low Duration of Therapy (DR2_LODOTX)
and DRCM High Duration of Therapy (DR2_HIDOTX):

a. If the prescribed duration of therapy is equal to either DR2_LODOTX or DR2_HIDOTX, or within the
value range, the order is acceptable and does not produce an alert.

b. If the prescribed duration of therapy is less than DR2_LODOTX, alert the user that the prescribed
duration is less than the recommended low duration for the drug (sample message 10).

c. If the prescribed duration of therapy is greater than DR2_HIDOTX, compare the recommended
maximum duration of therapy to the prescribed duration of therapy.

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c.

DR2_LODOTX DR2_HIDOTX Prescribed duration

1 1 1 day

In this example, the prescribed duration is equal to the DR2_LODOTX and DR2_HIDOTX value of 1
day. The system passes the order and continues screening.

3. Compare the prescribed daily dose (convert units if necessary) to DRCM Low Dose per Day (
DR2_LODOSD) and DRCM High Dose per Day (DR2_HIDOSD):

a. If the prescribed daily dose is equal to either DR2_LODOSD or DR2_HIDOSD, or within the value
range, the order is acceptable and does not produce an alert.

b. If the prescribed daily dose is less than DR2_LODOSD, alert the user that the prescribed dose is
less than the recommended low daily dose for the drug (sample message 1).

c. If the prescribed daily dose is greater than DR2_HIDOSD, compare the recommended maximum
daily dose to the prescribed daily dose.

The DRCM Dose Units Code Description (UNITS_DESC) column is from the DRCM Unit
Description Table (RDRCUND0_UNITS_DESC).

DR2_LODOSD 0.1

DR2_LODOSU 2

UNITS_DESC MG/KG/DAY

DR2_HIDOSD 0.3

DR2_HIDOSU 02

UNITS_DESC MG/KG/DAY

Prescribed dose per day 0.75 mg/day

Since the retrieved units are given in mg/kg/day and the prescription is written in mg/day, it is
necessary to convert the units of measure. See Converting Units During Dosage Range Checking
for more information about converting units.

The following table shows the data after the conversion.

DR2_LODOSD 0.1

DR2_LODOSU 01

UNITS_DESC MG/DAY

DR2_HIDOSD 0.45

DR2_HIDOSU 01

UNITS_DESC MGDAY

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Prescribed dose per day 0.75 mg/day

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the UNITS_DESC column.

DOSING_MODULE_UNIT_ABB UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

REV

MG/DAY mg/day milligram per day

In this example, the prescribed dose of 0.75 mg/day is greater than the DR2_HIDOSD value of 0.45
mg/day. The system alerts the user that the prescribed dose is greater than the DR2_HIDOSD
value of 0.45 mg/day. The system compares the prescribed daily dose to the recommended
maximum daily dose.

4. Compare the prescribed daily dose (convert units if necessary) to DRCM Maximum Dose per Day (
DR2_MXDOSD):

a. If the prescribed daily dose is equal to or less than DR2_MXDOSD, alert the user that the
prescribed dose exceeds the recommended high daily dose for the drug but is less than the
recommended maximum daily dose (sample message 2).

b. If the prescribed daily dose is greater than DR2_MXDOSD, alert the user that the prescribed dose
exceeds the recommended maximum daily dose for the drug ( sample message 3).

DR2_MXDOSD DR2_MXDOSU Prescribed Single Dose

0.75 02 0.75 mg/day

Since the retrieved units are given in mg/kg/day and the prescription is written in mg/day, it is
necessary to convert the units of measure. See Converting Units During Dosage Range Checking
for more information about converting units.

DR2_MXDOSD DR2_MXDOSU Prescribed Single Dose

1.125 01 0.75 mg/day

In this example, the prescribed dose of 0.75 mg/day is less than the DR2_MXDOSD value of 1.125
mg/day. The system alerts the user that the prescribed dose exceeds the recommended high daily
dose for the drug but is less than the recommended maximum daily dose and continues screening.

5. Compare the prescribed single dose (convert units if necessary) to DRCM Maximum Amount Per Single
Dose (DR2_MX1DOS) and the Not-to-Exceed Amount Per Single Dose (NTE_SINGLE_DOSE):

a. If the prescribed single dose is equal to or less than DR2_MX1DOS and NTE_SINGLE_DOSE, the
order is acceptable and does not produce an alert.

b. If the prescribed individual dose is greater than either DR2_MX1DOS and/or NTE_SINGLE_DOSE,
alert the user that the prescribed dose exceeds the recommended maximum single dose for the

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b.

drug (sample message 4a, 4b, or 4c).

The DRCM Dose Units Code Description (UNITS_DESC) column is from the DRCM Unit
Description Table (RDRCUND0_UNITS_DESC).

DR2_MX1DOS DR2_MX1DSU NTE_SINGLE_DO NTE_SINGLE_DO Prescribed Single

SE SE_UNIT_CODE Dose

2 28 2 28 0.75

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the UNITS_DESC column.

DOSING_MODULE_UNIT_ABB UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

REV

MG mg milligram

In this example, the prescribed single dose of 0.75 mg is less than the DR2_MX1DOS and
NTE_SINGLE_DOSE values of 2 mg. The system passes the order and continues screening.

6. Display the DRCM Maximum Lifetime Dose (DR2_MXLIFD) value:

a. If DR2_MXLIFD equals 0, the maximum lifetime dose is unavailable.

b. If DR2_MXLIFD does not equal 0, display the maximum lifetime dose value for the prescribed
medication (sample message 15).

In this example, the maximum lifetime dose equals 0 and is unavailable for display.

Part 4: Optionally Display Additional Dose Adjustment Information

1. Check the DRCM Hepatic Impairment Assessment Indicator (DR2_HEPIMP):

a. If DR2_HEPIMP equals N, the order is acceptable and does not produce an alert.

b. If DR2_HEPIMP equals Y, alert the user that the dose may need to be adjusted for hepatic
impairment (sample message 7).
This example has a positive return. The system alerts the user that the dose may need to be
adjusted for hepatic impairment and checks the display availability of the elimination half-life values.

2. Display the DRCM Low Elimination Half-Life (DR2_THAFLO) and DRCM High Elimination Half-Life (
DR2_THAFHI) range (or value):

a. If DR2_THAFLO and DR2_THAFHI equals 0, the elimination half-life range (or value) is
unavailable.

b. If DR2_THAFLO or DR2_THAFH does not equal 0, display the elimination half-life range (or value)
for the patient. (sample message 14).

DR2_THAFLO DR2_THAFHI DR2_THAFU Description

20 100 02 Hours

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In this example, the elimination half-life for the order does not equal 0. The system displays the
elimination half-life range as 20 hours - 100 hours.

ExampleUsing a Gender-Specific DxID Code

A patient with insomnia has a prescription for a maintenance dose (DR2_DOSTPI = 02) of zolpidem 10 mg tablet
(DR2_RT = 064) (Clinical Formulation ID [GCN_SEQNO] 19188) once a day for 7 days. The patient is female
(DXID = 14160), is 20,000 days old, and weighs 68,000 grams (68 kg).

Due to an FDA alert about gender-specific doing levels for zolpidem, FDB added new gender-specific
DXID values. Use the values in place of the default screening record only when the gender is known and
when performing dosage range checking for zolpidem. See Gender-Specific Record of the FDB Medical
Lexicon (FML) for additional information. Refer to the Performing Dosage Range Checking Using a DxID
or ICD Code for standard indication-specific checking.

Part 1: Collect Dosage Range Check Data

1. Select records from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) where the:

a. GCN_SEQNO column equals the Clinical Formulation ID (GCN_SEQNO) value of the prescribed
medication

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication

d. DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in days

e. DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in days

f. FML Disease Identifier (DXID) column equals the DXID of the patients gender

GCN_SEQNO 19188

DR2_RT 064

DR2_DOSTPI 02

DR2_LOAGED 6570

DR2_HIAGED 23724

DXID 14160

2. Select the Dosing Age Source Identifier (DOSING_AGE_SOURCE_ID) from the RDRCNMA2_MSTR table
where the columns equal the dosing record collected in step 1. According to your business needs:

a. Display the data source information to the end-user.

b.

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b. Determine by the source if the collected dosing record can be used in screening.

In this example, DOSING_AGE_SOURCE_ID equals 2, indicating that the source reference is for
the age range.

3. Check the Weight Required Indicator (WEIGHT_REQ_IND):

a. If WEIGHT_REQ_IND equals 0, the current weight is not required to select the screening record.

b. If WEIGHT_REQ_IND equals 1, the current weight is required to select the screening record.
If the weight of the patient is known, use the actual weight.
If the weight of the patient is unavailable, prompt the end-user to enter the weight. Optionally
the institution could provide a default nonmogram based weight, to proceed with screening.

In this example, WEIGHT_REQ_IND equals 0, indicating that the current weight is not required to
select the screening record. The system continues screening.

4. Check the NEOM Gestational Birth Age Required Indicator (NEOM_GEST_BIRTH_AGE_REQ_IND) if

screening for a neonatal patient:

a. If NEOM_GEST_BIRTH_AGE_REQ_IND equals 0, the gestational age at birth is not required to

select the screening record.

b. If NEOM_GEST_BIRTH_AGE_REQ_IND equals 1, the gestational age at birth is required to select

the screening record.

In this example, NEOM_GEST_BIRTH_AGE_REQ_IND equals 0, indicating that the gestational age

at birth is not required to select the screening record. The system continues to the renal impairment
assessment indicator.

5. Select the DRCM Renal Impairment Assessment Indicator (DR2_RENIMP):

a. If DR2_RENIMP equals N, the order is acceptable and does not produce an alert. Skip to Part 2:
Dose Range Checking.

b. If DR2_RENIMP equals Y, alert the user that the dose may need to be adjusted for renal impairment
(sample message 5) and continue with creatinine clearance checking.

In this example, DR2_RENIMP equals N, indicating a negative return (i.e., the order is acceptable).
The system begins dose range checking using the record retrieved in step 1.

Part 2: Dose Range Checking

This section compares the prescription information with the data retrieved in Part 1 and displays alerts when
needed. See Generating DRCM Warning Messages to view sample user alerts for each of the dose range
checks.

1. Compare the prescribed frequency of administration per day to DRCM Low Frequency of Administration (
DR2_LOFREQ) and DRCM High Frequency of Administration (DR2_HIFREQ):

a. If the prescribed frequency is equal to either DR2_LOFREQ or DR2_HIFREQ, or within the value

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a.

range, the order is acceptable and does not produce an alert.

b. If the prescribed frequency is less than DR2_LOFREQ, alert the user that the prescribed frequency
is less than the minimum frequency for the drug (sample message 8).

c. If the prescribed frequency is greater than DR2_HIFREQ, alert the user that the prescribed
frequency exceeds the maximum frequency for the drug (sample message 9).

DR2_LOFREQ DR2_HIFREQ Prescribed Frequency

1 2 1 per day

In this example, the prescribed frequency of 1 per day is equal to the DR2_LOFREQ and the
DR2_HIFREQ values of 1 per day. The system passes the order and continues screening.

2. Compare the prescribed duration of therapy in days to DRCM Low Duration of Therapy (DR2_LODOTX)
and DRCM High Duration of Therapy (DR2_HIDOTX):

a. If the prescribed duration of therapy is equal to either DR2_LODOTX or DR2_HIDOTX, or within the
value range, the order is acceptable and does not produce an alert.

b. If the prescribed duration of therapy is less than DR2_LODOTX, alert the user that the prescribed
duration is less than the low duration for the drug (sample message 10).

c. If the prescribed duration of therapy is greater than DR2_HIDOTX, compare the maximum duration
of therapy to the prescribed duration of therapy.

DR2_LODOTX DR2_HIDOTX Prescribed duration

1 35 7 days

In this example, the prescribed duration is equal to the DR2_LODOTX and DR2_HIDOTX value of 1
day. The system passes the order and continues screening.

3. Compare the prescribed daily dose (convert units if necessary) to DRCM Low Dose per Day (
DR2_LODOSD) and DRCM High Dose per Day (DR2_HIDOSD):

a. If the prescribed daily dose is equal to either DR2_LODOSD or DR2_HIDOSD, or within the value
range, the order is acceptable and does not produce an alert.

b. If the prescribed daily dose is less than DR2_LODOSD, alert the user that the prescribed dose is
less than the low daily dose for the drug (sample message 1).

c. If the prescribed daily dose is greater than DR2_HIDOSD, compare the maximum daily dose to the
prescribed daily dose.

The DRCM Dose Units Code Description (UNITS_DESC) column is from the DRCM Unit
Description Table (RDRCUND0_UNITS_DESC).

DR2_LODOSD 5

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DR2_LODOSU 01

UNITS_DESC MG/DAY

DR2_HIDOSD 5

DR2_HIDOSU 01

UNITS_DESC MGDAY

Prescribed dose per day 10 mg/day

In this example, the prescribed dose of 10 mg/day is greater than the DR2_HIDOSD value of 5
mg/day. The system alerts the user that the prescribed dose is greater than the DR2_HIDOSD
value of 5 mg/day. The system will continue to compare the prescribed daily dose to the maximum
daily dose.

4. Compare the prescribed daily dose (convert units if necessary) to DRCM Maximum Dose per Day (
DR2_MXDOSD):

a. If the prescribed daily dose is equal to or less than DR2_MXDOSD, alert the user that the
prescribed dose exceeds the high daily dose for the drug but is equal to or less than to the
maximum daily dose (sample message 2).

b. If the prescribed daily dose is greater than DR2_MXDOSD, alert the user that the prescribed dose
exceeds the maximum daily dose for the drug (sample message 3).

DR2_MXDOSD DR2_MXDOSU Prescribed Single Dose

10 01 10 mg/day

In this example, the prescribed dose of 10 mg/day is equal to the DR2_MXDOSD value of 10
mg/day. The system alerts the user that the prescribed dose exceeds the high daily dose for the
drug but is equal to the maximum daily dose. The system continues screening.

5. Compare the prescribed single dose (convert units if necessary) to DRCM Maximum Amount Per Single
Dose (DR2_MX1DOS) and the Not-to-Exceed Amount Per Single Dose (NTE_SINGLE_DOSE):

a. If the prescribed single dose is equal to or less than DR2_MX1DOS and NTE_SINGLE_DOSE, alert
the user that the prescribed dose exceeds the high daily dose for the drug but is equal to the
maximum daily dose (sample message 2) and equal to or less than the single dose.

b. If the prescribed individual dose is greater than either DR2_MX1DOS and/or NTE_SINGLE_DOSE,
alert the user that the prescribed dose exceeds the single dose for the drug ( sample message 4a,
4b, or 4c).

The DRCM Dose Units Code Description (UNITS_DESC) column is from the DRCM Unit
Description Table (RDRCUND0_UNITS_DESC).

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DR2_MX1DOS DR2_MX1DSU NTE_SINGLE_DO NTE_SINGLE_DO Prescribed Single

SE SE_UNIT_CODE Dose

10 28 10 28 10 mg

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the UNITS_DESC column.

DOSING_MODULE_UNIT_ABB UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

REV

MG mg milligram

In this example, the prescribed single dose of 10 mg is equal to the DR2_MX1DOS and
NTE_SINGLE_DOSE values of 10 mg. The system alerts the user that the prescribed dose exceeds
the high daily dose for the drug but is equal to the maximum daily dose and the single dose and
continues screening.

6. Display the DRCM Maximum Lifetime Dose (DR2_MXLIFD) value:

a. If DR2_MXLIFD equals 0, the maximum lifetime dose is unavailable.

b. If DR2_MXLIFD does not equal 0, display the maximum lifetime dose value for the prescribed
medication (sample message 15).

In this example, the maximum lifetime dose equals 0, indicating that the maximum lifetime dose
information is unavailable for display.

Part 3: Optionally Display Additional Dose Adjustment Information

1. Check the DRCM Hepatic Impairment Assessment Indicator (DR2_HEPIMP):

a. If DR2_HEPIMP equals N, the order is acceptable and does not produce an alert.

b. If DR2_HEPIMP equals Y, alert the user that the dose may need to be adjusted for hepatic
impairment (sample message 7).
In this example, the returned value is Y, indicating a a positive return. The system alerts the user
that the dose may need to be adjusted for hepatic impairment and checks the display availability of
the elimination half-life values.

2. Display the DRCM Low Elimination Half-Life (DR2_THAFLO) and DRCM High Elimination Half-Life (
DR2_THAFHI) range (or value):

a. If DR2_THAFLO and DR2_THAFHI equals 0, the elimination half-life range (or value) is
unavailable.

b. If DR2_THAFLO or DR2_THAFH does not equal 0, display the elimination half-life range (or value)
for the patient. (sample message 14).

DR2_THAFLO DR2_THAFHI DR2_THAFU Description

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1.4 4.5 02 Hours

In this example, the elimination half-life for the order does not equal 0, indicating there is half-life
range information. The system displays the elimination half-life range as 1.4 hours - 4.5 hours.

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Performing Dosage Range Checking for a Patient with Renal Impairment

This application describes how to perform dosage range checking for a patient who has renal impairment. The
renally adjusted dosage ranges are a best estimate for the population of renally impaired patients. Each patient
should be closely monitored for signs of efficacy and for drug toxicity within associated adjustment in the dose.
Drug levels should be monitored if possible. When in doubt, consult a nephrologist or pharmacist who is familiar
with drug dosing for patients with renal impairment.

Use this application if the DRCM Renal Impairment Assessment Indicator (DR2_RENIMP) equals Y during
normal dosage range screening and if the patients creatinine clearance is less than or equal to the DRCM
Creatinine Clearance Threshold (DR2_CRCLTH). Do not use this application both the Renal and Hepatic
Impairment Indicators are set to Y and the patient has both hepatic impairment and renal impairment below the
creatinine clearance threshold.

Renally adjusted dose screening is not available for patients aged 0-29 days.

When performing dosage range checking it may be necessary to convert the DRCM units to the
prescribed units. See the Converting Units During Dosage Range Checking application for more
information on converting units.

When performing dosage range checking on extemporaneously compounded drugs, each active
ingredient should be screened individually.

The DRCM Dose Units Code Description (UNITS_DESC) column is in the DRCM Unit Description Table
(RDRCUND0_UNITS_DESC).

The information in the UNITS_DESC column might include abbreviations considered inappropriate by
The Joint Commission (TJC) and Institute for Safe Medication Practices (ISMP). To retrieve the
corresponding TJC-compliant unit descriptions for the given unit in the UNITS_DESC column, query the
Units Description Table (RUNITSD0_UNITS_DESC) and use the description found in either the
UNIT_DESC_ABBR or UNIT_DESC_EXPANDED columns.

For specific medications, ages, and creatinine clearance ranges, multiple adjusted dosage range
checking values for renal impairment may be present. Multiple adjusted dosage range checking values
may only be present for the following DRCM Dosing Adjustment Type Code (DOSING_ADJ_TYPE_CD)
values:

- 3 (Adjust dose using multiplier)

- 4 (Adjust frequency)

- 5 (Adjust dose using multiplier and frequency)

- 10 (Default)

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An end-user administrator can choose a preferred global adjustment type or a preferred adjustment type
specific to a given drug. Alternatively, the adjustment code Default can be treated as the preferred
adjustment type when available.

The following application assumes familiarity with the various drug concepts and their identifiers and how to
access clinical information, as well as familiarity with the Dosage Range Checking application. See Dosage
Range Checking, page 528 for more information. This application begins at the Clinical Formulation level with the
Clinical Formulation ID (GCN_SEQNO). See Multiple Access Points (MAPs) for more information.

1. Retrieve the DRCM Dosing Adjustment Type Code (DOSING_ADJ_TYPE_CD) from the DRCM Renal
Master Table (RDRCRM0_RENAL_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Renal Low Age in Days (REN_LOAGED) column is less than or equal to the patient age in
days, and

e. DRCM Renal High Age in Days (REN_HIAGED) column is greater than or equal to the patient age
in days, and

f. DRCM Renal Low Creatinine Clearance mL/min (REN_LOCRCL) column is less than or equal to
the patient creatinine clearance value in mL/min, and

g. DRCM Renal High Creatinine Clearance mL/min (REN_HICRCL) column is greater than or equal to
the patient creatinine clearance value in mL/min, and

h. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record)

2. If preferences have been set for a preferred global adjustment type or a preferred adjustment type specific
to a given drug, filter the dosage range checking values from step 1 where the DRCM Dosing Adjustment
Type Code (DOSING_ADJ_TYPE_CD) matches a preferred DRCM Dosing Adjustment Type Code
selection.

3. Depending upon the DRCM Dosing Adjustment Type Code (DOSING_ADJ_TYPE_CD) found in step 1,
complete the following:

a. If the DOSING_ADJ_TYPE_CD equals 1 and

Dosing ranges all equal 0, present the DRCM Renal Adjustment Footnote Text (
REN_FOOTNOTE) to the user so they can screen the order manually based on the

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information presented in the footnote.

Dosing ranges do not all equal 0, proceed with renal dosage screening (beginning with step
3) and then present the DRCM Renal Adjustment Footnote Text (REN_FOOTNOTE) to the
user.

b. If the DOSING_ADJ_TYPE_CD equals 2, alert the user that the drug is not recommended for
patients with the specified level of organ function (sample message 16, page 636) and skip the
remainder of this application.

c. If the DOSING_ADJ_TYPE_CD equals 3, 4, 5, 8, or 10, continue renal dosage screening.

d. If the DOSING_ADJ_TYPE_CD equals 9, use the information from step 1 to retrieve the Renal
Monograph ID (REN_MONO_ID) and present an adjustment monograph to the user so they can
screen the order manually based upon the information in the monograph. Skip the remainder of this
application. See Accessing a Renal Adjustment Monograph, page 594 for more information
regarding how to display a renal adjustment monograph.

DOSING_ADJ_TYPE_CD values of 6 (Adjust dose to fixed amount) and 7 (Adjust dose to

fixed amount and adjust frequency) are not currently being used and will appear in future
releases of this content. In the meantime, the records which would have any of those values
have a value of 9 (See monograph) instead.

4. Compare the prescribed frequency of administration per day to DRCM Renally Adjusted Low Frequency of
Administration (REN_LOFREQ) and DRCM Renally Adjusted High Frequency of Administration (
REN_HIFREQ):

a. If the prescribed frequency is equal to either the REN_LOFREQ or REN_HIFREQ, or within the
value range, the order is acceptable and does not produce an alert.
Continue to step 4.

b. If the prescribed frequency is less than the REN_LOFREQ, alert the user that the prescribed
frequency is less than the recommended minimum frequency for the drug (sample message 8).

c. If the prescribed frequency is greater than the REN_HIFREQ, alert the user that the prescribed
frequency exceeds the recommended maximum frequency for the drug (sample message 9).

5. Compare the prescribed daily dose (convert units if necessary) to DRCM Renally Adjusted Low Dose per
Day (REN_LODOSD) and DRCM Renally Adjusted High Dose per Day (REN_HIDOSD):

a. If the prescribed daily dose is equal to either the REN_LODOSD or REN_HIDOSD, or within the
value range, the order is acceptable and does not produce an alert.
Skip to step 7.

b. If the prescribed daily dose is less than the REN_LODOSD, alert the user that the prescribed dose
is less than the recommended low daily dose for the drug (sample message 1). Skip to step 7.

c. If the prescribed daily dose is greater than the REN_HIDOSD, continue to step 6.

6.

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6. Compare the prescribed daily dose (convert units if necessary) to DRCM Renally Adjusted Maximum Dose
per Day (REN_MXDOSD):

a. If the prescribed daily dose is equal to or less than the REN_MXDOSD, alert the user that the
prescribed dose exceeds the recommended high daily dose for the drug but is less than the
recommended maximum daily dose (sample message 2).

b. If the prescribed daily dose is greater than the REN_MXDOSD, alert the user that the prescribed
dose exceeds the recommended maximum daily dose for the drug (sample message 3, page 634).

7. Compare the prescribed single dose (convert units if necessary) to DRCM Renally Adjusted Maximum
Amount per Single Dose (REN_MX1DOS) and the Renally Adjusted Not-to-Exceed Amount Per Single
Dose (REN_NTE_SINGLE_DOSE):

a. If the prescribed single dose is equal to or less than the REN_MX1DOS and
REN_NTE_SINGLE_DOSE, the order is acceptable and does not produce an alert. If the DRCM
Renal Adjustment Footnote Text (REN_FOOTNOTE) is available, present it to the user.

b. If the prescribed single dose is greater than either the REN_MX1DOS and/or
REN_NTE_SINGLE_DOSE, alert the user that the prescribed dose exceeds the recommended
maximum single dose for the drug (sample message 4a, 4b, and 4c).

ExampleDRCM Dosing Adjustment Type Code (DOSING_ADJ_TYPE_CD) Equals 1 (See Footnote)

A patient with renal dysfunction has a prescription for a maintenance dose (DR2_DOSTPI 02) of lisinopril (Clinical
Formulation ID [GCN_SEQNO] 000391) 20 mg oral (DR2_RT 064) 2 times per day for 10 days. The reason for
use is not available (DXID 00004892). The patient is 70 years old (25,550 days) and has a creatinine clearance
level of 25 mL/min.

1. Retrieve the DRCM Dosing Adjustment Type Code (DOSING_ADJ_TYPE_CD) from the DRCM Renal
Master Table (RDRCRM0_RENAL_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Renal Low Age in Days (REN_LOAGED) column is less than or equal to the patient age in
days, and

e. DRCM Renal High Age in Days (REN_HIAGED) column is greater than or equal to the patient age
in days, and

f. DRCM Renal Low Creatinine Clearance mL/min (REN_LOCRCL) column is less than or equal to
the patient creatinine clearance value in mL/min, and

g.

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g. DRCM Renal High Creatinine Clearance mL/min (REN_HICRCL) column is greater than or equal to
the patient creatinine clearance value in mL/min, and

h. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record)
In this example, the retrieved DOSING_ADJ_TYPE_CD equals 1.

GCN_SEQNO 000391

DR2_RT 064

DR2_DOSTPI 02

REN_LOAGED 23725

REN_HIAGED 40150

REN_LOCRCL 20

REN_HICRCL 29

DXID 4892

DOSING_ADJ_TYPE_CD 1

2. If preferences have been set for a preferred global adjustment type or a preferred adjustment type specific
to a given drug, filter the dosage range checking values from step 1 where the DRCM Dosing Adjustment
Type Code (DOSING_ADJ_TYPE_CD) matches a preferred DRCM Dosing Adjustment Type Code
selection.

3. Depending upon the DRCM Dosing Adjustment Type Code (DOSING_ADJ_TYPE_CD) found in step 1,
complete the following:

a. If the DOSING_ADJ_TYPE_CD equals 1 and

Dosing ranges all equal 0, present the DRCM Renal Adjustment Footnote Text (
REN_FOOTNOTE) to the user so they can screen the order manually based on the
information presented in the footnote.
Dosing ranges do not all equal 0, proceed with renal dosage screening (beginning with step
3) and then present the DRCM Renal Adjustment Footnote Text (REN_FOOTNOTE) to the
user.

b. If the DOSING_ADJ_TYPE_CD equals 2, alert the user that the drug is not recommended for
patients with the specified level of organ function (sample message 16, page 636) and skip the
remainder of this application.

c. If the DOSING_ADJ_TYPE_CD equals 3, 4, 5, 8, or 10, continue renal dosage screening.

d. If the DOSING_ADJ_TYPE_CD equals 9, use the information from step 1 to retrieve the Renal
Monograph ID (REN_MONO_ID) and present an adjustment monograph to the user so they can

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d.

screen the order manually based upon the information in the monograph. Skip the remainder of this
application. See Accessing a Renal Adjustment Monograph for more information regarding how to
display a renal adjustment monograph.

In this example, the DOSING_ADJ_TYPE_CD equals 1 (See Footnote) and dosing ranges all equal
0. The system presents the REN_FOOTNOTE to the user so they can screen the order manually.

ExampleDRCM Dosing Adjustment Type Code (DOSING_ADJ_TYPE_CD) Equals 2 (Administration is Not

Recommended at This Level of Organ Dysfunction)

A patient has a prescription for a maintenance dose (DR2_DOSTPI 02) of hydrochlorothiazide (Clinical
Formulation ID [GCN_SEQNO] 028915) 12.5 mg oral (DR2_RT 064) once per day for 14 days. The reason for
use is not available. The patient is 48 years old (17,520 days) and has a creatinine clearance level of 8 mL/min.
See the Generating DRCM Warning Messages application for more information on the sample message referred
to in this example.

1. Retrieve the DRCM Dosing Adjustment Type Code (DOSING_ADJ_TYPE_CD) from the DRCM Renal
Master Table (RDRCRM0_RENAL_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Renal Low Age in Days (REN_LOAGED) column is less than or equal to the patient age in
days, and

e. DRCM Renal High Age in Days (REN_HIAGED) column is greater than or equal to the patient age
in days, and

f. DRCM Renal Low Creatinine Clearance mL/min (REN_LOCRCL) column is less than or equal to
the patient creatinine clearance value in mL/min, and

g. DRCM Renal High Creatinine Clearance mL/min (REN_HICRCL) column is greater than or equal to
the patient creatinine clearance value in mL/min, and

h. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record)
In this example, the retrieved DOSING_ADJ_TYPE_CD equals 2.

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GCN_SEQNO 028915

DR2_RT 064

DR2_DOSTPI 02

REN_LOAGED 6570

REN_HIAGED 23724

REN_LOCRCL 0

REN_HICRCL 10

DXID 4892

DOSING_ADJ_TYPE_CD 2

2. Depending upon the DRCM Dosing Adjustment Type Code (DOSING_ADJ_TYPE_CD) found in step 1,
complete the following:

a. If the DOSING_ADJ_TYPE_CD equals 1 and

Dosing ranges all equal 0, present the DRCM Renal Adjustment Footnote Text (
REN_FOOTNOTE) to the user so they can screen the order manually based on the
information presented in the footnote.
Dosing ranges do not all equal 0, proceed with renal dosage screening (beginning with step
3) and then present the DRCM Renal Adjustment Footnote Text (REN_FOOTNOTE) to the
user.

b. If the DOSING_ADJ_TYPE_CD equals 2, alert the user that the drug is not recommended for
patients with the specified level of organ function (sample message 16, page 636) and skip the
remainder of this application.

c. If the DOSING_ADJ_TYPE_CD equals 3, 4, 5, 8, or 10, continue renal dosage screening.

d. If the DOSING_ADJ_TYPE_CD equals 9, use the information from step 1 to retrieve the Renal
Monograph ID (REN_MONO_ID) and present an adjustment monograph to the user so they can
screen the order manually based upon the information in the monograph. Skip the remainder of this
application. See Accessing a Renal Adjustment Monograph for more information regarding how to
display a renal adjustment monograph.

In this example, the DOSING_ADJ_TYPE_CD equals 2 (Administration is not recommended in this

level of organ dysfunction). The system alerts the user that the drug is not recommended for
patients with the specified level of organ function (sample message 16) and screening stops.

ExampleDRCM Dosing Adjustment Type Code (DOSING_ADJ_TYPE_CD) Equals 3 (Adjust Dose Using Multiplier)

A patient has a prescription for a maintenance dose (DR2_DOSTPI 02) of topiramate (Clinical Formulation ID
[GCN_SEQNO] 040902) 25 mg oral (DR2_RT 064) 2 times per day for 30 days. The reason for use is not
available. The patient is 19 years old (6,935 days) and has a creatinine clearance level of 50 mL/min. The

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organization has also selected a global preferred DRCM Dosing Adjustment Type Code
(DOSING_ADJ_TYPE_CD, page 1483) value of 3 (Adjust dose using multiplier).

See the Generating DRCM Warning Messages application for more information on the sample messages referred
to in this example.

1. Retrieve the DRCM Dosing Adjustment Type Code (DOSING_ADJ_TYPE_CD) from the DRCM Renal
Master Table (RDRCRM0_RENAL_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Renal Low Age in Days (REN_LOAGED) column is less than or equal to the patient age in
days, and

e. DRCM Renal High Age in Days (REN_HIAGED) column is greater than or equal to the patient age
in days, and

f. DRCM Renal Low Creatinine Clearance mL/min (REN_LOCRCL) column is less than or equal to
the patient creatinine clearance value in mL/min, and

g. DRCM Renal High Creatinine Clearance mL/min (REN_HICRCL) column is greater than or equal to
the patient creatinine clearance value in mL/min, and

h. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record)

2. If preferences have been set for a preferred global adjustment type or a preferred adjustment type specific
to a given drug, filter the dosage range checking values from step 1 where the DRCM Dosing Adjustment
Type Code (DOSING_ADJ_TYPE_CD) matches a preferred DRCM Dosing Adjustment Type Code
selection.
In this example, two DOSING_ADJ_TYPE_CD values are present, both 3 (Adjust dose using multiplier)
and 10 (Default). Per the organization's selected DOSING_ADJ_TYPE_CD preference, only the
DOSING_ADJ_TYPE_CD value 3 proceeds to step 3.

3. Depending upon the DRCM Dosing Adjustment Type Code (DOSING_ADJ_TYPE_CD) found in step 1,
complete the following:

a. If the DOSING_ADJ_TYPE_CD equals 1 and

Dosing ranges all equal 0, present the DRCM Renal Adjustment Footnote Text (
REN_FOOTNOTE) to the user so they can screen the order manually based on the
information presented in the footnote.

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Dosing ranges do not all equal 0, proceed with renal dosage screening (beginning with step
3) and then present the DRCM Renal Adjustment Footnote Text (REN_FOOTNOTE) to the
user.

b. If the DOSING_ADJ_TYPE_CD equals 2, alert the user that the drug is not recommended for
patients with the specified level of organ function (sample message 16) and skip the remainder of
this application.

c. If the DOSING_ADJ_TYPE_CD equals 3, 4, 5, 8, or 10, continue renal dosage screening.

d. If the DOSING_ADJ_TYPE_CD equals 9, use the information from step 1 to retrieve the Renal
Monograph ID (REN_MONO_ID) and present an adjustment monograph to the user so they can
screen the order manually based upon the information in the monograph. Skip the remainder of this
application. See Accessing a Renal Adjustment Monograph, page 594 for more information
regarding how to display a renal adjustment monograph.
In this example, the DOSING_ADJ_TYPE_CD equals 3 (Adjust Dose Using Multiplier) and 10
(Default). The system continues renal dosage screening with step 4.

GCN_SEQNO 040902 040902

DR2_RT 064 064

DR2_DOSTPI 02 02

REN_LOAGED 6570 6570

REN_HIAGED 40150 40150

REN_LOCRCL 10 10

REN_HICRCL 89 89

DXID 4892 4892

DOSING_ADJ_TYPE_CD 3 10

4. Compare the prescribed frequency of administration per day to DRCM Renally Adjusted Low Frequency of
Administration (REN_LOFREQ) and DRCM Renally Adjusted High Frequency of Administration (
REN_HIFREQ):

a. If the prescribed frequency is equal to either the REN_LOFREQ or REN_HIFREQ, or within the
value range, the order is acceptable and does not produce an alert.
Continue to step 5.

b. If the prescribed frequency is less than the REN_LOFREQ, alert the user that the prescribed
frequency is less than the recommended minimum frequency for the drug (sample message 8).

c. If the prescribed frequency is greater than the REN_HIFREQ, alert the user that the prescribed
frequency exceeds the recommended maximum frequency for the drug (sample message 9).

REN_LOFREQ REN_HIFREQ Prescribed Frequency

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1 2 2 per day

In this example, the prescribed frequency is equal to the REN_HIFREQ value of 2 per day. The
system passes the order and continues renal dosage screening.

5. Compare the prescribed daily dose (convert units if necessary) to DRCM Renally Adjusted Low Dose per
Day (REN_LODOSD) and DRCM Renally Adjusted High Dose per Day (REN_HIDOSD):

a. If the prescribed daily dose is equal to either the REN_LODOSD or REN_HIDOSD, or within the
value range, the order is acceptable and does not produce an alert.
Skip to step 7.

b. If the prescribed daily dose is less than the REN_LODOSD, alert the user that the prescribed dose
is less than the recommended low daily dose for the drug (sample message 1). Skip to step 7.

c. If the prescribed daily dose is greater than the REN_HIDOSD, continue to step 6.

The DRCM Dose Units Code Description (UNITS_DESC) column is from the DRCM Unit
Description Table (RDRCUND0_UNITS_DESC).

REN_LODOSD 12.5

REN_LODOSU 01

UNITS_DESC MG/DAY

REN_HIDOSD 800

REN_HIDOSU 01

UNITS_DESC MG/DAY

Prescribed dose per day 50 mg/day

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the UNITS_DESC column.

DOSING_MODULE_UNIT_ABB UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

REV

MG/DAY mg/day milligram per day

In this example, 25 mg are prescribed 2 times per day. Therefore, the dose per day is 25 X 2 = 50
mg/day. The prescribed daily dose of 50 mg/day is within the REN_LODOSD and REN_HIDOSD
value range of 12.5 mg/day to 800 mg/day. The system passes the order and continues renal
dosage screening.

6. Compare the prescribed single dose (convert units if necessary) to DRCM Renally Adjusted Maximum
Amount per Single Dose (REN_MX1DOS) and the Renally Adjusted Not-to-Exceed Amount Per Single
Dose (REN_NTE_SINGLE_DOSE):

a.

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a. If the prescribed single dose is equal to or less than the REN_MX1DOS and
REN_NTE_SINGLE_DOSE, the order is acceptable and does not produce an alert. If the DRCM
Renal Adjustment Footnote Text (REN_FOOTNOTE) is available, present it to the user.

b. If the prescribed single dose is greater than either the REN_MX1DOS and/or
REN_NTE_SINGLE_DOSE, alert the user that the prescribed dose exceeds the recommended
maximum single dose for the drug (sample message 4a, 4b, and 4c).

REN_MX1DOS REN_MX1DSU REN_NTE_SINGLE_DOSE Prescribed Single

REN_NTE_SINGLE_DOSE_UNIT_CODE
Dose

400 28 400 28 25 mg

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the UNITS_DESC column.

DOSING_MODULE_UNIT_ABB UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

REV

MG mg milligram

In this example, the prescribed dose of 25 mg is less than the REN_MX1DOS and
REN_NTE_SINGLE_DOSE values of 400 mg. No REN_FOOTNOTE is available, so the system
passes the order successfully.

ExampleDRCM Dosing Adjustment Type Code (DOSING_ADJ_TYPE_CD) Equals 8 (No Adjustment Necessary)

A patient has a prescription for a maintenance dose (DR2_DOSTPI 02) of ciprofloxacin Hcl (Clinical Formulation
ID [GCN_SEQNO] 059169) 500 mg oral (DR2_RT 064) once per day for 7 days. The reason for use is not
available. The patient is 69 years old (25,185 days) and has a creatinine clearance level of 35 mL/min.

See the Generating DRCM Warning Messages application for more information on the sample messages referred
to in this example.

1. Retrieve the DRCM Dosing Adjustment Type Code (DOSING_ADJ_TYPE_CD) from the DRCM Renal
Master Table (RDRCRM0_RENAL_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Renal Low Age in Days (REN_LOAGED) column is less than or equal to the patient age in
days, and

e. DRCM Renal High Age in Days (REN_HIAGED) column is greater than or equal to the patient age

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e.

in days, and

f. DRCM Renal Low Creatinine Clearance mL/min (REN_LOCRCL) column is less than or equal to
the patient creatinine clearance value in mL/min, and

g. DRCM Renal High Creatinine Clearance mL/min (REN_HICRCL) column is greater than or equal to
the patient creatinine clearance value in mL/min, and

h. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record)
In this example, the retrieved DOSING_ADJ_TYPE_CD equals 8.

GCN_SEQNO 059169

DR2_RT 064

DR2_DOSTPI 02

REN_LOAGED 6570

REN_HIAGED 40150

REN_LOCRCL 31

REN_HICRCL 50

DXID 4892

DOSING_ADJ_TYPE_CD 8

2. If preferences have been set for a preferred global adjustment type or a preferred adjustment type specific
to a given drug, filter the dosage range checking values from Step 1 where the DRCM Dosing Adjustment
Type Code (DOSING_ADJ_TYPE_CD) matches a preferred DRCM Dosing Adjustment Type Code
selection.

3. Depending upon the DRCM Dosing Adjustment Type Code (DOSING_ADJ_TYPE_CD) found in step 1,
complete the following:

a. If the DOSING_ADJ_TYPE_CD equals 1 and

Dosing ranges all equal 0, present the DRCM Renal Adjustment Footnote Text (
REN_FOOTNOTE) to the user so they can screen the order manually based on the
information presented in the footnote.
Dosing ranges do not all equal 0, proceed with renal dosage screening (beginning with step
3) and then present the DRCM Renal Adjustment Footnote Text (REN_FOOTNOTE) to the
user.

b. If the DOSING_ADJ_TYPE_CD equals 2, alert the user that the drug is not recommended for
patients with the specified level of organ function (sample message 16, page 636) and skip the
remainder of this application.

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If the DOSING_ADJ_TYPE_CD equals 3, 4, 5, 8, or 10, continue renal dosage screening.

If the DOSING_ADJ_TYPE_CD equals 9, use the information from step 1 to retrieve the Renal
Monograph ID (REN_MONO_ID) and present an adjustment monograph to the user so they can
screen the order manually based upon the information in the monograph. Skip the remainder of this
application. See Accessing a Renal Adjustment Monograph for more information regarding how to
display a renal adjustment monograph.

In this example, the DOSING_ADJ_TYPE_CD equals 8 (No adjustment necessary). The system
continues renal dosage screening to step 4.

4. Compare the prescribed frequency of administration per day to DRCM Renally Adjusted Low Frequency of
Administration (REN_LOFREQ) and DRCM Renally Adjusted High Frequency of Administration (
REN_HIFREQ):

a. If the prescribed frequency is equal to either the REN_LOFREQ or REN_HIFREQ, or within the
value range, the order is acceptable and does not produce an alert.
Continue to step 4.

b. If the prescribed frequency is less than the REN_LOFREQ, alert the user that the prescribed
frequency is less than the recommended minimum frequency for the drug (sample message 8).

c. If the prescribed frequency is greater than the REN_HIFREQ, alert the user that the prescribed
frequency exceeds the recommended maximum frequency for the drug (sample message 9).

REN_LOFREQ REN_HIFREQ Prescribed Frequency

1 1 1 per day

In this example, the prescribed frequency is equal to the REN_LOFREQ and REN_HIFREQ values
of 1 per day. The system passes the order and continues renal dosage screening.

5. Compare the prescribed daily dose (convert units if necessary) to DRCM Renally Adjusted Low Dose per
Day (REN_LODOSD) and DRCM Renally Adjusted High Dose per Day (REN_HIDOSD):

a. If the prescribed daily dose is equal to either the REN_LODOSD or REN_HIDOSD, or within the
value range, the order is acceptable and does not produce an alert.
Skip to step 7.

b. If the prescribed daily dose is less than the REN_LODOSD, alert the user that the prescribed dose
is less than the recommended low daily dose for the drug (sample message 1). Skip to step 7.

c. If the prescribed daily dose is greater than the REN_HIDOSD, continue to step 6.

The DRCM Dose Units Code Description (UNITS_DESC) column is from the DRCM Unit
Description Table (RDRCUND0_UNITS_DESC).

REN_LODOSD 500

REN_LODOSU 01

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UNITS_DESC MG/DAY

REN_HIDOSD 1000

REN_HIDOSU 01

UNITS_DESC MG/DAY

Prescribed dose per day 500 mg per day

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the UNITS_DESC column.

DOSING_MODULE_UNIT_ABB UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

REV

MG/DAY mg/day milligram per day

In this example, 500 mg are prescribed 1 time per day. Therefore, the dose per day is 500 X 1 =
500 mg/day. The prescribed daily dose of 500 mg/day is equal to the REN_LODOSD value range of
500 mg/day. The system passes the order and continues renal dosage screening.

6. Compare the prescribed single dose (convert units if necessary) to DRCM Renally Adjusted Maximum
Amount per Single Dose (REN_MX1DOS) and the Renally Adjusted Not-to-Exceed Amount Per Single
Dose (REN_NTE_SINGLE_DOSE):

a. If the prescribed single dose is equal to or less than the REN_MX1DOS and
REN_NTE_SINGLE_DOSE, the order is acceptable and does not produce an alert. If the DRCM
Renal Adjustment Footnote Text (REN_FOOTNOTE) is available, present it to the user.

b. If the prescribed single dose is greater than either the REN_MX1DOS and/or
REN_NTE_SINGLE_DOSE, alert the user that the prescribed dose exceeds the recommended
maximum single dose for the drug (sample message 4a, 4b, and 4c).

REN_MX1DOS REN_MX1DSU REN_NTE_SINGLE_DOSE Prescribed Single

REN_NTE_SINGLE_DOSE_UNIT_CODE
Dose

1000 28 1000 28 500 mg

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the UNITS_DESC column.

DOSING_MODULE_UNIT_ABB UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

REV

MG mg milligram

In this example, the prescribed dose of 500 mg is less than the REN_MX1DOS and
REN_NTE_SINGLE_DOSE values of 1000 mg. No REN_FOOTNOTE is available, so the system
passes the order successfully.

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ExampleDRCM Dosing Adjustment Type Code (DOSING_ADJ_TYPE_CD) Equals 9 (See Monograph)

A patient with renal dysfunction has a prescription for a maintenance dose (DR2_DOSTPI 02) of amoxicillin
(Clinical Formulation ID [GCN_SEQNO] 008995) 250 mg oral (DR2_RT 064) 3 times per day for 10 days. The
patient is 58 years old (21,170 days) and has a creatinine clearance level of 50 mL/min. The patients condition is
not available (DXID 00004892).

1. Retrieve the DRCM Dosing Adjustment Type Code (DOSING_ADJ_TYPE_CD) from the DRCM Renal
Master Table (RDRCRM0_RENAL_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Renal Low Age in Days (REN_LOAGED) column is less than or equal to the patient age in
days, and

e. DRCM Renal High Age in Days (REN_HIAGED) column is greater than or equal to the patient age
in days, and

f. DRCM Renal Low Creatinine Clearance mL/min (REN_LOCRCL) column is less than or equal to
the patient creatinine clearance value in mL/min, and

g. DRCM Renal High Creatinine Clearance mL/min (REN_HICRCL) column is greater than or equal to
the patient creatinine clearance value in mL/min, and

h. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record)
In this example, the retrieved DOSING_ADJ_TYPE_CD equals 9.

GCN_SEQNO 008995

DR2_RT 064

DR2_DOSTPI 02

REN_LOAGED 6570

REN_HIAGED 40150

REN_LOCRCL 0

REN_HICRCL 50

DXID 4892

DOSING_ADJ_TYPE_CD 9

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2. If preferences have been set for a preferred global adjustment type or a preferred adjustment type specific
to a given drug, filter the dosage range checking values from step 1 where the DRCM Dosing Adjustment
Type Code (DOSING_ADJ_TYPE_CD) matches a preferred DRCM Dosing Adjustment Type Code
selection.

3. Depending upon the DRCM Dosing Adjustment Type Code (DOSING_ADJ_TYPE_CD) found in step 1,
complete the following:

a. If the DOSING_ADJ_TYPE_CD equals 1 and

Dosing ranges all equal 0, present the DRCM Renal Adjustment Footnote Text (
REN_FOOTNOTE) to the user so they can screen the order manually based on the
information presented in the footnote.
Dosing ranges do not all equal 0, proceed with renal dosage screening (beginning with step
3) and then present the DRCM Renal Adjustment Footnote Text (REN_FOOTNOTE) to the
user.

b. If the DOSING_ADJ_TYPE_CD equals 2, alert the user that the drug is not recommended for
patients with the specified level of organ function (sample message 16, page 636) and skip the
remainder of this application.

c. If the DOSING_ADJ_TYPE_CD equals 3, 4, 5, 8, or 10, continue renal dosage screening.

d. If the DOSING_ADJ_TYPE_CD equals 9, use the information from step 1 to retrieve the Renal
Monograph ID (REN_MONO_ID) from the DRCM Renal Master Table (RDRCRM0_RENAL_MSTR)
and present an adjustment monograph to the user so they can screen the order manually based
upon the information in the monograph. Skip the remainder of this application. See Accessing a
Renal Adjustment Monograph, page 594 for more information regarding how to display a renal
adjustment monograph.

In this example, the DOSING_ADJ_TYPE_CD equals 9 (See monograph). The system uses the
patients information from step 1 to retrieve the REN_MONO_ID from the
RDRDRM0_RENAL_MSTR Table and presents an adjustment monograph to the user for manual
screening of the order. In this example, the REN_MONO_ID 2310 is retrieved.

See Accessing a Renal Adjustment Monograph for the continuation of this example.

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Accessing a Renal Adjustment Monograph

Adjustment monographs consist of the following sections:

Opening Statement
The purpose of this monograph section is to clarify the use and application of the dosing
information.
Excretion Profile
The excretion profile section of the monograph indicates the significance of renal/hepatic excretion
of the active drug.
Renal monographs contain the following Excretion Profile subsections:
Percent Excreted Unchanged by Kidney
Clearance
Half-Life
Normal Renal Function
End Stage Renal Disease
Hepatic monographs contain the following Excretion Profile subsections:
% Hepatic (Biliary/Fecal) Excretion
Metabolites
Clearance (Normal Hepatic function and Hepatic impairment)
Half-life (Normal Hepatic function and Hepatic impairment)
Volume of Distribution
This section provides information on the distribution of the drug in normal patients, as well as
patients with renal/hepatic impairment.
Protein Binding
The protein binding section provides information on the drug and active metabolites in normal
patients and those with renal/hepatic impairment.
Dosing Adjustment in Organ Dysfunction
This section contains options on how to adjust the dose in renal/hepatic impairment based
upon the severity of the disease.
Supplemental Dosing for Dialysis (renal only)
This section provides options on dosing the drug for patients on different forms of dialysis.
Renal Monographs contain the following Supplemental Dosing for Dialysis subsections:
HEMO
CAPD
CAVH
Comments
This section further explains the dosing adjustment suggestions, so that the prescriber can
better interpret the options being presented in the monograph.

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You can find the DRCM Renal Monograph ID (REN_MONO_ID) as part of the adjustment record in the DRCM
Renal Master Table (RDRCRM0_RENAL_MSTR). See Performing Dosage Range Checking for a Patient with
Renal Impairment for more information.

Perform the following steps to present an adjustment monograph to a user:

1. Retrieve the following from the DRCM Renal Adjustment Monograph Line Table
(RDRCRL0_RENAL_MONO_LINE) where the DRCM Renal Monograph ID (REN_MONO_ID) value
equals the REN_MONO_ID found in the results from the renally adjusted dosage range checking:
DRCM Renal Monograph Line Number (REN_MONO_LINE_NUMBER)
DRCM Renal Monograph Section Code (REN_MONO_SECTION_CD)
DRCM Renal Monograph Format Code (REN_MONO_FORMAT_CD)
DRCM Renal Monograph Line Text (REN_MONO_LINE_TEXT)

2. Display the content of the DRCM Renal Monograph Line Text (REN_MONO_LINE_TEXT) column and sort
the record using the DRCM Renal Monograph Line Number (REN_MONO_LINE_NUMBER) column.
Use the content of the DRCM Renal Monograph Format Code (REN_MONO_FORMAT_CD) to
determine whether each line should continue from the previous line or start a new line.
If the REN_MONO_FORMAT = 1, treat the text in REN_MONO_LINE_TEXT as a new line in your
presentation of the monograph. Add this text below the previous line.
If the REN_MONO_FORMAT = 2, append the text in REN_MONO_LINE_TEXT directly to the
previous line text.

Any leading spaces in the REN_MONO_LINE_TEXT are intentional and should be

maintained when presenting monographs. Customers using a fixed-width file will need to
trim any trailing spaces in REN_MONO_LINE_TEXT.

a. You can use the DRCM Renal Monograph Section Code (REN_MONO_SECTION_CD) to group
the lines into sections. You might choose to exclude some sections of the monograph, depending
on your business needs.

For best viewing results use a fixed width font with a minimum display width of at least 80
characters.

If the REN_MONO_LINE_TEXT contains empty spaces in a fixed-width file or no value in a

variable-width file, display a blank line in the monograph for readability.

ExampleAccessing a Renal Adjustment Monograph

A patient with renal dysfunction has a prescription for a maintenance dose (DR2_DOSTPI 02) of amoxicillin
(Clinical Formulation ID [GCN_SEQNO] 008995) 250 mg oral (DR2_RT 064) 3 times per day for 10 days. The

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patient is 58 years old (21,170 days) and has a creatinine clearance level of 50 mL/min. The patients condition is
not available (DXID 00004892). A DRCM Renal Monograph ID (REN_MONO_ID) value of 2310 was retrieved
from the dosage adjustment record.

This example uses information retrieved from the example DRCM Dosing Adjustment Type Code
(DOSING_ADJ_TYPE_CD) Equals 9 (See Monograph), page 590.

1. Retrieve the following from the DRCM Renal Adjustment Monograph Line Table
(RDRCRL0_RENAL_MONO_LINE) where the DRCM Renal Monograph ID (REN_MONO_ID) value
equals the REN_MONO_ID found in the results from the renally adjusted dosage range checking:
DRCM Renal Monograph Line Number (REN_MONO_LINE_NUMBER)
DRCM Renal Monograph Section Code (REN_MONO_SECTION_CD)
DRCM Renal Monograph Format Code (REN_MONO_FORMAT_CD)
DRCM Renal Monograph Line Text (REN_MONO_LINE_TEXT)

REN_MONO_ID REN_MONO_LINE_NUMBER
REN_MONO_SECTION_CD REN_MONO_LIN
REN_MONO_FORMAT_CD
E_TEXT

2310 1 19 1 Amoxicillin Dosing

in Renal Dysfunctio

2310 2 20 1 This monograph

information pertains
only to the
immediate-release
products: 250 mg,
500 mg, and 875
mg oral
tablets/capsules, all
chewable tablets,
and all oral
suspensions.

2310 3 12 1 Percent Excreted

Unchanged by
Kidney: 50-75%

2310 4 12 1

2310 5 12 1 Half-life

2310 6 12 1 Normal Renal

Function: adults =
0.7-2.3 h

2310 7 12 1 infants and children

= 1-2 h

2310 8 12 1

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2310 9 12 1 Renal Dysfunction

(CrCl 10-30
ml/min): adults =
4.5 h

2310 10 12 1 End Stage Renal

Disease (CrCl <10
ml/min): 12.6 h
(range = 5-21 h)

2310 11 12 1 Normal Renal

Function:
0.26-0.36 L/kg

2310 12 13 1 Renal Dysfunction:

no data

2310 13 13 1 Normal Renal

Function: 15-25%

2310 14 14 1 Renal Dysfunction:

no data

2310 15 15 1 Initial and

Maintenance Dose:
ALL
IMMEDIATE-RELE
ASE DOSAGE
FORMS <=500 mg
PER DOSAGE
UNIT (250 mg, 500
mg tabs/caps, all
chewable tabs, all
oral
suspensions)/infant
s and children (30
days-12 yr)

2310 16 15 1 GFR

2310 17 15 1 (ml/min)

2310 18 15 1 Normal >50 20-50

<20

... ... ... ... ...

2. Display the content of the DRCM Renal Monograph Line Text (REN_MONO_LINE_TEXT) column and sort
the record using the DRCM Renal Monograph Line Number (REN_MONO_LINE_NUMBER) column.
Use the content of the DRCM Renal Monograph Format Code (REN_MONO_FORMAT_CD) to
determine whether each line should continue from the previous line or start a new line.
If the REN_MONO_FORMAT = 1, treat the text in REN_MONO_LINE_TEXT as a new line in your
presentation of the monograph. Add this text below the previous line.
If the REN_MONO_FORMAT = 2, append the text in REN_MONO_LINE_TEXT directly to the

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previous line text.

Any leading spaces in the REN_MONO_LINE_TEXT are intentional and should be

maintained when presenting monographs. Customers using a fixed-width file will need to
trim any trailing spaces in REN_MONO_LINE_TEXT.

You can use the DRCM Renal Monograph Section Code (REN_MONO_SECTION_CD) to group
the lines into sections. You might choose to exclude some sections of the monograph, depending
on your business needs.

For best viewing results use a fixed width font with a minimum display width of at least 80
characters.

If the REN_MONO_LINE_TEXT contains empty spaces in a fixed-width file or no value in a

variable-width file, display a blank line in the monograph for readability.

The following example provides a sample display of the monograph text.

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Customer-Compiled Warning Messages

The section provides examples of text message alerts that are displayed that explain why clinical screening
information may not appear in dosing records due to age gaps. These customer-compiled alerts include
precaution severity levels, the age range exclusion reason, and the next dosing record text information.

ExampleSevere Precaution and Pediatric Gap

ExampleGeriatric Gap
ExampleContraindicated
ExampleGestational Age at Birth Gap and Current Weight Gap
ExampleMedication with Renal Screening and Age Gaps
ExampleMedication with Overlapping Precautions
ExampleWhen Only Child and Adolescent Dosage Checking Values Are Present
ExampleChild Age Range Exclusion Only

ExampleSevere Precaution and Pediatric Gap

A physician is screening a 1-day-old patient for the administration of potassium acetate 1 meq/kg/day (Clinical
Formulation ID [GCN_SEQNO] 1241) intravenous(DR2_RT 052) for a maintenance dose (DR2_DOSTPI 02).

1. Select records from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in days,
and

e. DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in days,
and

f. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record).
In this example, no corresponding dosing records are returned for the given criteria.

2. If no matching record is returned in the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR),
check the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS) for the Clinical Formulation ID (
GCN_SEQNO) value of the prescribed medication.
In this example, no corresponding records are returned.

3. If no matching record is returned in the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS), retrieve

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3.

records from the DRCM Age Exclusion Table (RDRCAR0_EXCLUSION_REASON) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID value of the
prescribed medication and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Exclusion Low Age in Days (EXCLUSION_LOAGED) column is less than or equal to the
patient age in days, and

e. DRCM Exclusion High Age in Days (EXCLUSION_HIAGED) column is greater than or equal to the
patient age in days, and

f. First Databank Disease Code (FDBDX) column equals the FDBDX of the patient condition to be
treated with this prescription. If the patient condition is not available or if a reason for use record for
a given age range is not available, the FDBDX equals 999 (default screening record).

GCN_SEQNO 1241

DR2_RT 052

DR2_DOSTPI 02

EXCLUSION_LOAGED 0

EXCLUSION_HIAGED 2

FDBDX 999

In this example, a corresponding DRCM Age Exclusion record is found for DRCM Exclusion Low
Age in Days (EXCLUSION_LOAGED) equal to 0 and DRCM Exclusion High Age in Days (
EXCLUSION_HIAGED) equal to 2.

4. Select the corresponding values in the DRCM Exclusion Reason Table

(RDRCAR0_EXCLUSION_REASON) and DRCM Severity Level Description Table
(RDRCSD0_SEVER_LEVEL_DESC) where the:

a. Exclusion Reason Code (EXCLUSION_REASON_CD) column from the DRCM Age Exclusion Table
(RDRCAE0_AGE_EXCLUSION) is equal to the Exclusion Reason Code (
EXCLUSION_REASON_CD) column in the DRCM Exclusion Reason Table
(RDRCAR0_EXCLUSION_REASON).

b. Severity Level Code (DR2_SL) column from the DRCM Age Exclusion Table
(RDRCAE0_AGE_EXCLUSION) table is equal to the Severity Level Code (DR2_SL) column in the
DRCM Severity Level Description Table (RDRCSD0_SEVER_LEVEL_DESC).

5. The system produces an alert stating any precaution severity level, age range exclusion reason, and the

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5.

next dosing record text information.

Possible Warning Scenario Sample Display Message

Medication is Contraindicated <DrugDescription> is contraindicated for this patient.

[EXCLUSION_REASON_TEXT_SHORT]
[NEXT_SCREENING_DOSE_TEXT]

Medication has a Severe Precaution <DrugDescription> has a severe precaution for this
patient. [EXCLUSION_REASON_TEXT_SHORT]
[NEXT_SCREENING_DOSE_TEXT]

Medication has a Management or Monitoring Precaution <DrugDescription> has a management or monitoring

precaution for this patient.
[EXCLUSION_REASON_TEXT_SHORT]
[NEXT_SCREENING_DOSE_TEXT]

In this example, the following alert will be produced as the medication has a severe precaution and uses
the GNN60 for the drug description:

Potassium acetate has a severe precaution for this patient. Administration of potassium to newborn
infants must be done with extreme caution until their renal function has been determined. The next
available dosing age range is for 3 days to 13 years of age. Low dose per day is 0.5 mEq/kg/day. High
dose per day is 3 mEq/kg/day. Max dose per day is 5 mEq/kg/day. Max single dose is 1 mEq/kg. Not to
exceed single dose is 40 mEq.

ExampleGeriatric Gap

A physician is screening a 70-year-old patient for the administration of desogestrel-ethinyl estradiol (Clinical
Formulation ID [GCN_SEQNO, page 1569] 17616) orally (DR2_RT 064) for a maintenance dose (DR2_DOSTPI
02).

1. Select records from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID value of the
prescribed medication and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in days,
and

e. DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in days,
and

f. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record).

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f.

In this example, no corresponding dosing records are returned for the given criteria.

2. If no matching record is returned in the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR),
check the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS) for the Clinical Formulation ID (
GCN_SEQNO) value of the prescribed medication.
In this example, no corresponding records are returned.

3. If no matching record is returned in the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS), retrieve

records from the DRCM Age Exclusion Table (RDRCAE0_AGE_EXCLUSION) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID value of the
prescribed medication and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Exclusion Low Age in Days (EXCLUSION_LOAGED) column is less than or equal to the
patient age in days, and

e. DRCM Exclusion High Age in Days (EXCLUSION_HIAGED) column is greater than or equal to the
patient age in days, and

f. First Databank Disease Code (FDBDX) column equals the FDBDX of the patient condition to be
treated with this prescription. If the patient condition is not available or if a reason for use record for
a given age range is not available, the FDBDX equals 999 (default screening record).

GCN_SEQNO 17616

DR2_RT 064

DR2_DOSTPI 02

EXCLUSION_LOAGED 23725

EXCLUSION_HIAGED 40150

FDBDX 999

In this example, the DRCM Age Exclusion record for the DRCM Exclusion Low Age in Days (
EXCLUSION_LOAGED) is 23725 and DRCM Exclusion High Age in Days (EXCLUSION_HIAGED)
is 40150.

4. Select the corresponding values from the DRCM Exclusion Reason Table
(RDRCAR0_EXCLUSION_REASON) and DRCM Severity Level Description Table
(RDRCSD0_SEVER_LEVEL_DESC) where the:

a. Exclusion Reason Code (EXCLUSION_REASON_CD) column from the DRCM Age Exclusion Table

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a.
(RDRCAE0_AGE_EXCLUSION) is equal to the Exclusion Reason Code (
EXCLUSION_REASON_CD) column in the DRCM Exclusion Reason Table
(RDRCAR0_EXCLUSION_REASON)

b. Severity Level Code (DR2_SL) column from the DRCM Age Exclusion Table
(RDRCAE0_AGE_EXCLUSION) table is equal to the Severity Level Code (DR2_SL) column in the
DRCM Severity Level Description Table (RDRCSD0_SEVER_LEVEL_DESC).

5. The system produces an alert that includes precaution severity levels, the age range exclusion reason, and
the next dosing record text information.

Possible Warning Scenario Sample Display Message

Medication is Contraindicated <DrugDescription> is contraindicated for this patient.

[EXCLUSION_REASON_TEXT_SHORT]
[NEXT_SCREENING_DOSE_TEXT]

Medication has a Severe Precaution <DrugDescription> has a severe precaution for this
patient. [EXCLUSION_REASON_TEXT_SHORT]
[NEXT_SCREENING_DOSE_TEXT]

Medication has a Management or Monitoring Precaution <DrugDescription> has a management or monitoring

precaution for this patient.
[EXCLUSION_REASON_TEXT_SHORT]
[NEXT_SCREENING_DOSE_TEXT]

In this example, the following alert will be produced as the medication has a management or monitoring
precaution and uses the GNN60 for the drug description:

Desogestrel-ethinyl estradiol has a management or monitoring precaution for this patient. This drug's
indications for use do not normally occur in geriatric and/or post menopausal patients. The next available
dosing age range is for 18 years to 65 years of age. Low dose per day is 1 tab-cap/day. High dose per day
is 1 tab-cap/day. Max dose per day is 1 tab-cap/day. Max single dose is 1 tab-cap. Not to exceed single
dose is 1 tab-cap.

ExampleContraindicated

A physician is screening a 1-year-old patient for the administration of democycline HCL (Clinical Formulation ID [
GCN_SEQNO] 9213) orally (DR2_RT 064) for a maintenance dose (DR2_DOSTPI 02).

1. Select records from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in days,

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d.
and

e. DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in days,
and

f. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record).
In this example, no corresponding dosing records are returned for the given criteria.

2. If no matching record is returned in the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR),
check the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS) for the Clinical Formulation ID (
GCN_SEQNO) value of the prescribed medication.
In this example, no corresponding records are returned.

3. If no matching record is returned in the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS) table, retrieve
records from the DRCM Age Exclusion Table (RDRCAE0_AGE_EXCLUSION) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Exclusion Low Age in Days (EXCLUSION_LOAGED) column is less than or equal to the
patient age in days, and

e. DRCM Exclusion High Age in Days (EXCLUSION_HIAGED) column is greater than or equal to the
patient age in days, and

f. First Databank Disease Code (FDBDX) column equals the FDBDX of the patient condition to be
treated with this prescription. If the patient condition is not available or if a reason for use record for
a given age range is not available, the FDBDX equals 999 (default screening record).

GCN_SEQNO 9213

DR2_RT 064

DR2_DOSTPI 02

EXCLUSION_LOAGED 0

EXCLUSION_HIAGED 2919

FDBDX 999

In this example, the corresponding DRCM Exclusion Low Age in Days (EXCLUSION_LOAGED) is 0
and the DRCM Exclusion High Age in Days (EXCLUSION_HIAGED) is 2919.

4.

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4. Select the corresponding values in the DRCM Exclusion Reason Table

(RDRCAR0_EXCLUSION_REASON) and DRCM Severity Level Description Table
(RDRCSD0_SEVER_LEVEL_DESC, page 610) where the:

a. Exclusion Reason Code (EXCLUSION_REASON_CD) column from the DRCM Age Exclusion Table
(RDRCAE0_AGE_EXCLUSION) table is equal to the Exclusion Reason Code (
EXCLUSION_REASON_CD) in the DRCM Exclusion Reason Table
(RDRCAR0_EXCLUSION_REASON) Table

The system produces an alert that includes precaution severity levels, age range exclusion reason,
and the next dosing record text information.

b. Severity Level Code (DR2_SL) column from the DRCM Age Exclusion Table
(RDRCAE0_AGE_EXCLUSION) is equal to the Severity Level Code (DR2_SL) column in the
DRCM Severity Level Description Table (RDRCSD0_SEVER_LEVEL_DESC).

5. The system produces an alert that includes precaution severity levels, age range exclusion reason, and the
next dosing record text information.

Possible Warning Scenario Sample Display Message

Medication is Contraindicated <DrugDescription> is contraindicated for this patient.

[EXCLUSION_REASON_TEXT_SHORT]
[NEXT_SCREENING_DOSE_TEXT]

Medication has a Severe Precaution <DrugDescription> has a severe precaution for this
patient. [EXCLUSION_REASON_TEXT_SHORT]
[NEXT_SCREENING_DOSE_TEXT]

Medication has a Management or Monitoring Precaution <DrugDescription> has a management or monitoring

precaution for this patient.
[EXCLUSION_REASON_TEXT_SHORT]
[NEXT_SCREENING_DOSE_TEXT]

In this example, the following alert will be produced as the medication has a contraindication and uses the
GNN60 for the drug description:

Democycline HCL is contraindicated for this patient. Due to potential toxicity, the drug is not normally used
in this aged patient. The next available dosing age range is for 8 years to 18 years of age. Low dose per
day is 6.6 mg/kg/day. High dose per day is 13.2 mg/kg/day. Max dose per day is 600 mg/day. Max single
dose is 6.6 mg/kg. Not to exceed single dose is 300 mg.

ExampleGestational Age at Birth Gap and Current Weight Gap

A physician is screening a 14-day-old with a gestational age at birth of 32 weeks and a current weight of 1500
grams for the administration of codeine phosphate (Clinical Formulation ID [ GCN_SEQNO] 4187) orally (DR2_RT
064) for a maintenance dose (DR2_DOSTPI 02).

1. Select records from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR, page 603) where
the:

a.

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1.

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in days,
and

e. DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in days,
and

f. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record).

2. Check the Weight Required Indicator (WEIGHT_REQ_IND):

a. If the Weight Required Indicator (WEIGHT_REQ_IND) equals 0, the current weight is not required to
select the screening record.

b. If the Weight Required Indicator (WEIGHT_REQ_IND) equals 1, the current weight is required to
select the screening record.

3. Filter the records returned in step 1 where the:

a. Low Current Weight in Grams (LOW_CURRENT_WEIGHT_GRAMS) is less than or equal to the

patients weight in grams, and

b. High Current Weight in Grams (HIGH_CURRENT_WEIGHT_GRAMS) is greater than or equal to

the patients weight in grams.

4. Check the Neonatal Gestational Birth Age Required Indicator (NEOM_GEST_BIRTH_AGE_REQ_IND) if

screening for a neonatal patient:

a. If the Neonatal Gestational Birth Age Required Indicator (NEOM_GEST_BIRTH_AGE_REQ_IND)

equals 0, the gestational age at birth is not required to select the screening record. Skip to step 6.

b. If the Neonatal Gestational Birth Age Required Indicator (NEOM_GEST_BIRTH_AGE_REQ_IND)

equals 1, the gestational age at birth is required to select the screening record.

5. Filter the records returned in step 1 where the:

a. Neonatal Low Gestational Age at Birth in Weeks (NEOM_LOW_GEST_BIRTH_AGE_WEEKS)

column is less than or equal to the patients gestational birth age in weeks, and

b. Neonatal High Gestational Age at Birth in Weeks (NEOM_HIGH_GEST_BIRTH_AGE_WEEKS)

column is greater than or equal to the patients gestational birth age.
In this example, no corresponding dosing records are returned for the given criteria.

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6. If no matching record is returned in the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR),
check the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS) for the Clinical Formulation ID (
GCN_SEQNO) value of the prescribed medication.
In this example, no corresponding records are returned.

7. If no matching record is returned in the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS), retrieve

records from the DRCM Age Exclusion Table (RDRCAE0_AGE_EXCLUSION) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Exclusion Low Age in Days (EXCLUSION_LOAGED) column is less than or equal to the
patient age in days, and

e. DRCM Exclusion High Age in Days (EXCLUSION_HIAGED) column is greater than or equal to the
patient age in days, and

f. First Databank Disease Code (FDBDX) column equals the FDBDX of the patient condition to be
treated with this prescription. If the patient condition is not available or if a reason for use record for
a given age range is not available, the FDBDX equals 999 (default screening record).

GCN_SEQNO 4180

DR2_RT 064

DR2_DOSTPI 02

EXCLUSION_LOAGED 0

EXCLUSION_HIAGED 29

FDBDX 999

8. Check the Low Current Weight in Grams (LOW_CURRENT_WEIGHT_GRAMS) and the High Current
Weight in Grams (HIGH_CURRENT_WEIGHT_GRAMS) values.

a. If the Low Current Weight in Grams (LOW_CURRENT_WEIGHT_GRAMS) and the High Current
Weight in Grams (HIGH_CURRENT_WEIGHT_GRAMS) are both equal to 0, then the current
weight is not required to select the exclusion record. Skip to step 10.

b. If the Low Current Weight in Grams (LOW_CURRENT_WEIGHT_GRAMS) or the High Current

Weight in Grams (HIGH_CURRENT_WEIGHT_GRAMS) is not equal to 0, then the current weight is
required to select the exclusion record.

9. Filter the records returned in step 7 where:

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9.

a. The Low Current Weight in Grams (LOW_CURRENT_WEIGHT_GRAMS) is less than or equal to

the patients weight in grams, and

b. The High Current Weight in Grams (HIGH_CURRENT_WEIGHT_GRAMS) is greater than or equal

to the patients weight in grams.

10. Check the Neonatal Low Gestational Age at Birth in Weeks (NEOM_LOW_GEST_BIRTH_AGE_WEEKS)
and the Neonatal High Gestational Age at Birth in Weeks (NEOM_HIGH_GEST_BIRTH_AGE_WEEKS)
values if screening for a neonatal patient.

a. If the Neonatal Low Gestational Age at Birth in Weeks (NEOM_LOW_GEST_BIRTH_AGE_WEEKS)

and the Neonatal High Gestational Age at Birth in Weeks (
NEOM_HIGH_GEST_BIRTH_AGE_WEEKS) are both equal to 0, then the gestational age at birth is
not required to select the exclusion record. Skip to step 12.

b. If the Neonatal Low Gestational Age at Birth in Weeks (NEOM_LOW_GEST_BIRTH_AGE_WEEKS)

or the Neonatal High Gestational Age at Birth in Weeks (
NEOM_HIGH_GEST_BIRTH_AGE_WEEKS) is not equal to 0, then the current weight is required to
select the exclusion record.

11. Filter the records returned in step 7 where the:

a. Neonatal Low Gestational Age at Birth in Weeks (NEOM_LOW_GEST_BIRTH_AGE_WEEKS)

column is less than or equal to the patients gestational birth age in weeks, and

b. The Neonatal High Gestational Age at Birth in Weeks (NEOM_HIGH_GEST_BIRTH_AGE_WEEKS)

column is greater than or equal to the patients gestational birth age in weeks.
In this example, a corresponding DRCM Age Exclusion record is found for the DRCM Exclusion Low
Age in Days (EXCLUSION_LOAGED) equal to 0, the DRCM Exclusion High Age in Days (
EXCLUSION_HIAGED) equal to 29, the Neonatal Low Gestational Age at Birth in Weeks (
NEOM_LOW_GEST_BIRTH_AGE_WEEKS) equal to 0, the Neonatal High Gestational Age at Birth
in Weeks (NEOM_HIGH_GEST_BIRTH_AGE_WEEKS) equal to 36, the Low Current Weight in
Grams (LOW_CURRENT_WEIGHT_GRAMS) equal to 0 and the High Current Weight in Grams (
HIGH_CURRENT_WEIGHT_GRAMS) equal to 2299.

12. Select the corresponding values in the DRCM Exclusion Reason Table
(RDRCAR0_EXCLUSION_REASON) and DRCM Severity Level Description Table
(RDRCSD0_SEVER_LEVEL_DESC) where the:

a. Exclusion Reason Code (EXCLUSION_REASON_CD) column from the DRCM Age Exclusion Table
(RDRCAE0_AGE_EXCLUSION) is equal to the Exclusion Reason Code (
EXCLUSION_REASON_CD) column in the DRCM Exclusion Reason Table
(RDRCAR0_EXCLUSION_REASON)

b. The Severity Level Code (DR2_SL) column from the DRCM Age Exclusion Table
(RDRCAE0_AGE_EXCLUSION) table is equal to the Severity Level Code (DR2_SL) column in the
DRCM Severity Level Description Table (RDRCSD0_SEVER_LEVEL_DESC).

13.

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13. The system produces an alert that includes precaution severity levels, the age range exclusion reason, and
the next dosing record text information.

Possible Warning Scenario Sample Display Message

Medication is Contraindicated <DrugDescription> is contraindicated for this patient.

[EXCLUSION_REASON_TEXT_SHORT]
[NEXT_SCREENING_DOSE_TEXT]

Medication has a Severe Precaution <DrugDescription> has a severe precaution for this
patient. [EXCLUSION_REASON_TEXT_SHORT]
[NEXT_SCREENING_DOSE_TEXT]

Medication has a Management or Monitoring Precaution <DrugDescription> has a management or monitoring

precaution for this patient.
[EXCLUSION_REASON_TEXT_SHORT]
[NEXT_SCREENING_DOSE_TEXT]

In this example, the following alert will be produced as the medication has a severe precaution and uses
the GNN60 for the drug description:

Codeine phosphate has a severe precaution for this patient. Dosing information is not established for
premature neonate (post-natal age <30 days and gestational age <37weeks) The next available dosing
age range is for birth to 29 days of age for gestational age at birth of 37 weeks and above and current
weight of 2300 grams and over. Low dose per day is 0.5 mg/kg/day. High dose per day is 6 mg/kg/day.
Max dose per day is 6 mg/kg/day. Max single dose 1 mg/kg. Not to exceed single dose is 60 mg.

ExampleMedication with Renal Screening and Age Gaps

In this scenario, the combination of a Clinical Formulation, DRCM Route of Administration Indicator ( DR2_RT),
RCM Dose Type Indicator (DR2_DOSTPI), and FML Disease Identifier FML Disease Identifier (DXID) has both
age exclusions and renal dosing records.
A physician is screening a 15-day-old patient for the administration of fentanyl citrate in 0.9% sodium chloride/PF
(Clinical Formulation ID [GCN_SEQNO] 48114) by continuous epidural (DR2_RT 013) for a maintenance dose
(DR2_DOSTPI 02).

1. Select records from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in days,
and

e. DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in days,

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e.

and

f. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record).
In this example, no corresponding dosing records are returned for the given criteria.

2. If no matching record is returned in the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR),
check the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS) for the Clinical Formulation ID (
GCN_SEQNO) value of the prescribed medication.
In this example, no corresponding records are returned.

3. If no matching record is returned in DRCM Exclusion Table (RDRCEX0_EXCLUSIONS), retrieve records

from the DRCM Age Exclusion Table (RDRCAE0_AGE_EXCLUSION) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Exclusion Low Age in Days (EXCLUSION_LOAGED) column is less than or equal to the
patient age in days, and

e. DRCM Exclusion High Age in Days (EXCLUSION_HIAGED) column is greater than or equal to the
patient age in days, and

f. First Databank Disease Code (FDBDX) column equals the FDBDX of the patient condition to be
treated with this prescription. If the patient condition is not available or if a reason for use record for
a given age range is not available, the FDBDX equals 999 (default screening record).

GCN_SEQNO 48114

DR2_RT 013

DR2_DOSTPI 02

EXCLUSION_LOAGED 0

EXCLUSION_HIAGED 29

FDBDX 999

In this example, the corresponding DRCM Age Exclusion record is found for the Exclusion Low Age
in Days (EXCLUSION_LOAGED) equal to 0 and the DRCM Exclusion High Age in Days (
EXCLUSION_HIAGED) equal to 29.

4.

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4. Select the corresponding values in the DRCM Age Exclusion Reason Table
(RDRCAR0_EXCLUSION_REASON, page 596) and DRCM Severity Level Description Table
(RDRCSD0_SEVER_LEVEL_DESC, page 610) where the:

a. Exclusion Reason Code (EXCLUSION_REASON_CD) column in the DRCM Age Exclusion Table
(RDRCAE0_AGE_EXCLUSION) is equal to the Exclusion Reason Code (
EXCLUSION_REASON_CD) column in the DRCM Exclusion Reason Table
(RDRCAR0_EXCLUSION_REASON, page 596)

b. The Severity Level Code (DR2_SL) column from the DRCM Age Exclusion Table
(RDRCAE0_AGE_EXCLUSION) is equal to the Severity Level Code (DR2_SL) column in the
DRCM Severity Level Description Table (RDRCSD0_SEVER_LEVEL_DESC).

5. The system produces an alert that includes the precaution severity levels, the age range exclusion reason,
and the next dosing record text information.

Possible Warning Scenario Sample Display Message

Medication is Contraindicated <DrugDescription> is contraindicated for this patient.

[EXCLUSION_REASON_TEXT_SHORT]
[NEXT_SCREENING_DOSE_TEXT]

Medication has a Severe Precaution <DrugDescription> has a severe precaution for this
patient. [EXCLUSION_REASON_TEXT_SHORT]
[NEXT_SCREENING_DOSE_TEXT]

Medication has a Management or Monitoring Precaution <DrugDescription> has a management or monitoring

precaution for this patient.
[EXCLUSION_REASON_TEXT_SHORT]
[NEXT_SCREENING_DOSE_TEXT]

In this example, the following alert will be produced as the medication has a severe precaution and uses
the GNN60 for the drug description:

Fentanyl citrate in 0.9% sodium chloride/PF has a severe precaution for this patient. Dosing is not
established, by this route, for neonatal (i.e., under 30 days of age) patients. The next available dosing age
range is for 30 days to 10 years of age. Low dose per day is 0.2 mcg/kg/hr. High dose per day is 0.8
mcg/kg/hr. Max dose per day is 1 mcg/kg/hr. Max single dose is 1 mcg/kg/hr. Not to exceed single dose is
100 microgram/hour.

ExampleMedication with Overlapping Precautions

This scenario provides an example of reducing the number of alerts produced if a customer is screened using
DRC Age Exclusions, Pediatric Precautions Module, and Geriatric Precautions Module.
A physician is screening a 12-year-old patient for the administration of moxifloxacin HCl (Clinical Formulation ID [
GCN_SEQNO] 43879) orally (DR2_RT 064) for a maintenance dose (DR2_DOSTPI 02).

1. Select records from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

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a.

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in days,
and

e. DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in days,
and

f. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record).
In this example, no corresponding dosing records are returned for the given criteria.

2. If no matching record is returned in the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR),
check the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS) for the Clinical Formulation ID (
GCN_SEQNO) value of the prescribed medication.
In this example, no corresponding records are located in the DRCM Exclusion Table
(RDRCEX0_EXCLUSIONS).

3. If no matching record is returned in the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS), retrieve

records from the DRCM Age Exclusion Table (RDRCAE0_AGE_EXCLUSION) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Exclusion Low Age in Days (EXCLUSION_LOAGED) column is less than or equal to the
patient age in days, and

e. DRCM Exclusion High Age in Days (EXCLUSION_HIAGED) column is greater than or equal to the
patient age in days, and

f. First Databank Disease Code (FDBDX) column equals the FDBDX of the patient condition to be
treated with this prescription. If the patient condition is not available or if a reason for use record for
a given age range is not available, the FDBDX equals 999 (default screening record).

GCN_SEQNO 43879

DR2_RT 064

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DR2_DOSTPI 02

EXCLUSION_LOAGED 0

EXCLUSION_HIAGED 6569

FDBDX 999

In this example, the corresponding DRCM Age Exclusion record is found for the DRCM Exclusion
Low Age in Days (EXCLUSION_LOAGED) equal to 0 and DRCM Exclusion High Age in Days (
EXCLUSION_HIAGED) equal to 6569.

4. Check the Available Precaution Indicator (AVAILABLE_PRECAUTION_IND). If the value is true (1), then
suppress the Pediatric Precautions Module or Geriatric Precautions Module alerts and display the alert
generated from the DRCM Age Exclusion. If the value is false (0), then generate the alert from DRC Age
Exclusion and no other similar alerts from the Pediatric Precautions Module or Geriatric Precautions
Module exist.
In this example, the Available Precaution Indicator (AVAILABLE_PRECAUTION_IND) is true (1), so the
Pediatric Precautions Module alert should be suppressed and the related DRCM Age Exclusion alert
should be displayed to users.

5. Select the corresponding values in the DRCM Exclusion Reason Table

(RDRCAR0_EXCLUSION_REASON) and DRCM Severity Level Description Table
(RDRCSD0_SEVER_LEVEL_DESC) where the:

a. Exclusion Reason Code (EXCLUSION_REASON_CD) column from the DRCM Age Exclusion Table
(RDRCAE0_AGE_EXCLUSION) is equal to the Exclusion Reason Code (
EXCLUSION_REASON_CD) column in the DRCM Exclusion Reason Table
(RDRCAR0_EXCLUSION_REASON)

b. The Severity Level Code (DR2_SL) column from the DRCM Age Exclusion Table
(RDRCAE0_AGE_EXCLUSION) is equal to the Severity Level Code (DR2_SL) column in the
DRCM Severity Level Description Table (RDRCSD0_SEVER_LEVEL_DESC).
The system produces an alert that includes the precaution severity levels, the age range exclusion
reason, and the next dosing record text information.

Possible Warning Scenario Sample Display Message

Medication is Contraindicated <DrugDescription> is contraindicated for this patient.

[EXCLUSION_REASON_TEXT_SHORT]
[NEXT_SCREENING_DOSE_TEXT]

Medication has a Severe Precaution <DrugDescription> has a severe precaution for this
patient. [EXCLUSION_REASON_TEXT_SHORT]
[NEXT_SCREENING_DOSE_TEXT]

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Medication has a Management or Monitoring <DrugDescription> has a management or monitoring

Precaution precaution for this patient.
[EXCLUSION_REASON_TEXT_SHORT]
[NEXT_SCREENING_DOSE_TEXT]

In this example, the following alert will be produced as the medication has a contraindication and
uses the GNN60 for the drug description:

Moxifloxacin HCl is contraindicated for this patient. Use of fluoroquinolones is contraindicated,

according to FDA-approved product labeling, in children and adolescents patients. The American
Academy of Pediatrics does have dosing recommendations for ciprofloxacin and levofloxacin. The
next available dosing age range is for 18 years to 65 years of age. Low dose per day is 400 mg/day.
High dose per day is 400 mg/day. Max dose per day is 400 mg/day. Max single dose is 400 mg. Not
to exceed single dose is 400 mg.

ExampleWhen Only Child and Adolescent Dosage Checking Values Are Present

A physician is screening a 6-month-old patient for the administration of procainamide HCL (Clinical Formulation
ID [GCN_SEQNO, page 1569] 230) intraosseously (DR2_RT 007) for a maintenance dose (DR2_DOSTPI 02).

1. Select records from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in days,
and

e. DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in days,
and

f. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record).
In this example, no corresponding dosing records are returned for the given criteria.

2. If no matching record is returned in the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR),
check the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS) for the Clinical Formulation ID (
GCN_SEQNO) value of the prescribed medication.
In this example, no corresponding records are returned.

3. If no matching record is returned in DRCM Exclusion Table (RDRCEX0_EXCLUSIONS), retrieve records

from the DRCM Age Exclusion Table (RDRCAE0_AGE_EXCLUSION) where the:

a.

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3.

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Exclusion Low Age in Days (EXCLUSION_LOAGED) column is less than or equal to the
patient age in days, and

e. DRCM Exclusion High Age in Days (EXCLUSION_HIAGED) column is greater than or equal to the
patient age in days, and

f. First Databank Disease Code (FDBDX) column equals the FDBDX of the patient condition to be
treated with this prescription. If the patient condition is not available or if a reason for use record for
a given age range is not available, the FDBDX equals 999 (default screening record).

GCN_SEQNO 230

DR2_RT 007

DR2_DOSTPI 02

EXCLUSION_LOAGED 0

EXCLUSION_HIAGED 364

FDBDX 999

In this example, a corresponding DRCM Age Exclusion record is found for the DRCM Exclusion Low
Age in Days (EXCLUSION_LOAGED) equal to 0 and the DRCM Exclusion High Age in Days (
EXCLUSION_HIAGED) equal to 364.

4. Select the corresponding values in the DRCM Exclusion Reason Table

(RDRCAR0_EXCLUSION_REASON) and DRCM Severity Level Description Table
(RDRCSD0_SEVER_LEVEL_DESC) where the:

a. Exclusion Reason Code (EXCLUSION_REASON_CD) column from the DRCM Age Exclusion Table
(RDRCAE0_AGE_EXCLUSION) is equal to the Exclusion Reason Code (
EXCLUSION_REASON_CD) column in the DRCM Exclusion Reason Table
(RDRCAR0_EXCLUSION_REASON)

b. The Severity Level Code (DR2_SL) column from the DRCM Age Exclusion Table
(RDRCAE0_AGE_EXCLUSION) is equal to the Severity Level Code (DR2_SL) column in the

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DRCM Severity Level Description Table (RDRCSD0_SEVER_LEVEL_DESC).

The system produces an alert that includes the precaution severity levels, the age range exclusion
reason, and the next dosing record text information.

Possible Warning Scenario Sample Display Message

Medication is Contraindicated <DrugDescription> is contraindicated for this patient.

[EXCLUSION_REASON_TEXT_SHORT]
[NEXT_SCREENING_DOSE_TEXT]

Medication has a Severe Precaution <DrugDescription> has a severe precaution for this
patient. [EXCLUSION_REASON_TEXT_SHORT]
[NEXT_SCREENING_DOSE_TEXT]

Medication has a Management or Monitoring <DrugDescription> has a management or monitoring

Precaution precaution for this patient.
[EXCLUSION_REASON_TEXT_SHORT]
[NEXT_SCREENING_DOSE_TEXT]

In this example, the following alert will be produced as the medication has a management or
monitoring precaution and uses the GNN60 for the drug description:

Procainamide HCL has a management or monitoring precaution for this patient. The dose of this
drug has not been established, by this route, for patients less than 1 years of age. The next
available dosing age range is for 1 year to 18 years of age. Low dose per day is 14.25 mg/kg/day.
High dose per day is 15.75 mg/kg/day. Max dose per day is 15.75 mg/kg/day. Max single dose is
15.75 mg/kg. Not to exceed single dose is 525 mg."

ExampleChild Age Range Exclusion Only

A physician is screening a 2-year-old patient for the administration of caffeine (Clinical Formulation ID [
GCN_SEQNO] 33) orally (DR2_RT 064) for a maintenance dose (DR2_DOSTPI 02).

1. Select records from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in days,
and

e. DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in days,
and

f. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age

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f.

range is not available, the DXID equals 4892 (default screening record).
In this example, no corresponding dosing records are returned for the given criteria.

2. If no matching record is returned in the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR),
check the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS) for the Clinical Formulation ID (
GCN_SEQNO) value of the prescribed medication.
In this example, no corresponding records are returned.

3. If no matching record is returned in the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS), retrieve

records from the DRCM Age Exclusion Table (RDRCAE0_AGE_EXCLUSION) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Exclusion Low Age in Days (EXCLUSION_LOAGED) column is less than or equal to the
patient age in days, and

e. DRCM Exclusion High Age in Days (EXCLUSION_HIAGED) column is greater than or equal to the
patient age in days, and

f. First Databank Disease Code (FDBDX) column equals the FDBDX of the patient condition to be
treated with this prescription. If the patient condition is not available or if a reason for use record for
a given age range is not available, the FDBDX equals 999 (default screening record).

GCN_SEQNO 33

DR2_RT 064

DR2_DOSTPI 02

EXCLUSION_LOAGED 0

EXCLUSION_HIAGED 365

FDBDX 999

In this example, a corresponding DRCM Age Exclusion record is found for the DRCM Low Age in
Days DRCM Exclusion Low Age in Days (EXCLUSION_LOAGED) equal to 365 and DRCM
Exclusion High Age in Days (EXCLUSION_HIAGED) equal to 4744.

4. Select the corresponding values in the DRCM Exclusion Reason Table

(RDRCAR0_EXCLUSION_REASON) and DRCM Severity Level Description Table
(RDRCSD0_SEVER_LEVEL_DESC) where the:

a.

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a. The Exclusion Reason Code (EXCLUSION_REASON_CD) column from the DRCM Age Exclusion
Table (RDRCAE0_AGE_EXCLUSION) is equal to the Exclusion Reason Code (
EXCLUSION_REASON_CD) column in the DRCM Exclusion Reason Table
(RDRCAR0_EXCLUSION_REASON).

b. The Severity Level Code (DR2_SL) column from the DRCM Age Exclusion Table
(RDRCAE0_AGE_EXCLUSION) is equal to the Severity Level Code (DR2_SL) column in the
DRCM Severity Level Description Table (RDRCSD0_SEVER_LEVEL_DESC).

5. The system produces an alert that includes precaution severity levels, the age range exclusion reason, and
the next dosing record text information.

Possible Warning Scenario Sample Display Message

Medication is Contraindicated <DrugDescription> is contraindicated for this patient.

[EXCLUSION_REASON_TEXT_SHORT]
[NEXT_SCREENING_DOSE_TEXT]

Medication has a Severe Precaution <DrugDescription> has a severe precaution for this
patient. [EXCLUSION_REASON_TEXT_SHORT]
[NEXT_SCREENING_DOSE_TEXT]

Medication has a Management or Monitoring Precaution <DrugDescription> has a management or monitoring

precaution for this patient.
[EXCLUSION_REASON_TEXT_SHORT]
[NEXT_SCREENING_DOSE_TEXT]

In this example, the following alert will be produced as the medication has a management or monitoring
precaution and uses the GNN60 for the drug description:

Caffeine has a management or monitoring precaution for this patient. Dosing has not been established for
children between the ages of 1 to 13 years. The next available dosing age range is for 18 years to 110
years of age. Low dose per day is 50 mg/day. High dose per day is 800 mg/day. Max dose per day is 1000
mg/day. Max single dose is 200 mg/kg. Not to exceed single dose is 200 mg."

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Utilizing FDB Preassembled Warning Messages

The section provides examples of text message alerts that are displayed that explain why clinical screening
information may not appear in dosing records due to age gaps. These FDB preassembled alerts include
precaution severity levels, the age range exclusion reason, and the next dosing record text information.

ExampleSevere Precaution and Pediatric Gap

A physician is screening a 1-day-old patient for the administration of potassium acetate 1 meq/kg/day (Clinical
Formulation ID [GCN_SEQNO] 1241) intravenous (DR2_RT 052) for a maintenance dose (DR2_DOSTPI 02).

1. Select records from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in days,
and

e. DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in days,
and

f. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record).
In this example, no corresponding dosing records are returned for the given criteria.

2. If no matching record is returned in the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR),
check the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS) for the Clinical Formulation ID (
GCN_SEQNO) value of the prescribed medication.
In this example, no corresponding records are returned.

3. If no matching record is returned in the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS), retrieve

records from the DRCM Age Exclusion Table (RDRCAE0_AGE_EXCLUSION) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Exclusion Low Age in Days (EXCLUSION_LOAGED) column is less than or equal to the

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d.

patient age in days, and

e. DRCM Exclusion High Age in Days (EXCLUSION_HIAGED) column is greater than or equal to the
patient age in days, and

f. First Databank Disease Code (FDBDX) column equals the FDBDX of the patient condition to be
treated with this prescription. If the patient condition is not available or if a reason for use record for
a given age range is not available, the FDBDX equals 999 (default screening record).

GCN_SEQNO 1241

DR2_RT 052

DR2_DOSTPI 02

EXCLUSION_LOAGED 0

EXCLUSION_HIAGED 2

FDBDX 999

In this example, a corresponding DRCM Age Exclusion record is returned for DRCM Exclusion Low
Age in Days (EXCLUSION_LOAGED) equal to 0 and DRCM Exclusion High Age in Days (
EXCLUSION_HIAGED) equal to 2.

4. Select the corresponding Exclusion Message Text (EXCLUSION_MESSAGE_TEXT).

5. Substitute actual the drug description for the <DrugDescription> tag in the Exclusion Message Text (
EXCLUSION_MESSAGE_TEXT).

6. The system produces an alert that includes the precaution severity levels, the age range exclusion reason,
and the next dosing record text information.
In this example, the following alert will be produced as the medication has a severe precaution and uses
the GNN60 for the drug description:

Potassium acetate has a severe precaution for this patient. Administration of potassium to newborn
infants must be done with extreme caution until their renal function has been determined. The next
available dosing age range is for 3 days to 13 years of age. Low dose per day is 0.5 mEq/kg/day. High
dose per day is 3 mEq/kg/day. Max dose per day is 5 mEq/kg/day. Max single dose is 1 mEq/kg. Not to
exceed single dose is 40 mEq.

ExampleGeriatric Gap

A physician is screening a 70-year-old patient for the administration of desogestrel-ethinyl estradiol (Clinical
Formulation ID [GCN_SEQNO] 17616) orally (DR2_RT 064) for a maintenance dose (DR2_DOSTPI 02).

1. Select records from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the

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b.
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in days,
and

e. DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in days,
and

f. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record).

In this example, no corresponding dosing records are returned for the given criteria.

2. If no matching record is returned in the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR),
check the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS) for the Clinical Formulation ID (
GCN_SEQNO) value of the prescribed medication.

In this example, no corresponding records are returned.

3. If no matching record is returned in the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS), retrieve

records from the DRCM Age Exclusion Table (RDRCAE0_AGE_EXCLUSION) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Exclusion Low Age in Days (EXCLUSION_LOAGED) column is less than or equal to the
patient age in days, and

e. DRCM Exclusion High Age in Days (EXCLUSION_HIAGED) column is greater than or equal to the
patient age in days, and

f. First Databank Disease Code (FDBDX) column equals the FDBDX of the patient condition to be
treated with this prescription. If the patient condition is not available or if a reason for use record for
a given age range is not available, the FDBDX equals 999 (default screening record).

GCN_SEQNO 17616

DR2_RT 064

DR2_DOSTPI 02

EXCLUSION_LOAGED 23725

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EXCLUSION_HIAGED 40150

FDBDX 999

In this example, a corresponding DRCM Age Exclusion record is found for DRCM Exclusion Low
Age in Days (EXCLUSION_LOAGED) equal to 23725 and DRCM Exclusion High Age in Days (
EXCLUSION_HIAGED) equal to 40150.

4. Select the corresponding Exclusion Message Text (EXCLUSION_MESSAGE_TEXT).

5. Substitute actual the drug description for the <DrugDescription> tag in the Exclusion Message Text (
EXCLUSION_MESSAGE_TEXT).

6. The system generates an alert stating any precaution severity levels, age range exclusion reason, and the
next dosing record text information.

In this example, the following alert will be produced as the medication has a management or monitoring
precaution and uses the GNN60 for the drug description:

Desogestrel-ethinyl estradiol has a management or monitoring precaution for this patient. This drug's
indications for use do not normally occur in geriatric and/or post menopausal patients. The next available
dosing age range is for 18 years to 65 years of age. Low dose per day is 1 tab-cap/day. High dose per day
is 1 tab-cap/day. Max dose per day is 1 tab-cap/day. Max single dose is 1 tab-cap. Not to exceed single
dose is 1 tab-cap.

ExampleContraindicated

A physician is screening a 1-year-old patient for the administration of democycline HCL (Clinical Formulation ID
[GCN_SEQNO] 9213) orally (DR2_RT 064) for a maintenance dose (DR2_DOSTPI 02).

1. Select records from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in days,
and

e. DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in days,
and

f. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record).

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In this example, no corresponding dosing records are returned for the given criteria.

2. If no matching record is returned in the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR),
check the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS) for the Clinical Formulation ID (
GCN_SEQNO) value of the prescribed medication.
In this example, no corresponding records are returned.

3. If no matching record is returned in the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS), retrieve

records from the DRCM Age Exclusion Table (RDRCAE0_AGE_EXCLUSION) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Exclusion Low Age in Days (EXCLUSION_LOAGED) column is less than or equal to the
patient age in days, and

e. DRCM Exclusion High Age in Days (EXCLUSION_HIAGED) column is greater than or equal to the
patient age in days, and

f. First Databank Disease Code (FDBDX) column equals the FDBDX of the patient condition to be
treated with this prescription. If the patient condition is not available or if a reason for use record for
a given age range is not available, the FDBDX equals 999 (default screening record).

GCN_SEQNO 9213

DR2_RT 064

DR2_DOSTPI 02

EXCLUSION_LOAGED 0

EXCLUSION_HIAGED 2919

FDBDX 999

In this example, a corresponding DRCM Age Exclusion record is found for DRCM Exclusion Low
Age in Days (EXCLUSION_LOAGED) equal to 0 and DRCM Exclusion High Age in Days (
EXCLUSION_HIAGED[) equal to 2919.

4. Select the corresponding Exclusion Message Text (EXCLUSION_MESSAGE_TEXT).

5. Substitute actual the drug description for the <DrugDescription> tag in the Exclusion Message Text (
EXCLUSION_MESSAGE_TEXT).

6. The system generates an alert stating any precaution severity levels, age range exclusion reason, and the
next dosing record text information.

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6.

In this example, the following alert will be produced as the medication is contraindicated and uses the
GNN60 for the drug description:

Democycline HCL is contraindicated for this patient. Due to potential toxicity, the drug is not normally used
in this aged patient. The next available dosing age range is for 8 years to 18 years of age. Low dose per
day is 6.6 mg/kg/day. High dose per day is 13.2 mg/kg/day. Max dose per day is 600 mg/day. Max single
dose is 6.6 mg/kg. Not to exceed single dose is 300 mg.

ExampleGestational Age at Birth Gap and Current Weight Gap

A physician is screening a 14-day-old with a gestational age at birth of 32 weeks and a current weight of 1500
grams for the administration of codeine phosphate (Clinical Formulation ID [GCN_SEQNO] 4180) orally (DR2_RT
064) for a maintenance dose (DR2_DOSTPI 02).

1. Select records from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in days,
and

e. DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in days,
and

f. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record).

2. Check the Weight Required Indicator (WEIGHT_REQ_IND) if screening for a neonatal patient:

a. If the Weight Required Indicator (WEIGHT_REQ_IND) equals 0, the current weight is not required to
select the screening record. Skip to step 4.

b. If the Weight Required Indicator (WEIGHT_REQ_IND) equals 1, the current weight is required to
select the screening record.

3. Filter the records returned in step 1 where the:

a. Low Current Weight in Grams (LOW_CURRENT_WEIGHT_GRAMS) is less than or equal to the

patients weight in grams, and

b. High Current Weight in Grams (HIGH_CURRENT_WEIGHT_GRAMS) is greater than or equal to

the patients weight in grams.

4.

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4. Check the Neonatal Gestational Birth Age Required Indicator (NEOM_GEST_BIRTH_AGE_REQ_IND) if

screening for a neonatal patient:

a. If the Neonatal Gestational Birth Age Required Indicator (NEOM_GEST_BIRTH_AGE_REQ_IND)

equals 0, the gestational age at birth is not required to select the screening record. Skip to step 6.

b. If the Neonatal Gestational Birth Age Required Indicator (NEOM_GEST_BIRTH_AGE_REQ_IND)

equals 1, the gestational age at birth is required to select the screening record.

5. Filter the records returned in step 1 where the:

a. Neonatal Low Gestational Age at Birth in Weeks (NEOM_LOW_GEST_BIRTH_AGE_WEEKS)

column is less than or equal to the patients gestational birth age in weeks, and

b. Neonatal High Gestational Age at Birth in Weeks (NEOM_HIGH_GEST_BIRTH_AGE_WEEKS)

column is greater than or equal to the patients gestational birth age.
In this example, no corresponding dosing records are returned for the given criteria.

6. If no matching record is returned in the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR),
check the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS) for the Clinical Formulation ID (
GCN_SEQNO) value of the prescribed medication.
In this example, no corresponding dosing records are returned for the given criteria.

7. If no matching record is returned in the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS), retrieve

records from the DRCM Age Exclusion Table (RDRCAE0_AGE_EXCLUSION) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Exclusion Low Age in Days (EXCLUSION_LOAGED) column is less than or equal to the
patient age in days, and

e. DRCM Exclusion High Age in Days (EXCLUSION_HIAGED) column is greater than or equal to the
patient age in days, and

f. First Databank Disease Code (FDBDX) column equals the FDBDX of the patient condition to be
treated with this prescription. If the patient condition is not available or if a reason for use record for
a given age range is not available, the FDBDX equals 999 (default screening record).

GCN_SEQNO 4180

DR2_RT 064

DR2_DOSTPI 02

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EXCLUSION_LOAGED 0

EXCLUSION_HIAGED 29

FDBDX 999

8. Check the Low Current Weight in Grams (LOW_CURRENT_WEIGHT_GRAMS) and the High Current
Weight in Grams (HIGH_CURRENT_WEIGHT_GRAMS) values.

a. If the Low Current Weight in Grams (LOW_CURRENT_WEIGHT_GRAMS) and the High Current
Weight in Grams (HIGH_CURRENT_WEIGHT_GRAMS) are both equal to 0, then the current
weight is not required to select the exclusion record. Skip to step 10.

b. If the Low Current Weight in Grams (LOW_CURRENT_WEIGHT_GRAMS) or the High Current

Weight in Grams (HIGH_CURRENT_WEIGHT_GRAMS) is not equal to 0, then the current weight is
required to select the exclusion record.

9. Filter the records returned in step 7 where:

a. The Low Current Weight in Grams (LOW_CURRENT_WEIGHT_GRAMS) is less than or equal to

the patients weight in grams, and

b. The High Current Weight in Grams (HIGH_CURRENT_WEIGHT_GRAMS) is greater than or equal

to the patients weight in grams.

10. Check the Neonatal Low Gestational Age at Birth in Weeks (NEOM_LOW_GEST_BIRTH_AGE_WEEKS)
and the Neonatal High Gestational Age at Birth in Weeks (NEOM_HIGH_GEST_BIRTH_AGE_WEEKS)
values if screening for a neonatal patient.

a. If the Neonatal Low Gestational Age at Birth in Weeks (NEOM_LOW_GEST_BIRTH_AGE_WEEKS)

and the Neonatal High Gestational Age at Birth in Weeks (
NEOM_HIGH_GEST_BIRTH_AGE_WEEKS) are both equal to 0, then the gestational age at birth is
not required to select the exclusion record. Skip to step 12.

b. If the Neonatal Low Gestational Age at Birth in Weeks (NEOM_LOW_GEST_BIRTH_AGE_WEEKS)

or the Neonatal High Gestational Age at Birth in Weeks (
NEOM_HIGH_GEST_BIRTH_AGE_WEEKS) is not equal to 0, then the current weight is required to
select the exclusion record.

11. Filter the records returned in step 7 where the:

a. Neonatal Low Gestational Age at Birth in Weeks (NEOM_LOW_GEST_BIRTH_AGE_WEEKS)

column is less than or equal to the patients gestational birth age in weeks, and

b. The Neonatal High Gestational Age at Birth in Weeks (NEOM_HIGH_GEST_BIRTH_AGE_WEEKS)

column is greater than or equal to the patients gestational birth age in weeks.

In this example, a corresponding DRCM Age Exclusion record is found for the DRCM Exclusion Low
Age in Days (EXCLUSION_LOAGED) equal to 0, the DRCM Exclusion High Age in Days (
EXCLUSION_HIAGED) equal to 29, the Neonatal Low Gestational Age at Birth in Weeks (

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NEOM_LOW_GEST_BIRTH_AGE_WEEKS) equal to 0, the Neonatal High Gestational Age at Birth

in Weeks (NEOM_HIGH_GEST_BIRTH_AGE_WEEKS) equal to 36, the Neonatal Low Current
Weight in Grams (NEOM_LOW_CURRENT_WEIGHT_GRAMS) equal to 0 and the Neonatal High
Current Weight in Grams (NEOM_HIGH_CURRENT_WEIGHT_GRAMS) equal to 2299.

12. Select the corresponding Exclusion Message Text (EXCLUSION_MESSAGE_TEXT).

13. Substitute the actual drug description for the <DrugDescription> tag in the Exclusion Message Text (
EXCLUSION_MESSAGE_TEXT)

14. The system generates an alert stating any precaution severity levels, age range exclusion reason, and the
next dosing record text information.

In this example, the following alert will be produced as the medication has a severe precaution and uses
the GNN60 for the drug description:

Codeine phosphate has a severe precaution for this patient. Dosing information is not established for
premature neonate (post-natal age <30 days and gestational age <37 weeks). The next available dosing
age range is for birth to 29 days of age for gestational age at birth of 37 weeks and above and current
weight of 2300 grams and over. Low dose per day is 0.5 mg/kg/day. High dose per day is 6 mg/kg/day.
Max dose per day is 6 mg/kg/day. Max single dose 1 mg/kg. Not to exceed single dose is 60 mg.

ExampleMedication with Renal Screening and Age Gaps

In this scenario, the combination of a Clinical Formulation, DRCM Route of Administration Indicator ( DR2_RT),
DRCM Dose Type Indicator (DR2_DOSTPI), and FML Disease Identifier FML Disease Identifier (DXID) has both
age exclusions and renal dosing records.

A physician is screening a 15-day-old patient for the administration of fentanyl citrate in 0.9% sodium chloride/PF
(Clinical Formulation ID [GCN_SEQNO] 48114) by continuous epidural (DR2_RT 013) for a maintenance dose
(DR2_DOSTPI 02).

1. Select records from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in days,
and

e. DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in days,
and

f. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with

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f.

this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record).
In this example, no corresponding dosing records are returned for the given criteria.

2. If no matching record is returned in the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR),
check the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS) for the Clinical Formulation ID (
GCN_SEQNO) value of the prescribed medication.
In this example, no corresponding records are returned.

3. If no matching record is returned in DRCM Exclusion Table (RDRCEX0_EXCLUSIONS), retrieve records

from the DRCM Age Exclusion Table (RDRCAE0_AGE_EXCLUSION) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Exclusion Low Age in Days (EXCLUSION_LOAGED) column is less than or equal to the
patient age in days, and

e. DRCM Exclusion High Age in Days (EXCLUSION_HIAGED) column is greater than or equal to the
patient age in days, and

f. First Databank Disease Code (FDBDX) column equals the FDBDX of the patient condition to be
treated with this prescription. If the patient condition is not available or if a reason for use record for
a given age range is not available, the FDBDX equals 999 (default screening record).

GCN_SEQNO 48114

DR2_RT 013

DR2_DOSTPI 02

EXCLUSION_LOAGED 0

EXCLUSION_HIAGED 29

FDBDX 999

In this example, a corresponding DRCM Age Exclusion record found for DRCM Exclusion Low Age
in Days (EXCLUSION_LOAGED) equals 0 and DRCM Exclusion High Age in Days (
EXCLUSION_HIAGED) equals 29.

4. Select the corresponding Exclusion Message Text (EXCLUSION_MESSAGE_TEXT).

5. Substitute actual the drug description for the <DrugDescription> tag in the Exclusion Message Text (
EXCLUSION_MESSAGE_TEXT) .

6.

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6. The system generates an alert stating any precaution severity levels, age range exclusion reason, and the
next dosing record text information.

In this example, the following alert will be produced as the medication has a severe precaution and uses
the GNN60 for the drug description:

Fentanyl citrate in 0.9% sodium chloride/PF has a severe precaution for this patient. Dosing is not
established, by this route, for neonatal (i.e., under 30 days of age) patients. The next available dosing age
range is for 30 days to 10 years of age. Low dose per day is 0.2 mcg/kg/hr. High dose per day is 0.8
mcg/kg/hr. Max dose per day is 1 mcg/kg/hr. Max single dose is 1 mcg/kg/hr. Not to exceed single dose is
100 microgram/hour.

ExampleMedication with Overlapping Precautions

The intent of this scenario is to decrease the number of alerts generated if a customer is screening by using DRC
Age Exclusions and the Pediatric Precautions Module.

A physician is screening a 12-year-old patient for the administration of moxifloxacin HCl (Clinical Formulation ID
[GCN_SEQNO] 43879) orally (DR2_RT 064) for a maintenance dose (DR2_DOSTPI 02).

1. Select records from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in days,
and

e. DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in days,
and

f. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record).
In this example, no corresponding dosing records are returned for the given criteria.

2. If no matching record is returned in the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR),
check the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS) for the Clinical Formulation ID (
GCN_SEQNO) value of the prescribed medication.
In this example, no corresponding records are returned.

3. If no matching record is returned in the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS), retrieve

records from the DRCM Age Exclusion Table (RDRCAE0_AGE_EXCLUSION) where the:

a.

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a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Exclusion Low Age in Days (EXCLUSION_LOAGED) column is less than or equal to the
patient age in days, and

e. DRCM Exclusion High Age in Days (EXCLUSION_HIAGED) column is greater than or equal to the
patient age in days, and

f. First Databank Disease Code (FDBDX) column equals the FDBDX of the patient condition to be
treated with this prescription. If the patient condition is not available or if a reason for use record for
a given age range is not available, the FDBDX equals 999 (default screening record).

GCN_SEQNO 43879

DR2_RT 064

DR2_DOSTPI 02

EXCLUSION_LOAGED 0

EXCLUSION_HIAGED 6569

FDBDX 999

In this example, a corresponding DRCM Age Exclusion record is found for DRCM Exclusion Low
Age in Days (EXCLUSION_LOAGED) equal to 0 and DRCM Exclusion High Age in Days (
EXCLUSION_HIAGED) equal to 6569.

4. Check the value of the Available Precaution Indicator (AVAILABLE_PRECAUTION_IND). If the value is
true (1), then suppress the Pediatric Precautions Module or Geriatric Precautions Module alerts and
display the alert produced from the DRCM Age Exclusion Table (RDRCAE0_AGE_EXCLUSION). If the
value is false (0), then no alerts will be produced from DRCM Age Exclusion Table
(RDRCAE0_AGE_EXCLUSION) and no other similar alerts from the Pediatric Precautions Module or
Geriatric Precautions Module exist.

In this example, the (AVAILABLE_PRECAUTION_IND) is true(1), so the Pediatric Precautions Module

alert should be suppressed and the related DRCM Age Exclusion alert should be displayed to users.

5. Select the corresponding Exclusion Message Text (EXCLUSION_MESSAGE_TEXT).

6. Substitute actual the drug description for the <DrugDescription> tag in the Exclusion Message Text (
EXCLUSION_MESSAGE_TEXT)

7. The system generates an alert stating any precaution severity levels, age range exclusion reason, and the

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7.

next dosing record text information.

In this example, the following alert will be produced as the medication has a contraindication and uses the
GNN60 for the drug description:

Moxifloxacin HCl is contraindicated for this patient. Use of fluoroquinolones is contraindicated, according
to FDA-approved product labeling, in children and adolescents patients. The American Academy of
Pediatrics does have dosing recommendations for ciprofloxacin and levofloxacin. The next available
dosing age range is for 18 years to 65 years of age. Low dose per day is 400 mg/day. High dose per day is
400 mg/day. Max dose per day is 400 mg/day. Max single dose is 400 mg. Not to exceed single dose is
400 mg.

ExampleOnly Child and Adolescent Dosage Checking Values Present

A physician is screening a 6-month-old patient for the administration of procainamide HCL (Clinical Formulation
ID [GCN_SEQNO] 230) intraosseously (DR2_RT 007) for a maintenance dose (DR2_DOSTPI 02).

1. Select records from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in days,
and

e. DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in days,
and

f. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record).
In this example, no corresponding dosing records are returned for the given criteria.

2. If no matching record is returned in the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR),
check the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS) for the Clinical Formulation ID (
GCN_SEQNO) value of the prescribed medication.
In this example, no corresponding records are returned.

3. If no matching record is returned in the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS), retrieve

records from the DRCM Age Exclusion Table (RDRCAE0_AGE_EXCLUSION) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b.

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b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Exclusion Low Age in Days (EXCLUSION_LOAGED) column is less than or equal to the
patient age in days, and

e. DRCM Exclusion High Age in Days (EXCLUSION_HIAGED) column is greater than or equal to the
patient age in days, and

f. First Databank Disease Code (FDBDX) column equals the FDBDX of the patient condition to be
treated with this prescription. If the patient condition is not available or if a reason for use record for
a given age range is not available, the FDBDX equals 999 (default screening record).

GCN_SEQNO 230

DR2_RT 007

DR2_DOSTPI 02

EXCLUSION_LOAGED 0

EXCLUSION_HIAGED 364

FDBDX 999

In this example, a corresponding DRCM Age Exclusion record is found for DRCM Exclusion Low
Age in Days (EXCLUSION_LOAGED) equal to 0 and DRCM Exclusion High Age in Days (
EXCLUSION_HIAGED) equal to 364.

4. Select the corresponding Exclusion Message Text (EXCLUSION_MESSAGE_TEXT).

5. Substitute the actual the drug description for the <DrugDescription> tag in the Exclusion Message Text (
EXCLUSION_MESSAGE_TEXT)

6. The system generates an alert stating any precaution severity levels, age range exclusion reason, and the
next dosing record text information.

In this example, the following alert will be produced as the medication has a contraindication and uses the
GNN60 for the drug description:

Procainamide HCL has a management or monitoring precaution for this patient. The dose of this drug has
not been established, by this route, for patients less than 1 years of age. The next available dosing age
range is for 1 year to 18 years of age. Low dose per day is 14.25 mg/kg/day. High dose per day is 15.75
mg/kg/day. Max dose per day is 15.75 mg/kg/day. Max single dose is 15.75 mg/kg. Not to exceed single
dose is 525 mg.

ExampleChild Age Range Exclusion Only

A physician is screening a 2-year-old patient for the administration of caffeine (Clinical Formulation ID

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[GCN_SEQNO] 33) orally (DR2_RT 064) for a maintenance dose (DR2_DOSTPI 02).

1. Select records from the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator(DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Low Age in Days (DR2_LOAGED) column is less than or equal to the patient age in days,
and

e. DRCM High Age in Days (DR2_HIAGED) column is greater than or equal to the patient age in days,
and

f. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 4892 (default screening record).
In this example, no corresponding dosing records are returned for the given criteria.

2. If no matching record is returned in the DRCM Neonatal and Adult Master Table (RDRCNMA2_MSTR),
check the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS) for the Clinical Formulation ID
(GCN_SEQNO) value of the prescribed medication.
In this example, no corresponding records are returned.

3. If no matching record is returned in the DRCM Exclusion Table (RDRCEX0_EXCLUSIONS), retrieve

records from the DRCM Age Exclusion Table (RDRCAE0_AGE_EXCLUSION) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. DRCM Route of Administration Indicator (DR2_RT) column equals the route of administration for the
prescribed medication, and

c. DRCM Dose Type Indicator (DR2_DOSTPI) column equals the dose type for the prescribed
medication, and

d. DRCM Exclusion Low Age in Days (EXCLUSION_LOAGED) column is less than or equal to the
patient age in days, and

e. DRCM Exclusion High Age in Days (EXCLUSION_HIAGED) column is greater than or equal to the
patient age in days, and

f. First Databank Disease Code (FDBDX) column equals the FDBDX of the patient condition to be
treated with this prescription. If the patient condition is not available or if a reason for use record for
a given age range is not available, the FDBDX equals 999 (default screening record).

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GCN_SEQNO 33

DR2_RT 064

DR2_DOSTPI 02

EXCLUSION_LOAGED 365

EXCLUSION_HIAGED 4744

FDBDX 999

In this example, a corresponding DRCM Age Exclusion record is found for the DRCM Exclusion Low
Age in Days (EXCLUSION_LOAGED) equal to 365 and DRCM Exclusion High Age in Days (
EXCLUSION_HIAGED) equal to 4744.

4. Select the corresponding Exclusion Message Text (EXCLUSION_MESSAGE_TEXT).

5. Substitute the actual drug description for the <DrugDescription> tag in the Exclusion Message Text (
EXCLUSION_MESSAGE_TEXT)

6. The system produces an alert that includes the precaution severity levels, age range exclusion reason, and
the next dosing record text information.

In this example, the following alert will be produced as the medication has a management or monitoring
precaution and uses the GNN60 for the drug description:

Caffeine has a management or monitoring precaution for this patient. Dosing has not been established for
children between the ages of 1 to 13 years. The next available dosing age range is for 18 years to 110
years of age. Low dose per day is 50 mg/day. High dose per day is 800 mg/day. Max dose per day is 1000
mg/day. Max single dose is 200 mg/kg. Not to exceed single dose is 200 mg.

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Generating DRCM Warning Messages

This application illustrates the general steps involved in creating DRCM messages and provides a list of sample
messages that can be used while screening. Messages should be generated to display DRCM data, and to notify
the end user when a prescribed dose falls outside an acceptable dose, administration frequency, or duration
range according to DRCM data. See the Dosage Range Checking application and Performing Dosage Range
Checking Using a DxID or ICD Code application.

Unit code descriptions for a message may be retrieved from the DRCM Dose Units Code Description (
UNITS_DESC) column in the DRCM Unit Description Table (RDRCUND0_UNITS_DESC). However, that
column might include abbreviations considered inappropriate by The Joint Commission (TJC) and
Institute for Safe Medication Practices (ISMP). To retrieve the corresponding TJC-compliant unit
descriptions for the given unit in the UNITS_DESC column, query the Units Description Table
(RUNITSD0_UNITS_DESC).

1. Familiarize yourself with the following possible warning scenarios and resulting display messages.

This table provides a list of sample messages that may be used when performing dosage range screening.
Variables within the Sample Display Message column refer to information found in the DRCM Neonatal
and Adult Master Table (RDRCNMA2_MSTR) or to patient-specific information. The Message Number
column contains a reference number used to identify appropriate messages for the scenarios illustrated
within the Dosage Range Checking application examples.

Possible Warning Scenario Sample Display Message Message Number

Prescribed daily dose is less than th Dosing range for [drug name] for 1
e recommended low daily dose for [patient name] [weight] [age] is
the drug. [LODOSD x patient weight (if
applicable)] [Low Dose UNITS_RUI]
- [HIDOSD x patient weight (if
applicable)] [High Dose
UNITS_RUI]. Prescribed dose of
[prescribed daily dose] [prescribed
dose units] is less than the
recommended low daily dose for the
drug. Please evaluate dose.

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Prescribed daily dose is greater than Dosing range for [drug name] for 2
the recommended high daily dose [patient name] [weight] [age] is
for the drug but is less than the [LODOSD x patient weight (if
recommended maximum daily dose applicable)] [Low Dose UNITS_RUI]
for the drug. - [HIDOSD x patient weight (if
applicable)] [High Dose
UNITS_RUI]. Prescribed dose of
[prescribed daily dose] [prescribed
dose units] is greater than the
recommended high daily dose for
the drug but is less than the
recommended maximum daily dose
of [MXDOSD x patient weight (if
applicable)] [Maximum Daily Dose
UNITS_RUI]. Please evaluate dose.

Prescribed daily dose is greater than Maximum dose per day for [drug 3
the recommended maximum daily name] for [patient name] [weight]
dose for the drug. [age] is [MXDOSD x patient weight
(if applicable)] [Maximum Daily Dose
UNITS_RUI]. Prescribed dose of
[prescribed daily dose] [prescribed
dose units] exceeds the
recommended maximum daily dose
for the drug. Please evaluate dose.

Prescribed single dose is greater Maximum single dose for [drug 4a

than the recommended maximum name] for [patient name] [weight]
single dose for the drug where [age] is [MX1DOS x patient weight
MX1DOS equals the (if applicable)] [MX1DSU] or
NTE_SINGLE_DOSE. [NTE_SINGLE_DOSE]
[NTE_SINGLE_DOSE_UNIT_CODE
]. Prescribed dose of [prescribed
single dose] [prescribed dose units]
exceeds the recommended
maximum single dose for the drug.
Please evaluate dose.

Prescribed single dose is greater Maximum single dose for [drug 4b

than the recommended maximum name] for [patient name] [weight]
single dose for the drug where the [age] is [MX1DOS x patient weight
MX1DOS is less than the (if applicable)] [MX1DSU].
NTE_SINGLE_DOSE. Prescribed dose of [prescribed
single dose] [prescribed dose units]
exceeds the recommended
maximum single dose for the drug.
Please evaluate dose.

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Prescribed single dose is greater Maximum single dose for [drug 4c

than the recommended maximum name] for [patient name] [weight]
single dose for the drug where the [age] is [NTE_SINGLE_DOSE]
MX1DOS is greater than the [NTE_SINGLE_DOSE_UNIT_CODE
NTE_SINGLE_DOSE. ]. Prescribed dose of [prescribed
single dose] [prescribed dose units]
exceeds the recommended
maximum single dose for the drug.
Please evaluate dose.

Significant renal impairment requires Dosage regimen needs to be 5

a dosing adjustment. adjusted for significant renal
impairment.

Patients creatinine clearance is less If the patients creatinine clearance 6

than the accepted creatinine is lower than [CRCLTH] [CRCLU], a
clearance threshold for the drug. drug dosage adjustment should be
considered.

Significant hepatic impairment Dosage regimen needs to be 7

requires a dosing adjustment. adjusted for hepatic impairment.

Prescribed frequency of Administration frequency for [drug 8

administration per day is less than th name] for [patient name] [weight]
e recommended minimum frequency [age] is [LOFREQ] - [HIFREQ] per
of administration range for the drug. day. Prescribed frequency of
[prescribed frequency] per day is
less than the recommended
minimum administration frequency
for the drug. Please evaluate
frequency.

Prescribed frequency of Administration frequency for [drug 9

administration per day is greater name] for [patient name] [weight]
than the recommended maximum [age] is [LOFREQ] - [HIFREQ] per
frequency of administration for the day. Prescribed frequency of
drug. [prescribed frequency] per day
exceeds the recommended
maximum administration frequency
for the drug. Please evaluate
frequency.

Prescribed duration is less than the Duration range for [drug name] for 10
recommended low duration for the [patient name] [weight] [age] is
drug. [LODOTX] - [HIDOTX] days.
Prescribed duration of [prescribed
duration] days is less than the
recommended low duration for the
drug. Please evaluate duration of
therapy.

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Prescribed duration is greater than t Duration range for [drug name] for 11
he highest recommended duration [patient name] [weight] [age] is
for the drug. [LODOTX] - [HIDOTX] days.
Prescribed duration of [prescribed
duration] days exceeds the
recommended high duration for the
drug. Please evaluate duration of
therapy.

Prescribed duration is greater than t Duration range for [drug name] for 12
he recommended high duration [patient name] [weight] [age] is
range for the drug but is less than th [LODOTX] - [HIDOTX] days.
e recommended maximum duration Prescribed duration of [prescribed
for the drug. duration] days exceeds the
recommended high duration for the
drug but is less than the
recommended maximum duration of
[MXDOTX] days. Please evaluate
duration of therapy.

Prescribed duration is greater than t Maximum duration for [drug name] 13

he recommended maximum duration for [patient name] [weight] [age] is
range for the drug. [MXDOTX] days. Prescribed
duration of [prescribed duration]
days exceeds the recommended
maximum duration for the drug.
Please evaluate duration of therapy.

Patients elimination half-life range. Elimination half-life for [drug name] 14

for [patient name] [weight] [age] is
[THAFLO] - [THAFHI] [THAFU].

Maximum lifetime dose for the drug. Maximum lifetime dose is [MXLIFD] 15
[MXLIFU].

The drug is not recommended for This drug is not recommended for 16
patients with the specified level of use in patients with this level of
organ function. renal impairment.

No adjustment information. Renal adjustment information is 17

unavailable for the specified level of
creatinine clearance.

2. Create informational or warning messages that meet your business needs using a combination of static
text and variables acquired from columns within the knowledge base or from patient specific information.

3. Display these messages to the end-user as the warning scenario dictates. See the Dosage Range
Checking application.

ExampleWarning Message

A pharmacist screens a prescription for amoxicillin 250 mg oral of 2 times per day for 10 days for a patient that is
18 years old (6,570 days) and weighs 120 pounds (54.5 kg). DRCM finds that the prescribed frequency of
administration is less than the accepted frequency of administration for the drug. See the Dosage Range

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Checking application.

The following message may be displayed:

Administration frequency for amoxicillin 250 mg oral for an 18-year-old patient weighing 120 pounds is 3 - 4 per day.
Prescribed frequency of 2 per day is below the accepted administration frequency range for the drug. Please evaluate
frequency.

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Considerations for Screening Drugs That Have a Frequency of Less Than Once Per Day Greater
Than Once Per Month
Considerations for Screening When Frequency for Prescribed Dose Is Less Than Once a Month

When screening a drug that has a dosing interval of greater than one month, screen the dose amount only.

Dosing intervals of greater than one month are coded as a single dose; therefore, screen the dose amount only.
Do not calculate a daily dose.

For example, a doctor prescribes 3 mg IV every 3 months of Ibandronate Sodium (GCN_SEQNO 60257) for a
21-year old patient. To perform screening, use the dose amount of 3 mg and compare it to the following values:

Low Daily Dose: 3 mg/day

High Daily Dose: 3 mg/day

Max Daily Dose: 3 mg/day

Max Single dose: 3 mg

NTE Single Dose: 3 mg

To pass screening, the single dose value should not be less than the low daily dose and not greater than the high
daily dose, max daily dose, or the NTE single dose values.

This order passes screening.

Considerations for Screening for Once Orders (Chemotherapy)

Chemotherapy drugs are coded as a single dose if not administered on consecutive days of a cycle.

When screening for drugs that have a frequency of once, such as with chemotherapy drugs, use the prescribed
dose as the single dose and screen the dose amount only.

For example, a doctor prescribes 500 mg IM once of Fulvestrant (GEN_SEQNO 50308) for a 21-year old patient.
To perform screening, use the dose amount of 500 mg and compare it to the following values:

Low Daily Dose: 500 mg/day

High Daily Dose: 500 mg/day

Max Daily Dose: 500 mg/day

Max Single dose: 500 mg

NTE Single Dose: 500 mg

To pass screening, the single dose value should not be less than the low daily dose and not greater than the high
daily dose, max daily dose, or the NTE single dose values.

This order passes screening.

Considerations for Screening When the Frequency of Prescribed Dose Is Less Than Once A Day/Greater Than Once
Per Month

When screening for drugs that have a frequency of less than once a day/greater than once per month, use the

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frequency value from the table in Frequency of Administration (see the Rules for Data Elements) to calculate the
daily dose.

For example, a doctor prescribes 150 mg once per month of ridedronate sodium (GCN_SEQNO 63925) for a
21-year old patient.

Per the table, the frequency for 1 time every 30 days is 0.03.

To calculate the daily dose amount, multiply the dose amount (150) x the frequency retrieved from the table
(0.03) = 4.5 mg/day.

To perform screening, use the daily dose amount of 4.5 mg and compare it to the following values:

Low Daily Dose: 4.05 mg/day

High Daily Dose: 6.6 mg/day

Max Daily Dose: 6.6 mg/day

Max Single dose: 165 mg

NTE Single Dose: 165 mg

To pass screening, the daily dose value should not be less than the low daily dose and not greater than the high
daily dose, max daily dose, or the NTE single dose values.
The order passes screening.

Considerations for Screening Drugs That Do Not Have a Match in Dose Checking Data for a Specific Route or Age
Range

There are instances in which FDB data does not include dose checking data for drugs of a certain route or age
range. If you screen a drug that is not in the DRCM Exclusion Table (RDRCES0_EXCLUSIONS) (meaning it is
not excluded from DRCM data), the drug and patient profile is not in the DRCM Age Exclusion Table
(RCRCAE0_AGE_EXCLUSION), and there is no match in dose checking data for the specific route or age range,
display the following alert to the user:

Dosing information not available for dose checking. Check dose manually.

Considerations for Screening When the Strength of the Prescribed Dose Amount Is Expressed in Terms of the
Alternate Strength Type

When the strength of the prescribed dose is expressed in terms of the alternate strength type (ALT_STRENGTH
and ALT_STRENGTH_TYP_CODE columns) as opposed to the primary strength type (STRENGTH and
STRENGTH_UOM_ID columns in the Clinical Formulation Ingredient Strength Component Table), special
considerations apply.

For example, the doctor prescribes 80 mg of elemental Iron for GCN_SEQNO 1645 for a 21-year old patient. For
GCN_SEQNO 1645, the primary strength is 200 mg (expressed as base plus salt), and the alternate strength is
40 mg (expressed as elemental). Because the strength of the prescribed dose is expressed in terms of the
alternate strength type, follow these steps:

1. Divide the prescribed strength by the alternate strength.

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1.
80 divided by 40 (alternate strength) = 2

2. Multiply the result by the primary strength.

2 x 200 mg (strength) =400 mg

Perform screening based on the 400 mg value.

Refer to Dosing Ranges and Ingredient Strength in the Rules for Data Elements for more information.

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Min-Max Applications
This section provides information on the practical use of the data for the Min/Max Dose Modules and is divided
into the following two sections:

MMAD, MMGD, MMAR, and MMGR Applications

Calculating and Screening the Prescribed Daily Dose for a Single-Ingredient Product
Calculating and Screening the Prescribed Daily Dose for a Multi-ingredient Product
Calculating and Screening the Prescribed Daily Dose for Drugs with Dosing in Intervals Greater Than 24
Hours
Calculating and Screening the Prescribed Daily Dose for Puffs, Applicator(s)ful, or Scoops
Calculating and Screening the Prescribed Daily Dose for Ophthalmic Solution and Suspension Products

PDM Applications

Calculating and Screening the Prescribed Daily Dose for a Single-Ingredient Product
Calculating and Screening the Prescribed Daily Dose for a Multi-ingredient Product
Calculating and Screening the Prescribed Daily Dose for Puffs, Applicator(s)ful, or Scoops
Calculating and Screening the Prescribed Daily Dose for Ophthalmic Solution and Suspension Products

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MMAD, MMGD, MMAR, and MMGR Applications

The examples in this section illustrate the following for the Adult Daily Dose (MMAD), Geriatric Daily Dose
(MMGD), Adult Daily Range (MMAR), and Geriatric Daily Range (MMGR) Min/Max Dose Modules:

Calculating and Screening the Prescribed Daily Dose for a Single-Ingredient Product

Calculating and Screening the Prescribed Daily Dose for a Multi-ingredient Product

Calculating and Screening the Prescribed Daily Dose for Drugs with Dosing in Intervals Greater Than 24 Hours

Calculating and Screening the Prescribed Daily Dose for Puffs, Applicator(s)ful, or Scoops

Calculating and Screening the Prescribed Daily Dose for Ophthalmic Solution and Suspension Products

Any of the following four tables can be used in the examples however, for the purposes of demonstration, the
data in each example is retrieved from the RMMADMA1_ADULT_DOSE_MSTR table:

MMAD Master Table (RMMADMA1_ADULT_DOSE_MSTR)

MMGD Master Table (RMMGDMA1_GERI_DOSE_MSTR)
MMAR Master Table (RMMARMA0_ADULT_RANGE_MSTR)
MMGR Master Table (RMMGRMA1_GERI_RANGE_MSTR)

The column names and column descriptions are also presented generically. There are asterisks before each
column name and column description to represent that these columns are common to all four modules and that
any of the four modules can be used in the application. For example, *_MND could represent the MMGR_MND
column in MMGR, the MMAR_MND column in MMAR, and so on.

In addition, the Dosing Age Source Identifier (DOSING_AGE_SOURCE_ID) indicates if the dosing range
populated for a specific age was based on referential information related directly to the specified age range or
was assigned based upon evaluation of dosing information for a different age range. Because all adult records
are considered as the referential standard for the given dosing information, only the Geriatric Min/Max tables
contain the DOSING_AGE_SOURCE_ID attribute. Therefore, these examples do not contain the
DOSING_AGE_SOURCE_ID example data. Please see the PDM Applications, page 653 section for illustrations
of these values.

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Calculating and Screening the Prescribed Daily Dose for a Single-Ingredient Product

This application illustrates how to compare the prescribed dose for a single-ingredient product to an acceptable
daily dosage range. The prescribed daily dose can be screened using either daily dose strength or daily dose
units. The following examples demonstrate both scenarios:

ExampleComparing Ranges Using Dose Strength

ExampleComparing Ranges Using Dose Units

ExampleComparing Ranges Using Dose Strength

A physician prescribes a 20-year-old patient Diazepam 10 mg tablets (Clinical Formulation ID [GCN_SEQNO]

003766). One tablet is to be taken twice daily, and the pharmacist wants to screen the daily dose using the dose
strength to see if it falls within an acceptable range.

1. Calculate the prescribed daily dose. Since the dose is to be given two times per day, multiply 10 mg by 2
to yield the prescribed dose per day of 20 mg.

2. Select the following column values from the modules Master Table where the GCN_SEQNO column
equals the Clinical Formulation ID (GCN_SEQNO) of the prescribed drug:
*Minimum Daily Dose Strength Quantity (*_MND)
*Minimum Daily Dose Strength Units (*_MNDU)
*Maximum Daily Dose Strength Quantity (*_MXD)
*Maximum Daily Dose Strength Units (*_MXDU)

GCN_SEQNO *_MND *_MNDU *_MXD *_MXDU

003766 000005.000 MG 000040.000 MG

*_MND is 5, which works in conjunction with the *_MNDU value of MG to express the minimum
value as 5 mg per day. The *_MXD is 40, which works in conjunction with the *_MXDU value of MG
to express the ceiling as 40 mg per day. Therefore, this example shows that the minimum
recommended strength of a diazepam 5 mg tablet is 5 mg and that the maximum is 40 mg per day.

3. To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the *Minimum Daily Dose Strength Units column
(*_MNDU) and *Maximum Daily Dose Strength Units column (*_MXDU).

DOSING_MODULE_UNIT_ABBRE UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

V

MG mg milligram

4. Compare the prescribed daily dose (20 mg) to the retrieved range (5 mg to 40 mg). The daily dose of 20
mg is greater than the minimum value (5 mg) but less than the maximum value (40 mg), so the prescribed
daily dose falls within an acceptable range.

5. Using the modules Master Table and Clinical Formulation ID (GCN_SEQNO), retrieve the Dosing Age
Source Identifier (DOSING_AGE_SOURCE_ID) value. According to your business needs:

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5.

Display the data source information to the end-user.

Determine by the source if the collected dosing record can be used in screening.
Because this example uses the MMAD Master Table (RMMADMA1_ADULT_DOSE_MSTR), the
DOSING_AGE_SOURCE_ID values are not available but may be considered as a Source
Reference for the Age Range.

ExampleComparing Ranges Using Dose Units

A physician prescribes a 20-year-old patient Diazepam 10 mg tablets (Clinical Formulation ID [GCN_SEQNO]

003766). One tablet is to be taken twice daily, and the pharmacist wants to screen the daily dose using the dose
units to see if it falls within an acceptable range.

1. Calculate the prescribed daily dose. The dose is to be given two times per day, so the prescribed daily
dose is 2 tablets per day.

2. Select the following columns from the modules Master Table where the GCN_SEQNO column equals the
Clinical Formulation ID (GCN_SEQNO) of the prescribed drug:
*Minimum Daily Dose Units Quantity (*_MNU)
*Minimum Daily Dose Units Form (*_MNUF)
*Maximum Daily Dose Units Quantity (*_MXU)
*Maximum Daily Dose Units Form (*_MXUF)

GCN_SEQNO *_MNU *_MNUF *_MXU *_MXUF

003766 000005.000 MG 000040.000 MG

*_MNU is 0.5, which works in conjunction with the *_MNUF value of EA to express the minimum
value of 0.5 each (or half of a tablet) per day. The *_MXU is 4, which works in conjunction with the
*_MXUF value of EA to express the maximum of 4 each (or 4 tablets) per day. Therefore, this
example shows that the minimum recommended dose of the diazepam 10 mg tablet is 0.5 tablet
and that the maximum is 4 tablets per day.

3. Compare the prescribed daily dose (2 tablets) to the retrieved range (0.5 to 4 tablets). The prescribed daily
dose of 2 tablets is greater than the minimum value (0.5 tablet) but less than the maximum value (4
tablets). Therefore, the prescribed daily dose falls within the acceptable range.

4. Using the modules Master Table and Clinical Formulation ID (GCN_SEQNO), retrieve the Dosing Age
Source Identifier (DOSING_AGE_SOURCE_ID) value. According to your business needs:

Display the data source information to the end-user.

Determine by the source if the collected dosing record can be used in screening.

Because this example uses the MMAD Master Table (RMMADMA1_ADULT_DOSE_MSTR), the
DOSING_AGE_SOURCE_ID values are not available but may be considered as a Source
Reference for Age Range.

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Calculating and Screening the Prescribed Daily Dose for a Multi-ingredient Product

This application illustrates how to compare the prescribed daily dose for a multi-ingredient product to an
acceptable daily dosage range. For a multi-ingredient product, the prescribed daily dose can only be screened
using daily dose units.

For purposes of demonstrating this application, the following scenario is used: A physician prescribes
Carbidopa/Levodopa 25-100 mg extended release tablet (Clinical Formulation ID [GCN_SEQNO] 019563) for a
60-year-old patient. The patient is to take 5 tablets twice daily. The pharmacist wants to screen the daily dose to
see if it falls within an acceptable range.

1. Calculate the prescribed daily dose. The patient is to take 5 tablets twice daily, so multiply 5 times 2 to
yield the prescribed daily dose of 10 sustained release tablets per day.

2. Select the following column values from the modules Master Table where the GCN_SEQNO column
equals the Clinical Formulation ID (GCN_SEQNO) of the prescribed drug:
*Minimum Daily Dose Units Quantity (*_MNU)
*Minimum Daily Dose Units Form (*_MNUF)
*Maximum Daily Dose Units Quantity (*_MXU)
*Maximum Daily Dose Units Form (*_MXUF)

GCN_SEQNO *_MNU *_MNUF *_MXU *_MXUF

019563 0004.000 EA 0008.000 EA

*_MNU is 4, which works in conjunction with the *_MNUF value of EA to express the minimum value
of 4 each (or 2 extended release tablets) per day. The *_MXU is 8, which works in conjunction with
the *_MXUF value of EA to express the maximum of 8 each (or 8 extended release tablets) per day.
Therefore, this example shows that the minimum recommended dose unit for Carbidopa/Levodopa
in 25/100 mg extended release tablet is 4 each and that the maximum is 8 each per day.

3. Compare the prescribed daily dose (10 extended release tablets) to the retrieved range (2 to 8 extended
release tablets). The prescribed daily dose of 10 extended release tablets is greater than the minimum
value (2 extended release tablets) and greater than the maximum value (8 extended release tablets).
Therefore, the prescribed daily dose does not fall within the acceptable range.

4. Since the prescribed dose does not fall within the acceptable range, generate the following message: This
daily dose exceeds the daily maximum.

The Min/Max Dose Modules do not generate warning messages. Your system must be
programmed to generate appropriate messages when the prescribed daily dose falls outside an
acceptable range.

Using the modules Master Table and Clinical Formulation ID (GCN_SEQNO), retrieve the Dosing Age
Source Identifier (DOSING_AGE_SOURCE_ID) value. According to your business needs:
Display the data source information to the end-user.

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Determine by the source if the collected dosing record can be used in screening.

Because this example uses the MMAD Master Table (RMMADMA1_ADULT_DOSE_MSTR), the
DOSING_AGE_SOURCE_ID values are not available but may be considered as a Source
Reference for Age Range.

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Calculating and Screening the Prescribed Daily Dose for Drugs with Dosing in Intervals Greater Than 24 Hours

This application illustrates how to screen doses which are expressed in intervals greater than 24 hours. The
prescribed daily dose can be screened using either daily dose strength or daily dose units. The following
examples demonstrate both scenarios:

ExampleComparing Ranges Using Dose Strength

ExampleComparing Ranges Using Dose Units

ExampleComparing Ranges Using Dose Strength

A physician prescribes a 62-year-old patient Fluoxetine in a 90 mg delayed release capsule (Clinical Formulation
ID [GCN_SEQNO] 047571). The patient is to take 1 capsule once a week. The pharmacist wants to screen the
daily dose to see if it falls within an acceptable range.

1. Calculate the prescribed daily dose. Since the dose is to be given once a week, divide 90 mg by 7 (since
there are 7 days in one week) to yield the prescribed dose per day of 12.857 mg.

2. Select the following column values from the modules Master Table where the GCN_SEQNO column
equals the Clinical Formulation ID (GCN_SEQNO) of the prescribed drug:

*Minimum Daily Dose Strength Quantity (*_MND)

*Minimum Daily Dose Strength Units (*_MNDU)
*Maximum Daily Dose Strength Quantity (*_MXD)
*Maximum Daily Dose Strength Units (*_MXDU)

GCN_SEQNO *_MND *_MNDU *_MXD *_MXDU

047571 000011.340 MG 000013.860 MG

*_MND is 11.34, which works in conjunction with the *_MNDU value of MG to express the minimum
value as 11.34 mg per day. The *_MXD is 13.86, which works in conjunction with the *_MXDU value
of MG to express the ceiling as 13.86 mg per day. Therefore, this example shows that the minimum
recommendation is 11.34 mg and that the maximum is 13.86 mg per day.

3. To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the *Minimum Daily Dose Strength Units column
(*_MNDU) and *Maximum Daily Dose Strength Units column (*_MXDU).

DOSING_MODULE_UNIT_ABBRE UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

V

MG mg milligram

4. Compare the prescribed daily dose (12.857 mg) to the retrieved range (11.34 mg to 13.86 mg). The daily
dose of 12.857 mg is greater than the minimum value (11.34 mg) and is less than the maximum value
(13.86 mg), so the prescribed daily dose falls within an acceptable range.

5.

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5. Using the modules Master Table and Clinical Formulation ID (GCN_SEQNO), retrieve the Dosing Age
Source Identifier (DOSING_AGE_SOURCE_ID) value. According to your business needs:
Display the data source information to the end-user.
Determine by the source if the collected dosing record can be used in screening.

Since this example uses the MMAD Master Table (RMMADMA1_ADULT_DOSE_MSTR), the
DOSING_AGE_SOURCE_ID values are not available but may be considered as a Source
Reference for Age Range.

ExampleComparing Ranges Using Dose Units

A physician prescribes a 62-year-old patient Fluoxetine in a 90 mg delayed release capsule (Clinical Formulation
ID [GCN_SEQNO] 047571). The patient is to take 1 capsule once a week. The pharmacist wants to screen the
daily dose to see if it falls within an acceptable range.

1. Calculate the prescribed daily dose. Since the dose (one tablet) is to be given once a week, divide 1 by 7
(since there are 7 days in one week) to yield the prescribed dose per day of 0.143 tablets.

2. Select the following column values from the modules Master Table where the GCN_SEQNO column
equals the Clinical Formulation ID (GCN_SEQNO) of the prescribed drug:

*Minimum Daily Dose Units Quantity (*_MNU)

*Minimum Daily Dose Units Form (*_MNUF)
*Maximum Daily Dose Units Quantity (*_MXU)
*Maximum Daily Dose Units Form (*_MXUF)

GCN_SEQNO *_MNU *_MNUF *_MXU *_MXUF

047571 0000.126 EA 0000.154 EA

*_MNU is 0.126, which works in conjunction with the *_MNUF value of EA to express the minimum
value of 0.126 each (or 0.126 tablets) per day. The *_MXU is 0.154, which works in conjunction with
the *_MXUF value of EA to express the maximum of 0.154 each (or 0.154 tablets) per day.
Therefore, this example shows that the minimum recommendation is 0.126 each and that the
maximum is 0.154 each per day.

3. Compare the prescribed daily dose (0.143 each) to the retrieved range (0.126 each to 0.154 each). The
prescribed daily dose is greater than the minimum value (0.126 each) and is less than the maximum value
(0.154 each). Therefore, the prescribed daily dose falls within the acceptable range.

4. Using the modules Master Table and Clinical Formulation ID (GCN_SEQNO), retrieve the Dosing Age
Source Identifier (DOSING_AGE_SOURCE_ID) value. According to your business needs:
Display the data source information to the end-user.
Determine by the source if the collected dosing record can be used in screening.

Because this example uses the MMAD Master Table (RMMADMA1_ADULT_DOSE_MSTR), the

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DOSING_AGE_SOURCE_ID values are not available but may be considered as a Source

Reference for Age Range.

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Calculating and Screening the Prescribed Daily Dose for Puffs, Applicator(s)ful, or Scoops

For products administered via inhalers, scoops, or applicators, the min/max daily units values are available in
terms of gram weight per inhalation, scoop, or applicator.

The following application shows how to determine the daily dose for a product administered via an inhaler and
how to compare that daily dose to acceptable ranges.

For purposes of demonstrating this application, the following scenario is used: A 30-day supply of
Proventil HFA inhaler 90 mcg (Clinical Formulation ID [GCN_SEQNO, page 1569] 028090) is dispensed to a
45-year-old patient. A total of 17 g is dispensed to the patient. The patient is to take 2 puffs four times per day.
The third party payer wants to screen the daily dose to see if it falls within an acceptable range for reimbursement
purposes.

Part 1: Determine the Prescribed Daily Dose in Units of Grams

Third party payers typically will only know the total quantity of the drug dispensed and the total number of days
the supply will last (known as days supply); therefore, the prescribed daily dose is determined by dividing the
total quantity dispensed (17 g) by the days supply (30 days). The result is 0.567 g per day.

Part 2: Retrieve Daily Dose Unit Ranges

Select the following column values from the modules Master Table where the GCN_SEQNO column equals the
Clinical Formulation ID (GCN_SEQNO) of the prescribed drug.

*Minimum Daily Dose Units Quantity (*_MNU)

*Minimum Daily Dose Units Form (*_MNUF)
*Maximum Daily Dose Units Quantity (*_MXU)
*Maximum Daily Dose Units Form (*_MXUF)

GCN_SEQNO *_MNU *_MNUF *_MXU *_MXUF

028090 0000.033 G 0001.080 G

*_MNU is 0.033, which works in conjunction with the *_MNUF value of G to express the minimum value of
0.033 g per day. The *_MXU is 1.080, which works in conjunction with the *_MXUF value of G to express
the maximum of 1.080 g per day. Therefore, this example shows that the minimum recommendation is
0.033 g per day and that the maximum is 1.080 g per day.

Part 3: Compare the Prescribed Daily Dose to the Acceptable Range

1. To determine whether the dose falls within an acceptable range, compare the prescribed daily dose (0.567
g per day) to the minimum daily dose units value (0.033 g per day) and the maximum daily dose units
value (1.080 g per day). The daily dose falls within the acceptable range so there are no dosing warnings
to issue.

2. Using the modules Master Table and Clinical Formulation ID (GCN_SEQNO), retrieve the Dosing Age
Source Identifier (DOSING_AGE_SOURCE_ID) value. According to your business needs:

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2.

Display the data source information to the end-user.

Determine by the source if the collected dosing record can be used in screening.

Because this example uses the MMAD Master Table (RMMADMA1_ADULT_DOSE_MSTR), the
DOSING_AGE_SOURCE_ID values are not available but may be considered as a Source
Reference for Age Range.

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Calculating and Screening the Prescribed Daily Dose for Ophthalmic Solution and Suspension Products

This application illustrates how to determine the minimum/maximum dosing per day for ophthalmic solution and
suspension products. The prescribed daily dose can be screened using either daily dose strength or daily dose
units. The following examples demonstrate both scenarios:

ExampleCompare Ranges Using Dose Strength

ExampleCompare Ranges Using Dose Units

ExampleCompare Ranges Using Dose Strength

A physician prescribes Timoptic 0.25% eye drops (Clinical Formulation ID [GCN_SEQNO] 007855) for a
30-year-old patient. The patient is to administer one drop into one eye twice daily. The pharmacist wants to
screen the daily dose to see if it falls within an acceptable range.

1. Calculate the prescribed daily dose. One drop is to be administered twice a day in one eye, so multiply 2
times 1 to yield the prescribed daily dose of 2 drops per day.

Dose strength is reported in the number of drops.

2. Select the following column values from the modules Master Table where the GCN_SEQNO column
equals the Clinical Formulation ID (GCN_SEQNO) of the prescribed drug.
*Minimum Daily Dose Strength Quantity (*_MND)
*Minimum Daily Dose Strength Units (*_MNDU)
*Maximum Daily Dose Strength Quantity (*_MXD)
*Maximum Daily Dose Strength Units (*_MXDU)

GCN_SEQNO *_MND *_MNDU *_MXD *_MXDU

007855 000001.000 GTT 000004.000 GTT

*_MND is 1.000, which works in conjunction with the *_MNDU value of GTT to express the minimum
value as 1 gtt per day. The *_MXD is 4.000, which works in conjunction with the *_MXDU value of
GTT to express the ceiling as 4 gtt per day. Therefore, this example shows that the minimum
recommendation is 1 drop per day with a maximum of 4 drops per day.

3. To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the *Minimum Daily Dose Strength Units column
(*_MNDU) and *Maximum Daily Dose Strength Units column (*_MXDU).

DOSING_MODULE_UNIT_ABBRE UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

V

GTT drop drop

4. Compare the prescribed daily dose (2 drops) to the retrieved range (1 to 4 drops). The daily dose of 2
drops is greater than the minimum value (1 drops) but less than the maximum value (4 drops), so the

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4.

prescribed daily dose falls within an acceptable range.

5. Using the modules Master Table and Clinical Formulation ID (GCN_SEQNO), retrieve the Dosing Age
Source Identifier (DOSING_AGE_SOURCE_ID) value. According to your business needs:
Display the data source information to the end-user.
Determine by the source if the collected dosing record can be used in screening.

Because this example uses the MMAD Master Table (RMMADMA1_ADULT_DOSE_MSTR), the
DOSING_AGE_SOURCE_ID values are not available but may be considered as a Source
Reference for Age Range.

ExampleCompare Ranges Using Dose Units

A physician prescribes Timoptic 0.25% eye drops (Clinical Formulation ID [GCN_SEQNO] 007855) for a
30-year-old patient. The patient is to administer one drop into one eye twice daily. The pharmacist wants to
screen the daily dose to see if it falls within an acceptable range.

1. Calculate the prescribed daily dose. FDB uses 20 drops/mL to determine droplet size. To determine the
size of one drop, divide 1 by 20 to yield 0.05 mL. Since the prescribed dose is 2 drops, multiply 2 by 0.05
to yield 0.100 mL.

Dose units are reported in milliliters (mL) to match the drug form.

2. Select the following column values from the modules Master Table where the GCN_SEQNO column
equals the Clinical Formulation ID (GCN_SEQNO) of the prescribed drug.
*Minimum Daily Dose Units Quantity (*_MNU)
*Minimum Daily Dose Units Form (*_MNUF)
*Maximum Daily Dose Units Quantity (*_MXU)
*Maximum Daily Dose Units Form (*_MXUF)

GCN_SEQNO *_MNU *_MNUF *_MXU *_MXUF

007855 0000.050 ML 0000.200 ML

*_MND is 1.000, which works in conjunction with the *_MNDU value of GTT to express the minimum
value as 1 gtt per day. The *_MXD is 4.000, which works in conjunction with the *_MXDU value of
GTT to express the ceiling as 4 gtt per day. Therefore, this example shows that the minimum
recommendation is 1 drop per day with a maximum of 4 drops per day.

3. To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the *Minimum Daily Dose Strength Units column
(*_MNDU) and *Maximum Daily Dose Strength Units column (*_MXDU).

DOSING_MODULE_UNIT_ABBRE UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

V

GTT drop drop

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4. Compare the prescribed daily dose (2 drops) to the retrieved range (1 to 4 drops). The daily dose of 2
drops is greater than the minimum value (1 drops) but less than the maximum value (4 drops), so the
prescribed daily dose falls within an acceptable range.

5. Using the modules Master Table and Clinical Formulation ID (GCN_SEQNO), retrieve the Dosing Age
Source Identifier (DOSING_AGE_SOURCE_ID) value. According to your business needs:
Display the data source information to the end-user.
Determine by the source if the collected dosing record can be used in screening.

Because this example uses the MMAD Master Table (RMMADMA1_ADULT_DOSE_MSTR), the
DOSING_AGE_SOURCE_ID values are not available but may be considered as a Source
Reference for Age Range.

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PDM Applications
This section provides information on the practical use of the data for the Pediatric Dose Module (PDM). PDM
applications are noted separately because dosing for some drugs for certain age ranges within the pediatric age
group may be dependent upon the weight of the child. Because of this, PDM applications may require additional
steps or the use of a PDM Weight/Age Table (RPDMWT1_PEDI_WEIGHT). In addition, some of the applications
for the other four Min/Max Dose Modules (MMAD, MMGD, MMAR, and MMGR) may not apply to PDM.

The following sections are included:

Calculating and Screening the Prescribed Daily Dose for a Single-Ingredient Product

Calculating and Screening the Prescribed Daily Dose for a Multi-ingredient Product

Calculating and Screening the Prescribed Daily Dose for Puffs, Applicator(s)ful, or Scoops

Calculating and Screening the Prescribed Daily Dose for Ophthalmic Solution and Suspension Products

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Calculating and Screening the Prescribed Daily Dose for a Single-Ingredient Product in PDM

This application illustrates how to compare the prescribed daily dose of a single-ingredient product to an
acceptable daily dosage range in three parts. Part 1 requires the Clinical Formulation ID (GCN_SEQNO) and
patient age to retrieve the min/max dosing range. The type of units reflected in the retrieved range indicates
whether the dose is weight-based. This information determines whether you move on to Part 2 or Part 3:

If the dose is weight-based, complete the steps in Part 2 in order to calculate the weight-based min/max
dosing range. Move on to Part 3 to use this range to determine whether the prescribed daily dose falls
within an acceptable range.
If the dose is not weight-based, move on to Part 3 to compare the prescribed daily dose to the daily dose
range retrieved in Part 1.

The prescribed daily dose can be screened using either daily dose strength or daily dose units. The following
examples demonstrate both scenarios:

ExampleComparing Ranges Using Dose Strength

ExampleCompare Ranges Using Dose Units

ExampleComparing Ranges Using Dose Strength

A physician prescribes Ampicillin 250 mg capsules (Clinical Formulation ID [GCN_SEQNO] 008941) to an

11-year-old male patient. This dose is weight-based, and the weight of the patient is unknown. One capsule is to
be taken twice daily, and the pharmacist wants to screen the daily dose to see if it falls within an acceptable
range.

Part 1: Retrieve Age-Specific Min/Max Dosing Range

1. For the given Clinical Formulation ID (GCN_SEQNO), query the PDM Master Table
(RPDMMA1_PEDI_MSTR) and retrieve the minimum daily dose strength value using the PDM Minimum
Daily Dose Strength Quantity (PDM_MND) column and the PDM Minimum Daily Dose Strength Units (
PDM_MNDU) column for the appropriate age of the patient. The patient age must be in the range noted by
the PDM Minimum Dosing Age (PDM_MNAGE) column and the PDM Maximum Dosing Age (
PDM_MXAGE) column.

GCN_SEQNO PDM_MNAGE PDM_MXAGE PDM_MND PDM_MNDU

008941 0030 4744 000050.0000000 10

The PDM_MNAGE column and the PDM_MXAGE column report age in days. One year equals
365 days.

2. Using the same table and Clinical Formulation ID (GCN_SEQNO), retrieve the maximum daily dose
strength value using the PDM Maximum Daily Dose Strength Quantity ( PDM_MXD) column and the PDM
Maximum Daily Dose Strength Units (PDM_MXDU) column for the appropriate age.

GCN_SEQNO PDM_MNAGE PDM_MXAGE PDM_MXD PDM_MXDU

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008941 0030 4744 000100.000000 10

3. Use the PDM Unit Description Table (RPDMUND0_PEDI_DOSE_UNIT_DESC) and the values from the
PDM_MNDU and PDM_MXDU columns to retrieve the dosing units from the PDM Units Code Description
column (PDM_UNDESC).

PDM_UNIT PDM_UNDESC

10 MG/KG/DAY

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the PDM_UNDESC column.

DOSING_MODULE_UNIT_ABBRE UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

V

MG/KG/DAY mg/kg/day milligram per killogram per day

PDM_MND is 50, which works in conjunction with the PDM_MNDU value of 10 (MG/KG/DAY) to express
the minimum value as 50 mg/kg/day. The PDM_MXD is 100, which works in conjunction with the
PDM_MXDU of 10 (MG/KG/DAY) to express the maximum as 100 mg/kg/day. Therefore, this example
shows that the minimum recommended weight-based guideline is 50 mg/kg/day and that the maximum is
100 mg/kg/day.

The dosing units reference kilograms, which means that the dose is weight-based. Therefore, proceed to
Part 2 to calculate the weight-based min/max dosing range. This is the range that the prescribed daily dose
will be compared to.

If the retrieved dosing units only reference an amount per time frame (such as milligram/day) and
not kilogram, the dose is not based on patient weight and it is not necessary to calculate the
weight-based min/max dosing range. If this the case, skip Part 2 and move on to Part 3.

Part 2: Calculate Weight-Based Min/Max Dosing Range

If the results from Part 1 indicate that dosing is based on patient weight, complete the steps in Part 2 to calculate
the weight-based min/max dosing range. This calculation can be made by multiplying the patients weight by the
previously retrieved min/max dosing range from Part 1. After the calculation is made, the maximum value must be
compared to the not-to-exceed daily dose value, and the lesser of the two should be used as the maximum value.

For the calculation, use either the actual weight of the patient or an estimate using the PDM Weight/Age Table.
This example assumes that the actual weight of the patient is unknown.

1. Estimate the weight of the patient if the actual weight is unknown. Using the sex and age of the patient,
query the PDM Weight/Age Table (RPDMWT1_PEDI_WEIGHT) to retrieve the weight of the patient using
the 50th percentile for an 11-year-old male.

PDM_MNAGE PDM_MXAGE PDM_AGEDSC PDM_M50WT

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4015 4196 11.0 years 035.30

The weight for an 11-year-old male patient in the 50th percentile is 35.3KG.

If the weight of the patient is known, use the actual weight.

Dosage ranges displayed and used for checking in the Pediatric Dose Module (PDM) can be
customized by picking the age/weight percentile to use for min/max ranges.

2. Multiply patient weight (35.3 kg) by the retrieved minimum daily weight-based dose (50 mg/kg/day) to yield
a minimum daily dose of 1765 mg/day.

3. Multiply patient weight (35.3 kg) by the retrieved maximum daily weight-based dose (100 mg/kg/day) to
yield a maximum daily dose of 3530 mg/day.

4. For the given Clinical Formulation ID (GCN_SEQNO), query the PDM Master Table
(RPDMMA1_PEDI_MSTR) and retrieve the not-to-exceed daily dose strength values using Pediatric
Dosing Not-to-Exceed Daily Dose Strength Quantity (PDM_NTED) and Pediatric Dosing Not-to-Exceed
Daily Dose Strength Units (PDM_NTEDU).

GCN_SEQNO PDM_NTED PDM_NTEDU

008941 003000.000000 11

PDM_NTED is 3000, which works in conjunction with the PDM_NTEDU value of 11 (MG/DAY) to express
the not-to-exceed value of 3000 mg/day.

5. Compare maximum daily dose strength value (3530 mg/day) to the not-to-exceed daily dose strength value
(3000 mg/day); use the lessor of the two values as the maximum daily dose strength value.

This example shows that the weight-based min/max dosing range is 1765 mg/day to 3000 mg/day for a
typical 11-year-old male.

Part 3: Compare the Prescribed Daily Dose to the Min/Max Dosing Range

Compare the prescribed daily dose to either the weight-based min/max dosing range from Part 2 or to the
non-weight-based Min/Max dosing range from Part 1. For this example, use the weight-based Min/Max dosing
range from Part 2.

1. Calculate the prescribed daily dose. Since the dose is to be given two times per day, multiply 250 mg by 2
to yield the prescribed daily dose of 500 mg per day.

2. Compare the prescribed daily dose (500 mg) to the retrieved daily dose range (1765 mg/day to 3000
mg/day). The daily dose of 500 mg is less than the minimum value (1765 mg/day) and the maximum value
(3000 mg/day), so the prescribed daily dose falls outside an acceptable range.

3. Since the prescribed dose does not fall within the acceptable range, the following message could be
generated: This daily dose is below the daily minimum.

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3.

PDM does not generate warning messages. Your system must be programmed to generate
appropriate messages when the prescribed daily dose falls outside an acceptable range.

4. Using the modules Master Table and Clinical Formulation ID (GCN_SEQNO), retrieve the Dosing Age
Source Identifier (DOSING_AGE_SOURCE_ID) value. According to your business needs:
Display the data source information to the end-user.
Determine by the source if the collected dosing record can be used in screening.

In this example, DOSING_AGE_SOURCE_ID equals 3, indicating that the populated dosing

information may not be specific to this age range.

ExampleCompare Ranges Using Dose Units

A physician prescribes Ampicillin 250 mg capsules (Clinical Formulation ID [GCN_SEQNO] 008941) to an

11-year-old male patient. This dose is weight-based, and the weight of the patient is unknown. One capsule is to
be taken twice daily, and the pharmacist wants to screen the daily dose to see if it falls within an acceptable
range.

Part 1: Retrieve Age-Specific Min/Max Dosing Range

1. For a given Clinical Formulation ID (GCN_SEQNO), query the RPDMMA0_PEDI_MSTR table and retrieve
the minimum daily dose units value using PDM Minimum Daily Dose Units Quantity column ( PDM_MNU)
and PDM Minimum Daily Dose Units Form column (PDM_MNUF) for the appropriate age of the patient.
The patient age must be in the range noted by the PDM Minimum Dosing Age ( PDM_MNAGE) column and
the PDM Maximum Dosing Age (PDM_MXAGE) column.

GCN_SEQNO PDM_MNAGE PDM_MXAGE PDM_MNU PDM_MNUF

008941 0030 4744 000000.200000 01

The PDM_MNAGE column and the PDM_MXAGE column report age in days. One year equals
365 days.

2. Using the same table and Clinical Formulation ID (GCN_SEQNO), retrieve the maximum daily dose units
value using PDM Maximum Daily Dose Units Quantity column (PDM_MXU, page 2079) and PDM
Maximum Daily Dose Units Form column (PDM_MXUF, page 2080) for the appropriate age.

GCN_SEQNO PDM_MNAGE PDM_MXAGE PDM_MXU PDM_MXUF

008941 0030 4744 000000.400000 01

Use the PDM Unit Description Table (RPDMUND0_PEDI_DOSE_UNIT_DESC, page 620) and the values
from the PDM_MNUF and PDM_MXUF columns to retrieve the dosing units from the PDM Units Code
Description column (PDM_UNDESC, page 2085).

PDM_UNIT PDM_UNDESC

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01 EA/KG/DAY

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the PDM_UNDESC column.

DOSING_MODULE_UNIT_ABBRE UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

V

EA/KG/DAY each/kg/day milligram per killogram per day

PDM_MNU is 0.2, which works in conjunction with the PDM_MNUF value of 01 (EA/KG/DAY) to express
the minimum value of 0.2 capsules per kg per day. The PDM_MXU is 0.4, which works in conjunction with
the PDM_MXUF value of 01 (EA/KG/DAY) to express the maximum of 0.4 capsules per kg per day.
Therefore, this example shows that the minimum recommended dose unit is 0.2 each/kg/day and that the
maximum is 0.4 each/kg/day.

The dosing units reference kilogram, which means that the dose is weight based. Therefore, proceed to
Part 2 to calculate the weight-based min/max dosing range. This is the range that the prescribed daily dose
will be compared to.

If the retrieved dosing units only reference an amount per time frame (such as mg/day), the dose is
not based on patient weight and it is not necessary to calculate the weight-based min/max dosing
range. If this the case, move on to Part 3.

Part 2: Calculate Min/Max Weight-Based Dosing Range

If the results from Part 1 indicate that dosing is based on patient weight, complete the steps in Part 2 to calculate
the weight-based min/max dosing range. This calculation can be made by multiplying the patients weight by the
previously retrieved min/max dosing range from Part 1. After the calculation, the maximum value must be
compared to the not-to-exceed daily dose value, and the lesser of the two should be used as the maximum value.

Use either the actual weight of the patient or an estimate using the PDM Weight/Age Table. This example
assumes that the actual weight of the patient is unknown.

1. Determine the weight of the patient. Using the sex and age of the patient, query the PDM Weight/Age
Table (RPDMWT1_PEDI_WEIGHT) to retrieve the weight of the patient using the 50th percentile for an
11-year-old male.

PDM_MNAGE PDM_MXAGE PDM_AGEDSC PDM_M50WT

4015 4196 11.0 years 035.30

The weight for an 11-year-old male patient in the 50th percentile is 35.3 kg.

If the weight of the patient is known, use the actual weight.

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Dosage ranges displayed in the Pediatric Dosing Module (PDM) can be customized by picking the
age/weight percentile to use for min/max ranges.

2. Multiply patient weight (35.3 kg) by the retrieved minimum daily weight-based dose (0.2 each/kg/day) to
yield a minimum daily dose of 7.06 each/day.

3. Multiply patient weight (35.3 kg) by the retrieved maximum daily weight-based dose (0.4 each/kg/day) to
yield a maximum daily dose of 14.12 each/day.

4. For the given Clinical Formulation ID (GCN_SEQNO), query the PDM Master Table
(RPDMMA1_PEDI_MSTR) and retrieve the not-to-exceed daily dose unit values using Pediatric Dosing
Not-to-Exceed Daily Dose Units Quantity (PDM_NTEU) and the Pediatric Dosing Not-to-Exceed Daily
Dose Units Form (PDM_NTEUF).

GCN_SEQNO PDM_NTED PDM_NTEDU

008941 000012.0000 02

5. Use the PDM Unit Description Table (RPDMUND0_PEDI_DOSE_UNIT_DESC) and the values from the
PDM_NTEUF column to retrieve the dosing units from the PDM Units Code Description column (
PDM_UNDESC).

PDM_UNIT PDM_UNDESC

02 EA/DAY

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the PDM_UNDESC column.

DOSING_MODULE_UNIT_ABBRE UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

V

EA/DAY each/day each per day

PDM_NTEU is 12, which works in conjunction with the PDM_NTEUF value of 02 (EA/DAY) to express the
not-to-exceed value of 12 each/day.

6. Compare maximum daily dose (14.12 each/day) to the not-to-exceed daily dose (12 each/day); use the
lessor of the two values as the maximum daily dose.
This example shows that the weight-based min/max dosing range is 7.06 each/day to 12 each/day.

Part 3: Compare the Prescribed Daily Dose to the Weight-Based Dosing Range

Compare the prescribed daily dose to either the weight-based min/max dosing range from Part 2 or to the
non-weight-based min/max dosing range from Part 1. For this example, use the weight-based min/max dosing
range from Part 2.

1. Calculate the prescribed daily dose. The dose is to be given two times per day, so the prescribed daily
dose is 2 capsules per day.

2.

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2. Compare the prescribed daily dose (2 capsules) to the retrieved daily dose range (7.06 each/day to 12
each/day). The daily dose of 2 capsules is less than the minimum value (7.06 capsules) and the maximum
value (12 capsules), so the prescribed daily dose falls outside an acceptable range.

3. Since the prescribed dose does not fall within the acceptable range, the following message could be
generated: This daily dose is below the daily minimum.

PDM does not generate warning messages. Your system must be programmed to generate
appropriate messages when the prescribed daily dose falls outside an acceptable range.

4. Using the modules Master Table and Clinical Formulation ID (GCN_SEQNO), retrieve the Dosing Age
Source Identifier (DOSING_AGE_SOURCE_ID) value. According to your business needs:
Display the data source information to the end-user.
Determine by the source if the collected dosing record can be used in screening.

In this example, DOSING_AGE_SOURCE_ID equals 3, indicating that the populated dosing

information may not be specific to this age range.

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Calculating and Screening the Prescribed Daily Dose for a Multi-ingredient Product in PDM

PDM compares the prescribed daily dose for a multi-ingredient product to an acceptable daily dosage range. For
a multi-ingredient product, the prescribed daily dose can only be screened using daily dose units.
For purposes of demonstrating this application, the following scenario is used: A physician prescribes Amoxicillin
Trihydrate/Clavulanic acid tablets (Clinical Formulation ID [GCN_SEQNO, page 1569] 008991) for a 13-year-old
patient. The patient is to take 5 tablets twice daily. The pharmacist wants to screen the daily dose to see if it falls
within an acceptable range.

1. Calculate the prescribed daily dose. The patient is to take 5 tablets twice daily, so multiply 5 times 2 to
yield the prescribed daily dose of 10 tablets per day.

2. For a given Clinical Formulation ID (GCN_SEQNO), query the PDM Master Table
(RPDMMA1_PEDI_MSTR) and retrieve the minimum daily dose units value using PDM Minimum Daily
Dose Units Quantity column (PDM_MNU) and PDM Minimum Daily Dose Units Form column (PDM_MNUF
) for the appropriate age. The patient age must be in the range noted by the PDM Minimum Dosing Age (
PDM_MNAGE) column and the PDM Maximum Dosing Age (PDM_MXAGE) column.

3. Using the same table and Clinical Formulation ID (GCN_SEQNO), retrieve the maximum daily dose units
value using PDM Maximum Daily Dose Units Quantity column ( PDM_MXU) and PDM Maximum Daily
Dose Units Form column (PDM_MXUF) for the appropriate age.

GCN_SEQN PDM_MNAG PDM_MXAG PDM_MNU PDM_MNI PDM_MXU PDM_MXUF

O E E

008991 3285 6569 000003.00000 02 000003.00000 02

The PDM_MNAGE and PDM_MXAGE columns report age in days. One year equals 365 days.

4. Use the PDM Unit Description Table (RPDMUND0_PEDI_DOSE_UNIT_DESC) and the values from the
PDM_MNUF and PDM_MXUF columns to retrieve the dosing units from the PDM Units Code Description
column (PDM_UNDESC).

PDM_UNIT PDM_UNDESC

02 EA/DAY

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the PDM_UNDESC column.

DOSING_MODULE_UNIT_ABBRE UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

V

EA/DAY each/day each per day

PDM_MNU is 3, which works in conjunction with the PDM_MNUF value of 02 (EA/DAY) to express the
minimum value of 3 tablets per day. The PDM_MXU is 3, which works in conjunction with the PDM_MXUF
value of 02 (EA/DAY) to express the maximum of 3 tablets per day. Therefore, this example shows that the

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minimum recommended dose unit for Amoxicillin Trihydrate/Clavulanic acid tablets is 3 each/day and that
the maximum is 3 each/day.

5. Compare the prescribed daily dose (10 tablets) to the retrieved range (3 each/day to 3 each/day). The
prescribed daily dose of 10 tablets is greater than the minimum and maximum value of 3 tablets.
Therefore, the prescribed daily dose falls outside the acceptable range.

6. Since the prescribed dose does not fall within the acceptable range, the following message could be
generated: This daily dose exceeds the daily maximum.

PDM does not generate warning messages. Your system must be programmed to generate
appropriate messages when the prescribed daily dose falls outside an acceptable range.

7. Using the modules Master Table and Clinical Formulation ID (GCN_SEQNO), retrieve the Dosing Age
Source Identifier (DOSING_AGE_SOURCE_ID) value. According to your business needs:
Display the data source information to the end-user.
Determine by the source if the collected dosing record can be used in screening.

In this example, DOSING_AGE_SOURCE_ID equals 3, indicating that the populated dosing

information may not be specific to this age range.

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Calculating and Screening the Prescribed Daily Dose for Puffs, Applicator(s)ful, or Scoops in PDM

For products administered via inhalers, scoops, or applicators, the min/max daily units values are available in
terms of gram weight per inhalation, scoop, or applicator.

Min/max daily dose units for inhalers are coded based on one package size. When more than one
package size exists, the data is coded based upon the most common size which is determined by the
FDB clinical staff. Inhalers will use the minimum dosage based upon the smallest package size, and the
maximum dosage based upon the largest package size. This provides a true dosing range, but does not
reflect each individual container.

The following application shows how to determine the daily dose for a product administered via an inhaler and
how to compare that daily dose to acceptable ranges retrieved from PDM.

For purposes of demonstrating this application, the following scenario is used: A 30-day supply of
Albuterol inhaler 90 mcg aerosol (Clinical Formulation ID [GCN_SEQNO] 028090) is dispensed to a 7-year-old
patient. A total of 17 g is dispensed to the patient. The patient is to take 2 puffs four times per day. The third party
payer wants to screen the daily dose to see if it falls within an acceptable range.

Part 1: Determine the Prescribed Daily Dose in Units of Grams

Third party payers typically will only know the total quantity of the drug dispensed and the total number of days
the supply will last (known as days supply); therefore, the prescribed daily dose is determined by dividing the
total quantity dispensed (17 g) by the days supply (30 days). The result is 0.567 g/day.

Part 2: Retrieve Daily Dose Unit Ranges

1. For a given Clinical Formulation ID (GCN_SEQNO), query the PDM Master Table
(RPDMMA1_PEDI_MSTR) and retrieve the minimum daily dose units value using PDM Minimum Daily
Dose Units Quantity column (PDM_MNU) and PDM Minimum Daily Dose Units Form column (PDM_MNUF
) for the appropriate age. The patient age must be in the range noted by the PDM Minimum Dosing Age (
PDM_MNAGE) column and the PDM Maximum Dosing Age (PDM_MXAGE) column.

2. Using the same table and Clinical Formulation ID (GCN_SEQNO), retrieve the maximum daily dose units
value using PDM Maximum Daily Dose Units Quantity column ( PDM_MXU) and PDM Maximum Daily
Dose Units Form column (PDM_MXUF) for the appropriate age.

GCN_SEQN PDM_MNAG PDM_MXAG PDM_MNU PDM_MNI PDM_MXU PDM_MXUF

O E E

028090 1460 4379 000000.03300 06 0000000.7200 06

0 00

GCN_SEQN PDM_MNAG PDM_MXAG PDM_MNU PDM_MNI PDM_MXU PDM_MXUF

O E E

058671 4380 6569 000000.10200 06 000000.81300 06

0 0

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The PDM_MNAGE and PDM_MXAGE columns report age in days. One year equals 365 days.

Use the PDM Unit Description Table (RPDMUND0_PEDI_DOSE_UNIT_DESC, page 620) and the values
from the PDM_MNUF and PDM_MXUF columns to retrieve the dosing units from the PDM Units Code
Description column (PDM_UNDESC, page 2085).

PDM_UNIT PDM_UNDESC

06 G/DAY

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC, page 131) using the values from the PDM_UNDESC column.

DOSING_MODULE_UNIT_ABBRE UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

V

G/DAY gram/day gram per day

PDM_MNU is 0.033, which works in conjunction with the PDM_MNUF value of 06 (G/DAY) to express the
minimum value of 0.033 g/day. The PDM_MXU is 0.720, which works in conjunction with the PDM_MXUF
value of 06 (G/DAY) to express the maximum of 0.720 g/day. Therefore, this example shows that the
minimum recommendation is 0.033 g/day and that the maximum is 0.720 g/day.

Part 3: Compare the Prescribed Daily Dose to the Acceptable Range

1. To determine whether the dose falls within an acceptable range, compare the prescribed daily dose (0.567
g/day) to the Minimum Daily Dose Units value (0.033 g/day) and the Maximum Daily Dose Units value
(0.720 g/day). The daily dose falls within the acceptable range so there are no dosing warnings to issue.

2. Using the modules Master Table and Clinical Formulation ID (GCN_SEQNO), retrieve the Dosing Age
Source Identifier (DOSING_AGE_SOURCE_ID) value. According to your business needs:
Display the data source information to the end-user.
Determine by the source if the collected dosing record can be used in screening.

In this example, DOSING_AGE_SOURCE_ID equals 3, indicating that the populated dosing

information may not be specific to this age range.

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Calculating and Screening the Prescribed Daily Dose for Ophthalmic Solution and Suspension Products in PDM

This application illustrates how to determine the minimum/maximum dosing per day for ophthalmic solution and
suspension products. The prescribed daily dose can be screened using either daily dose strength or daily dose
units. This example below uses a multi-ingredient product, which requires dose unit screening.

For purposes of demonstrating this application, the following scenario is used: A physician prescribes
Tobradex ST eye drops (Clinical Formulation ID [GCN_SEQNO] 066617) for a 15-year-old patient. The patient is
to administer one drop into one eye twice daily. The pharmacist wants to screen the daily dose to see if it falls
within an acceptable range. The prescribed daily dose can be screened using either daily dose strength or daily
dose units.

1. Calculate the prescribed daily dose. FDB uses a convention of 20 drops/mL to determine droplet volume.
To determine the volume of one drop, divide 1 by 20 to yield 0.05 mL. Since the prescribed dose is 2
drops, multiply 2 by 0.05 to yield 0.100 mL.

Dose units are reported in milliliters (mL) to match the drug form.

2. For a given Clinical Formulation ID (GCN_SEQNO), query the PDM Master Table
(RPDMMA1_PEDI_MSTR) table and retrieve the minimum daily dose units value using PDM Minimum
Daily Dose Units Quantity column (PDM_MNU) and PDM Minimum Daily Dose Units Form column (
PDM_MNUF) for the appropriate age of the patient. The patient age must be in the range noted by the
PDM Minimum Dosing Age (PDM_MNAGE) column and the PDM Maximum Dosing Age (PDM_MXAGE)
column.

3. Using the same table and Clinical Formulation ID (GCN_SEQNO), retrieve the maximum daily dose units
value using PDM Maximum Daily Dose Units Quantity column ( PDM_MXU) and PDM Maximum Daily
Dose Units Form column (PDM_MXUF).

GCN_SEQN PDM_MNAG PDM_MXAG PDM_MNU PDM_MNI PDM_MXU PDM_MXUF

O E E

066617 730 6569 000000.20000 04 000001.20000 04

0 0

The PDM_MNAGE and PDM_MXAGE columns report age in days. One year equals 365 days.

4. Use the PDM Unit Description Table (RPDMUND0_PEDI_DOSE_UNIT_DESC) and the values from the
PDM_MNUF and PDM_MXUF columns to retrieve the dosing units from the PDM Units Code Description
column (PDM_UNDESC).

PDM_UNIT PDM_UNDESC

04 ML/DAY

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the PDM_UNDESC column.

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DOSING_MODULE_UNIT_ABBRE UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

V

ML/DAY mL/day milliliter per day

PDM_MNU is 0.2, which works in conjunction with the PDM_MNUF value of 04 (ML/DAY) to express the
minimum value of 0.200 mL/day. The PDM_MXU is 1.200, which works in conjunction with the
PDM_MXUF value of 04 (ML/DAY) to express the maximum of 1.200 mL/day. Therefore, this example
shows that the minimum value is 0.200 mL/day and that the maximum is 1.200 mL/day.

5. Compare the prescribed daily dose (0.100 mL) to the retrieved range (0.200 mL/day to 1.200 mL/day). The
prescribed daily dose of 0.100 mL is less than the minimum value (0.200 mL/day) and less than the
maximum value (1.200 mL/day). Therefore, the prescribed daily dose falls outside the acceptable range.

6. Since the prescribed dose does not fall within the acceptable range, the following message can be
generated: This daily dose is below the daily minimum.

PDM does not generate warning messages. Your system must be programmed to generate
appropriate messages when the prescribed daily dose falls outside an acceptable range.

7. Using the modules Master Table and Clinical Formulation ID (GCN_SEQNO), retrieve the Dosing Age
Source Identifier (DOSING_AGE_SOURCE_ID) value. According to your business needs:
Display the data source information to the end-user.
Determine by the source if the collected dosing record can be used in screening.

In this example, DOSING_AGE_SOURCE_ID equals 3, indicating that the supporting reference may not
be specific to age.

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NEOM Applications
This section provides information about the practical application of data contained in the Neonatal and Infant
Dosage Range Check Module (NEOM). The following sections are included:

FDB offers a variety of drug concepts and their identifiers to support a range of applications using the data in
MedKnowledge. These identifiers represent drug products, ingredients, and formulations and are referred to as
Multiple Access Points (MAPs). From a development point of view, familiarity with the Multiple Access Points
(MAPs) section is advantageous before attempting the applications contained in this section.

Performing Dosage Range Checking

Considerations for Using NEOM

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Performing Dosage Range Checking

NEOM can be used to perform dosage range checking when a patients reason for use is either known or
unknown.

For an example of performing dosage range checking when a patients reason for use is known, see
Performing Dosage Range Checking Using a DxID or ICD Code.

Dosage range checking can be performed when some patient information is unknown, but the information
retrieved is less specific. For example, you can query for dosage range checking and not specify a dose type
which results in all of the available dose types being retrieved. If you still want to perform dosage range checking
without knowing the dose type, you can default to a dose type, such as a maintenance dose, and present the
dosage range information to the end user prefaced with a note that the range information is using the
maintenance dose type as the default.

When performing dosage range checking it may be necessary to convert the NEOM units to the
prescribed units. When performing dosage range checking on extemporaneously compounded drugs,
each active ingredient should be screened individually.

The following application assumes familiarity with the various drug concepts and their identifiers and how to
access clinical information. This application begins at the Clinical Formulation level with the Clinical Formulation
ID (GCN_SEQNO). See Multiple Access Points (MAPs) for more information.

The examples following the application demonstrate the following:

ExampleDose Range Checking for a Neonatal Patient

ExampleDose Range Checking of Non-patient Parameters
ExamplePerforming Dosage Range Checking of a Continuous Infusion
ExamplePerforming Dose Range Checking of an Intermittent Infusion

Part 1: Collect Dosage Range Check Data

This part of the application collects the appropriate data for dosage range checking.

1. Select records from the NEOM Master Table (RNEOMMA1_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. NEOM Route Code (NEOM_ROUTE_CODE) column equals the route of administration for the
prescribed medication, and

c. NEOM Dose Type Code (NEOM_DOSE_TYPE_CODE) column equals the dose type for the
prescribed medication, and

d. NEOM High Age in Days (NEOM_HIGH_AGE_DAYS) column is greater than or equal to the patient
age in days, and

e.

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e. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 00004892 (default screening record).

2. Select the Dosing Age Source Identifier (DOSING_AGE_SOURCE_ID) from the RDRCNMA2_MSTR table
where the columns equal the dosing record collected in step 1. According to your business needs:

a. Display the data source information to the end-user.

b. Determine by the source if the collected dosing record can be used in screening.

3. Check the NEOM Weight Required Indicator (NEOM_WEIGHT_REQ_IND):

a. If NEOM_WEIGHT_REQ_IND equals 0, the current weight is not required to select the screening
record.

b. If NEOM_WEIGHT_REQ_IND equals 1, the current weight is required to select the screening

record.

4. Check the NEOM Gestational Birth Age Required Indicator (NEOM_GEST_BIRTH_AGE_REQ_IND):

a. If NEOM_GEST_BIRTH_AGE_REQ_IND equals 0, the gestational age at birth is not required to

select the screening record.

b. If NEOM_GEST_BIRTH_AGE_REQ_IND equals 1, the gestational age at birth is required to select

the screening record.

5. Filter the records returned in step 1 where the:

a. NEOM Low Gestational Age at Birth in Weeks (NEOM_LOW_GEST_BIRTH_AGE_WEEKS) column

is less than or equal to the patients gestational birth age in weeks, and

b. NEOM High Gestational Age at Birth in Weeks (NEOM_HIGH_GEST_BIRTH_AGE_WEEKS)

column is greater than or equal to the patients gestational birth age in weeks.

Part 2: Dose Range Checking

This section compares the prescription information with the data retrieved in Part 1 and displays alerts when
needed. See Considerations for Generating DRCM Warning Messages to view sample user alerts for each of the
dose range checks.

1. Compare the prescribed frequency of administration per day to NEOM Low Frequency (
NEOM_LOW_FREQUENCY) and NEOM High Frequency (NEOM_HIGH_FREQUENCY):

a. If the prescribed frequency is equal to either NEOM_LOW_FREQUENCY or

NEOM_HIGH_FREQUENCY, or within the value range, the order is acceptable and does not
produce an alert.

b. If the prescribed frequency is less than NEOM_LOW_FREQUENCY, alert the user that the
prescribed frequency is less than the recommended minimum frequency for the drug (sample
message 8).

c.

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c. If the prescribed frequency is greater than NEOM_HIGH_FREQUENCY, alert the user that the
prescribed frequency exceeds the recommended maximum frequency for the drug (sample
message 9).

2. Compare the prescribed duration of therapy in days to NEOM Low Duration of Therapy (
NEOM_LOW_DURATION_OF_TX) and NEOM High Duration of Therapy (
NEOM_HIGH_DURATION_OF_TX):

a. If the prescribed duration of therapy is equal to either NEOM_LOW_DURATION_OF_TX or

NEOM_HIGH_DURATION_OF_TX, or within the value range, the order is acceptable and does not
produce an alert.

b. If the prescribed duration of therapy is less than NEOM_LOW_DURATION_OF_TX, alert the user
that the prescribed duration is less than the recommended low duration for the drug (sample
message 10).

c. If the prescribed duration of therapy is greater than NEOM_HIGH_DURATION_OF_TX, compare

the recommended maximum duration of therapy to the prescribed duration of therapy.

3. Compare the prescribed daily dose (convert units if necessary) to NEOM Low Dose per Day (
NEOM_LOW_DOSE_PER_DAY) and NEOM High Dose per Day (NEOM_HIGH_DOSE_PER_DAY):

a. If the prescribed daily dose is equal to either NEOM_LOW_DOSE_PER_DAY or

NEOM_HIGH_DOSE_PER_DAY, or within the value range, the order is acceptable and does not
produce an alert.

b. If the prescribed daily dose is less than NEOM_LOW_DOSE_PER_DAY, alert the user that the
prescribed dose is less than the recommended low daily dose for the drug (sample message 1).

c. If the prescribed daily dose is greater than NEOM_HIGH_DOSE_PER_DAY, compare the

recommended maximum daily dose to the prescribed daily dose.

4. Compare the prescribed daily dose (convert units if necessary) to NEOM Maximum Dose per Day (
NEOM_MAX_DOSE_PER_DAY):

a. If the prescribed daily dose is equal to or less than NEOM_MAX_DOSE_PER_DAY, alert the user
that the prescribed dose exceeds the recommended high daily dose for the drug but is less than the
recommended maximum daily dose (sample message 2).

b. If the prescribed daily dose is greater than NEOM_MAX_DOSE_PER_DAY, alert the user that the
prescribed dose exceeds the recommended maximum daily dose for the drug (sample message 3).

5. Compare the prescribed single dose (convert units if necessary) to NEOM Maximum Single Dose (
NEOM_MAX_SINGLE_DOSE) and the Not-to-Exceed Amount Per Single Dose (NTE_SINGLE_DOSE):

a. If the prescribed single dose is equal to or less than NEOM_MAX_SINGLE_DOS and

NTE_SINGLE_DOSE, the order is acceptable and does not produce an alert.

b. If the prescribed individual dose is greater than either NEOM_MAX_SINGLE_DOSE and/or

NTE_SINGLE_DOSE, alert the user that the prescribed dose exceeds the recommended maximum

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b.

single dose for the drug (sample message 4a, 4b, or 4c).

6. Display the NEOM Maximum Lifetime Dose (NEOM_MAX_LIFE_DOSE) value:

a. If NEOM_MAX_LIFE_DOSE equals 0, the maximum lifetime dose is unavailable.

b. If NEOM_MAX_LIFE_DOSE does not equal 0, display the maximum lifetime dose value for the
prescribed medication (sample message 15).

Part 3: Optionally Display Additional Dose Adjustment Information

1. Select the prescribed medications NEOM Renal Impairment Indicator (

NEOM_RENAL_IMPAIRMENT_IND):

a. If NEOM_RENAL_IMPAIRMENT_IND equals N, the order is acceptable and does not produce an

alert.

b. If NEOM_RENAL_IMPAIRMENT_IND equals Y, alert the user that the dose may need to be
adjusted for renal impairment (sample message 5).

2. Display the patients creatinine clearance (convert units if necessary) and the NEOM Creatinine Clearance
Threshold (NEOM_CREATININE_CLR_THRESHOLD) if necessary:

a. If NEOM_CREATININE_CLR_THRESHOLD equals 0, you may want to alert the user that creatinine
clearance threshold checking is unavailable.

b. If the patients creatinine clearance is unavailable, alert the user that a drug dosage adjustment
should be considered (sample message 6, appended to message 5).

c. If the patients creatinine clearance is less than NEOM_CREATININE_CLR_THRESHOLD, alert the

user that a drug dosage adjustment should be considered (sample message 6, appended to
message 5).

d. If the patients creatinine clearance is greater than NEOM_CREATININE_CLR_THRESHOLD,

continue screening the order without displaying any additional messages.

3. Check the NEOM Hepatic Impairment Indicator (NEOM_HEPATIC_IMPAIRMENT_IND):

a. If NEOM_HEPATIC_IMPAIRMENT_IND equals N, the order is acceptable and does not produce an

alert.

b. If NEOM_HEPATIC_IMPAIRMENT_IND equals Y, alert the user that the dose may need to be
adjusted for hepatic impairment (sample message 7).

4. Display the NEOM Low Elimination Half Life (NEOM_LOW_ELIM_HALF_LIFE) and NEOM High
Elimination Half Life (NEOM_HIGH_ELIM_HALF_LIFE) range (or value):

a. If both NEOM_LOW_ELIM_HALF_LIFE and NEOM_HIGH_ELIM_HALF_LIFE equal 0, the

elimination half-life range (or value) is unavailable.

b. If either NEOM_LOW_ELIM_HALF_LIFE or NEOM_HIGH_ELIM_HALF_LIFE does not equal 0,

display the elimination half-life range (or value) for the patient. (sample message 14).

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ExampleDose Range Checking for a Neonatal Patient

A patient has a prescription for a loading dose (NEOM_DOSE_TYPE_CODE 01) of Digoxin 0.25 mg/mL (Clinical
Formulation ID [GCN_SEQNO, page 1569] 15) 30 mcg intravenous(NEOM_ROUTE_CODE 052) given in 3
divided doses to be given as follows: 15 mcg now followed by 7.5 mcg for 2 doses. The reason for use is not
available. The patient is 10 days old and weighs 1,500 grams (1.5 kg). The gestational age at birth was 29 weeks.

Part 1: Collect Dosage Range Check Data

1. Select records from the NEOM Master Table (RNEOMMA1_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. NEOM Route Code (NEOM_ROUTE_CODE) column equals the route of administration for the
prescribed medication, and

c. NEOM Dose Type Code (NEOM_DOSE_TYPE_CODE) column equals the dose type for the
prescribed medication, and

d. NEOM High Age in Days (NEOM_HIGH_AGE_DAYS) column is greater than or equal to the patient
age in days, and

e. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 00004892 (default screening record).

GCN_SEQNO 15 15

DR2_RT 052 052

DR2_DOSTPI 01 01

DR2_LOAGED 0 0

DR2_HIAGED 119 119

DXID 4892 4892

2. Select the Dosing Age Source Identifier (DOSING_AGE_SOURCE_ID) from the RDRCNMA2_MSTR table
where the columns equal the dosing record collected in step 1. According to your business needs:

a. Display the data source information to the end-user.

b. Determine by the source if the collected dosing record can be used in screening.
In this example, DOSING_AGE_SOURCE_ID equals 3, indicating that this supporting reference
may not be specific to the given age group.

3. Check the NEOM Weight Required Indicator (NEOM_WEIGHT_REQ_IND):

a. If NEOM_WEIGHT_REQ_IND equals 0, the current weight is not required to select the screening
record.

b.

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b. If NEOM_WEIGHT_REQ_IND equals 1, the current weight is required to select the screening

record.
In this example, NEOM_WEIGHT_REQ_IND equals 0, indicating that the current weight is not
required to select the screening record. The system checks the gestational age at birth required
indicator.

4. Check the NEOM Gestational Birth Age Required Indicator (NEOM_GEST_BIRTH_AGE_REQ_IND):

a. If NEOM_GEST_BIRTH_AGE_REQ_IND equals 0, the gestational age at birth is not required to

select the screening record.

b. If NEOM_GEST_BIRTH_AGE_REQ_IND equals 1, the gestational age at birth is required to select

the screening record.
In this example, NEOM_GEST_BIRTH_AGE_REQ_IND equals 1. The system prompts the user to
enter the gestational age of the patient at birth in weeks.

5. Filter the records returned in step 1 where the:

a. NEOM Low Gestational Age at Birth in Weeks (NEOM_LOW_GEST_BIRTH_AGE_WEEKS) column

is less than or equal to the patients gestational birth age in weeks, and

b. NEOM High Gestational Age at Birth in Weeks (NEOM_HIGH_GEST_BIRTH_AGE_WEEKS)

column is greater than or equal to the patients gestational birth age in weeks.

GCN_SEQNO 15 15

DR2_RT 052 052

DR2_DOSTPI 01 01

DR2_LOAGED 0 0

DR2_HIAGED 119 119

DXID 4892 4892

NEOM_LOW_GEST_BIRTH_AG 370
E_WEEKS

NEOM_HIGH_GEST_BIRTH_A 0 36
GE_WEEKS

In this example, the weight range of 0 to 36 weeks is retrieved by the system after the user enters
the patients gestational age of the patient at birth of 29 weeks. Using the retrieved record, the
system begins dose range checking.

Part 2: Dose Range Checking

This section compares the prescription information with the data retrieved in Part 1 and displays alerts when
needed.

1. Compare the prescribed frequency of administration per day to NEOM Low Frequency (

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1.

NEOM_LOW_FREQUENCY) and NEOM High Frequency (NEOM_HIGH_FREQUENCY):

a. If the prescribed frequency is equal to either NEOM_LOW_FREQUENCY or

NEOM_HIGH_FREQUENCY, or within the value range, the order is acceptable and does not
produce an alert.

b. If the prescribed frequency is less than NEOM_LOW_FREQUENCY, alert the user that the
prescribed frequency is less than the recommended minimum frequency for the drug (sample
message 8).

c. If the prescribed frequency is greater than NEOM_HIGH_FREQUENCY, alert the user that the
prescribed frequency exceeds the recommended maximum frequency for the drug (sample
message 9).

NEOM_LOW_FREQUENCY NEOM_HIGH_FREQUENCY Prescribed Frequency

1 3 3 per day

In this example, the prescribed frequency of 3 per day is within the NEOM_LOW_FREQUENCY and
the NEOM_HIGH_FREQUENCY value range of 1 to 3 per day. The system passes the order and
continues screening.

2. Compare the prescribed duration of therapy in days to NEOM Low Duration of Therapy (
NEOM_LOW_DURATION_OF_TX) and NEOM High Duration of Therapy (
NEOM_HIGH_DURATION_OF_TX):

a. If the prescribed duration of therapy is equal to either NEOM_LOW_DURATION_OF_TX or

NEOM_HIGH_DURATION_OF_TX, or within the value range, the order is acceptable and does not
produce an alert.

b. If the prescribed duration of therapy is less than NEOM_LOW_DURATION_OF_TX, alert the user
that the prescribed duration is less than the recommended low duration for the drug (sample
message 10).

c. If the prescribed duration of therapy is greater than NEOM_HIGH_DURATION_OF_TX, compare

the recommended maximum duration of therapy to the prescribed duration of therapy.

NEOM_LOW_DURATION_OF_T NEOM_HIGH_DURATION_OF_ Prescribed duration

X TX

1 2 1 day

In this example, the prescribed duration is equal to the NEOM_LOW_DURATION_OF_TX value of 1

day. The system passes the order and continues screening.

3. Compare the prescribed daily dose (convert units if necessary) to NEOM Low Dose per Day (
NEOM_LOW_DOSE_PER_DAY) and NEOM High Dose per Day (NEOM_HIGH_DOSE_PER_DAY):

a. If the prescribed daily dose is equal to either NEOM_LOW_DOSE_PER_DAY or

NEOM_HIGH_DOSE_PER_DAY, or within the value range, the order is acceptable and does not

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a.

produce an alert.

b. If the prescribed daily dose is less than NEOM_LOW_DOSE_PER_DAY, alert the user that the
prescribed dose is less than the recommended low daily dose for the drug (sample message 1).

c. If the prescribed daily dose is greater than NEOM_HIGH_DOSE_PER_DAY, compare the

recommended maximum daily dose to the prescribed daily dose.
The NEOM Unit Code Description (NEOM_UNIT_CODE_DESC) column is from the NEOM Unit
Code Description Table (RNEOMUD0_UNITS_DESC).

NEOM_LOW_DOSE_PER_DAY 15

NEOM_LOW_DOSE_UNIT_CODE 46

NEOM_UNIT_CODE_DESC MCG/KG/DAY

NEOM_HIGH_DOSE_PER_DAY 35

NEOM_HIGH_DOSE_UNIT_CODE 46

NEOM_UNIT_CODE_DESC MCG/KG/DAY

Prescribed dose per day 30 mcg/day

In this example, 15 mcg is prescribed once and 7.5 is prescribed twice over 1 day. Therefore, the
dose per day is 15 + (7.5 X 2) = 30 mcg/day.
Since the retrieved units are given in mcg/kg/day and the prescription is written in mcg/day, it is
necessary to convert the units of measure. The following table shows the data after the conversion.

NEOM_LOW_DOSE_PER_DAY 22.5

NEOM_LOW_DOSE_UNIT_CODE 08

NEOM_UNIT_CODE_DESC MCG/DAY

NEOM_HIGH_DOSE_PER_DAY 52.5

NEOM_HIGH_DOSE_UNIT_CODE 08

NEOM_UNIT_CODE_DESC MCG/DAY

Prescribed dose per day 30 mcg/day

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the UNITS_DESC column.

DOSING_MODULE_UNIT_ABB UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

REV

MCG/DAY mcg/day microgram per day

In this example, the prescribed dose of 30 mcg/day is within the NEOM_LOW_DOSE_PER_DAY

and NEOM_HIGH_DOSE_PER_DAY value range. The system passes the order and continues

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screening.

4. Compare the prescribed single dose (convert units if necessary) to NEOM Maximum Single Dose (
NEOM_MAX_SINGLE_DOSE) and the Not-to-Exceed Amount Per Single Dose (NTE_SINGLE_DOSE):

a. If the prescribed single dose is equal to or less than NEOM_MAX_SINGLE_DOS and

NTE_SINGLE_DOSE, the order is acceptable and does not produce an alert.

b. If the prescribed individual dose is greater than either NEOM_MAX_SINGLE_DOSE and/or

NTE_SINGLE_DOSE, alert the user that the prescribed dose exceeds the recommended maximum
single dose for the drug (sample message 4a, 4b, or 4c).

NEOM_MAX_SIN NEOM_MAX_SIN NTE_SINGLE_DO NTE_SINGLE_DO Prescribed Single

GLE_DOSE GLE_DOSE_UNIT SE SE_UNIT_CODE Dose
_CODE

20 19 0.6 28 15 mcg

20 19 0.6 28 7.5 mcg

20 19 0.6 28 7.5 mcg

Since the retrieved units are given in mcg/kg and mg and the prescription is written in mcg, it is
necessary to convert the units of measure. The following table shows the data after the conversion.

NEOM_MAX_SIN NEOM_MAX_SIN NTE_SINGLE_DO NTE_SINGLE_DO Prescribed Single

GLE_DOSE GLE_DOSE_UNIT SE SE_UNIT_CODE Dose
_CODE

30 33 600 33 15 mcg

30 33 600 33 7.5 mcg

30 33 600 33 7.5 mcg

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the UNITS_DESC column.

DOSING_MODULE_UNIT_ABB UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

REV

MCG mcg microgram

The prescribed single doses of 15 mcg, 7.5 mcg, and 7.5 mcg are less than the
NEOM_MAX_SINGLE_DOSE and NTE_SINGLE DOSE values. The system passes the order and
continues screening.

5. Display the NEOM Maximum Lifetime Dose (NEOM_MAX_LIFE_DOSE) value:

a. If NEOM_MAX_LIFE_DOSE equals 0, the maximum lifetime dose is unavailable.

b. If NEOM_MAX_LIFE_DOSE does not equal 0, display the maximum lifetime dose value for the
prescribed medication (sample message 15).

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b.

In this example, the maximum lifetime dose equals 0 and is unavailable for display.

Part 3: Optionally Display Additional Dose Adjustment Information

1. Select the prescribed medications NEOM Renal Impairment Indicator (

NEOM_RENAL_IMPAIRMENT_IND):

a. If NEOM_RENAL_IMPAIRMENT_IND equals N, the order is acceptable and does not produce an

alert.

b. If NEOM_RENAL_IMPAIRMENT_IND equals Y, alert the user that the dose may need to be
adjusted for renal impairment (sample message 5).

This example has a positive return. The system alerts the user that the dose may need to be
adjusted for renal impairment and begins creatinine clearance checking.

2. Display the patients creatinine clearance (convert units if necessary) and the NEOM Creatinine Clearance
Threshold (NEOM_CREATININE_CLR_THRESHOLD) if necessary:

a. If NEOM_CREATININE_CLR_THRESHOLD equals 0, you may want to alert the user that creatinine
clearance threshold checking is unavailable.

b. If the patients creatinine clearance is unavailable, alert the user that a drug dosage adjustment
should be considered (sample message 6, appended to message 5).

c. If the patients creatinine clearance is less than NEOM_CREATININE_CLR_THRESHOLD, alert the

user that a drug dosage adjustment should be considered (sample message 6, appended to
message 5).

d. If the patients creatinine clearance is greater than NEOM_CREATININE_CLR_THRESHOLD,

continue screening the order without displaying any additional messages.

NEOM_CREATININE_ NEOM_CREATININE_ Description Patients Creatinine

CLR_THRESHOLD CLR_UNIT_CODE Clearance

50 01 ML/MIN ---

Concatenate the NEOM_CREATININE_CLR_THRESHOLD value of 50 with the

NEOM_CREATININE_CLR_UNIT_CODE description of ML/MIN to display the creatinine clearance
threshold of 50 ML/MIN to the user.

In this example, the patients creatinine clearance is unavailable. The system alerts the user that a
drug dosage adjustment should be considered and checks the order to determine if an hepatic
impairment adjustment is needed.

3. Check the NEOM Hepatic Impairment Indicator (NEOM_HEPATIC_IMPAIRMENT_IND):

a. If NEOM_HEPATIC_IMPAIRMENT_IND equals N, the order is acceptable and does not produce an

alert.

b. If NEOM_HEPATIC_IMPAIRMENT_IND equals Y, alert the user that the dose may need to be

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b.
adjusted for hepatic impairment (sample message 7).
This example has a positive return. The system alerts the user that the dose may need to be
adjusted for hepatic impairment and checks the display availability of the elimination half-life values.

4. Display the NEOM Low Elimination Half Life (NEOM_LOW_ELIM_HALF_LIFE) and NEOM High
Elimination Half Life (NEOM_HIGH_ELIM_HALF_LIFE) range (or value):

a. If both NEOM_LOW_ELIM_HALF_LIFE and NEOM_HIGH_ELIM_HALF_LIFE equal 0, the

elimination half-life range (or value) is unavailable.

b. If either NEOM_LOW_ELIM_HALF_LIFE or NEOM_HIGH_ELIM_HALF_LIFE does not equal 0,

display the elimination half-life range (or value) for the patient. (sample message 14).

NEOM_LOW_ELIM_HA NEOM_HIGH_ELIM_H NEOM_HALF_LIFE_U Description

LF_LIFE ALF_LIFE NIT_CODE

18 170 02 Hours

In this example, the elimination half-life for the order does not equal 0. The system displays the
elimination half-life range as 18 hours - 170 hours.

ExampleDose Range Checking of Non-patient Parameters

A patient has a prescription for a single dose (NEOM_DOSE_TYPE_CODE 07) of palivizumab (Clinical
Formulation ID [GCN_SEQNO] 59246) 100 mg/mL vial intramuscular (NEOM_ROUTE_CODE 040) 15 mg/kg
once per day. No reason for use is supplied. The patient is 1 year old (365 days) and weighs 22 pounds (10 kg).

Part 1: Collect Dosage Range Check Data

1. Select records from the NEOM Master Table (RNEOMMA1_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. NEOM Route Code (NEOM_ROUTE_CODE) column equals the route of administration for the
prescribed medication, and

c. NEOM Dose Type Code (NEOM_DOSE_TYPE_CODE) column equals the dose type for the
prescribed medication, and

d. NEOM High Age in Days (NEOM_HIGH_AGE_DAYS) column is greater than or equal to the patient
age in days, and

e. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 00004892 (default screening record).

GCN_SEQNO 59246

NEOM_ROUTE_CODE 040

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NEOM_DOSE_TYPE_CODE 02

NEOM_LOW_AGE_DAYS 0

NEOM_HIGH_AGE_DAYS 1094

DXID 4892

2. Select the Dosing Age Source Identifier (DOSING_AGE_SOURCE_ID) from the RDRCNMA2_MSTR table
where the columns equal the dosing record collected in step 1. According to your business needs:

a. Display the data source information to the end-user.

b. Determine by the source if the collected dosing record can be used in screening.
In this example, DOSING_AGE_SOURCE_ID equals 3, indicating that this supporting reference
may not be specific to the given age group.

Part 2: Dose Range Checking

1. Compare the prescribed frequency of administration per day to NEOM Low Frequency (
NEOM_LOW_FREQUENCY) and NEOM High Frequency (NEOM_HIGH_FREQUENCY):

a. If the prescribed frequency is equal to either NEOM_LOW_FREQUENCY or

NEOM_HIGH_FREQUENCY, or within the value range, the order is acceptable and does not
produce an alert.

b. If the prescribed frequency is less than NEOM_LOW_FREQUENCY, alert the user that the
prescribed frequency is less than the recommended minimum frequency for the drug (sample
message 8).

c. If the prescribed frequency is greater than NEOM_HIGH_FREQUENCY, alert the user that the
prescribed frequency exceeds the recommended maximum frequency for the drug (sample
message 9).

NEOM_LOW_FREQUENCY NEOM_HIGH_FREQUENCY Prescribed Frequency

1 1 1 per day

In this example, the prescribed frequency of 1 per day equals the NEOM_LOW_FREQUENCY and
NEOM_HIGH_FREQUENCY values of 1. The system passes the order and continues screening.

2. Compare the prescribed duration of therapy in days to NEOM Low Duration of Therapy (
NEOM_LOW_DURATION_OF_TX) and NEOM High Duration of Therapy (
NEOM_HIGH_DURATION_OF_TX):

a. If the prescribed duration of therapy is equal to either NEOM_LOW_DURATION_OF_TX or

NEOM_HIGH_DURATION_OF_TX, or within the value range, the order is acceptable and does not
produce an alert.

b. If the prescribed duration of therapy is less than NEOM_LOW_DURATION_OF_TX, alert the user
that the prescribed duration is less than the recommended low duration for the drug (sample

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b.

message 10).

c. If the prescribed duration of therapy is greater than NEOM_HIGH_DURATION_OF_TX, compare

the recommended maximum duration of therapy to the prescribed duration of therapy.

NEOM_LOW_FREQUENCY NEOM_HIGH_FREQUENCY Prescribed Duration

1 1 1 day

In this example, the prescribed frequency is equal to the NEOM_LOW_DURATION_OF_TX and

NEOM_HIGH_DURATION_OF_TX values of 1 day. The system passes the order and continues
screening.

3. Compare the prescribed daily dose (convert units if necessary) to NEOM Low Dose per Day (
NEOM_LOW_DOSE_PER_DAY) and NEOM High Dose per Day (NEOM_HIGH_DOSE_PER_DAY):

a. If the prescribed daily dose is equal to either NEOM_LOW_DOSE_PER_DAY or

NEOM_HIGH_DOSE_PER_DAY, or within the value range, the order is acceptable and does not
produce an alert.

b. If the prescribed daily dose is less than NEOM_LOW_DOSE_PER_DAY, alert the user that the
prescribed dose is less than the recommended low daily dose for the drug (sample message 1).

c. If the prescribed daily dose is greater than NEOM_HIGH_DOSE_PER_DAY, compare the

recommended maximum daily dose to the prescribed daily dose.

NEOM_LOW_DOSE_PER_DAY 13.5

NEOM_LOW_DOSE_UNIT_CODE 02

NEOM_UNIT_CODE_DESC MG/KG/DAY

NEOM_HIGH_DOSE_PER_DAY 16.5

NEOM_HIGH_DOSE_UNIT_CODE 02

NEOM_UNIT_CODE_DESC MG/KG/DAY

Prescribed dose per day 15 mg/kg

Since the retrieved and prescribed units are given in mg/kg/day, it is necessary to calculate the units
of measure. The following table shows the data after the conversion.

NEOM_LOW_DOSE_PER_DAY 135

NEOM_LOW_DOSE_UNIT_CODE 01

NEOM_UNIT_CODE_DESC MG/DAY

NEOM_HIGH_DOSE_PER_DAY 135

NEOM_HIGH_DOSE_UNIT_CODE 01

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NEOM_UNIT_CODE_DESC MG/DAY

Prescribed dose per day 150 mg/kg

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the UNITS_DESC column.

DOSING_MODULE_UNIT_ABB UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

REV

MG/DAY mg/day milligram per day

The prescribed daily dose is less than the NEOM_LOW_DOSE_PER_DAY value of 135 mg/day.
The system passes the order and continues screening.

4. Compare the prescribed single dose (convert units if necessary) to NEOM Maximum Single Dose (
NEOM_MAX_SINGLE_DOSE) and the Not-to-Exceed Amount Per Single Dose (NTE_SINGLE_DOSE):

a. If the prescribed single dose is equal to or less than NEOM_MAX_SINGLE_DOS and

NTE_SINGLE_DOSE, the order is acceptable and does not produce an alert.

b. If the prescribed individual dose is greater than either NEOM_MAX_SINGLE_DOSE and/or

NTE_SINGLE_DOSE, alert the user that the prescribed dose exceeds the recommended maximum
single dose for the drug (sample message 4a, 4b, or 4c).

NEOM_MAX_SIN NEOM_MAX_SIN NTE_SINGLE_DO NTE_SINGLE_DO Prescribed Single

GLE_DOSE GLE_DOSE_UNIT SE SE_UNIT_CODE Dose
_CODE

16.5 03 16.5 03 15 mg/kg

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the UNITS_DESC column.

DOSING_MODULE_UNIT_ABB UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

REV

MG mg milligram

In this example, the prescribed dose of 15 mg/kg is less than the NEOM_MAX_SINGLE_DOSE and
NTE_SINGLE_DOSE values of 16.5 mg/kg. The system passes the order and continues screening.

5. Display the NEOM Maximum Lifetime Dose (NEOM_MAX_LIFE_DOSE) value:

a. If NEOM_MAX_LIFE_DOSE equals 0, the maximum lifetime dose is unavailable.

b. If NEOM_MAX_LIFE_DOSE does not equal 0, display the maximum lifetime dose value for the
prescribed medication (sample message 15).
In this example, the maximum lifetime dose equals 0 and is unavailable for display.

Part 3: Optionally Display Additional Dose Adjustment Information

1.

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1. Select the prescribed medications NEOM Renal Impairment Indicator (

NEOM_RENAL_IMPAIRMENT_IND):

a. If NEOM_RENAL_IMPAIRMENT_IND equalsN, the order is acceptable and does not produce an

alert.

b. If NEOM_RENAL_IMPAIRMENT_IND equalsY, alert the user that the dose may need to be
adjusted for renal impairment (sample message 5).
This example has a negative return. The system passes the order and begins creatinine clearance
checking.

2. Display the patients creatinine clearance (convert units if necessary) and the NEOM Creatinine Clearance
Threshold (NEOM_CREATININE_CLR_THRESHOLD) if necessary:

a. If NEOM_CREATININE_CLR_THRESHOLD equals0, you may want to alert the user that creatinine
clearance threshold checking is unavailable.

b. If the patients creatinine clearance is unavailable, alert the user that a drug dosage adjustment
should be considered (sample message 6, appended to message 5).

c. If the patients creatinine clearance isl ess than NEOM_CREATININE_CLR_THRESHOLD, alert the
user that a drug dosage adjustment should be considered (sample message 6, appended to
message 5).

d. If the patients creatinine clearance is greater than NEOM_CREATININE_CLR_THRESHOLD,

continue screening the order without displaying any additional messages.
In this example, the patients creatinine clearance equals 0. The system alerts the user that
creatinine clearance threshold checking is unavailable and checks the order to determine if an
hepatic impairment adjustment is needed.

3. Check the NEOM Hepatic Impairment Indicator (NEOM_HEPATIC_IMPAIRMENT_IND):

a. If NEOM_HEPATIC_IMPAIRMENT_IND equals N, the order is acceptable and does not produce an

alert.

b. If NEOM_HEPATIC_IMPAIRMENT_IND equals Y, alert the user that the dose may need to be
adjusted for hepatic impairment (sample message 7).
This example has a negative return. The system passes the order and checks the display
availability of the elimination half-life values.

4. Display the NEOM Low Elimination Half Life (NEOM_LOW_ELIM_HALF_LIFE) and NEOM High
Elimination Half Life (NEOM_HIGH_ELIM_HALF_LIFE) range (or value):

a. If both NEOM_LOW_ELIM_HALF_LIFE and NEOM_HIGH_ELIM_HALF_LIFE equal 0, the

elimination half-life range (or value) is unavailable.

b. If either NEOM_LOW_ELIM_HALF_LIFE or NEOM_HIGH_ELIM_HALF_LIFE does not equal 0,

display the elimination half-life range (or value) for the patient. (sample message 14).

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NEOM_LOW_ELIM_HA NEOM_HIGH_ELIM_H NEOM_HALF_LIFE_U Description

LF_LIFE ALF_LIFE NIT_CODE

18 20 03 Days

In this example, the elimination half-life for the order does not equal 0 and is available for display.
The system displays the elimination half-life range as 18 days - 20 days.

ExamplePerforming Dosage Range Checking of a Continuous Infusion

A patient has a prescription for a maintenance dose (NEOM_DOSE_TYPE_CODE 02) of Ondansetron HCL 4
mg/2 ml Vial (Clinical Formulation ID [GCN_SEQNO] 61716) 0.25 mg/h continuous infusion
(NEOM_ROUTE_CODE 006) for 36 hours every 21 days. The reason for use is not available (DXID 4892). The
patient is 8 months old (243 days) and weighs 22 lbs (10 kg).

Please note that NEOM does not screen administration information or course of treatment information
often included within infusion orders. For example, the every 21 days course of treatment requirement in
the order above.

Part 1: Collect Dosage Range Check Data

1. Select records from the NEOM Master Table (RNEOMMA1_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. NEOM Route Code (NEOM_ROUTE_CODE) column equals the route of administration for the
prescribed medication, and

c. NEOM Dose Type Code (NEOM_DOSE_TYPE_CODE) column equals the dose type for the
prescribed medication, and

d. NEOM High Age in Days (NEOM_HIGH_AGE_DAYS) column is greater than or equal to the patient
age in days, and

e. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 00004892 (default screening record).

GCN_SEQNO 61716

NEOM_ROUTE_CODE 006

NEOM_DOSE_TYPE_CODE 02

NEOM_LOW_AGE_DAYS 0

NEOM_HIGH_AGE_DAYS 1094

DXID 4892

2.

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2. Select the Dosing Age Source Identifier (DOSING_AGE_SOURCE_ID) from the RDRCNMA2_MSTR table
where the columns equal the dosing record collected in step 1. According to your business needs:

a. Display the data source information to the end-user.

b. Determine by the source if the collected dosing record can be used in screening.
In this example, DOSING_AGE_SOURCE_ID equals 3, indicating that this supporting reference
may not be specific to the given age group.

3. Check the NEOM Weight Required Indicator (NEOM_WEIGHT_REQ_IND):

a. If NEOM_WEIGHT_REQ_IND equals 0, the current weight is not required to select the screening
record.

b. If NEOM_WEIGHT_REQ_IND equals 1, the current weight is required to select the screening

record.
In this example, NEOM_WEIGHT_REQ_IND equals 0, indicating that the current weight is not
required to select the screening record. The system checks the gestational age at birth required
indicator.

4. Check the NEOM Gestational Birth Age Required Indicator (NEOM_GEST_BIRTH_AGE_REQ_IND):

a. If NEOM_GEST_BIRTH_AGE_REQ_IND equals 0, the gestational age at birth is not required to

select the screening record.

b. If NEOM_GEST_BIRTH_AGE_REQ_IND equals 1, the gestational age at birth is required to select

the screening record.
In this example, NEOM_GEST_BIRTH_AGE_REQ_IND equals 0, indicating that the gestational age
at birth is not required.

Part 2: Dose Range Checking

1. Compare the prescribed frequency of administration per day to NEOM Low Frequency (
NEOM_LOW_FREQUENCY) and NEOM High Frequency (NEOM_HIGH_FREQUENCY):

a. If the prescribed frequency is equal to either NEOM_LOW_FREQUENCY or

NEOM_HIGH_FREQUENCY, or within the value range, the order is acceptable and does not
produce an alert.

b. If the prescribed frequency is less than NEOM_LOW_FREQUENCY, alert the user that the
prescribed frequency is less than the recommended minimum frequency for the drug (sample
message 8).

c. If the prescribed frequency is greater than NEOM_HIGH_FREQUENCY, alert the user that the
prescribed frequency exceeds the recommended maximum frequency for the drug (sample
message 9).

NEOM_LOW_FREQUENCY NEOM_HIGH_FREQUENCY Prescribed Frequency

1 0 2 days

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In this example, the prescribed duration of therapy is greater than the DR2_HIDOTX value of 0
days. The system compares the recommended maximum duration to the prescribed duration.

2. Compare the prescribed duration of therapy in days to NEOM Low Duration of Therapy (
NEOM_LOW_DURATION_OF_TX) and NEOM High Duration of Therapy (
NEOM_HIGH_DURATION_OF_TX):

a. If the prescribed duration of therapy is equal to either NEOM_LOW_DURATION_OF_TX or

NEOM_HIGH_DURATION_OF_TX, or within the value range, the order is acceptable and does not
produce an alert.

b. If the prescribed duration of therapy is less than NEOM_LOW_DURATION_OF_TX, alert the user
that the prescribed duration is less than the recommended low duration for the drug (sample
message 10).

c. If the prescribed duration of therapy is greater than NEOM_HIGH_DURATION_OF_TX, compare

the recommended maximum duration of therapy to the prescribed duration of therapy.

NEOM_MAX_DURATION_OF_TX Prescribed Duration

0 2 days

In this example, NEOM_MAX_DURATION_OF_TX equals 0, indicating that the maximum duration

of therapy has no limit. The system passes the order and continues screening.

3. Compare the prescribed daily dose (convert units if necessary) to NEOM Low Dose per Day (
NEOM_LOW_DOSE_PER_DAY) and NEOM High Dose per Day (NEOM_HIGH_DOSE_PER_DAY):

a. If the prescribed daily dose is equal to either NEOM_LOW_DOSE_PER_DAY or

NEOM_HIGH_DOSE_PER_DAY, or within the value range, the order is acceptable and does not
produce an alert.

b. If the prescribed daily dose is less than NEOM_LOW_DOSE_PER_DAY, alert the user that the
prescribed dose is less than the recommended low daily dose for the drug (sample message 1).

c. If the prescribed daily dose is greater than NEOM_HIGH_DOSE_PER_DAY, compare the

recommended maximum daily dose to the prescribed daily dose.

NEOM_LOW_DOSE_PER_DAY 0.018

NEOM_LOW_DOSE_UNIT_CODE 18

NEOM_UNIT_CODE_DESC MG/KG/H

NEOM_HIGH_DOSE_PER_DAY 0.02

NEOM_HIGH_DOSE_UNIT_CODE 18

NEOM_UNIT_CODE_DESC MG/KG/H

Prescribed dose per day 0.25mg/h

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To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the NEOM_UNIT_CODE_DESC column.

DOSING_MODULE_UNIT_ABB UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

REV

MG/KG/H mg/kg/hour milligram per kilogram per hour

Since the retrieved units are given in mg/kg/hour and the prescription is written in mg/hour, it is
necessary to convert the units of measure. The following table shows the data after the conversion.

NEOM_LOW_DOSE_PER_DAY 0.18

NEOM_LOW_DOSE_UNIT_CODE 17

NEOM_UNIT_CODE_DESC MG/H

NEOM_HIGH_DOSE_PER_DAY 0.2

NEOM_HIGH_DOSE_UNIT_CODE 17

NEOM_UNIT_CODE_DESC MG/H

Prescribed dose per day 0.25mg/h

In this example, the prescribed dose of 0.25mg/h is greater than the

NEOM_HIGH_DOSE_PER_DAY value of 0.2 mg/h. The system compares the prescribed daily
dose to the recommended maximum daily dose.

4. Compare the prescribed single dose (convert units if necessary) to NEOM Maximum Single Dose (
NEOM_MAX_SINGLE_DOSE) and the Not-to-Exceed Amount Per Single Dose (NTE_SINGLE_DOSE):

a. If the prescribed single dose is equal to or less than NEOM_MAX_SINGLE_DOS and

NTE_SINGLE_DOSE, the order is acceptable and does not produce an alert.

b. If the prescribed individual dose is greater than either NEOM_MAX_SINGLE_DOSE and/or

NTE_SINGLE_DOSE, alert the user that the prescribed dose exceeds the recommended maximum
single dose for the drug (sample message 4a, 4b, or 4c).

NEOM_MAX_SIN NEOM_MAX_SIN NTE_SINGLE_DO NTE_SINGLE_DO Prescribed Single

GLE_DOSE GLE_DOSE_UNIT SE SE_UNIT_CODE Dose
_CODE

0.02 18 1 17 0.25 mg/h

Since one of the retrieved units are given in MG/KG/H and the prescription is written in mg/h, it is
necessary to convert the units of measure. The following table shows the data after the conversion.

NEOM_MAX_ NEOM_MAX_ NTE_SINGLE_ NTE_SINGLE_ UNITS_DESC Prescribed

SINGLE_DOS SINGLE_DOS DOSE DOSE_UNIT_ Single Dose
E E_UNIT_COD CODE
E

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0.2 17 1 17 MG/H 0.25 mg/h

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the UNITS_DESC column.

DOSING_MODULE_UNIT_ABB UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

REV

MCG mcg microgram

In this example, the prescribed single dose of 0.25 mg/h is greater than the
NEOM_MAX_SINGLE_DOSE value of 0.2 mg/h but less than the NTE_SINGLE_DOSE value of 1
mg/h. The system alerts the user that the prescribed maximum single dose for the drug exceeds the
recommended maximum single dose for the drug (see Message 4b) and continues screening.

5. Display the NEOM Maximum Lifetime Dose (NEOM_MAX_LIFE_DOSE) value:

a. If NEOM_MAX_LIFE_DOSE equals 0, the maximum lifetime dose is unavailable.

b. If NEOM_MAX_LIFE_DOSE does not equal 0, display the maximum lifetime dose value for the
prescribed medication (sample message 15).
In this example, the maximum lifetime dose equals 0 and is unavailable for display.

Part 3: Optionally Display Additional Dose Adjustment Information

1. Select the prescribed medications NEOM Renal Impairment Indicator (

NEOM_RENAL_IMPAIRMENT_IND):

a. If NEOM_RENAL_IMPAIRMENT_IND equals N, the order is acceptable and does not produce an

alert.

b. If NEOM_RENAL_IMPAIRMENT_IND equals Y, alert the user that the dose may need to be
adjusted for renal impairment (sample message 5).
This example has a negative return. The system begins creatinine clearance threshold checking.

2. Display the patients creatinine clearance (convert units if necessary) and the NEOM Creatinine Clearance
Threshold (NEOM_CREATININE_CLR_THRESHOLD) if necessary:

a. If NEOM_CREATININE_CLR_THRESHOLD equals 0, you may want to alert the user that creatinine
clearance threshold checking is unavailable.

b. If the patients creatinine clearance is unavailable, alert the user that a drug dosage adjustment
should be considered (sample message 6, appended to message 5).

c. If the patients creatinine clearance is less than NEOM_CREATININE_CLR_THRESHOLD, alert the

user that a drug dosage adjustment should be considered (sample message 6, appended to
message 5).

d. If the patients creatinine clearance is greater than NEOM_CREATININE_CLR_THRESHOLD,

continue screening the order without displaying any additional messages.

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d.

NEOM_CREATININE_CLR_THR NEOM_CREATININE_CLR_UNI Patients Creatinine Clearance

ESHOLD T_CODE

0 --- ---

Concatenate the NEOM_CREATININE_CLR_THRESHOLD equals 0. The system alerts the user

that creatinine clearance threshold checking is unavailable and checks the order to determine if an
hepatic impairment adjustment is needed.

3. Check the NEOM Hepatic Impairment Indicator (NEOM_HEPATIC_IMPAIRMENT_IND):

a. If NEOM_HEPATIC_IMPAIRMENT_IND equals N, the order is acceptable and does not produce an

alert.

b. If NEOM_HEPATIC_IMPAIRMENT_IND equals Y, alert the user that the dose may need to be
adjusted for hepatic impairment (sample message 7).
This example has a positive return. The system alerts the user that the dose may need to be
adjusted for hepatic impairment and checks the display availability of the elimination half-life values.

4. Display the NEOM Low Elimination Half Life (NEOM_LOW_ELIM_HALF_LIFE) and NEOM High
Elimination Half Life (NEOM_HIGH_ELIM_HALF_LIFE) range (or value):

a. If both NEOM_LOW_ELIM_HALF_LIFE and NEOM_HIGH_ELIM_HALF_LIFE equal 0, the

elimination half-life range (or value) is unavailable.

b. If either NEOM_LOW_ELIM_HALF_LIFE or NEOM_HIGH_ELIM_HALF_LIFE does not equal 0,

display the elimination half-life range (or value) for the patient. (sample message 14).

NEOM_LOW_ELIM_HALF_LIFE NEOM_HIGH_ELIM_HALF_LIFE NEOM_HALF_LIFE_UNIT_COD

E

0 0

In this example, the low and high elimination half life for the order equals 0, indicating that the
elimination half-life range is unavailable and cannot be displayed.

ExamplePerforming Dose Range Checking of an Intermittent Infusion

A patient has a prescription for a maintenance dose (DR2_DOSTPI 02) of Cefazolin 1 GM Vial (Clinical
Formulation ID [GCN_SEQNO] 9060) intravenous (DR2_RT 052) 0.075 G over 30 minutes every 8 hours times 3
doses. The reason for use is not available (DXID 4892 [default screening record]). The patient is 1 week old (7
days) and weighs 8 lbs (3.63 kg).

Please note that NEOM does not screen administration information or course of treatment information
often included within infusion orders. For example, the over 30 minutes administration information
requirement in the order above.

Part 1: Collect Dosage Range Check Data

1.

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1. Select records from the NEOM Master Table (RNEOMMA1_MSTR) where the:

a. Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (GCN_SEQNO)

value of the prescribed medication, and

b. NEOM Route Code (NEOM_ROUTE_CODE) column equals the route of administration for the
prescribed medication, and

c. NEOM Dose Type Code (NEOM_DOSE_TYPE_CODE) column equals the dose type for the
prescribed medication, and

d. NEOM High Age in Days (NEOM_HIGH_AGE_DAYS) column is greater than or equal to the patient
age in days, and

e. FML Disease Identifier (DXID) column equals the DXID of the patient condition to be treated with
this prescription. If the patient condition is not available or if a reason for use record for a given age
range is not available, the DXID equals 00004892 (default screening record).

GCN_SEQNO 9060 9060

NEOM_ROUTE_CODE 052 052

NEOM_DOSE_TYPE_CODE 02 02

NEOM_LOW_AGE_DAYS 7 7

NEOM_HIGH_AGE_DAYS 29 29

DXID 4892 4892

2. Select the Dosing Age Source Identifier (DOSING_AGE_SOURCE_ID) from the RDRCNMA2_MSTR table
where the columns equal the dosing record collected in step 1. According to your business needs:

a. Display the data source information to the end-user.

b. Determine by the source if the collected dosing record can be used in screening.
In this example, DOSING_AGE_SOURCE_ID equals 3, indicating that this supporting reference
may not be specific to the given age group.

3. Check the NEOM Weight Required Indicator (NEOM_WEIGHT_REQ_IND):

a. If NEOM_WEIGHT_REQ_IND equals 0, the current weight is not required to select the screening
record.

b. If NEOM_WEIGHT_REQ_IND equals 1, the current weight is required to select the screening

record.
In this example, NEOM_WEIGHT_REQ_IND equals 1, indicating that the current weight is required
to select the screening record

4. Check the NEOM Gestational Birth Age Required Indicator (NEOM_GEST_BIRTH_AGE_REQ_IND):

a. If NEOM_GEST_BIRTH_AGE_REQ_IND equals 0, the gestational age at birth is not required to

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4.

a.

select the screening record.

b. If NEOM_GEST_BIRTH_AGE_REQ_IND equals 1, the gestational age at birth is required to select

the screening record.

GCN_SEQNO 9060 9060

NEOM_ROUTE_CODE 052 052

NEOM_DOSE_TYPE_CODE 02 02

NEOM_LOW_AGE_DAYS 7 7

NEOM_HIGH_AGE_DAYS 29 29

DXID 4892 4892

NEOM_LOW_CURRENT_WEIG 0 2001
HT_GRAMS

NEOM_HIGH_CURRENT_WEIG 2000 0
HT_GRAMS

In this example, the weight range of 2001 to 0 grams is retrieved by the system after the user enters
the patients current weight of 3630 G.

5. Filter the records returned in step 1 where the:

a. NEOM Low Gestational Age at Birth in Weeks (NEOM_LOW_GEST_BIRTH_AGE_WEEKS) column

is less than or equal to the patients gestational birth age in weeks, and

b. NEOM High Gestational Age at Birth in Weeks (NEOM_HIGH_GEST_BIRTH_AGE_WEEKS)

column is greater than or equal to the patients gestational birth age in weeks.
In this example, NEOM_GEST_BIRTH_AGE_REQ_IND equals 0, indicating that the gestational age
at birth is not required.

Part 2: Dose Range Checking

1. Compare the prescribed frequency of administration per day to NEOM Low Frequency (
NEOM_LOW_FREQUENCY) and NEOM High Frequency (NEOM_HIGH_FREQUENCY):

a. If the prescribed frequency is equal to either NEOM_LOW_FREQUENCY or

NEOM_HIGH_FREQUENCY, or within the value range, the order is acceptable and does not
produce an alert.

b. If the prescribed frequency is less than NEOM_LOW_FREQUENCY, alert the user that the
prescribed frequency is less than the recommended minimum frequency for the drug (sample
message 8).

c. If the prescribed frequency is greater than NEOM_HIGH_FREQUENCY, alert the user that the
prescribed frequency exceeds the recommended maximum frequency for the drug (sample
message 9).

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NEOM_LOW_FREQUENCY NEOM_HIGH_FREQUENCY Prescribed Frequency

3 3 3 per day

In this example, the prescribed frequency of 3 per day equals the NEOM_LOW_FREQUENCY and
NEOM_HIGH_FREQUENCY value of 3 per day. The system passes the order and continues
screening.

2. Compare the prescribed duration of therapy in days to NEOM Low Duration of Therapy (
NEOM_LOW_DURATION_OF_TX) and NEOM High Duration of Therapy (
NEOM_HIGH_DURATION_OF_TX):

a. If the prescribed duration of therapy is equal to either NEOM_LOW_DURATION_OF_TX or

NEOM_HIGH_DURATION_OF_TX, or within the value range, the order is acceptable and does not
produce an alert.

b. If the prescribed duration of therapy is less than NEOM_LOW_DURATION_OF_TX, alert the user
that the prescribed duration is less than the recommended low duration for the drug (sample
message 10).

c. If the prescribed duration of therapy is greater than NEOM_HIGH_DURATION_OF_TX, compare

the recommended maximum duration of therapy to the prescribed duration of therapy.

NEOM_LOW_DURATION_OF_T NEOM_HIGH_DURATION_OF_ Prescribed Duration

X TX

5 10 1 day (24 hours)

In this example, the prescribed duration of therapy is less than the

NEOM_LOW_DURATION_OF_TX value of 1 day. The system alerts the user that the prescribed
duration is less than the recommended low duration for the drug.

3. Compare the prescribed daily dose (convert units if necessary) to NEOM Low Dose per Day (
NEOM_LOW_DOSE_PER_DAY) and NEOM High Dose per Day (NEOM_HIGH_DOSE_PER_DAY):

a. If the prescribed daily dose is equal to either NEOM_LOW_DOSE_PER_DAY or

NEOM_HIGH_DOSE_PER_DAY, or within the value range, the order is acceptable and does not
produce an alert.

b. If the prescribed daily dose is less than NEOM_LOW_DOSE_PER_DAY, alert the user that the
prescribed dose is less than the recommended low daily dose for the drug (sample message 1).

c. If the prescribed daily dose is greater than NEOM_HIGH_DOSE_PER_DAY, compare the

recommended maximum daily dose to the prescribed daily dose.

NEOM_LOW_DOSE_PER_DAY 54

NEOM_LOW_DOSE_UNIT_CODE 02

NEOM_UNIT_CODE_DESC MG/KG/DAY

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NEOM_HIGH_DOSE_PER_DAY 69

NEOM_HIGH_DOSE_UNIT_CODE 02

NEOM_UNIT_CODE_DESC MG/KG/DAY

Prescribed dose per day 0.225 g/day

Since the retrieved units are given in mg/kg/day and the prescription is written in g/day, it is
necessary to convert the units of measure. The following table shows the data after the conversion.

NEOM_LOW_DOSE_PER_DAY 0.19602 g/day

NEOM_LOW_DOSE_UNIT_CODE 51

NEOM_UNIT_CODE_DESC G/DAY

NEOM_HIGH_DOSE_PER_DAY 0.25047 g/day

NEOM_HIGH_DOSE_UNIT_CODE 51

NEOM_UNIT_CODE_DESC G/DAY

Prescribed dose per day 0.225 g/day

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the UNITS_DESC column.

DOSING_MODULE_UNIT_ABB UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

REV

G/DAY gram/day gram per day

In this example, the prescribed daily dose of 0.225 g/day is within the
NEOM_LOW_DOSE_PER_DAY and NEOM_HIGH_DOSE_PER_DAY value range of 0.19602
g/day and 0.25047 g/day. The system passes the order and continues screening.

4. Compare the prescribed single dose (convert units if necessary) to NEOM Maximum Single Dose (
NEOM_MAX_SINGLE_DOSE) and the Not-to-Exceed Amount Per Single Dose (NTE_SINGLE_DOSE):

a. If the prescribed single dose is equal to or less than NEOM_MAX_SINGLE_DOS and

NTE_SINGLE_DOSE, the order is acceptable and does not produce an alert.

b. If the prescribed individual dose is greater than either NEOM_MAX_SINGLE_DOSE and/or

NTE_SINGLE_DOSE, alert the user that the prescribed dose exceeds the recommended maximum
single dose for the drug (sample message 4a, 4b, or 4c).

NEOM_MAX_SIN NEOM_MAX_SIN NTE_SINGLE_DO NTE_SINGLE_DO Prescribed

GLE_DOSE GLE_DOSE_UNIT SE SE_UNIT_CODE Individual Dose
_CODE

34.5 03 2 29 0.075 g

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Since the retrieved NEOM_MAX_SINGLE_DOSE units are given in mg/kg and the prescription is
written in g/day, it is necessary to convert the units of measure. The following table shows the data
after the conversion.

NEOM_MAX_SINGLE_DOSE 0.125

NEOM_MAX_SINGLE_DOSE_UNIT_CODE 29

NTE_SINGLE_DOSE 2

NTE_SINGLE_DOSE_UNIT_CODE 29

Prescribed dose per day 0.075 g

To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC) using the values from the UNITS_DESC column.

DOSING_MODULE_UNIT_ABB UNIT_DESC_ABBREV UNIT_DESC_EXPANDED

REV

G gram gram

In this example, the prescribed dose of 0.075 g is less than the NEOM_MAX_SINGLE_DOSE and
the NTE_SINGLE_DOSE values. The system passes the order and continues screening.

Part 3: Optionally Display Additional Dose Adjustment Information

1. Select the prescribed medications NEOM Renal Impairment Indicator (

NEOM_RENAL_IMPAIRMENT_IND):

a. If NEOM_RENAL_IMPAIRMENT_IND equals N, the order is acceptable and does not produce an

alert.

b. If NEOM_RENAL_IMPAIRMENT_IND equals Y, alert the user that the dose may need to be
adjusted for renal impairment (sample message 5).
This example has a positive return. The system alerts the user that the dose may need to be
adjusted for renal impairment and begins creatinine clearance threshold checking.

2. Display the patients creatinine clearance (convert units if necessary) and the NEOM Creatinine Clearance
Threshold (NEOM_CREATININE_CLR_THRESHOLD) if necessary:

a. If NEOM_CREATININE_CLR_THRESHOLD equals 0, you may want to alert the user that creatinine
clearance threshold checking is unavailable.

b. If the patients creatinine clearance is unavailable, alert the user that a drug dosage adjustment
should be considered (sample message 6, appended to message 5).

c. If the patients creatinine clearance is less than NEOM_CREATININE_CLR_THRESHOLD, alert the

user that a drug dosage adjustment should be considered (sample message 6, appended to
message 5).

d.

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d. If the patients creatinine clearance is greater than NEOM_CREATININE_CLR_THRESHOLD,

continue screening the order without displaying any additional messages.

NEOM_CREATININE_ NEOM_CREATININE_ Description Patients Creatinine

CLR_THRESHOLD CLR_UNIT_CODE Clearance

40 02 ML/MIN/1.73M ---

Concatenate the NEOM_CREATININE_CLR_THRESHOLD value of 40 with the

NEOM_CREATININE_CLR_UNIT_CODE description ML/MIN/1.73M2 to display the creatinine
clearance threshold of 40 ML/MIN/1.73M2 to the user.
In this example, the patients creatinine clearance is unavailable. The system alerts the user that a
drug dosage adjustment should be considered and checks the order to determine if an hepatic
impairment adjustment is needed.

3. Check the NEOM Hepatic Impairment Indicator (NEOM_HEPATIC_IMPAIRMENT_IND):

a. If NEOM_HEPATIC_IMPAIRMENT_IND equals N, the order is acceptable and does not produce an

alert.

b. If NEOM_HEPATIC_IMPAIRMENT_IND equals Y, alert the user that the dose may need to be
adjusted for hepatic impairment (sample message 7).
This example has a negative return. The system passes the order and checks the display
availability of the elimination half-life values.

4. Display the NEOM Low Elimination Half Life (NEOM_LOW_ELIM_HALF_LIFE) and NEOM High
Elimination Half Life (NEOM_HIGH_ELIM_HALF_LIFE) range (or value):

a. If both NEOM_LOW_ELIM_HALF_LIFE and NEOM_HIGH_ELIM_HALF_LIFE equal 0, the

elimination half-life range (or value) is unavailable.

b. If either NEOM_LOW_ELIM_HALF_LIFE or NEOM_HIGH_ELIM_HALF_LIFE does not equal 0,

display the elimination half-life range (or value) for the patient. (sample message 14).

NEOM_LOW_ELIM_HA NEOM_HIGH_ELIM_H NEOM_HALF_LIFE_U Description

LF_LIFE ALF_LIFE NIT_CODE

1.5 4 02 Hours

In this example, the elimination half life for the order does not equal 0. The system displays the
elimination half life range of 1.5 hours to 4 hours.

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Considerations for Using NEOM

Consider the following issues when preparing prescription data for processing:

If the prescribed drug is an ophthalmic or otic product, input the data for a single eye/ear. If processing is
returned without errors, the dose can be administered to both eyes/ears.
Most doses for single ingredient products are entered as ingredient strength (such as MG per day, or
MG/KG per day). When the product dosed is a combination of ingredients, the dosing is generally available
in units (such as tabs-caps or ML per day).
If the product is a single ingredient liquid product, the prescribed dose must be presented to NEOM as
metric weight (such as MG). For example, if the dose is 5 ML of 250MG/5ML, the dose presented to
NEOM for processing is 250MG.
If the product strength is presented as a %, the dose must be calculated to a metric weight unit (such as
GM or MG). For liquid products, % equals GM/100 ML; therefore, a 10% solution converts to
10GM/100ML. Multiply the 10GM/100ML by the volume of the order to convert to metric units (GM).
If the prescribed drug is administered at intervals greater than one day, determine the appropriate
frequency value from the table in Frequency of Administration.
If the prescribed product is a topical preparation, NEOM performs screening on the number of applications
per day.
For drugs that can be dosed as either elemental vs. base plus salt, or base vs. base plus salt, the dosing
range coded will match the Clinical Formulation ID (GCN_SEQNO).
When dosage intervals are greater than 30 days, dosage records are entered as a single dose.
Most chemotherapy dosage records are entered as a single dose under the assumption that the dose will
be prescribed for each use.
Consider the following dosing modifications to units in the NEOM Master Table:
The dose for Fosphenytoin is expressed in MG PE (phenytoin equivalent).
(1MG PE = 1MG of phenytoin.)
Ampicillin/Sulbactam is dosed as MG of total amount.
Amoxicillin/Clavulanate is dosed as ML/DAY.
Sulfamethoxazole/Trimethoprim is dosed as ML/KG.

Considerations for Setting Up a Weight Table

Since weight is an important factor in selecting the correct dose, it is vital that the system use a current weight.
For this reason, consider setting up a Valid Weight Table where the end user could specify various weight ranges
and the number of days a weight in that range is valid. The end user could use this table to verify that a particular
weight is valid before checking the dose against the NEOM data. If the weight is not valid, the end user could be
prompted to verify the system weight or enter a new weight. The following table is an example of a Valid Weight
Table.

The values in the table are provided for illustration purposes only.

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In the absence of the patient weight, FDB does not recommend using an estimated weight table to
calculate a dosage range. An estimated weight table calculates a dosage range based on percentile
weights for males and females. It may not detect dosages outside the appropriate range based on the
clinical situation of the patient.

ExampleValid Weight Table

Low Weight in Grams High Weight in Grams Number of Days Weight Is Valid

400 1500 1

1501 2500 2

2501 6500 3

Considerations for Handling Extemporaneously Prepared Dosage Forms

To screen doses for extemporaneously prepared dosage forms, the amount of the drug actually being given must
be calculated. For example, consider a .5MG tablet with a Clinical Formulation ID (GCN_SEQNO) of 123456. The
pharmacy prepares a suspension of that drug by crushing 10 tablets (5MG total) and then adding enough water to
make a final volume of 100ML (that is, a final concentration of .05MG/ML). The prescribed dose is 2ML every 12
hours (with a Daily Dose of 0.2MG and an Individual Dose of 0.1MG). Therefore, Clinical Formulation ID
(GCN_SEQNO) 123456, Daily Dose 0.2MG, and Individual Dose 0.1MG would be screened.

The developer may wish to facilitate the screening of extemporaneously prepared products by developing tables
where the products could be predefined. This is particularly important for a preparation containing more than one
Clinical Formulation ID (GCN_SEQNO) because screening would need to be done on more than one Clinical
Formulation ID (GCN_SEQNO). The same table could then be used to determine the components of the products
for all clinical screening.

Considerations for Determining Prescribed Dose Calculations

The prescribed dose per day (used for a single ingredient product) is determined by multiplying the individual
dose strength amount (MG, MG/KG) by dose frequency administrations per day.

The prescribed dose units per day (used for a product with a combination of ingredients) is determined by
multiplying the individual dose unit amount (tabs-caps) by dose frequency administrations per day.

This process is also illustrated in the following diagram.

NEOM Calculations of Input Dosing Field

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Considerations for Converting Units

Before the prescribed dose units can be compared to the retrieved units for NEOM High/Low Dose Per Day,
NEOM Maximum Dose Per Day, and NEOM Maximum Single Dose, the NEOM Unit Code Description Table
(RNEOMUD0_UNITS_DESC) should be used to determine whether additional input is required to calculate

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specific patient dose. Use the NEOM Conversion Factor (NEOM_CONVERSION_FACTOR) in the NEOM Unit
Conversion Table (RNEOMXU0_UNITS_CONVERSION) to convert to common units.

After you convert to common units, retrieve the unit code descriptions from the NEOM Unit Code
Description (NEOM_UNIT_CODE_DESC) column in the NEOM Unit Code Description Table
(RNEOMUD0_UNITS_DESC). However, the information in that column might include abbreviations
considered inappropriate by The Joint Commission (TJC) and Institute for Safe Medication Practices
(ISMP). To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC).

This process is also illustrated in the following diagram.

NEOM Units Processing and Conversion

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Considerations for Generating Warning Messages

Warning messages are generated if the prescribed dose for a given drug falls outside an acceptable dose range,
administration frequency, or duration range. In addition, messages are generated to indicate whether dosage
adjustments need to be made for creatinine clearance, hepatic impairment, or renal impairment. For more
information on the generation of these messages, refer to Performing Dosage Range Checking.

This section provides some suggested text for each message as well as information regarding generating
additional messages for High Elimination Half Life and Maximum Lifetime Dose.

Unit code descriptions for a message maybe retrieved from the NEOM Unit Code Description

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(NEOM_UNIT_CODE_DESC) column in the NEOM Unit Code Description Table

(RNEOMUD0_UNITS_DESC). However, the information in that column might include abbreviations
considered inappropriate by The Joint Commission (TJC) and Institute for Safe Medication Practices
(ISMP). To retrieve the corresponding TJC-compliant unit descriptions, query the Units Description Table
(RUNITSD0_UNITS_DESC).

Familiarize yourself with the following possible warning scenarios and resulting display messages.

This table provides a list of sample messages that may be used when performing dosage range screening.
Variables within the Sample Display Message column refer to information found in the NEOM Master Table
(RNEOMMA1_MSTR) or to patient-specific information. The Message Number column contains a reference
number used to identify appropriate messages for the scenarios illustrated within the Performing Dosage Range
Checking, page 667 application examples.

Possible Warning Scenario Sample Display Message Message Number

Prescribed daily dose is less than the Dosing range for [drug name] for 1
recommended low daily dose for the [patient name] [weight] [age] is
drug. [NEOM_LOW_DOSE_PER_DAY x
patient weight (if applicable)] [Low
Dose NEOM_RESULT_UNIT_CODE] -
[NEOM_HIGH_DOSE_PER_DAY x
patient weight (if applicable)] [High
Dose NEOM_RESULT_UNIT_CODE].
Prescribed dose of [prescribed daily
dose] [prescribed dose units] is less
than the recommended low daily dose
for the drug. Please evaluate dose.

Prescribed daily dose is greater than Dosing range for [drug name] for 2
the recommended high daily dose for [patient name] [weight] [age] is
the drug but is less than the [NEOM_LOW_DOSE_PER_DAY x
recommended maximum daily dose for patient weight (if applicable)] [Low
the drug. Dose NEOM_RESULT_UNIT_CODE] -
[NEOM_HIGH_DOSE_PER_DAY x
patient weight (if applicable)] [High
Dose NEOM_RESULT_UNIT_CODE].
Prescribed dose of [prescribed daily
dose] [prescribed dose units] is greater
than the recommended high daily dose
for the drug but is less than the
recommended maximum daily dose of
[NEOM_MAX_DOSE_PER_DAY x
patient weight (if applicable)]
[Maximum Daily Dose
NEOM_RESULT_UNIT_CODE].
Please evaluate dose.

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Prescribed daily dose is greater than Maximum dose per day for [drug 3
the recommended maximum daily name] for [patient name] [weight] [age]
dose for the drug. is [MXDOSD x patient weight (if
applicable)] [Maximum Daily Dose
UNITS_RUI]. Prescribed dose of
[prescribed daily dose] [prescribed
dose units] exceeds the recommended
maximum daily dose for the drug.
Please evaluate dose.

Prescribed single dose is greater than Maximum single dose for [drug name] 4a
the recommended maximum single for [patient name] [weight] [age] is
dose for the drug where MX1DOS [NEOM_MAX_SINGLE_DOSE x
equals NTE_SINGLE_DOSE. patient weight (if applicable)]
[NEOM_MAX_SINGLE_DOSE_UNIT_
CODE] or [NTE_SINGLE_DOSE]
[NTE_SINGLE_DOSE_UNIT_CODE].
Prescribed dose of [prescribed single
dose] [prescribed dose units] exceeds
the recommended maximum single
dose for the drug. Please evaluate
dose.

Prescribed single dose is greater than Maximum single dose for [drug name] 4b
the recommended maximum single for [patient name] [weight] [age] is
dose for the drug where MX1DOS is [NEOM_MAX_DOSE_PER_DAY x
less than NTE_SINGLE_DOSE. patient weight (if applicable)]
[NEOM_MAX_SINGLE_DOSE_UNIT_
CODE]. Prescribed dose of [prescribed
single dose] [prescribed dose units]
exceeds the recommended maximum
single dose for the drug. Please
evaluate dose.

Prescribed single dose is greater than Maximum single dose for [drug name] 4c
the recommended maximum single for [patient name] [weight] [age] is
dose for the drug where MX1DOS is [NTE_SINGLE_DOSE]
greater than NTE_SINGLE_DOSE. [NEOM_MAX_SINGLE_DOSE_UNIT_
CODE]. Prescribed dose of [prescribed
single dose] [prescribed dose units]
exceeds the recommended maximum
single dose for the drug. Please
evaluate dose.

Significant renal impairment requires a Dosage regimen needs to be adjusted 5

dosing adjustment. for significant renal impairment.

Patients creatinine clearance is less If the patients creatinine clearance is 6

than the accepted creatinine clearance lower than
threshold for the drug. [NEOM_CREATININE_CLEAR_THRE
SHOLD]
[NEOM_CREATININE_CLEAR_UNIT_
CODE], a drug dosage adjustment
should be considered.

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Significant hepatic impairment requires Dosage regimen needs to be adjusted 7

a dosing adjustment. for hepatic impairment.

Prescribed frequency of administration Administration frequency for [drug 8

per day is less than the recommended name] for [patient name] [weight] [age]
minimum frequency of administration is [NEOM_LOW_FREQUENCY] -
range for the drug. [NEOM_HIGH_FREQUENCY] per day.
Prescribed frequency of [prescribed
frequency] per day is less than the
recommended minimum administration
frequency for the drug. Please
evaluate frequency.

Prescribed frequency of administration Administration frequency for [drug 9

per day is greater than the name] for [patient name] [weight] [age]
recommended maximum frequency of is [NEOM_LOW_FREQUENCY] -
administration for the drug. [NEOM_HIGH_FREQUENCY] per day.
Prescribed frequency of [prescribed
frequency] per day exceeds the
recommended maximum
administration frequency for the drug.
Please evaluate frequency.

Prescribed duration is less than the Duration range for [drug name] for 10
recommended low duration for the [patient name] [weight] [age] is
drug. [NEOM_LOW_DURATION_OF_TX] -
[NEOM_HIGH_DURATION_OF_TX]
days. Prescribed duration of
[prescribed duration] days is less than
the recommended low duration for the
drug. Please evaluate duration of
therapy.

Prescribed duration is greater than the Duration range for [drug name] for 11
highest recommended duration for the [patient name] [weight] [age] is
drug. [NEOM_LOW_DURATION_OF_TX] -
[NEOM_HIGH_DURATION_OF_TX]
days. Prescribed duration of
[prescribed duration] days exceeds the
recommended high duration for the
drug. Please evaluate duration of
therapy.

Prescribed duration is greater than the Duration range for [drug name] for 12
recommended high duration range for [patient name] [weight] [age] is
the drug but is less than the [NEOM_LOW_DURATION_OF_TX] -
recommended maximum duration for [NEOM_HIGH_DURATION_OF_TX]
the drug. days. Prescribed duration of
[prescribed duration] days exceeds the
recommended high duration for the
drug but is less than the recommended
maximum duration of
[NEOM_MAX_DURATION_OF_TX]
days. Please evaluate duration of
therapy.

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Prescribed duration is greater than the Maximum duration for [drug name] for 13
recommended maximum duration [patient name] [weight] [age] is
range for the drug. [NEOM_MAX_DURATION_OF_TX]
days. Prescribed duration of
[prescribed duration] days exceeds the
recommended maximum duration for
the drug. Please evaluate duration of
therapy.

Patients elimination half-life range. Elimination half-life for [drug name] for 14
[patient name] [weight] [age] is
[NEOM_LOW_ELIM_HALF_LIFE] -
[NEOM_HIGH_ELIM_HALF_LIFE]
[NEOM_HALF_LIFE_UNIT_CODE].

Maximum lifetime dose for the drug. Maximum lifetime dose is 15

[NEOM_MAX_LIFE_DOSE]
[NEOM_MAX_LIFE_DOSE_UNIT_CO
DE].

Generating Additional Messages

This section clarifies how the system should be programmed to generate messages regarding Elimination Half
Life and Maximum Lifetime Dose.

1. If NEOM Low Elimination Half Life or NEOM High Elimination Half Life is greater than 0, generate message
14.

2. If the NEOM Maximum Lifetime Dose is greater than 0, generate message 15.

This process is also illustrated in the following diagram.

NEOM Additional Reports

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DRCM ERD and Technical Specifications

This section provides the technical specifications for each of the tables contained in this module. These table
names are listed below.

DRCM Tables
Dosage Range Check Module ERD

DRCM Tables
Dosing Age Source Description Table
DRCM Age Exclusion Table
DRCM Calculation Required Type Code Description Table
DRCM Dose Calculation Code Description Table
DRCM Dose Type Description Table
DRCM Dosing Adjustment Type Table
DRCM Exclusion Reason Table
DRCM Exclusion Status Description Table
DRCM Exclusion Table
DRCM Master Table
DRCM Math Process Code Description Table
DRCM Monograph Format Code Description Table
DRCM Monograph Section Code Description Table
DRCM Neonatal and Adult Master Table
DRCM Renal Adjustment Monograph Line Table
DRCM Renal Master Table
DRCM Route Conversion Table
DRCM Route Description Table
DRCM Severity Level Description Table
DRCM Unit Conversion Table
DRCM Unit Description Table

Dosage Range Check Module ERD

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Dosing Age Source Description Table

Table Name RDOSSRC0_DOSING_AGE_SOURCE

Revision Activity add.06-24-10

Purpose Relates the Dosing Age Source Identifier to its text

description.

Key Column Name Column Format Length Picture

Description

P DOSING_AGE_S Dosing Age N 4 9(4)

OURCE_ID Source Identifier

DOSING_AGE_S Dosing Age AN 50 X(50)

OURCE_DESC Source
Description

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DRCM Age Exclusion Table

Table Name RDRCAE0_AGE_EXCLUSION

Revision Activity add.01-18-13

Purpose Provides information regarding age, gestational age at birth,

and current weight ranges that are not currently
represented in DRCM Neonatal and Adult Master table. In
addition to providing missing ranges, the DRCM Age
Exclusion table shall provide clinical reasons why ranges
were intentionally excluded from the DRCM Neonatal and
Adult Master table, any contraindication severity levels, and
a narrative detailing the next age range and its associated
dosage screening values (i.e. Low Dose Per Day, High
Dose Per Day, Max Dose Per Day, Max Single Dose, and
Not to Exceed Dose).

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation
Identifier

PF DR2_RT DRCM Route of AN 3 X(3)

Administration
Indicator

P EXCLUSION_LO Exclusion Low N 5 9(5)

AGED Age in Days

P EXCLUSION_HIA Exclusion High N 5 9(5)

GED Age in Days

PF FDBDX First Databank AN 9 X(9)

Disease Code

PF DR2_DOSTPI DRCM Dosage AN 2 X(2)

Type Indicator

P NEOM_LOW_GE Neonatal Low N 2 9(2)

ST_BIRTH_AGE_ Gestational Age at
WEEKS Birth in Weeks

P NEOM_HIGH_GE Neonatal High N 2 9(2)

ST_BIRTH_AGE_ Gestational Age at
WEEKS Birth in Weeks

P NEOM_LOW_CU Neonatal Low N 5 9(5)

RRENT_WEIGHT Current Weight in
_GRAMS Grams

P NEOM_HIGH_CU Neonatal High N 5 9(5)

RRENT_WEIGHT Current Weight in
_GRAMS Grams

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F EXCLUSION_RE Exclusion Reason N 8 9(8)

ASON_CD Code

F DR2_SL DRCM Severity AN 1 X(1)

Level

F DXID FML Disease N 8 9(8)

Identifier

AVAILABLE_PRE Available N 1 9(1)

CAUTION_IND Precaution
Indicator

EXCLUSION_ME Exclusion AN 750 X(750)

SSAGE_TEXT Message Text

NEXT_SCREENI Next Screening AN 510 X(510)

NG_DOSE_TEXT Dose Text

NEXT_SCREENI Next Screening AN 255 X(255)

NG_DOSE_AGE_ Dose Age Text
TEXT

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DRCM Calculation Required Type Code Description Table

Table Name RDRCCD0_CALC_REQ_TYPE_DESC

Revision Activity add.10-03-2002

Purpose Relates the Units Required Calculation Type Code to its

text description.

Key Column Name Column Format Length Picture

Description

P UNITS_CTYP DRCM Units N 1 9(1)

Required
Calculation Type
Code

UNITS_CTYP_DE DRCM Units AN 50 X(50)

SC Required
Calculation Type
Code Description

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DRCM Dose Calculation Code Description Table

Table Name RDRCDD0_DOSE_CALC_DESC

Revision Activity add.10-03-2002

Purpose Relates the Units Dose Calculation Code to its text

description.

Key Column Name Column Format Length Picture

Description

P UNITS_DCC DRCM Units Dose AN 1 X(1)

Calculation Code

UNITS_DCC_DE DRCM Units Dose AN 50 X(50)

SC Calculation Code
Description

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DRCM Dose Type Description Table

Table Name RDRCDTD0_DOSE_TYPE_DESC

Revision Activity add.08-11-2000

Purpose Relates the Dose Type Indicator to its text description.

Key Column Name Column Format Length Picture

Description

P DR2_DOSTPI DRCM Dose Type AN 2 X(2)

Indicator

DOSTPI_DES DRCM Dose Type AN 25 X(25)

Indicator
Description

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DRCM Dosing Adjustment Type Table

Table Name RDRCAT0_ADJ_TYPE

Revision Activity add.11-17-2011

Purpose Relates the Dosing Adjustment Type Code to its text

description.

Key Column Name Column Format Length Picture

Description

P DOSING_ADJ_TY DRCM N 4 9(4)

PE_CD Adjustment Type
Code

DOSING_ADJ_TY DRCM AN 70 X(70)

PE_DESC Adjustment Type
Description

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DRCM Exclusion Reason Table

Table Name RDRCAR0_EXCLUSION_REASON

Revision Activity add.01-24-2013

Purpose Provides a unique list of clinical reasons for why age,

gestational age at birth, and current weight ranges have
been intentionally excluded from the DRCM Neonatal and
Adult Master table by FDB.

Key Column Name Column Format Length Picture

Description

P EXCLUSION_RE Exclusion Reason N 8 9(8)

ASON_CD Code

EXCLUSION_RE Exclusion Reason AN 750 X(750)

ASON_TEXT_LO Text Long
NG

EXCLUSION_RE Exclusion Reason AN 255 X(255)

ASON_TEXT_SH Text Short
ORT

F EXCLUSION_ST Exclusion Status N 8 9(8)

ATUS_CD Code

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DRCM Exclusion Status Description Table

Table Name RDRCSCD0_EXCLUSION_STATUS_DESC

Revision Activity add.01-24-2013

Purpose Relates the Exclusion Status Code to its text description.

Key Column Name Column Format Length Picture

Description

P EXCLUSION_ST Exclusion Status N 8 9(8)

ATUS_CD Code

EXCLUSION_ST Exclusion Status AN 30 X(30)

ATUS_CD_DESC Code Description

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DRCM Exclusion Table

Table Name RDRCEX0_EXCLUSIONS

Revision Activity add.06-18-09

Purpose Identifies Clinical Formulation IDs (GCN_SEQNO) excluded

from DRCM and the reason for the exclusion.

Key Column Name Column Format Length Picture

Description

P GCN_SEQNO Clinical N 6 9(6)

Formulation ID

EXCLUSION_CO Exclusion Code N 1 9(1)

DE

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DRCM Master Table

Table Name RDRCMA2_MSTR

Revision Activity rev.06-24-10

Purpose Associates a clinical formulation to its dosing information.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF DR2_RT DRCM Route of AN 3 X(3)

Administration
Indicator

P DR2_LOAGED DRCM Low Age in N 5 9(5)

days

P DR2_HIAGED DRCM High Age N 5 9(5)

in days

PF FDBDX First Databank AN 9 X(9)

Disease Code

PF DR2_DOSTPI DRCM Dose Type AN 2 X(2)

Indicator

DR2_LODOSD DRCM Low Dose N 9 9(5).9(3)

per day

F DR2_LODOSU DRCM Low Dose AN 2 X(2)

Units Code

DR2_HIDOSD DRCM High Dose N 9 9(5).9(3)

per day

F DR2_HIDOSU DRCM High Dose AN 2 X(2)

Units Code

DR2_MXDOSD DRCM Maximum N 9 9(5).9(3)

Dose per day

F DR2_MXDOSU DRCM Maximum AN 2 X(2)

Dose Units Code

DR2_LOFREQ DRCM Low N 5 9(2).9(2)

Frequency of
Administration

DR2_HIFREQ DRCM High N 5 9(2).9(2)

Frequency of
Administration

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DR2_RENIMP DRCM Renal AN 1 X(1)

Impairment
Assessment
Indicator

DR2_CRCLTH DRCM Creatinine N 3 9(3)

Clearance
Threshold

DR2_CRCLU DRCM Creatinine AN 2 X(2)

Clearance Units
Indicator

DR2_LODOTX DRCM Low N 5 9(5)

Duration of
Therapy

DR2_HIDOTX DRCM High N 5 9(5)

Duration of
Therapy

DR2_MXDOTX DRCM Maximum N 5 9(5)

Duration of
Therapy

DR2_HEPIMP DRCM Hepatic AN 1 X(1)

Impairment
Assessment
Indicator

DR2_THAFLO DRCM Low N 6 9(3).9(2)

Elimination
Half-Life

DR2_THAFHI DRCM High N 6 9(3).9(2)

Elimination
Half-Life

DR2_THAFU DRCM Units of AN 2 X(2)

Time Half-Life
Indicator

DR2_MX1DOS DRCM Maximum N 9 9(5).9(3)

Amount per Single
Dose

F DR2_MX1DSU DRCM Maximum AN 2 X(2)

Single Dose Units
Code

DR2_MXLIFD DRCM Maximum N 9 9(5).9(3)

Lifetime Dose

F DR2_MXLIFU DRCM Maximum AN 2 X(2)

Lifetime Dose
Units Code

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F DXID FML Disease N 8 9(8)

Identifier (Stable
ID)

NTE_SINGLE_D Not-to-Exceed N 9 9(5).9(3)

OSE Amount Per
Single Dose

F NTE_SINGLE_D Not-to-Exceed AN 2 X(2)

OSE_UNIT_COD Amount Per
E Single Dose Unit
Code

DOSING_AGE_S Dosing Age N 4 9(4)

OURCE_ID Source Identifier

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DRCM Math Process Code Description Table

Table Name RDRCMD0_MATH_PROCESS_DESC

Revision Activity add.10-03-2002

Purpose Relates the Units Math Indicator to its text description.

Key Column Name Column Format Length Picture

Description

P DCNV_MTHI DRCM Units Math AN 1 X(1)

Indicator

DCNV_MTHI_DE DRCM Units Math AN 50 X(50)

SC Indicator
Description

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DRCM Monograph Format Code Description Table

Table Name RDRCMF0_MONO_FORMAT_DESC

Revision Activity add.11-17-2011

Purpose Relates the DRCM Monograph Format Code to its text

description.

Key Column Name Column Format Length Picture

Description

P DRC_MONO_FO DRCM N 4 9(4)

RMAT_CD Monograph
Format Code

DRC_MONO_FO DRCM AN 50 X(50)

RMAT_CD_DESC Monograph
Format Code
Description

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DRCM Monograph Section Code Description Table

Table Name RDRCMS0_MONO_SECTION_DESC

Revision Activity add.11-17-2011

Purpose Relates the DRCM Monograph Section Code to its text

description.
The DRCM Monograph Section Code identifies the types of
text included in the monographs. This table provides you
with the ability to group the monograph lines into sections,
so that you can include or exclude some sections of a
monograph depending upon your businesss needs.

Key Column Name Column Format Length Picture

Description

P DRC_MONO_SE DRCM N 4 9(4)

CTION_CD Monograph
Section Code

DRC_MONO_SE DRCM AN 50 X(50)

CTION_CD_DES Monograph
C Section Code
Description

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DRCM Neonatal and Adult Master Table

Table Name RDRCNMA2_MSTR

Revision Activity rev.05-11-17 (previous:06-24-10)

Purpose Associates a clinical formulation, clinical route, age range,

reason for use, and dose type to related dosing information.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID

PF DR2_RT DRCM Route of AN 3 X(3)

Administration
Indicator

P DR2_LOAGED DRCM Low Age in N 5 9(5)

Days

P DR2_HIAGED DRCM High Age N 5 9(5)

in Days

PF FDBDX First Databank AN 9 X(9)

Disease Code

PF DR2_DOSTPI DRCM Dose Type AN 2 X(2)

Indicator

P NEOM_LOW_GE Neonatal Low N 2 9(2)

ST_BIRTH_AGE_ Gestational Age at
WEEKS Birth in Weeks

P NEOM_HIGH_GE Neonatal High N 2 9(2)

ST_BIRTH_AGE_ Gestational Age at
WEEKS Birth in Weeks

P LOW_CURRENT Low Current N 6 9(6)

_WEIGHT_GRAM Weight in Grams
S

P HIGH_CURRENT High Current N 6 9(6)

_WEIGHT_GRAM Weight in Grams
S

NEOM_GEST_BI Neonatal AN 1 X(1)

RTH_AGE_REQ_ Gestational Birth
IND Age Required
Indicator

WEIGHT_REQ_I Weight Required AN 1 X(1)

ND Indicator

DR2_LODOSD DRCM Low Dose N 9 9(5).9(3)

Per Day

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F DR2_LODOSU DRCM Low Dose AN 2 X(2)

Units Code

DR2_HIDOSD DRCM High Dose N 9 9(5).9(3)

Per Day

F DR2_HIDOSU DRCM High Dose AN 2 X(2)

Units Code

DR2_MXDOSD DRCM Maximum N 9 9(5).9(3)

Dose Per Day

F DR2_MXDOSU DRCM Maximum AN 2 X(2)

Dose Units Code

DR2_LOFREQ DRCM Low N 6 9(2).9(3)

Frequency of
Administration

DR2_HIFREQ DRCM High N 6 9(2).9(3)

Frequency of
Administration

DR2_RENIMP DRCM Renal AN 1 X(1)

Impairment
Assessment
Indicator

DR2_CRCLTH DRCM Creatinine N 3 9(3)

Clearance
Threshold

DR2_CRCLU DRCM Creatinine AN 2 X(2)

Clearance Units
Indicator

DR2_LODOTX DRCM Low N 5 9(5)

Duration of
Therapy

DR2_HIDOTX DRCM High N 5 9(5)

Duration of
Therapy

DR2_MXDOTX DRCM Maximum N 5 9(5)

Duration of
Therapy

DR2_HEPIMP DRCM Hepatic AN 1 X(1)

Impairment
Assessment
Indicator

DR2_THAFLO DRCM Low N 6 9(3).9(2)

Elimination
Half-Life

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DR2_THAFHI DRCM High N 6 9(3).9(2)

Elimination
Half-Life

DR2_THAFU DRCM Units of AN 2 X(2)

Time Half-Life
Indicator

DR2_MX1DOS DRCM Maximum N 9 9(5).9(3)

Amount Per
Single Dose

F DR2_MX1DSU DRCM Maximum AN 2 X(2)

Single Dose Units
Code

DR2_MXLIFD DRCM Maximum N 9 9(5).9(3)

Lifetime Dose

F DR2_MXLIFU DRCM Maximum AN 2 X(2)

Lifetime Dose
Units Code

F DXID FML Disease N 8 9(8)

Identifier

NTE_SINGLE_D Not-to-Exceed N 9 9(5).9(3)

OSE Amount Per
Single Dose

F NTE_SINGLE_D Not-to-Exceed AN 2 X(2)

OSE_UNIT_COD Amount Per
E Single Dose Unit
Code

DOSING_AGE_S Dosing Age N 4 9(4)

OURCE_ID Source Identifier

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DRCM Renal Adjustment Monograph Line Table

Table Name RDRCRL0_RENAL_MONO_LINE

Revision Activity add.11-17-2011

Purpose Relates the Dosing Adjustment Type Code to its text

description.
Use the DRCM Renal Monograph ID (REN_MONO_ID)
provided in the RDRCRM0_RENAL_MSTR table to access
the related renal adjustment monograph, if available.

Key Column Name Column Format Length Picture

Description

P REN_MONO_ID DRCM Renal N 8 9(8)

Monograph ID

P REN_MONO_LIN DRCM Renal N 8 9(8)

E_NUMBER Monograph Line
Number

F REN_MONO_SE DRCM Renal N 4 9(4)

CTION_CD Monograph
Section Code

F REN_MONO_FO DRCM Renal N 4 9(4)

RMAT_CD Monograph
Format Code

REN_MONO_LIN DRCM Renal AN 255 X(255)

E_TEXT Monograph Line
Text

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DRCM Renal Master Table

Table Name RDRCRM0_RENAL_MSTR

Revision Activity add.11-17-2011

Purpose Provides adjusted dose amounts for renal impairment.

When performing dosage range checking using the DRCM
Master Table (RDRCMA2_MSTR), you have the option to
check if a dose needs to be adjusted for the renally
impaired patient. If that dose needs to be adjusted for renal
impairment, you can now use the
RDRCRM0_RENAL_MSTR table to find dosing information
that is based upon a patients age and creatinine clearance.
Also, if you are screening drugs for a patient with known
renal impairment and creatinine clearance information, you
can begin screening using the RDRCRM0_RENAL_MSTR
table.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID

PF DR2_RT DRCM Route of AN 3 X(3)

Administration

P REN_LOAGED DRCM Renal Low N 5 9(5)

Age in Days

P REN_HIAGED DRCM Renal High N 5 9(5)

Age in Days

PF FDBDX First Databank AN 9 X(9)

Disease Code

PF DR2_DOSTPI DRCM Dose Type AN 2 X(2)

Indicator

P REN_LOCRCL DRCM Renal Low N 3 9(3)

Creatinine
Clearance mL/min

P REN_HICRCL DRCM Renal High N 3 9(3)

Creatinine
Clearance mL/min

P REN_SORT_ORD DRCM Renal Sort N 3 9(3)

ER Order

F DOSING_ADJ_TY DRCM Dosing N 4 9(4)

PE_CD Adjustment Type
Code

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REN_LODOSD DRCM Renally N 9 9(5).9(3)

Adjusted Low
Dose Per Day

F REN_LODOSU DRCM Renally AN 2 X(2)

Adjusted Low
Dose Per Day
Units Code

REN_HIDOSD DRCM Renally N 9 9(5).9(3)

Adjusted High
Dose Per Day

F REN_HIDOSU DRCM Renally AN 2 X(2)

Adjusted High
Dose Per Day
Units Code

REN_MXDOSD DRCM Renally N 9 9(5).9(3)

Adjusted
Maximum Dose
Per Day

F REN_MXDOSU DRCM Renally AN 2 X(2)

Adjusted
Maximum Dose
Per Day Units
Code

REN_LOFREQ DRCM Renally N 5 9(2).9(2)

Adjusted Low
Frequency of
Administration

REN_HIFREQ DRCM Renally N 5 9(2).9(2)

Adjusted High
Frequency of
Administration

REN_MX1DOS DRCM Renally N 9 9(5).9(3)

Adjusted
Maximum Amount
Per Single Dose

F REN_MX1DSU DRCM Renally AN 2 X(2)

Adjusted
Maximum Single
Dose Units Code

F DXID Disease Identifier N 8 9(8)

REN_NTE_SING DRCM Renally N 9 9(5).9(3)

LE_DOSE Adjusted
Not-to-Exceed
Amount Per
Single Dose

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F REN_NTE_SING DRCM Renally AN 2 X(2)

LE_DOSE_UNIT_ Adjusted
CODE Not-to-Exceed
Amount Per
Single Dose Units
Code

REN_FOOTNOTE DRCM Renal AN 255 X(255)

Adjustment
Footnote Text

F REN_MONO_ID DRCM Renal N 8 9(8)

Monograph ID

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DRCM Route Conversion Table

Table Name RDRCXRT0_XREF

Revision Activity add.08-11-2000

Purpose Enables the conversion of general administration routes to

more comprehensive dosage range check routes.

Key Column Name Column Format Length Picture

Description

P GCRT2 Route of AN 2 X(2)

Administration
Code
(2-character)

F DR2_RT DRCM Route of AN 3 X(3)

Administration
Indicator

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DRCM Route Description Table

Table Name RDRCRTD0_ROUTE_DESC

Revision Activity add.08-11-2000

Purpose Relates the Routes of Administration Indicator to its text

description.

Key Column Name Column Format Length Picture

Description

P DR2_RT DRCM Route of AN 3 X(3)

Administration
Indicator

ROUTES_DES DRCM Route of AN 22 X(22)

Administration
Description

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DRCM Severity Level Description Table

Table Name RDRCSD0_SEVER_LEVEL_DESC

Revision Activity add.01-24-2013

Purpose Relates the DRCM Severity Level to its text description and
to its corresponding geriatric and pediatric precaution
severity levels.

Key Column Name Column Format Length Picture

Description

P DR2_SL DRCM Severity AN 1 X(1)

Level

DR2_SL_DESC DRCM Severity AN 255 X(255)

Level Description

DR2_SL_MESSA DRCM Severity AN 255 X(255)

GE_TEXT Level Message
Text

F GERI_SL Geriatric AN 1 X(1)

Precaution
Severity Level

F PEDI_SL Pediatric AN 1 X(1)

Precaution
Severity Level

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DRCM Unit Conversion Table

Table Name RDRCCVU0_UNITS_CONVERSION

Revision Activity add.08-11-2000

Purpose Enables the conversion of unit identifiers.

Key Column Name Column Format Length Picture

Description

P DCNV_PUI DRCM Prescribed AN 2 X(2)

Unit Indicator

P UNITS_RUI DRCM Results AN 2 X(2)

Unit Code

F DCNV_MTHI DRCM Units Math AN 1 X(1)

Indicator

DCNV_CNVF DRCM Units N 16 9(10).9(5)

Conversion Factor

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DRCM Unit Description Table

Table Name RDRCUND0_UNITS_DESC

Revision Activity add.08-11-2000

Purpose Relates a Units Code to its text description.

Key Column Name Column Format Length Picture

Description

P DR2_UNITS DRCM Units Code AN 2 X(2)

UNITS_DESC DRCM Dose Units AN 12 X(12)

Code Description

F UNITS_CTYP DRCM Units N 1 9(1)

Required
Calculation Type
Code

F UNITS_DCC DRCM Units Dose AN 1 X(1)

Calculation Code

UNITS_RUI DRCM Results AN 2 X(2)

Unit Code

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MinMax ERD and Technical Specifications

This section provides the technical specifications for each of the tables in the Min/Max Dose Modules. The table
names are listed below.

Min/Max Tables
Min/Max Adult Daily Dose Module ERD
Min/Max Adult Daily Range Module ERD
Min/Max Geriatric Daily Dose Module ERD
Min/Max Geriatric Daily Range Module ERD
Pediatric Dose Module ERD

Min/Max Tables
Min/Max Dosing Age Source Description Table
MMAD Master Table
MMAR Master Table
MMGD Master Table
MMGR Master Table
PDM Master Table
PDM Unit Description Table
PDM Weight/Age Table

Min/Max Adult Daily Dose Module ERD

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Min/Max Adult Daily Range Module ERD

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Min/Max Geriatric Daily Dose Module ERD

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Min/Max Geriatric Daily Range Module ERD

Pediatric Dose Module ERD

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MinMax Dosing Age Source Description Table

Table Name RMMSRC0_DOSING_AGE_SOURCE

Revision Activity add.12-09-2010

Purpose Relates the Dosing Age Source Identifier to its text

description.

Key Column Name Column Format Length Picture

Description

P DOSING_AGE_S Dosing Age N 4 9(4)

OURCE_ID Source Identifier

DOSING_AGE_S Dosing Age AN 50 X(50)

OURCE_DESC Source
Description

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MMAD Master Table

Table Name RMMADMA1_ADULT_DOSE_MSTR

Revision Activity rev.03-09-1994

Purpose Associates a clinical formulation to minimum and maximum

adult daily dosing information.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

MMA_MND MMAD Minimum N 10 9(6).9(3)

Daily Dose
Strength Quantity

MMA_MNDU MMAD Minimum AN 3 X(3)

Daily Dose
Strength Units

MMA_MNU MMAD Minimum N 8 9(4).9(3)

Daily Dose Units
Quantity

MMA_MNUF MMAD Minimum AN 2 X(2)

Daily Dose Units
Form

MMA_MXD MMAD Maximum N 10 9(6).9(3)

Daily Dose
Strength Quantity

MMA_MXDU MMAD Maximum AN 3 X(3)

Daily Dose
Strength Units

MMA_MXU MMAD Maximum N 8 9(4).9(3)

Daily Dose Units
Quantity

MMA_MXUF MMAD Maximum AN 2 X(2)

Daily Dose Units
Form

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MMAR Master Table

Table Name RMMARMA0_ADULT_RANGE_MSTR

Revision Activity add.11-01-1996

Purpose Associates a clinical formulation to the minimum and

maximum adult daily dosing information not specific to
strength of product.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

MMAR_MND MMAR Minimum N 10 9(6).9(3)

Daily Dose
Strength Quantity

MMAR_MNDU MMAR Minimum AN 3 X(3)

Daily Dose
Strength Units

MMAR_MNU MMAR Minimum N 8 9(4).9(3)

Daily Dose Units
Quantity

MMAR_MNUF MMAR Minimum AN 2 X(2)

Daily Dose Units
Form

MMAR_MXD MMAR Maximum N 10 9(6).9(3)

Daily Dose
Strength Quantity

MMAR_MXDU MMAR Maximum AN 3 X(3)

Daily Dose
Strength Units

MMAR_MXU MMAR Maximum N 8 9(4).9(3)

Daily Dose Units
Quantity

MMAR_MXUF MMAR Maximum AN 2 X(2)

Daily Dose Units
Form

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MMGD Master Table

Table Name RMMGDMA1_GERI_DOSE_MSTR

Revision Activity add.12-09-2010

Purpose Associates a clinical formulation to minimum and maximum

geriatric daily dosing information.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

MMG_MND MMGD Minimum N 10 9(6).9(3)

Daily Dose
Strength Quantity

MMG_MNDU MMGD Minimum AN 3 X(3)

Daily Dose
Strength Units

MMG_MNU MMGD Minimum N 8 9(4).9(3)

Daily Dose Units
Quantity

MMG_MNUF MMGD Minimum AN 2 X(2)

Daily Dose Units
Form

MMG_MXD MMGD Maximum N 10 9(6).9(3)

Daily Dose
Strength Quantity

MMG_MXDU MMGD Maximum AN 3 X(3)

Daily Dose
Strength Units

MMG_MXU MMGD Maximum N 8 9(4).9(3)

Daily Dose Units
Quantity

MMG_MXUF MMGD Maximum AN 2 X(2)

Daily Dose Units
Form

DOSING_AGE_S Dosing Age N 4 9(4)

OURCE_ID Source Identifier

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MMGR Master Table

Table Name RMMGRMA1_GERI_RANGE_MSTR

Revision Activity add.12-09-2010

Purpose Associates a clinical formulation to the minimum and

maximum geriatric daily dosing information not specific to
the strength of the product.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

MMGR_MND MMGR Minimum N 10 9(6).9(3)

Daily Dose
Strength Quantity

MMGR_MNDU MMGR Minimum AN 3 X(3)

Daily Dose
Strength Units

MMGR_MNU MMGR Minimum N 8 9(4).9(3)

Daily Dose Units
Quantity

MMGR_MNUF MMGR Minimum AN 2 X(2)

Daily Dose Units
Form

MMGR_MXD MMGR Maximum N 10 9(6).9(3)

Daily Dose
Strength Quantity

MMGR_MXDU MMGR Maximum AN 3 X(3)

Daily Dose
Strength Units

MMGR_MXU MMGR Maximum N 8 9(4).9(3)

Daily Dose Units
Quantity

MMGR_MXUF MMGR Maximum AN 2 X(2)

Daily Dose Units
Form

DOSING_AGE_S Dosing Age N 4 9(4)

OURCE_ID Source Identifier

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PDM Master Table

Table Name RPDMMA1_PEDI_MSTR

Revision Activity rev.12-09-2010

Purpose Associates a clinical formulation to minimum and maximum

daily dosing information based on age.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

P PDM_MNAGE PDM Minimum N 4 9(4)

Dosing Age
(Days)

P PDM_MXAGE PDM Maximum N 4 9(4)

Dosing Age
(Days)

PDM_MND PDM Minimum N 13 9(6).9(6)

Daily Dose
Strength Quantity

F PDM_MNDU PDM Minimum AN 2 X(2)

Daily Dose
Strength Units

PDM_MNU PDM Minimum N 13 9(6).9(6)

Daily Dose Units
Quantity

F PDM_MNUF PDM Minimum AN 2 X(2)

Daily Dose Units
Form

PDM_MXD PDM Maximum N 13 9(6).9(6)

Daily Dose
Strength Quantity

F PDM_MXDU PDM Maximum AN 2 X(2)

Daily Dose
Strength Units

PDM_MXU PDM_MXUPDM N 13 9(6).9(6)

Maximum Daily
Dose Units
Quantity

F PDM_MXUF PDM Maximum AN 2 X(2)

Daily Dose Units
Form

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PDM_NTED PDM N 13 9(6).9(6)

Not-to-Exceed
Daily Dose
Strength Quantity

F PDM_NTEDU PDM AN 2 X(2)

Not-to-Exceed
Daily Dose
Strength Units

PDM_NTEU PDM N 13 9(6).9(6)

Not-to-Exceed
Daily Dose Units
Quantity

F PDM_NTEUF PDM AN 2 X(2)

Not-to-Exceed
Daily Dose Units
Form

DOSING_AGE_S Dosing Age N 4 9(4)

OURCE_ID Source Identifier

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PDM Unit Description Table

Table Name RPDMUND0_PEDI_DOSE_UNIT_DESC

Revision Activity add.01-10-1995

Purpose Relates the Units Code to its text description.

Key Column Name Column Format Length Picture

Description

P PDM_UNIT PDM Units Code AN 2 X(2)

PDM_UNDESC PDM Units Code AN 30 X(30)

Description

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PDM Weight-Age Table

Table Name RPDMWT1_PEDI_WEIGHT

Revision Activity rev.11-01-1996

Purpose Provides dosing information for a particular patient weight.

Key Column Name Column Format Length Picture

Description

P PDM_MNAGE PDM Minimum N 4 9(4)

Dosing Age
(Days)

P PDM_MXAGE PDM Maximum N 4 9(4)

Dosing Age
(Days)

PDM_AGEDSC PDM Age Range AN 30 X(30)

Description

PDM_M05WT PDM 5th N 6 9(3).9(2)

Percentile Weight
for Males

PDM_M25WT PDM 25th N 6 9(3).9(2)

Percentile Weight
for Males

PDM_M50WT PDM 50th N 6 9(3).9(2)

Percentile Weight
for Males

PDM_M75WT PDM 75th N 6 9(3).9(2)

Percentile Weight
for Males

PDM_M95WT PDM 95th N 6 9(3).9(2)

Percentile Weight
for Males

PDM_F05WT PDM 5th N 6 9(3).9(2)

Percentile Weight
for Females

PDM_F25WT PDM 25th N 6 9(3).9(2)

Percentile Weight
for Females

PDM_F50WT PDM 50th N 6 9(3).9(2)

Percentile Weight
for Females

PDM_F75WT PDM 75th N 6 9(3).9(2)

Percentile Weight
for Females

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PDM_F95WT PDM 95th N 6 9(3).9(2)

Percentile Weight
for Females

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NEOM ERD and Technical Specifications

This section provides the technical specifications for each of the tables contained in this module. These table
names are listed below.

NEOM Tables
Neonatal and Infant Dosage Range Check Module ERD

NEOM Tables
NEOM Calculation Required Type Code Description Table
NEOM Dose Calculation Code Description Table
NEOM Dose Type Code Description Table
NEOM Master Table
NEOM Math Process Code Description Table
NEOM Route Code Description Table
NEOM Route Conversion Table
NEOM Unit Code Description Table
NEOM Unit Conversion Table

Neonatal and Infant Dosage Range Check Module ERD

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NEOM Calculation Required Type Code Description Table

Table Name RNEOMCD0_CALC_REQ_TYPE_DESC

Revision Activity add.10-03-2002

Purpose Relates the Calculation Required Type Code to its text

description.

Key Column Name Column Format Length Picture

Description

P NEOM_CALC_RE NEOM Calculation N 1 9(1)

Q_TYPE_CODE Required Type
Code

NEOM_CALC_RE NEOM Calculation AN 50 X(50)

Q_TYPE_CODE_ Required Type
DESC Code Description

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NEOM Dose Calculation Code Description Table

Table Name RNEOMDD0_DOSE_CALC_DESC

Revision Activity add.10-03-2002

Purpose Relates the Dose Calculation Code to its text description.

Key Column Name Column Format Length Picture

Description

P NEOM_DOSE_C NEOM Dose AN 1 X(1)

ALC_CODE Calculation Code

NEOM_DOSE_C NEOM Dose AN 50 X(50)

ODE_DESC Code Description

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NEOM Dose Type Code Description Table

Table Name RNEOMTD0_DOSE_TYPE_DESC

Revision Activity add.10-03-2002

Purpose Relates the Dose Type Code to its text description.

Key Column Name Column Format Length Picture

Description

P NEOM_DOSE_TY NEOM Dose Type AN 2 X(2)

PE_CODE Code

NEOM_DOSE_TY NEOM Dose Type AN 25 X(25)

PE_CODE_DESC Code Description

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NEOM Master Table

Table Name RNEOMMA1_MSTR

Revision Activity rev.06-24-10

Purpose Associates a clinical formulation to its dosing information.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF NEOM_ROUTE_ NEOM Route AN 3 X(3)

CODE Code

P NEOM_LOW_AG NEOM Low Age in N 5 9(5)

E_DAYS Days

P NEOM_HIGH_AG NEOM High Age N 5 9(5)

E_DAYS in Days

PF FDBDX First Databank AN 9 X(9)

Disease Code

PF NEOM_DOSE_TY NEOM Dose Type AN 2 X(2)

PE_CODE Code

P NEOM_LOW_GE NEOM Low N 2 9(2)

ST_BIRTH_AGE_ Gestational Age at
WEEKS Birth in Weeks

P NEOM_HIGH_GE NEOM High N 2 9(2)

ST_BIRTH_AGE_ Gestational Age at
WEEKS Birth in Weeks

P NEOM_LOW_CU NEOM Low N 5 9(5)

RRENT_WEIGHT Current Weight in
_GRAMS Grams

P NEOM_HIGH_CU NEOM High N 5 9(5)

RRENT_WEIGHT Current Weight in
_GRAMS Grams

NEOM_GEST_BI NEOM AN 1 X(1)

RTH_AGE_REQ_ Gestational Birth
IND Age Required
Indicator

NEOM_WEIGHT_ NEOM Weight AN 1 X(1)

REQ_IND Required Indicator

NEOM_LOW_DO NEOM Low Dose N 9 9(5).9(3)

SE_PER_DAY per Day

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F NEOM_LOW_DO NEOM Low Dose AN 2 X(2)

SE_UNIT_CODE Unit Code

NEOM_HIGH_DO NEOM High Dose N 9 9(5).9(3)

SE_PER_DAY per Day

F NEOM_HIGH_DO NEOM High Dose AN 2 X(2)

SE_UNIT_CODE Unit Code

NEOM_MAX_DO NEOM Maximum N 9 9(5).9(3)

SE_PER_DAY Dose per Day

f NEOM_MAX_DO NEOM Maximum AN 2 X(2)

SE_UNIT_CODE Dose Unit Code

NEOM_LOW_FR NEOM Low N 5 9(2).9(2)

EQUENCY Frequency

NEOM_HIGH_FR NEOM High N 5 9(2).9(2)

EQUENCY Frequency

NEOM_RENAL_I NEOM Renal AN 1 X(1)

MPAIRMENT_IN Impairment
D Indicator

NEOM_CREATINI NEOM Creatinine N 3 9(3)

NE_CLR_THRES Clearance
HOLD Threshold

F NEOM_CREATINI NEOM Creatinine AN 2 X(2)

NE_CLR_UNIT_C Clearance
ODE Threshold Unit
Code

NEOM_LOW_DU NEOM Low N 5 9(5)

RATION_OF_TX Duration of
Therapy

NEOM_HIGH_DU NEOM High N 5 9(5)

RATION_OF_TX Duration of
Therapy

NEOM_MAX_DU NEOM Maximum N 5 9(5)

RATION_OF_TX Duration of
Therapy

NEOM_HEPATIC NEOM Hepatic AN 1 X(1)

_IMPAIRMENT_I Impairment
ND Indicator

NEOM_LOW_ELI NEOM Low N 6 9(3).9(2)

M_HALF_LIFE Elimination Half
Life

NEOM_HIGH_ELI NEOM High N 6 9(3).9(2)

M_HALF_LIFE Elimination Half
Life

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F NEOM_HALF_LIF NEOM Half Life AN 2 X(2)

E_UNIT_CODE Unit Code

NEOM_MAX_SIN NEOM Maximum N 9 9(5).9(3)

GLE_DOSE Single Dose

F NEOM_MAX_SIN NEOM Maximum AN 2 X(2)

GLE_DOSE_UNI Single Dose Unit
T_CODE Code

NEOM_MAX_LIF NEOM Maximum N 9 9(5).9(3)

E_DOSE Lifetime Dose

F NEOM_MAX_LIF NEOM Maximum AN 2 X(2)

E_DOSE_UNIT_ Lifetime Dose Unit
CODE Code

F DXID FML Disease N 8 9(8)

Identifier (DxID)

NTE_SINGLE_D Not-to-Exceed N 9 9(5).9(3)

OSE Amount Per
Single Dose

F NTE_SINGLE_D Not-to-Exceed AN 2 X(2)

OSE_UNIT_COD Amount Per
E Single Dose Unit
Code

DOSING_AGE_S Dosing Age N 4 9(4)

OURCE_ID Source Identifier

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NEOM Math Process Code Description Table

Table Name RNEOMMD0_MATH_PROCESS_DESC

Revision Activity add.10-03-2002

Purpose Relates the Math Process Code to its text description.

Key Column Name Column Format Length Picture

Description

P NEOM_MATH_P NEOM Math AN 1 X(1)

ROCESS_CODE Process Code

NEOM_MATH_P NEOM Math AN 50 X(50)

ROCESS_CODE Process Code
_DESC Description

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NEOM Route Code Description Table

Table Name RNEOMRD0_ROUTE_DESC

Revision Activity add.10-03-2002

Purpose Relates the Route Code to its text description.

Key Column Name Column Format Length Picture

Description

P NEOM_ROUTE_ NEOM Route AN 3 X(3)

CODE Code

NEOM_ROUTE_ NEOM Route AN 22 X(22)

CODE_DESC Code Description

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NEOM Route Conversion Table

Table Name RNEOMXR0_ROUTE_CONVERSION

Revision Activity add.10-03-2002

Purpose Enables the conversion of general administration routes to

more comprehensive dosage range check routes.

Key Column Name Column Format Length Picture

Description

P GCRT2 Route of AN 2 X(2)

Administration
Code
(2-character)

F NEOM_ROUTE_ NEOM Route AN 3 X(3)

CODE Code

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NEOM Unit Code Description Table

Table Name RNEOMUD0_UNITS_DESC

Revision Activity add.10-03-2002

Purpose Relates the Unit Code to its text description.

Key Column Name Column Format Length Picture

Description

P NEOM_UNIT_CO NEOM Unit Code AN 2 X(2)

DE

NEOM_UNIT_CO NEOM Unit Code AN 12 X(12)

DE_DESC Description

F NEOM_CALC_RE NEOM Calculation N 1 9(1)

Q_TYPE_CODE Required Type
Code

F NEOM_DOSE_C NEOM Dose AN 1 X(1)

ALC_CODE Calculation Code

F NEOM_RESULT_ NEOM Result Unit AN 2 X(2)

UNIT_CODE Code

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NEOM Unit Conversion Table

Table Name RNEOMXU0_UNITS_CONVERSION

Revision Activity add.10-03-2002

Purpose Enables the conversion of unit identifiers.

Key Column Name Column Format Length Picture

Description

PF NEOM_PRESCRI NEOM Prescribed AN 2 X(2)

BED_UNIT_COD Unit Code
E

PF NEOM_RESULT_ NEOM Result Unit AN 2 X(2)

UNIT_CODE Code

F NEOM_MATH_P NEOM Math AN 1 X(1)

ROCESS_CODE Process Code

NEOM_CONVER NEOM N 16 9(10).9(5)

SION_FACTOR Conversion Factor

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Drug Alergy Module (DAM) 4.0

Drug Allergy Module Editorial Policies
Applications
ERD and Technical Specifications

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Drug Allergy Module Editorial Policies

The policies and criteria that apply to the inclusion criteria, processes, and references used in the creation of this
module are provided in the following sections:

Overview
Definitions
Inclusion Criteria
Data Elements
Rule Sets
Maintenance
References
Appendix A: FDB Reported Inactives
Appendix B: Former Potentially Inactive Ingredients Available for Profiling Purposes Only

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Overview
Allergic reactions to drugs can result in serious and life-threatening consequences and should be carefully
considered when prescribing drug therapy. The Drug Allergy Module (DAM) identifies drugs that have been
reported to cause an allergic reaction. DAM also identifies cross-sensitivities among related drugs that might
cause reactions in patients allergic to similar compounds.

Drug knowledge is aggregated at the Clinical Formulation ID (GCN_SEQNO), Routed Medication ID (

ROUTED_MED_ID), and the Routed Generic ID (ROUTED_GEN_ID) levels in the First Databank (FDB)
knowledge base. Under certain circumstances, aggregated drug knowledge may not apply to all related
packaged products; more specific information may be found within product labels.

Allergen Pick List

Recording patient allergy data can be performed quickly and accurately using the Allergen Pick List. Patients
communicate allergens in different ways (such as by brand name, combination product, single ingredient, or by a
group name of allergens), and healthcare experts must be able to transcribe the information obtained from a
patient into codified FDB allergy concepts used by the Drug Allergy Module (DAM). If patients indicate that they
are allergic to penicillins, the information is easily transcribed into a Specific Allergen Group named 'Penicillins'
(DAM_ALRGN_GRP value 000476). However, if patients indicate that they are allergic to Tylenol with Codeine,
the allergy information must be recorded using the appropriate allergen concept, such as the brand Med Name
concept (MED_NAME_ID value 91892), as well as the specific ingredient allergen concept. There are no
abbreviations or synonyms available for concepts at this time.

FDB maintains two pick list tablesthe DAM Patient Profile Allergen Pick List Table
(RDAMAPM0_ALRGN_PICKLIST_MSTR) and the Drug Allergy Concept Attributes Table
(RDAMCA0_CONCEPT). Both pick list tables use the three different drug concept identifiers: brand Medication
concepts, ingredient base concepts, allergy group concepts; however, the Drug Allergy Concept Attributes Table
spans food-based and environmental-based allergy attributes for further customer filtering.

The Allergen Pick List is created using a rule based knowledge tool. Rules can be added, modified, or deleted if
new inclusion or exclusion policies are needed. The Allergen Pick List does not include every ingredient,
medication name, or allergy group.

Each week any new or updated FDB concepts (medication names [MED_NAME_IDs], DAM_ALRGN_GRPs, and
ingredients [HIC_SEQNs]) entered into FDB MedKnowledge are filtered through the rules to determine what will
be included or excluded in the Allergen Pick List.

Not every ingredient included on the DAM Pick List participates in drug allergy screening.
(See Appendix B: Former Potentially Inactive Ingredients Available for Profiling Purposes Only for a list of
ingredients on the pick list, which cannot be screened for allergies.)

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Definitions
This section defines important terms related to the module that users should understand. Some industry terms
that have a specific connotation in regards to the module are also defined.

This section includes the following terms:

Active Ingredient
Adverse Side Effect
Allergen Profile
Allergic Reaction
Base Ingredient
Cross-Sensitive Allergen
Cross-Sensitivity Episode
Idiosyncratic Adverse Reaction
Inactive Ingredient
Medication Name Concepts
Potentially Inactive Ingredient
Primary Allergen
Prospective Drug
Severe Allergic Reaction

Active Ingredient

Patients can be allergic to the active ingredients or inactive ingredients of a drug. Active ingredients serve a
therapeutic function; they make the product therapeutically effective. Inactive Ingredients usually serve
non-therapeutic functions; for example, a dye added to make a tablet yellow.

Adverse Side Effect

A negative effect resulting from an administered drug product. Side effects are not generally patient-specific. They
usually do not involve the immune system. They are usually more likely to occur at higher doses and are often
preventable. The adverse effects experienced by an allergic patient are not normally dosage-strength dependent,
and cannot be avoided by an allergic patient.

Additionally, while an idiosyncratic reaction (an unfavorable reaction to a drug that appears to be an allergic
reaction, but where prior sensitization to the offending drug was not present) to a drug is unlikely to result in the
drug's removal from the marketplace, a serious and documented side effect may result in the drug's removal from
the marketplace as determined by the manufacturer or the Food and Drug Administration (FDA).

Allergen Profile

The area of a patient's record devoted to documenting the patient's allergens. The term profile is sometimes
used as a verb meaning "to record on a patient's allergen profile."

Allergic Reaction

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The adverse effect of an immune event where there is an interaction between an antigen and antibody or
sensitized lymphocytes. Allergic reactions are considered synonymous with hypersensitivity episodes.

Base Ingredient

An ingredient that does not include a salt ester.

Cross-Sensitive Allergen

Drugs that have shown some degree of cross-allergenicity and are chemically related or structurally related to the
primary allergen. In DAM, cross-sensitive allergen ingredients have the same DAM Cross-Sensitive Allergen
Group Code value.

Cross-Sensitivity Episode

An allergic reaction to a drug that is structurally or chemically related to the primary allergen.

Idiosyncratic Adverse Reaction

A negative effect resulting from an administered drug product. This negative effect appears to be an allergy but
occurs without prior sensitization to the offending drug. By definition, an idiosyncratic reaction is a unique
instance. The method for storing an idiosyncratic episode via the Hierarchical Ingredient Code Sequence Number
is the same as for an allergic episode.

Inactive Ingredient

Inactive Ingredients usually serve non-therapeutic functions, for example, a dye added to make a tablet yellow.
Patients can be allergic to the active ingredients or inactive ingredients of a drug.

Medication Name Concepts

A series of four FDB medication identifiers that describe packaged products at varying degrees of specificity, from
general (the medication's name) to specific (the medication's name and formulation information). See the
Medication Name Concepts (MED) Editorial Policies for more information.

Potentially Inactive Ingredient

DAM utilizes the Potentially Inactive Indicator fields to determine whether an ingredient should be treated as an
inactive ingredient. Ingredients with a Potentially Inactive Indicator value of 0 are always active ingredients.
Ingredients with a Potentially Inactive Indicator value of 1 are sometimes active and sometimes inactive. These
should be treated with greater caution in the context of allergen screening because they are not as strictly
regulated as those ingredients that are considered always active.

Primary Allergen

An offending allergen. For a given ingredient, each of the salt and ester variations of the ingredient that belong to
the same chemical group and ingredients that have close structural similarities are considered primary allergens
to an allergic patient. In DAM, primary allergens are assigned DAM Specific Allergen Group Codes. Some
examples of primary allergens and drugs linked to them by the DAM Specific Allergen Group Codes include
penicillin VK and penicillin G, penicillin V sodium and amoxicillin, imipramine and protriptyline, and codeine and
morphine.

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Prospective Drug

A drug that undergoes allergy screening either a) prior to being prescribed to a patient, or b) prior to being
dispensed to a patient.

Severe Allergic Reaction

Defined as a life-threatening event or an event that might result in permanent damage.

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Inclusion Criteria
This section provides information detailing the criteria that guided the inclusion of the data contained within the
module as well as information pertaining to limitations or exclusions when appropriate to the discussion.

DAM establishes allergen code links to ingredients whenever biomedical literature shows one of the following:

The effects of the allergic reaction are potentially clinically significant.

A drug is pharmacologically and/or chemically related to ingredients that qualify. In this case, a DAM
Specific Allergen Group Code is created to include the qualifying ingredients. For example, the specific
allergen group Hydralazine (DAM Specific Allergen Group Code value 000144) includes both the
congeners hydralazine and dihydralazine even though only hydralazine allergens may be documented in
biomedical literature.

Allergen Pick List Rules for Inclusion/Exclusion

Rules for inclusion/exclusion may be created for each type of Pick List concept.

Ingredient (aka HIC Root)

Ingredients are candidates for inclusion in the Allergen Pick List file if they meet all of the following criteria:

Status is Live

Included in Appendix A: FDB Reported Inactives or Appendix B: Former Potentially Inactive Ingredients
Available for Profiling Purposes Only

Ingredients may be excluded from the Allergen Pick List file if they meet any of the following criteria:

Status is inactive, e.g., "obsolete" (e.g., HIC Description contains "DO NOT USE")
Ingredient "salt" descriptions (e.g., erythromycin stearate)
Medical devices, diagnostic tests, or medical supplies (e.g., condoms, diaphragms)
Gases (e.g., oxygen, carbon monoxide, carbon dioxide)
Ingredient names that use chemical nomenclature (e.g., 1,2-octanediol)
ALL inactive ingredients are excluded on the Canadian pick list.
Plants not known to be a significant allergen (e.g., acerola, amur corktree, lobelia seed)
Bacterial species or Lactobacillus (e.g., Streptococcus thermophilus)
Description contains "O.U.", meaning otherwise unspecified ingredient group concepts, (e.g., Antiamebic
drugs O.U.)
Ingredients with nonspecific classification-like descriptions (e.g., Antiseptic solution)
Ingredients classified as nutritional products and with "nutrition" in description (e.g., Nutritional therapy for
phenylketonuria, nutritional supplements)
Description contains "multivitamin"
Duplicates of Ingredients with "kit" in the description (e.g., Kit for the preparation of Yttrium-90)
Human or animal-derived extracts unless determined to be a significant allergy (e.g., Whale sperm, brain
extract)

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Duplicates of ingredients where the only difference is the ingredient-embedded strength (e.g., Dextran 40,
Dextran 60; the most common representative will be left on the Pick List and the others will be removed)
Inert excipient ingredientsnot included on the official FDB NDC review inactives list (see Appendix A: FDB
Reported Inactives)

Med Names

Med Names are candidates for inclusion in the Allergen Pick List file if they meet all of the following criteria:

Med Name is a brand

Med Name status is either Active, Inactive, Replaced, or Unassociated

Med Names may be excluded from the Allergen Pick List file if they meet any of the following criteria:

Status is Retired
"Generically" named Brand concepts
Single-ingredient, generically named Med Names
Medical devices, diagnostic tests, or medical supplies
Description has already been included as an Ingredient description
Med Names that have the same active ingredient list but have different strengths in the name
Only one strength, that is deemed the most common, will be included
Example: Aldoril-15 and Aldoril-25; Ambien and Ambien CR, Anaprox and Anaprox DS. Only one of
the med names in the pair is included.
Med Names that have the same active ingredient but have dose form or formulation details in description,
e.g., XR, CR, XL, DS, Max, extra strength, etc.
Only one Med Name concept will be included
Example: Adderall and Adderall XR, Tylenol and Tylenol extra strength

Allergen Group (DAM_ALRGN_GRP)

Allergen groups are candidates for inclusion in the Allergen Pick List file if they meet all of the following criteria:

Status is Live

Allergen Groups may be excluded from the Allergen Pick List file if they meet any of the following criteria:

Description is an exact match or close to a match for an Ingredient description or a Med Name that is
already included in the Allergen Pick List file
Only includes plants not known to be a significant allergy
Only includes bacteria species as ingredients

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Data Elements
This section contains additional information about particularly important tables and codes contained within the
module, as well as concepts about the data that the reader must understand in order to understand the module.

This section includes the following data elements:

Hierarchical Ingredient Code Sequence Number

DAM Specific Allergen Group Code
DAM Cross-Sensitive Allergen Group Code
Allergen Pick List

Hierarchical Ingredient Code Sequence Number

The Hierarchical Ingredient Code Sequence Number represents a patient's allergy to a specific ingredient.

DAM Specific Allergen Group Code

The DAM Specific Allergen Group Code represents the primary or offending allergen. It is a numeric identifier
assigned to a group of chemically similar drugs known to have similar allergenic potential.

ExamplePenicillin, amoxicillin, and piperacillin are chemically similar and therefore they have the same specific
allergen group (Penicillins 000476). A patient who displays an allergy to penicillin has the potential to suffer an
allergic reaction to any ingredients that have the same DAM Specific Allergen Group Code as penicillin.

DAM Cross-Sensitive Allergen Group Code

The DAM Cross-Sensitive Allergen Group Code is the "potential" allergen. It is a numeric identifier assigned to
the drugs that show some degree of cross-sensitivity and are chemically or structurally related to the primary
allergen.

ExampleThe ingredient penicillin G (Hierarchical Ingredient Code Sequence Number value 004977) has the
DAM Cross-Sensitive Allergen Group Code value of 0001, which links it to roughly 160 other beta lactam
antibiotics like penicillins, cephalosporins, and carbapenems. These 160 ingredients belong to a variety of
different specific allergen groups, but the risk of a cross-sensitive allergic reaction exists among the different beta
lactam antibiotics, so the ingredients all belong to the same cross-sensitive allergen group.

See the diagram below for an illustration of this relationship.

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Allergen Pick List

The Allergen Pick List is a list of ingredients that represents allergens at various levels of abstraction (brand
name, ingredient, allergy group).

FDB maintains two pick list tables:

The DAM Patient Profile Allergen Pick List Table (RDAMAPM0_ALRGN_PICKLIST_MSTR)

The Drug Allergy Concept Attributes Table (RDAMCA0_CONCEPT)

Both pick list tables use three different drug concept identifiers: brand Medication concepts, ingredient base
concepts, allergy group concepts; however, the Drug Allergy Concept Attributes Table Pick List spans food-based
and environmental-based allergy attributes for further customer filtering.

DAM Patient Profile Allergen Pick List Table

The DAM Patient Profile Allergen Pick List Table (RDAMAPM0_ALRGN_PICKLIST_MSTR) is created and
maintained by FDB. It contains three different drug concept identifiers: brand Medication concepts, ingredient
base concepts, and allergy group concepts.

Brand Med Name Concepts: Medication Name ID (MED_NAME_ID)

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Example: Zoloft- 00000035

Ingredient Concepts: Base Ingredient Code (HIC4_SEQN)
Example: Erythromycin- 002755
Allergy Group Concepts: DAM Specific Allergen Group Code (DAM_ALRGN_GRP)
Example: Penicillins- 000476

RDAMAPM0_ALRGN_PICKLIST_MSTR has the following three columns:

DAM Allergen Concept ID (DAM_CONCEPT_ID)

DAM Allergen Concept ID Type (DAM_CONCEPT_ID_TYP)
DAM Allergen Concept ID Description (DAM_CONCEPT_ID_TYP_DESC)

RDAMAPM0_ALRGN_PICKLIST_MSTR Table

DAM_CONCEPT_ID DAM_CONCEPT_ID_TYP DAM_CONCEPT_ID_DESC

00000035 002 Zoloft

00000476 001 Penicillins

00002755 006 Erythromycin

The DAM Allergen Concept ID (DAM_CONCEPT_ID) represents one of these three concepts:

A Med Name ID (MED_NAME_ID)

A DAM Specific Allergen Group Code (DAM_ALRGN_GRP)
An Ingredient (HIC_SEQN)

The DAM_CONCEPT_ID_TYP indicates if the DAM_CONCEPT_ID is a MED_NAME_ID, allergy group, or an

ingredient.

001 = Allergy Group (DAM_ALRGN_GRP)

002 = MED_NAME_ID
006 = Ingredient (HIC_SEQN)

Drug Allergy Concept Attributes Table

As an alternative, the Drug Allergy Concept Attributes Table (RDAMCA0_CONCEPT) can be used as the primary
pick list. The Drug Allergy Concept Attributes Table is created and maintained by FDB, and contains a superset of
the three different drug concept identifiers in the DAM Patient Profile Allergen Pick List: Med Name concepts,
ingredient base concepts, allergy group concepts. In addition, it spans food-based and environmental-based
allergy attributes for further customer filtering in patient profiles.

Brand Med Name Concepts: Medication Name ID (MED_NAME_ID)

Example: Zoloft- 00000035
Ingredient Concepts: Base Ingredient Code (HIC4_SEQN)
Example: Erythromycin- 002755

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Allergy Group Concepts: DAM Specific Allergen Group Code (DAM_ALRGN_GRP)

Example: Penicillins- 000476

RDAMCA0_CONCEPT has the following nine columns:

DAM Allergen Concept ID (DAM_CONCEPT_ID)

DAM Allergen Concept ID Type (DAM_CONCEPT_ID_TYP)
DAM Allergen Concept ID Description (DAM_CONCEPT_ID_DESC)
DAM Picklist Indicator (DAM_PICKLIST_IND)
DAM Spans Medication Indicator (DAM_MED_IND)
DAM Spans Food Indicator (DAM_FOOD_IND)
DAM Spans Environment Agent Indicator (DAM_ENVIRON_AGENT_IND)
DAM Non Allergen Indicator (DAM_NON_ALRGN_IND)
DAM Concept Status Code (DAM_CONCEPT_STATUS_CD)

RDAMCA0_CONCEPT Table

DAM_CONCEPT_ID 00000035 00000476 00002755

DAM_CONCEPT_ID_TYP 002 001 006

DAM_CONCEPT_ID_DESC Zoloft Penicillins Erythromycin

DAM_PICKLIST_IND 1 1 1

DAM_MED_IND 1 1 1

DAM_FOOD_IND 0 0 0

DAM_ENVIRON_AGENT_I 0 0 0
ND

DAM_NON_ALRGN_IND 0 0 0

DAM_CONCEPT_STATUS 0 0 0
_CD

The DAM Allergen Concept ID (DAM_CONCEPT_ID) represents one of these three concepts:

A Med Name ID (MED_NAME_ID)

A DAM Specific Allergen Group Code (DAM_ALRGN_GRP)
An Ingredient (HIC_SEQN)

The DAM_CONCEPT_ID_TYP indicates if the DAM_CONCEPT_ID is a MED_NAME_ID, allergy group, or an

ingredient.

001 = Allergy Group (DAM_ALRGN_GRP)

002 = MED_NAME_ID
006 = Ingredient (HIC_SEQN)

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Rule Sets
This section provides rules that the clinical team uses in regard to creating the module's data, both general rules
and rules specific to data elements.

Rules of General Applicability

Drug Allergy Module Specific Allergen Group Code Requirements
Drug Allergy Module Cross-Sensitive Allergen Group Code Requirements
Drug Allergy Module Linking Rules
Allergen Pick List Rules
Rules for Data Elements
Common vs. Technical Names
Retired, Replaced, or Obsolete Status Codes
Implementation Note
Allergen Pick List

Rules of General Applicability

This section describes editorial policies that have a broad impact on the module data or by nature are less
specific than those policies in other sections.

Drug Allergy Module Specific Allergen Group Code Requirements

The DAM Specific Allergen Group Code represents the primary or offending allergen. Ingredients must meet one
of the following requirements for categorization as a specific allergen group:

Listed in the Contraindication section (as a result of reported hypersensitivity) of recognized manufacturer's
prescribing information (for example, U.S., Canada, UK, Australia, etc).
Same related molecular moietyfor example, penicillin, amoxicillin, and piperacillin all have the beta
lactam moiety.
Two or more drugs containing the same chemical, such as Willow and Salicylic Acid. The bark of the willow
tree contains salicylic acid.
Metabolized to the same chemical.
Primary or published medical literature.

Drug Allergy Module Cross-Sensitive Allergen Group Code Requirements

The DAM Cross-Sensitive Allergen Group Code is the "potential" allergen. These are the drugs that show some
degree of cross-sensitivity and are either chemically or structurally related to the primary allergen. Ingredients
must meet one of the following requirements for categorization as cross-sensitive allergen group:

Listed as an analogue or derivative in the Description section of recognized manufacturer's prescribing

information (for example, U.S., Canada, UK, Australia, etc.)
Listed in the Warning or Precautions section (as a result of hypersensitivity) of recognized manufacturer's
prescribing information

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Primary or published medical literature

Drug Allergy Module Linking Rules

An ingredient that is associated to a specific allergen group also belongs to that group's associated
cross-sensitive allergen group. However, an ingredient can belong to a cross-sensitive allergen group
without first belonging to one of its specific allergen groups. Ingredients like this cause cross-sensitive
allergen group alerts instead of specific allergen group alerts.
For example, Torsemide belongs to the specific allergen group, Torsemide (DAM Specific Allergen Group
Code value of 000555) and the cross-sensitive allergen group, Sulfonylureas (DAM Cross-Sensitive
Allergen Group Code value of 001171). Torsemide does not belong to the specific allergen group,
Sulfonylurea (DAM Specific Allergen Group Code value of 000178), which is the corresponding specific
allergen group for the cross-sensitive allergen group, Sulfonylureas.
Not all ingredients need to be linked to a specific allergen group or cross-sensitivity group. Ingredients that
do not require an allergen group/cross-sensitivity can be stored in the patients profile by storing the
Hierarchical Ingredient Code Sequence Number.
A DAM Specific Allergen Group Code will not be created for associated ingredients that all have the same
Hierarchical Base Ingredient Code.
For example, the Hierarchical Ingredient Code value for Raltegravir is W5UA. Raltegravir has a salt
Raltegravir Potassium that has a value of W5UAKA. A DAM Specific Allergen Group Code does not need
to be created to link this salt to its base ingredient.
DAM provides the capability to screen products for active-ingredient and inactive-ingredient allergens.
Active ingredients do not require manual screening by healthcare experts. Inactive ingredients sometimes
require manual screening by healthcare experts. DAM only supports automatic screening of inactive
ingredients that are included on the approved FDB inactive ingredient list. Inactive ingredients not included
on the list of reviewed inactive ingredients must be manually screened when an inactive ingredient is
present on the patient's profile.

This illustration shows the inheritance between ingredients, Specific Allergen Groups, and Cross-sensitive
Allergen Groups. The tables that contain each of these relationships appear on the connecting line.

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Allergen Pick List Rules

All new HIC_SEQNs, MED_NAME_IDs, and DAM_ALRGN_GRPs are filtered through the Allergen Pick List
rules. A MED_NAME_ID, DAM_ALRGN_GRP, or ingredient will be filtered through the rules again any time a
change is made to it.

A hierarchical method is used to determine which DAM_CONCEPT_ID_TYP code will be on the Pick List when
duplicate descriptions exist, e.g., if a HIC_SEQN description is the same as its Allergen Group. The order by
which the DAM_CONCEPT_ID_TYP is selected for inclusion is:

1. 006 = Ingredient (HIC_SEQN)

2. 002 = MED_NAME_ID

3. 001 = Allergy Group (DAM_ALRGN_GRP)

FDB reserves the right to add or remove concepts from the Allergen Pick List at any time. Concepts removed
from the Allergen Pick List are not permanently removed from the database product and could be added back to
the Allergen Pick List as necessary.

A cross-sensitivity group is not intended to be stored in a patient's profile. Cross-sensitivity groups are not
included on the Allergen Pick List.

Additionally, when utilizing the Drug Allergy Concept Attributes Table pick list, food-based and
environmental-based allergy attributes are filtered for further use in patient profiles.

Rules for Data Elements

This section describes editorial policies that are more specific towards their effect on the data elements contained
in the module.

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Common vs. Technical Names

In some cases, it is more appropriate to use a "common" name instead of a "technical" name for the external and
internal description of a DAM Specific Allergen Group Code and DAM Cross-Sensitive Allergen Group Code. In
these instances, the common name should be listed first followed by the technical name for the group. The
common name should only be added to the external and internal description if it is a well known "nick-name" for
the ingredients. For example, for the HMG-CoA Reductase Inhibitors specific allergen group, the common name
of statins was added to the external and internal description before HMG-CoA Reductase Inhibitors. The external
description is "Statins- HMG-CoA Reductase Inhibitors."

Retired, Replaced, or Obsolete Status Codes

A DAM Specific Allergen Group Code or DAM Cross-Sensitive Allergen Group Code may have a status code of
live, retired, or replaced.

A DAM Specific Allergen Group Code and DAM Cross-Sensitive Allergen Group Code may be marked as retired
if:

The group no longer makes clinical sense; for example, altretamine, carmustine, chlorambucil,
estramustine, etc. used to be linked to the specific allergen group and cross-sensitive allergen group,
Nitrogen Mustards (DAM Specific Allergen Group Code value of 000470 and DAM Cross-Sensitive
Allergen Group Code value of 000039). Primary literature did not support a cross-sensitivity between all of
the nitrogen mustard ingredients, so the DAM Specific Allergen Group Code and DAM Cross-Sensitive
Allergen Group Code were retired.
The ingredient links are incorrect.
The DAM Specific Allergen Group Code only links to a single ingredient or all ingredients have the same
Hierarchical Base Ingredient Code Sequence Number.

A DAM Specific Allergen Group Code and DAM Cross-Sensitive Allergen Group Code may be marked as
replaced if the group is replaced by two or more groups to increase allergen hit specificity (prevent false allergy
hits). For example, the specific allergen group, Calcium Channel Blockers (DAM Specific Allergen Group Code
value of 000156) was replaced with four more specific allergen groups based on the structure of the ingredients:

Calcium Channel Blocking Agents- Phenylalkylamines (DAM Specific Allergen Group Code value of
900385)
Calcium Channel Blocking Agents- Benzaothiazepines (DAM Specific Allergen Group Code value of
900387)
Calcium Channel Blocking Agents- Diarylaminopropylamines (DAM Specific Allergen Group Code value of
900390)
Calcium Channel Blocking Agents- Dihydropyridines (DAM Specific Allergen Group Code value of 900392)

When a DAM Specific Allergen Group Code or DAM Cross-Sensitive Allergen Group Code is marked as retired or
replaced, the ingredient links remain live.

A DAM Specific Allergen Group Code and DAM Cross-Sensitive Allergen Group Code ingredient link may be
marked as obsolete if the link is incorrect. For example, the ingredient (hydrochlorothiazide) was unlinked from

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the specific allergen group, Sulfa (Sulfonamide Antibiotics) (DAM Specific Allergen Group Code value of 000491),
and the cross-sensitive allergen group, Drugs Containing Sulfonamide Moiety (DAM Cross-Sensitive Allergen
Group Code value of 000015), because the primary literature did not support a cross-sensitivity link between
hydrochlorothiazide and the sulfonamide antibiotics or other drugs with a sulfonamide moiety. Therefore, the
ingredient links were obsoleted because a customer does not need to continue to receive an allergy alert between
hydrochlorothiazide and the Sulfa (Sulfonamide Antibiotics) specific allergen group or the Drugs Containing
Sulfonamide Moiety cross-sensitive allergen group.

When an allergy that has a replacement is added to an ingredient, both the old allergy codes and replacement
allergy codes are added.

Implementation Note

In order to prevent potential patient safety issues with missed drug allergy hits, drug allergy screening should still
occur for all retired and replaced DAM Specific Allergen Group Codes that are present in the patients profile.

It is not recommended to store a MED Medication Name ID in a patient's profile. If a MED Medication Name ID is
chosen for profiling, it is good practice to also save/profile the associated Hierarchical Ingredient Code Sequence
Numbers.

Patients can be allergic to the active ingredients or inactive ingredients of a drug. Active ingredients serve a
therapeutic function in that they make the product therapeutically effective. Inactive ingredients usually serve
non-therapeutic functions, for example, a dye added to make a tablet yellow. A potentially inactive ingredient is
sometimes active and sometimes inactive.

The Hierarchical Ingredient Code Sequence Number Potentially Inactive Indicator is set to "true"
programmatically when the inert indicator for a cross-referenced CHEM number is set to true (CHEM # = inert).

The "potentially inactive" flag for a Specific Allergen Group Code and DAM Cross-Sensitive Allergen Group Code
in DAM Version 4.0 is set to true when at least one of the Hierarchical Ingredient Codes in the allergy group is
"potentially inactive." For example, the specific allergen group Salicylates (DAM Specific Allergen Group Code
value of 000270) is marked as potentially inactive in DAM version 4.0 but not DAM version 3.0. Not all
Hierarchical Ingredient Codes linked to the DAM Specific Allergen Group Code and DAM Cross-Sensitive
Allergen Group Code are marked potentially inactive. The Hierarchical Ingredient Code for sodium salicylates
(Hierarchical Ingredient Code value of H3DANA and Hierarchical Ingredient Code Sequence Number value of
1586) is marked as potentially inactive and therefore the DAM Specific Allergen Group Code, Salicylates is
marked as potentially inactive in DAM version 4.0.

Allergen Pick List

Using an Allergen Pick List, the healthcare end-user will be able to select from a wide range of descriptions that
represent allergens at various levels of abstraction (such as the brand name of a combination product, a single
ingredient, or a group of ingredients), making the recording process quicker and easier for the end-user.

This illustration shows how the three different concepts combine into an allergen pick list:

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Maintenance
This section contains information regarding the ongoing maintenance of the module's data.

FDB produces a number of internal reports that are reviewed to help with the decision to create a new allergen
group or a link to an already existing allergen group in DAM. The following reports, which include new product
additions to the MedKnowledge database, are reviewed daily for inclusion in DAM.

New and Published Report

All manufacturers product information received by FDB is reviewed and compared to existing allergy data. Any
new data is categorized and added to DAM as a new allergy code or is linked to an existing allergy code.

New drug approvals that need to be added to DAM are reviewed and added to the module within one week of the
receipt of product information.

All data is reviewed by a Research Associate and double checked by a Registered Pharmacist.

Drug class reviews are performed on an as needed basis. When a member of a drug class within a certain
allergen group has a change made to its prescribing information, a thorough review is performed on it and all
related drugs.

Manufacturer package insert reviews are performed:

When a product is newly introduced into the MedKnowledge database

When a change is made to a Hierarchical Ingredient Code in the MedKnowledge database
When a change related to allergies is made in the manufacturers package information
When MedWatch or CDER alerts related to allergies are received

Drug class reviews are also performed when new information is available regarding cross-sensitivities within a
drug class or between more than one drug class.

United Kingdom, Canada, and Hong Kong

Product reviews for allergy information are reviewed as necessary as determined by the pharmacist assigned to
the Drug Allergy Module. Reviews may be conducted as a result of a customer inquiry.

Data Changes in the Drug Allergy Module

A data change in the Drug Allergy Module is usually the result of one of the following:

More specific allergy code needed to replace existing allergen code

Less specific allergy code needed to replace existing allergen code
A new allergy code is needed
An allergy group needs to be retired

When any one of the above takes place, a message that alerts customers of the change is placed in the Clinical
Highlights, a weekly newsletter sent to FDBs customers.

If a FDB customer has a question regarding the Drug Allergy Module content, they are asked to contact the FDB
Customer Service Department. Once contacted, a customer service representative will route the question to the

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appropriate department (for example, editors or implementation) through Sales Logix. An answer is then
generated and returned to customer service, who contacts the customer.

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References
This section lists sources used by FDB to compile the information contained in the module.

FDB utilizes many reference sources including, but not limited to, the primary medical literature (for example,
published journal articles), medical reference texts, published expert treatment guidelines, and manufacturer
product package inserts. FDB uses current source editions or versions when coding and updating data, as well as
when researching questions about data. However, a formal data review does not occur for every new release of
source editions or versions. Additional sources include:

Lippincott Williams & Wilkins. A Wolters Kluwer Company. Wilson and Gisvolds Textbook of Organic
Medicinal and Pharmaceutical Chemistry.
Blumenthal M, Busse WR, Goldberg A. The American Botanical Council: The Complete German
Commission E Monographs CD-ROM: Therapeutic Guide to Herbal Medicines.
Brunton L, Lazo J. Goodman and Gilmans the Pharmacological Basis of Therapeutics.
Canadian Pharmacists Association. Compendium of Pharmaceutical and Specialities 2006.
Chandler F, MD, ed. Herbs: Everyday Reference for Health Professionals.
DerMarderosian A, Liberti L, ed., Beutler JA, ed. The Review of Natural Products.
electronic Medicines Compendium. Available at: http://emc.medicines.org.uk/.
Fetrow CH, PharmD; Avila JR, PharmD. Professionals Handbook of Complementary & Alternative
Medicines.
Food and Drug Administration MedWatch: Medical Product Safety Information. Available at:
http://www.fda.gov/medwatch/safety.htm.
IPHA Medicines Compendium. Available at: http://www.medicines.ie/.
National Library of Medicine: ChemIDplusAdvanced. Available at: http://chem.sis.nlm.nih.gov/chemidplus/.
ONeil MJ, Smith A, Heckelman PE, Obenchain JR, Gallipeau JAR, DArecca MA, eds. Merck Index: An
Encyclopedia of Chemicals, Drugs, & Biologicals.
Published by authority of the Board of Directors of the American Society of Health-Systems Pharmacists.
American Hospital Formulary Service (AHFS) Drug Information 2004.
Published by Pharmaceutical Care Information Services Pty Limited. Australian Drug Information for the
Healthcare Professional.
Rowe RC, Sheskey PJ, Owen SC. Handbook of Pharmaceutical Excipients.
Sweetman, Sean. Martindale: The Complete Drug Reference.
Swiss Pharmaceutical Society. Index Nominum: International Drug Directory.
Therapeutic Research Faculty, ed. Natural Medicines: Comprehensive Database.
Weiss RF, MD. Herbal Medicine.
Williams DA, Lemke TL. Foyes Principles of Medicinal Chemistry.

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Appendix A: FDB Reported Inactives

The following table shows reported inactive ingredients. The Reported Ingredient column shows ingredients
reported in the drug product as inactive ingredients. The Related Ingredient column shows ingredients that will
display as the reported ingredient if an allergy hit occurs.

Hierarchical Ingredient Code Reported Ingredient Related Ingredient

Sequence Number
(HICN_SEQN)

3245 Adhesive

3263 Adhesive Bandage

10691 Adhesive Foot Cushion

3254 Adhesive Tape

11469 Latex Foam for Cerv.Collar,Adh

10657 Silicone, Adhesive

2464 Alcohol

6364 Aluminum Silicate Magnesium

2325 Aminobenzoic Acid

3198 Benzylparaben

3197 Butylparaben

5164 Ethylparaben

6421 Ethylparaben sodium

1345 Isobutyl P-Aminobenzoate

11698 Isobutylparaben

3195 Methylparaben

6422 Methylparaben Sodium

3196 Propylparaben

6420 Propylparaben sodium

7286 Annatto

9639 Annatto Extract

2605 Aspartame

9283 Beef derived (Bovine)

11719 Collagen Matrix, Type I Bovine

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7634 Collagen, Bovine

3910 Tallow

11853 Veal Bone

3141 Benzalkonium Chloride

3142 Benzethonium Chloride

3192 Benzyl Alcohol

10138 Blue Dye

10433 Blue D&C No.2

14253 Blue Royal (food color)

10827 D & C No.1 (Blue)

7234 FD & C Blue No.1

10100 FD & C Blue No.10

10149 FD & C Blue No.6

9246 FD & C No.2 (Indigotine)

10415 Lake Blend Blue

11540 Lake Blend Green LB-217

11290 Opadry Blue

10215 Opadry Blue OY-20921

10455 Opadry II Blue #40L10890

10601 Opadry II Blue 85F10919

10992 Opaspary Light Blue

9820 Patent Blue V

774 Calcium Chloride

781 Calcium Phosphate

9290 Cremophor El (Poly.Castor Oil)

10402 Polyoxyl 35 Castor Oil

10480 Polyoxyl 40 Castor Oil

10487 Polyoxyl 40 Hydrogenated Casto

3785 Edetic Acid

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1091 Edetate Calcium Disodium

1090 Edetate Disodium

2560 Edetate Sodium

7732 Edetate Trisodium

6947 Egg

7551 Albumen (albumin)

9279 Chicken Embryo Derived

8413 Egg White

6948 Egg Yolk

7243 Lecithin, Egg

7967 Phospholipids, Egg

1539 Ethyl Alcohol

8923 FD & C No.5 (Tartrazine)

10150 D & C No.10 (Yellow)

10151 D & C No.11 (Yellow)

12623 D & C No.40 (Yellow)

10152 D & C No.8 (Yellow)

9247 FD & C No.10 (Quinoline WS)

9248 FD & C No.11 (Quinoline SS)

9252 FD & C No.6 (Sunset Yellow FCF)

10153 FD & C Yellow No.1

12263 FD & C Yellow No.3

10154 FD & C Yellow No.7

11540 Lake Blend Green LB-217

10437 Lake Blend Yellow

11982 Opadry AMB 80W 52110 Yellow

10628 Opadry II Yellow 40L12200

10213 Opadry Light Yellow

10214 Opadry Yellow OY 52945

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10993 Opaspray Yellow

10513 Yellow LB-1637

10218 Yellow LB-1684

10217 Yellow, Velo

9278 Fish derived

10398 Menhaden Oil

7207 Gluten

7908 Wheat Bran

1023 Wheat Germ Oil

7510 Wheat Starch

2432 Lactose

9042 Milk, Nonfat, Dried (Skim)

9037 Whey

8921 Latex

4652 Condoms, Latex, Lubricated

4651 Condoms, Latex, Non-lubricated

8920 Gloves, Latex

6551 Latex Dams

11469 Latex Foam for Cerv.Collar,Adh

7230 Magnesium Carbonate

11883 Aluminum Mag Hydroxide Stear

785 Magnesium Carbonate

2272 Mannitol

4521 Mannitol

8922 Milk

9042 Milk, Nonfat, Dried (Skim)

9037 Whey

2530 Oleic Acid

9036 Oleyl Oleate

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3203 Paraben

3198 Benzylparaben

3197 Butylparaben

5164 Ethylparaben

6421 Ethylparaben sodium

1345 Isobutyl P-Aminobenzoate

11698 Isobutylparaben

3195 Methylparaben

6422 Methylparaben Sodium

3196 Propylparaben

6420 Propylparaben sodium

568 Peanut

2473 Peanut Oil

31995 Phenol

6582 Orthophenylphenol

3172 Phenol

3542 Phenylalanine

9277 Pork derived (porcine)

767 Potassium Chloride

769 Potassium Phosphate

9291 Potassium Bisulfite

7513 Potassium Metabisulfite

1189 Potassium Phosphate, Monobasic

2468 Propylene Glycol

12503 Laurylmethicone Copolyol

10403 Polypropylene Glycol

10492 PPG 20 Methyl Glucose Ether

13284 PPG-1 Trideceth-7

10367 PPG-10 Cetyl Ether

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10242 PPG-5 Laureth-5

2524 Prop Glycol Alginate

10364 Propylene Glycol Diacetate

10552 Propylene Glycol Dioctanoate

10303 Propylene Glycol Monostearate

10283 Propylene Glycol Oleate

10141 Red Dye

2623 Amaranth

2629 Carmine

2624 Congo Red

10155 D & C No.22 (red)

10156 D & C No.27 (Red)

10144 D & C No.30 (Red)

10157 D & C No.33 (Red)

10158 D & C No.40 (Red)

10159 D & C No.6 (Red)

10145 D & C No.7 (Red)

3786 Erythrosine

9245 FD & C No.17 (Toney Red)

9250 FD & C No.22 (Eosin)

9763 FD & C No.28 (Red)

9249 FD & C No.3 (Erythrosine)(Obs)

10088 FD & C No.30 (Red)

9244 FD & C No.36 (Flaming Red)

9251 FD & C No.4 (Ponceau SX)

10089 FD & C No.40 (Red)

10526 FD&C Red No.33

3013 Neutral Red

10379 Opadry II Red 40L15175

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10220 Red, Acid No.17

2626 Scarlet Red

2600 Saccharin

2601 Saccharin sodium

2475 Sesame Oil

11754 Shellfish Derived

756 Sodium Acetate

7627 Sodium Acetate Trihydrate

2334 Sodium Acid Pyrophosphate

743 Sodium Bicarbonate

2332 Sodium Citrate

7629 Sodium Citrate Dihydrate

3671 Sodium Iodide

750 Sodium Lactate

1586 Sodium Salicylate

7543 Sorbitan Esters

10234 PEG-40 Sorbitan Diisostearate

10458 PEG-40 Sorbitan Peroleate

10507 Sorbitan Hydrides

7545 Sorbitan Monolaurate

7546 Sorbitan Monooleate

10186 Sorbitan Monopalmitate

7544 Sorbitan Monostearate

1898 Sorbitan Sesquioleate

10278 Sorbitan Trioleate

10271 Sorbitan Tristerate

13405 Soy

10108 Hydrogenated Soybean Oil

10632 Hydrognat Soy Phosphatidylchol

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572 Lecithin, Soy

10615 Peg-10 Soya Sterol

12887 PEG-25 Soy Sterol

11524 PEG-5 Soy Sterol

11534 Phospholipids, Soybean

10194 Soy Fatty Acid

11036 Soy Polysaccharides

7895 Soy Protein

10300 Soy Sterol

955 Soybean Oil

4982 Tryptic Soy Broth

6300 Sulfite

11282 Acetone Sodium Bisulfite

9291 Potassium Bisulfite

7513 Potassium Metabisulfite

2557 Sodium Bisulfite

10204 Sodium Hydrosulfite

70073 Sodium Metabisulfite

9284 Sulfur Dioxide

3125 Thimerosal

3126 Thimerosal Glycerite

16161 Thimerosal (trace)

2213 Triethanolamine

7213 Triethanolamine Salicylate

11919 Triethanolamine Stearate

5454 Turmeric

13412 Wheat

7908 Wheat Bran

10511 Wheat Flour

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1023 Wheat Germ Oil

7510 Wheat Starch

10143 Yellow Dye

10150 D & C No.10 (Yellow)

10151 D & C No.11 (Yellow)

12623 D & C No.40 (Yellow)

10152 D & C No.8 (Yellow)

9247 FD & C No.10 (Quinoline WS)

9248 FD & C No.11 (Quinoline SS)

9252 FD & C No.6 (Sunset Yellow FCF)

10153 FD & C Yellow No.1

12263 FD & C Yellow No.3

10154 FD & C Yellow No.7

11540 Lake Blend Green LB-217

10437 Lake Blend Yellow

11982 Opadry AMB 80W 52110 Yellow

10628 Opadry II Yellow 40L12200

10213 Opadry Light Yellow

10214 Opadry Yellow OY 52945

10993 Opaspray Yellow

10513 Yellow LB-1637

10218 Yellow LB-1684

10217 Yellow, Velo

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Appendix B: Former Potentially Inactive Ingredients Available for Profiling Purposes Only
Examples of the types of ingredients that may be added to the Allergy Pick List for profiling purposes are listed
below.

Animal Derived

Hierarchical Ingredient Code Sequence Number Ingredient

(HICN_SEQN)

9281 Hamster Protein

9280 Mouse Protein

11198 Murine Protein

Dyes

Hierarchical Ingredient Code Sequence Number Ingredient

(HICN_SEQN)

10137 Black Dye

12199 D & C Orange No.4

12664 D&C Violet No.2

12657 FD&C Brown Lake Blend

10253 Ferric Oxide Black

10185 Ferric Oxide Brown

10255 Ferric Oxide Orange

6623 Ferric Oxide Red

6624 Ferric Oxide Yellow

10139 Green Dye

10435 Lake Blend Light Orange

10148 Maroon Dye

10140 Pink Dye

10591 Purple Dye

10142 White Dye

Flavoring

Hierarchical Ingredient Code Sequence Number Ingredient

(HICN_SEQN)

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8376 Banana Flavor

8378 Berry Flavor

8394 Citrus Flavor

8407 Coconut Flavor

10453 Fruit Flavor

8417 Fruit Punch Flavor

8425 Lemon Flavor

8426 Lemon-Lime Flavor

8428 Lime Flavor

12555 Menthol Eucalyptus Flavor

8433 Mint Flavor

8438 Peach Flavor

10091 Peppermint Flavor

10092 Pineapple Flavor

8445 Strawberry Flavor

8446 Strawberry-Banana Flavor

8449 Tropical Fruit Flavor

8452 Watermelon Flavor

8453 Wild Berry Flavor

8455 Wintergreen Flavor

Fruit

Hierarchical Ingredient Code Sequence Number Ingredient

(HICN_SEQN)

10861 Blueberry

9368 Kiwi (Actinidia chinensis)

10566 Lemon

8774 Lime

9637 Strawberry

Other

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Hierarchical Ingredient Code Sequence Number Ingredient

(HICN_SEQN)

5639 Carrageenan

8395 Cethexonium

7258 Diethylene Glycol

10196 Gentisic Acid

1114 Monosodium Glutamate

11836 Neotame

10500 Silicone

10101 Sucralose

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DAM Applications
This section provides information about the practical use of the data contained in DAM.

FDB offers a variety of drug concepts and their identifiers to support drug-lab interference screening. These
identifiers are referred to as Multiple Access Points (MAPs) and represent drug products, ingredients, and
formulations. Familiarity with the MAPs section is recommended before attempting the applications contained in
this section.

Drug Allergy Screening Overview

Screening an NDC for an Ingredient Allergen (Scenario A)

Screening an NDC for a MED_NAME_ID Allergen (Illustration of Scenario B)

Screening an NDC for a DAM_ALRGN_GRP Allergen (Illustration of Scenario C)

Screening a MEDID for an Ingredient Allergen (Illustration of Scenario D)

Customizing the Allergen Pick List

Recording Patient Allergy Information

Retrieving a Replacement Specific Allergen Group

Displaying Inactive Ingredients for a Product

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Drug Allergy Screening Overview

This section illustrates the methodology of screening prospective drugs for profiled patient allergies.

FDB offers a variety of drug concepts and their identifiers to support DAM Allergy Screening. These identifiers are
referred to as Multiple Access Points (MAPs) and represent drug products, ingredients, and formulations.
Familiarity with the MAPs section is recommended before attempting the applications contained in this section

The following topics are discussed in this section:

Illustration of the Drug Allergy Screening Process

The Six Different Allergy Screening Scenarios
Inactive Ingredient Screening

Illustration of the Drug Allergy Screening Process

DAM facilitates drug allergy screening by comparing the ingredients of a prospective drug to collections of
ingredients that pose a patient allergy risk. The following illustration shows a graphical diagram of this approach,
and uses some sample data to illustrate the comparisons. The light-gray line represents the comparison interface
between the two sets of gathered data, where the ingredients above the interface (the prospective ingredients)
and the ingredients below the interface (those that put the patient at risk of suffering an allergic reaction) are
compared for matching values. Matches signify an allergy risk to the patient.

FDB does not recommend storing and screening only the MED_NAME_ID. If a MED_NAME_ID is
chosen for profiling, you must also save/profile the associated HIC_SEQNs.

The area above the dotted line uses database table navigation to collect the ingredients of the prospective

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drug(s). The area below the dotted line uses database table navigation to collect the ingredients related to each
allergen listed on the patients allergen profile. Different navigational paths are used for each of the three allergen
concept types (ingredients, Medication Names, and DAM Specific Allergen Groups).

The Six Different Allergy Screening Scenarios

Your screening application must carry out a pre-defined sequence of steps to screen a prospective drug for
patient allergens. However, these steps depend upon the following initial screening conditions: prospective drug
type, and patient allergen type. For example, the process of screening a prospective NDC for a patients
ingredient allergen differs from the process of screening a prospective NDC for a Medication Name ID allergen.
This process, in turn, differs from the process of screening a prospective Medication for a given allergen rather
than screening a prospective NDC.

All allergen groups (DAM_AGCSP) and ingredients (HIC_SEQN) stored within a patients profile should
always be screened for allergy hits regardless of their status. See Retired, Replaced, or Obsolete Status
Codes for more information.

Replaced ingredients should be screened using the replacement ingredient identifier value. See Finding a
Replacement Ingredient Identifier for more information.

The following table defines the six possible screening scenarios:

Screening Scenario Prospective Drug Type Patient Allergen Type

A NDC Ingredient (HIC_SEQN)

B NDC Medication Name ID (MED_NAME_ID)

C NDC Specific Allergen Group

(DAM_ALRGN_GRP)

D Medication Concept Ingredient (HIC_SEQN)

E Medication Concept Medication Name ID (MED_NAME_ID)

F Medication Concept Specific Allergen Group

(DAM_ALRGN_GRP)

Scenarios A, B, and C tend to occur in the order fulfillment environment, where healthcare experts work with
specificNDCs. Scenarios D, E, and F tend to occur in the order entry environment, where healthcare experts work
with medication names and dosage strengths rather than packaged products.

Scenarios A, B, C, and D have illustrated example applications in this chapter. Scenarios E and F use similar
steps to scenarios B and C respectively, but scenarios E and F follow the steps for retrieving ingredients related
to Medication Concepts rather thanNDCs.See Scenario A to Scenario D below to review the example
applications.

Inactive Ingredient Screening

FDB relies on notification by the manufacturer and NDC review to keep inactive-ingredient information current.

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For this reason, inactive ingredient information is subject to change at any time without notice.

Manufacturers should notify FDB as soon as possible whenever a products inactive ingredients change.

Support for inactive ingredient screening differs from active ingredient screening because automatic
inactive-ingredient screening occurs only for NDCs that have already been reviewed by FDB clinical experts.
These drug products are listed in the NDC Inactive Ingredients Reviewed Master Table
(RNDCINR0_INACTV_REVIEWED). Because a products inactive ingredient information might change without
notice, FDB uses a process of NDC review to provide inactive ingredient allergy screening data. This review
process provides the best possible accuracy of inactive ingredient information; however, this also means that if an
NDC has not yet been reviewed by FDB, the product will require manual screening for potentially inactive allergen
concepts listed on the patients allergen profile.

For screening scenarios D, E, and F, your application should provide statistical inactive ingredient information
about the concepts related packaged products. See the Screening a MEDID for an Ingredient Allergen
(Illustration of Scenario D) (Illustration of Scenario D) for an illustrated example.

See Inactive Ingredients Editorial Policies for more information.

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Screening an NDC for an Ingredient Allergen (Scenario A)

This application uses the following scenario at the point of order fulfillment (dispensing) to screen a prescribed
NDC for a patients profiled ingredient allergen:

Prospective NDC: Zyrtec 5mg Chewable Tablet (NDC = 00069144003)

Profiled Allergen Concept: Carmine (HIC_SEQN = 002629)

Part 1 retrieves the prospective NDCs related ingredients. Part 2 retrieves the profiled ingredient allergens
related ingredients, and performs the allergy alert checking. See the The Six Different Allergy Screening
Scenarios section for more information about the different allergy screening scenarios.

Part 1: Retrieve Prospective NDC Ingredient Information

1. Retrieve the NDC's Clinical Formulation ID (GCN_SEQNO) using the NDC Table (RNDC14_NDC_MSTR).

NDC GCN_SEQNO

00069144003 053980

2. Retrieve the Ingredient List Identifier (HICL_SEQNO) for the Clinical Formulation ID (GCN_SEQNO) using
the Clinical Formulation ID Table (RGCNSEQ4_GCNSEQNO_MSTR).

GCN_SEQNO HICL_SEQNO

053980 006544

3. Retrieve the DAM Allergen Hierarchical Ingredient Code Sequence Number (DAM_ALRGN_HIC_SEQN)
values related to the HICL_SEQNO using the Drug Allergy Screening HICL_SEQNO/HIC Relation Table
(RDAMHHA0_HIC_HICL_ALG_LINK).

HICL_SEQNO DAM_ALRGN_HIC_SEQN

006544 003804

Some HICL_SEQNOs have more than one related ingredient code.

Alternately, the HICL_SEQNO/HIC Relation Table (RHICL1_HIC_HICLSEQNO_LINK) can be

used to retrieve the Hierarchical Ingredient Code Sequence Number. It is important to note that the
HICL_SEQNO/HIC Relation Table will return non-allergen ingredients.

4. Compare the Hierarchical Ingredient Parent HIC4 Sequence Number (HIC_ROOT) for each prospective
NDC and Profiled Allergen HIC_SEQN value using the Hierarchical Ingredient Code Description Table
(RHICD5_HIC_DESC).
Retrieve the HIC_ROOT description values (HIC4_DESC) from the Hierarchical Base Ingredient Code
Table (RHIC4D2_HIC_BASE_ING_DESC).

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DAM_ALRGN_HIC_SEQ HIC_SEQN HIC_ROOT HIC4_DESC

N

003804 003804 003803 cetirizine

002629 002629 002629 carmine

Display an alert to the end-user and end screening if any ingredient-based allergy alerts exist. In this
example, the HIC_ROOT values do not match, no alert is displayed and screening continues.

5. Retrieve the Related Hierarchical Ingredient Code Sequence Numbers ( RELATED_HIC_SEQN) for each
HIC_SEQN value using the HIC_SEQN/HIC_SEQN Link Table (RHICHCR0_HIC_HIC_LINK).

HIC_SEQN RELATED_HIC_SEQN HIC_DESC

003804 003803 cetirizine

003804 003804 cetirizine HCl

6. Check the NDC Inactive Ingredients Reviewed Master Table (RNDCINR0_INACTV_REVIEWED) for the
presence of the prospective NDC in question. If the NDC appears in the RNDCINR0_INACT_REVIEWED
table, skip to step 9. Otherwise continue to step 7.
In this example, the NDC appears in the RNDCINR0_INACTV_REVIEWED table.

For more information on screening inactive ingredients, please see Inactive Ingredient Screening.

7. Check the patient allergen profile for the presence of any potentially inactive concepts. Both Ingredients
and Specific Allergen Groups have potentially inactive indicators (see Implementation Note for more
information about these indicators). Use the Hierarchical Ingredient Code Description Table and/or the
DAM Specific Allergen Group Code Description Table (RDAMAGD1_ALRGN_GRP_DESC) to find each
codes Potentially Inactive Indicator.

HIC_SEQN HIC_DESC HIC_POTENTIALLY_INACTV_IND

002629 carmine 1

8. For each allergen code with a potentially inactive indicator of 1, alert the end-user to manually check the
package insert of each NDC that did not appear in the reviewed list (identified in step 6) for the potentially
inactive concept. For example: Check product XXXX for the presence of Carmine. Carmine is listed on the
patients profile as an allergen, and Carmine is considered a potentially inactive ingredient .

If the potentially inactive concept is a Specific Allergen Group, you should present the end-user
with both the DAM Specific Allergen Group Code Description (DAM_ALRGN_GRP_DESC) and a
list of related ingredients. Find related ingredients using the DAM Ingredient/Allergen Group Link
Table (RDAMGHC0_HIC_ALRGN_GRP_LINK).

9. Retrieve a list of the products inactive ingredients using the NDC/HIC_SEQN Inactive Ingredient Relation

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9.

Table (RNDCINH0_NDC_INACTV_LINK). If the product has not been reviewed for inactive ingredient
information, this step will return zero results.

NDC HIC_SEQN HIC_DESC

00069144003 002272 mannitol

00069144003 002432 lactose

00069144003 010138 blue dye

00069144003 010141 red dye

10. Combine the products active ingredients (found in step 5) with the inactive ingredients (found in step 9). In
this example, the resulting list contains every ingredient found in Zyrtec 5mg Chewable Tablet.

HIC_SEQN HIC_DESC

002272 mannitol

002432 lactose

010138 blue dye

010141 red dye

Part 2: Screen the Prospective NDC for Profiled Ingredient Allergens

1. Retrieve the Related Hierarchical Ingredient Code Sequence Number (RELATED_HIC_SEQN) for each
ingredient allergen on the patients allergen profile using the HIC_SEQN/HIC_SEQN Link Table
(RHICHCR0_HIC_HIC_LINK).

HIC_SEQN RELATED_HIC_SEQN HIC_DESC

002629 002629 carmine

Replaced HIC_SEQN values are never removed from the database. However the application can
optionally determine if the ingredients stored on a patients profile are replaced and retrieve any
replacement ingredient identifier values to store on the patients profile. See Finding a
Replacement Ingredient Identifier for more information.

2. Compare each RELATED_HIC_SEQN value to the list of prospective HIC_SEQN values.

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3. Display an alert to the end-user if any ingredient-based allergy alerts exist. Zyrtec shares one ingredient
with the list of RELATED_HIC_SEQN value. Notify the end-user that this NDC poses an ingredient-based
allergy risk to this patient.

One ingredient-based allergy alert exists for Carmine (HIC_SEQN 002629). Notify the end-user of the following:

Sample output for the example data:

Zyrtec contains carmine. This patient's profile indicates Carmine as an allergen. Zyrtec poses the risk of causing an
ingredient-based allergic reaction in this patient.

Continue drug allergy screening if there are no ingredient allergen alerts.

Steps Performed During this Process

The following flowchart illustrates the process involved in screening prospective NDCs for an ingredient allergen.
This application carried out only the darker steps. Steps shown with a dashed outline are necessary only if your
application implements inactive-ingredient screening:

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Screening an NDC for a MED_NAME_ID Allergen (Illustration of Scenario B)

This application uses the following scenario at the point of order fulfillment (dispensing) to screen a prescribed
NDC for a patients profiled MED_NAME_ID allergen:

Prospective NDC: Maxipime 2 gram vial (NDC = 00409022011)

Profiled Allergen Concept: Ceftin (MED_NAME_ID = 00003716)

Part 1 retrieves the prospective NDCs related ingredients. Part 2 retrieves the profiled MED_NAME_ID allergens
related ingredients, and performs the allergy alert checking. See The Six Different Allergy Screening Scenarios
section for more information about the different allergy screening scenarios.

Part 1: Retrieve Prospective NDC Ingredient Information

1. Retrieve the NDCs Clinical Formulation ID (GCN_SEQNO) using the NDC Table (RNDC14_NDC_MSTR).

NDC GCN_SEQNO

00409022011 24095

2. Retrieve the Ingredient List Identifier (HICL_SEQNO) for the Clinical Formulation ID (GCN_SEQNO) using
the Clinical Formulation ID Table (RGCNSEQ4_GCNSEQNO_MSTR).

GCN_SEQNO HICL_SEQNO

24095 010132

3. Retrieve the DAM Allergen Hierarchical Ingredient Code Sequence Number (DAM_ALRGN_HIC_SEQN)
values related to the HICL_SEQNO using the Drug Allergy Screening HICL_SEQNO/HIC Relation Table
(RDAMHHA0_HIC_HICL_ALG_LINK).

HICL_SEQNO DAM_ALRGN_HIC_SEQN

010132 004975

Some HICL_SEQNOs have more than one related ingredient code.

Alternately, the HICL_SEQNO/HIC Relation Table (RHICL1_HIC_HICLSEQNO_LINK) can be

used to retrieve the Hierarchical Ingredient Code Sequence Number. It is important to note that the
HICL_SEQNO/HIC Relation Table will return non-allergen ingredients.

4. Retrieve the Related Hierarchical Ingredient Code Sequence Numbers ( RELATED_HIC_SEQN) for each
HIC_SEQN value using the HIC_SEQN/HIC_SEQN Link Table (RHICHCR0_HIC_HIC_LINK).

DAM_ALRGN_HIC_SEQ HIC_SEQN RELATED_HIC_SEQN HIC_DESC

N

004975 004975 004974 cefepime

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5. Check the NDC Inactive Ingredients Reviewed Master Table (RNDCINR0_INACTV_REVIEWED) for the
presence of the prospective NDC in question. If the NDC appears in the RNDCINR0_INACT_REVIEWED
table, skip to step 8. Otherwise continue to step 6.
In this example, the NDC appears in the RNDCINR0_INACTV_REVIEWED table, so skip to step 9.

For more information on screening inactive ingredients, please see Inactive Ingredient Screening.

6. Check the patient allergen profile for the presence of any potentially inactive concepts. Both Ingredients
and Specific Allergen Groups have potentially inactive indicators (see Implementation Note for more
information about these indicators). Use the RHICD5_HIC_DESC table, and/or the DAM Specific Allergen
Group Code Description Table (RDAMAGD1_ALRGN_GRP_DESC) to find each codes related Potentially
Inactive Indicator.

7. For each allergen code with a potentially inactive indicator of 1, alert the end-user to manually check the
package insert of each NDC that did not appear in the reviewed list (identified in step 5) for the potentially
inactive concept. For example: Check product XXXX for the presence of Carmine. Carmine is listed on the
patients profile as an allergen, and Carmine is considered a potentially inactive ingredient.

If the potentially inactive concept is a Specific Allergen Group, you should present the end-user
with both the DAM Specific Allergen Group Code Description (DAM_ALRGN_GRP_DESC) and a
list of related ingredients. Find related ingredients using the DAM Ingredient/Allergen Group Link
Table (RDAMGHC0_HIC_ALRGN_GRP_LINK).

8. Retrieve a list of the products inactive ingredients using the NDC/HIC_SEQN Inactive Ingredient Relation
Table (RNDCINH0_NDC_INACTV_LINK).

In this example, the NDC was reviewed but has no inactive ingredients.

9. Combine the products active ingredients (found in step 4) with the inactive ingredients (found in step 8.)
The resulting list contains every ingredient found in Maxipime 2 gram vial.

HIC_SEQN HIC_DESC

004974 cefepime

Part 2: Screen the Prospective NDC for Profiled MED_NAME_ID Allergens

1. Retrieve the MED_NAME_IDs related HICL_SEQNO using the MED MED Concept/HICL_SEQNO
Relation Table (RMEDMHL0_MED_HICLSEQNO_LINK). Use Ceftins MED_NAME_ID of 00003716 for
the MED Concept ID (MED_CONCEPT_ID). Use the MED Concept ID Type (MED_CONCEPT_ID_TYP)
value of 1, which signifies that the MED_CONCEPT_ID is in fact a Medication Name ID value.

MED_CONCEPT_ID MED_CONCEPT_ID_TYP HICL_SEQNO MED_CONCEPT_HICL_

SRC_CD

00003716 1 003991 1

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The MED Concept HICL_SEQNO Source Code (MED_CONCEPT_HICL_SRC_CD) may cause

otherwise identical entries during this step. Read more about the
MED_CONCEPT_HICL_SRC_CD to determine if utilizing this concept in drug allergy screening
would benefit your application.

2. Retrieve the DAM Allergen Hierarchical Ingredient Code Sequence Number (DAM_ALRGN_HIC_SEQN)
values related to the HICL_SEQNO using the Drug Allergy Screening HICL_SEQNO/HIC Relation Table
(RDAMHHA0_HIC_HICL_ALG_LINK).

HICL_SEQNO DAM_ALRGN_HIC_SEQN

018548 007588

Some HICL_SEQNOs have more than one related ingredient code.

Alternately, the HICL_SEQNO/HIC Relation Table (RHICL1_HIC_HICLSEQNO_LINK) can be

used to retrieve the Hierarchical Ingredient Code Sequence Number. It is important to note that the
HICL_SEQNO/HIC Relation Table will return non-allergen ingredients.

3. Compare the Hierarchical Ingredient Parent HIC4 Sequence Number (HIC_ROOT) for each prospective
NDC and Profiled Allergen HIC_SEQN value using the Hierarchical Ingredient Code Description Table (
RHICD5_HIC_DESC). Retrieve the HIC_ROOT description values (HIC4_DESC) from the Hierarchical
Base Ingredient Code Table (RHIC4D2_HIC_BASE_ING_DESC).

HIC_SEQN HIC_ROOT HIC4_DESC

004974 004974 cefepime

Display an alert to the end-user and end screening if any ingredient-based allergy alerts exist. In this
example, the HIC_ROOT values do not match, no alert is displayed and screening continues.

4. Retrieve the Related Hierarchical Ingredient Code Sequence Numbers ( RELATED_HIC_SEQN) for each
HIC_SEQN value using the HIC_SEQN/HIC_SEQN Link Table (RHICHCR0_HIC_HIC_LINK).

HIC_SEQN RELATED_HIC_SEQN HIC_DESC

004974 004974 cefepime

004974 004975 cefepime HCl

5. Compare each RELATED_HIC_SEQN value to the list of prospective HIC_SEQN values.

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6. Display an alert to the end-user if any ingredient-based allergy alerts exist. Maxipime had no ingredient
matches with the RELATED_HIC_SEQN values, and therefore does not pose an ingredient-level allergy
risk to this patient.

7. Using the HIC_SEQN value(s) found in step 2 above (not the list of RELATED_HIC_SEQN values from
step 3), retrieve each HIC_SEQNs related DAM Specific Allergen Group Code ( DAM_ALRGN_GRP)
values using the DAM Ingredient/Allergen Group Link Table (RDAMGHC0_HIC_ALRGN_GRP_LINK).

HIC_SEQN DAM_ALRGN_GRP DAM_ALRGN_GRP_DESC

002730 000477 Cephalosporins

8. Retrieve all HIC_SEQN values related to all DAM_ALRGN_GRP values using the same
RDAMGHC0_HIC_ALRGN_GRP_LINK table. Only a portion of the resulting values are displayed in the
table below:

DAM_ALRGN_GRP HIC_SEQN HIC_DESC

000477 006034 cefetamet

000477 006723 ceftazidime

000477 006724 ceftazidime sodium

000477 006821 cefmenoxime

000477 006822 cefmenoxime HCl

000477 006830 cephalexin monohydrate

000477 007588 cefdinir

000477 007869 ceftibuten dihydrate

000477 008157 cefteram

000477 008158 cefteram pivoxil

000477 009348 cefadroxil hydrate

000477 009507 cefditoren

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000477 009508 cefditoren pivoxil

000477 010923 cefroxadine

000477 010924 ceftezole

... ... ...

9. Compare each HIC_SEQN value to the list of prospective HIC_SEQN values.

10. Display an alert to the end-user if any Specific Allergen Group level allergy alerts exist. Maxipime shares
one ingredient with the list of RELATED_HIC_SEQN value. Notify the end-user that this NDC poses a
Specific Allergen Group level allergy alert risk to this patient.

One Specific Allergen Group based allergy alert exists for Ceftin (MED_NAME_ID 00003716). Notify the end-user
of the following:

Sample output for the example data:

Maxipime contains cefepime, which is closely related to the ingredient cefuroxime axetil. This patient's profile indicates
Ceftin as an allergen, and Cefuroxime Axetil appears as an ingredient in Ceftin's formulation. Therefore, Maxipime poses
the risk of causing a Specific Allergen Group based allergic reaction in this patient.

Continue drug allergy screening if there are no allergy group level alerts.

Steps Performed During this Process

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Screening an NDC for a DAM_ALRGN_GRP Allergen (Illustration of Scenario C)

This application uses the following scenario at the point of order fulfillment (dispensing) to screen a prescribed
NDC for a patients profiled DAM_ALRGN_GRP allergen:

Prospective NDC: Suprax 100 mg Tablet Chewable (NDC = 27437020311)

Profiled Allergen Concept: Penicillamine (DAM_ALRGN_GRP = 900028)

Part 1 retrieves the prospective NDCs related ingredients. Part 2 retrieves the profiled DAM_ALRGN_GRP
allergens related ingredients, and performs the allergy alert checking. See the The Six Different Allergy
Screening Scenarios section for more information about the different allergy screening scenarios.

Part 1: Retrieve Prospective NDC Ingredient Information

1. Retrieve the NDCs Clinical Formulation ID (GCN_SEQNO) using the NDC Table (RNDC14_NDC_MSTR).

NDC GCN_SEQNO

27437020108 070122

2. Retrieve the Ingredient List Identifier (HICL_SEQNO) for the Clinical Formulation ID (GCN_SEQNO) using
the Clinical Formulation ID Table (RGCNSEQ4_GCNSEQNO_MSTR).

GCN_SEQNO HICL_SEQNO

070122 003999

3. Retrieve the DAM Allergen Hierarchical Ingredient Code Sequence Number (DAM_ALRGN_HIC_SEQN)
values related to the HICL_SEQNO using the Drug Allergy Screening HICL_SEQNO/HIC Relation Table
(RDAMHHA0_HIC_HICL_ALG_LINK).

HICL_SEQNO DAM_ALRGN_HIC_SEQN

003999 002737

Some HICL_SEQNOs have more than one related ingredient code.

Alternately, the HICL_SEQNO/HIC Relation Table (RHICL1_HIC_HICLSEQNO_LINK) can be

used to retrieve the Hierarchical Ingredient Code Sequence Number. It is important to note that the
HICL_SEQNO/HIC Relation Table will return non-allergen ingredients.

4. Check the NDC Inactive Ingredients Reviewed Master Table (RNDCINR0_INACTV_REVIEWED) for the
presence of the prospective NDC in question. If the NDC appears in the RNDCINR0_INACT_REVIEWED
table, skip to step 7. Otherwise continue to step 5.
In this example, the NDC appears in the RNDCINR0_INACTV_REVIEWED table.

For more information on screening inactive ingredients, please see Inactive Ingredient Screening.

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5. Check the patient allergen profile for the presence of any potentially inactive concepts. Both Ingredients
and Specific Allergen Groups have potentially inactive indicators (see Potentially Inactive Ingredient for
more information about these indicators). Use the RHICD5_HIC_DESC and/or the DAM Specific Allergen
Group Code Description Table (RDAMAGD1_ALRGN_GRP_DESC) to find each codes related Potentially
Inactive Indicator.

DAM_ALRGN_GRP DAM_ALRGN_GRP_DESC DAM_GRP_POTENTIALLY_INAC

TV_IND

900028 Penicillamine 0

6. For each allergen code with a potentially inactive indicator of 1, alert the end-user to manually check the
package insert of each NDC that did not appear in the reviewed list (identified in step 4) for the potentially
inactive concept. For example: Check product XXXX for the presence of Carmine. Carmine is listed on the
patients profile as an allergen, and Carmine is considered a potentially inactive ingredient.

If the potentially inactive concept is a Specific Allergen Group, you should present the end-user
with both the DAM Specific Allergen Group Code Description (DAM_ALRGN_GRP_DESC) and a
list of related ingredients. Find related ingredients using the DAM Ingredient/Allergen Group Link
Table (RDAMGHC0_HIC_ALRGN_GRP_LINK).

7. Retrieve a list of the products inactive ingredients using the NDC/HIC_SEQN Inactive Ingredient Relation
Table (RNDCINH0_NDC_INACTV_LINK).

NDC HIC_SEQN HIC_DESC

27437020311 002272 mannitol

27437020311 002605 aspartame

27437020311 010141 red dye

8. Combine the products HIC_SEQN with the inactive ingredients (found in step 7). The resulting list contains
every ingredient found in Suprax 400mg Tablet.

HIC_SEQN HIC_DESC

002272 mannitol

002605 aspartame

010141 red dye

Part 2: Screen the Prospective NDC for Profiled DAM_ALRGN_GRP Allergens

1. Retrieve all HIC_SEQN values related to the DAM_ALRGN_GRP value for Penicillamine
(DAM_ALRGN_GRP = 9000028) using the DAM Ingredient/Allergen Group Link Table
(RDAMGHC0_HIC_ALRGN_GRP_LINK) table.

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DAM_ALRGN_GRP HIC_SEQN HIC_DESC

900028 001088 penicillamine

900028 003510 cysteamine

900028 004750 cysteamine bitartrate

The following DAM_ALRGN_GRP values indicate when allergy information is unknown,

unavailable, or undiscovered and should be ignored when one of these values appears on the
patients allergen profile while screening:

900388 NO KNOWN ALLERGIES

900590 NO KNOWN DRUG ALLERGIES
000143 NO ALLERGY INFORMATION AVAILABLE
000795 UNABLE TO ASSESS
000815 NO KNOWN DRUG INTOLERANCES
000816 NO KNOWN INTOLERANCES

It is advisable to update any replaced allergen groups in the patient profile because using the new
group(s) provides a more focused and pertinent set of results. See Retired, Replaced, or Obsolete
Status Codes for more information.

2. Compare each HIC_SEQN value to the list of prospective HIC_SEQN values.

3. Display an alert to the end-user if any Specific Allergen Group level allergy alerts exist. Suprax had no
ingredient matches with the (RELATED_HIC_SEQN) values, and therefore does not pose a Specific
Allergen Group level allergy risk to this patient.

4. Retrieve the DAM Cross-Sensitive Allergen Group Code (DAM_ALRGN_XSENSE) values associated to
DAM_ALRGN_GRP 9000028 using the DAM Allergen Group/Cross-Sensitivity Link Table (
RDAMGX0_ALRGN_GRP_XSENSE_LINK).

DAM_ALRGN_GRP DAM_ALRGN_XSENSE DAM_ALRGN_XSENSE_DESC

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9000028 0001 Beta Lactam Antibiotic

9000028 0304 Penicillamine

5. Retrieve all HIC_SEQN values related to the DAM_ALRGN_XSENSE values of 0001 and 0304 using the
DAM Ingredient/Cross-Sensitivity Link Table (RDAMXHC0_HIC_ALRGN_XSENSE_LINK). Track which
DAM_ALRGN_XSENSE group each ingredient relates to, and deliver this information when you alert the
end-user of an allergen risk. Only a subset of 14 values from the total 163 returned values are displayed in
the table below:

DAM_ALRGN_XSENSE HIC_SEQN HIC_DESC

0001 1088 penicillamine

0001 2679 penicillin G sodium

0001 2680 penicillin G potassium

0001 2681 penicillin G procaine

0001 2682 penicillin G procaine-Al stea

0001 2683 penicillin G benzathine

0001 2684 penicillin V

0001 2685 penicillin V hydrabamine

0001 2686 penicillin V potassium

0001 2687 phenethicillin potassium

... ... ...

6. Compare each HIC_SEQN value to the list of prospective HIC_SEQN values.

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7. Display an alert to the end-user if any Cross-sensitive Allergen Group level allergy alerts exist. Suprax
shares one ingredient with the list of RELATED_HIC_SEQN value. Notify the end-user that this NDC
poses a Cross-sensitive Allergen Group level allergy alert risk to this patient.

One Cross-sensitive Allergen Group based allergy alert exists for Cefixime (HIC_SEQN 002737). Notify the
end-user of the following:

Sample output for the example data:

If this message is too complex or too long, a simplified version may read:

Simplified output for the example data:

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Steps Performed During this Process

The following flowchart illustrates the process involved in screening prospective NDCs for a DAM_ALRGN_GRP
allergen. This application carried out only the darker steps. Steps shown with a dashed outline are necessary only
if your application implements inactive-ingredient screening:

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Screening a MEDID for an Ingredient Allergen - Illustration of Scenario D

This application illustrates how to screen for ingredient allergens using the MEDID of a prescribed product. See
the The Six Different Allergy Screening Scenarios section for more information.

Prospective MEDID: Miconazole 7 2% Vaginal Cream (MEDID = 00216543)

Profiled Allergen Concepts: Ketoconazole (HIC_SEQN = 002903) and Glyceryl Stearate SE (HIC_SEQN
008801)

Part 1 retrieves the prospective MEDIDs related active ingredients. Part 2 retrieves the profiled ingredient
allergens related ingredients, and performs the allergy alert checking. See the The Six Different Allergy
Screening Scenarios section for more information about the different allergy screening scenarios. FDB does not
recommend implementing a system that screens prospective medication concepts for inactive ingredients.
Medication Name concepts normally apply to more than one individual product, each of which has its own
assortment of inactive ingredients. Automatically screening for these would probably generate many false-positive
allergen hits. As an alternative to automatically screening MED Concepts for inactive ingredients, display the
above statistical information to help the prescriber make a decision based on the related inactive ingredient
concepts.

Part 1: Retrieve Prospective MED Concepts Ingredient Information

1. Identify the prospective MED Concepts MED Concept ID Type (MED_CONCEPT_ID_TYP) using the MED
MED Concept ID Type Description Table (RMEDCD0_MED_CONCEPT_TYP_DESC). According to this
table, MEDIDs have a MED_CONCEPT_ID_TYP value of 3.

MED_CONCEPT_ID_TYP GCN_SEQNO

1 Medication Name

2 Routed Medication

3 Medication

7 Routed Dosage Form Medication

2. Retrieve the Ingredient List Identifier (HICL_SEQNO) values for Miconazoles MEDID using the MED MED
Concept/HICL_SEQNO Relation Table (RMEDMHL0_MED_HICLSEQNO_LINK). Use Miconazoles
MEDID of 00216543 for the MED Concept ID (MED_CONCEPT_ID). Use a MED_CONCEPT_ID_TYP
value of 3.
The RMEDMHL0_MED_HICLSEQNO_LINK table does not include medication concepts with a retired
status. Therefore, medication concepts with a retired status are excluded from this example.

MED_CONCEPT_ID CONCEPT_ID_TYP HICL_SEQNO

00216543 3 003031

3. Retrieve the DAM Allergen Hierarchical Ingredient Code Sequence Number (DAM_ALRGN_HIC_SEQN)
values related to the HICL_SEQNO using the Drug Allergy Screening HICL_SEQNO/HIC Relation Table
(RDAMHHA0_HIC_HICL_ALG_LINK).

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HICL_SEQNO DAM_ALRGN_HIC_SEQN

003031 002919

Some HICL_SEQNOs have more than one related ingredient code.

Alternately, the HICL_SEQNO/HIC Relation Table (RHICL1_HIC_HICLSEQNO_LINK) can be

used to retrieve the Hierarchical Ingredient Code Sequence Number. It is important to note that the
HICL_SEQNO/HIC Relation Table will return non-allergen ingredients.

4. Retrieve the Related Hierarchical Ingredient Code Sequence Numbers ( RELATED_HIC_SEQN) for each
HIC_SEQN value using the HIC_SEQN/HIC_SEQN Link Table (RHICHCR0_HIC_HIC_LINK).

DAM_ALRGN_HIC_SEQ HIC_SEQN RELATED_HIC_SEQN HIC_DESC

N

002919 002919 002918 miconazole

002919 002919 002919 miconazole nitrate

5. Find each ingredient (HIC_SEQN) and Specific Allergen Group (DAM_ALRGN_GRP) listed as an allergen
on the patients allergen profile, and check each codes potentially inactive indicator (see Potentially
Inactive Ingredient) using the RHICD5_HIC_DESC table, and/or the DAM Specific Allergen Group Code
Description Table (RDAMAGD1_ALRGN_GRP_DESC). If any of these concepts have a potentially inactive
indicator of 1, continue to step 6. Otherwise skip step 6 and proceed directly to step 7.

HIC_SEQN HIC_DESC POTENTIAL_INACTV_IND

002903 ketoconazole 0

008801 glyceryl stearate se 1

In this example, the RHICD5_HIC_DESC table is used to check the potentially inactive indicator for each
ingredient listed on the patients allergen profile. The results show that Glyceryl Stearate SE (HIC_SEQN
008801) has an inactive indicator of 1. The application continues to step 6.

6. FDB recommends that when a general drug concept identifies the prospective drug instead of a specific
product ID, and the patient lists a potentially inactive ingredient as an allergen, that you display inactive
ingredient statistical information to the end-user. See Retrieving a MED Concepts Inactive Ingredient
Statistics for more information. Display these statistics at the time other notifications take place.

7. The list of ingredients found in step 4 contains every active ingredient associated with Miconazole 7 2%
Vaginal Cream.

HIC_SEQN HIC_DESC

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002918 miconazole

002919 miconazole nitrate

Part 2: Screen the Prospective MEDID for Profiled Ingredient Allergens

1. Retrieve the Related Hierarchical Ingredient Code Sequence Number (RELATED_HIC_SEQN) for each
ingredient allergen on the patients allergen profile using the HIC_SEQN/HIC_SEQN Link Table
(RHICHCR0_HIC_HIC_LINK).

HIC_SEQN RELATED_HIC_SEQN HIC_DESC

002903 002903 ketoconazole

008801 008801 glyceryl stearate se

2. Compare each RELATED_HIC_SEQN value to the prospective MEDIDs list of HIC_SEQN values.

3. Display an alert to the end-user if any ingredient-based allergy alerts exist. Miconazole had no ingredient
matches with the RELATED_HIC_SEQN values, and therefore does not pose an ingredient-level allergy
alert to this patient.

4. Using the HIC_SEQN value(s) on the patients allergen profile (not the list of RELATED_HIC_SEQN
values from step 1), retrieve each HIC_SEQNs related DAM Specific Allergen Group Code (
DAM_ALRGN_GRP) values using the DAM Ingredient/Allergen Group Link Table
(RDAMGHC0_HIC_ALRGN_GRP_LINK).

HIC_SEQN DAM_ALRGN_GRP DAM_ALRGN_GRP_DESC

002903 900074 Imidazole Antifungal

008801 000630 Glyceryl Stearate SE

5. Retrieve all HIC_SEQN values related to the DAM_ALRGN_GRP value of 900074 and 000630 using the
same RDAMGHC0_HIC_ALRGN_GRP_LINK table.

DAM_ALRGN_GRP HIC_SEQN HIC_DESC

000630 008801 glyceryl stearate se

000630 008815 herbal complex no. 103

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000630 011513 emollient combination no. 14

000630 011652 emollient combination no. 20

000630 011653 emollient combination no. 21

000630 011660 emollient combination no. 22

000630 012771 emollient combination no.31

000630 012797 emollient combination no.32

000630 012888 emollient combination no.36

900074 002903 ketoconazole

900074 002916 clotrimazole

900074 002918 miconazole

900074 002919 miconazole nitrate

900074 002923 econazole

900074 002924 econazole nitrate

900074 002926 tioconazole

900074 002928 butoconazole nitrate

900074 002932 oxiconazole nitrate

900074 002933 sulconazole nitrate

900074 003740 isoconazole

900074 003986 isoconazole nitrate

900074 004316 bifonazole

900074 004962 butoconazole

900074 004963 oxiconazole

900074 004964 sulconazole

900074 005463 fenticonazole nitrate

900074 005485 fenticonazole

900074 005693 omoconazole

900074 005694 omoconazole nitrate

900074 006417 sertaconazole

900074 006418 sertaconazole nitrate

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900074 009433 flutrimazole

6. Compare each HIC_SEQN value to the list of prospective medications HIC_SEQN values.

Display an alert to the end-user if any Specific Allergen Group level allergy alerts exist. In this example,
Miconazole 7 2% Cream had ingredient matches with the RELATED_HIC_SEQN values, and therefore
does pose a Specific Allergen Group level allergy risk to this patient

7. Using the HIC_SEQN value(s) on the patients allergen profile, retrieve each HIC_SEQNs related DAM
Cross-Sensitive Allergen Group Code (DAM_ALRGN_XSENSE) values using the DAM
Ingredient/Cross-Sensitivity Link Table (RDAMXHC0_HIC_ALRGN_XSENSE_LINK).

HIC_SEQN DAM_ALRGN_XSENSE DAM_ALRGN_XSENSE_DESC

002903 0112 Imidazole Antifungal

8. Retrieve all HIC_SEQN values related to the DAM_ALRGN_XSENSE value of 0112 using the same
RDAMXHC0_HIC_ALRGN_XSENSE_LINK table.

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8.

DAM_ALRGN_XSENSE HIC_SEQN HIC_DESC

0112 002903 ketoconazole

0112 002916 clotrimazole

0112 002918 miconazole

0112 002919 miconazole nitrate

0112 002923 econazole

0112 002924 econazole nitrate

0112 002926 tioconazole

0112 002928 butoconazole nitrate

0112 002932 oxiconazole nitrate

0112 002933 sulconazole nitrate

0112 003740 isoconazole

0112 003986 isoconazole nitrate

0112 004316 bifonazole

0112 004962 butoconazole

0112 004963 oxiconazole

0112 004964 sulconazole

0112 005463 fenticonazole nitrate

0112 005485 fenticonazole

0112 005693 omoconazole

0112 005694 omoconazole nitrate

0112 006417 sertaconazole

0112 006418 sertaconazole nitrate

0112 009433 flutrimazole

9. Compare each HIC_SEQN value to the list of prospective medications HIC_SEQN values.

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10. Display an alert to the end-user if any Cross-sensitive Allergen Group level allergy alerts exist. Miconazole
had ingredient matches with the RELATED_HIC_SEQN values, and therefore does pose a Cross-sensitive
Allergen Group level allergy risk to this patient.

Active ingredient allergy alerts were identified for this patients allergy to ketoconazole and glyceryl stearate.

If your application implements inactive ingredient screening, continue to the next section. Otherwise skip to Steps
Performed During this Process to conclude this application.

Screening a MED Concept for Inactive Ingredients

To screen a MED Concept for inactive ingredient allergens, replace Part 1 of this application with the process
described in Retrieving a MED Concepts Inactive Ingredient Statistics. For example:

6% of Miconazole packaged products have been reviewed for inactive ingredients

MEDID Inactive Ingredient HIC_S Inactive Ingredients Percentage of occurrence

EQN description in reviewed products

00216543 000738 Water 10% of reviewed products

00216543 000959 Vegetable Oil 10% of reviewed products

00216543 002477 Mineral Oil 100% of reviewed products

00216543 003193 Benzoic Acid 4% of reviewed products

00216543 005675 Butylated Hydroxyanisole 4% of reviewed products

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00216543 008801 Glyceryl Stearate SE 50% of reviewed products

00216543 010111 Pegoxol 7 Stearate 100% of reviewed products

00216543 010420 Polyoxyl 5 Oleate 100% of reviewed products

Repeat the steps in Part 2 above, but use the inactive ingredient HIC_SEQN codes. To summarize what you
would find for Miconazole 7 2% Cream, the inactive ingredient Glyceryl Stearate SE (HIC_SEQN 008801)
produces an ingredient-level allergy alert because of its relationship to the HIC_SEQN value 008801:

MED Concepts often relate to more than one packaged product. Screening MED Concepts in this way could
generate one or more false-positive allergen hits because the MED -> Inactive Ingredient relationships are
statistics based on a survey of all reviewed packaged products. If your application implements inactive ingredient
screening behind the scenes, FDB recommends that you still display inactive ingredient statistics to the end-user.

Steps Performed During this Process

The following flowchart illustrates the process involved in screening prospective Medication Concepts (either
Medication Names, Routed Medications, Routed Dosage Forms, or Medication IDs) for ingredient allergens. This
application carried out only the darker steps. Steps shown with a dashed outline are necessary only if your

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application implements inactive-ingredient screening:

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Customizing the Allergen Pick List

FDB provides the DAM Patient Profile Allergen Pick List Table (RDAMAPM0_ALRGN_PICKLIST_MSTR) to serve
as a default Allergen Pick List. In addition, the Drug Allergy Concept Attributes Table (RDAMCA0_CONCEPT)
can be utilized as an alternate Pick List. The Drug Allergy Concept Attributes Table incorporates the same three
drug concept identifies in the DAM Allergy Concept Attributes Table along with additional food-based and
environmental-based allergy attributes for further customer filtering.

It is important to note that neither Pick List accommodates specific customer concerns such as inventory,
obsolete ingredient lists, nor detailed information about MED_NAME_ID ingredient lists. In addition, the Pick List
does not include every ingredient or allergen group. Please contact FDB customer implementation specialists for
more detailed information about customizing the Allergen Pick List.

The Allergen Pick List compacts Medication Name information for the sake of brevity. Some MED_NAME_IDs are
associated with more than one formulation, but these names only appear once in the pick list. If you wish to
provide more context for these types of MED_NAME_IDs you can customize the pick list to include extra
information.

The MED_NAME_ID for Dermagran (MED_NAME_ID 00008592) appears in the both the
RDAMAPM0_ALRGN_PICKLIST_MSTR and RDAMCA0_CONCEPT tables as follows:

Utilizing the RDAMAPM0_ALRGN_PICKLIST_MSTR Table

DAM_CONCEPT_ID DAM_CONCEPT_ID_TYP DAM_CONCEPT_ID_DESC

00008592 002 Dermagran

Utilizing the RDAMCA0_CONCEPT Table

DAM_CONCEPT_ID 00008592

DAM_CONCEPT_ID_TYP 002

DAM_CONCEPT_ID_DESC Dermagran

DAM_PICKLIST_IND 1

DAM_MED_IND 0

DAM_FOOD_IND 0

DAM_ENVIRON_AGENT_IND 0

DAM_NON_ALRGN_IND 0

DAM_CONCEPT_STATUS_CD 0

Use the MED MED Concept/HICL_SEQNO Relation Table (RMEDMHL0_MED_HICLSEQNO_LINK) to look up

MED_NAME_ID 00008592. It is linked to four different ingredient lists (HICL_SEQNO). The Generic Name - Short
Version (GNN) description columns for the HICL_SEQNOs are available in the Ingredient List Identifier
Description Table (RHICLSQ2_HICLSEQNO_MSTR):

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MED_CONCEPT_ID MED_CONCEPT_ID_TYP HICL_SEQNO GNN

001 001 001179 aluminum hydroxide

001 001 004350 gel dressing

001 001 009729 wet dressing

001 001 009849 zinc acetate

This MED_NAME_ID is a good candidate to appear multiple times in a customized Allergen Pick List because it is
linked to multiple formulations. You could replace the existing Dermagran record with four new records and
customize their DAM_CONCEPT_ID_DESC column values. For example:

Customizing the RDAMAPM0_ALRGN_PICKLIST_MSTR Table

DAM_CONCEPT_ID DAM_CONCEPT_ID_TYP DAM_CONCEPT_ID_DESC

00008592 002 Dermagran - ALUMINUM

HYDROXIDE

00008592 002 Dermagran - GEL DRESSING

00008592 002 Dermagran - WET DRESSING

00008592 002 Dermagran - ZINC ACETATE

Customizing the RDAMCA0_CONCEPT Table

DAM_CONCEPT_ID 00008592 00008592 00008592 00008592

DAM_CONCEPT_ID_ 002 002 002 002

TYP

DAM_CONCEPT_ID_ Dermagran - Dermagran - GEL Dermagran - WET Dermagran - ZINC

DESC ALUMINUM DRESSING DRESSING ACETATE
HYDROXIDE

DAM_PICKLIST_IND 1 1 1 1

DAM_MED_IND 0 0 0 0

DAM_FOOD_IND 0 0 0 0

DAM_ENVIRON_AG 0 0 0 0
ENT_IND

DAM_NON_ALRGN_I 0 0 0 0
ND

DAM_CONCEPT_ST 0 0 0 0
ATUS_CD

Filtering the Allergen Pick List to Exclude Potentially Inactive Ingredients

If your screening application does not perform inactive-ingredient screening, FDB recommends that you consider
filtering the pick list to exclude potentially inactive concepts. Use a process similar to the one illustrated in

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Example 4 Filtering results to eliminate potentially inactive concepts to modify the pick list table so it does not
display potentially inactive concepts.

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Recording Patient Allergy Information

This application illustrates how to use the DAM Patient Profile Allergen Pick List Table
(RDAMAPM0_ALRGN_PICKLIST_MSTR) or the alternate Drug Allergy Concept Attributes Table
(RDAMCA0_CONCEPT) to assist end-users in profiling patient allergens. Please read the Allergen Pick List
section of this chapter prior to reading this application.

If a duplicate pick list concept description exists at both the Specific Allergen Group level and the
ingredient level, only the ingredient description and its corresponding ingredient code appear in the table .
This constraint is consistent with FDBs recommendation to profile ingredients whenever possible.

This application consists of the following examples:

Example 1Profiling a Specific Allergen Group

Example 2Profiling a Medication Name ID
Example 3Profiling an ingredient or base ingredient
Example 4Filtering results to eliminate potentially inactive concepts

Example 1Profiling a Specific Allergen Group

If a patient reports an allergy to a general group of chemically related ingredients, the end-user should record the
appropriate Specific Allergen Group (DAM_ALRGN_GRP) as an allergen on the patients allergen profile.

FDB does not recommend allowing users to choose an allergen group with a retired status for storage on
a patients allergen profile. Screening conducted with a retired allergen group code may not be as
accurate as using an active code.

For the purposes of demonstrating this application, the following scenario is used: A patient reports an
allergy to carbamates.

1. Query the DAM Allergen Concept ID Description column (DAM_CONCEPT_ID_DESC) in the

RDAMAPM0_ALRGN_PICKLIST_MSTR table or the RDAMCA0_CONCEPT table to find all entries with
the description carbamates."

2. FDB recommends recording the DAM_CONCEPT_ID value, the DAM_CONCEPT_ID_TYP value, and the
current date (the date that the allergy was reported) on the patients allergen profile. Recording these
identifiers assists in future allergy screening, and gives healthcare experts an idea of the time this allergy
was reported.

Example 2Profiling a Medication Name ID

If a patient reports an allergy to a branded Medication Name, the end-user should record the appropriate
Medication Name ID (MED_NAME_ID) as an allergen on the patients allergen profile.

If a MED_NAME_ID is chosen for profiling, you must also save/profile the associated HIC_SEQNs.

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For the purposes of demonstrating this application, the following scenario is used: A patient reports an
allergy to Tylenol plus Codeine.

1. Query the DAM Allergen Concept ID Description column (DAM_CONCEPT_ID_DESC) in the

RDAMAPM0_ALRGN_PICKLIST_MSTR table or the RDAMCA0_CONCEPT table to find all entries that
include the words Tylenol and Codeine in the description. Sorted by description, the results may be:

RDAMAPM0_ALRGN_PICKLIST_MSTR table records that include Tylenol and Codeine

DAM_CONCEPT_ID DAM_CONCEPT_ID_TYP DAM_CONCEPT_ID_DESC

00003136 002 Tylenol-Codeine

00003137 002 Tylenol-Codeine #2

00003138 002 Tylenol-Codeine #3

00003139 002 Tylenol-Codeine #4

RDAMCA0_CONCEPT table records that include Tylenol and Codeine

DAM_CONCEPT_ID 00003136 00003137 00003138 00003139

DAM_CONCEPT_ID 002 002 002 002

_TYP

DAM_CONCEPT_ID Tylenol-Codeine Tylenol-Codeine #2 Tylenol-Codeine #3 Tylenol-Codeine #4

_DESC

DAM_PICKLIST_IN 0 0 1 0
D

DAM_MED_IND 0 0 1 1

DAM_FOOD_IND 0 0 0 0

DAM_ENVIRON_A 0 0 0 0
GENT_IND

DAM_NON_ALRGN 0 0 0 0
_IND

DAM_CONCEPT_S 0 0 0 0
TATUS_CD

2. The healthcare expert should chose the record or records that properly reflect the medication. In this case
all four candidates are likely, so the healthcare expert may highlight/select all four from the list.

FDB recommends recording the DAM_CONCEPT_ID value, the DAM_CONCEPT_ID_TYP value,

and the current date (the date that the allergy was reported) for each of these products on the
patients allergen profile. Recording these identifiers assists in future allergy screening, and gives

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healthcare experts an idea of the time this allergy was reported.

3. Retrieve the MED_NAME_IDs related HICL_SEQNO from the MED MED Concept/HICL_SEQNO Relation
Table (RMEDMHL0_MED_HICLSEQNO_LINK) using the Tylenol-Codeines MED_NAME_IDs of
00003136, 00003137, 00003138, and 00003139 for the Med Concept ID. Use the MED Concept ID Type
(MED_CONCEPT_ID_TYP) value of 1, which indicates that the MED_CONCEPT_IDs are Medication
Name ID values.

MED_CONCEPT_ID MED_CONCEPT_ID_TYP HICL_SEQNO MED_CONCEPT_HICL_

SRC_CD

00003136 1 1717 1

00003137 1 1717 1

00003138 1 1717 1

00003139 1 1717 1

The MED Concept HICL_SEQNO Source Code (MED_CONCEPT_HICL_SRC_CD) may cause

identical entries during this step. Read more about the MED_CONCEPT_HICL_SRC_CD to
determine if utilizing this concept in drug allergy screening benefits your application.

4. Retrieve the DAM Allergen Hierarchical Ingredient Code Sequence Number (DAM_ALRGN_HIC_SEQN)
values related to the HICL_SEQNO using the Drug Allergy Screening HICL_SEQNO/HIC Relation Table
(RDAMHHA0_HIC_HICL_ALG_LINK).

HICL_SEQNO DAM_ALRGN_HIC_SEQN

1717 1551

1717 1605

Some HICL_SEQNOs have more than one related ingredient code.

Alternately, the HICL_SEQNO/HIC Relation Table (RHICL1_HIC_HICLSEQNO_LINK) can be

used to retrieve the Hierarchical Ingredient Code Sequence Number. It is important to note that the
HICL_SEQNO/HIC Relation Table will return non-allergen ingredients.

5. Retrieve the Related Hierarchical Ingredient Code Sequence Numbers ( RELATED_HIC_SEQN) for each
HIC_SEQN value using the HIC_SEQN/HIC_SEQN Link Table (RHICHCR0_HIC_HIC_LINK).

DAM_ALRGN_HIC_SEQ HIC_SEQN RELATED_HIC_SEQN HIC_DESC

N

1551 1551 1550 codeine

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1551 1551 1551 codeine phosphate

1551 1551 1552 codeine polistirex

1551 1551 1553 codeine sulfate

1551 1551 4126 codeine hyprochloride

1551 1551 5189 codeine anhydrous

1551 1551 5391 codeine hydrobromide

1551 1551 5478 codeine camsylate

1551 1602 1605 acetaminophen

Example 3Profiling an ingredient or base ingredient

If a patient reports an allergy to a specific ingredient (HIC_SEQN) or base ingredient HIC4_SEQN), the end-user
should record the appropriate ingredient identifier as an allergen on the patients allergen profile.

For the purposes of demonstrating this application, the following scenario is used: A patient reports an
allergy to peanuts.

1. Query the DAM Allergen Concept ID Description column (DAM_CONCEPT_ID_DESC) in the

RDAMAPM0_ALRGN_PICKLIST_MSTR table or the RDAMCA0_CONCEPT table to find all entries with
the description peanut. For example:

RDAMAPM0_ALRGN_PICKLIST_MSTR table records with the description Peanut

DAM_CONCEPT_ID DAM_CONCEPT_ID_TYP DAM_CONCEPT_ID_DESC

00000568 006 Peanut

00002473 006 Peanut Oil

RDAMCA0_CONCEPT table records with the description Peanut

DAM_CONCEPT_ID 00000568 00002473

DAM_CONCEPT_ID_TYP 006 006

DAM_CONCEPT_ID_DESC Peanut Peanut Oil

DAM_PICKLIST_IND 1 0

DAM_MED_IND 1 1

DAM_FOOD_IND 1 0

DAM_ENVIRON_AGENT_IND 0 0

DAM_NON_ALRGN_IND 0 0

DAM_CONCEPT_STATUS_CD 0 0

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2. FDB recommends recording the DAM_CONCEPT_ID value, the DAM_CONCEPT_ID_TYP value, and the
current date (the date that the allergy was reported) on the patients allergen profile. Recording these
identifiers assists in future allergy screening, and gives healthcare experts an idea of the time this allergy
was reported.

Example 4Filtering results to eliminate potentially inactive concepts

If your allergy screening system does not implement inactive ingredient screening, FDB recommends that you
filter the pharmacists available concepts to exclude potentially inactive concepts.

For the purposes of demonstrating this application, the following scenario is used: A patient reports an
allergy to peanuts.

1. Query the DAM Allergen Concept ID Description column (DAM_CONCEPT_ID_DESC) in he

RDAMAPM0_ALRGN_PICKLIST_MSTR table or the RDAMCA0_CONCEPT table to find all entries with
the description peanut. For example:

RDAMAPM0_ALRGN_PICKLIST_MSTR table records with the description Peanut

DAM_CONCEPT_ID DAM_CONCEPT_ID_TYP DAM_CONCEPT_ID_DESC

00000568 006 Peanut

00002473 006 Peanut Oil

RDAMCA0_CONCEPT table records with the description Peanut

DAM_CONCEPT_ID 00000568 00002473

DAM_CONCEPT_ID_TYP 006 006

DAM_CONCEPT_ID_DESC Peanut Peanut Oil

DAM_PICKLIST_IND 1 0

DAM_MED_IND 1 1

DAM_FOOD_IND 1 0

DAM_ENVIRON_AGENT_IND 0 0

DAM_NON_ALRGN_IND 0 0

DAM_CONCEPT_STATUS_CD 0 0

2. Determine each identifiers type using the DAM Pick List Concept ID Description Table
(RDAMCD0_PICKLIST_CON_TYP_DESC).

DAM_CONCEPT_ID_TYP DAM_CONCEPT_ID_TYP_DESC

001 Specific Allergen Group

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002 Medication Name ID

006 Base Ingredient

3. Retrieve each concepts potentially inactive indicator from the appropriate table. In this case, because this
is an ingredient, use the Hierarchical Ingredient Code Description Table (RHICD5_HIC_DESC).

HIC_SEQN HIC_DESC HIC_POTENTIALLY_INACTV_IND

000568 peanut 1

002473 peanut oil 1

Suppress each record that has HIC_POTENTIALLY_INACTV_IND value of 1. In this case both values are
suppressed. If all returned records were potentially inactive, notify the pharmacist that the noted ingredient
is potentially inactive, and that manually screening prospective products for this particular allergen is the
only way to guarantee this patients safety in the future.

FDB also recommends recording the current date (the date that the allergy was reported) on the
patients allergen profile.

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Retrieving a Replacement Specific Allergen Group

This application illustrates how to retrieve a replacement value for a replaced Specific Allergen Group. This
application will be added to the Drug Allergy Module (DAM) in the FDB MedKnowledge Documentation.

1. Select the DAM Specific Allergen Group Status Code (DAM_ALRGN_GRP_STATUS_CD) values from the
DAM Specific Allergen Group Code Description Table (RDAMAGD1_ALRGN_GRP_DESC) where the
DAM Specific Allergen Group Code (DAM_ALRGN_GRP) column equals the DAM_ALRGN_GRP value of
a given specific allergen group.

2. If the DAM_ALRGN_GRP_STATUS_CD value equals 1 (replaced), select the following columns from the
DAM Specific Allergen Group Code History Table (RDAMGRH0_ALRGN_GRP_HIST) where the Previous
DAM Specific Allergen Group Code (PREV_DAM_ALRGN_GRP) column equals the replaced
DAM_ALRGN_GRP value from the previous step:
Replacement DAM Specific Allergen Group Code (REPL_DAM_ALRGN_GRP)
Specific Allergen Group Code Replacement Effective Date (DAM_ALRGN_GRP_REPL_EFF_DT)

3. Repeat steps 1 and 2 using the replacement DAM_ALRGN_GRP values retrieved in the previous step until
the DAM_ALRGN_GRP_STATUS_CD value is 0 (active) or 2 (retired).

ExampleRetrieving a Replacement Specific Allergen Group

For purposes of demonstrating this application, the following scenario is used: Upon selection of the
specific allergen group Camella Sinensis (DAM_ALRGN_GRP 658), a healthcare system first checks its status to
determine whether it has been replaced.

1. Select the DAM Specific Allergen Group Status Code (DAM_ALRGN_GRP_STATUS_CD) values from the
DAM Specific Allergen Group Code Description Table (RDAMAGD1_ALRGN_GRP_DESC) where the
DAM Specific Allergen Group Code (DAM_ALRGN_GRP) column equals the DAM_ALRGN_GRP value of
a given Allergen Group.
In this example, DAM_ALRGN_GRP 658 has a DAM_ALRGN_GRP_STATUS_CD of 1, meaning it has
been replaced.

DAM_ALRGN_GRP DAM_ALRGN_GRP_DESC DAM_ALRGN_GRP_STATUS_CD

658 Camella Sinensis 1

2. Select the following columns from the DAM Specific Allergen Group Code History Table (
RDAMGRH0_ALRGN_GRP_HIST) where the Previous DAM Specific Allergen Group Code (
PREV_DAM_ALRGN_GRP) column equals the replaced DAM_ALRGN_GRP value from Step 1:
Replacement DAM Specific Allergen Group Code (REPL_DAM_ALRGN_GRP)
Specific Allergen Group Code Replacement Effective Date (DAM_ALRGN_GRP_REPL_EFF_DT)

In this example, DAM_ALRGN_GRP 658 (Camella Sinensis) was replaced by DAM_ALRGN_GRP 71

(Green Tea [Camellia Sinensis]) on November 2, 2010.

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PREV_DAM_ALRG DAM_ALRGN_GRP REPL_DAM_ALRG DAM_ALRGN_GRP DAM_ALRGN_GRP

N_GRP _DESC N_GRP _DESC _REPL_EFF_DT

658 Camella Sinensis 71 Green Tea 20101102

(Camellia Sinensis)

You can retrieve the descriptions from the DAM Specific Allergen Group Code Table
(RDAMAGD1_ALRGN_GRP_DESC).

3. Repeat steps 1 and 2 using the replacement DAM_ALRGN_GRP values retrieved in the previous step until
the DAM Specific Allergen Group Status Code (DAM_ALRGN_GRP_STATUS_CD) value is 0 (active) or 2
(retired).
In this example, DAM_ALRGN_GRP 71 has a DAM_ALRGN_GRP_STATUS_CD value of 0 (active) and is
returned to the user as the replacement specific allergen group value.

DAM_ALRGN_GRP DAM_ALRGN_GRP_DESC DAM_ALRGN_GRP_STATUS_CD

71 Green Tea (Camella Sinensis) 0

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Displaying Inactive Ingredients for a Product

This application illustrates how to retrieve and display clinically significant inactive ingredients for a given product
as a visual adjuvant to point of care, programmatic allergy screening.

1. Verify that the given drug product is supported with inactive ingredient information by locating its
associated National Drug Code (NDC) in the NDC Inactive Ingredients Reviewed Master Table
(RNDCINR0_INACTV_REVIEWED).
If the associated NDC is not present, no inactive ingredient information is currently available.
If the NDC is present, proceed to step 2.

Displaying the clinically significant inactive ingredients for a product must be

performed using a product's NDC. Additional NDC attributes may be retrieved from the NDC
Master Table (RNDC14_NDC_MSTR), such as the Label Name or Brand Name, as
determined by user need.

2. Using the NDC from the previous step, retrieve zero-to-many Ingredient ID ( HIC_SEQN) values from the
NDC/HIC_SEQN Inactive Ingredient Relation Table (RNDCINH0_NDC_INACTV_LINK).

3. Retrieve the Ingredient ID description (HIC_DESC) for each ingredient from the Hierarchical Ingredient
Code Description Table (RHICD5_HIC_DESC) where the HIC_SEQN equals the value(s) retrieved in the
previous step.

4. Sort and display results to user.

ExampleDisplaying Inactive Ingredients for a Product

In this scenario, a prescriber is reviewing the influenzae (flu) vaccine FLUVIRIN 2015-2016 SYRINGE (NDC
66521011812) for the presence of thimerosal in planning a pediatric immunization.

1. Verify that the given drug product is supported with inactive ingredient information by locating its
associated National Drug Code (NDC) in the NDC Inactive Ingredients Reviewed Master Table
(RNDCINR0_INACTV_REVIEWED).
If the associated NDC is not present, no inactive ingredient information is currently available.
If the NDC is present, proceed to step 2.

Additional NDC attributes may be retrieved from the NDC Table (RNDC14_NDC_MSTR),
such as the Label Name or Brand Name, as determined by user need.

2. Retrieve the ingredient ID (HIC_SEQN) value(s) from the NDC/HIC_SEQN Inactive Ingredient Relation
Table (RNDCINH0_NDC_INACTV_LINK) where the NDC column equals the value from the previous step.

NDC HIC_SEQN

66521011812 16161

3.

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3. Retrieve the Ingredient Description (HIC_DESC) value(s) from the Hierarchical Ingredient Code
Description Table (RHICD5_HIC_DESC) where the HIC_SEQN equals the value(s) retrieved in the
previous step.

HIC_SEQN HIC_DESC

16161 Thimerosal (trace)

4. Sort and display results to user. In this scenario, the clinician sees that the given vaccine contains only
trace amounts of the inactive ingredient thimerosal and is therefore an influenzae (flu) vaccine suitable for
pediatric administration as labeled. Knowledge that the thimerosol ingredient is "trace", not
full preservative-strength thimerosal, is valuable in understanding the choice of agents and having an
informed discussion with the patient and the patient's family.

Results may be sorted and filtered according to institutional or user prescribed criteria.

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Drug Allergy Module ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

Drug Allergy Module Tables

Drug Allergy Module ERD

Drug Allergy Module Tables

DAM Allergen Group Cross/Sensitivity Link Table
DAM Concept Description Table
DAM Cross-Sensitive Allergen Group Code Description Table
DAM Cross-Sensitive Allergen Group Code History Table
DAM Cross-Sensitive Allergen Group Code Status Code Description Table
DAM Ingredient/Allergen Group Link Table
DAM Ingredient/Cross-Sensitivity Link Table
DAM Patient Profile Allergen Pick List Table
DAM Pick List Concept ID Description Table
DAM Specific Allergen Group Code Description Table
DAM Specific Allergen Group Code History Table
DAM Specific Allergen Group Code Status Code Description Table
Drug Allergy Concept Attributes Table
Drug Allergy Screening HICL_SEQNO/HIC Relation Table

Drug Allergy Module ERD

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DAM Allergen Group Cross-Sensitivity Link Table

Table Name RDAMGX0_ALRGN_GRP_XSENSE_LINK

Revision Activity add. 07-29-2004

Purpose Links the Specific Allergen Group Code to the

Cross-Sensitive Allergen Group Code.

Key Column Name Column Format Length Picture

Description

PF DAM_ALRGN_G DAM Specific N 6 9(6)

RP Allergen Group
Code (Stable ID)

PF DAM_ALRGN_XS DAM N 4 9(4)

ENSE Cross-Sensitive
Allergen Group
Code (Stable ID)

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DAM Concept Description Table

Table Name RDAMCAS0_STATUS_DESC

Revision Activity add.06-25-2015

Purpose Relates the DAM concept status code to its text description.

Key Column Name Column Format Length Picture

Description

P DAM_CONCEPT_ DAM Concept AN 1 X(1)

STATUS_CD Status Code

DAM_CONCEPT_ DAM Concept AN 50 X(50)

STATUS_CD_DE Status Code
SC Description

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DAM Cross-Sensitive Allergen Group Code Description Table

Table Name RDAMCSD1_XSENSIT_ALLERGY_DESC

Revision Activity rev.07-29-2004

Purpose Provides the Cross-Sensitive Allergen Group Code's text

description, Possibly Inactive Indicator, and Status code.

Key Column Name Column Format Length Picture

Description

P DAM_ALRGN_XS DAM N 4 9(4)

ENSE Cross-Sensitive
Allergen Group
Code (Stable ID)

DAM_ALRGN_XS DAM AN 50 X(50)

ENSE_DESC Cross-Sensitive
Allergen Group
Code Description

DAM_XSENSE_P DAM N 1 9(1)

OTENTIAL_INCT Cross-Sensitive
V_IND Allergen Group
Potentially
Inactive Indicator

F DAM_ALRGN_XS DAM N 1 9(1)

ENSE_STATUS_ Cross-Sensitive
CD Allergen Group
Status Code

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DAM Cross-Sensitive Allergen Group Code History Table

Table Name RDAMXSH0_ALRGN_XSENSE_HIST

Revision Activity add. 07-29-2004

Purpose Tracks the replacement history of the Cross-Sensitive

Allergen Group Code.

Key Column Name Column Format Length Picture

Description

PF REPL_DAM_ALR Replacement N 4 9(4)

GN_XSENSE DAM
Cross-Sensitive
Allergen Group
Code

PF PREV_DAM_ALR Previous DAM N 4 9(4)

GN_XSENSE Cross-Sensitive
Allergen Group
Code

DAM_ALRGN_XS DAM N 8 9(8)

ENSE_REPL_EF Cross-Sensitive
F_DT Allergen Group
Code
Replacement
Effective Date

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DAM Cross-Sensitive Allergen Group Code Status Code Description Table

Table Name RDAMXSD0_XSENSE_STATUS_DESC

Revision Activity add. 07-29-2004

Purpose Provides the description of the Cross-Sensitive Allergen

Group Status Code.

Key Column Name Column Format Length Picture

Description

P DAM_ALRGN_XS DAM N 1 9(1)

ENSE_STATUS_ Cross-Sensitive
CD Allergen Group
Status Code

DAM_ALRGN_XS DAM AN 50 X(50)

ENSE_STATUS_ Cross-Sensitive
CD_DSC Allergen Group
Status Code
Description

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DAM Ingredient Allergen Group Link Table

Table Name RDAMGHC0_HIC_ALRGN_GRP_LINK

Revision Activity add.07-29-2004

Purpose Links an ingredient to one or more Specific Allergen Group

Codes.

Key Column Name Column Format Length Picture

Description

PF HIC_SEQN Hierarchical N 6 9(6)

Ingredient Code
Sequence
Number

PF DAM_ALRGN_G DAM Specific N 6 9(6)

RP Allergen Group
Code (Stable ID)

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DAM Ingredient Cross-Sensitivity Link Table

Table Name RDAMXHC0_HIC_ALRGN_XSENSE_LINK

Revision Activity add.07-29-2004

Purpose Links an ingredient to one or more Cross-Sensitive Allergen

Group Codes.

Key Column Name Column Format Length Picture

Description

PF HIC_SEQN Hierarchical N 6 9(6)

Ingredient Code
Sequence
Number

PF DAM_ALRGN_XS DAM N 4 9(4)

ENSE Cross-Sensitive
Allergen Group
Code

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DAM Patient Profile Allergen Pick List Table

Table Name RDAMAPM0_ALRGN_PICKLIST_MSTR

Revision Activity add.07-29-2004

Purpose Provides a selection of MED Names, Base Ingredients, and

Specific Allergen Group codes for use in patient profiles.

Key Column Name Column Format Length Picture

Description

P DAM_CONCEPT_ DAM Allergen N 8 9(8)

ID Concept ID

PF DAM_CONCEPT_ DAM Allergen N 3 9(3)

ID_TYP Concept ID Type

DAM_CONCEPT_ DAM Allergen AN 50 X(50)

ID_DESC Concept ID
Description

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DAM Pick List Concept ID Description Table

Table Name RDAMCD0_PICKLIST_CON_TYP_DESC

Revision Activity add.07-29-2004

Purpose Provides the description of the DAM Concept ID.

Key Column Name Column Format Length Picture

Description

P DAM_CONCEPT_ DAM Allergen N 3 9(3)

ID_TYP Concept ID Type

DAM_CONCEPT_ DAM Allergen AN 50 X(50)

ID_TYP_DESC Concept ID Type
Description

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DAM Specific Allergen Group Code Description Table

Table Name RDAMAGD1_ALRGN_GRP_DESC

Revision Activity rev.07-29-2004

Purpose Provides the Specific Allergen Group Code's text

description, Possibly Inactive Indicator, and Status code.

Key Column Name Column Format Length Picture

Description

P DAM_ALRGN_G DAM Specific N 6 9(6)

RP Allergen Group
Code (Stable ID)

DAM_ALRGN_G DAM Specific AN 50 X(50)

RP_DESC Allergen Group
Code Description

DAM_GRP_POTE DAM Specific N 1 9(1)

NTIALLY_INACT Allergen Group
V_IND Potentially
Inactive Indicator

F DAM_ALRGN_G DAM Specific N 1 9(1)

RP_STATUS_CD Allergen Group
Status Code

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DAM Specific Allergen Group Code History Table

Table Name RDAMGRH0_ALRGN_GRP_HIST

Revision Activity add.07-29-2004

Purpose Tracks the replacement history of the Specific Allergen

Group Code.

Key Column Name Column Format Length Picture

Description

PF REPL_DAM_ALR Replacement N 6 9(6)

GN_GRP DAM Specific
Allergen Group
Code

PF PREV_DAM_ALR Previous DAM N 6 9(6)

GN_GRP Specific Allergen
Group Code

DAM_ALRGN_G DAM Specific N 8 9(8)

RP_REPL_EFF_ Allergen Group
DT Code
Replacement
Effective Date

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DAM Specific Allergen Group Code Status Code Description Table

Table Name RDAMGSD0_GRP_STATUS_DESC

Revision Activity add.07-29-2004

Purpose Provides the description of the Allergen Group Status Code.

Key Column Name Column Format Length Picture

Description

P DAM_ALRGN_G DAM Specific N 1 9(1)

RP_STATUS_CD Allergen Group
Status Code

DAM_ALRGN_G DAM Specific AN 50 X(50)

RP_STATUS_CD Allergen Group
_DESC Status Code
Description

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Drug Allergy Concept Attributes Table

Table Name RDAMCA0_CONCEPT

Revision Activity add.06-25-2015

Purpose Provides the DAM Concept ID which represents a selection

of Medication Names, Base Ingredients, Specific Allergen
Group codes, and spans food-based and
environmental-based allergy attributes for use in patient
profiles.

Key Column Name Column Format Length Picture

Description

P DAM_CONCEPT_ DAM Concept ID N 8 9(8)

ID

PF DAM_CONCEPT_ DAM Concept N 3 9(3)

ID_TYP Type ID

DAM_CONCEPT_ DAM Concept AN 50 X(50)

ID_DESC Type Description

DAM_PICKLIST_I DAM Picklist AN 1 X(1)

ND Indicator

DAM_MED_IND DAM Spans AN 1 X(1)

Medication
Indicator

DAM_FOOD_IND DAM Spans Food AN 1 X(1)

Indicator

DAM_ENVIRON_ DAM Spans AN 1 X(1)

AGENT_IND Environment
Agent Indicator

DAM_NON_ALR DAM Non AN 1 X(1)

GN_IND Allergen Indicator

F DAM_CONCEPT_ DAM Concept AN 1 X(1)

STATUS_CD Status Code

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Drug Allergy Screening HICL_SEQNO HIC Relation Table

Table Name RDAMHHA0_HIC_HICL_ALG_LINK

Revision Activity add.06-25-2015

Purpose Links individual ingredients to an ingredient list for the

purpose of allergy screening.

Key Column Name Column Format Length Picture

Description

PF HICL_SEQNO Ingredient List N 6 9(6)

Identifier (formerly
the Hierarchical
Ingredient Code
List Sequence
Number) (Stable
ID)

PF DAM_ALRGN_HI DAM Allergen N 6 9(6)

C_SEQN Hierarchical
Ingredient Code
Sequence
Number (Stable
ID)

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Drug-Disease Contraindications Module (DDCM) 2.0

Drug-Disease Contraindications Module Editorial Policies
Applications
ERD and Technical Specifications

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Drug-Disease Contraindications Module Editorial Policies

The policies and criteria that apply to the inclusion criteria, processes, and references used in creation of the
module are provided in the following sections:

Overview
Inclusion Criteria
Data Elements
Rule Sets
Maintenance
References

Overview
The Drug-Disease Contraindications Module (DDCM) is designed to create warnings concerning the use of
certain drugs in patients with specific health-related conditions and diseases, or patients who have had certain
procedures or diagnostic tests. Healthcare professionals can use these warnings to make informed decisions
about altering a patients drug therapy when these conditions exist. This information can be incorporated into
Drug Utilization Review by identifying potentially hazardous prescribing practices.

Inclusion Criteria
This section provides information detailing the criteria that guided the inclusion of the data contained within the
module as well as information pertaining to limitations or exclusions when appropriate to the discussion.

Inclusion - Drug Scope

U.S. FDA-approved prescription (Rx) product ingredients with NDA, ANDA, BLA
U.S. over-the-counter (OTC) products with NDAs or ANDAs
U.S. OTC drug product ingredients consistent with FDA OTC Monographs
Herbal products enumerated in the FDB Herbal Products Inclusion List

Inclusion - Warnings Content Scope

Included are:

Diseases, conditions or procedures that are contraindications.

Precautions or warnings including those that may be monitored by laboratory tests, physical examination,
or radiology.
Conditions that affect drug metabolism to the point of requiring dose adjustment or complete drug
avoidance (for example, liver or renal disease, drug metabolizing enzyme genotype variant).
Risk factor conditions that increase adverse reaction rates.
Drug ingredients in the Pregnancy Module assigned SL=1 (Contraindicated) or FDA X will be represented
in DDCM with DXID 3446-Pregnancy SL=1 (Contraindicated).
Drug ingredients in the Pregnancy Module assigned SL=3 (Generally not recommended) or FDA D will be

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represented in DDCM with DXID 3446-Pregnancy SL=2 (Severe Warning).

Drug ingredients in the Lactation Module assigned SL=1 (Contraindicated) will be represented in DDCM
with DXID 3452-Lactating Mother SL=1.
DDCM contraindications, warnings, and precautions are not country-specific.

The Pregnancy Precautions Module and the Lactation Precautions Module are also available from
First Databank.

Exclusion - Drug Scope

Self-proclaimed Rx products without ANDA/NDA/BLA

Rx drug products with 510K device approval
Dietary supplements
Large volume parenteral, nutritional, irrigation or dialysis solutions
Nutraceuticals
Diluent solutions
Herbal products except those enumerated in the FDB Herbal Products Inclusion List
Homeopathic drugs
OTC products that are not described by FDA OTC Monographs
Bulk drugs or chemicals
Medical supplies, soaps, cleansers
Cosmetics
Veterinary drugs
Inactive ingredients

Exclusion - Warning Content

Warning statements describing prior allergies or hypersensitivity to drug product ingredients are NOT
included within DDCM. Prior allergies or hypersensitivity reactions are always assumed to be a
contraindication to future use of a drug. Even though allergies may be ICD encoded, DDCM is not
designed to generate alert messages for any hypersensitivity reactions including latex allergy and animal
protein allergy.
Condition statements describing indication exclusion or treatment failure statements. These are conditions
related to the indications for use, but have not been explicitly approved as part of the indication labeling. (
For example, Diabeta is contraindicated in patients: With type I diabetes mellitus, diabetic ketoacidosis.
This condition should be treated with insulin.)
Warning statements that relate to contraindicated routes or methods of drug administration.
Condition statements describing specific symptoms of included contraindicated diseases.
Rare side effect conditions as stated or described by the manufacturer.
Warning statements regarding toxic overdose conditions or symptoms.

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Condition statements regarding "at risk" patient characteristics, such as gender, age or race, or
concomitant drug use.

Age-related precautions can be found in the Geriatric and Pediatrics Precautions modules.

Data Elements
This section contains additional information about particularly important tables and codes contained within the
module, as well as concepts about the data that the reader must understand in order to understand the module.

DDCM Drug-Disease Contraindications Code

The DDCM Drug-Disease Contraindications Code (DDXCN) is a system-assigned dumb number for each drug
group.

Each ingredient in a multi-ingredient product may have its own Drug-Disease Contraindications Code (
DDXCN code) and description.

DDXCN codes are linked to the following First Databank drug identifiers within specific linking tables:

Routed Medication ID (ROUTED_MED_ID)

Routed Generic Identifier (ROUTED_GEN_ID)
Clinical Formulation ID (GCN_SEQNO)

ExampleRDDCMGC0_CONTRA_GCNSEQNO_LINK

GCN_SEQNO DDXCN

45131 51081

45132 51081

45133 51081

45134 51081

47821 51081

DDCM Drug-Disease Contraindications Description

The description is assigned to the Drug-Disease Contraindications Code (DDXCN). This drug group description is
usually ingredient-based but can be broader and include a collection of ingredients (e.g., "Bulk Laxatives") or may
be narrower and include only certain dose forms or routes, etc. (e.g., "Potassium Cl (Oral, Non-Solid).

ExampleRDDCMDD0_CONTRA_DRUG_DESC

DDXCN DDXCN_DRUG_DESC

51081 LINEZOLID

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Disease Identifiers

Each DDCM contraindicated disease, condition or procedure is encoded utilizing concepts that are maintained in
the First Databank Medical Lexicon (FML). The concepts are called Disease Identifiers ( DXIDs) and their numeric
identifier is a system assigned dumb number. First Databank Disease Codes (FDBDX) are legacy disease codes
that are also published and have a one-to-one relationship with DxIDs. FDBDX codes are created and include
embedded ICD Codes.

DDCM Severity Level

There are three possible severity level messages in DDCM that can be assigned to each DxID record.

DDXCN_SL Value Description

Value Description

1 Contraindication

2 Severe Warning

3 Moderate Warning

DDCM Sequence Number

Sequencing of DxIDs is represented by DDCM Sequence Number (DDXCN_SN) values and is generated by the
system. It is not a priority sequence, but it is a numeric sort of FDBDX codes. This is not a stable code.

DDCM Reference

Field values are short, 26-character length reference citation descriptions assigned to each DxID.

ExampleRDDCMMA1_CONTRA_MSTR

DDXCN DDXCN_SN FDBDX DDXCN_SL DDXCN_REF DXID

51081 0 01.008450 2 ZYVOX PI, 12/09 26

51081 1 03.259200 2 ZYVOX PI, 12/09 654

51081 2 03.276203 2 ZYVOX PI, 12/09 740

51081 3 04.284800 2 ZYVOX PI, 12/09 829

51081 4 04.284807 2 ZYVOX PI, 12/09 836

51081 5 04.285900 2 ZYVOX PI, 12/09 842

51081 6 04.284500 2 ZYVOX PI, 12/09 878

51081 7 04.288004 2 ZYVOX PI, 12/09 886

51081 8 06.333991 1 MEDWATCH 1072

11/05

51081 9 06.356901 3 ZYVOX PI, 12/09 1146

51081 10 06.377490 2 ZYVOX PI, 12/09 1334

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51081 11 16.780300 3 MEDWATCH 3053

04/07

51081 12 07.401909 2 ZYVOX PI, 12/09 13999

51081 13 02.227900 2 ZYVOX PI, 12/09 505

51081 14 03.242800 2 ZYVOX PI, 12/09 579

51081 15 06.368900 2 ZYVOX PI, 12/09 1241

Rule Sets
This section provides rules that the clinical team uses in regards to creating the module's data, both general rules
and rules specific to data elements.

Trigger content text (for example, Sporadic MedWatch alert text) is reviewed and concepts applicable to DDCM
are identified. Disease terminology concepts within FML are searched and codes/descriptions selected. New
concepts or synonyms are added to FML as needed through a vetting request process. Associated attributes of
severity level and reference citation are included. Trigger content drug(s) are identified and contraindications
coding is applied to all applicable DDXCN drug groups.

Rules of General Applicability

This section describes editorial policies that have a broad impact on the module data or by nature are less
specific than those policies in other sections.

Drug knowledge is aggregated at the drug grouper level and then linked to Clinical Formulation IDs, Routed
Medication IDs, and the Routed Generic IDs in the First Databank knowledge base. Linkage or assignment of
DDCM information to drugs is therefore not manufacturer-specific.

Non-U.S. drug Clinical Formulations may inherit U.S.-based DDCM clinical data.

Rules for Data Elements

This section describes editorial policies that are more specific towards their effect on the data elements contained
in the module.

DDCM Severity Level

There are three possible severity level messages in DDCM that can be assigned to each DxID record.

The following are detailed descriptions utilized for making severity level assignments:

Contraindication is reserved for warnings that are most significant, where harm is likely to occur to the
patient. The drug should generally not be given to a patient for severity level 1 assignments. In many
cases, these are "boxed warnings" for newer prescription products.
Severe Warning is a tempered contraindication assigned to those diagnoses (DxIDs) that are clinically
significant, where the condition can be managed or treated before the drug may be given safely. "Boxed
warning" information may also be included that requires medical specialist assessment for risk versus
benefit.

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Moderate Warning is assigned to those DxIDs where adequate patient monitoring is recommended for
safer drug use.

Maintenance
The following section describes the processes and criteria the clinical editors use to add or review database
elements.

External Triggers for Clinical Review

The First Databank Knowledge Base Services Department utilizes a robust methodology for capture,
documentation, triage and tracking of the most important sources for drug knowledge changes. The external
triggers that are triaged to the clinical editors for review are the following:

MedEffects Alerts from Health Canada (except non-U.S. product alerts exclusive to Canada)
FDA MedWatch Medical Product Safety Information Alerts
FDA CDER NEW
FDA CBER What's New
MedWatch Safety Alerts from FDA
FDA Division of Drug Information (DDI)
FDA Hematology/Oncology (Cancer) Approvals and Safety Notifications
What's New at FDA in HIV/AIDS
FDA Table of Pharmacogenomic Biomarkers in Drug Labels
FDA Press Announcements
Briggs Pregnancy and Lactation Newsletter

Internal Triggers for Clinical Review

The internal trigger that prompts the clinical editors to add or review DDCM drug groups or DxID content is a new
Clinical Formulation (GCN_SEQNO) added to MedKnowledge along with its U.S. product labeling.

References
This section lists sources used by First Databank to compile the information contained in the module.

First Databank utilizes many reference sources including, but not limited to, the primary medical literature (for
example, published journal articles), medical reference texts, published expert treatment guidelines, and
manufacturer product package inserts. First Databank uses current source editions or versions when coding and
updating data, as well as when researching questions about data. However, a formal data review does not occur
for every new release of source editions or versions. Additional sources include:

Briggs GG, Freeman RK, Yaffe SJ, eds. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal
and Neonatal Risk.
Drugs in Pregnancy and Breastfeeding. Available at: http://www.perinatology.com.
Friedman JM, Polifka JE. Teratogenic Effects of Drugs (TERIS): A Resource for Clinicians.
AHFS Drug Information. Published by American Society of Health System Pharmacists.

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DDCM Applications
This section provides information about the practical application of data contained in this module. The
applications utilize tables in the First Databank Medical Lexicon Module, and successful use of these applications
depends upon the following:

Familiarity with the First Databank Medical Lexicon Module and the Disease Identifier ( DXID). Refer to the
FDB Medical Lexicon (FML) 2.0 for more information.

Ability to navigate to a Clinical Formulation ID (GCN_SEQNO) from a concept such as the NDC or MEDID.
Refer to MedKnowledge Identifiers and Attributes for more information.

Familiarity with drug concepts and their identifiers. Refer to the Multiple Access Points (MAPs) for more
information.

Assignment of a DxID or ICD Code to a given disease state. Refer to the FDB Medical Lexicon (FML)
2.0 for more information.

Retrieving a List of Drug Contraindications

Comparing Patient ICD Codes to Prospective Drug TherapyUsing the Exclusion Table to Reduce Alerts

Comparing Patient DxIDs to Prospective Drug Therapy

Checking Inferred Patient Diagnoses for Drug-Disease Contraindications Associated with Prospective Drug Therapy

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Retrieving a List of Drug Contraindications

This application illustrates how to use DDCM to retrieve a list of drug contraindications based on its Routed
Medication ID (ROUTED_MED_ID).

This example uses ROUTED_MED_ID 00007086 representing the drug verapamil Oral.

1. Retrieve the DDCM Drug-Disease Contraindications Code (DDXCN) related to ROUTED_MED_ID

00007086 using the DDCM Routed Medication Table (RDDCMRM0_ROUTED_MED_LINK). The
DDXCNs text description (DDXCN_DRUG_DESC) from the DDCM Drug Description Table
(RDDCMDD0_CONTRA_DRUG_DESC) is shown for illustrative purposes.

ROUTED_MED_ID DDXCN DDXCN_DRUG_DESC

00007086 50225 VERAPAMIL

Multi-ingredient drugs may have different contraindications (DDXCNs) for each ingredient.

Retrieve the FML Disease Identifier (DXID) values associated with DDXCN 50225 from the DDCM Master Table
(RDDCMMA1_CONTRA_MSTR).

DDXCN DXID

50225 00001154

50225 00001157

50225 00001447

50225 00001451

50225 00001502

50225 00001512

50225 00001517

50225 00001521

50225 00001528

50225 00001543

50225 00001562

50225 00001563

50225 00001579

50225 00001588

50225 00001709

50225 00001713

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50225 00002202

50225 00002292

50225 00003184

50225 00013479

Retrieve the FML 100-Character Description (DXID_DESC100) for each DXID value using the FML Disease
Identifier (DxID) Table (RFMLDX0_DXID).

DXID DXID_DESC100

00001154 Neuromuscular Transmission Deficiency

00001157 Duchenne Dystrophy

00001447 Acute ST Elevation Myocardial Infarction

00001451 Acute Myocardial Infarct with Pulmonary Congestion

00001502 Severe Aortic Valve Stenosis

00001512 Idiopathic Hypertrophic Subaortic Stenosis

00001517 Complete Atrioventricular Block

00001521 Incomplete AV Heart Block

00001528 Wolff-Parkinson-White Pattern

00001543 Ventricular Tachycardia

00001562 Sick Sinus Syndrome

00001563 Bradycardia

00001579 Severe Chronic Heart Failure

00001588 Heart Failure

00001709 Hypotension

00001713 Severe Hypotension

00002202 Disease of Liver

00002292 Renal Disease

00003184 Cardiogenic Shock

00013479 Lown-Ganong-Levine Syndrome

You may now display the results to the end-user. Multiple sorting and filtering options can be used at this point
depending on your requirements. The following illustration sorts based on the DDCM Severity Level ( DDXCN_SL)
and the DDCM Severity Level Description (DDXCN_SL_DESC). See the DDXCN_SL data dictionary entry for

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important information about each severity levels precise meaning.

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Comparing Patient ICD Codes to Prospective Drug Therapy - Using the Exclusion Table to
Reduce Alerts
This application illustrates how to prospectively identify possible contraindications to prescribed therapy by
comparing a collection of patient ICD codes (both ICD-9-CM and ICD-10-CM/PCS codes).

ExampleComparing a Patients ICD Codes to Prospective Drug TherapyUsing the Exclusion Table to
Reduce Alerts

The following steps assume you have a formulary that identifies medications with Clinical Formulation ID (
GCN_SEQNO) values. In this procedure, you retrieve all single-route Orderable Meds and discretionary-route
Orderable Meds related to drugs on your formulary.

1. Query the FML ICD Search Exclusion Table (RFMLISR1_ICD_SEARCH) for the FML Related DxID (
RELATED_DXID) and the FML Navigation Code (FML_NAV_CODE) where:
the Search ICD Code (SEARCH_ICD_CD) equals the code you are checking,
the ICD Code Type (ICD_CD_TYPE) column equals the value of the type of ICD code you are
checking, and
the FML Clinical Module Code (FML_CLIN_CODE) equals 03.

The FML Navigation Code describes the relationship between the DxID and the ICD Code. You
will use it later in this process when you compile information and construct the DDCM alert
message.

2. Find the Clinical Formulation ID (GCN_SEQNO) of the prescribed drug.

3. Find the drugs DDCM Drug-Disease Contraindications Code (DDXCN) using the DDCM
GCN_SEQNO/Drug-Disease Code Relation Table (RDDCMGC0_CONTRA_GCNSEQNO_LINK). See the
note below about multi-ingredient products.

Multi-ingredient drugs may have more than one DDXCN. In these cases, the DDXCNs associated
DDCM Drug-Disease Contraindications Drug Description (DDXCN_DRUG_DESC), found in the
DDCM Drug Description Table (RDDCMDD0_CONTRA_DRUG_DESC), can be helpful when
displaying alerts by specifying which drug group(s) in the product cause a problem.

For example, if both DDXCN 50001 (acetaminophen) and DDXCN 50003 (caffeine) appear during
this step you might say simply that the entire drug poses potential problems to the patient.
However, using the DDXCN_DRUG_DESC, you can qualify the results and indicate to the
end-user which ingredients cause the alert (in this example acetaminophen and caffeine).

4. Retrieve each DDXCNs FML Disease Identifiers (DXID) and their DDCM Severity Level (
DDXCN_SL_DESC) codes using the DDCM Master Table (RDDCMMA1_CONTRA_MSTR). At this point,
you also have the following option:
Filter or sort based upon DDCM Severity Level (DDXCN_SL_DESC).

5.

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5. Construct a list of the matching DXID values between the set of FML Related DXID (RELATED_DXID)
values found in Step 1 (signifying DDCM contraindications for the patients ICD codes), and the set of
DXID values found in Step 4 (signifying DDCM contraindications for sumatriptan). In addition to the DXIDs,
include the following values:
Search ICD Codes (SEARCH_ICD_CD)
FML Navigation Code (FML_NAV_CODE) values found in step 1
DDCM Drug-Disease Contraindications Code (DDXCN) value found in Step 3
DDCM Severity Level (DDXCN_SL_DESC) values found in Step 4
FML Clinical Module Code (FML_CLIN_CODE)

6. Query the FML ICD Search Exclusion Table (RFMLISX0_ICD_SEARCH_EXCLUSION) with the following
fields from Step 5:
FML Search ICD Code (SEARCH_ICD_CD)
ICD Code Type (ICD_CD_TYPE)
FML Related DXIDs (RELATED_DXID) (DXID match results from Step 5)
FML Clinical Module Code (FML_CLIN_CODE_DESC)
Clinical Drug Group (CLIN_DRUG_GROUP) (In this example, the DDXCN populates this field.)

7. Remove matching query records (if found) that appear in Step 6 from records in Step 5.

8. Sort the results of the previous step.

If you wish to sort by top-priority contraindications, sort by the DDCM Severity Level (
DDXCN_SL_DESC).
If you wish to prioritize patient-context condition matching, sort by the FML Navigation Code (
FML_NAV_CODE).

9. Retrieve the drugs MED Medication Description (MED_MEDID_DESC) using the MED Medication Table
(RMIID2_MED) table.

10. Retrieve the FML ICD Code Description (ICD_DESC) for each ICD Code identified in Step 7 using the FML
ICD Code Type Description Table (RFMLINM1_ICD_DESC).

11. Retrieve the DxID description for each DxID value identified in Step 7 using the FML Disease Identifier
(DxID) Table (RFMLDX0_DXID).
To retrieve a primary professional description for each DxID value, use either the FML 56-character
Description (DXID_DESC56) or the FML 100-character Description (DXID_DESC100).
To retrieve a primary layman description, refer to the Finding DXID Description and Synonyms
application in the FDB MedKnowledge manual.

12. Construct each of the following messages that applies to the results of step 7 using the information found
above:
If FML_NAV_CODE = 01 and
DDXCN_SL = 1 then display, Your patient was found to have [ICD_DESC] on their problem
list. The drug [MED_MEDID_DESC] is contraindicated in patients with [DXID_DESC100].

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DDXCN_SL = 2 then display, Your patient was found to have [ICD_DESC] on their problem
list. Patients with [DXID_DESC100] should be carefully evaluated before initiating therapy
and monitored closely while taking [MED_MEDID_DESC].
DDXCN_SL = 3 then display, Your patient was found to have [ICD_DESC] on their problem
list. Patients with [DXID_DESC100] should be carefully monitored during therapy with [
MED_MEDID_DESC].
If FML_NAV_CODE = 02 or FML_NAV_CODE = 03 and
DDXCN_SL = 1 then display, Your patient was found to have [ICD_DESC] on their problem
list, a condition similar to [DXID_DESC100] which is a contraindication for the use of [
MED_MEDID_DESC].
DDXCN_SL = 2 then display, Your patient was found to have [ICD_DESC] on their problem
list, a condition similar to [DXID_DESC100], and therefore should be carefully evaluated
before initiating therapy and monitored closely while taking [MED_MEDID_DESC].
DDXCN_SL = 3 then display, Your patient was found to have [ICD_DESC] on their problem
list, a condition similar to [DXID_DESC100], and therefore should be carefully monitored
during therapy with [MED_MEDID_DESC].

The sample message templates above are suggestions based on interpretations of the
DDXCN_SL descriptions. Customers can modify these warnings as they see fit. See the DDCM
Severity Level section within your FDB MedKnowledge manual for more information.

13. Display the results to the end user.

ExampleComparing a Patients ICD Codes to Prospective Drug TherapyUsing the Exclusion Table to Reduce
Alerts

This example prospectively identifies possible drug-disease contraindications (DDCM) to the patients prescribed
therapy of sumatriptan 100 mg Tab (MEDID 00177730), using the patients ICD Codes of 346 (ICD-9-CM code for
Migraine) and G43.909 (ICD-10-CM code for Migraine).

1. Query the FML ICD Search Table (RFMLISR1_ICD_SEARCH) for the FML Related DxID (
RELATED_DXID) and the FML Navigation Code (FML_NAV_CODE) where
the Search ICD Code(s) (SEARCH_ICD_CD) equals the 346 and G43.909,
the ICD Code Type (ICD_CD_TYPE) column equals 01 and 05, respectively, and
the FML Clinical Module Code (FML_CLIN_CODE) equals 03.

SEARCH_ICD_CD ICD_CD_TYPE RELATED_DXID FML_CLIN_CODE FML_NAV_CODE

346 01 00001114 03 02

346 01 00001116 03 01

346 01 00003154 03 02

346 01 00003157 03 03

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346 01 00013524 03 02

346 01 00013885 03 02

G43.909 05 00001114 03 03

The FML Navigation Code describes the relationship between the DxID and the ICD Code. You
will use it later in this process when you compile information and construct the DDCM alert
message.

2. Find the Clinical Formulation ID (GCN_SEQNO) of the prescribed drug.

MEDID GCN_SEQNO

00177730 017129

In this example, the Medication ID (MEDID) is used to find the GCN_SEQNO in the MED Medication Table
(RMIID2_MED).

3. Find the drugs DDCM Drug-Disease Contraindications Code (DDXCN) using the DDCM
GCN_SEQNO/Drug-Disease Code Relation Table (RDDCMGC0_CONTRA_GCNSEQNO_LINK). See the
note below about multi-ingredient products.

Multi-ingredient drugs may have more than one DDXCN. In these cases, the DDXCNs associated
DDCM Drug-Disease Contraindications Drug Description (DDXCN_DRUG_DESC), found in the
DDCM Drug Description Table (RDDCMDD0_CONTRA_DRUG_DESC), can be helpful when
displaying alerts by specifying which drug group(s) in the product cause a problem.

GCN_SEQNO DDXCN

017129 50530

4. Retrieve each DDXCNs FML Disease Identifiers (DXID) and their DDCM Severity Level (
DDXCN_SL_DESC) codes using the DDCM Master Table (RDDCMMA1_CONTRA_MSTR). At this point,
you also have the following option:
Filter or sort based upon DDCM Severity Level (DDXCN_SL_DESC).

DDXCN DXID DDXCN_SL

50530 00002202 3

50530 00002203 1

50530 00003176 2

50530 00001072 1

50530 00000701 3

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50530 00001114 1

The example above shows a partial list of the results of this step.

5. Construct a list of the matching DXID values between the set of FML Related DXID (RELATED_DXID)
values found in Step 1 (signifying DDCM contraindications for the patients ICD codes), and the set of
DXID values found in Step 4 (signifying DDCM contraindications for sumatriptan). In addition to the DXIDs,
include the following values:
Search ICD Codes (SEARCH_ICD_CD)
FML Navigation Code (FML_NAV_CODE) values found in step 1
DDCM Drug-Disease Contraindications Code (DDXCN) value found in Step 3
DDCM Severity Level (DDXCN_SL_DESC) values found in Step 4
FML Clinical Module Code (FML_CLIN_CODE)

This compiled list summarizes the possible contraindications that exist based on a combination of the
prescribed medication(s) and the patients ICD code condition(s).

SEARCH_IC ICD_CD_TY RELATED_DXIDDDXCN FML_CLIN_ FML_NAV_C DDXCN_SL

D_CODE PE (Matching CODE ODE
DXIDs)

346 01 00001114 50530 03 02 1

G43.909 05 00001114 50530 03 03 1

6. Query the FML ICD Search Exclusion Table (RFMLISX0_ICD_SEARCH_EXCLUSION) with the following
fields from Step 5:
FML Search ICD Code (SEARCH_ICD_CD)
ICD Code Type (ICD_CD_TYPE)
FML Related DXIDs (RELATED_DXID) (DXID match results from Step 5)
FML Clinical Module Code (FML_CLIN_CODE_DESC)
Clinical Drug Group (CLIN_DRUG_GROUP) (In this example, the DDXCN populates this field.)

SEARCH_ICD_CD ICD_CD_TYPE RELATED_DXID FML_CLIN_CODE CLIN_DRUG_GRO

UP

346 01 00001114 03 50530

346 01 00001114 03 50883

346 01 00001114 03 50885

346 01 00001114 03 50911

346 01 00001114 03 51148

346 01 00001114 03 51164

346 01 00001114 03 51244

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G43.909 05 00001114 03 50530

G43.909 05 00001114 03 50883

G43.909 05 00001114 03 50885

G43.909 05 00001114 03 50911

G43.909 05 00001114 03 51148

G43.909 05 00001114 03 51164

G43.909 05 00001114 03 51244

7. Remove matching query records (if found) that appear in Step 6 from records in Step 5. In this example,
the related DXID 00001114 (Hemiplegic Migraine) appears as an exclusion. The application stops because
there are no remaining records after this step. No alert is generated.

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Comparing Patient DxIDs to Prospective Drug Therapy

This application illustrates how to prospectively identify possible contraindications to prescribed therapy by
comparing a collection of DxIDs (representative of the patients diagnoses or medical problems) to the prescribed
drugs associated Disease Identifiers (DxID).

This example prospectively identifies possible DDCM contraindications to the patients prescribed therapy of
minocycline 50 mg capsule (MEDID 00250247), using the patients profiled DxID codes of 594 (Type 2 Diabetes
Mellitus), 3446 (Pregnancy), and 1742 (Acute Maxillary Moraxella Catarrhalis Sinusitis), and 1993 (Erosive
Esophagitis).

1. Find the patients profiled DxID codes in the FML Search DxID column ( SEARCH_DXID) and retrieve each
FML Related DxID (RELATED_DXID) and FML Navigation Code (FML_NAV_CODE) using the FML
Disease Identifier (DxID) Search Table (RFMLDSR0_DXID_SEARCH). Furthermore, filter the results
based on FML Clinical Module Code (FML_CLIN_CODE) value 03 for the DDCM module.

SEARCH_DXID RELATED_DXID FML_CLIN_CODE FML_NAV_CODE

00000594 00000594 03 01

00000594 00000599 03 02

00000594 00000600 03 02

00000594 00000604 03 03

00000594 00000606 03 02

00000594 00003275 03 03

00000594 00003278 03 03

00000594 00003284 03 02

00000594 00007662 03 02

00000594 00013399 03 02

00000594 00013484 03 03

00000594 00013526 03 02

00001742 00000154 03 03

00001742 00000155 02 02

00001742 00000412 03 03

00001742 00000413 03 03

00001742 00001757 03 03

00001742 00006276 03 02

00001993 00001991 03 03

00001993 00001992 03 02

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00001993 00001993 03 03

00001993 00001995 03 01

00001993 00001999 03 03

00001993 00002035 03 02

00001993 00002048 03 03

00001993 00002048 03 03

00001993 00005181 03 02

00003446 00002538 03 02

00003446 00002539 03 02

00003446 00002540 03 02

00003446 00002541 03 02

00003446 00002542 03 02

00003446 00002543 03 02

00003446 00002544 03 02

00003446 00002553 03 02

00003446 00002557 03 02

00003446 00002560 03 02

00003446 00002562 03 02

00003446 00003086 03 02

00003446 00003446 03 01

00003446 00003452 03 02

00003446 00007836 03 02

00003446 00013550 03 02

00003446 00013555 03 02

00003446 00013568 03 02

00003446 00013582 03 02

00003446 00013603 03 02

00003446 00013689 03 02

00003446 00013758 03 02

The FML Navigation Code describes the relationship between the two DxID values. You will use it
later in this process when you compile information and construct the DDCM alert message.

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2. Find minocyclines Clinical Formulation ID (GCN_SEQNO) using its MEDID and the MED Medication Table
(RMIID1_MED).

MEDID GCN_SEQNO

00250247 009227

3. Find minocyclines DDCM Drug-Disease Contraindications Code (DDXCN) using the DDCM
GCN_SEQNO/Drug-Disease Code Relation Table (RDDCMGC0_CONTRA_GCNSEQNO_LINK). See the
note below about multi-ingredient products.

GCN_SEQNO DDXCN

009227 51227

Multi-ingredient drugs may have more than one DDXCN. In these cases, the DDXCNs associated
DDCM Drug-Disease Contraindications Drug Description (DDXCN_DRUG_DESC), found in the
DDCM Drug Description Table (RDDCMDD0_CONTRA_DRUG_DESC), can be helpful while
displaying alerts by specifying which drug group(s) in the product cause a problem.

For example, if both DDXCN 50001 (acetaminophen) and DDXCN 50003 (caffeine) appear during
this step you might say simply that the entire drug poses potential problems to the patient.
However, using the DDXCN_DRUG_DESC , you can qualify the results and indicate to the
end-user which ingredients cause the alert (in this example acetaminophen and caffeine).

4. Retrieve each DDXCNs related FML Disease Identifier (DXID) and DDCM Severity Level (
DDXCN_SL_DESC) codes using the DDCM Master Table (RDDCMMA1_CONTRA_MSTR). At this point
you may optionally retrieve either of the following:
The DDCM Sequence Number (DDXCN_SN)
The DDCM Reference (DDXCN_REF)

The following results are sorted by DDXCN_SN:

DDXCN DXID DDXCN_SL DDXCN_SN DDXCN_REF

51227 00000026 2 00 MINOCIN PI, 08/10

51227 00005181 2 01 THE ESOPHAGUS

1999:527-37

51227 00002202 2 02 MINOCIN PI, 08/10

51227 00002292 3 03 MINOCIN PI, 08/10

51227 00003446 1 04 MINOCIN PI, 08/10

51227 00003277 3 05 MINOCIN PI, 08/10

51227 00001121 2 06 MINOCIN PI, 08/10

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5. Construct a list of the matching DXID values between the set of RELATED_DXID values found in step 1
(signifying DDCM contraindications for the patients profiled DxID codes), and the set of DXID values found
in step 4 (signifying DDCM contraindications for Minocycline). Take note of the SEARCH_DXID and
related FML_NAV_CODE values (found in step 1), and the related DDXCN_SL values (found in step 4).
This compiled list summarizes the possible contraindications that exist based on a combination of the
prescribed medication(s) and the patients profiled condition(s).

Search DXID Matching DXID Navigation Code Severity Level

(from step 1) (from step 1 and step 4) (from step 1) (from step 4)

00001996 00005181 02 2

00003446 00003446 01 1

The SEARCH_DXID values indicate which of the patients conditions may cause problems with the
prescribed therapy. This step has revealed that neither the patients Type 2 Diabetes Mellitus
(DxID 594) nor his or her Acute Maxillary Moraxella Catarrhalis Sinusitis (DxID 1742) have any
contraindications for minocycline.

6. Sort the results of the previous step. Top priority contraindications are those with an FML_NAV_CODE
value of 01. Sort the remaining contraindications by their severity level ( DDXCN_SL value 01 is the most
severe, so sort in ascending order).

SEARCH_DXID DXID FML_NAV_CODE DDXCN_SL

00003446 00003446 01 1

00001993 00005181 02 2

7. Retrieve Minocyclines MED Medication Description (MED_MEDID_DESC) using the RMIID1_MED table.

MEDID MED_MEDID_DESC

00250247 minocycline 50 mg Cap

8. Retrieve the FML 100-character Description (DXID_DESC100) for each SEARCH_DXID and DXID code
identified in step 5 using the FML Disease Identifier (DxID) Table (RFMLDX0_DXID).

DXID DXID_DESC100

00001993 Erosive Esophagitis

00003446 Pregnancy

9. Construct each of the following messages that applies to the results of step 5 using the information found
above. When the FML_NAV_CODE does not equal 01, you must display two DxID descriptions. The
Search DXID_DESC100 denotes a patient problem DxID, and the Related DXID_DESC100 denotes a
DxID present in the prescribed therapy.

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If FML_NAV_CODE = 01 and
DDXCN_SL = 1 then display, Your patient was found to have [Search DXID_DESC100] on
their problem list. The drug [MED_MEDID_DESC] is contraindicated in patients with [Search
DXID_DESC100].
DDXCN_SL = 2 then display, Your patient was found to have [Search DXID_DESC100] on
their problem list. Patients with [Search DXID_DESC100] should be carefully evaluated
before initiating therapy and monitored closely while taking [MED_MEDID_DESC].
DDXCN_SL = 3 then display, Your patient was found to have [Search DXID_DESC100] on
their problem list. Patients with [Search DXID_DESC100] should be carefully monitored
during therapy with [MED_MEDID_DESC].
If FML_NAV_CODE = 02 or FML_NAV_CODE = 03 and
DDXCN_SL = 1 then display, Your patient was found to have [Search DXID_DESC100] on
their problem list, a condition similar to [Related DXID_DESC100] which is a contraindication
for the use of [MED_MEDID_DESC].
DDXCN_SL = 2 then display, Your patient was found to have [Search DXID_DESC100] on
their problem list, a condition similar to [Related DXID_DESC100], and therefore should be
carefully evaluated before initiating therapy, and monitored closely while taking [
MED_MEDID_DESC].
DDXCN_SL = 3 then display, Your patient was found to have [Search DXID_DESC100] on
their problem list, a condition similar to [Related DXID_DESC100], and therefore should be
carefully monitored during therapy with [MED_MEDID_DESC].

The sample message templates above are suggestions based on interpretations of the
DDXCN_SL descriptions. Customers can modify these warnings as they see fit. See the DDCM
Severity Level (DDXCN_SL) section for more information.

10. Display the results to the end-user.

Your patient was found to have Pregnancy on their problem list. The drug Minocycline 50 mg Cap is
contraindicated in patients with Pregnancy.

Your patient was found to have Erosive Esophigitis on their problem list, a condition similar to Esophageal
Dysmotility and therefore should be carefully evaluated before initiating therapy, and monitored closely while taking
Minocycline 50 mg Cap.

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Checking Inferred Patient Diagnoses for Drug-Disease Contraindications Associated with

Prospective Drug Therapy
This application illustrates how to use the Indications Module (INDM) along with the Drug-Disease
Contraindications Module (DDCM) to populate inferred patient diagnoses when patient problem list information is
not available, specifically for the purpose of screening a prescribed drug for drug-disease contraindications.

This example screens prescribed Adderall XR 5 mg 24 hour capsules (MEDID 00443812) for drug-disease
contraindications. No diagnosis information exists for the patient, so indications will be inferred based on the
patients current medication of Timoptic 0.25% Eye Drops (MEDID 00167659).

1. Find Timoptics Clinical Formulation ID (GCN_SEQNO) using its MEDID and the MED Medication Table
(RMIID1_MED).

MEDID GCN_SEQNO

00167659 007855

2. Find the INDM Indications Code (INDCTS) related to Clinical Formulation ID (GCN_SEQNO) 007855 using
the INDM GCN_SEQNO/Indications Code Relation Table (RINDMGC0_INDCTS_GCNSEQNO_LINK).

GCN_SEQNO INDCTS

007855 00929

3. Retrieve each INDCTS codes set of INDM Predictor Code (PRED_CODE) and FML Disease Identifier (
DXID) using the INDM Master Table (RINDMMA2_INDCTS_MSTR). Those DXID codes that have a
PRED_CODE of 1 or 2 (certain or somewhat certain, respectively) represent likely indications based on the
patients current medication(s).

INDCTS DXID PRED_CODE

00929 00001205 1

DXIDs with a PRED_CODE of 3 represent conditions that may exist based on current medication,
but they have less predictive value than PRED_CODE 1 or 2. You may want to include these
DxIDs (indications) or otherwise take this into account in your end-user message.

4. For each DXID retrieved in the previous step, query the FML Disease Identifier (DxID) Search Table
(RFMLDSR0_DXID_SEARCH) and retrieve the Related DxID (RELATED_DXID) and FML Navigation
Code (FML_NAV_CODE) values. Use the DXID from the previous step as the Search DxID (
SEARCH_DXID). Retrieve only those RELATED_DXID values which have an FML Clinical Module Code (
FML_CLIN_CODE) value of 03 (Drug-Disease Contraindications Module).

SEARCH_DXID RELATED_DXID FML_CLIN_CODE FML_NAV_CODE

00001205 00001205 03 01

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00001205 00001211 03 03

The FML Navigation Code describes the relationship between the two DxID values. You will use it
later in this process when you compile information and construct the DDCM alert message.

Not every DxID appears as a SEARCH_DXID.

5. Follow the steps detailed in the Retrieving a List of Drug Contraindications application earlier in this
chapter to find DDCM information for the new medication being prescribed. The results of this process
when carried out for Adderall are summarized below.

DDXCN DDXCN_SL DXID DXID_DESC100

50023 1 00000580 Hyperthyroidism

50023 2 00000962 Psychotic Disorder

50023 2 00001001 Drug Dependence

50023 1 00001005 Drug Abuse

50023 2 00001012 Gilles De La Tourette

Syndrome

50023 1 00001018 Feeling Agitated

50023 1 00001211 Glaucoma

50023 3 00001432 Hypertension

50023 1 00001594 Disease of Cardiovascular

System

50023 1 00001641 Severe Arteriosclerotic

Vascular Disease

50023 2 00003145 Anorexia

50023 1 00003452 Lactating Mother

50023 1 00004739 Moderate Hypertension

50023 1 00013488 Structural Disorder of

Heart

6. Construct a list of the matching DXID values between the set of RELATED_DXID values found in step 4
(signifying proxy indications inferred from the patients active medications, in this case Timoptic), and the
set of DXID values found in step 5 (signifying DDCM contraindications for Adderall). Also take note of the
SEARCH_DXID and related FML_NAV_CODE values (found in step 4), and the related DDXCN_SL
values (found in step 5). The compiled list below (in this case a single DxID) summarizes the DxID
matches for this example.

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Search DXID Related DXID Navigation Code Severity Level

(from step 4) (from step 4 and step 5) (from step 4) (from step 5)

00001205 00001211 03 1

7. Retrieve the FML 100-character Description (DXID_DESC100) for each SEARCH_DXID and DXID in the
previous step using the FML Disease Identifier (DxID) Table (RFMLDX0_DXID).

DXID DXID_DESC100

00001205 Open Angle Glaucoma

00001211 Glaucoma

8. Retrieve the MED Medication Description (MED_MEDID_DESC) for both Adderall and Timoptic using the
RMIID1_MED table.

MEDID MED_MEDID_DESC

00167659 Timoptic 0.25% Eye Drops

00443812 Adderall XR 5 mg 24 hr Cap

This step is only required if you intend to display medication descriptions in the alert message.

9. Construct each of the following messages that applies to the results of step 6 using the information found
above. When the FML_NAV_CODE does not equal 01, you must display two DxID descriptions. The
Inferred DXID_DESC100 denotes an inferred indication, and the Matched Related DXID_DESC100
denotes an indication related to prescribed therapy.
If FML_NAV_CODE = 01 and
DDXCN_SL = 1 then display, Your patient has an inferred diagnosis of [Inferred
DXID_DESC100] based on your patient's current use of [Current Medication
MED_MEDID_DESC]. The drug [Prescribed Medication MED_MEDID_DESC] is
contraindicated in patients with [Inferred DXID_DESC100].
DDXCN_SL = 2 then display, Your patient has an inferred diagnosis of [Inferred
DXID_DESC100] based on your patient's current use of [Current Medication
MED_MEDID_DESC]. Patients with [Inferred DXID_DESC100] should be carefully evaluated
before initiating therapy and monitored closely while taking [Prescribed MED_MEDID_DESC
].
DDXCN_SL = 3 then display, Your patient has an inferred diagnosis of [Inferred
DXID_DESC100] based on your patient's current use of [Current Medication
MED_MEDID_DESC]. Patients with [Inferred DXID_DESC100] should be carefully monitored
during therapy with [Prescribed MED_MEDID_DESC].
If FML_NAV_CODE = 02 or FML_NAV_CODE = 03 and

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DDXCN_SL = 1 then display, Your patient has an inferred diagnosis of [Inferred

DXID_DESC100] based on your patient's current use of [Current Medication
MED_MEDID_DESC]. This condition is similar to [Matched Related DXID_DESC100] which
is a contraindication for the use of [Prescribed MED_MEDID_DESC].
DDXCN_SL = 2 then display, Your patient has an inferred diagnosis of [Inferred
DXID_DESC100] based on your patient's current use of [Current Medication
MED_MEDID_DESC]. This condition is similar to [Matched Related DXID_DESC100] which
should be carefully evaluated before initiating therapy, and patients should be monitored
closely while taking [Prescribed MED_MEDID_DESC].
DDXCN_SL = 3 then display, Your patient has an inferred diagnosis of [Inferred
DXID_DESC100] based on your patient's current use of [Current Medication
MED_MEDID_DESC]. This condition is similar to [Matched Related DXID_DESC100], and
patients should be carefully monitored during therapy with [Prescribed MED_MEDID_DESC
].

The sample message templates above are suggestions based on interpretations of the
DDXCN_SL descriptions. Customers can modify these warnings as they see fit.

10. Display the results to the end-user.

Your patient has an inferred diagnosis of Open Angle Glaucoma based on your patient's current use of Timoptic
0.25% Eye Drops. This condition is similar to Glaucoma which is a contraindication for the use of Adderall XR 5
mg 24 hr Cap.

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DDCM ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

Drug-Disease Contraindications Module Tables

Drug-Disease Contraindications Module ERD

Drug-Disease Contraindications Module Tables

DDCM Drug Description Table
DDCM GCN_SEQNO/Drug-Disease Code Relation Table
DDCM Master Table
DDCM Routed Generic Table
DDCM Routed Medication Table
DDCM Severity Level Table

Drug-Disease Contraindications Module ERD

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DDCM Drug Description Table

Table Name RDDCMDD0_CONTRA_DRUG_DESC

Revision Activity add. 03-14-2002

Purpose Relates the Drug-Disease Contraindications Code to the

text description of the drug associated with it.

Key Column Name Column Format Length Picture

Description

p DDXCN DDCM N 5 9(5)

Drug-Diseae
Contraindications
Code

DDXCN_DRUG_ DDCM AN 100 X(100)

DESC Drug-Disease
Contraindications
Drug Description

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DDCM GCN_SEQNO - Drug-Disease Code Relation Table

Table Name RDDCMGC0_CONTRA_GCNSEQNO_LINK

Revision Activity original

Purpose Links a drug to its contraindicated disease state.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF DDXCN DDCM N 5 9(5)

Drug-Disease
Contraindications
Code

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DDCM Master Table

Table Name RDDCMMA1_CONTRA_MSTR

Revision Activity rev. 10-30-2014

Purpose Associates a drug or class of drugs to a contraindicated

disease state and provides attributes of that relationship.

Key Column Name Column Format Length Picture

Description

P DDXCN DDCM N 5 9(5)

Drug-Disease
Contraindications
Code

P DDXCN_SN DDCM Sequence N 2 9(2)

Number

F FDBDX First Databank AN 9 X(9)

Disease Code

F DDXCN_SL_DES DDCM Severity AN 1 X(1)

C Level

DDXCN_REF DDCM Reference AN 26 X(26)

F DXID FML Disease N 8 9(8)

Identifier (Stable
ID)

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DDCM Routed Generic Table

Table Name RDDCMRG0_ROUTED_GEN_LINK

Revision Activity original

Purpose Links a routed generic to a list of contraindications.

Key Column Name Column Format Length Picture

Description

PF ROUTED_GEN_I Routed Generic N 8 9(8)

D Identifier

PF DDXCN DDCM N 5 9(5)

Drug-Disease
Contraindications
Code

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DDCM Routed Medication Table

Table Name RDDCMRM0_ROUTED_MED_LINK

Revision Activity add. 07-01-2002

Purpose Links a routed medication to a list of contraindications.

Key Column Name Column Format Length Picture

Description

PF ROUTED_MED_I MED Routed N 8 9(8)

D Medication ID
(Stable ID)

PF DDXCN DDCM N 5 9(5)

Drug-Disease
Contraindications
Code

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DDCM Severity Level Table

Table Name RDDCMSL0_SEVER_LEVEL

Revision Activity add. 10-30-2014

Purpose Relates the Drug-Disease Contraindications severity level

numerical code to the text description of the level.

Key Column Name Column Format Length Picture

Description

P DDXCN_SL DDCM Severity AN 1 X(1)

Level

DDXCN_SL_DES DDCM Severity AN 255 X(255)

C Level Description

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Drug-Lab Interference Module (DLIM ) 2.0

Drug-Lab Interference Module Editorial Policies
Applications
ERD and Technical Specifications

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Drug-Lab Interference Module Editorial Policies

The policies and criteria that apply to the inclusion criteria, processes, and references used in creation of the
Drug-Lab Interference Module (DLIM) module are provided in the following sections:

Overview
Inclusion Criteria
Data Elements
Rule Sets
Maintenance
References

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DLIM Overview
The Drug-Lab Interference Module (DLIM) is used by hospitals, hospital pharmacies, physicians and other
healthcare professionals, and clinical laboratories to identify drugs that may falsely alter laboratory test results.
DLIM provides the following types of information:

the drug group description associated with the interference that can cause the potential false test result
the specific laboratory test that may have the false result (described in terms of the analyte, specimen, and
laboratory test method)
monographs providing discussion text, statements on potential impact on clinical care, and related
reference citations for a given drug-lab
strength of the literature-based evidence supporting analytic drug-lab interferences

A drug can falsely alter a laboratory test result by causing an analytic interference in a laboratory test. For
example, cefoxitin is an antibiotic used to treat various systemic infections. Patients with these serious infections
often have their kidney function monitored by a serum creatinine test. Depending on the serum creatinine test
method employed, cefoxitin has been shown to falsely increase serum creatinine test results. In this way, the
results of the laboratory test for serum creatinine are falsely altered by the presence of the drug cefoxitin.

The use of DLIM, both as a screening tool and reference, may be part of systems solutions that reduce medical
errors caused by inappropriate treatment or follow-up tests based on erroneous laboratory test results. In
addition, the use of DLIM may help reduce wasted laboratory testing and healthcare resources and may save
time for everyone involved. As a result, patient comfort is increased because there is no need for multiple
specimen collection.

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DLIM Inclusion Criteria

This section provides information detailing the criteria that guided the inclusion of the data contained within the
module as well as information pertaining to limitations or exclusions when appropriate to the discussion.

This section includes the following topics:

InclusionAnalyte Scope
InclusionLaboratory Test Method
InclusionDrug Scope
InclusionWarnings Content Scope
ExclusionAnalyte
ExclusionTest Method
ExclusionDrug Scope
ExclusionWarnings Content Scope

InclusionAnalyte Scope

Centers for Medicare & Medicaid Services (CMS) and Clinical Laboratory Improvement Amendments
(CLIA) regulated routine chemistry and endocrinology analytes (See the CMS-CLIA Routine Chemistry and
Endocrinology Analyte List below.)
Analytes that are drug substances, which require routine therapeutic drug monitoring (TDM)
Analytes associated with warnings in sporadic Food and Drug Administration (FDA) MedWatch or Health
Canada MedEffects Alerts

CMS-CLIA Routine Chemistry and Endocrinology Analyte List

Alanine Aminotranferase

Albumin

Alkaline Phosphatse

Amylase

Aspartate Aminotranferase

Bilirubin, total

Calicium, total

Chloride

Cholesterol, total

Cholesterol, HDL

Creatine Kine, total

Creatine Kinase, isoenzyme

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Creatinine

Glucose

Iron, total

Lactate Dehydrogenase (LDH), total

LDH Isoenzymes (LDH1/LDH2)

Magnesium

Potassium

Sodium

Total Protein

Triglycerides

Urea Nitrogen

Uric Acid

Cortisol

Free Thyroxine

Human Chorionic Gonadotropin

T3 Uptake

Triiodothyronine

InclusionLaboratory Test Method

Methods used by greater than 2% of the laboratory institutions participating in the College of American
Pathologists (CAP) Survey Program. Threshold of 2% deemed sufficient to evaluate method.

InclusionDrug Scope

U.S. FDA-approved Rx product ingredients with New Drug Application (NDA), Abbreviated New Drug
Application (ANDA), or Biologic License Application (BLA)
U.S. Over-the-counter (OTC) products with NDAs or ANDAs
U.S. OTC drug product ingredients consistent with FDA OTC Monographs
Herbals listed on the FDB-approved Herbal Products Inclusion List, which contains National Center for
Complementary and Integrative Health (NCCIH) herbs

InclusionWarnings Content Scope

Drug-lab interferences can occur when a drug falsely alters a laboratory test result causing an erroneous
interference in a laboratory test. For example, cefoxitin is an antibiotic used to treat various systemic infections.

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Patients with serious infections often have their kidney function monitored by a serum creatinine test. Depending
on the serum creatinine test method employed, cefoxitin has been shown to falsely increase serum creatinine test
results.

DLIM only includes published drug-lab interference information that pertains to drug concentrations up to three
times the maximum expected therapeutic drug concentration in accordance with the Clinical and Laboratory
Standards Institute (CLSI) standard.

ExclusionAnalyte

Analytes primarily used in toxicology screening.

ExclusionTest Method

Point-of-care testing, as proprietary test method details are unavailable and interferences rare; these are
considered waived tests by CMS.

Select point-of-care tests may be included in DLIM if a significant and relevant drug/lab warning is
identifiedfor example, serum glucose.

ExclusionDrug Scope

Items from below may be included in DLIM if a trigger is received (see the Maintenance section).

Non-U.S. products that contain ingredients exclusive to other countries

Self-proclaimed Rx products without ANDA/NDA/BLA
Rx drug products with FDA device registration approval
Dietary supplements
Large volume parenteral, nutritional, irrigation, or dialysis solutions
Nutraceuticals
Diluent solutions
Herbal products except those enumerated in the First Databank NDC Attributes inclusion list
Homeopathic drugs
OTC products that are not described by FDA OTC Monographs
Bulk drugs or chemicals
Medical supplies, soaps, cleansers
Cosmetics
Veterinary drugs
Inactive ingredients

ExclusionWarnings Content Scope

Physiologic effects that manifest as altered lab results are not included. For example, toxicity or adverse
effects or "Statin" drugs can elevate liver enzymes).

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DLIM excludes interferences that occur solely in the toxic range.

DLIM content not adequately described or referenced even when part of trigger contentfor example, the
manufacturer package insert.

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DLIM Data Elements

This section contains additional information about particularly important tables and codes contained within the
module, as well as concepts about the data that the reader must understand in order to understand the module.

This section includes the following data elements:

DLIM Drug Group Identifier

DLIM Drug Group Description
Medical Test Lexicon Specific Lab ID
DLIM Documentation Level Code and Description
DLIM Monograph Identifier and Title

DLIM Drug Group Identifier

The DLIM Drug Group Identifier is a system-assigned number for each drug group. Groups are many times
created at the ingredient level. DLIM Drug Group Identifiers are linked to the following First Databank drug
identifiers:

MED Routed Medication ID

Routed Generic Identifier
Clinical Formulation ID

Example 1 below shows clinical formulations with the same ingredient (such as, spironolactone) are linked to the
same DLIM Drug Group Identifier.

Example 1

DLIM Drug Group Identifier DLIM Drug Group Description Clinical Formulation ID

48 Spironolactone 6813

48 Spironolactone 6814

48 Spironolactone 6815

48 Spironolactone 6816

48 Spironolactone 6817

48 Spironolactone 6818

Example 2 below shows multi-ingredient clinical formulation (such as, Acid/Zinc Gluconate) with two DLIM Drug
Group Identifiers..

Example 2

Clinical Formulation ID DLIM Drug Group Identifier DLIM Drug Group Description

22036 2060 Ascorbic Acid/Vitamin C (oral ONLY)

22036 284 Zinc

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DLIM Drug Group Description

The DLIM Drug Group Description created is usually ingredient based, but it can also include qualifiers such as
strength, route, or dose form to more specifically describe the drug associated with the interference.

Example 1

DLIM_DRUG_GRP_ID DLIM_DRUG_GRP_ID_DESC

48 Spironolactone

Example 2Qualified Break-out

DLIM_DRUG_GRP_ID DLIM_DRUG_GRP_ID_DESC

2060 Ascorbic Acid/Vitamin c (oral ONLY)

2102 Maltose (High Dose, IV)

Medical Test Lexicon Specific Lab ID

The MTL Specific Laboratory Test Identifier (or SLID) is a system-assigned First Databank unique code.

MTL Specific Laboratory Test Identifier Description

The SLID is assigned to each unique combination of specimen type, analyte, and specific lab method.

Example

MTL Specific Laboratory Test Identifier MTL Specific Laboratory Test Identifier Description

449 Serum Digoxin, Fluorescence Polarization Immunoassay

Interference Type Code and Description

There are seven DLIM Interference Type Codes that can be assigned to a given DLIM Drug Group Identifier. A
DLIM Drug Group Identifier can have more than one DLIM Interference Type Code.

DLIM Interference Type Code DLIM Interference Type Code Description

01 Falsely Increases

02 Falsely Decreases

03 Causes False Positive

04 Causes False Negative

05 Falsely Increases or Falsely Decreases

06 Causes False Negative or False Positive

99 Not Applicable

"Not Applicable" is not utilized at this time.

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DLIM Documentation Level Code and Description

There are four documentation levels that may be assigned to a DLIM Drug Group ID. See Rules for
Documentation Level in the Rule Sets section for more information.

DLIM Documentation Level Code DLIM Documentation Level Code Description

01 Established

02 Probable

03 Possible

99 Not Applicable

"Not Applicable" is not utilized at this time.

DLIM Monograph Identifier and Title

The DLIM Monograph Identifier is a system-assigned number. The DLIM Monograph Title is programmatically
generated and includes the DLIM Drug Group Identifier name and the MTL Specific Laboratory Test Identifier
Description value.

Example

DLIM Monograph Identifier DLIM Monograph Title

109 Dopamine - Serum Total Bilirubin, Jendrassik-Grof

Monograph Text Sections

DLIM Text includes the DLIM Text Type Code and DLIM Text Type Code Description for the sections listed
below.

Brief Overview

The Brief Overview section is programmatically generated and includes four elements: drug grouper name,
interference type, SLID and evidence level. For example: Spironolactone Falsely Increases Serum Digoxin,
Fluorescence Polarization Immunoassay. Evidence: Probable.

DLIM Text Type Code DLIM Text Type Code Description

01 Brief Overview

Discussion

The Discussion section provides a summary of the evidence evaluated for a given interference.

DLIM Text Type Code DLIM Text Type Code Description

10 Discussion

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Potential Significant Impact on Patient Care

The Potential Significant Impact on Patient Care section contains potential patient outcomes resulting from the
interference, for example, clinical or economical outcomes.

DLIM Text Type Code DLIM Text Type Code Description

20 Potential Significant Impact on Patient Care

References

The References section contains the following types of referential information:

DLIM_TXT_TYP_CODE DLIM_TXT_TYP_CODE_DESC

91 References (Manufacturer's Information)

92 References (Human Study)

94 References (Meeting Abstract)

95 References (In vitro/Animal Study)

96 References (Review Article)

97 References (AHFS)

99 References (Unclassified)

Primary medical literature references are formatted according to PubMed standards and include the associated
PubMed ID link.

The Reference (Review Article) may contain the following referential sources:

Summary statements from FDA MedWatch sporadic alerts

Summary statements from Health Canada MedEffect
Laboratory Test Guidelines

An example of DLIM monograph 808 is shown below:

ExampleMonograph ID 808 with Text Sections

DLIM_MONOGRAPH DLIM_MONOGRAPH DLIM_TEXT_TYP_C DLIM_TXT_TYP_CO DLIM_TEXT

_ID _TITLE ODE DE_DESC

808 Spironolactone - 01 Brief Overview Spironolactone

Serum Digoxin, Falsely Increases
Fluorescence Serum Digoxin,
Polarization Fluorescence
Immunoassay Polarization
Immunoassay.
Evidence: Probable

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808 Spironolactone - 10 Discussion Because of structural

Serum Digoxin, similarity,
Fluorescence spironolactone and its
Polarization active metabolite
Immunoassay canrenone may
cross-react with and
falsely increase serum
digoxin levels. Total
daily spironolactone
doses of >100mg
increase susceptibility
to this interference.
Spironolactone also
interferes with the
microparticle enzyme
immunoassay (MEIA)
for digoxin. Alternative
test methods include a
Heterogeneous
Competitive Enzyme
Immunoassay,
Particle Enhanced
Turbidimetric
Immunoassay, or
Chemiluminescence
Assay.

808 Spironolactone - 20 Potential Significant Many patients receive

Serum Digoxin, Impact on Patient both spironolactone
Fluorescence Care and digoxin for chronic
Polarization heart failure.
Immunoassay Spironolactone and its
metabolite canrenone
may falsely increase
serum digoxin levels.
This laboratory
interference may lead
to inappropriate
underdosing of
digoxin.

808 Spironolactone - 91 References Beckman Coulter,

Serum Digoxin, (Manufacturer's "Synchron Systems
Fluorescence Information) Chemistry Information
Polarization Sheet - Digoxin",
Immunoassay November 2004.

808 Spironolactone - 91 References Ortho-Clinical

Serum Digoxin, (Manufacturer's Diagnostics,
Fluorescence Information) "Instructions for use -
Polarization Vitros Chemistry
Immunoassay Products Digoxin
Slides", 2004.

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808 Spironolactone - 95 References (In Dasgupta A, Saffer H,

Serum Digoxin, vitro/Animal Study) Wells A, Datta P.
Fluorescence Bidirectional
Polarization (positive/negative)
Immunoassay interference of
spironolactone,
canrenone, and
potassium canrenoate
on serum digoxin
measurement:
elimination of
interference by
measuring free
digoxin or using a

808 Spironolactone - 95 References (In chemiluminescent

Serum Digoxin, vitro/Animal Study) assay for digoxin. J
Fluorescence Clin Lab Anal.
Polarization 2002;16(4):172-7.
Immunoassay [Pub Med URL: http://
www.ncbi.nlm.nih.gov/
entrez/query.fcgi?cmd
=Retrieve&db=PubMe
d&list_uids=12112389
&dopt=Abstract]

808 Spironolactone - 95 References (In Datta P, Dasgupta A.

Serum Digoxin, vitro/Animal Study) A new turbidometric
Fluorescence digoxin immunoassay
Polarization on the ADVIA 1650
Immunoassay analyzer is free from
interference by
spironolactone,
potassium
canrenoate, and their
common metabolite
canrenone. Ther Drug
Monit. 2003
Aug;25(4):478-82.
[Pub Med URL:

808 Spironolactone - 95 References (In http://www.ncbi.nlm.ni

Serum Digoxin, vitro/Animal Study) h.gov/entrez/query.fcg
Fluorescence i?cmd=Retrieve&db=P
Polarization ubMed&list_uids=128
Immunoassay 83233&dopt=Abstract]

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808 Spironolactone - 95 References (In Steimer W, Muller C,

Serum Digoxin, vitro/Animal Study) Eber B. Digoxin
Fluorescence assays: frequent,
Polarization substantial, and
Immunoassay potentially dangerous
interference by
spironolactone,
canrenone, and other
steroids. Clin Chem.
2002
Mar;48(3):507-16.
[Pub Med URL:

808 Spironolactone - 95 References (In http://www.ncbi.nlm.ni

Serum Digoxin, vitro/Animal Study) h.gov/entrez/query.fcg
Fluorescence i?cmd=Retrieve&db=P
Polarization ubMed&list_uids=118
Immunoassay 61441&dopt=Abstract]

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DLIM Rule Sets

This section provides rules that the clinical team uses in regards to creating the module's data, both general rules
and rules specific to data elements.

Internal and external triggers are evaluated for applicability to DLIM warning content. (See the Maintenance
section for more information.) Trigger content drug(s) are identified and DLIM precautions coding is applied to all
applicable DLIM drug groups.

Rules of General Applicability

Rules for DLIM Concept Linking
Rules for Documentation Level

Rules of General Applicability

This section describes editorial policies that have a broad impact on the module data or by nature are less
specific than those policies in other sections.

Drug knowledge is aggregated at the DLIM drug group level (see DLIM Drug Group Identifier) and then
linked to Clinical Formulation IDs. Drug group linking to other drug identifiers (MED Routed Medication
Identifiers and the Routed Generic Identifiers) in the First Databank knowledge base is programmatically
performed. Linkage of DLIM information to drugs is not drug manufacturer specific.
Non-U.S. drug clinical formulations may inherit U.S.-based DLIM clinical data.

Rules for DLIM Concept Linking

The interference specifications determine the linking to drug group(s), specific lab ID(s), type(s) of interference(s),
and documentation level(s). The examples below illustrate link relationships in DLIM.

Example 1 below shows one DLIM Drug Group Identifier linked to two different SLIDs and two types of
interferences.

Example 1DLIM Drug Group Identifier to MTL Specific Laboratory Test Identifier

DLIM Drug Group DLIM Drug Group MTL Specific DLIM Interference DLIM Interference
Identifier Description Laboratory Test Type Code Type Code
Identifier Description
Description

48 Spironolactone Serum Digoxin, 01 Falsely Increases

Fluorescence
Polarization
Immunoassay

48 Spironolactone Serum Digoxin, 02 Falsely Decreases

Microparticle Enzyme
Immunoassay (MEIA)

Example 2 below shows one SLID linked to two DLIM Drug Group Identifiers.

Example 2MTL Specific Laboratory Test Identifier to DLIM Drug Group Identifier

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MTL Specific MTL Specific DLIM Drug DLIM Drug DLIM DLIM
Laboratory Test Laboratory Test Group Identifier Group Interference Documentation
Identifier Identifier Description Type Code Level Code
Description Description Description

978 Serum 2026 Piperacillin Falsely Decreases Established

Tobramycin, (Parenteral)
Enzyme-Multiplied
Immunoassay
Technique (EMIT)

978 Serum 2094 Mezlocillin Falsely Decreases Probable

Tobramycin, (Parenteral)
Enzyme-Multiplied
Immunoassay
Technique (EMIT)

Rules for Documentation Level

This section provides the evidence schema used to define documentation levels.

Documentation Level 1 (Established) may be assigned based on evaluation of:

Drug manufacturer labeling, only if adequate description of interference.
Laboratory Test Manufacturer labeling with in vivo interference data.
Trigger Warning Content (for example, FDA MedWatch and Health Canada MedEffect).
More than 1 human study with the analyte and test method described.
Documentation Level 2 (Probable) may be assigned based on evaluation of Human case reports and/or in
vitro studies, but a causal relationship has not been reconfirmed in humans.
Documentation Level 3 (Possible) may be assigned for referenced in:
Human case reports and/or in vitro studies but a causal relationship has not been reconfirmed in
humans.
The quality of the data do not support the predictability of the interference occurring.

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DLIM Maintenance
This section contains information regarding the ongoing maintenance of the module's data.

External Triggers for Clinical Review

The First Databank Knowledge Base Services Department utilizes a robust methodology for capture,
documentation, triage and tracking of the most important sources for drug knowledge changes. The external
triggers that are triaged to the clinical editors for review are the following:

MedEffects Alerts from Health-Canada (except Non-U.S. product alerts exclusive to Canada)
FDA MedWatch Medical Product Safety Information Alerts
FDA CDER NEW
FDA CBER What's New
FDA MedWatch Monthly Label Changes
FDA Division of Drug Information (DDI)
FDA Hematology/Oncology (Cancer) Approvals and Safety Notifications
What's New at FDA in HIV/AIDS
FDA Table of Pharmacogenomic Biomarkers in Drug Labels
FDA Press Announcements

Internal Triggers for Clinical Review

The internal trigger that prompts the clinical editors to add or review DLIM drug groups is a new Clinical
Formulation Identifier added to MedKnowledge and its U.S. product labeling.

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DLIM References
This section lists sources used by First DataBank to compile the information contained in the module.

First Databank utilizes many reference sources including, but not limited to, the primary medical literature (for
example, published journal articles), medical reference texts, published expert treatment guidelines, and
manufacturer product package inserts. First Databank uses current source editions or versions when coding and
updating data, as well as when researching questions about data. However, a formal data review does not occur
for every new release of source editions or versions. Additional sources include:

Clinical and Laboratory Standards Institute (CLSI). Interference Testing in Clinical Chemistry; Approved
Guidelines.
Kaplan LA, Pesce AJ, Kramierczak SC. Clinical Chemistry Theory, Analysis, Correlation.
Centers for Medicare and Medicaid Services (CMS). Clinical Laboratory Improvement Amendments (CLIA)
.
Laboratory Testing Method Manufacturer product information.
Sonntag O, Scholer A. Drug Interference in Clinical Chemistry: Recommendation for Drugs and Their
Concentrations to be Used in Drug Interference Studies.
College of American Pathologists (CAP). Surveys, 2004 C-B Chemistry.
College of American Pathologists (CAP). Surveys, 2004 Z-B Therapeutic Monitoring.
Salway JG, ed. Drug-Test Interactions Handbook.
Young D. Effects of Drugs on Clinical Laboratory Test.
Primary Medical Literature.

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DLIM Applications
This section provides information about the practical application of data contained in DLIM. The following sections
are included:

Determining the Clinical Review Status of a Drug

Screening a Drug for Possible Laboratory Test Interferences

Screening a Laboratory Test for Possible Drug Interferences

Displaying an Alternative Laboratory Test Method When an Interference Is Found

Displaying Drug-Lab Interference Monograph Information

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DLIM Determining the Clinical Review Status of a Drug

This application illustrates how to determine the clinical review status of a drug.DLIM indicates whether a drug
has been reviewed by FDB clinical editors for possible participation in a drug-lab interference at the Clinical
Formulation ID (GCN_SEQNO) level, the Routed Medication Identifier (ROUTED_MED_ID) level, or at the
Routed Generic Identifier (ROUTED_GEN_ID) level. This application begins at the Clinical Formulation ID
(GCN_SEQNO) level and assumes familiarity with the various drug concepts and their identifiers. See Multiple
Access Points (MAPs) for more information.

1. Select the DLIM Drug Identifier Type Code (DLIM_DRUG_ID_TYP_CODE) value from the DLIM Drug
Identifier Type Code Description Table (RDLIMDR0_DRUG_ID_TYP_DESC) where the DLIM Drug
Identifier Type Code Description (DLIM_DRUG_ID_TYP_CODE) column equals the
DLIM_DRUG_ID_TYP_CODE_DESC of the drug product.

2. Select the DLIM Status Code (DLIM_STATUS_CODE) values from the DLIM Clinically Reviewed Status
Table (RDLIMCR0_CLIN_REVIEW_STATUS) where the DLIM_DRUG_ID_TYP_CODE column equals the
DLIM_DRUG_ID_TYPE_CODE value from the previous step, and the DLIM Drug Identifier (
DLIM_DRUG_ID) column equals the identifier values of the drug product.

3. Select the DLIM Status Code Description (DLIM_STATUS_CODE_DESC) value from the DLIM Status
Code Description Table (RDLIMSD0_STATUS_DESC) where the DLIM_STATUS_CODE column equals
the DLIM_STATUS_CODE values from the previous step.

ExampleDetermining the Clinical Review Status of a Clinical Formulation ID (GCN_SEQNO)

A physician determines the clinical review status for ascorbic acid (Clinical Formulation ID [ GCN_SEQNO]
00002143).

1. Select the DLIM Drug Identifier Type Code (DLIM_DRUG_ID_TYP_CODE) value from the DLIM Drug
Identifier Type Code Description Table (RDLIMDR0_DRUG_ID_TYP_DESC) where the DLIM Drug
Identifier Type Code Description (DLIM_DRUG_ID_TYP_CODE) column equals the
DLIM_DRUG_ID_TYP_CODE_DESC of the drug product.

DLIM_DRUG_ID_TYP_CODE_DESC DLIM_DRUG_ID_TYP_CODE

GCN_SEQNO 01

Routed Medication Identifier 02

Routed Generic Identifier 03

In this example, ascorbic acid is represented by the Clinical Formulation ID ( GCN_SEQNO). Therefore, the
DLIM_DRUG_ID_TYP_CODE is identified as 01.

2. Select the DLIM Status Code (DLIM_STATUS_CODE) values from the DLIM Clinically Reviewed Status
Table (RDLIMCR0_CLIN_REVIEW_STATUS) where the DLIM_DRUG_ID_TYP_CODE column equals the
DLIM_DRUG_ID_TYPE_CODE value from the previous step, and the DLIM Drug Identifier (
DLIM_DRUG_ID) column equals the identifier values of the drug product.

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DLIM_DRUG_ID DLIM_DRUG_ID_TYP_CODE DLIM_STATUS_CODE

00002143 01 01

As indicated in the scenario above, the identifier value of 00002143 is used.

3. Select the DLIM Status Code Description (DLIM_STATUS_CODE_DESC) values from the DLIM Status
Code Description Table (RDLIMSD0_STATUS_DESC) where the DLIM_STATUS_CODE column equals
the DLIM_STATUS_CODE values from the previous step.

DLIM_STATUS_CODE DLIM_STATUS_CODE_DESC

01 Reviewed; associated to one or more lab interference

records

In this example, ascorbic acid has been reviewed by a FDB clinical editor, and is associated to one or
more lab interference records.

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DLIM Screening a Drug for Possible Laboratory Test Interferences

DLIM can be used to identify possible laboratory test results that may be erroneously affected by a given drug.
This application shows how to query for those results and how to apply filters on the data if desired (for example,
Documentation Level).

Part 1: Determine the clinical review status of the drug to see whether it is associated to a laboratory test
interference.

1. Select the DLIM Drug Identifier Type Code (DLIM_DRUG_ID_TYP_CODE) value from the DLIM Drug
Identifier Type Code Description Table (RDLIMDR0_DRUG_ID_TYP_DESC) where the DLIM Drug
Identifier Type Code Description (DLIM_DRUG_ID_TYP_CODE) column equals the
DLIM_DRUG_ID_TYP_CODE_DESC of the drug product.

2. Select the DLIM Status Code (DLIM_STATUS_CODE) values from the DLIM Clinically Reviewed Status
Table (RDLIMCR0_CLIN_REVIEW_STATUS) where the DLIM_DRUG_ID_TYP_CODE column equals the
DLIM_DRUG_ID_TYP_CODE value from the previous step, and the DLIM Drug Identifier (
DLIM_DRUG_ID) column equals the identifier value of the drug product.

3. Select the DLIM Status Code Description (DLIM_STATUS_CODE_DESC) values from the DLIM Status
Code Description Table (RDLIMSD0_STATUS_DESC) where the DLIM_STATUS_CODE column equals
the DLIM_STATUS_CODE values from the previous step.

Part 2: Retrieve the Drug Group Identifier for the drug to be screened.

1. Select the DLIM Drug Group Identifier (DLIM_DRUG_GRP_ID) values from one of the following:
the DLIM GCN_SEQNO to Drug Group Table (RDLIMGC1_GCNSEQNO_DRUG_GROUP) where
the Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID
(GCN_SEQNO) value of the drug product.
the DLIM Routed Medication Identifier to Drug Group Table
(RDLIMRM0_ROUTED_MED_DRUG_GROUP) where the MED Routed Medication ID
(ROUTED_MED_ID) column equals the ROUTED_MED_ID value of the drug product.

the DLIM Routed Generic Table (RDLIMRG0_ROUTED_GEN_LINK) where the Routed Generic
Identifer (ROUTED_GEN_ID) column equals the ROUTED_GEN_ID value of the drug product.

2. Select the DLIM Drug Group Description (DLIM_DRUG_GRP_ID_DESC) values from the DLIM Drug
Group Identifier Table (RDLIMDI0_DRUG_GRP_ID) where the DLIM_DRUG_GRP_ID column equals the
DLIM_DRUG_GRP_ID values from the previous step.

Part 3: Retrieve all laboratory tests associated with the Drug Group Identifier.

1. Select the following column values from the DLIM Laboratory Interference Master Table
(RDLIMMA1_LAB_INTERFERENCE_MSTR) where the DLIM_DRUG_GRP_ID column equals the
DLIM_DRUG_GRP_ID values from Part 2.
DLIM Specific Laboratory Test Identifier (MTL_SPEC_LAB_ID)
DLIM Interference Type Code (DLIM_INTER_TYP_CODE)

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DLIM Documentation Level Code (DLIM_DOC_LEVEL_CODE)

2. Select the MTL Specific Laboratory Test Identifier Description (MTL_SPEC_LAB_ID_DESC) values from
the MTL Specific Laboratory Test Identifier Table (RMTLSLT0_SPECIFIC_LAB_ID) where the
MTL_SPEC_LAB_ID column equals the MTL_SPEC_LAB_ID values from the previous step.

Part 4: Retrieve associated drug-lab interference information.

1. Select the DLIM Interference Type Code Description (DLIM_INTER_TYP_CODE_DESC) values from the
DLIM Interference Type Code Description Table (RDLIMID0_INTERFERENCE_TYP_DESC) where the
DLIM_INTER_TYP_CODE column equals the DLIM_INTER_TYP_CODE values from Part 3.

2. Select the DLIM Documentation Level Code Description (DLIM_DOC_LEVEL_CODE_DESC) values from
the DLIM Documentation Level Code Description Table (RDLIMDD0_DOC_LEVEL_DESC) where the
DLIM_DOC_LEVEL_CODE column equals the DLIM_DOC_LEVEL_CODE values from Part 3.

Part 5: Retrieve monograph information.

1. Select the DLIM Monograph Identifier (DLIM_MONOGRAPH_ID) values from the

RDLIMMA1_LAB_INTERFERENCE_MSTR table where the DLIM_DRUG_GRP_ID and the
MTL_SPEC_LAB_ID columns equal the DLIM_DRUG_GRP_ID and the MTL_SPEC_LAB_ID values from
Part 2 and Part 3.

2. Retrieve, construct, and display the monograph information. See the DLIM Displaying Drug-Lab
Interference Monograph Information application for an illustration on how to construct and display DLIM
monograph information.

ExampleScreening a Drug for Possible Laboratory Test Interferences

A physician screens cefoxitin Inj (ROUTED_MED_ID of 00005894) for all possible laboratory test interferences.

Part 1: Determine the clinical review status of the drug to see whether it is associated to a laboratory test
interference.

1. Select the DLIM Drug Identifier Type Code (DLIM_DRUG_ID_TYP_CODE) value from the DLIM Drug
Identifier Type Code Description Table (RDLIMDR0_DRUG_ID_TYP_DESC) where the DLIM Drug
Identifier Type Code Description (DLIM_DRUG_ID_TYP_CODE) column equals the
DLIM_DRUG_ID_TYP_CODE_DESC of the drug product.

DLIM_DRUG_ID_TYP_CODE_DESC DLIM_DRUG_ID_TYP_CODE

GCN_SEQNO 01

Routed Medication Identifier 02

Routed Generic Identifier 03

In this example, cefoxitin Inj is represented by the Routed Medication Identifier ( ROUTED_MED_ID).
Therefore, the DLIM_DRUG_ID_TYP_CODE is identified as 02.

2. Select the DLIM Status Code (DLIM_STATUS_CODE) values from the DLIM Clinically Reviewed Status

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2.
Table (RDLIMCR0_CLIN_REVIEW_STATUS) where the DLIM_DRUG_ID_TYP_CODE column equals the
DLIM_DRUG_ID_TYP_CODE value from the previous step, and the DLIM Drug Identifier (
DLIM_DRUG_ID) column equals the identifier value of the drug product.

DLIM_DRUG_ID DLIM_DRUG_ID_TYP_CODE DLIM_STATUS_CODE

00005894 02 01

As indicated in the scenario text above, the identifier value of 00005894 is used.

3. Select the DLIM Status Code Description (DLIM_STATUS_CODE_DESC) values from the DLIM Status
Code Description Table (RDLIMSD0_STATUS_DESC) where the DLIM_STATUS_CODE column equals
the DLIM_STATUS_CODE values from the previous step.

DLIM_STATUS_CODE DLIM_STATUS_CODE_DESC

01 Reviewed; associated to one or more lab interference

records

In this example, cefoxitin Inj has been reviewed by a FDB clinical editor, and is associated to one or more
lab interference records. To identify the associated laboratory tests, continue to Part 2.

Part 2: Retrieve the Drug Group Identifier for the drug to be screened.

1. Select the DLIM Drug Group Identifier (DLIM_DRUG_GRP_ID) value from one of the following:
the DLIM GCN_SEQNO to Drug Group Table (RDLIMGC1_GCNSEQNO_DRUG_GROUP) where
the Clinical Formulation ID (GCN_SEQNO) column equals the Clinical Formulation ID (
GCN_SEQNO) value of the drug product.
the DLIM Routed Medication Identifier to Drug Group Table
(RDLIMRM0_ROUTED_MED_DRUG_GROUP) where the Routed Generic Identifer (
ROUTED_GEN_ID) column equals the ROUTED_GEN_ID value of the drug product.

the DLIM Routed Generic Table (RDLIMRG0_ROUTED_GEN_LINK) where the Routed Generic
Identifer (ROUTED_GEN_ID) column equals the ROUTED_GEN_ID value of the drug product.

In this example, cefoxitin Inj is represented by the Routed Medication Identifier ( ROUTED_MED_ID).
Therefore, the DLIM_DRUG_GRP_ID is selected from the DLIM Routed Medication Identifier to Drug
Group Table (RDLIMRM0_ROUTED_MED_DRUG_GROUP).

ROUTED_MED_ID DLIM_DRUG_GRP_ID

00005894 02019

A Clinical Formulation ID (GCN_SEQNO), ROUTED_MED_ID, or ROUTED_GEN_ID may be

associated to more than one DLIM_DRUG_GRP_ID.

2. Select the DLIM Drug Group Description (DLIM_DRUG_GRP_ID_DESC) values from the DLIM Drug

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2.

Group Identifier Table (RDLIMDI0_DRUG_GRP_ID) where the DLIM_DRUG_GRP_ID column equals the
DLIM_DRUG_GRP_ID values from the previous step.

DLIM_DRUG_GRP_ID DLIM_DRUG_GRP_ID_DESC

02019 Cefoxitin

Part 3: Retrieve all laboratory tests associated with the Drug Group Identifier.

1. Select the following column values from the DLIM Laboratory Interference Master Table
(RDLIMMA1_LAB_INTERFERENCE_MSTR) where the DLIM_DRUG_GRP_ID column equals the
DLIM_DRUG_GRP_ID values from Part 2.
DLIM Specific Laboratory Test Identifier (MTL_SPEC_LAB_ID)
DLIM Interference Type Code (DLIM_INTER_TYP_CODE)
DLIM Documentation Level Code (DLIM_DOC_LEVEL_CODE)

DLIM_DRUG_GRP_ID MTL_SPEC_LAB_ID DLIM_INTER_TYP_COD DLIM_DOC_LEVEL_CO

E DE

02019 00000034 01 01

02019 00001075 01 02

02019 00001080 01 03

There may be more than one MTL_SPEC_LAB_ID associated to a DLIM_DRUG_GRP_ID.

2. Select the MTL Specific Laboratory Test Identifier Description (MTL_SPEC_LAB_ID_DESC) values from
the MTL Specific Laboratory Test Identifier Table (RMTLSLT0_SPECIFIC_LAB_ID) where the
MTL_SPEC_LAB_ID column equals the MTL_SPEC_LAB_ID values from the previous step.

DLIM_DRUG_GRP_ID MTL_SPEC_LAB_ID MTL_SPEC_LAB_ID_DESC

02019 00000034 Serum Creatinine, Alkaline Picrate

(Jaffe Reaction)

02019 00001075 Serum Tobramycin, Cloned Enzyme

Donor Immunoassay (CEDIA)

02019 00001080 Serum Theophylline, Cloned

Enzyme Donor Immunoassay
(CEDIA)

Part 4: Retrieve associated drug-lab interference information.

1. Select the DLIM Interference Type Code Description (DLIM_INTER_TYP_CODE_DESC) values from the

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1.

DLIM Interference Type Code Description Table (RDLIMID0_INTERFERENCE_TYP_DESC) where the

DLIM_INTER_TYP_CODE column equals the DLIM_INTER_TYP_CODE values from Part 3.

DLIM_INTER_TYP_CODE DLIM_INTER_TYP_CODE_DESC

01 Falsely increases

2. Select the DLIM Documentation Level Code Description (DLIM_DOC_LEVEL_CODE_DESC) values from
the DLIM Documentation Level Code Description Table (RDLIMDD0_DOC_LEVEL_DESC) where the
DLIM_DOC_LEVEL_CODE column equals the DLIM_DOC_LEVEL_CODE values from Part 3.

DLIM_DOC_LEVEL_CODE DLIM_DOC_LEVEL_CODE_DESC

01 Established

02 Probable

03 Possible

Data can be filtered by documentation level using the DLIM_DOC_LEVEL_CODE.

Part 5: Retrieve monograph information.

1. Select the DLIM Monograph Identifier (DLIM_MONOGRAPH_ID) values from the DLIM Laboratory
Interference Master Table (RDLIMMA1_LAB_INTERFERENCE_MSTR) where the DLIM_DRUG_GRP_ID
and the MTL_SPEC_LAB_ID columns equal the DLIM_DRUG_GRP_ID and the MTL_SPEC_LAB_ID
values from Part 2 and Part 3.

DLIM_DRUG_GRP_ID MTL_SPEC_LAB_ID DLIM_MONOGRAPH_ID

02019 00000034 00001456

02019 00001075 00001665

02019 00001080 00001709

2. Retrieve, construct, and display the monograph information. See the DLIM Displaying Drug-Lab
Interference Monograph Information application for an illustration on how to construct and display DLIM
monograph information.
In summary, the drug cefoxitin Inj was found to have interferences with multiple laboratory tests.

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Screening a Laboratory Test for Possible Drug Interferences

DLIM can be used to identify possible drugs that may erroneously affect laboratory test results.

Part 1: Retrieve the MTL Specific Laboratory Test Identifier for the laboratory test.

1. Select the MTL Laboratory Test Identifier (LAB_ID) value from the MTL Laboratory Test Identifier Table
(RMTLLAB0_LAB_ID) where the MTL Laboratory Test Identifier Description ( MTL_LAB_ID_DESC)
column equals the laboratory test of interest, and the MTL Laboratory Test Identifier Status Code (
MTL_LAB_ID_STATUS) column equals a value of 0 (Live).

2. Select the MTL Specific Laboratory Test Identifier (MTL_SPEC_LAB_ID) and the MTL Specific Laboratory
Test Identifier Description (MTL_SPEC_LAB_ID_DESC) values from the MTL Specific Laboratory Test
Identifier Table (RMTLSLT0_SPECIFIC_LAB_ID) where the LAB_ID column equals the LAB_ID value from
the previous step.

Part 2: Identify the drugs associated with the MTL Specific Laboratory Test Identifier.

1. Select the following column values from the DLIM Laboratory Interference Master Table
(RDLIMMA1_LAB_INTERFERENCE_MSTR) where the MTL_SPEC_LAB_ID column equals the
MTL_SPEC_LAB_ID values from Part 1.
DLIM Drug Group Identifier (DLIM_DRUG_ID)
DLIM Interference Type Code (DLIM_INTER_TYP_CODE)
DLIM Documentation Level Code (DLIM_DOC_LEVEL_CODE)

2. Select the DLIM Drug Group Description (DLIM_DRUG_GRP_ID_DESC) values from the DLIM Drug
Group Identifier Table (RDLIMDI0_DRUG_GRP_ID) where the DLIM_DRUG_GRP_ID column equals the
DLIM_DRUG_GRP_ID values from the previous step.

Part 3: Retrieve associated drug-lab interference records.

1. Select the DLIM Interference Type Code Description (DLIM_INTER_TYP_CODE_DESC) values from the
DLIM Interference Type Code Description Table (RDLIMID0_INTERFERENCE_TYP_DESC) where the
DLIM_INTER_TYP_CODE column equals the DLIM_INTER_TYP_CODE values found in Part 2.

2. Select the DLIM Documentation Level Code Description (DLIM_DOC_LEVEL_CODE_DESC) values from
the DLIM Documentation Level Code Description Table (RDLIMDD0_DOC_LEVEL_DESC) where the
DLIM_DOC_LEVEL_CODE column equals the DLIM_DOC_LEVEL_CODE values found in Part 2.

Part 4: Retrieve monograph information.

1. Select the DLIM Monograph Identifier (DLIM_MONOGRAPH_ID) values from the

RDLIMMA1_LAB_INTERFERENCE_MSTR table where the DLIM_DRUG_GRP_ID and the
MTL_SPEC_LAB_ID columns equal the DLIM_DRUG_GRP_ID and the MTL_SPEC_LAB_ID values from
Part 1 and Part 2.

2. Retrieve, construct, and display the monograph information. See the Displaying Drug-Lab Interference
Monograph Information application for an illustration on how to construct and display DLIM monograph
information.

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ExampleScreening a Laboratory Test for Possible Drug Interferences

A physician identifies possible drug interferences associated with a Serum Digoxin laboratory test. Show the
interferences monograph in an abbreviated format that only includes the "Brief Overview" and "Potential
Significant Impact on Patient Care" statements.

Part 1: Retrieve the MTL Specific Laboratory Test Identifier for the laboratory test.

1. Select the MTL Laboratory Test Identifier (LAB_ID, page 1780) value from the MTL Laboratory Test
Identifier Table (RMTLLAB0_LAB_ID) where the MTL Laboratory Test Identifier Description (
MTL_LAB_ID_DESC) column equals the laboratory test of interest, and the MTL Laboratory Test Identifier
Status Code (MTL_LAB_ID_STATUS) column equals a value of 0 (Live).

MTL_LAB_ID_DESC MTL_LAB_ID_STATUS LAB_ID

Serum Digoxin 0 00000117

2. Select the MTL Specific Laboratory Test Identifier (MTL_SPEC_LAB_ID) and the MTL Specific Laboratory
Test Identifier Description (MTL_SPEC_LAB_ID_DESC) values from the MTL Specific Laboratory Test
Identifier Table (RMTLSLT0_SPECIFIC_LAB_ID) where the LAB_ID column equals the LAB_ID value from
the previous step.
The example below displays partial results.

LAB_ID MTL_SPEC_LAB_ID MTL_SPEC_LAB_ID_DESC

00000117 00000126 Serum Digoxin, Radioimmunoassay

00000117 00000448 Serum Digoxin, Enzyme-Multiplied

Immunoassay Technique (EMIT)

00000117 00000449 Serum Digoxin, Fluorescence

Polarization Immunoassay

Part 2: Identify the drugs associated with the MTL Specific Laboratory Test
Identifier.
1. Select the following column values from the DLIM Laboratory Interference Master Table
(RDLIMMA1_LAB_INTERFERENCE_MSTR) where the MTL_SPEC_LAB_ID column equals the
MTL_SPEC_LAB_ID values from Part 1.
DLIM Drug Group Identifier (DLIM_DRUG_ID)
DLIM Interference Type Code (DLIM_INTER_TYP_CODE)
DLIM Documentation Level Code (DLIM_DOC_LEVEL_CODE)

The example below displays partial results.

MTL_SPEC_LAB_ID DLIM_DRUG_GRP_ID DLIM_INTER_TYP_COD DLIM_DOC_LEVEL_CO

ED DE

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00000449 00048 01 02

00000449 00348 01 02

00000449 02021 01 02

00000449 02024 01 02

2. Select the DLIM Drug Group ID Description (DLIM_DRUG_GRP_ID_DESC) values from the DLIM Drug
Group Identifier Table (RDLIMDI0_DRUG_GRP_ID) where the DLIM_DRUG_GRP_ID column equals the
DLIM_DRUG_GRP_ID values from the previous step.

MTL_SPEC_LAB_ID DLIM_DRUG_GRP_ID DLIM_DRUG_GRP_ID_DESC

00000449 00048 Spironolactone

00000449 00348 Digoxin Immune Fab

00000449 02021 Siberian Ginseng

00000449 02024 Asian Ginseng

An MTL_SPEC_LAB_ID may be associated to more than one DLIM_DRUG_GRP_ID.

Part 3: Retrieve associated drug-lab interference records.

1. Select the DLIM Interference Type Code Description (DLIM_INTER_TYP_CODE_DESC) values from the
DLIM Interference Type Code Description Table (RDLIMID0_INTERFERENCE_TYP_DESC) where the
DLIM_INTER_TYP_CODE column equals the DLIM_INTER_TYP_CODE values found in Part 2.

DLIM_INTER_TYP_CODE DLIM_INTER_TYP_CODE_DESC

01 Falsely Increases

2. Select the DLIM Documentation Level Code Description (DLIM_DOC_LEVEL_CODE_DESC) values from
the DLIM Documentation Level Code Description Table (RDLIMDD0_DOC_LEVEL_DESC) where the
DLIM_DOC_LEVEL_CODE column equals the DLIM_DOC_LEVEL_CODE values found in Part 2.

DLIM_DOC_LEVEL_CODE DLIM_DOC_LEVEL_CODE_DESC

01 Established

02 Probable

Part 4: Retrieve monograph information.

1. Select the DLIM Monograph Identifier (DLIM_MONOGRAPH_ID) values from the DLIM Laboratory
Interference Master Table (RDLIMMA1_LAB_INTERFERENCE_MSTR) where the DLIM_DRUG_GRP_ID
and the MTL_SPEC_LAB_ID columns equal the DLIM_DRUG_GRP_ID and the MTL_SPEC_LAB_ID
values from Part 1 and Part 2.

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MTL_SPEC_LAB_ID DLIM_DRUG_GRP_ID DLIM_MONOGRAPH_ID

00000449 00048 00000808

00000449 00348 00001611

00000449 02021 00001458

00000449 02024 00001466

2. Retrieve, construct, and display the monograph information. See the DLIM Displaying Drug-Lab
Interference Monograph Information application for an illustration on how to construct and display DLIM
monograph information.
In this example, the interferences monograph is shown in an abbreviated format that only includes the
"Brief Overview" and "Potential Significant Impact on Patient Care" statements. See the "Displaying
Monograph Sections" example in Displaying Drug-Lab Interference Monograph Information for an
illustration of displaying specific monograph statements.
In summary, a Serum Digoxin lab test performed using the Fluorescence Polarization Immunoassay
method has been reviewed by a FDB clinical editor and was found to have interferences with multiple
drugs.

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DLIM Displaying an Alternative Laboratory Test Method When an Interference Is Found

This application illustrates how to display an alternative laboratory test method when an interference is found.
However MTL may not include every known method for a given laboratory test.

1. Select the MTL Laboratory Test Identifier (LAB_ID) value from the MTL Specific Laboratory Test Identifier
Table (RMTLSLT0_SPECIFIC_LAB_ID) where the MTL Specific Laboratory Test Identifier (
MTL_SPEC_LAB_ID) column equals the MTL_SPEC_LAB_ID value of the laboratory test.

2. Select the following column values from the RMTLSLT0_SPECIFIC_LAB_ID table where the LAB_ID
column equals the LAB_ID value from the previous step.
MTL Specific Laboratory Test Identifier (MTL_SPEC_LAB_ID)
MTL Methodology Identifier (MTL_METHOD_ID)
MTL Specific Laboratory Test Identifier Status Code (MTL_SPEC_LAB_ID_STATUS)

3. Select the following column values from the DLIM Laboratory Interference Master Table
(RDLIMMA1_LAB_INTERFERENCE_MSTR) where the DLIM_DRUG_GRP_ID column equals the
DLIM_DRUG_GRP_ID values of the drug.
MTL Specific Laboratory Test Identifier (MTL_SPEC_LAB_ID)
DLIM Interference Type Code (DLIM_INTER_TYP_CODE)
DLIM Documentation Level Code (DLIM_DOC_LEVEL_CODE)
DLIM Monograph Identifier (DLIM_MONOGRAPH_ID)

This step identifies other laboratory test methods that are a problem with a given drug or a set of
drugs. These have to be removed from the final "alternate test" list.

4. Filter the results from step 2 by removing any records associated to the MTL_SPEC_LAB_ID values
retrieved in step 3.

5. Select the MTL Methodology Identifier Description (MTL_METHOD_ID_DESC) values from the MTL
Methodology Identifier Table (RMTLMID0_METHODOLOGY_ID) where the MTL_METHOD_ID column
equals the MTL_METHOD_ID values from step 4.

6. Display the information to the end-user using the descriptions retrieved in the steps above.

ExampleDisplaying an Alternative Laboratory Test Method When an Interference Is Found

A physician identifies that trimethoprim (DLIM_DRUG_GRP_ID 00468) falsely increases serum methotrexate
levels when the Competitive Binding Protein Assay (CBPA Method) ( MTL_METHOD_ID 00049) is used (
MTL_SPEC_LAB_ID 00000152) and needs to locate an alternative laboratory test method.

1. Select the MTL Laboratory Test Identifier (LAB_ID) value from the MTL Specific Laboratory Test Identifier
Table (RMTLSLT0_SPECIFIC_LAB_ID) where the MTL Specific Laboratory Test Identifier (
MTL_SPEC_LAB_ID) column equals the MTL_SPEC_LAB_ID value of the laboratory test.

MTL_SPEC_LAB_ID LAB_ID

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00000152 00000142

2. Select the following column values from the RMTLSLT0_SPECIFIC_LAB_ID table where the LAB_ID
column equals the LAB_ID value from the previous step.
MTL Specific Laboratory Test Identifier (MTL_SPEC_LAB_ID)
MTL Specific Laboratory Test Identifier Status Code Description (MTL_SPEC_LAB_ID_DESC)
MTL Methodology Identifier (MTL_METHOD_ID)

LAB_ID MTL_SPEC_LAB_ID MTL_SPEC_LAB_ID_DE MTL_METHOD_ID

SC

00000142 00000152 Serum Methotrexate, 00049

Competitive Binding
Protein Assay (CBPA
Method)

00000142 00000356 Serum Methotrexate, High 00027

Performance Liquid
Chromatography

00000142 00000357 Serum Methotrexate, 00016

Radioimmunoassay

00000142 00000973 Serum Methotrexate, 00118

Fluorescence Polarization
Immunoassay

00000142 00000974 Serum Methotrexate, 00031

Enzyme-Multiplied
Immunoassay Technique

00000142 00000975 Serum Methotrexate, 00164

Enzyme Inhibition

00000142 00000976 Serum Methotrexate, 00317

Homogeneous Enzyme
Immunoassay

Should the list be filtered by status using the MTL Specific Laboratory Test Identifier Status Code (
MTL_SPEC_LAB_ID_STATUS)? Would a physician want to see both active and retired tests? Within this
example, if the retired tests are removed then MTL_SPEC_LAB_ID 152 is removed here and not in step 4
below.

3. Select the following column values from the DLIM Laboratory Interference Master Table
(RDLIMMA1_LAB_INTERFERENCE_MSTR) where the DLIM_DRUG_GRP_ID column equals the
DLIM_DRUG_GRP_ID values of the drug.
MTL Specific Laboratory Test Identifier (MTL_SPEC_LAB_ID)
DLIM Interference Type Code (DLIM_INTER_TYP_CODE)
DLIM Documentation Level Code (DLIM_DOC_LEVEL_CODE)
DLIM Monograph Identifier (DLIM_MONOGRAPH_ID)

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DLIM_DRUG_GRP MTL_SPEC_LAB_I DLIM_INTER_TYP_ DLIM_DOC_LEVEL DLIM_MONOGRAP

_ID D CODE _CODE H_ID

00468 00000034 03 03 00000342

00468 00000152 01 01 00000343

00468 00000933 02 03 00001716

As indicated in the scenario above, DLIM_DRUG_GRP_ID value of 00468 is used. This step identifies
other serum methotrexate assay methods that are a problem with trimethoprim and that have to removed
from the final alternate test list.

4. Filter the results from step 2 by removing any records associated to the MTL_SPEC_LAB_ID values
retrieved in step 3.
The table below shows all of the results from step 2.

MTL_SPEC_LAB_ID LAB_ID MTL_SPEC_LAB_ID_DE MTL_METHOD_ID

SC

00000152 00000142 Serum Methotrexate, 00049

Competitive Binding
Protein Assay (CBPA
Method)

00000356 00000142 Serum Methotrexate, High 00027

Performance Liquid
Chromatography

00000357 00000142 Serum Methotrexate, 00016

Radioimmunoassay

00000973 00000142 Serum Methotrexate, 00118

Fluorescence Polarization
Immunoassay

00000974 00000142 Serum Methotrexate, 00031

Enzyme-Multiplied
Immunoassay Technique

00000975 00000142 Serum Methotrexate, 00164

Enzyme Inhibition

00000976 00000142 Serum Methotrexate, 00317

Homogeneous Enzyme
Immunoassay

In this example, the first record (highlighted above) would be filtered from the list because it is associated
to the MTL_SPEC_LAB_ID value of 00000152 retrieved in step 2.

5. Select the MTL Methodology Identifier Description (MTL_METHOD_ID_DESC) values from the MTL
Methodology Identifier Table (RMTLMID0_METHODOLOGY_ID) where the MTL_METHOD_ID column
equals the MTL_METHOD_ID values from the previous step.

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MTL_SPEC_LAB_ID MTL_METHOD_ID MTL_METHOD_ID_DESC

00000356 00027 High Performance Liquid

Chromatography

00000357 00016 Radioimmunoassay

00000973 00118 Fluorescence Polarization

Immunoassay

00000974 00031 Enzyme-Multiplied Immunoassay

Technique (EMIT)

00000975 00164 Enzyme Inhibition

00000976 00317 Homogeneous Enzyme

Immunoassay

6. Display the information to the end-user using the descriptions retrieved in the steps above. For example:

False increases may occur with Serum Methotrexate, Competitive Binding Protein Assay (CBPA Method);
however, the following methods for determining Serum Methotrexate are not found to have the same interference:
High Performance Liquid Chromatography; Radioimmunoassay; Fluorescence Polarization Immunoassay;
Enzyme-Multiplied Immunoassay Technique (EMIT); Enzyme Inhibition; Homogeneous Enzyme Immunoassay.

Laboratory test methodologies can be filtered from MTL and DLIM application results if a
laboratory facility does not use them.

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DLIM Monograph Information

This application illustrates how to construct and display DLIM monograph information for end-user drug-lab
interference messages.

ExampleDisplaying the Full DLIM Monograph Text

ExampleDisplaying Monograph Sections

Part 1: Retrieve Monograph Title, Section Headers, and Text

1. Select the DLIM Monograph Title (DLIM_MONOGRAPH_TITLE) values from the DLIM Monograph
Identifier Table (RDLIMMI0_MONO_ID) where the DLIM Monograph Identifier (DLIM_MONOGRAPH_ID)
column equals the DLIM_MONOGRAPH_ID values of the drug-lab interference monograph.

2. Select the following column values from the DLIM Monograph Table (RDLIMMO1_MONO) where the
DLIM_MONOGRAPH_ID column equals the DLIM_MONOGRAPH_ID values from step 1.
DLIM Text Sequence Number (DLIM_TEXT_SEQNO)
DLIM Text Type Code (DLIM_TXT_TYP_CODE)
DLIM Text (DLIM_TEXT)
You can choose to include or exclude monograph sections by listing or excluding values from the
DLIM_TXT_TYP_CODE column. Only the Brief Overview section (DLIM_TXT_TYP_CODE value of 01) is
available within every monograph. All other sections are optional and may not be available.

3. Select the DLIM Text Type Code Description (DLIM_TXT_TYP_CODE_DESC) values from the DLIM
Monograph Text Type Description Table (RDLIMTD0_MONO_TXT_TYP_DESC) where the
DLIM_TXT_TYP_CODE column equals the DLIM_TXT_TYP_CODE values from the previous step.

Part 2: Construct and Display the Monograph

1. Begin the monograph with the monograph title from step 1 in Part 1.

2. For each available section, use the DLIM_TXT_TYP_CODE_DESC values from step 3 as the section
header.

3. Concatenate the section text for each section in the sequence determined by the DLIM_TEXT_SEQNO
values from step 2.
While concatenating the text, the following must be taken into consideration:
Trim all trailing space from the end of each DLIM_TEXT record and insert one space before
concatenating two DLIM_TEXT values.
When constructing the reference text, please note that five spaces are placed at the start of each
new citation. For readability each new citation should begin with a new paragraph. Single citations
split over multiple DLIM_TEXT records should be formatted as noted in the bullet above.

4. Display the monograph details to the end-user.

ExampleDisplaying the Full DLIM Monograph Text

A physician identifies possible drug interferences associated with a laboratory test and wishes to see monograph

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text for the laboratory results that may be erroneously affected by a given drug. In this example, the monograph
for the drug-lab interaction between the drug group cefoxitin Inj and the Serum Creatinine, Alkaline Picrate (Jaffe
Reaction) laboratory test (DLIM_MONOGRAPH_ID 00001456) is retrieved for display.

Part 1: Retrieve Monograph Title, Section Headers, and Text

1. Select the DLIM Monograph Title (DLIM_MONOGRAPH_TITLE) values from the DLIM Monograph
Identifier Table (RDLIMMI0_MONO_ID) where the DLIM Monograph Identifier (DLIM_MONOGRAPH_ID)
column equals the DLIM_MONOGRAPH_ID values of the drug-lab interference monograph.

DLIM_MONOGRAPH_ID DLIM_MONOGRAPH_TITLE

00001456 Cefoxitin - Serum Creatinine, Alkaline Picrate (Jaffe

Reaction)

2. Select the following column values from the DLIM Monograph Table (RDLIMMO1_MONO) where the
DLIM_MONOGRAPH_ID column equals the DLIM_MONOGRAPH_ID values from step 1.
DLIM Text Sequence Number (DLIM_TEXT_SEQNO)
DLIM Text Type Code (DLIM_TXT_TYP_CODE)
DLIM Text (DLIM_TEXT)

You can choose to include or exclude monograph sections by listing or excluding values from the
DLIM_TXT_TYP_CODE column. Only the Brief Overview section (DLIM_TXT_TYP_CODE value of 01) is
available within every monograph. All other sections are optional and may not be available.
Please note that the table below only contains a sample of the available references for this monograph,
therefore some DLIM_TEXT_SEQNO numbers are not illustrated.

DLIM_MONOGRAPH_ID DLIM_TEXT_SEQNO DLIM_TXT_TYP_CODE DLIM_TEXT

00001456 1 01 Cefoxitin Falsely Increases

Serum Creatinine, Alkaline
Picrate (Jaffe Reaction).
Evidence: Established

00001456 2 10 This interference appears

to be
concentration-dependent
and also dependent
somewhat on the different
assay systems or
autoanalyzers utilizing the
Jaffe reaction method.

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00001456 3 20 Higher serum cefoxitin

drug concentrations
(50-100 mcg/ml) are
reported to cause a more
significant interference.
Therefore, blood samples
from patients should not
be sent for creatinine
analysis if drawn within 2
hours of cefoxitin
administration (at the

00001456 4 20 peak) and preferably

drawn at the trough.
Erroneous creatinine
values may lead to
inappropriate clinical
decisions, such as
alteration in therapy that
may adversely affect
outcomes.

00001456 5 91 Mefoxin Package Insert;

Merck and Co., Inc. May
2002

00001456 6 93 Allen LC, Michalko K,

Coons C. More on
cephalosporin interference
with creatinine
determinations. Clin
Chem. 1982
Mar;28(3):555-6. [Pub Med
URL: http://www.ncbi.nlm.
nih.gov/entrez/query.fcgi?c
md=Retrieve&db=PubMed
&list_uids=7067111&dopt=
Abstract]

00001456 7 93 Durham SR, Bignell AH,

Wise R. Interference of
cefoxitin in the creatinine
estimation and its clinical
relevance. J Clin Pathol.
1979 Nov;32(11):1148-51.
[Pub Med URL:

00001456 8 93 http://www.ncbi.nlm.nih.go
v/entrez/query.fcgi?cmd=R
etrieve&db=PubMed&list_
uids=512029&dopt=Abstra
ct]

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00001456 12 95 Green AJ, Halloran SP,

Mould GP, Barbour HM,
Pritchard JL, Hallworth MJ,
Labib M. Interference by
newer cephalosporins in
current methods for
measuring creatinine. Clin
Chem. 1990
Dec;36(12):2139-40. [Pub
Med URL:

00001456 13 95 http://www.ncbi.nlm.nih.go
v/entrez/query.fcgi?cmd=R
etrieve&db=PubMed&list_
uids=2253366&dopt=Abstr
act]

00001456 36 96 Spencer K. Analytical

reviews in clinical
biochemistry: the
estimation of creatinine.
Ann Clin Biochem. 1986
Jan;23 ( Pt 1):1-25. [Pub
Med URL: http://www.ncbi.
nlm.nih.gov/entrez/query.fc
gi?cmd=Retrieve&db=Pub
Med&list_uids=3532908&d
opt=Abstract]

3. Select the DLIM Text Type Code Description (DLIM_TXT_TYP_CODE_DESC) values from the DLIM
Monograph Text Type Description Table (RDLIMTD0_MONO_TXT_TYP_DESC) where the
DLIM_TXT_TYP_CODE column equals the DLIM_TXT_TYP_CODE values from the previous step.

DLIM_TXT_TYP_CODE DLIM_TXT_TYP_CODE_DESC

01 Brief Overview

10 Discussion

20 Potential Significant Impact on Patient Care

91 References (Manufacturers Information)

93 References (Case Report)

95 References (In vitro/Animal Study)

96 References (Review Article)

Part 2: Construct and Display the Monograph

1. Begin the monograph with the monograph title from step 1 in Part 1.

2. For each available section, use the DLIM_TXT_TYP_CODE_DESC values from the step as the section
header.

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3. Concatenate the section text for each section in the sequence determined by the DLIM_TEXT_SEQNO
values from step 2.
While concatenating the text, the following must be taken into consideration:
Trim all trailing space from the end of each DLIM_TEXT record and insert one space before
concatenating two DLIM_TEXT values.
When constructing the reference text, please note that five spaces are placed at the start of each
new citation. For readability each new citation should begin with a new paragraph. Single citations
split over multiple DLIM_TEXT records should be formatted as noted in the bullet above.

In this example, the References (Case Report) section (DLIM_TXT_TYP_CODE value of 93) includes the
following two DLIM_TEXT references.

DLIM_MONOGRAPH_ID DLIM_TEXT_SEQNO DLIM_TXT_TYP_CODE DLIM_TEXT

00001456 6 93 Allen LC, Michalko K,

Coons C. More on
cephalosporin interference
with creatinine
determinations. Clin
Chem. 1982
Mar;28(3):555-6. [Pub Med
URL: http://www.ncbi.nlm.
nih.gov/entrez/query.fcgi?c
md=Retrieve&db=PubMed
&list_uids=7067111&dopt=
Abstract]

00001456 7 93 Durham SR, Bignell AH,

Wise R. Interference of
cefoxitin in the creatinine
estimation and its clinical
relevance. J Clin Pathol.
1979 Nov;32(11):1148-51.
[Pub Med URL:

00001456 8 93 http://www.ncbi.nlm.nih.go
v/entrez/query.fcgi?cmd=R
etrieve&db=PubMed&list_
uids=512029&dopt=Abstra
ct]

Note that the first DLIM_TEXT value for this section does not contain an ending character; however, the
second DLIM_TEXT reference value has five leading spaces. Therefore, the second DLIM_TEXT value is
a new citation and should be joined as a new paragraph.

Note that the second DLIM_TEXT value does not contain an ending character and the third value does not
contain leading spaces. Trim all trailing space and insert a single space before joining the two values. See
the following step for an example of how the text should appear in the Reference (Case Report) section of
the monograph.

4. Display the monograph details to the end-user.

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4.

Cefoxitin - Serum Creatinine, Alkaline Picrate (Jaffe Reaction)

Brief Overview
Cefoxitin Falsely Increases Serum Creatinine, Alkaline Picrate (Jaffe Reaction). Evidence: Established
Discussion
This interference appears to be concentration-dependent and also dependent somewhat on the different assay
systems or autoanalyzers utilizing the Jaffe reaction method.
Potential Significant Impact on Patient Care
Higher serum cefoxitin drug concentrations (50-100 mcg/ml) are reported to cause a more significant interference.
Therefore, blood samples from patients should not be sent for creatinine analysis if drawn within 2 hours of
cefoxitin administration (at the peak) and preferably drawn at the trough. Erroneous creatinine values may lead to
inappropriate clinical decisions, such as alteration in therapy that may adversely affect outcomes.
References (Manufacturers Information)
Mefoxin Package Insert; Merck and Co., Inc. May 2002
References (Case Report)
Allen LC, Michalko K, Coons C. More on cephalosporin interference with creatinine determinations. Clin Chem.
1982 Mar;28(3):555-6. [Pub Med URL: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&l
ist_uids=
7067111&dopt=Abstract]
Durham SR, Bignell AH, Wise R. Interference of cefoxitin in the creatinine estimation and its clinical relevance. J
Clin Pathol. 1979 Nov;32(11):1148-51. [Pub Med URL: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retriev
e&db=PubMed&list_uids=512029&dopt=Abstract]
References (In vitro/Animal Study)
Green AJ, Halloran SP, Mould GP, Barbour HM, Pritchard JL, Hallworth MJ, Labib M. Interference by newer
cephalosporins in current methods for measuring creatinine. Clin Chem. 1990 Dec;36(12):2139-40. [Pub Med
URL: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=
PubMed&list_uids=2253366&dopt=Abstract]
References (Review Article)
Spencer K. Analytical reviews in clinical biochemistry: the estimation of creatinine. Ann Clin Biochem. 1986 Jan;23(
Pt 1):1-25. [Pub Med URL: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=35
32908&dopt=Abstract]

ExampleDisplaying Monograph Sections

A physician identifies possible drug interferences associated with a laboratory test and wishes to see monograph
text in an abbreviated format that only includes the Brief Overview and Potential Significant Impact on Patient
Care statements, if available. In this example, the monograph (DLIM_MONOGRAPH_ID 00001611) for the
drug-lab interaction between the drug group Digitoxin Immune Fab and the Serum Digoxin laboratory test is
retrieved for display.

Part 1: Retrieve Monograph Title, Section Headers, and Text

1. Select the DLIM Monograph Title (DLIM_MONOGRAPH_TITLE) values from the DLIM Monograph
Identifier Table (RDLIMMI0_MONO_ID) where the DLIM Monograph Identifier (DLIM_MONOGRAPH_ID)
column equals the DLIM_MONOGRAPH_ID value of the drug-lab interference monograph.

DLIM_MONOGRAPH_ID DLIM_MONOGRAPH_TITLE

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00001611 Digoxin Immune Fab - Serum Digoxin, Fluorescence

Polarization Immunoassay

2. Select the following column values from the DLIM Monograph Table (RDLIMMO1_MONO) where the
DLIM_MONOGRAPH_ID column equals the DLIM_MONOGRAPH_ID values from step 1.
DLIM Text Sequence Number (DLIM_TEXT_SEQNO)
DLIM Text Type Code (DLIM_TXT_TYP_CODE)
DLIM Text (DLIM_TEXT)

You can choose to include or exclude monograph sections by listing or excluding values from the
DLIM_TXT_TYP_CODE column. Only the Brief Overview section (DLIM_TXT_TYP_CODE value of 01) is
available within every monograph. All other sections are optional and may not be available.
In this example the monograph is filtered to only include the General Overview and the Potential Significant
Impact on Patient Care sections. The DLIM_TXT_TYP_CODE column value is equal to the values of 01
and 20.

DLIM_MONOGRAPH_ID DLIM_TXT_TYP_CODE DLIM_TEXT_SEQNO DLIM_TEXT

00001611 01 1 Digoxin Immune Fab

Falsely Increases Serum
Digoxin, Fluorescence
Polarization Immunoassay.
Evidence: Probable

00001611 20 3 A blood sample for serum

digoxin concentration
should be obtained before
administration of digoxin
immune Fab if possible.
Following digoxin antidote
administration, serum
digoxin levels may be
misleading and should not
be relied upon to guide
treatment.

00001611 20 4 If levels are required, one

author recommends
ultrafiltration followed by
measurement of free
digoxin levels.

3. Select the DLIM Text Type Code Description (DLIM_TXT_TYP_CODE_DESC) values from the DLIM
Monograph Text Type Description Table (RDLIMTD0_MONO_TXT_TYP_DESC) where the
DLIM_TXT_TYP_CODE column equals the DLIM_TXT_TYP_CODE values from the previous step.

DLIM_TXT_TYP_CODE DLIM_TXT_TYP_CODE_DESC

01 Brief Overview

20 Potential Significant Impact on Patient Care

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Part 2: Construct and Display the Monograph

1. Begin the monograph with the monograph title from step 1 in Part 1.

2. For each available section, use the DLIM_TXT_TYP_CODE_DESC values from step 3 in Part 1 as the
section header.

3. Concatenate the section text for each section in the sequence determined by the DLIM_TEXT_SEQNO
values from step 2 in Part 1.
While concatenating the text, the following must be taken into consideration:
Trim all trailing space from the end of each DLIM_TEXT record and insert one space before
concatenating two DLIM_TEXT values.
When constructing the reference text, please note that five spaces are placed at the start of each
new citation. For readability each new citation should begin with a new paragraph. Single citations
split over multiple DLIM_TEXT records should be formatted as noted in the bullet above.

In this example, the Potential Significant Impact on Patient Care section ( DLIM_TXT_TYP_CODE value of
20) includes the following two DLIM_TEXT statements.

DLIM_MONOGRAPH_ID DLIM_TXT_TYP_CODE DLIM_TEXT_SEQNO DLIM_TEXT

00001611 20 3 A blood sample for serum

digoxin concentration
should be obtained before
administration of digoxin
immune Fab if possible.
Following digoxin antidote
administration, serum
digoxin levels may be
misleading and should not
be relied upon to guide
treatment.

00001611 20 4 If levels are required, one

author recommends
ultrafiltration followed by
measurement of free
digoxin levels.

In this example, the second value should be joined by removing all trailing space at the end of the first text
value and adding a space to the start of the following text. See the following step for an example of how
the text should appear in the Potential Significant Impact on Patient Care section of the monograph.

4. Display the monograph details to the end-user.

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Digoxin Immune Fab - Serum Digoxin, Fluorescence Polarization Immunoassay

Brief Overview
Digoxin Immune Fab Falsely Increases Serum Digoxin, Fluorescence Polarization Immunoassay. Evidence:
Probable
Potential Significant Impact on Patient Care
A blood sample for serum digoxin concentration should be obtained before administration of digoxin immune Fab if
possible. Following digoxin antidote administration, serum digoxin levels may be misleading and should not be
relied upon to guide treatment. If levels are required, one author recommends ultrafiltration followed by
measurement of free digoxin levels.

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DLIM ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

DLIM Tables
DLIM ERD

DLIM Tables
DLIM Clinically Reviewed Status Table
DLIM Documentation Level Code Description Table
DLIM Drug Group Identifier Table
DLIM Drug Identifier Type Code Description Table
DLIM GCN_SEQNO to Drug Group Table
DLIM Interference Type Code Description Table
DLIM Laboratory Interference Master Table
DLIM Monograph Identifier Table
DLIM Monograph Table
DLIM Monograph Text Type Description Table
DLIM Routed Generic Table
DLIM Routed Medication Identifier to Drug Group Table
DLIM Status Code Description Table

DLIM ERD

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DLIM Clinically Reviewed Status Table

Table Name RDLIMCR0_CLIN_REVIEW_STATUS

Revision Activity add. 07-01-2003

Purpose Indicates whether a drug has been reviewed by First

Databank (FDB) clinicians for possible participation in a
drug-lab interference record.

Key Column Name Column Format Length Picture

Description

P DLIM_DRUG_ID DLIM Drug N 8 9(8)

Identifier

PF DLIM_DRUG_ID_ DLIM Drug AN 2 X(2)

TYP_CODE Identifier Type
Code

DLIM_STATUS_C DLIM Status Code AN 2 X(2)

ODE

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DLIM Documentation Level Code Description Table

Table Name RDLIMDD0_DOC_LEVEL_DESC

Revision Activity add. 07-01-2003

Purpose Relates the Documentation Level Code to its text

description.

Key Column Name Column Format Length Picture

Description

P DLIM_DOC_LEV DLIM AN 2 X(2)

EL_CODE Documentation
Level Code

DLIM_DOC_LEV DLIM AN 50 X(50)

EL_CODE_DESC Documentation
Level Code
Description

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DLIM Drug Group Identifier Table

Table Name RDLIMDI0_DRUG_GRP_ID

Revision Activity add. 07-01-2003

Purpose Represents a collection of drug concepts that are

associated to common drug-lab interference records.

Key Column Name Column Format Length Picture

Description

P DLIM_DRUG_GR DLIM Drug Group N 5 9(5)

P_ID Identifier

DLIM_DRUG_GR DLIM Drug Group AN 100 X(100)

P_ID_DESC Description

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DLIM Drug Identifier Type Code Description Table

Table Name RDLIMDR0_DRUG_ID_TYP_DESC

Revision Activity add. 07-01-2003

Purpose Relates the Drug Identifier Type Code to its text description.

Key Column Name Column Format Length Picture

Description

P DLIM_DRUG_ID_ DLIM Drug AN 2 X(2)

TYP_CODE Identifier Type
Code

DLIM_DRUG_ID_ DLIM Drug AN 100 X(100)

TYP_CODE_DES Identifier Type
C Code Description

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DLIM GCN_SEQNO to Drug Group Table

Table Name RDLIMGC1_GCNSQNO_DRUG_GROUP

Revision Activity add. 07-01-2003

Purpose Links the clinical formulation to a set of drugs associated

with a particular lab interference record.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF DLIM_DRUG_GR DLIM Drug Group N 5 9(5)

P_ID Identifier

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DLIM Interference Type Code Description Table

Table Name RDLIMID0_INTERFERENCE_TYP_DESC

Revision Activity add. 07-01-2003

Purpose Relates the Interference Type Code to its text description.

Key Column Name Column Format Length Picture

Description

P DLIM_INTER_TY DLIM Interference AN 2 9(2)

P_CODE Type Code

DLIM_INTER_TY DLIM Interference AN 50 9(50)

P_CODE_DESC Type Code
Description

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DLIM Laboratory Interference Master Table

Table Name RDLIMMA1_LAB_INTERFERENCE_MSTR

Revision Activity add. 07-01-2003

Purpose Associates a collection of drug concepts to a laboratory test

(with measurement method) and defines the nature of the
possible drug-lab interference.

Key Column Name Column Format Length Picture

Description

PF DLIM_DRUG_GR DLIM Drug Group N 5 9(5)

P_ID Identifier

PF MTL_SPEC_LAB MTL Specific N 8 9(2)

_ID Laboratory Test
Identifier (Stable
ID)

F DLIM_INTER_TY DLIM Interference AN 2 X(2)

P_CODE Type Code

F DLIM_DOC_LEV DLIM AN 2 X(2)

EL_CODE Documentation
Level Code

F DLIM_MONOGRA DLIM Monograph N 8 9(8)

PH_ID Identifier

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DLIM Monograph Identifier Table

Table Name RDLIMMI0_MONO_ID

Revision Activity add. 07-01-2003

Purpose Uniquely identifies a drug-lab interference monograph

record.

Key Column Name Column Format Length Picture

Description

P DLIM_MONOGRA DLIM Monograph N 8 9(8)

PH_ID Identifier

DLIM_MONOGRA DLIM Monograph AN 255 X(255)

PH_TITLE Title

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DLIM Monograph Table

Table Name RDLIMMO1_MONO

Revision Activity add. 07-01-2003

Purpose Provides additional information related to the drug-lab

interference record.

Key Column Name Column Format Length Picture

Description

PF DLIM_MONOGRA DLIM Monograph N 8 9(8)

PH_ID Identifier

P DLIM_TEXT_SEQ DLIM Text N 5 9(5)

NO Sequence
Number

F DLIM_TXT_TYP_ DLIM Text Type AN 2 X(2)

CODE Code

DLIM_TEXT DLIM Text AN 255 X(255)

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DLIM Monograph Text Type Description Table

Table Name RDLIMTD0_MONO_TEXT_TYP_DESC

Revision Activity add. 07-01-2003

Purpose Relates the Text Type Code to its text description.

Key Column Name Column Format Length Picture

Description

P DLIM_TXT_TYP_ DLIM Text Type AN 2 X(2)

CODE Code

DLIM_TXT_TYP_ DLIM Text Type AN 50 X(50)

CODE_DESC Code Description

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DLIM Routed Generic Table

Table Name RDLIMRG0_ROUTED_GEN_LINK

Revision Activity original

Purpose Links a routed generic to a set of drugs associated with a

particular lab interference record.

Key Column Name Column Format Length Picture

Description

PF ROUTED_GEN_I Routed Generic N 8 9(8)

D Identifier

PF DLIM_DRUG_GR Drug-Lab N 5 9(5)

P_ID Interference
Module Drug
Group Identifier

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DLIM Routed Medication Identifier to Drug Group Table

Table Name RDLIMRM0_ROUTED_MED_DRUG_GROUP

Revision Activity add. 07-01-2003

Purpose Links a routed medication to a set of drugs associated with

a particular lab interference record.

Key Column Name Column Format Length Picture

Description

PF ROUTED_MED_I MED Routed N 8 9(8)

D Medication ID
(Stable ID)

PF DLIM_DRUG_GR DLIM Drug Group N 5 9(5)

P_ID Identifier

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DLIM Status Code Description Table

Table Name RDLIMSD0_STATUS_DESC

Revision Activity add. 07-01-2003

Purpose Relates the Status Code to its text description.

Key Column Name Column Format Length Picture

Description

P DLIM_STATUS_C DLIM Status Code AN 2 X(2)

ODE

DLIM_STATUS_C DLIM Status Code AN 100 X(100)

ODE_DESC Description

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Duplicate Therapy Module (DPT) 1.0

Duplicate Therapy Module Editorial Policies
Applications
ERD and Technical Specifications

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Duplicate Therapy Module Editorial Policies

The policies and criteria that apply to the inclusion criteria, processes, and references used in creation of the
Duplicate Therapy Module are provided in the following sections:

Overview
Inclusion Criteria
Data Elements
Rule Sets
Maintenance
References

Overview
Detecting and preventing duplicate therapy improves patient safety and reduces the risk of additive clinical effects
by calling the duplications to the attention of healthcare personnel. Additionally, eliminating redundant therapies
can reduce the cost of medication therapy.

The Duplicate Therapy Module offers point-of-care screening to identify potential duplications of drug therapy by
comparing new drug orders to drugs that already exist in a patient drug profile. This is achieved using duplicate
therapy class checking.

Duplicate therapy class checking uses specialized therapeutic drug classes developed specifically for duplicate
therapy detection. The module identifies the drug groups involved and provides a duplicate therapy class name
relative to the duplication.

Drug knowledge is aggregated at the Clinical Formulation ID (GCN_SEQNO), Routed Medication ID (

ROUTED_MED_ID), and the Routed Generic ID (ROUTED_GEN_ID) levels in the First Databank (FDB)
knowledge base. Under certain circumstances, aggregated drug knowledge may not apply to all related
packaged products; more specific information may be found within product labels.

Inclusion Criteria
This section provides information detailing the criteria that guided the inclusion of the data contained within the
module as well as information pertaining to limitations or exclusions when appropriate to the discussion.

Duplicate Therapy is defined as unintentional duplicate "use" indications, duplicative pharmacology, or duplicative
mechanisms of action that are not considered "adjunctive therapy." The Duplicate Therapy Module encompasses
drugs with NDAs, ANDAs, BLAs, OTC drugs which contain FDA listed OTC Ingredients, nutritional products that
contain significant amounts of iron, and limited herbal products (for example, St. John's Wort) that fall within the
above definition.

Data Elements
This section contains additional information about particularly important tables and codes contained within the
module, as well as concepts about the data that the reader must understand in order to understand the module.

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The customer file name for this component is DPT Class Table (RDPTCL0_CLASS_ID):

RDPTCL0_CLASS_ID

DPT_CLASS_ID DPT_CLASS_DESC DPT_ALLOWANCE

2 Angiotensin Converting Enzyme (ACE) 0

Inhibitors

Key Column Name Column Format Length Picture

Description

P DPT_CLASS_ID DPT Class N 8 9(8)

Identifier

DPT_CLASS_DE DPT Class AN 60 X(60)

S Description

DPT_ALLOWANC DPT Duplication N 2 9(2)

E Allowance

Column Name Column Description

DPT Class ID This is a stable system-generated numeric identifier

associated with the Duplicate Therapy Class.

DPT_Class_Desc Duplicate Therapy Class Description is intended to convey

the general intent of the DPT Class. For example:
HMGCo-A Reductase Inhibitors

Allowance Factor Indicates the number of drugs within a class that may be
present in a patient's profile without generating an alert. A
Duplicate Therapy Allowance Factor is assigned to each
DPT Class.

ExampleDPT_ALLOWANCE and associated columns

DPT_CLASS_ID DPT_CLASS_DESC DPT_ALLOWANCE

1058 Antihistamines 00

1059 Ophthalmic Antiglaucoma 02

483 HMGCo-A Reductase Inhibitors 00

1062 Antihyperlipidemics 01

1061 Antimalarial 01

1063 Antiplatelet Drugs 00

DPT screening can occur at the level of the Clinical Formulation (GCN_SEQNO); the Routed Medication ID; or at
the Routed Generic (a GCN_SEQNO based data element analogous to the Routed Med).

DPT GCN_SEQNO Table

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Table Name RDPTGC0_GCNSEQNO_LINK

Purpose Links a Clinical Formulation (GCN_SEQNO) to a Duplicate

Therapy Class(es)

Column Summary

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO MED Routed N 6 9(6)

Medication ID

PF DPT_CLASS_ID DPT Class N 8 9(8)

Identifier

DPT Routed Medication ID Table

Table Name RDPTRTM0_ROUTED_MED_LINK

Purpose Links a Routed Medication to its Duplicate Therapy

Class(es)

Column Summary

Key Column Column Format Length Picture

Description Description

PF ROUTED_MED_I MED Routed N 8 9(8)

D Medication ID

PF DPT_CLASS_ID DPT Class N 8 9(8)

Identifier

DPT Routed Generic Table

Table Name RDPTRG0_ROUTED_GEN_LINK

Purpose Links a Routed Generic to its Duplicate Therapy Class(es)

Column Summary

Key Column Name Column Format Length Picture

Description

PF ROUTED_GEN_I Routed Generic N 8 9(8)

D Identifier

PF DPT_CLASS_ID DPT Class N 8 9(8)

Identifier

The Routed Med and Routed Generic relationships are programmatically generated from the Clinical Formulation.

Rule Sets

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This section provides rules that the clinical team uses in regards to creating the module's data, both general rules
and rules specific to data elements.

Creation and Maintenance of Class Associations

Each new clinical formulation is assessed based on its indications, pharmacology, or mechanism of action for
inclusion in DPT. Once a DPT Class is published to customers it will not be deleted, but it may become obsolete.
Obsolete DPT Classes will not be linked to Clinical Formulations and are currently screened programmatically
from the Class Description file RDPTCL0.

Examples:

Class associations are based on the following:

a. Pharmacologically and structurally similar drugs, such as ACE Inhibitors as a DPT Class, as well as
structurally related drugs that share pharmacologic effects but are NOT similar therapeutic uses
(azathioprine and 6-mercaptopurine)

b. Drugs with related pharmacologic effects and similar therapeutic uses, such as H2 Antagonist and
Proton Pump Inhibitors share a single DPT class

c. Groups of drugs which share therapeutic uses but differ pharmacologically, such as a combination
of the antipseudomonal extended spectrum penicillin, Zosyn Piperacillin/Tazobactam), with an
antipseudomonal carbapenem

Example: Primaxin (Imipenem/Cilastatin) in the DPT class: 454 Extended Spectrum or

Antipseudomonal Antibiotics.
Primaxin also participates in other specific class groupings such as 452 Carbapenems (All) and in
the large structural group 96 Beta-Lactams.

Duplication Allowance Factors

For the majority of Duplicate Therapy Classes, the Allowance Factor is zero, indicating that an alert will be
triggered when two or more drugs in the same duplicate therapy class are present. The most common scenario
for Duplicate Therapy Checking is comparing a newly ordered drug to the patient's existing medication list. If a
new drug shares the same DPT class as a drug in the patient's medication list, and if the allowance factor is
"zero," then a "match" of two drugs will generate a Duplicate Therapy alert. A Duplication Allowance Factor of "1"
requires a match on three drugs to trigger an alert. A Duplication Allowance Factor of "2" requires a match on four
drugs to trigger an alert and so on.

Maintenance
This section contains information regarding the ongoing maintenance of the module's data.

Triggers for Clinical Review

FDA MedWatch Safety.

Newly created or enhanced Clinical Formulations are reviewed weekly to determine if they meet the
inclusion criteria.

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Customer or manufacturer clinical inquiries are reviewed daily and the database is updated weekly as
appropriate.

References
This section lists sources used by FDB to compile the information contained in the module.

FDB utilizes many reference sources including, but not limited to, the primary medical literature (for example,
published journal articles), medical reference texts, published expert treatment guidelines, and manufacturer
product package inserts. FDB uses current source editions or versions when coding and updating data, as well as
when researching questions about data. However, a formal data review does not occur for every new release of
source editions or versions. Additional sources include:

Gilman AG, Hardman JG, Limbird LE. Goodman & Gilman's The Pharmacological Basis of Therapeutics.
Treatment Guidelines
PubMed.gov. Available at: http://www.ncbi.nlm.nih.gov/sites/entrez?db=PubMed
Product labeling
ChemIDpluslite, an NLM sponsored ingredient structure and synonym search website. Available at:
http://chem2.sis.nlm.nih.gov/chemidplus/chemidlite.jsp
USP Dictionary Online, U.S. naming standard and ingredient structure search website. Available at:
http://www.uspusan.com/usan/

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DPT Applications
This section provides information about the practical application of data contained in this module.

Introduction

Detecting Therapeutic Class Duplications

Comparing Duplicate Therapy Classifications

Implementing the DPT Duplication Allowance

Generating Messages, Warnings, and Reports

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Introduction
In general, upon initial implementation, FDB recommends checking the patient profile for duplicate therapies
between the active drugs in the profile. To do this, treat each active drug in the profile as a new drug and perform
duplicate therapy checking against the remaining active drugs in the profile.

After the initial implementation, duplicate therapy checking is most efficient if limited to checking new therapies
against drugs already in the patient profile (current therapy) rather than checking current therapy against current
therapy each time.

The following sections provide detailed information about duplicate therapy checking. FDB offers a variety of drug
concepts and their identifiers to support duplicate therapy checking. These identifiers are referred to as Multiple
Access Points (MAPs) and represent drug products, ingredients, and formulations. Familiarity with the MAPs
section is recommended before attempting the applications contained in this section.

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Detecting Therapeutic Class Duplications

To detect a duplication of therapy, use the following application:

1. Retrieve the Routed Medication ID (ROUTED_MED_ID) in the DPT Routed Medication ID Table, or
Routed Generic Identifier (ROUTED_GEN_ID) in the DPT Routed Generic Table, or Clinical Formulation
ID (GCN_SEQNO) in the DPT GCN_SEQNO Table for the newly prescribed (prospective) drug and for
each drug in the patient profile (profiled drugs).

2. Retrieve the associated DPT Class Identifiers (DPT_CLASS_ID) from the DPT Class Table
(RDPTCL0_CLASS_ID) for each prospective drug and each profiled drug.

3. Compare the DPT_CLASS_IDs and retrieve the DPT Class Description (DPT_CLASS_DESC) record from
the RDPTCL0_CLASS_ID table when Duplicate Therapy Class matches occur.

4. Compare the number of times that a match of a given class is returned with the DPT Duplication Allowance
(DPT_ALLOWANCE) from the RDPTCL0_CLASS_ID table. If the number of matches exceeds the
DPT_ALLOWANCE value, a duplicate therapy exists. In most instances, the duplication allowance is zero.
Programming for a duplication allowance of one or more should occur only for drugs in the same class that
are used concurrently, per accepted medical practice.

This process is also illustrated in the Detecting Therapeutic Class Duplications diagram below.

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In the example below, gentamicin sulfate is prescribed to a patient who is currently taking tobramycin. Both drugs
participate in Duplicate Therapy Class 19Aminoglycosides, Parenteral. The DPT_ALLOWANCE value for this
class is zero; therefore, two prescriptions in this class represent a duplicate therapy and a warning message
should be generated.

Profile Status Screened Drugs GCN_SEQNO Duplicate Therapy Duplication

Class Identifier Allowance

New Gentamicin Sulfate 009287 19Aminoglycosides, 0

Parenteral

Active Tobramycin 009302 19Aminoglycosides, 0

Parenteral

Considerations for Detecting Therapeutic Class Duplications

The Routed Medication ID (ROUTED_MED_ID) and the Routed Generic Identifier (ROUTED_GEN_ID) represent
more general concepts than the Clinical Formulation ID (GCN_SEQNO). A drug at the ROUTED_MED_ID or
ROUTED_GEN_ID level may participate in a duplicate therapy class that the same drug at the Clinical

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Formulation ID (GCN_SEQNO) level would not. The broader assignment of duplicate therapy classes at the
ROUTED_MED_ID or ROUTED_GEN_ID level may require further inquiry to the Clinical Formulation ID (
GCN_SEQNO) level for the greatest degree of specificity.

Loss of Strength Distinction at the ROUTED_MED_ID Level

The tables below show the duplicate therapy classes that the following drug products, each having a different
strength, participate in at the Clinical Formulation ID (GCN_SEQNO) level.

Aspirin 81 mg Chewable Tab Clinical Formulation ID (GCN_SEQNO) 004380 participates in the following
duplicate therapy class:

DPT_CLASS_ID DPT_CLASS_DESC

00001634 Low dose Aspirin (81 mg or less)

Low dose aspirin is intentionally excluded from the salicylate/NSAID DPT Classes to avoid nuisance hits
and over-messaging for physicians. Low dose aspirin is rarely, if ever, administered as an analgesic in
adults, so alerting against other NSAIDs and salicylates in DPT Class 276 Non-Steroidal
Anti-Inflammatory (NSAID) & Salicylates is generally not useful.

Aspirin 325 mg Tab (Clinical Formulation ID [GCN_SEQNO] 004376) participates in the following duplicate
therapy classes:

DPT_CLASS_ID DPT_CLASS_DESC

00000276 Non-Steroidal Anti-Inflammatory (NSAID) & Salicylates

00001064 Antiplatelet and Antithrombotic Drugs

00001784 Antiplatelet and Antithrombotic Drugs (Selected Group 2)

Aspirin 500 mg Tab (Clinical Formulation ID [GCN_SEQNO] 004377) participates in the following duplicate
therapy classes:

DPT_CLASS_ID DPT_CLASS_DESC

00000276 Non-Steroidal Anti-Inflammatory (NSAID) & Salicylates

00001063 Antiplatelet Drug-excluding antiplatelet ASA 325 mg &

below

00001064 Antiplatelet and Antithrombotic Drugs

00001784 Antiplatelet and Antithrombotic Drugs (Selected Group 2)

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Notice, as shown below, that the same duplicate therapy classes are assigned but the strength distinction found
at the Clinical Formulation ID (GCN_SEQNO) level is lost at the ROUTED_MED_ID level.

Aspirin Oral (ROUTED_MED_ID 00001082) participates in the following duplicate therapy classes:

DPT_CLASS_ID DPT_CLASS_DESC

00000276 Non-Steroidal Anti-Inflammatory (NSAID) & Salicylates

00001063 Antiplatelet Drug-excluding antiplatelet ASA 325 mg &

below

00001064 Antiplatelet and Antithrombotic Drugs

00001634 Low dose Aspirin (81 mg or less)

00001784 Antiplatelet and Antithrombotic Drugs (Selected Group 2)

Broader Assignment of Classes at the ROUTED_GEN_ID Level

The following example shows the Duplicate Therapy Classes that a drug product participates in at the Clinical
Formulation ID (GCN_SEQNO) level.

Wellbutrin 100 mg Tab (Clinical Formulation ID [GCN_SEQNO] 046237) participates in the following duplicate
therapy classes:

DPT_CLASS_ID DPT_CLASS_DESC

00000041 Antidepressants

00001155 Norepinephrine & Dopamine RU Inhib (NDRIs)

Antidepressants

Notice, as shown below, that the assignment of classes broadens at the ROUTED_GEN_ID concept level.

Bupropion HCL Oral (ROUTED_GEN_ID 01050229) participates in the following duplicate therapy classes:

DPT_CLASS_ID DPT_CLASS_DESC

00000041 Antidepressants

00001155 Norepinephrine & Dopamine RU Inhib (NDRIs)

Antidepressants

00001529 Smoking Deterrents - Nicotinic or Bupropion (NDRI)-Type

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Comparing Duplicate Therapy Classifications

When comparing the DPT Class Identifiers (DPT_CLASS_ID) for the new drug against the active drugs in the
profile, we recommend that you do not limit the search to one match per pair. Although it may seem helpful if your
screening functions are processed serially (for example, the system stops processing when it encounters a match
and resumes processing after the match is addressed), matches are not processed in priority order, so later
matches may be more clinically relevant or otherwise more important. The following example illustrates a
potential problem with stopping duplication searches after a single match:

New Drug lovastatin lovastatin

Active Drug in Profile atorvastatin atorvastatin

Duplicate Therapy Class 1062Antihyperlipidemics 0483HMG-CoA Reductase Inhibitors

DPT Duplication Allowance 1 0

Number of duplications present? 1 1

Exceeds Allowance? No Yes

Using lovastatin and atorvastatin as the prescribed drugs, the first duplicate therapy match occurs in the
Antihyperlipidemics class and screening is stopped because a match has occurred. The reporting of this
duplication is suppressed because the DPT Duplication Allowance (DPT_ALLOWANCE) for this class is one, and
therefore this match is allowed. However, had processing continued, another match in the HMG-CoA Reductase
Inhibitors class would occur. This class has a DPT_ALLOWANCE of zero, so the match would exceed the
allowance and generate a warning message.

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Implementing the DPT Duplication Allowance

The DPT Duplication Allowance (DPT_ALLOWANCE) designates a maximum number of duplicate therapy
matches allowed for a duplicate therapy class before alerting the end-user. The duplicate therapy warnings may
be suppressed in situations where the concurrent use of more than one medication from the same class is an
accepted medical practice. Additionally, you can implement the Duplicate Therapy Module without screening or
displaying the DPT_ALLOWANCE value. This offers faster processing of duplicate therapy screening by
simplifying the screening application.

Class Description DPT Duplication Allowance

Antihyperlipidemics 1

HMG-CoA Reductase Inhibitors 0

Using the DPT_ALLOWANCE example values above, a total of two active prescriptions (one duplication match)
for the Antihyperlipidemics class is considered acceptable. However, if a third Antihyperlipidemia drug is added,
causing two duplication matches, a warning is generated.

For HMG-Coa Reductase Inhibitors, a second active prescription for a drug in this class generates a warning, as
a single match exceeds the DPT_ALLOWANCE value of zero.

The options for implementing the DPT_ALLOWANCE are as follows:

For full functionality of Duplicate Therapy Module as a screening tool for duplicate therapies, implement the
DPT Duplication Allowance.
Allow end-users to enable or disable screening using the DPT Duplication Allowance by implementing the
DPT Duplication Allowance as an optional feature. If the end-user disables use of the DPT Duplication
Allowance, all possible duplicates are returned so that the end-user must use professional judgment to
screen for false alerts. If the end-user enables screening, the system would function the same as the
option listed above.
To require review and enable the end-user to exercise professional judgment to evaluate possible false
alerts, display the DPT Duplication Allowance value to the end-user but do not implement the alert
suppression based on the DPT Duplication Allowance.
To provide end-users with the ability to use their own table of values for DPT Duplication Allowances,
implement the DPT Duplication Allowance feature to allow end-users to create user-defined tables. This
type of implementation provides the end-user with the advantage of customizing this field for regional
standards of practice or specialized patient populations. However, this type of implementation also requires
extra programming for the user-defined table and differentiating reports and warnings based on
user-defined values from FDB default values.
To speed processing, limit the process of counting DPT Duplication Allowances to the few drug classes
that have DPT Duplication Allowances greater than zero.

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Generating Messages, Warnings, and Reports

Three conditions can occur when screening a new drug for duplicate therapy. These conditions and the
suggested formats for messages, warnings, and reports are described below.

No Match

If a new drug is recognized by the Duplicate Therapy Module, but no matches are found, a message to reflect this
condition can be generated in the following format:

No Match Message Format

THERAPEUTIC DUPLICATION MESSAGE

No duplicate therapy found with [HOST DRUG NAME 1]

ExampleNo Match Message

THERAPEUTIC DUPLICATION MESSAGE

No duplicate therapy found with Lasix.

Drug Not Available

If a new drug is not recognized by, or is not classified in the Duplicate Therapy Module, a message to reflect this
condition should be generated in the following format:

Drug Not Available Message Format

THERAPEUTIC DUPLICATION MESSAGE

Duplicate therapy checking with [HOST DRUG NAME 1] not available.

ExampleDrug Not Available Message

THERAPEUTIC DUPLICATION MESSAGE

Duplicate therapy checking with Zanoterone not available.

This message helps users distinguish when an alert is not generated because there is no Duplicate
Therapy issue, and when an alert is not generated because a new drug is not recognized or classified in
this module. Medical devicesDTC 99999999 should generate a Not Applicable message.

Match Found

If a new drug is recognized by the Duplicate Therapy Module and matches are found, warnings or reports should
be generated in the following formats.

Duplicate Allowance of Zero

If the duplication allowance is zero, and a single match occurs, the following format is suggested:

Warning Message FormatSingle Match

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THERAPEUTIC DUPLICATION WARNING

Duplication Allowance: [DUPLICATION ALLOWANCE]
[HOST DRUG NAME 1] and [HOST DRUG NAME 2] are members of the [CLASS DESCRIPTION] class and may
represent duplicate therapy.

ExampleSingle Match Message

THERAPEUTIC DUPLICATION WARNING

Duplication Allowance: 0
Dalmane and Valium are members of the Benzodiazepine class and may represent duplicate therapy.

Duplicate Allowance of 1 or More

If the duplication allowance is one or more, we recommend structuring the warning to show all drugs identified as
a match:

Warning Message FormatMultiple Match

THERAPEUTIC DUPLICATION WARNING

Duplication Allowance: [DUPLICATION ALLOWANCE]
[HOST DRUG NAME 1] and [HOST DRUG NAME 2, HOST DRUG NAME 3,...] are members of the [CLASS
DESCRIPTION] class and may represent duplicate therapy.

ExampleMultiple Match Message

THERAPEUTIC DUPLICATION WARNING

Duplication Allowance: 1
INVIRASE, NORVIR, and CRIXIVAN are members of the Antiviral-HIV (Antiretroviral) Protease Inhibitor class and may
represent duplicate therapy.

Printing a Report

To print a report when all possible information is desired, we recommend the following format. This type of report
is most appropriate in the outpatient setting. The previous example is illustrated below using multiple matches:

Report FormatAll Possible Information

THERAPEUTIC DUPLICATION REPORT

Duplication Allowance: [DUPLICATION ALLOWANCE]
[HOST DRUG NAME 1] and [HOST DRUG NAME 2, HOST DRUG NAME 3,...] are members of the [CLASS
DESCRIPTION] class and may represent duplicate therapy.
Patient received [QUANTITY] of [HOST DRUG NAME 2] on [DATE].
Patient received [QUANTITY] of [HOST DRUG NAME 3] on [DATE].
...
[DTCOPY]

ExampleAll Possible Information Report

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THERAPEUTIC DUPLICATION REPORT

Duplication Allowance: 1
INVIRASE, NORVIR, and CRIXIVAN are members of the Antiviral-HIV (Antiretroviral) Protease Inhibitor class and may
represent duplicate therapy.
Patient received 200 MG of INVIRASE on 10/1/07.
Patient received 80 MG/ML of NORVIR on 10/1/07.
Patient received 400 MG of CRIXIVAN on 10/1/07.
Copyright 2007 First Databank Inc.
Expires December 2008.

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DPT ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

Duplicate Therapy Module Tables

Duplicate Therapy Module ERD

Duplicate Therapy Module Tables

DPT Class Table
DPT GCN_SEQNO Table
DPT Routed Generic Table
DPT Routed Medication ID Table

Duplicate Therapy Module ERD

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DPT Class Table

Table Name RDPTCL0_CLASS_ID

Revision Activity add.01-01-2002

Purpose Provides attributes for a duplicate therapy class including its

duplication allowances.

Key Column Name Column Format Length Picture

Description

P DPT_CLASS_ID DPT Class N 8 9(8)

Identifier

DPT_CLASS_DE DPT Class AN 60 X(60)

SC Description

DPT_ALLOWANC DPT Duplication N 2 9(2)

E Allowance

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DPT GCN_SEQNO Table

Table Name RDPTGC0_GCNSEQNO_LINK

Revision Activity add.01-01-2002

Purpose Links a clinical formulation to a duplicate therapy class.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF DPT_CLASS_ID DPT Class N 8 9(8)

Identifier

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DPT Routed Generic Table

Table Name RDPTRG0_ROUTED_GEN_LINK

Revision Activity original

Purpose Links a routed generic to a duplicate therapy class. The

routed generic relationships are programmatically
generated from the clinical formulation.

Key Column Name Column Format Length Picture

Description

PF ROUTED_GEN_I Routed Generic N 8 9(8)

D Identifier

PF DPT_CLASS_ID DPT Class N 8 9(8)

Identifier

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DPT Routed Medication ID Table

Table Name RDPTRTM0_ROUTED_MED_LINK

Revision Activity add.01-01-2002

Purpose Links a routed medication to its duplicate therapy class(es).

The routed medication relationships are programmatically
generated from the clinical formulation.

Key Column Name Column Format Length Picture

Description

PF ROUTED_MED_I Med Routed N 8 9(8)

D Medication ID
(Stable ID)

PF DPT_CLASS_ID DPT Class N 8 9(8)

Identifier

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Inactive Ingredients Editorial Policies

The policies and criteria that apply to the inclusion criteria and processes are provided in the following sections:

Overview
Inclusion/Exclusion Criteria
Covered NDCs
Clinically Significant Inactive Ingredients
Data Source
Rule Sets
Identification of Reviewed NDCs
Potentially Inactive Ingredient Indicator
Ingredients Reported When They May Be Present
Reliance on SPL
Related Ingredient Names Collapsed into Single Name
Maintenance

Overview
The Inactive Ingredient information published by First Databank (FDB) is obtained from Structured Product Labels
(SPLs) filed with the FDA and collected daily. FDB programmatically reviews the excipient information reported in
the SPLs and collects clinically significant ingredients: those that are allergens, members of interaction pairings or
can otherwise cause significant adverse effects. By relying on the SPL listings and reducing the list of inactive
ingredients to those with clinical impact, the data reported can remain current, provide expanded coverage and
limit overalerting.

Maintenance of inactive ingredient data will be based exclusively on SPLs published by the FDA.

Inclusion/Exclusion Criteria
This section provides information detailing the criteria that guided the inclusion of the data as well as information
pertaining to limitations or exclusions when appropriate to the discussion.

Covered NDCs
Inclusion
All products that have an SPL, including prescription and over-the-counter drugs, medical devices
and supplies and prescription nutritional supplements.
Exclusion
Repackaged products

Clinically Significant Inactive Ingredients

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A selection of chemicals, identified below with their synonyms or related ingredients, based on allergen,
interaction, and adverse effect potential that is reported in FDB MedKnowledge.

Ingredient HIC_SEQN

Adhesive 3245

Alcohol 2464

aluminum silicate magnesium 6364

aminobenzoic acid 2325

Annatto 7286

Aspartame 2605

beef derived (bovine) 9283

benzalkonium chloride 3141

benzethonium chloride 3142

benzyl alcohol 3192

blue dye 10138

calcium chloride 774

calcium phosphate 781

Cinnamon 2564

coconut 16176

corn syrup 10093

cremophor el (poly.castor oil) 9290

Dextrose 915

edetic acid 3785

Egg 6947

Erythritol 10760

ethyl alcohol 1539

FD & C No.5 (Tartrazine) 8923

fish derived 9278

Fructose 2606

Gelatin 2549

Gluten 7207

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Heparin 15153

Inverted Sugar 919

Isomalt 9147

Lactitol 3987

Lactose 2432

Latex 8921

magnesium carbonate 7230

Maltitol 10095

Maltose 5153

Mannitol 2272

Milk 8922

Neomycin 2775

oleic acid 2530

Paraben 3203

Peanut 568

Phenol 3199

Phenylalanine 3542

pork derived (porcine) 9277

propylene glycol 2468

red dye 10141

Saccharin 2600

sesame oil 2475

shellfish derived 11754

sodium acetate 756

sodium acid pyrophosphate 2334

sodium bicarbonate 743

sodium bicarbonate 11039

sodium citrate 2332

sodium iodide 3671

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sodium lactate 750

sorbitan esters 7543

Sorbitol 2599

Soy 13405

Sucrose 2598

Sulfite 6300

sulfur dioxide 9284

Thimerosal 3125

Trehalose 10697

Turmeric 5454

Wheat 13412

Xylitol 6331

yellow dye 10143

Data Source

Information identifying a product's inactive ingredients is obtained from the SPLs listed in the National
Library of Medicine's DailyMed website.

Rule Sets
This section provides rules that the clinical team uses in regards to creating the data, both general rules and rules
specific to data elements.

Identification of Reviewed NDCs

Not all NDCs have inactive ingredient information available.
NDCs that have been checked by FDB for inactive ingredients are referred to as reviewed NDCs. These
NDCs are identified in the NDC Inactive Ingredients Reviewed Master Table
(RNDCINR0_INACTV_REVIEWED).
Clinically significant inactive ingredients for these NDCs appear in the NDC Inactive Ingredients Reviewed
Master Table (RNDCINR0_INACTV_REVIEWED). It is common for an NDC to have no clinically significant
inactive ingredients and therefore, no entries in this table.

Potentially Inactive Ingredient Indicator

In certain cases, an ingredient may appear as active in some products and inactive in others, and such
ingredients are identified with the Potentially Inactive Indicator in the HIC Potentially Inactive Indicator
(HIC_POTENTIALLY_INACTV_IND) and HIC4 Potentially Inactive Indicator

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(HIC4_POTENTIALLY_INACTV_IND) fields. If an ingredient has a Potentially Inactive Indicator value of 0

(zero), the ingredient will only be identified when it is an active ingredient. Ingredients with a Potentially
Inactive Indicator value of 1 may be active or inactive ingredients.

Ingredients Reported When They May Be Present

When the text in an SPL states that a product may include a substance, that substance will be identified
and reported in the product's list of inactive ingredients.

Examples:

Prefilled syringe, without needle, 0.25 mL, package of 10 prefilled syringes per carton (may contain latex) -
NDC 49281-010-25.

Prefilled syringe, without needle, 0.5 mL, package of 10 prefilled syringes per carton (may contain latex) -
NDC 49281-010-50.

Other ingredients may include corn syrup, lactose, magnesium stearate, potato starch and talc.

Inert ingredients are: glycine; magnesium stearate and sodium lauryl sulfate. May also include the following:
hydroxypropyl cellulose; hypromellose; opaspray (which may include Blue 2 Lake, Yellow 6 Lake, Yellow 10
Lake, and other inert ingredients); opadry light yellow (which may contain D&C Yellow 10 Lake, FD&C
Yellow 6 LAKE and other inert ingredients); opadry clear (which may contain other inert ingredients).

Reliance on SPL

The Inactive Ingredient review relies on pharmaceutical manufacturers' compliance with their obligation to
provide all relevant information accurately and completely in their products' SPLs.

Related Ingredient Names Collapsed into Single Name

When SPLs report the same, related or similar ingredients under different names, they have been grouped for
reporting purposes in the Inactive Ingredient data, for example:

erythrosine; Red D & C No. 6; and F D & C No. 22 (eosin) are each reported in the Inactive Ingredient
data as red dye
egg yolk; albumen; and lecithin, egg are each reported as egg
collagen, bovine; tallow; and veal bone are each reported as beef derived (bovine)

Sample Data

NDC LN HIC_SEQN HIC_DESC HIC_POTENTIALLY_

INACTIV_IND

00024540131 AMBIEN 5 MG 2432 lactose 1

TABLET

00024540131 AMBIEN 5 MG 10141 red dye 1

TABLET

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00024540131 AMBIEN 5 MG 4147 zolpidem tartrate 0

TABLET

Maintenance
This section contains information regarding the ongoing maintenance of the data.

Changes in a manufacturer's SPL information will trigger a review and, if necessary, updating of the
inactive ingredients reported for a product.

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Indications Module (INDM) 2.0

Indications Module Editorial Policies
Applications
ERD and Technical Specifications

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Indications Module Editorial Policies

The policies and criteria that apply to the inclusion criteria, processes, and references used in creation of the
module are provided in the following sections:

Overview
Inclusion Criteria
Exclusion Criteria
Data Elements
Rule Sets
Rules for Data Elements
Maintenance
References

Overview
The purpose of the Indications Module (INDM) is to deliver drug knowledge that helps clinicians make
informed decisions regarding therapy options, based on current medical evidence. The module includes both
FDA-approved and some non-FDA-approved, "unlabeled" indications substantiated by primary medical literature
or treatment guidelines.INDM content may also be used to generate an inferred patient problem list and facilitate
Drug-Disease Contraindications (DDC) checking when actual patient diagnoses are unavailable. INDM content
may also be used to build disease groups for Medication Therapy Management (MTM).

Inclusion Criteria
Drug Scope

Drugs included are those that have a Clinical Formulation ID ( GCN_SEQNO) in FDB MedKnowledge and are
either:

FDA-approved prescription products with a New Drug Application (NDA), Abbreviated New Drug
Application (ANDA), or Biologics License Application (BLA)
FDA-approved over-the-counter (OTC) products with an OTC New Drug Application (NDA) or FDA OTC
Drug Monograph
Some non-FDA approved products may also be included

Indications Content Scope

All indications listed in FDA-approved prescribing information (PI) will be reviewed for inclusion in INDM.
Indications listed in FDA OTC Drug Monographs with a Tentative Final Ruling Category I (Generally
Recognized As Safe and Effective) are reviewed for inclusion in INDM.
Non-FDA approved indications substantiated by treatment guidelines, consensus statements, pivotal
clinical trials, inclusion in select tertiary references or labeling for non-US products (see the Maintenance
section) may also be reviewed for inclusion in INDM.
More specific indications than those listed in the Indications section of the PI may be listed in INDM to

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support indication-specific dosing for the Dosing and Ordering modules.

Exclusion Criteria
Drug Scope

Self-proclaimed U.S. Rx products without ANDA/NDA/BLA

Rx drug products with 510K (medical device) approval
Dietary supplements
Herbal supplements
Large volume parenteral, nutritional, irrigation or dialysis solutions
Nutraceuticals
Diluent solutions
Homeopathic drugs
OTC products without an FDA OTC Monograph
Bulk packaged products
Medical supplies, soaps, cleansers
Cosmetics, unless also FDA approved as a prescription drug (for example, botulinum toxin, bimatoprost)
Veterinary drugs
Inactive ingredients
U.S. products with Clinical Formulation routes that are not supported by FDA-approved package insert
labeling.
U.S. products with unapproved routes or dose forms

Indications Content

Clinical trial demographic details and outcome statements are not included within indications:

Study population demographics

Example: population studied were male, non-HIV age less than 65 years
Treatment outcome which is not a disease
Example: Atorvastatin - Reduce risk of hospitalization for CHF"
Current Use Limited (CUL) indications: Standards for appropriate medication treatment evolve based upon
improved understanding and new treatment options for a disease. INDM may exclude labeled indications
for older drugs if usage is not consistent with present day standards of care.
Example: Glycopyrrolate for treatment of peptic ulcer disease

Data Elements
This section contains additional information about particularly important tables and codes contained within the
module, as well as concepts about the data that the reader must understand in order to understand the module.

INDM Indication Code

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The INDM Indication Code (INDCTS) is a system-generated number for each collection of drug indications.

INDM Indications Drug Description

The INDM Indications Drug Description (INDCTS_DRUG_DESC) assigned to the INDM Indication Code (INDCTS
) provides information about drug(s) linked to the indication list.

Disease Identifiers

Each indication is encoded with an FML Disease Identifier (DXID), which identifies specific disease states,
procedures, condition related concepts, and diagnostic tests associated with drug use. The DXID is a
system-generated number maintained in the First Databank Medical Lexicon (FML). First Databank also
publishes legacy First Databank Disease Code (FDBDX). FDBDXs are created and include embedded ICD9cm
codes. FDBDXs have a one-to-one relationship with DXIDs.

INDM Labeled Code

There are three possible values, one of which is assigned to each DXID record.

ExampleRINDMLD0_LABELED_DESC

INDCTS_LB INDLBLDESC

L Drug Indication has been approved by the FDA

P Grouper Indication for Proxy only

U Non-FDA Approved Drug Indication

The INDM Labeled Code (INDCTS_LBL) identifies whether the drug indication has been approved by the FDA ( L
), is a non-FDA approved drug indication (U), or whether it is a Proxy indication (P). Proxy indications (P) are
broad disease descriptions to be used solely for the purpose of Drug-Disease Contraindication (DDC) checking
(for further details, see the Data Elements section.)

By definition, Proxy indications are neither FDA approved (L) nor evidence-based unapproved (U)
indications. Thus, Proxy indications are not intended for use/display in a drugs to treat application of the
data, or for indication-based dose screening (see the Rule Sets section for further details.)

INDM Proxy Indicator

Field values are N (no) or Y (yes).

If the Indication Description is a Proxy, the INDM Proxy Indicator (PROXY_IND) field value will always be Y
(Yes).

If the Indication Description is Labeled or Unlabeled, this field value will always be N (No).

This field is programmatically generated based upon assigned labeled field INDM Labeled Code ( INDCTS_LBL)
values.

ExampleRINDMMA2_INDCTS_MSTR

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INDCTS INDCTS_SN INDCTS_LBL FDBDX DXID PRED_CODE PROXY_IND

278 0 L 01.038900 110 3 N

278 1 P 01.041900 154 1 Y

278 2 L 07.421000 1483 3 N

INDM Sequence Number

Sequencing of FML Disease Identifier (DXID) values is represented by INDM Sequence Number (INDCTS_SN)
values and is generated by the system. It is not a priority sequence, but is a numeric sort of First Databank
Disease Code (FDBDX) codes. This is not a stable code.

INDM Predictor Code

The INDM Predictor Code (PRED_CODE) field values are 1, 2, or 3.

ExampleRINDMMA2_INDCTS_MSTR

INDCTS INDCTS_SN INDCTS_LBL DXID PRED_CODE PROXY_IND

253 0 L 1117 3 N

253 1 L 1432 2 N

253 2 L 1448 2 N

253 3 U 1460 3 N

253 4 U 1500 3 N

Rule Sets
This section provides rules that the clinical team uses in regard to creating the module's data, both general rules
and rules specific to data elements.

Trigger content text (for example, FDA CDER New labeling updates) are reviewed, and concepts applicable to
INDM are identified. See the Maintenance section for list of triggers. Disease terminology concepts within the First
Databank Medical Lexicon (FML) are searched and codes/descriptions are selected. Associated attributes of
Labeled, Predictor, and Proxy are included. Trigger content drug(s) are identified and indications coding is applied
to all applicable drug groups in the module.

Rules of General Applicability

A Clinical Formulation ID (GCN_SEQNO) with one or more ingredients is linked to a single INDM Indication Code
(INDCTS)

ExampleSingle Indication for Multiple GCN_SEQNO

GCN_SEQNO INDCTS INDCTS_DRUG_DE STR GCDF_DESC

SC

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57865 2037 EZETIMIBE,SIMVAST 10MG-40MG TABLET

ATIN

57864 2037 EZETIMIBE,SIMVAST 10MG-40MG TABLET

ATIN

57863 2037 EZETIMIBE,SIMVAST 10MG-40MG TABLET

ATIN

57859 2037 EZETIMIBE,SIMVAST 10MG-40MG TABLET

ATIN

GCN_SEQNO aggregates drug products that share like ingredient sets, route of administration, dosage form, and
strength of drug but are marketed by multiple manufacturers. Therefore, assignment of INDM information to drugs
is NOT manufacturer-specific.

ExampleSingle Indication for Multiple Manufacturers

GCN_SEQN INDCTS INDCTS_D RT GCDF_DES STR BN NDC

O RUG_DESC C

46216 25 FLUOXETIN ORAL TABLET 10MG PROZAC 0000240060

E 2

46216 25 FLUOXETIN ORAL TABLET 10MG PROZAC 0000240063

E 0

46216 25 FLUOXETIN ORAL TABLET 10MG FLUOXETIN 0009371881

E E HCL 0

46216 25 FLUOXETIN ORAL TABLET 10MG FLUOXETIN 0009371885

E E HCL 6

46216 25 FLUOXETIN ORAL TABLET 10MG SARAFEM 0043002101

E 4

Routed Medication ID and Routed Generic ID links to the INDM are programmatically assigned.

Non-U.S. drug Clinical Formulations may inherit U.S.-based INDM clinical data

Indications content is not published at the NDC level. Thus, under certain circumstances, aggregated
indications drug knowledge relevant to the labeled or unlabeled status of a given INDM master table
may not apply to all products linked to the master table content. For example, both Betapace and
Betapace AF contain the same active ingredient (sotalol) but have different FDA-approved indications.
Betapace is approved for treatment of ventricular arrhythmias while Betapace AF is approved for
treatment of atrial fibrillation. However, FDB has a single set of indications for sotalol-containing drugs
because clinically, either product can be used to treat either type of cardiac arrhythmia

Rules for Indication Code Drug Groups: Description and Linking

A Clinical Formulation ID (GCN_SEQNO) is linked to an INDCTS drug group that is usually based on having a
common ingredient list, but can be broader to include a class of ingredients (for example, ANALGESIC,

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EXPECTORANT), or may be narrower to include only certain dose forms, routes or strengths of a single
ingredient (for example, Metoprolol EXT REL, Metronidazole 750mg ER).

ExampleBreak Out Groups Based on Dose Form, Route, and Strength for RINDMDD0_INDCTS_DRUG_DESC

INDCTS INDCTS_DRUG_DESC

248 METOPROLOL (PO IMMEDIATE RELEASE)

1349 METOPROLOL (EXT REL)

1350 METOPROLOL (IV)

1994 METOPROLOL, HYDROCHLOROTHIAZIDE

1482 METRONIDAZOLE (750MG ER)

ExampleAggregated Clinical Formulations

GCN_SEQ INDCTS INDCTS_ RT GCDF_DE STR BN HIC3 HICL

NO DRUG_DE SC
SC

51657 1945 TADALAFI ORAL TABLET 20MG CIALIS F2A A7GB

L

65368 1945 TADALAFI ORAL TABLET 20MG ADCIRCA B1D A7GB

L

Rules for Indication Descriptions

A list of indications is created for each INDM Indication Code (INDCTS). Each indication consists of a
DXID/FDBDX code-description pair.
Limit detailed descriptions for indications, that is, consolidated indication. Indications need not be
described to the level of detail that includes the phase of illness or the sub-type of disease, unless
required for dosing purposes or unless illness subtypes require different drug therapy.
Example 1 of consolidated indication: Indication may not reflect demographics of the specific
patient population used for FDA approval. Therefore, use DXID for HIV infection instead of:
[Etravirine] is a human immunodeficiency virus type 1 (HIV-1) non-nucleoside reverse transcriptase
inhibitor (NNRTI) indicated for treatment of HIV-1 infection in treatment-experienced patients 6
years of age and older with viral strains resistant to an NNRTI and other antiretroviral agents.
Example 2 of consolidated indication: Indication may not reflect specific FDA-approved stage of
disease or priority of therapy for a specific disease. Therefore, use DXID for Multiple Myeloma
instead of KYPROLIS is indicated for the treatment of patients with multiple myeloma who have
received at least two prior therapies including bortezomib and an immunomodulatory agent and
have demonstrated disease progression on or within 60 days of completion of the last therapy.
Approval is based on response rate [see Clinical Studies (14.1) at
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ea66eb30-e665-4693-99a1-a9d3b4bbe2d6#i4i_section_id
]. Clinical benefit, such as improvement in survival or symptoms, has not been verified.

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Indication description needs to have sufficient detail, especially if a sub-type of the disease is a relative
contraindication. In addition, some drugs that are indicated for one form of the illness are contraindicated
in another form of the illness. For example, Sotalol is indicated for prevention, but contraindicated for
cardioversion of atrial fibrillation.
Indication description needs to have sufficient detail, especially if a sub-type of the disease requires
different drug therapy.
Example: When evaluating drugs to treat Atrial Fibrillation, breakouts (that is, more granular
disease descriptions) were needed as different drug therapy is used for:
Cardioversion of Atrial Fibrillation
Prevention of Recurrent Atrial Fibrillation
Ventricular Rate Control in Atrial Fibrillation
Indication description needs to have sufficient detail, especially if a sub-type of the disease has a different
dosing regimen.
If a required FML Disease Identifier (DXID) is not available in FML, a new DXID is created.

Rules for Data Elements

INDM Predictor Code

The INDM Predictor Code (PRED_CODE) is a numerical value assigned to each drug-indication pair and is an
estimate of the likelihood that the drug is being used for the indication specified.

Programmatic Predictor Code Validations:

An indication group (group by INDCTS) may have only one indication with a Predictor Code of 1. In
this case, all other indications must have a Predictor Code of 3.
An indication group may have up to three indications with Predictor Codes of 2. All other indications
must have a Predictor Code of 3.
All Proxy Indications have a Predictor Code of 1.
Predictor codes are 1, 2, or 3. An indication with a predictor code of 1 corresponds to a high likelihood, that
is, a greater than 90% of patients taking this medication, 2 corresponds to a moderate likelihood, 30 to
50% of patients taking this medication, and 3 corresponds to less than 30% likelihood that patients are
taking this medication for the particular indication.
The utility of the PRED_CODE is to infer or prioritize the indications for a known drug when patient
diagnoses are unavailable. Often this diagnosis information is unknown, but can be inferred by the
indications for drugs the patient is taking.
For example, a patient taking glyburide would almost certainly have type 2 diabetes mellitus.
Glyburide has a predictor code of 1.
Assignment of the PRED_CODE is based upon:
Frequency of a particular disease, represented by the indication, in the population.
The relative ranking of the drug (represented by the INDCTS) for the indication in focus. For
example, is this drug a national performance measure versus a second line drug therapy for a

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particular disease?
The granularity (detail) of the disease concept.
The place of a particular indication viewed in context of the INDCTS entire indication list.
Predictor Codes and Labeled Codes (L, U or P) are independently assigned.

INDM Proxy Indication

Proxy indications or conditions describe a drug's use more generally for the purpose of facilitating drug disease
contraindication (DDC) checking. Proxy indications are added to the indication code list when existing indications
are too specific to trigger DDC alerts. An indication group (group for INDCTS) is evaluated for a proxy indication
when:

The indication list has very granular indications, that is, DXIDs are not likely to be used in DDC. For
example, broad spectrum antibiotics with bacteria and site-specific indications will be assigned a proxy
indication of Bacterial Infection.
A drug has many (that is, greater than three) common uses and greater than 90% of indications are within
a specific/specialty treatment area. For example, cisplatin and doxorubicin are each commonly used for a
wide variety of cancers. Their proxy indication is Malignancy.

Maintenance
This section contains information regarding the ongoing maintenance of the module's data.

External Triggers for Clinical Review

The First Databank Knowledge Base Services Department utilizes a robust methodology for the capture,
documentation, triage, and tracking of the most important sources for drug knowledge changes. The external
triggers that are triaged to the clinical editors for review are the following:

MedEffects Alerts from Health Canada

FDA MedWatch Medical Product Safety Information Alerts
FDA CDER NEW
FDA CBER What's New
FDA MedWatch Monthly Label Changes
FDA Division of Drug Information (DDI)
FDA Hematology/Oncology (Cancer) Approvals and Safety Notifications
What's New at FDA in HIV/AIDS
FDA Press Announcements

Internal Triggers for Clinical Review

The internal trigger that prompts the clinical editors to add or review INDM drug groups or DXID content is when a
drug product is first linked to a Clinical Formulation ID (GCN_SEQNO).

References

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This section lists sources used by First Databank to compile the information contained in the module.

First Databank utilizes many reference sources including, but not limited to, the primary medical literature (for
example, published journal articles), medical reference texts, published expert treatment guidelines, and
manufacturer product package inserts. First Databank uses current source editions or versions when coding and
updating data, as well as when researching questions about data. However, a formal data review does not occur
for every new release of source editions or versions.

First Databank may rely on current source reference text editions or versions when updating data, as well as
when researching questions about data. However, a formal data Indications module review does not occur for
every new release of source editions or versions. Additional sources include:

FDA OTC Monographs

AHFS Drug Information. Published by American Society of Health System Pharmacists
The Harriet Lane Handbook
The Medical Letter, Inc. The Medical Letter Treatment Guidelines and The Medical Letter on Drugs and
Therapeutics
Zynx Health Inc. products. Available at: http://www.zynxhealth.com.
Primary Medical Literature content: clinical trials, consensus statements, guidelines
Product information for non-U.S. products

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INDM Applications
This section provides information about the practical application of data contained in this module. These
applications may use tables from the FDB Medical Lexicon (FML) 2.0 module. These applications depend
upon the following conditions:

Familiarity with FML and its primary identifier, the FML Disease Identifier ( DXID). Refer to the FDB Medical
Lexicon (FML) 2.0 module for more information.

The ability to navigate to a Clinical Formulation ID (GCN_SEQNO) from a concept such as the NDC or
MEDID. Refer to MedKnowledge Identifiers and Attributes for more information.

Familiarity with drug concepts and their identifiers. Refer to the Multiple Access Points (MAPs) for more
information.

Assignment of a DxID or ICD Code to a given disease state. Refer to the FDB Medical Lexicon (FML)
2.0 module for more information.

Retrieving a Drugs List of Indications

Retrieving Drugs Indicated for a Selected ConditionUsing the Exclusion Table to Refine the Treatment Options

Checking Inferred Patient Diagnoses for Drug-Disease Contraindications Associated with Prospective Drug Therapy

Detecting Possible Drug-Related Iatrogenic Diseases

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Retrieving a Drug's List of Indications

This application illustrates how to retrieve a drugs list of indications. It uses the process described in the FML
modules Finding DXID Descriptions and Synonyms application to find each indications Primary Professional
Name. You can change the process to display any description or synonym type.

You can retrieve all indications, only indications that are FDA-approved, or only indications that are non-FDA
approved.

This application displays a list of FDA-approved indications for Zithromax 250mg oral tablets (Clinical Formulation
ID [GCN_SEQNO] 026721).

1. Retrieve the INDM Indications Code (INDCTS) associated to the drug products Clinical Formulation ID (
GCN_SEQNO) using the INDM GCN_SEQNO/Drug Indications Code Relation Table
(RINDMGC0_INDCTS_GCNSEQNO_LINK).

GCN_SEQNO INDCTS

026721 00662

2. For each Clinical Formulation ID (GCN_SEQNO)/INDCTS combination retrieved in step 2, retrieve the
following columns from the INDM Master Table (RINDMMA2_INDCTS_MSTR):
INDM Sequence Number (INDCTS_SN)
INDM Labeled Code (INDCTS_LBL)
FML Disease Identifier (DXID)
INDM Proxy Indicator (PROXY_IND)

INDCTS INDCTS_SN INDCTS_LBL DXID PROXY_IND

00662 00 U 00004346 N

00662 01 U 00000051 N

00662 02 U 00000052 N

00662 03 U 00000055 N

00662 04 U 00000056 N

00662 05 L 00000082 N

00662 06 L 00000083 N

00662 07 L 00000261 N

00662 08 L 00000267 N

00662 09 U 00008229 N

00662 10 U 00008228 N

00662 11 L 00000290 N

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00662 12 L 00000294 N

00662 13 L 00000296 N

00662 14 U 00013495 N

00662 15 P 00000412 Y

00662 16 L 00001378 N

00662 17 L 00001379 N

00662 18 L 00001380 N

00662 19 L 00001382 N

00662 20 L 00001385 N

00662 21 U 00001485 N

00662 22 L 00001744 N

00662 23 L 00001745 N

00662 24 L 00001746 N

00662 25 L 00001796 N

00662 26 L 00001801 N

00662 27 U 00008226 N

00662 28 U 00001815 N

00662 29 U 00001816 N

00662 30 L 00001819 N

00662 31 L 00001820 N

00662 32 L 00001821 N

00662 33 U 00001839 N

00662 34 U 00001840 N

00662 35 U 00001842 N

00662 36 L 00001846 N

00662 37 L 00006572 N

00662 38 L 00006573 N

00662 39 L 00006574 N

00662 40 L 00004199 N

00662 41 U 00002434 N

00662 42 U 00002437 N

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00662 43 U 00002438 N

00662 44 U 00002439 N

00662 45 L 00002597 N

00662 46 L 00002598 N

00662 47 L 00002608 N

00662 48 L 00003656 N

3. Filter the results of step 2 to remove the record with a PROXY_IND value of Y (Yes). This example only
filters out one record (INDCTS_SN = 15) from step 2s example data. See the section about the INDM
Proxy Indicator (PROXY_IND) for more information on this column.

4. Filter (or sort, if you prefer) the results of step 3 if you wish to remove FDA-approved or non-FDA-approved
indications. This example filters out numerous non-FDA-approved indications by removing results with an
INDCTS_LBL value of U (Unlabeled).

5. Follow the process described in the FML modules Finding DXID Descriptions and Synonyms application
to find each DXID values Primary Professional Name.

6. Display the resulting set of Primary Professional Names. In this example the names appear sorted by their
INDCTS_SN value (hidden from the end-user), but this sorting is arbitrary.

If applicable, you may also separate the results into two groups when you display them to the
end-user: FDA-approved indications and non-FDA-approved indications.

ExamplePartial list of Zithromaxs FDA-approved indications (Primary Professional Names)

Primary Professional Name

Pharyngitis due to Streptococcus Pyogenes

Streptococcal Tonsillitis

Acute Gonococcal Urethritis

Acute Gonococcal Cervicitis

Chancroid

Chlamydia Trachomatis Urethritis

Chlamydia Cervicitis

Haemophilus Influenzae Acute Otitis Media

Streptococcus Acute Otitis Media

Moraxella Catarrhalis Acute Otitis Media

Pneumococcal Acute Otitis Media

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Acute Otitis Media Infection

Acute Streptococcus Pneumoniae Bacterial Sinusitis

Acute Haemophilus Influenzae Bacterial Sinusitis

Acute Moraxella Catarrhalis Bacterial Sinusitis

Pneumococcal Pneumonia

Haemophilus Influenzae Pneumonia

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Retrieving Drugs Indicated for a Selected Condition - Using the Exclusion Table to Refine the
Treatment Options
This application illustrates how to build a list of drugs that are indicated for a selected diagnosis or medical
problemrepresented by an ICD code. You can customize the end results of this process based on your
applications requirements. Some examples of the different identifiers that this application can return include:

National Drug Code (NDC)Present a list of packaged products to the end-user. Useful for order-fulfilment
and pharmacy audiences. You can easily narrow this list down to fit within a pharmacys formulary.
MED Medication ID (MEDID)Present a list of brand and/or generic medications that include strength,
dosage form, and route information to the end-user. Useful for CPOE, physician, and pharmacy audiences.
MED Medication Name (MED_NAME)Present a list of Brand and/or Generic medication names to the
end-user. Less specific than the MEDID above. Useful for presenting a short, concise list of products to
prescriber and physician audiences.
The Generic Name - Short Version (GNN) or Long Version (GNN60)Present a list of generically-named
clinical formulations to the end-user.
Hierarchical Specific Therapeutic Class Code (HIC3)Optionally present a list of specific therapeutic
classes to the end-user. This concept is useful as a grouping mechanism. Each Clinical Formulation ID
(GCN_SEQNO) has one HIC3 to sort the retrieved drug concepts.

This application may yield drugs that are indicated for conditions different from, but closely related to, the original
ICD code or condition used in the query. First Databank (FDB) suggests that you display the results as
drug/condition pairs so the end-user can tell which condition each drug is indicated for. Additionally, FDB reminds
you that, if applicable, you may want to filter obsolete products out of the return set.

This application is broken into the following three parts:

Part 1 retrieves Generic MEDIDs that are indicated for the initial search condition and any applicable
condition related to the initial search condition. However, because of spacial restrictions, this example only
uses a small subset of the retrieved MEDIDs in the sample data. All drugs retrieved in this example have
either FDA-approved or unlabeled indications relating to the original search ICD code. Part 1 also retrieves
other pieces of information necessary to the other parts of the application.
Part 2 retrieves descriptions for both the drug products and DxID conditions.
Part 3 groups the resulting medications based on how closely their indications relate to the initial condition.
It also includes an option to display information to the user and exit the application.

Part 1: Retrieve MEDIDs and specific indication information

Part 1 builds a list of MEDIDs indicated for the initial condition (or one of its related conditions). It also gathers
other pieces of information for use in later parts of this example.

1. Query the FML ICD Search Table (RFMLISR1_ICD_SEARCH) for the FML Related DxID (
RELATED_DXID) and the FML Navigation Code (FML_NAV_CODE) where:
the Search ICD Code (SEARCH_ICD_CD) equals the code you are checking,
the ICD Code Type (ICD_CD_TYPE) column equals the value of the type of ICD code you are

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checking, and
the FML Clinical Module Code (FML_CLIN_CODE) equals 01.

The Related DxID (RELATED_DXID) will be used in the next step to retrieve related
indications.
The FML_CLIN_CODE value of 01 restricts DxID semantic neighborhood results to
indication information.
The FML Navigation Code (FML_NAV_CODE) describes how the SEARCH_DXID
relates to the RELATED_DXID. It will be used during Part 3 of this application

2. Query the DXID column of the INDM Master Table (RINDMMA2_INDCTS_MSTR) using each of the DXID
values found in Step 1 to retrieve their INDM Indication Codes (INDCTS) and INDM Labeled Code (
INDCTS_LBL).

3. Retrieve the INDM Labeled Code (INDCTS_LBL). Use the INDCTS_LBL value of P to filter out proxy
indications. A value of P means the indication is a Proxy indication (used to infer patient diagnoses
exclusively for contraindication checking algorithm). See the INDM Proxy Indicator section in your FDB
MedKnowledge manual for more information on this column. Optionally, you may perform additional
filtering and sorting using the INDM Labeled Code (INDCTS_LBL) (see Step 6) or the INDM Predictor
Code (PRED_CODE) (see Step 7) at this time.

4. Query the FML ICD Search Exclusion Table (RFMLISX0_ICD_SEARCH_EXCLUSION) with the following
fields from Step 2:
FML Search ICD Code (SEARCH_ICD_CD)
ICD Code Type (ICD_CD_TYPE)
FML Related DXIDs (RELATED_DXID)
FML Clinical Module Code (FML_CLIN_CODE_DESC)
Clinical Drug Group (CLIN_DRUG_GROUP) (In this application, the INDCTS populates this field.)

5. Filter the results of Step 4 from the results of Step 3.

6. Optional: If you wish to filter or sort indications based on FDA-approval status, use the INDCTS_LBL. A
value of U means the indication is Unlabeled (i.e., not currently FDA-approved), and a value of L means
the indication is FDA-approved.

7. Optional: If you wish to filter or sort indications based on their degree of certainty, use the PRED_CODE.
See the INDM Predictor Code in your FDB MedKnowledge manual for more information on the nature of
this column.

8. Retrieve the INDM Indications Drug Description (INDCTS_DRUG_DESC) for the INDM Indication Code (
INDCTS) treatment options from the INDM Drug Description Table (RINDMDD0_INDCTS_DRUG_DESC)
and present this list to the end user.

9. Query the INDCTS column of the INDM GCN_SEQNO/Drug Indications Code Relation Table

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9.

(RINDMGC0_INDCTS_GCNSEQNO_LINK) using the INDCTS values found in Step 2 (or those INDCTS
codes that remain after filtering in Steps 6 and 7) to retrieve their related GCN_SEQNOs.

10. Optional: If you wish to eliminate obsolete products from the final results, query the GCN_SEQNO column
of the NDC Table (RNDC14_NDC_MSTR) and specify an Obsolete Date (OBSDTEC) value of zero. A
similar process could be used to filter the final results based on your local institutional formulary. This step
eliminates GCN_SEQNO values that relate exclusively to obsolete products.

11. Query the GCN_SEQNO column of theMED Medication ID Table (RMIID1_MED)using the filtered list of
GCN_SEQNOs that remain after Step 10 to retrieve the related MEDIDs.

12. Rearrange the results to form the following result set:

FML Search ICD Code (SEARCH_ICD_CD)
FML Navigation Code (FML_NAV_CODE) from Step 1
FML Related DXIDs (RELATED_DXID)
MED Medication ID (MEDID)
INDM Labeled Code (INDCTS_LBL)

Part 2: Retrieve descriptions for the codes found in Part 1

Part 2 retrieves plain-english descriptions for the information found in part 1. However, part 2 ignores the
GCN_SEQNO because its description is not necessary to display MEDIDs to the end-user.

1. Query the ICD Code Description (ICD_DESC) column of the FML ICD Code Description Table
(RFMLINM1_ICD_DESC) using the Search ICD Code (SEARCH_ICD_CD) from Part 1 to retrieve the
description for each SEARCH_ICD_CD.

2. Query the MEDID column of the MED Medication Table (RMIID2_MED) using the MEDID values found in
part 1 to retrieve each MEDIDs MED Medication Description ( MED_MEDID_DESC).

3. Follow the process described in the application about Finding DXID Descriptions and Synonyms in your
FDB MedKnowledge Manual to retrieve each DXIDs Primary Layman Name.

4. Query the FML_NAV_CODE column of the FML Navigation Description Table

(RFMLNVD0_NAVIGATION_DESC) to find each FML_NAV_CODEs FML Navigation Code Description (
FML_NAV_CODE_DESC).

5. Query the INDCTS_LBL column of the INDM Labeled Code Description Table
(RINDMLD0_LABELED_DESC) to find each INDCTS_LBL codes INDM Labeled Code Description (
INDLBLDESC).

Optionally, you may use an equivalent text description. For example, instead of Drug Indication
has been approved by the FDA you can use FDA-Approved.

Part 3: Sort the products based on how their indications relate to the initial search condition

Part 3 sorts the data found in part 1 and part 2 based on how the drug indications relate to the initial condition.

1.

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1. Sort the drugs from part 2 based on their FML_NAV_CODE_DESC. Construct a string to present to the
end user that loosely follows these guidelines:
If FML_NAV_CODE_DESC = Equal; The following drugs are indicated for the management of [
DXID_SYN_DESC100].
If FML_NAV_CODE_DESC = Broader or Narrower; The following drugs are indicated for the
management of [DXID_SYN_DESC100], a condition related to the initial search condition [Initial
Search Conditions DXID_SYN_DESC100].

2. Conclude the application by displaying the drugs to the end-user.

This process will return duplicate strengths, routes, and dosage forms for drugs of the same
medication name. If you wish to narrow the results down to eliminate these types of duplicates,
navigate to a less-specific Medication Name Concept. See the MED Applications in your FDB
MedKnowledge manual for more information on navigating between the various medication
concepts.

You can also sort by specific therapeutic class (HIC3) or Enhanced Therapeutic Classification
(ETC).

ExampleRetrieving Drugs Indicated for a Selected ConditionUsing the Exclusion Table to Refine the Treatment
Options

For purposes of demonstrating this application, the following scenario is used: A pregnant patient is
diagnosed with hypertension (ICD-9-CM code 642.00) and a physician would like to prescribe a medication to
treat the hypertension that can be safely administered to this pregnant patient.

Part 1: Retrieve MEDIDs and specific indication information

Part 1 builds a list of MEDIDs indicated for the initial condition (or one of its related conditions). It also gathers
other pieces of information for use in later parts of this example.

1. Query the FML ICD Search Table (RFMLISR1_ICD_SEARCH) for the FML Related DxID (
RELATED_DXID) and the FML Navigation Code (FML_NAV_CODE) where:
the Search ICD Code(s) (SEARCH_ICD_CD) equals the 642.00
the ICD Code Type (ICD_CD_TYPE) column equals 01
the FML Clinical Module Code (FML_CLIN_CODE) equals 01

SEARCH_ICD_CD ICD_CD_TYPE RELATED_DXID FML_CLIN_CODE FML_NAV_CODE

642.00 01 00001432 01 03

642.00 01 00002543 01 03

642.00 01 00002553 01 03

642.00 01 00002554 01 03

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642.00 01 00002556 01 03

642.00 01 00003446 01 03

The Related DxID (RELATED_DXID) will be used in the next step to retrieve related
indications.
The FML_CLIN_CODE value of 01 restricts DxID semantic neighborhood results to
indication information.
The FML Navigation Code (FML_NAV_CODE) describes how the SEARCH_DXID relates
to the RELATED_DXID. It will be used during Part 3 of this application.

2. Query the DXID column of the INDM Master Table (RINDMMA2_INDCTS_MSTR) using each of the DXID
values found in Step 1 to retrieve their INDM Indication Codes (INDCTS) and INDM Labeled Code (
INDCTS_LBL).

SEARCH_ICD_ ICD_CD_TYPE RELATED_DXI FML_CLIN_CO INDCTS INDCTS_LBL

CD D DE

... ... ... ... ... ...

642.00 01 00001432 01 1141 L

642.00 01 00001432 01 1142 L

642.00 01 00001432 01 1144 L

642.00 01 00001432 01 1145 L

642.00 01 00001432 01 1146 L

642.00 01 00001432 01 1147 L

642.00 01 00001432 01 1160 L

642.00 01 00001432 01 1205 L

642.00 01 00001432 01 1215 L

642.00 01 00001432 01 1226 L

642.00 01 00001432 01 1228 L

... ... ...

642.00 01 00001432 01 1751 L

... ... ...

3. Retrieve the INDM Labeled Code (INDCTS_LBL). Use the INDCTS_LBL value of P to filter out proxy
indications. A value of P means the indication is a Proxy indication (used to infer patient diagnoses
exclusively for contraindication checking algorithm). See the INDM Proxy Indicator section in your FDB
MedKnowledge manual for more information on this column. Optionally, you may perform additional

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filtering and sorting using the INDM Labeled Code (INDCTS_LBL) (see Step 6) or the INDM Predictor
Code (PRED_CODE) (see Step 7) at this time.

4. Query the FML ICD Search Exclusion Table (RFMLISX0_ICD_SEARCH_EXCLUSION) with the following
fields from Step 2:
FML Search ICD Code (SEARCH_ICD_CD)
ICD Code Type (ICD_CD_TYPE)
FML Related DXIDs (RELATED_DXID)
FML Clinical Module Code (FML_CLIN_CODE_DESC)
Clinical Drug Group (CLIN_DRUG_GROUP) (In this application, the INDCTS populates this field.)

SEARCH_ICD_CD ICD_CD_TYPE RELATED_DXID FML_CLIN_CODE CLIN_DRUG_GR

OUP

642.00 01 00001432 01 1228

642.00 01 00001432 01 1751

In this example, CLIN_DRUG_GROUP 1228 (valsartan) and 1751 (valsartan, hydrochlorothiazide)

appear as exclusions.

5. Filter the results of Step 4 from the results of Step 3, as shown below.

SEARCH_ICD_ ICD_CD_TYPE RELATED_DXI FML_CLIN_CO INDCTS INDCTS_LBL

CD D DE

... ... ... ... ... ...

642.00 01 00001432 01 1141 L

642.00 01 00001432 01 1142 L

642.00 01 00001432 01 1144 L

642.00 01 00001432 01 1145 L

642.00 01 00001432 01 1146 L

642.00 01 00001432 01 1147 L

642.00 01 00001432 01 1160 L

642.00 01 00001432 01 1205 L

642.00 01 00001432 01 1245 L

642.00 01 00001432 01 1226 L

... ... ...

6. Optional: If you wish to filter or sort indications based on FDA-approval status, use the INDCTS_LBL. A
value of U means the indication is Unlabeled (i.e., not currently FDA-approved), and a value of L means
the indication is FDA-approved. This example does not filter any results.

7.

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7. Optional: If you wish to filter or sort indications based on their degree of certainty, use the PRED_CODE.
See the INDM Predictor Code in your FDB MedKnowledge manual for more information on the nature of
this column. This example does not filter any results.

8. Retrieve the INDM Indications Drug Description (INDCTS_DRUG_DESC) for the INDM Indication Code (
INDCTS) treatment options from the INDM Drug Description Table (RINDMDD0_INDCTS_DRUG_DESC)
and present this list to the end user.

INDCTS INDCTS_DRUG_DESC INDCTS_LBL

... ...

1141 NIFEDIPINE (EXTENDED L

RELEASE)

1142 DILTIAZEM (EXT-REL) L

1144 NICARDIPINE(SUST REL) L

1145 ISRADIPINE (EXTENDED L

RELEASE)

1146 FELODIPINE(SUST REL) L

1147 NISOLDIPINE(SUST REL) L

1160 TRANDOLAPRIL L

1205 ENALAPRILAT L

1215 TRANDOLAPRIL,VERAPAMIL L

1226 ENALAPRIL L
MALEATE,FELODIPINE

...

9. In this example, Nifedipine (Extended Release) (INDCTS = 1141) is selected. Query the INDCTS column
of the INDM GCN_SEQNO/Drug Indications Code Relation Table
(RINDMGC0_INDCTS_GCNSEQNO_LINK) using the INDCTS values found in Step 2 (or those INDCTS
codes that remain after filtering in Steps 6 and 7) to retrieve their related GCN_SEQNOs. The following
GCN_SEQNOs represent a small sample from the resulting set; the remainder of this application will only
use the following GCN_SEQNOs:

INDCTS INDCTS_LBL GCN_SEQNO

1141 L 11792

1141 L 12059

1141 L 12060

1141 L 12061

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1141 L 17309

1141 L 17310

1141 L 17312

1141 L 19932

1141 L 20551

1141 L 20616

1141 L 20617

1141 L 20618

1141 L 28395

1141 L 41326

1141 L 41327

1141 L 41762

Please note that your results will probably outnumber this example applications results.

10. Optional: If you wish to eliminate obsolete products from the final results, query the GCN_SEQNO column
of the NDC Table (RNDC14_NDC_MSTR) and specify an Obsolete Date (OBSDTEC) value of zero. A
similar process could be used to filter the final results based on your local institutional formulary. This step
eliminates GCN_SEQNO values that relate exclusively to obsolete products.

11. Query the GCN_SEQNO column of theMED Medication ID Table (RMIID1_MED)using the filtered list of
GCN_SEQNOs that remain after Step 10 to retrieve the related MEDIDs.

GCN_SEQNO MEDID INDCTS INDCTS_LBL

020616 00150971 1141 L

012061 00174216 1141 L

012059 00200428 1141 L

020617 00227404 1141 L

020618 00233862 1141 L

012060 00283789 1141 L

The example above is filtered for generically named packaged products only (MED_NAME_SOURCE_CD
= 2).

12. Rearrange the results to form the following result set:

FML Search ICD Code (SEARCH_ICD_CD)

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12.

FML Navigation Code (FML_NAV_CODE) from Step 1

FML Related DXIDs (RELATED_DXID)
MED Medication ID (MEDID)
INDM Labeled Code (INDCTS_LBL)

SEARCH_ICD_CD FML_NAV_CODE RELATED_DXID MEDID INDCTS_LBL

642.00 03 00001432 00150971 L

642.00 03 00001432 00174216 L

642.00 03 00001432 00200428 L

642.00 03 00001432 00227404 L

642.00 03 00001432 00233862 L

642.00 03 00001432 00283789 L

Part 2: Retrieve descriptions for the codes found in Part 1

Part 2 retrieves descriptions for the information found in part 1. However, part 2 ignores the GCN_SEQNO
because its description is not necessary to display MEDIDs to the end-user.

1. Query the ICD Code Description (ICD_DESC) column of the ICD Description Table
(RFMLINM1_ICD_DESC) using the Search ICD Code (SEARCH_ICD_CD) from Part 1 to retrieve the
description for each SEARCH_ICD_CD.

ICD_DESC FML_NAV_CODE RELATED_DXID MEDID INDCTS_LBL

ESSEN HYPERTEN 03 00001432 00150971 L

PREG-UNSP

ESSEN HYPERTEN 03 00001432 00174216 L

PREG-UNSP

ESSEN HYPERTEN 03 00001432 00200428 L

PREG-UNSP

ESSEN HYPERTEN 03 00001432 00227404 L

PREG-UNSP

ESSEN HYPERTEN 03 00001432 00233862 L

PREG-UNSP

ESSEN HYPERTEN 03 00001432 00283789 L

PREG-UNSP

2. Query the MEDID column of theMED Medication Table (RMIID1_MED)using the MEDID values found in
part 1 to retrieve each MEDIDs MED Medication Description ( MED_MEDID_DESC).

ICD_DESC FML_NAV_CODE RELATED_DXID MED_MEDID_DES INDCTS_LBL

C

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ESSEN HYPERTEN 03 00001432 nifedipine ER 30 mg L

PREG-UNSP 24 hr Tab

ESSEN HYPERTEN 03 00001432 nifedipine ER 90 mg L

PREG-UNSP Tab

ESSEN HYPERTEN 03 00001432 nifedipine ER 30 mg L

PREG-UNSP Tab

ESSEN HYPERTEN 03 00001432 nifedipine ER 60 mg L

PREG-UNSP 24 hr Tab

ESSEN HYPERTEN 03 00001432 nifedipine ER 90 mg L

PREG-UNSP 24 hr Tab

ESSEN HYPERTEN 03 00001432 nifedipine ER 60 mg L

PREG-UNSP Tab

3. Follow the process described in the application about Finding DXID Descriptions and Synonyms in your
FDB MedKnowledge Manual to retrieve each DXIDs Primary Layman Name.

ICD_DESC FML_NAV_CODE DXID_SYN_DESC MED_MEDID_DES INDCTS_LBL

100 C

ESSEN HYPERTEN 03 High Blood Pressure nifedipine ER 30 mg L

PREG-UNSP 24 hr Tab

ESSEN HYPERTEN 03 High Blood Pressure nifedipine ER 90 mg L

PREG-UNSP Tab

ESSEN HYPERTEN 03 High Blood Pressure nifedipine ER 30 mg L

PREG-UNSP Tab

ESSEN HYPERTEN 03 High Blood Pressure nifedipine ER 60 mg L

PREG-UNSP 24 hr Tab

ESSEN HYPERTEN 03 High Blood Pressure nifedipine ER 90 mg L

PREG-UNSP 24 hr Tab

ESSEN HYPERTEN 03 High Blood Pressure nifedipine ER 60 mg L

PREG-UNSP Tab

4. Query the FML_NAV_CODE column of the FML Navigation Description Table

(RFMLNVD0_NAVIGATION_DESC) to find each FML_NAV_CODEs FML Navigation Code Description (
FML_NAV_CODE_DESC).

ICD_DESC FML_NAV_CODE_ DXID_SYN_DESC MED_MEDID_DES INDCTS_LBL

DESC 100 C

ESSEN HYPERTEN Narrower High Blood Pressure nifedipine ER 30 mg L

PREG-UNSP 24 hr Tab

ESSEN HYPERTEN Narrower High Blood Pressure nifedipine ER 90 mg L

PREG-UNSP Tab

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ESSEN HYPERTEN Narrower High Blood Pressure nifedipine ER 30 mg L

PREG-UNSP Tab

ESSEN HYPERTEN Narrower High Blood Pressure nifedipine ER 60 mg L

PREG-UNSP 24 hr Tab

ESSEN HYPERTEN Narrower High Blood Pressure nifedipine ER 90 mg L

PREG-UNSP 24 hr Tab

ESSEN HYPERTEN Narrower High Blood nifedipine ER 60 mg L

PREG-UNSP Pressure Tab

5. Query the INDCTS_LBL column of the INDM Labeled Code Description Table
(RINDMLD0_LABELED_DESC) to find each INDCTS_LBL codes INDM Labeled Code Description (
INDLBLDESC).

ICD_DESC FML_NAV_CODE_ DXID_SYN_DESC MED_MEDID_DES INDLBLDESC

DESC 100 C

ESSEN HYPERTEN Narrower High Blood Pressure nifedipine ER 30 mg Drug Indication has
PREG-UNSP 24 hr Tab been approved by
the FDA

ESSEN HYPERTEN Narrower High Blood Pressure nifedipine ER 90 mg Drug Indication has
PREG-UNSP Tab been approved by
the FDA

ESSEN HYPERTEN Narrower High Blood Pressure nifedipine ER 30 mg Drug Indication has
PREG-UNSP Tab been approved by
the FDA

ESSEN HYPERTEN Narrower High Blood Pressure nifedipine ER 60 mg Drug Indication has
PREG-UNSP 24 hr Tab been approved by
the FDA

ESSEN HYPERTEN Narrower High Blood Pressure nifedipine ER 90 mg Drug Indication has
PREG-UNSP 24 hr Tab been approved by
the FDA

ESSEN HYPERTEN Narrower High Blood nifedipine ER 60 mg Drug Indication has

PREG-UNSP Pressure Tab been approved by
the FDA

Optionally, you may use an equivalent text description. For example, instead of Drug Indication
has been approved by the FDA you can use FDA-Approved. The example output later in this
application uses descriptions that differ from the INDLBLDESC value.

Part 3: Sort the products based on how their indications relate to the initial search condition

Part 3 sorts the data found in part 1 and part 2 based on how the drug indications relate to the initial condition.
Additionally, this part of the application presents you with an optional step that concludes the example without
grouping the drugs by their therapeutic class codes.

1.

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1. Sort the drugs from part 2 based on their FML_NAV_CODE_DESC. Construct a string to present to the
end user that loosely follows these guidelines:
If FML_NAV_CODE_DESC = Equal; The following drugs are indicated for the management of [
DXID_SYN_DESC100].
If FML_NAV_CODE_DESC = Broader or Narrower; The following drugs are indicated for the
management of [DXID_SYN_DESC100], a condition related to the initial search condition [Initial
Search Conditions ICD_DESC].

2. Conclude the application by displaying the drugs to the end-user.

This process will return duplicate strengths, routes, and dosage forms for drugs of the same
medication name. If you wish to narrow the results down to eliminate these types of duplicates,
navigate to a less-specific Medication Name Concept. See the MED Applications in your FDB
MedKnowledge manual for more information on navigating between the various medication
concepts.

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Checking Inferred Patient Diagnoses for Drug-Disease Contraindications Associated with

Prospective Drug Therapy
This application illustrates how to use the Drug-Disease Contraindications Module (DDCM) along with the
Indications Module (INDM) to populate inferred patient diagnoses when patient problem list information is not
available, specifically for the purpose of screening a prescribed drug for drug-disease contraindications.

This example screens prescribed Adderall XR 5 mg 24 hour capsules (MEDID 00443812) for drug-disease
contraindications. No diagnosis information exists for the patient, so indications will be inferred based on the
patients current medication of Timoptic 0.25% Eye Drops (MEDID 00167659).

1. Find Timoptics Clinical Formulation ID (GCN_SEQNO) using its MEDID and the MED Medication Table
(RMIID1_MED).

MEDID GCN_SEQNO

00167659 007855

2. Find the INDM Indications Code (INDCTS) related to Clinical Formulation ID (GCN_SEQNO) 007855 using
the INDM GCN_SEQNO/Indications Code Relation Table (RINDMGC0_INDCTS_GCNSEQNO_LINK).

GCN_SEQNO INDCTS

007855 00929

3. Retrieve each INDCTS codes set of INDM Predictor Code (PRED_CODE) and FML Disease Identifier (
DXID) using the INDM Master Table (RINDMMA2_INDCTS_MSTR). Those DXID codes that have a
PRED_CODE of 1 or 2 (certain or somewhat certain, respectively) represent likely indications based on the
patients current medication(s).

INDCTS DXID PRED_CODE

00929 00001205 1

DXIDs with a PRED_CODE of 3 represent conditions that may exist based on current medication,
but they have less predictive value than PRED_CODE 1 or 2. You may want to include these
DxIDs (indications) or otherwise take this into account in your end-user message.

4. For each DXID retrieved in the previous step, query the FML Disease Identifier (DxID) Search Table
(RFMLDSR0_DXID_SEARCH) and retrieve the Related DxID (RELATED_DXID) and FML Navigation
Code (FML_NAV_CODE) values. Use the DXID from the previous step as the Search DxID (
SEARCH_DXID). Retrieve only those RELATED_DXID values which have an FML Clinical Module Code (
FML_CLIN_CODE) value of 03 (Drug-Disease Contraindications Module).

SEARCH_DXID RELATED_DXID FML_CLIN_CODE FML_NAV_CODE

00001205 00001205 03 01

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00001205 00001211 03 01

The FML Navigation Code describes the relationship between the two DxID values. You will use it
later in this process when you compile information and construct an alert message.

Not every DxID appears as a SEARCH_DXID.

5. Follow the steps detailed in the Retrieving a List of Drug Contraindications application of the DDCM
chapter to find DDCM information for the new medication being prescribed. The results of this process
when carried out for Adderall are summarized below.

DDXCN DDXCN_SL DXID DXID_DESC100

50023 1 00000580 Hyperthyroidism

50023 2 00000962 Psychotic Disorder

50023 2 00001001 Drug Dependence

50023 1 00001005 Drug Abuse

50023 2 00001012 Gilles De La Tourette

Syndrome

50023 1 00001018 Feeling Agitated

50023 1 00001211 Glaucoma

50023 3 00001432 Hypertension

50023 1 00001594 Disease of Cardiovascular

System

50023 1 00001641 Severe Arteriosclerotic

Vascular Disease

50023 2 00003145 Anorexia

50023 1 00003452 Lactating Mother

50023 1 00004739 Moderate Hypertension

50023 1 00013488 Structural Disorder of

Heart

6. Construct a list of the matching DXID values between the set of RELATED_DXID values found in step 4
(signifying indications inferred from the patients active medications, in this case Timoptic), and the set of
DXID values found in step 5 (signifying DDCM contraindications for Adderall). Also take note of the
SEARCH_DXID and related FML_NAV_CODE values (found in step 4), and the related DDXCN_SL
values (found in step 5). The compiled list below (in this case a single DxID) summarizes the DxID
matches for this example.

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Search DXID Related DXID Navigation Code Severity Level

(from step 4) (from step 4 and step 5) (from step 4) (from step 5)

00001205 00001211 03 1

7. Retrieve the FML 100-character Description (DXID_DESC100) for each SEARCH_DXID and DXID in the
previous step using the FML Disease Identifier (DxID) Table (RFMLDX0_DXID).

DXID DXID_DESC100

00001205 Open Angle Glaucoma

00001211 Glaucoma

8. Retrieve the MED Medication Description (MED_MEDID_DESC) for both Adderall and Timoptic using the
RMIID1_MED table.

MEDID MED_MEDID_DESC

00167659 Timoptic 0.25 % Eye Drops

00443812 Adderall XR 5 mg 24 hr Cap

This step is only required if you intend to display medication descriptions in the alert message.

9. Construct each of the following messages that applies to the results of step 6 using the information found
above. When the FML_NAV_CODE does not equal 01, you must display two DxID descriptions. The
Inferred DXID_DESC100 denotes an inferred indication, and the Matched Related DXID_DESC100
denotes an indication related to prescribed therapy.
If FML_NAV_CODE = 01 and
DDXCN_SL = 1 then display, Your patient has an inferred diagnosis of [Inferred
DXID_DESC100] based on your patient's current use of [Current Medication
MED_MEDID_DESC]. The drug [Prescribed Medication MED_MEDID_DESC] is
contraindicated in patients with [Inferred DXID_DESC100].
DDXCN_SL = 2 then display, Your patient has an inferred diagnosis of [Inferred
DXID_DESC100] based on your patient's current use of [Current Medication
MED_MEDID_DESC]. Patients with [Inferred DXID_DESC100] should be carefully evaluated
before initiating therapy and monitored closely while taking [Prescribed
MED_MEDID_DESC].
DDXCN_SL = 3 then display, Your patient has an inferred diagnosis of [Inferred
DXID_DESC100] based on your patient's current use of [Current Medication
MED_MEDID_DESC]. Patients with [Inferred DXID_DESC100] should be carefully monitored
during therapy with [Prescribed MED_MEDID_DESC].
If FML_NAV_CODE = 02 or FML_NAV_CODE = 03 and
DDXCN_SL = 1 then display, Your patient has an inferred diagnosis of [Inferred

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DXID_DESC100] based on your patient's current use of [Current Medication

MED_MEDID_DESC]. This condition is similar to [Matched Related DXID_DESC100] which
is a contraindication for the use of [Prescribed MED_MEDID_DESC].
DDXCN_SL = 2 then display, Your patient has an inferred diagnosis of [Inferred
DXID_DESC100] based on your patient's current use of [Current Medication
MED_MEDID_DESC]. This condition is similar to [Matched Related DXID_DESC100], which
should be carefully evaluated before initiating therapy, and patients should be monitored
closely while taking [Prescribed MED_MEDID_DESC].
DDXCN_SL = 3 then display, Your patient has an inferred diagnosis of [Inferred
DXID_DESC100] based on your patient's current use of [Current Medication
MED_MEDID_DESC]. This condition is similar to, [Matched Related DXID_DESC100], and
patients should be carefully monitored during therapy with [Prescribed MED_MEDID_DESC
].

The sample message templates above are suggestions based on interpretations of

the DDXCN_SL descriptions. Customers can modify these warnings as they see fit.

10. Display the results to the end-user.

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Detecting Possible Drug-Related Iatrogenic Diseases

This application illustrates how to use the INDM module in conjunction with the Side Effects Module (SIDE) 2.0
to help identify cases when a prescribed drug may be treating a drug-related Iatrogenic disease. If a patients
prospective drug indications match current drug side effects, it is possible that the prospective drug is being
prescribed to treat problems caused by the patients current drug (see illustration).

In cases like these, it may be appropriate to modify prescribed therapy for the drug causing the side effect rather
than simply prescribing a second drug to treat the drug-related problems or side effects.

You can use this application in cases where neither drug is truly current or prospective (for example, to
compare two drugs on a patient profile). In these cases, carry out the steps of this application iteratively
for each drug, each time using one drug as the current drug and the other as the prospective drug.

This example uses Prozac 20MG capsule (Clinical Formulation ID [GCN_SEQNO] 046214) as the patients
current drug, with a prospective drug of Viagra 50MG tablet (Clinical Formulation ID [GCN_SEQNO] 039190).

Part 1: Build a Side Effects Table for the Current Drug

Part 1 builds a table of all side effects related to the patients current drugs.

1. Query the GCN_SEQNO column of the SIDE GCN_SEQNO/Drug Side Effect Code Relation Table
(RSIDEGC0_GCNSEQNO_LINK) using the current drugs Clinical Formulation ID (GCN_SEQNO) value to
retrieve the related SIDE Side Effects Codes (SIDE).

GCN_SEQNO SIDE

046214 00951

2. Query the SIDE column of the SIDE Master Table (RSIDEMA3_MSTR) using the SIDE values found in
step 1 to retrieve their related FML Disease Identifier (DXID). The data below only reflects a portion of this
steps results.

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GCN_SEQNO SIDE DXID

046214 00951 00000967

046214 00951 00000985

... ... ...

046214 00951 00003387

046214 00951 00003410

3. Store each distinct combination of the Clinical Formulation ID (GCN_SEQNO), SIDE, and DXID codes in a
Temporary Side Effects Table for later use.

GCN_SEQNO SIDE DXID

046214 00951 00000607

046214 00951 00000736

... ... ...

046214 00951 00003387

046214 00951 00003410

Part 2: Build an Indications Table for the Prospective Drug

Part 2 builds a table of all indications related to the prospective drugs

1. Query the GCN_SEQNO column of the INDM GCN_SEQNO/Indications Code Relation Table
(RINDMGC0_INDCTS_GCNSEQNO_LINK) using the drugs Clinical Formulation ID (GCN_SEQNO) value
to retrieve the related INDM Indication Code (INDCTS).

GCN_SEQNO INDCTS

039190 01343

Some Clinical Formulation IDs (GCN_SEQNOs) have zero related INDCTS codes; you may want
to take this into account when you program your application.

2. Query the INDCTS column of the INDM Master Table (RINDMMA2_INDCTS_MSTR) using each INDCTS
value from step 1 to retrieve the related DXIDs. You can also retrieve the INDM Predictor Code (
PRED_CODE) at this time to improve the sensitivity of the inferred indication.

GCN_SEQNO INDCTS DXID

039190 01343 00002383

3. Query the FML Search DxID (SEARCH_DXID) column of the FML Disease Identifier (DxID) Search Table
(RFMLDSR0_DXID_SEARCH) using the DXID values found in step 2 to retrieve their FML Related DxID (

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3.

RELATED_DXID) valuesif any existand FML Navigation Code (FML_NAV_CODE) values. Specify an
FML Clinical Code (FML_CLIN_CODE) value of 02 to restrict the results to side effect information.

GCN_SEQNO INDCTS SEARCH_DXID RELATED_DXID FML_NAV_CODE

039190 01343 00002383 00002383 01

4. Store each distinct combination of the Clinical Formulation ID (GCN_SEQNO), INDCTS, SEARCH_DXID,
RELATED_DXID, and FML_NAV_CODE codes in a Temporary Indications Table for later use.

GCN_SEQNO INDCTS SEARCH_DXID RELATED_DXID FML_NAV_CODE

039190 01343 00002383 00002383 01

Part 3: Compare Side Effects to Indications and Display Results

1. Join the Temporary Side Effects Table from part 1 and the Temporary Indications Table from part 2.
Retrieve all records from the Temporary Side Effects Table where:
The Clinical Formulation ID (GCN_SEQNO) from the Temporary Side Effects Table does not equal
the Clinical Formulation ID (GCN_SEQNO) from the Temporary Indications Table, and
The DXID from the Temporary Side Effects Table equals the RELATED_DXID from the Temporary
Indications Table

This query returns current drugs whose side effects match prospective drug indications.

GCN_SEQNO SIDE DXID RELATED_DXID FML_NAV_CODE

046214 00951 00002383 00002383 01

2. Follow the process described in Finding DXID Descriptions and Synonyms to retrieve each
RELATED_DXIDs Primary Professional Name.

RELATED_DXID DXID_DESC100

00002383 Erectile Dysfunction

If the RELATED_DXID and SEARCH_DXID values differ, keep track of which description is the
related DxID description, and which is the search DxID description. You will use both descriptions
in step 4 below.

3. Optional: Query the SIDE Master Table (RSIDEMA3_MSTR) using the SIDE value to retrieve any of the
various Side Effect columns. See the Side Effects Module (SIDE) 2.0 chapter for more information about
the various side effect attributes.

4. Construct a string to present to the end user that loosely follows these guidelines:
If FML_NAV_CODE = 01; [DXID_DESC100] appears as a possible side effect of [Current Drug]. [
Prospective Drug] is indicated in patients with [DXID_DESC100], therefore it may be appropriate to

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make sure that [Prospective Drug] has not been prescribed solely to treat a drug-related iatrogenic
disease caused by [Current Drug].
If FML_NAV_CODE = 02 or 03; [Search DXID_DESC100] appears as a possible side effect of [
Current Drug]. Because [Prospective Drug] is indicated in patients with [Related DXID_DESC100],
which is related to [Search DXID_DESC100], it may be appropriate to make sure that [Prospective
Drug] has not been prescribed solely to treat a drug-related iatrogenic disease caused by [ Current
Drug].

5. Display the final results.

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INDM ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

Indications Module Tables

Indications Module ERD

Indications Module Tables

INDM Drug Description Table
INDM GCN_SEQNO/Indications Code Relation Table
INDM Labeled Code Description Table
INDM Master Table
INDM Predictor Code Description Table
INDM Routed Generic Table
INDM Routed Medication Table

Indications Module ERD

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INDM Drug Description Table

Table Name RINDMDD0_INDCTS_DRUG_DESC

Revision Activity add.03-14-2002

Purpose Relates the INDM Indications Code to a text description of

the drug associated with it.

Key Column Name Column Format Length Picture

Description

P INDCTS INDM Indications N 5 9(5)

Code

INDCTS_DRUG_ INDM Indications AN 100 X(100)

DESC Drug Description

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INDM GCN_SEQNO Indications Code Relation Table

Table Name RINDMGC0_INDCTS_GCNSEQNO_LINK

Revision Activity original

Purpose Links a drug to a list of indications.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF INDCTS INDM Indications N 5 9(5)

Code

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INDM Labeled Code Description Table

Table Name RINDMLD0_LABELED_DESC

Revision Activity add.03-14-2002

Purpose Relates the INDM Labeled Code to its text description.

Key Column Name Column Format Length Picture

Description

P INDCTS_LBL INDM Labeled AN 1 X(1)

Code

INDLBLDESC INDM Labeled AN 90 X(90)

Code Description

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INDM Master Table

Table Name RINDMMA2_INDCTS_MSTR

Revision Activity rev.03-14-2002

Purpose Associates a drug product to an indication and provides

attributes of that relationship.

Key Column Name Column Format Length Picture

Description

P INDCTS INDM Indications N 5 9(5)

Code

P INDCTS_SN INDM Sequence N 2 9(2)

Number

F INDCTS_LBL INDM Labeled AN 1 X(1)

Code

F FDBDX First Databank AN 9 X(9)

Disease Code

F DXID FML Disease N 8 9(8)

Identifier (Stable
ID)

PROXY_IND INDM Proxy AN 1 X(1)

Indicator

F PRED_CODE INDM Predictor AN 1 X(1)

Code

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INDM Predictor Code Description Table

Table Name RINDMPD0_PREDICTOR_DESC

Revision Activity add.03-14-2002

Purpose Relates the INDM Predictor Code to its text description.

Key Column Name Column Format Length Picture

Description

P PRED_CODE INDM Predictor AN 1 X(1)

Code

PREDDESC INDM Predictor AN 90 X(90)

Code Description

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INDM Routed Generic Table

Table Name RINDMRG0_ROUTED_GEN_LINK

Revision Activity original

Purpose Links a routed generic to an indication.

Key Column Name Column Format Length Picture

Description

PF ROUTED_GEN_I Routed Generic N 8 9(8)

D Identifier

PF INDCTS INDM Indications N 5 9(5)

Code

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INDM Routed Medication Table

Table Name RINDMRM0_ROUTED_MED_LINK

Revision Activity add.07-01-2002

Purpose Links the routed medication to an indication.

Key Column Name Column Format Length Picture

Description

PF ROUTED_MED_I MED Routed N 8 9(8)

D Medication ID
(Stable ID)

PF INDCTS INDM Indications N 5 9(5)

Code

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Interactions
Drug-Drug Interaction Module (DDIM)
Drug-Drug Interaction Module for Consumers (DDIM-C)
Drug-Food Interaction Module (DFIM)
Drug-Food Interaction Module for Consumers (DFIM-C) 1.0

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Drug-Drug Interaction Module

Drug-Drug Interaction Module (DDIM) 3.3

General Information
Drug-Drug Interaction Module Editorial Policies
Applications
ERD and Technical Specifications

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DDIM General Information

The General Information section contains high-level information about the module.

Overview
Definitions
Drug-Drug Interaction
Concepts
Finding Drug-Drug Interactions
DDI_MONOX
DDI_CODEX
Interaction Monographs
The Drug-Drug Expanded Interaction Code
The Drug-Drug Interaction Description
The Drug-Drug Interaction Expanded Monograph Number
The Drug-Drug Interaction Clinical Effect Code
The Drug-Drug Interaction Severity Levels
The Reference Category Line Identifiers

Overview

The First Databank (FDB) Drug-Drug Interaction Module (DDIM) for professionals assists in identifying and
preventing drug interactions between two administered drug products. DDIM supports marketable drug products
and reports only the most clinically significant interactions.

Drug knowledge is aggregated at the Clinical Formulation ID (GCN_SEQNO), Routed Medication ID (

ROUTED_MED_ID), and the Routed Generic ID (ROUTED_GEN_ID) levels in the FDB knowledge base.
Under certain circumstances, aggregated drug knowledge may not apply to all related packaged
products; more specific information may be found within the DDIM monograph for the interaction.

Definitions

This section defines important terms related to the module that users should understand. Some industry terms
that have a specific connotation in regards to the module may also be defined.

Drug-Drug Interaction

A pharmacologic response in a patient who receives two agents that differs from the expected pharmacologic
response had the patient taken each drug separately. This definition includes synergistic and antagonistic effects,
as well as some additive side effects. An additive side effect (as defined by DDIM and DDIM-C editorial policy) is
a potentially life-threatening side effect. This definition includes side effects caused by non-contraindicated drug
combinations to concurrent therapy, previously only identified in FDBs Side Effects Module (SIDE).

Concepts

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This section describes concepts and database elements that are important for understanding the module.

Finding Drug-Drug Interactions

DDIM codifies drug-drug interactions using the Drug-Drug Expanded Interaction Code ( DDI_CODEX).

There are two options for determining if an interaction exists between two drug products (drug1 and drug2): The
DDI_MONOX equal value method, which uses the Drug-Drug Interaction Expanded Monograph Number (
DDI_MONOX), and the DDI_CODEX sum value method, which uses the DDI_CODEX.

Your requirements will likely determine which method will work best for you. The DDI_MONOX equal value
method can be performed strictly utilizing database joins. The DDI_CODEX sum value method requires iterative
logic and data structures. Both yield the same results and neither method is more or less correct than the other.

DDI_MONOX

For the DDI_MONOX equal value method, if BOTH of the following are true, there is an interaction:

(DDI_MONOX of drug1) equals [=] (DDI_MONOX of drug2)

(DDI_CODEX of drug1) does not equal [not =] (DDI_CODEX of drug2)

Drug products can have more than one DDI_MONOX value. Therefore, to identify an interaction between two
drugs, take all the DDI_MONOX values associated to each drug product and see if any DDI_MONOX values
match. The corresponding DDI_CODEX values must be different for there to be an interaction.

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For example:

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DDI_CODEX

For the DDI_CODEX sum value method, if the following is true, there is an interaction:

(DDI_CODEX of drug1) plus [+] (DDI_CODEX of drug2) equals [=] 32,000

Drug products can have more than one DDI_CODEX value. Therefore, to identify an interaction between two
drugs, take the sum of each DDI_CODEX value associated to each drug product and see if any pairs add up to
32,000.

For Example:

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DDI_CODEX values are associated to drug products at the following levels:

MedKnowledge Concept Active Ingredient Interactions Inactive Ingredient Interactions

Clinical Formulation ID (GCN_SEQNO Yes No

)

Packaged Product (NDC) Yes Yes

Routed Medication Identifier (ROUTED Yes No

_MED_ID)

Routed Generic Identifier (ROUTED_G Yes No

EN_ID)

Inactive ingredient interactions that involve either two inactive ingredients, or one inactive ingredient and one
active ingredient, are supported at the NDC level only.

Interaction Monographs

Each drug-drug interaction has an interaction monograph, which provides detailed information about the given
drug interaction. Monographs provide:

Clinical significance
The mechanism of action
Clinical effects
Predisposing factors that may make the interaction more severe in certain patients
Patient management recommendations
Discussion sectionReferences to the primary literature. Reference citations are formatted as in the National
Library of Medicines MedLine

FDB recommends that you provide the entire DDIM monograph for a given interaction to the end-user.

The Drug-Drug Expanded Interaction Code

DDIM uses the Drug-Drug Expanded Interaction Code (DDI_CODEX) to identify drug-drug interactions, reference
interaction monographs, and supply additional interaction information. The DDI_CODEX and its text description,
the Drug-Drug Interaction Description (DDI_DES) column, reside in the Drug-Drug Interaction Master Table

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(RADIMMA5_MSTR).

DDI_CODEX values are associated with drugs at the following MedKnowledge concept levels using the following
MedKnowledge tables:

The Clinical Formulation ID (GCN_SEQNO) in the GCN_SEQNO/Drug-Drug Interaction Code Relation

Table (RADIMGC4_GCNSEQNO_LINK)
The National Drug Code/Packaged Product (NDC) in the DDIM NDC/Inactive Ingredient Interaction Code
Link Table (RDDIMIN0_NDC_INACTV_DDIM_LINK)
The MED Routed Medication ID (ROUTED_MED_ID) in the DDIM Routed Medication Table
(RDDIMRM0_ROUTED_MED_LINK)
The Routed Generic ID (ROUTED_GEN_ID) in the DDIM Routed Generic Table
(RDDIMRG0_ROUTED_GEN_LINK)

An interaction exists between two drugs if any two of their DDI_CODEX values add up to 32,000 or if any two of
the DDI_MONOX values matches and the corresponding DDI_CODEX values do not match. In addition to vital to
the drug-interaction identification process, the DDI_CODEX also provides access to other columns that offer
various types of interaction information (see the Drug-Drug Interaction Master Table [RADIMMA5_MSTR]).

DDIM accommodates up to 16,000 drug monographs, which can cover multiple pairs of interacting agents.

The Drug-Drug Interaction Description

The Drug-Drug Interaction Description (DDI_DES) contains a text description of the associated DDI_CODEX.
There are two different DDI_DES descriptions for each drug interaction, for example:

DDI_CODEX DDI_DES

01130 SELECTED XANTHINE DERIVATIVES/FLUVOXAMINE

30870 FLUVOXAMINE/SELECTED XANTHINE DERIVATIVES

Two descriptions exist for each drug-drug interaction; one for each DDI_CODEX value.

The Drug-Drug Interaction Expanded Monograph Number

Each Drug-Drug Interaction Expanded Monograph Number (DDI_MONOX) is associated with a DDIM monograph
in the Drug-Drug Interaction Monograph Text Table (RADIMMO5_MONO). DDIM Monographs explain drug-drug
interactions in greater detail and provide information references for end-users. FDB recommends that you allow
end-users to access the monographs at the time of drug interaction screening.

The RADIMMO5_MONO table contains one or more rows for each DDI_MONOX. A complete monograph
consists of all rows with the same DDI_MONOX number. Each row contains a line of descriptive text in the
Drug-Drug Interaction Monograph Text column (IAMTEXTN).

The rows are further categorized by type, such as Discussion text, Clinical Effects text, or Reference text, using
the Drug-Drug Interaction Monograph Line Identifier (IAMIDENTN). The texts sequence of appearance on the

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monograph is specified by the Drug-Drug Interaction Monograph Text Sequence Number ( ADI_MONOSN).
Finally, the Drug-Drug Interaction Reference Category Line Identifier (IAMREFCAT) column provides more
information about rows that have an IAMIDENTN type of R.

For example, the monograph for xanthine derivatives and fluvoxamine (DDI_MONOX 01130) contains 60 lines of
text. Here are the first 10 lines as they appear in the RADIMMO5_MONO table (sorted by ADI_MONOSN):

DDI_MONOX ADI_MONOSN IAMIDENTN IAMTEXTN IAMREFCAT

01130 001 T MONOGRAPH TITLE:

Selected Xanthine
Derivatives

01130 002 B

01130 003 L SEVERITY LEVEL:

3-Moderate
Interaction: Assess
the risk to the patient

01130 004 L and take action as

needed.

01130 005 B

01130 006 A MECHANISM OF

ACTION: Fluvoxamine
may inhibit the
metabolism of the
xanthine

01130 007 A derivatives by the

cytochrome P450-1A2
isoenzyme.(1,2)

01130 008 B

01130 009 E CLINICAL EFFECTS:

Concurrent use of
fluvoxamine and
xanthine derivatives

01130 010 E may result in elevated

levels of the xanthine
derivative and toxicity.

See the RADIMMO5_MONO, page 893 Technical Specification for descriptions of these columns. Displayed in a
more user-friendly format, the ten rows in the monograph above may appear like this:

ExampleSample of the Monograph Text for DDIM Monograph 01130

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MONOGRAPH TITLE: Selected Xanthine Derivatives

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: Fluvoxamine may inhibit the metabolism of the xanthine derivatives by the cytochrome
P450-1A2 isoenzyme.(1,2)
CLINICAL EFFECTS: Concurrent use of fluvoxamine and xanthine derivatives may result in elevated levels of the
xanthine derivative and toxicity.

The Drug-Drug Interaction Clinical Effect Code

The Drug-Drug Interaction Clinical Effect Code (ADI_EFFTC) provides an abbreviated version of a given
interactions clinical effect description, using the Drug-Drug Interaction/Clinical Effects Relation Table
(RADIMIE4_CLIN_EFFECTS_LINK). This code and its description column are located in the Drug-Drug
Interaction/Clinical Effects Description Table (RADIMEF0_CLIN_EFFECT).

The RADIMEF0_CLIN_EFFECT table

ADI_EFFTC ADI_EFFTXT

ADD Additive side effects form both drugs

ARF Adverse reaction of the former drug

ARL Adverse reaction of the latter drug

AVD Avoid concurrent use when possible

CEE Conflicting evidence exists for these drugs

CIS Contraindicated in some patients

DEF Decreased effect of the former drug

DEL Decreased effect of the latter drug

INF Increased effect of the former drug

INL Increased effect of the latter drug

MAR Adverse reaction with both drugs

MXF Mixed effects of the former drug

MXL Mixed effects of the latter drug

LBC Labeling conflicts between countries or products

The Drug-Drug Interaction Severity Levels

The Drug-Drug Interaction Severity Levels (DDI_SL) classify drug interactions based on their degree of patient
risk. DDI_SL values are associated with DDI_CODEX values in the Drug-Drug Interaction Master Table
(RADIMMA5_MSTR). Severity levels do not incorporate the level of documentation for an interaction.

Interactions have severity levels of 1, 2, 3, and 9, where 1 represents the highest patient risk potential. Because

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all of the interactions within the DDIM module are considered clinically significant, FDB does not recommend
entirely shutting off any severity levels of 1-3 during drug-drug interaction screening. FDB does recognize the
need for and encourages the use of different levels and styles of alerts setting for different end-users (e.g.
physicians, pharmacists, etc) and settings (e.g. inpatient, outpatient, etc).

DDI_SL Severity Level Description Severity Level Implications

1 Contraindicated Drug Combination This drug combination is

contraindicated and generally should
not be dispensed or administered to
the same patient.

2 Severe Interaction Action is required to reduce risk of

severe adverse interaction.

3 Moderate Interaction Assess risk to patient and take action

as needed.

9 Undetermined SeverityAlternative Assess risk to patient and take action

Therapy Interaction as needed.

Severity Level 1, Contraindicated Drug Combination

Drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label
warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of
clinical evidence or lack of clinical evidence to support the contraindication.

Severity Level 2, Severe Interaction

Interactions that produce serious consequences in most patients. However, monitoring and/or titrating the
agent(s) involved in severe interactions can significantly minimize the risk of adverse effects. If a drug products
label contains the phrase, concurrent use should be avoided, the interaction is assigned this severity level. The
drug combination may be absolutely contraindicated in some but not all patients, and the corresponding DDIM
monograph contains information on how to identify these patients. The DDIM monograph also includes drugs that
patients can take on a staggered schedule, but should never take at the same time. Actions required for severe
interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering
administration scheduling, and providing additional patient monitoring.

Severity Level 3, Moderate Interaction

Interactions of moderate severity. The clinician should assess the patients characteristics and take action as
needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both
agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring.

Severity Level 9, Undetermined Severity - Alternative Therapy Interaction

Interactions that involve alternative therapy agents. These interactions may exist between drugs and alternative
therapy agents, or between multiple alternative therapy agents.

FDB defines alternative drug therapy as therapies not subject to the documentation of safety and efficacy through
the United States Food and Drug Administration (FDA), such as a New Drug Application (NDA), an Abbreviated

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New Drug Application (ANDA), and so on. Alternative therapies include, but are not limited to,
phytopharmaceuticals (herbal agents), Homeopathics, Nutriceuticals, and Anthroposophics.

Undetermined Severity indicates that an interaction is possible, but its potential severity is unknown. Actions
required for undetermined severity interactions include, but are not limited to, discontinuing one or both agents,
adjusting dosage, altering administration scheduling, and additional patient monitoring.

Current DDIM version severity levels do not directly correspond to the significance levels used in DDIM
version 3.1, or in the obsolete DDIM version 3.0.

In the current DDIM version, Severity Levels 1 and 2 represent the most clinically significant interactions
(contraindications and severe interactions). In past the DDIM versions 3.0 and 3.1, the most clinically significant
interactions were contained in significance levels 1 and 3, depending on the amount of documentation available
to support the interaction.

The Reference Category Line Identifiers

FDB provides the Drug-Drug Interaction Reference Category Line Identifier (IAMREFCAT) to assist clinicians in
evaluating the quantity and type of documentation available for a given interaction. Each reference listed on an
interactions monograph has an associated IAMREFCAT value that describes the nature of the reference.

IAMREFCAT IAMREFCATD

1 Manufacturers Information

2 Human Clinical Trial

3 Case Report

4 Meeting Abstract

5 In vitro/Animal Study

6 Review article

Reference indicators should not be used to mask or turn off severity levels. Rather, you can utilize these
indicators to provide more detailed interaction alert messages.

Manufacturers information encompasses product labeling, Dear Healthcare Professional letters, and
correspondence between manufacturers and FDB. Human clinical trials encompass clinical trials of any size and
type (single-blind, double-blind, placebo and non-placebo controlled, controlled, non-controlled, etc).

Review articles are infrequently utilized in DDIM because they typically refer to the same references incorporated
in the DDIM monograph. Use of review articles is limited to those articles that draw new conclusions from
previous works.

Without accessing an interactions entire monograph, you can use the Drug-Drug Reference Category Indicators
provided in the Drug-Drug Interaction Master Table (RADIMMA5_MSTR) to quickly determine its available

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reference types. The following table lists the IAMREFCAT values and their associated reference category
indicator columns:

IAMREFCAT value Associated RADIMMA5_MSTR column

1 Drug-Drug Interaction Reference Category Indicator -

Manufacturer Info (DDI_MFGI)

2 Drug-Drug Interaction Reference Category Indicator -

Human Clinical Trial (DDI_TRIALI)

3 Drug-Drug Interaction Reference Category Indicator - Case

Reports (DDI_CASEI)

4 Drug-Drug Interaction Reference Category Indicator -

Meeting Abstract (DDI_ABSI)

5 Drug-Drug Interaction Reference Category Indicator - In

vitro/Animal Study (DDI_IVASI)

6 Drug-Drug Interaction Reference Category Indicator -

Review (DDI_REVI)

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Drug-Drug Interaction Module Editorial Policies

Editorial Process
Sources

To maintain the integrity between the interaction codes and the tables, FDB recommends that you load all
files with every update.

Editorial Process

The following section describes the processes and criteria the clinical editors use to add or review database
elements.

To maintain the integrity between the interaction codes and the tables, FDB recommends that you load all
files with every update.

External Triggers for Clinical Review

The external triggers that prompt the clinical editors to add or review data are the following:

MedEffect Canada Alerts from Health Canada

MedWatch Safety Alerts
Internal Triggers for Clinical Review
CredibleMeds Updates

Internal Triggers for Clinical Review

The internal trigger that prompts the Clinical editors to add or review data is a new Clinical Formulation ID (
GCN_SEQNO).

Inclusion Criteria

DDIM is not intended to be comprehensive, but instead is intended to be a clinically relevant subset of
evidence-based interactions that do not unnecessarily burden the prescribing and dispensing workflows with
alerts. DDIM uses the following as guidance: expected clinical severity, the quantity and quality of available
evidence or documentation, and, for pharmacodynamics interactions, the unexpected nature of the potential
interaction that may have pharmacodynamic effects including reduced efficacy or toxicity (e.g. additive effects on
QT Prolongation). The DDIM monographs discuss the interactions frequency of occurrence, but frequency is no
part of the criteria for inclusion in the module.

Interactions are evaluated based upon ingredient, route, dose form, and strength. Interaction characteristics
determine the level of specificity applied to drug interaction linking. For example, cimetidine and ranitidine belong
to the same therapeutic class, but have different interaction potential, and therefore different interaction profiles.

When evaluating drug interactions, detailed patient-specific data is desirable, but not often available. DDIM is
designed to function without patient specific data, but many interaction monographs include patient variable
discussions. Onset, predisposing factors, and risk versus benefit are all patient-specific considerations.

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Onsetappears in the DISCUSSION section of the monograph. This information is extremely

patient-specific. If a patient is on the verge of toxicity with one drug, adding another drug that impairs the
first drugs elimination can rapidly produce toxicity (within a matter of hours). However, in a different
patient, the same interaction may instead produce toxicity after a week of concurrent administration.

Predisposing Factorsappears in the PREDISPOSING FACTORS section of the monograph. Certain

patient populations may be predisposed to the effects of an interaction due to their medical conditions. For
example, the interaction between amino glycosides and penicillin usually concerns only those patients with
pre-existing renal disease.

Risk Versus BenefitIn some situations, the benefit of administering two interacting drugs may outweigh
the potential risk. Treating all patients in the same manner is inappropriate. The PREDISPOSING
FACTORS and MANAGEMENT sections of the monograph address these issues and help the clinician
develop a management strategy for individual patients.

Additive QT Prolongation

One potentially life-threatening additive side effect covered by DDIM is additive QT prolongation. DDIM maintains
lists of Known QT Prolonging Agents and Possible QT Prolonging Agents. The starting point for these lists are the
lists of Drugs with Known Risk of Torsades de Pointes and Drugs with Possible Risk of Torsades de Pointes
maintained by CredibleMeds.org. In addition to the lists maintained by CredibleMeds.org, information from
regulatory approved prescribing information, regulatory reviews, and primary medical literature is considered
when evaluating agents for inclusion on and exclusion from DDIMs list of Known QT Prolonging Agents and
Possible QT Prolonging Agents.

Inactive Ingredient Interactions

Changes to product inactive ingredients are not regulated by the FDA, so FDB relies on notification by the
manufacturer and a process of NDC review to keep its inactive ingredient information current. For this reason
inactive ingredient data may change at any time without notice.

DDIM version 3.3 added support for interactions that involve inactive ingredients, using the DDIM NDC/Inactive
Ingredient Interaction Code Link Table (RDDIMIN0_NDC_INACTV_DDIM_LINK). This table supplies inactive
ingredient drug-drug interaction information at the NDC level. If an NDC has any inactive-ingredient related
interactions, this table lists each inactive ingredient that participates in a given drug-drug interaction using the
Inactive Ingredient Code (DDI_NDC_HICSEQN) column, and the Drug-Drug Expanded Interaction Code (
DDI_CODEX) of the interaction.

For example, Norvir Solution (NDC value 00074194063) appears in the RDDIMIN0_NDC_INACTV_DDIM_LINK
table numerous times because of the ingredient ethyl alcohol. The text description for the DDI_NDC_HICSEQN
value is found in the RHICD5_HIC_DESC table.

DDI_NDC DDI_CODEX DDI_NDC_HICSEQN HIC_DESC

00074194063 01360 001539 ethyl alcohol

00074194063 01361 001539 ethyl alcohol

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00074194063 01373 001539 ethyl alcohol

00074194063 01374 001539 ethyl alcohol

00074194063 01377 001539 ethyl alcohol

00074194063 30622 001539 ethyl alcohol

00074194063 30624 001539 ethyl alcohol

00074194063 30625 001539 ethyl alcohol

00074194063 30638 001539 ethyl alcohol

Ethyl alcohol interacts with a number of different ingredients, and therefore has many listings for Norvir Solutions
NDC. If a patient currently taking Norvir Solution were also prescribed Flagyl 500mg tablets (NDC value
00025182131), DDIM would identify the following interaction:

Flagyl 500mg tablets contain metronidazole, which interacts unfavorably with the ethyl alcohol in Norvir
solution. This interaction has a Severity Level of 1clearly contraindicated in all cases, and should not
be jointly dispensed or administered to the same patient.

Products not yet researched for inactive ingredients (as described in the NDC Inactive Ingredients Reviewed
Master Table section) are not present in this table because FDB has no inactive ingredient information concerning
them. FDB recommends that the customers make sure each NDCs presence in the NDC Inactive Ingredients
Reviewed Master Table (RNDCINR0_INACTV_REVIEWED) be established prior to using the
RDDIMIN0_NDC_INACTV_DDIM_LINK table.

Inactive ingredient content can change in a manner that will not be immediately reflected in our database.
Consequently, if a patient's allergen profile contains a potentially harmful inactive ingredient or allergen
group, the inactive ingredient file should not be used as the exclusive source of this information, and
prospective drugs should be manually screened for potentially harmful inactive ingredients. The same
precaution should be observed for drug-drug interactions in which inactive ingredients participate. The
package insert and product labeling remain the authoritative sources for inactive ingredient information.

See the application about Screening for Active and Inactive Ingredient Drug-Drug Interactions for more
information. In addition, see Inactive Ingredients Editorial Policies.

Exclusion Criteria

DDIM excludes interactions that involve tobacco, illicit drugs, and those interactions that are only clinically
significant in the context of overdose.
When a drug is withdrawn from worldwide marketing, historical interaction data will not be removed from the
database; however, new monographs may not be created for the product.

Sources

This section lists sources used by FDB to compile the information contained in the module.

References for DDIM include government approved prescribing information (from any country in which FDB has

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customers) printed in English, primary medical literature, and occasionally a secondary reference.

The primary medical literature that is cited within DDIM consists mostly of human clinical trials and case reports.
Use of in vitro studies or animal data is reserved for documenting the mechanism of the interaction or for
confirming that related agents interact as well. Use of review articles is limited to those that provide a new
conclusion or recommendation about the interaction. Use of secondary references is limited to documenting the
mechanism of the interaction, confirming that related agents interact as well, or providing a new conclusion or
recommendation about the interaction. Secondary references are classified as review articles.

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DDIM Applications
Screening for Active Ingredient Drug-Drug Interactions
Screening for Active and Inactive Ingredient Drug-Drug Interactions
Screening for Inactive Ingredient Drug-Drug Interactions
Displaying Drug-Drug Interaction Screening Messages
Listing Interacting Agents
Using DDIM as a Reference Tool
Examples that use DDIM
Displaying Coadministration Text
Screening Drugs with a Washout Period

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DDIM Screening for Active Ingredient Drug-Drug Interactions

This application illustrates how to identify drug-drug interactions that result from a products active ingredients and
methods on how to display this information to the user. An interaction exists between two products if the sum of
any two Drug-Drug Expanded Interaction Codes (DDI_CODEX) equals 32,000 or if the Drug-Drug Interaction
Expanded Monograph Number (DDI_MONOX) values of any two drug products match and the DDI_CODEX
values do not match.To perform an inactive ingredient interaction check, see the Screening for Inactive Ingredient
Drug-Drug Interactions application.For purposes of demonstrating this application, the following scenario is used:
A physician prescribes the following drug products to a patient experiencing chronic conditions:

Drug Product GNN60 NDC

Indomethacin 25MG Capsule Indomethacin 52959008021

Lithium ER 300MG Tablet Lithium Carbonate 00054002125

Seromycin 250MG Pulvule Cycloserine 13845120202

Part 1: Determine the DDI_CODEX Values

1. Select the Clinical Formulation ID (GCN_SEQNO) values from the NDC Table (RNDC14_NDC_MSTR)
where the NDC column equals the NDC values of the products to screen.

NDC GCN_SEQNO

52959008021 008336

00054002125 004004

13845120202 009319

2. Select the Drug-Drug Expanded Interaction Code (DDI_CODEX) values from the GCN_SEQNO/Drug-Drug
Interaction Code Relation Table (RADIMGC4_GCNSEQNO_LINK) where the GCN_SEQNO column
equals the values from the previous step.Only the first few related DDI_CODEX values are shown below
for illustrative purposes.

GCN_SEQNO DDI_CODEX

004004 00077

004004 00223

004004 00225

004004 00297

Part 2: Find a Drug-Drug Interaction

Depending on your business needs, use either the DDI_CODEX sum value method or the DDI_MONOX equal
value method to determine if there is an interaction.

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Part 2A: DDI_MONOX equal value method

1. Select the Drug-Drug Interaction Expanded Monograph Number (DDI_MONOX) values from the
Drug-Drug Interaction Master Table (RADIMMA5_MSTR) where the DDI_CODEX column equals the
values from the previous step.

DDI_CODEX DDI_MONOX

00077 00077

00223 00223

00225 00225

00297 00297

31881 00119

2. Compare all the associated DDI_MONOX values of each drug product to locate matching DDI_MONOX
values that correspond to different DDI_CODEX values, which indicates that the two drugs interact.

Only a subset of the value comparisons are illustrated. This application does not stop at the first instance
of an interaction, as FDB recommends that you present every interaction to the clinician.

Part 2B: DDI_CODEX sum value method

For each of the drug products Drug-Drug Expanded Interaction Code ( DDI_CODEX) values, add the value to
each DDI_CODEX value for the other drug products you are screening to locate pairs whose sum equals 32,000,
which indicates that the two drugs interact.

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Only a subset of the sum calculations are illustrated. This application does not stop at the first instance of
an interaction, as FDB recommends that you present every interaction to the clinician.

Part 3: Display the Drug-Drug Interaction Information to End-User

Display the drug-drug interaction information to the end-user. See the Displaying Drug-Drug Interaction Screening
Messages application for display options.

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DDIM Screening for Active and Inactive Ingredient Drug-Drug Interactions

This application illustrates how to identify drug-drug interactions that result from a products active and inactive
ingredients. Use this application if you want to implement active and inactive screening concurrently.

This application requires that each NDC in question has been reviewed by FDB for inactive ingredient information
and is therefore listed in the NDC Inactive Ingredients Reviewed Master Table
(RNDCINR0_INACTV_REVIEWED).

NDCs not listed in this table require manual review of their package insert for inactive ingredient
interactions and are not supported by this application.

For the purposes of demonstrating this application, the following scenario is used: A physician prescribes Zyprexa
Zydis to a patient currently taking Orfadin.

Drug Product NDC

Zyprexa Zydis 00002445301

Orfadin 66607100206

Part 1: Retrieve the active ingredient drug-drug interaction codes for each NDC.

1. Select the Clinical Formulation ID (GCN_SEQNO) values from the NDC Table (RNDC14_NDC_MSTR)
where the NDC column equals one of the NDC values of the products to screen.

NDC GCN_SEQNO

00002445301 045190

66607100206 049853

2. Select the Drug-Drug Expanded Interaction Code (DDI_CODEX) values from the GCN_SEQNO/Drug-Drug
Interaction Code Relation Table (RADIMGC4_GCNSEQNO_LINK) where the GCN_SEQNO column
equals the values from the previous step. Only the first few related DDI_CODEX values are shown below
for illustrative purposes.

GCN_SEQNO DDI_CODEX

045190 30657

049853 30697

... ...

Part 2: Retrieve the inactive ingredient drug-drug interaction codes for each NDC.

Select the DDI_CODEX values from the DDIM NDC/Inactive Ingredient Interaction Code Link Table
(RDDIMIN0_NDC_INACTV_DDIM_LINK) where the Drug-Drug Interaction Product National Drug Code (
DDI_NDC) column equals the NDC value of the product to screen.

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DDI_NDC DDI_CODEX

00002445301 01303

00002445301 31651

66607100206 (N/A)

NDC 66607100206 does not appear in either the RDDIMIN0_NDC_INACTV_DDIM_LINK or the

RNDCINR0_INACTV_REVIEWED table. NDCs not listed in RNDCINR0_INACTV_REVIEWED require
manual review of their package insert for inactive ingredient interactions and are not supported by this
application.

Part 3: Identify drug-drug interactions.

Determine if there is a drug-drug interaction by using either the DDI_CODEX sum value method or the
DDI_MONOX equal value method.

Note that screening for active and inactive ingredient drug-drug interactions must consider potentially harmful
combinations amongst both active and inactive drug ingredients, and thus you must perform four different
comparisons.

Part 3A: DDI_MONOX equal value method

1. Select the Drug-Drug Interaction Expanded Monograph Number (DDI_MONOX) values from the
Drug-Drug Interaction Master Table (RADIMMA5_MSTR) where the DDI_CODEX column equals the
values from the previous step. Only the first few related DDI_MONOX values are shown below for
illustrative purposes.

DDI_CODEX DDI_MONOX

30657 01343

01303 01303

31651 00349

30697 01303

... ...

2. For each drug products active and inactive DDI_MONOX values, compare all the DDI_MONOX values
(both active and inactive) to locate pairs that have matching DDI_MONOX values but have different
DDI_CODEX values, which indicates that the two drugs interact.

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In this scenario, an inactive ingredient (DDI_CODEX 01303) of Zyprexa Zydia interacts with the active
ingredient (DDI_CODEX 30697) of the prescribed drug, Orfadin, because the DDI_MONOX values match
and the corresponding DDI_CODEX values do not match.

Part 3B: DDI_CODEX sum value method

For each drug products active and inactive Drug-Drug Expanded Interaction Code ( DDI_CODEX) values, add the
value to each active and inactive DDI_CODEX value for the other drugs you are screening to locate pairs whose
sum equals 32,000, which indicates that the two drugs interact.

In this scenario, an inactive ingredient (DDI_CODEX 01303) of Zyprexa Zydia interacts with the active ingredient
(DDI_CODEX 30697) of the prescribed drug, Orfadin, because the sum of the two DDI_CODEX values is 32,000.

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Part 4: Display drug-drug interaction information to the end-user.

1. Select the Inactive Ingredient Code (DDI_NDC_HICSEQN) value from the DDIM NDC/Inactive Ingredient
Interaction Code Link Table (RDDIMIN0_NDC_INACTV_DDIM_LINK) where the DDI_CODEX column
equals the DDI_CODEX value of the inactive ingredient that participates in an interaction and the
DDI_NDC column equals the NDC value of the drug product that contains the inactive ingredient.

DDI_NDC DDI_CODEX DDI_NDC_HICSEQN

00002445301 01303 002605

2. Select the HIC_DESC values from the Hierarchical Ingredient Code Description Table
(RHICD5_HIC_DESC) where the HIC_SEQN column equals the DDI_NDC_HICSEQN value from the
previous step.

HIC_SEQN HIC_DESC

002605 aspartame

3. Display the inactive-ingredient based drug-drug interaction information. For example:

Orfadin interacts with aspartame, an inactive ingredient in Zyprexa Zydis.

This interaction information only includes the results from this application. If manual drug-drug
interaction was completed, consider the interactions found manually.

4. Display additional interaction information to the end-user. See the Displaying Drug-Drug Interaction
Screening Messages application for display options.

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DDIM Screening for Inactive Ingredient Drug-Drug Interactions

This application illustrates how to identify drug-drug interactions that result from a products inactive ingredients.

Use this application if you currently perform only active ingredient screening and want to implement
additional inactive ingredient screening into your current screening process. (See Inactive Ingredients
Editorial Policies for additional information.)

This application requires that each NDC in question has been reviewed by FDB for inactive ingredient
information, and is therefore listed in the NDC Inactive Ingredients Reviewed Master Table
(RNDCINR0_INACTV_REVIEWED).

NDCs not listed in this table require a manual review of their package insert for inactive ingredient
interactions and are not supported by this application.

For the purposes of demonstrating this application, the following scenario is used: A physician prescribes Zyprexa
Zydis to a patient currently taking Orfadin.

Drug Product NDC

Zyprexa Zydis 00002445301

Orfadin 66607100206

Part 1: Retrieve the active ingredient drug-drug interaction codes for each NDC.

1. Select the Clinical Formulation ID (GCN_SEQNO) values from the NDC Table
(RNDC14_NDC_MSTR) where the NDC column equals one of the NDC values of the products
to screen.

NDC GCN_SEQNO

00002445301 045190

66607100206 049853

2. Select the Drug-Drug Expanded Interaction Code (DDI_CODEX) values from the GCN_SEQNO/Drug-Drug
Interaction Code Relation Table (RADIMGC4_GCNSEQNO_LINK) where the GCN_SEQNO column
equals the values from the previous step. Only the first few related DDI_CODEX values are shown below
for illustrative purposes.

GCN_SEQNO DDI_CODEX

045190 30657

049853 30697

... ...

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Part 2: Retrieve the inactive ingredient drug-drug interaction codes for each NDC.

Select the DDI_CODEX values from the DDIM NDC/Inactive Ingredient Interaction Code Link Table
(RDDIMIN0_NDC_INACTV_DDIM_LINK) where the Drug-Drug Interaction Product National Drug Code (
DDI_NDC) column equals the NDC value of the product to screen.

DDI_NDC DDI_CODEX

00002445301 01303

00002445301 31651

66607100206 (N/A)

NDC 66607100206 does not appear in either the RDDIMIN0_NDC_INACTV_DDIM_LINK or the

RNDCINR0_INACTV_REVIEWED table. NDCs not listed in RNDCINR0_INACTV_REVIEWED require
manual review of their package insert for inactive ingredient interactions and are not supported by this
application.

Part 3: Identify drug-drug interactions.

Determine if there is a drug-drug interaction by using either the DDI_CODEX sum value method or the
DDI_MONOX equal value method.

Part 3A: DDI_MONOX equal value method

1. Select the Drug-Drug Interaction Expanded Monograph Number (DDI_MONOX) values from the
Drug-Drug Interaction Master Table (RADIMMA5_MSTR) where the DDI_CODEX column equals the
values from the previous step. Only the first few elated DDI_MONOX values are shown below for
illustrative purposes.

DDI_CODEX DDI_MONOX

30657 01343

01303 01303

31651 00349

30697 01303

... ...

2. Compare the value of each drug products active ingredient DDI_MONOX value to all inactive ingredient
DDI_MONOX values for the other drugs you are screening to locate matching DDI_MONOX values that
correspond to different DDI_CODEX values, which indicates that the two drugs interact.

3. Compare the value of each drug products inactive ingredient DDI_MONOX value to all active or inactive
ingredient DDI_MONOX values for the other drugs you are screening to locate matching DDI_MONOX
values that correspond to different DDI_CODEX values, which indicates that the two drugs interact.

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In this scenario, an inactive ingredient (DDI_CODEX 01303) of Zyprexa Zydia interacts with the active
ingredient (DDI_CODEX 30697) of the prescribed drug, Orfadin, because the DDI_MONOX values match
and the corresponding DDI_CODEX values do not match.

Note that screening for inactive drug-drug interactions does not screen for interactions between
two active ingredients of the two drugs (in the above example, DDI_CODEX values 30657 and
30697). It only screens for inactive/inactive and active/inactive drug-drug interaction combinations.
This application should only be used if you already have active drug-drug interaction screening in
place.

Part 3B: DDI_CODEX sum value method

For each drug products active and inactive Drug-Drug Expanded Interaction Code ( DDI_CODEX) values, add the
following to locate pairs whose sum equals 32,000:

1. Add the value of each drug products active ingredient DDI_CODEX values to each inactive ingredient
DDI_CODEX value for the other drugs you are screening to locate pairs that add up to 32,000, which
indicates that there is an interaction.

2. Add the value of each drug products inactive ingredient DDI_CODEX values to each active and inactive
ingredient DDI_CODEX value for the other drugs you are screening to locate pairs that add up to 32,000,
which indicates that there is an interaction.

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In this scenario, an inactive ingredient (DDI_CODEX 01303) of Zyprexa Zydia interacts with the active
ingredient (DDI_CODEX 30697) of the prescribed drug, Orfadin, because the sum of the two DDI_CODEX
values is 32,000.

Note that screening for inactive drug-drug interactions does not screen for interactions between
two active ingredients of the two drugs (in the above example, DDI_CODEX values 30657 and
30697). It only screens for inactive/inactive and active/inactive drug-drug interaction combinations.
This application should only be used if you already have active drug-drug interaction screening in
place.

Part 4: Display drug-drug interaction information to the end-user.

1. Select the Inactive Ingredient Code (DDI_NDC_HICSEQN) value from the DDIM NDC/Inactive Ingredient
Interaction Code Link Table (RDDIMIN0_NDC_INACTV_DDIM_LINK) where the DDI_CODEX column
equals the DDI_CODEX value of the inactive ingredient that participates in an interaction and the
DDI_NDC column equals the NDC value of the drug product that contains the inactive ingredient.

DDI_NDC DDI_CODEX DDI_NDC_HICSEQN

00002445301 01303 002605

2. Select the Hierarchical Ingredient Code Description (HIC_DESC) value from the Hierarchical Ingredient
Code Description Table (RHICD5_HIC_DESC) where the HIC_SEQN column equals the
DDI_NDC_HICSEQN value from the previous step.

HIC_SEQN HIC_DESC

002605 Aspartame

3. Display the inactive-ingredient based drug-drug interaction information. For example:

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3.

Orfadin interacts with aspartame, an inactive ingredient in Zyprexa Zydis.

This interaction information only includes the results from this application. If manual drug-drug
interaction was completed, consider the interactions found manually.

4. Display additional interaction information to the end-user. See the Displaying Drug-Drug Interaction
Screening Messages application for display options.

Note that screening for inactive drug-drug interactions does not screen for interactions between
two active ingredients of the two drugs (in the above example, DDI_CODEX values 30657 and
30697). It only screens for inactive/inactive and active/inactive drug-drug interaction combinations.
This application should only be used if you already have active drug-drug interaction screening in
place.

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DDIM Displaying Drug-Drug Interaction Screening Messages

This application illustrates the display options for end-user drug-drug interaction messages.

Use the following steps to display active and inactive ingredient interactions.

For purposes of demonstrating this application, the following scenario is used: A clinician wishes to see
interaction messages displayed for the following drug-drug interaction:

DDI_CODEX DDI_DES

00119 NSAIDS/LITHIUM

31881 LITHIUM/NSAIDS

Displaying the Full Monograph Text

See "Interaction Monographs" and "Drug-Drug Expanded Interaction Code" in the Concepts section for more
information on displaying DDIM monographs.

1. Select the Drug-Drug Interaction Expanded Monograph Number (DDI_MONOX) value from the Drug-Drug
Interaction Master Table (RADIMMA5_MSTR) where the DDI_CODEX column equals a DDI_CODEX
value that participates in an interaction.

DDI_CODEX DDI_DES DDI_MONOX

00119 NSAIDS/LITHIUM 00119

31881 LITHIUM/NSAIDS 00119

Both DDI_CODEX values link to the same DDI_MONOX value, so you may use either value to perform this
step.

2. Select the records from the Drug-Drug Interaction Monograph Text Table (RADIMMO5_MONO) where the
DDI_MONOX column equals the DDI_MONOX value from the previous step.
Display the Drug-Drug Interaction Monograph Text (IAMTEXTN) column in the order indicated by the
Drug-Drug Interaction Monograph Text Sequence Number (ADI_MONOSN) column.

DDI_MONOX ADI_MONOSN IAMIDENTN IAMTEXTN IAMREFCAT

00119 001 T MONOGRAPH

TITLE:
NSAIDs/Lithium

00119 002 B

00119 003 L SEVERITY LEVEL:

3-Moderate
Interaction: Assess
the risk to the patient
and

00119 004 L take action as

needed.

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00119 005 B

00119 006 A MECHANISM OF

ACTION: Decreased
renal excretion of
lithium, possibly

00119 007 A resulting from

NSAID-induced
prostaglandin
inhibition.

00119 008 B

00119 009 E CLINICAL

EFFECTS: May
observe increased
lithium toxicity.

00119 010 B

00119 011 P PREDISPOSING

FACTORS: None
determined.

00119 012 B

00119 013 M PATIENT

MANAGEMENT: If
both drugs are
administered,
monitor plasma
lithium

00119 014 M levels and observe

the patient for signs
and symptoms of
lithium toxicity.

00119 015 M Adjust the dose of

lithium accordingly.

00119 016 B

00119 017 D DISCUSSION:

Numerous studies
and case reports
have been
documented that

00119 018 D administration of a

NSAID to a patient
stabilized on lithium
therapy may

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00119 019 D result in increased

serum lithium levels
and possible toxicity.
Full effects

00119 020 D may take 1 to 2

weeks to develop
and may persist for a
week after the
NSAID

00119 021 D is discontinued.

00119 022 B

00119 023 R REFERENCES:

00119 024 B

00119 025 R 1.Frolich JC, 2

Leftwich R, Ragheb
M, Oates JA,
Reimann I,
Buchanan D.

00119 026 R Indomethacin 2

increases plasma
lithium. Br Med J
1979 Apr
28;1(6171):1115-6

00119 027 R 2.Ragheb M, Ban 2

TA, Buchanan D,
Frolich JC.
Interaction of
indomethacin and

00119 028 R ibuprofen with lithium 2

in manic patients
under a steady-state
lithium

00119 029 R level. J Clin 2

Psychiatry 1980
Nov;41(11):397-8.

... ... ... ...

You can choose to include or exclude monograph sections by listing or excluding values from the
Drug-Drug Interaction Monograph Line Identifier column (IAMIDENTN) and the Drug-Drug
Interaction Reference Category Line Identifier column (IAMREFCAT).

For example:

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Patient Management: If both drugs are administered, monitor plasma lithium levels and observe the patient for
signs and symptoms of lithium toxicity. Adjust the dose of lithium accordingly.

3. Display the monograph details to the end-user. A sample of the monograph text is shown below.

MONOGRAPH TITLE: NSAID/Lithium

SEVERITY LEVEL: 3 - Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Decreased renal excretion of lithium, possibly resulting from NSAID-induced
prostaglandin inhibition.

CLINICAL EFFECTS: May observe increased lithium toxicity.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: If both drugs are administered, monitor plasma lithium levels and observe the patient
for signs and symptoms of lithium toxicity. Adjust the dose of lithium accordingly.

DISCUSSION: Numerous studies and case reports have been documented that administration of a NSAID to a
patient stabilized on lithium therapy may result in increased serum lithium levels and possibly toxicity. Full effects
may take 1 to 2 weeks to develop and may persist for a week after the NSAID is discontinued.

REFERENCES:
1. Frolich JC, Leftwich R, Ragheb M, Oates JA, Reimann I, Buchanan D. Indomethacin increases plasma lithium.
Br Med J 1979 Apr 28;1(6171):1115-6
2. Ragheb M, Ban TA, Buchanan D, Frolich JC. Interaction of indomethacin and ibuprofen with lithium in manic
patients under a steady-state lithium level. J Clin Psychiatry 1980 Nov;41(11):397-8.

Displaying the Drug-Drug Interaction Severity Level

See "Drug-Drug Interaction Severity Levels" in the Concepts section for more information on the severity level
column descriptions.

1. Select the Drug-Drug Interaction Severity Level (DDI_SL) value from the Drug-Drug Interaction Master
Table (RADIMMA5_MSTR) where the DDI_CODEX column equals a selected DDI_CODEX value that
participates in the above interaction.

DDI_CODEX DDI_SL

00119 3

Both DDI_CODEX values link to the same DDI_SL value, so you may use either code to perform this step.

2. Select the Drug_Drug Interaction Severity Level Text (DDI_SLTXT) value from the Drug-Drug Interaction
Severity Levels Table (RADIMSL1_SEVER_LEVEL) where the DDI_SL column equals the values from the
previous step.

3. Display the Drug-Drug Interaction Severity Level to the end-user in the order indicated in the Drug-Drug
Interaction Severity Level Text Sequence Number (DDI_SL). For example:

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

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Displaying the Drug-Drug Interaction Clinical Effects Description

See "Drug-Drug Interaction Clinical Effect Code" in the Concepts section for more information on the clinical
effects column descriptions.

1. Select the Drug-Drug Interaction Clinical Effect Code (ADI_EFFTC) value from the Drug-Drug
Interaction/Clinical Effects Relation Table (RADIMIE4_CLIN_EFFECTS_LINK) where the DDI_CODEX
column equals a selected DDI_CODEX value that participates in the above interaction.

DDI_CODEX ADI_EFFTC

00119 INL

2. Select the Drug-Drug Interaction Clinical Effect Text (ADI_EFFTXT) value from the Drug-Drug Interaction
Clinical Effects Description Table (RADIMEF0_CLIN_EFFECT) where the ADI_EFFTC column equals the
values from the previous step.

3. Display the drug-drug interaction clinical effect description to the end-user. For example:

CLINICAL EFFECTS: INL-Increased effect of the latter drug.

Displaying the Drug-Drug Interaction Description and EDI Reference Page Numbers

1. Select the Drug-Drug Interaction Description (DDI_DES) and the Drug-Drug Interaction Page References
EDI (DDI_PGEDI) values from the from the Drug-Drug Interaction Master Table (RADIMMA5_MSTR)
where the DDI_CODEX column equals a selected DDI_CODEX value that participates in the above
interaction.

DDI_CODEX DDI_DES DDI_PGEDI

00119 NSAIDS/LITHIUM 10/047.00

2. Display the drug-drug interaction information to the end-user.

Interaction Drugs:
NSAIDs
Lithium
Evaluation of Drug Interaction Page Reference:
10/047.00

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DDIM Listing Interacting Agents

This application illustrates how to generate a list of interacting agents for a given interaction.

For purposes of demonstrating this application, the following scenario is used: A clinician wishes to view
ingredients that relate to the following interaction:

DDI_CODEX DDI_DES

00251 TRIAMTERENE; AMILORIDE/SELECTED NSAIDS

31749 SELECTED NSAIDS/TRIAMTERENE; AMILORIDE

1. Select the Drug-Drug Interaction Agent Description Sequence Number (DDI_AGSN) values and the
Drug-Drug Interaction Agent Description (DDI_AGD) values from the Drug-Drug Interaction Agent
Description Table (RDDIMAG0_AGENT) where the Drug-Drug Expanded Interaction Code (DDI_CODEX)
column equals the DDI_CODEX values that participate in the interaction. Any agents related to
DDI_CODEX 00251 react unfavorably with any agents related to DDI_CODEX 31749.

DDI_CODEX DDI_AGSN DDI_AGD

00251 001 TRIAMTERENE

00251 002 AMILORIDE

DDI_CODEX DDI_AGSN DDI_AGD

31749 001 ACECLOFENAC

31749 002 ALMINOPROFEN

31749 003 ALMINOPROFEN

31749 004 BENZYDAMINE

31749 005 DEXIBUPROFEN

31749 006 DICLOFENAC

31749 007 FLURBIPROFEN

31749 008 IBUPROFEN

31749 009 INDOMETHACIN

2. Display the list of interacting agents to the end-user.

Interacting Agents List

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TRIAMTERENE: AMILORIDE/SELECTED NSAIDS: SELECTED NSAIDS/TRIAMTERENE: AMILORIDE:

Amiloride Aceclofenac
Triamterene Acemetacin
Alminoprofen
Benzydamine
Dexibuprofen
Diclofenac
Flurbiprofen
Ibuprofen
Indomethacin

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DDIM Using DDIM as a Reference Tool

This application illustrates how to use DDIM to display clinical interaction information about a given drug without
going through a patient profile and entering a new order.

For purposes of demonstrating this application, the following scenario is used: A clinician wishes to view
all interaction information about A-Hydrocort 500 MG univial Clinical Formulation ID (GCN_SEQNO = 051560).

1. Select the Drug-Drug Expanded Interaction Code (DDI_CODEX) values from the GCN_SEQNO/Drug-Drug
Interaction Code Relation Table (RADIMGC4_GCNSEQNO_LINK) where the GCN_SEQNO column
equals the Clinical Formulation ID (GCN_SEQNO) value of the product to screen.

GCN_SEQNO DDI_CODEX

051560 00021

051560 00023

051560 00065

051560 00121

051560 01058

051560 01502

051560 01503

051560 29966

051560 30001

051560 30112

051560 30401

051560 30557

051560 30591

051560 30654

051560 30702

051560 30735

051560 30916

051560 31802

051560 31869

051560 31914

051560 31915

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2. Select the Drug-Drug Interaction Description (DDI_DES) values from the Drug-Drug Interaction Master
Table (RADIMMA5_MSTR) where the DDI_CODEX column equals the values from the previous step.

DDI_CODEX DDI_DES

00021 CORTICOSTEROIDS/HORMONAL
CONTRACEPTIVES; ESTROGENS

00023 CORTICOSTEROIDS/CARBAMAZEPINE;
HYDANTOINS

00065 CORTICOSTEROIDS/RIFAMYCINS

00121 CORTICOSTEROIDS/SELECTED MACROLIDE

ANTIBIOTICS

01058 CORTICOSTEROIDS/GLYCYRRHIZA (LICORICE)

01502 SYSTEMIC CORTICOSTEROIDS/LIVE VACCINES

01503 SELECTED CORTICOSTEROIDS/ITRACONAZOLE;

KETOCONAZOLE

29966 GLUCOCORTICOIDS/QUETIAPINE

30001 CORTICOSTEROIDS/MIFAMURTIDE

30112 CORTICOSTEROIDS/ERLOTINIB

30401 CORTICOSTEROIDS; CORTICOTROPIN

(ACTH)/AMPHOTERICIN B

30557 CORTICOSTEROIDS/QUINOLONES

30591 IMMUNOSUPPRESSIVES;
IMMUNOMODULATORS/EFALIZUMAB;
NATALIZUMAB

30654 STEROIDS/BUPROPION

30702 GLUCOCORTICOIDS/ALDESLEUKIN

30735 CORTICOSTEROIDS/ANTICOAGULANTS

30916 CORTICOSTEROIDS/MIFEPRISTONE

31802 CORTICOSTEROIDS/SELECTED
ANTICHOLINESTERASE

31869 CORTICOSTEROIDS/BARBITURATES

31914 CORTICOSTEROIDS/SALICYLATES

31915 CORTICOSTEROIDS/INDOMETHACIN

3. Display the drug-drug interactions to the end-user.

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3.

Interaction 1 of 21
Corticosteroids & Hormonal Contraceptives; Estrogens
(Click for more information)
Interaction 2 of 21
Corticosteroids & Carbamazepine; Hydantoins
(Click for more information)
Interaction 3 of 21
Corticosteroids & Rifamycins
(Click for more information)
Interaction 4 of 21
Corticosteroids & Selected Macrolide Antibiotics
(Click for more information)
Interaction 5 of 21
Corticosteroids & Glycyrrhiza (Licorice)
(Click for more information)
...etc

4. Display interaction information for the end-user. See the Displaying Drug-Drug Interaction Screening
Messages application for display options. For example:

Interaction Number 2 of 21

Interaction Drugs:
Corticosteroids
Carbamazepine; Hydantoins

Severity Level:
3 - Moderate Interaction: Assess the risk to the patient and take action as needed.

Evaluation of Drug Interaction Page Reference:

05/043.00

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DDIM Examples that use DDIM

This section provides four examples of drug interactions for assisted learning, demonstrations, and testing
purposes.

Example 1: Standard Drug Interaction Example

Example 2: Route-Specific Example
Example 3: Combination Product Example, First Ingredient
Example 4: Combination Product Example, Second Ingredient

These examples use the following NDCs:

NDC GCN GCN_SEQNO Brand Name Used in Example(s)

00603016821 16720 004381 Aspirin EC 1

00056017270 25793 006562 Coumadin 1, 4

00009082501 26650 006696 Solu-Cortef 2

00006499900 25449 059690 Proquad 2

00168002016 30951 007547 Hydrocortisone 2

00378000101 51940 000340 Clorpre 3

00781148601 16512 046043 Amitriptyline HCL 3

00074227712 63101 034068 Vicoprofen 4

Example 1: Standard Drug Interaction Example

This example illustrates a basic drug-drug interaction alert. DDIM codes the interaction between aspirin and
warfarin as aspirin and anticoagulants.

Interaction codes exist for all appropriate NDCs.

Key DDI_CODEX Code Combination: 31999 + 00001 = 32000

Key DDI_MONOX Code Match: 00001 = 00001 for DDI_CODEX 00001 and 31999
DDIM Data

NDC Descriptive Information

00603016821 Label Name: ASPIRIN EC 325 MG TABLET

Route: ORAL
Generic Name - Long Version: ASPIRIN
DDI_CODEX values: 00086...... 31825 31888 31908 31909
31926 31999
DDI_MONOX values: 00086 ....... 00175 00112 00092
00091 00074 00001

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00056017270 Label Name: COUMADIN 5 MG TABLET

Route: ORAL
Generic Name - Long Version: WARFARIN SODIUM
DDI_CODEX values: 00001 ...... 00114 00140 00141
00145 31973 31982
DDI_MONOX values: 00001 ...... 00114 00140 00141
00145 00027 00018

Specific Interaction Data

DDI_CODEX DDI_DES ADI_EFFTC DDI_SL

00001 ANTICOAGULANTS/SALIC INF 2

YLATES

31999 SALICYLATES/ANTICOAG INL 2

ULANTS

Testing Notes

This example tests whether the first master table record can be found. If the NDCs are reversed, it tests whether
the last master table record can be found.

Demonstration Notes

This example demonstrates that new package sizes and generics from new labelers still have clinical interaction
data, because DDIM maintains drug interaction data at the appropriate ingredient or therapeutic level.

Example 2: Route-Specific Example

This example illustrates DDIMs route-specific alert system.

Proquad Vial (NDC 00006499900) interacts with injection Solu-Cortef (NDC 00009082501) but does not interact
with topical Hydrocortisone (NDC 00168002016).

Key DDI_CODEX Code Combination: 01502 + 30498 = 32000

Key DDI_MONOX Code Match: 01502 = 01502 for DDI_CODEX 01502 and 30498
DDIM Data

NDC Descriptive Information

00009082501 Label Name: SOLU-CORTEF 100 MG VIAL

Route: INJECTION
Generic Name - Long Version: HYDROCORTISONE SOD
SUCCINATE
DDI_CODEX values: 00021 00023 00121 01058 01502 ...
31915
DDI_MONOX values: 00021 00023 00121 01058 01502 ...
00085

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00006499900 Label Name: PROQUAD VIAL

Route: SUB-Q
Generic Name - Long Version: MEASLES, MUMPS,
RUBELLA, AND VARICELLA VACCINE/PF
DDI_CODEX Values: 01304 01437 01588 01993 02065
02119 30007 30498
DDI_MONOX values: 01304 01437 01588 01993 02065
02119 01993 01502

00168002016 Label Name: HYDROCORTISONE 1% OINTMENT

Route: TOPICAL
Generic Name - Long Version: HYDROCORTISONE
DDI_CODEX values: (None)
DDI_MONOX values: (None)

Specific Interaction Data

DDI_CODEX DDI_DES ADI_EFFTC DDI_SL

01502 SYSTEMIC CIS 2

CORTICOSTEROIDS/LIVE
VACCINES

30498 LIVE CIS 2

VACCINES/SYSTEMIC
CORTICOSTEROIDS

Testing Notes

This example tests your algorithm with an NDCa DIN that has no Drug-Drug Expanded Interaction Code values.

Demonstration Notes

This example demonstrates that DDIM is route-specific and does not generate alerts based solely on ingredients.

Example 3: Combination Product Example, First Ingredient

This example illustrates how DDIM generates alerts for a multi-ingredient product.

The first ingredient of Clorpres, clonidine, interacts with the amitriptyline found in an amitriptyline tablet.

Key DDI_CODEX Code Combination: 00036 + 31964 = 32000

Key DDI_MONOX Code Match: 00036 = 00036 for DDI_CODEX 00036 and 31964
DDIM Data

NDC Descriptive Information

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00378000101 Label Name: CLORPRES 0.1-15 TABLET

Route: ORAL
Generic Name - Long Version: CLONIDINE
HCL/CHLORTHALIDONE
DDI_CODEX values: 00036 00081 00161 00203 ... 31923
31925 31983
DDI_MONOX values: 00036 00081 00161 00203 ... 00077
00075 00017

00781148601 Label Name: AMITRIPTYLINE HCL 10 MG TAB

Route: ORAL
Generic Name - Long Version: AMITRIPTYLINE HCL
DDI_CODEX values: 00088 00265 ... 31690 31801 31907
31964 31966
DDI_MONOX values: 00088 00265 ... 00310 00199 00093
00036 00034

Specific Interaction Data

DDI_CODEX DDI_DES ADI_EFFTC DDI_SL

00036 CLONIDINE/TRICYCLIC DEF 3

COMPOUNDS;
MIRTAZAPINE

31964 TRICYCLIC COMPOUNDS; DEL 3

MIRTAZAPINE/CLONIDINE

Testing Notes

This example tests the ability of your algorithm to compare both the first Interaction Code (00036) and the sixth
(31964) and checks that not just the first Interaction Codes in each product are being compared. Testing the
NDCs in reverse order will also ensure that your algorithm is not order-of-NDC specific (that is, screens drugs in
both A-B and B-A order).

Demonstration Notes

This example demonstrates ingredient specificity in a combination drug.

Example 4: Combination Product Example, Second Ingredient

This example illustrates how DDIM generates alerts for a multi-ingredient product.

The second ingredient of Vicoprofen, Ibuprofen, interacts with warfarin sodium found in a Coumadin Tablet.

Key DDI_CODEX Code Combination: 00496 + 31504 = 32000

Key DDI_MONOX Code Match: 00496 = 00496 for DDI_CODEX 31504 and 00496
DDIM Data

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NDC Descriptive Information

00074227712 Label Name: VICOPROFEN 200-7.5 TABLET

Route: ORAL
Generic Name - Long Version: HYDROCODONE/IBRUP
ROFEN
DDI_CODEX values: 00103 ... 30685 31504 31569 31575
... 31866
DDI_MONOX values: 00103 ... 01315 00496 00431 00425
... 00134

00056017270 Label Name: COUMADIN 5 MG TABLET

Route: ORAL
Generic Name - Long Version: WARFARIN SODIUM
DDI_CODEX values: 00001 ... 00496 00497 00498 01028
... 31982
DDI_MONOX values: 00001 ... 00496 00497 00498 01028
... 0001

Specific Interaction Data

DDI_CODEX DDI_DES ADI_EFFTC DDI_SL

00496 ANTICOAGULANTS/NSAID INF 3

S

31504 NSAIDS/ANTICOAGULANT INL 3

S

Testing Notes

None.

Demonstration Notes

This example demonstrates ingredient specificity in a combination drug.

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Displaying Coadministration Text

This application illustrates how to display coadministration text for a drug pair.

For purposes of demonstrating this application, the following scenario is used: A physician prescribes the
following drug products.

GCN_SEQNO Clinical Formulation Description

9218 Doxycycline hyclate 100 mg

2142 Calcium carbonate 500 mg

Following the screening logic highlighted in the Screening for Active Ingredient Drug-Drug Interactions
application, Drug-Drug Interaction Expanded Monograph Number (DDI_MONOX 69) for Tetracyclines/Divalent &
Trivalent Cations is returned.

1. Select the Coadministration Dosing Text (COADMIN_DOSING_TEXT) from the Drug-Drug Interaction
Clinical Formulation Exception Table (RADIGE0_DDI_GCNSEQNO_EXCEPT) where:
Drug-Drug Interaction Side A Clinical Formulation ID (SIDE_A_GCN_SEQNO) is equal to 9218 or
2142.
Drug-Drug Interaction Side B Clinical Formulation ID (SIDE_B_GCN_SEQNO) is equal to 9218 or
2142.
Drug-Drug Interaction Expanded Monograph Number (DDI_MONOX) is equal to 69.

2. Display the Coadministration Dosing Text (COADMIN_DOSING_TEXT) information to the end-user:

Administer tetracyclines at least two hours before or after medications containing magnesium, aluminum, calcium,
zinc and iron.

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Screening Drugs with a Washout Period

This application demonstrates the ability to screen previously discontinued drugs for drug-drug interactions within
a given washout period. An interaction exists between a discontinued drug and an active drug:

If the number of days since discontinuation of the drug is less than the specified washout period and the
sum of any two Drug-Drug Expanded Interaction Codes (DDI_CODEX) equals 32,000.
If the number of days since discontinuation is less than the specified washout period and the Drug-Drug
Interaction Expanded Monograph Number (DDI_MONOX) values of any two drug products match and the
DDI_CODEX values do not match.

For purposes of demonstrating this application, the following scenario is used: A physician orders selegine
5 mg tablet (GCN_SEQNO 12070) to a patient on February 16, 2016. The patient has previously discontinued
fluoxetine HCL 10 mg tablet (GCN_SEQNO 18765) on February 1, 2016.

Part 1: Determine the DDI_CODEX Values

1. Select the Drug-Drug Expanded Interaction Code (DDI_CODEX) values from the GCN_SEQNO/Drug-Drug
Interaction Code Relation Table (RADIMGC4_GCNSEQNO_LINK) where the GCN_SEQNO column
equals the values from the order. Only the first few related DDI_CODEX values are shown below for
illustrative purposes.

GCN_SEQNO DDI_CODEX

12070 31806

12070 31833

12070 31858

12070 31912

12070 31970

18765 194

18765 1045

18765 1046

18765 1399

Part 2: Find a Drug-Drug Interaction

Depending on your business needs, use either the DDI_CODEX sum value method or the DDI_MONOX equal
value method to determine if there is an interaction.

Part 2A: DDI_MONOX equal value method

1. Select the Drug-Drug Interaction Expanded Monograph Number (DDI_MONOX) values from the
Drug-Drug Interaction Master Table (RADIMMA5_MSTR) where the DDI_CODEX column equals the
values from the previous step.

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DDI_CODEX DDI_MONOX

31806 194

31833 167

31858 142

31912 88

31970 30

194 194

1045 1045

1046 1046

1399 1399

2. Compare all the associated DDI_MONOX values of each drug product to locate matching DDI_MONOX
values that correspond to different DDI_CODEX values, which indicates that the two drugs interact.

Part 2B: DDI_CODEX sum value method

1. For each of the drug products Drug-Drug Expanded Interaction Code (DDI_CODEX) values, add the
value to each DDI_CODEX value for the other drug products you are screening to locate pairs whose sum
equals 32,000, which indicates that the two drugs interact.

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Part 3: Check Washout period

With drug-drug interaction identified from the previous step and the drug discontinuation date from the scenario,
the presence of a washout period for that drug and drug-drug interaction shall be evaluated.

1. Select the Drug-Drug Interaction Discontinued Medication Screening Amount (

DDI_DC_DAYS_SCREEN_AMOUNT) from the Drug-Drug Interaction Discontinued Clinical Formulation
Screening Table (RADIDC0_DDI_DC_GCNSEQNO_SCREEN) where:
The Drug-Drug Interaction Expanded Monograph Number (DDI_MONOX) matches the value from
the previous step and
The Clinical Formulation ID (GCN_SEQNO) matches the value of the discontinued drug.

DDI_MONOX GCN_SEQNO DDI_DC_DAYS_SCREEN_AMO

UNT

194 18765 35

2. Select the difference in days from the date the order is being placed, in this example February 16, 2016,
and the date the drug was discontinued, in this example February 1, 2016. In this example, there is a 16
day difference between the order date and the drug discontinuation date.

3. Compare the difference between the order date and drug discontinuation date to the Drug-Drug Interaction
Discontinued Medication Screening Amount (DDI_DC_DAYS_SCREEN_AMOUNT) value.
If the difference from the previous step is less than or equal to the Drug-Drug Interaction
Discontinued Medication Screening Amount (DDI_DC_DAYS_SCREEN_AMOUNT), then present
the drug-drug interaction to the physician as the washout period has not yet completed.
If the difference from the previous step is greater than the Drug-Drug Interaction Discontinued
Medication Screening Amount (DDI_DC_DAYS_SCREEN_AMOUNT), then do not present the
drug-drug interaction to the physician as the washout period has been met.

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In this scenario, the 16 day difference from Step 2 is less than the 35 day Drug-Drug Interaction
Discontinued Medication Screening Amount (DDI_DC_DAYS_SCREEN_AMOUNT) value.
Therefore, drug-drug interaction information for Drug-Drug Interaction Expanded Monograph
Number (DDI_MONOX) 194 should be displayed to the physician.

Part 4: Display the Drug-Drug Interaction Information to End-User

Display the drug-drug interaction information to the end-user. See the Displaying Drug-Drug Interaction Screening
Messages application for display options.

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DDIM ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

DDIM Tables
DDIM ERD

DDIM Tables

DDIM NDC/Inactive Ingredient Interaction Code Link Table

DDIM Routed Generic Table
DDIM Routed Medication Table
Drug-Drug Interaction Agent Description Table
Drug-Drug Interaction Clinical Effects Description Table
Drug-Drug Interaction/Clinical Effects Relation Table
Drug-Drug Interaction Clinical Formulation Exception Table
Drug-Drug Interaction Discontinued Clinical Formulation Screening Table
Drug-Drug Interaction Display Action Table
Drug-Drug Interaction Master Table
Drug-Drug Interaction Monograph Master Table
Drug-Drug Interaction Monograph Text Table
Drug-Drug Interaction Routed Generic Exception Table
Drug-Drug Interaction Routed Medication Exception Table
Drug-Drug Interaction Severity Levels Table
Drug-Drug Reference Category Description Table
GCN_SEQNO/Drug-Drug Interaction Code Relation Table

DDIM ERD

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DDIM NDC-Inactive Ingredient Interaction Code Link Table

Table Name RDDIMIN0_NDC_INACTV_DDIM_LINK

Revision Activity add.07-29-2004

Purpose Links a packaged product to each of its inactive ingredient

interaction codes. Each Drug-Drug Expanded Interaction
Code (DDI_CODEX) in this table results from a drug-drug
interaction that involves the specified Inactive Ingredient
(DDI_NDC_HICSEQN).

Key Column Name Column Format Length Picture

Description

P DDI_NDC Drug-Drug AN 11 X(11)

Interaction
Product National
Drug Code

PF DDI_CODEX Drug-Drug N 5 N(5)

Expanded
Interaction Code

P DDI_NDC_HICSE Inactive Ingredient N 6 N(6)

QN Code

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DDIM Routed Generic Table

Table Name RDDIMRG0_ROUTED_GEN_LINK

Revision Activity original

Purpose Links a routed generic to a drug interaction.

Key Column Name Column Format Length Picture

Description

PF ROUTED_GEN_I Routed Generic N 8 9(8)

D Identifier

PF DDI_CODEX Drug-Drug N 5 9(5)

Expanded
Interaction Code

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DDIM Routed Medication Table

Table Name RDDIMRM0_ROUTED_MED_LINK

Revision Activity ADD.07-01-2002

Purpose Links a routed medication to a drug interaction.

Key Column Name Column Format Length Picture

Description

PF ROUTED_MED_I MED Routed N 8 9(8)

D Medication ID
(Stable ID)

PF DDI_CODEX Drug-Drug N 5 9(5)

Expanded
Interaction Code

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Drug-Drug Interaction Agent Description Table

Table Name RDDIMAG0_AGENT

Revision Activity add.05-01-1999

Purpose Relates the Drug-Drug Expanded Interaction Code to the

specific agents involved in the interaction.

Key Column Name Column Format Length Picture

Description

P DDI_CODEX Drug-Drug N 5 9(5)

Expanded
Interaction Code

P DDI_AGSN Drug-Drug N 3 9(3)

Interaction Agent
Description
Sequence
Number

DDI_AGD Drug-Drug AN 41 X(41)

Interaction Agent
Description

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Drug-Drug Interaction Clinical Effects Description Table

Table Name RADIMEF0_CLIN_EFFECT

Revision Activity add.05-20-1993

Purpose Relates the Clinical Effect Code to its text description.

Key Column Name Column Format Length Picture

Description

P ADI_EFFTC Drug-Drug AN 3 X(3)

Interaction Clinical
Effect Code

ADI_EFFTXT Drug-Drug AN 50 X(50)

Interaction Clinical
Effect Text

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Drug-Drug Interaction-Clinical Effects Relation Table

Table Name RADIMIE4_CLIN_EFFECTS_LINK

Revision Activity rev.05-01-1999

Purpose Links the drug interaction to the clinical effect of the

interaction.

Key Column Name Column Format Length Picture

Description

PF DDI_CODEX Drug-Drug N 5 9(5)

Expanded
Interaction Code

PF ADI_EFFTC Drug-Drug AN 3 X(3)

Interaction Clinical
Effect Code

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Drug-Drug Interaction Clinical Formulation Exception Table

Table Name RADIGE0_DDI_GCNSEQNO_EXCEPT

Revision Activity add.04-14-2016

Purpose Provides a list of all clinical formulation pairs related to a

drug-drug interaction which have coadministration dosing
information.

Key Column Name Column Format Length Picture

Description

PF DDI_MONOX Drug-Drug N 5 9(5)

Interaction
Expanded
Monograph
Number

PF SIDE_A_GCN_S Drug-Drug N 6 9(6)

EQNO Interaction Side A
Clinical
Formulation ID

PF SIDE_B_GCN_S Drug-Drug N 6 9(6)

EQNO Interaction Side B
Clinical
Formulation ID

F DDI_SL Drug-Drug AN 1 X(1)

Interaction
Severity Level

F DDI_DISPLAY_A Drug-Drug N 8 9(8)

CTION_ID Interaction Display
Action Identifier

COADMIN_DOSI Coadministration AN 255 X(255)

NG_TEXT Dosing Text

DDI_EXCEPT_A Drug-Drug N 8 9(8)

DD_DT Interaction
Exception Add
Date

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Drug-Drug Interaction Discontinued Clinical Formulation Screening Table

Table Name RADIDC0_DDI_DC_GCNSEQNO_SCREEN

Revision Activity add.04-14-2016

Purpose Relates a clinical formulation to a time duration to continue

screening the drug after administration has been
discontinued for drug-drug interactions.

Key Column Name Column Format Length Picture

Description

PF DDI_MONOX Drug-Drug N 5 9(5)

Interaction
Expanded
Monograph
Number

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID

DDI_DC_DAYS_ Drug-Drug N 5 9(5)

SCREEN_AMOU Interaction
NT Discontinued
Medication
Screening Amount

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Drug-Drug Interaction Display Action Table

Table Name RADIDA0_DISPLAY_ACTION

Revision Activity add.04-14-2016

Purpose Provides the recommended alerting level of a drug-drug

interaction such as interrupt, halt, or informative.

Key Column Name Column Format Length Picture

Description

P DDI_DISPLAY_A Drug-Drug N 8 9(8)

CTION_ID Interaction Display
Action Identifier

DDI_DISPLAY_A Drug-Drug AN 50 X(50)

CTION_DESC Interaction Display
Action Description

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Drug-Drug Interaction Master Table

Table Name RADIMMA5_MSTR

Revision Activity rev.05-01-1999

Purpose Provides attributes of a drug interaction.

Key Column Name Column Format Length Picture

Description

P DDI_CODEX Drug-Drug N 5 9(5)

Expanded
Interaction Code

DDI_DES Drug-Drug AN 60 X(60)

Interaction
Description

F DDI_SL Drug-Drug Interac AN 1 X(1)

tion Severity Level

F DDI_MONOX Drug-Drug Interac N 5 9(5)

tion Expanded
Monograph
Number

DDI_PGEDI Drug-Drug Interac AN 9 X(9)

tion Page
References EDI

DDI_TREE This column is not N 5 9(5)

currently being
used.

DDI_MFGI Drug-Drug Interac AN 1 X(1)

tion Reference
Category Indicator
- Manufacturer
Info

DDI_TRIALI Drug-Drug Interac AN 1 X(1)

tion Reference
Category Indicator
- Human Clinical
Trial

DDI_CASEI Drug-Drug Interac AN 1 X(1)

tion Reference
Category Indicator
- Case Reports

DDI_ABSI Drug-Drug Interac AN 1 X(1)

tion Reference
Category Indicator
- Meeting Abstract

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DDI_IVASI Drug-Drug Interac AN 1 X(1)

tion Reference
Category Indicator
- In Vitro/Animal
Study

DDI_REVI Drug-Drug Interac AN 1 X(1)

tion Reference
Category Indicator
- Review

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Drug-Drug Interaction Monograph Master Table

Table Name RADIMM0_MONOX_MSTR

Revision Activity add.04-14-2016

Purpose Provides a master list of all drug-drug interaction

monographs.

Key Column Name Column Format Length Picture

Description

PF DDI_MONOX Drug-Drug N 5 9(5)

Interaction
Expanded
Monograph
Number

MONOX_TITLE Drug-Drug AN 255 X(255)

Interaction
Monograph Title

F DDI_SL Drug-Drug AN 1 X(1)

Interaction
Severity Level

F DDI_DISPLAY_A Drug-Drug N 8 9(8)

CTION_ID Interaction Display
Action Identifier

F SIDE_A_DDI_CO Drug-Drug N 5 9(5)

DEX Expanded
Interaction Code
for Side A

F SIDE_B_DDI_CO Drug-Drug N 5 9(5)

DEX Expanded
Interaction Code
for Side B

DDI_PHARMACO Drug-Drug AN 1 X(1)

DYNAMIC_IND Interaction
Pharmacodynami
c Indicator

DDI_PHARMACO Drug-Drug AN 1 X(1)

KINETIC_IND Interaction
Pharmacokinetic
Indicator

MONOX_END_D Drug-Drug N 8 9(8)

T Interaction
Monograph End
Date

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Drug-Drug Interaction Monograph Text Table

Table Name RADIMMO5_MONO

Revision Activity rev.05-01-1999

Purpose Provides the text for the professional drug interaction

monograph.

Key Column Name Column Format Length Picture

Description

P DDI_MONOX Drug-Drug N 5 9(5)

Interaction
Expanded
Monograph
Number

P ADI_MONOSN Drug-Drug N 3 9(3)

Interaction
Monograph Text
Sequence
Number

IAMIDENTN Drug-Drug AN 1 X(1)

Interaction
Monograph Line
Identifier

IAMTEXTN Drug-Drug AN 76 X(76)

Interaction
Monograph Text

F IAMREFCAT Drug-Drug AN 1 X(1)

Interaction
Reference
Category Line
Identifier

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Drug-Drug Interaction Routed Generic Exception Table

Table Name RADIRGE0_DDI_RTD_GEN_EXCEPT

Revision Activity add.04-14-2016

Purpose Provides a list of all routed generic pairs related to a

drug-drug interaction which have coadministration dosing
information.

Key Column Name Column Format Length Picture

Description

PF DDI_MONOX Drug-Drug N 5 9(5)

Interaction
Expanded
Monograph
Number

PF SIDE_A_ROUTE Drug-Drug N 8 9(8)

D_GEN_ID Interaction Side A
Routed Generic
Identifier

PF SIDE_B_ROUTE Drug-Drug N 8 9(8)

D_GEN_ID Interaction Side B
Routed Generic
Identifier

F DDI_SL Drug-Drug AN 1 X(1)

Interaction
Severity Level

F DDI_DISPLAY_A Drug-Drug N 8 9(8)

CTION_ID Interaction Display
Action Identifier

COADMIN_DOSI Coadministration AN 255 X(255)

NG_TEXT Dosing Text

DDI_EXCEPT_A Drug-Drug N 8 9(8)

DD_DT Interaction
Exception Add
Date

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Drug-Drug Interaction Routed Medication Exception Table

Table Name RADIRME0_DDI_RTD_MED_EXCEPT

Revision Activity add.04-14-2016

Purpose Provides a list of all routed medication pairs related to a

drug-drug interaction which have coadministration dosing
information.

Key Column Name Column Format Length Picture

Description

PF DDI_MONOX Drug-Drug N 5 9(5)

Interaction
Expanded
Monograph
Number

PF SIDE_A_ROUTE Drug-Drug N 8 9(8)

D_MED_ID Interaction Side A
MED Routed
Medication
Identifier

PF SIDE_B_ROUTE Drug-Drug N 8 9(8)

D_MED_ID Interaction Side B
MED Routed
Medication
Identifier

F DDI_SL Drug-Drug AN 1 X(1)

Interaction
Severity Level

F DDI_DISPLAY_A Drug-Drug N 8 9(8)

CTION_ID Interaction Display
Action Identifier

COADMIN_DOSI Coadministration AN 255 X(255)

NG_TEXT Dosing Text

DDI_EXCEPT_A Drug-Drug N 8 9(8)

DD_DT Interaction
Exception Add
Date

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Drug-Drug Interaction Severity Levels Table

Table Name RADIMSL1_SEVER_LEVEL

Revision Activity rev.05-01-1999

Purpose Relates the Drug-Drug Interaction Severity Level to its text

description.

Key Column Name Column Format Length Picture

Description

P DDI_SL Drug-Drug AN 1 X(1)

Interaction
Severity Level

P DDI_SLSN Drug-Drug N 2 9(2)

Interaction
Severity Level
Text Sequence
Number

DDI_SLTXT Drug-Drug AN 70 X(70)

Interaction
Severity Level
Text

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Drug-Drug Reference Category Description Table

Table Name RDDIMRD0_REF_CATEGORY

Revision Activity add.05-01-1999

Purpose Relates the Drug-Drug Interaction Reference Category Line

Identifier to its text description.

Key Column Name Column Format Length Picture

Description

P IAMREFCAT Drug-Drug AN 1 X(1)

Interaction
Reference
Category Line
Identifier

IAMREFCATD Drug-Drug AN 40 X(40)

Interaction
Reference
Category
Description

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GCN_SEQNO Drug-Drug Interaction Code Relation Table

Table Name RADIMGC4_GCNSEQNO_LINK

Revision Activity rev.05-01-1999

Purpose Links drugs or drug classes to the drug interactions in which

they participate.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF DDI_CODEX Drug-Drug N 5 9(5)

Expanded
Interaction Code

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Drug-Drug Interaction Module for Consumers

Drug-Drug Interaction Module for Consumers (DDIM-C) 3.3
General Information
Drug-Drug Interaction Module for Consumers Editorial Policies
Application: Displaying Drug-Drug Interaction Messages for Consumers
ERD and Technical Specifications

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DDIM-C General Information

The General Information section contains high-level information about the module.

Overview
Concepts

Overview

The Drug-Drug Interaction Module for Consumers (DDIM-C) provides text-based monographs of drug-drug
interaction information for consumer use. The module is based upon the content of the Drug-Drug Interaction
Module (DDIM), a clinically reviewed module that reports only the most clinically significant interactions. DDIM
provides, among other things, a professional monograph detailing the interaction between two drugs when used
in combination. Consumer versions of the professional monograph provide the drug-drug interaction information
in consumer-friendly language.

The consumer-based module shares the DDIM Master Table with the professional module. In other words, once a
drug interaction is identified, the interaction code serves as an index into the Master Table. Access to the
consumer tables for severity level and monograph text occurs via the Master Table. The Master Table allows
access to both the professional monograph and the consumer monograph, provided you are licensed to receive
both sets of monograph text.

Drug knowledge is aggregated at the Clinical Formulation ID (GCN_SEQNO), Routed Medication ID (

ROUTED_MED_ID), and the Routed Generic ID (ROUTED_GEN_ID) levels in the First Databank (FDB)
knowledge base. Under certain circumstances, aggregated drug knowledge may not apply to all related
packaged products; more specific information may be found within the DDIM monograph for the
interaction.

Concepts

This section describes concepts and database elements that are important for understanding the module.

Understanding Monograph for Consumer Elements

Each DDIM-C monograph consists of the following sections, described in detail below:

title
medical warning
how the interaction occurs
what might happen
what you should do about this interaction
references

TITLE: includes the drugs or drug classes involved in the interaction. This is included in a format identical to the
professional monograph.

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For consumer monographs, it is recommended that the names of the specific drugs that resulted in the
interaction be placed just above or just below the monograph title.

MEDICAL WARNING: provides a brief description of the severity of the interaction. This section is based upon the
Severity Level in the professional monograph for DDIM version 3.2. A separate Severity Level table for the
consumer-based monographs is provided. Depending upon which of the four severity levels is assigned to a
drug-drug interaction, one of the following warnings is provided to the consumer:

Severity Levels

Value Description

1 Severe; These medicines may interact and cause very

harmful effects and are usually not taken together. Contact
your healthcare professional (e.g., doctor or pharmacist) for
more information.

2 Serious; These medicines may interact and cause very

harmful effects. Contact your healthcare professional (e.g.,
doctor or pharmacist) for more information.

3 Moderate; These medicines may cause some risk when

taken together. Contact your healthcare professional (e.g.,
doctor or pharmacist) for more information.

9 Unknown; Alternative Therapy Interaction. Warning: These

medications may cause some risk when taken together.
Contact your healthcare professional (e.g., doctor or
pharmacist) for more information.

HOW THE INTERACTION OCCURS: describes the manner in which the two drugs interact, if known. The
mechanism by which the interaction is purported to occur is explained in consumer language.

WHAT MIGHT HAPPEN: describes possible physiologic (therapeutic and toxic as applicable) effects of the
interaction on the patient.

WHAT YOU SHOULD DO ABOUT THIS INTERACTION: guides the patient regarding action they should take
relative to the interaction. In situations where the drug combination is generally contraindicated (severity level 1),
the patient is instructed to immediately contact their healthcare professional. In cases where a drug combination
may result in symptoms that a patient may recognize, these symptoms are listed in patient-friendly terms, with a
referral to a healthcare professional. In the event that specific monitoring of the interaction may be warranted, the
patient is provided with this information.

REFERENCES: lists all reference source data found in the reference section of the professional monograph.

The professional monographs also include Predisposing Factors and Discussion sections. The Predisposing
Factors section describes situations in which the drug-drug interaction may be more likely to occur or more
severe in occurrence. The Discussion section describes the findings as reported in the cited references. While the

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consumer monograph does not include specific sections corresponding to Predisposing Factors or Discussion,
applicable information from these sections of the professional monograph is incorporated into the consumer
monograph in one or more of the sections described above.

Displaying Disclaimers

When using DDIM-C, one or more disclaimers are required. Use of each disclaimer, along with its specific text, is
described below. Refer to your licensing agreement for information regarding the disclaimers required in your
specific environment or application(s).

Monograph Disclaimer

Each consumer monograph includes a disclaimer. This disclaimer must be provided with the monograph in all
developer applications, regardless of whether the monograph is electronically displayed or printed as a document.
The monograph disclaimer reads as follows:

Monograph Disclaimer

This information is generalized and not intended as specific medical advice. Consult your healthcare professional before
taking or discontinuing any drug or commencing any course of treatment.

The monograph disclaimer is assigned to print code Z.

Terms of Use (Terms and Conditions) Disclaimer

The Terms of Use Disclaimer must be implemented in all web environments for consumers and healthcare
professionals. The Terms of Use Disclaimer reads as follows:

You agree not to commercialize or redistribute the contents of this web site.
This site is designed to offer you general health information for educational purposes only. The health information
furnished on this site and the interactive responses is not intended to be professional advice and is not intended to replace
personal consultation with a qualified physician, pharmacist, or other healthcare professional. You must always seek the
advice of a professional for questions related to your disease, disease symptoms, and appropriate therapeutic treatments.
If you have or suspect that you have a medical problem or condition, please contact a qualified healthcare provider
immediately. You should never disregard medical advice or delay in seeking it because of something you have read on this
site. We do not make any warranty that the content on this site satisfies government regulations requiring disclosure of
information on prescription drug products. The content was developed for use in the United States, and neither we nor our
content providers make any representation concerning the content when used in any other country. While information on
this site has been obtained from sources believed to be reliable, neither we nor our content providers warrant the accuracy
of codes, prices or other data contained on this site.
We do not give medical advice, nor do we provide medical or diagnostic services. Medical information changes rapidly.
Neither we nor our content providers guarantee that the content covers all possible uses, directions, precautions, drug
interactions, or adverse effects that may be associated with any therapeutic treatments.
Your reliance upon information and content obtained by you at or through this site is solely at your own risk. Neither we nor
our content providers assume any liability or responsibility for damage or injury (including death) to you, other persons or
property arising from any use of any product, information, idea or instruction contained in the content or services provided
to you.

Click Through Agreement (Conditions of Use)

The Conditions of Use must be implemented as a click through agreement in all web environments for
consumers and healthcare professionals. The Conditions of Use reads as follows:

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and
judgment of your healthcare professional. The information is not intended to cover all possible uses, directions,
precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe,
appropriate or effective for you. You should consult your healthcare professional before taking or discontinuing any drug or
commencing any course of treatment.

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Drug-Drug Interaction Module for Consumers Editorial Policies

The policies and criteria that apply to the scope and processes of the DDIM-C module are provided in the
following sections:

Scope

DDIM-C is intended to provide a text-based monograph targeted to the consumer audience. This monograph may
be generated by the healthcare professional and distributed to the patient. Alternately, the monographs may be
incorporated into a system providing access directly to the consumer for use in self-care and ambulatory medical
care. This may include, but is not limited to, the Internet, stand-alone kiosks, or other systems. DDIM-C provides
monographs directed to patients, in language they can understand.

Editorial Process

The following section describes the processes and criteria the clinical editors use to add or review database
elements.

External Triggers for Clinical Review

The external triggers that prompt the clinical editors to add or review data are the following:

MedEffects Alerts from Health Canada

MedWatch Safety Alerts

Internal Triggers for Clinical Review

The internal trigger that prompts the clinical editors to add or review data is a new Clinical Formulation ID
(GCN_SEQNO).

Module Maintenance

This module is updated and expanded regularly by FDB. As content additions, changes, and enhancements are
identified, both professional and consumer monographs are developed or modified as appropriate. Our policy is to
stay current and dynamic with changing drug information. However, all decisions regarding drug therapy must be
based on independent judgement due to the dynamic nature of drug information and changing medical practice.

Inclusion Criteria

Clinical severity, as well as the quantity and quality of documentation, are some of the criteria considered when
determining the inclusion of a drug interaction in DDIM. If a professional monograph is deemed warranted, a
corresponding consumer monograph will be developed.

Monograph Readability

All efforts are made to enhance the readability of the monograph by the consumer public. Each monograph is
evaluated for consistency in wording and phrasing when compared to existing monographs. In addition, sentence
structure and grammar are constructed for maximum reading ease.

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Application: Displaying Drug-Drug Interaction Messages for Consumers

This application illustrates the generation of display options for consumer drug-drug interaction messages for
consumers.

Consider the following when developing applications for consumer drug-drug monographs:

provide access to all four severity levels during drug-food interaction screening
supplement the monograph title with the name of the specific drug that resulted in the interaction by
including the drug name directly above or directly below the title
identify the section header (for example, Medical Warning, How the Interaction Occurs) with bold text

The following application begins at the Clinical Formulation level with the Clinical Formulation ID ( GCN_SEQNO)
and assumes familiarity with the various drug concepts and their identifiers. See Multiple Access Points
(MAPs) for more information.

1. Select the Drug-Drug Expanded Interaction Code (DDI_CODEX) column from the
GCN_SEQNO/Drug-Drug Interaction Code Relation Table (RADIMGC4_GCNSEQNO_LINK) where the
GCN_SEQNO column equals the GCN_SEQNO value of the drug product.

2. Select the following columns from the Drug-Drug Interaction Master Table (RADIMMA5_MSTR) where the
DDI_CODEX column equals the DDI_CODEX value from the previous step.

a. Drug-Drug Interaction Description (DDI_DES)

b. Drug-Drug Interaction Severity Level (DDI_SL)

c. Drug-Drug Interaction Expanded Monograph Number (DDI_MONOX)

3. Display the Drug-Drug Interaction details to the end-user.

4. Select the following columns from the Consumer Drug Interaction Monograph Text Table
(RDDICMO5_CONSUMER_MONO) where the DDI_MONOX column equals the DDI_MONOX value from
step 1.

a. Drug-Drug Interaction Monograph Text Sequence Number (Consumer) (DDC_MONOSN)

b. Drug-Drug Interaction Monograph Line Identifier (Consumer) (IACIDENTN)

c. Drug-Drug Interaction Monograph Text (Consumer) (IACTEXTN)

d. Drug-Drug Interaction Reference Category Line Identifier (IAMREFCAT)

5. Display the monograph details to the end-user in the order indicated by the DDC_MONOSN column.

ExampleDisplaying Drug-Drug Interaction Messages for Consumers

A clinician wishes to generate all available drug-drug interaction documentation for the consumer when screening
for drug-drug interactions. The example below demonstrates the generation of these messages for the drug
product Ansaid (Clinical Formulation ID [GCN_SEQNO] 008363).

1. Select the Drug-Drug Expanded Interaction Code (DDI_CODEX) column from the

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1.

GCN_SEQNO/Drug-Drug Interaction Code Relation Table (RADIMGC4_GCNSEQNO_LINK) where the

GCN_SEQNO column equals the GCN_SEQNO value of the drug product.

GCN_SEQNO LN DDI_CODEX

008363 ANSAID 100 MG CAPSULE 00119

2. Select the following columns from the Drug-Drug Interaction Master Table (RADIMMA5_MSTR) where the
DDI_CODEX column equals the DDI_CODEX value from the previous step.

a. Drug-Drug Interaction Description (DDI_DES)

b. Drug-Drug Interaction Severity Level (DDI_SL)

c. Drug-Drug Interaction Expanded Monograph Number (DDI_MONOX)

DDI_DES NSAIDS/LITHIUM

DDI_SL 3

DDI_MONOX 00119

3. Display the Drug-Drug Interaction details to the end-user.

NSAIDs/Lithium Interaction
Severity Level: 3 - Moderate. These medicines may cause some risk when taken together. Contact your healthcare
professional (e.g. doctor or pharmacist) for more information.

4. Select the following columns from the Consumer Drug Interaction Monograph Text Table
(RDDICMO5_CONSUMER_MONO) where the DDI_MONOX column equals the DDI_MONOX value from
step 1.

a. Drug-Drug Interaction Monograph Text Sequence Number (Consumer) (DDC_MONOSN)

b. Drug-Drug Interaction Monograph Line Identifier (Consumer) (IACIDENTN)

c. Drug-Drug Interaction Monograph Text (Consumer) (IACTEXTN)

d. Drug-Drug Interaction Reference Category Line Identifier (IAMREFCAT)

DDC_MONOSN IACIDENTN IACTEXTN IAMREFCAT

001 Z This information is

generalized and not
intended as specific
medical advice.

002 Z Consult your healthcare

professional before
taking or discontinuing
any drug

003 Z or commencing any

course of treatment.

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004 B

005 T Monograph Title

006 T NSAIDs/Lithium

007 B

008 L Medical Warning

009 L Moderate. These

medicines may cause
some risk when taken
together.

010 L Contact your healthcare

professional (e.g. doctor
or pharmacist) for

011 L more information

012 B

013 A How The Interaction

Occurs

014 A When these two

medicines are taken
together, your body may
not process

015 A lithium properly.

016 B

017 E What Might Happen

018 E Your blood levels of

lithium may increase and
cause toxic effects.

019 B

020 M What You Should Do

About This Interaction

021 M If you experience

diarrhea, nausea,
vomiting, muscle
weakness, trembling

022 M of the hands, slurred

speech, or unsteady
walking, contact your
doctor.

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023 M Your doctor may want to

check your blood levels
of lithium and adjust
your

024 M dose.

025 M Your healthcare

professionals (e.g. doctor
or pharmacist) may
already be

026 M aware of this drug

interaction and may be
monitoring you for it. Do
not

027 M start, stop, or change the

dosage of any medicine
before checking with
them

028 M first.

029 B

030 R References

031 B

032 R 1. Frolich JC, Leftwich R, 2

Ragheb M, Oates JA,
Reimann I, Buchanan D.

033 R Indomethacin increases 2

plasma lithium. Br Med J
1979 Apr
28;1(6171):1115-6

034 R 2. Ragheb M, Ban TA, 2

Buchanan D, Frolich JC.
Interaction of
indomethacin and

035 R ibuprofen with lithium in 2

manic patients under a
steady-state lithium

036 R level. J Clin Psychiatry 2

1980 Nov;41(11):397-8.

... ... ... ...

5. Display the monograph details to the end-user in the order indicated by the DDC_MONOSN column. The
example below displays partial results.

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DDIM-C ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

DDIM-C Tables
DDIM-C ERDs

DDIM-C Tables

Consumer Drug Interaction Monograph Text Table

Consumer Drug Interaction Severity Levels Table

DDIM-C ERDs

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Consumer Drug Interaction Monograph Text Table

Table Name RDDICMO5_CONSUMER_MONO

Revision Activity add.02-25-2000

Purpose Provides the text, in consumer language, for the drug

interaction monograph.

Key Column Name Column Format Length Picture

Description

P DDI_MONOX Drug-Drug N 5 9(5)

Interaction
Expanded
Monograph
Number

P DDC_MONOSN Drug-Drug N 3 9(3)

Interaction
Monograph Text
Sequence
Number

IACIDENTN Drug-Drug AN 1 X(1)

Interaction
Monograph Line
Identifier

IACTEXTN Drug-Drug AN 76 X(76)

Interaction
Monograph Text

F IAMREFCAT Drug-Drug AN 1 X(1)

Interaction
Reference
Category Line
Identifier

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Consumer Drug Interaction Severity Levels Table

Table Name RDDICSL1_CONSUMER_SEVER_LEVEL

Revision Activity add.02-25-2000

Purpose Relates the Drug-Drug Interaction Severity Level to its text

description, worded for the consumer.

Key Column Name Column Format Length Picture

Description

P DDI_SL Drug-Drug AN 1 X(1)

Interaction
Severity Level

P DDC_SEVSN Drug-Drug N 2 9(2)

Interaction
Severity Level
Text Sequence
Number
(Consumer)

DDC_SEVTXT Drug-Drug AN 70 X(70)

Interaction
Severity Level
Text (Consumer)

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Drug-Food Interaction Module (DFIM)

General Information
Drug-Food Interaction Module Editorial Policies
Application: Displaying Drug-Food Interaction Messages
ERD and Technical Specifications

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DFIM General Information

The General Information section contains high-level information about the module.

Overview
Concepts
Understanding Professional Monograph Elements
Accessing DFIM Data

Overview

The Drug-Food Interaction Module (DFIM) was designed to provide alerts on the potential of interactions
occurring between certain drugs and foodstuffs or food components when used in combination. In addition, the
DFIM provides the capability for generating cautions and other advisory information specific to each potential
drug-food interaction.

The specific cautions and advisories are linked to a Drug-Food Interaction Food Code (FDCDE). The code, in
turn, is linked to a hierarchical pair of data sets that respectively define the broad nature of the drug-food
interaction. The data sets also provide the facility to produce condensed hard copy messages and complete
monograph information on the nature of the drug-food interaction.

The DFIM can operate in a stand-alone pharmacy system environment with no electronic link to a patients dietary
status, but if such a link is available, the use of DFIM will enhance the systems operation.

It should be noted that the body of evidence available on drug-food interactions is limited and not nearly
as extensive, for example, as drug-drug interactions.

Drug knowledge is aggregated at the Clinical Formulation ID (GCN_SEQNO), Routed Medication ID (

ROUTED_MED_ID), and the Routed Generic ID (ROUTED_GEN_ID) levels in the First Databank (FDB)
knowledge base. Under certain circumstances, aggregated drug knowledge may not apply to all related
packaged products; more specific information may be found within the DFIM monograph for the
interaction.

Concepts

This section describes concepts and database elements that are important for understanding the module.

Understanding Professional Monograph Elements

The information for each monograph is stored in a text format. Each line of text consists of 80 columns of data.

Each DFIM monograph consists of the following sections, described in detail below:

title
significance level
mechanism of action
clinical effects

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management
discussionreference

TITLE: includes the drug or drug class and the interacting food.

SIGNIFICANCE LEVEL: More precisely, this section has evolved into a severity level, with a documentation
statement standardized for all sections. Level 1 is the most severe, and level 3 the least severe. The levels are as
follows:

Significance Levels

Value Description

1 Most Significant; Documented (more clinical data may be

needed): Action to reduce risk of adverse interaction usually
required

2 More Significant; Documented (more clinical data may be

needed): Assess risk to patient and take action as needed.

3 Significant; Documented (more clinical data may be

needed): Conservative measures are recommended until
more is known

The MECHANISM OF ACTION section describes the drug-food interaction from a molecular, cellular, or
physicochemical perspective if known. The mechanism by which the interaction is purported to occur is explained.

The CLINICAL EFFECTS section describes the expected physiologic (therapeutic and adverse as applicable)
effects upon the patient.

The PATIENT MANAGEMENT section discusses strategies to minimize the effects of the interaction, and/or
appropriate monitoring parameters to be instituted. Patient-specific information is presented as appropriate, with
consideration for specific patient populations as necessary.

The DISCUSSION section describes, when available, the clinical studies or other relevant data related to the
interaction. This detailed data will enhance and clarify the recommendations and facts in the other sections noted.

The REFERENCES section lists all reference source data.

Accessing DFIM Data

DFIM uses the Drug-Food Interaction Food Code (FDCDE) to identify drug-food interactions, reference interaction
monographs, and supply additional interaction information. The FDCDE column and its attributes reside in the
Drug-Food Interaction Master Table (RDFIMMA0_MSTR[). Five occurrences are allowed for each record and
blanks are the default.

FDCDE values are associated with drugs at the following MedKnowledge concept levels using the following
tables:

The Clinical Formulation ID (GCN_SEQNO) in the GCN_SEQNO/Drug-Food Code Relation Table

(RDFIMGC0_GCNSEQNO_LINK)

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The MED Routed Medication ID (ROUTED_MED_ID) in the DFIM Routed Medication Table
(RDFIMRM0_ROUTED_MED_LINK)
The Routed Generic ID (ROUTED_GEN_ID) in the DFIM Routed Generic Table
(RDFIMRG0_ROUTED_GEN_LINK)

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Drug-Food Interaction Module Editorial Policies

The policies and criteria that apply to the scope and processes of the Drug-Food Interaction Module are provided
in the following sections:

Scope
Editorial Process
External Triggers for Clinical Review
Internal Triggers for Clinical Review
Module Maintenance
Inclusion Criteria

Scope

The Drug-Food Interaction Module is intended to provide professional-level decision support for healthcare
professionals, including physicians, pharmacists, dietitians, and nurses. The Joint Commission (TJC) and
community practice standards include provision of drug-food interaction information to patients and caregivers. As
self-care and ambulatory medical care are emphasized more and more, the importance of a well-educated patient
and caregiver is evident. DFIM information aids in the process of establishing and implementing safe diet-drug
regimens.

Use of DFIM does not require a patients specific dietary regimen or history. DFIM is used to provide advisory
information to the healthcare professional and/or patient at the system users discretion. Whenever a drug product
with a potential drug-food interaction is dispensed, the application system can automatically alert the user that the
particular drug product has this potential. The application system should then allow for operator discretion in
deciding whether to instruct the system to provide additional information on the detected drug-food interaction or
to the generation of monographs. Typically, a system

provides an alert that the potential for drug-food interaction exists with a particular drug product.
generates essential drug-food interaction documentation for the detected interaction. Most systems will
allow for automatic or passive override of this capability and leave it to the operators discretion on whether
to continue.
generates Drug-Food Interaction Monographs.

The Drug-Food Interaction Module consists of interactions with accompanying concise narrative-style clinical
results, a two-line message intended for prescription label printing and complete professional monographs. A
concise (45-byte) summary of the clinical result of the interaction in question is provided.

Secondly, the label messages identify the most important take home message about the medication being
dispensed or administered. This two-line (54-byte) message contains key points the pharmacist would ideally
want the user to address.

Editorial Process

The following section describes the processes and criteria editors use to add or review database elements.

External Triggers for Clinical Review

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The external triggers that prompt the clinical editors to add or review data are the following:

MedEffects Alerts from Health Canada

MedWatch Safety Alerts

Internal Triggers for Clinical Review

The internal trigger that prompts the clinical editors to add or review data is a new Clinical Formulation ID (
GCN_SEQNO).

Module Maintenance

This module is updated and expanded regularly by FDB staff. Content is exhaustively and critically reviewed. Of
course, all decisions regarding drug therapy must be based on independent judgment due to the dynamic nature
of drug information and changing medical practice. Our policy is to stay current and dynamic with changing drug
information.

Inclusion Criteria

The inclusion criteria for interactions includes severity and documentation of the interaction and complexity of
patient management. If an interaction is effectively managed by taking the drug with food, for example, then it is
more appropriate to address the issue with a prioritized label warning. A drug-food interaction monograph would
not be generated. The more complex interactions (for example, cytochrome P450 enzyme inhibition by grapefruit
juice constituents) are included in DFIM.

Current criteria also address severity. Interactions generally require some patient monitoring, if not proactive dose
adjustments, in order to be included in the module.

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Application: Displaying Drug-Food Interaction Messages

This application illustrates the automated generation of display options for end-user drug-food interaction
messages. However, a DFIM application program should allow for operator discretion in deciding whether to
instruct the system to provide additional information on the detected drug-food interaction or to the generation of
monographs.

The following application begins at the Clinical Formulation level with the Clinical Formulation ID ( GCN_SEQNO)
and assumes familiarity with the various drug concepts and their identifiers. See Multiple Access Points
(MAPs), page 42 for more information.

1. Select the Drug-Food Interaction Food Code (FDCDE) column from the GCN_SEQNO/Drug-Food Code
Relation Table (RDFIMGC0_GCNSEQNO_LINK) where the GCN_SEQNO column equals the
GCN_SEQNO value of the drug product.

2. Select the following columns from the Drug-Food Interaction Master Table (RDFIMMA0_MSTR) where the
FDCDE column equals the FDCDE value from the previous step.
Drug-Food Interaction Drug Name (DNAME)
Drug-Food Severity Level (FD_SL)
Drug-Food Interaction - Result (RESULT)
Drug-Food Interaction - First Line Message (FDMSG1)
Drug Food Interaction - Second Line Message (FDMSG2)

3. Display the Drug-Food Interaction details to the end-user.

4. Display the Drug-Food Interaction message for label printing by placing the FDMSG2 information directly
under the FDMSG1 information.

5. Select the following columns from the Drug-Food Interaction Monograph Text Table (RDFIMMO0_MONO)
where the FDCDE column equals the FDCDE value from step 1.
Drug-Food Interaction Monograph Text Sequence Number (FDCDE_SN)
Drug-Food Interaction Text Code (TXTCDE)
Drug-Food Interaction Data (FDTXT)

6. Display monograph details to the end-user in the order indicated by the FDCDE_SN column.

ExampleDisplaying Drug-Food Interaction Messages

A clinician wishes to generate all available drug-food interaction documentation when screening for drug-food
interactions. The example below demonstrates the generation of these messages for the drug product Allegra
(Clinical Formulation ID (GCN_SEQNO) 045261).

1. Select the Drug-Food Interaction Food Code (FDCDE) column from the GCN_SEQNO/Drug-Food Code
Relation Table (RDFIMGC0_GCNSEQNO_LINK) where the GCN_SEQNO column equals the Clinical
Formulation ID (GCN_SEQNO) value of the drug product.

GCN_SEQNO LN FDCDE

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045261 ZITHROMAX 30 MG TABLET 075

2. Select the following columns from the Drug-Food Interaction Master Table (RDFIMMA0_MSTR) where the
FDCDE column equals the FDCDE value from the previous step.
Drug-Food Interaction Drug Name (DNAME)
Drug-Food Severity Level (FD_SL)
Drug-Food Interaction - Result (RESULT)
Drug-Food Interaction - First Line Message (FDMSG1)
Drug Food Interaction - Second Line Message (FDMSG2)

FDCDE 075

DNAME FEXOFENADINE

FD_SL 3

RESULT FRUIT JUICES MAY IMPAIR ABSORPTION.

FDMSG1 AVOID APPLE, GRAPEFRUIT

FDMSG2 AND ORANGE JUICE.

3. Display the Drug-Food Interaction details to the end-user.

Fexofendadine/Fruit Juices Interaction

Severity Level: 3 - Significant. Documented; (more clinical data may be needed). Conservative measures are
recommended until more is known.
Result: Fruit juices may impair absorption.

4. Display the Drug-Food Interaction message for label printing by placing the FDMSG2 information directly
under the FDMSG1 information. For example:

Avoid Apple, Grapefruit

and Orange Juice.

5. Select the following columns from the Drug-Food Interaction Monograph Text Table (RDFIMMO0_MONO)
where the FDCDE column equals the FDCDE value from step 1.
Drug-Food Interaction Monograph Text Sequency Number (FDCDE_SN)
Drug-Food Interaction Text Code (TXTCDE)
Drug-Food Interaction Data (FDTXT)

FDCDE FDCDE_SN TXTCDE FDTXT

075 001 T MONOGRAPH TITLE:

Fexofenadine/Fruit
Juices

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075 002 B

075 003 L SIGNIFICANCE LEVEL:

3-Possibly Significant;
some/little available:

075 004 L Conservative measures

are recommended until
more is known.

075 005 B

075 006 A MECHANISM OF

ACTION: Apple,
grapefruit, and orange
juice may inhibit

075 007 A fexofenadine uptake by

organic anion
transporting polypeptids
(OATP).(1)

075 008 B

075 009 E CLINICAL EFFECTS:

Administration of
fexofenadine with apple,
grapefruit,

075 010 E or orange juice may

result in decreased
levels and effectiveness
of

075 011 E fexofenadine.(1,2)

075 012 B

075 013 M PATIENT

MANAGEMENT:
Suggest that patients
avoid taking
fexofenadine

075 014 M with apple, grapefruit, or

orange juice. The
manufacturer of
fexofenadine

075 015 M recommends that

fexofenadine be taken
with water.(2)

075 016 B

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075 017 D DISCUSSION: In a

five-way cross-over
study in 10 subjects,
each subject

075 018 D received fexofenadine

(120 mg) with 300 ml of
water, apple juice,
orange

075 019 D juice, grapefruit juice,

and 25% grapefruit juice.
There was a one-week

075 020 D wash-out period between

phases. Apple juice
decreased the
fexofenadine

075 021 D area-under-curve (AUC)

and maximum
concentration (Cmax) by
73% and by 72%,

075 022 D respectively. Orange

juice decreased the
fexofenadine AUC and
Cmax by 69%

075 023 D and by 67%,

respectively. Grapefruit
juice at 100% decreased
fexofenadine

075 024 D AUC and Cmax by 63%

and by 62%,
respectively. Grapefruit
juice at 25%

075 025 D decreased fexofenadine

AUC by 23%.(1)

075 026 D Three clinical studies

using histamine induced
skin wheals and flares

075 027 D indicate that wheal and

flare responses were
larger when
fexofenadine was

075 028 D administered with either

grapefruit juice or orange
juices and fexofenadine

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075 029 D bioavailability was

decreased by 36%.
Literature indicates
similar results

075 030 D can be expected from

apple juice.(2)

075 031 B

075 032 R REFERENCES:

075 033 B

075 034 R 1.Dresser GK, Bailey

DG, Leake BF, Schwarz
UI, Dawson PA,
Freeman DJ, Kim

075 035 R RB: Fruit juices inhibit

organic anion
transporting
polypeptide-mediated

075 036 R drug uptake to decrease

the oral availability of
fexofenadine. Clin

075 037 R Pharmacol Ther

2002;71:11-20.

075 038 R 2. Allegra (fexofenadine

hydrochloride) US
prescribing information.
Sanofi-

075 039 R Aventis U.S. LLC.

October, 2006.

You can choose to include or exclude monograph sections by listing or excluding values
from the Drug-Food Interaction Text Code (TXTCDE) column. For example:

Patient Management:

Suggest that patients avoid taking fexofenadine with apple, grapefruit, or orange juice. The
manufacturer of fexofenadine recommends that fexofenadine be taken with water.(2)

6. Display the monograph details to the end-user in the order indicated by the FDCDE_SN column.

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DFIM Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

Drug-Food Interaction Module Tables

Drug-Food Interaction Module ERD

Drug-Food Interaction Module Tables

DFIM Routed Generic Table

DFIM Routed Medication Table
Drug-Food Interaction Master Table
Drug-Food Interaction Monograph Text Table
GCN_SEQNO/Drug-Food Code Relation Table

Drug-Food Interaction Module ERD

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DFIM Routed Generic Table

Table Name RDFIMRG0_ROUTED_GEN_LINK

Revision Activity original

Purpose Links a routed generic to a drug-food interaction.

Key Column Name Column Format Length Picture

Description

PF ROUTED_GEN_I Routed Generic N 8 9(8)

D identifier

PF FDCDE Drug-Food N 3 9(3)

Interaction Food
Code

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DFIM Routed Medication Table

Table Name RDFIMRM0_ROUTED_MED_LINK

Revision Activity add.07-01-2002

Purpose Links a routed medication to a drug-food interaction.

Key Column Name Column Format Length Picture

Description

PF ROUTED_MED_I MED Routed N 8 9(8)

D Medication ID
(Stable ID)

PF FDCDE Drug-Food N 3 9(3)

Interaction Food
Code

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Drug-Food Interaction Master Table

Table Name RDFIMMA0_MSTR

Revision Activity original

Purpose Provides attributes of the drug-food interaction, including a

professional message describing the result of the
interaction.

Key Column Name Column Format Length Picture

Description

P FDCDE Drug-Food N 3 9(3)

Interaction Food
Code

DNAME Drug-Food AN 21 X(21)

Interaction Drug
Name

FD_SL Drug-Food AN 1 X(1)

Severity Level

RESULT Drug-Food AN 45 X(45)

Interaction -
Result

FDMSG1 Drug-Food AN 27 X(27)

Interaction - First
Line Message

FDMSG2 Drug-Food AN 27 X(27)

Interaction -
Second Line
Message

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Drug-Food Interaction Monograph Text Table

Table Name RDFIMMO0_MONO

Revision Activity original

Purpose Provides the text for the drug-food interaction professional

monograph.

Key Column Name Column Format Length Picture

Description

PF FDCDE Drug-Food N 3 9(3)

Interaction Food
Code

P FDCDE_SN Drug-Food N 3 9(3)

Interaction
Monograph Text
Sequence
Number

TXTCDE Drug-Food AN 1 X(1)

Interaction Text
Code

FDTXT Drug-Food AN 76 X(76)

Interaction Data

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GCN_SEQNO - Drug-Food Code Relation Table

Table Name RDFIMGC0_GCNSEQNO_LINK

Revision Activity original

Purpose Links clinical formulations to food interactions.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF FDCDE Drug-Food N 3 9(3)

Interaction Food
code

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Drug-Food Interaction Module for Consumers (DFIM-C) 1.0

General Information
Drug-Food Interaction for Consumers Module Editorial Policies
Application: Displaying Drug-Food Interaction Messages for Consumers
ERD and Technical Specifications

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General Information DFIM-C

The General Information section contains high-level information about the module.

Overview
Concepts

Overview

The Drug-Food Interaction Module for Consumers (DFIM-C) provides text-based monographs of drug-food
interaction information for consumer use. The module is based upon the content of the Drug-Food Interaction
Module (DFIM), a clinically reviewed module that reports only the most clinically significant interactions. DFIM
provides, among other things, a professional monograph detailing the interaction between certain drugs and
foods when ingested together. Consumer versions of the monograph provide the drug-food interaction information
in text created for consumer use.

The consumer-based module shares the DFIM Master Table with the professional module. In other words, the
Drug-Food Interaction Food Code (FDCDE) allows access to both the professional monograph and the consumer
monograph via the Master Table, provided you are licensed to receive both sets of monograph text.

Concepts

This section describes concepts and database elements that are important for understanding the module.

Understanding Consumer Monograph Elements

Each DFIM-C monograph consists of the following sections, described in detail below:

title
medical warning
how the interaction occurs
what might happen
what you should do about this interaction
references

TITLE: includes the drug or drug class and the interacting food. This is included in a format identical to the
professional monograph.

For consumer monographs, it is recommended that the name of the specific drug that resulted in the
interaction be placed just above or just below the monograph title.

MEDICAL WARNING: provides a brief description of the significance of the interaction. This section is based
upon the Significance Level in the professional monograph. The interaction between a drug and food may be
potentially harmful or beneficial to the patient. The Medical Warning outlines possible action the physician may
deem warranted based upon the significance of the interaction and its resultant effect. Depending upon which of
the three significance levels is assigned to a drug-food interaction, one of the following messages is provided to
the consumer:

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Significance Levels

Level Warning

1 Most important. A change in your diet, medicine, or dosage

is likely to be necessary. Promptly consult your doctor or
pharmacist.

2 Very important. A change in your diet, medicine, or dosage

may be necessary. Promptly consult your doctor or
pharmacist

3 Important. Possible changes in your diet, medicine, or

dosage should be discussed with your doctor or pharmacist.

HOW THE INTERACTION OCCURS: describes the manner in which the drug and food interact, if known. The
mechanism by which the interaction is purported to occur is explained in consumer language.

WHAT MIGHT HAPPEN: describes possible physiologic (therapeutic and toxic, as applicable) effects of the
interaction on the patient.

WHAT YOU SHOULD DO ABOUT THIS INTERACTION: discusses methods to avoid or counteract the effects of
the drug-food interaction. In situations where the drug-food interaction may be a beneficial one, the patient is
provided with information on methods to maximize the benefit. In cases where a drug-food combination may
result in symptoms that a patient may recognize, these symptoms are listed in patient-friendly terms, with a
referral to a healthcare professional. In the event that specific monitoring of the interaction may be warranted, the
patient is provided with this information. As applicable, a specific food list relevant to the interaction is also
included.

REFERENCES: lists all reference source data found in the reference section of the professional monograph.

Discussion information, which describes the findings as reported in the cited references, is not included
within a specific section of the consumer monograph. Applicable information from this section of the
professional monograph is incorporated into the consumer monograph in one or more of the sections
described above.

Displaying Disclaimers

Each consumer monograph includes a disclaimer. This disclaimer must be provided with the monograph in all
developer applications, regardless of whether the monograph is electronically displayed or printed as a document.
The monograph disclaimer reads as follows:

ExampleThis information is generalized and not intended as specific medical advice. Consult your healthcare
professional before taking or discontinuing any drug, changing your diet, or commencing any course of treatment.

The monograph disclaimer is assigned to print code Z. Refer to Understanding Consumer Monograph Elements
for more information about DFIM-C print codes.

Monograph Disclaimer

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When using DFIM-C, one or more disclaimers are required. Use of each disclaimer, along with its specific text, is
described below. Refer to your licensing agreement for information regarding the disclaimers required in your
specific environment or application(s).

Terms of Use (Terms and Conditions) Disclaimer

The Terms of Use Disclaimer must be implemented in all web environments for consumers and healthcare
professionals. The Terms of Use Disclaimer reads as follows:

Use Restrictions
You agree not to commercialize or redistribute the contents of this web site.
Medical Disclaimers
This site is designed to offer you general health information for educational purposes only. The health information
furnished on this site and the interactive responses is not intended to be professional advice and is not intended to replace
personal consultation with a qualified physician, pharmacist, or other healthcare professional. You must always seek the
advice of a professional for questions related to your disease, disease symptoms, and appropriate therapeutic treatments.
If you have or suspect that you have a medical problem or condition, please contact a qualified healthcare provider
immediately. You should never disregard medical advice or delay in seeking it because of something you have read on this
site.
We do not make any warranty that the content on this site satisfies government regulations requiring disclosure of
information on prescription drug products. The content was developed for use in the United States, and neither we nor our
content providers make any representation concerning the content when used in any other country. While information on
this site has been obtained from sources believed to be reliable, neither we nor our content providers warrant the accuracy
of codes, prices or other data contained on this site.
We do not give medical advice, nor do we provide medical or diagnostic services. Medical information changes rapidly.
Neither we nor our content providers guarantee that the content covers all possible uses, directions, precautions, drug
interactions, or adverse effects that may be associated with any therapeutic treatments.
Your reliance upon information and content obtained by you at or through this site is solely at your own risk. Neither we nor
our content providers assume any liability or responsibility for damage or injury (including death) to you, other persons or
property arising from any use of any product, information, idea or instruction contained in the content or services provided
to you.

This disclaimer text is provided in a separate table. Refer to Technical Specifications for more information.

Click Through Agreement (Conditions of Use)

The Conditions of Use must be implemented as a click through agreement in all web environments for
consumers and healthcare professionals. The Conditions of Use reads as follows:

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and
judgment of your healthcare professional. The information is not intended to cover all possible uses, directions,
precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe,
appropriate or effective for you. You should consult your healthcare professional before taking or discontinuing any drug or
commencing any course of treatment.

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Drug-Food Interaction for Consumers Module Editorial Policies

The policies and criteria that apply to the scope, processes, and sources of the Drug-Food Interaction for
Consumers Module are provided in the following sections.

Scope

DFIM-C is intended to provide a text-based monograph targeted to the consumer audience. This monograph may
be generated by the healthcare professional and distributed to the patient. Alternately, the monographs may be
incorporated into a system providing access directly to the consumer for use in self-care and ambulatory medical
care. This may include, but is not limited to, the Internet, stand-alone kiosks, or other systems. DFIM-C can assist
healthcare professionals in meeting Joint Commission (TJC) and community practice standards regarding the
provision of drug-food interaction information. DFIM-C aids in the process by providing monographs directed to
patients, in language they can understand.

As with the DFIM module, the DFIM-C module can operate in a stand-alone system environment with no
electronic link to a patients medication list. However, if such a link is available, the use of DFIM-C will enhance
the systems operation.

It should be noted that the body of evidence available on drug-food interactions is limited and not nearly
as extensive, for example, as drug-drug interactions.

Editorial Process

The following section describes the processes and criteria the clinical editors use to add or review database
elements.

External Triggers for Clinical Review

The external triggers that prompt the clinical editors to add or review data are the following:

MedEffects Alerts from Health Canada

MedWatch Safety Alerts
Changes to government approved prescribing information
Primary medical literature

Internal Triggers for Clinical Review

The internal trigger that prompts the clinical editors to add or review data is a new Clinical Formulation ID (
GCN_SEQNO).

Module Maintenance

This module is updated and expanded regularly by First Databank (FDB). As content additions, changes, and
enhancements are identified, both professional and consumer monographs are developed or modified as
appropriate. FDBs policy is to stay current and dynamic with changing drug information. However, all decisions
regarding drug therapy must be based on independent judgement due to the dynamic nature of drug information
and changing medical practice.

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Inclusion Criteria

Clinical severity, quantity and quality of documentation, and complexity of patient management are some of the
criteria considered when determining the inclusion of an interaction in DFIM. If a professional monograph is
deemed warranted, a corresponding consumer monograph will be developed.

Monograph Readability

All efforts are made to enhance the readability of the monograph by the consumer public. Each monograph is
evaluated for consistency in wording and phrasing when compared to existing monographs. In addition, sentence
structure and grammar are constructed for maximum reading ease.

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Application: Displaying Drug-Food Interaction Messages for Consumers

This application illustrates the generation of display options for consumer drug-food interaction messages for
consumers.

Consider the following when developing applications for consumer drug-food monographs:

provide access to all three significance levels during drug-food interaction screening
supplement the monograph title with the name of the specific drug that resulted in the interaction by
including the drug name directly above or directly below the title
identify the section header (for example, Medical Warning, How the Interaction Occurs) with bold text

The following application begins at the Clinical Formulation level with the Clinical Formulation ID ( GCN_SEQNO)
and assumes familiarity with the various drug concepts and their identifiers. See Multiple Access Points (MAPs)
for more information.

1. Select the Drug-Food Interaction Food Code (FDCDE) column from the GCN_SEQNO/Drug-Food Code
Relation Table (RDFIMGC0_GCNSEQNO_LINK) where the GCN_SEQNO column equals the
GCN_SEQNO value of the drug product.

2. Select the following columns from the Drug-Food Interaction Master Table (RDFIMMA0_MSTR) where the
FDCDE column equals the FDCDE value from the previous step.

a. Drug-Food Interaction Drug Name (DNAME)

b. Drug-Food Severity Level (FD_SL)

c. Drug-Food Interaction - Result (RESULT)

d. Drug-Food Interaction - First Line Message (FDMSG1)

e. Drug Food Interaction - Second Line Message (FDMSG2)

3. Display the Drug-Food Interaction details to the end-user.

4. Display the Drug-Food Interaction message for label printing by placing the FDMSG2 information directly
under the FDMSG1 information.

5. Select the following columns from the Consumer Food Interaction Monograph Text Table
(RDFICMO0_CONSUMER_MONO) where the FDCDE column equals the FDCDE value from step 1.

a. Drug-Food Interaction Monograph Text Sequence Number (Consumer) (FDCCDE_SN)

b. Drug-Food Interaction Text Code (Consumer) (TXTCDEC)

c. Drug-Food Interaction Data (Consumer) (FDCTXT)

6. Display monograph details to the end-user in the order indicated by the FDCCDE_SN column.

ExampleDisplaying Drug-Food Interaction Messages for Consumers

A clinician wishes to generate all available drug-food interaction documentation for the consumer when screening
for drug-food interactions. The example below demonstrates the generation of these messages for the drug

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product Matulane (Clinical Formulation ID [GCN_SEQNO] 008836).

1. Select the Drug-Food Interaction Food Code (FDCDE) column from the GCN_SEQNO/Drug-Food Code
Relation Table (RDFIMGC0_GCNSEQNO_LINK) where the GCN_SEQNO column equals the Clinical
Formulation ID (GCN_SEQNO) value of the drug product.

GCN_SEQNO LN FDCDE

008836 MATULANE 50 MG CAPSULE 012

2. Select the following columns from the Drug-Food Interaction Master Table (RDFIMMA0_MSTR) where the
Drug-Food Interaction Food Code (FDCDE) column equals the FDCDE value from the previous step.

a. Drug-Food Interaction Drug Name (DNAME)

b. Drug-Food Severity Level (FD_SL)

c. Drug-Food Interaction - Result (RESULT)

d. Drug-Food Interaction - First Line Message (FDMSG1)

e. Drug Food Interaction - Second Line Message (FDMSG2)

FDCDE 012

DNAME MAOIS

FD_SL 1

RESULT FOOD CONTAINING TYRAMINE CAN INCREASE

BP.

FDMSG1 AVOID HIGH TYRAMINE FOODS.

FDMSG2 ...

3. Display the Drug-Food Interaction details to the end-user.

MAOIs/Tyramine-containing Foods Interaction

Severity Level: 1 - Most significant. Documented; (more clinical data may be needed). Action to reduce risk of
adverse interaction usually required.
Result: Food containing tyramine can increase BP.

4. Display the Drug-Food Interaction message for label printing by placing the FDMSG2 information directly
under the FDMSG1 information, when applicable. For example:

Avoid High Tyramine Foods.

5. Select the following columns from the Drug-Food Interaction Monograph Text Table (RDFIMMO0_MONO)
where the FDCDE column equals the FDCDE value from step 1.

a. Drug-Food Interaction Monograph Text Sequence Number (Consumer) (FDCCDE_SN)

b.

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b. Drug-Food Interaction Text Code (Consumer) (TXTCDEC)

c. Drug-Food Interaction Data (Consumer) (FDCTXT)

FDCDE FDCCDE_SN TXTCDEC FDCTXT

012 001 Z This information is

generalized and not
intended as specific
medical advice.

012 002 Z Consult your healthcare

professional before
taking or discontinuing
any

012 003 Z drug, changing your diet

or commencing any
course of treatment.

012 004 B

012 005 T Monograph Title

012 006 T MAOIs/Tyramine-contai

ning Foods

012 007 B

012 008 L Medical Warning

012 009 L Most important. A

change in your diet,
medicine, or dosage is
likely to

012 010 L be necessary. Promptly

consult your doctor or
pharmacist.

012 011 B

012 012 A How the Interaction

Occurs

012 013 A Tyramine is normally

broken down in your
body by an enzyme
called MAO

012 014 A (monoamine oxidase).

When MAO inhibitor
(MAOI) medicines are
taken,

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012 015 A excessive amounts of

tyramine enter the
bloodstream, leading to
the release

012 016 A of adrenaline-like

substances
(norepinephrine) in the
body. Increased blood

012 017 A pressure then occurs.

012 018 B

012 019 E What Might Happen

012 020 E Large increases in blood

pressure may occur,
which could lead to very

012 021 E serious problems such

as strokes or chest
pain/heart attacks.

012 022 B

012 023 M What You Should Do

About This Interaction

012 024 M It is very important that

you follow special dietary
restrictions in

012 025 M order to limit the amount

of tyramine in your diet
while you are taking

012 026 M this medicine.

012 027 M Foods and beverages

high in tyramine should
be avoided (see list
below).

012 028 M Excessive amounts of

coffee, chocolate, sour
cream, or avocados
have also

012 029 M produced symptoms of

high blood pressure in
some cases. The
following is a

012 030 M tyramine food list:

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012 031 M High tyramine level

foods include aged
cheeses (cheddar,
camembert,

012 032 M emmenthaler, brie,

stilton blue, gruyere,
gouda, brick, bleu,
roquefort,

012 033 M boursault, parmesan,

romano, provolone,
liederkranz, colby,
edam); aged,

012 034 M dried, fermented, salted,

smoked, pickled and
processed meats and
fish

012 035 M (includes bacon, summer

sausage, liverwurst, hot
dogs, corned beef,

012 036 M pepperoni, salami,

bologna, ham,
mortadella, pickled or
dried herring);

012 037 M banana peel; beef and

chicken liver (stored, not
fresh); bouillon cubes,

012 038 M commercial gravies;

concentrated yeast
extracts (marmite); fava
beans,

012 039 M Italian green beans,

broad beans, fermented
bean curd, homemade
yeast-

012 040 M leavened bread; kim

chee (Korean fermented
cabbage); miso, orange
pulp;

012 041 M overripe or spoiled fruits;

packaged soups, red
wine, sauerkraut,
sherry,

012 042 M snow pea pods,

sourdough bread, soy
sauce, soya bean, soya
bean paste; tap

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012 043 M beer and ale; vermouth.

012 044 M Moderate-to-low

tyramine level foods
include alcohol-free
beer,

012 045 M avocados, bananas;

bottled beer and ale;
chocolate and products
made

012 046 M with chocolate; coffee,

cola; cultured dairy
products (e.g.,
buttermilk,

012 047 M yogurt, sour cream);

distilled spirits, eggplant,
canned figs, fish roe

012 048 M (caviar), green bean

pods, pate, peanuts, port
wine, raisins,
raspberries,

012 049 M red plums, spinach,

tomatoes, white wine.

012 050 M Tell your doctor or

pharmacist immediately
if you notice symptoms
of high

012 051 M blood pressure such as

fast or slow heartbeat,
vomiting, sweating or

012 052 M headache, chest pain,

sudden vision changes,
one-sided weakness or
slurred

012 053 M speech.

012 054 M Contact your healthcare

professional (e.g.,
doctor, pharmacist or

012 055 M dietitian) for more

information, including
recommendations for
your diet.

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012 056 M Your healthcare

professionals may be
aware of this interaction
and may

012 057 M be monitoring you for it.

Do not start, stop, or
change your medicine
or

012 058 M diet before checking with

them first.

012 059 B

012 060 R References

012 061 B

012 062 R 1. Pare CM, Al Mousawi

M, Sandler M, Glover V.
Attempts to attenuate
the

012 063 R 'cheese effect'.

Combined drug therapy
in depressive illness. J
Affect

012 064 R Disord 1985;9:137-41.

012 065 R 2. Shulman KI, Walker

SE, MacKenzie S,
Knowles S. Dietary
restriction,

012 066 R tyramine, and the use of

monoamine oxidase
inhibitors. J Clin

012 067 R Psychopharmacol

1989;9:397-402.

... ... ... ...

6. Display the monograph details to the end-user in the order indicated by the FDCCDE_SN column. The
example below provides a sample of the monograph text.

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DFIM-C ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

DFIM-C Tables
DFIM-C ERD

DFIM-C Tables

Consumer Food Interaction Monograph Text Table

DFIM-C ERD

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Consumer Food Interaction Monograph Text Table

Table Name RDFICMO0_CONSUMER_MONO

Revision Activity add.02-25-2000

Purpose Provides the text for the drug-food interaction consumer

monograph.

Key Column Name Column Format Length Picture

Description

PF FDCDE Drug-Food N 3 9(3)

Interaction Food
Code

P FDCCDE_SN Drug-Food N 3 9(3)

Interaction
Monograph Text
Sequence
Number

TXTCDEC Drug-Food AN 1 X(1)

Interaction Text
Code (Consumer)

FDCTXT Drug-Food AN 76 X(76)

Interaction Data
(Consumer)

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Intravenous Module (IVM) 1.0

General Information
Intravenous Module Editorial Policies
Applications
ERD and Technical Specifications

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General Information
The General Information section contains high-level information about the module.

Overview
Definitions
Concepts

Overview
The Intravenous Module (IVM) provides information from the Handbook of Injectable Drugs by the American
Society of Health-System Pharmacists (ASHP) to enable screening of intravenous drug preparations for
physicochemical compatibility or incompatibility.

IVM is unique in its comprehensiveness and convenience. It helps avoid compatibility problems frequently
encountered in the compounding and dispensing of IV (intravenous) preparations, decreases the time spent
investigating compatibilities manually, and eliminates speculation. This improves management of IV preparation.
Additionally, IVM reduces waste of time and materials on physically or chemically incompatible IV mixtures.

Due to continually advancing technology in drug delivery, it is necessary to provide compatibility and
incompatibility data for multiple intravenous drug delivery methods. The four methods of intravenous drug delivery
described in IVM are:

single drug-in-solution
multiple drugs-in-solution
multiple drugs-in-syringe
Y-site

All four of these IV delivery modes can affect both the nature and extent of drug stability and compatibility.
Because the reverse is also true, attention must be paid to a drugs compatibility and stability when selecting a
particular delivery system. It is possible, then, that IVM can assist the healthcare professional in choosing
alternative administration systems.

Drug knowledge is aggregated at the Clinical Formulation ID (GCN_SEQNO), Routed Medication ID (

ROUTED_MED_ID), and the Routed Generic ID (ROUTED_GEN_ID) levels in the First Databank (FDB)
knowledge base. Under certain circumstances, aggregated drug knowledge may not apply to all related
packaged products; more specific information may be found within product labels.

Definitions
This section defines important terms related to the module that users should understand. Some industry terms
that have a specific connotation in regards to the module may also be defined.

Compatibility (C)

Compatibility is determined from the specific study or studies referenced in the text. Compatibility is defined as
either physical compatibility (no visible incompatibility) or stability of the drugs or solutions in each study for at

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least 24 hours (or less if stated in the study) with less than 10% decomposition. IV mixtures determined to be
compatible are noted with a value of C in the IVM Study Group Test Result Code (IVMRSLT) column.

Incompatibility (I)

Various criteria are considered in determining the incompatibility of an IV mixture. IV mixtures determined to be
incompatible are noted with a value of I in the IVM Study Group Test Result Code (IVMRSLT) column.

Physical Incompatibility (such as precipitation, haze, color change, etc.) Both visible and non-visible
incompatibilities are included in IVM. Many studies evaluate only physical incompatibility. Visibly
observable effects, such as color change or haze, are definite incompatibilities.
Chemical Incompatibility (such as decomposition) An IV mixture may exhibit more than 10%
decomposition within 24 hours, but may still be useful during a shorter period. Factors that influence
decomposition, such as the amount of decomposition, temperature, contact time, and pH, are included in
the remarks associated with IVM compatibility test results.
Instability Instability defines a chemical reaction that is not reversible and results in degradation
products that may be toxic and therapeutically inactive. Examples include hydrolysis and oxidative
reactions. Hydrolysis is a common mechanism of chemical decomposition causing the majority of drug
instability cases.

Equivocal Compatibility (?)

The Handbook on Injectable Drugs notes compatibility as equivocal in situations in which compatibility results are
transient (such as turbidity that is resolved during a short time period), uncertain, or inconsistent. These results do
not fit generally accepted criteria for compatibility or incompatibility. In the IVM Module, such results are assigned
an IVM Study Group Test Result Code (IVMRSLT) value of ?.

Concepts
This section describes concepts and database elements that are important for understanding the module.

IVM Codes

IVM Component, IVM Admixture, IVM Study Group, and IVM Remark codes are not stable and can change over
time, for example, a value might change with a new edition of the Handbook on Injectable Drugs. Reference the
table below for a list of these and other IVM codes with their descriptions.

Code Description Description

IVMCOMP IVM Component Assigned to a drug, solution, or total

parenteral nutrition solution (TPN). All
IVM components are assigned
component codes.

IVMADMIX IVM Admixture One or more IVM components as a

unit being tested in an IVM Study
Group. An admixture groups one or
more IVM components together in a
non-test condition.

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IVMSGRP IVM Study Group A unique combination of IVM

admixtures.

IVMTESTSN IVM Study Group Test An individual compatibility investigation

performed on the admixtures of an IVM
Study Group.

IVMRSLT IVM Study Group Test Result Denotes whether the mixture is
compatible, incompatible, or equivocal.

IVMTTYPE IVM Study Group Test Type This value denotes whether the study
type is a single drug in solution
(solution study, multiple drugs in a
solution (additive study), drugs in
syringe (syringe study), or a Y-site
study.

IVMRMK IVM Remarks Additional information regarding a

study which may include time,
temperature, stability, container, and
other variables used in determining
compatibility.

IVMMFG IVM Manufacturer Abbreviations assigned to

manufacturers per the Handbook on
Injectable Drugs.

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Intravenous Module Editorial Policies

The policies and criteria that apply to the processes and sources of the Intravenous Module are provided in the
following sections:

Scope
Editorial Process
Sources

Scope
The Intravenous Module enables the automatic screening of intravenous drug preparations for physicochemical
compatibility or incompatibility. A system utilizing IVM data is typically capable of the following:

providing an alert if there is an incompatibility

allowing screening for all incompatibilities
allowing screening for all compatibilities with possible alternatives to any incompatibilities
allowing screening by mode of administration to eliminate extraneous or irrelevant data
allowing screening based upon specific products or upon formulation level attributes of the Clinical
Formulation ID (GCN_SEQNO)

Editorial Process
The following section describes the processes and criteria for adding database elements.

Inclusion and Exclusion Criteria

Information in the IVM Module is based on the most current information available from the publishers of the
Handbook on Injectable Drugs by the American Society of Health-System Pharmacists (ASHP). The specific data
compiled in IVM reflects all the information presented in tabular format in the handbook reference. Other
information that resides in the text format of this handbook are not usually included in the data content of IVM.
The information compiled in this book represents the results of published reports from primary references of
compatibility testing of intravenous drugs.

The IVM data is updated monthly and supplied to FDB by the American Society of Health-System Pharmacists
(ASHP). Only information supplied by ASHP is available in the IVM Module. FDB does not editorially adjust the
data in any way. Upon request, information not included in the Handbook on Injectable Drugs may be added to
IVM upon ASHP review and determination that the information is clinically significant and warrants inclusion.
Please direct any inquiries or error reports to FDB Customer Service.

In addition to the description above, IVM may include/exclude the following other factors and exceptions.

Strength Specificity

Incompatibility studies are strength-specific. Therefore, both the Handbook on Injectable Drugs and IVM are also
strength-specific regarding solutions. For instance, precipitation might occur for a given component in a D10W
solution but not in D5W. However, for non-solutions, data is spread to all available strengths; the strength
specificity for other components may be noted within the remarks associated with IVM compatibility test results.

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Drugs-in-Syringe

IVM contains data for only intravenous administration. An exception to this, however, occurs when one or more
drugs are in a syringe. The data for drugs-in-syringe can be applied to intramuscular and subcutaneous routes.

Diluents

The studies for drugs-in-syringe may not address diluents due to the fact that the diluents are not mentioned in
the original studies.

Therapeutic Incompatibilities

Therapeutic incompatibilities have not been included. Although decomposition is noted, the therapeutic effect is
not quantified.

Pre-made Solutions

IVM reflects the data as reported in the Handbook on Injectable Drugs; therefore, studies will include component
codes for pre-made IV solutions if and when they are reported in the test.

IVM Update Information

Updated IVM data is supplied to FDB on a monthly basis by the American Society of Health-System
Pharmacists (ASHP). However, larger than normal updates may occur when ASHP globally applies
maintenance and clarification changes (such as updated IVM code values) to the IVM content. Please be aware
that these types of changes will occur during the months of March and October, unless a change is required that
pertains to patient safety.

Sources
This section lists sources used by FDB to compile the information contained in the module.

The IVM data is supplied to FDB by the American Society of Health-System Pharmacists (ASHP).

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IVM Applications
This section provides information about the practical application of data contained in this module.

IVM Application Overview

IVM Application Examples

IVM Programming Examples

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IVM Application Overview

This application section offers a general description of the processes required to access normalized tables for
retrieval of the data and demonstrates two of these processes. As you review each general example, refer to the
Intravenous Module ERD for data sources and relationships. Also, please keep the following in mind:

Specific programming instructions for the retrieval of IVM data must take into account both the installation
platform and the metrics of the desired processing. Therefore, such instructions are outside the scope of this
manual. However, any navigation through IVM tables is dependent upon the basic IVM data design.

Programming Logic
Understanding the IVM Admixture Concept
A Note on TPNs as Components

Programming Logic

The IVM module enables the automatic screening of intravenous drug preparations for physicochemical
compatibility or incompatibility. A system utilizing IVM data is typically capable of the following:

providing an alert if there is an incompatibility

allowing screening for all incompatibilities
allowing screening for all compatibilities with possible alternatives to any incompatibilities
allowing screening by mode of administration to eliminate extraneous or irrelevant data
allowing screening based upon specific products (such as byNDC) or upon formulation level attributes of
the Clinical Formulation ID (GCN_SEQNO)

IVM component codes are associated through the Clinical Formulation ID (GCN_SEQNO) to drugs having routes
of A (intravenous), 2 (injection) or, in selected cases, C (intramuscularonly applies to syringe data), or E
(epiduralonly applies to syringe data). The Clinical Formulation ID (GCN_SEQNO) in turn provides linkage to
specific manufacturer products.

If IVM content does not exist for a given IVM Component Code, users should be alerted to consult
alternative reference sources, such as the Handbook on Injectable Drugs.

Understanding the IVM Admixture Concept

Significant to the understanding of the IVM data model is the use of the IVM Admixture Code ( IVMADMIX) to
group one or more IVM components together in a non-test condition. IVM compatibility is reported for tests upon
admixtures. The components of any one admixture are not examined for compatibility against one another in a
reported study associated with that admixture. Their compatibility as stand-alone drugs may, however, be
reported in a separate study performed upon single-component admixtures.

With this design, IVM data is able to distinguish between tests, for example, performed by adding Drug C to the
combination of Drug A in Solution B from tests performed by adding Drug A to the combination of Drug C in
Solution B. Yet another distinct test may be identified which gives the results of combining the admixture of Drug
A in Solution B with the admixture of Drug C in Solution B.

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A Note on TPNs as Components

Many IVM admixtures include Total Parenteral Nutrition (TPN) components. Conceptually, TPNs function as
components in the IVM design and are shown as an IVM component subtype in the IVM data model.

As subtypes, these TPN components have attributes that distinguish them from the non-TPN components. TPNs
do not exist as products identifiable byNDCs or other international product designation. They cannot be identified
at the drug level using the Clinical Formulation ID (GCN_SEQNO).

For TPNs to be available to the end-user for selection or display in an IVM inquiry, the Intravenous Module TPN
Description Table (RIVMTPN0_TPN_DESC) and Intravenous Module TPN Ingredient Description Table
(RIVMTPI0_TPN_ING_DESC) must be accessible to the application. The individual ingredients of each TPN may
have a manufacturer specified as well as a concentration, and these values are constant for every reference to
that TPN. In contrast, these details may vary for non-TPN components in each individual investigation performed
upon the admixtures containing them.

The RIVMTPN0_TPN_DESC table and the Non-TPN table, the Intravenous Module Component Description
Table (RIVMCDS0_COMP_DESC), may be merged to form a single component description table. TPN
component codes are distinguished from other IVM component codes by the presence of a value of 9 in the first
byte.

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IVM Application Examples

Four different examples demonstrating each mode of IV administration are presented in this section to show the
flexibility and functionality of IVM data. Navigation through the various IVM tables is graphically illustrated in the
Intravenous Module ERD. For specific programming logic guidelines, refer to Programming Logic in the IVM
Application Overview section.

ExampleA drug-in-solution compatibility and incompatibility

ExampleThe compatibility of two drugs in solution
ExampleThe incompatibility of two admixtures administered via Y-site
ExampleCompatibility of two drugs in a syringe

ExampleA drug-in-solution compatibility and incompatibility

The Drug-in-Solution method of administration is selected.NDCs for specific products of Metoclopramide HCl and
Dextrose 5% are known. TheseNDCs have associated Clinical Formulation ID ( GCN_SEQNO) values that yield
their IVM Component Code (IVMCOMP) values through the GCN_SEQNO/Intravenous Module Component Code
Relation Table (RIVMCGC0_COMP_GCNSEQNO_LINK).

NDC LN GCN_SEQNO IVMCOMP Component

Description

58016481101 REGLAN 5MG/ML 005229 582129 Metoclopramide

VIAL Hydrochloride

00264110155 DEXTROSE 001972 250012 Dextrose 5%

5%-WATER IV SOLN

For the purposes of the IVM, components are grouped conceptually into Admixtures which may contain several
components or only one component. Admixtures are the items which are combined in a test situation to determine
their compatibility.

For this example, we want to determine the compatibility test results of the two single-component admixtures that
represent only the component Metoclopramide and only the component Dextrose 5%. The actual IVM Admixture
Code (IVMADMIX) values returned are of no interest to the end-user. They are intermediate results used to find
which investigations involve those Admixture codes.

In IVM terminology, we find all Drug-in-Solution tests involving the Study Group represented by the
Metoclopramide-only and the Dextrose 5%-only Admixture Codes. IVM contains information for 27 such tests.
The data associated with four of those tests appears below.

Manufacturer Concentration

TEST RESULT: COMPATIBLE

COMPONENT #1: Dextrose 5% TR

COMPONENT #2: Metoclopramide RB 200mg/1L

Hydrochloride

TEST REMARK #1: Physically compatible with no loss in 24 hr at 25 DGC exposed to normal room light

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TEST REMARK #2: Tested in PVC containers

TEST RESULT: COMPATIBLE

COMPONENT #1: Dextrose 5% TR

COMPONENT #2: Metoclopramide RB 200mg/1L

Hydrochloride

TEST REMARK #1: 9% loss after 2 weeks and 14% loss after 4 weeks frozen at -20 DGC followed by 24 hr at room
temperature

TEST REMARK #2: Tested in PVC containers

TEST RESULT: COMPATIBLE

COMPONENT #1: Dextrose 5% TR

COMPONENT #2: Metoclopramide RB 3.2G/1L

Hydrochloride

TEST REMARK #1: Physically compatible with 5% loss in 24 hr at 25 DGC exposed to normal room light

TEST REMARK #2: Tested in PVC containers

TEST RESULT: INCOMPATIBLE

COMPONENT #1: Dextrose 5% TR

COMPONENT #2: Metoclopramide RB 3.2G/1L

Hydrochloride

TEST REMARK #1: 11% loss after 1 week and 37% loss after 4 weeks frozen at -20 DGC followed by 24 hr at room
temperature

ExampleThe compatibility of two drugs in solution

The Multiple Drugs-in-Solution method of administration is selected. Heparin Sodium, Penicillin G Potassium, and
Dextrose 5% are selected by name. Their IVM Component Code ( IVMCOMP) values are obtained from the
Intravenous Module Component Description Table (RIVMCDS0_COMP_DESC). As in the example above (A
drug-in-solution compatibility and incompatibility), all three components stand alone as single-component
admixtures. Three tests are found for the Study Group representing all three admixtures, as shown in the table
below. The results illustrate how different concentrations of the same solution can return various test results.

Manufacturer Concentration

TEST RESULT: COMPATIBLE

COMPONENT #1: Heparin Sodium 1200u/1L

COMPONENT #2: Penicillin G Potassium 1mmU/1L

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COMPONENT #3: Dextrose 5%

TEST REMARK #1: Physically compatible

TEST RESULT: COMPATIBLE

COMPONENT #1: Heparin Sodium AB 20000u/1L

COMPONENT #2: Penicillin G Potassium SQ 1mmU/1L

COMPONENT #3: Dextrose 5%

TEST REMARK #1: Penicillin potency retained for 24 hr at 25 DGC

Penicillin potency retained INCOMPATIBLE

for 24 hr at 25 DGC

COMPONENT #1: Heparin Sodium UP 4000u/1L

COMPONENT #2: Penicillin G Potassium SQ 20mmU/1L

COMPONENT #3: Dextrose 5%

TEST REMARK #1: Physically incompatible

In this example, we find an incompatible test result based on differences in the components concentrations.

ExampleThe incompatibility of two admixtures administered via Y-site

This example shows how IVM is able to simplify a complex situation: one drug in a solution in one intravenous
line coming into contact with another drug in a second solution. Through the Admixture concept, IVM data can
distinguish a specific drug-solution combination as an aggregate item that is being tested against another
aggregate drug-solution Admixture. This illustrates the capability of IVM to be highly selective and report only
those studies that are relevant.

The Y-site method of administration is selected. Two combinations of drugs, Ondansetron in normal saline and
Aminophylline in D5W, are specified by description. IVM Component Code (IVMCOMP) values are obtained from
the Intravenous Module Component Description Table (RIVMCDS0_COMP_DESC).

Combination Generic Name IVMCOMP

1 ONDANSETRON HCL 591006

1 NORMAL SALINE 250023

2 AMINOPHYLLINE 582006

2 DEXTROSE 5%-WATER 250012

The Admixture concept allows the proper grouping of the drug-solution pairs. An IVM Admixture Code (
IVMADMIX) that is associated with both the Component Code for Ondansetron HCl and the Component Code for

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Sodium Chloride 0.9% is identified. Another IVMADMIX value that is associated with the IVMCOMP values for
both Aminophylline and D5W is also identified.

As in first example above (A drug-in-solution compatibility and incompatibility), these IVMADMIX values are
intermediate values and are not necessarily useful to the user. Making an inquiry to find all test results that are
associated with the two identified IVMADMIX values yields:

MANUFACTURER CONCENTRATION

TEST RESULT: INCOMPATIBLE

Admixture #1:

COMPONENT #1: ONDANSETRON HCL GL 1mg/1mL

COMPONENT #2: NORMAL SALINE

Admixture #2:

COMPONENT #1: AMINOPHYLLINE AMR 2.5mg/1mL

COMPONENT #2: DEXTROSE

5%-WATER

TEST REMARK #1: Immediate turbidity and precipitation

ExampleCompatibility of two drugs in a syringe

The Drugs in Syringe method of administration is selected. When Promethazine HCl and Morphine sulfate are
selected by brand name, specific product records are retrieved (in this caseNDCs) with their associated Clinical
Formulation ID (GCN_SEQNO) values. The Clinical Formulation IDs (GCN_SEQNOs) are used to retrieve IVM
Component Code (IVMCOMP) values from the Intravenous Module Component Description Table
([RIVMCDS0_COMP_DESC).

Brand Name NDC GCN_SEQNO IVMCOMP

PHENERGAN 54868059700 003866 582174

MORHPHINE SULFATE 10019017936 004077 582136

Data retrieval proceeds using the same logic as the first example, A drug-in-solution compatibility and
incompatibility. All tests associated with the single-component IVM Admixture Code (IVMADMIX) values for
Phenergan and for are retrieved with the following results:

MANUFACTURER CONCENTRATION

TEST RESULT: COMPATIBLE

COMPONENT #1: Promethazine Hydrochloride WY 50mg/2mL

COMPONENT #2: Morphine Sulfate WY 15mg/1mL

TEST REMARK #1: Physically compatible for at

least 15 min

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TEST RESULT: COMPATIBLE

COMPONENT #1: Promethazine Hydrochloride PO 50mg/2mL

COMPONENT #2: Morphine Sulfate ST 15mg/1mL

TEST REMARK #1: Physically compatible for at

least 15 min

TEST RESULT: INCOMPATIBLE

COMPONENT #1: Promethazine Hydrochloride WY 8mg

COMPONENT #2: Morphine Sulfate WY 12.55mg

TEST REMARK #1: Cloudiness develops

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IVM Programming Examples

This section provides programming examples for compatibility and incompatibility screening.

ExampleA drug-in-solution compatibility and incompatibility

ExampleThe incompatibility of two admixtures administered via Y-site

ExampleA drug-in-solution compatibility and incompatibility

In this example, the user elects to specify particular NDCs for metoclopramide HCl and dextrose 5% products and
also has restricted the search to a Drug-in-Solution method of administration. The selected products are
metoclopramide 5MG/ML vial (NDC 58016481101) and Dextrose 5% (NDC 00264110155). (For more
information, review the example, A drug-in-solution compatibility and incompatibility, in IVM Application Examples
.)

1. The Clinical Formulation ID (GCN_SEQNO) values for the selected NDCs are retrieved from the NDC
Table (RNDC14_NDC_MSTR).The Label Name (LN) shown in the sample data is also obtained from the
RNDC14_NDC_MSTR table.

NDC LN GCN_SEQNO

00264110155 DEXTROSE 5%-WATER IV SOLN 001972

58016481101 REGLAN 5 MG/ML VIAL 005229

2. Each Clinical Formulation ID (GCN_SEQNO) value is used to obtain the IVM Component Code (
IVMCOMP) from the GCN_SEQNO/IVM Component Code Relation Table
(RIVMCGC0_COMP_GCNSEQNO_LINK).
The retrieved IVMCOMP values correspond to all products associated with the Clinical Formulation ID
(GCN_SEQNO) values from step 1, not merely the originally-selectedNDCs. The IVMCOMP values in turn
may be used to search the Intravenous Module Component Description Table
(RIVMCDS0_COMP_DESC), returning the IVM Non-TPN Component Description (IVMCOMPDSC).

GCN_SEQNO IVMCOMP IVMCOMPDSC

001972 250012 Dextrose 5%

005229 582129 Metoclopramide Hydrochloride

3. Because IVM Study Group Tests are performed upon groups of admixtures, not components, we need to
retrieve the IVM Admixture Code (IVMADMIX) values for the selected components as admixtures
containing single drugs not in combination with any other IVM component; that is, we are seeking
single-component admixtures.

This is a crucial concept for the correct retrieval of IVM data.

Select the IVMADMIX records from the Intravenous Module Admixture/Component Code Relation Table
(RIVMACO0_ADMXTR_COMP_LINK) that match the IVMCOMP values retrieved in the previous step.

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Each of the IVMADMIX values in the retrieved records is compared to the Intravenous Module Admixture
Master Table (RIVMAMA0_ADMXTR_MSTR) to locate the IVMADMIX value that has an IVM Admixture
Non-TPN Component Count (IVMCCNT) of 1 and an IVM Admixture TPN Component Count (IVMTPNCNT
) of 0. (If no such record is found within the RIVMAMA0_ADMXTR_MSTR table, the selected IVM
component has not been reported in any study as a stand-alone drug but has only been studied in
combination with another component.)

IVMCOMP IVMADMIX IVMCCNT IVMTPNCNT

250012 000803 1 1

250012 000804 2 0

250012 250012 1 0

582129 582129 1 0

582129 000005 1 0

There may be multiple IVMADMIX codes associated with IVMCOMP 250012. The search may be
discontinued, however, as soon as the IVMCOMP record of 250012 with IVMCCNT value of 1 and
IVMTPNCNT value of 0 is identified. The actual logic used to perform the above selections depends on
your database and application software.

4. We wish to examine studies that report the compatibility of the two single-component admixtures identified
in the previous step. In a process logically similar to that of the previous step, we now select from the
Intravenous Module Study Group/Admixture Relation Table (RIVMSAD0_STDY_GRP_ADMXTR_LINK)
the records that have an IVM Study Group Code (IVMSGRP) associated with both IVMADMIX values of
250012 and 582129.

At this point, we can obtain and report compatibility test results for any investigations involving the
identified admixtures, including those in which additional admixtures are present. Large numbers of
records may be retrieved in this step. In this example, there are multiple study groups associated only with
IVMADMIX 250012 or only to IVMADMIX 582129, and a few study groups associated with both of them.

To restrict the data, we must process the IVMSGRP values now gathered should be restricted if possible to
those studies involving only the desired two admixtures. To do this, we select from this set of IVMSGRP
values the one with a corresponding Intravenous Module Study Group Master Table
(RIVMSMA0_STDY_GRP_MSTR) record that shows an IVM Study Group Admixture Count (IVMADCNT)
of 2. A small sample of results is shown below.

IVMADMIX IVMSGRP IVMADCNT

582129 012414 2

250012 012415 2

582129 012415 2

582129 012416 2

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5. Every Study Group in IVM has at least one reported compatibility investigation. The basic information for
each such test is the type of test, that is, the method of administration (drug-in-solution, Y-site, syringe)
and the test result. This data resides on the Intravenous Module Study Group Test Master Table
(RIVMTMA0_STDY_GRP_TST_MSTR).
In this example, four test records are identified by gathering all records from this table that have the
two-admixture IVMSGRP value of 012415. All of these records show an IVM Study Group Test Type Code
(IVMTTYPE) value of 1, indicating the Drug-in-Solution method of administration, and thus all are
candidates for display according to the users selection criteria. Of the four test records, three have an IVM
Study Group Test Result Code (IVMRSLT) value of C, indicating compatible, and one returns an IVMRSLT
value of I, indicating incompatible.

IVMSGRP IVMTESTSN IVMTTYPE IVMRSLT

012415 1 1 C

012415 2 1 C

012415 3 1 C

012415 4 1 I

If only compatibility results are desired for display, the access of IVM data is completed at this step. Much
more information is available, however, from other IVM tables. By accessing the remarks associated with
these study group tests, text information may be found that clarifies the test conditions (such as lighting or
temperature) or test results (for example, duration of compatibility, reason for incompatibility). Specific
information regarding the concentration of components or manufacturers of the actual samples used in
each test (these may vary in each investigation) may be retrieved from the test component detail tables.
The remaining steps explain the data retrieval for these additional tables.

6. To retrieve textual remark information relating to each Study Group Test, we first use the IVMSGRP code
plus the IVM Study Group Test Number (IVMTESTSN) from each investigation to read the Intravenous
Module Study Group Test/Remarks Relation Table (RIVMTRM0_STDY_GRP_TST_REMARK). IVM
Remarks Code (IVMRMK) associated with each test are retrieved from this table with an IVM Study Group
Test Remarks Sequence Number (IVMRMKSN), which indicates the order in which the remarks should be
read for proper interpretation.

IVMSGRP IVMTESTSN IVMRMKSN IVMRMK

012415 1 1 000046

012415 1 2 003387

012415 2 1 000046

012415 2 2 003388

012415 3 1 000046

012415 3 2 003389

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012415 4 1 000046

012415 4 2 003390

Note that all tests have two associated remarks codes.

7. The text fields for the remarks codes identified in step 6 are read from the Intravenous Module Remarks
Table (RIVMRMK0_REMARKS) using the IVMRMK code. There may be more than one 70-byte text
record for every IVM Remarks Code (IVMRMK) value. Continuation of text fields and correct sequencing
may be determined using the IVM Remarks Continuation Sequence Number ( IVMRMKSEQ) from this
table.
The remarks for some of the compatibility tests for IVMSGRP 012415 are:

IVMTESTSN IVMRMK IVMRMKSEQ IVMREMARK

1 000046 1 Tested in PVC containers

003387 1 Physically compatible with

no loss in 24 hr at 25 DGC
exposed to

003387 2 normal room light

2 000046 1 Tested in PVC containers

003388 1 9% loss after 2 weeks and

14% loss after 4 weeks
frozen at -20 DGC

003388 2 followed by 24 hr at room

temperature

3 000046 1 Tested in PVC containers

003389 1 Physically compatible with

5% loss in 24 hr at 25
DGC exposed to

003389 2 normal room light

4 000046 1 Tested in PVC containers

003390 1 11% loss after 1 week and

37% loss after 4 weeks
frozen at -20 DGC

003390 2 followed by 24 hr at room

temperature

Note that the remarks for the tests above continue onto a second and third record. All lines are
part of the single remark code.

8.

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8. IVM provides test-specific data for each component of each admixture included in every study group. To
access this information, we use the Intravenous Module Study Group Test Component Detail Table/IVM
Study Group Test/Component Relation Table (RIVMTCO0_STDY_GRP_TST_COMP_DT).
This table may be read with all or any subsets of the concatenated key comprised of study group + test +
admixture + component. (The admixture specification is important because the same component may be
present in more than one admixture within a study group, in each case returning different data from the
table).
Fields on this table include the IVM Manufacturer Code ( IVMMFG), IVM Strength Number (IVMSTR), and
IVM Volume Units Code (IVMVOLU) data. In this example, the following records are retrieved for
IVMSGRP 012415.

IVMTESTSN IVMADMIX IVMCOMP Strength Volume IVMMFG

1 250012 250012 00000000v000 00000000n000 TR

1 582129 582129 00000200n000m 00000001n000L RB

g

2 250012 250012 00000000n000 00000000n000 TR

2 582129 582129 00000200n000m 00000001n000L RB

g

3 250012 250012 00000000n000 00000000n000 TR

3 582129 582129 00000003n200G 00000001n000L RB

4 250012 250012 00000000n000 00000000n000 TR

4 582129 582129 00000003n200G 00000001n000L RB

To retrieve the corresponding TJC-compliant unit descriptions for the given IVM units ( IVMVOLU and
IVMSTRU), query the Units Description Table (RUNITSD0_UNITS_DESC). Please be aware that the IVM
unit values within the RIVMTCO0_STDY_GRP_TST_COMP_DT table are provided in a mixed-case
format. To retrieve the corresponding TJC-compliant unit descriptions, these values must be converted to
upper-case.

9. The names of the component manufacturers indicated by the IVM Manufacturer Code Description (
IVMMFGD) returned in step 8 may be accessed from the Intravenous Module Manufacturer Description
Table (RIVMMFG0_MANUFACTURER_DESC).

IVMMFG IVMMFGD

RB Robbins

TR Travenol

ExampleThe incompatibility of two admixtures administered via Y-site

In this example, the Drug/Solution admixtures Aminophylline in D5W and Ondansetron HCl in Sodium chloride
(0.9%) are specified by description of their components and the Y-site method of administration is selected. (For

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more information, review The incompatibility of two admixtures administered via Y-site.)

1. The user selects the IVM Non-TPN Component Description (IVMCOMPDSC) values from the Intravenous
Module Component Description Table (RIVMCDS0_COMP_DESC).
The system must provide a facility for the user to specify that these components are to be selected as a
combined item (such as a single admixture).

__...
__AMINOHIPPURATE SODIUM
__AMINOPHYLLINE
__AMINOPHYLLINE/NORMAL SALINE
__AMIODARONE HYDROCHLORIDE
__...
__D5NS (DEXTROSE 5%-SODIUM CHLORIDE 0.9%)
__D5R (DEXTROSE 5%-RINGERS)
__D5W (DEXTROSE-WATER 5%)
__D5W-ELECTROLYTE B (IONOSOL)
__...

For each IVMCOMPDSC values selected above, the system retrieves the corresponding IVM Component
Code (IVMCOMP) values from the RIVMCDS0_COMP_DESC table.

IVMCOMPDSC IVMCOMP

Dextrose 5% 250012

Aminophylline 582006

2. When the user specifies the select as Admixture process for the components chosen, the system selects
from the Intravenous Module Admixture/Component Code Relation Table
(RIVMACO0_ADMXTR_COMP_LINK) the one IVM Admixture Code (IVMADMIX) code that is associated
with both of the IVMCOMP codes in the previous step, and no other. (This search may be optimized by
also using the Intravenous Module Admixture Master Table (RIVMAMA0_ADMXTR_MSTR) to determine
which admixtures are associated with exactly two components).
In this example, the admixture representing Aminophylline in D5W is IVMADMIX is 000159.

IVMCOMP IVMADMIX IVMCCNT IVMTPNCNT

582006 000004 1 0

582006 000159 2 0

582006 000277 2 0

...

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250012 000091 2 0

250012 000108 2 0

250012 000159 2 0

250012 000184 2 0

3. The user repeats step 1 to select the components Ondansetron HCl and Sodium Chloride 0.9% (NS),
again using the systems facility to specify them as components in combination in a single admixture.

__.....
__OFLOXACIN HCL
__ONDANSETRON HCL/D5W
__ONDANSETRON HYDROCHLORIDE
__OPIUM
__ORPHENADRINE CITRATE
__...
__SODIUM CHLORIDE 0.5%
__SODIUM CHLORIDE 0.9% (NS)
__SODIUM CHLORIDE 3%
__SODIUM CHLORIDE 5%
__.....

The system retrieves from the RIVMCDS0_COMP_DESC table the corresponding IVMCOMP codes for
the selected components.

IVMCOMPDSC IVMCOMP

Ondansetron Hydrochloride 591006

Sodium chloride 0.9% 250023

4. Because the user specifies that these two components are to be selected as a single admixture, the
system then selects the one IVMADMIX code from the RIVMACO0_ADMXTR_COMP_LINK table that is
associated with both of these IVMCOMP values and no other (as in step 2). (This search may be optimized
by also using the RIVMAMA0_ADXTR_MSTR table to determine which admixtures are associated with
exactly two components).
The IVM admixture representing Ondansetron HCl in Sodium chloride 0.9% is 000071.

IVMCOMP IVMADMIX IVMCCNT IVMTPNCNT

591006 000071 2 0

591006 000296 2 0

591006 000767 2 0

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...

250023 000070 2 0

250023 000071 2 0

250023 000087 2 0

250023 000302 2 0

The search for IVM admixture code(s) will be more restricted if the set of admixture codes
associated with the non-solution component(s) of an admixture are collected first. This subset of
admixture codes is then examined to locate those codes that are also associated with the
solution component. In general, there are many more admixture/component pairs for solution
components than for non-solutions. In the example above, there are only three admixture codes
associated with Ondansetron HCl, but there are multiple admixture codes associated with Sodium
chloride 0.9%.

5. The system selects from the Intravenous Module Study Group/Admixture Relation Table
(RIVMSAD0_STDY_GRP_ADMXTR_LINK) all of the IVM Study Group Code (IVMSGRP) values that are
associated with both IVMADMIX values 000159 and 000071.
This process parallels that performed in step 4 of A drug-in-solution compatibility and incompatibility in the
Programming Examples section.
We find that, as in Programming Example above, there are many study groups to review. The large
number can be reduced somewhat by limiting the selection to a subset of study groups selected from the
Intravenous Module Study Group Master Table (RIVMSMA0_STDY_GRP_MSTR) which show an IVM
Study Group Admixture Count (IVMADCNT) value of 2.

IVMADMIX IVMSGRP IVMADCNT

...

000159 000762 2

000159 000763 2

000159 000764 2

...

000071 000170 2

000071 000509 2

000071 000763 2

000071 001142 2

...

6.

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6. Selecting all records from the Intravenous Module Study Group Test Master Table
(RIVMTMA0_STDY_GRP_TST_MSTR) that are associated with IVMSGRP value of 000763 and that have
a test type code IVM Study Group Test Type Code (IVMTTYPE) value of 4 (signifying Y-site), we find only
one.

IVMSGRP IVMTESTSN IVMTTYPE IVMRSLT

000763 1 4 1

7. The only investigation combining the specified admixtures by the Y-site method found that they were
incompatible. To retrieve further textual information regarding this test, the system retrieves from the
Intravenous Module Study Group Test/Remarks Relation Table (RIVMTRM0_STDY_GRP_TST_REMARK)
all IVM Remarks Code (IVMRMK) values associated with this test, in their indicated sequence. This
selection process returns only one record.

IVMSGRP IVMTESTSN IVMRMKSN IVMRMK

000763 1 1 000309

8. The IVM Remarks Text (IVMREMARK) related to the identified IVMRMK value of 000309 is retrieved from
the Intravenous Module Remarks Table (RIVMRMK0_REMARKS).

IVMRMK IVRMKSEQ IVMREMARK

000309 1 Immediate turbidity and precipitation

9. If information regarding the specific components used in this compatibility test is desired, the system
accesses the Intravenous Module Study Group Test/Component Relation Table
(RIVMTCO0_STDY_GRP_TST_COMP_DT) to select all records for IVMSGRP 000763 and IVMTESTSN 1
.

IVMADMIX IVMCOMP Strength Volume IVMMFG

000071 591006 00000001000 mg 00000001v000 m GL

000071 250023 00000000000 00000000v000

000159 582006 00000002500 mg 00000001v000 mL AMR

000159 250012 00000000000 00000000v000

To retrieve the corresponding TJC-compliant unit descriptions for the given IVM units ( IVMVOLU and
IVMSTRU), query the Units Description Table (RUNITSD0_UNITS_DESC). Please be aware that the IVM
unit values within the RIVMTCO0_STDY_GRP_TST_COMP_DT table are provided in a mixed-case
format. To retrieve the corresponding TJC-compliant unit descriptions, these values must be converted to
upper-case.

10. The names of the component manufacturers, indicated by the IVM Manufacturer Code Description (
IVMMFG) values returned in the previous step, may be read from the Intravenous Module Manufacturer

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10.

Description Table (RIVMMFG0_MANUFACTURER_DESC).

IVMMFG IVMMFGD

AMR American Regent

GL Glaxo

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IVM ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

IVM Tables
IVM ERD

IVM Tables
GCN_SEQNO/Intravenous Module Component Code Relation Table
Intravenous Module Admixture/Component Code Relation Table
Intravenous Module Admixture Master Table
Intravenous Module Component Description Table
Intravenous Module Manufacturer Description Table
Intravenous Module Remarks Table
Intravenous Module Study Group/Admixture Relation Table
Intravenous Module Study Group Master Table
Intravenous Module Study Group Test/Component Relation Table
Intravenous Module Study Group Test Master Table
Intravenous Module Study Group Test/Remarks Relation Table
Intravenous Module TPN Description Table
Intravenous Module TPN Ingredient Description Table

IVM ERD

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GCN_SEQNO Intravenous Module Component Code Relation Table

Table Name RIVMCGC0_COMP_GCNSEQNO_LINK

Revision Activity rev.09-25-2008

Purpose Links a clinical formulation to a component.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

F IVMCOMP IVM Component AN 6 X(6)

Code

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Intravenous Module Admixture Component Code Relation Table

Table Name RIVMACO0_ADMXTR_COMP_LINK

Revision Activity rev.09-25-2008

Purpose Links components to an admixture.

Key Column Name Column Format Length Picture

Description

PF IVMADMIX IVM Admixture AN 6 X(6)

Code

PF IVMCOMP IVM Component AN 6 X(6)

Code

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Intravenous Module Admixture Master Table

Table Name RIVMAMA0_ADMXTR_MSTR

Revision Activity rev.09-25-2008

Purpose Provides attributes of an admixture.

Key Column Name Column Format Length Picture

Description

P IVMADMIX IVM Admixture AN 6 X(6)

Code

IVMCCNT IVM Admixture N 1 9(1)

Non-TPN
Component Count

IVMTPNCNT IVM Admixture N 1 9(1)

TPN Component
Count

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Intravenous Module Component Description Table

Table Name RIVMCDS0_COMP_DESC

Revision Activity rev.09-25-2008

Purpose Relates the Component Code to its non-TPN component

description.

Key Column Name Column Format Length Picture

Description

P IVMCOMP IVM Component AN 6 X(6)

Code

IVMCOMPDSC IVM Non-TPN AN 50 X(50)

Component
Description

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Intravenous Module Manufacturer Description Table

Table Name RIVMMFG0_MANUFACTURER_DESC

Revision Activity rev.09-25-2008

Purpose Relates the Manufacturer Code to its text description.

Key Column Name Column Format Length Picture

Description

P IVMMFG IVM Manufacturer AN 3 X(3)

Code

IVMMFGD IVM Manufacturer AN 50 X(50)

Code Description

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Intravenous Module Remarks Table

Table Name RIVMRMK0_REMARKS

Revision Activity rev.09-25-2008

Purpose Relates the Remarks Code for a study group test to its text.

Key Column Name Column Format Length Picture

Description

P IVMRMK IVM Remarks AN 6 X(6)

Code

P IVMRMKSEQ IVM Remarks N 3 9(3)

Continuation
Sequence
Number

IVMRMKTYP This column is not AN 1 X(1)

currently being
used

IVMREMARK IVM Remarks AN 70 X(70)

Text

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Intravenous Module Study Group Admixture Relation Table

Table Name RIVMSAD0_STDY_GRP_ADMXTR_LINK

Revision Activity rev.09-25-2008

Purpose Links admixtures to study groups.

Key Column Name Column Format Length Picture

Description

PF IVMSGRP IVM Study Group AN 6 X(6)

Code

PF IVMADMIX IVM Admixture AN 6 X(6)

Code

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Intravenous Module Study Group Master Table

Table Name RIVMSMA0_STDY_GRP_MSTR

Revision Activity rev.09-25-2008

Purpose Provides attributes of a study group.

Key Column Name Column Format Length Picture

Description

P IVMSGRP IVM Study Group AN 6 X(6)

Code

IVMADCNT IVM Study Group N 2 9(2)

Admixture Count

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Intravenous Module Study Group Test Component Relation Table

Table Name RIVMTCO0_STDY_GRP_TST_COMP_DT

Revision Activity rev.09-25-2008

Purpose Links the strength and/or volume information to a

component within an admixture in a study group test.

Key Column Name Column Format Length Picture

Description

PF IVMSGRP IVM Study Group AN 6 X(6)

Code

P IVMTESTSN IVM Study Group N 3 9(3)

Test Number

PF IVMADMIX IVM Admixture AN 6 X(6)

Code

PF IVMCOMP IVM Component AN 6 X(6)

Code

IVMSTR IVM Strength N 12 9(8).9(3)

Number

IVMSTRU IVM Strength AN 3 X(3)

Units Code

IVMVOL IVM Volume N 12 9(8).9(3)

Number

IVMVOLU IVM Volume Units AN 3 X(3)

Code

F IVMMFG IVM Manufacturer AN 3 X(3)

Code

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Intravenous Module Study Group Test Master Table

Table Name RIVMTMA0_STDY_GRP_TST_MSTR

Revision Activity rev.09-25-2008

Purpose Provides attributes of a study group test.

Key Column Name Column Format Length Picture

Description

PF IVMSGRP IVM Study Group AN X(6)

Code

P IVMTESTSN IVM Study Group N 3 9(3)

Test Number

IVMTTYPE IVM Study Group AN 1 X(1)

Test Type Code

IVMRSLT IVM Study Group AN 1 X(1)

Test Result Code

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Intravenous Module Study Group Test Remarks Relation Table

Table Name RIVMTRM0_STDY_GRP_TST_REMARK

Revision Activity rev.09-25-2008

Purpose Links textual remark information to a test within a study

group.

Key Column Name Column Format Length Picture

Description

PF IVMSGRP IVM Study Group AN 6 X(6)

Code

P IVMTESTSN IVM Study Group N 3 9(3)

Test Number

P IVMRMKSN IVM Study Group N 2 9(2)

Test Remarks
Sequence
Number

IVMRMK IVM Remarks AN 6 X(6)

Code

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Intravenous Module TPN Description Table

Table Name RIVMTPN0_TPN_DESC

Revision Activity rev.09-25-2008

Purpose Relates the Component Code to its TPN component

description.

Key Column Name Column Format Length Picture

Description

P IVMCOMP IVM Component AN 6 X(6)

Code

IVMTPNDSC IVM TPN AN 50 X(50)

Component
Description

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Intravenous Module TPN Ingredient Description Table

Table Name RIVMTPI0_TPN_ING_DESC

Revision Activity rev.09-25-2008

Purpose Relates the Component Code to the text description of a

TPN ingredient within a component and provides attributes
of that relationship.

Key Column Name Column Format Length Picture

Description

PF IVMCOMP IVM Component AN 6 X(6)

Code

P IVMTPNINGR IVM TPN AN 50 X(50)

Ingredient
Description

IVMSTR IVM Strength N 12 9(8).9(3)

Number

IVMSTRU IVM Strength AN 3 X(3)

Units Code

IVMVOL IVM Volume N 12 9(8).9(3)

Number

IVMVOLU IVM Volume Units AN 3 X(3)

Code

F IVMMFG IVM Manufacturer AN 3 X(3)

Code

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Precaution Modules
Geriatric Precautions Module (GERI) 2.0
Lactation Precautions Module (LACT) 1.0
Pediatric Precautions Module (PEDI) 2.0
Pregnancy Precautions Module (PREG) 2.0

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Geriatric Precautions Module (GERI) 2.0

Geriatric Precautions Module Editorial Policies
Applications
ERD and Technical Specifications

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Geriatric Precautions Module Editorial Policies

The policies and criteria that apply to the inclusion criteria, processes, and references used in creation of the
module are provided in the following sections:

Overview
Definitions
Inclusion/Exclusion Criteria
Data Elements
Rule Sets
Maintenance
References

Overview

The Geriatric Precautions Module (GERI) module contains precaution information for the use of drugs in a
geriatric patient. Geriatric is a term that usually describes patients over the age of 65.

Geriatric age threshold is not intended to be absolute and might not be applicable to your practice
environment. You may set a higher threshold age to trigger alerts.

The GERI module enables you to create warning messages about drug use in the geriatric patient population.
These warnings allow healthcare professionals to make informed decisions about altering a patients drug therapy
when potential problems exist. Although system access to the patients age and gender enhances the
functionality of the product, it is not a requirement to achieve valuable results. The GERI module can work in a
stand-alone pharmacy system or as part of an integrated system.

The GERI module is intended for use as a screening mechanism to detect geriatric drug precautions specific to
the geriatric patient population. The precautions are clinically relevant and are generally well documented in the
literature. Warnings may not be included if there is no data on a particular drug usage in the geriatric patient
population.

Systems using GERI can provide the following information:

Severity level of the precaution

Indicators for select organ systems associated with the precaution
Indicators to identify whether a Geriatric Precaution for a drug exists on the BEERS, HEDIS, or STOPP
lists
Geriatric precaution narrative (optional usage data field)

There are situations when geriatric dosing data exists in the dosing modules for a drug that is
contraindicated in geriatric patients. Though this may seem like a conflict, clinically, drug

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contraindications are rarely absolute and in these situations, the dosing modules may provide geriatric
dosing data as a safety check. The presence of this data in the dosing modules shall not be construed as
a recommendation from First Databank (FDB) that such use is acceptable.

Definitions

This section defines important terms related to the module that users should understand. Some industry terms
that have a specific connotation in regards to the module are also defined.

Geriatric

Geriatric is a term that usually describes patients over the age of 65.

Geriatric age threshold is not intended to be absolute and might not be applicable to your practice environment.
You may set a higher threshold age to trigger alerts in your application of the Geriatrics Precautions Module.

Inclusion/Exclusion Criteria

This section provides information detailing the criteria that guided the inclusion of the data contained within the
module as well as information pertaining to limitations or exclusions when appropriate to the discussion.

Inclusion - Drug Scope

U.S. FDA-approved Rx product ingredients with New Drug Application (NDA), Abbreviated New Drug
Application (ANDA), or Biologic License Application (BLA)
U.S. over-the-counter (OTC) products with NDAs or ANDAs
U.S. OTC drug product ingredients consistent with FDA OTC Monographs
Herbal products enumerated in the FDB Herbal Products Inclusion List

Inclusion - Warnings Content Scope

Content pertains to drug use in the geriatric patient population. The following information is included for a given
drug when available:

Known risk in the geriatric population

Adverse effect of a drug that is unique to the geriatric population
Known severe adverse effect of drug with an increased frequency in the geriatric population
Precaution statements where a drug is not recommended for use within the geriatric population
Renal warnings for drug dose adjustment when CrCL is in the normal range for an elderly patient (40-90
mL/min)
Common adverse drug events that may have a significant impact on the elder adult

Exclusion - Drug Scope

Non-U.S. products that are exclusive to other countries

Self-proclaimed Rx products without ANDA/NDA/BLA
Rx drug products with 510K device approval

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Dietary supplements
Large volume parenteral, nutritional, irrigation or dialysis solutions
Nutraceuticals
Diluent solutions
Herbal products, except those enumerated in the FDB Herbal Products Inclusion List
Homeopathic drugs
OTC products that are not described by FDA OTC Monographs
Bulk drugs or chemicals
Medical supplies, soaps, cleansers
Cosmetics
Veterinary drugs
Inactive ingredients

Exclusion - Warnings Content

General dose selection warning in geriatrics when no evidence is presented to support the warning (for
example, verbiage such as "In general, dose selection for the elderly patients should be cautious, keeping
in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease
or other drug therapy," is not considered evidence).
Warnings that apply to disease conditions common in geriatrics but not exclusive to this population (for
example, general heart failure warnings). These types of warnings are better handled by a patient-specific
triggered alert such as is available with a Drug-Disease Contraindications Module (DDCM) implementation.

Data Elements

This section contains additional information about particularly important tables and codes contained within the
module, as well as concepts about the data that the reader must understand in order to understand the module.

Geriatric Precaution Code

The Geriatric Precaution Code (GERI_CODE) is a system-assigned six-character number unique for each drug
group.

GERI codes are linked to the following FDB drug identifiers:

Routed Medication ID (ROUTED_MED_ID)

Routed Generic Identifier (ROUTED_GEN_ID)

Clinical Formulation ID (GCN_SEQNO)

Geriatric Precaution Description

A single unique description (GERI_DESC) is assigned to each GERI code. This drug group description is usually
ingredient-based but can be broader and include a collection of ingredientsfor example, "CALCIUM
SALTS"or may be narrower and include only certain dose forms or routesfor example, "NIFEDIPINE (SHORT
ACTING)."

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ExampleGeriatric Precautions Master Table (RGERIMA1_GERI_MSTR)

GERI_CODE GERI_DESC

40 Dipyridamole (Long Acting)

49 Nifedipine (Short Acting)

56 Potassium Salts (Injectable)

57 Calcium Supplements

Geriatric Precaution Severity Level

Each GERI code is assigned one severity level (GERI_SL). There are two numeric valid values for severity level:
1 or 2.

GERI Severity Level Description Table (RGERISD0_GERI_SEVER_LEVEL_DESC)

GERI_SL GERI_SL_DESC

1 Contraindication

2 Management or Monitoring Precaution

Geriatric Precautions Organ System Flag

Each GERI code may optionally have one or many specific organ system flag(s) associated with it. These flags
identify that, with use of the drug in a geriatric patient, either the specific organ system is at increased risk for
toxicity (for example, nephrotoxicity) or there is increased risk of adverse reactions with pre-existing organ
impairment.

Specific Organ Flag Definitions

Geriatric Precaution Organ System Function - Renal (GERI Renal Organ System
_RNL)

Geriatric Precaution Organ System Function - Hepatic (GE Hepatic Organ System
RI_HEP)

Geriatric Precaution Organ System Function - Cardiac Organ System

Cardiovascular (GERI_CARD)

Geriatric Precaution Organ System Function - Pulmonary ( Pulmonary Organ System

GERI_PULM)

Geriatric Precaution Organ System Function - Neurologic/Psychiatric System

Neurologic/Psychiatric (GERI_NEUR)

Geriatric Precaution Organ System Function - Endocrine (G Endocrine Organ System

ERI_END)

Valid Organ Flag Values and Definition

A one-character alphanumeric denoted by one of the following:

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Y Activated organ flag that indicates increased risk to the

organ system or increased adverse reactions with
pre-existing organ system impairment.

N No known or expected increased risk to the organ system in

geriatrics.

Geriatric Precautions Indicators

On BEERS List

The On BEERS List indicator (GERI_BEERS_IND) is a one-character alphanumeric value that indicates whether
the drug is on the BEERS List, denoting higher risk drugs in the elderly.

GERI_BEERS_IND Description

Y On the BEERS List

N Not on the BEERS List

On HEDIS List

The HEDIS List indicator (GERI_HEDIS_IND) is a one-character alphanumeric value that indicates whether the
drug is on the HEDIS (Healthcare Effectiveness Data and Information Set) drug list, identifying high-risk
medications in the elderly and developed and maintained by the National Committee for Quality Assurance
(NCQA).

Valid Values Table

GERI_HEDIS_IND Description

Y On the HEDIS List

N Not on the HEDIS List

On STOPP List

The STOPP List indicator (GERI_STOPP_IND) is a one-character alphanumeric value that indicates whether the
drug is on the STOPP List, a subset of the STOPP/START screening tool criteria used to help identify
inappropriate/appropriate drug use in the elderly.

Valid Values Table

GERI_STOPP_IND Description

Y On the STOPP List

N Not on the STOPP List

Geriatric Precautions Narrative

The Geriatric Precaution Narrative (GERI_NARRATIVE) in v2.0 is an enhanced 500-character optional field used
to provide additional details on the geriatric precaution information.

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ExampleGeriatric Precautions Master Table

GERI_CODE 492 845 51

GERI_DESC Hydrochlorothiazide Acetaminophen (oral,rectal) Nicardipine

GERI_SL 2 2 2

GERI_RN Y N Y

GERI_HEP N Y Y

GERI_CARD Y N Y

GERI_PULM N N N

GERI_NEUR N N N

GERI_END Y N N

GERI_BEERS N N Y

GERI_HEDIS N Y N

GERI_STOPP Y N Y

GERI_NARRATIVE Cardiovascular-Increased Hepatic-Elderly are more Renal-Elderly with moderate

sensitivity to effects on blood susceptible to hepatotoxicity. renal dysfunction may have
pressure. Metabolic-More Strict adherence to a elevated serum
likely to develop maximum daily dose of concentrations of
hypokalemia or 3000mg is advised. nicardipine. Follow blood
hypomagnesemia. pressure closely.
Endocrine-May worsen Hepatic-Elderly with hepatic
glucose control in diabetics. dysfunction or descreased
Renal-Less effective with hepatic blood flow may have
severe renal impairment. elevated serum
concentrations of
nicardipine. Follow blood
pressure closely.
Gastrointestinal-May cause
constipation or exacerbation
of pre-existing constipation.

Rule Sets

This section provides rules that the clinical team uses in regard to creating the module's data, both general rules
and rules specific to data elements.

Rules of General Applicability

This section describes editorial policies that have a broad impact on the module data or by nature are less
specific than those policies in other sections.

Drug knowledge is aggregated at the drug group level (see Geriatric Precaution Code) and then linked to Clinical
Formulation IDs, Routed Medication IDs, and the Routed Generic IDs in the FDB knowledge base. Linkage or
assignment of GERI information to drugs is therefore not manufacturer-specific.

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Non-U.S. drug Clinical Formulations may inherit U.S.-based GERI clinical data.

Rules for Geriatric Precaution Code Drug Groups: Description and Linking

Clinical Formulation IDs (GCN_SEQNOs) are linked to a GERI code drug group that is most commonly based on
having identical ingredients, but can be broader to include a class of ingredients when there is a larger ingredient
class effectfor example, "Calcium Salts"or may be narrower to include only certain dose forms, routes, or
strengths of a single ingredientfor example, "Nifedipine (Short Acting)."

Rules for Data Elements

This section describes editorial policies that are more specific towards their effect on the data elements contained
in the module.

Geriatric Precaution Severity Level Assignment

The severity level assignment is primarily determined by the geriatric warning content in FDA-approved
manufacturer prescriber information. Other sources that may contribute to the severity level assignment also may
include STOPP Criteria comments, BEERS List comments, and other comments as pertinent.

Severity Level 1 is reserved for warnings that state there is known risk. There are stated severe adverse
outcomes, or a potential for severe morbidity or mortality exists.

Severity Level 1 may not be an "absolute" contraindication.

Severity Level 2 is reserved for warnings that state there is a known risk or evidence of a potential adverse
effect.

Evidence Schema

Severity Level 1

Boxed Warning labeling with specific mention of avoidance in geriatric population

Contraindicated labeling with any mention of the geriatric population in association with the
contraindication
Warnings or Precautions section with any bolded statements (or all capitalization format) regarding severe
adverse reactions in geriatrics and recommended avoidance in this population
Geriatric Use section of labeling states not recommended because use has demonstrated severe adverse
effects

Severity Level 2

Boxed Warning labeling with specific mention of adverse reaction risk in geriatric population, but the drug
has indicated uses in geriatrics and monitoring adverse reactions is recommended.
Contraindicated labeling in geriatrics only with an associated, specific co-morbid condition listed (for
example, PALIPERIDONE; CONTRAINDICATED IN SENILE DEMENTIA DUE TO HIGHER RATES OF

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DEATH).
Non-bolded Warnings or Precautions labeling with specific mention of adverse reaction risk in geriatric
population and also with a labeled indicated use in geriatrics.
Geriatric Use section of labeling states:
No efficacy established in formal geriatric studies, and evidence of geriatric adverse reactions
exists.
Safety and efficacy established, and known risk of adverse effects that can be monitored.
Geriatric Use/Dosing sections state the drug is used in geriatrics, but specific dosing or monitoring is
recommended (for example, CrCL-based dosing or specific laboratory monitoring).
Geriatric Use/Dosing sections state that the drug is used commonly in geriatrics, but a specific population
of geriatrics are at risk for adverse reactions (for example, calcium supplement use in geriatrics with
chronic constipation).
Warnings or Precautions labeling pertaining to common adverse drug reactions described in adult
populations that may have a significant impact on geriatrics:
Nephrotoxicity
Effects on vestibular function
Effects on hearing
Effects on cognitive function
Effects on ability to ambulate or effects that increase fall risk (strongly sedative, orthostatic
hypotension, effects on cerebellar function)
Effects on the urinary system (anticholinergic, sympathomimetic)

Maintenance

This section contains information regarding the ongoing maintenance of the module's data.

External Triggers for Clinical Review

The external triggers that prompt the clinical editors to add or review data are the following:

MedEffects Alerts from Health-Canada (except Non-U.S. product alerts exclusive to Canada). Available at:
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/index_e.html.
MedWatch Safety Alerts from FDA http://www.fda.gov/medwatch.
FDA CDER NEW listserv emails.
FDA CBER What's New listserv emails.
FDA MedWatch Monthly Label Changes.
Beers Drug List: American Geriatrics Society Updated Beers Criteria for Potentially Inappropriate
Medication Use in Older Adults. Available at:
http://geriatricscareonline.org/toc/american-geriatrics-society-updated-beers-criteria-for-potentially-inappropriate-medica
STOPP Drug List: Gallagher, P et al. STOPP (Screening Tool of Older Person's Prescriptions) and START
(Screening Tool to Alert Doctors to Right Treatment). Consensus Validation. Int J Clin Pharm Ther
2007:46:72-83.

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HEDIS Drug List: The National Committee for Quality Assurance. Drugs to be Avoided in the Elderly: as
specified by NCQA's HEDIS measure: Use of High-Risk Medications in the Elderly . Available at:
http://www.ncqa.org/HEDISQualityMeasurement/HEDISMeasures/HEDIS2016/HEDIS2016NDCLicense/HEDIS2016Fin

Internal Triggers for Clinical Review

The internal triggers that prompt the clinical editors to add or review GERI drug groups is a new Clinical
Formulation (GCN_SEQNO) added to MedKnowledge and its product labeling.

References

This section lists sources used by First Databank to compile the information contained in the module.

FDB utilizes many reference sources including, but not limited to, the primary medical literature (for example,
published journal articles), medical reference texts, published expert treatment guidelines, and manufacturer
product package inserts. FDB uses current source editions or versions when coding and updating data, as well as
when researching questions about data. However, a formal data review does not occur for every new release of
source editions or versions.

Additional sources include:

Published by authority of the Board of Directors of the American Society of Health-System Pharmacists.
AHFS Drug Information.

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GERI Applications
This section provides information about the practical application of data contained in this module.

Screening a Drug for Geriatric Precautions

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Screening a Drug for Geriatric Precautions

Systems can use the Geriatric Precautions Module to identify warnings that might impact drug ordering and
dispensing decisions. This application illustrates how to screen a drug for geriatric precautions.

1. Do one of the following:

Select Geriatric Precaution Code (GERI_CODE) from the GERI GCN_SEQNO Link Table
(RGERIGC0_GERI_GCNSEQNO_LINK) where the Clinical Formulation ID (GCN_SEQNO) column
equals the Clinical Formulation ID (GCN_SEQNO) of the drug to screen.
Select the GERI_CODE from the GERI ROUTED_MED_ID Link Table
(RGERIRM0_ROUTED_MED_LINK) where the MED Routed Medication ID (ROUTED_MED_ID)
column equals the ROUTED_MED_ID of the drug to screen.
Select the GERI_CODE from the GERI Routed Generic Table (RGERIRG0_ROUTED_GEN_LINK)
where the Routed Generic Identifier (ROUTED_GEN_ID) column equals the ROUTED_GEN_ID of
the drug to screen.
If no records exist in a link table, the drug has no precautions in that module.

The system might need to perform additional navigation to access the GERI_CODE from
the user-entered drug identifier. See Multiple Access Points (MAPs) for more information.

2. Select GERI precautions information from the Geriatric Precautions Master Table
(RGERIMA1_GERI_MSTR) where the GERI_CODE column equals the GERI_CODE value from the
previous step.

3. (Optional) Filter the results according to institution convention or user-entered criteria.

4. Display the results to the user.

ExampleScreening a Drug for Geriatric Precautions with the ROUTED_MED_ID

ExampleScreening a Drug for Geriatric Precautions with the ROUTED_GEN_ID
ExampleScreening a Drug for Geriatric Precautions with the Clinical Formulation ID
ExampleFiltering Geriatric Precaution Information on Severity Level
ExampleFiltering Geriatric Precaution Information on Severity Level and Indicator

ExampleScreening a Drug for Geriatric Precautions with the ROUTED_MED_ID

For the purposes of demonstrating this application, the following scenario is used: A physician screens
Diazepam Rect (ROUTED_MED_ID 14541) for all possible GERI information. The MED Routed

Medication ID (ROUTED_MED_ID) is in the MED Routed Medication Table (RMIRMID1_ROUTED_MED).

1. Select the Geriatric Precaution Code (GERI_CODE) value from the GERI ROUTED_MED_ID Link Table
(RGERIRM0_ROUTED_MED_LINK) where the ROUTED_MED_ID column equals the ROUTED_MED_ID

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value of the drug to screen.

ROUTED_MED_ID 14541

GERI_CODE 000217

2. Select the Geriatric Precaution Description (GERI_DESC), Geriatric Precaution Severity Level (GERI_SL),
affected organ systems, indicators, and Geriatric Precaution Narrative (GERI_NARRATIVE) values from
the Geriatric Precautions Master Table (RGERIMA1_GERI_MSTR) where the GERI_CODE column equals
the value from the previous step.

GERI_CODE 000217

GERI_DESC Diazepam

GERI_SL 2

GERI_RNL Y

GERI_HEP N

GERI_CARD N

GERI_PULM N

GERI_NEUR Y

GERI_END N

GERI_BEERS_IND Y

GERI_HEDIS_IND Y

GERI_STOPP_IND Y

GERI_NARRATIVE General-Due to the long drug half-life and active

metabolites, the elderly are particularly predisposed to
the neurological effects. Limit to short term usage and
maximum of 5 mg/day. Neuro/Psych-Elderly have a
much higher risk for sedation, depression, cognitive
impairment and falls. Renal-Active metabolites are
renally excreted. Use caution in renal impairment with
initial dosing starting with 2 to 2.5 mg/day and titrate as
tolerated.

3. Display the results to the user.

In this example, the system alert contains the drug name, the severity level, the precaution narrative, and
the BEERS, HEDIS, and STOPP Indicators:
Example Geriatric Precaution Alert

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Diazepam use has management or monitoring precaution(s) in geriatric patients.

General-Due to the long drug half-life and active metabolites, the elderly are particularly predisposed to the neurological
effects. Limit to short term usage and maximum of 5 mg/day.
Neuro/Psych-Elderly have a much higher risk for sedation, depression, cognitive impairment and falls.
Renal-Active metabolites are renally excreted. Use caution in initial dosing starting with 2 to 2.5 mg/day and titrate as
tolerated.
Diazepam is included in the following "potentially harmful drugs in the elderly" lists: BEERS, HEDIS, STOPP

ExampleScreening a Drug for Geriatric Precautions with the ROUTED_GEN_ID

For the purposes of demonstrating this application, the following scenario is used: A physician screens
Digoxin Oral (ROUTED_GEN_ID 01048580) for all possible GERI information. The Routed Generic Identifier (
ROUTED_GEN_ID) is in the Routed Generic Table (RRTGN0_ROUTED_GEN_MSTR).

1. Select the Geriatric Precaution Code (GERI_CODE) value from the GERI Routed Generic Table
(RGERIRG0_ROUTED_GEN_LINK) where the ROUTED_GEN_ID column equals the ROUTED_GEN_ID
value of the drug to screen.

ROUTED_GEN_ID 4358

GERI_CODE 000001

2. Select the Geriatric Precaution Description (GERI_DESC), Geriatric Precaution Severity Level (GERI_SL),
affected organ systems, indicators, and Geriatric Precaution Narrative (GERI_NARRATIVE) values from
the Geriatric Precautions Master Table (RGERIMA1_GERI_MSTR) where the GERI_CODE column equals
the value from the previous step.

GERI_CODE 000001

GERI_DESC Digitalis Glycosides

GERI_SL 2

GERI_RNL Y

GERI_HEP N

GERI_CARD N

GERI_PULM N

GERI_NEUR N

GERI_END N

GERI_BEERS_IND Y

GERI_HEDIS_IND N

GERI_STOPP_IND Y

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GERI_NARRATIVE Renal-Decreased renal clearance in aging. Use lower

starting dose of 0.125 mg and monitor plasma drug
levels more frequently. Metabolic-Correct hypokalemia,
hypomagnesemia and hypercalcemia to minimize
digoxin toxicity below plasma levels of 2.0 ng/mL.

3. Display the results to the user.

In this example, the system alert contains the drug name, the severity level, the affected organ systems,
the precaution narrative, and the BEERS and STOPP Indicators:
Example Geriatric Precaution Alert

Digitalis Glycoside use has management or monitoring precaution(s) in geriatric patients.

The following organ system(s) is associated and/or may be adversely affected:
- Renal
Renal-Decreased renal clearance in aging. Use lower starting dose of 0.125 mg and monitor plasma drug levels more
frequently.
Metabolic-Correct hypokalemia, hypomagnesemia and hypercalcemia to minimize digoxin toxicity below plasma levels of
2.0 ng/mL.
Digitalis Glycosides are included in the following "potentially harmful drugs in the elderly" lists: BEERS, STOPP.

ExampleScreening a Drug for Geriatric Precautions with the Clinical Formulation ID

For the purposes of demonstrating this application, the following scenario is used: A pharmacist screens
pseudoephedrine/acetaminophen (Clinical Formulation ID [GCN_SEQNO] 001112) for all possible GERI
information. The Clinical Formulation ID (GCN_SEQNO) is in the Clinical Formulation ID Table
(RGCNSEQ4_GCNSEQNO_MSTR).

1. Select the Geriatric Precaution Code (GERI_CODE) value from the GERI GCN_SEQNO Link Table
(RGERIGC0_GERI_GCNSEQNO_LINK) where the GCN_SEQNO column equals the Clinical Formulation
ID (GCN_SEQNO) value of the drug to screen.

GCN_SEQNO 001112 001112

GERI_CODE 000389 000845

2. Select the Geriatric Precaution Description (GERI_DESC), Geriatric Precaution Severity Level (GERI_SL),
affected organ systems, indicators, and Geriatric Precaution Narrative (GERI_NARRATIVE) values from
the Geriatric Precautions Master Table (RGERIMA1_GERI_MSTR) where the GERI_CODE column equals
the values from the previous step.

GERI_CODE 000389 000845

GERI_DESC Pseudoephedrine Acetaminophen (oral,rectal)

GERI_SL 2 2

GERI_RNL Y N

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GERI_HEP N Y

GERI_CARD Y N

GERI_PULM N N

GERI_NEUR Y N

GERI_END N N

GERI_BEERS_IND Y N

GERI_HEDIS_IND Y N

GERI_STOPP_IND N N

GERI_NARRATIVE Cardiovascular-Elderly are more Hepatic-Elderly are more

sensitive to tachycardia and susceptible to hepatotoxicity. Strict
hypertensive effects. May adherence to a maximum daily dose
exacerbate symptomatic coronary of 3000mg is advised.
insufficiency. Genitourinary-May
cause urinary retention.
Neuro/Psych-May worsen cognitive
impairment in some elderly with
dementia. Insomnia risk.

3. Display the results to the user.

In this example, the system returned two GERI codes, both with a severity level of 2. The system alert
contains a phrase associated with severity level 2, followed by the drug names, and the precaution
narrative:
Example Geriatric Precaution Alert

SEVERITY LEVEL 2: Drug use has management or monitoring precaution(s) in geriatric patients.
PSEUDOEPHEDRINE
Cardiovascular-Elderly are more sensitive to tachycardia and hypertensive effects. May exacerbate
symptomatic coronary insufficiency.
Genitourinary-May cause urinary retention.
Neuro/Psych-May worsen cognitive impairment in some elderly with dementia. Insomnia risk.
ACETAMINOPHEN (ORAL,RECTAL)
Hepatic-Elderly are more susceptible to hepatotoxicity. Strict adherence to a maximum daily dose
of 3000mg is advised.

ExampleFiltering Geriatric Precaution Information on Severity Level

For purposes of demonstrating this application, the following scenario is used: A nurse practitioner
screens Cordarone 200MG Tablet (Clinical Formulation ID [GCN_SEQNO] 000266) for geriatric precautions, and
the institution has decided to filter warnings to display only those with a severity level of 1. The Clinical
Formulation ID is in the Clinical Formulation ID Table(RGCNSEQ4_GCNSEQNO_MSTR).

1. Select the Geriatric Precaution Code (GERI_CODE) value from the GERI GCN_SEQNO Link Table

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1.
(RGERIGC0_GERI_GCNSEQNO_LINK) where the GCN_SEQNO column equals the Clinical Formulation
ID (GCN_SEQNO) value of the drug to screen.

GCN_SEQNO 000266

GERI_CODE 000009

2. Select the Geriatric Precaution Description (GERI_DESC), Geriatric Precaution Severity Level (GERI_SL),
affected organ systems, indicators, and Geriatric Precaution Narrative (GERI_NARRATIVE) values from
the Geriatric Precautions Master Table (RGERIMA1_GERI_MSTR) where the GERI_CODE column equals
the value from the previous step.

GERI_DESC Amiodarone

GERI_SL 2

GERI_RNL N

GERI_HEP Y

GERI_CARD Y

GERI_PULM Y

GERI_NEUR Y

GERI_END Y

GERI_BEERS_IND Y

GERI_HEDIS_IND N

GERI_STOPP_IND N

GERI_NARRATIVE Cardiovascular-Risk for Torsades de pointes. Follow

QTc intervals. Endocrine-Monitor for hyperthyroidism.
Pulmonary-Toxicity has been reported days to weeks
after drug initiation. Preexisting pulmonary disease
incurs a poorer prognosis if toxicity develops. Monitor
for cough and progressive dyspnea. Hepatic-Elevated
hepatic transaminases are common.
Neuro/Psych-Monitor for peripheral neuropathy,
coordination and gait deficits. Optic neuropathy and
neuritis has been reported.

3. Filter the results according to institution convention or user-entered criteria.

In this example, the institution convention is to display alerts for records with a severity level 1. In this
example, the only returned record contains a value of 2 in the GERI_SL column, so it does not meet the
criteria.

4. Display the results to the user. In this example, the system does not generate an alert because the
returned record does not meet the criteria.

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ExampleFiltering Geriatric Precaution Information on Severity Level and Indicator

For purposes of demonstrating this application, the following scenario is used: A physician screens
combination product atenolol and chlorthalidone (ROUTED_MED_ID 16214) for all possible geriatric precautions,
and the institution decided to filter warnings to display all severity level 1 alerts, and only those with a severity
level 2 that also have a BEERS indicator. The MED Routed Medication ID ( ROUTED_MED_ID) is in the MED
Routed Medication Table (RMIRMID1_ROUTED_MED).

1. Select the Geriatric Precaution Code (GERI_CODE) value from the GERI ROUTED_MED_ID Link Table
(RGERIRM0_ROUTED_MED_LINK) where the ROUTED_MED_ID column equals the ROUTED_MED_ID
value of the drug to screen.

ROUTED_MED_ID 16214 16214

GERI_CODE 000398 000892

2. Select the Geriatric Precaution Description (GERI_DESC), Geriatric Precaution Severity Level (GERI_SL),
affected organ systems, indicators, and Geriatric Precaution Narrative (GERI_NARRATIVE) values from
the Geriatric Precautions Master Table (RGERIMA1_GERI_MSTR) where the GERI_CODE column equals
the value from the previous step.

GERI_CODE 000398 000892

GERI_DESC Atenolol Chlorthalidone

GERI_SL 2 2

GERI_RNL Y Y

GERI_HEP N N

GERI_CARD Y Y

GERI_PULM N N

GERI_NEUR Y N

GERI_END N N

GERI_BEERS_IND N N

GERI_HEDIS_IND N N

GERI_STOPP_IND Y Y

GERI_NARRATIVE Cardiovascular-Minimize dose to More sensitive to blood pressure

decrease dizziness and falls. and electrolyte wasting. less
Renal-Renal elimination; use caution effective in severe renal impairment.
in starting dose and dose escalation.

3. Filter the results according to institution convention or user-entered criteria.

In this example, the institution convention is to display all severity level 1 alerts, and only those with a

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3.

severity level 2 that also have a BEERS indicator. In this example, the returned records contain a value of
2 in the GERI_SL column, but they contain a value of N in the GERI_BEERS_IND column; therefore, they
do not meet the criteria.

4. Display the results to the user. In this example, the system does not generate an alert because the
returned records do not meet the criteria.

For an example of a scenario in which the filter criteria are met and the system generates an alert, consider the
following.

For the purposes of demonstrating this application, the following scenario is used: A physician screens
Diazepam Rect (ROUTED_MED_ID 14541) for all possible geriatric precautions, and the institution decided to
filter warnings to display all severity level 1 alerts, and only those with a severity level 2 that also have a BEERS
indicator. The MED Routed Medication ID (ROUTED_MED_ID) is in the MED Routed Medication Table
(RMIRMID1_ROUTED_MED).

1. Select the Geriatric Precaution Code (GERI_CODE) value from the GERI ROUTED_MED_ID Link Table
(RGERIRM0_ROUTED_MED_LINK) where the ROUTED_MED_ID column equals the ROUTED_MED_ID
value of the drug to screen.

ROUTED_MED_ID 14541

GERI_CODE 000217

2. Select the Geriatric Precaution Description (GERI_DESC), Geriatric Precaution Severity Level (GERI_SL),
affected organ systems, indicators, and Geriatric Precaution Narrative (GERI_NARRATIVE) values from
the Geriatric Precautions Master Table (RGERIMA1_GERI_MSTR) where the GERI_CODE column equals
the value from the previous step.

GERI_CODE 000217

GERI_DESC Diazepam

GERI_SL 2

GERI_RNL Y

GERI_HEP N

GERI_CARD N

GERI_PULM N

GERI_NEUR Y

GERI_END N

GERI_BEERS_IND Y

GERI_HEDIS_IND Y

GERI_STOPP_IND Y

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GERI_NARRATIVE General-Due to the long drug half-life and active

metabolites, the elderly are particularly predisposed to
the neurological effects. Limit to short term usage and
maximum of 5 mg/day. Neuro/Psych-Elderly have a
much higher risk for sedation, depression, cognitive
impairment and falls. Renal-Active metabolites are
renally excreted. Use caution in renal impairment with
initial dosing starting with 2 to 2.5 mg/day and titrate as
tolerated.

3. Filter the results according to institution convention or user-entered criteria.

In this example, the institution convention is to display all severity level 1 alerts, and only those with a
severity level 2 that also have a BEERS indicator. In this example, the only returned record contains a
value of 2 in the GERI_SL column and a value of Y in the GERI_BEERS_IND column; therefore, it meets
the criteria.

4. Display the results to the user.

In this example, the system alert contains the drug name, the severity level, the precaution narrative, and
the BEERS, HEDIS, and STOPP Indicators:
Example Geriatric Precaution Alert

Diazepam use has management or monitoring precaution(s) in geriatric patients.

General-Due to the long drug half-life and active metabolites, the elderly are particularly predisposed to the neurological
effects. Limit to short term usage and maximum of 5 mg/day.
Neuro/Psych-Elderly have a much higher risk for sedation, depression, cognitive impairment and falls.
Renal-Active metabolites are renally excreted. Use caution in initial dosing starting with 2 to 2.5 mg/day and titrate as
tolerated.
Diazepam is included in the following "potentially harmful drugs in the elderly" lists: BEERS, HEDIS, STOPP

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GERI ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module. These table names are listed below.

GERI Tables
GERI ERDs

GERI Tables

Geriatric Precautions Master Table

GERI GCN_SEQNO Link Table
GERI ROUTED_MED_ID Link Table
GERI Routed Generic Table
GERI Severity Level Description Table

GERI ERDs

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Geriatric Precautions Master Table

Table Name RGERIMA1_GERI_MSTR

Revision Activity rev.11-22-2011

Purpose Provides attributes of geriatric precaution information for a

particular drug.

Key Column Name Column Format Length Picture

Description

P GERI_CODE Geriatric N 6 9(6)

Precaution Code

GERI_DESC Geriatric AN 41 X(41)

Precaution
Description

GERI_SL Geriatric AN 1 X(1)

Precaution
Severity Level

GERI_RNL Geriatric AN 1 X(1)

Precaution Organ
System Function -
Renal

GERI_HEP Geriatric AN 1 X(1)

Precaution Organ
System Function -
Hepatic

GERI_CARD Geriatric AN 1 X(1)

Precaution Organ
System Function -
Cardiovascular

GERI_PULM Geriatric AN 1 X(1)

Precaution Organ
System Function -
Pulmonary

GERI_NEUR Geriatric AN 1 X(1)

Precaution Organ
System Function -
Neurologic/Psychi
atric

GERI_END Geriatric AN 1 X(1)

Precaution Organ
System Function -
Endocrine

GERI_BEERS_IN On BEERS List AN 1 X(1)

D

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GERI_HEDIS_IN On HEDIS List AN 1 X(1)

D

GERI_STOPP_IN On STOPP List AN 1 X(1)

D

GERI_NARRATIV Geriatric AN 500 X(500)

E Precaution
Narrative

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GERI GCN_SEQNO Link Table

Table Name RGERIGC0_GERI_GCNSEQNO_LINK

Revision Activity original

Purpose Links a clinical formulation to geriatric precaution

information.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF GERI_CODE Geriatric N 6 9(6)

Precaution Code

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GERI ROUTED_MED_ID Link Table

Table Name RGERIRM0_ROUTED_MED_LINK

Revision Activity add.07-01-2002

Purpose Links a routed medication to geriatric precaution

information.

Key Column Name Column Format Length Picture

Description

PF ROUTED_MED_I MED Routed N 8 9(8)

D Medication ID
(Stable ID)

PF GERI_CODE Geriatric N 6 9(6)

Precaution Code

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GERI Routed Generic Table

Table Name RGERIRG0_ROUTED_GEN_LINK

Revision Activity original

Purpose Links a routed generic to geriatric precaution information.

Key Column Name Column Format Length Picture

Description

PF ROUTED_GEN_I Routed Generic N 8 9(8)

D Identifier

PF GERI_CODE Geriatric N 6 9(6)

Precaution Code

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GERI Severity Level Description Table

Table Name RGERISD0_GERI_SEVER_LEVEL_DESC

Revision Activity add.11-22-2011

Purpose Relates the Geriatric Precaution Severity Level to its text

description.

Key Column Name Column Format Length Picture

Description

P GERI_SL Geriatric AN 1 X(1)

Precaution
Severity Level

GERI_SL_DESC Geriatric AN 255 X(255)

Precaution
Severity Level
Description

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Lactation Precautions Module (LACT) 1.0

Lactation Precautions Module Editorial Policies
Applications
ERD and Technical Specifications

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Lactation Precautions Module Editorial Policies

The policies and criteria that apply to the inclusion criteria, processes, and references used in creation of the
module are provided in the following sections:

Overview
Inclusion/Exclusion Criteria
Data Elements
Rule Sets
Maintenance
References

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Lactation Precautions Module Overview

The Lactation Precautions Module (LACT) module contains precaution information for the use of drugs in a
future lactating (for example, pregnant) or currently lactating patient who wishes to continue breast-feeding an
infant.

The LACT module enables you to create warning messages about drug use in future or currently lactating
women. These warnings allow healthcare professionals to make informed decisions about altering a patients
drug therapy when potential problems exist. Although system access to the patients age and gender enhances
the functionality of the product, it is not a requirement to achieve valuable results.

The LACT module is intended for use as screening mechanisms to detect drug precautions specific to future or
currently lactating patients. The precautions are clinically relevant and are generally well documented in the
literature. However, lactation information may not be as conclusive in the literature and inconclusive precautions
or precautions based on very limited data may be presented. Warnings may not be included if there is no data on
a particular drug usage in future lactating or currently lactating patients.

Systems using LACT can provide the following information:

Severity level of the precaution

Whether the drug is excreted into breast milk
Whether the drug affects the nursing infant
Lactation precaution narrative (this is an optional usage data field)

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Lactation Precautions Module Inclusion-Exclusion Criteria

This section provides information detailing the criteria that guided the inclusion of the data contained within the
module as well as information pertaining to limitations or exclusions when appropriate to the discussion.
This section includes the following topics:

Inclusion - Drug Scope

Inclusion - Warnings Content Scope
Exclusion - Drug Scope

Inclusion - Drug Scope

U.S. FDA-approved Rx product ingredients with New Drug Application (NDA), Abbreviated New Drug
Application (ANDA), or Biologic License Application (BLA)
U.S. over-the-counter (OTC) products with NDAs or ANDAs
U.S. OTC drug product ingredients consistent with FDA OTC Monographs
Herbal products enumerated in the FDB Herbal Products Inclusion List

Inclusion - Warnings Content Scope

Content pertains to safety of drug use in lactating women, and in pregnant women who may breastfeed after
delivery. The following information is included for a given drug when available:

Safety of the drug in the nursing infant and the lactating mother
The excretion potential into breast milk for a given drug
Effect of the drug on the nursing infant

The most severe warnings in the LACT precautions module are FDB Severity Level 1. These severe warnings are
also included in the Drug Disease Contraindications Module (DDCM) and a Severity Level 1 is assigned to DXID
3452 (Lactating Mother).

Exclusion - Drug Scope

Non-U.S. products that are exclusive to other countries

Self-proclaimed Rx products without ANDA, NDA, or BLA
Rx drug products with 510K device approval
Dietary supplements
Large volume parenteral, nutritional, irrigation or dialysis solutions
Nutraceuticals
Diluent solutions
Herbal products, except those enumerated in the FDB Herbal Products Inclusion List
Homeopathic drugs
OTC products that are not described by FDA OTC Monographs
Bulk drugs or chemicals
Medical supplies, soaps, cleansers

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Cosmetics
Veterinary drugs
Inactive ingredients

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Lactation Precautions Module Data Elements

This section contains additional information about particularly important tables and codes contained within the
module, as well as concepts about the data that the reader must understand in order to understand the module.

This section includes the following data elements:

Lactation Precaution Code

Lactation Precaution Code Description
Lactation Precaution Severity Level
Lactation Precaution Excretion Potential Code
Lactation Precaution Effects on Infant Code
Lactation Precaution Narrative

Lactation Precaution Code

The Lactation Precaution Code (LACT_CODE) is a system-assigned dumb number for each drug group.

Each ingredient in a multi-ingredient product will have its own LACT code and description.
LACT codes are linked to the following FDB drug identifiers:

Routed Medication ID (ROUTED_MED_ID)

Routed Generic Identifier (ROUTED_GEN_ID)

Clinical Formulation ID (GCN_SEQNO)

Example 1 below shows clinical formulations with the same ingredient and therefore linked to the same LACT
code.

Example 1

GCN_SEQNO LACT_CODE LACT_DESC

45131 1461 LINEZOLID

45132 1461 LINEZOLID

45133 1461 LINEZOLID

45134 1461 LINEZOLID

47821 1461 LINEZOLID

Example 2 below shows multi-ingredient clinical formulation with two LACT codes.

Example 2

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GCN_SEQNO LACT_CODE LACT_DESC

374 31 CAPTOPRIL

374 539 HYDROCHLOROTHIAZIDE

Lactation Precaution Code Description

The description is assigned to the Lactation Precaution Code (LACT_CODE). This drug group description is
usually ingredient-based but can be broader and include a collection of ingredientsfor example, ESTROGENS,
CONJUGATED (ORAL/INJ)or may be narrower and include only certain dose forms or routesfor example,
OFLOXACIN (OPHTH/OTIC).

Example 1 below shows a single ingredient drug group.

Example 1

LACT_CODE LACT_DESC

1461 LINEZOLID

Example 2 below shows an ingredient break-out drug group.

Example 2

LACT_CODE LACT_DESC LACT_SL LACT_EXCRT LACT_LCTN LACT_PRCTN

1017 OFLOXACIN 2 1 2 INSUFFICIENT

(ORAL,IV) DATA
AVAILABLE;
REPORTS OF
ARTHROPATHY
IN ANIMAL
STUDIES

1596 OFLOXACIN 2 2 2 INSUFFICIENT

(OPHTH/OTIC) DATA
AVAILABLE

Lactation Precaution Severity Level

There are three severity levels (LACT_SL) that can be assigned to a given LACT code. Each LACT code is
assigned only one severity level. (See Rule Set for Lactation Precaution Severity Level (LACT_SL) description.)

Example

LACT_CODE LACT_DESC LACT_SL

916 ZIDOVUDINE 1

1739 HEPARIN 3

2056 SAXAGLIPTIN 2

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Lactation Precaution Excretion Potential Code

There are three excretion values (LACT_EXCRT) that can be assigned to a given LACT code. Each LACT code
is assigned only one excretion value. (See Rule Set for Lactation Precaution Excretion Potential Code
(LACT_EXCRT) descriptions.)

Example

LACT_CODE LACT_DESC LACT_SL LACT_EXCRT

916 ZIDOVUDINE 1 1

1739 HEPARIN 3 3

2056 SAXAGLIPTIN 2 2

Lactation Precaution Effects on Infant Code

There are three values for "effect on infant" (LACT_LCTN) that can be assigned to a LACT code. Each LACT
code is assigned only one value. (See Rule Set for Lactation Precaution Effects on Infant Code (LACT_LCTN)
descriptions.)

Example

LACT_CODE LACT_DESC LACT_SL LACT_EXCRT LACT_LCTN

916 ZIDOVUDINE 1 1 2

1739 HEPARIN 3 3 3

2056 SAXAGLIPTIN 2 2 2

Each medication ordered or ingredient in a multi-ingredient clinical formulation will have a set of three
valuesthat is, one value for severity level, one value for excretion, and one value for effect on infant.
These set values may be sorted and evaluated in algorithms within an application.

Lactation Precaution Narrative

The narrative field, limited to 77 characters, offers space to provide additional details on a given severity level,
excretion, or effect on infant value (LACT_PRCTN). This field is optional.

Example

LACT_CODE LACT_DESC LACT_SL LACT_EXCRT LACT_LCTN LACT_PRCTN

916 ZIDOVUDINE 1 1 2 CDC DOES NOT

RECOMMEND
BREASTFEEDIN
G IN
HIV-POSITIVE
WOMEN

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2056 SAXAGLIPTIN 2 2 2 INSUFFICIENT

HUMAN DATA;
EXCRETED IN
RATS

16 HYDRALAZINE 3 1 2 LIMITED DATA

SUGGEST
INFANT
EXPOSURE IS
MINIMAL WITH
NO ADV
EFFECTS

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Lactation Precautions Module Rule Sets

This section provides rules that the clinical team uses in regard to creating the module's data, both general rules
and rules specific to data elements.

Rules of General Applicability

Rules for Data Elements

Trigger content (for example, Sporadic MedWatch alerts) is reviewed and concepts applicable to LACT are
identified. (See Maintenance for list of triggers.) Trigger content drug(s) are identified and LACT precautions
coding is applied to all applicable LACT drug groups.

Rules of General Applicability

This section describes editorial policies that have a broad impact on the module data or by nature are less
specific than those policies in other sections.

Drug knowledge is aggregated at the drug group level (see Lactation Precaution Code ( LACT_CODE) and then
linked to Clinical Formulation IDs, Routed Medication IDs, and the Routed Generic IDs in the FDB knowledge
base. Linkage or assignment of LACT information to drugs is therefore not manufacturer-specific.

Non-U.S. drug Clinical Formulations may inherit U.S.-based LACT clinical data.

Rules for Data Elements

This section describes editorial policies that are more specific towards their effect on the data elements contained
in the module.

Lactation Precaution Severity Level

The severity level assignment (LACT_SL) is primarily determined by the lactation warnings content in the
FDA-approved manufacturer prescription information for a given drug.

Severity Level Descriptions

The LACT Severity Level Description Table (RLACTSD0_SEVER_LEVEL_DESC) contains the following
Lactation Precaution Severity Levels (LACT_SL) and Lactation Precaution Severity Level Descriptions (
LACT_SL_DESC):

1. Absolute contraindication (Human data usually available to support recommendations). This drug should
not be given to breastfeeding mothers.

2. Precaution exists (No data or inconclusive human data). Use of this drug by breastfeeding mothers should
be evaluated carefully.

3. No known risk. This drug has no known risks for nursing infants and does not adversely affect lactation.

Evidence Schema

Severity Level 1 - May be assigned for manufacturer labeling:

Boxed warning labeling containing specific-to-breastfeeding-mothers warnings

Contraindicated section labeling referring to mother or infant

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Warnings or Precautions labeling indicating adverse outcomes in nursing infant or mother

Post-marketing human manufacturer labeling that indicates adverse outcomes in nursing infant

Severity Level 2 - May be assigned for either manufacturer or Briggs reference lactation warnings content:

Warnings or Precautions mentioning adverse outcomes in nursing infant, but with limited outcome data
Post-market human or animal data mentioning adverse outcomes in nursing infant, but with limited
outcome data
Specific mention of insufficient human or animal data that demonstrates safety during nursing

Severity Level 3 - May be assigned from manufacturer labeling:

Specific mention indicating no known risk to nursing infant or mother

Lactation Precaution Excretion Potential Code

The excretion value assignment (LACT_EXCRT) is primarily determined by the lactation warnings content in the
FDA-approved manufacturer prescription information for a given drug. In addition to the prescription label
information, other expert opinion references are also consulted.

Excretion Value Descriptions

The LACT Excretion Potential Code Description Table (RLACTED0_EXCRT_POTENTIAL_DESC) contains the
following Lactation Precaution Excretion Potential Codes (LACT_EXCRT) and Lactation Precaution Excretion
Potential Code Descriptions (LACT_EXCRT_DESC):

1. Excreted. This drug is known to be excreted in human breast milk.

2. Unknown. It is unknown whether the drug is excreted in human breast milk.

3. Not excreted. This drug is known NOT to be excreted in human breast milk.

Evidence Schema

Excretion Value 1 - May be assigned for either manufacturer or Briggs reference content:

Human data indicates drug excretion in breast milk.

Post-marketing human data that indicates drug excretion in breast milk.

Excretion Value 2 - May be assigned for either manufacturer or Briggs reference content:

Animal data indicates drug excretion in breast milk.

Molecular weight for a given drug is less than 300, allowing for possible excretion into breast milk. This
molecular weight threshold is established by authoritative sources.
Human or animal data for a chemically similar drug that is known to be excreted in breast milk.
Specific mention of insufficient human or animal data regarding excretion of drug in to breast milk.

Excretion Value 3 - May be assigned for either manufacturer or Briggs reference content:

Specific mention indicating drug does not transfer to breast milk.

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Lactation Precaution Effects on Infant Code

The effect on the infant value assignment (LACT_LCTN) is primarily determined by the lactation warnings content
in the FDA-approved manufacturer prescription information for a given drug. In addition to the prescription label
information, other expert opinion references are also consulted.

Effect on Infant Value Descriptions

The LACT Effects on Infant Code Description Table (RLACTID0_EFFECTS_INFANTS_DESC) contains the
following Lactation Precaution Effects on Infant Codes (LACT_LCTN) and Lactation Precaution Effects on Infant
Code Descriptions (LACT_LCTN_DESC):

1. This drug has been shown to have an adverse effect on the nursing infant.

2. It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive
human data.)

3. This drug has been shown not to have an adverse effect on the nursing infant.

Evidence Schema

Effect on Infant Value 1 - May be assigned for either manufacturer or Briggs reference lactation warnings content:

Human data indicates adverse effects in nursing infant

Warnings or Precautions indicating adverse outcomes in nursing infant
Post-marketing human or animal data that indicates adverse outcomes in nursing infant

Effect on Infant Value 2 - May be assigned for either manufacturer or Briggs reference lactation warnings content:

Specific mention of insufficient human or animal data regarding effect on infant

Warnings or Precautions mentioning adverse outcomes in nursing infant, but with limited outcome data
Post-market human or animal data mentioning adverse outcomes in nursing infant, but with limited
outcomes data

Effect on Infant Value 3 - May be assigned for either manufacturer or Briggs reference lactation warnings content:

Specific mention indicating no known adverse effect risk to nursing infant

This type of declaration is found rarely.

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Lactation Precautions Module Maintenance

This section contains information regarding the ongoing maintenance of the module's data.

External Triggers for Clinical Review

Internal Triggers for Clinical Review

External Triggers for Clinical Review

The external triggers that prompt the clinical editors to add or review data are the following:

MedEffects Alerts from Health-Canada (except Non-U.S. product alerts exclusive to Canada)
MedWatch Safety Alerts from FDA
FDA CDER NEW listserv emails
FDA CBER What's New listserv emails
FDA MedWatch Monthly Label Changes
Briggs Pregnancy and Lactation Newsletter

Internal Triggers for Clinical Review

The internal triggers that prompt the clinical editors to add or review LACT drug groups is a new Clinical
Formulation (GCN_SEQNO) added to MedKnowledge and its U.S. product labeling.

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Lactation Precautions Module References

This section lists sources used by First Databank to compile the information contained in the module.

FDB utilizes many reference sources including, but not limited to, the primary medical literature (for example,
published journal articles), medical reference texts, published expert treatment guidelines, and manufacturer
product package inserts. FDB uses current source editions or versions when coding and updating data, as well as
when researching questions about data. However, a formal data review does not occur for every new release of
source editions or versions. Additional sources include:

Briggs GG, Freeman RK, Yaffe SJ, eds. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal
and Neonatal Risk.
Briggs GG, Freeman RK, Yaffe SJ, eds. Briggs Update [Newsletter].
National Library of Medicine LactMed Database. Available at: http://toxnet.nlm.nih.gov.
World Health Organization. BREASTFEEDING AND MATERNAL MEDICATION Recommendations for
Drugs in the Eleventh WHO Model List of Essential Drugs 2002.
Thomas W. Hale, R.Ph. Ph.D. Professor of Pediatrics. Available at:
http://www.infantrisk.com/content/drug-entry-human-milk.
American Congress of Obstetricians and Gynecologists. Available at: http://www.acog.org/.
Drugs in Pregnancy and Breastfeeding. Available at: http://www.perinatology.com.
Lawrence. Breastfeeding: A Guide for the Medical Profession.
Hale TW, Ph.D. Medications and Mothers Milk.

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Lactation Precautions Module Applications

This section provides information about the practical application of data contained in this module.

Screening a Drug for Lactation Precautions

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Screening a Drug for Lactation Precautions

Systems can use the Lactation Precautions Module to identify warnings that might impact drug ordering and
dispensing decisions. This application illustrates how to screen a drug for precautions.

1. Do one of the following:

Select the Lactation Precaution Code (LACT_CODE) from the LACT GCN_SEQNO Link Table
(RLACTGC0_LACT_GCNSEQNO_LINK) where the Clinical Formulation ID (GCN_SEQNO) column
equals the Clinical Formulation ID (GCN_SEQNO) of the drug to screen.
Select the LACT_CODE from the LACT ROUTED_MED_ID Link Table
(RLACTRM0_ROUTED_MED_LINK) where the MED Routed Medication ID ( ROUTED_MED_ID)
column equals the ROUTED_MED_ID of the drug to screen.
Select the LACT_CODE from the LACT Routed Generic Table (RLACTRG0_ROUTED_GEN_LINK)
where the Routed Generic Identifier (ROUTED_GEN_ID) column equals the ROUTED_GEN_ID of
the drug to screen.
If no records exist in a link table, the drug has no precautions in that module.

The system might need to perform additional navigation to access the LACT_CODE from
the user-entered drug identifier. See Multiple Access Points (MAPs) for more information.

2. Select LACT precautions information from the Lactation Precautions Master Table
(RLACTMA0_LACT_MSTR) where the LACT_CODE column equals the LACT_CODE value from the
previous step.

3. (Optional) Filter the results according to institution convention or user-entered criteria.

4. Display the results to the user.

ExampleScreening a Drug for Lactation Precautions with the ROUTED_MED_ID

ExampleScreening a Drug for Lactation Precautions with the ROUTED_GEN_ID
ExampleScreening a Drug for Lactation Precautions with the Clinical Formulation ID
ExampleFiltering Lactation Precaution Information

ExampleScreening a Drug for Lactation Precautions with the ROUTED_MED_ID

For the purposes of demonstrating this application, the following scenario is used: A physician screens
Cipro XR Oral (ROUTED_MED_ID 064649) for all possible LACT information. The MED Routed Medication ID (
ROUTED_MED_ID) is in the MED Routed Medication Table (RMIRMID1_ROUTED_MED).

1. Select the Lactation Precaution Code (LACT_CODE) value from the LACT ROUTED_MED_ID_Link Table
(RLACTRM0_ROUTED_MED_LINK) where the ROUTED_MED_ID column equals the
ROUTED_MED_ID value of the drug to screen.

ROUTED_MED_ID 064649

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LACT_CODE 000860

2. Select the Lactation Precaution Description (LACT_DESC), Lactation Precaution Severity Level (LACT_SL
), Lactation Precaution Excretion Potential Code (LACT_EXCRT), Lactation Precaution Effects on Infant
Code (LACT_LCTN), and Lactation Precaution Narrative (LACT_PRCTN) values from the Lactation
Precautions Master Table (RLACTMA0_LACT_MSTR) where the LACT_CODE column equals the value
from the previous step.

LACT_CODE 000860

LACT_DESC CIPROFLOXACIN (ORAL,IV)

LACT_SL 2

LACT_EXCRT 1

LACT_LCTN 2

LACT_PRCTN INSUFFICIENT DATA AVAILABLE; LIMITED DATA

SUGGEST MINIMAL AMOUNT EXCRETED.

3. Display the results to the user.

In this example, the system alert is abbreviated and contains only the description and the severity level
description:

Example Lactation Precaution Alert

CIPROFLOXACIN (ORAL,IV) - PRECAUTION EXISTS (NO DATA OR INCLUSIVE HUMAN DATA). USE OF THIS DRUG
BY BREASTFEEDING MOTHERS SHOULD BE EVALUATED CAREFULLY.

ExampleScreening a Drug for Lactation Precautions with the ROUTED_GEN_ID

For the purposes of demonstrating this application, the following scenario is used: A physician screens
Digoxin Oral (ROUTED_GEN_ID 01048580) for all possible LACT information. The Routed Generic Identifier (
ROUTED_GEN_ID) is in the Routed Generic Table (RRTGN0_ROUTED_GEN_MSTR).

1. Select the Lactation Precaution Code (LACT_CODE) value from the LACT Routed Generic Table
(RLACTRG0_ROUTED_GEN_LINK) where the ROUTED_GEN_ID column equals the ROUTED_GEN_ID
value of the drug to screen.

ROUTED_GEN_ID 01048580

LACT_CODE 000001

2. Select the Lactation Precaution Description (LACT_DESC), Lactation Precaution Severity Level (LACT_SL
), Lactation Precaution Excretion Potential Code (LACT_EXCRT), Lactation Precaution Effects on Infant

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Code (LACT_LCTN), and Lactation Precaution Narrative (LACT_PRCTN) values from the Lactation
Precautions Master Table (RLACTMA0_LACT_MSTR) where the LACT_CODE column equals the value
from the previous step.

LACT_CODE 000001

LACT_DESC DIGITALIS GLYCOSIDES

LACT_SL 3

LACT_EXCRT 1

LACT_LCTN 3

LACT_PRCTN LIMITED DATA SUGGEST LOW AMOUNTS

EXCRETED W/ NO ADVERSE EFFECT ON THE
INFANT.

3. Display the results to the user.

In this example, the system alert is abbreviated and contains only the lactation precaution description and
the severity level description.

ExampleLactation Precaution Alert

DIGITALIS GLYCOSIDES - NO KNOWN RISK. THIS DRUG HAS NO KNOWN RISKS TO NURSING INFANTS AND
DOES NOT ADVERSELY AFFECT LACTATION

ExampleScreening a Drug for Lactation Precautions with the Clinical Formulation ID

For the purposes of demonstrating this application, the following scenario is used: A pharmacist screens
Acetaminophen w/Codeine No. 3 (Clinical Formulation ID [GCN_SEQNO] 004165) for all possible LACT
information. The Clinical Formulation ID (GCN_SEQNO) is in the Clinical Formulation ID Table
(RGCNSEQ4_GCNSEQNO_MSTR).

1. Select the Lactation Precaution Code (LACT_CODE values from the LACT GCN_SEQNO Link Table
(RLACTGC0_LACT_GCNSEQNO_LINK) where the GCN_SEQNO column equals the Clinical Formulation
ID (GCN_SEQNO) value of the drug to screen.

GCN_SEQNO 004165 004165

LACT_CODE 000293 000314

2. Select the Lactation Precaution Description (LACT_DESC), Lactation Precaution Severity Level (LACT_SL
), Lactation Precaution Excretion Potential Code (LACT_EXCRT), Lactation Precaution Effects on Infant
Code (LACT_LCTN), and Lactation Precaution Narrative (LACT_PRCTN) values from the Lactation
Precautions Master Table (RLACTMA0_LACT_MSTR) where the LACT_CODE column equals the values
from the previous step.

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LACT_CODE 000293 000314

LACT_DESC CODEINE ACETAMINOPHEN

LACT_SL 2 3

LACT_EXCRT 1 1

LACT_LCTN 2 3

LACT_PRCTN CNS/RESPIRATORY LOW LEVELS EXCRETED WITH

DEPRESSION,APNEA LOW RISK FOR ADVERSE
POSSIBLE;CAUTION W/ FAST EFFECTS IN INFANT
CYP2D6 METABOLIZER

3. Display the results to the user.

In this example, the system alert contains the descriptions of the severity levels, excretion potentials, and
effect on infant codes. The descriptions are followed by the precaution narratives from the LACT_PRCTN
field:

Example Lactation Precaution Alert

CODEINE
Severity Level 2: Use of this drug by breast feeding mothers should be evaluated carefully.
Excretion Potential: This drug is excreted in human breast milk
Effect on Infant: It is not known whether this drug has an effect on the nursing infant (no data or inconclusive human data)
Comment: CNS/RESPIRATORY DEPRESSION,APNEA POSSIBLE;CAUTION W/ FAST CYP2D6 METABOLIZER
---------------------------------------------------------
ACETAMINOPHEN
Severity Level 3: Studies have shown this drug has no risks to nursing infants and does not affect lactation.
Excretion Potential: This drug is excreted in human breast milk
Effect on Infant: This drug has been shown to have no adverse effect on the nursing infant
Comment: LOW LEVELS EXCRETED WITH LOW RISK FOR ADVERSE EFFECTS IN INFANT

ExampleFiltering Lactation Precaution Information

For purposes of demonstrating this application, the following scenario is used: A nurse practitioner
screens Cefazolin Sodium IV (Clinical Formulation ID [GCN_SEQNO] 009065) for lactation precautions, and the
institution has decided to filter warnings to display only those with a severity level of 1 or 2. The Clinical
Formulation ID (GCN_SEQNO) is in the Clinical Formulation ID Table (RGCNSEQ4_GCNSEQNO_MSTR).

1. Select the Lactation Precaution Code (LACT_CODE) value from the LACT GCN_SEQNO Link Table
(RLACTGC0_LACT_GCNSEQNO_LINK) where the GCN_SEQNO column equals the Clinical Formulation
ID (GCN_SEQNO) value of the drug to screen.

GCN_SEQNO 009065

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LACT_CODE 000644

2. Select the Lactation Precaution Severity Level (LACT_SL), Lactation Precaution Excretion Potential Code (
LACT_EXCRT), Lactation Precaution Effects on Infant Code (LACT_LCTN), and Lactation Precaution
Narrative (LACT_PRCTN) values from the Lactation Precautions Master Table
(RLACTMA0_LACT_MSTR) where the LACT_CODE column equals the value from the previous step.

LACT_CODE 000644

LACT_SL 3

LACT_EXCRT 1

LACT_LCTN 2

LACT_PRCTN LIMITED DATA SUGGEST MINIMAL EXCRETION;

MONITOR INFANT FOR GI FLORA CHANGES

3. Filter the results according to institution convention or user-entered criteria.

In this example, filter the value in the LACT_SL column by the institution convention that the severity level
be 1 or 2. In this example, the only returned record contains a value of 3 in the LACT_SL column, so it
does not meet the criteria.

4. Display the results to the user. In this example, the system does not generate an alert because the
returned record does not meet the criteria.

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Lactation Precautions Module ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

LACT Tables
LACT ERD

LACT Tables

LACT GCN_SEQNO Link Table

LACT Effects on Infant Code Description Table
LACT Excretion Potential Code Description Table
LACT Routed Generic Table
LACT ROUTED_MED_ID Link Table
LACT Severity Level Description Table
Lactation Precautions Master Table

LACT ERD

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Lactation Precautions Master Table

Table Name RLACTMA0_LACT_MSTR

Revision Activity original

Purpose Provides attributes of lactation precaution information for a

particular drug.

Key Column Name Column Format Length Picture

Description

P LACT_CODE Lactation N 6 9(6)

Precaution Code

LACT_DESC Lactation AN 40 X(40)

Precaution
Description

F LACT_SL Lactation AN 1 X(1)

Precaution
severity Level -
Indicates the
general
recommendation
as to whether
there are risks to
breast feeding
while taking a
particular
medication.

F LACT_EXCRT Lactation AN 1 X(1)

Precaution
Excretion
Potential Code -
Indicates whether
a given drug is
excreted in breast
milk.

F LACT_LCTN Lactation AN 1 X(1)

Precaution Effects
on Infant Code -
Designates
whether or not the
drug may affect
the infant.

LACT_PRCTN Lactation AN 77 X(77)

Precaution
Narrative

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LACT Effects on Infant Code Description Table

Table Name RLACTID0_EFFECTS_INFANTS_DESC

Revision Activity add.01-01-2003

Purpose Relates the Lactation Precaution effects on Infant code to

its text description.

Key Column Name Column Format Length Picture

Description

P LACT_LCTN Lactation AN 1 X(1)

Precaution Effects
on Infant Code -
Designates
whether or not the
drug may affect
the infant.

P LACT_LCTNSN Lactation N 2 9(2)

Precaution Effects
on Infant
Description Text
Sequence
Number -
Assigned to each
line of text within a
description to
maintain proper
order of the text.

LACT_LCTN_DE Lactation AN 60 X(60)

SC Precaution Effects
on Infant Code
Description -
Provides the text
description for
(LACT_LCTN).

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LACT Excretion Potential Code Description Table

Table Name RLACTED0_EXCRT_POTENTIAL_DESC

Revision Activity add.01-01-2003

Purpose Relates the Lactation Precaution Excretion Potential Code

to its text description.

Key Column Name Column Format Length Picture

Description

P LACT_EXCRT Lactation AN 1 X(1)

Precaution
Excretion
Potential Code -
Indicates whether
a given drug is
excreted in breast
milk.

P LACT_EXCRTSN Lactation N 2 9(2)

Precaution
Excretion
Potential
Description Text
Sequence
Number -
Assigned to each
line of text within a
description to
maintain proper
order of the text.

LACT_EXCRT_D Lactation AN 60 X(60)

ESC Precaution
Excretion
Potential Code
Description -
Provides the text
description for the
Lactation
Precaution
Excretion
Potential Code
(LACT_EXCRT).

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LACT GCN_SEQNO Link Table

Table Name RLACTGC0_LACT_GCNSEQNO_LINKS

Revision Activity rev.03-15-1992

Purpose Links a clinical formulation to lactation precaution

information.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF LACT_CODE Lactation N 6 9(6)

Precaution Code

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LACT ROUTED_MED_ID Link Table

Table Name RLACTRM0_ROUTED_MED_LINK

Revision Activity add.07-01-2002

Purpose Links the routed medication to lactation precaution

information.

Key Column Name Column Format Length Picture

Description

PF ROUTED_MED_I MED Routed N 8 9(8)

D Medication ID
(Stable ID)

PF LACT_CODE Lactation N 6 9(6)

Precaution Code

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LACT Routed Generic Table

Table Name RLACTRG0_ROUTED_GEN_LINK

Revision Activity original

Purpose Links a routed generic to lactation precaution information.

Key Column Name Column Format Length Picture

Description

PF ROUTED_GEN_I Routed Generic N 8 9(8)

D Identifier

PF LACT_CODE Lactation N 6 8(6)

Precaution Code

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LACT Severity Level Description Table

Table Name RLACTSD0_SEVER_LEVEL_DESC

Revision Activity add.01-01-2003

Purpose Relates the Lactation Precaution Severity Level to its text

description.

Key Column Name Column Format Length Picture

Description

P LACT_SL Lactation AN 1 X(1)

Precaution
Severity Level -
Indicates the
general
recommendation
as to whether
there are risks to
breast feeding
while taking a
particular
medication.

P LACT_SLSN Lactation N 2 9(2)

Precaution
Severity Level
Description Text
Sequence
Number -
Assigned to each
line of text within a
description to
maintain proper
order or the text.

LACT_SL_DESC Lactation AN 60 X(60)

Precaution
Severity Level
Description -
Provides the text
description for
LACT_SL.

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Pediatric Precautions Module (PEDI) 2.0

Pediatric Precautions Module Editorial Policies
Application: Screening a Drug for Pediatric Precautions
ERD and Technical Specifications

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Pediatric Precautions Module Editorial Policies

Overview
Definitions
Inclusion Criteria
Data Elements
Rule Sets
Maintenance
Resources

Overview

The Pediatric Precautions Module (PEDI) contains precaution information for the use of drugs in a pediatric
patient. Pediatric is a term that classically describes a patient who is under 18 years old.

The PEDI module enables you to create warning messages about drug use in the pediatric patient population.
These warnings allow healthcare professionals to make informed decisions about altering or monitoring a
patients drug therapy when potential problems exist. Although system access to the patients age significantly
enhances the utility of the product, it is not a requirement to achieve results. The PEDI module can work in a
stand-alone pharmacy system or as part of an integrated system.

The PEDI module is intended for use as a screening mechanism to detect pediatric drug precautions specific to
the pediatric patient population. The precautions are clinically relevant and are generally well documented.
Warnings may not be included if there is no data on a particular drugs usage in the pediatric population.

Systems using PEDI can provide the following information:

Severity level of the precaution

The age range to which the precaution applies (this range can also be used as a filter)
Pediatric precaution narrative (this is an optional usage data field)

Definitions

The Definitions section defines important terms related to the module that users should understand. Some
industry terms that have a specific connotation in regards to the module are also defined.

Pediatric

Pediatric is a term that classically describes a patient who is under 18 years old.

This section provides information detailing the criteria that guided the inclusion of the data contained within the
module as well as information pertaining to limitations or exclusions when appropriate to the discussion.

Inclusion Criteria

This section provides information detailing the criteria that guided the inclusion of the data contained within the
module as well as information pertaining to limitations or exclusions when appropriate to the discussion.

Inclusion - Drug Scope

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U.S. FDA-approved prescription (Rx) product ingredients with New Drug Application (NDA), Abbreviated
New Drug Application (ANDA), or Biologic License Application (BLA)
U.S. over-the-counter (OTC) products with NDAs or ANDAs
U.S. OTC drug product ingredients consistent with FDA OTC Monographs
Herbal products enumerated in the FDB Herbal Products Inclusion List

Inclusion - Warnings Content Scope

Content pertains to drug use in the pediatric patient population. The following information is included for a given
drug when available:

Growth or developmental problem or risk in the pediatric population

Adverse effect of drug unique to pediatric population
Severe adverse effect of drug with an increased frequency in the pediatric population
Precaution statements where a drug is not recommended within the pediatric population
Precaution statements where a drug is not yet clinically evaluated within the pediatric population (for
example, "not indicated" or "no safety/efficacy data")

Exclusion - Drug Scope

Non-U.S. products that are exclusive to other countries

Self-proclaimed Rx products without ANDA/NDA/BLA
Rx drug products with 510K device approval
Dietary supplements
Large volume parenteral, nutritional, irrigation, or dialysis solutions
Nutraceuticals
Diluent solutions
Herbal products, except those enumerated in the FDB Herbal Products Inclusion List
Homeopathic drugs
OTC products that are not described by FDA OTC Monographs
Bulk drugs or chemicals
Medical supplies, soaps, cleansers
Cosmetics
Veterinary drugs
Inactive ingredients

Exclusion - Warnings Content

Warnings relating to drug use in premature infants are excluded.

Data Elements

This section contains additional information about particularly important tables and codes contained within the
module, as well as concepts about the data that the reader must understand in order to understand the module.

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Pediatric Precaution Code

The Pediatric Precaution Code (PEDI code) is a system assigned number for each drug group and unique age
range in days beginning with 1 day through 18 years (6,569 days).

PEDI Age Range

The pediatric age range consists of two fields that identify both the minimum and maximum ages associated with
the precaution. The Pediatric Precaution Age Range Minimum Days (PEDI_MINAG) and Pediatric Precaution
Age Range Maximum Days (PEDI_MAXAG) contain a numeric value in days.

Each ingredient in a multi-ingredient product may have its own PEDI code and description.

PEDI codes are linked to the following FDB drug identifiers:

Routed Medication ID (ROUTED_MED_ID)

Routed Generic Identifier (ROUTED_GEN_ID)
Clinical Formulation ID (GCN_SEQNO)

Example 1 below shows that each PEDI code has a specified age range in days.

Example 1

PEDI_CODE PEDI_MINAG PEDI_MAXAG

525 1 2189

1169 1 6569

163 1 4379

1138 1 6569

1146 1 13

93 1 364

Example 2 below shows that a given multi-ingredient Clinical Formulation ID ( GCN_SEQNO) may have several
assigned PEDI codes and associated age ranges.

Example 2

GCN_SEQNO PEDI_CODE PEDI_MINAG PEDI_MAXAG

61308 525 1 2189

61308 589 1 29

61308 1268 30 2189

Pediatric Precaution Description

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A Pediatric Precaution Description is assigned to each PEDI code. This drug group description is usually
ingredient-based but can be broader and include a collection of ingredientsfor example,
"TETRACYCLINES"or may be narrower and include only certain dose forms or routefor example,
FENTANYL (PATCH)."

Example

PEDI_CODE PEDI_DESC PEDI_MINAG PEDI_MAXAG

1448 Fentanyl (Patch) 730 6569

1134 Pseudoephedrine (SR or 1 4379

High Dose)

667 Tetracyclines 1 2919

Pediatric Precaution Severity Level

Each PEDI code is assigned one severity level. There are three numeric values (1, 2, or 3) for each severity level.

PEDI Severity Level Description Table (RPEDISD0_PEDI_SEVER_LEVEL_DESC)

PEDI_SL PEDI_SL_DESC

1 Contraindication

2 Severe Precaution

3 Management or Monitoring Precaution

Pediatric Precaution Narrative

The Pediatric Precaution Narrative in v 2.0 is a 500-character optional field used to provide additional details on
the precaution information.

Example

PEDI_CODE PEDI_DESC PEDI_SL PEDI_MINAG PEDI_MAXAG PEDI_NARRATI

VE

1619 Carbinoxamine 1 730 2189 Risk of CNS

(cough-cold) excitation or
depression and/or
decreased mental
alertness. Do not
use for cough/cold
age < 6 years
without clinician
consult.

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1596 Diphenhydramine 1 30 2189 Do not use unless

(Cough-Cold) as directed by
clinician
consultation. Risk
of adverse CNS
effects include
sedation or
paradoxical
excitation.

1330 Certolizumab 2 1 6569 Possible

lymphoma/malign
ancy risk. No
safety and
efficacy
information. Not
indicated in
pediatrics.

1594 Diphenhydramine 2 30 364 Use with caution

(Syst.antihist.) and with clinician
consultation. Risk
of adverse CNS
effects includes
sedation or
paradoxical
excitation.

1612 Diphth, 2 1 3649 Use DTaP

aPertussis,Tet(Td formulation for
ap <10 y) vaccination series
to age 7 years.
Tdap
recommended for
catch-up
immunization
when necessary.

1278 Doxycycline 2 1 2919 Permanent tooth

discoloration
and/or enamel
hypoplasia may
occur. Slowed
growth possible
secondary to
calcium complex
in bone tissue.
Weigh
risk-benefit. Limit
duration of use.

Rule Sets

This section provides rules that the clinical team uses in regards to creating the module's data, both general rules
and rules specific to data elements.

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Trigger content (for example, Sporadic MedWatch alert text) is reviewed and warning information that is
applicable to pediatric population are identified. Trigger content drug(s) are identified and PEDI precaution coding
is applied to all applicable PEDI drug groups.

Rules of General Applicability

This section describes editorial policies that have a broad impact on the module data or by nature are less
specific than those policies in other sections.

Drug knowledge is aggregated at the drug group level and then linked to Clinical Formulation IDs, Routed
Medication IDs, and the Routed Generic IDs in the FDB knowledge base. Linkage or assignment of PEDI
information to drugs is therefore not manufacturer-specific.

Non-U.S. drug Clinical Formulations may inherit U.S.-based PEDI clinical data.

Rules for Pediatric Precaution Code (PEDI code) Drug Groups: Description and Linking

Clinical Formulation IDs (GCN_SEQNOs) are linked to a PEDI code drug group that is usually based on having a
common ingredient, but can be broader to include a class of ingredients when there is a larger ingredient class
effect (for example, "Tetracyclines"), or may be narrower to include only certain dose forms, routes, or strengths
of a single ingredient (for example, "Fentanyl Patch").

Rules for Data Elements

This section describes editorial policies that are more specific towards their effect on the data elements contained
in the module.

Pediatric Precaution Severity Level (PEDI_SL) Assignment

The severity level assignment is primarily determined by the pediatric warning content in FDA-approved
manufacturer prescriber information.

Severity Level 1: "Contraindication" is reserved for warnings that state there is known risk. There exists
known or potential for severe adverse outcomes or severe harm, or physical deformity, or lethality.
Severity Level 2: "Severe Precaution" is reserved for warnings that state there is a known risk or evidence
of a potential adverse effect.
Severity Level 3: "Management or Monitoring Precaution" is reserved for precautions when a drug is to be
monitored closely or stated to be not indicated or not recommended in pediatrics because of lack of
information or studies in the pediatric population.

Evidence Schema

Severity Level 1

Boxed Warning labeling with specific mention of avoidance in pediatric population

Contraindicated labeling with any mention of the pediatric age range
Warnings or Precautions section with any bolded statements (or all capitalization format) regarding severe
adverse reactions in pediatric, and no indicated use or rare use in pediatrics
Pediatric Use section of labeling states:

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No pediatric studies were done because of potential risk of severe or long-term adverse reaction
sequelae
Not recommended because use has demonstrated severe adverse effect

Severity Level 2

Boxed Warning labeling with specific mention of adverse reaction risk in pediatric population, but indicated
use in pediatrics and monitoring adverse reactions are mentioned
Contraindicated labeling with mention of the pediatric age range and a specific pediatric condition (for
example, hyperbilirubinemia)
Warnings or Precautions labeling with specific mention of adverse reaction risk in pediatric population; also
indicated use in labeling or in other reference source (that is, Harriet Lane)
Pediatric Use section of labeling states:
No pediatric studies, but potential risk of adverse reaction
No efficacy established in formal pediatric studies, but evidence of pediatric adverse events exists
Safety and efficacy established, but known risk of adverse effects can be monitored
Formal pediatric studies failed to demonstrate efficacy

Severity Level 3

Pediatric Use section states not studied in pediatric population (safety and efficacy studies) and labeling
has no mention of other warnings or avoidance
Pediatric Use section states not indicated in pediatric population and labeling has no mention of other
warnings or avoidance
Pediatric Use/Dosing sections state drug is used in pediatrics, but specific monitoring recommended (for
example, weight-based dosing or lab monitoring)
Pediatric Use/Dosing sections state drug is used commonly in pediatrics, but specific population of
pediatrics is at risk for adverse reactions (for example, cardiac structural defect)
Pediatric Use section states that the drug ingredient combination is inappropriate in pediatrics despite
safety and efficacy for any of individual ingredients

PEDI Age Range Assignment

Any age range between 1 day through 18 years (6,569 days).

In the absence of a specified age range (for example, adolescent), the verbiage from pediatric warning
content is translated into standardized age ranges in days. See the table below.
Age range descriptions such as "1 year up to 12 years" are calculated in days based on formulas present
in the table below.

Age Statements Low Age High Age

"up to age X years" 1 day X years minus 1 day (for example, up

to 12 years is 4379 days)

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"under X years old" 1 day X years minus 1 day (for example,

under 6 years is 2189 days)

"up through X year" 1 day X years plus 364 days (for example, up
through 12 years is 4744 days)

"X and under years old" 1 day X years times 365 days plus 364 days
(for example, "3 years and under" is
1459 days)

"over X years old" X years times 365 days X years times 365 days 18 years (the
pediatric limit) minus 1 day (6569
days)

"X to Y years old" X years times 365 days Y years times 365 days plus 364 days

Neonate 1 day 29 days

Infant 30 days (or 1 day depending on 1 year minus 1 day (364 days)
wording)

Young Children 365 days up to 6 years (6 years minus 1 day =

2189 days)

Child/Children 1 year or 365 days (1 day depending 12 years plus 364 days (4744 days)
on wording)

Pre-pubertal Children 365 days up to 11 years (11 years minus 1 day =

4014 days)

Adolescent 13 years or 4745 days up to 18th birthday (18 years minus 1

day = 6569 days)

Pediatric (unspecified) 1 day (18 years minus 1 day = 6569 days)

Maintenance

This section contains information regarding the ongoing maintenance of the module's data.

External Triggers for Clinical Review

The external triggers that prompt the clinical editors to add or review data are the following:

MedEffects Alerts from Health-Canada (except Non-U.S. product alerts exclusive to Canada). Available at:
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/index_e.html.
MedWatch Safety Alerts from FDA. Available at: http://www.fda.gov/medwatch.
FDA CDER NEW listserv emails
FDA CBER What's New listserv emails
FDA MedWatch Monthly Label Changes

Internal Triggers for Clinical Review

The internal trigger that prompts the clinical editors to add or review PEDI drug groups is a new Clinical
Formulation ID (GCN_SEQNO) added to MedKnowledge and its U.S. product labeling.

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Resources

This section lists sources used by FDB to compile the information contained in the module.

FDB utilizes many reference sources including, but not limited to, the primary medical literature (for example,
published journal articles), medical reference texts, published expert treatment guidelines, and manufacturer
product package inserts. FDB uses current source editions or versions when coding and updating data, as well as
when researching questions about data. However, a formal data review does not occur for every new release of
source editions or versions. Additional sources include:

Food and Drug Administration New Pediatric Labeling Information Database. Available at:
http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=labelingdatabase.
Custer J, Rau R, editors. The Harriet Lane Handbook.
Published by authority of the Board of Directors of the American Society of Health-System Pharmacists.
American Hospital Formulary Service (AHFS) Drug Information.
American Academy of Pediatric recommendations and Pediatric Care online. Available at: https://www.
pediatriccareonline.org/pco/ub.

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Application: Screening a Drug for Pediatric Precautions

Systems can use the Pediatric Precautions Module to identify warnings that might impact drug ordering and
dispensing decisions. This application illustrates how to screen a drug for precautions.

1. Do one of the following:

Select the Pediatric Precaution Code (PEDI_CODE) from the PEDI GCN_SEQNO Link Table
(RPEDIGC0_PEDI_GCNSEQNO_LINK) where the Clinical Formulation ID (GCN_SEQNO) column
equals the Clinical Formulation ID (GCN_SEQNO) of the drug to screen.
Select the PEDI_CODE from the PEDI ROUTED_MED_ID Link Table
(RPEDIRM0_ROUTED_MED_LINK) where the MED Routed Medication ID (ROUTED_MED_ID)
column equals the ROUTED_MED_ID of the drug to screen.
Select the PEDI_CODE from the PEDI Routed Generic Table (RPEDIRG0_ROUTED_GEN_LINK)
where the Routed Generic Identifier (ROUTED_GEN_ID) column equals the ROUTED_GEN_ID of
the drug to screen.

If no records exist in a link table, the drug has no precautions in that module.

The system might need to perform additional navigation to access the PEDI_CODE from
the user-entered drug identifier. See Multiple Access Points (MAPs) for more
information.

2. Select PEDI precautions information from the Pediatric Precautions Master Table
(RPEDIMA1_PEDI_MSTR) where the PEDI_CODE column equals the PEDI_CODE value from the
previous step.

3. (Optional) Filter the results according to institution convention or user-entered criteria.

4. Display the results to the user.

ExampleScreening a Drug for Pediatric Precautions with the ROUTED_MED_ID

ExampleScreening a Drug for Pediatric Precautions with the ROUTED_GEN_ID
ExampleScreening a Drug for Pediatric Precautions with the Clinical Formulation ID
ExampleFiltering Pediatric Precaution Information

ExampleScreening a Drug for Pediatric Precautions with the ROUTED_MED_ID

For the purposes of demonstrating this application, the following scenario is used: A physician screens
Chloromycetin IV (ROUTED_MED_ID 009076) for all possible PEDI information. The MED Routed Medication ID
(ROUTED_MED_ID) is in theMED Routed Medication Table (RMIRMID1_ROUTED_MED).

1. Select the Pediatric Precaution Code (PEDI_CODE) value from the PEDI ROUTED_MED_ID Link Table
(RPEDIRM0_ROUTED_MED_LINK) where the ROUTED_MED_ID column equals the ROUTED_MED_ID
value of the drug to screen.

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ROUTED_MED_ID 144657

PEDI_CODE 001121

2. Select the Pediatric Precaution Description (PEDI_DESC), Pediatric Precaution Severity Level (PEDI_SL),
Pediatric Precaution Age Range Minimum Days (PEDI_MINAG), Pediatric Precaution Age Range
Maximum Days (PEDI_MAXAG), and Pediatric Precaution Narrative (PEDI_NARRATIVE) values from the
Pediatric Precautions Master Table (RPEDIMA1_PEDI_MSTR) where the PEDI_CODE column equals the
value from the previous step.

PEDI_CODE 001121

PEDI_DESC Etanercept

PEDI_SL 3

PEDI_MINAG 0730

PEDI_MAXAG 6569

PEDI_NARRATIVE Increased risk of infection, inflammatory bowel disease.

Monitor for infection, lymphoma, leukemia, malignancy.

3. Display the results to the user.

In this example, the system alert contains the description, severity level, affected age range, and
precaution narrative:

Example Pediatric Precaution Alert

Etanercept has a severity level of 3 (Management or monitoring precaution ) for use in patients between 730 and 6569
days old.
Increased risk of infection, inflammatory bowel disease. Monitor for infection, lymphoma, leukemia, malignancy.

ExampleScreening a Drug for Pediatric Precautions with the ROUTED_GEN_ID

For the purposes of demonstrating this application, the following scenario is used: A physician screens
Fluoxetine HCL Oral (ROUTED_GEN_ID 01050231) for all possible PEDI information. The Routed Generic
Identifier (ROUTED_GEN_ID) is in the Routed Generic Table (RRTGN0_ROUTED_GEN_MSTR).

1. Select the Pediatric Precaution Code (PEDI_CODE) value from the PEDI Routed Generic Table
(RPEDIRG0_ROUTED_GEN_LINK) where the ROUTED_GEN_ID column equals the ROUTED_GEN_ID
value of the drug to screen.

ROUTED_GEN_ID 01050231

PEDI_CODE 000770

2. Select the Pediatric Precaution Description (PEDI_DESC), Pediatric Precaution Severity Level (PEDI_SL),
Pediatric Precaution Age Range Minimum Days (PEDI_MINAG), Pediatric Precaution Age Range
Maximum Days (PEDI_MAXAG), and Pediatric Precaution Narrative (PEDI_NARRATIVE) values from the

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Pediatric Precautions Master Table (RPEDIMA1_PEDI_MSTR) where the PEDI_CODE column equals the
value from the previous step.

PEDI_CODE 000770

PEDI_DESC Fluoxetine

PEDI_SL 2

PEDI_MINAG 2555

PEDI_MAXAG 6569

PEDI_NARRATIVE Monitor growth and behavior. Possible aggression,

mania, suicidal ideation. Reports of hyperkinesia,
agitation, personality disorder.

3. Display the results to the user.

In this example, the system alert contains the description, severity level, affected age range, and
precaution narrative:

Example Pediatric Precaution Alert

Fluoxetine has a severity level of 2 (Severe Precaution) for use in patients between 2555 and 6569 days old.
Monitor growth and behavior. Possible aggression, mania, suicidal ideation. Reports of hyperkinesia, agitation, personality
disorder.

ExampleScreening a Drug for Pediatric Precautions with the Clinical Formulation ID

For the purposes of demonstrating this application, the following scenario is used: A pharmacist screens
phenylephrine HCl/promethazine HCl (Clinical Formulation ID [GCN_SEQNO] 048495) for all possible PEDI
information. The Clinical Formulation ID (GCN_SEQNO) is in the Clinical Formulation ID Table
(RGCNSEQ4_GCNSEQNO_MSTR).

1. Select the Pediatric Precaution Code (PEDI_CODE) values from the PEDI GCN_SEQNO Link Table
(RPEDIGC0_PEDI_GCNSEQNO_LINK) where the GCN_SEQNO column equals the Clinical Formulation
ID (GCN_SEQNO) value of the drug to screen.

GCN_SEQNO 048495 048495 048495

PEDI_CODE 000576 000991 000525

2. Select the Pediatric Precaution Description (PEDI_DESC), Pediatric Precaution Severity Level (PEDI_SL),
Pediatric Precaution Age Range Minimum Days (PEDI_MINAG), Pediatric Precaution Age Range
Maximum Days (PEDI_MAXAG), and Pediatric Precaution Narrative (PEDI_NARRATIVE) values from the
Pediatric Precautions Master Table (RPEDIMA1_PEDI_MSTR) where the PEDI_CODE column equals the
values from the previous step.

PEDI_CODE 000576 000991 00525

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PEDI_DESC Promethazine Promethazine Phenylephrine

(Oral,Rectal)

PEDI_SL 1 2 1

PEDI_MINAG 0001 0730 0001

PEDI_MAXAG 0729 6569 2189

PEDI_NARRATIVE Potential for fatal Caution:use the lowest Risk of CNS excitation.
respiratory depression age effective dose due to risk Do not use age <6 years
< 2 years. Avoid use. of respiratory depression. without clinician consult.

3. Display the results to the user.

In this example, the system alert contains the description, the age range each applies to, the severity level
descriptions, and the precaution narratives:

Example Pediatric Precaution Alert

Promethazine (0-2 years) - Contraindication

Potential for fatal respiratory depression age < 2 years. Avoid use.
Promethazine (2-18 years)- Serious Precaution
Caution: use the lowest effective dose due to risk of respiratory depression.
Phenylephrine (Oral,Rectal) (0-6 years)-Contraindication
Risk of CNS excitation. Do not use age <6 years without clinician consult.

ExampleFiltering Pediatric Precaution Information

For purposes of demonstrating this application, the following scenario is used: A nurse practitioner
screens Aminophylline (Clinical Formulation ID ([GCN_SEQNO] 000122) for pediatric precautions, and the
institution has decided to filter warnings to display only those with a severity level of 1 or 2. The Clinical
Formulation ID is in the Clinical Formulation ID Table (RGCNSEQ4_GCNSEQNO_MSTR).

1. Select the Pediatric Precaution Code (PEDI_CODE) value from the PEDI GCN_SEQNO Link Table where
the GCN_SEQNO column equals the Clinical Formulation ID (GCN_SEQNO) of the drug to screen.

GCN_SEQNO 000122

PEDI_CODE 000785

2. Select the Pediatric Precaution Description (PEDI_DESC), Pediatric Precaution Severity Level (PEDI_SL),
Pediatric Precaution Age Range Minimum Days (PEDI_MINAG), Pediatric Precaution Age Range
Maximum Days (PEDI_MAXAG), and Pediatric Precaution Narrative (PEDI_NARRATIVE) values from the
Pediatric Precautions Master Table (RPEDIMA1_PEDI_MSTR) where the PEDI_CODE column equals the
value from the previous step.

PEDI_CODE 000785

PEDI_DESC Xanthines (select)

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PEDI_SL 3

PEDI_MINAG 1

PEDI_MAXAG 364

PEDI_NARRATIVE Clearance may be reduced age < 1 year. Administer

with caution.

3. Filter the results according to institution convention or user-entered criteria.

In this example, filter the value in the PEDI_SL column by the institution convention that the severity level
be 1 or 2. In this example, the only returned record contains a value of 3 in the PEDI_SL column, so it does
not meet the criteria.

4. Display the results to the user. In this example, the system does not generate an alert because the
returned record does not meet the criteria.

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Pediatric Precautions Module ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

Pediatric Precautions Module Tables

Pediatric Precautions Module ERD

Pediatric Precautions Module Tables

Pediatric Precautions Master Table

PEDI GCN_SEQNO Link Table
PEDI ROUTED_MED_ID Link Table
PEDI Routed Generic Table
PEDI Severity Level Description Table

Pediatric Precautions Module ERD

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Pediatric Precautions Master Table

Table Name RPEDIMA1_PEDI_MSTR

Revision Activity rev.11-22-2011

Purpose Provides attributes of pediatric precaution information for a

particular drug.

Key Column Name Column Format Length Picture

Description

P PEDI_CODE Pediatric N 6 9(6)

Precaution Code

PEDI_DESC Pediatric AN 34 X(34)

Precaution
Description

PEDI_SL Pediatric AN 1 X(1)

Precaution
Severity Level

PEDI_MINAG Pediatric N 4 9(4)

Precaution Age
Range (Minimum
Days)

PEDI_MAXAG Pediatric N 4 9(4)

Precaution Age
Range (Maximum
Days)

PEDI_NARRATIV Pediatric AN 500 X(500)

E Precaution
Narrative

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PEDI GCN_SEQNO Link Table

Table Name RPEDIGC0_PEDI_GCNSEQNO_LINK

Revision Activity original

Purpose Links a clinical formulation to pediatric precaution

information.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF PEDI_CODE Pediatric N 6 9(6)

Precaution Code

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PEDI ROUTED_MED_ID Link Table

Table Name RPEDIRM0_ROUTED_MED_LINK

Revision Activity add.07-01-2002

Purpose Links a routed medication to pediatric precaution

information.

Key Column Name Column Format Length Picture

Description

PF ROUTED_MED_I MED Routed N 8 9(8)

D Medication ID
(Stable ID)

PF PEDI_CODE Pediatric N 6 9(6)

Precaution code

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PEDI Routed Generic Table

Table Name RPEDIRG0_ROUTED_GEN_LINK

Revision Activity original

Purpose Links a routed generic to pediatric precaution information.

Key Column Name Column Format Length Picture

Description

PF ROUTED_GEN_I Routed Generic N 8 9(8)

D Identifier

PF PEDI_CODE Pediatric N 6 9(6)

Precaution Code

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PEDI Severity Level Description Table

Table Name RPEDISD0_PEDI_SEVER_LEVEL_DESC

Revision Activity add.11-22-2011

Purpose Relates the Pediatric Precaution Severity Level to its text

description.

Key Column Name Column Format Length Picture

Description

P PEDI_SL Pediatric AN 1 X(1)

Precaution
Severity Level

PEDI_SL_DESC Pediatric AN 255 X(255)

Precaution
Severity Level
Description

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Pregnancy Precautions Module (PREG) 2.0

Pregnancy Precautions Module Editorial Policies
Applications
ERD and Technical Specifications

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Pregnancy Precautions Module Editorial Policies

Overview
Inclusion/Exclusion Criteria
Data Elements
Rule Sets
Maintenance
References

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Pregnancy Precautions Module Overview

The Pregnancy Precautions Module (PREG) contains precaution information for the use of drugs in a pregnant
patient or in female patients who are in the childbearing age group.

The PREG module enables you to create warning messages about drug use in pregnant patients or female
patients who are in the childbearing age group. These warnings allow healthcare professionals to make informed
decisions about altering a patients drug therapy when potential problems exist. Although system access to the
patients age and gender enhances the functionality of the product, it is not a requirement to achieve valuable
results. The PREG module can work in a stand-alone pharmacy system or as part of an integrated system.

The PREG module is intended for use as a screening mechanism to detect pregnancy drug precautions specific
to pregnant patients or female patients who are in the childbearing age group. The precautions are clinically
relevant and are generally well documented in the literature. However, pregnancy information may not be as
conclusive in the literature and inconclusive precautions or precautions based on very limited data may be
presented. Warnings may not be included if there is no data on a particular drug usage in the population covered
by the PREG module.

Systems using PREG can provide the following information:

Severity level of the precaution, which indicates either the Food and Drug Administration (FDA) pregnancy
risk category or the First Databank (FDB) pregnancy severity level
Pregnancy precaution narrative (this is an optional usage data field)

What's New in PREG 2.0?

Pregnancy Precautions Module (PREG) 2.0 has been updated to include the following features:

Additional numeric severity levels and a more detailed description for severity level 1
Monograph with sections that correlate with the new sections in the drug manufacturer labeling
Fetal Risk Summary
Clinical Considerations
Data (includes Human and Animal)
Pregnancy Registry Contact Information
Boxed Warning Indicator
Included for FDA-approved prescription drugs where the drug labeling contains fetal/neonatal risk or
pregnancy warnings in the Boxed Warning section
References
Citations using standardized reference formats

To accomodate these changes, the Pregnancy Precautions Narrative (PREG_PRCTN) column has been
removed and following tables have been added:

PREG Monograph Line Table (RPREGPL0_MONO_LINE)

PREG Monograph Section Description Table (RPREGMS0_MONO_SECTION_DESC)
PREG Reference Table (RPREGRE0_PREG_REFERENCE)

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PREG Reference Link Table (RPREGRL0_PREG_REFERENCE_LINK)

PREG Reference Type Table (RPREGRT0_PREG_REFERENCE_TYPE)

Customers must program to version 2.0 to leverage this new content.

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Pregnancy Precautions Module Inclusion-Exclusion Criteria

This section provides information detailing the criteria that guided the inclusion of the data contained within the
module as well as information pertaining to limitations or exclusions when appropriate to the discussion. This
section includes the following topics:

Inclusion - Drug Scope

Inclusion - Warnings Content Scope
Exclusion - Drug Scope

Inclusion - Drug Scope

U.S. FDA-approved Rx product ingredients with New Drug Application (NDA), Abbreviated New Drug
Application (ANDA), Biologic License Application (BLA)
U.S. over-the-counter (OTC) products with NDAs or ANDAs
U.S. OTC drug product ingredients consistent with FDA OTC Monographs
Herbal products enumerated in the FDB Herbal Products Inclusion List

Inclusion - Warnings Content Scope

Content pertains to drug use in pregnant patients or female patients in the childbearing age group. The following
information is included for a given drug when available:

Teratogenic risk of drug in the human or animal fetus

Adverse effect(s) of drug on the human or animal fetus
Adverse effect(s) of drug on the mother during gestation, labor, or delivery
Carcinogenicity and mutagenicity of a drug on the human or animal fetus

The most severe warnings in the PREG precautions module are FDA category D and X, or FDB Severity Level 1.
These severe warnings are also included in the Drug-Disease Contraindications Module (DDCM) 2.0, and a
Severity Level 1 is assigned to DXID 3446 (Pregnancy).

Exclusion - Drug Scope

Self-proclaimed Rx products without ANDA/NDA/BLA

Rx drug products with 510K device approval
Dietary supplements
Large volume parenteral, nutritional, irrigation or dialysis solutions
Nutraceuticals
Diluent solutions
Herbal products, except those enumerated in the FDB NDC Attributes Inclusion list
Homeopathic drugs
OTC products that are not described by FDA OTC Monographs
Bulk drugs or chemicals
Medical supplies, soaps, cleansers

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Cosmetics
Veterinary drugs
Inactive ingredients

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Pregnancy Precautions Module Data Elements

This section contains additional information about particularly important tables and codes contained within the
module, as well as concepts about the data that the reader must understand in order to understand the module.
This section includes the following data elements:

Pregnancy Precautions Code

Pregnancy Precautions Description
Pregnancy Precautions Severity Level
Pregnancy Precautions Monograph
PREG Boxed Warning Indicator
PREG References

Pregnancy Precautions Code

The Pregnancy Precautions Code (PREG_CODE) is a system-assigned dumb number for each drug group.

Each ingredient in a multi-ingredient product will have its own PREG code and description.
PREG codes are linked to the following FDB drug identifiers:

Routed Medication ID (ROUTED_MED_ID)

Clinical Formulation ID (GCN_SEQNO)

Routed Generic Identifier (ROUTED_GEN_ID)

Example 1 below shows clinical formulations with the same ingredient and therefore linked to the same PREG
code.
Example 1PREG GCN_SEQNO Link Table (RPREGGC0_PREG_GCNSEQNO_LINK)

GCN_SEQNO PREG_CODE

45131 1549

45132 1549

45133 1549

45134 1549

47821 1549

Example 2 below shows a given multi-ingredient clinical formulation with two PREG codes.
Example 2Multi-Ingredient Clinical Formulation with PREG codes

GCN_SEQNO PREG_CODE PREG_DESC

374 35 CAPTOPRIL

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374 484 HYDROCHLOROTHIAZIDE

Pregnancy Precautions Description

The description is assigned to the Pregnancy Precautions Code (PREG_CODE). This drug group description is
usually ingredient-based but can be broader and include a collection of ingredientsfor example, "ORAL
CONTRACEPTIVES"or may be narrower and include only certain dose forms or routesfor example,
"GENTAMICIN (OPHTH)."
Example 1Pregnancy Precautions Master Table (RPREGMA0_PREG_MSTR)

PREG_CODE PREG_DESC

1549 LINEZOLID

Example 2 below shows the ingredient break-out.

Example 2Pregnancy Precautions Master Table (RPREGMA0_PREG_MSTR)

PREG_CODE PREG_DESC PREG_SL PREG_PRCTN

628 GENTAMICIN D 8TH CRANIAL NERVE

(INJECTABLE) TOXICITY IN FETUS
REPORTED WITH OTHER
AMINOGLYCOSIDES

1773 GENTAMICIN (OPHTH) C

Pregnancy Precautions Severity Level

There are nine severity levels that can be assigned to a given drug with a PREG code. Each PREG code is
assigned only one severity level. (See Rule Set for Pregnancy Precautions Severity Level (PREG_SL)
description.)

Value Description:

FDA Pregnancy Risk Categories: A, B, C, D, and X (will be phased out over time as updated FDA
guidelines are adopted)
FDB Severity Level: 1, 3, 4, and 5
ExamplePregnancy Precautions Master Table (RPREGMA0_PREG_MSTR)

PREG_CODE PREG_DESC PREG_SL

37 LISINOPRIL D

409 HEPARIN C

Pregnancy Precautions Monograph

The monograph is comprised of four individual sections, each populated with available information located in the
pregnancy section of the manufacturer drug labeling or additional references. (See Rule Sets for content

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inclusion)

The following sections comprise the Pregnancy Precautions Monograph:

Fetal Risk Summary

Clinical Considerations
Data
Pregnancy Exposure Registry Information

PREG Boxed Warning Indicator

A one character alpha value indicates the presence of pregnancy/fetal/neonatal information in the boxed warning
section of the manufacturer drug labeling.
Valid Values for PREG_BXW_IND

PREG_BXW_IND Description

1 Boxed warning section of the manufacturer drug labeling

contains pregnancy/fetal/neonatal information

0 No pregnancy/fetal/neonatal information present in the

boxed warnings section of the manufacturer drug labeling

PREG References

The following columns contain reference information used in content creation for pregnancy precautions
monographs:

Pregnancy Reference Author (PREG_REFERENCE_AUTHOR)

Pregnancy Reference Edition (PREG_REFERENCE_EDITION)
Pregnancy Reference Name (PREG_REFERENCE_NAME)
Pregnancy Reference Identifier (PREG_REFERENCE_ID)
Pregnancy Reference Issue (PREG_REFERENCE_ISSUE)
Pregnancy Reference Issue Date Text (PREG_REFERENCE_ISSUE_DT_TXT)
Pregnancy Reference Location (PREG_REFERENCE_LOCATION)
Pregnancy Reference Page (PREG_REFERENCE_PAGE)
Pregnancy Reference PUBMED Identifier (PREG_REFERENCE_PUBMED_ID)
Pregnancy Reference Supplement Number (PREG_REFERENCE_SUPPLEMENT_NBR)
Pregnancy Reference Title (PREG_REFERENCE_TITLE)
Pregnancy Reference Type Description (PREG_REFERENCE_TYPE_DESC)

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Pregnancy Precautions Module Rule Sets

This section provides rules that the clinical team uses in regard to creating the module's data, both general rules
and rules specific to data elements.

Rules of General Applicability

Rules for Data Elements

Trigger content text (for example, Sporadic MedWatch alert text) are reviewed and concepts applicable to PREG
are identified. Trigger content drug(s) are identified and PREG precautions coding is applied to all applicable
PREG drug groups.

Rules of General Applicability

This section describes editorial policies that have a broad impact on the module data or by nature are less
specific than those policies in other sections.

Non-U.S. drug Clinical Formulations may inherit U.S.-based PREG clinical data.

Rules for Data Elements

This section describes editorial policies that are more specific towards their effect on the data elements contained
in the module.

Pregnancy Precautions Severity Level

Evidence Schema
Pregnancy Monograph Sections

Pregnancy Precautions Severity Level

The FDA pregnancy risk category is assigned as the severity level for a given drug with a PREG code.
Alternatively, an FDB severity level may be assigned when applicable. Only one severity level is assigned to a
drug group for a given PREG code.

Below are detailed descriptions from the PREG Severity Level Description Table
(RPREGSL1_PREG_SEVER_LEVEL) utilized for making severity level assignments and distinctions between
FDA pregnancy risk categories versus FDB severity level assignments.
FDA Pregnancy Risk Categories

Severity Level Description

A Adequate & well-controlled studies in pregnant women have

failed to demonstrate a risk to the fetus in 1st trimester of
pregnancy (and no evidence of risk in later trimesters).

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B Animal studies have failed to demonstrate a risk to the fetus

but there are no well-controlled studies in pregnant women;
or animal reproduction studies have shown an adverse
effect (other than decrease in fertility), but adequate and
well-controlled studies in pregnant women have failed to
demonstrate a risk to the fetus during the first trimester of
pregnancy (and there is no evidence of a risk in later
trimesters).

C Animal studies have shown adverse effect on fetus but no

well-controlled studies in humans: potential benefits may
warrant use in pregnant women despite potential risks; or
no animal reproduction studies and no adequate and
well-controlled studies in humans.

D Positive evidence of human fetal risk based on investigation

or marketing information but potential benefits may warrant
use of drug in pregnant women despite potential risks.

X Studies in animals or humans have shown fetal

abnormalities and/or there is positive evidence of fetal risk
based on investigational or marketing information and risks
involved in use of drug in pregnant women clearly outweigh
potential benefits.

FDB Assigned Pregnancy Severity Level Descriptions

Severity Level Description

1 Contraindicated or not recommended. Existing FDA

teratogenicity category (if available) is augmented by
information supporting a more severe warning.

3 Known or theoretical risk. For some indications, maternal

treatment benefit may outweigh fetal/neonatal risk.
Available human and/or animal data suggest fetal/neonatal
risk or there is a considerable theoretical risk.

4 Assess risk/benefit. Human data limited or unavailable.

Maternal treatment may outweigh the unclear fetal/neonatal
risk. Animal data suggest no fetal/neonatal risk.

5 No known fetal/neonatal risk. Available human and/or

animal data suggest no risk.

FDB severity levels can be assigned to drug ingredients that do not carry an FDA pregnancy risk category (that
is, teratogenicity category). For example, some FDA prescription drugs approved before 1980 do not have FDA
teratogenicity category assignment. Additionally, FDB severity levels can replace the existing FDA pregnancy risk
category for a given drug to convey more severe pregnancy warnings. For drugs assigned an FDB severity level,
the narrative section is used to indicate the presence or absence of an FDA risk category.

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The FDB severity level assignment is primarily determined by the pregnancy warnings content in the FDA
approved manufacturer prescription information for a given drug. In addition to the prescription label information,
other expert opinion references are also consulted (see Pregnancy Precautions Module Rule Sets).

Evidence Schema

FDB Severity Level 1

Contraindicated during pregnancy or in women of childbearing age

Manufacturer drug labeling contains pregnancy/fetal/neonatal warnings in the following sections: Boxed
Warning, Contraindications, Warnings, Precautions, Pregnancy
Post-marketing human or animal data that indicates adverse maternal or fetal outcomes
FDB Severity Level 3

Not recommended during pregnancy or in women of childbearing age.

Manufacturer drug labeling contains pregnancy/fetal/neonatal warnings in the following sections: Boxed
Warning, Warnings, Precautions, Pregnancy.
Drug pharmacology and/or available data indicate fetal/neonatal risk.
FDA approved indication for medication may have maternal treatment benefits that outweigh possible
fetal/neonatal risks (e.g.-anti-epileptic drugs, chemotherapy).
Post-marketing human or animal data that indicate adverse maternal or fetal outcomes.
FDB Severity Level 4

Fetal/neonatal risk is unclear since human and/or animal data are unavailable or limited.
FDA approved indication for medication may improve maternal health outcomes.
Pharmacology and/or available data do not suggest clear fetal/neonatal risk.
FDB Severity Level 5

Available human and/or animal data have shown no known fetal/neonatal risk.

Pregnancy Monograph Sections

The PREG monograph contains the following information when available: detailed risk information,
recommendations to reduce risk, supporting evidence as well as pregnancy registry contact information. When
the drug manufacturer labeling does not contain additional detailed risk information, the existing narrative will be
used and displayed in the fetal risk section of the PREG monograph. Additionally, when information is absent, the
corresponding PREG monograph section will not be populated.

Fetal Risk Summary

This section will be populated with fetal/neonatal risk information found in the manufacturer drug labeling or other
expert references. Short and succinct and standardized sentences will be used to describe the known, potential
or unknown risks.

Clinical Considerations

This section will be populated with recommendations to possibly minimize the known or potential maternal or

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fetal/neonatal risks. These recommendations will be derived from the drug manufacturer labeling and/or other
expert references. Maternal treatment benefit and fetal/neonatal risks may be presented in this section.

Data

The data presented in the manufacturer drug labeling will be stated in the exact manner in which they appear in
the pregnancy section of the manufacturer drug labeling, within allowable data field limits. Both human and animal
data can be populated when made available in the drug manufacturer labeling.

Registry Information

If pregnancy registry information is listed, it will be stated in the exact manner in which they appear in the
pregnancy section of the manufacturer drug labeling.

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Pregnancy Precautions Module Maintenance

This section contains information regarding the ongoing maintenance of the module's data.

External Triggers for Clinical Review

Internal Triggers for Clinical Review
Additional Sources

External Triggers for Clinical Review

The external triggers that prompt the clinical editors to add or review data are the following:

MedEffects Alerts from Health-Canada (except Non-U.S. product alerts exclusive to Canada)
MedWatch Safety Alerts from FDA
FDA CDER NEW listserv emails
FDA CBER What's New listserv emails
FDA MedWatch Monthly Label Changes
Briggs Pregnancy and Lactation Newsletter

Internal Triggers for Clinical Review

The internal trigger that prompts the clinical editors to add or review PREG drug groups is a new Clinical
Formulation (GCN_SEQNO) added to MedKnowledge and its U.S. product labeling.

Additional Sources

First Databank may rely on current source editions or versions when coding and updating data, as well as when
researching questions about data. However, a formal data review does not occur for every new release of source
editions or versions. Additional sources include:

Briggs GG, Freeman RK. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal
Risk.
American Congress of Obstetricians and Gynecologists. Available at: http://www.acog.org/

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Pregnancy Precautions Module References

This section lists sources used by First Databank to compile the information contained in the module.

FDB utilizes many reference sources including, but not limited to, the primary medical literature (for example,
published journal articles), medical reference texts, published expert treatment guidelines, and manufacturer
product package inserts. FDB may relay on current source editions or versions when coding and updating data,
as well as when researching questions about data. However, a formal data review does not occur for every new
release of source editions or versions. Additional sources include:

Briggs GG, Freeman RK, Yaffe SJ, eds. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal
and Neonatal Risk.
American Congress of Obstetricians and Gynecologists. Available at: http://www.acog.org/.

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Pregnancy Precautions Module Applications

This section provides information about the practical application of data contained in this module.

Screening a Drug for Pregnancy Precautions

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Screening a Drug for Pregnancy Precautions

Systems can use the Pregnancy Precautions Module to identify warnings that might impact drug ordering and
dispensing decisions. This application illustrates how to screen a drug for precautions.

1. Do one of the following:

Select the Pregnancy Precautions Code (PREG_CODE) from the PREG GCN_SEQNO Link Table
(RPREGGC0_PREG_GCNSEQNO_LINK) where the Clinical Formulation ID (GCN_SEQNO)
column equals the Clinical Formulation ID (GCN_SEQNO) of the drug to screen.
Select the PREG_CODE from the PREG ROUTED_MED_ID Link Table
(RPREGRM0_ROUTED_MED_LINK) where the MED Routed Medication ID ( ROUTED_MED_ID)
column equals the ROUTED_MED_ID of the drug to screen.
Select the PREG_CODE from the PREG Routed Generic Table
(RPREGRG0_ROUTED_GEN_LINK) where the Routed Generic Identifier (ROUTED_GEN_ID)
column equals the ROUTED_GEN_ID of the drug to screen.

2. If no records exist in a link table, the drug has no pregnancy precautions. If records do exist in a link table,
the drug has pregnancy precautions.

The system might need to perform additional navigation to access the PREG_CODE from the
user-entered drug identifier. See Multiple Access Points (MAPs) for more information.

3. Select pregnancy precautions information from the Pregnancy Precautions Master Table
(RPREGMA1_PREG_MSTR) where the PREG_CODE column equals the PREG_CODE value from the
previous step.

4. Select the pregnancy precautions monograph information from the PREG Monograph Line Table
(RPREGPL0_MONO_LINE) and PREG Monograph Section Description Table
(RPREGMS0_MONO_SECTION_DESC).

5. (Optional) Select the pregnancy precautions reference information from the PREG Reference Link Table
(RPREGRL0_PREG_REFERENCE_LINK), PREG Reference Table (RPREGRE0_PREG_REFERENCE),
and PREG Reference Type Table (RPREGRT0_PREG_REFERENCE_TYPE).

6. (Optional) Filter the results according to institution convention or user-entered criteria.

7. Display the results to the user.

ExampleScreening a Drug for Pregnancy Precautions with a ROUTED_MED_ID

ExampleScreening a Drug for Pregnancy Precautions with a ROUTED_GEN_ID
ExampleScreening a Drug for Pregnancy Precautions with a Clinical Formulation ID
ExampleFiltering Pregnancy Precaution Information

ExampleScreening a Drug for Pregnancy Precautions with a ROUTED_MED_ID

For the purposes of demonstrating this application, the following scenario is used: A physician screens
Atorvastatin Calcium Oral (ROUTED_MED_ID 000841) for all possible PREG information. The MED Routed

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Medication ID (ROUTED_MED_ID) is in the MED Routed Medication Table (RMIRMID1_ROUTED_MED).

1. Select the Pregnancy Precautions Code (PREG_CODE) value from the PREG ROUTED_MED_ID Link
Table (RPREGRM0_ROUTED_MED_LINK) where the ROUTED_MED_ID column equals the
ROUTED_MED_ID value of the drug to screen.

ROUTED_MED_ID 000841

PREG_CODE 000399

2. Select the Pregnancy Precautions Description (PREG_DESC), Pregnancy Precautions Severity Level
(PREG_SL), and Pregnancy Precautions Boxed Warning (BXW) Indicator (
PREG_BOXED_WARNING_IND) values from the Pregnancy Precautions Master Table
(RPREGMA1_PREG_MSTR) where the PREG_CODE column equals the value from the previous step.

PREG_CODE 000399

PREG_DESC HMG COA REDUCTASE INHIBITORS

PREG_SL X

PREG_BOXED_WARNING_IND 0

3. Retrieve the following from the PREG Monograph Line Table (RPREGPL0_MONO_LINE) where the
Pregnancy Precautions Code (PREG_CODE) value equals the Pregnancy Precautions Code
(PREG_CODE) value from step 1:
Pregnancy Monograph Section Code (PREG_MONO_SECTION_CD)
Pregnancy Monograph Line (PREG_MONO_LINE)
Pregnancy Monograph Sequence Number (PREG_MONO_SN)

PREG_CODE 000399

PREG_DESC HMG COA REDUCTASE INHIBITORS

PREG_SL X

PREG_BOXED_WARNING_IND 0

PREG_MONO_SECTION_CD 1

PREG_MONO_SN 1

PREG_MONO_LINE Source content to be reviewed.

4. Sort the content of the Pregnancy Monograph Line (PREG_MONO_LINE) for each Pregnancy Monograph
Section Code (PREG_MONO_SECTION_CD) and sort the records using the Pregnancy Monograph
Sequence Number (PREG_MONO_SN) column.

5. Select the Pregnancy Reference Identifier (PREG_REFERENCE_ID) values from the PREG Reference
Link Table (RPREGRL0_PREG_REFERENCE_LINK) where the where the Pregnancy Precautions Code (

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5.

PREG_CODE) column equals the value from step 1.

6. Select the pregnancy reference information from the PREG Reference Table
(RPREGRE0_PREG_REFERENCE) where the Pregnancy Reference Identifier (PREG_REFERENCE_ID)
column equals the value from the previous step.

7. Select the Pregnancy Reference Type Description (PREG_REFERENCE_TYPE_DESC) from the PREG
Reference Type Table (RPREGRT0_PREG_REFERENCE_TYPE).

8. Display the results to the user.

In this example, the system alert contains the Pregnancy Precautions Significance Level Description (PREG_SLD
) from the PREG Severity Level Description Table (RPREGSL1_PREG_SEVER_LEVEL) for the FDA pregnancy
risk category X:
Example Pregnancy Precaution Alert

ATORVASTATIN
FDA-ASSIGNED SEVERITY LEVEL OF X.
STUDIES IN ANIMALS OR HUMANS HAVE SHOWN FETAL ABNORMALITIES
AND/OR THERE IS POSITIVE EVIDENCE OF FETAL RISK BASED ON
INVESTIGATIONAL OR MARKETING INFORMATION AND RISKS INVOLVED
IN USE OF DRUG IN PREGNANT WOMEN CLEARLY OUTWEIGH POTENTIAL
BENEFITS.

In this example, the PREG description is a drug class description, not an ingredient description.

ExampleScreening a Drug for Pregnancy Precautions with a ROUTED_GEN_ID

For the purposes of demonstrating this application, the following scenario is used: A physician screens
Digoxin Oral (ROUTED_GEN_ID 01048580) for all possible PREG information. The Routed Generic Identifier (
ROUTED_GEN_ID) is in the Routed Generic Table (RRTGN0_ROUTED_GEN_MSTR).

1. Select the Pregnancy Precautions Code (PREG_CODE) value from the PREG Routed Generic Table
(RPREGRG0_ROUTED_GEN_LINK) where the ROUTED_GEN_ID column equals the ROUTED_GEN_ID
value of the drug to screen.

ROUTED_GEN_ID 01048580

PREG_CODE 000001

2. Select the Pregnancy Precautions Description (PREG_DESC), Pregnancy Precautions Severity Level (
PREG_SL), and Pregnancy Precautions Boxed Warning (BXW) Indicator (
PREG_BOXED_WARNING_IND) values from the Pregnancy Precautions Master Table
(RPREGMA1_PREG_MSTR) where the PREG_CODE column equals the value from the previous step.

PREG_CODE 000001

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PREG_DESC DIGITALIS

PREG_SL C

PREG_BOXED_WARNING_IND 0

3. Retrieve the following from the PREG Monograph Line Table (RPREGPL0_MONO_LINE) where the
Pregnancy Precautions Code (PREG_CODE) value equals the Pregnancy Precautions Code
(PREG_CODE) value from step 1:
Pregnancy Monograph Section Code (PREG_MONO_SECTION_CD)
Pregnancy Monograph Line (PREG_MONO_LINE)
Pregnancy Monograph Sequence Number (PREG_MONO_SN)

PREG_CODE 000001

PREG_DESC DIGITALIS

PREG_SL C

PREG_BOXED_WARNING_IND 0

PREG_MONO_SECTION_CD 1

PREG_MONO_SN 1

PREG_MONO_LINE Insufficient human data; consider maternal

treatment benefit versus infant risk

4. Sort the content of the Pregnancy Monograph Line (PREG_MONO_LINE) for each Pregnancy Monograph
Section Code (PREG_MONO_SECTION_CD) and sort the records using the Pregnancy Monograph
Sequence Number (PREG_MONO_SN) column.

5. Select the Pregnancy Reference Identifier (PREG_REFERENCE_ID) values from the PREG Reference
Link Table (RPREGRL0_PREG_REFERENCE_LINK) where the where the Pregnancy Precautions Code (
PREG_CODE) column equals the value from step 1.

6. Select the pregnancy reference information from the PREG Reference Table
(RPREGRE0_PREG_REFERENCE) where the Pregnancy Reference Identifier (PREG_REFERENCE_ID)
column equals the value from the previous step.

7. Select the Pregnancy Reference Type Description (PREG_REFERENCE_TYPE_DESC) from the PREG
Reference Type Table (RPREGRT0_PREG_REFERENCE_TYPE).

8. Display the results to the user.

In this example, the system alert contains the Pregnancy Precautions Significance Level Description (PREG_SLD
) from the PREG Severity Level Description Table (RPREGSL1_PREG_SEVER_LEVEL) for the FDA pregnancy
risk category C:
Example Pregnancy Precaution Alert

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DIGITALIS
FDA-ASSIGNED SEVERITY LEVEL OF C.
ANIMAL STUDIES HAVE SHOWN ADVERSE EFFECT ON FETUS BUT NO
WELL-CONTROLLED STUDIES IN HUMANS: POTENTIAL BENEFITS MAY
WARRANT USE IN PREGNANT WOMEN DESPITE POTENTIAL RISKS; OR
NO ANIMAL REPRODUCTION STUDIES AND NO ADEQUATE AND WELL-
CONTROLLED STUDIES IN HUMANS.

ExampleScreening a Drug for Pregnancy Precautions with a Clinical Formulation ID

For purposes of demonstrating this application, the following scenario is used: A pharmacist screens
Enalapril/Hydrochlorothiazide 10 mg-25 mg Tablet (Clinical Formulation ID [GCN_SEQNO] 000382) for all
possible PREG information. The Clinical Formulation ID (GCN_SEQNO) is in the Clinical Formulation ID Table
(RGCNSEQ4_GCNSEQNO_MSTR).

1. Select the Pregnancy Precautions Code (PREG_CODE) values from the PREG GCN_SEQNO Link Table
(RPREGGC0_PREG_GCNSEQNO_LINK) where the GCN_SEQNO column equals the Clinical
Formulation ID (GCN_SEQNO) value of the drug to screen.

GCN_SEQNO 000382 000382

PREG_CODE 000036 000484

2. Select the Pregnancy Precautions Description (PREG_DESC), Pregnancy Precautions Severity Level (
PREG_SL), and Pregnancy Precautions Boxed Warning (BXW) Indicator (
PREG_BOXED_WARNING_IND) values from the Pregnancy Precautions Master Table
(RPREGMA1_PREG_MSTR) where the PREG_CODE column equals the value from the previous step.

PREG_CODE 000036 000484

PREG_DESC ENALAPRIL HYDROCHLOROTHIAZIDE

PREG_SL D B

PREG_BOXED_WARNING_IND 1 0

3. Retrieve the following from the PREG Monograph Line Table (RPREGPL0_MONO_LINE) where the
Pregnancy Precautions Code (PREG_CODE) value equals the Pregnancy Precautions Code
(PREG_CODE) value from step 1:
Pregnancy Monograph Section Code (PREG_MONO_SECTION_CD)
Pregnancy Monograph Line (PREG_MONO_LINE)
Pregnancy Monograph Sequence Number (PREG_MONO_SN)

PREG_CODE 000036 000484

PREG_DESC ENALAPRIL HYDROCHLOROTHIAZIDE

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PREG_SL D B

PREG_BOXED_WARNING_IND 1 0

PREG_MONO_SECTION_CD 1 1

PREG_MONO_LINE Fetal death/morbidity w/use in Not recommended in

2nd & 3rd trimester, stop when pre-eclampsia and other
pregnancy detected pregnancy-induced hypertension.

PREG_MONO_SN 1 1

4. Sort the content of the Pregnancy Monograph Line (PREG_MONO_LINE) for each Pregnancy Monograph
Section Code (PREG_MONO_SECTION_CD) and sort the records using the Pregnancy Monograph
Sequence Number (PREG_MONO_SN) column.

5. Select the Pregnancy Reference Identifier (PREG_REFERENCE_ID) values from the PREG Reference
Link Table (RPREGRL0_PREG_REFERENCE_LINK) where the where the Pregnancy Precautions Code (
PREG_CODE) column equals the value from step 1.

6. Select the pregnancy reference information from the PREG Reference Table
(RPREGRE0_PREG_REFERENCE) where the Pregnancy Reference Identifier (PREG_REFERENCE_ID)
column equals the value from the previous step.

7. Select the Pregnancy Reference Type Description (PREG_REFERENCE_TYPE_DESC) from the PREG
Reference Type Table (RPREGRT0_PREG_REFERENCE_TYPE).

8. Display the results to the user.

In this example, the system alert contains the Pregnancy Precautions Significance Description ( PREG_SLD) from
the PREG Severity Level Description Table (RPREGSL1_PREG_SEVER_LEVEL), and precautions narratives:
Example Pregnancy Precaution Alert

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ENALAPRIL FDA-ASSIGNED SEVERITY LEVEL OF D

POSITIVE EVIDENCE OF HUMAN FETAL RISK BASED ON
INVESTIGATION OR MARKETING INFORMATION BUT POTENTIAL
BENEFITS MAY WARRANT USE OF DRUG IN PREGNANT WOMEN DESPITE
POTENTIAL RISKS.
FETAL DEATH/MORBIDITY W/USE IN 2ND & 3RD TRIMESTER, STOP
WHEN PREGNANCY DETECTED
HYDROCHLOROTHIAZIDE FDA-ASSIGNED SEVERITY LEVEL OF B
ANIMAL STUDIES HAVE FAILED TO DEMONSTRATE A RISK TO THE
FETUS BUT THERE ARE NO WELL-CONTROLLED STUDIES IN PREGNANT
WOMEN; OR ANIMAL REPRODUCTION STUDIES HAVE SHOWN AN ADVERSE
EFFECT (OTHER THAN DECREASE IN FERTILITY), BUT ADEQUATE AND
WELL-CONTROLLED STUDIES IN PREGNANT WOMEN HAVE FAILED TO
DEMONSTRATE A RISK TO THE FETUS DURING THE FIRST TRIMESTER
OF PREGNANCY (AND THERE IS NO EVIDENCE OF A RISK IN LATER
TRIMESTERS).
NOT RECOMMENDED IN PRE-ECLAMPSIA AND OTHER PREGNANCY-
INDUCED HYPERTENSION

ExampleFiltering Pregnancy Precaution Information

For purposes of demonstrating this application, the following scenario is used: A nurse practitioner
screens Fluoxetine 10mg Oral Capsule (Clinical Formulation ID [GCN_SEQNO] 046213) for pregnancy
precautions, and the institution has decided to filter warnings to display only those with a severity level of C, D, X,
or 1. The Clinical Formulation ID (GCN_SEQNO) is in the Clinical Formulation ID Table
(RGCNSEQ4_GCNSEQNO_MSTR).

1. Select the Pregnancy Precautions Code (PREG_CODE) value from the PREG GCN_SEQNO Link Table
(RPREGGC0_PREG_GCNSEQNO_LINK) where the GCN_SEQNO column equals the Clinical
Formulation ID (GCN_SEQNO) value of the drug to screen.

GCN_SEQNO 046213

PREG_CODE 000251

2. Select the Pregnancy Precautions Description (PREG_DESC), Pregnancy Precautions Severity Level (
PREG_SL), and Pregnancy Precautions Boxed Warning (BXW) Indicator (
PREG_BOXED_WARNING_IND) values from the Pregnancy Precautions Master Table
(RPREGMA1_PREG_MSTR) where the PREG_CODE column equals the value from the previous step.

PREG_CODE 000251

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PREG_DESC FLUOXETINE

PREG_SL C

PREG_BOXED_WARNING_IND 0

3. Retrieve the following from the PREG Monograph Line Table (RPREGPL0_MONO_LINE) where the
Pregnancy Precautions Code (PREG_CODE) value equals the Pregnancy Precautions Code
(PREG_CODE) value from step 1:
Pregnancy Monograph Section Code (PREG_MONO_SECTION_CD)
Pregnancy Monograph Line (PREG_MONO_LINE)
Pregnancy Monograph Sequence Number (PREG_MONO_SN)

PREG_CODE 000251

PREG_DESC FLUOXETINE

PREG_SL C

PREG_BOXED_WARNING_IND 0

PREG_MONO_SECTION_CD 1

PREG_MONO_LINE Risk of persistent pulm HTN after 20 wks; neonate

behavior syndr 3rd trimester

PREG_MONO_SN 1

4. Sort the content of the Pregnancy Monograph Line (PREG_MONO_LINE) for each Pregnancy Monograph
Section Code (PREG_MONO_SECTION_CD) and sort the records using the Pregnancy Monograph
Sequence Number (PREG_MONO_SN) column.

5. Select the Pregnancy Reference Identifier (PREG_REFERENCE_ID) values from the PREG Reference
Link Table (RPREGRL0_PREG_REFERENCE_LINK) where the where the Pregnancy Precautions Code (
PREG_CODE) column equals the value from step 1.

6. Select the pregnancy reference information from the PREG Reference Table
(RPREGRE0_PREG_REFERENCE) where the Pregnancy Reference Identifier (PREG_REFERENCE_ID)
column equals the value from the previous step.

7. Select the Pregnancy Reference Type Description (PREG_REFERENCE_TYPE_DESC) from the PREG
Reference Type Table (RPREGRT0_PREG_REFERENCE_TYPE).

8. Filter the results according to institution convention or user-entered criteria.

In this example, filter the value in the PREG_SL column by the institution convention that the severity level
be C, D, X, or 1. In this example, the only returned record contains a value of C in the PREG_SL column,
so it meets the criteria.

9. Display the results to the user.

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9.

Drug ingredients with a severity level of C may contain warnings that impact patient safety and
care.

In this example, the system alert contains the Pregnancy Precautions Significance Description ( PREG_SLD) from
the PREG Severity Level Description Table (RPREGSL1_PREG_SEVER_LEVEL), and the precautions
narratives:
Example Pregnancy Precaution Alert

FLUOXETINE FDA-ASSIGNED SEVERITY LEVEL OF C

ANIMAL STUDIES HAVE SHOWN ADVERSE EFFECT ON FETUS BUT NO
WELL-CONTROLLED STUDIES IN HUMANS: POTENTIAL BENEFITS MAY
WARRANT USE IN PREGNANT WOMEN DESPITE POTENTIAL RISKS; OR
NO ANIMAL REPRODUCTION STUDIES AND NO ADEQUATE AND WELL-
CONTROLLED STUDIES IN HUMANS.
RISK OF PERSISTENT PULM HTN AFTER 20 WKS; NEONATE BEHAVIOR
SYNDR 3RD TRIMESTER

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Pregnancy Precautions Module ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module. The table names are listed below.

Pregnancy Precautions Tables

Pregnancy Precautions ERD

Pregnancy Precautions Tables

PREG GCN_SEQNO Link Table

PREG Monograph Line Table
PREG Monograph Section Description Table
Pregnancy Precautions Master Table
PREG Reference Link Table
PREG Reference Table
PREG Reference Type Table
PREG ROUTED_MED_ID Link Table
PREG Routed Generic Table
PREG Severity Level Description Table

Pregnancy Precautions ERD

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PREG GCN_SEQNO Link Table

Table Name RPREGGC0_PREG_GCNSEQNO_LINK

Revision Activity original

Purpose Links a clinical drug formulation to pregnancy precaution

information.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF PREG_CODE Pregnancy N 6 9(6)

Precautions Code

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PREG Monograph Line Table

Table Name RPREGPL0_PREG_MONO_LINE

Revision Activity add.10-01-2015

Purpose Provides monograph information for a given pregnancy

precaution.

Key Column Name Column Format Length Picture

Description

P PREG_MONO_ID Pregnancy N 8 9(8)

Monograph
Identifier

PF PREG_MONO_S Pregnancy N 4 9(4)

ECTION_CD Monograph
Section Code

P PREG_MONO_S Pregnancy N 2 9(2)

N Monograph
Sequence
Number

F PREG_CODE Pregnancy N 6 9(6)

Precautions Code

PREG_MONO_LI Pregnancy AN 500 X(500)

NE Monograph Line

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PREG Monograph Section Description Table

Table Name RPREGMS0_MONO_SECTION_DESC

Revision Activity add.10-01-2015

Purpose Relates the Pregnancy Monograph Section Code to its text

description. The Pregnancy Monograph Section Code
identifies the types of text included in the monographs. This
table provides the ability to group the monograph lines into
sections, including or excluding individual sections of a
monograph depending upon specific business needs.

Key Column Name Column Format Length Picture

Description

P PREG_MONO_S Pregnancy N 4 9(4)

ECTION_CD Monograph
Section Code

PREG_MONO_S Pregnancy AN 50 X(50)

ECTION_CD_DE Monograph
SC Section Code
Description

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Pregnancy Precautions Master Table

Table Name RPREGMA1_PREG_MSTR

Revision Activity rev.10-01-2015

Purpose Provides attributes of pregnancy precaution information for

a particular drug.

Key Column Name Column Format Length Picture

Description

P PREG_CODE Pregnancy N 6 9(6)

Precautions Code

PREG_DESC Pregnancy AN 41 X(41)

Precautions
Description

F PREG_SL Pregnancy AN 1 X(1)

Precautions
Severity Level

PREG_BOXED_ Pregnancy AN 1 X(1)

WARNING_IND Precautions
Boxed Warning
(BXW) Indicator

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PREG Reference Link Table

Table Name RPREGRL0_PREG_REFERENCE_LINK

Revision Activity add.10-01-2015

Purpose Links a pregnancy precaution to its defining references.

Key Column Name Column Format Length Picture

Description

PF PREG_CODE Pregnancy N 6 9(6)

Precautions Code

PF PREG_REFEREN Pregnancy N 8 9(8)

CE_ID Reference
Identifier

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PREG Reference Table

Table Name RPREGRE0_PREG_REFERENCE

Revision Activity add.10-01-2015

Purpose Contains sources used by FDB to compile the information

contained in the pregnancy precaution.

Key Column Name Column Format Length Picture

Description

P PREG_REFEREN Pregnancy N 8 9(8)

CE_ID Reference
Identifier

F PREG_REFEREN Pregnancy N 8 9(8)

CE_TYPE_ID Reference Type
Identifier

PREG_REFEREN Pregnancy AN 255 X(255)

CE_TITLE Reference Title

PREG_REFEREN Pregnancy AN 255 X(255)

CE_AUTHOR Reference Author

PREG_REFEREN Pregnancy AN 255 X(255)

CE_NAME Reference Name

PREG_REFEREN Pregnancy AN 25 X(25)

CE_ISSUE_DT_T Reference Issue
XT Date Text

PREG_REFEREN Pregnancy AN 80 X(80)

CE_VOLUME Reference
Volume

PREG_REFEREN Pregnancy AN 80 X(80)

CE_SUPPLEMEN Reference
T_NBR Supplement
Number

PREG_REFEREN Pregnancy AN 80 X(80)

CE_EDITION Reference Edition

PREG_REFEREN Pregnancy AN 80 X(80)

CE_LOCATION Reference
Location

PREG_REFEREN Pregnancy N 8 9(8)

CE_ACCESSED_ Reference
DT Accessed Date

PREG_REFEREN Pregnancy AN 80 X(80)

CE_ISSUE Reference Issue

PREG_REFEREN Pregnancy AN 80 X(80)

CE_PAGE Reference Page

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PREG_REFEREN Pregnancy AN 50 X(50)

CE_PUBMED_ID Reference
PUBMED
Identifier

PREG_REFEREN Pregnancy AN 500 X(500)

CE_URL_TEXT Reference URL
Text

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PREG Reference Type Table

Table Name RPREGRT0_PREG_REFERENCE_TYPE

Revision Activity add.10-01-2015

Purpose Categorizes sources used by FDB to compile the

information contained in the pregnancy precaution.

Key Column Name Column Format Length Picture

Description

P PREG_REFEREN Pregnancy N 8 9(8)

CE_TYPE_ID Reference Type
Identifier

PREG_REFEREN Pregnancy AN 255 X(255)

CE_TYPE_DESC Reference Type
Description

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PREG ROUTED_MED_ID Link Table

Table Name RPREGRM0_ROUTED_MED_LINK

Revision Activity add.07-01-2002

Purpose Links a routed medication to pregnancy precaution

information.

Key Column Name Column Format Length Picture

Description

PF ROUTED_MED_I MED Routed N 8 9(8)

D Medication ID
(Stable ID)

PF PREG_CODE Pregnancy N 6 9(6)

Precautions Code

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PREG Routed Generic Table

Table Name RPREGRG0_ROUTED_GEN_LINK

Revision Activity original

Purpose Links a routed generic to pregnancy precaution information.

Key Column Name Column Format Length Picture

Description

PF ROUTED_GEN_I Routed Generic N 8 9(8)

D Identifier

PF PREG_CODE Pregnancy N 6 9(6)

Precautions Code

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PREG Severity Level Description Table

Table Name RPREGSL1_PREG_SEVER_LEVEL

Revision Activity rev.10-01-2015

Purpose Relates the Pregnancy Precaution Severity Level to its text

description.

Key Column Name Column Format Length Picture

Description

P PREG_SL Pregnancy AN 1 X(1)

Precautions
Severity Level

P PREG_SLSN Pregnancy N 2 9(2)

Precautions
Severity Level
Description Text
Sequence
Number

PREG_SLD Pregnancy AN 60 X(60)

Precautions
Severity Level
Description

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Side Effects Module (SIDE) 2.0

Side Effects Module Editorial Policies
Applications
ERD and Technical Specifications

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Side Effects Module Editorial Policies

The policies and criteria that apply to the inclsion criteria, processes, and references used in creation of the Side
Effects Module are provided in the following sections:

Overview
Inclusion/Exclusion Criteria
Data Elements
Rule Sets
Maintenance
Resources

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SIDE Overview
The Side Effects Module (SIDE) addresses the problem of drug-induced illness/side effects. It can be used in
prospective and retrospective environments in systems for prescribers, community or hospital pharmacies,
nursing homes or long-term care facilities, and third party processors.

Detailed and comprehensive lists of side effects can be generated for use in patient monitoring and counseling.
The potential for additive side effects between two or more medications can be checked. Drug-induced adverse
effects can be detected, which facilitates compliance with The Joint Commission (TJC) requirements stating that
medication errors and adverse drug reactions shall be reported immediately.

Drug knowledge is aggregated at the Clinical Formulation ID (GCN_SEQNO), Routed Medication ID (

ROUTED_MED_ID), and the Routed Generic ID (ROUTED_GEN_ID) levels in the First Databank
knowledge base. Under certain circumstances, aggregated drug knowledge may not apply to all related
packaged products; more specific information may be found within product labels.

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SIDE Inclusion and Exclusion Criteria

This section provides information detailing the criteria that guided the inclusion of the data contained within the
module as well as information pertaining to limitations or exclusions when appropriate to the discussion.

This section includes the following topics:

Inclusion - Drug Scope

Inclusion - Content Scope
Exclusion - Drug Scope
Exclusion - SIDE Content

Inclusion - Drug Scope

U.S. FDA-approved Rx product ingredients with NDA, ANDA, BLA

U.S. OTC products with NDAs or ANDAs
U.S. OTC drug product ingredients consistent with FDA OTC Monographs
Herbal products enumerated in the FDB Herbal Products Inclusion List

Inclusion - Content Scope

The SIDE module includes documented drug-induced illnesses, conditions, manifestations of drug intolerance,
hypersensitivity reactions and may include lab test changes (for example, decreased serum potassium) that
reflects side effects from physiological changes.

Exclusion - Drug Scope

Non-U.S. products that are exclusive to other countries

Self-proclaimed Rx products without ANDA/NDA/BLA
Rx drug products with 510K device approval
Dietary supplements
Large volume parenteral, nutritional, irrigation or dialysis solutions
Nutraceuticals
Diluent solutions
Herbal products, except those enumerated in the FDB Herbal Products Inclusion List
Homeopathic drugs
OTC products that are not described by FDA OTC Monographs
Bulk drugs or chemicals
Medical supplies, soaps, cleansers
Cosmetics
Veterinary drugs
Inactive ingredients

Exclusion - SIDE Content

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The Side Effects Module is not intended to include the full listing of adverse events as reported in the
manufacturer labeling. Less commonly reported adverse reactions notated as "other adverse reactions" and
frequently organized by system may not be included. Similarly, adverse events reported from uncontrolled trials
where causality is not established or stated as "may be related" may not be included.

Other examples of exclusions:

Adverse events occurring from medication withdrawal or conditions or rebound effects occurring after
discontinuing therapy (for example, beta-blockers and rebound hypertension)
Adverse events that occur from routes or methods of drug administration not approved by the FDA (for
example, ocular administration of a topical solution)
Side effects due to a drug-drug interaction
Side effects that occur from overdose conditions
Reported adverse events associated with the indication or underlying condition being treated
Indirect adverse events due to physiologic condition in response to previous or current therapy (that is,
tumor lysis syndrome associated with chemotherapy, immune reconstitution syndrome associated with
HAART, radiation recall seen with anthracycline and other chemotherapy treatments)
Adverse event incidence occurs higher in placebo group than in treatment group (when available from
prescribing information)
Antibody formation caused by protein (or peptide based) drug therapy
Side effects occurring from product contamination (for example, rotavirus vaccine contaminated with
porcine flu strain)
Lab test result abnormalities that have no associated physiologic effects or are not reasonably associated
with the known pharmacology of the drug
Multiple listings of side effects that express similar disease concepts (that is, arrhythmia is included instead
of separate listings: bradycardia, tachycardia)

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SIDE Data Elements

This section contains additional information about particularly important tables and codes contained within the
module, as well as concepts about the data that the reader must understand in order to understand the module.

This section includes the following data elements:

SIDE Code Description

Disease Identifiers
SIDE Frequency of Occurrence Code
SIDE Severity Code
SIDE Visibility Code
SIDE Lab/Diagnostic Tests Code
SIDE Physician Code
SIDE Hypersensitivity Indicator

SIDE Code Description

Each SIDE code has a unique Side code description (SIDE_DRUG_DESC). This drug group description is
usually ingredient-based but can be broader and include a collection of ingredients (for example, "Bulk
Laxatives") or may be narrower and include only certain dose forms or routes. (for example, "NASAL
DECONGESTANTS (TOP)").

Example

SIDE SIDE_DRUG_DESC

777 NASAL DECONGESTANTS (TOP)

1119 DONEPEZIL

1122 FOSPHENYTOIN

Some drug groups may have more than 99 listed side effects and are programmatically assigned a
second SIDE code. The second drug description is the original drug group name and qualified as
"(CONTINUED)" in the SIDE_DRUG_DESC field from the RSIDEDD0_DRUG_DESC table.

Example

SIDE SIDE_DRUG_DESC

1173 SILDENAFIL

1174 SILDENAFIL (CONTINUED)

Multi-ingredient products may have more than one SIDE code and description, or a single SIDE code for
the combination.

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Example

GCN_SEQNO GNN SIDE SIDE_DRUG_DESC

29123 IPRATROPIUM 341 IPRATROPIUM

BROMIDE/ALBUTEROL

29123 ALBUTEROL INHALATION 566 ALBUTEROL INHALATION

46601 LOPINAVIR/RITONAVIR 1378 LOPINAVIR/RITONAVIR

Disease Identifiers

Each side effect listed in the master table is encoded with a Disease Identifier ( DxID) that is maintained in the
First Databank Medical Lexicon (FML).

SIDE Frequency of Occurrence Code

The SIDE frequency of occurrence (SIDE_FREQ) indicates the approximate relative frequency that a side effect
occurs with a given drug product. SIDE_FREQ has the following valid values.

SIDE_FREQ Values and Descriptions

Value Description

0 Incidence more frequent

1 Incidence less frequent

2 Incidence rare or very rare

SIDE Severity Code

There are two possible severity levels (SIDE_SEV) that can be assigned to each DxID record.

SIDE_SEV Values and Descriptions

Value Description

0 "less severe" if it is non-threatening (such as constipation)

1 "severe" if it may be life-threatening (such as

agranulocytosis)

SIDE Visibility Code

The SIDE Visibility Code (SIDE_VISCD) characterizes the presentation of a side effect. It has the following valid
values and descriptions:

SIDE_VISCD Values and Descriptions

Value Description

0 "Visible" if it is definitely detectable (for example, rash).

Visible during routine physical exam.

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1 "May be communicated by patient." In these cases, it is

assumed that the patient is responsive and communicative
(for example, nausea).

2 "Not visible" if it is definitely not visible (for example,

neutropenia), or if it is not detectable by routine physical
exam.

SIDE Lab/Diagnostic Tests Code

The SIDE Lab/Diagnostic Test Code (SIDE_LABCD) indicates whether a lab or diagnostic test is necessary as
follow-up or to elucidate a given drug side effect. It does not establish which lab tests should be ordered for a
given drug as a baseline or for monitoring.

SIDE_LABCD Values and Descriptions

Value Description

0 No Lab or Diagnostic Test Recommended

1 Lab or Diagnostic Test Recommended

SIDE Physician Code

The SIDE Physician Code (SIDE_PHYS) indicates the need for physician notification.

SIDE_PHYS Values and Descriptions

Value Description

0 Contact MD only if becomes bothersome

1 MD should be contacted

SIDE Hypersensitivity Indicator

The SIDE Hypersensitivity Indicator field (SIDE_HYPER) may be populated with a value of H or left null. "H"
identifies side effects likely due to immunological mechanisms or immune-mediated reactions, such as skin rash,
bronchospasm, or anaphylaxis. This indicator enables the user to selectively screen specific side effects that fit
the criteria of this type.

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SIDE Rule Sets

This section provides rules that the clinical team uses in regard to creating the module's data, both general rules
and rules specific to data elements.

Rules of General Applicability

Rules for Data Elements

Trigger content is reviewed and concepts applicable to SIDE are identified. (See Maintenance for list of triggers).
Disease terminology concepts within FML are searched and codes/descriptions are selected. Associated
attributes of frequency, severity level, visibility, laboratory study association, physician and hypersensitivity
indicators are included.

Rules of General Applicability

This section describes editorial policies that have a broad impact on the module data or by nature are less
specific than those policies in other sections.

Side effect clinical content is reviewed, collected, and associated to a drug group reflected by the Side Code
Description. Group linking to other drug identifiers (Routed Medication IDs, Routed Generic IDs, and Clinical
Formulations) is programmatically derived. Linkage or assignment of SIDE information is not drug
manufacturer-specific.

Non-U.S. drug Clinical Formulations may inherit U.S.-based SIDE clinical data.

Example

SIDE SIDE_DRUG_DESC GCN_SEQNO

592 BUDESONIDE NASAL 18166

591 BUDESONIDE INH 24187

591 BUDESONIDE INH 24872

1715 BUDESONIDE - ORAL 25750

1718 BUDESONIDE - ORAL (CONTINUED) 25750

Rules for Data Elements

This section describes editorial policies that are more specific towards their effect on the data elements contained
in the module.

SIDE Frequency

There are three possible frequency values in SIDE (SIDE_FREQ) that can be assigned to each DxID record. The
following description is utilized for making frequency assignments.

Evidence Schema

Incidence more frequentAdverse effects that are listed as more frequent in the "Highlights of
Prescribing Information" product label or occurring in the highest percentage of patients in controlled trials

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or clinical use of the drug product label are assigned a frequency of "0."
Incidence less frequentAdverse events with a lower percent occurrence rate are assigned a frequency
level of "1."
Incidence rare or very rareAdverse events that are rare or rarely reported or may be included in the
post marketing section of the manufacturer label are assigned a frequency of "2."

SIDE Severity Level

There are two possible severity level messages in SIDE (SIDE_SEV) that can be assigned to each DxID record.
The following are detailed descriptions utilized for making severity level assignments:

Less severe is assigned to adverse effects that are less threatening or mild in effect. These DxID's have
an assigned severity level of "0."
More severe is for warnings that are more significant or where harm is a more likely outcome if it occurs.
These DxID's are assigned a severity level of "1."

Evidence Schema

Severity Level 1

Boxed Warning labeling adverse event content

Warnings and Precautions section adverse event content
Adverse Event section for side effects with potential for severe or life threatening consequence or
compromise
Post-marketing section for side effects with potential for severe or life threatening consequence or
compromise

Severity Level 0

Adverse Event section for side effects unlikely to result in serious or permanent effects

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SIDE Maintenance
This section contains information regarding the ongoing maintenance of the module's data.

External Triggers for Clinical Review

The First Databank Knowledge Base Services Department utilizes a robust methodology for capture,
documentation, triage and tracking of the most important sources for drug knowledge changes. The external
triggers that are triaged to the clinical editors for review are the following:

MedEffects Alerts from Health-Canada (except Non-U.S. product alerts exclusive to Canada)
FDA MedWatch Medical Product Safety Information Alerts
FDA CDER NEW
FDA CBER What's New
FDA MedWatch Monthly Label Changes
FDA Division of Drug Information (DDI)
FDA Hematology/Oncology (Cancer) Approvals and Safety Notifications
What's New at FDA in HIV/AIDS
FDA Table of Pharmacogenomic Biomarkers in Drug Labels
FDA Press Announcements

Internal Triggers for Clinical Review

The internal triggers that prompt the clinical editors to add or review data are the following:
New Clinical Formulations (GCN_SEQNO) added to the MedKnowledge database and their associated U.S.
product labeling are internal triggers that prompt the clinical editors to add or review SIDE drug group linking or
SIDE group (DxID) content.

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SIDE Resources
This section lists sources used by First DataBank to compile the information contained in the module.

The following references contain bibliographic information about the resources used by the clinical pharmacist
editorial staff to author the information contained in the module.

First Databank utilizes many reference sources including, but not limited to, the primary medical literature (for
example, published journal articles), medical reference texts, published expert treatment guidelines, and
manufacturer product package inserts. First Databank uses current source editions or versions when coding and
updating data, as well as when researching questions about data. However, a formal data review does not occur
for every new release of source editions or versions. Additional sources include:

American Society of Health System Pharmacists. AHFS Drug Information.

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SIDE Applications
This section provides information about the practical application of data contained in this module. The
applications utilize tables in the First Databank Medical Lexicon Module, and successful use of these applications
depends upon the following:

Familiarity with the First Databank Medical Lexicon Module and the Disease Identifier (DXID). Refer to the
FDB Medical Lexicon (FML) 2.0 for more information.
Ability to navigate to a Clinical Formulation ID (GCN_SEQNO) from a concept such as the NDC or MEDID.
Refer to MedKnowledge Identifiers and Attributes for more information.
Familiarity with drug concepts and their identifiers. Refer to the Multiple Access Points (MAPs) for
more information.
Assignment of a DxID or ICD Code to a given disease state. Refer to the FDB Medical Lexicon (FML)
2.0 for more information.

Retrieving a List of Side Effects

Detecting Additive Side Effects

Comparing Side Effects to Current Patient Conditions

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Retrieving a List of Side Effects

This application illustrates how to use SIDE to retrieve a list of drug side effects based on its Clinical Formulation
ID (GCN_SEQNO).

This example displays the following pieces of side effect information about pseudophedrine 30MG capsules
(Clinical Formulation ID [GCN_SEQNO] 013493):

Each side effects Primary Layman Name

Its frequency of occurrence
Its severity

This list of side effects can be sorted in a variety of ways (see the final step of the application for sorting options).

1. Query the GCN_SEQNO column of the SIDE GCN_SEQNO/Drug Side Effect Code Relation Table
(RSIDEGC0_GCNSEQNO_LINK) using the drugs Clinical Formulation ID (GCN_SEQNO) value to
retrieve all of its related SIDE Side Effects Code (SIDE) values.

GCN_SEQNO SIDE

013493 00361

Multi-ingredient drugs may have different side effects (SIDEs) for each ingredient.

2. Query the SIDE column of the SIDE Master Table (RSIDEMA3_MSTR) using each SIDE value from the
previous step to retrieve the following columns:
SIDE Frequency of Occurrence Code (SIDE_FREQ)
SIDE Severity Code (SIDE_SEV)
FML Disease Identifier (DXID)

GCN_SEQNO SIDE SIDE_FREQ SIDE_SEV DXID

013493 00361 0 0 00003063

013493 00361 0 0 00003305

013493 00361 1 0 00003133

013493 00361 1 0 00003059

013493 00361 1 0 00004389

013493 00361 1 0 00003092

013493 00361 1 0 00003153

013493 00361 1 0 00003176

013493 00361 1 0 00003189

013493 00361 1 0 00003223

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013493 00361 1 0 00003226

013493 00361 1 0 00003251

013493 00361 1 0 00003077

013493 00361 2 1 00003199

013493 00361 2 1 00001563

013493 00361 2 1 00003055

013493 00361 2 1 00003050

013493 00361 2 1 00001572

You may retrieve other side effect columns during this step, too, if your application requires
additional information.

3. Follow the process described in the FML modules Finding DXID Descriptions and Synonyms application
to find each DXID values Primary Layman Name.

GCN_SEQNO SIDE SIDE_FREQ SIDE_SEV DXID DXID_SYN_DE

SC100

013493 00361 0 0 00003063 Abnormal

Trouble
Sleeping

013493 00361 0 0 00003305 Nervous

013493 00361 1 0 00003133 Loss of Skin

Color

013493 00361 1 0 00003059 Dizzy

013493 00361 1 0 00004389 Feeling Weak

013493 00361 1 0 00003092 Involuntary

Quivering

013493 00361 1 0 00003153 Head Pain

013493 00361 1 0 00003176 Fast Heartbeat

013493 00361 1 0 00003189 Change in Pulse

013493 00361 1 0 00003223 Feel Like

Throwing Up

013493 00361 1 0 00003226 Throwing Up

013493 00361 1 0 00003251 Difficult or

Painful Urination

013493 00361 1 0 00003077 Excessive

Sweating

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013493 00361 2 1 00003199 Trouble

Breathing

013493 00361 2 1 00001563 Slow Heartbeat

013493 00361 2 1 00003055 Fit

013493 00361 2 1 00003050 Hallucination

013493 00361 2 1 00001572 Abnormal Heart

Rhythm

4. Use the Data Dictionary to find descriptions for the SIDE_FREQ and SIDE_SEV columns. For this
example we display information to the end-user based on the following descriptions:

SIDE_FREQ Description

0 Incidence more frequent

1 Incidence less frequent

2 Incidence rare or very rare

SIDE_SEV Description

0 less severe if it is non-threatening (such as

constipation)

1 severe if it may be life-threatening (such as

agranulocytosis)

5. Display the results to the end-user. You may sort the results based on a variety of columns, including
severity, frequency of occurrence, or name. The following results are grouped by frequency, then sorted in
each frequency group first by severity, then alphabetically:

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Detecting Additive Side Effects

This applications illustrates how to use SIDE to detect the chance of additive side effects by comparing the
potential side effects of the drugs on a patient profile. Shared side effects run the risk of being additive in nature,
and can be detrimental to the patient.

This example identifies the possible additive side effects between the following two medications based on their
Clinical Formulation IDs (GCN_SEQNO):

Enalapril Maleate 20 mg tablet (Clinical Formulation ID [GCN_SEQNO] 000386)

Methadone 10 mg tablet (Clinical Formulation ID [GCN_SEQNO] 004240)

The application presents each side effects Primary Professional Name to the end user.

1. Query the GCN_SEQNO column of the SIDE GCN_SEQNO/Drug Side Effect Code Relation Table
(RSIDEGC0_GCNSEQNO_LINK) using each drugs Clinical Formulation ID (GCN_SEQNO) value to
retrieve all of their related SIDE Side Effects Codes (SIDE).

GCN_SEQNO SIDE

000386 00002

004240 00116

2. Query the SIDE column of the SIDE Master Table (RSIDEMA3_MSTR) using each SIDE code found in the
previous step to retrieve their related FML Disease Identifiers (DXID). A sample of each Clinical
Formulation IDs (GCN_SEQNOs) related DXIDs are displayed below (total results exceed 100 DXID
codes).

GCN_SEQNO SIDE DXID

000386 00002 00000753

000386 00002 00000882

000386 00002 00000897

... ... ...

000386 00002 00012480

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000386 00002 00013393

GCN_SEQNO SIDE DXID

004240 00116 00000937

004240 00116 00000989

004240 00116 00000993

... ... ...

004240 00116 00003378

004240 00116 00003387

3. Query the FML Search DXID (SEARCH_DXID) column of the FML Disease Identifier (DxID) Search Table
(RFMLDSR0_DXID_SEARCH) using each DXID code found in the previous step to retrieve their FML
Related DXID (RELATED_DXID) and FML Navigation Code (FML_NAV_CODE) values. Additionally,
specify an FML Clinical Module Code (FML_CLIN_CODE) of 02 for the Side Effects module. A sample of
each Clinical Formulation IDs (GCN_SEQNOs) RELATED_DXIDs are displayed below.

GCN_SEQNO SIDE SEARCH_DXID RELATED_DXI FML_CLIN_CO FML_NAV_CO

D DE DE

000386 00002 00000753 00000753 02 01

000386 00002 00000882 00000882 02 01

000386 00002 00000897 00000897 02 01

... ... ... ... ... ...

000386 00002 00012480 00012480 02 01

000386 00002 00013393 00013393 02 01

GCN_SEQNO SIDE SEARCH_DXID RELATED_DXI FML_CLIN_CO FML_NAV_CO

D DE DE

004240 00116 00000937 00000937 02 01

004240 00116 00000989 00000989 02 01

004240 00116 00000993 00000993 02 01

... ... ... ... ... ...

004240 00116 00003378 00003378 02 01

004240 00116 00003387 00003387 02 01

You will use the FML_NAV_CODE when constructing alerts later in this process.

4.

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4. Compare the two sets of RELATED_DXIDs found in the previous step to identify the DXIDs that appear on
both lists. Matching codes represent side effects that are associated to both products.

5. Follow the process described in the FML modules Finding DXID Descriptions and Synonyms application to
find each matching RELATED_DXID values Primary Professional Name.

RELATED_DXID DXID_DESC100

00001709 Hypotension

00001791 Laryngeal Edema

00003051 Fainting

00003059 Dizziness

If any DXID values had an FML_NAV_CODE of 02 or 03, be sure to keep track of which DXID
code was the search code, and which was the related code. You will use both descriptions in the
user-output string (see the next step for more details).

6. Construct a string to present to the end user that loosely follows these guidelines. These guidelines refer to

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6.
the two drugs as Drug A and Drug B. Note that FML_NAV_CODE values of 02 and 03 require you to use
the SEARCH_DXID and RELATED_DXID values from step 3.
If FML_NAV_CODE = 01; [Drug A] and [Drug B] share the side effect [DXID_DESC100], which
may be additive in nature.
If FML_NAV_CODE = 02 or 03; [Drug A] and [Drug B] both exhibit side effects that relate to the
condition [Related DXID_DESC100]. [Drug A] has a potential side effect of [Drug A SEARCH_DXID
]. [Drug B] has a potential side effect of [Drug B SEARCH_DXID]. These two side effects are similar
and therefore may be additive in nature.

7. Display results to the end-user.

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Comparing Side Effects to Current Patient Conditions

This application illustrates how to use SIDE to compare potential side effects to a patients current conditions
(codified on their profile as ICD Codes or DXIDs).

1. Query the GCN_SEQNO column of the SIDE GCN_SEQNO/Drug Side Effect Code Relation Table
(RSIDEGC0_GCNSEQNO_LINK) using each drugs Clinical Formulation ID (GCN_SEQNO) value to
retrieve all of their related SIDE Side Effects Codes (SIDE).

A drug may have more than one SIDE code. Some or all of these SIDE codes may be filtered out
by the FML ICD Search Exclusion Table (RFMLISX0_ICD_SEARCH_EXCLUSION).

2. Query the SIDE column of the SIDE Master Table (RSIDEMA3_MSTR) using each SIDE code retrieved in
step 1 to retrieve their related FML Disease Identifiers (DXID).

3. Query the Clinical Module Drug Group (CLIN_DRUG_GROUP) column of the FML ICD Search Exclusion
Table (RFMLISX0_ICD_SEARCH_EXCLUSION) using each SIDE code retrieved in step 1 to retrieve ICD
to DxID mappings with FML_CLIN_CODE=02 that are to be excluded from the query in the next step.

4. Query the Search ICD Code (SEARCH_ICD_CD) column of the FML ICD Search Table
(RFMLISR1_ICD_SEARCH) using the ICD Code(s) from the patients profile to retrieve their FML Related
DXID (RELATED_DXID) and FML Navigation Code (FML_NAV_CODE) values. Additionally, specify an
FML Clinical Module Code (FML_CLIN_CODE) of 02 for the Side Effects module. Exclude any retrieved
ICD to DxID mapping records identified in step 3 from the results in this step.

If this step returns zero results, no potential side effects relate to the patient's current conditions.

5. Compare the DXIDs found in step 2 to the RELATED_DXIDs found in step 4 and identify the values that
appear on both lists. Matching codes represent side effects that are associated to a prescribed drug and a
patient condition.

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6. Follow the process described in the FML modules Finding DXID Descriptions and Synonyms application to
find each matching DXID values Primary Professional Name.

7. Follow the process described in the FML modules Retrieving an ICD Codes Alternate Description
application to find the SEARCH_ICD_CDs ICD Description (ICD_DESC).

8. Construct a string to present to the end user that loosely follows these guidelines based on each DXIDs
related FML_NAV_CODE found in step 3. You may present a warning for each side effect or prioritize
them as you see fit.
If FML_NAV_CODE = 01; [Prescribed Drug] has a potential side effect of [DXID_DESC100], which
is clinically equivalent to the patients current condition of [ICD_DESC].
If FML_NAV_CODE = 02, 03, or 04; [Prescribed Drug] has a potential side effect of [
DXID_DESC100], a condition related to the patients current condition of [ICD_DESC].

9. Display the results to the end-user.

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SIDE ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module. These table names are listed below.

SIDE Tables
SIDE ERD

SIDE Tables
SIDE GCN_SEQNO/Drug Side Effect Code Relation Table
SIDE Master Table
SIDE Routed Generic Table
SIDE Routed Medication Table
SIDE Side Effects Drug Description Table

SIDE ERD

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SIDE GCN_SEQNO-Drug Side Effect Code Relation Table

Table Name RSIDEGC0_GCNSEQNO_LINK

Revision Activity original

Purpose Links a clinical formulation to a side effect.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

P SIDE SIDE Side Effects N 5 9(5)

Code

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SIDE Master Table

Table Name RSIDEMA3_MSTR

Revision Activity rev.03-14-2002

Purpose Provides attributes of a side effect.

Key Column Name Column Format Length Picture

Description

P SIDE SIDE Side Effects N 5 9(6)

Code

P SIDE_SN SIDE Sequence N 2 9(2)

Number

F FDBDX First Databank AN 9 X(9)

Disease Code

SIDE_FREQ SIDE Frequency AN 1 X(1)

of Occurrence
Code

SIDE_SEV SIDE Severity AN 1 X(1)

Code

SIDE_VISCD SIDE Visibility AN 1 X(1)

Code

SIDE_LABCD SIDE Lab/Diagnos AN 1 X(1)

tic Test Code

SIDE_PHYS SIDE Physician AN 1 X(1)

Code

SIDE_HYPER SIDE AN 1 X(1)

Hypersensitivity
Indicator

F DXID FML Disease N 8 9(8)

Identifier (Stable
ID)

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SIDE Routed Generic Table

Table Name RSIDERG0_ROUTED_GEN_LINK

Revision Activity original

Purpose Links a routed generic to a side effect.

Key Column Name Column Format Length Picture

Description

PF ROUTED_GEN_I Routed Generic N 8 9(8)

D Identifier

PF SIDE SIDE Side Effects N 5 9(5)

Code

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SIDE Routed Medication Table

Table Name RSIDERM0_ROUTED_MED_LINK

Revision Activity add.07-01-2002

Purpose Links a routed medication to a side effect.

Key Column Name Column Format Length Picture

Description

PF ROUTED_MED_I MED Routed N 8 9(8)

D Medication ID
(Stable ID)

PF SIDE SIDE Side Effects N 5 9(5)

Code

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SIDE Side Effects Drug Description Table

Table Name RSIDEDD0_DRUG_DESC

Revision Activity add.02-20-2002

Purpose Relates the Side Effects Code to the text description of the
drug associated with it.

Key Column Name Column Format Length Picture

Description

P SIDE SIDE Side Effects N 5 9(5)

Code

SIDE_DRUG_DE SIDE Side Effects AN 100 X(100)

SC Drug Description

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Counseling Messages Module (CMM) 1.0

Counseling Messages Module Editorial Policies
Applications
ERD and Technical Specifications

In this module, U.S. data and external identifiers are used in the examples.

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Counseling Messages Module Editorial Policies

The policies and criteria that apply to the inclusion criteria, processes, and references used in the creation of this
module are provided in the following sections:

Overview
Definitions
Concepts
Inclusion Criteria
Data Elements
Rule Sets
Maintenance
References

Overview
The Counseling Messages Module (CMM) is intended to be used as an aid for the healthcare professional
involved in providing counseling to patients about the proper use, side effects, and other important information
about the medicine they receive. It also serves as an educational tool for the patient.

CMM must not be used as a substitute for Patient Education Module (PEM) monographs when
providing medication counseling to patients. CMM, like the PEM module, is not intended to be and must
not be used as, a substitute for oral medication counseling. CMM provides "counseling tips" for drug
products, but is not comprehensive.

Drug knowledge is aggregated at the Clinical Formulation ID (GCN_SEQNO), Routed Medication ID (

ROUTED_MED_ID), and the Routed Generic ID (ROUTED_GEN_ID) levels in the First Databank (FDB)
knowledge base. CMM associates clinical information at the Clinical Formulation ID ( GCN_SEQNO)
level. Under certain circumstances, aggregated drug knowledge may not apply to all related packaged
products; more specific information may be found within product labels.

Definitions
This section defines important terms related to the module that users should understand. Some industry terms
that have a specific connotation in regards to the module may also be defined.

CMMC
The Counseling Messages Message Codes (CMMC) are associated with a Clinical Formulation ID (
GCN_SEQNO) and each code references a set of text messages consisting of a one- or two-line professional
message and a one- or two-line patient message.

Concepts

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This section describes concepts important for understanding the Counseling Messages Module.

Counseling Messages Message Code

The Counseling Messages Module consists of a link between a drug record and a list of up to eight Counseling
Messages Message Codes. The Counseling Messages Message Code values are stored from left to right and are
not sorted (codes are stored in order of importance, so the left-most code is considered to be relatively more
important than the code on its right, and so forth).

Using the Counseling Messages Message Codes from a particular drug, the text of the message is determined by
searching the Counseling Messages Text Table for each Counseling Messages Message Code. You can display
all messages at the terminal, or you can display the professional messages and print the patient messages with
the prescription label. You can also do a combination of both of these options. All patient messages have a
corresponding professional message. However, messages that are only appropriate for the professional do not
have a corresponding patient message.

Inclusion Criteria
This section provides information detailing the criteria that guided the inclusion of the data contained within the
module as well as information pertaining to limitations or exclusions when appropriate to the discussion.

1. CMM includes CMM message sets created for specific ingredients and routes of administration and, as
necessary, specific dosage forms and ingredient strengths. CMM message sets are primarily based on
high-volume-use ambulatory care drug products.

2. CMM does not include CMM message sets covering medical supplies or devices, bulk chemical products,
oral/enteral nutritional supplements such as Ensure, or homeopathic remedies. CMM does not include
CMM message sets related to drug products that are administered and monitored solely by a healthcare
professional (as opposed to a patient or lay caregiver). An example would be general anesthetic gases or
general surgical parenteral products.

3. CMM message sets consist of the following:

Messages are provided for both the healthcare professional and the patient. Messages for the healthcare
professional are more technical and sometimes more explanatory. Each pair of messages (the
professional and corresponding patient message) is rated according to the importance of the information to
the patient. Therefore, all messages for the patient (which include the corresponding professional
messages) are rated first, and then if applicable, the stand-alone professional messages follow. At times,
one message might be equally as important as the next. When this occurs, the messages are arbitrarily
assigned rank. There are up to eight message pairs within a CMM message set.

CMM messages are available in the following languages: English, Spanish, and French.

Data Elements
This section contains additional information about particularly important tables and codes contained within the
module, as well as concepts about the data that the reader must understand in order to understand the module.

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Counseling Messages Module Message Text Table

This table contains all professional and patient counseling messages for English. English is included in the base
product but French and Spanish languages are premium modules and must be ordered separately.

CMMC
A four-byte numeric value that associates a counseling message to both the English language professional
message and patient message text. The other languages modules have a similar field in their message text table.
The CMMCF field is for the French messages and the CMMCS is for Spanish.

CMMC_RN
A one-character numeric value that identifies the priority (1,2,3, and so on) of a specific message in the CMM
message set attached to a given Clinical Formulation ID (GCN_SEQNO). It is used to determine message display
order.

CMRPH1(2)
Two fields of 34 characters each that contain the professional message text.

CMPAT1(2)
Two fields of 25 characters each that contain the patient message text.

GCN_SEQNO/Counseling Messages Module Counseling Message Relation Table

This table links a clinical formulation to an associated counseling message by the CMMC.

Rule Sets
This section provides rules that the clinical team uses in regards to creating the module's data, both general rules
and rules specific to data elements.

Rules of General Applicability

This section describes editorial policies that have a broad impact on the module data or by nature are less
specific than those policies in other sections.

As the Patient Education Module (PEM) serves as the source information for authoring the CMM Module, the
following from the PEM editorial policy applies to CMM:

The Action Plan for the Provision of Useful Prescription Medication Information (aka Keystone Guidelines)
and the 2006 Food and Drug Administration (FDA) Consumer Medication Information (CMI) Guidance
document form the industry guidelines for authoring and editing patient education monographs. PEM
editorial policy and work instructions reflect the recommendations within these documents.
Clinical Sources.

Rules for Data Elements

This section describes editorial policies that are more specific towards their effect on the data elements contained

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in the module.

1. CMMs are linked to clinical formulations meeting CMM inclusion criteria and further linked to activeNational
Drug Codes (NDC)or those that have been inactive less than 2 years.

2. Clinical formulations consisting of products without New Drug Application (NDA), Abbreviated New Drug
Application (ANDA), Biologic License Application (BLA), or an Over-the-Counter (OTC) Monograph are
excluded.

3. CMMs are linked to ingredient(s), route of administration, dosage form, and ingredient strength (that is, a
clinical formulation).

4. CMMs are deleted and stored in an archive database if all attached products (NDCs) become greater than
2 years obsolete, or the products have been officially withdrawn from the U.S. and Canadian markets for
greater than one year.

5. Spanish and French CMMs utilize the same Counseling Messages Message Code numeric value as the
corresponding English CMM.

Maintenance
This section contains information regarding the ongoing maintenance of the module's data.

External Triggers for Clinical Review

The external triggers that prompt the clinical editors to add or review data are the following:

MedEffects Alerts from Health Canada are reviewed and if such information meets inclusion criteria, CMM
data is updated on a weekly basis.
Ad hoc customer or manufacturer clinical inquiries are reviewed daily and the database is updated weekly
as appropriate.
FDA MedWatch Safety Alerts are reviewed and if such information meets inclusion criteria, CMM data is
updated on a weekly basis.
FDA MedWatch Safety Data - monthly professional labeling changes are reviewed and if such information
meets inclusion criteria, CMM data is updated on a monthly basis.

Internal Triggers for Clinical Review

The internal triggers that prompt the clinical editors to add or review data are the following:

New clinical formulations are reviewed against the CMM inclusion criteria on a daily basis. CMMs are
authored and attached to clinical formulations meeting inclusion criteria.
Changes to existing clinical formulations that result in potential CMM linkage changes are reviewed on a
daily basis.

References
This section lists sources used by FDB to compile the information contained in the module. The following

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references contain bibliographic information about the sources used by the clinical pharmacist editorial staff to
author the information contained in the module.

FDB primarily utilizes the following reference sources for the CMM module:

Manufacturer's professional prescribing information.

Briggs G. Drugs in Pregnancy and Lactation.
Additional pregnancy and lactation references that may be consulted include NLMs LACTMED database,
Hale's Medications and Mothers' Milk, and the Organization of Teratology Information Specialists (OTIS)
Food and Drug Administration. MedWatch: The FDA Safety Information and Adverse Event Reporting
Program. Available at: http://www.fda.gov/medwatch.
Health Canada. Safety Alerts. Available at: http://healthycanadians.gc.ca/ra/dd-mmm-eng.php.
Medical Economics Staff. Physicians' Desk Reference.
Published by authority of the Board of Directors of the American Society of Health-System Pharmacists.
American Hospital Formulary Service (AHFS) Drug Information.

The following are references for the FDB approved set of herbal and dietary supplements:

Natural Medicines Comprehensive Database - Pharmacists Letter. Available at:

www.naturaldatabase.com/(S(m5kdfcfyw5lhx355dv2ydgir))/home.aspx?cs=&s=ND
NIH: National Center for Complementary and Integrative Health: https://nccih.nih.gov/

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Applications
This section provides information about the practical application of data contained in this module.

Sample Data

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Sample Data
The following examples illustrate the capabilities of the Counseling Message Module. In each example the
Counseling Messages Message Codes (CMMC) are retrieved from the drug record, and then the related text
messages are retrieved, sorted by the Counseling Messages Module Codes Relative Importance Number (
CMMC_RN), and displayed as shown on the following pages.

Example 1
Example 2

Example 1

NDC 00140 - 0005 - 01

Label Name VALIUM 5MG TABLET

Generic Name DIAZEPAM

GCN_SEQNO 003768

GCN 14222

CMMCs 1110, 1554, 1367, 1198, 1670, 1718, 1395, 1916

CMMC CMMC_RN Professional Message Patient Message

(CMRPH1 and CMRPH2) (CMPAT1 and CMPAT2)

1110 1 Not recommended during Do not take while breast

pregnancy feeding or when pregnant
or breast feeding

1554 2 May cause drowsiness or May make you drowsy or

dizziness dizzy. Drive with caution
Use caution driving

1367 3 Avoid taking with other CNS Avoid alcohol/other drugs

depressant drugs or alcohol that make you sleepy

1198 4 Instruct not to coadminister Avoid taking grapefruit

with juice/grapefruit with med
grapefruit or grapefruit juice

1670 5 Check with doctor before Call Dr before increasing

increasing dose or frequency dose or frequency

1718 6 Discuss gradual dose MD may need to reduce the

reduction dose before you stop it
with MD before stopping
medication

1395 7 Many drug-drug interactions Review all drugs you are

possible with this drug taking with your doctor

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1916 8 Depression or thoughts of Immediately report to MD

suicide any thoughts of suicide
should be reported to MD
ASAP

Example 2

NDC 00093-4155-73

Label Name AMOXICILLIN 250 MG/5 ML SUSP

Generic Name AMOXICILLIN TRIHYDRATE

GCN_SEQNO 008998

GCN 39683

CMMC 0282, 0857, 0320, 1688, 0020, 0052, 1689, 1687

CMMC CMMC_RN Professional Message Patient Message

(CMRPH1 and CMRPH2) (CMPAT1 and CMPAT2)

0282 1 Do not use if allergic Do not take if you are

to penicillins allergic to penicillin

0857 2 Tell doctor what medicines Tell doctor what medicines

you are taking you are taking

0320 3 Shake well before using Shake well before using

1688 4 Discard unused portion Discard unused portion

after 14 days after 14 days

0020 5 Must complete full course Must use for full length
of therapy of treatment

0052 6 Space doses evenly Space doses evenly

throughout the day

1689 7 Oral or vaginal yeast Watch for oral thrush or

infections vaginal yeast infections
may occur due to changes in
flora

1687 8 Call doctor if rash Call DR if rash

or severe diarrhea occur or severe diarrhea occur

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CMM ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

Counseling Messages Tables

Counseling Messages ERD

Counseling Messages Tables

Counseling Message Module Message Text Table
GCN_SEQNO/Counseling Message Module Counseling Message Relation Table
Counseling Message Module French Language Message Text Table
GCN_SEQNO/Counseling Message Module French Language Counseling Message Relation Table
Counseling Message Module Spanish Language Message Text Table
GCN_SEQNO/Counseling Message Module Spanish Language Counseling Message Relation Table

Counseling Messages ERD

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Counseling Message Module French Language Message Text Table

Table Name FCMMD0_FRENCH_DESC

Revision Activity original

Purpose Associates a counseling message to both the

French-language professional and patient message text.

Key Column Name Column Format Length Picture

Description

P CMMCF Counseling N 4 9(4)

Messages
French-Language
Message Code

CMRPH1 Counseling AN 34 X(34)

Messages
Professional Text
Column 1

CMRPH2 Counseling AN 34 X(34)

Messages
Professional Text
Column 2

CMPAT1 Counseling AN 25 X(25)

Messages Patient
Text Column 1

CMPAT2 Counseling AN 25 X(25)

Messages Patient
Text Column 2

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Counseling Message Module Message Text Table

Table Name RCMMD0_DESC

Revision Activity add.01-22-1993

Purpose Associates a counseling message to both the professional

message and patient message text.

Key Column Name Column Format Length Picture

Description

P CMMC Counseling N 4 9(4)

Messages
Message Code

CMRPH1 Counseling AN 34 X(34)

Messages
Professional Text
Column 1

CMRPH2 Counseling AN 34 X(34)

Messages
Professional Text
Column 2

CMPAT1 Counseling AN 25 X(25)

Messages Patient
Text Column 1

CMPAT2 Counseling AN 25 X(25)

Messages Patient
Text Column 2

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Counseling Message Module Spanish Language Message Text Table

Table Name SCMMD0_SPNSH_DESC

Revision Activity add.06-15-1995

Purpose Associates a counseling message to both the

Spanish-language professional and patient message text.

Key Column Name Column Format Length Picture

Description

P CMMCS Counseling N 4 9(4)

Messages
Spanish-Languag
e Message Code

CMRPH1 Counseling AN 34 X(34)

Messages
Professional Text
Column 1

CMRPH2 Counseling AN 34 X(34)

Messages
Professional Text
Column 2

CMPAT1 Counseling AN 25 X(25)

Messages Patient
Text Column 1

CMPAT2 Counseling AN 25 X(25)

Messages Patient
Text Column 2

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GCN_SEQNO Counseling Message Module Counseling Message Relation

Table
Table Name RCMMGC0_GCNSEQNO_LINK

Revision Activity add.01-22-1993

Purpose Links a clinical formulation to an associated counseling

message.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF CMMC Counseling N 4 9(4)

Messages
Message Code

CMMC_RN Counseling N 1 9(1)

Messages Module
Codes Relative
Importance
Number

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GCN_SEQNO Counseling Message Module French Language Counseling

Message Relation Table
Table Name FCMMGC0_FRENCH_GCNSEQNO_LINK

Revision Activity original

Purpose Links a clinical formulation to an associated

French-language counseling message.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF CMMCF Counseling N 4 9(4)

Messages
French-Language
Message Code

CMMC_RN Counseling N 1 9(1)

Messages Module
Codes Relative
Importance
Number

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GCN_SEQNO Counseling Message Module Spanish Language Counseling

Message Relation Table
Table Name SCMMGC0_SPNSH_GCNSEQNO_LINK

Revision Activity add.06-15-1995

Purpose Links a generic formulation to an associated

Spanish-language counseling message.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID

PF CMMCS Counseling N 4 9(4)

Messages
Spanish-Languag
e Message Code

CMMC_RN Counseling N 1 9(1)

Messages Module
Codes Relative
Importance
Number

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Drug Images Module 2.0

General Information
Drug Images Module Editorial Policies
Applications
ERD and Technical Specifications

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Drug Images General Information

The General Information section contains high-level information about the module.

Overview
Concepts

Overview
The Drug Images Module provides a collection of electronically stored photographs of drugs, as well as a
cross-reference of each external drug identifier (such as an NDC, UPC, HRI, or PIN) to its corresponding
photograph. The electronically stored photographs are referred to as image files.

Each photograph is provided in Joint Photographic Experts Group Format (.jpg).

You must use a monitor with at least 256-color format to ensure accurate color representation.

Concepts
This section describes concepts and database elements that are important for understanding the module.

Image Lifespans
Images have Image Start Date (IMGSTRTDT) and Image Stop Date (IMGSTOPDT) attributes. Use these dates to
determine whether the image is active or expired.

The Start Date field contains the date the image was added to the IMG database. This policy took effect
December 18, 2003 and it applies to all subsequently entered data. Images added prior to December 18, 2003
may be represented either by the date the NDC was added to the Drug Images Module or the date a change was
made to the drugs image.

The stop date is applied to an image when the product image and/or image description has changed and is no
longer marketed with that appearance. If an image has a Stop Date there could be a more up-to-date image on
file. In addition, a single NDC may have multiple active images when the manufacturer is actively marketing both
images. When FDB is notified the product image is no longer marketed, a stop date will be applied.

The Drug Images Module retains historical image data for three years after a drug product is marked
obsolete in the OBSDTEC field. This allows users continued access to images of drugs that were
changed or deleted by their manufacturers.

Repackagers/Redistributors
FDB will permit linkage of repackaged products under certain conditions. See the Repackagers/Redistributors
section of the Packaged Product Module for details.

Some historic images for some repackagers may exist on the database with a Stop Date.

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You can combine the Drug Images Module with the Drug Imprints Module to provide both visual and interpretive
descriptions of a drug. The Drug Imprints Module has descriptive information about drugs including, but not
limited to, color, dosage form, shape, imprint, and score marks. For more information about the Drug Imprints
Module, refer to the Drug Imprints Module 2.1.

Products with Multiple Images and Imprints

Pursuant to controlling FDA regulations, if a labeler makes changes to its product's image it is required to obtain a
new NDC for it. This policy addresses the likelihood of confusion by dispensers and patients who would otherwise
be confronted with a conflict when an image and a dispensed product with the same NDC have a different
appearance.

Nonetheless, labelers have marketed a limited number of NDCs that are present on FDB's MedKnowledge
database with such multiple versions, some for a protracted period of time. To address this situation, FDB has
developed the following policy.

When FDB becomes aware that an NDC has been marketed with more than one image or imprint, we will:

Inform the manufacturer that FDA regulations require the issuance of a new NDC.
Forward a copy of the communication to the FDA.
Maintain both image versions in the database with the addition of an electronic watermark on both the
original and the new image (when we acquire it) stating "Mfg markets alternative version."
Output a blank image with a watermark of "No image available - Mfg markets alternative version" when
FDB has not yet been able to obtain the alternative image.

Through these indicators, dispensing pharmacists who receive images will at least be afforded a possible
explanation for an inconsistency between a product and its image on our database.

Since technical considerations prevent the inclusion of a corresponding message in our imprint file,
imprint-only customers will have to review the FDB-maintained list to identify when an NDC has been
marketed with different appearances.

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Drug Images Module Editorial Policies

The policies and criteria that apply to the scope and processes of the Drug Images Module are provided in the
following sections:

Scope
Editorial Process

Scope
The Drug Images Module provides electronically-stored digital photographs of drugs intended to assist the
healthcare professional and patients in identifying drugs. The drug images include the following characteristics:

standard gray background (The background for some images may vary for optimal color and grayscale
printing.)
same size on the screen
JPEG file format (.jpg)
.jpg files are provided in a compressed format
quality defined by the capturing of the true color of the image and the readability of the imprint
file sizes kept to a minimum (when possible) without reducing the quality expected by the end-users

The database contains images of numerous dosage forms, including tablets, capsules, liquids, creams,
ointments, and suppositories. The dosage form, packaging, and/or route of the drug define its image. For an oral
tablet or capsule the database contains images of both sides of the drug.

Requests for specific product additions to the database will be considered on an individual basis. Image requests
must be routed through Customer Service and meet established criteria. Prescription, solid oral dosage forms,
and products assigned NDCs are our highest priorities.

Editorial Process
The following section describes the processes and criteria the clinical editors use to add or review database
elements.

External Triggers for Clinical Review

The external triggers that prompt the clinical editors to add or review data are the following:

MedWatch Safety Alerts

Change in Structured Product Labeling
Manufactuer updates

Internal Triggers for Clinical Review

Not applicable.

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Drug Images Module Applications

This section provides information about the practical application of data contained in this module.

Displaying and/or Printing Images

Placing Images on Patient Education Monographs

Using Images in Interactive Computer Applications

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Displaying and|or Printing Images

Use the following application to display and/or print images from the Drug Images Module.

1. Retrieve the associated record(s) from the Unique Drug Table using the External Drug ID value of a given
drug product.
The External Drug ID, such as an NDC, identifies the appropriate Unique Drug ID when retrieving
records.
If searching for an NDC, the full 11 digits of the NDC can be used, or a partial NDC (such as the first
nine digits of the NDC) can be used. Although there are exceptions, most labelers use the last two
digits of the NDC to identify packaging for a drug, so the image of the drug product may be the
same for all package sizes. This is usually true for tablet and capsule dosage forms where the
package is not included in the image; however, in cases such as bulk bottles of liquid or tubes of
ointment, distinct package sizes are represented by different image records. Selecting the first
match on the partial NDC may or may not return the desired drug products image record. If multiple
images are returned, searching on the full 11-digit NDC will eliminate image records associated with
other package sizes.
There may be more than one Unique Drug ID for an External Drug ID. This would occur when a
labeler sells the same External Drug ID from two or more manufacturers. In this situation, the drug
product is referred to as a repackaged/redistributed drug.
A repackaged/redistributed drug will have a manufacturer identifier associated with the External
Drug ID. The manufacturer name should be retrieved from the Drug Manufacturer Table using the
Manufacturer ID. Only repackaged/redistributed drugs have Manufacturer IDs. The Unique Drug ID
will only point to a unique combination of an External Drug ID and a Manufacturer ID.
The Start and Stop Dates, located in the Unique Drug Image Journal Table, are used to identify
which image record is active for a specified Unique Drug ID. To see an image of the most recent
version of a drug, select only the active record. To see historical data as well as the most recent
version, select all records for that Unique Drug ID. See the Image Lifespans in the Concepts section
earlier in this section for more information.
If there is no matching record in the Unique Drug Image Journal Table, an image is not available for
that drug product. Leave the area blank on printed documents or inform the end-user in an
interactive application.
If there is more than one record for a particular External Drug ID that does not have a Stop Date,
then multiple images are active for that External Drug ID. Devise a routine to display each image
with its corresponding manufacturer name to the user and allow the user to select the appropriate
image to be displayed or printed.

2. Concatenate the Image Filename value in that record with the extension for the image format utilized by
your application.
.jpg (Joint Photographic Experts Group Format)
For Example 1, the image file for NDC 00071000724 is P_D00070.jpg.
For Example 2, the image file for NDC 54569047801 is MYN01520.jpg.

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3. Retrieve the image file(s) with the filename obtained in Step 2, from either the products CD-ROM or from
your environment (if you have moved the image files to your environment). The subdirectories on the
CD-ROM are:
.jpg (Joint Photographic Experts Group Format)

The previous instructions are correct for a DOS/Windows environment. The method may vary with
other operating systems (such as UNIX).

4. Display or print the image with the drug name and/or NDC obtained from an NDC-based drug file.

There may be an interpretive description of a drug product in the Drug Imprints Module even
though no image is found in the Drug Images Module. (Refer to the Drug Imprints Module 2.1
Documentation Manual for more information.)

ExampleDisplaying and/or Printing Images

Input

External Drug ID: 00071000724 (NDC)

Drug Start Date Stop Date Image Filename

DILANTIN 50 MG INFATAB 2/07/1997 P_D00070

ExampleDisplaying and/or Printing Images for Repackaged/Redistributed Drug

Input

External Drug Identifier: 55289007301 (NDC)

Drug Start Date Stop Date Image Filename Manufacturer

Clonidine HCl 0.1MG 5/11/2016 MYN01520 PD-Rx

Tablets Pharmaceutical

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Placing Images on Patient Education Monographs

1. Use the previous application to obtain an image, matching on a partial NDC. Where multiple images are
returned due to differences in images resulting from different package sizes or in the case of a
repackaged/redistributed drug, select the correct image prior to generating the Patient Education
Monograph.

2. Display the image on the Patient Education Monograph at preset coordinates reserved for the drug image.

ExamplePlacing Images on Patient Education Monographs

Input

External Drug ID: 00071-0007

Expected Results

The following pages contain an example of a drug image placed on a Patient Education monograph.

This example is for documentation illustration purposes only. The font size, line length, white space, and
spacing that you use should be selected to maximize reading ease by a wide variety of patients.

ExamplePatient Education Monograph with Drug Image

IMPORTANT NOTE: THE FOLLOWING INFORMATION IS INTENDED TO SUPPLEMENT, NOT SUBSTITUTE FOR,
THE EXPERTISE AND JUDGMENT OF YOUR PHYSICIAN, PHARMACIST OR OTHER HEALTHCARE
PROFESSIONAL. IT SHOULD NOT BE CONSTRUED TO INDICATE THAT USE OF THE DRUG IS SAFE,
APPROPRIATE, OR EFFECTIVE FOR YOU. CONSULT YOUR HEALTHCARE PROFESSIONAL BEFORE USING THIS
DRUG.

PHENYTOIN ORAL

(fen-eh-TOE-in, FEN-eh-toyn)

COMMON BRAND NAME(S): Dilantin

USES: This medication is used to treat seizures and epilepsy.

HOW TO USE: Take with food or milk if stomach upset occurs. Capsules should be swallowed whole unless otherwise
directed. Chewable tablets must be chewed thoroughly before swallowing. The suspension must be shaken well before
measuring each dose.

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This medication must be taken as prescribed. Do not stop taking this drug suddenly without consulting your doctor as
seizures may occur.

It is important to take all doses on time to keep the level of medication in your blood constant. Do this by taking doses at
the same time(s) each day. Do not skip doses.

SIDE EFFECTS: Constipation, dizziness and drowsiness may occur. If these effects continue or worsen, inform your
doctor.

Unlikely but report: blurred vision, unsteadiness, nausea, mood changes or confusion, slurred speech, rash, insomnia,
headache.

Very unlikely but report: vomiting, stomach pain, uncoordinated movements, tingling in hands or feet, fever, yellowing of
the eyes or skin, swollen glands, sore throat, unusual bleeding or bruising.

May cause enlargement of the gums. This can be minimized by maintaining good oral hygiene with regular brushing,
flossing and massaging of the gums.

In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention. Symptoms of an allergic
reaction include: rash, itching, swelling, dizziness, trouble breathing.

If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Tell your doctor your medical history, especially of: blood disorders (e.g., porphyria), allergies (especially
drug allergies), liver disease.

Use caution operating machinery or performing tasks requiring alertness if this medication makes you dizzy or drowsy.

Limit alcohol use as it may increase the drowsiness effect of this medication.

Limit your caffeine usage.

Phenytoin is not recommended for use during pregnancy. Consult your doctor before taking this drug.

This drug is excreted into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Inform your doctor of all the medicines you may use (both prescription and nonprescription),
especially of: warfarin, cimetidine, omeprazole, sucralfate, disulfiram, oral antifungal medication (azoles), xanthine drugs
(e.g., theophylline), isoniazid, folic acid, pyrimethamine, sulfa antibiotics, birth control pills, rifampin, trimethoprim, amiodar
one, fluoxetine, anticancer drugs, valproic acid or divalproex, estrogens, disopyramide, levodopa, felodipine, primidone,
felbamate, digoxin, metyrapone, dopamine, chloramphenicol, phenylbutazone, quinidine, doxycycline, diazoxide,
cyclosporine, corticosteroids (e.g., prednisone,hydrocortisone), narcotic pain medicines (e.g., codeine).

Phenytoin may interfere with the effectiveness of birth control pills. Discuss using other methods of birth control with your
doctor.

Do not start or stop any medicine without doctor or pharmacist approval.

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OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately.
Symptoms of overdose may include unusual eye movements, unsteadiness, nausea, dizziness, confusion, tremor, slurred
speech, drowsiness, and loss of consciousness.

NOTES: Do not change from one brand of this product to another without consulting your doctor or pharmacist. Products
made by different companies may not be equally effective.

Lab tests may be done to monitor your progress.

MISSED DOSE: If you miss a dose and take 1 dose daily: take as soon as remembered unless you do not remember until
the next day. In that case, skip the missed dose and resume your usual dosing schedule the following day. If you take
several doses daily and should miss a dose: take as soon as remembered unless it is within 4 hours of the next dose. In
that case, skip the missed dose and resume your usual schedule. Check with your doctor if you miss doses for more than
2 days in a row. Do not double the dose to catch up.

STORAGE: Store at room temperature away from moisture and sunlight. Do not store in the bathroom.

Your condition can cause complications in a medical emergency. For information on enrollment call Medic Alert at
1-800-854-1166. In Canada call 1-800-668-1507.

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Using Images in Interactive Computer Applications

To use images in interactive computer applications, complete the following steps:

1. Prompt the user for the selected drug, or use the drug being referred to in a patients pharmacy or hospital
record.

2. Display the image at the default image size provided.

3. There may be more than one active image, as in the case of a repackaged/redistributed drug. You may
need to allow the user to view all the images for a drug, along with the corresponding manufacturer name.

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4. The images may be enlarged to fill any area, up to the full screen. FDB suggests programming a hot key or
another short keystroke to give the end-user an easy way to enlarge the image, if preferred.

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Drug Images Module ERD and Technical Specifications

This section provides the technical specifications for each of the tables contained in this module. These table
names are listed below.

Drug Images Module Tables

Drug Images Module ERD

Drug Images Module Tables

Image Drug Manufacturer Table
Image Table
Image Unique Drug Table
Image Unique Drug Image Journal Table

Drug Images Module ERD

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Image Drug Manufacturer Table

Table Name RIMGMFG2_DRUG_MANUFACTURER

Revision Activity add.08-01-2001

Purpose Relates the Manufacturer ID to its text description.

Key Column Name Column Format Length Picture

Description

P IMGMFGID Image N 10 9(10)

Manufacturer ID

IMGMFGNAME Image AN 30 X(30)

Manufacturer
Name

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Image Table
Table Name RIMGIMG2_IMAGE

Revision Activity add.08-01-2001

Purpose Provides the numeric identifier for drugs electronically

stored photograph.

Key Column Name Column Format Length Picture

Description

P IMGID Image ID N 10 9(10)

IMGFILENM Image Filename AN 20 X(20)

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Image Unique Drug Image Journal Table

Table Name RIMGUIJ2_UNQ_DRUG_JRNL

Revision Activity add.08-01-2001

Purpose Tracks the replacement history of a Unique Drug ID.

Key Column Name Column Format Length Picture

Description

PF IMGUNIQID Image Unique N 10 9(10)

Drug ID

P IMGSTRTDT Image Start Date N 8 9(8)

IMGSTOPDT Image Stop Date N 8 9(8)

F IMGID Image ID N 10 9(10)

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Image Unique Drug Table

Table Name RIMGUDG2_UNQ_DRUG

Revision Activity add.08-01-2001

Purpose Links a specific drug to its manufacturer.

Key Column Name Column Format Length Picture

Description

P IMGUNIQID Image Unique N 10 9(10)

Drug ID

F IMGDFID Image Dosage N 5 9(5)

Form ID

F IMGNDC Image External AN 20 X(20)

Drug ID

F IMGMFGID Image N 10 9(10)

Manufacturer ID

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Drug Imprints Module 2.1

General Information
Drug Imprints Module Editorial Policies
ERD and Technical Specifications

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General Information Drug Imprints

The General Information section contains high-level information about the module.

Overview
Concepts

Overview
The Drug Imprints Module provides descriptive data used to characterize prescription and over-the-counter (OTC)
drug products in sufficient detail so end-users can identify a specific drug product (such as a tablet, capsule, or
liquid). For tablets and capsules, the description may include but is not limited to:

color(s)
imprint(s)
score mark(s) (for tablets)
shape

The description for liquids may include:

color
flavor
product clarity

In some cases, the description may be too specific for search purposes so the addition of a more basic
description may include but is not limited to:

color(s)
shape

The Drug Imprints Module includes records for inactive drug products for up to 36 months after the
obsolete date.

The Drug Imprints Module may be combined with FDB's Drug Images Module to provide both visual and
interpretive descriptions of a drug. The Drug Images Module has electronic photographs of many of the products
contained in the Drug Imprints Module.

Concepts
This section describes concepts and database elements that are important for understanding the module.

Descriptors
Dosage Form
Imprint (1 or 2)
Text

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Imprint Label ID

Descriptors
Each of the descriptors used in the Drug Imprints Module is explained below. Examples are provided to assist you
in understanding how FDBs editorial staff maintains data to provide the most useful information for end-users.

Color

The Color descriptors identify a products color(s). Examples of this field are shown below:

Description Color

White tablet White

Capsule which is green on one side and Green Green

yellow on the other Yellow

Tablet with layers of white, pink, and blue White

Pink

Blue

Clear is considered a color for description purposes.

Drug products such as oral contraceptives may contain multiple tablets each with a different color. In this
example, the product color may be listed as multi-colored (3) where the (3) indicates three different colored
tablets within the package.

The color description used to describe the drug product generally comes from the manufacturer. When supplied
with a drug product labeled as Flesh or Flesh color, it is FDBs policy to always input the color as Peach.

Shape

The Shape descriptor helps to identify the drug product by general description of the shape.

Examples include:

oval - described as oval

capsule-shaped - described as oblong

Score Marks

Score marks (lines that divide tablets to assist with breaking the tablet) help to identify the drug product. For drug
products with a single score, the word "scored" is used. Drug products that have a double score are indicated as
"double-scored." Other terms may be used to describe distinctive score marks.

Coating

Whether or not a tablet is coated may aid in the product description. If the product is coated, the description used
is that of the manufacturer.

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Examples include

coated
film-coated
sugar-coated
enteric-coated

Clarity

The Clarity descriptor is generally not output for most products. However, this field will be populated if it helps
describe the product. For example, solutions that are red in color and are clear have the word "clear" in the Clarity
field. Products such as suspensions are not described as cloudy or hazy.

Flavor

The Flavor descriptor is used to help describe flavored products. Generally, all liquids have a color and a flavor.
However, color and flavor only appear in the Drug Imprints Module if provided by the manufacturer.

Dosage Form
The Dosage Form field uses the most common noun to identify the product. Most drug products are described as
tablet, capsule, suspension, or elixir. Some manufacturers use descriptions that may be confusing to the general
public if printed on a patient drug education monograph (for example, caplet). Since most individuals would
identify this as a tablet, the more common term tablet is used to identify such dosage forms.

Imprint (1 or 2)
Imprints are those characters or symbols that are printed on tablets and capsules and are usually unique to that
particular product. Imprints may be coded numbers, letters, or combinations of numbers and letters. Some
products may have the product name or the companys logo imprinted.

Since the manufacturers logo is not easily described, the presence of a logo will be simply identified in the Imprint
field as logo. Some examples of imprints and how they will be printed are as follows:

Example Imprint field

Product imprinted with a single group of numbers, letters, or A2C

combination

Product with two sets of numbers or letters on one side of 7720 BMS 250
product

Product with imprints on both sides 60MG (Imprint 1)

1102 (Imprint 2)

Products with a logo and a number logo and 538

Products with 2 possible imprints logo and 843 or KEM

Text

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This field is used to provide any other information that may be useful in identifying a product. Generally, we do not
recommend that this information be printed on patient monographs because it is difficult to provide a uniform
format. (Examples of data in the Text field might include the color of beads within a capsule or the color of ink
used for an imprint.)

Imprint Label ID
The Imprint Label ID identifies a unique set of key characteristics of a drug product. The ID, along with the details
of the characteristics, are supplied to third-party label vendors so that customers who implement third-party label
printing technology can quickly print auxiliary labels, pre-defined in size and content, with key information
describing the physical appearance and characteristics of a drug product.

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Drug Imprints Module Editorial Policies

The policies and criteria that apply to the scope, processes, and sources of the Drug Imprints Module are
provided in the following sections:

Scope
Editorial Process
Sources

Scope
The Drug Imprints Module provides data that assists healthcare professionals in identifying drug products using a
variety of descriptors. This information may be printed on a patient drug education monograph as a teaching tool
or as a mechanism to ensure that patients have received the correct medication. Although an individual descriptor
may not be sufficient to identify a drug product, the combination of various descriptors combined with the dosage
form and imprint information will, in most cases, allow the end-user or patient to identify the medication.
Descriptors used in the Drug Imprints Module include:

color(s)
shape
score mark(s)
coating
clarity (liquids, if applicable)
flavor (liquids and chewables, if applicable)

Editorial Process
The following section describes the processes and criteria the clinical editors use to add or review database
elements.

External Triggers for Clinical Review

Internal Triggers for Clinical Review
Imprint Lifespans
Reconstituted Products
Repackagers/Redistributors
Products With Multiple Imprints or Images

External Triggers for Clinical Review

The external triggers that prompt the clinical editors to add or review data are the following:

MedWatch Safety Alerts

Change in Structured Product Labeling

Internal Triggers for Clinical Review

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Not applicable.

Imprint Lifespans
Imprints have Imprint Journal Start Date (IPTSTRTDT) and Imprint Journal Stop Date (IPTSTOPDT) attributes.
Use these dates to determine whether the imprint is active or expired.

The Start Date field contains the date the imprint was added to the IPT database. This policy took effect
December 18, 2003 and it applies to all subsequently entered data. Data added prior to December 18th could
have represented either the date the NDC was added to IPT or a change in the drugs imprint.

If an imprint has a Stop Date, there could be a more up-to-date imprint data on file.

The Drug Imprints Module retains historical imprint data for three years after a drug product is marked
obsolete. This allows users continued access to imprints of drugs that were changed or deleted by their
manufacturers.

Reconstituted Products
The Imprint Description column (IPTDESC) contains the color of the final (reconstituted) product when the color is
available from the manufacturer. In addition, information about the color of the powder before reconstitution is
contained in the Imprint Text column (IPTTEXT).

When the color for a product after reconstitution is not available from the manufacturer, the Imprint Description
column does not contain an associated color descriptor. However, the powder color appears in the Imprint Text
column.

Repackagers/Redistributors
FDB will permit linkage of repackaged products under certain conditions. See
the Repackagers/Redistributors section of the Packaged Product Module's Editorial Policy for details.

Some historic imprints for some repackagers may exist on the database with Stop Dates.

You can combine the Drug Images Module with the Drug Imprints Module to provide both visual and interpretive
descriptions of a drug. The Drug Images Module provides a collection of electronically stored photographs of
drugs. For more information about the Drug Images Module, refer to the Drug Images Module 2.0
documentation.

Products With Multiple Imprints or Images

Pursuant to controlling FDA regulations, if a labeler makes changes to its product's imprint it is required to obtain
a new NDC for it. This policy addresses the likelihood of confusion by dispensers and patients who would
otherwise be confronted with a conflict when an image and a dispensed product with the same NDC have a
different appearance.

Nonetheless, labelers have marketed a limited number of NDCs that are present on FDB's MedKnowledge

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database with such multiple versions, some for a protracted period of time. To address this situation, FDB has
developed the following policy.

When FDB becomes aware that an NDC has been marketed with more than one image or imprint, we will:

Inform the manufacturer that FDA regulations require the issuance of a new NDC.
Forward a copy of the communication to the FDA.
Maintain both imprint versions in the database with the addition of an electronic watermark on both the
original and the new image (when we acquire it) stating "Mfg markets alternative version."
Output a blank image with a watermark of "No image available - Mfg markets alternative version" when
FDB has not yet been able to obtain the alternative image.

Through these indicators, dispensing pharmacists who receive images will at least be afforded a possible
explanation for an inconsistency between a product and its image on our database.

Since technical considerations prevent the inclusion of a corresponding message in our imprint file,
imprint-only customers will have to review the FDB-maintained list to identify when an NDC has been
marketed with different appearances.

Sources
Manufacturer data is used as the primary reference for imprint information. Package inserts or structured product
labels (SPL) are used during editorial review to ensure the Imprint data correctly represents the manufacturer
information. If FDB obtains the image of the product, the imprint will be updated as needed. Occasionally,
manufacturers will change their imprints, especially if the product is sold to another company. The editorial staff at
FDB makes changes as soon as information is received in our office and confirmed with the manufacturer.

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Drug Imprints ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

Drug Imprints Module Tables

Drug Imprints Module ERD

Drug Imprints Module Tables

Imprint Basic Descriptor Table
Imprint Descriptor Category Table
Imprint Descriptor Table
Imprint Dosage Form Table
Imprint Drug Manufacturer Table
Imprint Property Descriptor Table
Imprint Property Imprint Table
Imprint Property Text Table
Imprint Text Table
Imprint Unique Drug Imprint Image Journal Table
Imprint Unique Drug Imprint Journal Table
Imprint Unique Drug Table

Drug Imprints Module ERD

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Imprint Basic Descriptor Table

Table Name RIPTBSC2_BASIC_DESCRIPTOR

Revision Activity add.08-01-2001

Purpose Associates similar descriptors to a more basic description,

and relates the Basic Descriptor ID to its text description.

Key Column Name Column Format Length Picture

Description

PF IPTCATID Imprint Category N 5 9(5)

ID

P IPTBSCDID Imprint Basic N 5 9(5)

Descriptor

IPTBSCDESC Imprint Basic AN 30 X(30)

Description

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Imprint Descriptor Category Table

Table Name RIPTCAT2_DESCRIPTOR_CATEGORY

Revision Activity add.08-01-2001

Purpose Relates the Category ID to its text description.

Key Column Name Column Format Length Picture

Description

P IPTCATID Imprint Category N 5 9(5)

ID

IPTCATDESC Imprint Category AN 30 X(30)

Description

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Imprint Descriptor Table

Table Name RIPTDES2_DESCRIPTOR

Revision Activity add.08-01-2001

Purpose Associates descriptive data to a unique drug, and relates

the Descriptor ID to its text description.

Key Column Name Column Format Length Picture

Description

PF IPTCATID Imprint Category N 5 9(5)

ID

PF IPTDESCID Imprint Descriptor N 5 9(5)

ID

F IPTBSCDID Imprint Basic N 5 9(5)

Descriptor ID

IPTDESC Imprint AN 30 X(30)

Description

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Imprint Dosage Form Table

Table Name RIPTDOS2_DOSE_FORM

Revision Activity add.08-01-2001

Purpose Relates the Dosage Form ID to its text description.

Key Column Name Column Format Length Picture

Description

P IPTDFID Imprint Dosage N 5 9(5)

Form ID

IPTDFDESC Imprint Dosage AN 30 X(30)

Form Description

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Imprint Drug Manufacturer Table

Table Name RIPTMFG2_DRUG_MANUFACTURER

Revision Activity add.08-01-2001

Purpose Relates the Manufacturer ID to its text description.

Key Column Name Column Format Length Picture

Description

P IPTMFGID Imprint N 10 9(10)

Manufacturer ID

IPTMFGNAME Imprint AN 30 X(30)

Manufacturer
Name

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Imprint Property Descriptor Table

Table Name RIPTPDE2_PROPERTY_DESCRIPTOR

Revision Activity add.08-01-2001

Purpose Links a unique drug to its descriptive data.

Key Column Name Column Format Length Picture

Description

P IPTPROPID Imprint Property N 10 9(10)

ID

PF IPTCATID Imprint Category N 5 9(5)

ID

PF IPTDESCID Imprint Descriptor N 5 9(5)

ID

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Imprint Property Imprint Table

Table Name RIPTPIM2_PROPERTY_IMPRINT

Revision Activity add.08-01-2001

Purpose Associates descriptions of both sides of a drug to a unique

drug.

Key Column Name Column Format Length Picture

Description

PF IPTPROPID Imprint Property N 10 9(10)

ID

IPTSIDE1 Imprint Side 1 AN 40 X(40)

IPTSIDE2 Imprint Side 2 AN 40 X(40)

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Imprint Property Text Table

Table Name RIPTPTX2_PROPERTY_TEXT

Revision Activity add.08-01-2001

Purpose Links additional descriptive text to a particular drug product.

Key Column Name Column Format Length Picture

Description

PF IPTPROPID Imprint Property N 10 9(10)

ID

PF IPTTEXTID Imprint Text ID N 10 9(10)

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Imprint Text Table

Table Name RIPTTXT2_TEXT

Revision Activity add.08-01-2001

Purpose Relates the Text ID to its text description and provides

attributes of that association.

Key Column Name Column Format Length Picture

Description

P IPTTEXTID Imprint Text ID N 10 9(10)

P IPTLINENO Imprint Line N 3 9(3)

Number

IPTTEXT Imprint Text AN 70 X(70)

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Imprint Unique Drug Imprint Image Journal Table

Table Name RIPTUII2_UNQ_DRUG_IMG_IPT_JRNL

Revision Activity add.08-01-2001

Purpose Tracks changes to the start and stop date for a drug product
record and links the Image Module and the Imprint Module
to a unique drug.

Key Column Name Column Format Length Picture

Description

PF IPTUNIQID Imprint Unique N 10 9(10)

Drug ID

P IPTISTRTDT Image-Imprint N 8 9(8)

Journal Start Date

IPTISTOPDT Image-Imprint N 8 9(8)

Journal Stop Date

F IPTPROPID Imprint Property N 10 9(10)

ID

F IPTIMGID Imprint Image ID N 10 9(10)

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Imprint Unique Drug Imprint Journal Table

Table Name RIPTUIJ4_UNQ_DRUG_JRNL

Revision Activity add.01-01-2003

Purpose Tracks changes to the start and stop date for a drug product
record, and links a unique drug to its descriptive data.

Key Column Name Column Format Length Picture

Description

PF IPTUNIQID Imprint Unique N 10 9(10)

Drug ID

P IPTSTRTDT Imprint Journal N 8 9(8)

Start Date

IPTSTOPDT Imprint Journal N 8 9(8)

Stop Date

F IPTPROPID Imprint Property N 10 9(10)

ID

IPTLBLID Imprint Label ID N 7 9(7)

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Imprint Unique Drug Table

Table Name RIPTUDG2_UNQ_DRUG

Revision Activity add.08-01-2001

Purpose Provides attributes of a unique manufactured drug. It

differentiates between drugs having the same External Drug
ID but different appearances, because more than one
manufacturer is supplying the drug to a
repackager/redistributor.

Key Column Name Column Format Length Picture

Description

P IPTUNIQID Imprint Unique N 10 9(10)

Drug ID

F IPTDFID Imprint Dosage N 5 9(5)

Form ID

IPTNDC Imprint External AN 20 X(20)

Drug ID

F IPTMFGID Imprint N 10 9(10)

Manufacturer ID

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FDB High Risk Medication Module

FDB High Risk Medication Module Editorial Policies
Applications
ERD and Technical Specifications

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FDB High Risk Medication Module Editorial Policies

Overview
Definitions
Inclusion Criteria
Data Elements
Rule Sets
Maintenance
Resources

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High Risk Medication Module Overview

The FDB High Risk Medication Module is comprised of two distinct sets of high risk drug information: Risk
Evaluation Mitigation Strategies (REMS) and Boxed Warnings (BXW).

Risk Evaluation and Mitigation Strategy (REMS)

Boxed Warning (BXW)

Risk Evaluation and Mitigation Strategy (REMS)

The Food and Drug Administration Amendments Act of 2007 (FDAAA) gave the Food and Drug Administration
(FDA) the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure
that the benefits of a drug or biological product outweigh its potential risks. The FDA REMS program consists of
five components:

Medication Guide
Communication Plan
Elements to Assure Safe Use (ETASU)
Implementation System
Timetable for Submission of Assessments

The FDB High Risk Medication Module is designed to work independently or in conjunction with the FDB
MedGuides Module to provide Medication Guides for FDA REMS Program drugs that are ultimately
represented within the REMS documents posted on the FDA REMS website
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.

This module provides REMS indicators across six FDB medication concept levels, from the National Drug Code
(NDC) to the OrderKnowledge Orderable Medication Identifier (ORD_MED_ID), allowing incorporation of REMS
requirements directly into the user workflow. Actionable messages are targeted to the associated actor (the
prescribing physician or the dispensing pharmacist) to reduce message overload and to aid compliance with
REMS requirements.

When employing the data within the High Risk Medication Module, users should also refer to the FDA REMS
website and the individual REMS program websites (if applicable) for the most up to date information and
requirements related to specific REMS programs.

Boxed Warning (BXW)

The FDA provides guidance to pharmaceutical companies for including boxed warning (BXW) information in the
labeling of certain prescription drugs. This content provides information regarding serious, potentially
life-threatening adverse effects and risks associated with the medication.

The FDB High Risk Medication Module BXW component delivers drug knowledge on boxed warnings for
implementation in decision support systems. Boxed warnings are described in the Code of Federal Regulations
(21CFR 201.57c.1) and FDA documentation.

The following is an example of a full text FDA boxed warning:

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WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in
short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with
antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and
older [see Warnings and Precautions].
In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and for emergence of
suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with
the prescriber [see Warnings and Precautions].
PROZAC is not approved for use in children less than 7 years of age [see Warnings and Precautions and Use in Specific
Populations].
When using PROZAC and olanzapine in combination, also refer to Boxed Warning section of the package insert for
Symbyax.

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High Risk Medication Module Definitions

This section defines important terms related to the module that users should understand. Some industry terms
that have a specific connotation in regards to the module are also defined.

Action
Actor
Boxed Warning (BXW)
Boxed Warning (BXW) Representative Text
Boxed Warning (BXW) Summary
Medication Use Cycle
High Risk Medication
Infobyte
Risk Evaluation and Mitigation Strategies (REMS)

Action
A specific requirement that must be performed to meet the criteria of the REMS program or certain steps to be
taken to reduce the risk of a particular adverse reaction (as provided by a BXW). Examples of actions can include
Provide a Medication Guide to the patient, or Sign Patient-Physician Agreement Form (PPAF) or Avoid use in
patient undergoing concurrent irradiation.

Actor
This term is used to identify the healthcare professional (such as the prescriber, nurse, or dispenser [pharmacist
or physician]) to whom an action is associated.

Boxed Warning (BXW)

A Boxed Warning (BXW) is a special type of warning that is represented by a border ("box") around the warning
text in some drug labels. The purpose of the warning is to alert health care providers to serious, potentially
life-threatening adverse events that may be associated with the use of a particular drug, as well as strategies to
prevent, mitigate, or treat the serious adverse event.

Boxed Warning (BXW) Representative Text

The BXW representative text consists of excerpted information from the representative label. This information
may be specific to an ingredient, dose form or strength of a drug, or a therapeutic class of drugs (e.g.,
antidepressants).

Boxed Warning (BXW) Summary

A FDB-authored summarization of the full text boxed warning that includes clinically relevant, drug or drug
group-specific information.

Medication Use Cycle

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The medication use cycle is the term used to identify the chronological steps of the medication use process
where a BXW-specific action might take place.

High Risk Medication

High risk medications are drugs or biologics that have a heightened risk of causing significant patient harm, even
when used as intended.

Infobyte
An infobyte is a short description of a single clinical concept, such as hematologic toxicity or thromboembolic risk,
that is addressed in the Boxed Warning. Each Infobyte may be associated with one or more Actions.

Risk Evaluation and Mitigation Strategies (REMS)

A Risk Evaluation and Mitigation Strategies (REMS) is an FDA required program that must be implemented by a
manufacturer to ensure that the benefits of a drug outweigh the risks of a drug as per the Food and Drug
Administration Amendments Act of 2007 (FDAAA). REMS can include all or some of the following: a Medication
Guide, a communication plan, elements to assure safe use, or implementation system.

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Inclusion Criteria
This module is intended to be used as an aid for the healthcare professional to meet the requirements of the FDA
approved Risk Evaluation and Mitigation Strategies (REMS) program.

REMS Inclusion/Exclusion Criteria

BXW Inclusion Criteria
BXW Exclusion Criteria
Methods for Identifying Candidate BXW Labels

REMS Inclusion/Exclusion Criteria

The FDB High Risk Medication Module includes FDA REMS Program drugs that are ultimately represented within
the REMS documents posted on the FDA website:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

The FDB High Risk Medication Module consists of the following REMS related information and criteria:

Actors such as prescribers, dispensers, pharmacy, etc.

Actions such as Obtain or certify training, Enroll patient in REMS program, Perform pregnancy test at
manufacturer recommended intervals, etc.
Additional Text for clarification or product specific information.
The FDA REMS program components are codified in the Risk Identifier ( RISK_ID) by the designating
manufacturer as the actor.
The URL to the FDA REMS website are provided with each Risk Identifier ( RISK_ID), to allow easy
access.
Audit Trail is provided through the REMS Version Date, the High Risk Medication Module Risk Identifier,
the Risk Previous/Replacement table, and the Risk Identifier delivered date. Audit trail will only be available
from the date the module is initially released.
The REMS module covers only those drugs listed on the FDA REMS website. (RiskMAP drugs will be
included in the REMS module when the RiskMAP drug is officially approved as an FDA REMS Program
drug.)
The REMS module is only available in English.

The combination of the actor with the action/additional text describes the responsible party and the
actions that will meet the REMS program requirement(s).

BXW Inclusion Criteria

The FDB High Risk Medication Module includes FDA approved prescription medications that include a boxed
warning (BXW) in the drug label.

The FDB High Risk Medication Module consists of the BXW related drug information for FDA approved human
prescription drug products meeting the following criteria:

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Drug Scope

New Drug Application (NDA), Biologics License Application (BLA), or Abbreviated New Drug Application
(ANDA)
National Drug Code (NDC) in FDB MedKnowledge

Content Scope

Structured Product Labels (SPLs) with warning content bordered by a box on the DailyMed website
(identified by Logical Observation Identifiers Names and Codes [LOINC] identifier 34066-1)
Portable Document Format (PDF) versions of labels with warning content bordered by a box

BXW Exclusion Criteria

The FDB High Risk Medication Module excludes BXW related information and criteria from the following:

Drug Exclusions

Non-US products
Non-FDA-approved products
Bulk packaged products
Bacteriostatic products (e.g., benzyl alcohol containing saline and water)
Over-the-counter (OTC) products, including those with NDAs
Parenteral nutrition support products
Dietary supplements
Herbal supplements
Bulk drug substances for pharmacy compounding
Medical supplies, soaps, and cleansers
Veterinary drugs
Discontinued (off market) products

Content Exclusions

Boxed warnings that were present in historic labeling but no longer present in current labeling (removed
boxed warnings)
Bordered information derived from US Pharmacopeia guidances:
Heparin sodium, porcine

WARNING: Not for use in neonates

Bordered warnings in labeling for nonprescription drugs:

Prenatal vitamins no.74/ferrous fumarate/folic acid/dha

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WARNING: Accidental overdose of iron-containing products

is a leading cause of fatal poisoning in children under 6. Keep
this product out of reach of children. In case of accidental
overdose, call a doctor or poison control center immediately.

Bordered warnings in labeling for unapproved dose forms:

Ondansetron HCl

CAUTION: This 4 MG/2 ML single dose prefilled syringe is

not for use in pediatric patients less than 40kg. Dilution
required prior to administration for chemotherapy induced
nausea and vomiting.

Bordered warnings within the consumer labeling sections (Instructions for Use, MedGuide, Patient
Package Insert, etc.):
zolpidem tartrate

SEDATIVE-HYPNOTICS are federally controlled substances

(C-IV) because they can be abused or lead to dependence.
Keep SEDATIVE-HYPNOTICS in a safe place to prevent misuse
and abuse. Selling or giving away SEDATIVE-HYPNOTICS may
harm others, and is against the law. Tell your doctor if you have
ever abused or been dependent on alcohol, prescription
medicines or street drugs.

Design graphic where box is used for formatting:

albuterol sulfate

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Other misuse of LOINC identifier 34066-1

Methods for Identifying Candidate BXW Labels

Boxed warning (BXW) content included in the FDB High Risk Medication Module is based on the BXW content of
approved prescription drug labels. The main source of drug labels utilized is the National Library of Medicine
(NLM) DailyMed website, which stores the Structured Product Label (SPL) XML version of drug labeling. Drug
label PDF versions are used when an SPL is not available (e.g., labels available on the FDA Approved Products
Database, Drugs@FDA).

Boxed warnings are identified in one or more of the following ways:

Presence of LOINC 34066-1 in the extensible markup language (XML) file for a SPL (subject to
limitations as defined in the BXW Exclusion Criteria).
Presence of warning text surrounded by a box in the boxed warning section of the drug label
Presence of the word boxed warning within the text of the drug label

When a given drug formulation with a boxed warning has multiple labels and/or manufacturers, a single
representative label will be selected. For drugs with an active NDA or BLA, the most current label will be selected.
For drugs with only ANDA manufacturer(s) available, the most current label for the FDA-designated Reference
Listed Drug (RLD) will be selected as the representative label when available.

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The following schematic illustrates the process for identifying and including SPLs with boxed warnings:

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Data Elements
This section contains additional information about particularly important tables and codes contained within the
module, as well as concepts about the data that the reader must understand in order to understand the module.

Linking Elements
Functional Elements
Descriptive Elements
Additional Data Elements

Linking Elements
Risk Identifiers (RISK_ID) are linked to NDCs meeting inclusion criteria. If all NDCs (active, plus up to three years
obsolete) linked to a given concept represent the same RISK_ID, the RISK_ID will be rolled up to higher level
concepts. Note that an NDC that is not linked to a RISK_ID is not considered the same or is thrown out of the
roll-up algorithm. This means that if a concept is linked to two NDCs (one with a RISK_ID and one without a
RISK_ID) the RISK_ID is not rolled up to that concept level.

The following tables are linking elements within the FDB High Risk Medication Module:

NDC to Risk Link Table (RHRMNDL0_NDC_RISK_LINK)

Orderable Med to Risk Link Table (RHRMOML0_ORD_MED_RISK_LINK)
Clinical Formulation to Risk Link Table (RHRMGCL0_GCNSEQNO_RISK_LINK)
Routed Med to Risk Link Table (RHRMMDL0_MED_RISK_LINK)
Routed Generic to Risk Link Table (RHRMRGL0_RTD_GEN_RISK_LINK)

Functional Elements
The following tables provide information on the functional elements within the FDB High Risk Medication Module:

Risk Master Table (RHRMRMA0_RISK_MSTR)

Risk Previous/Replacement Table (RHRMREP0_RISK_REPL)
Risk Action Description Table (RHRMAND0_RISK_ACTION_DESC)
Risk Action ID (RISK_ACTION_ID)
Risk Action ID Description (RISK_ACTION_ID_DESC)

Example:

RISK_ACTION_ID RISK_ACTION_DESC

1 Ensure patient has met specified safe-use criteria for

pregnancy.

9 Inform patient about pregnancy risks and requirement for

effective contraception.

21 Perform pregnancy test at manufacturer recommended

intervals.

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REMS Specific Functional Elements

Risk Actor Description Table (RHRMARD0_RISK_ACTOR_DESC)

BXW Specific Functional Elements

Risk Mitigation (REMS) Table (RHRMRMI0_RISK_MITIGATION)

Risk Monograph Table (RHRMRMO0_RISK_MONO)

Descriptive Elements
The following tables provide text descriptions for elements associated with a given risk. Examples of
associated descriptions include those for the actor, action, additional text, type, and status of a risk.

Risk Type Description Table (RHRMRTD0_RISK_TYP_DESC)

Risk Status Description Table (RHRMSTD0_RISK_STATUS_DESC)
Risk Status Description Table (RHRMSTD0_RISK_STATUS_DESC)
Risk Action Description Table (RHRMAND0_RISK_ACTION_DESC)

REMS Specific Descriptive Elements

Risk Additional Text Description Table (RHRMATD0_RISK_ADDL_TEXT_DESC)

BXW Specific Descriptive Elements

Risk Actor Description Table (RHRMARD0_RISK_ACTOR_DESC)

Risk Med Cycle Description Table (RHRMCYD0_RISK_MED_CYCLE_DESC)
Risk Monograph Type Description Table (RHRMMTD0_RISK_MONO_TYP_DESC)
Risk Monograph Format Description Table (RHRMMFD0_RISK_MONO_FORMAT_DESC)
Risk Infobyte (BXW) Description Table (RHRMRID0_RISK_INFOBYTE_DESC)
Risk Infobyte Identifier (RISK_INFOBYTE_ID)A system-generated numerical value
assigned to each FDB Infobyte. Infobytes describe the distinct clinical concepts within a given
boxed warning. One Infobyte describes a single clinical concept; thus, a drug may be
associated with one or multiple Infobytes, depending on the content of the full boxed warning.
Risk Infobyte Identifier Description (RISK_INFOBYTE_ID_DESC)Provides a text
description of the clinical concept associated with an infobyte.

Example:

RISK_INFOBYTE_CD RISK_INFOBYTE_ID_DESC

5 Accidental Secondary Exposure

10 Pancreatitis

13 Lactic Acidosis

Risk Category (BXW) Description Table (RHRMRCD0_RISK_CATEGORY_DESC)

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Risk Category Code (RISK_CATEGORY_CD)A numerical value assigned to each Infobyte.

There are three possible risk category values, based on FDA criteria for boxed warning
content, that can be used to filter or sort information within applications.
Risk Category Code (RISK_CATEGORY_CD_DESC)
Risk Category Code Short Description (RISK_CATEGORY_CD_DESC_SHORT)

Example:

RISK_CATEGORY_CD RISK_CATEGORY_CD_DESC RISK_CATEGORY_CD_SHORT

1 Adverse reaction is so serious in Assess risk-benefit.

proportion to the potential benefit
that it is essential that it be
considered in assessing risk versus
benefit.

2 Serious adverse reaction that can Appropriate use may prevent or

be prevented or reduced in minimize adverse reaction.
frequency or severity by
appropriate use of the drug (e.g.,
patient selection, monitoring,
avoiding use in a specific clinical
situation).

3 FDA-approval of drug with Restricted distribution.

restricted distribution or use.

Risk Monograph Format Description Table (RHRMMFD0_RISK_MONO_FORMAT_DESC)

Risk Monograph Type Description Table (RHRMMTD0_RISK_MONO_TYP_DESC)
Risk Category (BXW) Description Table (RHRMRCD0_RISK_CATEGORY_DESC)

Additional Data Elements

Risk Group Description(RISK_GRP_DESC)Text description inked to a particular RISK_ID
providing information about the drugs(s). The RISK_GRP_DESC may be at the ingredient level
(e.g., lisinopril) or be specific to a dose form or strength (e.g., tapentadol extended release tablet).
Risk Start Date (RISK_START_DT)
Risk Status Code (RISK_STATUS_CD)
Risk Status Code Description (RISK_STATUS_CD_DESC)
Risk URL Text (RISK_URL_TXT)Provides the stable website URL to a representative label with
the boxed warning for a particular drug. The representative label may be specific to an ingredient,
dose form or strength of a drug, or a therapeutic class of drugs (e.g., antidepressants).
Risk Version Date (RISK_VERSION_DT)Provides the publication date of the drug label that FDB
referenced for the clinical content. Over time the NLM posts new versions of a manufacturer label
(e.g., with a new side effect or formulation); thus, the RISK_VERSION_DT may not necessarily
reflect the publication date of the drug label associated with the RISK_URL_TEXT. The
RISK_VERSION_DT will default to the first day of the month.

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Additional BXW Specific Data Elements

Risk End Date (RISK_END_DT)

Risk Infobyte Start Date (RISK_INFOBYTE_START_DT)
Risk Infobyte Version Date (RISK_INFOBYTE_VERSION_DT)
Risk Infobyte End Date (RISK_INFOBYTE_END_DT)
Risk Link Sequence Number (RISK_LINK_SEQNO)Maintains clinically prioritized sort orders for
the RISK_INFOBYTE_ID, RISK_MED_CYCLE_ID, and RISK_ACTION_ID. The
RISK_LINK_SEQNO serves to keep these three data elements sorted relative to each other for
each unique RISK_ID and is generated from a prioritized sort order. By using the
RISK_LINK_SEQNO, the ordering of these elements can be maintained whether displaying only the
RISK_INFOBYTE_ID and RISK_ACTION_ID or any other combination of these three elements.
Risk Medication Cycle Identifier (RISK_MED_CYCLE_ID)A numerical value assigned to the
chronological step of the FDB-modified medication use cycle where a BXW-driven action might take
place.
Risk Medication Cycle Identifier Description (RISK_MED_CYCLE_ID_DESC)Provides a
description of each step of the medication use cycle. The content is intended to be used to filter or
sort information/actions across various applications.
Risk Monograph Text (RISK_MONO_TXT)Provides both the actual full text of the representative
boxed warning and the FDB-authored boxed warning summary.
Risk Monograph Type Code (RISK_MONO_TYP_CD)
Risk Monograph Type Code Description (RISK_MONO_TYP_CD_DESC)

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Rule Sets
This section provides an outline of the criteria used in the creation and maintenance of the High Risk Medication
Module data, both general and specific data elements.

General Rules of Applicability for REMS

Rules for REMS Data Elements
General Rules of Applicability for BXW Content
Rules for BXW Data Elements
Rules for BXW Description and Linking Elements
Rules for Selecting the Boxed Warning Representative Text
Rules for Selecting Boxed Warning Summary Content
Rules for Infobytes
Rules for BXW Risk Type Categories
Rules for Action ID and Medication Use Cycle

General Rules of Applicability for REMS

The FDA REMS website is the information source for High Risk Medication REMS Module data. The individual
REMS programs, the single shared REMS programs, and those REMS listed as released with dates after the
release of the REMS module are all covered in the High Risk Medication REMS module.

Rules for REMS Data Elements

REMS are linked to NDCs meeting REMS inclusion criteria (such as NDCs associated to the NDA, ANDA, and
BLA on the FDA REMS website or within the Application holder documents contained in the FDA REMS website).
Additionally, repackager NDCs will be included for the drugs found in the REMS as found in the FDB
MedKnowledge database.

General Rules of Applicability for BXW Content

Each Clinical Formulation Identifier (GCN_SEQNO) may be linked to zero or one RISK_ID code. Because the
GCN_SEQNO aggregates drug products that share like ingredient sets, route of administration, dose form and
strength and may be marketed by different manufacturers, assignment of BXW information to drugs is not
manufacturer-specific.

Rules for BXW Data Elements

Recommended actions are derived from the full boxed warning text and referenced sections of the drug label
within the boxed warning. Actions are selected from an FDB-maintained internal action hierarchy. For each
Infobyte, relevant actions are linked to the appropriate step of the medication use process. An Infobyte may be
associated with multiple actions for multiple steps in the medication use process.

Rules for BXW Description and Linking Elements

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The association of RISK_ID codes to GCN_SEQNOs is accomplished by the creation of rules within a rules
engine that may utilize Hierarchical Ingredient Code (HIC), ETC Identifier (ETC_ID), or Ingredient List Identifier (
HICL_SEQNO) for drug abstraction level along with route, dose form, or strength as enumerated criteria in the
rule. At database build, the rule engine runs and identifies the relevant drug identifier associations matching the
rule and proposes links to the RISK_ID in focus. Proposed links are manually reviewed for all RISK_ID and
GCN_SEQNO concepts and then published.

Rules for Selecting the Boxed Warning Representative Text

Selection of a representative boxed warning may vary depending on the drug group, its linked GCN_SEQNOs,
and the availability of a SPL version of the drug labels on the NLM DailyMed website. The following example
illustrates the process for selecting BXW Representative Text:

Type of Drug Group Type of Drug Labels Available Procedure

GCN_SEQNOs linked based on Drug labels associated with NDA or Choose representative boxed warning
common ingredient(s) or drug class BLA; NDA is the reference listed drug from the most recent label associated
with NDA or BLA.
OR
qualified based on dose form, routes,
or strengths of a single ingredient

Drug labels associated with ANDA (no Look up reference listed drug on the
labels associated with NDA reference online FDA Orange Book.
listed drug available)
Choose the representative boxed
warning from the most recent drug
label for the reference listed drug.

Drug labels assicated with ANDA (no Look up reference listed drug on the
labels associated with NDA available) online FDA Orange Book.
Among the labels for the reference
listed drug(s), choose representative
boxed warning based on content and
currency (most current label may not
reflect most current boxed warning).

Rules for Selecting Boxed Warning Summary Content

The FDB-authored boxed warning summary is an abbreviated version of the full boxed warning text from the
manufacturer drug label. The summary includes the same clinical concepts arranged in the same sequence as
the full text. Additional details from other sections of labeling referenced in the original boxed warning may also be
utilized. Specific information (for example, name and contact information for restricted distribution programs) that
is not encompassed by associated Infobyte(s) or action(s) may also be included in the summary.

The following is an example of a BXW Summary Monograph:

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Avoid use during pregnancy due to risk of fetal abnormalities. Two negative pregnancy tests are required prior to
treatment. Contraception is required beginning 4 weeks prior to therapy, during therapy and for 4 weeks post treatment.
Two contraceptive methods are necessary for females; males must use latex condom. Regularly scheduled pregnancy
tests are required.
This drug is available only through the Revlimid REMS program. Prescriber, patient and pharmacy are required to register;
visit www.celgeneriskmanagement.com or call 1-888-423-5436.
Grade 3 and 4 neutropenia and thrombocytopenia is more common among patients on therapy for del 5q myelodysplastic
syndrome. Patients may require dose reduction or interruption and/or use of blood products or growth factors.
Thromboembolic risk may result in pulmonary embolism or deep venous thrombosis.

Rules for Infobytes

Infobytes reflect a clinical concept within the boxed warning and are numerically sequenced or ordered in the way
that the concepts appear in the full text boxed warning. Infobytes are selected from an established FDB lexicon.
The following is an example of an Infobyte sequence for the drug Lenalidomide (Revlimid):

Infobyte #1: Teratogenicity

Infobyte #2: Restricted Distribution
Infobyte #3: Thrombocytopenia and Neutropenia (Myelodysplastic Syndrome)
Infobyte #4: Thromboembolic Disorder

Restricted Distribution is a stand-alone Infobyte.

Rules for BXW Risk Type Categories

Risk Categories are assigned based on review and evaluation of boxed warning content related to the Infobyte in
focus, as based on the FDA publication Guidance for Industry: Warnings and Precautions, Contraindications, and
Boxed Warning sections of labeling for Human Prescription Drug and Biological Products. See the Risk Category
(BXW) Description Table (RHRMRCD0_RISK_CATEGORY_DESC) for more information.

Rules for Action ID and Medication Use Cycle

Recommended actions are derived from the full boxed warning text and referenced sections of the drug label
within the boxed warning. Actions to prevent or mitigate risk of an adverse reaction will be included; only in some
cases will actions to manage an adverse reaction also be included.

Actions are selected from an FDB-maintained internal action hierarchy. For each Infobyte, relevant actions are
linked to the appropriate phase of the medication use cycle. An Infobyte may be associated with multiple actions
and multiple phases of the medication use cycle. The same action may appear in more than one step in the
medication use cycle. Actions are listed in an editorially controlled sequential order when a given medication use
cycle phase is associated with multiple actions.

The following is a partial example of the Risk Action hierarchy for the drug Lenalidomide (Revlimid):

RISK_MED_CYCLE_ID RISK_ACTION_ID_DESC RISK_MED_CYCLE_ID_DESC

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700000 Avoid use in a pregnant woman or Pre-Treatment

woman who intends to become
pregnant.

700000 Verify two negative pregnancy tests. Pre-Treatment

Perform first test within 10 to 14 days
and the second test within 24 hours
prior to prescribing this drug.

701000 Check complete blood count with Prescribing

differential.

702000 Ensure prescriber is certified through Dispensing

the restricted access program.

705000 Verify negative pregnancy test during Monitoring

any dose interruption.

705000 If pregnancy occurs, refer patient to Monitoring

OB-GYN experienced in reproductive
toxicity and report the pregnancy to the
manufacturer and FDA Medwatch
(1-800-FDA-1088).

705000 Verify negative pregnancy test weekly Monitoring

for the first month, then monthly
thereafter in women with regular
menstrual cycles, or every 2 weeks in
women with irregular menstrual
cycles.

706000 Inform female patient about pregnancy Patient Counseling

risks and the need for two forms of
contraception for 4 weeks prior to
therapy, during therapy, during therapy
interruptions, and 4 weeks after
stopping therapy.

Avoid use during pregnancy due to risk of fetal abnormalities. Two negative pregnancy tests are required prior to
treatment. Contraception is required beginning 4 weeks prior to therapy, during therapy and for 4 weeks post
treatment. Two contraceptive methods are necessary for females; males must use latex condom. Regularly
scheduled pregnancy tests are required.

This drug is available only through the Revlimid REMS program. Prescriber, patient and pharmacy are required to
register; visit www.celgeneriskmanagement.com or call 1-888-423-5436.

Grade 3 and 4 neutropenia and thrombocytopenia is more common among patients on therapy for del 5q
myelodysplastic syndrome. Patients may require dose reduction or interruption and/or use of blood products or
growth factors.

Thromboembolic risk may result in pulmonary embolism or deep venous thrombosis.

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Maintenance
This section contains information regarding the ongoing maintenance of the module's data.

External Triggers for Clinical ReviewREMS

Internal Triggers for Clinical ReviewREMS
External Triggers for Clinical ReviewBXW
Internal Triggers for Clinical ReviewBXW
New Label Versions Change ManagementBXW
BXW Inconsistencies

External Triggers for Clinical ReviewREMS

The FDA REMS website is monitored routinely. As changes to the website are noted, REMS module information
is added, updated, or deleted weekly as appropriate.
Ad hoc customer or manufacturer clinical inquiries are reviewed and the database updated weekly, as
appropriate.

Internal Triggers for Clinical ReviewREMS

New NDCs are reviewed against the REMS inclusion criteria on a daily basis. NDCs are attached if appropriate or
new REMS module data is created for new REMS programs.
Changes to existing NDCs that result in potential Risk Identifier ( RISK_ID) linkage changes are reviewed on a
daily basis.

External Triggers for Clinical ReviewBXW

The FDA Center for Drug Evaluation and Research (CDER) and FDA MedWatch websites are monitored
routinely. As changes to the website are noted, BXW module information is reviewed to be added, updated, or
deleted as appropriate.

Internal Triggers for Clinical ReviewBXW

FDA DailyMed content is reviewed for changes or additions in BXW information. New GCN_SEQNOs with BXW
content are reviewed against inclusion criteria. On a monthly basis, drugs are reviewed for an associated Risk
Version Date (RISK_VERSION_DT) greater than three years old and re-evaluated for update.

New Label Versions Change ManagementBXW

Based on internal and external triggers, changes may need to take place for a given RISK_ID:

Assignment of a new RISK ID occurs when there is a change in the full text URL, accompanied by
significant changes in the full text boxed warning content requiring a change in the BXW summary and
addition or deletion of an infobyte.
If there is a change in the full text URL that does not necessitate an addition or deletion of an infobyte, the
RISK ID will be retained and only the RISK_VERSION_DT will be updated.

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BXW Inconsistencies
For drug classes with identical warnings but inconsistent use of the boxed warning (e.g., oral beta-blockers,
anabolic steroids, loop diuretics), all drugs within the class may be included in the module. In these cases the
representative monograph and the FDB authored BXW summary will contain the following disclaimer:

Labeling for each drug within the [insert name of drug class] class of drugs contains identical warnings
for [insert adverse event]. Only the labels for drugs [fill in drug name(s)] contain the warning in a box.

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High Risk Medication Module Resources

This section lists sources used by First DataBank to compile the information contained in the module.

First DataBank utilizes many reference sources including, but not limited to, the primary medical literature (e.g.,
published journal articles), medical reference texts, published expert treatment guidelines, and manufacturer
product package inserts. First DataBank uses current source editions or versions when coding and updating data,
as well as when researching questions about data. However, a formal data review does not occur for every new
release of source editions or versions. Additional sources include:

FDA Orange Book. Available at http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm.

National Library of Medicine DailyMed website. Available at http://www.dailymed.nlm.nih.gov.
Nasr A, Lauterio TJ, Davis MW. Unapproved drugs in the United States and the Food and Drug
Administration. Adv Ther, 2011;28(10): 842-856.
U.S. Food and Drug Administration. Approved Risk Evaluation and Mitigation Strategies (REMS). Available
at
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm
.
U.S. Food and Drug Administration. Code of Federal Regulations Title 21, sec. 201.57(c)(1). Available at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm.
U.S. Food and Drug Administration. Guidance for Industry: Warnings and Precautions, Contraindications,
and Boxed Warning sections of labeling for Human Prescription Drug and Biological ProductsContent and
Format. Available at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075096.pdf
.
U.S. Food and Drug Administration. Guidance for Industry, Format and Content of Proposed Risk
Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications .
Available at http://www.fda.gov/downloads/Drugs/Guidances/UCM184128.pdf.
U.S. Food and Drug Administration. Guidance for Industry: Warnings and Precautions, Contraindications,
and Boxed Warning sections of labeling for Human Prescription Drug and Biological Products, October
2011. Available at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075096.pdf
US Phamacopeia. Good Repackaging Practices. USP 29, sec. 1178. Available at
http://www.pharmacopeia.cn/v29240/usp29nf24s0_c1.html.
US Pharmacopeia. Bacteriostatic Water for Injection. USP 29. Available at
http://www.pharmacopeia.cn/v29240/usp29nf24s0_m88830.html.
US Pharmacopeia. Bacteriostatic Saline for Injection. USP 29. Available at
http://www.pharmacopeia.cn/v29240/usp29nf24s0_m76080.html
US Pharmacopeia. Medication Use Process. Available at
http://www.achca.org/content/pdf/LTCPLC_Stmt3_MedUseProcess_081031.pdf.

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High Risk Medication Applications

This section provides information about the practical application of data contained in this module.

Determining Whether a Given Drug has a REMS

Displaying All REMS Related Actions for a Given Drug

Retrieving REMS Content for a Given Drug at the Time of Dispensing

Displaying Historical Information for a Replaced REMS

Displaying All Boxed Warning (BXW) Content for a Given Drug

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Determining Whether a Given Drug has a REMS

This application illustrates how to determine if a given drug has a REMS at the time of dispensing.

1. Retrieve the Risk Identifier (RISK_ID) value for the drug being dispensed from the NDC to Risk Link Table
(RHRMNDL0_NDC_RISK_LINK) where the National Drug Code (NDC) value equals the NDC of the drug.

2. Retrieve the Risk Type Code (RISK_TYP_CD) and Risk Status Code (RISK_STATUS_CD) values from
the Risk Master Table (RHRMRMA0_RISK_MSTR) where the Risk Identifier (RISK_ID) value equals the
RISK_ID value retrieved in the previous step.

3. Filter the results retrieved in step 2 for a Risk Type Code (RISK_TYP_CD) value equal to 1 (Risk
Evaluation and Mitigation Strategy [REMS]).
If records with a RISK_TYP_CD value of 1 remain, the drug has a REMS.
If records with a RISK_STATUS_CD value of 0 remain, the REM is active.
If no records remain after filtering, the drug does not have a REMS.

4. Present the results of step 3 to the end user.

ExampleDetermining Whether a Given Drug has a REMS

For purposes of demonstrating this application, the following scenario is used: The pharmacist receives an order
to dispense Tikosyn 250 mcg capsule (NDC 00069581060) and needs to determine if the drug has a REMS.

1. Retrieve the Risk Identifier (RISK_ID) value from the NDC to Risk Link Table
(RHRMNDL0_NDC_RISK_LINK) where the National Drug Code (NDC) value equals 00069581060
(Tikosyn 250mcg capsule).

NDC RISK_ID

00069581060 54

2. Retrieve the Risk Type Code (RISK_TYP_CD) and Risk Status Code (RISK_STATUS_CD) values from
the Risk Master Table (RHRMRMA0_RISK_MSTR) where the Risk Identifier (RISK_ID) value equals 54.

RISK_ID RISK_TYP_ CD RISK_TYP_CD_DESC RISK_STATUS_CD

54 1 Risk Evaluation and 0

Mitigation Strategy
(REMS)

The RISK_TYP_CD_DESC column is shown for descriptive reasons only and is not necessary to
this step. The RISK_TYP_CD_DESC column is located in the RHRMRTD0_RISK_TYP_DESC.

3. Filter the results retrieved in step 2 for a Risk Type Code (RISK_TYP_CD) value equal to 1 (Risk
Evaluation and Mitigation Strategy [REMS]) and a Risk Status Code (RISK_STATUS_CD) value equal to 0
(Active):
If records with a RISK_TYP_CD value of 1 remain, the drug has a REMS.

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If records with a RISK_STATUS_CD value of 0 remain, the REM is active.

If no records remain after filtering, the drug does not have a REMS.
In this example, Tikosyn has an active REMS.

Text descriptions for Risk Status Codes (RISK_STATUS_CD) can be retrieved from the
Risk Status Code Description (RISK_STATUS_CD_DESC) column.

4. Present the results of step 3 to the end user. In this example, the user is alerted that the drug has an active
REMS.

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Displaying All REMS Related Actions for a Given Drug

This application illustrates how to display REMS related actions for a drug.

1. Retrieve the Risk Identifier (RISK_ID) value for the drug being dispensed from the Routed Med to Risk Link
Table (RHRMRML0_ROUTED_MED_RISK_LINK) where the Routed Medication Identifier (
ROUTED_MED_ID) value equals the Medication Identifier of the drug.

2. Retrieve the Risk Type Code (RISK_TYP_CD) and Risk Status Code (RISK_STATUS_CD) column values
from the Risk Master Table (RHRMRMA0_RISK_MSTR) where the Risk Identifier (RISK_ID) value equals
the RISK_ID retrieved in the previous step.

3. Retrieve the Risk Action Identifier (RISK_ACTION_ID), Risk Actor Identifier (RISK_ACTOR_ID), and Risk
Mitigation Sequence Number (RISK_MITIGATION_SEQNO) column values from the Risk Mitigation
(REMS) Table (RHRMRMI0_RISK_MITIGATION) where the Risk Identifier (RISK_ID) column value equals
the RISK_ID value retrieved in the step 1.

4. Retrieve descriptions for the Risk Actor Identifier (RISK_ACTOR_ID values retrieved in the previous step
from the Risk Actor Description Table (RHRMARD0_RISK_ACTOR_DESC).

5. Retrieve descriptions for the Risk Action Identifier (RISK_ACTION_ID) values retrieved in step 3 from the
Risk Action Description Table (RHRMAND0_RISK_ACTION_DESC).

6. Sort and display REMS content actions by actor.

ExampleDisplaying all REMS Related Actions for a Given Drug

For purposes of demonstrating this application, the following scenario is used: A hospital administrator wants to
view the REMS related actions for Isotretinoin Oral (Routed Medication Identifier 00006662).

1. Retrieve the Risk Identifier (RISK_ID) value from the Routed Med to Risk Link Table
(RHRMRML0_ROUTED_MED_RISK_LINK) where the Routed Medication Identifier (ROUTED_MED_ID)
column value equals 00006662.

RISK_ID ROUTED_MED_ID

71 00006662

2. Confirm that the given drug has an active REMS. Retrieve the Risk Type Code ( RISK_TYP_CD) and Risk
Status Code (RISK_STATUS_CD) column values from the Risk Master Table (RHRMRMA0_RISK_MSTR)
where the Risk Identifier (RISK_ID) column value equals 71.

RISK_ID RISK_TYP_CD RISK_STATUS_CD

71 1 0

In this example, the RISK_ID associated to the given drug has a RISK_TYP_CD value of 1 (REMS) and a
RISK_STATUS_CD value of 0 (Active), confirming that the drug has an active REMS.

3.

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3. Retrieve the Risk Action Identifier (RISK_ACTION_ID), Risk Actor Identifier (RISK_ACTOR_ID), and Risk
Mitigation Sequence Number (RISK_MITIGATION_SEQNO) column values from the Risk Mitigation
(REMS) Table (RHRMRMI0_RISK_MITIGATION) where the Risk Identifier (RISK_ID) column value equals
71.

RISK_ID RISK_ACTION_ID RISK_MITIGATION_SEQ RISK_ACTOR_ID

NO

71 831 1 506000

71 832 2 506000

71 19 3 506000

71 833 4 506000

71 816 5 500000

71 818 6 500000

71 830 7 500000

71 834 8 500000

71 835 9 500000

71 9 10 500000

71 21 11 500000

71 807 12 500000

71 837 13 500000

71 837 14 500000

71 808 15 500000

71 838 16 500000

71 118 17 500000

71 839 18 507000

71 817 19 507000

71 840 20 507000

71 843 21 507000

71 859 22 502000

71 844 23 502000

71 845 24 502000

71 846 25 502000

71 847 26 502000

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71 848 27 502000

71 808 28 502000

71 849 29 502000

71 17 30 502000

71 850 31 502000

71 851 32 502000

4. Retrieve descriptions for the Risk Actor Identifier (RISK_ACTOR_ID) values retrieved in the previous step
from the Risk Actor Description Table (RHRMARD0_RISK_ACTOR_DESC).

RISK_ACTOR_ID RISK_ACTOR_DESC

506000 Manufacturer

500000 Prescriber

507000 Pharmacy

502000 Dispsenser

5. Retrieve descriptions for the Risk Action Identifier (RISK_ACTION_ID) values retrieved in step 3 from the
Risk Action Description Table (RHRMAND0_RISK_ACTION_DESC).

RISK_ACTION_ID RISK_ACTION_ID_DESC

831 Medication Guide requirement.

832 ETASU - Elements to Assure Safe Use requirements.

19 Implementation system requirement.

833 Timetable for Submission of Assessments

requirements.

816 Become certified to prescribe drug.

818 Must enroll in REMS program.

830 Must complete Prescriber Enrollment Form.

834 Register each patient in REMS program.

835 Document female patient's childbearing potential.

9 Inform patient about pregnancy risks and contraception.

21 Perform pregnancy test at manufacturer recommended

intervals.

807 Verify negative pregnancy test.

837 Document negative pregnancy test.

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837 Document two chosen forms of contraception.

808 Limit days supply of the drug to 30 days at a time.

838 Prescribe with no refills.

118 Report pregnancy to manufacturer.

839 Identify a responsible site pharmacist.

817 Become certified to dispense drug.

840 Must complete Pharmacy Enrollment Form.

843 Re-activate pharmacy REMS registration annually.

859 Know the risk and severity of fetal injury/birth defects

caused by drug.

844 Dispense only FDA-approved isotretinoin products.

845 Obtain isotretinoin from iPLEDGE registered

wholesalers.

846 Do not sell, borrow, loan, or transfer drug to or from

another pharmacy.

847 Dispense only to registered patients in REMS program.

848 Document Risk Management Authorization (RMA)

number on each prescription.

808 Limit days supply of the drug to 30 days at a time.

849 Dispense with no refills.

17 Provide Medication Guide to patient.

850 Dispense prior to "do not dispense to a patient after"

date.

851 Dispense only to females who are not pregnant nor

breastfeeding.

6. Sort the values retrieved in steps 3 4 by Risk Actor Identifier ( RISK_ACTOR_ID) and then by Risk
Mitigation Sequence Number (RISK_MITIGATION_SEQNO) and display the actor description followed by
the associated action:

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Manufacturer

Medication Guide requirement.

ETASU - Elements to Assure Safe Use requirements.
Implementation system requirement.
Timetable for Submission of Assessments requirement
Prescriber

Become certified to prescribe drug.

Must enroll in REMS program.
Must complete Prescriber Enrollment Form.
Register each patient in REMS program.
Document female patient's childbearing potential.
Inform patient about pregnancy risks and contraception.
Perform pregnancy test at manufacturer recommended intervals.
Verify negative pregnancy test.
Document negative pregnancy test.
Document two chosen forms of contraception.
Limit days supply of the drug to 30 days at a time.
Prescribe with no refills.
Report pregnancy to manufacturer.

Pharmacy

Identify a responsible site pharmacist.

Become certified to dispense drug.
Must complete Pharmacy Enrollment Form.
Re-activate pharmacy REMS registration annually.

Dispenser

Know the risk and severity of fetal injury/birth defects caused by drug.
Dispense only FDA-approved isotretinoin products.
Obtain isotretinoin from iPLEDGE registered wholesalers.
Do not sell, borrow, loan, or transfer drug to or from another pharmacy.
Dispense only to registered patients in REMS program.
Document Risk Management Authorization (RMA) number on each prescription.
Limit days supply of the drug to 30 days at a time.
Dispense with no refills.
Provide Medication Guide to patient.
Dispense prior to "do not dispense to a patient after" date.
Dispense only to females who are not pregnant nor breastfeeding.

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Retrieving REMS Content for a Given Drug at the Time of Dispensing

This application illustrates how to retrieve REMS content for a drug at the time of dispensing.

Part 1: Retrieve and Display REMS Content for a Given Drug

1. Retrieve the Risk Identifier (RISK_ID) value from the NDC to Risk Link Table
(RHRMNDL0_NDC_RISK_LINK) where the National Drug Code (NDC) column value equals the NDC for
the drug being dispensed.

2. Retrieve all column values from the Risk Mitigation (REMS) Table (RHRMAND0_RISK_ACTION_DESC)
where:
The Risk Identifier (RISK_ID) column value equals the RISK_ID value retrieved in step 1.
The Risk Actor Identifier (RISK_ACTOR_ID) column value equals 502000 (dispenser).

3. Retrieve descriptions for the Risk Action Identifier (RISK_ACTION_ID) values retrieved in the previous step
from the Risk Action Description Table (RHRMAND0_RISK_ACTION_DESC).

4. Retrieve descriptions for the Risk Additional Text Identifier Description ( RISK_ADDL_TEXT_ID_DESC)
values retrieved in step 2 from the Risk Additional Text Description Table
(RHRMATD0_RISK_ADDL_TEXT_DESC).

5. Display results to end user.

Part 2: Filter Displayed Results

1. Retrieve the Parent Risk Action Identifier (PARENT_RISK_ACTION_ID) value from the Risk Action
Description Table (RHRMAND0_RISK_ACTION_DESC) where the Risk Action Identifier (
RISK_ACTION_ID) column equals the RISK_ACTION_ID value from Part 1, step 2.

2. Retrieve the Parent Risk Action Identifier (PARENT_RISK_ACTION_ID) value from the Risk Action
Description Table (RHRMAND0_RISK_ACTION_DESC) where the Risk Action Identifier (
RISK_ACTION_ID) column value equals the new Parent Risk Action Identifier (
PARENT_RISK_ACTION_ID) value retrieved in the previous step.

3. Repeat step 2 until the Parent Risk Action Identifier (PARENT_RISK_ACTION_ID) column value is null.

4. Repeat steps 1 2 for each of the actions retrieved in Part 1, discarding Parent Risk Action Identifier (
PARENT_RISK_ACTION_ID) column values that have an ultimate Parent Risk Action Identifier (
PARENT_RISK_ACTION_ID) value equal to the value to be excluded, and display filtered results to user.

ExampleDisplaying REMS Content at the Time of Dispensing

For purposes of demonstrating this application, the following scenario is used: A pharmacist receives an
order for Revlimid 15 mg capsule (NDC 5957204152) and needs to display REMS content. In this example, the
institution convention is to display all actions required by the dispenser.

Results can be filtered per institutional convention or user-entered criteria.

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Part 1: Retrieve and Display REMS Content for a Given Drug

1. Retrieve the Risk Identifier (RISK_ID) value from the NDC to Risk Link Table
(RHRMNDL0_NDC_RISK_LINK) where the National Drug Code (NDC) column value equals
59572041521.

NDC RISK_ID

59572041521 42

See Determining Whether a Given Drug has a REMS, page 1594 for additional information.

2. Retrieve the Risk Action Identifier (RISK_ACTION_ID), Risk Mitigation Sequence Number (
RISK_MITIGATION_SEQNO), and Risk Additional Text Identifier (RISK_ADDL_TEXT_ID) values from the
Risk Mitigation (REMS) Table (RHRMRMI0_RISK_MITIGATION) where:
The Risk Identifier (RISK_ID) column value equals 42.
The Risk Actor Identifier (RISK_ACTOR_ID) column value equals 502000 (dispenser).

RISK_ID RISK_ACTOR_ID RISK_ACTION_ID RISK_MITIGATIO RISK_ADDL_TEX

N_SEQNO T_ID

42 502000 878 29

42 502000 865 30 3

42 502000 874 31

42 502000 885 32

42 502000 877 33 30

42 502000 875 34

42 502000 866 35

42 502000 849 36

42 502000 873 37

42 502000 868 38

42 502000 854 39

42 502000 810 40 9

42 502000 878 41

42 502000 310 42

42 502000 809 43

42 502000 879 44 12

42 502000 880 45

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42 502000 881 46

42 502000 882 47 9

42 502000 883 48

42 502000 118 49

3. Retrieve descriptions for the Risk Action Identifier (RISK_ACTION_ID) values retrieved in the previous step
from the Risk Action Description Table (RHRMAND0_RISK_ACTION_DESC).

RISK_ACTION_ID RISK_ACTION_DESC

827 Trained regarding REMS program.

872 Ensure authorization number from prescriber is on

prescription.

865 Authorization number valid only 7 days from date of last

pregnancy test for females of childbearing age.

874 Obtain confirmation number from REMS program and

document on prescription.

885 Do not dispense without obtaining confirmation number.

877 Complete REMS checklist prior to dispensing.

875 Must dispense/ship within 24 hours of obtaining

confirmation number from REMS program.

866 Limit days supply of the drug to 28 days at a time.

849 Dispense with no refills.

873 Dispense subsequent prescriptions only if there are 7

days or less remaining on existing prescription.

868 Must return unused product to manufacturer.

854 Inform patients not to share medication with others.

810 Inform patients about blood donation restriction.

878 Inform patient not to break, chew, or open capsules.

310 Provide written educational material to patient.

809 Inform patient about pregnancy risks and contraception

during therapy.

879 Inform female patients of childbearing potential of need

for 2 forms of effective contraception.

880 Inform patient to stop treatment immediately and contact

physician if they become pregnant or suspect they may
be pregnant.

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881 Inform male patients to use barrier contraception.

882 Inform male patients not to donate sperm.

883 Report adverse events to manufacturer.

118 Report pregnancy to manufacturer.

4. Retrieve descriptions for the Risk Additional Text Identifier Description ( RISK_ADDL_TEXT_ID_DESC)
values retrieved in step 2 from the Risk Additional Text Description Table
(RHRMATD0_RISK_ADDL_TEXT_DESC).

RISK_ACTION_ID RISK_ADDL_TEXT_DESC

865 30 days for females not of childbearing potential and

males.

877 REVLIMID REMS Education and Counseling Checklist.

810 Avoid donations during treatment, during dose

interruptions, and for 4 weeks after stopping treatment.

879 Continue even if treatment is interrupted and for at least

4 weeks after stopping treatment.

882 Avoid donations during treatment, during dose

interruptions, and for 4 weeks after stopping treatment.

Descriptions of actors, actions, and additional text can be found in the

following tables:

Risk Actor Description Table (RHRMARD0_RISK_ACTOR_DESC)

Risk Action Description Table (RHRMAND0_RISK_ACTION_DESC)
Risk Additional Text Description Table (RHRMATD0_RISK_ADDL_TEXT_DESC)

5. Display results to end user. In this example, the Risk Additional Text Identifier Description (
RISK_ADDL_TEXT_ID_DESC) appears in brackets.

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Trained regarding REMS program.

Ensure authorization number from prescriber is on prescription.
Authorization number valid only 7 days from date of last pregnancy test for females of childbearing age. [30
days for females not of childbearing potential and males.]
Obtain confirmation number from REMS program and document on prescription.
Do not dispense without obtaining confirmation number.
Complete REMS checklist prior to dispensing. [REVLIMID REMS Education and Counseling Checklist.]
Must dispense/ship within 24 hours of obtaining confirmation number from REMS program.
Limit days supply of the drug to 28 days at a time.
Dispense with no refills.
Dispense subsequent prescriptions only if there are 7 days or less remaining on existing prescription.
Must return unused product to manufacturer.
Inform patients not to share medication with others.
Inform patients about blood donation restriction. [Avoid donations during treatment, during dose interruptions,
and for 4 weeks after stopping treatment.]
Inform patient not to break, chew, or open capsules.
Provide written educational material to patient.
Inform patient about pregnancy risks and contraception during therapy.
Inform female patients of childbearing potential of need for 2 forms of effective contraception. [Continue even if
treatment is interrupted and for at least 4 weeks after stopping treatment.]
Inform patient to stop treatment immediately and contact physician if they become pregnant or suspect they
may be pregnant.
Inform male patients to use barrier contraception.
Inform male patients not to donate sperm. [Avoid donations during treatment, during dose interruptions, and for
4 weeks after stopping treatment.]
Report adverse events to manufacturer.
Report pregnancy to manufacturer.

Note that the resulting list can sometimes be long due to its comprehensiveness. See Filter
Displayed Results below for additional steps to help make the display more user friendly.

Part 2: Filter Displayed Results

Results can be filtered by removing optional actions/actions that may not be useful to the dispenser. In this
example, actions with an ultimate parent Risk Action Identifier ( RISK_ACTION_ID) value of 700 (Take
administrative action) will be filtered from the retrieved results.

Ultimate parent Risk Action Identifiers (RISK_ACTION_ID) are those values whose associated Parent
Risk Action Identifier (PARENT_RISK_ACTION_ID) column value is null within the Risk Action
Description Table (RHRMAND0_RISK_ACTION_DESC).

1. Retrieve the Parent Risk Action Identifier (PARENT_RISK_ACTION_ID) value from the Risk Action
Description Table (RHRMAND0_RISK_ACTION_DESC) where the Risk Action Identifier (
RISK_ACTION_ID) column equals the RISK_ACTION_ID value retrieved in Part 1, step 2. In this example,
the RISK_ACTION_ID value 827 is used:

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RISK_ACTION_ID RISK_ACTION_ID_DESC PARENT_RISK_ACTION_ID

827 Trained regarding REMS program 10

2. Retrieve the Parent Risk Action Identifier (PARENT_RISK_ACTION_ID) value from the Risk Action
Description Table (RHRMAND0_RISK_ACTION_DESC) where the Risk Action Identifier (
RISK_ACTION_ID) column equals the new Parent Risk Action Identifier (PARENT_RISK_ACTION_ID)
value retrieved in the previous step.

RISK_ACTION_ID RISK_ACTION_ID_DESC PARENT_RISK_ACTION_ID

10 Obtain or certify training 700

3. Repeat step 2 until the Parent Risk Action Identifier (PARENT_RISK_ACTION_ID) column value is null.

RISK_ACTION_ID RISK_ACTION_ID_DESC PARENT_RISK_ACTION_ID

700 Take administrative action

In this example, the ultimate Parent Risk Action Identifier is 700 (Take administrative action). Because
this example filters out administrative actions, this result can be excluded from the actions displayed to the
user.

4. Repeat steps 1 2 for each of the 22 actions retrieved in Part 1, discarding Parent Risk Action Identifier (
PARENT_RISK_ACTION_ID) column values that have an ultimate Parent Risk Action Identifier (
PARENT_RISK_ACTION_ID)value of 700, and display filtered results to user. In the following results,
additional text was not output:

Ensure authorization number from prescriber is on prescription.

Authorization number valid only 7 days from date of last pregnancy test for females of childbearing age.
Obtain confirmation number from REMS program and document on prescription.
Do not dispense without obtaining confirmation number.
Complete REMS checklist prior to dispensing.
Must dispense/ship within 24 hours of obtaining confirmation number from REMS program.
Limit days supply of the drug to 28 days at a time.
Dispense with no refills.
Dispense subsequent prescriptions only if there are 7 days or less remaining on existing prescription.
Inform patients not to share medication with others.
Inform patients about blood donation restriction.
Inform patient not to break, chew, or open capsules.
Provide written educational material to patient.
Inform patient about pregnancy risks and contraception during therapy.
Inform female patients of childbearing potential of need for 2 forms of effective contraception.
Inform patient to stop treatment immediately and contact physician if they become pregnant or suspect they
may be pregnant.
Inform male patients to use barrier contraception.
Inform male patients not to donate sperm.

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Using reverse search logic from Part 2, step 3 and retaining only results with an ultimate parent
Risk Action Identifier (RISK_ACTION_ID) value of 700, the pharmacist can limit results to actions
designated Take administrative action:

Trained regarding REMS program.

Must return unused product to manufacturer.
Report adverse events to manufacturer.
Report pregnancy to manufacturer.

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Displaying Historical Information for a Replaced REMS

If the REMS for a drug changes significantly (new or removed actions), the current Risk Identifier ( RISK_ID) is
end-dated and a Replacement Risk Identifier (REPL_RISK_ID) is created and linked to the associated concept
linking files.

This application illustrates how to retrieve the historical REMS data for a Replace,ent Risk Identifier (
REPL_RISK_ID).

1. Retrieve the Replacement Risk Identifier (REPL_RISK_ID) and Replacement Risk Effective Date (
REPL_RISK_EFF_DT) from the Risk Previous/Replacement Table (RHRMREP0_RISK_REPL).

2. Retrieve the Risk Group Description (RISK_GRP_DESC), Risk URL Text (RISK_URL_TXT), Risk Start
Date (RISK_START_DT), Risk Version Date (RISK_VERSION_DT), Risk End Date (RISK_END_DT) and
Risk Status Code (RISK_STATUS_CD) for the selected Risk Identifier (RISK_ID) and its associated
Replacement Risk Identifier (REPL_RISK_ID) from the Risk Master Table (RHRMRMA0_RISK_MSTR).

Actions, actors, and additional text for a Previous Risk Identifier (PREV_RISK_ID) remain in the
Risk Mitigation (REMS) Table (RHRMRMI0_RISK_MITIGATION) after the Risk Identifier (
RISK_ID) is retired or replaced. In this way, users can view actions that were historically in effect.

ExampleDisplaying Historical Information for a Replaced REMS

For purposes of demonstrating this application, the following scenario is used: RISK_ID 1200 has been
replaced by RISK_ID 1300, and the user wants to view all historical data for this replacement.

In the following example all search criteria data is fictitious example data only and does not reflect active
data.

1. Retrieve the Replacement Risk Identifier (REPL_RISK_ID) and Replacement Risk Effective Date (
REPL_RISK_EFF_DT) from the Risk Previous/Replacement Table (RHRMREP0_RISK_REPL) where the
Previous Risk Identifier (PREV_RISK_ID) column value equals 1200.

PREV_RISK_ID REPL_RISK_ID REPL_RISK_EFF_DT

1200 1300 20130919

2. Retrieve the Risk Group Description (RISK_GRP_DESC), Risk URL Text (RISK_URL_TXT), Risk Start
Date (RISK_START_DT), Risk Version Date (RISK_VERSION_DT), Risk End Date (RISK_END_DT) and
Risk Status Code (RISK_STATUS_CD) for the selected Risk Identifier (RISK_ID) and its associated
Replacement Risk Identifier (REPL_RISK_ID) from the Risk Master Table (RHRMRMA0_RISK_MSTR)
where:
The Risk Identifier (RISK_ID) column values equal the original Risk Identifier (RISK_ID) value (1200
) and the Replacement Risk Identifier (REPL_RISK_ID) value retrieved in the previous step (1300).
The Risk Type Code (RISK_TYP_CD) column value equals 1 (REMS).

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RISK_ID RISK_TY RISK_GR RISK_UR RISK_ST RISK_VE RISK_EN RISK_ST

P_ CD P_DESC L_TXT ART_DT RSION_D D_DT ATUS_CD
T

1200 1 Example https://.. 20130724 20101022 20130919 1

Drug

1300 1 Example https://.. 20130919 20130916 0

Drug

In this example, the Previous Risk Identifier (PREV_RISK_ID) 1200 has a valid Risk End Date (
RISK_END_DT) value and a Risk Status Code (RISK_STATUS_CD) value of 1 (Replaced),
indicating that it is no longer an active identifier. The Replacement Risk Identifier ( PREV_RISK_ID)
1300 has a Risk Status Code (RISK_STATUS_CD) value of 0 (Active), indicating that it is an
appropriate replacement.

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Displaying All Boxed Warning (BXW) Content for a Given Drug

BXW content can be extensive, so it may be desirable to customize searches by sorting or filtering returned
results. Boxed Warning (BXW) content can be filtered or sorted by the medication use cycle (prescribing,
dispensing, etc.) or other user-specified criteria. FDB provides two levels of BXW content: Boxed Warning (BXW)
Summary and Boxed Warning (BXW) Representative Text. See Definitions for more information.

This application can be performed from the National Drug Code (NDC), Clinical Formulation ID (
GCN_SEQNO), Medication Identifier (MEDID), Orderable Medication Identifier (ORD_MED_ID), Routed
Generic Identifier (ROUTED_GEN_ID), or MED Routed Medication ID (ROUTED_MED_ID) levels.

Part 1: Determining Whether a Given Drug has Active Boxed Warning (BXW) Content

1. Retrieve the Risk Identifier (RISK_ID) value from the NDC to Risk Link Table
(RHRMNDL0_NDC_RISK_LINK) where the National Drug Code (NDC) value equals the given drug.

2. Retrieve the Risk Type Code (RISK_TYP_CD) and Risk Status Code (RISK_STATUS_CD) values from
the Risk Master Table (RHRMRMA0_RISK_MSTR) where the RISK_ID value equals the value(s) retrieved
in the previous step.

3. Filter the results retrieved in step 2 for a RISK_TYP_CD value equal to 2 (Boxed Warning [BXW]) and a
RISK_STATUS_CD value equal to 0 (Active).

4. Display results to user.

Part 2: Retrieving BXW Risk Action Content for a Given Drug

1. Retrieve the Risk Medication Cycle Identifier (RISK_MED_CYCLE_ID), Risk Infobyte Identifier (
RISK_INFOBYTE_ID), Risk Link Sequence Number (RISK_LINK_SEQNO), and Risk Action Identifier (
RISK_ACTION_ID) from the Risk Infobyte (BXW) Link Table (RHRMINL0_RISK_INFOBYTE_LINK) where
the Risk Identifier (RISK_ID) column equals the value for the given drug, as retrieved in the Part 1, step 1.

2. Retrieve the Risk Medication Cycle Identifier Description (RISK_MED_CYCLE_ID_DESC) values from the
Risk Med Cycle Description Table (RHRMCYD0_RISK_MED_CYCLE_DESC) where the
RISK_MED_CYCLE_ID column equals the values retrieved in the previous step.

3. Retrieve the Risk Infobyte ID Description(s) (RISK_INFOBYTE_ID_DESC) from the Risk Infobyte (BXW)
Description Table (RHRMRID0_RISK_INFOBYTE_DESC) where the RISK_INFOBYTE_ID column equals
the value(s) retrieved in the step 1.

4. Retrieve the Risk Action Identifier Description (RISK_ACTION_ID_DESC) value(s) from the Risk Action
Description Table (RHRMAND0_RISK_ACTION_DESC) where the RISK_ACTION_ID column equals the
value(s) retrieved in the step 1.

5. Display results to user.

Part 3: Displaying the Boxed Warning Summary and/or Representative Boxed Warning Monograph for a Given Drug

1. Retrieve the Risk Monograph Identifier (RISK_MONO_ID) from the Risk Monograph Link Table

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1.
(RHRMMRL0_RISK_MONO_LINK) where the Risk Identifier (RISK_ID) column equals the value retrieved
in Part 1, step 1.

2. Retrieve the Risk Monograph Line Sequence Number (RISK_MONO_LINE_SEQNO), Risk Monograph
Format Code (RISK_MONO_FORMAT_CD), Risk Monograph Type Code (RISK_MONO_TYP_CD), and
Risk Monograph Text (RISK_MONO_TXT) values from the Risk Monograph Table
(RHRMRM0_RISK_MONO) where the RISK_MONO_ID column equals the value retrieved in the previous
step.

3. Display results to user.

Part 4: Retrieving the Representative Boxed Warning Product Labeling URL for a Given Drug

1. Retrieve the Risk URL Text (RISK_URL_TXT) from the Risk Master Table (RHRMRMA0_RISK_MSTR)
where the Risk Identifier (RISK_ID) column equals the value retrieved in Part 1, step 1.

2. Display results to user.

ExampleDisplaying all BXW Content for a Given Drug

Part 1: Determining Whether a Given Drug has Active Boxed Warning (BXW) Content

For purposes of demonstrating this application, the following scenario is used: A user needs to determine if
Revlimid 15 mg capsule (NDC 59572041521) has BXW content.

1. Retrieve the Risk Identifier (RISK_ID) value from the NDC to Risk Link Table
(RHRMNDL0_NDC_RISK_LINK) where the National Drug Code (NDC) value equals 59572041521
(Revlimid 15 mg capsule).

NDC RISK_ID

59572041521 251

59572041521 42

The Risk Identifier (RISK_ID) value can also be retrieved from the following tables, as necessitated
by the FDB drug identifier used in your system:

Clinical Formulation to Risk Link Table (RHRMGCL0_GCNSEQNO_RISK_LINK)

MEDID to Risk Link Table (RHRMMDL0_MED_RISK_LINK)

Orderable Med to Risk Link Table (RHRMOML0_ORD_MED_RISK_LINK)

Routed Generic to Risk Link Table (RHRMRGL0_RTD_GEN_RISK_LINK)

Routed Med to Risk Link Table (RHRMRML0_ROUTED_MED_RISK_LINK)

2. Retrieve the Risk Type Code (RISK_TYP_CD) and Risk Status Code (RISK_STATUS_CD) values from
the Risk Master Table (RHRMRMA0_RISK_MSTR) where the Risk Identifier (RISK_ID) value equals the

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2.

value(s) retrieved in the previous step (251).

RISK_ID RISK_TYP_CD RISK_TYP_CD_DE RISK_STATUS_CD RISK_STATUS_CD

SC _DESC

251 2 Boxed Warning 0 Active

(BXW)

42 1 Risk Evaluation and 0 Active

Mitigation Strategy
(REMS)

The RISK_TYP_CD_DESC and RISK_STATUS_CD_DESC columns are shown here for

descriptive purposes only and are not necessary to this step.
The RISK_TYP_CD_DESC column is located in the Risk Type Description Table (
RHRMRTD0_RISK_TYP_DESC).
The RISK_STATUS_CD_DESC is located in the Risk Status Description Table (
RHRMSTD0_RISK_STATUS_DESC).

3. Filter the results retrieved in the previous step for a RISK_TYP_CD value equal to 2 (Boxed Warning
[BXW]) and a RISK_STATUS_CD value equal to 0 (Active):
If records with a RISK_TYP_CD value of 2 remain, the drug has a BXW.
If records with a RISK_STATUS_CD value of 0 remain, the BXW is active.
If no records remain after filtering, the drug does not have a BXW.

RISK_ID RISK_TYP_CD RISK_STATUS_CD

251 2 0

4. Display results to user:

Revlimid has active BXW content.

Part 2: Retrieving BXW Risk Action Content for a Given Drug

For the purposes of this demonstrating application, the following scenario is used: A user needs to display all
BXW risk action content for Revlimid 15 mg capsule (NDC 59572041521). In this example, the user has already
retrieved the associated Risk_ID value and determined that Revlimid has active BXW content.

1. Retrieve the Risk Medication Cycle Identifier (RISK_MED_CYCLE_ID), Risk Infobyte Identifier (
RISK_INFOBYTE_ID), Risk Link Sequence Number (RISK_LINK_SEQNO) and Risk Action Identifier (
RISK_ACTION_ID) from the Risk Infobyte (BXW) Link Table (RHRMINL0_RISK_INFOBYTE_LINK) where
the Risk Identifier (RISK_ID) column equals 251 (Revlimid 15 mg capsule), as retrieved in the Part 1, step
1.

RISK_ID RISK_MED_CYCLE RISK_INFOBYTE_I RISK_LINK_SEQN RISK_ACTION_ID

_ID D O

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251 700000 129 1 1753

251 700000 129 2 2396

251 700000 80 20 3

251 700000 297 16 1809

251 700000 2 12 2344

251 700000 2 13 2385

251 700000 2 14 792

251 701000 297 17 1809

251 702000 2 15 847

251 705000 80 21 8

251 705000 129 3 2397

251 705000 129 4 2398

251 705000 129 5 2518

251 705000 297 18 2399

251 706000 80 22 7

251 706000 129 6 2389

251 706000 129 7 2522

251 706000 129 8 880

251 706000 129 9 2390

251 706000 129 10 2325

251 706000 129 11 2392

251 706000 297 19 2402

2. Retrieve the Risk Medication Cycle Identifier Description (RISK_MED_CYCLE_ID_DESC) values from the
Risk Med Cycle Description Table (RHRMCYD0_RISK_MED_CYCLE_DESC) where the
RISK_MED_CYCLE_ID column equals the values retrieved in the previous step.

RISK_MED_CYCLE_ID RISK_MED_CYCLE_ID_DESC

700000 Pre-Treatment

701000 Prescribing

702000 Dispensing

705000 Monitoring

706000 Patient Counseling

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BXW content can be filtered by medication use cycle. This can be accomplished by filtering the
values retrieved in the step 1 to retain only results with a Risk Medication Cycle Identifier (
RISK_MED_CYCLE_ID) value equal to the desired med use cycle. For example, a pharmacist
may choose to retain only results with a Risk Medication Cycle Identifier (RISK_MED_CYCLE_ID)
value of 702000 (Dispensing).

3. Retrieve the Risk Infobyte ID Description(s) (RISK_INFOBYTE_ID_DESC) from the Risk Infobyte (BXW)
Description Table (RHRMRID0_RISK_INFOBYTE_DESC) where the RISK_INFOBYTE_ID column equals
the value(s) retrieved in step 1.

RISK_INFOBYTE_ID RISK_INFOBYTE_ID_DESC

129 Teratogenicity

2 Restricted Distribution

297 Thtombocytopenia and Neutropenia (Myelodysplastic

Syndrome)

80 Thromboembolic Disorder

4. Retrieve the Risk Action Identifier Description (RISK_ACTION_ID_DESC) value(s) from the Risk Action
Description Table (RHRMAND0_RISK_ACTION_DESC) where the RISK_ACTION_ID column equals the
value(s) retrieved in the step 1.

RISK_ACTION_ID RISK_ACTION_ID_DESC

1753 Avoid use in a pregnant woman or woman who intends

to become pregnant.

2396 Verify two negative pregnancy tests. Perform first test

within 10 to 14 days and the second test within 24 hours
prior to prescribing this drug.

3 Assess if patient is candidate for prophylactic

anti-coagulation/anti-platelet therapy.

1809 Check complete blood count with differential.

2344 Ensure prescriber is certified through the restricted

access program.

2385 Ensure pharmacy is certified through the restricted

access program.

792 Ensure patient is registered with restricted access

program.

1809 Check complete blood count with differential.

847 Dispense only to registered patient in REMS program.

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2397 Verify negative pregnancy test weekly for the first

month, then monthly thereafter in women with regular
menstrual cycles, or every 2 weeks in women with
irregular menstrual cycles.

2398 Verify negative pregnancy test during any dose

interruption.

2518 If pregnancy occurs, refer patient to OB-GYN

experienced in reproductive toxicity and report the
pregnancy to the manufacturer and FDA Medwatch
(1-800-FDA-1088).

2399 Monitor complete blood count with differential weekly for

the first 8 weeks and at least monthly thereafter; reduce
dose or interrupt therapy for hematologic toxicities.

8 Monitor for signs and symptoms of deep vein

thrombosis and pulmonary embolism.

7 Inform patient on signs and symptoms of deep vein

thrombosis and pulmonary embolism.

2389 Inform female patient about pregnancy risks and the

need for two forms of contraception for 4 weeks prior to
therapy, during therapy, during therapy interruptions,
and 4 weeks after stopping therapy.

2522 Advise female patient of reproductive potential that she

can call 1-888-668-2528 for information on emergency
contraception in the event of unprotected sex or
suspected contraceptive failure.

880 Inform female patient to stop treatment immediately and

contact physician if she becomes pregnant or suspects
she may be pregnant.

2390 Advise male patient to use latex or synthetic condom

during sexual contact with females of reproductive
potential during therapy, during therapy interruptions,
and for 28 days after stopping therapy.

2525 Inform male patient not to donate sperm during

treatment or any treatment interruptions, and for 4
weeks after stopping this drug.

2392 Instruct all patients not to donate blood while taking this
drug and for 1 month following discontinuation of this
drug.

2402 Inform patient on risk of neutropenia and

thrombocytopenia and the need for scheduled blood
tests during treatment.

5. Display results to user. Results can be sorted and displayed according to different primary and secondary
sort orders. See Data Elements for additional information. The following examples illustrate two methods

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5.

for sorting retrieved results:

When a Medication Use Cycle has multiple Infobytes, the Risk Link Sequence Number (
RISK_LINK_SEQNO) values retrieved in step 1 are used to group and order Infobytes and their
associated actions within the hierarchy.

Example Sort 1: MED_USE_CYCLE is used as the primary sort and the RISK_LINK_SEQNO is used as the secondary
sort.

Text results are organized and displayed in the following hierarchy:

Drug Name

Medication use cycle description

Infobyte description
Action description

Lenalidomide

Pre-Treatment
Teratogenicity
Avoid use in a pregnant woman or woman who intends to become pregnant.
Verify two negative pregnancy tests. Perform first test within 10 to 14 days and the second
test within 24 hours prior to prescribing this drug.
Restricted Distribution
Ensure prescriber is certified through the restricted access program.
Ensure pharmacy is certified through the restricted access program.
Ensure patient is registered with restricted access program.
Thrombocytopenia and Neutropenia (Myelodysplastic Syndrome)
Check complete blood count with differential.
Thromboembolic Disorder
Assess if patient is candidate for prophylactic anticoagulation/anti-platelet therapy.
Prescribing
Thrombocytopenia and Neutropenia (Myelodysplastic Syndrome)
Check complete blood count with differential.
Dispensing
Restricted Distribution
Dispense only to registered patient in REMS program.
Monitoring
Teratogenicity

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Verify negative pregnancy test during any dose interruption.

If pregnancy occurs, refer patient to OB-GYN experienced in reproductive toxicity and report
the pregnancy to the manufacturer and FDA Medwatch (1-800-FDA-1088).
Verify negative pregnancy test weekly for the first month, then monthly thereafter in women
with regular menstrual cycles, or every 2 weeks in women with irregular menstrual cycles.
Thrombocytopenia and Neutropenia (Myelodysplastic Syndrome)
Monitor complete blood count with differential weekly for the first 8 weeks and at least
monthly thereafter; reduce dose or interrupt therapy for hematologic toxicities.
Thromboembolic Disorder
Monitor for signs and symptoms of deep vein thrombosis and pulmonary embolism.
Patient Counseling
Teratogenicity
Inform female patient about pregnancy risks and the need for two forms of contraception for 4
weeks prior to therapy, during therapy, during therapy interruptions, and 4 weeks after
stopping therapy.
Advise female patient of reproductive potential that she can call 1-888-668-2528 for
information on emergency contraception in the event of unprotected sex or suspected
contraceptive failure.
Inform female patient to stop treatment immediately and contact physician if she becomes
pregnant or suspects she may be pregnant.
Advise male patient to use latex or synthetic condom during sexual contact with females of
reproductive potential during therapy, during therapy interruptions, and for 28 days after
stopping therapy.
Inform male patient not to donate sperm during treatment or any treatment interruptions, and
for 4 weeks after stopping this drug.
Instruct all patients not to donate blood while taking this drug and for 1 month following
discontinuation of this drug.
Thrombocytopenia and Neutropenia (Myelodysplastic Syndrome)
Inform patient on risk of neutropenia and thrombocytopenia and the need for scheduled blood
tests during treatment.
Thromboembolic Disorder
Inform patient on signs and symptoms of deep vein thrombosis and pulmonary embolism.

Example Sort 2: RISK_LINK_SEQNO is used as the primary sort

Text results are organized and displayed in the following hierarchy:

Drug Name

Risk Infobyte description

Action description

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Medication use cycle description

Lenalidomide

Teratogenicity
Avoid use in a pregnant woman or woman who intends to become pregnant.
Verify two negative pregnancy tests. Perform first test within 10 to 14 days and the second test
within 24 hours prior to prescribing this drug.
Pre-Treatment
Verify negative pregnancy test during any dose interruption.
If pregnancy occurs, refer patient to OB-GYN experienced in reproductive toxicity and report the
pregnancy to the manufacturer and FDA Medwatch (1-800-FDA-1088).
Verify negative pregnancy test weekly for the first month, then monthly thereafter in women with
regular menstrual cycles, or every 2 weeks in women with irregular menstrual cycles.
Monitoring
Inform female patient about pregnancy risks and the need for two forms of contraception for 4
weeks prior to therapy, during therapy, during therapy interruptions, and 4 weeks after stopping
therapy.
Advise female patient of reproductive potential that she can call 1-888-668-2528 for information on
emergency contraception in the event of unprotected sex or suspected contraceptive failure.
Inform female patient to stop treatment immediately and contact physician if she becomes pregnant
or suspects she may be pregnant.
Advise male patient to use latex or synthetic condom during sexual contact with females of
reproductive potential during therapy, during therapy interruptions, and for 28 days after stopping
therapy.
Inform male patient not to donate sperm during treatment or any treatment interruptions, and for 4
weeks after stopping this drug.
Instruct all patients not to donate blood while taking this drug and for 1 month following
discontinuation of this drug.
Patient Counseling
Restricted Distribution
Ensure prescriber is certified through the restricted access program.
Ensure pharmacy is certified through the restricted access program.
Ensure patient is registered with restricted access program.
Pre-Treatment
Dispense only to registered patient in REMS program.
Dispensing
Thrombocytopenia and Neutropenia (Myelodysplastic Syndrome)
Check complete blood count with differential.

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Pre-Treatment
Check complete blood count with differential.
Prescribing
Monitor complete blood count with differential weekly for the first 8 weeks and at least monthly
thereafter; reduce dose or interrupt therapy for hematologic toxicities.
Monitoring
Inform patient on risk of neutropenia and thrombocytopenia and the need for scheduled blood tests
during treatment.
Patient Counseling
Thromboembolic Disorder
Assess if patient is candidate for prophylactic anticoagulation/anti-platelet therapy.
Pre-Treatment
Monitor for signs and symptoms of deep vein thrombosis and pulmonary embolism.
Monitoring
Inform patient on signs and symptoms of deep vein thrombosis and pulmonary embolism.
Patient Counseling

Part 3: Displaying the Boxed Warning Summary and/or Representative Boxed Warning Monograph for a Given Drug

For the purposes of this demonstrating application, the following scenario is used: A user needs to display the
Boxed Warning Summary and/or Representative Boxed Warning Monograph for Revlimid 15 mg capsule (NDC
59572041521). In this example, the user has already retrieved the associated Risk_ID value and determined that
Revlimid has active BXW content.

1. Retrieve the Risk Monograph Identifier(s) (RISK_MONO_ID) from the Risk Monograph Link Table
(RHRMMRL0_RISK_MONO_LINK) where the RISK_ID column equals 251 (Revlimid 15 mg capsule), as
retrieved in the Part 1, Step 1.

RISK_ID RISK_MONO_ID

251 377

251 441

2. Retrieve the Risk Monograph Line Sequence Number (RISK_MONO_LINE_SEQNO), Risk Monograph
Format Code (RISK_MONO_FORMAT_CD), Risk Monograph Type Code (RISK_MONO_TYP_CD) and
Risk Monograph Text (RISK_MONO_TXT) values from the Risk Monograph Table (
RHRMRMO0_RISK_MONO) where the RISK_MONO_ID column equals the value retrieved in the previous
step and:
The Risk Monograph Type Code (RISK_MONO_TYP_CD) equals 1 (Boxed Warning (BXW)
Representative Text).
The Risk Monograph Type Code (RISK_MONO_TYP_CD) equals 2 (Boxed Warning (BXW)
Summary).

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RISK_MONO_ID RISK_MONO_LIN RISK_MONO_FO RISK_MONO_TY RISK_MONO_TXT

E_SEQNO RMAT_CD P_CD

441 1 1 2 Avoid use during

pregnancy due to
risk of fetal
abnormalities. Two
negative pregnancy
tests are required
prior to treatment.
Contraception is
required beginning
4 weeks prior to
therapy, during
therapy and for 4
weeks post
treatment. Two
contraceptive
methods are
necessary for
females; males
must use latex
condom. Regularly
scheduled
pregnancy tests are
required.

441 2 1 2 This drug is

available only
through Revlimid
REMS program.
Prescriber, patient
and pharmacy
require registration;
visit
www.celgeneriskm
anagement.comor
call
1-888-423-5436.

441 3 1 2 Grade 3 and 4

neutropenia and
thrombocytopenia
is more common
among patients on
therapy for del 5q
myelodysplastic
syndrome. Patients
may require dose
reduction or
interruption and/or
use of blood
products or growth
factors.

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441 4 1 2 Thromboembolic
risk may result in
pulmonary
embolism or deep
venous thrombosis.

RISK_MONO_ID RISK_MONO_LIN RISK_MONO_FO RISK_MONO_TY RISK_MONO_TXT

E_SEQNO RMAT_CD P_CD

377 1 1 1 WARNING:
EMBRYO-FETAL
TOXICITY,
HEMATOLOGIC
TOXICITY, and
VENOUS
THROMBOEMBOL
ISM

377 2 1 1 Embryo-Fetal
Toxicity

377 3 1 1 Do not use

REVLIMID during
pregnancy.
Lenalidomide, a
thalidomide
analogue, caused
limb abnormalities
in a developmental
monkey study.
Thalidomide is a
known human
teratogen that
causes severe
life-threatening
human birth
defects. If
lenalidomide is
used during
pregnancy, it may
cause birth defects
or embryo-fetal
death. In females of
reproductive
potential, obtain 2
negative pregnancy
tests before starting
REVLIMID
treatment. Females
of reproductive
potential must use
2 forms of
contraception

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377 4 2 1 or continuously
abstain from
heterosexual sex
during and for 4
weeks after
REVLIMID
treatment [see
Warnings and
Precautions (5.1),
and Medication
Guide (17)]. To
avoid embryo-fetal
exposure to
lenalidomide,
REVLIMID is only
available through a
restricted
distribution
program, the
REVLIMID REMS
program (formerly
known as the "Rev
Assist"
program(5.2).

377 5 1 1 Information about

the REVLIMID
REMS program is
available at
www.celgeneriskm
anagement.comor
by calling the
manufacturer's
toll-free number
1-888-423-5436.

377 6 1 1 Hematologic
Toxicity
(Neutropenia and
Thrombocytopenia)

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377 7 1 1 REVLIMID can

cause significant
neutropenia and
thrombocytopenia.
Eighty percent of
patients with del 5q
myelodysplastic
syndromes had to
have a dose
delay/reduction
during the major
study. Thirty-four
percent of patients
had to have a
second dose
delay/reduction.
Grade 3 or 4
hematologic toxicity
was seen in 80% of
patients enrolled in
the study. Patients
on therapy for del
5q myelodysplastic
syndromes should
have their complete
blood counts
monitored weekly
for the first 8 weeks
of therapy and

377 8 2 1 at least monthly

thereafter. Patients
may require dose
interruption and/or
reduction. Patients
may require use of
blood product
support and/or
growth factors [see
Dosage and
Administration
(2.2)].

377 9 1 1 Venous
Thromboembolism

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377 10 1 1 REVLIMID has

demonstrated a
significantly
increased risk of
deep vein
thrombosis (DVT)
and pulmonary
embolism (PE) in
patients with
multiple myeloma
who were treated
with REVLIMID and
dexamethasone
therapy. Patients
and physicians are
advised to be
observant for the
signs and
symptoms of
thromboembolism.
Patients should be
instructed to seek
medical care if they
develop symptoms
such as shortness
of breath, chest
pain, or arm or leg
swelling. It is not
known whether
prophylactic
anticoagulation

377 11 2 1 or antiplatelet
therapy prescribed
in conjunction with
REVLIMID may
lessen the potential
for venous
thromboembolism.
The decision to
take prophylactic
measures should
be done carefully
after an
assessment of an
individual patient's
underlying risk
factors [see
Warnings and
Precautions (5.4)].

Results can be filtered by the RISK_MONO_TYP to display the Boxed Warning (BXW)
Summary, Boxed Warning (BXW) Representative Monograph, or both. Text descriptions for
RISK_MONO_TYP values may be retrieved from the Risk Monograph Type Code

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Description Table (RISK_MONO_TYP_CD_DESC).

In this example the given drug has both FDB Boxed Warning Summary content (2) and
Representative BXW full text (1). See Definitions for more information.

Due to text length, the Risk Monograph Text (RISK_MONO_TXT) for both Boxed Warning
(BXW) Representative Text and Boxed Warning (BXW) Summary content may be divided
into multiple lines. The Risk Monograph Line Sequence Number (
RISK_MONO_LINE_SEQNO) and Risk Monograph Format Code (
RISK_MONO_FORMAT_CD) values may be used to arrange and group content into the
proper text order.

3. Display results to user.

Summary Monograph

Avoid use during pregnancy due to risk of fetal abnormalities. Two negative pregnancy tests are required prior to
treatment. Contraception is required beginning 4 weeks prior to therapy, during therapy and for 4 weeks post
treatment. Two contraceptive methods are necessary for females; males must use latex condom. Regularly
scheduled pregnancy tests are required.

This drug is available only through the Revlimid REMS program. Prescriber, patient and pharmacy
are required to register; visit www.celgeneriskmanagement.com or call 1-888-423-5436.
Grade 3 and 4 neutropenia and thrombocytopenia is more common among patients on therapy for del 5q
myelodysplastic syndrome. Patients may require dose reduction or interruption and/or use of blood products or
growth factors.
Thromboembolic risk may result in pulmonary embolism or deep venous thrombosis.

Representative Boxed Warning

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WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS THROMBOEMBOLISM

Embryo-Fetal Toxicity
Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a
developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human
birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females
of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Females of
reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and
for 4 weeks after REVLIMID treatment [see Warnings and Precautions (5.1), and Medication Guide (17)]. To avoid
embryo-fetal exposure to lenalidomide, REVLIMID is only available through a restricted distribution program, the
REVLIMID REMS program (formerly known as the "Rev Assist" program(5.2).

Information about the REVLIMID REMS program is available at www.celgeneriskmanagement.com by calling the
manufacturer's toll-free number 1-888-423-5436.
Hematologic Toxicity (Neutropenia and Thrombocytopenia)
REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q
myelodysplastic syndromes had to have a dose delay/reduction during the major study. Thirty-four percent of
patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients
enrolled in the study. Patients on therapy for del 5q myelodysplastic syndromes should have their complete blood
counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose
interruption and/or reduction. Patients may require use of blood product support and/or growth factors [see Dosage
and Administration (2.2)].
Venous Thromboembolism
REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism
(PE) in patients with multiple myeloma who were treated with REVLIMID and dexamethasone therapy. Patients and
physicians are advised to be observant for the signs and symptoms of thromboembolism. Patients should be
instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg
swelling. It is not known whether prophylactic anticoagulation or antiplatelet therapy prescribed in conjunction with
REVLIMID may lessen the potential for venous thromboembolism. The decision to take prophylactic measures
should be done carefully after an assessment of an individual patient's underlying risk factors [see Warnings and
Precautions (5.4)].

Part 4: Retrieving the Representative Boxed Warning Product Labeling URL for a Given Drug at the Time of
Dispensing

For the purposes of this demonstrating application, the following scenario is used: A user needs to display
the Representative Boxed Warning Product Labeling URL for Revlimid 15 mg capsule (NDC 59572041521). In
this example, the user has already retrieved the associated Risk_ID value and determined that Revlimid
has active BXW content.

1. Retrieve the Risk URL Text (RISK_URL_TXT) from the Risk Master Table (RHRMRMA0_RISK_MSTR)
where the Risk Identifier (RISK_ID) column equals the value retrieved in Part 1, step 1.

RISK_ID RISK_URL_TXT

251 http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=
5fa97bf5-28a2-48f1-8955-f56012d296be

2. Display results to user.

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High Risk Medication Module ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

High Risk Medication Module Tables

High Risk Medication Module ERD

High Risk Medication Module Tables

Clinical Formulation to Risk Link Table
MEDID to Risk Link Table
NDC to Risk Link Table
Orderable Med to Risk Link Table
Risk Action Description Table
Risk Actor Description Table
Risk Additional Text Description Table
Risk Category (BXW) Description Table
Risk Infobyte (BXW) Description Table
Risk Infobyte (BXW) Link Table
Risk Infobyte (BXW) Table
Risk Master Table
Risk Med Cycle Description Table
Risk Mitigation (REMS) Table
Risk Monograph Format Description Table
Risk Monograph Link Table
Risk Monograph Table
Risk Monograph Type Description Table
Risk Previous/Replacement Table
Risk Status Description Table
Risk Type Description Table
Routed Generic to Risk Link Table
Routed Med to Risk Link Table

High Risk Medication Module ERD

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Clinical Formulation to Risk Link Table

Table Name RHRMGCL0_GCNSEQNO_RISK_LINK

Revision Activity add. 07-24-2013

Purpose Links Clinical Formulation Identifiers to associated Risk

Identifiers.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF RISK_ID Risk Identifier N 8 9(8)

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MEDID to Risk Link Table

Table Name RHRMMDL0_MED_RISK_LINK

Revision Activity add. 07-24-2013

Purpose Links Medication Identifiers to associated Risk Identifiers.

Key Column Name Column Format Length Picture

Description

PF MEDID MED Medication N 8 9(8)

ID

PF RISK_ID Risk Identifier N 8 9(8)

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NDC to Risk Link Table

Table Name RHRMNDL0_NDC_RISK_LINK

Revision Activity add. 07-24-2013

Purpose Links National Drug Codes (NDC) to associated Risk

Identifiers.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

PF RISK_ID Risk Identifier N 8 9(8)

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Orderable Med to Risk Link Table

Table Name RHRMOML0_ORD_MED_RISK_LINK

Revision Activity add. 07-24-2013

Purpose Links OrderKnowledge Orderable Medication Identifiers to

Risk Identifiers.

Key Column Name Column Format Length Picture

Description

PF ORD_MED_ID Orderable N 8 9(8)

Medication
Identifier

PF RISK_ID Risk Identifier N 8 9(8)

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Risk Action Description Table

Table Name RHRMAND0_RISK_ACTION_DESC

Revision Activity add. 07-24-2013

Purpose Relates the Risk Action Identifier to its text description and
indicates parent-child relationships that can consolidate
actions. Examples of risk actions include prescriber training
or certification, lab tests, and prescription limits.

Key Column Name Column Format Length Picture

Description

P RISK_ACTION_ID Risk Action N 8 9(8)

Identifier

RISK_ACTION_I Risk Action AN 200 X(200)

D_DESC Identifier
Description

F PARENT_RISK_A Parent Risk Action N 8 9(8)

CTION_ID Identifier

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Risk Actor Description Table

Table Name RHRMARD0_RISK_ACTOR_DESC

Revision Activity add. 07-24-2013

Purpose Relates the Risk Actor Identifier to its text description.

Actors include such roles as prescriber or dispenser.

Key Column Name Column Format Length Picture

Description

P RISK_ACTOR_ID Risk Actor N 8 9(8)

Identifier

RISK_ACTOR_ID Risk Actor AN 50 X(50)

_DESC Identifier
Description

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Risk Additional Text Description Table

Table Name RHRMATD0_RISK_ADDL_TEXT_DESC

Revision Activity add. 07-24-2013

Purpose Relates the Risk Additional Text Identifier to its text

description

Key Column Name Column Format Length Picture

Description

P RISK_ADDL_TEX Risk Additional N 8 9(8)

T_ID Text Identifier
(REMS)

RISK_ADDL_TEX Risk Additional AN 500 X(500)

T_ID_DESC Text Identifier
Description

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Risk Category (BXW) Description Table

Table Name RHRMRCD0_RISK_CATEGORY_DESC

Revision Activity add. 07-24-2013

Purpose Relates the Risk Category Code to its text description

Key Column Name Column Format Length Picture

Description

P RISK_CATEGOR Risk Category N 4 9(4)

Y_CD Code

RISK_CATEGOR Risk Category AN 250 X(250)

Y_CD_DESC Code Description

RISK_CATEGOR Risk Category AN 100 X(100)

Y_CD_DESC_SH Short Description
ORT

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Risk Infobyte (BXW) Description Table

Table Name RHRMRID0_RISK_INFOBYTE_DESC

Revision Activity add. 07-24-2013

Purpose Relates the Risk Infobyte Identifier to its text description.

Key Column Name Column Format Length Picture

Description

P RISK_INFOBYTE Risk Infobyte N 8 9(8)

_ID Identifier (Stable
ID)

RISK_INFOBYTE Risk Infobyte AN 500 X(500)

_ID_DESC Identifier
Descriptiuon

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Risk Infobyte (BXW) Link Table

Table Name RHRMINL0_RISK_INFOBYTE_LINK

Revision Activity add. 07-18-2014

Purpose Links Infobytes to various actions and where they should

occur in the medication use cycle.

Key Column Name Column Format Length Picture

Description

PF RISK_ID Risk Identifier N 8 9(8)

P RISK_LINK_SEQ Risk Link N 8 9(8)

NO Sequence
Number

F RISK_INFOBYTE Risk Infobyte N 8 9(8)

_ID Identifier

F RISK_ACTION_ID Risk Action N 8 9(8)

Identifier

F RISK_MED_CYC Risk Medication N 8 9(8)

LE_ID Cycle Identifier

F RISK_ACTOR_ID Risk Actor N 8 9(8)

Identifier

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Risk Infobyte (BXW) Table

Table Name RHRMRIN0_RISK_INFOBYTE

Revision Activity add. 07-24-2013

Purpose Provides infobytes identified within a Boxed Warning.

Key Column Name Column Format Length Picture

Description

PF RISK_ID Risk Identifier N 8 9(8)

PF RISK_INFOBYTE Risk Infobyte N 8 9(8)

_ID Identifier

RISK_INFOBYTE Risk Infobyte N 8 9(8)

_SEQNO Sequence
Number

F RISK_CATEGOR Risk Category N 4 9(4)

Y_CD Code

RISK_INFOBYTE Risk Infobyte Start N 8 9(8)

_START_DT Date

RISK_INFOBYTE Risk Infobyte N 8 9(8)

_VERSION_DT Version Date

RISK_INFOBYTE Risk Infobyte End N 8 9(8)

_END_DT Date

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Risk Master Table

Table Name RHRMRMA0_RISK_MSTR

Revision Activity add. 07-24-2013

Purpose Provides attributes of the Risk Identifier.

Key Column Name Column Format Length Picture

Description

P RISK_ID Risk Identifier N 8 9(8)

(Stable ID)

F RISK_TYP_CD Risk Type Code N 2 9(2)

RISK_GRP_DES Risk Group AN 100 X(100)

C Description

RISK_URL_TXT Risk URL Text AN 500 X(500)

RISK_START_DT Risk Start Date N 8 9(8)

RISK_VERSION_ Risk Version Date N 8 9(8)

DT

RISK_END_DT Risk End Date N 8 9(8)

RISK_STATUS_C Risk Status Code N 2 9(2)

D

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Risk Med Cycle Description Table

Table Name RHRMCYD0_RISK_MED_CYCLE_DESC

Revision Activity add. 07-24-2013

Purpose Relates the Risk Medication Cycle Identifier to its text

description.

Key Column Name Column Format Length Picture

Description

P RISK_MED_CYC Risk Medication N 8 9(8)

LE_ID Cycle Identifier

RISK_MED_CYC Risk Medication AN 50 X(50)

LE_ID_DESC Cycle Identifier
Description

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Risk Mitigation (REMS) Table

Table Name RHRMRMI0_RISK_MITIGATION

Revision Activity add. 07-24-2013

Purpose Links Risk Identifiers to their associated mitigation

strategies.

Key Column Name Column Format Length Picture

Description

PF RISK_ID Risk Identifier N 8 9(8)

PF RISK_ACTION_ID Risk Action N 8 9(8)

Identifier

P RISK_MITIGATIO Risk Mitigation N 8 9(8)

N_SEQNO Sequence
Number

F RISK_ACTOR_ID Risk Actor N 8 9(8)

Identifier

F RISK_MED_CYC Risk Medication N 8 9(8)

LE_ID Cycle Identifier

RISK_ADDL_TEX Risk Additional N 8 9(8)

T_ID Text Identifier

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Risk Monograph Format Description Table

Table Name RHRMMFD0_RISK_MONO_FORMAT_DESC

Revision Activity add. 07-24-2013

Purpose Relates the Risk Monograph Format Code to its text

description.

Key Column Name Column Format Length Picture

Description

P RISK_MONO_FO Risk Monograph N 2 9(2)

RMAT_CD Format Code

RISK_MONO_FO Risk Monograph AN 50 X(50)

RMAT_CD_DESC Format Code
Description

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Risk Monograph Link Table

Table Name RHRMMRL0_RISK_MONO_LINK

Revision Activity add. 12-19-2013

Purpose Links risk monographs to associated Risk Identifiers.

Key Column Name Column Format Length Picture

Description

PF RISK_ID Risk Identifier N 8 9(8)

PF RISK_MONO_ID Risk Monograph N 8 9(8)

Identifier

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Risk Monograph Table

Table Name RHRMRMO0_RISK_MONO

Revision Activity rev. 12-19-2013

Purpose Provides monographs for given Risk Identifiers.

Key Column Name Column Format Length Picture

Description

P RISK_MONO_ID Risk Monograph N 8 9(8)

Identifier

P RISK_MONO_LIN Risk Monograph N 8 9(8)

E_SEQNO Line Sequence
Number

F RISK_MONO_FO Risk Monograph N 2 9(2)

RMAT_CD Format Code

F RISK_MONO_TY Risk Monograph N 2 9(2)

P_CD Type Code

RISK_MONO_TX Risk Monograph AN 500 X(500)

T Text

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Risk Monograph Type Description Table

Table Name RHRMMTD0_RISK_MONO_TYP_DESC

Revision Activity add. 07-24-2013

Purpose Relates the Risk Monograph Type Code to its text

description.

Key Column Name Column Format Length Picture

Description

P RISK_MONO_TY Risk Monograph N 2 9(2)

P_CD Type Code

RISK_MONO_TY Risk Monograph AN 100 X(100)

P_CD_DESC Type Code
Description

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Risk Previous-Replacement Table

Table Name RHRMREP0_RISK_REPL

Revision Activity add. 07-24-2013

Purpose Provides the replacement history of a replaced Risk

Identifier.

Key Column Name Column Format Length Picture

Description

PF REPL_RISK_ID Replacement Risk N 8 9(8)

Identifier

PF PREV_RISK_ID Previous Risk N 8 9(8)

Identifier

REPL_RISK_EFF Replacement Risk N 8 9(8)

_DT Effective Date

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Risk Status Description Table

Table Name RHRMSTD0_RISK_STATUS_DESC

Revision Activity add. 07-24-2013

Purpose Relates the Risk Status Code to its text description.

Key Column Name Column Format Length Picture

Description

P RISK_STATUS_C Risk Status Code N 2 9(2)

D

RISK_STATUS_C Risk Status Code AN 50 X(50)

D_DESC Description

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Risk Type Description Table

Table Name RHRMRTD0_RISK_TYP_DESC

Revision Activity add. 07-24-2013

Purpose Relates the Risk Type Code to its text description.

Key Column Name Column Format Length Picture

Description

P RISK_TYP_CD Risk Type Code N 2 9(2)

RISK_TYP_CD_D Risk Type Code AN 100 X(100)

ESC Description

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Routed Generic to Risk Link Table

Table Name RHRMRGL0_RTD_GEN_RISK_LINK

Revision Activity add. 07-24-2013

Purpose Links Routed Generic Identifiers to associated Risk

Identifiers.

Key Column Name Column Format Length Picture

Description

PF ROUTED_GEN_I Routed Generic N 8 9(8)

D Identifier

PF RISK_ID Risk Identifier N 8 9(8)

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Routed Med to Risk Link Table

Table Name RHRMRML0_ROUTED_MED_RISK_LINK

Revision Activity add. 07-24-2013

Purpose Links Routed Medication Identifiers to associated Risk

Identifiers.

Key Column Name Column Format Length Picture

Description

PF ROUTED_MED_I Routed N 8 9(8)

D Medication
Identifier

PF RISK_ID Risk Identifier N 8 9(8)

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FDB Interoperability Module 1.0

FDB Interoperability Module Editorial Policies
Applications
ERD and Technical Specifications

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FDB Interoperability Module Editorial Policies

Overview
Definitions
Inclusion Criteria
Data Elements
Rule Sets
Maintenance
Resources

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Interoperability Overview
The FDB Interoperability Module provides cross-references between FDB MedKnowledge vocabulary
concepts and federal medication terminologies including the National Library of Medicine (NLM) RxNorm
vocabulary, the Centers for Disease Control and Prevention immunization code sets and SNOMED CT value
sets.

Interoperable drug knowledge is of vital importance to Electronic Health Record (EHR) adoption and effective
EHR use as it supports the portability of patient medication, immunization, and allergy history among disparate
healthcare information systems. Use of interoperable drug knowledge enables clinical information exchange,
electronic prescribing, the calculation of clinical quality measures, immunization and medication allergen decision
support, and streamlines clinical information reconciliation.

The extension of FDB MedKnowledge to standardized vocabularies is essential for organizations striving to meet
the increased vocabulary interoperability requirements set forth in EHR certification criteria.

Interoperable medication management requires cross references from a wide variety of source FDB
MedKnowledge vocabulary concepts to interoperable vocabulary concepts. The breadth of cross references
required varies by the types of interoperable exchanges needed. To provide maximum flexibility, FDB provides
both Core and Enhanced Interoperability module packages.

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Interoperability Module Layers in Brief

Depending upon your business needs, there are two versions of the FDB Interoperability Module: Core and
Enhanced.

Core

Provides FDB Medication Cross-References to RxNorm concepts and CVX/MVX codes

Primarily supports outbound translations of FDB medications
Meets Stage 1 meaningful use criteria such as basic e-Prescribing, Part D Formulary Compilation, and
translation of FDB medications to Clinical Quality Measure medication value sets

Enhanced

Provides Core functionality

Supports expression of outbound allergy and integration of reported inbound allergies to FDB concepts

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Supports enhanced medication reconciliation processing of inbound patient medications to FDB concepts
Supports translation and classification of FDB medications and allergies to applicable clinical quality
measure medication value sets
Supports translation of FDB indications to candidate SNOMED CT problems and drug-disease
contraindication checking using SNOMED CT problems
FDB also provides SNOMED CT concepts, terms, relationships, cross-references to FDB disease
identifiers and value sets for advanced allergy and intolerance documentation purposes. These value sets
include:
Problem Severities
Allergy/Adverse Event Types
Reactions
Food Allergens
Environmental Agents
Supports the translation of FDB-based components to components used for medication order messaging
or electronic prescription directions. These mappings include:

FDB Source HL7 Vocabulary Type NCPDP Vocabulary Type

Administrative Method Code SNOMED-CT

Anatomic Site Identifier SNOMED-CT SNOMED-CT

PRN Identifier SNOMED-CT SNOMED-CT

Dosage Form Identifier NCIt Terminology Code NCIt Terminology Code

Route Master Identifier NCIt Terminology Code SNOMED-CT

Unit of Measure Master ID UCUM/SNOMED-CT SNOMED-CT/NCIt Terminology

Code

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Interoperability Definitions
This section defines important terms related to the module that users should understand. Some industry terms
that have a specific connotation in regards to the module are also be defined.

Child SNOMED CT Concept Identifier

Centers for Disease Control and Prevention (CDC)
Clinical Decision Support
Clinical Quality Measures (CQM)
Concept Identifier
Continuity of Care Document (CCD)
Current Prescribable Content
Current Procedural Terminology (CPT)
CVX Code
Derived Relationship
Electronic Health Record (EHR)
Electronic Medical Record (EMR)
Electronic Measure (eMeasure)
Electronic Prescription (e-prescription)
Environmental Allergen Agent
Federal Medication (FedMed)
Federal Medication Terminologies (FMT)
Frequency and Interval
Global Document Type Identifier (GTDI)
Health Level Seven (HL7) Object Identifier (OID)
Manufacturers of Vaccines (MVX Code)
Medication Reconciliation
National Drug File - Reference Terminology (NDF-RT)
National Council for Prescription Drug Programs (NCPDP) SCRIPT
National Library of Medicine (NLM)
The National Quality Forum (NQF)
NCI Thesaurus Code (NCit )
Parent SNOMED CT Concept Identifier
Personal Health Record (PHR)
Persistent Identifier
RxNorm
RxNorm Concept Unique Identifier (RXCUI)
RxNorm Code (CODE)

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RxNorm Source Abbreviation (SAB)

RxNorm String (STR)
RxNorm Term Type (TTY)
SNOMED CT Fully Specified Term
SNOMED CT Problem Severity
SNOMED CT Preferred Term
SNOMED CT Synonym Term
SNOMED CT Relationship
Stable Identifier
Systematized Nomenclature of MedicineClinical Terms (SNOMED CT)
Term
Unified Code for Units of Measure (UCUM)
Unified Medical Language System (UMLS) Metathesaurus
Unique Ingredient Identifier (UNII) Code
United States Health Information Knowledgebase (USHIK)
Unspecified Formulation
Vaccines Administered (CVX Code)
Vaccine Group
Vaccine Information Statement (VIS)
Value set
Vocabulary

Child SNOMED CT Concept Identifier

A child concept is a more specific SNOMED CT value of a parent (broader) concept. For example, Feltys
syndrome is a child concept of the parent concept Inflammatory disorder.

Centers for Disease Control and Prevention (CDC)

The national public health institute of the United States. Utilized by FDB as the information source for Vaccines
Administered (CVX) and the Manufacturers of Vaccines (MVX) code sets as used in Health Level Seven
International's (HL7) messaging standard.

Clinical Decision Support

An interactive support system designed to assist physicians and other health professionals with decision making
tasks, such as determining diagnosis of patient data.

Clinical Quality Measures (CQM)

CQMs are tools that measure and track the quality of healthcare services provided, including health outcomes,
clinical processes, patient safety, efficient use of healthcare resources, care coordination, patient engagements,
population and public health, and clinical guidelines.

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Concept Identifier
Identifier associated to a collection of vocabulary terms that all have the same meaning (for example, 3841003 is
the SNOMED CT concept that spans a fully specified name of hypertensive disorder, systemic arterial [disorder]
with synonym terms of hypertension and high blood pressure).

Continuity of Care Document (CCD)

An electronic document exchange standard for sharing patient summary information about current and past
health status.

Current Prescribable Content

Defined by the NLM as a subset of currently prescribable drugs found in RxNorm intended to be an approximation
of the prescription drugs currently marketed in the U.S., tailored for e-Prescribing. The subset also includes some
frequently-prescribed over-the-counter drugs, and the subset includes only the active RxNorm normalized names,
codes (RXCUIs), attributes, and relationships. RXCUIs included in the prescribable data subset are all sourced
from NLM (SAB = RXNORM) and excludes all suppressed or obsolete data.

Current Procedural Terminology (CPT)

Maintained by the American Medical Association (AMA), the CPT code set describes medical, surgical, and
diagnostic services and is designed to communicate uniform information about medical services and procedures
among physicians, coders, patients, accreditation organizations, and payers for administrative, financial, and
analytical purposes.

CVX Code
The CVX code identifies the immunization and is used in HL7 messaging as the standard immunization identifier
for transmission to local Immunization Information System (IIS) registries. The CVX code facilitates
interoperability between EHR systems and a local IIS.

Derived Relationship
Derived relationships are created according to NLM editorial policy using the FDB Hierarchical Ingredient Code
Description and the Clinical Formulation ID.

Electronic Health Record (EHR)

A systematic collection of electronic health information about individual patients or populations that is maintained
within an institution and is capable of being shared across different health care settings.

Electronic Medical Record (EMR)

An electronic patient record created in hospitals and ambulatory environments that can serve as a data source for
the EHR.

Electronic Measure (eMeasure)

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Standardized performance measures in an electronic format.

Electronic Prescription (e-prescription)

A computer-generated prescription created by a healthcare provider and sent directly to a pharmacy.

Environmental Allergen Agent

A chemical or biological substance (e.g., pollen, animal dander, house dust mite proteins) present in the living or
working environment that induces an allergic state or reaction, characterized by hypersensitivity-like reactions
(e.g., rash, shortness of breath).

Federal Medication (FedMed)

Interagency collaboration that organizes standard sets of terminologies and code sets from component
vocabulary systems developed and maintained by the Food and Drug Administration, National Library of
Medicine, Veterans Health Administration, National Cancer Institute, and Agency for Healthcare Research and
Quality, Centers for Medicare and Medicaid Services, Department of Defense, and Environmental Protection
Agency.

Federal Medication Terminologies (FMT)

Terminologies and code sets organized by the FedMed. Resources and related standards encompass
medication and ingredient names, codes, routes of administration, dosage forms, units of presentation,
mechanisms of action, physiologic effects, and structure,

Frequency and Interval

The frequency, interval and interval unit of measure indicate how often per unit of time to administer a drug. The
frequency is the numeric value of how many times to administer a drug per unit of time. The interval is the
numeric value of the time component. For example for the frequency interval "twice a day", the frequency is 2
and the interval is 1, and the interval unit of measure is day.

Global Document Type Identifier (GTDI)

A unique serial number used to identify and maintain the record of a given document.

Health Level Seven (HL7) Object Identifier (OID)

A unique, globally standardized identifier created by Health Level Seven, Inc. HL7 OIDs are linked to given FDB
EVD Vocabulary Type IDs (EVD_VOCAB_TYPE_ID).

Manufacturers of Vaccines (MVX Code)

The MVX code set is developed and maintained by the Centers for Disease Control's (CDC) National Center of
Immunization and Respiratory Diseases (NCIRD). This nomenclature represents the manufacturers of vaccine
and passive immunization products available in the United States.

Medication Reconciliation

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A formal process in which healthcare providers partner with patients and their families to ensure accurate and
complete medication information transfer at interfaces of care including admission and discharge from a hospital
or changes in care setting, service, or level of care.

National Drug File - Reference Terminology (NDF-RT)

An extension of the National Drug File (NDF) produced by the U.S. Department of Veterans Affairs (VA), the
NDF-RT is used for modeling drug characteristics including ingredients, chemical structure, dose form,
physiologic effect, mechanism of action, pharmacokinetics, and related diseases.

National Council for Prescription Drug Programs (NCPDP) SCRIPT

NCPDP SCRIPT is a standard created to facilitate the electronic transfer of prescription data between
pharmacies, prescribers, intermediaries, and payers. Version 10.6, effective date - July 1, 2010, NCPDP SCRIPT
standard was recognized by the Centers for Medicare and Medicaid Services (CMS) regulation, for early adopters
use.

National Library of Medicine (NLM)

A U.S. biomedical library and part of the National Institutes of Health.

The National Quality Forum (NQF)

A nonprofit organization that operates to improve the quality of American healthcare by creating a national
strategy for health care quality measurement and performance reporting.

NCI Thesaurus Code (NCit )

The National Cancer Institute component terminology within the FMT is the NCI Thesaurus (NCIt). NCIt content
comes from NCI, NIH, agencies and standards development organizations such as FDA and CDISC, other
partners, user requests, and ongoing review of the scientific literature. FDB utilizes NCIt Thesaurus
Codes sourced from the FDA and NCPDP.

Parent SNOMED CT Concept Identifier

A parent concept is a broader SNOMED CT value of a child (specific) concept. For example, Inflammatory
disorder is a parent concept with a child concept of Feltys syndrome.

Personal Health Record (PHR)

A health record in which data and information related to the care of a patient is maintained by the patient.

Persistent Identifier
A concept that is managed and updated over a defined time period to maintain the most current data available for
a given concept.

RxNorm
RxNorm is a standardized nomenclature for medications produced and maintained by the U.S. National Library of

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Medicine (NLM) in cooperation with proprietary vendors. RxNorms concepts are linked by NLM to multiple drug
identifiers for each of the commercially available drug databases within the Unified Medical Language System
(UMLS) Metathesaurus.
RxNorm facilitates the interoperability between computer systems that use different drug nomenclatures. To
accomplish this, NLM assigns RxNorm Concept Unique Identifier (RXCUI) to various drug abstraction concepts
and creates relationships between these concepts to form a semantic network that links RXCUIs similar to
proprietary vendor concepts (such as, semantic clinical drug concepts, ingredients, and branded names). A
normalized name is also created for each concept. For example, RXCUI 310386 has the normalized name,
Fluoxetine 4 MG/ML Oral Solution, and is assigned an RxNorm Term Type (TTY) value of SCD (Semantic Clinical
Drug) because it contains the elements of ingredient plus strength and dose form; Fluoxetine (RXCUI 4493) is
assigned a TTY of IN (Ingredient).

RxNorm Concept Unique Identifier (RXCUI)

The numerical identifier assigned by NLM for the various RxNorm concepts.

RxNorm Code (CODE)

Source asserted identifier (if the source vocabulary has more than one identifier), or a Metathesaurus-generated
source entry identifier (if the source vocabulary has none).

RxNorm Source Abbreviation (SAB)

The abbreviation of the source of the attribute. RXCUIs in this module are limited to RXCUIs provided by FDB
(SAB = NDDF) or RxNorm (SAB = RXNORM).

RxNorm String (STR)

The text description string for an RXCUI.

RxNorm Term Type (TTY)

Identifies the RxNorm naming standard used to create the description for each RXCUI and identifies the drug
level of abstraction. The following TTYs are associated with this module.

BN (Brand Name)A proprietary name for a family of products containing a specific active ingredient set;
for example, Prozac.
BPCK (Branded Pack)Branded Drug Delivery Device (a pack that contains multiple clinical drugs or
clinical drugs designed to be administered in a specified sequence); for example, {12 (Ethinyl Estradiol
0.035 MG / Norethindrone 0.5 MG Oral Tablet)/ 9 (Ethinyl Estradiol 0.035 MG / Norethindrone 1 MG Oral
Tablet)/ 7 (Inert Ingredients 1 MG Oral Tablet)} Pack [Leena 28 Day]).
GPCK (Generic Pack)Generic Drug Delivery Device; for example, {11 [varenicline 0.5 MG Oral Tablet] /
42 (varenicline 1 MG Oral Tablet)} Pack.
IN (Ingredient)A compound or moiety that gives the drug its distinctive clinical properties, for example,
Fluoxetine, Insulin, and Isophane.
MIN (Multiple Ingredients)Two or more ingredients appearing together in a single drug preparation,

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created from SCDF. In rare cases when IN/PIN or PIN/PIN combinations of the same base ingredient exist,
created from SCD.
PIN (Precise Ingredient)A specified form of the ingredient that may or may not be clinically active. Most
precise ingredients are salt or isomer forms, for example Fluoxetine Hydrochloride.
SBD (Semantic Branded Drug)Ingredient, strength, and dose form plus brand name, for example,
Fluoxetine 4 MG/ML Oral Solution [Prozac].
SBDC (Semantic Branded Drug Component)Ingredient, strength, plus brand name; for example,
Fluoxetine 4 MG/ML [Prozac].
SBDF (Semantic Branded Drug Form)Ingredient, dose form, plus brand name; for example, Fluoxetine
Oral Solution [Prozac].
SBDG (Semantic Branded Dose Form Group)Brand name plus dose form group; for example, Prozac
Oral Product.
SCD (Semantic Clinical Drug)Ingredients plus strength and dose form, for example, Fluoxetine 4 MG/ML
Oral Solution. Please note that route is not explicitly modeled but may be inherent within the dose form
attribute.
SCDC (Semantic Clinical Drug Component)Ingredient plus strength; for example, Fluoxetine 4 MG/ML.
SCDF (Semantic Clinical Drug Form)Ingredient plus dose form; for example, Fluoxetine Oral Solution.
SCDG (Semantic Clinical Dose Form Group)Ingredient plus dose form group; for example, Fluoxetine
Oral Liquid Product.
SCDG (Semantic Clinical Dose Form Group)Ingredient plus dose form group; for example, Fluoxetine
Oral Liquid Product.

SNOMED CT Fully Specified Term

A unique term used by clinicians to describe a concept and clarify its meaning. The Fully Specified Term is not a
commonly used term or natural phrase and addresses the concept at a greater level of specificity than the
Preferred Term.

SNOMED CT Problem Severity

An attribute used to subclass a Clinical finding or concept that is defined relative to the expected degree of
intensity or hazard of the Clinical finding being qualified.

SNOMED CT Preferred Term

A common word or phrase used by clinicians to name a concept in natural language. Each concept has only one
preferred term.

SNOMED CT Synonym Term

A term, other than the Fully Specified Term or Preferred Term, that can be used to represent a concept in a
particular language or dialect.

SNOMED CT Relationship

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Each concept in SNOMED CT is logically defined through its link(s) (relationships) to other concepts. Every active
SNOMED CT concept (except the SNOMED CT Concept Root concept) has at least one is a relationship to a
parent concept.

Stable Identifier
Numeric identifiers that will always represent a single concept, ensuring stability in customer data. For example,
the ingredient code (HIC_SEQN) for diphenhydramine HCl is 3369, and this number will always represent only
diphenhydramine HCL.

Systematized Nomenclature of MedicineClinical Terms (SNOMED CT)

Comprehensive clinical terminology maintained by SNOMED International.

Term
Unique string of text (for example hypertension, high blood pressure).

Unified Code for Units of Measure (UCUM)

The Unified Code for Units of Measure (UCUM) is a code system intended to include all units of measures being
contemporarily used in international science, engineering, and business. It is commonly used in HL7 messaging.
See http://unitsofmeasure.org/trac for additional information.

Unified Medical Language System (UMLS) Metathesaurus

The Metathesaurus is a very large, multi-purpose, and multi-lingual vocabulary database that contains information
about biomedical and health-related concepts, their various names, and the relationships among them. See
http://www.nlm.nih.gov/pubs/factsheets/umlsmeta.html for more information.

Unique Ingredient Identifier (UNII) Code

Generated by the U.S. Food and Drug Administration (FDA), the Unique Ingredient Identifier (UNII) is a
non-proprietary, free, unique, unambiguous, non semantic, alphanumeric identifier based on a substances
molecular structure and/or descriptive information. The NLM associates UNII Codes to RxNorm (SAB=RXNORM)
atoms of term type IN (Ingredient).

United States Health Information Knowledgebase (USHIK)

An online, publicly accessible registry and repository of health-related data, metadata, and standards. The
Meaningful Use portal contains specifications, artifacts, downloads, search tools, and other resources for
Meaningful Use, including Clinical Quality Measures, Value Sets, and Objectives for Stage 1 and Stage 2.

Unspecified Formulation
A term used by the CDC in select CVX code description data to indicate records that lack specificity. The CDC
does not recommend using these codes for current vaccine administrations. They recommend reserving them for
transmission of historical vaccine administration data in cases when the specific vaccine formulation is not known
(for example, vaccine is recorded as tetanus shot on a paper vaccine record).

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Vaccines Administered (CVX Code)

The CVX Code Set (also referred to as vaccine codes) is developed and maintained by the CDC's National
Center of Immunization and Respiratory Diseases (NCIRD). This nomenclature represents human immunization
biologicals currently and previously available in the United States. Additionally, the CDC has included higher level
CVX codes (Unspecified Formulation codes), and legacy codes that represent immunization products that are
either investigational or have not yet made it to the U.S. market. The CVX code identifies the immunization and is
used in HL7 messaging as the standard immunization identifier for transmission to local Immunization Information
System (IIS) registries. The CVX code facilitates interoperability between EHR systems and a local IIS.

Vaccine Group
A collection of independent vaccines that can be used to vaccinate against a disease or diseases.

Vaccine Information Statement (VIS)

Information sheets produced by the CDC that explain both the benefits and risks of a vaccine.

Value set
A vocabulary subset comprised of a collection of concept indicters and terms that is used for a specified purpose.

Vocabulary
A collection of concept identifiers and terms that are published together (for example, SNOMED CT is a
vocabulary).

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Interoperability Inclusion Criteria

Interoperable medication management requires cross-references from a wide variety of source FDB
MedKnowledge concepts to interoperable vocabulary concepts. The breadth of cross-references required by our
customers varies by the types of interoperable exchanges required by the vendor or self-programming customer
end-users. For this reason, FDB provides core and enhanced FDB Interoperability Module packages.

This section provides information detailing the criteria that guided the inclusion of the data contained within the
module as well as information pertaining to limitations or exclusions when appropriate. The following topics are
included:

Medication Reconciliation
Clinical Information Exchange
Allergy Clinical Information Exchange
Clinical Quality Reporting
Clinical Quality Measures Value Set
FDB Interoperability Domains
Immunization
Clinical Screening
RXCUI Change History

Medication Reconciliation
The FDB Interoperability Module provides bidirectional cross-references between FDB MedKnowledge
interface terminologies and interoperable vocabularies.

The creation of outbound translations of FDB Medications to RxNorm concepts is well supported within the FDB
Interoperability Module Core Package. The Enhanced Package provides reverse mapping content that assists

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the receiving system in reconciling RxNorm reported medications within an inbound record to FDB medications
already on file in the context of an active patient medication. Mapping to externally reported medications may
occur at multiple levels

When the nature of the interoperable exchange requires that a single best fit RXCUI value be used for a FDB
concept, algorithms that leverage the FDB MedID Name Source Code and the FDB NDC Generic Name Indicator
attributes may be used to selectively fetch the proper branded or generically named RxNorm value.

Clinical Information Exchange

The FDB Interoperability Module vocabulary concepts recognize standardized medication vocabularies in order
to support the portability of patient medication, immunization, and allergy history between disparate health
information systems.

For clinical information exchange, the HL7 Implementation Guide for CDA Release 2.0 Consolidated CDA
Templates (US Realm) calls for the required (i.e. shall) use of a generically named RxNorm clinical drug concept
in the context of a Coded Product Name, and when appropriate (i.e. may), a branded RxNorm clinical drug
concept is used in the context of the Coded Brand Name.

HL7 also supports the inclusion of the interface term (vocabulary concepts selected within the users interface)
and associated code stored within the reporting EHR in the structured XML along with the interoperable code
(vocabulary concept identified for interoperability transactions). When the interface term and code is included, it is
handled as a translation code. FDB recommends this practice, as receiving systems that use FDB
MedKnowledge are likely to have improved clinical information reconciliation results when using the FDB code
directly in lieu of the interoperable code.

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Allergy Clinical Information Exchange

Based upon the interoperable exchange constraints required of the system, the link to both the interoperable code
and the RXCUI provides flexibility to the system developer to send either the interoperable code, the RXCUI, or
both when required for outbound exchange of patient allergens. Similarly, upon receipt of exchanged patient
allergens, associations to the interoperable code and the RXCUI will support clinical information reconciliation and
filing of externally reported allergens into the recipients system.

AllergyIntolerance Outbound Exchange

AllergyIntolerance Inbound Reconciliation

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Clinical Quality Reporting

Beginning in 2014, all providers, regardless of whether they are in Stage 1 or Stage 2 of meaningful use, are
required to report on the Clinical Quality Measures in the Stage 2 rule.

Interoperable Transmissions and Reporting

The FDB Interoperability Module provides vocabulary concepts and recognized standard medication
vocabularies to support the portability of patient medication, immunization, and allergy history required in
interoperability transactions or reporting. Information may be used (but not limited) to support the following:

HL7 Transmissions

The U.S. Department of Health and Human Services published the Final Rule for Health Information
Technology that included an Initial Set of Standards, Implementation Specifications, and Certification
Criteria for Electronic Health Record Technology. The following HL7 standards can be supported using

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data provided by the FDB Interoperability Module:

HL7 v2.5.1 Immunization Registry Reporting
HL7 Quality Reporting Document Architecture (QRDA) Quality reporting to CMS
Continuity of Care Document (CCD) Patient Summaries
Clinical Document Architecture (CDA) Patient Summaries
C-CDA Medication Information template (2.16.840.1.113883.10.20.22.4.23)
Medication Clinical Drug Name Value Set 2.16.840.1.113883.3.88.12.80.17 (RxNorm codes)
C-CDA Medication Information template (2.16.840.1.113883.10.20.22.4.23)
Medication Clinical Drug Name Value Set 2.16.840.1.113883.3.88.12.80.17 (RxNorm codes)
C-CDA Allergy Intolerance Observation template (2.16.840.1.113883.10.20.22.4.7)
Allergy to medication: Medication Brand Name 2.16.840.1.113883.3.88.12.80.16 (RxNorm
codes) OR Medication Clinical Drug 2.16.840.1.113883.3.88.12.80.17 (RxNorm codes)
Allergy to med class: Medication Drug Class 2.16.840.1.113883.3.88.12.80.18 (NDF-RT)
Allergy to food/substance: Ingredient Name 2.16.840.1.113883.3.88.12.80.20 (UNII)

NCPDP Transmissions

NCPDP Script Standard

-S19-1-13 DRU (Drug Segment)
New Prescriptions
Refill Request
Refill Response
Resupply
Prescription Fill Status Notification
Verify
Prescription Change Request
Prescription Change Response
Cancel Prescription Request
Medication History Response
-S19-1-13 ALG (Allergy Segment)
No Known Allergies
Adverse Event Type
Drug Product Coded
Reaction Coded
Severity Coded
NCPDP Formulary and Benefit Standard
Formulary Status Detail
Formulary Alternatives Detail

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Coverage Information Detail

Product Coverage Exclusion, Prior Authorization, Step Therapy
Quantity Limits
Gender Limits
Copay Information
Quantity Limits List

CMS Reporting

NLM Value Set Authority Center (VSAC) released Eligible Hospital Clinical Quality Measure (CQM) Value
Sets
National Quality Forum (NQF) Electronic Quality Measures (eMeasures)
CMS Formulary Reference File (FRF) Information
Medicare Part D formulary submission to Centers for Medicare & Medicaid Services (CMS) requires
submission of RxNorm codes to describe each item on a payers formulary.

Clinical Quality Measures Value Set

The National Library of Medicines (NLM) Value Set Authority Center (VSAC) is the authoritative source of
vocabulary value sets referenced within the Clinical Quality Measures (CQM). The Clinical Quality Measures
value set content from the United States Health Information Knowledgebase (USHIK) is provided in the FDB
Interoperability Enhanced Module. USHIK, maintained by the Agency for Healthcare Research and Quality,
provides public access to CQM and VSAC data. Redistribution of VSAC value set content by FDB provides a
convenient source of vocabulary code sets specified for the programmatic computation of CQM eMeasure
information for electronic reporting to CMS.

The use of CQM value set content is required for use by all Medicare-eligible providers in their second year and
beyond of meaningful use adoption for the mandatory electronic reporting of CQM data to CMS. Demonstration
of the ability to use CQM value sets in the compilation of CQM summary reports for CMS submission is required
for base Electronic Health Record (EHR) systems certification.

Along with FDB Interoperability Module medication cross-references, the implementation of USHIK CQM Value
Set content enables the programmatic comparison of FDB-based medications and allergens to CQM collections
of RxNorm-based medications and allergy-intolerance exclusions. Patient context references to RxNorm-based
medications and allergens or intolerances are then included when compiling summary reports to CMS.

In addition to the programmatic computation of CQM summary reports, developers may use relationships
between CQM value sets and FDB collections of patient medications and allergens to implement advanced
decision support reminders to promote clinician adherence to quality measures adopted within the enterprise.
The following diagram illustrates the relationship between CQM eMeasure rules and CQM value set content
where value set medications are linked to generically named RxNorm clinical drugs and allergy or intolerances
are linked to RxNorm ingredients and brand names.

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CQM value sets, when used in concert with our medication and allergen cross-references, may be
programmatically tested against FDB-based medications and allergens when a patient has been determined to
meet the inclusion criteria for the eMeasure. The following diagram illustrates how our cross-references provide
navigational relationship between RxNorm-based CQM value sets and FDB-based medications and allergens.

FDB Interoperability Domains

The FDB Interoperability Module provides cross-references between FDB MedKnowledge Concepts and the
United States terminologies for the following domains:

Medication
Immunization
Clinical Screening
Allergen
Problem/Reaction (SNOMED)

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Clinical Quality Measures (CQM) Value Set

Information identifying the external data sources current data version date, data description, and source
description is provided.

Medication

The module provides important cross-references between FDB MedKnowledge concepts and interoperable
vocabularies named for use in the United States market. The methodology used to create each association is
provided (i.e. RxNorm Pass-thru, Derivation via Common NDC, Derivation via Clinical Formulation, Derivation via
RxNorm Term Type, etc.).

FDB to RxNorm Medication Concepts

The FDB Interoperability Module associates MedKnowledge concepts and select RxNorm Term Type values.

Not all RxNorm Term Types are cross-referenced to MedKnowledge concepts at this time.

The FDB to National Library of Medicine (NLM) concepts are mapped as follows:

Links Created By NLM

Clinical Formulation ID (GCN_SEQNO) to Semantic Clinical Drug (SCD)

GCN_SEQNO to Branded Pack (BPCK)
GCN_SEQNO to Semantic Clinical Drug Form (SCDF)
Hierarchical Ingredient Code Sequence Number (HIC_SEQN) to Ingredient (IN)
HIC_SEQN to Precise Ingredient (PIN)

Value-added FDB Mappings (includes both core and enhanced mappings):

Branded MEDID to Brand Pack (BPCK)

Clinical Formulation ID (GCN_SEQNO) to Semantic Branded Drug (SBD)
GCN_SEQNO to Generic Pack (GPCK)
Generic Med Name to Brand Name (BN)
Generic MEDID to Brand Pack (BPCK)
Generic MEDID to Semantic Branded Drug (SBD)
Hierarchical Ingredient Code Sequence Number (HIC_SEQN) to FDA Unique Ingredient Identifier (UNII)
National Drug Code (NDC) to Semantic Clinical Drug (SCD)
NDC to SBD
NDC to GPCK
NDC to BPCK
MED Medication ID (MEDID) to SCD
MEDID to BPCK
MEDID to SBD

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MEDID to GPCK
MED Medication Name ID (MED_NAME_ID) to Brand Name (BN)
Branded MED_NAME_ID to Ingredient (IN)
Branded MED_NAME_ID to Precise Ingredient (PIN)
Branded MED_NAME_ID to Multiple Ingredient (MIN)

These mappings represent a sample of the mapping set. Additional value-added mappings are included
as they become available.

NLM-derived relationships are created according to NLM editorial policy using full files of the Hierarchical
Ingredient Code Description Table (RHICD5_HIC_DESC) and the Clinical Formulation ID Table
(RGCNSEQ4_GCNSEQNO_MSTR) provided by FDB.

For an RxNorm concept to be included in the External Vocabulary Description Table

(REVDEV0_EXT_VOCAB_DESC), it must be linked to at least one FDB concept. RXCUIs that do not map to at
least one FDB concept will not appear in this table. When MedKnowledge concepts link to brand packs in
RxNorm, FDB pulls in the shortest synonym as the description for the RXCUI in the External Vocabulary
Description Table (REVDEV0_EXT_VOCAB_DESC) if it is available.

Additionally, data that is passed through from the NLM to the RxNorm Concept Tables is filtered for concepts
where the Source Abbreviation (SAB) equals NDDF or RXNORM and the Term Type (TTY) does not include
CDC, CDA, or TMSY.

The National Library of Medicine can replace an RXCUI with a new one, and they can also replace a replacement
RXCUI with yet another RXCUI. This replacement history is listed in their Atom Archive Table. FDB provides an
RXCUI Ultimate Replacement table, which links a replaced RXCUI to its ultimate replacement (express method).
FDB also offers a Vocabulary Replacement table (historical method) to identify when a change occurred.

When the FDB MEDID or MED_NAME_ID identifiers are retired, replaced, or unassociated, they are excluded.
Only active or inactive MEDIDs or MED_NAME_IDs are included.

RxNorm Medication Concepts to FDB

Additional tables provide customers with a method to retrieve information regarding an RxNorm concept. Not all
RxNorm Term Types are cross-referenced to MedKnowledge concepts.

Features include:

Tables to provide selected RxNorm data as received from the NLM.

Accommodations taken to format description text strings longer than 255 characters.
Additional term type (TTY) information included (e.g. synonyms)
Expanding the available vocabularies to include concepts which exist in only the RxNorm or the NDDF
namespace.
A shared indicator is provided to identify RXCUIs that are shared by both FDB and RxNorm.
An exclusion indicator identifies concepts which were intentionally excluded from RXCUI mapping in the

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External Vocabulary Link Table (REVDEL0_EXT_VOCAB_LINK).

Providing the Unique Ingredient Identifier (UNII) code assigned by the FDA to medication ingredients.
Relates to RXCUIs where term type is IN or PIN.
To accommodate NLMs modified method of identifying the prescribable content; if the data element
Content View Flag (CVF) contains the value of 4096 for RxNorm vocabulary values included within the
NLM concept file (RXNCONSO), the RXCUI will be assigned the EVD_PRESCRIBABLE_RXCUI_IND =
1 (TRUE) within the RxNorm Concept Master Table (REVDRC0_RXN_CONCEPT_MSTR).

Immunization
Immunization codes published by the CDC are specified for use in reporting immunizations to immunization
registries. The FDB Interoperability Module associates MedKnowledge identifiers to the following CDC data:

CVX Code
MVX Code

The FDB to CDC concepts are mapped as follows:

Links Created Editorially By FDB

Clinical Formulation ID (GCN_SEQNO) to CVX code

National Drug Code (NDC) to MVX code

Links Created Programmatically By FDB

MED Medication ID (MEDID) to CVX code

MED Routed Medication ID (ROUTED_MED_ID) to CVX code
MED Routed Dosage Form Medication ID (ROUTED_DOSAGE_FORM_MED_ID) to CVX code
MED Medication Name (MED_NAME) to CVX code
NDC to CVX code
Routed Generic Identifier (ROUTED_GEN_ID) to CVX code

Additionally, the following tables are provided without FDB editorial changes:

HL7 Standard Code Set Mapping CVX to Vaccine Groups Table (REVDVG0_CDC_CVX_VG_LINK)
HL7 Standard Code Set CVX-VIS Mapping Table (REVDVL0_CDC_CVX_VIS_LINK)
Vaccine Information Statement (VIS) Lookup Table(REVDVB0_CDC_VIS_LOOKUP)
CPT to CVX Link Table (REVDCPT0_EXT_CPT_CVX_LINK)

The CPT to CVX Link Table provides the unedited CDCs mapping of CPT codes to CVX codes.

CVX and MVX codes that do not link to at least one FDB concept do not appear in the External Vocabulary
Description Table (REVDEV0_EXT_VOCAB_DESC). CVX or MVX code concepts that are not mapped to any
FDB identifier are, however, permanently maintained in the code source description tables
(REVDCVX0_EXT_VOCAB_CVX_DESC and REVDMVX0_EXT_VOCAB_MVX_DESC) respectively.

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The following FDB identifiers are excluded when they are retired, replaced, or unassociated (only active or
inactive values are included):

MEDID
ROUTED_DOSAGE_FORM_MED_ID
MED_NAME_ID
ROUTED_MED_ID

Clinical Screening
RxNorm to FDB Clinical Screening

The RxNorm to FDB clinical screening content extends the functionality of this module by:

Denormalizing links from RxNorm concepts to FDB:

Clinical Formulations
Routed Generic IDs
Ingredients
MEDIDs
Med Name IDs
Allowing for the translation of lists of external RxNorm-based medication concepts for use in:
Clinical screening
Medication reconciliation
Clinical quality measure calculations
Advanced decision support
Providing the ability to view full and partial clinical formulation concept matches as well as a listing of
external concepts that do not have complete matches with FDB concepts.
Adding a preferred indicator as a useful mechanism to designate default FDB Clinical Formulation ID or
MedID target concepts for the addition of an externally reported medication to a patients active medication
list when a match to a single existing active record is not found.

These features are supported by the following tables:

RxNorm to FDB Clinical Screening Link Table (RIMKCS0_RXN_FDB_CS_LNK)

RxNorm to FDB Clinical Screening Exception Table (RIMKCSE0_RXN_FDB_CS_EXCEPT)

The RxNorm to FDB Clinical Screening Link Table provides links (when available) from RxNorm branded and
generically named concepts-likely to be received in the context of externally reported patient medications to FDB
Medication ID (MEDID), FDB Medication Name ID (MED_NAME_ID), Clinical Formulation ID (GCN_SEQNO),
Routed Generic ID (ROUTED_GEN_ID), and Ingredient (HIC_SEQN).

The RxNorm to FDB Clinical Screening Exception Table (RIMKCSE0_RXN_FDB_CS_EXCEPT) provides lists of
RxNorm formulations which have partial ingredient cross-references to FDB. This table also provides the
description of RxNorm ingredients that are not able to be translated.

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Allergen

Allergy documentation and exchange are vital to ensuring patient safety. In the context of allergy interoperability,
the FDB Interoperability Module facilitates the translation of key FDB allergy medication concepts (which are
typically included within EHR allergy lists) into the National Library of Medicine's RxNorm vocabulary.

Medication Allergies are identified using NLM RxNorm Concepts.

Allergen Groups are identified using the NLM supplied VA NDFRT.
Ingredients are identified using NLM supplied FDA UNII.

For medication allergy interoperability, FDA UNII codes will be used only when the RxNorm ingredient code is not
assigned within the RxNorm terminology space as a source vocabulary concept.

FDB has identified and mapped a starter set of non-drug allergens that span commonly used food and
environmental agents to SNOMED CT concepts with the SNOMED CT Value Set Table
(RIMKVS0_SCT_VALUE_SET). FDB provides cross-references from SNOMED CT foods and environmental
agents to FDB ingredients and Specific Allergen Group identifiers within the SNOMED CT to FDB Link Table
(RIMKSVF0_SCT_FDB_VOCAB_LNK). This enables the dual filing of a food or environmental allergy as a
FDB-based medication allergy, further supporting medication allergy screening for applicable substances. For
example, Snomed CT 102263004 (Eggs [edible]) has a preferred link to FDBs ingredient egg (HIC_SEQN =
6947) and an additional link to the Specific Allergen Group Egg/Poultry (900508). This supports the alerting of an
egg allergy when the patient is ordered an influenza vaccination.

Encoding allergy content is inherently complex by virtue of needing to represent the allergen and the resulting
allergic reaction with its clinical manifestations and severity. SNOMED CT values for allergic intolerance
documentation are provided in SNOMED CT Value Set Table (RIMKVS0_SCT_VALUE_SET).

The following value sets can be used for HL7 Allergy Exchange:

Common Reactions (SNOMED CT)

Problem Severity (SNOMED CT)
Allergy/Adverse Event Type (SNOMED CT)
No Known Allergies Identification (SNOMED CT)

A Vocabulary Type Link to HL7 Object Identifiers Value Set is provided as a convenience for FDB customers. It
provides an association from the vocabulary type to the HL7 Object Identifier (OID) and OID description when
referencing interoperable codes within HL7 Clinical Document Architecture templates.

FDB to External Allergen Vocabulary Concepts

FDB Ingredient mapped to RxNorm IN/PIN or FDA UNII

FDB MedNameID to RxNorm BN/IN/PIN/MIN or FDA UNII
FDB Specific Allergen Groups to RxNorm VA NDF-RT/ or IN/PIN/MIN/FDA UNII
VA NDF-RT mapping is limited to:
NDF-RT class concepts integrated within RxNorm (SAB = NDFRT) that span types of:
Mechanism of Action (MECHANISM_OF_ACTION_KIND)

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Physiologic Effect (PHYSIOLOGIC_EFFECT_KIND)

Chemical Structure (INGREDIENT_KIND)
An indicator is provided to denote if concept is on the FDB DAM Picklist.
A Multi-Set Indicator denotes whether a given FDB concept spans multiple external concepts, resulting in
the best fit being chosen as the column value.

External Allergen Vocabulary Concepts to FDB

RxNorm IN/PIN/MIN/BN is mapped to FDB ingredient or MedNameID or Specific Allergen Group.

RxNorm FDA UNII is mapped to FDB Ingredient or FDB Specific Allergen Group.
RxNorm VA NDF-RT Classes are mapped to FDB Specific Allergen Group or FDB ingredient.

Problem/Reactions (SNOMED CT)

SNOMED CT descriptive content from the National Library of Medicine (NLM) and cross-references to FDB
Disease Identifiers (DXID) which support drug-disease contraindication checking within the FDB Interoperability
Module Enhanced PackageSNOMED CT Module are provided in this domain. The domain is composed of two
sets of data:

Best fit cross-mappings of FDB DXID concepts to post-coordinated SNOMED CT values and Reverse mappings
from SNOMED CT to DXID values to support access to FDB disease based knowledge

National Library of Medicine SNOMED CT Release Format 2 (RF2) tables for concepts, descriptions,
relationships, and language

SNOMED CT is a comprehensive healthcare terminology maintained and distributed by SNOMED International. It

has emerged as a problem list vocabulary standard for the exchange of patient problems within and between
health information systems and clinical quality measures within systems that are certified to satisfy Stage 2
meaningful use requirements. The NLM is the authoritative U.S. distribution source of SNOMED CT, and FDB
redistributes the Release Format 2 (RF2) of the US Edition of SNOMED CT to provide descriptions for
cross-referenced SNOMED CT values and as a convenience for our customers. Specifically, the following types
of SNOMED CT files are redistributed:

Concept
Descriptions
Relationships
Language

Implementation of FDBs comprehensive mappings between SNOMED CT and DXID enables drug-disease
contraindication screening of prospective medications directly against the SNOMED CT based problem list.

Access to SNOMED CT to DXID mappings will be supported within the existing tables:

SNOMED CT to DXID Search Exclusion

SNOMED CT to DXID Best Fit
SNOMED CT to DXID Best Fit History

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Best fit mappings:

Are context agnostic (i.e. the translation to SNOMED-CT is not specific to a context of indications, side effects or
drug-disease).

One active DXID will span one-to-many SNOMED CT values in the context of best fit. Most frequently, a single
primary SNOMED CT value will be listed; an additional value will be listed when in the judgment of the clinical
team multiple SNOMED CT values should be presented to the clinician as candidate patient problems for entry in
the patient record.

RXCUI Change History

The National Library of Medicine (NLM) may replace a RXCUI with one-to-many RXCUI values. Furthermore, this
new RXCUI may then be replaced with yet another RXCUI at a later date. This replacement history is listed in the
NLMs Atom Archive file. FDB acknowledges the NLM as the source of our RxNorm data and disclaims the
possibility of dead ends, based upon the nature of the RxNorm source.

There are two different methods to identify changes in a RXCUI:

Express Methodused to determine current value

Historical Methodused to determine current value and change history

Express Method: Determining Current Value of a RXCUI

This method is used when the primary search criteria of the RXCUI search is to determine the current value. The
RXCUI Ultimate Replacement Table (REVDUR0_RXCUI_ULT_REPL) links a given RXCUI to its ultimate
replacement, when applicable. For example, if the National Library of Medicine (NLM) replaced RXCUI A with B,
and then later replaced B with C, this table will directly relate A to C and B to C. By eliminating the replacement
relationship between A and B, this table provides the RXCUI with which A was ultimately replaced (current value).

EVD_EXT_VOCAB_ID EVD_EXT_ULT_REP_VOCAB_ID

1246535 1422080

1235568 1422080

1011757 1422080

807748 1422080

Historical Method: Determining Current Value and Change History of a RXCUI

Expanded expression of RxNorm change history is accommodated with the addition of the Vocabulary
Replacement History Table (REVDRH0_RXCUI_REP_HIST). This table provides links from a previous RxNorm
concept to its replacement and ultimate replacement RxNorm concepts along with associated change dates.
This content enables the developer to build an audit trail for the incremental replacement of RxNorm concepts
over time. Advantages of this table over the RXCUI Ultimate Replacement Table
(REVDUR0_RXCUI_ULT_REPL) are the addition of a change date and the cataloging of incremental RxNorm
replacements over time.

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EVD_EXT_PREV_V 1246535 1235568 1011757 807748

OCAB_ID

EVD_EXT_CHANGE 20130508 20120307 20120102 20100916

_DT

EVD_EXT_REP_VO 14422080 1246535 1235568 1011757

CAB_ID

EVD_EXT_ULT_REP 14422080 14422080 14422080 14422080

_VOCAB_ID

EVD_EXT_VOCAB_ Lidocaine Lidocaine Lidocaine Lidocaine 40 MG/ML

DESC Hydrochloride 40 Hydrochloride 40 Hydrochloride 40 Topical Cream
MG/ML Topical Cream MG/ML Rectal Cream MG/ML Topical Cream [AneCream]
[AneCream] [AneCream] [AneCream]

Text descriptions for EVD External Previous Vocabulary Identifier (EVD_EXT_PREV_VOCAB_ID) values
can be retrieved from the (EVD_EXT_VOCAB_DESC) column, located in the Vocabulary Replacement
History Description Table (REVDRHD0_RXCUI_REP_DESC).

Only one representative description per value is provided (more than one description may have been
previously available).

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Interoperability Data Elements

This section contains additional information about particularly important tables and codes contained within the
module, as well as concepts about the data that the reader must understand in order to understand the module.

Cross-Reference Elements
External Vocabulary Link Table
CPT to CVX Link Table
CVX to MVX Link Table
DXID to SNOMED CT Best Fit Table
External Allergen to FDB Link Table
HL7 Standard Code Set CVX-VIS Mapping Table
Master FDB Unit of Measure to UCUM Link Table
NDC to CVX-MVX Link Table
RxNorm to FDB Clinical Screening Link Table
SIG FDB to External Vocabulary Link Table
SIG Frequency Interval Table
SIG Frequency Interval Event Table
Description Elements
External Vocabulary Description Table
Vocabulary Type Definition Table
External Vocabulary Link Type Description Table
Source Description Table
CDC Vocabulary Descriptive Information
RXCUI Ultimate Replacement Table
RxNorm Concept Tables
RxNorm Concept Master Table
RxNorm Concept Source Table
RxNorm Concept Description Table
SNOMED CT Type Description Table
SNOMED CT Value Set Description Table
SNOMED CT Concept Type Description Table

Cross-Reference Elements
This section provides information on cross-reference elements within the FDB Interoperability Module.

External Vocabulary Link Table

The External Vocabulary Link Table (REVDEL0_EXT_VOCAB_LINK) relates FDB concepts to external
vocabulary concepts. This link table is available with three types of mappings for NDCs: up to one year obsolete,

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three years obsolete, or 99 years obsolete.

The external vocabulary identifier is associated to its text description within the External Vocabulary Description
Table (REVDEV0_EXT_VOCAB_DESC).

CPT to CVX Link Table

The CDC provides and maintains a mapping table of CPT codes to the CDCs CVX codes. This table is
programmatically reformatted and presented in the FDB Interoperability Module as the CPT to CVX Link Table
(REVDCPT0_EXT_CPT_CVX_LINK). The content in this table is not editorially reviewed by FDB; the data and
data changes are managed by the CDC. This table is not intended to be a definitive source for a CPT code,
description, or status. The table includes both current and historical CPT-CVX mapping records. Active CPT
codes, inactive CPT codes and pre-release CPT codes are also included.

CVX to MVX Link Table

Programmatically derived, the CVX to MVX Link Table (REVDCM0_CVX_MVX_LINK) links CVX codes to their
associated MVX codes and provides their associated attributes.

DXID to SNOMED CT Best Fit Table

The DXID to SNOMED CT Best Fit Table (RIMKBF0_DXID_SCT_BEST_FIT) identifies links that have been
determined to be the best fit between FDB DXIDs and SNOMED CT Concept IDs. If a SNOMED CT concept
has been selected as the best fit for a DXID, the DXID to SNOMED CT Concept ID Link Indicator will be
populated with a 1 (DXID is linked to a SNOMED CT Concept ID). Otherwise the DXID to SNOMED CT Concept
ID Link Indicator will be populated with a 0 (DXID is not linked to a SNOMED CT Concept ID).

External Allergen to FDB Link Table

The External Allergen to FDB Link Table (RIMKEAF0_EXT_ALG_FDB_VOCAB_LNK) is used when an external
concept is presented that needs mapped to an FDB concept. The table provides the external concept identifier,
the FDB assigned type identifier, the external vocabulary description for the external concept, the identifier
representing what type of concept within FDB the external concept links to (i.e. GCN_SEQNO, NDC, MEDID) the
internal description for the FDB concept, and the RXCUI associated with the external concept.

Additionally, when the users process requires limiting the selections, two indicators assist in determining an
appropriate selection. The IMK Preferred Indicator will be populated with a 1 for the identified preferred link. The
IMK Related Indicator is used to identify links created using related ingredients, a value of 0 indicates if it was
linked using actual ingredients, a value of 1 indicates it was linked using related ingredients.

HL7 Standard Code Set CVX-VIS Mapping Table

HL7 Standard Code Set CVX-VIS Mapping Table (REVDVL0_CDC_CVX_VIS_LINK) data is provided without
editorial review or modifications. It identifies a CVX that has a Vaccine Information Statement (VIS). Vaccine
Information Statements are information sheets produced by the Centers for Disease Control and Prevention
(CDC). The VIS explains both the benefits and risks of a vaccine to adult vaccine recipients and the parents/legal
representative of a minor. Federal Law requires that a VIS be handed out whenever certain vaccinations are
given.

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Master FDB Unit of Measure to UCUM Link Table

The Master FDB Unit of Measure to UCUM Link Table (RIMKUCM0_ MSTRUOM_TO_UCUM_LINK) uses the
UOM Master Description (UOM_MSTR_DESC) and the UOM Master ID (UOM_MSTR_ID) from the Unit of
Measure Master Table [RPEIUM0_UOM_MSTR]) to populate the IMK FDB Vocabulary Identifier (
IMK_FDB_VOCAB_NO_ID) and the IMK FDB Vocabulary Description (IMK_FDB_VOCAB_DESC).

The UCUM Code (UCUM_CD) symbols presented by FDB are case-sensitive. Representation of mapped UCUM
codes follow guidelines established by the Unified Code for Units of Measure (UCUM) organization.

NDC to CVX-MVX Link Table

Programmatically derived, the NDC to CVX-MVX Link Table (REVDNCM0_NDC_CVX_MVX_LINK) associates an

NDC to a single best CVX and MVX code. It can be used in applications where the intent is to transmit
information to a registry.

RxNorm to FDB Clinical Screening Link Table

The RxNorm to FDB Clinical Screening Link Table (RIMKCS0_RXN_FDB_CS_LNK) is used when an RXCUI is
presented that needs mapped to an FDB concept. The table provides the RXCUI, the FDB assigned value for its
TTY (term type), the RxNorm description, the identifier representing what type of concept within FDB the RXCUI
links to (i.e. GCN_SEQNO, NDC, MEDID) and the internal description for the FDB concept.

Additionally, when the users process requires limiting the selections, two indicators assist in determining an
appropriate selection. The IMK Preferred Indicator will be populated with a 1 for the identified preferred link. The
IMK Related Indicator is used to identify links created using related ingredients, a value of 0 indicates if it was
linked using actual ingredients, a value of 1 indicates it was linked using related ingredients.

SIG FDB to External Vocabulary Link Table

The SIG FDB to External Vocabulary Link Table (RIMKSSE0_SIG_FDB_TO_EXT_LINK) relates FDB concepts to
external vocabulary concept identifiers to support interoperable translation of codified components for electronic
transmissions. This table is used to retrieve a specified vocabulary constraint to support specific structured
representation of medication instructions.

SIG Frequency Interval Table

The SIG Frequency Interval Table (RIMKHFI0_SIG_FREQ_INT_LINK) relates First Databank's frequency and
interval concepts to HL7 concepts. The table is based strictly on time periods; for example, days, hours, times per
day. For indicating times per day, HL7 uses fractional amounts; for example, twice a day is represented as 0.5 d
(1 [day] divided by 2).

XML presentations and element representation are based on HL7 recommendations available at time of creation
(April 2016).

SIG Frequency Interval Event Table

The SIG Frequency Interval Event Table (RIMKHIE0_SIG_FREQ_INT_EVENT) relates First Databank's
frequency and interval concepts to HL7 concepts when the instructions are related to a specific event (for
example, at bedtime or after meals) and not a specific time period or interval. The table is only used in

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conjunction with the SIG Frequency Interval Table. Specific time periods associated with the event may be
designated. HL7 representation of specific events (for example, exact hour, once, or specific days of the week)
are not included within HL7 at this time.

XML presentations and element representation are based on HL7 recommendations available at time of creation
(April 2016).

Description Elements
This section provides information on description elements within the FDB Interoperability Module.

External Vocabulary Description Table

The External Vocabulary Description Table (REVDEV0_EXT_VOCAB_DESC) relates the external vocabulary
identifier to its text description. In cases where the vocabulary description exceeds 255 characters in length, it is
parsed into shorter lengths to accommodate field length limitations of 255 characters and assigned sequential
numeric values.

Vocabulary Type Definition Table

The Vocabulary Type Definition Table (REVDVT0_VOCAB_TYPE_DEF) provides the identifier type and source
of a given vocabulary concept. Data from this table is retrieved using the following identifiers within the External
Vocabulary Link Table (REVDEL0_EXT_VOCAB_LINK):

EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID)

EVD External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID)

External Vocabulary Link Type Description Table

The External Vocabulary Link Type Description Table (REVDLT0_LINK_TYPE_DESC) identifies how a given
relationship was derived and the source that created the link.
For RxNorm vocabulary data, this table can be used to identify links derived via common NDC, clinical
formulation, RxNorm pass-through, RxNorm defined NDC, or RxNorm term type.
For CVX-MVX code set information, this table can used to identify links that are derived via clinical formulation or
that are editorially maintained.

Source Description Table

The Source Description Table (REVDVS0_SOURCE_DESC) provides the source description for the EVD Source
Identifier (EVD_SOURCE_ID) within the Vocabulary Type Definition Table(REVDVT0_VOCAB_TYPE_DEF) and
the External Vocabulary Link Type Description Table (REVDLT0_LINK_TYPE_DESC) tables.

CDC Vocabulary Descriptive Information

The CDC vocabulary descriptive information appears in the following tables:

External Vocabulary CVX Description Table (REVDCVX0_EXT_VOCAB_CVX_DESC)

External Vocabulary MVX Description Table (REVDMVX0_EXT_VOCAB_MVX_DESC)
External Vocabulary Note Table (REVDEVN0_EXT_VOCAB_NOTE)

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Vocabulary Data Version Table (REVDVD0_VOCAB_DATA_VERSION)

REVDCVX0_EXT_VOCAB_CVX_DESC

The External Vocabulary CVX Description Table (REVDCVX0_EXT_VOCAB_CVX_DESC) contains the CVX
code and its associated CDC and FDB-authored attributes. The CDC-authored column values are populated as
received from the CDC with the following exceptions noted in the Editorial Policy/Comment column below:

Column Name Column Description Editorial Policy/Comment

EVD_CVX_CD EVD CVX Code from CDC Distributed as received from the CDC.

EVD_CVX_CD_DESC_SHORT EVD CVX Code Short Description Distributed as received from the CDC
but can be supplemented or edited by
FDB for clarification.

EVD_CVX_CD_DESC_LONG EVD CVX Code Long Description Distributed as received from the CDC
but can be supplemented or edited by
FDB for clarification.

EVD_CVX_CD_USAGE EVD CVX Code Usage Editorially assigned while taking into
account several CDC-authored CVX
code attributes and descriptive
information. For example, unspecified
formulation vs. more specific
formulation; vaccine vs. non-vaccines;
CDC status; and CVX code
retirement.
The usage code can be used to
identify the single best CVX code to
transmit when more than one CVX
code is linked.

EVD_CVX_CODE_STATUS EVD CVX Code Status from CDC Distributed as received from the CDC
to indicate if the CVX code is currently
active. An additional status of never
active or pending are also assigned
by the CDC to CVX codes
representing immunizations that have
never been marketed in the U.S. or
have current investigational status
respectively.
Can be used in algorithms to
preferentially retrieve active CVX
codes for IIS submissions versus
retrieval of inactive CVX codes for
historical reporting.

EVD_CVX_CD_NONVACCINE EVD CVX Non-Vaccine from CDC Distributed as received from the CDC.
Used by the CDC to identify CVX
codes that do not represent
immunizations and are intended for
other purposes (for example, 998 [no
vaccine administered] and 99
[RESERVED - do not use]).

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EVD_CVX_CD_ADD_DT EVD CVX Code Add Date Editorially assigned by FDB when the
CVX code is added to the FDB
Interoperability Module data.

EVD_CVX_CD_OBS_DT EVD CVX Code Obsolete Date Editorially assigned when the CDC
retires the CVX code indicating that it
should no longer be used in
transmissions or when a CVX code no
longer appears in the data received
from the CDC.

EVD_CVX_LAST_UPDATE_DT EVD CVX Last Update Date Provides the date a given CVX code
record was updated by the CDC. This
field is populated with the Last Update
Date acquired from the CDC.
However, if a CVX record changes and
the last update date does not change,
this field is populated with the date
FDB imported the file.

REVDMVX0_EXT_VOCAB_MVX_DESC

The External Vocabulary MVX Description Table (REVDMVX0_EXT_VOCAB_MVX_DESC) contains the MVX
code and its associated attributes. All column values in this table are populated as received from the CDC.

Column Name Column Description Editorial Policy/Comment

EVD_MVX_CD EVD MVX Code from CDC Distributed as received from the CDC.

EVD_MVX_CD_DESC EVD MVX Code Description from CDC Distributed as received from the CDC.

EVD_MVX_CD_STATUS EVD MVX Code Status from CDC Distributed as received from the CDC
to indicate if the manufacturer is
currently producing and distributing
vaccines in the United States.

EVD_MVX_LAST_UPDATE_DT EVD MVX Last Update Date from CDC Provides the date a given MVX code
record was updated by the CDC. This
field is populated with the Last Update
Date acquired from the CDC.
However, if an MVX record changes
and the last update date does not
change, this field is populated with the
date FDB imported the file.

REVDEVN0_EXT_VOCAB_NOTE

The External Vocabulary Note Table (REVDEVN0_EXT_VOCAB_NOTE) provides usage notes for the CVX and
MVX codes as provided by the CDC. The note text can be supplemented or edited by FDB for clarification.

Column Name Column Description Editorial Policy/Comment

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EVD_EXT_VOCAB_ID EVD External Vocabulary Identifier Represents the identifier of a given

external vocabulary concept. Only
CVX and MVX code identifiers are
contained within this table. These
values are distributed as received from
the CDC.

EVD_EXT_VOCAB_TYPE_ID EVD External Vocabulary Type Identifies the type of external

Identifier vocabulary (for example, CVX code
and MVX code) using a numeric
identifier.

EVD_SEQ_SN EVD Sequence Number Assigned programmatically and

identifies a sequence of associated
text strings.

EVD_EXT_VOCAB_NOTE EVD External Vocabulary Usage Note Received from the CDC but can be
supplemented or edited by FDB for
clarification. May provide additional
descriptions, such as the appropriate
use of a code or code replacement
information. When the original note is
more than 255 characters in length, it
is parsed into shorter lengths and
assigned sequential numeric values.
This allows accommodation for field
length limitations of 255 characters.

REVDVD0_VOCAB_DATA_VERSION

The Vocabulary Data Version Table (REVDVD0_VOCAB_DATA_VERSION) provides a version or issue date
associated with an external vocabulary data set. Since external data sets are updated at varying frequencies, this
table can be used to determine which version FDB used to build the relationships that currently appear in the
External Vocabulary Link Table (REVDEL0_EXT_VOCAB_LINK).

Column Name Column Description Editorial Policy/Comment

EVD_DATA_ID EVD Data Identifier FDB assigned numeric value.

EVD_DATA_DESC EVD Data Description Provides the description of the data

type, such as RxNorm, CVX, and
MVX.

EVD_SOURCE_ID EVD Source Identifier A programmatically assigned value

that identifies the vocabulary source of
a given vocabulary data set.

EVD_SOURCE_DESC EVD Source Description The text description for the

EVD_SOURCE_ID.

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EVD_DATA_VERSION_DT EVD Data Version Date Contains a version or issue date

associated with an external vocabulary
data set.
For CVX-MVX, this is the most recent
date in the last update date field for the
CVX and MVX description tables. Each
CVX and MVX description table is
assigned its own
EVD_DATA_VERSION_DT.
For RxNorm data, it is the date of the
most recent full update file created by
NLM.

Additional Description Tables

Additional CDC vocabulary descriptive information created by FDB appears in the CVX Usage Table
(REVDUSE0_EXT_VOCAB_CVX_USAGE). This three column table provides the EVD CVX Code Usage (
EVD_CVX_CD_USAGE) and its short and long descriptions. Each CVX code is editorially assigned a single CVX
usage code. The editorial policy for mapping a CVX code to a CVX usage code is included in the table below.

EVD_CVX_CD_USAGE EVD_CVX_CD_USAGE_D EVD_CVX_CD_USAGE_D EDITORIAL_POLICY

ESC_SHORT ESC_LONG

1 Specified Formulation-Active Preferred code for real-time Assigned to CVX codes that
vaccinations and registry are NOT described as
transmissions for a currently unspecified by the CDC.
available vaccine These CVX codes should
have a CDC status of
ACTIVE (for example, CVX
Code 20, DTaP) or
PENDING (For example,
CVX Code 145)

20 Specified Preferred code for Assigned to CVX codes that

Formulation-Inactive Code retrospective reporting of a are NOT described as
known vaccine formulation unspecified by the CDC.
no longer available These CVX codes should
have a CDC status of
INACTIVE (for example,
CVX Code 125, Novel
Influenza-H1N1-09, nasal).
Products represented here
were generally available on
the U.S. Market, but are now
no longer marketed.

30 Unspecified Preferred code for Assigned to CVX codes that

Formulation-Inactive Code retrospective reporting when are described as
the exact vaccine unspecified or all
formulation is not sufficiently formulations.
clear

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40 Specified Retired code; do not transmit Assigned to CVX codes that

Formulation-Retired Code to registry; use current are NOT described as
replacement code unspecified by the CDC
and also described as
retired or replaced in the
CDC CVX description or
notes.

50 Unspecified Retired non-specific code; Assigned to CVX codes that

Formulation-Retired Code do not transmit to registry; are described as
use current replacement unspecified or all
code formulations and are also
described by the CDC to be
retired or replaced.

60 Specified Non-Immunization Preferred code for a Assigned to CVX codes that

Biologic Formulation non-immunization biological are NOT described as
unspecified or all
formulations and represent
actual biologicals but are not
considered by the CDC to be
vaccines.

70 Unspecified Preferred code for Assigned to CVX codes that

Non-Immunization Biologic retrospective reporting when are described as
Formulation the exact non-immunization unspecified or all
biological formulation is not formulations.
sufficiently clear

90 Never Active on US Market Immunization never FDA Assigned to CVX codes that
approved for the US market are assigned a CDC status
of Never Active or where
no FDA approved product is
identified in available FDA
records. These CVX codes
are not linked to any Clinical
Formulation IDs
(GCN_SEQNOs).

99 No Vaccine Administration Does not represent a known Identifies CVX codes that do
vaccine administration-in not represent a known
general do not transmit to a immunization administration.
registry These CVX codes are not
linked to any Clinical
Formulation IDs
(GCN_SEQNOs).

The CVX usage code can be implemented in algorithms to create a rank ordering when the MedKnowledge drug
identifier is linked to more than one CVX code. This rank ordering is used to determine the single best CVX code
to transmit to an immunization registry. (See Retrieving CVX Code Identifiers for a Given FDB Concept.)

RXCUI Ultimate Replacement Table

The RXCUI Ultimate Replacement Table (REVDUR0_RXCUI_ULT_REPL) is a historical data table that assists
with Medicare Part D Formulary File management and other applications where a stored RXCUI may not be the

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most current code. This table enables the identification of an RXCUI has that been replaced by the National
Library of Medicine (NLM) and provides the ultimate replacement code. For instance, if the National Library of
Medicine replaced RXCUI A with B and then later replaced B with C, this table directly relates A to C and B to C.
This table provides the RXCUI with which A was ultimately replaced by eliminating the replacement relationship
between A and B.

RxNorm Concept Tables

The RxNorm concept tables provide codes and descriptions for additional RxNorm concepts that may do not have
direct relationships to FDB concepts. Additionally, NDDF concepts that are sent to the NLM receive RXCUIs and
are included within these tables regardless of whether the NDDF RXCUI relates to an RxNorm RXCUI.

RxNorm Concept Master Table

The RxNorm Concept Master Table provides the ability to apply the following options to RxNorm Concept Unique
Identifiers (RXCUIs):

View RxNorm concepts that are mapped to FDB concepts using the Shared RXCUI Indicator (
EVD_SHARED_RXCUI_IND).
View RxNorm concepts that are not mapped to FDB concepts.
Filter for RxNorm concepts that are included in the subset of RxNorm Current Prescribable Content using
the Prescribable RXCUI Indicator (EVD_PRESCRIBABLE_RXCUI_IND).
View Unique Ingredient Identifier (UNII) Codes that are associated to RxNorm concepts (if available).

RxNorm Concept Source Table

The RxNorm Concept Source Table provides information about an RxNorm concept including its related Source
Abbreviations (SAB), Term Types (TTY), and Codes (CODE). This information is derived from the National
Library of Medicine (NLM)s Concept and Source Information Table (RXNCONSO).

Fields with column names that end with _KEY are not persistent. Any change to corresponding fields
within the record will result in the regeneration of the key.

RxNorm Concept Description Table

The RxNorm Concept Description Table provides text descriptions for RxNorm concepts. It includes the ability to
view text description that are longer than 255 characters using the RxNorm Sequence Number (
EVD_RXN_SEQ_SN).

Fields with column names that end with _KEY are not persistent. Any change to corresponding fields
within the record will result in the regeneration of the key.

SNOMED CT Type Description Table

The SNOMED CT Type Description Table (RIMKTD0_SCT_TYPE_DES) relates the SNOMED CT Type Identifier
to the text description that provides a text description of the SNOMED CT Description Type Identifier. There are

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three type identifiers used in association for the allergens:

Preferred Term: a word or phrase that is used by clinicians to name a clinical concept (e.g. walnut nut).
Synonym: an additional term used to define the concept at the same level of granularity (e.g. English
walnut, walnut).
Fully Specified Name: the Preferred Term with a semantic tag as a suffix to indicate the type of concept
and to eliminate ambiguity (e.g. walnut nut [substance]).

SNOMED CT Value Set Description Table

The SNOMED CT Value Set Description Table (RIMKVSD0_SCT_VALUE_SET_DESC) provides the name and
definition for an associated SNOMED CT value set identifier to its description. Additional descriptive information
(e.g. the HL7 CDA OID) is populated in the IMK SNOMED CT Value Set Comment field (
IMK_SCT_VALUE_SET_COMMENT) when deemed applicable.

SNOMED CT Concept Type Description Table

The SNOMED CT Concept Type Description Table (RIMKSID0_SCT_TYPE_DESC) relates the SNOMED CT
Concept Type Identifier to its text description. Currently the module supports the US Edition of SNOMED CT.

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Interoperability Rule Sets

This section provides rules that the clinical team uses in regard to creating the module's data, both general rules
and rules specific to data elements.

General Rules of Applicability

RxNorm Vocabulary Data Linking Methodology
CVX and MVX Linking Methodology
Clinical Quality Measures Value Set
Allergen Concepts
FDB Allergen Vocabulary Concepts
SNOMED CT to DXID Linking Methodology
SNOMED CT Release Format 2 (RF2)
Structured Product Labeling (SPL) Terminology Files
National Council for Prescription Drug Programs (NCPDP) Terminology Files
Codified and Structured Sigs Linking Methodology
Rules for Data Elements
EVD Link Type Identifier

General Rules of Applicability

This section describes editorial policies that have a broad impact on the module data or by nature are less
specific than those policies in other sections.

RxNorm Vocabulary Data Linking Methodology

This section defines the linking methodology for incorporating the RxNorm vocabulary information received from
NLM. The cross-reference relationships are created weekly. The weekly MedKnowledge database build includes
additional relationships to FDB identifiers that are derived programmatically or from the original NLM-created
maps. The Interoperability Module is limited to United States drugs.

By providing a means of mapping between vocabulary sets, RxNorm can be of significant clinical value in
communicating between disparate health information systems. Users must be aware that differences such as how
the data is represented between MedKnowledge drug concepts and RxNorm concepts will at times occur,
creating inherent ambiguities that will need to be addressed in your application.

Other difficulties that are inherent when mapping between vocabulary sets from different sources include:

Timing issues - Timing issues can occur due to update cycles, access to information, and the lag time that
it takes for NLM to include MedKnowledge concepts within the RxNorm download files.
Reuse of identifiers - Maintenance policies for incorporating new information, such as retired/replaced
identifiers and reused identifiers can also vary and result in inconsistencies.

FDB follows good vocabulary practices and does not revise or reuse identifiers. However, we have no

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control over the vocabulary practices for external identifiers (for example, NDC).

Not all RxNorm Term Types are cross-referenced to MedKnowledge concepts.

There are potential lag times for NLM to include MedKnowledge concepts within the RxNorm download
files
The RXCUI Replacement Files are sourced from the NLM RxNorm Atom Archive file. Due to NLM
practices, the replacement target may not exist in the External Vocabulary Link Table
(REVDEL0_EXT_VOCAB_LINK) or the RxNorm Concept Source Table
(REVDCS0_RXN_CONCEPT_SOURCE).

CVX and MVX Linking Methodology

This section defines the linking methodology for incorporating the CVX and MVX information received from the
CDC. The CVX and MVX relationships are created weekly.

FDB editorially maintains the following relationships within the External Vocabulary Link Table
(REVDEL0_EXT_VOCAB_LINK):

The U.S. subset of FDB's Clinical Formulation IDs (GCN_SEQNO) to the CDC's CVX code values
FDB's National Drug Code (NDC) to the CDC's MVX Code values for NDCs that are active or are up
to three years obsolete

1. CVX codes are also associated with the following FDB identifiers based on their relationships to the
Clinical Formulation ID (GCN_SEQNO):
National Drug Code (NDC)
MED Medication ID (MEDID)
MED Routed Dosage Form Medication ID (ROUTED_DOSAGE_FORM_MED_ID)
MED Routed Medication ID (ROUTED_MED_ID)
MED Medication Name ID (MED_NAME_ID)
Routed Generic Identifier (ROUTED_GEN_ID)

2. The following enforced editorial policies for the EVD_CVX_CD_USAGE fields ensure its utility as a priority
sort variable:
A MedKnowledge Clinical Formulation ID (GCN_SEQNO) can be mapped to zero to many CVX
codes.
A Clinical Formulation ID (GCN_SEQNO) included in the CVX mapping within the FDB
Interoperability Module is mapped to at least one CVX code.
A CVX code can be mapped to zero to many Clinical Formulation IDs (GCN_SEQNOs).
If a Clinical Formulation ID (GCN_SEQNO) is mapped to a CVX code with an
EVD_CVX_CD_USAGE value of 1 (Specified Formulation-Active), 20 (Specified
Formulation-Inactive Code), or 60 (Specified Non-Immunization Biologic Formulation), it should not
be mapped to any other CVX code with an EVD_CVX_CD_USAGE value of 1, 20, or 60.
Any medication concept, Clinical Formulation IDs (GCN_SEQNOs), National Drug Code (NDC), or

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Routed Generic Identifier (ROUTED_GEN_ID) may only be mapped to (at most) one CVX code with
an EVD_CVX_CD_USAGE value of 30 (Unspecified Formulation).
Any medication concept, Clinical Formulation ID (GCN_SEQNO), NDC, or ROUTED_GEN_ID may
only be mapped to (at most) one CVX code with an EVD_CVX_CD_USAGE value of 70
(Unspecified Non-Immunization Biologic Formulation).

Clinical Formulation ID (GCN_SEQNO) to CVX Code Editorial Linking Methodology

1. While the level of abstraction is consistent for the FDB Clinical Formulation ID ( GCN_SEQNO), it is not for
the CVX code. The level of granularity for the CVX code varies. The CVX code at least includes the
vaccine entity but may additionally include other descriptive information:
Vaccine entity (usually named as the infectious agent the vaccine is designed to protect against)
Vaccine valence (when relevant)
Serotypes included (when relevant)
Conjugation
Route of administration (when relevant to distinguish from other routes for the same immunization
entity)
Dosage (for example, adult and pediatric, when relevant)
Preservative free state

2. The FDB Clinical Formulation ID (GCN_SEQNO) consistently includes the following level of abstraction for
immunizations:
Vaccine entity or ingredients (which includes the valence, serotypes, conjugation, preservative free
state or coverage year when relevant)
Representative route of administration
Dosage form
Strength

3. Mapping of CVX codes to Clinical Formulation IDs (GCN_SEQNOs) is accomplished by the creation of
rules that may include the Hierarchical Specific Therapeutic Class Code (HIC3), Hierarchical Ingredient
Code (HIC4 or HIC4 plus salt), ETC_ID, or Ingredient List Identifier (HICL_SEQNO) with route, dose form,
or strength as enumerated criteria in the rule.
From the published Clinical Formulation ID (GCN_SEQNO) to CVX code relationships, CVX codes are
linked to relevant NDCs regardless of obsolete status. Relevant NDCs are only linked to MVX codes for
active and no more than 3 years obsolete NDCs in the link table.

4. Clinical Formulation IDs (GCN_SEQNOs) contained in the External Vocabulary Link Table
(REVDEL0_EXT_VOCAB_LINK) may have more than one CVX code linked. For example, the CDC
creates CVX codes at differing levels of granularity. Some CVX codes may describe an immunization
product at several levels of granularity to support CVX code transmission when an end user has less
specific information about the vaccine given, particularly in a historical reporting scenario. If several CVX

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codes exist with different levels of granularity for an immunization product, all conceptually matching CVX
codes will be linked to the Clinical Formulation ID (GCN_SEQNO) describing the same immunization
product.

5. Clinical Formulation IDs (GCN_SEQNOs) may be linked to CVX codes with a status of active or inactive,
but never to a CVX code with a status of never active. The CDC may create additional CVX code status
values in the future. FDB editorial policy for new CVX code status values will be developed at that time.

6. In some instances, the CDC may assess that a certain CVX code is no longer appropriate for transmission
to an IIS and provides a replacement code(s). When this occurs, FDB considers the replacement code(s)
as the go forward code(s) for transmissions. In this situation, Clinical Formulation IDs (GCN_SEQNOs)
remain linked to the retired CVX code and are mapped to the appropriate, newly-created CVX code,
intended by the CDC for ongoing IIS transmissions. The retired CVX code is then assigned a different EVD
CVX Usage Code (EVD_CVX_CD_USAGE) for retired CVX codes (for example,
EVD_CVX_CD_USAGE=40 or 50).

7. CVX codes do not have Clinical Formulation ID (GCN_SEQNO) links when the CVX code does not have a
conceptual Clinical Formulation ID (GCN_SEQNO) match in MedKnowledge.

NDC to MVX Editorial Linking Methodology

1. NDCs that are mapped to an MVX code must be:

Linked to a CVX code via their Clinical Formulation ID (GCN_SEQNO) associations, and
Currently active and on the U.S. market, or
Previously active on the U.S. market and no more than three years obsolete

All NDC to CVX code links are derived from Clinical Formulation ID ( GCN_SEQNO) to CVX
code relationships. These links are not filtered based on the NDC obsolete date within the
External Vocabulary Link Table (REVDEL0_EXT_VOCAB_LINK). However, an NDC greater
than three years obsolete must be associated to a CVX code to be linked to an MVX code.

2. NDCs that are mapped to an MVX code are mapped to only one MVX code that is a conceptual match to
the source manufacturer of the immunization product, as identified on the FDA-approved product labeling.

3. Not all MVX codes have NDC links for the following reasons:
The manufacturer no longer exists or was purchased by another corporation.
The existing manufacturer no longer manufactures applicable immunization products for IIS
transmissions.

4. MVX codes that are identified as representing manufacturers that are no longer in business are coded with
an FDB internal maintenance system indicator ("No Links to Labeler/NDC"), which prevents linking to
NDCs. This indicator is under editorial control and may be removed to allow future NDC linking.

Some inconsistencies inherent when mapping between vocabulary sets from different sources include:

Timing issues - Timing issues can occur due to update cycles, access to information, and the lag time that

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may occur for CDC to include new CVX or MVX concepts within their download files.
Reuse of identifiers - Though the current CDC policy does not allow for reuse of identifiers, future
maintenance policies for incorporating new information, such as retired/replaced identifiers and reused
identifiers, could vary and result in inconsistencies.
Unintended data errors by the CDC.

Clinical Quality Measures Value Set

FDB publishes the USHIK Value Sets data as received as does not editorially review or validate.

Content for the current CMS reporting year is available in the USHIK Master Table
(RIMKUK0_USHIK_MSTR).
Historical content for the most recent NLM published version and previous four CMS reporting years is
available in the USHIK History Table (RIMKUKH0_USHIK_HIST).

FDB publishes the USHIK Value Sets data as received as does not editorially review or validate. Some of the
columns in this table have a not Null constraint (meaning they must contain a value). If FDB receives CQM
value set information in which certain data fields are reported with no information:

The word Null is passed through for alphanumeric columns

A 0 value is passed through for numeric columns

We will not replace Null or 0 for Primary Keys or a field that is defined as nullable.

Allergen Concepts

Substances deemed not recognizable by a consumer were not included; the bias is that this list will not satisfy the
needs of an allergist conducting skin testing; it is intended more to capture commonly consumer reported foods or
allergens.

Two Indicators in the SNOMED CT to FDB Link Table are used to support allergen documentation for
non-medication reconciliation: the Related Indicator and the Preferred Indicator.

For Foods and Environmental Agents

Related Indicator
A method to always resolve the related FDB Ingredient or Allergen Group to a single SNOMED CT
concept target was not found.
A related indicator of True (1) was given if the FDB ingredient was deemed not a conceptually
equivalent match. Links from FDB ingredients to Specific Allergen Groups were used to identify
candidate links.
If the Related Indicator associated to the FDB Ingredient or Specific Allergen Group is False (0) it
links to one SNOMED CT concept.
If the Related Indicator associated to the FDB Ingredient or Specific Allergen Group is True (1), it
may span multiple SNOMED CT values.
A relatively small subset of Specific Allergen Group values were identified that cant link broad

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groups to a similarly broad SNOMED CT value (e.g., Egg/Poultry, Fish Product Derivatives, Milk
Products, Shellfish, Latex Natural Rubber, Sulfite Derivatives).
Preferred Indicator
A Preferred Indicator of True for a SNOMED CT value is assigned to the HIC_SEQN if it is NOT
related; otherwise the preferred link is the Specific Allergen Group.

For Reactions (Cross-Reference to DXID)

Related Indicator
The Related Indicator is marked as True (1) when the FDB DXID is not a quite a conceptually
equivalent match.
Preferred Indicator
A SNOMED CT value may be linked to only one DXID with a Preferred Indicator of True (1).
A DXID may be linked to only one SNOMED CT value with a Preferred Indicator of True (1) when
the Related Indicator is False (0).

FDB Allergen Vocabulary Concepts

FDB Ingredients are mapped to RxNorm IN/PIN or FDA UNII

If an RxNorm IN/PIN is not identified; ingredients are identified using FDA Unique Ingredient
Identifiers (UNII) when available.
FDB MedNameIDs are mapped to RxNorm BN/IN/PIN/MIN
FDB Specific Allergen Groups are mapped to RxNorm VA NDF-RT/ or IN/PIN/FDA UNII
VA NDF-RT mapping is limited to:
NDF-RT class concepts integrated within RxNorm (SAB = NDFRT) that span types of:
Mechanism of Action (MECHANISM_OF_ACTION_KIND)
Physiologic Effect (PHYSIOLOGIC_EFFECT_KIND)
Chemical Structure (INGREDIENT_KIND)
An indicator is provided to denote if concept is on the FDB DAM Picklist.
A Multi-Set Indicator denotes whether a given FDB concept spans multiple external concepts, resulting in
the best fit being chosen as the column value.
Not all drugs are included in the different interoperability domains.
Drug based classes represent a subset of the most frequently observed drug allergies and do not
represent all allergens. Similarly, FDB chose to evaluate only a subset of common environmental and food
allergens.

SNOMED CT to DXID Linking Methodology

The DXID to SNOMED CT Best Fit Table (RIMKBF0_DXID_SCT_BEST_FIT) is used to identify the SNOMED CT
Concept ID that represents the Best Fit for mapping to a DXID. The Link Indicator ( LINK_IND) will have a value
of 0 when a DXID is not linked to a SNOMED CT Concept ID and a value of 1 if the DXID is linked to a SNOMED
CT Concept ID.

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Not all DXID codes are appropriate to have best fit.

The Interoperability Module is limited to United States drugs.
FDB redistributes the SNOMED CT description files from the NLM for those that appear to be constrained
to English.
A single or combination SNOMED CT code may be used:
The single SNOMED CT code and its descendants should trigger the display of FDB based
knowledge associated to its DXID in the context of Drug-Disease Contraindications code (DDCM).
A second or third code could be linked for DXID pre-coordinated terms that span multiple families in
SNOMED CT; each of the linked best fit values when true in a patient record, can trigger the display of
linked FDB knowledge via the DXID.

Inactive links can be defined as no longer best fit; and be viewed in the DXID to SNOMED CT Best Fit History
Table (RIMKBFH0_DXID_SCT_BEST_FIT_HX). Best Fit links can change from active to inactive:

As the result of editorial action; history will be retained

When the SNOMED CT code has been retired/removed
When the DXID is retired

SNOMED CT Release Format 2 (RF2)

SNOMED CT descriptive content (US Edition Release Format 2) from the National Library of Medicine provides
descriptions for cross-reference SNOMED CT values as a convenience for our customers. FDB does not
editorially review or validate the contents.

Structured Product Labeling (SPL) Terminology Files

Although this terminology set contains numerous NCIt subsets, the mapping of this data set is limited to the
Structured Product Labeling Drug Route of Administration Terminology Subset (C54455), which provides
terminology used for representation of information on pharmaceutical product route of administration in the
framework of the Structured Product Labeling. A preferred FDB concept can be mapped to only one NCIt code,
although an NCIt code can be mapped to more than one FDB concept.

National Council for Prescription Drug Programs (NCPDP) Terminology Files

Released monthly, this set of NCIt files multiple subsets and descriptions for NCIt . The NCPDP Preferred Term
associated with the NCIt Code is used for the description in the SIG FDB to External Vocabulary Link Table
(RIMKSSE0_SIG_FDB_TO_EXT_LINK). A preferred FDB concept can be mapped to only one NCPDP NCIt
code. Two subsets of this NCIt terminology file set utilized in SIG mappings are:

NCPDP Quantity Unit Of Measure Terminology (Subset C89510)A set of terminology for NCPDP that
contains concepts of the intended or actual dispensed quantity unit of measure; for example, 1 Package, 1
Inhaler, 17 grams, 30 tablets, 473 ML, 3 Eaches.
NCPDP Dose Unit Of Measure Terminology (Subset C121847)A set of terminology for NCPDP that
contains concepts of the intended dose unit of measuretablet, scoopful, puff, or ml, for exampleas

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presented in the medication directions for use (Sig). Because this subset exists as a means of stating
dosing quantities, the concepts contained within may not be the same, or appropriate, units used for
dispensing/billing.

Codified and Structured Sigs Linking Methodology

Table Link Add Date". The add date will reflect the date a link was added to table (production run date).
Table Link Inactive Date. A link would become inactive if editorially, FDB determined it is no longer
valid. An inactive date will not be automatically set to inactive based upon the FDB or external code being
retired.
Mapping provided is not bi-directional. Focus is for FDB concepts to external concepts.
Not all concepts will link to external concepts for the associated vocabulary type. FDB concepts not linked
are excluded from the dataset.
When applicable Sig Preferred and Sig Related Indicators are provided.
IMK Preferred Indicator: The IMK Preferred Indicators are populated with a value of "1" (true) to
indicate this is a preferred match between an FDB Concept and the External Source Concept.
Exact matches can be identified by Sig Preferred Indicators populated with a value of "1" (true) AND
Sig Related Indicators with a value of 0 (false). The text descriptions do not need to be identical to
be considered a preferred exact match; for example, FDB description (Ophthalmic), SNOMED CT
description (Ophthalmic route).
Initial load all elements will have Sig Preferred Indicator populated with value of 1. If editorial
determines a new/different external value is better suited the current Sig Preferred Indicator will be
populated with value of 0 and a new link will be created.
IMK Related Indicator: All FDB IDs that are not an exact match will have their Sig Preferred
Indicator populated as true (1) to indicate this was considered still considered a preferred match;
however, the Sig Related Indicator will be populated as true (1) to identify the match was based on
relationship; for example, FDB Intra-Urethral mapped to SNOMED CT Urethral.

Route of Administration

The Route of Administration Master Table (RPEIRM0_RT_MSTR) is the internal concept source used to link
a First Databank route of administration identifier to an external source route of administration identifier. The
Route of Administration Master Table serves as the centralized location for all routes including linkages to
route identifiers in other modules. The Route Identifier (RT_ID) and the Route Description
(RT_DESC_LONG) from this table are used to populate the IMK_FDB_VOCAB_NO_ID and the
IMK_FDB_VOCAB_DESC elements in the SIG FDB to External Vocabulary Link Table
(RIMKSSE0_SIG_FDB_TO_EXT_LINK). Not all FDB concepts will map to external concepts for the
associated vocabulary type. Both the EVD_FDB_VOCAB_TYPE_ID and the associated
EVD_EXT_VOCAB_TYPE_ID are required to bring back correct results. Mappings will be established
editorially.

FDB Routes to SNOMED CT Concept

SNOMED CT contains a listing of the current set of terms related to routes of administration

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for clinical therapeutics. The US Edition of SNOMED CT contains the International and US
Extension Releases.
FDB Route Identifiers that cannot be linked to a corresponding SNOMED CT code, (for
example, multiple routes contained within one FDB Route_ID - RT_ID 233: Oral or Rectal or
IV), will not be included in the dataset.
FDB Route Identiifiers are linked to a corresponding SNOMED Concept ID with the Fully
Specified Name provided for informational reference.
FDB Routes to NCIt Concept
Mappings for FDB routes are limited to NCIt codes belonging to the SPL Drug Route of
Administration Terminology Subset.
FDB Route Identifiers that cannot be linked to a corresponding NCIt ID (for example,FDB
Route_ID - RT_ID 233: Oral or Rectal or IV, that contains multiple routes), will not be
included in the data set.

Dosage Form

Dosage Forms are being mapped in the context of the Dose Unit of Measure; not necessarily the product
description (for example, tablet represents extended-release tablets, effervescent tablets, in addition to
numerous other types of tablets). Dosage Forms are mapped using a subset of the Dosage Form Master
Table (RPEIDM0_DOSAGE_FORM_MSTR) which limits to medication dosage forms to those that link to an
OrderKnowledge Order Unit Of Measure. The Dosage Form Master Table serves as a centralized location
for all dosage forms including linkages to dosage form identifiers in other modules. A subset of the Dosage
Form Identifier (DOSAGE_FORM_ID) and the Dosage Form Description (DOSAGE_FORM_DESC_SHORT)
from this table are used to populate the IMK_FDB_VOCAB_NO_ID and the IMK_FDB_VOCAB_DESC
elements in the SIG FDB to External Vocabulary Link Table (RIMKSSE0_SIG_FDB_TO_EXT_LINK). These
mappings will be established editorially.

Customers using either a full order or dispensable order from OrderKnowledge should use the Unit Of
Measure to NCIt mapping instead of the Dosage Form to NCIt mapping.

NCIt Concept
The NCIT NCPDP Terminology File subset, NCPDP Dose Unit Of Measure Terminology, will be
used for mapping the FDB Dosage Form. Neither NCPDP nor HL7 currently has a mandatory
requirement for dosage form mapping to SNOMED CT Concept IDs at this time.
The NCPDP Dose Unit Of Measure Terminology subset is recommended for utilization in the
NCPDP SCRIPT Structured Sig Dose Composite Segment (040-S025). The NCPDP Dose
Composite Segment can define a fixed dose or can repeat to define a variable dose, dose range, or
dose options. Usually providing the noun for patient instructions; for example:
Take one tablet twice daily
Apply one patch daily
Apply three applications daily

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Chew one wafer four times a day

The NCPDP Structured Sig Dosing Composite requires:
Qualifier to identify the code system being used; for example, 2 (NCIt)
The NCIt code representing the Dose Form; for example, C48480
The textual representation of the Dose Form; for example, Capsule
The NCIT Dose Unit of Measure Terminology subset does not contain a value for kit. If a FDB
designated kit contains products of the same dose form it will be mapped; for example, syringe kit
will be mapped to syringe.

Unit of Measure (UOM)/ Dose Unit of Measure

Units of Measure will be used to define prescription and order entry dictionaries used by Pharmacies and
Providers (e.g. ordering dose amounts, and recording times for dosing). The Unit of Measure Master
Identifier (UOM_MSTR_ID) will be used to link First Databank units of measure to external unit of measure
identifiers. The UOM_MSTR_ID is found in the Unit of Measure Master Table (RPEIUM0_UOM_MSTR),
which serves as the centralized location for all units of measure including linkages to unit of measure
identifiers in other modules. The Unit of Measure Master ID and the UOM Master Description
(UOM_MSTR_DESC) found in the Unit of Measure Master Table will be used to populate the
IMK_FDB_VOCAB_NO_ID and the IMK_FDB_VOCAB_DESC elements in the SIG FDB to External
Vocabulary Link Table (RIMKSSE0_SIG_FDB_TO_EXT_LINK). Mappings will be established editorially.

SNOMED CT Concept
Only FDB Unit of Measure IDs that can be mapped to SNOMED CT Concept IDs are
represented.
SNOMED CT codes will be used to populate the IMK External Vocabulary Identifier
(IMK_EXT_VOCAB_ID),the Fully Specified Name description, and the IMK External
Vocabulary Description (IMK_EXT_VOCAB_DESC) elements in the SIG FDB to External
Vocabulary Link Table (RIMKSSE0_SIG_FDB_TO_EXT_LINK). Some of the Unit of Measure
Types provided include:
Area
Length
Quantity
Time
Volume
Weight
NCIt Code
The FDB Unit of Measure Identifier represents units of measure as well as units of dose.
UCUM Code
Relates First Databank (FDB) concepts to UCUM (Unified Code Units of Measure) Codes.
Links are created and maintained editorially.

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UCUM Codes may be created editorially using character set and lexical rules defined by the
UCUM Organization.

PRN ID

The PRN ID (PRN_ID) element in the OrderKnowledge PRN Text Table (PRN_TEXT) is the internal concept
source used to link First Databank PRN conditions to SNOMED CT Concept Identifiers. The PRN condition
is the reason a medication is used on an as-needed basis. The PRN ID (PRN_ID) will be used to populate
the IMK_FDB_VOCAB_NO_ID and the PRN Text (PRN_ID_TEXT) will populate the associated
IMK_FDB_VOCAB _DESC elements in the SIG FDB to External Vocabulary Link Table
(RIMKSSE0_SIG_FDB_TO_EXT_LINK). FDB PRN_ID descriptions containing multiple indications may be
mapped to more than one related SNOMED-CT concept.

Within the NCPDP Structured Sig Segment of Script 10.6, PRN information is used in Composite 120-S034
to populate the following:

Indication Text: Cough

Indication Text Code Qualifier: 1 [SNOMED-CT]

Indication Text Code: 49727002

SNOMED CT Concept
SNOMED CT has been identified by NCPDP as a preferred source for indications. Within the
NCPDP Sig Standard 10.6, the Structured Sig Element (Composite SIG-120) provides
guidance on how to communicate PRN conditions.
The SNOMED CT Concept ID and Fully Specifiied Name description will be used to populate
the IMK External Vocabulary Identifier (IMK_EXT_VOCAB_ID) and the IMK External
Vocabulary Description (IMK_EXT_VOCAB_ID_DESC) in the SIG FDB to External
Vocabulary Link Table (RIMKSSE0_SIG_FDB_TO_EXT_LINK).

Frequency and Interval

First Databank's Frequency and Interval IDs have been parsed to allow utilization in HL7 and FHIR
transactions. Within HL7 the FDB FREQ_INT_ID is utilized to display time period parameters and event
parameters when applicable. Only Frequency and Interval Identifiers that map to HL7 codes will be
presented. Two tables are used:

The primary table, SIG Frequency and Interval Link Table (RIMKHFI0_SIG_FREQ_INT_LINK) is
based strictly on time periods (e.g. days, hours, times per day).
For indicating times per day, HL7 uses fractional amounts. For example twice a day is
represented as 0.5 d (1(day) divided by 2).
When a Frequency and Interval instruction is based off an event (e.g. before breakfast, at bedtime)
the SIG Frequency and Interval Event Table (RIMKHIE0_SIG_FREQ_INT_EVENT) is linked to the
SIG Frequency and Interval Link Table.

Element representation are based from HL7 recommendations available at time of creation (April 2016).

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HL7 representation for exact hour, once, or specific days of the week are not included at this time.

Indication Precursor Text and Dose Delivery Method Text

The NCPDP Structure Sig Element SIG-120-01 (Indication Precursor Text), is to be populated with the textual
representation of the indication precursor. FDB has identified SNOMED CT Concept IDs representing commonly
used precursors and have provided their SNOMED CT code and description in the SNOMED CT Value Set Table
(RIMKVS0_SCT_VALUE_SET).

The SNOMED Concept ID representing FOR has been provided but is not part of the SNOMED CT
subtype hierarchy Irregular frequency at this time.

The NCPDP Structure Sig Element SIG-040 (Dose Delivery Method Text), is to be populated with the textual
representation of the method in which the dose is delivered (describes how the dose is administered/consumed).
Patient instruction examples would include Take, Inject, and Inhale. FDB has identified SNOMED CT Concept
IDs representing commonly used verbs used to create the Dose Delivery Method and have provided their
SNOMED CT code and description in the SNOMED CT Value Set Table (RIMKVS0_SCT_VALUE_SET).

The SNOMED Concept ID representing IMPLANT and SPRAY have been provided but are not part of
the SNOMED CT subtype hierarchy dosing instruction imperative at this time.

Rules for Data Elements

This section describes editorial policies that are more specific toward their effect on the data elements contained
in the module.

EVD Link Type Identifier

The EVD Link Type Identifier (EVD_LINK_TYPE_ID) identifies how a link was derived and the source for that link.

EVD_LINK_TYPE_ID EVD_LINK_TYPE_DESC

1 Derivation Via Clinical Formulation

2 RxNorm Pass-thru

3 Derivation Via RxNorm Term Type

4 RxNorm Asserted NDC Relationship

5 Derivation Via Common NDC

6 Editorially Maintained Linkage

7 Derivation Via Common NDC Application ID

8 Derivation Via String Match

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An EVD_LINK_TYPE_ID value of 1 indicates a link derived by FDB based on the Clinical Formulation ID (
GCN_SEQNO) relationships maintained by FDB. Relationships between the following FDB concepts and RxNorm
and CVX/MVX concepts may be assigned a value of 1:

Medication Name ID (MED_NAME_ID) to CVX

MED Medication ID (MEDID_SN) to CVX
Med Medication ID (MEDID) to Semantic Clinical Drug (SCD)
MEDID to Generic Pack (GPCK)
National Drug Code (NDC) to SCD
NDC to CVX
Routed Dosage Form Medication ID (ROUTED_DOSAGE_FORM_MED_ID) to CVX
Routed Generic Identifier (ROUTED_GEN_ID) to CVX
Routed Medication ID (ROUTED_MED_ID) to CVX

A value of 2 indicates a link derived by NLM and passed through by FDB. Relationships between the following
FDB and RxNorm concepts are assigned a value of 2:

Clinical Formulation ID (GCN_SEQNO) to SCD

Clinical Formulation ID (GCN_SEQNO) to Semantic Clinical Drug Form (SCDF)
Clinical Formulation ID (GCN_SEQNO) to GPCK
Hierarchical Ingredient Code Sequence Number (HIC_SEQN) to Ingredient (IN)
HIC_SEQN to Precise Ingredient (PIN)

A value of 3 indicates a link derived by FDB utilizing NLM-based Term Type relationships maintained by NLM.
Relationships between the following FDB and RxNorm concepts are assigned a value of 3:

Clinical Formulation ID (GCN_SEQNO) to Branded Pack (BPCK)

Clinical Formulation ID (GCN_SEQNO) to Semantic Branded Drug (SBD)
HIC_SEQN to UNII Code as specified by the NLM
MED_NAME_ID to Brand Name (BN)
MEDID to BPCK
MEDID to SBD
Some NDCs to GPCK

A value of 4 indicates a link derived by NLM defined relationships between the NDC and a single RXCUI. Within
RxNorm, an NDC may be assigned to SCDs, SBDs, GPCKs, or Brand Name Packs (BPCK) (aka NLM-asserted
NDCs).

A value of 5 indicates a link derived by FDB between common NDCs of both sources. Relationships between the
following FDB and RxNorm concepts may be assigned a value of 5:

MED_NAME_ID to BN
MEDID to BPCK

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MEDID to SBD

A value of 6 indicates a link that is editorially maintained. Relationships between the following FDB and CVX-MVX
codes may be assigned a value of 6:

Clinical Formulation ID (GCN_SEQNO) to CVX

NDC to Manufacturers of Vaccines Code (MVX)

A value of 7 indicates a link derived by FDB via Common NDC Application ID. This link type is created only when
a Link cannot be created using one of the six linking type strategies defined above.

Clinical Formulation ID (GCN_SEQNO) to Semantic Branded Drug (SBD)

Clinical Formulation ID (GCN_SEQNO) to Semantic Brand Pack (BPCK)
Clinical Formulation ID (GCN_SEQNO) to Semantic Generic Pack (GPCK)
NDC to Semantic Clinical Drug (SCD)
NDC to Semantic Branded Drug (SBD)
NDC to Semantic Brand Pack (BPCK)
NDC to Semantic Generic Pack (GPCK)
MedID to Semantic Clinical Drug (SCD)
MedID to Semantic Branded Drug (SBD)
MedID to Semantic Brand Pack (BPCK)
MedID to Semantic Generic Pack (GPCK)
MedName to BrandName (BN)

A value of 8 indicates a link derived via string match. This link type is created only when a link cannot be created
using one of the seven linking type strategies defined above.

MedName to BrandName (BN)

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Interoperability Maintenance
This section contains information regarding the ongoing maintenance of the module's data.

RxNorm Vocabulary Data Maintenance Policies

CVX and MVX Code Sets Maintenance Policies
HL7 Standard Code Set Mapping for CVX Vaccine Groups
SNOMED CT Data Maintenance Policies
USHIK

RxNorm Vocabulary Data Maintenance Policies

The RxNorm full files are typically made available by NLM on the first Monday of the month and updates are
posted weekly. FDB accesses the UMLS Knowledge Source Server to download files.

On a weekly basis, FDB updates the FDB Interoperability Module mappings against the most current
MedKnowledge data. These mappings are published on a weekly and monthly frequency, regardless of whether
updated RxNorm content is available.

New NDCs added to MedKnowledge are updated in the External Vocabulary Link Table
(REVDEL0_EXT_VOCAB_LINK) if NLM has created a link between the FDB Clinical Formulation ID (
GCN_SEQNO) and RxNorm's Semantic Clinical Drug (SCD), or the new drug has a common FDB and RxNorm
NDC that share the same ingredients.

New RXCUIs published by the NLM each month are included in the FDB Interoperability Concept Tables. See
FDB Interoperability Concept Tables for more information about these tables.

Triggers for Clinical Review

Triggers for adding or removing new mapping relationships include new MedKnowledge concept links and
NLM data updates.

CVX and MVX Code Sets Maintenance Policies

The CDC's total files are always available on the various CDC web pages referenced in the CVX and MVX
Linking Methodology section. Since the CDC files are sporadically updated only as needed by the CDC, these
files are automatically pulled down once weekly by the FDB internal maintenance system and are
programmatically compared to the previous files loaded into the FDB internal database. When changes are
detected, a CDC file change maintenance system queue is populated, identifying the field changed and the
before and after values. Each change must be editorially reviewed and published before the individual field
changes are included in the internal database files. If the reviewing Clinical Pharmacist perceives there to be a
possible error in the downloaded CDC data files, the suspect file or field changes are not published. The Clinical
Pharmacist contacts the appropriate personnel at the CDCs NCIRD to request a file change review and, if
necessary, a correction by the CDC. Once the corrected files are posted on the CDC web pages, they are
downloaded into the FDB internal maintenance system during the next weekly cycle.

On a weekly basis, FDB updates the FDB Interoperability Module CVX and MVX mappings for new

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MedKnowledge identifiers. These mappings are published weekly, regardless of whether new CVX or MVX
content is available. Once a new drug is available within MedKnowledge, it is available in the upcoming FDB
Interoperability Module weekly update; assuming that FDB has created a link between the FDB Clinical
Formulation ID (GCN_SEQNO) or National Drug Code (NDC) and the CDC's CVX or MVX codes.

Triggers for Clinical Review

Triggers for adding, changing, or removing mapping relationships include the following:

Newly published CVX code

Newly published MVX code
Newly published Clinical Formulation ID (GCN_SEQNO)
Newly published NDC
Clinical Formulation ID (GCN_SEQNO) attribute change
Manufacturer for an NDC changes
NDC linked to an MVX code ages past three years obsolete
NDC linked to a Clinical Formulation ID (GCN_SEQNO) changes

HL7 Standard Code Set Mapping for CVX Vaccine Groups

On a weekly basis, FDB updates HL7 Standard Code Set Mapping for CVX Vaccine Groups with data retrieved
from the CDC. FDB does not editorially review or validate these contents.

SNOMED CT Data Maintenance Policies

On a semi-annual basis, FDB updates the FDB Interoperability Module with the most current SNOMED CT
data. The last import date for these external files can be retrieved from the Vocabulary Data Version Table
(REVDVD0_VOCAB_DATA_VERSION).

USHIK
FDB monitors the NLM (VSAC) and CMS websites for changes or updates for files. This data is delivered to
customers on a weekly basis.

The following chart demonstrates the maintenance workflow for this content. (Timelines are subject to change.)

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Interoperability Resources
This section lists sources used by First Databank to compile the information contained in the module.

FDB utilizes many reference sources including, but not limited to, the primary medical literature (e.g., published
journal articles), medical reference texts, published expert treatment guidelines, and manufacturer product
package inserts. FDB uses current source editions or versions when coding and updating data, as well as when
researching questions about data. However, a formal data review does not occur for every new release of source
editions or versions. Additional sources include:

Centers for Disease Control's (CDC) National Center of Immunization and Respiratory Diseases. CPT
Codes Mapped to CVX Codes. Available at:
http://www2a.cdc.gov/vaccines/IIS/IISStandards/vaccines.asp?rpt=cpt
Centers for Disease Control's (CDC) National Center of Immunization and Respiratory Diseases. IIS: HL7
Standard Code Set CVX -- Vaccines Administered. Available at:
http://www2a.cdc.gov/vaccines/IIS/IISStandards/vaccines.asp?rpt=cvx
Centers for Disease Control's (CDC) National Center of Immunization and Respiratory Diseases. IIS: HL7
Standard Code Set MVX -- Manufacturers of Vaccines. Available at:
http://www2a.cdc.gov/vaccines/IIS/IISStandards/vaccines.asp?rpt=mvx
Centers for Medicare & Medicaid Services (CMS). eCQM Library. Available at:
https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/eCQM_Library.html
HL7 Standard Code Set CVX - VIS Mapping Table. Available at
http://www2a.cdc.gov/vaccines/iis/iisstandards/vaccines.asp?rpt=cvxvis
National Library of Medicine (NLM): Unified Medical Language System (UMLS): SNOMED CT Route of
Administration Subset. Available at:
https://download.nlm.nih.gov/umls/kss/RouteOfAdministration/der_RouteOfAdministration_current-en-US_US_20150301
National Library of Medicine (NLM): Unified Medical Language System (UMLS). Available at:
http://www.nlm.nih.gov/research/umls
National Library of Medicine (NLM): Value Set Authority Center (VSAC). Available at:
https://vsac.nlm.nih.gov/
NCI Thesaurus (NCIt) - NCPDP. Available at: http://evs.nci.nih.gov/ftp1/NCPDP
NCI Thesaurus (NCIt) - SPL. Available at :http://www.cancer.gov/research/resources/terminology/fda
Packaged product inserts. Published by authority of the Board of Directors of the American Society of
Health-System Pharmacists. American Hospital Formulary Service (AHFS) Drug Information.
SNOMED CT Documentation. Available at: https://confluence.ihtsdotools.org/display/DOC
SNOMED International: http://www.snomed.org/
Unified Code for Units of Measure (UCUM). Available at: http://unitsofmeasure.org/ucum.html
United States Health Information Knowledgebase (USHIK). Available at https://ushik.ahrq.gov/
Vaccine Information Statement (VIS) Lookup Table. Available at
http://www.cdc.gov/vaccines/programs/iis/code-sets/vis-barcode-lookup-table.html

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Interoperability Applications
This section provides information about the practical application of data contained in this module.

General Interoperability Applications

Considerations When Implementing RxNorm Vocabulary Data
Retrieving the Description Text of the Source Identifiers
Medication Interoperability Applications
Retrieving External Vocabulary Identifiers for a Given FDB Concept
Retrieving a Single RxNorm Vocabulary Identifier for a Given NDC and Term Type Shared with
NLM
Retrieving FDB Identifiers for an RxNorm Vocabulary Identifier
Retrieving Description Text for the External Vocabulary and Vocabulary Type Identifiers
Retrieving RxNorm Ingredients for a Generically Named MED Medication Name ID
Selecting RXCUIs for Outbound e-Prescriptions
Retrieving RxNorm Vocabulary Identifiers for a Replaced MEDID
Retrieving RxNorm Vocabulary Identifiers for an Unassociated MEDID
Retrieving a Replaced RXCUIs Replacement Value
Clinical Screening Interoperability Applications
Finding Tall Man Descriptions for FDB Concepts Retrieved from RxNorm Vocabulary Identifiers
Using a Tall Man Description in a Continuity of Care Document (CCD)
Finding Additional Synonyms for an RxNorm Semantic Branded Drug (SBD)
Retrieving FDB Concepts for a Given Externally Reported RxNorm-based Medication Concept
Immunization Interoperability Applications
Retrieving CVX Code Identifiers for a Given FDB Concept
Retrieving CVX and MVX Codes Associated to an NDC for Registry Transmission
Retrieving Note Text for a CVX Code
Submitting a Manufacturer for a Repackaged NDC to an Immunization Registry
Allergen Interoperability Applications
Navigating from a UNII Code to an Associated Ingredient
Retrieving an External Allergen Interoperable Concept for a Given FDB Allergen Concept
Retrieving FDB Allergen Interoperable Concepts for a Given External Allergen Concept
Retrieving an HL7 Object Identifier (OID) for a Given Interoperable Concept Type
Documenting Food or Environmental Allergies Using SNOMED CT Concepts
Problem|Reaction (SNOMED) Interoperability Applications
Retrieving an Active SNOMED CT Clinical Finding Using the Term Description Field
Retrieving an Active SNOMED CT Description for a Given SNOMED CT Concept Identifier
Retrieving an Active SNOMED CT Description for a Given SNOMED CT Description Identifier

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Retrieving Active Child SNOMED CT Concept Identifiers

Retrieving Active Parent SNOMED CT Concept Identifiers
Retrieving a Single Description for a SNOMED CT Concept Identifier
Retrieving a SNOMED CT Concept Identifiers Associated DXIDs
Clinical Quality Measures (CQM) Value Set Applications
Presenting RXCUI Changes for Clinical Quality Measures
Structured & Codified Sig Applications
Retrieving an External Interoperable Concept for a Given FDB Interoperable Concept
Retrieving an HL7 Concept for a Given Frequency and Interval ID
Retrieving a UCUM Code for a Given FDB Master Unit of Measure Identifier

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General Interoperability Applications

Considerations When Implementing RxNorm Vocabulary Data

Retrieving the Description Text of the Source Identifiers

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Considerations When Implementing RxNorm Vocabulary Data

Before implementing, please take the following into consideration:

Please be aware that each First Databank (FDB) identifier may map to more than one RxNorm concept
type and RXCUI, and in turn each RxNorm RXCUI may map to more than one FDB concept.

When implementing interoperability within your system, it is good practice for the sending system to
include the text description of the item chosen by the user. If available, any supporting attributes should
also be stored. For example, if storing data from the RxNorm Concept Source Table
(REVDCS0_RXN_CONCEPT_SOURCE), the NLM's Concept Identifier (EVD_RXN_RXCUI), Source
Abbreviation (EVD_RXN_SAB), Term Type (EVD_RXN_TTY), Code (EVD_RXN_CODE), and text
description (EVD_RXN_STR) should also be stored. This ensures that the user's intent is communicated
accurately and provides a quality check between the two parties to ensure the supporting attributes and
name matches the code.

The FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) is an alphanumeric column that links to

MedKnowledge numeric columns, such as the MED Medication ID ( MEDID), MED Medication Name ID (
MED_NAME_ID), and Clinical Formulation ID (GCN_SEQNO). Please take this into account when creating
queries or navigating between tables.

RxNorm Concepts (RXCUIs) will be deleted from the FDB customer files when FDB no longer receives the
RxNorm Concept from the NLM. FDB does not maintain RxNorm Concept History. Any Primary Keys
related to RxNorm Concepts are not considered stable and are not persistent. If planning to maintain
history, it is recommended that the primary key and all the supporting attributes for that primary key also be
stored so that the full definition and description of that element can be retrieved.

Since some of the Primary Keys related to RxNorm Concepts are not considered stable and are not
persistent, it is recommended that changes are keyed off the natural key. For example, in the RxNorm
Concept Source Table (REVDCS0_RXN_CONCEPT_SOURCE), the NLM's Concept Identifier (
EVD_RXN_RXCUI), Source Abbreviation (EVD_RXN_SAB), Term Type (EVD_RXN_TTY), and Code (
EVD_RXN_CODE) is the natural key for processing data updates.

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Retrieving the Description Text of the Source Identifiers

The EVD Source Identifiers (EVD_SOURCE_ID) can identify a link source in the External Vocabulary Link Type
Description Table (REVDLT0_LINK_TYPE_DESC) or a vocabulary source in the Vocabulary Type Definition
Table (REVDVT0_VOCAB_TYPE_DEF). This example illustrates how to retrieve the vocabulary source
description. See Retrieving a Single RxNorm Vocabulary Identifier for a Given NDC for an application that
illustrates identifying a link source.

For purposes of illustration, this example uses an NDC value of 00006074954 (Zocor 40 mg Tablet).

1. Retrieve the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) and the EVD External
Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) values from the External Vocabulary Link Table
(REVDEL0_EXT_VOCAB_LINK) where the EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID)
column equals the NDC value of 00006074954 and the EVD FDB Vocabulary Type Identifier (
EVD_FDB_VOCAB_TYPE_ID) column equals 100 (indicating NDC).

EVD_FDB_VOCAB EVD_FDB_VOCAB EVD_EXT_VOCAB EVD_EXT_VOCAB EVD_EXT_VOCAB

_ID _TYPE_ID _ID _TYPE_ID _DESC

00006074954 100 198211 501 Simvastatin 40 MG

Oral Tablet

00006074954 100 152923 502 Simvastatin 40 MG

Oral Tablet [Zocor]

Retrieve the EVD External Vocabulary Description (EVD_EXT_VOCAB_DESC) values from the
External Vocabulary Description Table (REVDEV0_EXT_VOCAB_DESC).

2. Retrieve the EVD Source Identifier (EVD_SOURCE_ID) values from the Vocabulary Type Definition Table
(REVDVT0_VOCAB_TYPE_DEF) where the EVD Vocabulary Type Identifier (EVD_VOCAB_TYPE_ID)
column equals the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) values retrieved in the
previous step.

EVD_VOCAB_TYPE_ID EVD_SOURCE_ID

501 2

502 2

3. Retrieve the EVD Source Description (EVD_SOURCE_DESC) values from the Source Description Table
(REVDVS0_SOURCE_DESC) where the EVD Source Identifier (EVD_SOURCE_ID) column equals the
value retrieved in the previous step.

EVD_SOURCE_ID EVD_SOURCE_DESC

2 National Library of Medicine

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Medication Interoperability Applications

Retrieving External Vocabulary Identifiers for a Given FDB Concept

Retrieving a Single RxNorm Vocabulary Identifier for a Given NDC and Term Type Shared with NLM

Retrieving FDB Identifiers for an RxNorm Vocabulary Identifier

Retrieving Description Text for the External Vocabulary and Vocabulary Type Identifiers

Retrieving RxNorm Ingredients for a Generically Named MED Medication Name ID

Selecting RXCUIs for Outbound e-Prescriptions

Retrieving RxNorm Vocabulary Identifiers for a Replaced MEDID

Retrieving RxNorm Vocabulary Identifiers for an Unassociated MEDID

Retrieving a Replaced RXCUIs Replacement Value

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Retrieving External Vocabulary Identifiers for a Given FDB Concept

This application illustrates how to retrieve RxNorm vocabulary identifiers for a given FDB concept identifier.

1. Determine if your identifier has been replaced by a different value if the identifier is a National Drug Code (
NDC), MED Medication ID (MEDID), MED Medication Name ID (MED_NAME_ID), or Hierarchical
Ingredient Code Sequence Number (HIC_SEQN).
Please reference one of the following applications for information on determining if a given identifier has
been replaced:
For an NDC identifier, see the Finding a Replacement or Previous NDC application in the
MedKnowledge manual.
For a MEDID or MED_NAME_ID identifier, see the Retrieving RxNorm Vocabulary Identifiers for a
Replaced MEDID.
For a HIC_SEQN identifier, see the Finding a Replacement Ingredient Identifier application in the
MedKnowledge manual.

2. Retrieve the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) and the EVD External
Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) values from the External Vocabulary Link Table
(REVDEL0_EXT_VOCAB_LINK) where (one of the following):
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals a MED_NAME_ID value
and the EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) column equals 1
(indicating MED_NAME_ID).
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals a MEDID value and the
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) column equals 3 (indicating
MEDID).
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals a Clinical Formulation ID
(GCN_SEQNO) value and the EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID)
column equals 6 (indicating GCN_SEQNO).
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals an NDC value and the EVD
FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) column equals 100 (indicating
NDC).
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals a HIC_SEQN value and the
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) column equals 104 (indicating
HIC_SEQN).

3. Retrieve the EVD External Vocabulary Description (EVD_EXT_VOCAB_DESC) values from the External
Vocabulary Description Table (REVDEV0_EXT_VOCAB_DESC) where the EVD External Vocabulary
Identifier (EVD_EXT_VOCAB_ID) and the EVD External Vocabulary Type Identifier (
EVD_EXT_VOCAB_TYPE_ID) columns equal the values retrieved in the previous step.

ExampleRetrieving External Vocabulary Identifiers for a MEDID Concept

For purposes of demonstrating this application, the following scenario is used: A physician prescribes
Vytorin 10-40 mg Tablet (MED Medication ID [MEDID] 471147) and needs to include the RxNorm vocabulary

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identifier in the prescription before submitting it electronically to the pharmacy.

1. Determine if the MED Medication ID (MEDID) has been replaced by a different value. See Retrieving
RxNorm Vocabulary Identifiers for a Replaced MEDID application for an illustration of this step. In this
example, the MEDID is active and has not been replaced.

2. Retrieve the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) and the EVD External
Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) values from the External Vocabulary Link Table
(REVDEL0_EXT_VOCAB_LINK) where:
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals the MEDID value of the
product, and
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) column equals 3 (indicating
MEDID).

EVD_FDB_VOCAB_ID EVD_FDB_VOCAB_TYP EVD_EXT_VOCAB_ID EVD_EXT_VOCAB_TYP

E_ID E_ID

471147 3 476350 501

471147 3 543354 502

When more than one RXCUI is returned, the list can be filtered and decisions can be made
according to vocabulary type:

To restrict the list to brand-specific RXCUIs, use the EVD_EXT_VOCAB_TYPE_ID value of

502 or 504.
To restrict the list to generically named RXCUIs, use the EVD_EXT_VOCAB_TYPE_ID
value of 501 or 503.

The preference for an SBD or SCD RXCUI may depend on whether the original drug is a branded
name or generically-named product. For example, if starting with a branded name product and you
want your application to preserve that aspect of the drug, the application gives preference to an
SBD RXCUI, if one is present.

3. Retrieve the EVD External Vocabulary Description (EVD_EXT_VOCAB_DESC) values from the External
Vocabulary Description Table (REVDEV0_EXT_VOCAB_DESC) where the EVD External Vocabulary
Identifier (EVD_EXT_VOCAB_ID) and the EVD External Vocabulary Type Identifier (
EVD_EXT_VOCAB_TYPE_ID) columns equal the values retrieved in the previous step.

EVD_EXT_VOCAB_ID EVD_EXT_VOCAB_TYPE_ID EVD_EXT_VOCAB_DESC

476350 501 ezetimibe 10 MG / Simvastatin 40

MG Oral Tablet

543354 502 ezetimibe 10 MG / Simvastatin 40

MG Oral Tablet [Vytorin]

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Retrieving a Single RxNorm Vocabulary Identifier for a Given NDC

The External Vocabulary Link Type Description Table (REVDLT0_LINK_TYPE_DESC) relates the link
methodology and source to its description text. This application and the example below illustrate how to retrieve a
single RxNorm Vocabulary Identifier for a given NDC and Term Type when available.

1. Determine if the NDC has been replaced by a different value. See the Finding a Replacement or Previous
NDC application in the MedKnowledge manual for an illustration of this step.

2. Retrieve the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) and the EVD External
Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) values from the External Vocabulary Link Table
(REVDEL0_EXT_VOCAB_LINK) where:
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals the NDC value of the
product,
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) column equals 100 (indicating
NDC), and
EVD Link Type Identifier (EVD_LINK_TYPE_ID) column equals 4 (indicating RxNorm Asserted NDC
Relationship). The value of 4 indicates that the retrieved RXCUI is the NLM asserted RXCUI for the
NDC.

3. Retrieve the EVD External Vocabulary Description (EVD_EXT_VOCAB_DESC) values from the External
Vocabulary Description Table (REVDEV0_EXT_VOCAB_DESC) where the EVD External Vocabulary
Identifier (EVD_EXT_VOCAB_ID) and the EVD External Vocabulary Type Identifier (
EVD_EXT_VOCAB_TYPE_ID) columns equal the values retrieved in the previous step.

ExampleRetrieving a Single RxNorm Vocabulary Identifier for a Given NDC and Term Type Shared with NLM

For purposes of demonstrating this application, the following scenario is used: Before submitting a
Medicare Part D formulary to CMS, a Physician Benefit Managers (PBM) database system using FDB data
validates the representative NDCs to ensure they are assigned by NLM. In this example, the system checks NDC
00456340029 (Namenda XR) to see if there is an NLM-assigned NDC value.

1. Determine if the NDC has been replaced by a different value. See Finding a Replacement or Previous
NDC application for an illustration of this step.
In this example, the REPNDC field is null. Therefore, the NDC is not replaced.

2. Retrieve the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) and the EVD External
Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) values from the External Vocabulary Link Table
(REVDEL0_EXT_VOCAB_LINK) where:
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals the NDC value of the
product,
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) column equals 100 (indicating
NDC),
EVD Link Type Identifier (EVD_LINK_TYPE_ID) column equals 4 (indicating RxNorm Asserted NDC
Relationship). The value of 4 indicates that the retrieved RXCUI is the NLM defined RXCUI for the

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NDC

EVD_FDB_VOC EVD_FDB_VOC EVD_LINK_TY EVD_LINK_TY EVD_EXT_VOC EVD_EXT_VOC

AB_ID AB_TYPE_ID PE_ID PE_DESC AB_ID AB_TYPE_ID

00456340029 100 4 RxNorm 996633 504

Asserted NDC
Relationship

Retrieve the EVD Link Type Description (EVD_LINK_TYPE_DESC) values from the External
Vocabulary Link Type Description Table (REVDLT0_LINK_TYPE_DESC).

3. Retrieve the EVD External Vocabulary Description (EVD_EXT_VOCAB_DESC) values from the External
Vocabulary Description Table (REVDEV0_EXT_VOCAB_DESC) where the EVD External Vocabulary
Identifier (EVD_EXT_VOCAB_ID) and the EVD External Vocabulary Type Identifier (
EVD_EXT_VOCAB_TYPE_ID) columns equal the values retrieved in the previous step.

EVD_EXT_VOCAB_ID EVD_EXT_VOCAB_TYPE_ID EVD_EXT_VOCAB_DESC

996633 504 Namenda XR 28 Day Titration Pack

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Retrieving FDB Identifiers for an RxNorm Vocabulary Identifier

This application illustrates how to navigate to FDB data for an RxNorm concept.

1. Retrieve the EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) and the EVD FDB Vocabulary Type
Identifier (EVD_FDB_VOCAB_TYPE_ID) values from the External Vocabulary Link Table
(REVDEL0_EXT_VOCAB_LINK) where the following:
EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) column equals the RxNorm value you
wish to input
EVD External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) equals the vocabulary
type of the RXCUI

2. Retrieve the EVD Vocabulary Type Description (EVD_VOCAB_TYPE_DESC) values from the Vocabulary
Type Definition Table (REVDVT0_VOCAB_TYPE_DEF) where the EVD Vocabulary Type Identifier (
EVD_VOCAB_TYPE_ID) column equals the EVD FDB Vocabulary Type Identifier (
EVD_FDB_VOCAB_TYPE_ID) values retrieved the previous step.

The EVD_EXT_VOCAB_TYPE_ID criteria is optional if the external vocabulary type is unknown.

3. Depending on the EVD_FDB_VOCAB_TYPE_ID and EVD_VOCAB_TYPE_DESC values returned in the

previous two steps, perform one of the following:
Retrieve the required National Drug Code (NDC) attributes from the NDC Table
(RNDC14_NDC_MSTR) where the NDC column equals the EVD FDB Vocabulary Identifier (
EVD_FDB_VOCAB_ID) values retrieved in step 1.
Retrieve the required Clinical Formulation ID (GCN_SEQNO) attributes from the Clinical
Formulation ID Table (RGCNSEQ4_GCNSEQNO_MSTR) where the Clinical Formulation ID (
GCN_SEQNO) column equals the EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) values
retrieved in step 1.
Retrieve the required Hierarchical Ingredient Code Sequence Number (HIC_SEQN) attributes from
the Hierarchical Ingredient Code Description Table (RHICD5_HIC_DESC) where the HIC_SEQN
column equals the EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) values retrieved in step
1.
Retrieve the required MED Medication Name ID (MED_NAME_ID) attributes from the MED
Medication Name Table (RMINMID1_MED_NAME) where the MED_NAME_ID column equals the
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) values retrieved in step 1.
Retrieve the required MED Medication ID (MEDID) attributes from the MED Medication Table
(RMIID1_MED) where the MEDID column equals the EVD FDB Vocabulary Identifier (
EVD_FDB_VOCAB_ID) values retrieved in step 1.

To determine if the MED_NAME_ID is a brand name or generic name, use the MED Medication
Name Type Code (MED_NAME_TYPE_CD) column from the RMINMID1_MED_NAME table.

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ExampleRetrieving an FDB Ingredient Identifier for an RxNorm Ingredient Concept

For purposes of demonstrating this application, the following scenario is used: A patients Personal Health
Record (PHR) identifying an allergy to Codeine at the ingredient level (RXCUI [IN] 2670) is available. The allergy
information needs to be transferred to a Physician Management System using FDBs ingredient identifiers. The
database system retrieves and stores the related FDB HIC_SEQN with its description.

When creating an allergy or clinical screening application using the FDB Interoperability Module, keep in
mind that differences in the representation of strength values, specificity of dosage form, and ingredients
can occur. Data sources may represent ingredients according to different editorial policies or may not list
all ingredients present in a formulation.

1. Retrieve the EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) and the EVD FDB Vocabulary Type
Identifier (EVD_FDB_VOCAB_TYPE_ID) values from the External Vocabulary Link Table
(REVDEL0_EXT_VOCAB_LINK) where the following:
EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) column equals the RxNorm value you
wish to input.
EVD External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) equals the vocabulary
type of the RXCUI.

In this example, EVD_EXT_VOCAB_ID equals the RXCUI value of 2670 and the
EVD_EXT_VOCAB_TYPE_ID equals 500 (indicating Ingredient [IN]).

EVD_EXT_VOCAB EVD_EXT_VOCAB EVD_EXT_VOCAB EVD_FDB_VOCAB EVD_FDB_VOCAB

_ID _TYPE_ID _DESC _ID _TYPE_ID

2670 500 Codeine 1550 104

2. Retrieve the EVD External Vocabulary Description (EVD_EXT_VOCAB_DESC) values from the External
Vocabulary Description Table (REVDEV0_EXT_VOCAB_DESC).
Retrieve the EVD Vocabulary Type Description (EVD_VOCAB_TYPE_DESC) values from the Vocabulary
Type Definition Table (REVDVT0_VOCAB_TYPE_DEF) where the EVD Vocabulary Type Identifier (
EVD_VOCAB_TYPE_ID) column equals the EVD FDB Vocabulary Type Identifier (
EVD_FDB_VOCAB_TYPE_ID) values retrieved the previous step.

EVD_VOCAB_TYPE_ID EVD_VOCAB_TYPE_DESC

104 HIC_SEQN

3. Retrieve the required HIC_SEQN attributes from the Hierarchical Ingredient Code Description Table
(RHICD5_HIC_DESC) where the HIC_SEQN column equals the EVD FDB Vocabulary Identifier (
EVD_FDB_VOCAB_ID) values retrieved in step 1.

HIC_SEQN HIC_DESC

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1550 codeine

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Retrieving Description Text for the External Vocabulary and Vocabulary Type Identifiers
This example illustrates how to retrieve the following:
Retrieving the Description Text of an External Vocabulary Identifier
Retrieving the Description Text of the Vocabulary Type Identifiers

Retrieving the Description Text of an External Vocabulary Identifier

This example illustrates how to retrieve the text description of an external vocabulary identifier.

For the purpose of illustration, this example finds the RxNorm concepts for the drug product Codeine Sulfate 30
mg Tablet (Clinical Formulation ID (GCN_SEQNO) 4186) and retrieves the related RxNorm descriptions.

1. Retrieve the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) and the EVD External
Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) values from the External Vocabulary Link Table
(REVDEL0_EXT_VOCAB_LINK) where the EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID)
column equals the Clinical Formulation ID (GCN_SEQNO) value of 4186 and the EVD FDB Vocabulary
Type Identifier (EVD_FDB_VOCAB_TYPE_ID) column equals the value of 6 (indicating GCN_SEQNO).

EVD_FDB_VOCAB_ID EVD_FDB_VOCAB_TYP EVD_EXT_VOCAB_ID EVD_EXT_VOCAB_TYP

E_ID E_ID

4186 6 197538 501

2. Select the EVD External Vocabulary Description (EVD_EXT_VOCAB_DESC) values from the External
Vocabulary Description Table (REVDEV0_EXT_VOCAB_DESC) where the EVD External Vocabulary
Identifier (EVD_EXT_VOCAB_ID) and the EVD External Vocabulary Type Identifier (
EVD_EXT_VOCAB_TYPE_ID) columns equal the values retrieved in the previous step.

EVD_EXT_VOCAB_ID EVD_EXT_VOCAB_TYPE_ID EVD_EXT_VOCAB_DESC

197538 501 Codeine 30 MG Oral Tablet

Use the EVD Sequence Number (EVD_SEQ_SN) column values to sort the results of step 2 when
necessary.

Retrieving the Description Text of the Vocabulary Type Identifiers

This example illustrates how to use the Vocabulary Type Definition Table (REVDVT0_VOCAB_TYPE_DEF) to
retrieve the text description for an EVD External Vocabulary Type Identifier ( EVD_EXT_VOCAB_TYPE_ID). This
table can also be used to access the text description for the EVD FDB Vocabulary Type Identifier (
EVD_FDB_VOCAB_TYPE_ID).

For the purposes of illustration, this example uses an RXCUI value of 197538 (Codeine 30 mg Oral Tablet).

1. Retrieve the EVD_EXT_VOCAB_TYPE_ID values from the External Vocabulary Link Table
(REVDEL0_EXT_VOCAB_LINK) where the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID)
column equals the RXCUI value of 197538.

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EVD_EXT_VOCAB_ID EVD_EXT_VOCAB_TYPE_ID

197538 501

2. Retrieve the EVD Vocabulary Type Description (EVD_VOCAB_TYPE_DESC) value from the Vocabulary
Type Definition Table (REVDVT0_VOCAB_TYPE_DEF) where the EVD Vocabulary Type Identifier (
EVD_VOCAB_TYPE_ID) column equals the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID)
value retrieved in the previous step.

EVD_VOCAB_TYPE_ID EVD_VOCAB_TYPE_DESC

501 Semantic Clinical Drug (SCD)

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Retrieving RxNorm Ingredients for a Generically Named MED Medication Name ID

This example illustrates how to navigate from a specific generically-named MED Medication Name ID (
MED_NAME_ID) to its related ingredient term type RXCUI values for their inclusion in a list of potential mapping
concepts.

1. Retrieve the Ingredient List Identifier (HICL_SEQNO) values from the MED MED Concept/HICL_SEQNO
Relation Table (RMEDMHL0_MED_HICLSEQNO_LINK) where:
MED Concept ID (MED_CONCEPT_ID) column equals the generically-named MED_NAME_ID, and
MED Concept ID Type (MED_CONCEPT_ID_TYP) column equals the value of 1 (indicating
Medication Name).

The MED Concept HICL_SEQNO Source Code (MED_CONCEPT_HICL_SRC_CD) may cause

otherwise identical entries during this step. Read more about the
MED_CONCEPT_HICL_SRC_CD to determine if utilizing this concept in drug allergy screening
would benefit your application.

2. Retrieve the Hierarchical Ingredient Code Sequence Number (HIC_SEQN) values from the
HICL_SEQNO/HIC Relation Table (RHICL1_HIC_HICLSEQNO_LINK) where the Ingredient List Identifier (
HICL_SEQNO) column equals the values retrieved in the previous step.

3. Retrieve the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) and the EVD External
Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) values from the External Vocabulary Link Table
(REVDEL0_EXT_VOCAB_LINK) where:
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals the Hierarchical Ingredient
Code Sequence Number (HIC_SEQN) values retrieved in the previous step, and EVD FDB
Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) column equals 104 (indicating
HIC_SEQN).

4. Select the EVD External Vocabulary Description (EVD_EXT_VOCAB_DESC) values from the External
Vocabulary Description Table (REVDEV0_EXT_VOCAB_DESC) where the EVD_EXT_VOCAB_ID and the
EVD_EXT_VOCAB_TYPE_ID columns equal the EVD_EXT_VOCAB_ID and
EVD_EXT_VOCAB_TYPE_ID values from the previous step.

ExampleRetrieving RxNorm Ingredients for a Generically Named MED Medication Name ID

For purposes of demonstrating this application, the following scenario is used: A patient enters the hospital
where he is prescribed an aspirin. The hospital needs to relate FDBs generically named MED Concept of Aspirin
(MED Medication ID [MED_NAME_ID] 1076) to the patients Physician, whose office uses an Electronic Medical
Records (EMR) system that does not utilize FDB identifiers. To ensure that the patient's medication information is
transferred to the physicians office, the hospital EMR retrieves the RxNorm ingredient identifier with its
description, and produces an outbound Continuity of Care Document (CCD) that contains this medication
information.

1. Retrieve the Ingredient List Identifier (HICL_SEQNO) values from the MED MED Concept/HICL_SEQNO

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1.

Relation Table (RMEDMHL0_MED_HICLSEQNO_LINK) where:

MED Concept ID (MED_CONCEPT_ID) column equals the generically-named MED_NAME_ID, and
MED Concept ID Type (MED_CONCEPT_ID_TYP) column equals the value of 1 (indicating
Medication Name).

MED_CONCEPT_ID MED_CONCEPT_ID_TYP MED_CONCEPT_HICL_ HICL_SEQNO

SRC_CD

1076 1 0 1820

1076 1 1 1820

The MED Concept HICL_SEQNO Source Code (MED_CONCEPT_HICL_SRC_CD) may cause

otherwise identical entries during this step. Read more about the
MED_CONCEPT_HICL_SRC_CD to determine if utilizing this concept in drug allergy screening
would benefit your application.

2. Retrieve the Hierarchical Ingredient Code Sequence Number (HIC_SEQN) values from the
HICL_SEQNO/HIC Relation Table (RHICL1_HIC_HICLSEQNO_LINK) where the ingredient List Identifier (
HICL_SEQNO) column equals the values retrieved in the previous step.

HICL_SEQNO HIC_SEQN

1820 1587

3. Retrieve the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) and the EVD External
Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) values from the External Vocabulary Link Table
(REVDEL0_EXT_VOCAB_LINK) where:
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals the Hierarchical Ingredient
Code Sequence Number (HIC_SEQN) values retrieved in the previous step, and
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) column equals 104 (indicating
HIC_SEQN).

EVD_FDB_VOCAB_ID EVD_FDB_VOCAB_TYP EVD_EXT_VOCAB_ID EVD_EXT_VOCAB_TYP

E_ID E_ID

1587 104 1191 500

4. Retrieve the EVD External Vocabulary Description (EVD_EXT_VOCAB_DESC) values from the External
Vocabulary Description Table (REVDEV0_EXT_VOCAB_DESC) where the EVD_EXT_VOCAB_ID and the
EVD_EXT_VOCAB_TYPE_ID columns equal the EVD_EXT_VOCAB_ID and
EVD_EXT_VOCAB_TYPE_ID values from the previous step.

EVD_EXT_VOCAB_ID EVD_EXT_VOCAB_TYPE_ID EVD_EXT_VOCAB_DESC

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1191 500 Aspirin

Use the EVD Sequence Number (EVD_SEQ_SN) column values to sort the results of step 4 when
necessary.

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Selecting RXCUIs for Outbound e-Prescriptions

This application explains how to retrieve RxNorm Concept Unique Identifiers (RXCUIs) for use in outbound
e-prescriptions. Before using this application, refer to Retrieving External Vocabulary Identifiers for a Given FDB
Concept.

1. Retrieve related RXCUIs for a given FDB concept. See Retrieving External Vocabulary Identifiers for a
Given FDB Concept for more information.

2. Filter the RXCUIs (EVD_EXT_VOCAB_ID) from the previous step for the following EVD External
Vocabulary Type Identifiers (EVD_EXT_VOCAB_TYPE_ID):
501Semantic Clinical Drug (SCD)
502Semantic Branded Drug (SBD)
503Generic Pack (GPCK)
504Branded Pack (BPCK)

3. If the previous step resulted in multiple EVD_EXT_VOCAB_IDs values, retrieve the RxNorm RXCUI (
EVD_RXN_RXCUI) values from the RxNorm Concept Master Table (REVDRC0_RXN_CONCEPT_MSTR)
where the RxNorm Prescribable RXCUI Indicator (EVD_PRESCRIBABLE_RXCUI_IND) equals 1.

ExampleSelecting an RXCUI for an Outbound e-Prescription

For purposes of demonstrating this application, the following scenario is used: A physician needs to to
send a prescription order for bupivacaine (PF) 0.25% 4 mL/hour 500 mL Local Infiltration, Elastic Pump via
e-Prescribing software that uses FDB concepts.

1. Retrieve related RXCUIs for a given FDB concept. See Retrieving External Vocabulary Identifiers for a
Given FDB Concept for more information.

EVD_FDB_VOCAB_ID EVD_FDB_VOCAB_TYP EVD_EXT_VOCAB_ID EVD_EXT_VOCAB_TYP

E_ID E_ID

568670 3 1012396 501

568670 3 1012400 502

568670 3 1012455 502

568670 3 106546 502

568670 3 108776 502

2. Filter the RXCUIs (EVD_EXT_VOCAB_ID) from the previous step for the following EVD External
Vocabulary Type Identifiers (EVD_EXT_VOCAB_TYPE_ID):
501Semantic Clinical Drug (SCD)
502Semantic Branded Drug (SBD)
503Generic Pack (GPCK)
504Branded Pack (BPCK)
In this example, the results do not change.

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3. If the previous step resulted in multiple EVD_EXT_VOCAB_IDs values, retrieve the RxNorm RXCUI (
EVD_RXN_RXCUI) values from the RxNorm Concept Master Table (REVDRC0_RXN_CONCEPT_MSTR)
where the RxNorm Prescribable RXCUI Indicator (EVD_PRESCRIBABLE_RXCUI_IND) equals 1.

EVD_RXN_RXCUI EVD_PRESCRIBABLE_RXCUI_IND

1012396 1

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Retrieving RxNorm Vocabulary Identifiers for a Replaced MEDID

A MED Medication Status Code (MED_STATUS_CD) of Replaced indicates that the MEDID identifier has been
replaced with another value and that a link has been provided from the old identifier to its replacement identifier.
Unless specific steps are taken, an application retrieving RXCUIs using a replaced MEDID may not return any
results. This application illustrates how to retrieve RxNorm vocabulary identifiers for replaced MED Medication
IDs (MEDID).

1. Retrieve the MED Medication Status Code (MED_STATUS_CD) value from the MED Medication Table
(RMIID1_MED) where the MEDID column equals the MEDID value of the medication.
If the MED_STATUS_CD value equals 1 (indicating Replaced), continue to step 2.
If the MED_STATUS_CD value equals 0 (indicating Active), 2 (indicating Retired), 3 (indicating
Inactive), or 9 (indicating Unassociated), this application ends.

2. Retrieve the MED Replacement Medication ID (MED_REPL_MEDID) values from MED Medication
Replacement History Table (RMIRH1_MED_HIST) where the MED Previous Medication ID (
MED_PREV_MEDID) column equals the replaced MEDID value from the previous step.

3. Repeat step 1 and step 2 (if necessary) using the MED_REPL_MEDID values retrieved in the previous
step until the MED_STATUS_CD of the replacement MEDID equals 0 (indicating Active), 3 (indicating
Inactive), or 9 (indicating Unassociated).

4. Retrieve the following values from the External Vocabulary Link Table (REVDEL0_EXT_VOCAB_LINK)
where the EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals the MEDID value from
the previous step and the EVD FDB Vocabulary Type Identifier ( EVD_FDB_VOCAB_TYPE_ID) column
equals 3 (indicating MEDID).
EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID)
EVD External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID)
EVD Vocabulary Type Description (EVD_VOCAB_TYPE_DESC)

5. Retrieve the EVD External Vocabulary Description (EVD_EXT_VOCAB_DESC) values from the External
Vocabulary Description Table (REVDEV0_EXT_VOCAB_DESC) where the EVD External Vocabulary
Identifier (EVD_EXT_VOCAB_ID) and EVD External Vocabulary Type Identifier (
EVD_EXT_VOCAB_TYPE_ID) columns equal the values retrieved in the previous step.

ExampleRetrieving RxNorm Vocabulary Identifiers for a Replaced MEDID

For purposes of demonstrating this application, the following scenario is used: While creating a Continuity
of Care Document (CCD), the software attempts to find the RXCUI for each of the medications on the patients
medication list. When an RXCUI for Matzim LA 360 mg 24 hr Tab (MED Medication ID [ MEDID] 562839) is not
returned, the system checks the MEDIDs status and determines that it has been replaced.

1. Retrieve the MED Medication Status Code (MED_STATUS_CD) value from the MED Medication Table
(RMIID1_MED) where the MEDID column equals the MEDID value of the medication.
If the MED_STATUS_CD value equals 1 (indicating Replaced), continue to step 2.
If the MED_STATUS_CD value equals 0 (indicating Active), 2 (indicating Retired), 3 (indicating

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Inactive), or 9 (indicating Unassociated), this application ends.

Retrieve the MED Medication Status Code Description (MED_STATUS_CD_DESC) values from the MED
Status Code Description Table (RMISCD1_STATUS_DESC).

MEDID MED_MEDID_DESC MED_STATUS_CD MED_STATUS_CD_DES

C

562839 Matzim LA 360 mg 24 hr 1 Replaced

Tab

In this example, the retrieved MED_STATUS_CD value equals 1 (indicating Replaced). The application
continues to step 2.

2. Retrieve the MED Replacement Medication ID (MED_REPL_MEDID) values from MED Medication
Replacement History Table (RMIRH1_MED_HIST) where the MED Previous Medication ID (
MED_PREV_MEDID) column equals the replaced MEDID value from the previous step.

MED_PREV_MEDID MED_REPL_MEDID

562839 448712

3. Repeat step 1 and step 2 (if necessary) using the MED_REPL_MEDID values retrieved in the previous
step until the MED_STATUS_CD of the replacement MEDID equals 0 (indicating Active), 3 (indicating
Inactive), or 9 (indicating Unassociated).

MEDID MED_MEDID_DESC MED_STATUS_CD MED_STATUS_CD_DES

C

448712 diltiazem ER 360 mg 24 hr 0 Active

Tab

In this example, step 1 is repeated to show that MEDID 448712 is the active replacement value for the
replaced MEDID 562839 (Matzim LA 360 mg 24 hr Tab).

4. Retrieve the following values from the External Vocabulary Link Table (REVDEL0_EXT_VOCAB_LINK)
where the EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals the MEDID value from
the previous step and the EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) column
equals 3 (indicating MEDID).
EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID)
EVD External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID)
EVD Vocabulary Type Description (EVD_VOCAB_TYPE_DESC)

The EVD Vocabulary Type Description (EVD_VOCAB_TYPE_ID) column is found within the Vocabulary
Type Definition Table (REVDVT0_VOCAB_TYPE_DEF).

EVD_FDB_VOCAB EVD_FDB_VOCAB EVD_EXT_VOCAB EVD_EXT_VOCAB EVD_VOCAB_TYP

_TYPE_ID _ID _TYPE_ID E_DESC

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448712 3 830897 501 Semantic Clinical

Drug (SCD)

448712 3 830898 502 Semantic Branded

Drug (SBD)

448712 3 1091638 502 Semantic Branded

Drug (SBD)

When more than one RXCUI is returned, the list can be filtered and decisions can be made
according to vocabulary type:
To restrict the list to brand-specific RXCUIs, use the EVD_EXT_VOCAB_TYPE_ID value of 502 or
504.
To restrict the list to generically named RXCUIs, use the EVD_EXT_VOCAB_TYPE_ID value of
501 or 503.
The preference for an SBD or SCD RXCUI may depend on whether the original drug is a branded
name or generically-named product. For example, if starting with a branded name product and you
want your application to preserve that aspect of the drug, the application gives preference to an
SBD RXCUI, if one is present.

5. Retrieve the EVD External Vocabulary Description (EVD_EXT_VOCAB_DESC) values from the External
Vocabulary Description Table (REVDEV0_EXT_VOCAB_DESC) where the EVD External Vocabulary
Identifier (EVD_EXT_VOCAB_ID) and EVD External Vocabulary Type Identifier (
EVD_EXT_VOCAB_TYPE_ID) columns equal the values retrieved in the previous step.

EVD_EXT_VOCAB_ID EVD_EXT_VOCAB_TYPE_ID EVD_EXT_VOCAB_DESC

830897 501 24 HR Diltiazem Hydrochloride 360

MG Extended Release Tablet

830898 502 24 HR Diltiazem Hydrochloride 360

MG Extended Release Tablet
[Cardizem]

1091638 502 24 HR Diltiazem Hydrochloride 360

MG Extended Release Tablet
[Matzim]

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Retrieving RxNorm Vocabulary Identifiers for an Unassociated MEDID

A MED Medication Status Code (MED_STATUS_CD) of Unassociated indicates that a medication concept
represents no NDCs, although it may represent one or more Clinical Formulation IDs ( GCN_SEQNO). Unless
specific steps are taken, an application retrieving RXCUIs using an unassociated MEDID may not return any
results. This application illustrates how to retrieve RxNorm vocabulary identifiers for MED Medication IDs (MEDID
) that are unassociated.

The examples following the application demonstrate the following:

ExampleRetrieving RxNorm Vocabulary Identifiers for an Unassociated MEDID with a Distinct Clinical
Formulation
ExampleRetrieving RxNorm Vocabulary Identifiers for an Unassociated MEDID with Multiple Clinical
Formulations

1. Retrieve the MED Medication Status Code (MED_STATUS_CD) value from the MED Medication Attribute
Table (RMIID1_MED) where the MEDID column equals the MEDID value of the medication.
If the MED_STATUS_CD value equals 9 (indicating Unassociated), continue to step 2.
If the MED_STATUS_CD value equals 0 (indicating Active), 1 (indicating Replaced), 2 (indicating
Retired), or 3 (indicating Inactive), this application ends.

2. Retrieve the MED GCN_SEQNO Assignment Code (MED_GCNSEQNO_ASSIGN_CD) values from the
RMIID1_MED table where the MED Medication ID (MEDID) column equals the MEDID value of the
medication.

a. If the MED_GCNSEQNO_ASSIGN_CD value equals 0 (indicating No GCN_SEQNO assigned), 1

(indicating Distinct GCN_SEQNO assigned), or 9 (indicating No Value), the MEDID has a single
related Clinical Formulation ID (GCN_SEQNO). In the next step, retrieve the Clinical Formulation ID
(GCN_SEQNO) using the MED Medication Table (RMIID1_MED).

b. If the MED_GCNSEQNO_ASSIGN_CD value equals 2 (indicating Representative GCN_SEQNO

assigned), the MEDID has multiple related Clinical Formulation IDs (GCN_SEQNOs). In the next
step, retrieve the Clinical Formulation IDs (GCN_SEQNO) using the MED GCN_SEQNO to MED
GCN_SEQNO to Medication ID Cross-Reference Table (RMIGC1_MEDID_GCNSEQNO_LINK).

3. Retrieve the Clinical Formulation ID (GCN_SEQNO) from the table determined in the previous step where
the MEDID column equals the MEDID value of the medication.

4. Retrieve the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) and the EVD External
Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) values from the External Vocabulary Link Table
(REVDEL0_EXT_VOCAB_LINK) where the following:
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) equals the Clinical Formulation ID
(GCN_SEQNO) value from the previous step
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) equals 6 (indicating
GCN_SEQNO)

5. Retrieve the EVD External Vocabulary Description (EVD_EXT_VOCAB_DESC) values from the External

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5.
Vocabulary Description Table (REVDEV0_EXT_VOCAB_DESC) where the EVD External Vocabulary
Identifier (EVD_EXT_VOCAB_ID) and EVD External Vocabulary Type Identifier (
EVD_EXT_VOCAB_TYPE_ID) columns equal the values retrieved in the previous step.

ExampleRetrieving RxNorm Vocabulary Identifiers for an Unassociated MEDID with a Distinct Clinical Formulation

For purposes of demonstrating this application, the following scenario is used: While creating a Continuity
of Care Document (CCD), the software attempts to find the RXCUI for each of the medications on the patients
medication list. When an RXCUI for morphine 4 mg/mL Injection (MED Medication ID [ MEDID] 150742) is not
returned, the system checks the MEDIDs status and determines that it is unassociated.

1. Retrieve the MED Medication Status Code (MED_STATUS_CD) value from the MED Medication Attribute
Table (RMIID1_MED) where the MED Medication ID (MEDID) column equals the MEDID value of the
medication (150742).
If the MED_STATUS_CD value equals 9 (indicating Unassociated), continue to step 2.
If the MED_STATUS_CD value equals 0 (indicating Active), 1 (indicating Replaced), 2 (indicating
Retired), or 3 (indicating Inactive), this application ends.

MEDID MED_STATUS_CD MED_STATUS_CD_DESC

150742 9 Unassociated

In this example, the retrieved MED_STATUS_CD value equals 9 (indicating Unassociated). The
application continues to step 2.

2. Retrieve the MED GCN_SEQNO Assignment Code (MED_GCNSEQNO_ASSIGN_CD) from the MED
Medication Attribute Table (RMIID1_MED) where the MED Medication ID (MEDID) column equals the
MEDID value of the medication.
If the MED_GCNSEQNO_ASSIGN_CD value equals 0 (indicating No GCN_SEQNO assigned), 1
(indicating Distinct GCN_SEQNO assigned), or 9 (indicating No Value), the MEDID has a single
related Clinical Formulation ID (GCN_SEQNO). In the next step, retrieve the Clinical Formulation ID
(GCN_SEQNO) using the MED Medication Table (RMIID1_MED).
If the MED_GCNSEQNO_ASSIGN_CD value equals 2 (indicating Representative GCN_SEQNO
assigned), the MEDID has multiple related Clinical Formulation IDs (GCN_SEQNOs). In the next
step, retrieve the Clinical Formulation IDs (GCN_SEQNO) using the MED GCN_SEQNO to
Medication ID Cross-Reference Table (RMIGC1_MEDID_GCNSEQNO_LINK).

Retrieve the MED GCN_SEQNO Assignment Code Description (MED_GCNSEQNO_ASSIGN_CD_DESC)

values from the MED GCN_SEQNO Assignment Code Description Table
(RMIGCND1_GCNSEQNO_ASSGN_DESC).

MEDID MED_GCNSEQNO_ASSIGN_CD MED_GCNSEQNO_ASSGN_CD_D

ESC

150742 1 Distinct GCNSEQNO assigned

In this example, the MED_GCNSEQNO_ASSIGN_CD equals 1, indicating that the MEDID has a single

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related Clinical Formulation ID (GCN_SEQNO). In the next step, retrieve the Clinical Formulation ID
(GCN_SEQNO) using the MED Medication Table (RMIID1_MED).

3. Retrieve the Clinical Formulation ID (GCN_SEQNO) from the MED Medication Table (RMIID1_MED)
where the MEDID column equals the MEDID value of the medication.

MEDID GCN_SEQNO

150742 004065

4. Retrieve the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) and the EVD External
Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) values from the External Vocabulary Link Table
(REVDEL0_EXT_VOCAB_LINK) where the following:
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) equals the Clinical Formulation ID
(GCN_SEQNO) value from the previous step
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) equals 6 (indicating
GCN_SEQNO)

EVD_FDB_VOCAB EVD_FDB_VOCAB_TYP EVD_EXT_VOCAB_ID EVD_EXT_VOCAB_TYP

E_ID E_ID

004065 6 895216 501

When more than one RXCUI is returned, the list can be filtered and decisions can be made
according to vocabulary type:

To restrict the list to brand-specific RXCUIs, use the EVD_EXT_VOCAB_TYPE_ID value of

502 or 504.
To restrict the list to generically named RXCUIs, use the EVD_EXT_VOCAB_TYPE_ID
value of 501 or 503.

The preference for an SBD or SCD RXCUI may depend on whether the original drug is a branded
name or generically-named product. For example, if starting with a branded name product and you
want your application to preserve that aspect of the drug, the application gives preference to an
SBD RXCUI, if one is present.

5. Retrieve the EVD External Vocabulary Description (EVD_EXT_VOCAB_DESC) values from the External
Vocabulary Description Table (REVDEV0_EXT_VOCAB_DESC) where the EVD External Vocabulary
Identifier (EVD_EXT_VOCAB_ID) and EVD External Vocabulary Type Identifier (
EVD_EXT_VOCAB_TYPE_ID) columns equal the values retrieved in the previous step.

EVD_EXT_VOCAB_ID EVD_EXT_VOCAB_TYPE_ID EVD_EXT_VOCAB_DESC

895216 501 Morphine Sulfate 4 MG/ML

Injectable Solution

ExampleRetrieving RxNorm Vocabulary Identifiers for an Unassociated MEDID with Multiple Clinical Formulations

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For purposes of demonstrating this application, the following scenario is used: While creating a Continuity
of Care Document (CCD), the software attempts to find the RXCUI for each of the medications on the patients
medication list. When an RXCUI for atropine 0.6 mg/mL Injection (MED Medication ID [ MEDID] 563890) is not
returned, the system checks the MEDIDs status and determines that it has been unassociated.

1. Retrieve the MED Medication Status Code (MED_STATUS_CD) value from the MED Medication Table
(RMIID1_MED) where the MEDID column equals the MEDID value of the medication.
If the MED_STATUS_CD value equals 9 (indicating Unassociated), continue to step 2.
If the MED_STATUS_CD value equals 0 (indicating Active), 1 (indicating Replaced), 2 (indicating
Retired), or 3 (indicating Inactive), this application ends.

MEDID MED_STATUS_CD MED_STATUS_CD_DESC

563890 9 Unassociated

In this example, the retrieved MED_STATUS_CD value equals 9 (indicating Unassociated). The
application continues to step 2.

2. Retrieve the MED GCN_SEQNO Assignment Code (MED_GCNSEQNO_ASSIGN_CD) from the

RMIID1_MED table where the MEDID column equals the MEDID value of the medication.
If the MED_GCNSEQNO_ASSIGN_CD value equals 0 (indicating No GCN_SEQNO assigned), 1
(indicating Distinct GCN_SEQNO assigned), or 9 (indicating No Value) the MEDID has a single
related Clinical Formulation ID (GCN_SEQNO). In the next step, retrieve the Clinical Formulation ID
(GCN_SEQNO) using the MED Medication Table (RMIID1_MED).
If the MED_GCNSEQNO_ASSIGN_CD value equals 2 (indicating Representative GCN_SEQNO
assigned), the MEDID has multiple related Clinical Formulation IDs (GCN_SEQNOs). In the next
step, retrieve the Clinical Formulation IDs (GCN_SEQNO) using the MED GCN_SEQNO to
Medication ID Cross-Reference Table (RMIGC1_MEDID_GCNSEQNO_LINK).

Retrieve the MED GCN_SEQNO Assignment Code Description (MED_GCNSEQNO_ASSIGN_CD_DESC)

values from the MED GCN_SEQNO Assignment Code Description Table
(RMIGCND1_GCNSEQNO_ASSGN_DESC).

MEDID MED_GCNSEQNO_ASSIGN_CD MED_GCNSEQNO_ASSGN_CD_D

ESC

563890 2 Representative GCNSEQNO

assigned

In this example, the MED_GCNSEQNO_ASSIGN_CD equals 2, indicating that the MEDID has multiple
related Clinical Formulation IDs (GCN_SEQNO). In the next step, retrieve the Clinical Formulation IDs
(GCN_SEQNOs) using the MED GCN_SEQNO to Medication ID Cross-Reference Table
(RMIGC1_MEDID_GCNSEQNO_LINK).

3. Retrieve the Clinical Formulation ID (GCN_SEQNO) values from the MED GCN_SEQNO to Medication ID
Cross-Reference Table (RMIGC1_MEDID_GCNSEQNO_LINK) where the MEDID column equals the

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3.

MEDID value of the medication.

MEDID GCN_SEQNO

563890 004814

563890 004822

4. Retrieve the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) and the EVD External
Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) values from the External Vocabulary Link Table
(REVDEL0_EXT_VOCAB_LINK) where the following:
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) equals the Clinical Formulation ID
(GCN_SEQNO) values from the previous step
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) equals 6 (indicating
GCN_SEQNO)

EVD_FDB_VOCAB EVD_FDB_VOCAB_TYP EVD_EXT_VOCAB_ID EVD_EXT_VOCAB_TYP

E_ID E_ID

004814 6 245349 501

004822 6 245349 501

In this example, both Clinical Formulation IDs (GCN_SEQNOs) are associated to one branded drug name.

5. Retrieve the EVD External Vocabulary Description (EVD_EXT_VOCAB_DESC) values from the External
Vocabulary Description Table (REVDEV0_EXT_VOCAB_DESC) where the EVD External Vocabulary
Identifier (EVD_EXT_VOCAB_ID) and EVD External Vocabulary Type Identifier (
EVD_EXT_VOCAB_TYPE_ID) columns equal the values retrieved in the previous step.

EVD_EXT_VOCAB_ID EVD_EXT_VOCAB_TYPE_ID EVD_EXT_VOCAB_DESC

245349 501 Atropine 0.6 MG/ML Injectable

Solution

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Retrieving a Replaced RXCUIs Replacement Value

The National Library of Medicine (NLM) maintains the RXCUI values and sometimes elects to refine them by
replacing one RXCUI with another. This application illustrates how to retrieve the replacement RXCUIs, if
available, which will provide a greater likelihood of finding a linked FDB identifier in the External Vocabulary Link
Table (REVDEL0_EXT_VOCAB_LINK).

1. Retrieve the EVD External Ultimate Replacement Vocabulary Identifier (EVD_EXT_ULT_REP_VOCAB_ID

) from the RXCUI Ultimate Replacement Table (REVDUR0_RXCUI_ULT_REPL) where the EVD External
Vocabulary Identifier (EVD_EXT_VOCAB_ID) equals the RXCUI that might be replaced.
If the EVD_EXT_VOCAB_ID is not found, then the RXCUI has not been replaced.
If the EVD_EXT_VOCAB_ID is found, then at least one ultimate replacement RXCUI value is
available.

2. Use the retrieved RXCUI(s) in the EVD External Ultimate Replacement Vocabulary Identifier (
EVD_EXT_ULT_REP_VOCAB_ID) field to continue with your application.

ExampleRetrieving a Replacement Value for a Replaced RXCUI

For purposes of demonstrating this application, the following scenario is used: A hospital is updating its list
of RXCUIs in their Medicare Part D Formulary Reference file and wants to determine whether RXCUI 1000560
(Sulfacetamide Sodium 100 mg/mL / Sulfur 50 mg/mL Medicated Liquid) has been replaced and with which
RXCUI.

1. Retrieve the EVD External Ultimate Replacement Vocabulary Identifier (EVD_EXT_ULT_REP_VOCAB_ID

) from the RXCUI Ultimate Replacement Table (REVDUR0_RXCUI_ULT_REPL) where the EVD External
Vocabulary Identifier (EVD_EXT_VOCAB_ID) equals the RXCUI that might be replaced.
If the EVD_EXT_VOCAB_ID is not found, then the RXCUI has not been replaced.
If the EVD_EXT_VOCAB_ID is found, then at least one ultimate replacement RXCUI value is
available.

EVD_EXT_VOCAB_ID EVD_EXT_ULT_REP_VOCAB_ID

1000560 1013034

In this example, RXCUI 1000560 is found in the REVDUR0_RXCUI_ULT_REPL table and an ultimate
replacement RXCUI value of 1013034 is available.

2. Use the retrieved RXCUI(s) in the EVD External Ultimate Replacement Vocabulary Identifier (
EVD_EXT_ULT_REP_VOCAB_ID) field to continue with your application.

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Clinical Screening Interoperability Applications

Finding Tall Man Descriptions for FDB Concepts Retrieved from RxNorm Vocabulary Identifiers

Using a Tall Man Description in a Continuity of Care Document (CCD)

Finding Additional Synonyms for an RxNorm Semantic Branded Drug (SBD)

Retrieving FDB Concepts for a Given Externally Reported RxNorm-based Medication Concept

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Finding Tall Man Descriptions for FDB Concepts Retrieved from RxNorm Vocabulary Identifiers
This application illustrates how to navigate to the Tall Man lettering descriptions for the National Drug Code (NDC
), MED Medication ID (MEDID), and Medication Name Identifier (MED_NAME_ID) concepts retrieved from
RxNorm Vocabulary Identifiers.

Tall Man descriptions are not available for the Clinical Formulation ID ( GCN_SEQNO) and Hierarchical
Ingredient Code Sequence Number (HIC_SEQN) identifiers.

1. Select the EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) values from the External Vocabulary
Link Table (REVDEL0_EXT_VOCAB_LINK) where the following:
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) equals the type of FDB
vocabulary identifier you wish to retrieve.
EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) column equals the input RXCUI value.
If the EVD_FDB_VOCAB_TYPE_ID value returned in the previous step equals 100 (indicating NDC),
select the MEDID value from the MED NDC to Medication ID Cross-Reference Table
(RMINDC1_NDC_MEDID) where the NDC column equals the NDC value returned above.

2. For your MED concept, do one of the following:

Select the TM Altered Medication Description (TM_ALT_MEDID_DESC) value from the Tall Man
Medication ID Table (RTMMID1_TM_MED) where the MEDID column equals the MEDID value
retrieved in step 1.
Select the TM Altered Medication Name Description (TM_ALT_MED_NAME_DESC) value from the
Tall Man Medication Name Table (RTMNMID1_TM_MED_NAME) where the MED_NAME_ID
column equals the MED_NAME_ID value from step 1.

ExampleFinding the Tall Man Description for NDCs Retrieved from an RxNorm Vocabulary Identifier

For the purposes of demonstrating this application, the following scenario is used: A patient enters the
hospital for a pre-scheduled surgery. Prior to the surgery, the hospital receives the patients medication
information within a Continuity of Care Document (CCD) from the physician, whose office utilizes RXCUIs. The
hospital that is sent the CCD has a system that uses MedKnowledge, and they need to relate the RXCUIs in the
CCD to National Drug Code (NDC) identifiers. For printing and displaying the medication information, the hospital
wants to use Tall Man lettering, when available.

In this example, the CCD states that the patient currently takes Omeprazole 20 mg Enteric Coated Tablet
[Prilosec] (RXCUI = 608796) once daily.

1. Select the EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) values from the External Vocabulary
Link Table (REVDEL0_EXT_VOCAB_LINK) where the following:
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) column equals 100 (indicating
NDC).
EVD_EXT_VOCAB_ID column equals the input RXCUI value.

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EVD_EXT_VOCAB_ID EVD_EXT_VOCAB_DES EVD_FDB_VOCAB_TYP EVD_FDB_VOCAB_ID

C E_ID

608796 Omeprazole 20 MG 100 37000045502

Enteric Coated Tablet
[Prilosec]

608796 Omeprazole 20 MG 100 37000045503

Enteric Coated Tablet
[Prilosec]

608796 Omeprazole 20 MG 100 37000045504

Enteric Coated Tablet
[Prilosec]

608796 Omeprazole 20 MG 100 37000045505

Enteric Coated Tablet
[Prilosec]

608796 Omeprazole 20 MG 100 49999078714

Enteric Coated Tablet
[Prilosec]

608796 Omeprazole 20 MG 100 54868530900

Enteric Coated Tablet
[Prilosec]

In this example, the hospital system compares the retrieved list of NDCs to their formulary and selects the
NDCs that appear. The system then selects the preferred NDC value of 37000045502.

Use the External Vocabulary Description Table (REVDEV0_EXT_VOCAB_DESC) to retrieve the

EVD_EXT_VOCAB_DESC value.

2. Select the MEDID value from the MED NDC to Medication ID Cross-Reference Table
(RMINDC1_NDC_MEDID) where the NDC column equals the NDC value returned in the previous step.

NDC MEDID MED_MEDID_DESC

37000045502 451488 Prilosec OTC 20 mg Tab

The MED_MEDID_DESC was retrieved from the MED Medication Table (RMIID1_MED) and is
used here for illustrative purposes.

3. Depending on your MED concept, do one of the following:

Select the TM Altered Medication Description (TM_ALT_MEDID_DESC) value from the Tall Man
Medication ID Table (RTMMID1_TM_MED) where the MEDID column equals the MEDID value
retrieved in step 2.
Select the TM Altered Medication Name Description (TM_ALT_MED_NAME_DESC) value from the
Tall Man Medication Name Table (RTMNMID1_TM_MED_NAME) where the MED_NAME_ID

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column equals the MED_NAME_ID value from step 1.

In this example, the retrieved value is a MEDID. Therefore, the RTMMID0_TM_MED table is used.

MEDID TM_ALT_MEDID_DESC

451488 PriLOSEC OTC 20 mg Tab

ExampleRetrieving the Tall Man Text for MEDIDs Retrieved from an RxNorm Vocabulary Identifier

For the purposes of demonstrating this application, the following scenario is used: A patients Personal
Health Record (PHR) identifying an allergy to Zidovudine 300 mg Oral Tablet (RXCUI = 199663) is available. The
allergy information needs to be transferred to a Physician Management System using FDBs MED Medication
Identifier (MEDID), and the system will use the associated Tall Man lettering descriptions, when available.

1. Select the EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) values from the External Vocabulary
Link Table (REVDEL0_EXT_VOCAB_LINK) where the following:
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) column equals 3 (indicating
MEDID).
EVD_EXT_VOCAB_ID column equals the input RXCUI value.

EVD_EXT_VOCAB_ID EVD_EXT_VOCAB_DES EVD_FDB_VOCAB_TYP EVD_FDB_VOCAB_ID

C E_ID

199663 Zidovudine 300 MG Oral 3 254026

Tablet

2. Select the TM Altered Medication Description (TM_ALT_MEDID_DESC) value from the Tall Man
Medication ID Table (RTMMID1_TM_MED) where the MEDID column equals the MEDID value retrieved in
step 1.

MEDID TM_ALT_MEDID_DESC

254026 zidovuDINE 300 mg Tab

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Using a Tall Man Description in a Continuity of Care Document-CCD

This application illustrates how to use a Tall Man description in a Continuity of Care Document (CCD). This
application can only be performed for the following FDB identifiers:

National Drug Code (NDC)

MED Medication Identifier (MEDID)
Medication Name Identifier (MED_NAME_ID)

If you are beginning with a National Drug Code (NDC), retrieve the associated MED Medication Identifier
(MEDID) from the MED NDC to Medication ID Cross-Reference Table (RMINDC1_NDC_MEDID).

1. Retrieve the Tall Man description using either the MED Medication Identifier ( MEDID) or the Med Name
Identifier (MED_NAME_ID).
If you are using the MEDID, select the Tall Man Altered Medication Description (
TM_ALT_MEDID_DESC) from the Tall Man Medication ID Table (RTMMID1_TM_MED).
If you are using the MED_NAME_ID, select the Tall Man Altered Medication Name Description (
TM_ALT_MED_NAME_DESC) from the Tall Man Medication Name Table
(RTMNMID1_TM_MED_NAME).

2. Retrieve the RXCUI for the given FDB concept. Please reference the Retrieving External Vocabulary
Identifiers for a Given FDB Concept application for more information on completing this step.

3. Compile the following information retrieved above:

FDB identifier (NDC, MEDID, or MED_NAME_ID)
Tall Man description
EVD FDB Vocabulary Identifier (EVD_EXT_VOCAB_ID)

4. Include the values from Step 3 in the outgoing Continuity of Care Document (CCD).

ExampleUsing a MEDIDs Tall Man Description in a Continuity of Care Document (CCD)

For the purposes of demonstrating this application, the following scenario is used: A patients Personal
Health Record (PHR) lists the patient medication history of Zyprexa 10 mg Tab (MEDID = 174836). The
medication history information needs to be included in the patients Continuity of Care Document (CCD), and the
system will use Tall Man lettering for the medication if available.

1. Retrieve the Tall Man Altered Medication Description (TM_ALT_MEDID_DESC) from the Tall Man
Medication ID Table (RTMMID1_TM_MED) where the MED Medication Identifier (MEDID) equals 174836
for Zyprexa 10 mg Tab.

MEDID TM_ALT_MEDID_DESC

174836 ZyPREXA 10 mg Tab

2. Retrieve the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) and the EVD External

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2.

Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) values from the External Vocabulary Link Table
(REVDEL0_EXT_VOCAB_LINK) where the EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID)
column equals the MED Medication Identifier (MEDID) value (174836) and the EVD FDB Vocabulary Type
Identifier (EVD_FDB_VOCAB_TYPE_ID) column equals 3 (indicating MEDID).

EVD_FDB_VOCAB_ID EVD_FDB_VOCAB_TYP EVD_EXT_VOCAB_ID EVD_EXT_VOCAB_TYP

E_ID E_ID

174836 3 153048 502

174836 3 314154 501

3. The system selects the branded EVD External Vocabulary Description (EVD_EXT_VOCAB_DESC) value
from the External Vocabulary Description Table (REVDEV0_EXT_VOCAB_DESC) based on the fact that
this MEDID is a branded MEDID value.

EVD_EXT_VOCAB_ID EVD_EXT_VOCAB_TYPE_ID EVD_EXT_VOCAB_DESC

153048 502 olanzapine 10 MG Oral Tablet

[Zyprexa]

4. Compile the following information retrieved above:

FDB identifier (MEDID)
Tall Man description
EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID)in this case an RXCUI.

MEDID EVD_EXT_VOCAB_ID TM_ALT_MEDID_DESC

174836 153048 ZyPREXA 10 mg Tab

Note that in the Tall Man description above, ZyPREXA replaced Zyprexa.

5. Include the values from Step 4 in the outgoing Continuity of Care Document (CCD).

ExampleUsing a MED_NAME_IDs Tall Man Description on a Continuity of Care Document (CCD)

For the purposes of demonstrating this application, the following scenario is used: A patients Personal
Health Record (PHR) lists the patients allergy to Zyprexa (MED_NAME_ID = 1684). Allergy history information
needs to be included in the patients Continuity of Care Document (CCD), and the system will use Tall Man
lettering for the medication if available.

1. Retrieve the Tall Man Altered Medication Name Description ( TM_ALT_MED_NAME_DESC) from the Tall
Man Medication Name Table (RTMNMID1_TM_MED_NAME) where the Medication Name Identifier (
MED_NAME_ID) equals 1684 (Zyprexa).

MED_NAME_ID TM_ALT_MED_NAME_DESC

ZyPREXA

2. Retrieve the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) and the EVD External

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2.
Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) values from the External Vocabulary Link Table
(REVDEL0_EXT_VOCAB_LINK) where the EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID)
column equals the MED Medication Identifier (MEDID) value (174836) and the EVD FDB Vocabulary Type
Identifier (EVD_FDB_VOCAB_TYPE_ID) column equals 1 (indicating MED_NAME_ID).

EVD_FDB_VOCAB_ID EVD_FDB_VOCAB_TYP EVD_EXT_VOCAB_ID EVD_EXT_VOCAB_TYP

E_ID E_ID

1684 1 135423 505

3. Compile the following information retrieved above:

FDB identifier (MED_NAME_ID)
Tall Man description
EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID), in this case an RXCUI

MED_NAME_ID EVD_EXT_VOCAB_ID TM_ALT_MED_NAME_DESC

1684 135423 ZyPREXA

Note that in the Tall Man description above, ZyPREXA replaced Zyprexa.

4. Include these values in the outgoing Continuity of Care Document (CCD).

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Finding Additional Synonyms for an RxNorm Semantic Branded Drug-SBD

The default description for a Semantic Branded Drug (SBD) in RxNorm features the brand name in brackets at
the end of the text description string. This application explains how to find a synonym for an SBD that features the
brand name at the beginning of the text description.

1. Retrieve the RxNorm Concept Source Key (EVD_RXN_CONCEPT_SOURCE_KEY) from the RxNorm
Concept Source Table (REVDCS0_RXN_CONCEPT_SOURCE) where the:
RxNorm RXCUI (EVD_RXN_RXCUI) equals the EVD External Vocabulary Identifier (
EVD_EXT_VOCAB_ID) value of the concept for which you need a synonym,
External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) equals 502 (SBD), and
RxNorm Term Type (EVD_RXN_TTY) equals SY (designated synonym).

2. Present the results of the previous step to the end user.

While this application works when there is a one-to-one relationship between an SBD and a
synonym, some SBDs have many associated synonyms. If preferred, limit the results
programmatically to produce only one synonym.

ExampleFinding Additional Synonyms for a Given SBD

For purposes of demonstrating this application, the following scenario is used: A developer would like to
provide the ability to sort strings for RXCUIs that represent SBDs using the brand name. However, brand names
appear in brackets at the end of each string and it would be easier to display the strings with the brand name
unbracketed at the beginning of the string, substituting the generic name at the beginning of the string for the
brand name. This example uses RXCUI 211394 for the SBD choline salicylate 174 MG/ML Oral Solution
[Arthropan].

1. Retrieve the RxNorm Concept Source Key (EVD_RXN_CONCEPT_SOURCE_KEY) from the RxNorm
Concept Source Table (REVDCS0_RXN_CONCEPT_SOURCE) where the:
RxNorm RXCUI (EVD_RXN_RXCUI) equals the EVD External Vocabulary Identifier (
EVD_EXT_VOCAB_ID) value of 211394,
External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) equals 502 (SBD),
RxNorm Source Abbreviation (EVD_RXN_SAB) equals RXNORM, and
RxNorm Term Type (EVD_RXN_TTY) equals SY (designated synonym).

EVD_RXN_RXCUI EVD_RXN_TTY EVD_RXN_STR

211394 SY Arthropan 174 MG/ML Oral Solution

2. Present the result of the previous step to the end user. In this example, there is only one synonym
available; therefore, no sorting is necessary.

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Retrieving FDB Concepts for a Given Externally Reported RxNorm-based Medication Concept
This application illustrates how to process externally reported lists of RxNorm-based medications when the
desired outcome is to:

Execute FDB-based decision support for reported RxNorm concepts (such as drug-drug interaction
checking and allergy checking).
Reconcile reported RxNorm medications with an FDB-based active medication list.
Compare a list of FDB-based medications to membership within defined eMeasure (Clinical Quality
Measure) value sets.
Implement FDB-based prescribing or order entry reminders to enforce adherence to eMeasure guidelines.

If the desired FDB translation targets are FDB clinical drugs (such as the MEDID or Clinical Formulation ID
[GCN_SEQNO]), complete the following steps to translate external lists of RxNorm-based medications to FDB
clinical drug concepts using the RxNorm to FDB Clinical Screening Link Table (RIMKCS0_RXN_FDB_CS_LNK):

1. Validate that the external list of medications spans the RxNorm vocabulary. (The HL7 Object Identifier [
HL7_OID] value for the code or value set equals 2.16.840.1.113883.6.88 [NLM RxNorm]).

2. Retrieve associated FDB concepts that span the RxNorm RXCUI value, filtering returned values to those
that span either an FDB MEDID (EVD_FDB_VOCAB_TYPE_ID = 3) or Clinical Formulation ID
(EVD_FDB_VOCAB_TYPE_ID = 6 [GCN_SEQNO]).

a. If the RxNorm RXCUI does not span an FDB MEDID or Clinical Formulation ID, retrieve its FDB
Routed Generic ID (ROUTED_GEN_ID), if available (EVD_FDB_VOCAB_TYPE_ID = 5).

b. If the RxNorm RXCUI does not span a Routed Generic ID, fetch its FDB Ingredient(s), if available
(EVD_FDB_VOCAB_TYPE_ID = 104 [HIC_SEQN]).

c. Further exception handling:

Use the RxNorm to FDB Clinical Screening Exception Table
(RIMKCSE0_RXN_FDB_CS_EXCEPT) when the IMK Partial Indicator (IMK_PARTIAL_IND)
equals 1 to check whether the RXCUI has partial ingredient links to an FDB concept.
Use the RXCUI Ultimate Replacement Table (REVDUR0_RXCUI_ULT_REPL) to check
whether the RXCUI has been replaced. See Retrieving a Replaced RXCUIs Replacement
Value for more information.

3. Depending upon the application supportedmedication reconciliation, clinical quality measure reporting,
decision support, or the presentation of medication ordering reminderscompare the collection of
retrieved FDB concepts for associated external RxNorm medications to a separate list of FDB concepts.

Medication Reconciliation

For medication reconciliation, MEDID and Clinical Formulation ID relationships to Routed Generic ID and
Ingredients may be used to present "partial matches." For example, the patient may have previously been listed
with an active medication of Lipitor 20 mg Tablet. An externally reported medication of Atorvastatin 40 mg Tablet
with a more recent hospital discharge date than the posting of the EHR record for the Lipitor could be matched to

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the Lipitor record. It could be suggested to "supersede" the previous EHR record because both the RxNorm
Atorvastatin 40 mg Tablet and the FDB Lipitor 20 mg Tablet span the same ingredient and route of administration
(Routed Generic ID 1060980 "ATORVASTATIN CALCIUM ORAL").

For medication reconciliation applications, the "Preferred Indicator" value of 1(Preferred) represents a default
FDB clinical drug that may be used to append a new medication entry within the patient's medication list if no
match is found.

The following diagram illustrates some of the types of matching that may occur between an externally reported
RxNorm medication and an FDB clinical drug concept.

Decision Support

For decision support purposes, either the Clinical Formulation ID value or the Routed Generic Identifier is the
primary translation target for performing FDB-based screening. The Routed Generic ID serves as an alternative
for RxNorm concepts without a clinical drug cross-reference. Links to ingredient may be used directly for allergy
screening.

Clinical Quality Measures

For prescribing or order entry reminders from clinical quality measures, links to the FDB MEDID or Clinical

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Formulation ID may be used to present candidate drugs for prescribing. For example, a list of statin medications
may be presented at the time of hospital discharge for a patient with acute myocardial infarction. Similarly, links
from the FDB MedID or Clinical Formulation ID to inpatient "orderable medications" (such as FDB Routed
Medication ID, FDB Routed Dosage Form ID, FDB OrderKnowledge Orderable Medication ID) may be used to
present candidate orders.

Use this application when an electronic submission is received that includes an interoperable concept identifier,
interoperable concept description, and an HL7 Object Identifier (OID).

1. Validate that the external list of medications spans the RxNorm vocabulary. (The HL7 Object Identifier [
HL7_OID] value for the code or value set equals 2.16.840.1.113883.6.88 [NLM RxNorm]).

2. Retrieve the following values from the RxNorm to FDB Clinical Screening Link Table
(RIMKCS0_RXN_FDB_CS_LNK):
IMK FDB Vocabulary Identifier (IMK_FDB_VOCAB_NO_ID)
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID)
RxNorm RXCUI Description (EVD_RXN_RXCUI_DESC)
IMK FDB Vocabulary Description (IMK_FDB_VOCAB_DESC)
IMK Preferred Indicator (IMK_PREFERRED_IND)
where the RxNorm RXCUI (EVD_RXN_RXCUI) value equals the value of the given RxNorm-based
medication concept and the EVD External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID)
equals the value for the Term Type of the RXCUI, as follows:
501 (Semantic Clinical Drug [SCD])
502 (Semantic Branded Drug [SBD])
503 (Generic Pack [GPCK])
504 (Branded Pack [BPCK])
507 (Semantic Clinical Drug Form [SCDF])
511 (Semantic Branded Drug Form [SBDF])
513 (Semantic Clinical Dose Form Group [SCDG])
514 (Semantic Branded Dose Form Group [SBDG])

3. If more than one row is returned from the previous step, retrieve the record where the EVD FDB
Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) equals 3 (MEDID) or 6 (GCN_SEQNO).

a. If the RxNorm RXCUI does not span an FDB MEDID or Clinical Formulation ID ( GCN_SEQNO),
retrieve the active record where the EVD_FDB_VOCAB_TYPE_ID equals 5 (ROUTED_GEN_ID), if
available.

b. If the RxNorm RXCUI does not span a Routed Generic ID, retrieve the active record where the
EVD_FDB_VOCAB_TYPE_ID equals 104 (HIC_SEQN), if available.

c. For further exception handling:

Use the RxNorm to FDB Clinical Screening Exception Table
(RIMKCSE0_RXN_FDB_CS_EXCEPT) when the IMK Partial Indicator (IMK_PARTIAL_IND)

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equals 1 to check whether the RXCUI has partial ingredient links to an FDB concept.
Use the RXCUI Ultimate Replacement Table (REVDUR0_RXCUI_ULT_REPL) to check
whether the RXCUI has been replaced. See Retrieving a Replaced RXCUIs Replacement
Value for more information.

If there is no direct link to an FDB MEDID for the given RxNorm-based medication concept,
retrieve the Routed Generic Description associated to the MEDID Description via the Clinical
Formulation ID that is associated to the FDB MEDID.

a. Retrieve the Clinical Formulation ID (GCN_SEQNO) from the MED GCN_SEQNO to

Medication ID Cross-Reference Table (RMIGC1_MEDID_GCNSEQNO_LINK) for the given
Medication ID (MEDID).

b. Retrieve the Routed Generic ID (ROUTED_GEN_ID) and Routed Generic Description (

ROUTED_GEN_DESC) from the Routed Generic Clinical Formulation Identifier Link Table
(RRTGNGC0_RTD_GEN_GCNSEQNO_LNK).

If there no Routed Generic Identifier is available, retrieve the ingredient(s) ( HIC_SEQN) for the
FDB MEDID via the Clinical Formulation ID that is associated to it.

Multiple scenarios for this application are presented in the following examples:

ExampleMedication Reconciliation Integration of an Externally Reported Medication

Scenario 1Externally Reported Semantic Branded Drug (SBD) Matches Active Brand MEDID in
Patient Profile
Scenario 2Externally Reported Semantic Clinical Drug (SCD) Matches Active Brand MEDID in
Patient Profile
Scenario 3Externally Reported Semantic Clinical Drug (SCD) Received and No Active
Medications Exist in Patient Profile
Scenario 4Externally Reported Semantic Clinical Drug (SCD) Received and has Different
Strength than Medication in Patient Profile
Scenario 5Externally Reported Semantic Clinical Drug (SCD) Received Contains Additional
Ingredient(s) as Compared to Ingredients for Medication in Patient Profile
ExampleComparison of FDB Medication to Clinical Quality Measure Value Set
ExampleComparing FDB Medication Allergens to Clinical Quality Measure Value Sets
ScenarioComparison of FDB Medication Allergen to Clinical Quality Measure Value Set for
Allergy or Intolerance
ExampleImplementation of Clinical Quality Measure Medication Reminders
ExampleImplementation of FDB Decision Support for RxNorm Concepts
Scenario 1Consumer Web Portal Enabled Selection of Patient Medications for Drug-Drug
Interaction Screening

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Scenario 2Consumer Web Portal Enabled Selection of Medications for Allergy Screening

ExampleMedication Reconciliation Integration of an Externally Reported Medication

For purposes of demonstrating this application, the following scenarios are used:

Scenario 1Externally Reported Semantic Branded Drug (SBD) Matches Active Brand MEDID in Patient
Profile
Scenario 2Externally Reported Semantic Clinical Drug (SCD) Matches Active Brand MEDID in Patient
Profile
Scenario 3Externally Reported Semantic Clinical Drug (SCD) Received and No Active Medications Exist
in Patient Profile
Scenario 4Externally Reported Semantic Clinical Drug (SCD) Received and has Different Strength than
Medication in Patient Profile
Scenario 5Externally Reported Semantic Clinical Drug (SCD) Received Contains Additional Ingredient(s)
as Compared to Ingredients for Medication in Patient Profile

Scenario 1Externally Reported Semantic Branded Drug (SBD) Matches Active Brand MEDID in Patient Profile

The active medication on the patients profile is MEDID 209964 (Lipitor 20 mg tablet) and the externally reported
medication is RXCUI 617318 (Lipitor 20 MG Oral Tablet). It has been validated that the external list of
medications spans the RxNorm vocabulary.

1. Retrieve the following values from the RxNorm to FDB Clinical Screening Link Table
(RIMKCS0_RXN_FDB_CS_LNK):
IMK FDB Vocabulary Identifier (IMK_FDB_VOCAB_NO_ID)
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID)
RxNorm RXCUI Description (EVD_RXN_RXCUI_DESC)
IMK FDB Vocabulary Description (IMK_FDB_VOCAB_DESC)
IMK Preferred Indicator (IMK_PREFERRED_IND)

where the RxNorm RXCUI (EVD_RXN_RXCUI) value equals 617318 and the EVD External Vocabulary
Type Identifier (EVD_EXT_VOCAB_TYPE_ID) equals 502 (Semantic Branded Drug [SBD]).

EVD_RXN_RXC EVD_EXT_VOC IMK_FDB_VOC EVD_FDB_VOC IMK_FDB_VOC IMK_PREFERR

UI AB_TYPE_ID AB_NO_ID AB_TYPE_ID AB_DESC ED_IND

617318 502 29968 6 atorvastatin 1

calcium 20 mg
Oral Tablet

617318 502 163181 3 atorvastatin 20 0

mg tablet

617318 502 209964 3 Lipitor 20 mg 1

tablet

617318 502 1060980 5 ATORVASTATIN 0

CALCIUM ORAL

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617318 502 6321 104 atorvastatin 0

2. If more than one row is returned from the previous step, retrieve the record where the EVD FDB
Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) equals 3 (MEDID) or 6 (GCN_SEQNO).
In this scenario, the externally reported RXCUI 617318 matches the active medication entry for FDB
MEDID 209964. The external medication record is merged within the user interface with the active record
for Lipitor 20 mg tablet.

EVD_RXN_RXC EVD_EXT_VOC IMK_FDB_VOC EVD_FDB_VOC IMK_FDB_VOC IMK_PREFERR

UI AB_TYPE_ID AB_NO_ID AB_TYPE_ID AB_DESC ED_IND

617318 502 209964 3 Lipitor 20 mg 1

tablet

Scenario 2Externally Reported Semantic Clinical Drug (SCD) Matches Active Brand MEDID in Patient Profile

The active medication on the patients profile is MEDID 209964 (Lipitor 20 mg tablet) and the externally reported
medication is RXCUI 617310 (atorvastatin 20 MG Oral Tablet). It has been validated that the external list of
medications spans the RxNorm vocabulary.

1. Retrieve the following values from the RxNorm to FDB Clinical Screening Link Table
(RIMKCS0_RXN_FDB_CS_LNK):
IMK FDB Vocabulary Identifier (IMK_FDB_VOCAB_NO_ID)
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID)
RxNorm RXCUI Description (EVD_RXN_RXCUI_DESC)
IMK FDB Vocabulary Description (IMK_FDB_VOCAB_DESC)
IMK Preferred Indicator (IMK_PREFERRED_IND)

where the RxNorm RXCUI (EVD_RXN_RXCUI) value equals 617310 and the EVD External Vocabulary
Type Identifier (EVD_EXT_VOCAB_TYPE_ID) equals 501 (Semantic Clinical Drug [SCD]).

EVD_RXN_RXC EVD_EXT_VOC IMK_FDB_VOC EVD_FDB_VOC IMK_FDB_VOC IMK_PREFERR

UI AB_TYPE_ID AB_NO_ID AB_TYPE_ID AB_DESC ED_IND

617310 501 29968 6 atorvastatin 1

calcium 20 mg
Oral Tablet

617310 501 209964 3 Lipitor 20 mg 0

tablet

617310 501 163181 3 atorvastatin 20 1

mg tablet

617310 501 1060980 5 ATORVASTATIN 0

CALCIUM ORAL

617310 501 6321 104 atorvastatin 0

2. If more than one row is returned from the previous step, retrieve the record where the EVD FDB

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2.

Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) equals 3 (MEDID) or 6 (GCN_SEQNO).

In this scenario, the externally reported RXCUI 617310 matches the active medication entry for FDB
MEDID 209964. The external medication record is merged within the user interface with the active record
for Lipitor 20 mg tablet.

EVD_RXN_RXC EVD_EXT_VOC IMK_FDB_VOC EVD_FDB_VOC IMK_FDB_VOC IMK_PREFERR

UI AB_TYPE_ID AB_NO_ID AB_TYPE_ID AB_DESC ED_IND

617310 502 209964 3 Lipitor 20 mg 0

tablet

Scenario 3Externally Reported Semantic Clinical Drug (SCD) Received and No Active Medications Exist in Patient
Profile

There are no active medications on the patients profile but an externally reported medication, RXCUI 617310
(atorvastatin 20 MG Oral Tablet), is received. It has been validated that the external list of medications spans the
RxNorm vocabulary.

1. Retrieve the following values from the RxNorm to FDB Clinical Screening Link Table
(RIMKCS0_RXN_FDB_CS_LNK):
IMK FDB Vocabulary Identifier (IMK_FDB_VOCAB_NO_ID)
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID)
RxNorm RXCUI Description (EVD_RXN_RXCUI_DESC)
IMK FDB Vocabulary Description (IMK_FDB_VOCAB_DESC)
IMK Preferred Indicator (IMK_PREFERRED_IND)

where the RxNorm RXCUI (EVD_RXN_RXCUI) value equals 617310 and the EVD External Vocabulary
Type Identifier (EVD_EXT_VOCAB_TYPE_ID) equals 501 (Semantic Clinical Drug [SCD]).

EVD_RXN_RXC EVD_EXT_VOC IMK_FDB_VOC EVD_FDB_VOC IMK_FDB_VOC IMK_PREFERR

UI AB_TYPE_ID AB_NO_ID AB_TYPE_ID AB_DESC ED_IND

617310 501 29968 6 atorvastatin 1

calcium 20 mg
Oral Tablet

617310 501 209964 3 Lipitor 20 mg 0

tablet

617310 501 163181 3 atorvastatin 20 1

mg tablet

617310 501 1060980 5 ATORVASTATIN 0

CALCIUM ORAL

617310 501 6321 104 atorvastatin 0

2. If more than one row is returned from the previous step, retrieve the record where the EVD FDB
Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) equals 3 (MEDID) or 6 (GCN_SEQNO).

In this scenario, no direct matches are found for the FDB MEDID because there was no active medication

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on the patients profile. Present the candidate link (FDB MEDID with IMK_PREFERRED_IND value of 1) to
the end user.

EVD_RXN_RXC EVD_EXT_VOC IMK_FDB_VOC EVD_FDB_VOC IMK_FDB_VOC IMK_PREFERR

UI AB_TYPE_ID AB_NO_ID AB_TYPE_ID AB_DESC ED_IND

617310 501 163181 3 atorvastatin 20 1

mg tablet

Scenario 4Externally Reported Semantic Clinical Drug (SCD) Received and has Different Strength than Medication
in Patient Profile

The active medication on the patients profile is MEDID 286939 (Lipitor 10 mg tablet) and the externally reported
medication is RXCUI 617310 (atorvastatin 20 MG Oral Tablet). It has been validated that the external list of
medications spans the RxNorm vocabulary.

1. Retrieve the following values from the RxNorm to FDB Clinical Screening Link Table
(RIMKCS0_RXN_FDB_CS_LNK):
IMK FDB Vocabulary Identifier (IMK_FDB_VOCAB_NO_ID)
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID)
RxNorm RXCUI Description (EVD_RXN_RXCUI_DESC)
IMK FDB Vocabulary Description (IMK_FDB_VOCAB_DESC)
IMK Preferred Indicator (IMK_PREFERRED_IND)

where the RxNorm RXCUI (EVD_RXN_RXCUI) value equals 617310 and the EVD External Vocabulary
Type Identifier (EVD_EXT_VOCAB_TYPE_ID) equals 501 (Semantic Clinical Drug [SCD]).

EVD_RXN_RXC EVD_EXT_VOC IMK_FDB_VOC EVD_FDB_VOC IMK_FDB_VOC IMK_PREFERR

UI AB_TYPE_ID AB_NO_ID AB_TYPE_ID AB_DESC ED_IND

617310 501 29968 6 atorvastatin 1

calcium 20 mg
Oral Tablet

617310 501 209964 3 Lipitor 20 mg 0

tablet

617310 501 163181 3 atorvastatin 20 1

mg tablet

617310 501 1060980 5 ATORVASTATIN 0

CALCIUM ORAL

617310 501 6321 104 atorvastatin 0

2. If more than one row is returned from the previous step, retrieve the record where the EVD FDB
Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) equals 3 (MEDID) or 6 (GCN_SEQNO).
If the RxNorm RXCUI does not span an FDB MEDID or Clinical Formulation ID (GCN_SEQNO),
retrieve the active record where the EVD_FDB_VOCAB_TYPE_ID equals 5 (ROUTED_GEN_ID), if
available.

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In this scenario, no direct matches are found for the FDB MEDID, so the Routed Generic Description is
retrieved.

EVD_RXN_RXC EVD_EXT_VOC IMK_FDB_VOC EVD_FDB_VOC IMK_FDB_VOC IMK_PREFERR

UI AB_TYPE_ID AB_NO_ID AB_TYPE_ID AB_DESC ED_IND

617310 501 1060980 5 ATORVASTATIN 0

CALCIUM ORAL

Routed Generic ID links for RXCUI 617310 are compared to Routed Generic ID links for MEDID 286939.
Routed Generic ID 1060980 ATORVASTATIN CALCIUM ORAL spans both concepts, so the user interface
may link the externally reported 20 mg Atorvastatin entry to the active medication list entry for 10 mg for
clinician review.
If the clinician elects to discontinue the previous Lipitor 10 mg tablet entry and promote atorvastatin 20 MG
Oral Tablet as an active medication, FDB MEDID 163181 (atorvastatin 20 mg tablet) may be presented
because it has a IMK Preferred Indicator (IMK_PREFERRED_IND) value of 1.

Scenario 5Externally Reported Semantic Clinical Drug (SCD) Received Contains Additional Ingredient(s) as
Compared to Ingredients for Medication in Patient Profile

The active medication on the patients profile is MEDID 286939 (Lipitor 10 mg tablet) and the externally reported
medication is RXCUI 597980 (Amlodipine 5 MG / atorvastatin 20 MG Oral Tablet). It has been validated that the
external list of medications spans the RxNorm vocabulary.

1. Retrieve the following values from the RxNorm to FDB Clinical Screening Link Table
(RIMKCS0_RXN_FDB_CS_LNK):
IMK FDB Vocabulary Identifier (IMK_FDB_VOCAB_NO_ID)
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID)
RxNorm RXCUI Description (EVD_RXN_RXCUI_DESC)
IMK FDB Vocabulary Description (IMK_FDB_VOCAB_DESC)
IMK Preferred Indicator (IMK_PREFERRED_IND)

where the RxNorm RXCUI (EVD_RXN_RXCUI) value equals 597980 and the EVD External Vocabulary
Type Identifier (EVD_EXT_VOCAB_TYPE_ID) equals 501 (Semantic Clinical Drug [SCD]).

EVD_RXN_RXC EVD_EXT_VOC IMK_FDB_VOC EVD_FDB_VOC IMK_FDB_VOC IMK_PREFERR

UI AB_TYPE_ID AB_NO_ID AB_TYPE_ID AB_DESC ED_IND

597980 501 53690 6 amlodipine/atorv 1

astatin 5 mg-20
mg Oral Tablet

597980 501 454460 3 amlodipine-atorv 1

astatin 5 mg-20
mg tablet

597980 501 467348 3 Caduet 5 mg-20 0

mg tablet

597980 501 6321 104 atorvastatin 0

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597980 501 3672 104 amlodipine 0

597980 501 1074527 5 AMLODIPINE 0

BESYLATE/ATO
RVASTATIN
CALCIUM ORAL

2. If more than one row is returned from the previous step, retrieve the record where the EVD FDB
Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) equals 3 (MEDID) or 6 (GCN_SEQNO).

a. If the RxNorm RXCUI does not span an FDB MEDID or Clinical Formulation ID (GCN_SEQNO),
retrieve the active record where the EVD_FDB_VOCAB_TYPE_ID equals 5 (ROUTED_GEN_ID), if
available.

b. If the RxNorm RXCUI does not span a Routed Generic ID, retrieve the active record where the
EVD_FDB_VOCAB_TYPE_ID equals 104 (HIC_SEQN), if available.

In this scenario, no direct matches are found for the FDB MEDID or the Routed Generic ID, so the
ingredient is retrieved.

EVD_RXN_RXC EVD_EXT_VOC IMK_FDB_VOC EVD_FDB_VOC IMK_FDB_VOC IMK_PREFERR

UI AB_TYPE_ID AB_NO_ID AB_TYPE_ID AB_DESC ED_IND

597980 501 6321 104 atorvastatin 0

The ingredient atorvastatin (HIC_SEQN 6321) for the FDB formulation matches an FDB ingredient linked
to RXCUI 597980. The externally reported Amlodipine 5 MG / atorvastatin 20 MG Oral Tablet may be
presented within the user interface as related to the patient's Lipitor 10 mg tablet entry for clinician
review.

Alternatively, if the clinician elects to discontinue the previous Lipitor 10 mg table entry and use Amlodipine
5 MG / atorvastatin 20 MG Oral Tablet as an active medication, FDB MEDID 454460
(amlodipine-atorvastatin 5 mg-20 mg tablet) may be presented, because it has a IMK Preferred Indicator (
IMK_PREFERRED_IND) value of 1.

ExampleComparison of FDB Medication to Clinical Quality Measure Value Set

For purposes of demonstrating this application, the following scenario is used: A hospital patient has been
discharged with a diagnosis of Acute myocardial infarction of unspecified site, initial episode of care (ICD-9-CM
410.91), which meets the inclusion criteria for eMeasure (NQF 0639) Statin Prescribed at Discharge. The
patient's discharge list of medications includes MEDID 286939 (Lipitor 10 mg tablet), and the list is compared to
the Statin value set for potential matches.

In this scenario, RxNorm-based medications are retrieved for MEDID 286939 using the RxNorm to FDB Clinical
Screening Link Table (RIMKCS0_RXN_FDB_CS_LNK).

IMK_FDB_VOCA EVD_FDB_VOC IMK_FDB_VOCA EVD_RXN_RXC EVD_EXT_VOC EVD_RXN_RXC

B_NO_ID AB_TYPE_ID B_DESC UI AB_TYPE_ID UI_DESC

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286939 3 Lipitor 10 mg 617312 501 atorvastatin 10

tablet MG Oral Tablet

286939 3 Lipitor 10 mg 617314 502 Lipitor 10 MG Oral

tablet Tablet

The value set list of Statin medications that span eMeasure 30 are retrieved from the published National Library
of Medicine (NLM) collection of value sets (Value Set Authority Center [VSAC]), as shown in the sample table
below. These values are available in the USHIK Master Table (RIMKUK0_USHIK_MSTR).

USHIK_MEASU USHIK_VALUE_ USHIK_VALUE_ USHIK_CODE_S USHIK_CONCEP USHIK_CONCEP

RE_IDENTIFIER SET_OID SET_NAME YSTEM T T_DESCRIPTIO
N

30 2.16.840.1.11388 Statins RxNorm RXNORM 617310 atorvastatin 20

3.3.117.1.7.1.824 Value Set MG Oral Tablet

30 2.16.840.1.11388 Statins RxNorm RXNORM 617311 atorvastatin 40

3.3.117.1.7.1.824 Value Set MG Oral Tablet

30 2.16.840.1.11388 Statins RxNorm RXNORM 617312 atorvastatin 10

3.3.117.1.7.1.824 Value Set MG Oral Tablet

30 2.16.840.1.11388 Statins RxNorm RXNORM 259255 atorvastatin 80

3.3.117.1.7.1.824 Value Set MG Oral Tablet

30 2.16.840.1.11388 Statins RxNorm RXNORM 404011 Amlodipine 5 MG /

3.3.117.1.7.1.824 Value Set atorvastatin 80
MG Oral Tablet

In this scenario, FDB MEDID 286939 spans the value set entry for RXCUI 617312 (atorvastatin 10 MG Oral
Tablet); therefore, the patient meets the numerator criteria for the eMeasure.

ExampleComparing FDB Medication Allergens to Clinical Quality Measure Value Sets

eMeasure population criteria may include denominator exclusions (or exceptions) that refer to situations where a
documented patient allergy or intolerance to the recommended medication is present. For example, eMeasure
ID 105 Discharged on Statin Medication (National Quality Forum Number 043) which was updated on April 1,
2013, references the following Denominator Exception.

Denominator Exceptions =
AND:

OR: Medication, Allergy: Statin Allergen starts before or during Occurrence A of Encounter, Performed: Non-Elective
Inpatient Encounter
OR:
OR: Medication, Discharge not done: Patient Refusal for Statin RxNorm Value Set
OR: Medication, Discharge not done: Medical Reason for Statin RxNorm Value Set during Occurrence A of
Encounter, Performed: Non-Elective Inpatient Encounter

Within the Data Criteria section, the Medication, Allergy: Statin Allergen is further specified:

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Medication, Allergy: Statin Allergen using Statin Allergen RxNorm Value Set (2.16.840.1.113883.3.117.1.7.1.423)

Specified medication allergen or intolerance value sets can be programmatically compared to collections of
FDB-based patient medication ingredient and Medication Name ID allergens. Links from FDB Allergen Groups to
FDB Ingredients can be used to further extend value set checking to FDB Specific Allergen Group Codes or FDB
Cross-Sensitive Allergen Group Codes. To make these comparisons:

1. For FDB ingredients and Medication Name ID allergens, retrieve distinct RxNorm values from the External
Allergy to FDB Link Table (RIMKEAF0_EXT_ALG_FDB_VOCAB_LNK).

2. Compare the collection of active patient FDB ingredient and Medication Name ID allergen RxNorm links to
applicable values from the USHIK Master Table (RIMKUK0_USHIK_MSTR). To identify such applicable
values, choose one of the following:

a. To find values that meet the denominator exception criteria for the given eMeasure, select records
in which one-to-many of the patient's active medication allergens span one-to-many of the
referenced FDB USHIK Master Table value set members.

b. To find values that do not meet the denominator exception criteria for the given eMeasure, select
records in which none of the patient's active medication allergens span one-to-many of the
referenced FDB USHIK Master Table value set members.

ScenarioComparison of FDB Medication Allergen to Clinical Quality Measure Value Set for Allergy or Intolerance

For purposes of demonstrating this application, the following scenario is used: A hospitalized Ischemic
Stroke patient meets the initial patient population criteria for the eMeasure ID 105 Discharged on Statin
Medication. The patient's active allergy list includes a reference to the FDB Ingredient 3621 (Simvastatin), and
the entry is compared to the Medication, Allergy: Statin Allergen value set for potential matches.

1. Retrieve the following values from the External Allergy to FDB Link Table
(RIMKEAF0_EXT_ALG_FDB_VOCAB_LNK):
RxNorm RXCUI (EVD_RXN_RXCUI)
EVD External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID)
IMK External Vocabulary Description (IMK_EXT_VOCAB_DESC)

where IMK FDB Vocabulary Identifier (IMK_FDB_VOCAB_NO_ID), EVD FDB Vocabulary Type Identifier (
EVD_FDB_VOCAB_TYPE_ID), and IMK FDB Vocabulary Description (IMK_FDB_VOCAB_DESC) values
correspond to the given FDB ingredients (HIC_SEQN) or Medication Name ID (MED_NAME_ID) allergens.

IMK_FDB_VOCAB_NO_ID
EVD_FDB_VOCAB_TYPE_ID
IMK_FDB_VOCAB_DESC
EVD_RXN_RXCUI EVD_EXT_VOCAB_TYPE_ID
IMK_EXT_VOCAB_DESC

3621 104 simvastatin 36567 500 Simvastatin

In this scenario, one RxNorm-based allergen, RXCUI 36567, is retrieved for FDB Ingredient 3621 using the
External Allergen to FDB Link Table (RIMKEAF0_EXT_ALG_FDB_VOCAB_LNK).

2. Compare the collection of active patient FDB ingredient and Medication Name ID allergen RxNorm links to
applicable values from the FDB USHIK Master Table (RIMKUK0_USHIK_MSTR). To identify such

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2.

applicable values, choose one of the following:

a. To find values that meet the denominator exception criteria for the given eMeasure, select records
in which one-to-many of the patient's active medication allergens span one-to-many of the
referenced RIMKUK0_USHIK_MSTR value set members.

b. To find values that do not meet the denominator exception criteria for the given eMeasure, select
records in which none of the patient's active medication allergens span one-to-many of the
referenced RIMKUK0_USHIK_MSTR value set members.

The value set list of Medication, Allergy: Statin Allergen allergens that span eMeasure 105 are retrieved
from the USHIK Master Table (RIMKUK0_USHIK_MSTR), as shown in the sample table below:

USHIK_MEASU USHIK_VALUE USHIK_VALUE USHIK_CODE_ USHIK_CONCE USHIK_CONCE

RE_IDENTIFIE _SET_OID _SET_NAME SYSTEM PT PT_DESCRIPTI
R ON

105 2.16.840.1.1138 Statin Allergen RXNORM 1189803 Simvastatin /

83.3.117.1.7.1.4 RxNorm Value sitagliptin
23 Set

105 2.16.840.1.1138 Statin Allergen RXNORM 153165 Lipitor

83.3.117.1.7.1.4 RxNorm Value
23 Set

105 2.16.840.1.1138 Statin Allergen RXNORM 196503 Zocor

83.3.117.1.7.1.4 RxNorm Value
23 Set

105 2.16.840.1.1138 Statin Allergen RXNORM 36567 Simvastatin

83.3.117.1.7.1.4 RxNorm Value
23 Set

105 2.16.840.1.1138 Statin Allergen RXNORM 404773 Amlodipine /

83.3.117.1.7.1.4 RxNorm Value atorvastatin
23 Set

105 2.16.840.1.1138 Statin Allergen RXNORM 484211 ezetimibe /

83.3.117.1.7.1.4 RxNorm Value Simvastatin
23 Set

105 2.16.840.1.1138 Statin Allergen RXNORM 803516 Niacin

83.3.117.1.7.1.4 RxNorm Value / Simvastatin
23 Set

105 2.16.840.1.1138 Statin Allergen RXNORM 83367 atorvastatin

83.3.117.1.7.1.4 RxNorm Value
23 Set

In this scenario, FDB Ingredient 3621 (found in Step 1) spans the value set entry for RXCUI 36567
(Simvastatin), which spans the given Measure Identifier (105), so the patient meets the denominator
exception criteria for eMeasure 105.

ExampleImplementation of Clinical Quality Measure Medication Reminders

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For purposes of demonstrating this application, the following scenario is used: A hospital patient has been
discharged with a diagnosis of Acute myocardial infarction of unspecified site, initial episode of care (ICD-9-CM
410.91), which meets the inclusion criteria for eMeasure 30 and a reminder: Statin Prescribed at Discharge. The
patient's discharge list of medications includes MEDID 172480 (Aspirin 325 mg tablet); no statin medications are
included in the medication list for patient discharge.

In this scenario, RxNorm links for MEDID 172480 (from the patients discharge medication list) are retrieved using
the RxNorm to FDB Clinical Screening Link Table (RIMKCS0_RXN_FDB_CS_LNK). RxNorm values for the
Statins RxNorm Value Set are also retrieved from the USHIK Master Table (RIMKUK0_USHIK_MSTR), but no
matches are found with the patients discharge list of medications.
The hospital compares the list of Statins RxNorm Value Set to its list of formulary medications and produces the
following results.

When joining the USHIK Master Table to the RxNorm To FDB Clinical Screening Link Table, the SCD
(EVD_EXT_VOCAB_TYPE_ID = 501) is used to pull all values.

In this scenario, the user interface alerts the discharge clinician, suggesting that a statin be prescribed based
upon the evidence included within the clinical quality measure or that a medical reason be selected to document
the decision not to prescribe.

ExampleImplementation of FDB Decision Support for RxNorm Concepts

For purposes of demonstrating this application, the following scenarios are used:

Scenario 1Consumer Web Portal Enabled Selection of Patient Medications for Drug-Drug Interaction
Screening
Scenario 2Consumer Web Portal Enabled Selection of Medications for Allergy Screening

Scenario 1Consumer Web Portal Enabled Selection of Patient Medications for Drug-Drug Interaction Screening

Consumer selects RxNorm RXCUI 617318 (Lipitor 20 MG Oral Tablet) and RXCUI 197853 (Ketoconazole 200
MG Oral Tablet) as look up medications for drug-drug interaction screening. FDB concepts are required for
completing this screening, which uses FDB MedKnowledge content and functionality.

1. Retrieve the following values from the RxNorm to FDB Clinical Screening Link Table
(RIMKCS0_RXN_FDB_CS_LNK):
IMK FDB Vocabulary Identifier (IMK_FDB_VOCAB_NO_ID)
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID)
RxNorm RXCUI Description (EVD_RXN_RXCUI_DESC)
IMK FDB Vocabulary Description (IMK_FDB_VOCAB_DESC)

where the RxNorm RXCUI (EVD_RXN_RXCUI) value equals the value of each given RxNorm-based
medication concept and the EVD External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID)
equals the value for the Term Type of each RXCUI.

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EVD_RXN_RXCUI EVD_EXT_VOCAB_TYPE_ID
IMK_FDB_VOCAB_NO_ID IMK_FDB_VOCAB
EVD_FDB_VOCAB_TYPE_ID
_DESC

197853 502 9544 6 ketoconazole 200

mg Oral Tablet

617318 501 29968 6 atorvastatin calcium

20 mg Oral Tablet

In this scenario, FDB Clinical Formulation IDs (GCN_SEQNO) 9544 (ketoconazole 200 mg Oral Tablet)
and 29968 (atorvastatin calcium 20 mg Oral Tablet) are retrieved and compared to each other for drug
interactions. The following consumer based drug-drug interaction information is returned.

Monograph Title
Selected Azoles/Selected HMG-CoA Reductase Inhibitors
Medical Warning
Severe. These medicines may interact and cause very harmful effects and are usually not taken together. Contact
your healthcare professional (e.g. doctor or pharmacist) for more information.

See Drug-Drug Interaction Module (DDIM) for more information about performing drug-drug interaction
screening.

Scenario 2Consumer Web Portal Enabled Selection of Medications for Allergy Screening

Consumer selects RxNorm RXCUI 1013647 (Cidaflex [chondroitin sulfates 400 MG / glucosamine hydrochloride
500 MG]) is selected, along with medication intolerance to RxNorm Ingredient (IN) 2473 (Chondroitin Sulfates).
FDB concepts are required for completing this screening, which uses FDB MedKnowledge content and
functionality.

1. Retrieve the following values from the RxNorm to FDB Clinical Screening Link Table
(RIMKCS0_RXN_FDB_CS_LNK):
IMK FDB Vocabulary Identifier (IMK_FDB_VOCAB_NO_ID)
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID)
RxNorm RXCUI Description (EVD_RXN_RXCUI_DESC)
IMK FDB Vocabulary Description (IMK_FDB_VOCAB_DESC)
IMK Partial Indicator (IMK_PARTIAL_IND)

where the RxNorm RXCUI (EVD_RXN_RXCUI) value equals the value of each given RxNorm-based
medication concept and the EVD External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID)
equals the value for the Term Type of each RXCUI.

EVD_RXN_RXCUI EVD_EXT_VOCAB_TYPE_ID
IMK_FDB_VOCAB_NO_ID IMK_FDB_VOC
EVD_FDB_VOCAB_TYPE_ID IMK_PARTIAL_IND
AB_DESC

1013647 502 4563 104 glucosamine 1

1013647 502 6428 104 glucosamine HCl 1

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FDB ingredients for RXCUI 1013647 are retrieved. However, the IMK_PARTIAL_IND value equals 1
indicating that the cross-reference to FDB is not complete.

2. Retrieve the RxNorm RXCUI Unscreened (EVD_RXN_RXCUI_UNSCREENED) and RxNorm RXCUI

Unscreened Description (EVD_RXN_RXCUI_UNSCREENED_DESC) from the RxNorm to FDB Clinical
Screening Exception Table (RIMKCSE0_RXN_FDB_CS_EXCEPT) where the RxNorm RXCUI Screened (
EVD_RXN_RXCUI_SCREENED) value equals 1013647.

EVD_RXN_RXCUI_SCREENED EVD_RXN_RXCUI_UNSCREENED EVD_RXN_RXCUI_UNSCREENED

_DESC

1013647 2473 Chondroitin Sulfates

In this scenario, when executing the allergy checking, the user interface can display a warning stating the
following:

Not all ingredients for Cidaflex (chondroitin sulfates 400 MG / glucosamine hydrochloride 500 MG) Oral
Tablet have been screened for allergy. Please compare the unscreened ingredient Chondroitin Sulfates to
the list of allergies for potential problems.

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Immunization Interoperability Applications

Retrieving CVX Code Identifiers for a Given FDB Concept

Retrieving CVX and MVX Codes Associated to an NDC for Registry Transmission

Retrieving Note Text for a CVX Code

Submitting a Manufacturer for a Repackaged NDC to an Immunization Registry

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Retrieving CVX Code Identifiers for a Given FDB Concept

This application illustrates how to retrieve CVX Codes for a given FDB concept identifier.

This application does not illustrate retrieving code sets for an NDC. See the Retrieving CVX and MVX
Codes Associated to an NDC for Registry Transmission application for an illustration of this of retrieving
code sets for an NDC.

The EVD CVX Code Usage (EVD_CVX_CD_USAGE) field can be used to identify the single, best CVX code to
transmit for prospective and historical CVX code reporting. When retrieving CVX codes associated to FDB
concepts, more than one EVD CVX Code from CDC (EVD_CVX_CD) value may be linked.

The EVD_CVX_CD_USAGE field can be used to create a sort order for CVX codes when more than one CVX
code is associated to a more specific FDB identifier, such as the National Drug Code ( NDC), Clinical Formulation
ID (GCN_SEQNO), or MED Medication ID (MEDID). CVX codes should be sorted on usage code in ascending
order. The correct CVX code to transmit will always be the one with the lowest numerical usage code value. See
the Retrieving a CVX Code Identifier associated to a MEDID Concept example for an illustration.

For FDB identifiers that are less specific (at a higher level of abstraction), such as the MED Routed Medication ID
(ROUTED_MED_ID), MED Routed Dosage Form Medication ID (ROUTED_DOSAGE_FORM_MED_ID), Routed
Generic Identifier (ROUTED_GEN_ID), and MED Medication Name ID (MED_NAME_ID), there are cases when
more than one linked CVX code can be considered the preferred code for registry transmissions for a currently
available vaccine. (For example, a given MED_NAME_ID is linked to three EVD_CVX_CDs with
EVD_CVX_CD_USAGE values of 1.) In such cases, without additional knowledge, it is not possible to determine
the preferred CVX code. Therefore, when using these identifiers, modify your algorithm as follows. When more
than one CVX code is associated to one of those identifiers, the correct CVX code to transmit will be the one with
the lowest numeric usage code value unless more than one CVX code has a usage code value of 1(Specified
formulation - active), the preferred code for registry transmissions for a currently available vaccine, or 20
(Specified formulation - inactive code). If that is the case, transmit the CVX code with the usage code value of 30
(Unspecified formulation). See the Retrieving a CVX Code Identifier Associated to a Medication Name ID
Concept example for an illustration.

NOTE: If you are transmitting CVX codes for non-immunization biologics, your algorithm needs to take
usage codes 60 (Specified Non-Immunization Biologic) and 70 (Unspecified Non-Immunization Biologic
Formulation) into consideration.

The following examples demonstrate the application:

Retrieving a CVX Code Identifier associated to a MEDID Concept

Retrieving a CVX Code Identifier Associated to a Medication Name ID Concept
Retrieving a CVX Code Identifier Associated to a Non-immunization Biologic Formulation

1. Retrieve the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) values from the External
Vocabulary Link Table (REVDEL0_EXT_VOCAB_LINK) where (one of the following):

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1.

EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals a MED Medication Name ID
(MED_NAME_ID) value, the EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID)
column equals 1 (indicating MED_NAME_ID), and the EVD External Vocabulary Type Identifier (
EVD_EXT_VOCAB_TYPE_ID) column equals 701 (indicating CVX).
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals a MED Routed Medication
ID (ROUTED_MED_ID) value, the EVD FDB Vocabulary Type Identifier (
EVD_FDB_VOCAB_TYPE_ID) column equals 2 (indicating ROUTED_MED_ID), and the EVD
External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) column equals 701 (indicating
CVX).
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals a MED Medication ID (
MEDID) value, the EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) column
equals 3 (indicating MEDID), and the EVD External Vocabulary Type Identifier (
EVD_EXT_VOCAB_TYPE_ID) column equals 701 (indicating CVX).
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals a Routed Generic Identifier
(ROUTED_GEN_ID) value, the EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID
) column equals 5 (indicating ROUTED_GEN_ID), and the EVD External Vocabulary Type Identifier
(EVD_EXT_VOCAB_TYPE_ID) column equals 701 (indicating CVX).
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals a Clinical Formulation ID (
GCN_SEQNO) value, the EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID)
column equals 6 (indicating GCN_SEQNO), and the EVD External Vocabulary Type Identifier (
EVD_EXT_VOCAB_TYPE_ID) column equals 701 (indicating CVX).
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals a MED Routed Dosage
Form Medication ID (ROUTED_DOSAGE_FORM_MED_ID) value, the EVD FDB Vocabulary Type
Identifier (EVD_FDB_VOCAB_TYPE_ID) column equals 7 (indicating
ROUTED_DOSAGE_FORM_MED_ID), and the EVD External Vocabulary Type Identifier (
EVD_EXT_VOCAB_TYPE_ID) column equals 701 (indicating CVX).

2. Retrieve the following values from the External Vocabulary CVX Description Table
(REVDCVX0_EXT_VOCAB_CVX_DESC) where the EVD CVX Code from CDC ( EVD_CVX_CD) column
equals the EVD_EXT_VOCAB_ID values from the previous step:
EVD CVX Code Long Description (EVD_CVX_CD_USAGE_DESC_LONG)
EVD CVX Code Status from CDC (EVD_CVX_CODE_STATUS) [Optional]
EVD CVX Usage Code (EVD_CVX_CD_USAGE)

3. Sort the retrieved records in ascending order according to their EVD_CVX_CD_USAGE value.

4. Transmit the appropriate EVD_CVX_CD value with its associated long description to the immunization
registry where (one of the following):
If retrieving values using the NDC, Clinical Formulation ID (GCN_SEQNO), or MEDID, sort the
retrieved records in ascending order according to their EVD_CVX_CD_USAGE value and transmit
the CVX code associated to the lowest numerical EVD_CVX_CD_USAGE value with its associated
long description.

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If retrieving values using less specific identifiers (such as the ROUTED_MED_ID,

ROUTED_DOSAGE_FORM_MED_ID, ROUTED_GEN_ID, and ROUTED_NAME_ID) and more
than one EVD_CVX_CD_USAGE value of 1 (Specified formulation - active) or 20 (Specified
formulation - inactive) is retrieved, transmit the CVX code associated to the EVD_CVX_CD_USAGE
value of 30 (Unspecified formulation).

If you are transmitting CVX codes for non-immunization biologics, your algorithm needs to take
usage codes 60 (Specified Non-Immunization Biologic) and 70 (Unspecified Non-Immunization
Biologic Formulation) into consideration.

ExampleRetrieving a CVX Code Identifier associated to a MEDID Concept

For purposes of demonstrating this application, the following scenario is used: A physician inputs an order
for an influenza virus vac. tri-split IM vaccine (MED Medication ID [MEDID] 220816), and the order entry
application submits the associated CVX code to the immunization registry.

1. Retrieve the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) values from the External
Vocabulary Link Table (REVDEL0_EXT_VOCAB_LINK) where:
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals the MEDID value of the
product.
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) column equals 3 (indicating
MEDID).
EVD External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) column equals 701
(indicating CVX).

EVD_FDB_VOCAB_ID EVD_FDB_VOCAB_TYP EVD_EXT_VOCAB_TYP EVD_EXT_VOCAB_ID

E_ID E_ID

220816 3 701 141

220816 3 701 15

220816 3 701 88

2. Retrieve the following values from the External Vocabulary CVX Description Table
(REVDCVX0_EXT_VOCAB_CVX_DESC) where the EVD CVX Code from CDC ( EVD_CVX_CD) column
equals the EVD_EXT_VOCAB_ID values from the previous step:
EVD CVX Code Long Description (EVD_CVX_CD_DESC_LONG)
EVD CVX Code Status from CDC (EVD_CVX_CODE_STATUS) [Optional]
EVD CVX Code Usage (EVD_CVX_CD_USAGE)

EVD_CVX_CD EVD_CVX_CD_DESC_L EVD_CVX_CD_STATUS EVD_CVX_CD_USAGE

ONG

141 Influenza, seasonal, Active 1

injectable

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15 influenza virus vaccine, Inactive 30

split virus (incl. purified
surface antigen)-retired
CODE

88 influenza virus vaccine, Inactive 40

unspecified formulation

3. Sort the retrieved records in ascending order according to their EVD_CVX_CD_USAGE value.

EVD_CVX_CD_USAGE EVD_CVX_CD EVD_CVX_CD_DESC_L EVD_CVX_CD_STATUS

ONG

1 141 Influenza, seasonal, Active

injectable

30 15 influenza virus vaccine, Inactive

split virus (incl. purified
surface antigen)-retired
CODE

40 88 influenza virus vaccine, Inactive

unspecified formulation

4. Transmit the appropriate EVD_CVX_CD value with its associated long description to the immunization
registry where one (of the following is true):
If retrieving values using the National Drug Code (NDC), Clinical Formulation ID (GCN_SEQNO), or
MEDID, sort the retrieved records in ascending order according to their EVD_CVX_CD_USAGE
value and transmit the CVX code associated to the lowest numerical EVD_CVX_CD_USAGE value
with its associated long description.
If retrieving values using less specific identifiers, such as listed below, and more than one
EVD_CVX_CD_USAGE value of 1 (Specified formulation - active) or 20 (Specified formulation -
inactive) is retrieved, transmit the CVX code associated to the EVD_CVX_CD_USAGE value of 30
(Unspecified formulation).
MED Routed Medication ID (ROUTED_MED_ID)
MED Routed Dosage Form Medication ID (ROUTED_DOSAGE_FORM_MED_ID)
Routed Generic Identifier (ROUTED_GEN_ID)
MED Medication Name (MED_NAME)
This example retrieves values using the MEDID. Therefore, the records are sorted into ascending
order according to their EVD_CVX_CD_USAGE value and the lowest EVD_CVX_CD_USAGE
value is transmitted. In this example, the EVD_CVX_CD value and description of 141 (Influenza,
seasonal, injectable) is retrieved, processed, and transmitted to the immunization registry.

ExampleRetrieving a CVX Code Identifier Associated to a Medication Name ID Concept

For purposes of demonstrating this application, the following scenario is used: A physician is recording a
patient's immunization history, and comes across a paper record that specifies a hepatitis B virus vaccine PF
(MED Medication Name ID [MED_NAME_ID] =113680). No other details for the vaccine are provided. The

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physician wants to send this history to a registry.

1. Retrieve the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) values from the External
Vocabulary Link Table (REVDEL0_EXT_VOCAB_LINK) where (one of the following):
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals a MED_NAME_ID value
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) column equals 1 (indicating
MED_NAME_ID)
EVD External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) column equals 701
(indicating CVX).

EVD_FDB_VOCAB_ID EVD_FDB_VOCAB_TYP EVD_EXT_VOCAB_TYP EVD_EXT_VOCAB_ID

E_ID E_ID

113680 1 701 08

113680 1 701 43

113680 1 701 44

113680 1 701 45

2. Retrieve the following values from the External Vocabulary CVX Description Table
(REVDCVX0_EXT_VOCAB_CVX_DESC) where the EVD CVX Code from CDC ( EVD_CVX_CD) column
equals the EVD_EXT_VOCAB_ID values from the previous step:
EVD CVX Code Long Description (EVD_CVX_CD_DESC_LONG)
EVD CVX Code Status from CDC (EVD_CVX_CODE_STATUS) [Optional]
EVD CVX Usage Code (EVD_CVX_CD_USAGE)

EVD_CVX_CD EVD_CVX_CD_DESC_L EVD_CVX_CD_STATUS EVD_CVX_CD_USAGE

ONG

08 hepatitis B vaccine, Active 1

pediatric or
pediatric/adolescent
dosage

45 45 hepatitis B vaccine, Active 30

unspecified formulation

43 43 hepatitis B vaccine, Active 1

adult dosage

44 44 hepatitis B vaccine, Inactive 1

dialysis patient dosage

3. Sort the retrieved records in ascending order according to their EVD_CVX_CD_USAGE value.

EVD_CVX_CD_USAGE EVD_CVX_CD EVD_CVX_CD_DESC_L EVD_CVX_CD_STATUS

ONG

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1 08 hepatitis B vaccine, Active

pediatric or
pediatric/adolescent
dosage

1 43 hepatitis B vaccine, adult Active

dosage

1 44 hepatitis B vaccine, Inactive

dialysis patient dosage

30 45 hepatitis B vaccine, Active

unspecified formulation

4. Transmit the appropriate EVD_CVX_CD value with its associated long description to the immunization
registry where (one of the following is true):
If retrieving values using the National Drug Code (NDC), Clinical Formulation ID (GCN_SEQNO), or
MED Medication ID (MEDID), sort the retrieved records in ascending order according to their
EVD_CVX_CD_USAGE value and transmit the CVX code associated to the lowest numerical
EVD_CVX_CD_USAGE value with its associated long description.
If retrieving values using less specific identifiers, such as listed below, and more than one
EVD_CVX_CD_USAGE value of 1 (Specified formulation - active) or 20 (Specified formulation -
inactive) is retrieved, transmit the CVX code associated to the EVD_CVX_CD_USAGE value of 30
(Unspecified formulation).
MED Routed Medication ID (ROUTED_MED_ID)
MED Routed Dosage Form Medication ID (ROUTED_DOSAGE_FORM_MED_ID)
Routed Generic Identifier (ROUTED_GEN_ID)
MED_NAME_ID
This example retrieves values using the MED_NAME_ID where more than one EVD_CVX_CD_USAGE
value of 1 (Specified formulation - active) is returned. Therefore, the EVD_CVX_CD value associated to
the EVD_CVX_CD_USAGE value of 30 (Unspecified formulation) is transmitted. In this example, the
EVD_CVX_CD value and description of 45 (hepatitis B vaccine, unspecified formulation) is retrieved,
processed, and transmitted to the immunization registry.

ExampleRetrieving a CVX Code Identifier Associated to a Non-immunization Biologic Formulation

For purposes of demonstrating this application, the following scenario is used: A physician has tested a
patient for Tuberculosis (Clinical Formulation ID [GCN_SEQNO 009698]) and wants to send this information to
the registry.

1. Retrieve the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) values from the External
Vocabulary Link Table (REVDEL0_EXT_VOCAB_LINK) where (one of the following):
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals a Clinical Formulation ID
(GCN_SEQNO) value
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) column equals 6 (indicating
GCN_SEQNO)

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EVD External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) column equals 701

(indicating CVX)

EVD_FDB_VOCAB_ID EVD_FDB_VOCAB_TYP EVD_EXT_VOCAB_TYP EVD_EXT_VOCAB_ID

E_ID E_ID

009698 6 701 96

009698 6 701 98

2. Retrieve the following values from the External Vocabulary CVX Description Table
(REVDCVX0_EXT_VOCAB_CVX_DESC) where the EVD CVX Code from CDC ( EVD_CVX_CD) column
equals the EVD_EXT_VOCAB_ID values from the previous step:
EVD CVX Code Long Description (EVD_CVX_CD_DESC_LONG)
EVD CVX Code Status from CDC (EVD_CVX_CODE_STATUS) [Optional]
EVD CVX Usage Code (EVD_CVX_CD_USAGE)

EVD_CVX_CD EVD_CVX_CD_DESC_L EVD_CVX_CD_STATUS EVD_CVX_CD_USAGE

ONG

96 tuberculin skin test; Inactive 60

purified protein derivative
solution, intradermal

98 tuberculin skin test; Inactive 70

unspecified formulation

3. Sort the retrieved records in ascending order according to their EVD_CVX_CD_USAGE value. This
ensures that the CVX code most appropriate for transmission to a registry is sorted to the top.

EVD_CVX_CD_USAGE EVD_CVX_CD EVD_CVX_CD_DESC_L EVD_CVX_CD_STATUS

ONG

60 96 Inactive
tuberculin skin test;
purified protein derivative
solution, intradermal

70 98 tuberculin skin test; Inactive

unspecified formulation

4. Transmit the appropriate EVD_CVX_CD value with its associated long description to the immunization
registry where (one of the following is true):
If retrieving values using the National Drug Code (NDC, page 1968), Clinical Formulation ID (
GCN_SEQNO), or MED Medication ID (MEDID), sort the retrieved records in ascending order
according to their EVD_CVX_CD_USAGE value and transmit the CVX code associated to the
lowest numerical EVD_CVX_CD_USAGE value with its associated long description.
If retrieving values using less specific identifiers, such as listed below, and more than one
EVD_CVX_CD_USAGE value of 1 (Specified formulation - active) or 20 (Specified formulation -

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inactive) is retrieved, transmit the CVX code associated to the EVD_CVX_CD_USAGE value of 30
(Unspecified formulation).
MED Routed Medication ID (ROUTED_MED_ID)
MED Routed Dosage Form Medication ID (ROUTED_DOSAGE_FORM_MED_ID)
Routed Generic Identifier (ROUTED_GEN_ID)
MED Medication Name ID (MED_NAME_ID)
This example retrieves values using the Clinical Formulation ID (GCN_SEQNO). Therefore, the retrieved
records are sorted into ascending order according to their EVD_CVX_CD_USAGE value and the lowest
EVD_CVX_CD_USAGE value is transmitted. However, because this is a non-immunization biologic, the
usage code values of 60 and 70 are taken into consideration.
In this example, the EVD_CVX_CD value and description of 96 (tuberculin skin test; unspecified
formulation) is retrieved, processed, and transmitted to the immunization registry.

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Retrieving CVX and MVX Codes Associated to an NDC for Registry Transmission
This application and example below illustrate how to retrieve CVX and MVX codes for a given National Drug
Code (NDC).

For the purposes of this application, the relationship between NDCs and their associated CVX and MVX values
can be found using the following tables:

External Vocabulary Link Table (REVDEL0_EXT_VOCAB_LINK), which relates various FDB concepts to
their external identifiers
NDC to CVX-MVX Link Table (REVDNCM0_NDC_CVX_MVX_LINK) table, which relates NDCs to their
associated CVX and MVX codes

It is possible to use either of the two above tables for the purposes of this application. However, the NDC to
CVX-MVX Link Table (REVDNCM0_NDC_CVX_MVX_LINK) associates each NDC to a single best CVX code for
applications where the intent is the transmission to a registry. This table provides one-step navigation for
transmitting real-time and/or retrospective immunization information at the NDC level.

Note that the NDC to CVX-MVX Link Table (REVDNCM0_NDC_CVX_MVX_LINK) contains only active NDCs and
NDCs which have been obsolete for up to three years. For applications involving the association of NDCs to CVX
codes which have been obsolete for greater than three years, use the External Vocabulary Link Table
(REVDEL0_EXT_VOCAB_LINK) instead.

The following examples demonstrate the application:

Retrieving CVX and MVX Codes for an NDC Using the External Vocabulary Link Table
Retrieving CVX and MVX Codes Using the NDC to CVX-MVX Link Table

ExampleRetrieving CVX and MVX Codes for an NDC Using the External Vocabulary Link Table

For purposes of demonstrating this application, the following scenario is used: After administering a Gardisil
vaccine (National Drug Code [NDC] 00006404500), a healthcare professional retrieves and submits the vaccines
CVX code and MVX code to the immunization registry.

1. Retrieve the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) values from the External
Vocabulary Link Table (REVDEL0_EXT_VOCAB_LINK) where:
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals the NDC value of the
product.
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) column equals 100 (indicating
NDC).
EVD External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) column equals 701
(indicating CVX code).

EVD_FDB_VOCAB_ID EVD_FDB_VOCAB_TYP EVD_EXT_VOCAB_TYP EVD_EXT_VOCAB_ID

E_ID E_ID

00006404500 100 701 62

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00006404500 100 701 137

2. Retrieve the related values from the External Vocabulary CVX Description Table
(REVDCVX0_EXT_VOCAB_CVX_DESC) where the EVD CVX Code from CDC ( EVD_CVX_CD) column
equals the EVD_EXT_VOCAB_ID values from the previous step:
EVD CVX Code Long Description (EVD_CVX_CD_USAGE_DESC_LONG)
EVD_CVX_CD_USAGE (EVD_CVX_CD_USAGE)
EVD CVX Code Status from CDC (EVD_CVX_CODE_STATUS)

EVD_CVX_CD EVD_CVX_CD_DESC_L EVD_CVX_CD_USAGE EVD_CVX_CD_STATUS

ONG

62 human papilloma virus 1 Active

vaccine, quadrivalent

137 HPV, unspecified 30 Inactive

formulation

Description values can also retrieved within the External Vocabulary Description Table
(REVDEV0_EXT_VOCAB_DESC); however, the status information is only available in the External
Vocabulary CVX Description Table (REVDCVX0_EXT_VOCAB_CVX_DESC).

3. If needed, sort the retrieved records in ascending order according to their EVD_CVX_CD_USAGE value.
This ensures that the EVD_CVX_CD most appropriate for transmission to a registry is sorted to the top.

EVD_CVX_CD EVD_CVX_CD_DESC_L EVD_CVX_CD_USAGE EVD_CVX_CD_STATUS

ONG

62 human papilloma virus 1 Active

vaccine, quadrivalent

137 HPV, unspecified 30 Inactive

formulation

See Retrieving CVX Code Identifiers for a Given FDB Concept for more information on using the
EVD_CVX_CD_USAGE value.

In this example, the NDC is associated to more than one EVD_CVX_CD. After sorting the retrieved
records in ascending order, EVD_CVX_CD 62 (human papilloma virus vaccine, quadrivalent) with an
EVD_CVX_CD_USAGE value of 1 is determined to be the appropriate CVX code to transmit to the
registry.

4. Retrieve the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) values from the External
Vocabulary Link Table (REVDEL0_EXT_VOCAB_LINK) where:
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals the NDC value of the
product.

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EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) column equals 100 (indicating
NDC).
EVD External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) column equals 702
(indicating MVX alphanumeric code).

EVD_FDB_VOCAB_ID EVD_FDB_VOCAB_TYP EVD_EXT_VOCAB_TYP EVD_EXT_VOCAB_ID

E_ID E_ID

00006404500 100 702 MSD

5. Retrieve the following values from the External Vocabulary MVX Description Table
(REVDMVX0_EXT_VOCAB_MVX_DESC) where the EVD MVX Code from CDC ( EVD_MVX_CD) column
equals the EVD_EXT_VOCAB_ID values from the previous step:
EVD MVX Code Description (EVD_MVX_CD_DESC)
EVD MVX Code Status from CDC (EVD_MVX_CD_STATUS)

EVD_MVX_CD EVD_MVX_CD EVD_MVX_CD_STATUS

MSD Merck & Co., Inc. Active

In this example, the CVX code and description of 62 (human papilloma virus vaccine, quadrivalent) and
MVX code of MSD (Merck & Co., Inc.) are retrieved, processed, and transmitted to the immunization
registry.

ExampleRetrieving CVX and MVX Codes Using the NDC to CVX-MVX Link Table

For purposes of demonstrating this application, the following scenario is used: After administering a
Gardisil vaccine (National Drug Code [NDC] 00006404500), a healthcare professional retrieves and submits the
vaccines CVX code and manufacturer to the immunization registry.

1. Retrieve the following values from the NDC to CVX-MVX Link Table
(REVDNCM0_NDC_CVX_MVX_LINK) where the NDC column equals the NDC value of the product:
EVD CVX Code from CDC (EVD_CVX_CD)
EVD CVX Code Long Description (EVD_CVX_CD_DESC_LONG)
EVD MVX Code from CDC (EVD_MVX_CD)
EVD MVX Code Description from CDC (EVD_MVX_CD_DESC)

NDC EVD_CVX_CD EVD_CVX_CD_DE EVD_MVX_CD EVD_MVX_CD_DE

SC_LONG SC

00006404500 62 human papilloma MSD Merck & Co., Inc.

virus vaccine,
quadrivalent

In this example, the CVX code and description of 62 (human papilloma virus vaccine, quadrivalent) and
MVX code of MSD (Merck & Co., Inc.) are retrieved, processed, and transmitted to the immunization
registry.

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Retrieving Note Text for a CVX Code

This example illustrates how to retrieve note text for a given CVX code.

1. Retrieve the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) values from the External
Vocabulary Link Table (REVDEL0_EXT_VOCAB_LINK) where (one of the following is true):
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals a MED Medication Name ID
(MED_NAME_ID) value, the EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID)
column equals 1 (indicating MED_NAME_ID), and the EVD External Vocabulary Type Identifier (
EVD_EXT_VOCAB_TYPE_ID) column equals 701 (indicating CVX).
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals a MED Routed Medication
ID (ROUTED_MED_ID) value, the EVD FDB Vocabulary Type Identifier (
EVD_FDB_VOCAB_TYPE_ID) column equals 2 (indicating ROUTED_MED_ID), and the EVD
External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) column equals 701 (indicating
CVX).
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals a MED Medication ID (
MEDID) value, the EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) column
equals 3 (indicating MEDID), and the EVD External Vocabulary Type Identifier (
EVD_EXT_VOCAB_TYPE_ID) column equals 701 (indicating CVX).
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals a Routed Generic Identifier
(ROUTED_GEN_ID) value, the EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID
) column equals 5 (indicating ROUTED_GEN_ID), and the EVD External Vocabulary Type Identifier
(EVD_EXT_VOCAB_TYPE_ID) column equals 701 (indicating CVX).
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals a Clinical Formulation ID (
GCN_SEQNO) value, the EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID)
column equals 6 (indicating GCN_SEQNO), and the EVD External Vocabulary Type Identifier (
EVD_EXT_VOCAB_TYPE_ID) column equals 701 (indicating CVX).
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals a MED Routed Dosage
Form Medication ID (ROUTED_DOSAGE_FORM_MED_ID) value, the EVD FDB Vocabulary Type
Identifier (EVD_FDB_VOCAB_TYPE_ID) column equals 7 (indicating
ROUTED_DOSAGE_FORM_MED_ID), and the EVD External Vocabulary Type Identifier (
EVD_EXT_VOCAB_TYPE_ID) column equals 701 (indicating CVX).

2. Retrieve the EVD External Vocabulary Usage Notes (EVD_EXT_VOCAB_NOTE) and EVD Sequence
Number (EVD_SEQ_SN) values from the External Vocabulary Note Table
(REVDEVN0_EXT_VOCAB_NOTE) where the EVD_EXT_VOCAB_ID and the
EVD_EXT_VOCAB_TYPE_ID columns equal the EVD_EXT_VOCAB_ID and
EVD_EXT_VOCAB_TYPE_ID values from the previous step.

ExampleRetrieving Note Text for a CVX Code

This example finds the usage notes for the Hepatitis B Virus vaccine (Clinical Formulation ID [ GCN_SEQNO]
062514).

1.

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1. Retrieve the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) values from the External
Vocabulary Link Table (REVDEL0_EXT_VOCAB_LINK) where:
EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) column equals the Clinical Formulation ID
(GCN_SEQNO) value of 062514
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) column equals the value of 6
(indicating GCN_SEQNO)
EVD External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) column equals the value
of 701 (indicating CVX code)

EVD_FDB_VOCAB_ID EVD_EXT_VOCAB_TYPE_IDEVD_EXT_VOCAB_ID
EVD_FDB_VOCAB_TYPE_ID

062514 6 701 43

2. Retrieve the EVD External Vocabulary Usage Notes (EVD_EXT_VOCAB_NOTE) and EVD Sequence
Number (EVD_SEQ_SN) values from the External Vocabulary Note Table
(REVDEVN0_EXT_VOCAB_NOTE) where the EVD_EXT_VOCAB_ID and the
EVD_EXT_VOCAB_TYPE_ID columns equal the EVD_EXT_VOCAB_ID and
EVD_EXT_VOCAB_TYPE_ID values from the previous step.

EVD_EXT_VOCAB_ID EVD_EXT_VOCAB_TYP EVD_SEQ_SN EVD_EXT_VOCAB_NOT

E_ID ES

43 701 1 As of September 1999, a

2-dose hepatitis B
schedule for adolescents
(11-15 year olds) was FDA
approved for Merck's
Recombivax HB adult
formulation. Use code 43
for both the 2-dose and the
3- dose schedules.

Use the EVD_SEQ_SN column values to sort the results of step 2 when necessary.

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Submitting a Manufacturer for a Repackaged NDC to an Immunization Registry

This example illustrates the submission of a manufacturer for a repackaged National Drug Code ( NDC) to an
immunization registry. The Centers for Disease Control and Preventions (CDC) intention for their MVX code is to
describe the source manufacturer of a product. FDBs Labeler Identifier (LBLRID) field is designed to always
identify the labeler of a product (the labeler can be a source manufacturer, repackager, or drug distributor). The
labeler is the entity named on the physical package of a drug.

In order to allow access to the most comprehensive information and to ensure that the correct MVX code is
submitted, FDB provides the NDC to CVX-MVX Link Table (REVDNCM0_NDC_CVX_MVX_LINK), which
provides a direct link from an NDC to both its MVX code and its LBLRID code.

The External Vocabulary Link Table (REVDEL0_EXT_VOCAB_LINK) can also be used to identify and transmit
MVX codes as each NDC is only mapped to one MVX code; however, the direct link from an NDC to an MVX
code within the NDC to CVX-MVX Link Table (REVDNCM0_NDC_CVX_MVX_LINK) ensures that, as per CDC's
intent, the source manufacturer information is sent to immunization registries.

1. Retrieve the following values from the NDC to CVX-MVX Link Table
(REVDNCM0_NDC_CVX_MVX_LINK) where the NDC column equals the NDC value of the product:
Repackaged Indicator (REPACK)
LBLRID
EVD CVX Code from CDC (EVD_CVX_CD)
EVD CVX Code Long Description (EVD_CVX_CD_DESC_LONG)
EVD MVX Code from CDC (EVD_MVX_CD)
EVD MVX Code Description from CDC (EVD_MVX_CD_DESC)

ExampleSubmitting a Manufacturer for a Repackaged NDC to an Immunization Registry

For purposes of demonstrating this application, the following scenario is used: A nurse administers
Haverix 720 unit/0.5 mL syringe (National Drug Code [NDC] 54569588800). This NDC belongs to the repackager,
A-S Medication. The system needs to submit the correct CVX and MVX codes to the immunization registry.

1. Retrieve the following values from the NDC to CVX-MVX Link Table
(REVDNCM0_NDC_CVX_MVX_LINK) where the NDC column equals the NDC value of the product:
Repackaged Indicator (REPACK)
Labeler Identifier (LBLRID)
EVD CVX Code from CDC (EVD_CVX_CD)
EVD CVX Code Long Description (EVD_CVX_CD_DESC_LONG)
EVD MVX Code from CDC (EVD_MVX_CD)
EVD MVX Code Description from CDC (EVD_MVX_CD_DESC)

NDC 54569588800

REPACK 1

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LBLRID A54569

MFG A-S Medication

EVD_MVX_CD SKB

EVD_MVX_CD_DESC GlaxoSmithKline

EVD_CVX_CD 83

EVD_CVX_CD_DESC_LONG hepatitis A vaccine, pediatric/adolescent dosage, 2 dose

schedule

Retrieve the Manufacturer (MFG) value from the Labeler Identifier Description Table
(RLBLRID3_LBLR_DESC).

In this example, the REPACK value is 1, indicating that this NDC is a repackaged product. Therefore,
EVD_MVX_CD value of SKB (GlaxoSmithKline) is submitted to the immunization registry. A message is
sent to the user stating that Haverix 720 unit/0.5 mL syringe, packaged by A-S Medication, was submitted
to the immunization registry with the manufacturer GlaxoSmithKline.

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Allergen Interoperability Applications

Navigating from a UNII Code to an Associated Ingredient

Retrieving an External Allergen Interoperable Concept for a Given FDB Allergen Concept

Retrieving FDB Allergen Interoperable Concepts for a Given External Allergen Concept

Retrieving an HL7 Object Identifier (OID) for a Given Interoperable Concept Type

Documenting Food or Environmental Allergies Using SNOMED CT Concepts

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Navigating from a UNII Code to an Associated Ingredient

FDA Unique Ingredient Identifier (UNII) Codes may appear on patient allergy profiles. This application explains
how to navigate from a UNII Code to an associated ingredient, such as an FDB Hierarchical Ingredient Code
Sequence Number (HIC_SEQN) or an RxNorm Precise Ingredient (PIN).

Part 1: Determine whether the UNII Code is Present in the External Vocabulary Link Table
(REVDEL0_EXT_VOCAB_ID)

1. Retrieve the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) value of the UNII Code on the
patients profile from the External Vocabulary Link Table (REVDEL0_EXT_VOCAB_LINK) where the EVD
External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) value equals 508.
If the UNII Code is present in the External Vocabulary Link Table (REVDEL0_EXT_VOCAB_LINK),
continue to Part 2A: Navigating from a UNII Code to a Hierarchical Ingredient Code Sequence
Number (HIC_SEQN).
If the UNII Code is not present in the REVDEL0_EXT_VOCAB_LINK Table, continue to Part 2B:
Navigating from a UNII to an RXCUI.

Part 2: Retrieve the Associated Identifier and Description for the UNII Code

Part 2A: Navigating from a UNII Code to a Hierarchical Ingredient Code Sequence Number (HIC_SEQN)

This section explains how to find the HIC_SEQN and its description for a UNII Code.

1. Retrieve the EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) from the External Vocabulary Link
Table (REVDEL0_EXT_VOCAB_LINK) where the EVD External Vocabulary Identifier (
EVD_EXT_VOCAB_ID) equals the UNII Code queried in Part 1, the EVD External Vocabulary Type
Identifier (EVD_EXT_VOCAB_TYPE_ID) value equals 508, and the EVD FDB Vocabulary Type Identifier (
EVD_FDB_VOCAB_TYPE_ID) value equals 104.

2. Retrieve the Hierarchical Ingredient Code Description (HIC_DESC) from the Hierarchical Ingredient Code
Description Table (RHICD5_HIC_DESC) where the Hierarchical Ingredient Code Sequence Number (
HIC_SEQN) column equals the EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) value retrieved in
the previous step.

Part 2B: Navigating from a UNII to an RXCUI

This section explains how to find an RxNorm Concept Unique Identifier (RXCUI) and its description for a UNII
Code.

1. Retrieve the RxNorm RXCUI (EVD_RXN_RXCUI) value from the RxNorm Concept Master Table
(REVDRC0_RXN_CONCEPT_MSTR) where the UNII Code (UNII_CODE) value equals the UNII Code
queried in Part 1.

2. Retrieve the RxNorm Concept Source Key (EVD_RXN_CONCEPT_SOURCE_KEY) values from the
RxNorm Concept Source Table (REVDCS0_RXN_CONCEPT_SOURCE) where the RxNorm RXCUI (
EVD_RXN_RXCUI) column equals the RxNorm RXCUI (EVD_RXN_RXCUI) value retrieved in the
previous step.

3.

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3. Retrieve the RxNorm String (EVD_RXN_STR) and RxNorm Sequence Number (EVD_RXN_SEQ_SN)
values from the RxNorm Concept Description Table (REVDCD0_RXN_CONCEPT_DESC) where the
RxNorm Concept Source Key (EVD_RXN_CONCEPT_SOURCE_KEY) column equals the value retrieved
in the previous step.

4. Sort the results of the previous step in order by EVD_RXN_SEQ_SN, if applicable.

ExampleNavigating from a UNII Code to a HIC_SEQN when the UNII Code is Present in the External Vocabulary Link
Table (REVDEL0_EXT_VOCAB_ID)

An incoming patient allergy profile contains the UNII Code for Dihydrocodeine (N9I9HDB855), and the allergy
profile needs to be codified to be accepted by the recipients internal EMR system, which uses FDB data.

Part 1: Determine whether the UNII Code is Present in the External Vocabulary Link Table
(REVDEL0_EXT_VOCAB_ID)

1. Retrieve the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) value of the UNII Code on the
patients profile from the External Vocabulary Link Table (REVDEL0_EXT_VOCAB_LINK) where the EVD
External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) value equals 508.
If the UNII Code is present in the REVDEL0_EXT_VOCAB_LINK Table, continue to Part 2A:
Navigating from a UNII Code to a Hierarchical Ingredient Code Sequence Number (HIC_SEQN).
If the UNII Code is not present in the REVDEL0_EXT_VOCAB_LINK Table, continue to Part 2B:
Navigating from a UNII to an RXCUI.

In this example, the UNII Code is present in the REVDEL0_EXT_VOCAB_LINK table.

EVD_EXT_VOCAB_ID EVD_EXT_VOCAB_TYPE_ID

N9I9HDB855 508

Part 2: Retrieve the Associated Identifier and Description for the UNII Code

1. Retrieve the EVD FDB Vocabulary Identifier (EVD_FDB_VOCAB_ID) from the External Vocabulary Link
Table (REVDEL0_EXT_VOCAB_LINK) where the EVD External Vocabulary Identifier (
EVD_EXT_VOCAB_ID) equals the UNII Code N9I9HDB855, the EVD External Vocabulary Type Identifier (
EVD_EXT_VOCAB_TYPE_ID) value equals 508, and the EVD FDB Vocabulary Type Identifier (
EVD_FDB_VOCAB_TYPE_ID) value equals 104.

EVD_EXT_VOCAB_ID EVD_EXT_VOCAB_TYP EVD_FDB_VOCAB_ID EVD_FDB_VOCAB_TYP

E_ID E_ID

N9I9HDB855 508 1557 104

2. Retrieve the Hierarchical Ingredient Code Description (HIC_DESC) from the Hierarchical Ingredient Code
Description Table (RHICD5_HIC_DESC) where the Hierarchical Ingredient Code Sequence Number (
HIC_SEQN) column equals the value of the EVD FDB Vocabulary Identifier ( EVD_FDB_VOCAB_ID) value
retrieved in the previous step.

EVD_FDB_VOCAB_ID HIC_SEQN HIC_DESC

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1557 1557 dihydrocodeine

ExampleNavigating from a UNII Code to a HIC_SEQN when the UNII Code is not Present in the External Vocabulary
Link Table (REVDEL0_EXT_VOCAB_ID)

An incoming patient allergy profile contains the UNII Code for Ambrosia Artemisifolia Pollen (K20Y81ACO3), and
the allergy profile needs to be codified to be accepted by the recipients internal EMR system, which uses FDB
data.

Part 1: Determine whether the UNII Code is Present in the External Vocabulary Link Table
(REVDEL0_EXT_VOCAB_ID)

1. Retrieve the EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) value of the UNII Code on the
patients profile from the External Vocabulary Link Table (REVDEL0_EXT_VOCAB_LINK) where the EVD
External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) value equals 508.
If the UNII Code is present in the REVDEL0_EXT_VOCAB_LINK Table, continue to Part 2A:
Navigating from a UNII Code to a Hierarchical Ingredient Code Sequence Number (HIC_SEQN).
If the UNII Code is not present in the REVDEL0_EXT_VOCAB_LINK Table, continue to Part 2B:
Navigating from a UNII to an RXCUI.
In this example, the UNII Code is not present in the REVDEL0_EXT_VOCAB_LINK table.

Part 2: Retrieve the Associated Identifier and Description for the UNII Code

1. Retrieve the RxNorm RXCUI (EVD_RXN_RXCUI) value from the RxNorm Concept Master Table
(REVDRC0_RXN_CONCEPT_MSTR) where the UNII Code (UNII_CODE) value equals the UNII Code
K20Y81ACO3.

UNII_CODE EVD_RXN_RXCUI

K20Y81ACO3 314453

2. Retrieve the RxNorm Concept Source Key (EVD_RXN_CONCEPT_SOURCE_KEY) values from the
RxNorm Concept Source Table (REVDCS0_RXN_CONCEPT_SOURCE) where the RxNorm RXCUI (
EVD_RXN_RXCUI) column equals the RxNorm RXCUI (EVD_RXN_RXCUI) value retrieved in the
previous step.

EVD_RXN_RXCUI EVD_RXN_CONCEPT_SOURCE_KEY

314453 221883

3. Retrieve the RxNorm String (EVD_RXN_STR) and RxNorm Sequence Number (EVD_RXN_SEQ_SN)
values from the RxNorm Concept Description Table (REVDCD0_RXN_CONCEPT_DESC) where the
RxNorm Concept Source Key (EVD_RXN_CONCEPT_SOURCE_KEY) column equals the value retrieved
in the previous step.

EVD_RXN_RXCUI EVD_RXN_CONCEPT_S EVD_RXN_SEQ_SN EVD_RXN_STR

OURCE_KEY

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314453 221883 1 ALLERGENIC EXTRACT,

SHORT RAGWEED

4. Sort the results of the previous step in order by EVD_RXN_SEQ_SN, if applicable.

In this example, only the RXCUI and its description are displayed.

EVD_RXN_RXCUI EVD_RXN_STR EVD_RXN_SEQ_SN

314453 ALLERGENIC EXTRACT, SHORT 1

RAGWEED

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Retrieving an External Allergen Interoperable Concept for a Given FDB Allergen Concept
This application illustrates how to retrieve an external allergen interoperable concept for a given FDB allergen
concept, such as a Specific Allergen Group (DAM_ALRGN_GRP), Ingredient (HIC_SEQN), or Medication Name
Identifier (MED_NAME_ID).

Use this application when an electronic submission requires an interoperable concept identifier, interoperable
concept description, and an RXCUI. If an HL7 Object Identifier (HL7_OID) is also required, see the Retrieving an
HL7 Object Identifier (OID) for a Given Interoperable Concept Type application for information on retrieving the
OID.

1. Determine whether your identifier has been replaced by a different value if the identifier is a Specific
Allergen Group (DAM_ALRGN_GRP), MED Medication Name ID (MED_NAME_ID), or Hierarchical
Ingredient Code Sequence Number (HIC_SEQN).
Please reference one of the following applications in your MedKnowledge manual for information on
determining if a given identifier has been replaced:
For a Medication Name Identifier (MED_NAME_ID), see the Finding a Replacement MED Concept
at Any Level of Specificity application in the MedKnowledge manual.
For a Hierarchical Ingredient Code Sequence Number (HIC_SEQN), see the Finding a
Replacement Ingredient Identifier application in the MedKnowledge manual.
For a DAM Specific Allergen Group Code (DAM_ALRGN_GRP), see the Retrieving a Replacement
Specific Allergen Group application in the MedKnowledge manual.

2. Retrieve the following values from the FDB Allergen to External Vocabulary Link Table
(RIMKFAE0_FDB_ALG_EXT_VOCAB_LNK):
IMK External Vocabulary Identifier (IMK_EXT_VOCAB_ID)
EVD External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID)
IMK External Vocabulary Description (IMK_EXT_VOCAB_DESC)
IMK FDB Vocabulary Description (IMK_FDB_VOCAB_DESC)
RxNorm RXCUI (EVD_RXN_RXCUI)
Link Inactive Date (LINK_INACTIVE_DATE)
where (one of the following):
the IMK FDB Vocabulary Identifier (IMK_FDB_VOCAB_NO_ID) equals the given DAM Specific
Allergen Group (DAM_ALRGN_GRP) and the EVD FDB Vocabulary Type Identifier (
EVD_FDB_VOCAB_TYPE_ID) column equals 110 (DAM_ALRGN_GRP).
the IMK FDB Vocabulary Identifier (IMK_FDB_VOCAB_NO_ID) equals the given Hierarchical
Ingredient Code Sequence Code (HIC_SEQN) and the EVD FDB Vocabulary Type Identifier (
EVD_FDB_VOCAB_TYPE_ID) column equals 104 (HIC_SEQN).
the IMK FDB Vocabulary Identifier (IMK_FDB_VOCAB_NO_ID) equals the given Medication Name
Identifier (MED_NAME_ID) and the EVD FDB Vocabulary Type Identifier (
EVD_FDB_VOCAB_TYPE_ID) column equals 1 (MED_NAME_ID).

3. If more than one row is returned from the previous step, choose the active link. Active links have null Link

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3.

Inactive Date (LINK_INACTIVE_DATE) values. If there is no active link available, choose the link with the
most recent LINK_INACTIVE_DATE.

4. (Optional) If no external links are available and you are working with a Clinical Document Architecture
(CDA) document, such as a Continuity of Care Document (CCD), this exception can be handled as No
Information (nullFlavor = NI) and the FDB description can be used in the context of originalText.

ExampleRetrieving an External Allergen Interoperable Concept for a Given FDB Specific Allergen Group

For purposes of demonstrating this application, the following scenario is used: A patient's record shows an
allergy to Penicillins (DAM_ALRGN_GRP 476) and electronic submission requires an interoperable concept
identifier, interoperable concept description, RXCUI, and HL7_OID.

1. Determine whether the FDB DAM Specific Allergen Group (DAM_ALRGN_GRP) has been replaced by a
different value. See the Retrieving a Replacement Specific Allergen Group application in your
MedKnowledge manual for an illustration of this step.
In this example, the DAM_ALRGN_GRP is active and has not been replaced.

2. Retrieve the following values from the FDB Allergen to External Vocabulary Link Table
(RIMKFAE0_FDB_ALG_EXT_VOCAB_LNK):
IMK External Vocabulary Identifier (IMK_EXT_VOCAB_ID)
EVD External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID)
IMK External Vocabulary Description (IMK_EXT_VOCAB_DESC)
IMK FDB Vocabulary Description (IMK_FDB_VOCAB_DESC)
RxNorm RXCUI (EVD_RXN_RXCUI)
Link Inactive Date (LINK_INACTIVE_DATE)

where the IMK FDB Vocabulary Identifier (IMK_FDB_VOCAB_NO_ID) equals the given DAM Specific
Allergen Group (DAM_ALRGN_GRP) and the EVD FDB Vocabulary Type Identifier (
EVD_FDB_VOCAB_TYPE_ID) column equals 110 (DAM_ALRGN_GRP).

IMK_FDB_VOCAB_NO_ID
EVD_FDB_VOCAB_TYPE_ID
IMK_EXT_VOCAB_ID
EVD_EXT_VOCAB_TYPE_ID
IMK_EXT_VOCAB_DESC
IMK_FDB_VOCAB_DESC
EVD_RXN_RXCUI
LINK_INACTIVE_DATE

476 110 N00000112 530 Penicillins Penicillins 7986

81

3. If more than one row is returned from the previous step, choose the active link. Active links have null Link
Inactive Date (LINK_INACTIVE_DATE) values. If there is no active link available, choose the link with the
most recent LINK_INACTIVE_DATE.
In this example, one active link is returned.

ExampleRetrieving an External Allergen Interoperable Concept for a Given FDB Ingredient

For purposes of demonstrating this application, the following scenario is used: A patient's record shows an
allergy to Amoxicillin (HIC_SEQN 3675) and electronic submission requires an interoperable concept identifier,
interoperable concept description, RXCUI, and HL7_OID.

1.

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1. Determine whether the FDB Hierarchical Ingredient Code Sequence Number (HIC_SEQN) has been
replaced by a different value. See the Finding a Replacement Ingredient Identifier application in your
MedKnowledge manual for an illustration of this step.
In this example, the HIC_SEQN is active and has not been replaced.

2. Retrieve the following values from the FDB Allergen to External Vocabulary Link Table
(RIMKFAE0_FDB_ALG_EXT_VOCAB_LNK):
IMK External Vocabulary Identifier (IMK_EXT_VOCAB_ID)
EVD External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID)
IMK External Vocabulary Description (IMK_EXT_VOCAB_DESC)
IMK FDB Vocabulary Description (IMK_FDB_VOCAB_DESC)
RxNorm RXCUI (EVD_RXN_RXCUI)
Link Inactive Date (LINK_INACTIVE_DATE)

where the IMK FDB Vocabulary Identifier (IMK_FDB_VOCAB_NO_ID) equals the given Hierarchical
Ingredient Code Sequence Code (HIC_SEQN) and the EVD FDB Vocabulary Type Identifier (
EVD_FDB_VOCAB_TYPE_ID) column equals 104 (HIC_SEQN).

IMK_FDB_VOCAB_NO_ID
EVD_FDB_VOCAB_TYPE_ID
IMK_EXT_VOCAB_ID
EVD_EXT_VOCAB_TYPE_ID
IMK_EXT_VOCAB_DESC
IMK_FDB_VOCAB_DESC
EVD_RXN_RXCUI
LINK_INACTIVE_DATE

3675 104 723 500 Amoxicillin Amoxicillin 723

3. If more than one row is returned from the previous step, choose the active link. Active links have null Link
Inactive Date (LINK_INACTIVE_DATE) values. If there is no active link available, choose the link with the
most recent LINK_INACTIVE_DATE.

In this example, one active link is returned.

ExampleRetrieving an External Allergen Interoperable Concept for a Given FDB Medication Name ID
(MED_NAME_ID)

For purposes of demonstrating this application, the following scenario is used: A patient's record shows an allergy
to Bactrim (MED_NAME_ID 5086) and electronic submission requires an interoperable concept identifier,
interoperable concept description, RXCUI, and HL7_OID.

1. Determine whether the FDB MedNameID (MED_NAME_ID) has been replaced by a different value. See
the Finding a Replacement MED Concept at Any Level of Specificity application in your MedKnowledge
manual for an illustration of this step.
In this example, the MED_NAME_ID is active and has not been replaced.

2. Retrieve the following values from the FDB Allergen to External Vocabulary Link Table
(RIMKFAE0_FDB_ALG_EXT_VOCAB_LNK):
IMK External Vocabulary Identifier (IMK_EXT_VOCAB_ID)
EVD External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID)
IMK External Vocabulary Description (IMK_EXT_VOCAB_DESC)
IMK FDB Vocabulary Description (IMK_FDB_VOCAB_DESC)

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RxNorm RXCUI (EVD_RXN_RXCUI)

Link Inactive Date (LINK_INACTIVE_DATE)

the IMK FDB Vocabulary Identifier (IMK_FDB_VOCAB_NO_ID) equals the given Medication Name
Identifier (MED_NAME_ID) and the EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID)
column equals 1 (MED_NAME_ID).

IMK_FDB_VOCAB_NO_ID
EVD_FDB_VOCAB_TYPE_ID
IMK_EXT_VOCAB_ID
EVD_EXT_VOCAB_TYPE_ID
IMK_EXT_VOCAB_DESC
IMK_FDB_VOCAB_DESC
EVD_RXN_RXCUI
LINK_INACTIVE_DATE

5086 1 151399 505 Bactrim Bactrim 151399

3. If more than one row is returned from the previous step, choose the active link. Active links have null Link
Inactive Date (LINK_INACTIVE_DATE) values. If there is no active link available, choose the link with the
most recent LINK_INACTIVE_DATE.

In this example, one active link is returned.

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Retrieving FDB Allergen Interoperable Concepts for a Given External Allergen Concept
This application illustrates how to use inbound external allergen concepts to retrieve FDB allergen concepts for
the clinical information reconciliation of allergens. FDB allergen concepts include the Specific Allergen Group
(DAM_ALRGN_GRP), Ingredient (HIC_SEQN), and Medication Name Identifier (MED_NAME_ID).

In general, use the following steps to translate inbound allergen information into FDB allergen concepts:

1. Receive external allergen code, description, and Object Identifier (OID) from an electronic submission.

2. Fetch all associated FDB allergy concepts for the external allergy information. For the sake of discussion,
we will refer to these as the candidate FDB allergen concepts.

3. Compare the candidate FDB allergen concepts to the patients medication allergy list.

a. If any of the concepts match, merge those concepts into the existing profile for the patient.

b. If none of the concepts match, use the FDB allergen concept with a Preferred Indicator value of 1
(Preferred) for the patients profile.

Use this application when an electronic submission is received that includes an interoperable concept identifier,
interoperable concept description, and an HL7 Object Identifier (OID).

1. Retrieve all EVD Vocabulary Type Identifier (EVD_VOCAB_TYPE_ID) from the Vocabulary Type to HL7
OID Link Table (RIMKVHO0_VOCAB_TYP_HL7_OID_LNK) where the HL7 OID (HL7_OID) value equals
the value of the HL7 OID received from the electronic submission.

2. Retrieve the following values from the External Allergen to FDB Link Table
(RIMKEAF0_EXT_ALG_FDB_VOCAB_LNK):
IMK FDB Vocabulary Identifier (IMK_FDB_VOCAB_NO_ID)
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID)
IMK FDB Vocabulary Description (IMK_FDB_VOCAB_DESC)
IMK Internal Vocabulary Description (IMK_EXT_VOCAB_DESC)
IMK Preferred Indicator (IMK_PREFERRED_IND)
IMK Related Indicator (IMK_RELATED_IND)
Link Inactive Date (LINK_INACTIVE_DATE)
where the IMK External Vocabulary Identifier (IMK_EXT_VOCAB_ID) value equals the given external
allergen concept and the EVD External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) equals
the value of the EVD_VOCAB_TYPE_ID retrieved in step 1, as follows:
If the HL7 OID represents a VA NDF-RT code, the EVD_EXT_VOCAB_TYPE_ID equals one of the
following:
530 (INGREDIENT_KIND as specified by NDF-RT).
531 (MECHANISM_OF_ACTION_KIND as specified by NDF-RT).
532 (PHYSIOLOGIC_EFFECT_KIND as specified by NDF-RT).
If the HL7 OID represents an NLM RxNorm RXCUI, the EVD_EXT_VOCAB_TYPE_ID equals one
of the following:

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500 (Ingredient [IN]).

505 (Brand Name [BN]).
506 (Precise Ingredient [PIN]).
512 (Multiple Ingredients [MIN]).
If the HL7 OID represents an FDA UNII code, the EVD_EXT_VOCAB_TYPE_ID equals 550 (UNII
Code as specified by MTHSPL).
If the HL7 OID represents a SNOMED CT identifier, the EVD_EXT_VOCAB_TYPE_ID equals 570
(SNOMED-CT).

3. If more than one row is returned from the previous step, choose the active link where the IMK Preferred
Indicator (IMK_PREFERRED_IND) equals 1 (Preferred). If no Preferred link is available, choose the active
link where the IMK Related Indicator (IMK_RELATED_IND) equals 1 (Linked using related Ingredients).

4. Active links have null Link Inactive Date (LINK_INACTIVE_DATE) values. If there is no active link
available, choose the link with the most recent LINK_INACTIVE_DATE.

ExampleRetrieving an FDB Allergen Interoperable Concept for a Given NDF-RT Code

For purposes of demonstrating this application, the following scenario is used: A hospitals admissions
department received an electronic Continuity of Care Document (CCD) for an inbound patient and NDF-RT
N0000011281 is identified as an allergen. The hospital uses First Databank as the drug formulary provider.

1. Retrieve all EVD Vocabulary Type Identifier (EVD_VOCAB_TYPE_ID) from the Vocabulary Type to HL7
OID Link Table (RIMKVHO0_VOCAB_TYP_HL7_OID_LNK) where the HL7 OID (HL7_OID) value equals
the value of the HL7 OID received from the electronic submission.

2. Retrieve the following values from the External Allergen to FDB Link Table
(RIMKEAF0_EXT_ALG_FDB_VOCAB_LNK):
IMK FDB Vocabulary Identifier (IMK_FDB_VOCAB_NO_ID)
EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID)
IMK FDB Vocabulary Description (IMK_FDB_VOCAB_DESC)
IMK Internal Vocabulary Description (IMK_EXT_VOCAB_DESC)
IMK Preferred Indicator (IMK_PREFERRED_IND)
IMK Related Indicator (IMK_RELATED_IND)
Link Inactive Date (LINK_INACTIVE_DATE)
where:
the IMK External Vocabulary Identifier (IMK_EXT_VOCAB_ID) value equals the given external
allergen concept and the EVD External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID)
equals 530 (INGREDIENT_KIND as specified by NDF-RT).

IMK_EXT_VOCAB_ID N0000011281

EVD_EXT_VOCAB_TYPE_ID 530

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IMK_FDB_VOCAB_NO_ID 476

EVD_FDB_VOCAB_TYPE_ID 110

IMK_FDB_VOCAB_DESC Penicillins

IMK_EXT_VOCAB_DESC Penicillins

IMK_PREFERRED_IND 1

IMK_RELATED_IND 0

LINK_INACTIVE_DATE

3. If more than one row is returned from the previous step, choose the active link where the IMK Preferred
Indicator (IMK_PREFERRED_IND) equals 1 (Preferred). If no Preferred link is available, choose the active
link where the IMK Related Indicator (IMK_RELATED_IND) equals 1 (Linked using related Ingredients).
In this example, one active link with an IMK_PREFERRED_IND value of 1 is returned.

4. Active links have null Link Inactive Date (LINK_INACTIVE_DATE) values. If there is no active link
available, choose the link with the most recent LINK_INACTIVE_DATE.
In this example, one active link is returned.

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Retrieving an HL7 Object Identifier (OID) for a Given Interoperable Concept Type
This application illustrates how to retrieve a Health Level Seven International (HL7) Object Identifier (OID) for a
given interoperable concept type, such as a Specific Allergen Group (DAM_ALRGN_GRP) from FDB or an
RxNorm RXCUI from the National Library of Medicine (NLM).

Use this application in conjunction with the Retrieving an External Allergen Interoperable Concept for a Given
FDB Allergen Concept application when an electronic submission requires an HL7 OID.

1. Retrieve the Interoperable Code HL7 Object Identifier (HL7_OID) and the Code HL7 Object Identifier (
HL7_OID_DESC) values from the Vocabulary Type to HL7 OID Link Table
(RIMKVHO0_VOCAB_TYP_HL7_OID_LNK) where the Vocabulary Type ID (EVD_VOCAB_TYPE_ID)
equals the External Vocabulary Type ID (EVD_EXT_VOCAB_TYPE_ID) value of the given vocabulary
type.

2. Retrieve the Interoperable Code HL7 Object Identifier (HL7_OID) and the Code HL7 Object Identifier (
HL7_OID_DESC) values from the Vocabulary Type to HL7 OID Link Table
(RIMKVHO0_VOCAB_TYP_HL7_OID_LNK) where the Vocabulary Type ID (EVD_VOCAB_TYPE_ID)
equals the EVD FDB Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) value of the given
vocabulary type.

3. For instances where the VOCAB_TYPE_IDs are used in an interoperable exchange, always use the OIDs
retrieved in the previous step.
The code snippet below shows a template for inputting the retrieved OIDs within a CDA document.

<code code=[IMK_EXT_VOCAB_ID]
displayName=[IMK_EXT_VOCAB_DESC]
codeSystem=[HL7_OID]
codeSystemName=[HL7_OID_DESC]>
<translation code=[IMK_FDB_VOCAB_NO_ID]
displayName=[IMK_FDB_VOCAB_DESC]
codeSystem=[HL7_OID]
codeSystemName=[HL7_OID_DESC]/>
</code>

4. For instances where the interoperable code value's RXCUI is to be used in an interoperable exchange
regardless of the vocabulary type, always use the HL7_OID value associated to RxNorm
(2.16.840.1.113883.6.88).

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<code code=[EVD_RXN_RXCUI]
displayName=[IMK_EXT_VOCAB_DESC]
codeSystem=2.16.840.1.113883.6.88
codeSystemName=NLM RxNorm>
<translation code=[IMK_FDB_VOCAB_NO_ID]
displayName=[IMK_FDB_VOCAB_DESC]
codeSystem=[HL7_OID]
codeSystemName=[HL7_OID_DESC]/>
</code>

ExampleRetrieving the OIDs for a VA NDF-RT and a FDB Specific Allergen Group Code (DAM_ALRGN_GRP) for Use
in a CDA Document

For purposes of demonstrating this application, the following scenario is used: An electronic submission
requires an interoperable concept identifier, interoperable concept description, RXCUI, and HL7_OID. All other
information was gathered with the exception of the HL7_OID, which is required in the interoperable exchange. In
this example, the following information has been gathered:

IMK_FDB EVD_FDB IMK_EXT EVD_EXT IMK_FDB IMK_EXT EVD LINK_

_VOCAB _VOCAB _VOCAB_ID _VOCAB _VOCAB _VOCAB _RXN INACTIVE
_NO_ID _TYPE_ID _TYPE_ID _DESC _DESC _RXCUI _DATE

476 110 N000001128 530 Penicillins Penicillins 7986

1

OIDs are required to represent the NLM RXCUI (EVD_EXT_VOCAB_TYPE_ID = 530) and the FDB
DAM_ALRGN_GRP (EVD_FDB_VOCAB_TYPE_ID = 110).

1. Retrieve the Interoperable Code HL7 Object Identifier (HL7_OID) and the Code HL7 Object Identifier (
HL7_OID_DESC) values from the Vocabulary Type to HL7 OID Link Table (RIMKVS0_SCT_VALUE_SET)
where the Vocabulary Type Identifier (EVD_VOCAB_TYPE_ID) equals 530 (INGREDIENT_KIND as
specified by NDF-RT).

VOCAB_TYPE_ID HL7_OID HL7_OID_DESC

530 2.16.840.1.113883.3.26.1.5 VA NDF-RT

2. Retrieve the Interoperable Code HL7 Object Identifier (HL7_OID) and the Code HL7 Object Identifier (
HL7_OID_DESC) values from the Vocabulary Type to HL7 OID Link Table (RIMKVS0_SCT_VALUE_SET)
where the Vocabulary Type ID (EVD_VOCAB_TYPE_ID) equals 110.

3. For instances where the INGREDIENT_KIND or the DAM_ALRGN_GRP are used in an interoperable
exchange, always use the OIDs retrieved in the previous steps.
The code snippet below shows an example for inputting the retrieved OIDs within a CDA document.

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<code code=N0000011281
displayName=Penicillins
codeSystem=2.16.840.1.113883.3.26.1.5
codeSystemName=VA NDF-RT>
<translation code=476
displayName=Penicillins
codeSystem=2.16.840.1.113883.4.296
codeSystemName=DAM_ALRGN_GRP/>
</code>

For instances where the interoperable code value's RXCUI is to be used in an interoperable exchange
regardless of the vocabulary type, always use the HL7_OID value associated to RxNorm
(2.16.840.1.113883.6.88).

<code code=7986displayName=Penicillins
codeSystem=2.16.840.1.113883.6.88
codeSystemName=NLM RxNorm>
<translation code=476
displayName=Penicillins
codeSystem=2.16.840.1.113883.4.296
codeSystemName=DAM_ALRGN_GRP/>
</code>

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Documenting Food or Environmental Allergies Using SNOMED CT Concepts

This application illustrates how to retrieve SNOMED CT value sets for use in patient allergy profiles and
Continuity of Care Documents (CCD). This application can be used for retrieving commonly used terms within a
user interface that is designed for adding information to a patients allergy profile. For example, drop-down menus
that include more common selections can be provided to the user.

There are four elements to retrieve for documenting the allergy:

SNOMED CT Allergen Concept, either a Food (such as eggs) or an Environmental Allergy (such as latex)
Patients reaction (such as dermatitis)
Severity of the reaction (such as moderate)
Type of event (such as food allergy)

1. Retrieve the SNOMED CT Concept Identifier, SNOMED CT Description Identifier, SNOMED CT Term, and
SNOMED CT Type Identifier for each of these elements (as outlined in Parts 1-4 below).

2. Store the SNOMED CT information retrieved in the previous step along with the HL7 Object Identifier (OID)
in the patients allergy profile. (See Retrieving an HL7 Object Identifier (OID) for a Given Interoperable
Concept Type for more information about retrieving an HL7 OID.)

3. Add the information retrieved above into the patients allergy profile for external reporting.

Optionally, you can retrieve and store the related FDB concepts (DXID, DAM Allergen Group,
HICSEQN) for the SNOMED CT concept using the SNOMED CT to FDB Link Table
(RIMKSVF0_SCT_FDB_VOCAB_LNK).

Part 1: Retrieve SNOMED CT Allergen Concept for Documenting a Patients Allergy

1. Retrieve the following columns from the SNOMED CT Value Set Table (RIMKVS0_SCT_VALUE_SET)
where the IMK SNOMED CT Value Set Identifier (IMK_SCT_VALUE_SET_ID) equals 4 (Foods) or 5
(Environmental Agents):
SNOMED CT Concept Identifier (SCT_CONCEPT_ID)
SNOMED CT Description Identifier (SCT_DESCRIPTION_ID)
SNOMED CT Term (SCT_TERM)
SNOMED CT Type Identifier (SCT_TYPE_ID)

2. Search the SNOMED CT Term (SCT_TERM) column for the food or environmental agent using the results
of step 1.

3. Add the SNOMED CT Concept Identifier (SCT_CONCEPT_ID) value for the retrieved concept to the
patients allergy profile.

Part 2: Document Patient Reaction Using Most Common SNOMED CT Concepts

1. Retrieve the following columns from the SNOMED CT Value Set Table (RIMKVS0_SCT_VALUE_SET)
where the IMK SNOMED CT Value Set Identifier (IMK_SCT_VALUE_SET_ID) equals 3 (Reactions):

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1.

SNOMED CT Concept Identifier (SCT_CONCEPT_ID)

SNOMED CT Description Identifier (SCT_DESCRIPTION_ID)
SNOMED CT Term (SCT_TERM)
SNOMED CT Type Identifier (SCT_TYPE_ID)

2. Search the SNOMED CT Term (SCT_TERM) column for the reactions needed for the patients profile or
CCD using the results of step 1.

3. Add the SNOMED CT Concept Identifier (SCT_CONCEPT_ID) value for the retrieved concept to the
patients allergy profile.

Part 3: Document Event Type

1. Retrieve the following columns from the SNOMED CT Value Set Table (RIMKVS0_SCT_VALUE_SET)
where the IMK SNOMED CT Value Set Identifier (IMK_SCT_VALUE_SET_ID) equals 2 (Allergy/Adverse
Event Type):
SNOMED CT Concept Identifier (SCT_CONCEPT_ID)
SNOMED CT Description Identifier (SCT_DESCRIPTION_ID)
SNOMED CT Term (SCT_TERM)
SNOMED CT Type Identifier (SCT_TYPE_ID)

2. Search the SNOMED CT Term (SCT_TERM) column for the event type needed for the patients allergy
profile using the results of step 1.

3. Add the SNOMED CT Concept Identifier (SCT_CONCEPT_ID) value for the retrieved concept to the
patients allergy profile.

Part 4: Document Problem Severity

1. Retrieve the following columns from the SNOMED CT Value Set Table (RIMKVS0_SCT_VALUE_SET)
where the IMK SNOMED CT Value Set Identifier (IMK_SCT_VALUE_SET_ID) equals 1 (Problem
Severity):
SNOMED CT Concept Identifier (SCT_CONCEPT_ID)
SNOMED CT Description Identifier (SCT_DESCRIPTION_ID)
SNOMED CT Term (SCT_TERM)
SNOMED CT Type Identifier (SCT_TYPE_ID)

2. Search the SNOMED CT Term (SCT_TERM) column for the problem severity needed for the patients
profile using the results of step 1.

3. Add the SNOMED CT Concept Identifier (SCT_CONCEPT_ID) value for the retrieved concept to the
patients allergy profile.

Part 5: Store and Reproduce for External Reporting

1. Store the SNOMED CT information retrieved in the previous step along with the HL7 Object Identifier (OID)
in the patients allergy profile. (See Retrieving an HL7 Object Identifier (OID) for a Given Interoperable

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1.

Concept Type for more information about retrieving an HL7 OID.)

2. Add the information retrieved above into the patients allergy profile for external reporting.

Optionally, you can retrieve and store the related FDB concepts (DXID, DAM Allergen Group,
HICSEQN) for the SNOMED CT concept using the SNOMED CT to FDB Link Table
(RIMKSVF0_SCT_FDB_VOCAB_LNK).

ExampleRetrieving SNOMED CT Concepts to Identify a Food Allergen

For purposes of demonstrating this application, the following scenario is used: A clinic nurse needs to
update a patient's allergy profile to include a moderate food allergy reaction to eggs where the patients reactions
included nausea and swelling of the throat and tongue.

Part 1: Retrieve SNOMED CT Allergen Concept for Documenting a Patients Allergy

1. Retrieve the following columns from the SNOMED CT Value Set Table (RIMKVS0_SCT_VALUE_SET)
where the IMK SNOMED CT Value Set Identifier (IMK_SCT_VALUE_SET_ID) equals 4 (Foods):
SNOMED CT Concept Identifier (SCT_CONCEPT_ID)
SNOMED CT Description Identifier (SCT_DESCRIPTION_ID)
SNOMED CT Term (SCT_TERM)
SNOMED CT Type Identifier (SCT_TYPE_ID)

2. Search the SNOMED CT Term (SCT_TERM) column for eggs using the results of step 1.

IMK_SCT_V IMK_SCT_V SCT_TYPE_I SCT_TYPE_ SCT_CONCE SCT_DESCR SCT_TERM

ALUE_SET_I ALUE_SET_ D DESC PT_ID IPTION_ID
D DESC

4 Foods 1 Preferred 102263004 165406014 Eggs (edible)

The IMK_SCT_VALUE_SET_DESC and the SCT_TYPE_DESC are shown for descriptive

purposes.

The IMK_SCT_VALUE_SET_DESC column is in the SNOMED CT Value Set Description

Table (RIMKVSD0_SCT_VALUE_SET_DESC).
The SCT_TYPE_DESC column is in the SNOMED CT Type Description Table
(RIMKTD0_SCT_TYPE_DESC).

3. Add the SNOMED CT Concept Identifier (SCT_CONCEPT_ID) value of 102263004 to the patients allergy
profile.

Part 2: Document Patient Reaction Using Most Common SNOMED CT Concepts

1. Retrieve the following columns from the SNOMED CT Value Set Table (RIMKVS0_SCT_VALUE_SET)
where the IMK SNOMED CT Value Set Identifier (IMK_SCT_VALUE_SET_ID) equals 3 (Reactions):

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1.

SNOMED CT Concept Identifier (SCT_CONCEPT_ID)

SNOMED CT Description Identifier (SCT_DESCRIPTION_ID)
SNOMED CT Term (SCT_TERM)
SNOMED CT Type Identifier (SCT_TYPE_ID)

2. Search the SNOMED CT Term (SCT_TERM) column for the reactions needed for the patients profile
using the results of step 1. In this example, the reactions included nausea, tongue swelling, and swelling of
the throat.

IMK_SCT_V IMK_SCT_V SCT_TYPE_I SCT_TYPE_ SCT_CONCE SCT_DESCR SCT_TERM

ALUE_SET_I ALUE_SET_ D DESC PT_ID IPTION_ID
D DESC

3 Reactions 1 Preferred 422587007 2643930014 Nausea

3 Reactions 2 Synonym 102617004 165948012 Swelling of

throat

3 Reactions 1 Preferred 421262002 2616927018 Tongue

swelling

3. Add the SNOMED CT Concept Identifier (SCT_CONCEPT_ID) values of 422587007, 102617004, and
421262002 to the patients allergy profile.

Part 3: Document Event Type

1. Retrieve the following columns from the SNOMED CT Value Set Table (RIMKVS0_SCT_VALUE_SET)
where the IMK SNOMED CT Value Set Identifier (IMK_SCT_VALUE_SET_ID) equals 2 (Allergy/Adverse
Event Type):
SNOMED CT Concept Identifier (SCT_CONCEPT_ID)
SNOMED CT Description Identifier (SCT_DESCRIPTION_ID)
SNOMED CT Term (SCT_TERM)
SNOMED CT Type Identifier (SCT_TYPE_ID)

2. Search the SNOMED CT Term (SCT_TERM) column for the event type needed for the patients profile
using the results of step 1. In this example, the patient has a food allergy.

IMK_SCT_V IMK_SCT_V SCT_TYPE_I SCT_TYPE_ SCT_CONCE SCT_DESCR SCT_TERM

ALUE_SET_I ALUE_SET_ D DESC PT_ID IPTION_ID
D DESC

2 Allergy/Adver 1 Preferred 414285001 2534292019 Food allergy

se Event Type

3. Add the SNOMED CT Concept Identifier (SCT_CONCEPT_ID) value of 414285001 to the patients allergy
profile.

Part 4: Document Problem Severity

1. Retrieve the following columns from the SNOMED CT Value Set Table (RIMKVS0_SCT_VALUE_SET)

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1.
where the IMK SNOMED CT Value Set Identifier (IMK_SCT_VALUE_SET_ID) equals 1 (Problem
Severity):
SNOMED CT Concept Identifier (SCT_CONCEPT_ID)
SNOMED CT Description Identifier (SCT_DESCRIPTION_ID)
SNOMED CT Term (SCT_TERM)
SNOMED CT Type Identifier (SCT_TYPE_ID)

2. Search the SNOMED CT Term (SCT_TERM) column for the problem severity needed for the patients
profile using the results of step 1. In this example, the patient had a moderate reaction.

IMK_SCT_V IMK_SCT_V SCT_TYPE_I SCT_TYPE_ SCT_CONCE SCT_DESCR SCT_TERM

ALUE_SET_I ALUE_SET_ D DESC PT_ID IPTION_ID
D DESC

1 Problem 1 Preferred 6736007 12164010 Moderate

Severity

3. Add the SNOMED CT Concept Identifier (SCT_CONCEPT_ID) values of 6736007 to the patients allergy
profile.

Part 5: Store and Reproduce for External Reporting

1. Store the SNOMED CT information retrieved in the previous step along with the HL7 Object Identifier (OID)
in the patients allergy profile. (See Retrieving an HL7 Object Identifier (OID) for a Given Interoperable
Concept Type for more information about retrieving an HL7 OID.)

2. Add the information retrieved above into the patients allergy profile for external reporting.

Optionally, you can retrieve and store the related FDB concepts (DXID, DAM Allergen Group,
HICSEQN) for the SNOMED CT concept using the SNOMED CT to FDB Link Table
(RIMKSVF0_SCT_FDB_VOCAB_LNK).

ExampleRetrieving a SNOMED CT Concept to Identify an Environmental Allergen

For purposes of demonstrating this application, the following scenario is used: A clinic nurse needs to update a
patient's allergy profile to include a mild to moderate reaction to Latex where the patients reactions included
Dermatitis from contact with latex.

Part 1: Retrieve SNOMED CT Allergen Concept for Documenting a Patients Allergy

1. Retrieve the following columns from the SNOMED CT Value Set Table (RIMKVS0_SCT_VALUE_SET)
where the IMK SNOMED CT Value Set Identifier (IMK_SCT_VALUE_SET_ID) equals 4 (Foods):
SNOMED CT Concept Identifier (SCT_CONCEPT_ID)
SNOMED CT Description Identifier (SCT_DESCRIPTION_ID)
SNOMED CT Term (SCT_TERM)
SNOMED CT Type Identifier (SCT_TYPE_ID)

2.

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2. Search the SNOMED CT Term (SCT_TERM) column for latex using the results of step 1.

IMK_SCT_V IMK_SCT_V SCT_TYPE_I SCT_TYPE_ SCT_CONCE SCT_DESCR SCT_TERM

ALUE_SET_I ALUE_SET_ D DESC PT_ID IPTION_ID
D DESC

5 Environmental 1 Preferred 111088007 177133019 Latex

Agents

The IMK_SCT_VALUE_SET_DESC and the SCT_TYPE_DESC are shown for descriptive

purposes.

The IMK_SCT_VALUE_SET_DESC column is in the SNOMED CT Value Set Description

Table (RIMKVSD0_SCT_VALUE_SET_DESC).
The SCT_TYPE_DESC column is in the SNOMED CT Type Description Table
(RIMKTD0_SCT_TYPE_DESC).

3. Add the SNOMED CT Concept Identifier (SCT_CONCEPT_ID) value of 111088007 to the patients allergy
profile.

Part 2: Document Patient Reaction Using Most Common SNOMED CT Concepts

1. Retrieve the following columns from the SNOMED CT Value Set Table (RIMKVS0_SCT_VALUE_SET)
where the IMK SNOMED CT Value Set Identifier (IMK_SCT_VALUE_SET_ID) equals 3 (Reactions):
SNOMED CT Concept Identifier (SCT_CONCEPT_ID)
SNOMED CT Description Identifier (SCT_DESCRIPTION_ID)
SNOMED CT Term (SCT_TERM)
SNOMED CT Type Identifier (SCT_TYPE_ID)

2. Search the SNOMED CT Description (SCT_TERM) column for the reactions needed for the patients
profile using the results of step 1. In this example, the reaction resulted in Dermatitis from contact with the
allergen (Contact Dermatitis).

IMK_SCT_V IMK_SCT_V SCT_TYPE_I SCT_TYPE_ SCT_CONCE SCT_DESCR SCT_TERM

ALUE_SET_I ALUE_SET_ D DESC PT_ID IPTION_ID
D DESC

3 Reactions 1 Preferred 24079001 40423010 Atopic

dermatitis

3 Reactions 1 Preferred 40275004 63652013 Contact

dermatitis

3 Reactions 1 Preferred 182782007 282571017 Dermatitis

3 Reactions 2 Synonym 399992009 1787060018 Exfoliative

dermatitis

3. Add the SNOMED CT Concept Identifier (SCT_CONCEPT_ID) value of 40275004 (Contact dermatitis) to

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3.

the patients allergy profile.

Part 3: Document Event Type

1. Retrieve the following columns from the SNOMED CT Value Set Table (RIMKVS0_SCT_VALUE_SET)
where the IMK SNOMED CT Value Set Identifier (IMK_SCT_VALUE_SET_ID) equals 2 (Allergy/Adverse
Event Type):
SNOMED CT Concept Identifier (SCT_CONCEPT_ID)
SNOMED CT Description Identifier (SCT_DESCRIPTION_ID)
SNOMED CT Term (SCT_TERM)
SNOMED CT Type Identifier (SCT_TYPE_ID)

2. Search the SNOMED CT Term (SCT_TERM) column for the event type needed for the patients profile
using the results of step 1. In this example, the patient is allergic to a particular substance.

IMK_SCT_V IMK_SCT_V SCT_TYPE_I SCT_TYPE_ SCT_CONCE SCT_DESCR SCT_TERM

ALUE_SET_I ALUE_SET_ D DESC PT_ID IPTION_ID
D DESC

2 Allergy/Adver 1 Preferred 419199007 2576504018 Allergy to

se Event Type substance

3. Add the SNOMED CT Concept Identifier (SCT_CONCEPT_ID) value of 419199007 to the patients allergy
profile.

Part 4: Document Problem Severity

1. Retrieve the following columns from the SNOMED CT Value Set Table (RIMKVS0_SCT_VALUE_SET)
where the IMK SNOMED CT Value Set Identifier (IMK_SCT_VALUE_SET_ID) equals 1 (Problem
Severity):
SNOMED CT Concept Identifier (SCT_CONCEPT_ID)
SNOMED CT Description Identifier (SCT_DESCRIPTION_ID)
SNOMED CT Term (SCT_TERM)
SNOMED CT Type Identifier (SCT_TYPE_ID)

2. Search the SNOMED CT Term (SCT_TERM) column for the problem severity needed for the patients
profile using the results of step 1. In this example, the patient had a mild to moderate reaction.

IMK_SCT_V IMK_SCT_V SCT_TYPE_I SCT_TYPE_ SCT_CONCE SCT_DESCR SCT_TERM

ALUE_SET_I ALUE_SET_ D DESC PT_ID IPTION_ID
D DESC

1 Problem 1 Preferred 371923003 1210513019 Mild to

Severity moderate

3. Add the SNOMED CT Concept Identifier (SCT_CONCEPT_ID) values of 371923003 to the patients
allergy profile.

Part 5: Store and Reproduce for External Reporting

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1. Store the SNOMED CT information retrieved in the previous step along with the HL7 Object Identifier (OID)
in the patients allergy profile. (See Retrieving an HL7 Object Identifier (OID) for a Given Interoperable
Concept Type for more information about retrieving an HL7 OID.)

2. Add the information retrieved above into the patients allergy profile for external reporting.

Optionally, you can retrieve and store the related FDB concepts (DXID, DAM Allergen Group,
HICSEQN) for the SNOMED CT concept using the SNOMED CT to FDB Link Table
(RIMKSVF0_SCT_FDB_VOCAB_LNK).

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Problem|Reaction (SNOMED) Interoperability Applications

Retrieving an Active SNOMED CT Clinical Finding Using the Term Description Field

Retrieving an Active SNOMED CT Description for a Given SNOMED CT Concept Identifier

Retrieving an Active SNOMED CT Description for a Given SNOMED CT Description Identifier

Retrieving Active Child SNOMED CT Concept Identifiers

Retrieving Active Parent SNOMED CT Concept Identifiers

Retrieving a Single Description for a SNOMED CT Concept Identifier

Retrieving a SNOMED CT Concept Identifiers Associated DXIDs

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Retrieving an Active SNOMED CT Clinical Finding Using the Term Description Field
This application illustrates how to retrieve the SNOMED CT Concept Description Identifier for a clinical finding by
using the term description. (A clinical finding is the SNOMED CT hierarchy concept representing clinical
observation, assessment, or judgment.)
Retrieve the NLM Concept Identifier (NLM_CONCEPT_ID), the NLM Description Identifier (
NLM_DESCRIPTION_ID), NLM Type Identifier (NLM_TYPE_ID) and NLM Terminology (NLM_TERM)
values from the NLM SNOMED CT Concept Description Table (RIMKSD0_NLM_SCT_CONCEPT_DESC)
where the NLM Terminology (NLM_TERM) value contains the term description requested. Select the
appropriate SNOMED CT Concept Description Identifier for the clinical finding from the list provided.

ExampleRetrieving an Active SNOMED CT Clinical Finding Using the Term Description Field

For purposes of demonstrating this application, the following scenario is used: A provider is adding an
adverse drug interaction to a patients medical record and needs to identify an applicable SNOMED CT
Description Identifier representing the reaction.

1. Retrieve the NLM Concept Identifier (NLM_CONCEPT_ID) value from the NLM SNOMED CT Concept
Description Table (RIMKSD0_NLM_SCT_CONCEPT_DESC) where:
The NLM Terminology (NLM_TERM) contains the text Adverse Drug Interaction.
The Active Indicator (NLM_ACTIVE_IND) value equals 1 (active).
The NLM Type Identifier (NLM_TYPE_ID) can be optionally equal to either:
900000000000003001 (fully specified name)
900000000000013009 (synonym)

NLM_TERM NLM_CONCEPT NLM_ACTIVE_I NLM_TYPE_ID NLM_DESCRIPT

_ID ND ION_ID

Adverse drug 448090008 1 90000000000000 2897230018

interaction with 3001
food (disorder)

Adverse drug 448090008 1 90000000000001 2900560013

interaction with 3009
food

Adverse drug 448091007 1 90000000000000 2897231019

interaction with 3001
alcohol (disorder)

Adverse drug 448091007 1 90000000000001 2900561012

interaction with 3009
alcohol

Adverse drug 448177004 1 90000000000000 2898895017

interaction 3001
(disorder)

Adverse drug 448177004 1 90000000000001 2900450018

interaction 3009

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Adverse drug 448178009 1 90000000000000 2898896016

interaction with 3001
drug (disorder)

Adverse drug 448178009 1 90000000000001 2900451019

interaction with 3009
drug

2. Select the corresponding NLM Description Identifier (NLM_DESCRIPTION_ID) for the appropriate clinical
finding.

NLM_TERM NLM_CONCEPT_ID NLM_ACTIVE_IND NLM_TYPE_ID NLM_DESCRIPTION_ID

Adverse drug 448178009 1 9000000000000030 2898896016

interaction with drug 01
(disorder)

Alternatively, the NLM Concept Identifier (NLM_CONCEPT_ID) can be selected for

documentation.

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Retrieving an Active SNOMED CT Description for a Given SNOMED CT Concept Identifier

This application illustrates how to retrieve a SNOMED CT description using the SNOMED CT Concept Identifier.

1. Retrieve the NLM Concept Identifier (NLM_CONCEPT_ID), NLM Description Identifier (

NLM_DESCRIPTION_ID), and NLM Terminology (NLM_TERM) values from the NLM SNOMED CT
Concept Description Table (RIMKSD0_NLM_SCT_CONCEPT_DESC) where the NLM Concept Identifier (
NLM_CONCEPT_ID) value equals the given SNOMED CT Concept Identifier.

2. Select the appropriate SNOMED CT description from the NLM Terminology ( NLM_TERM) value(s)
retrieved.

ExampleRetrieving a SNOMED CT Description for a SNOMED CT Concept Identifier

For purposes of demonstrating this application, the following scenario is used: A provider received
SNOMED CT Concept Identifier 38341003 and wants the fully specified term it represents.

1. Retrieve the NLM Description Identifier (NLM_DESCRIPTION_ID), and NLM Terminology (NLM_TERM)
values from the NLM SNOMED CT Concept Description Table (RIMKSD0_NLM_SCT_CONCEPT_DESC)
where:

The NLM Concept Identifier (NLM_CONCEPT_ID) value equals the given SNOMED CT Concept
Identifier value of 38341003.
The Active Indicator (NLM_ACTIVE_IND) is optionally set to 1 (active).
The NLM Type Identifier (NLM_TYPE_ID) is optionally set to either:
900000000000003001 (fully specified name)
900000000000013009 (synonym)

NLM_CONCEPT_ID NLM_ACTIVE_IND NLM_TYPE_ID NLM_DESCRIPTIO NLM_TERM

N_ID

38341003 1 9000000000000030 1202949014 Hypertensive

01 disorder, systemic
arterial (disorder)

38341003 0 9000000000000030 773296011 Raised blood

01 pressure (disorder)

38341003 1 9000000000000130 1215744012 Hypertensive

09 disorder

38341003 1 9000000000000130 490276019 Raised blood

09 pressure

38341003 1 9000000000000130 64176011 Hypertension

09

38341003 0 9000000000000130 64168014 Hypertensive

09 disease

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38341003 1 9000000000000130 64171018 Hyperpiesis

09

38341003 1 9000000000000130 64172013 High blood pressure

09

2. Select the appropriate SNOMED CT description from the NLM Terminology ( NLM_TERM) values
retrieved. In this example, the only active fully specified name is Hypertensive disorder, systemic arterial
(disorder).

NLM_CONCEPT_ID NLM_ACTIVE_IND NLM_TYPE_ID NLM_DESCRIPTIO NLM_TERM

N_ID

38341003 1 9000000000000030 1202949014 Hypertensive

01 disorder, systemic
arterial (disorder)

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Retrieving an Active SNOMED CT Description for a Given SNOMED CT Description Identifier

This application illustrates how to retrieve the SNOMED CT description for a given SNOMED CT Description
Identifier.
Retrieve the NLM Description Identifier (NLM_DESCRIPTION_ID) and NLM Terminology (NLM_TERM)
values from the SNOMED CT Concept Type Description Table (RIMKSD0_NLM_SCT_CONCEPT_DESC)
where the NLM Description Identifier (NLM_DESCRIPTION_ID) value equals the given SNOMED CT
Description Identifier.

ExampleRetrieving a SNOMED CT Description for a SNOMED CT Description Identifier

For purposes of demonstrating this application, the following scenario is used: A provider received
SNOMED CT Description Identifier 64172013 and wants to determine what it represents.

Retrieve the NLM Terminology (NLM_TERM) value from the NLM SNOMED CT Concept Description
Table (RIMKSD0_NLM_SCT_CONCEPT_DESC) where:
The NLM Description Identifier (NLM_DESCRIPTION_ID) value equals the given SNOMED CT
Description Identifier value of 64172013.
The NLM Active Indicator (NLM_ACTIVE_IND) value equals 1 (active).

NLM_DESCRIPTION_ID NLM_ACTIVE_IND NLM_TERM

64172013 1 High blood pressure

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Retrieving Active Child SNOMED CT Concept Identifiers

This application illustrates how to retrieve the child SNOMED CT Concept Identifier for a given parent SNOMED
CT Concept Identifier. Each concept in SNOMED CT is logically defined through its relationships to other
concepts. A concept can have more than one is a relationship to other concepts.

1. Retrieve the NLM Source Identifier (NLM_SOURCE_ID) and NLM Destination Identifier (
NLM_DESTINATION_ID) values from the NLM SNOMED CT Relationship Table
(RIMKSRS0_NLM_SCT_RELATIONSHIP) where:
The NLM Destination Identifier (NLM_DESTINATION_ID) value equals the parent SNOMED CT
Concept Identifier value.
The NLM Type Identifier (NLM_TYPE_ID) equals 116680003, representing the is a relationship.
The NLM Active Indicator (NLM_ACTIVE_IND) equals 1 (active).

2. Retrieve the NLM Term (NLM_TERM) from the NLM SNOMED CT Concept Description Table
(RIMKSD0_NLM_SCT_CONCEPT_DESC) where the NLM Concept Identifier (NLM_CONCEPT_ID)
equals the NLM Source Identifier (NLM_SOURCE_ID) retrieved in the previous step. See Retrieving an
Active SNOMED CT Description for a Given SNOMED CT Concept Identifier for additional instruction
about retrieving the description.

ExampleRetrieve an Active Child SNOMED CT Concept Identifier

For purposes of demonstrating this application, the following scenario is used: A provider received a
SNOMED CT Concept Identifier for pneumonia (233604007) and wants to obtain a child SNOMED CT Concept
Identifier.

This example represents three levels from the SNOMED CT Concept Identifier provided. Additional
relationships may exist.

Part 1: Retrieve a Child SNOMED CT Concept Identifier

1. Retrieve the NLM Source Identifier (NLM_SOURCE_ID) value from the NLM SNOMED CT Relationship
Table (RIMKSRS0_NLM_SCT_RELATIONSHIP) where:
The NLM Destination Identifier (NLM_DESTINATION_ID) column equals 233604007 (researched
SNOMED CT Concept Identifier).
The NLM Type Identifier (NLM_TYPE_ID) value equals 116680003 (is a relationship).
The NLM Active Indicator (NLM_ACTIVE_IND) equals 1 (active).

NLM_DESTINATION_ID NLM_TYPE_ID NLM_ACTIVE_IND NLM_SOURCE_ID

233604007 116680003 1 41207000

233604007 116680003 1 274103002

233604007 116680003 1 312342009

233604007 116680003 1 385093006

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The example above shows a partial list of the results of this step.

2. Retrieve the NLM Term (NLM_TERM) from the NLM SNOMED CT Concept Description Table
(RIMKSD0_NLM_SCT_CONCEPT_DESC) where:
The NLM Type Identifier (NLM_TYPE_ID) equals 900000000000003001 (fully specified named
terms).
The NLM Concept Identifier (NLM_CONCEPT_ID) equals the NLM Source Identifier (
NLM_SOURCE_ID) retrieved in the previous step.

NLM_TYPE_ID NLM_CONCEPT_ID NLM_TERM

900000000000003001 41207000 Adenoviral pneumonia (disorder)

900000000000003001 274103002 Pneumonia NOS (disorder)

900000000000003001 312342009 Infective pneumonia (disorder)

3. Select the appropriate NLM CONCEPT Identifier (NLM_CONCEPT_ID) from the selection provided in step
2. For purposes of this application, NLM Concept Identifier 312342009 (infective pneumonia [disorder]) will
be used.

NLM_TYPE_ID NLM_CONCEPT_ID NLM_TERM

900000000000003001 312342009 Infective pneumonia (disorder)

Part 2: Substitute Values to Retrieve Child Concept Identifier

Repeat steps 1 3 of Part 1, substituting the NLM Destination Identifier (NLM_DESTINATION_ID) value
with the newly-retrieved child SNOMED CT Concept Identifier ( NLM_CONCEPT_ID) value selected (
312342009) until the specific concept is identified or no child values remain. Results provide a collection of
related, more specific SNOMED CT values.

NLM_SOURCE_ID NLM_DESTINATION_ID NLM_TERM

53084003 312342009 Bacterial pneumonia (disorder)

NLM_SOURCE_ID NLM_DESTINATION_ID NLM_TERM

420544002 53084003 Bacterial pneumonia associated with

AIDS (disorder)

The following diagram illustrates the relationship of these example values:

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Retrieving Active Parent SNOMED CT Concept Identifiers

This application illustrates how to retrieve the child SNOMED CT Concept Identifier for a given parent SNOMED
CT Concept Identifier. Each concept in SNOMED CT is logically defined through its relationships to other
concepts. A concept can have more than one is a relationship to other concepts.

1. Retrieve the NLM Source Identifier (NLM_SOURCE_ID) and NLM Destination Identifier (
NLM_DESTINATION_ID) values from the NLM SNOMED CT Relationship Table
(RIMKSRS0_NLM_SCT_RELATIONSHIP) where:
The NLM Destination Identifier (NLM_DESTINATION_ID) value equals the parent SNOMED CT
Concept Identifier value.
The NLM Type Identifier (NLM_TYPE_ID) equals 116680003, representing the is a relationship.
The NLM Active Indicator (NLM_ACTIVE_IND) equals 1 (active).

2. Retrieve the NLM Term (NLM_TERM) from the NLM SNOMED CT Concept Description Table
(RIMKSD0_NLM_SCT_CONCEPT_DESC) where the NLM Concept Identifier (NLM_CONCEPT_ID)
equals the NLM Source Identifier (NLM_SOURCE_ID) retrieved in the previous step. See Retrieving an
Active SNOMED CT Description for a Given SNOMED CT Concept Identifier for additional instruction
about retrieving the description.

ExampleRetrieve an Active Parent SNOMED CT Concept Identifier

For purposes of demonstrating this application, the following scenario is used: A physician received a
SNOMED CT Concept Identifier for Feltys syndrome (57160007) and wants to obtain an associated parent
SNOMED CT Concept Identifier.

This example represents three levels from the SNOMED CT Concept Identifier provided. Additional
relationships may exist.

Part 1: Retrieve the parent SNOMED CT Identifier(s)

1. Retrieve the NLM Destination Identifier (NLM_DESTINATION_ID) from the NLM SNOMED CT
Relationship Table (RIMKSRS0_NLM_SCT_RELATIONSHIP) where:
The NLM Source Identifier (NLM_SOURCE_ID) value equals 57160007 (the child SNOMED
Concept Identifier).
The NLM Type Identifier (NLM_TYPE_ID) value equals 116680003 (the is a relationship).
The NLM Active Indicator (NLM_ACTIVE_IND) value equals 1 (active).

NLM_SOURCE_ID NLM_TYPE_ID NLM_ACTIVE_ID NLM_DESTINATION_ID

57160007 116680003 1 69896004

2. Retrieve the NLM Term (NLM_TERM) value from the NLM SNOMED CT Concept Description Table
(RIMKSD0_NLM_SCT_CONCEPT_DESC) where:
The NLM Type Identifier (NLM_TYPE_ID) value equals 900000000000003001 (fully specified

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name).
The NLM Concept Identifier (NLM_CONCEPT_ID) value equals the NLM Destination Identifier (
NLM_DESTINATION_ID) value retrieved in the previous step.

NLM_TYPE_ID NLM_CONCEPT_ID NLM_TERM

900000000000003001 69896004 Rheumatoid arthritis (disorder)

3. Select the appropriate SNOMED CONCEPT Identifier (NLM_CONCEPT_ID) from the results provided in
step 2.

NLM_TYPE_ID NLM_CONCEPT_ID NLM_TERM

900000000000003001 69896004 Rheumatoid arthritis (disorder)

Part 2: Substitute Values to Retrieve Parent Concept Identifier

Repeat steps 1 3 from Part 1, substituting the NLM Source Identifier ( NLM_SOURCE_ID) value with the
newly-retrieved parent SNOMED CT Concept Identifier (NLM_CONCEPT_ID) value selected until the
specific concept is identified or no parent values remain. Results provide a collection of related, less
specific SNOMED CT values.

NLM_SOURCE_ID NLM_DESTINATION_ID NLM_TERM

69896004 85828009 Autoimmune disease (disorder)

69896004 53338001 Arthropathy associated with a

hypersensitivity reaction (disorder)

69896004 3723001 Arthritis (disorder)

NLM_SOURCE_ID NLM_DESTINATION_ID NLM_TERM

3723001 128139000 Inflammatory disorder (disorder)

The following diagram illustrates the relationship of these example values:

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Retrieving a Single Description for a SNOMED CT Concept Identifier

This application illustrates how to retrieve a single preferred concept term description for an active SNOMED CT
Concept Identifier.

1. Retrieve the NLM Concept Identifier (NLM_CONCEPT_ID) and the NLM Effective Time (
NLM_EFFECTIVE_TIME) from the NLM SNOMED CT Concept Description Table
(RIMKSD0_NLM_SCT_CONCEPT_DESC) where:
The NLM Active Indicator (NLM_ACTIVE_IND) value equals 1 (active).
The NLM Effective Time (NLM_EFFECTIVE_TIME) value equals the most current effective date.

2. Retrieve the NLM Description Identifier (NLM_DESCRIPTION_ID), NLM Effective Time (

NLM_EFFECTIVE_TIME), NLM Concept Identifier (NLM_CONCEPT_ID) NLM Active Indicator (
NLM_ACTIVE_IND), and NLM Terminology (NLM_TERM) values from the NLM SNOMED CT Concept
Description Table (RIMKSD0_NLM_SCT_CONCEPT_DESC) where:
The NLM CONCEPT Identifier (NLM_CONCEPT_ID) from step 1 equals the NLM CONCEPT
Identifier (NLM_CONCEPT_ID).
NLM Effective Time (NLM_EFFECTIVE_TIME) retrieved in step 1 equals the NLM Effective Time (
NLM_EFFECTIVE_TIME).
The NLM Active Indicator (NLM_ACTIVE_IND) value equals 1 (active).
The NLM Type Identifier (NLM_TYPE_ID) value equals to 900000000000003001 (fully specified
name).

3. Retrieve the NLM Referenced Component Identifier (NLM_REFERENCED_COMPONENT_ID) from the

NLM SNOMED CT Language Table (RIMKSLG0_NLM_SCT_LANGUAGE) where:
The NLM Acceptability Identifier (NLM_ACCEPTABILITY_ID) value equals 900000000000548007
(preferred term).
The NLM Refset Identifier (NLM_REFSET_ID) value equals 900000000000509007 (US English).

4. Retrieve the NLM Referenced Component Identifier (NLM_REFERENCED_COMPONENT_ID) and NLM

Terminology (NLM_TERM) value from step 2 where:
The NLM CONCEPT Identifier (NLM_CONCEPT_ID) value equals the given SNOMED CT
CONCEPT Identifier.
The NLM Description Identifier (NLM_DESCRIPTION_ID) retrieved in step 2 equals the NLM
Referenced Component Identifier (NLM_REFERENCED_COMPONENT_ID) retrieved in step 3.

ExampleRetrieving a Single Description for the Fully Specified Name of a SNOMED CT Concept Identifier

For purposes of demonstrating this application, the following scenario is used: A physician has been provided a
SNOMED CT Concept Identifier 21522001 and wants only the preferred term returned.

1. Retrieve the NLM Concept Identifier (NLM_CONCEPT_ID) value from the NLM SNOMED CT Concept
Description Table (RIMKSD0_NLM_SCT_CONCEPT_DESC) where:
The Active Indicator (NLM_ACTIVE_IND) value equals 1 (active).
The NLM Effective Time (NLM_EFFECTIVE_TIME) value is the most current effective date.

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NLM_ACTIVE_IND NLM_EFFECTIVE_TIME NLM_CONCEPT_ID

1 20020131 21522001

2. Retrieve the NLM Description Identifier (NLM_DESCRIPTION_ID), NLM Effective Time (

NLM_EFFECTIVE_TIME), NLM Concept Identifier (NLM_CONCEPT_ID) NLM Active Indicator (
NLM_ACTIVE_IND), and NLM Terminology (NLM_TERM) values from the NLM SNOMED CT Concept
Description Table (RIMKSD0_NLM_SCT_CONCEPT_DESC) where:
The NLM Concept Identifier (NLM_CONCEPT_ID) from step 1 equals the NLM Concept Identifier (
NLM_CONCEPT_ID).
The NLM Effective Time (NLM_EFFECTIVE_TIME) from step 1 equals the NLM Effective Time (
NLM_EFFECTIVE_TIME).
The Active Indicator (NLM_ACTIVE_IND) value equals 1 (active).
The NLM Type Identifier (NLM_TYPE_ID) value equals 900000000000003001 (fully specified
name).

NLM_CONCEP NLM_EFFECTI NLM_ACTIVE_I NLM_TYPE_ID NLM_DESCRIP NLM_TERM

T_ID VE_TIME ND TION_ID

21522001 20020131 1 9000000000000 36112013 Abdominal pain

13009

21522001 20020131 1 9000000000000 481053019 AP - Abdominal

13009 pain

21522001 20020131 1 9000000000000 750827015 Abdominal pain

03001 (finding)

3. Retrieve the NLM Referenced Component Identifier (NLM_REFERENCED_COMPONENT_ID) from the

NLM SNOMED CT Language Table (RIMKSLG0_NLM_SCT_LANGUAGE) where:
The NLM Acceptability Identifier (NLM_ACCEPTABILITY_ID) value equals 900000000000548007
(preferred term).
NLM Reference Set Identifier (NLM_REFERENCED_COMPONENT_ID) value equals
900000000000509007 (US English).

NLM_ACCEPTABILITY_I NLM_REFSET_ID NLM_TERM NLM_REFERENCED_COMPONENT_ID

D

900000000000549004 900000000000509007 AP - Abdominal pain 481053019

900000000000548007 900000000000509007 Abdominal pain (finding) 750827015

900000000000548007 900000000000509007 Abdominal pain 36112013

4. Retrieve the NLM Terminology (NLM_TERM) value from step 2 where:

The NLM Concept Identifier (NLM_CONCEPT_ID) value equals the given SNOMED CT Concept
Identifier (21522001).

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The NLM Description Identifier (NLM_DESCRIPTION_ID) retrieved in step 2 (750827015) equals

the NLM Referenced Component Identifier (NLM_REFERENCED_COMPONENT_ID) retrieved in
step 3.

NLM_CONCEPT_ID NLM_REFERENCED_CO NLM_ACCEPTABILITY_I NLM_TERM

MPONENT_ID D

21522001 750827015 900000000000548007 Abdominal pain (finding)

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Retrieving a SNOMED CT Concept Identifiers Associated DXIDs

This application illustrates how to retrieve an input SNOMED CT Concept Identifiers associated DXIDs as a
method of entry into any of the FDB disease decision support or dosing modules.

1. Using the given SNOMED CT Concept as the Search SNOMED CT Concept Identifier (
SEARCH_SCT_CONCEPT_ID) and the SNOMED CT Concept Identifier Type (
SCT_CONCEPT_ID_TYPE), retrieve the following columns from the SNOMED CT to DXID Search Table
(RIMKSR0_SCT_DXID_SRCH):
FML Related DXID (RELATED_DXID)
Clinical Code (CLIN_CD) - (used in step 2)
Navigation Code (NAV_CD) - (used in step 3)

2. Filter the results of step 1 on the CLIN_CD column, which identifies the RELATED_DXIDs disease
decision support or dosing module. See the Clinical Code Description (CLIN_CD_DESC) columns data
dictionary description for information about the different CLIN_CD values.

3. Retrieve the Navigation Code Description (NAV_CD) for the given NAV_CODE using the Navigation Code
Description Table (RIMKNVD0_NAVIGATION_DESC).

ExampleRetrieving Associated DXIDs for a Given SNOMED CT Code for use in Drug-Disease Contraindications
Screening

This application retrieves the DXIDs associated to SNOMED CT Concept Identifier 307762000 (bone marrow
depression) for use in the Drug-Disease Contraindications Module (DDCM). For illustrative purposes, it also
displays descriptive information about the DXIDs relationship to the SNOMED CT Concept (broader, narrower,
equal, or related).

1. Using the given SNOMED CT Concept as the Search SNOMED CT Concept Identifier (
SEARCH_SCT_CONCEPT_ID) and the SNOMED CT Concept Identifier Type (
SCT_CONCEPT_ID_TYPE), retrieve the following columns from the SNOMED CT to DXID Search Table
(RIMKSR0_SCT_DXID_SRCH):
FML Related DXID (RELATED_DXID)
Clinical Module Code (CLIN_CD) - (used in step 2)
Navigation Code (NAV_CD) - (used in step 3)

SEARCH_SCT_CO SCT_CONCEPT_ID RELATED_DXID CLIN_CD NAV_CD

NCEPT_ID _TYPE

307762000 10 836 02 01

307762000 10 836 03 01

307762000 10 837 02 04

307762000 10 837 03 04

307762000 10 908 03 04

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The results shown in this step represent a small sample of the full result set.

2. Filter the results of step 1 on the CLIN_CD column, which identifies the RELATED_DXIDs disease
decision support or dosing module. After filtering for CLIN_CD value of 03 (Contraindications Module), the
resulting RELATED_DXID values are appropriate for use in DDCM. See the Clinical Code Description (
CLIN_CD_DESC) columns data dictionary description for information about the different CLIN_CD values.

SEARCH_SCT_CO SCT_CONCEPT_ID RELATED_DXID CLIN_CD NAV_CD

NCEPT_ID _TYPE

307762000 10 837 02 04

307762000 10 837 03 04

307762000 10 836 02 01

307762000 10 836 03 01

307762000 10 908 03 04

3. Retrieve the Navigation Code Description (NAV_CD) for the given NAV_CODE using the Navigation Code
Description Table (RIMKNVD0_NAVIGATION_DESC). The NAV_CD column can be used to assist in
constructing Disease Contraindication Alert messages (recall that this examples results have been filtered
for the DDCM module). The following table shows this examples result set of DXIDs and their descriptive
text.

ExampleDXID values associated to SNOMED CT CONCEPT Identifiers for use in the DDCM module

SEARCH_SCT_ SCT_CONCEPT RELATED_DXID DXID_DESC100 CLIN_CD NAV_CD

CONCEPT_ID _ID_TYPE

307762000 10 837 Severe Bone 04 Related

Marrow
Depression

307762000 10 836 Bone Marrow 01 Equal

Depression

307762000 10 908 Blood Dyscrasias 04 Related

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Clinical Quality Measures (CQM) Value Set Applications

Presenting RXCUI Changes for Clinical Quality Measures

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Presenting RXCUI Changes for Clinical Quality Measures

Meaningful Use Clinical Quality Measure (CQM) vocabulary-based value sets are represented in the USHIK
Master Table (RIMKUK0_USHIK_MSTR). This application illustrates how to use the Vocabulary Replacement
History Table (REVDRH0_RXCUI_REP_HIST) to determine if a given RxNorm concept identifier is current.

1. Retrieve the USHIK Concept (USHIK_CONCEPT) values from the USHIK Master Table
(RIMKUK0_USHIK_MSTR) where:
The USHIK Category (USHIK_CATEGORY) column equals Medication.
The USHIK Code System (USHIK_CODE_SYSTEM) column equals RXNORM.

2. Retrieve the EVD External Previous Vocabulary Identifier (EVD_EXT_PREV_VOCAB_ID), EVD External
Change Date (EVD_EXT_CHANGE_DT), EVD External Replacement Vocabulary Identifier (
EVD_EXT_REP_VOCAB_ID), and EVD External Ultimate Replacement Vocabulary Identifier (
EVD_EXT_ULT_REP_VOCAB_ID) values from the Vocabulary Replacement History Table
(REVDRH0_RXCUI_REP_HIST) table where:
The EVD External Previous Vocabulary Identifier (EVD_EXT_PREV_VOCAB_ID) column equals
the USHIK Concept (USHIK_CONCEPT) value retrieved in the previous step.
The EVD External Change Date (EVD_EXT_CHANGE_DT) is greater than or equal to the time
period in question.

3. Display results to user.

ExamplePresenting RXCUI Changes for Clinical Quality Measures

For purposes of demonstrating this application, the following scenario is used: An auditor is preparing a
validation worksheet for internal review compliance of 2014 CQMs, Quality Data Elements, Value Sets, and
Concept Codes & Descriptions version 20130401 requirements. To ensure all applicable RXCUIs are current, the
auditor must identify any recent RXCUI changes that may impact the audit.

1. Retrieve the USHIK Concept (USHIK_CONCEPT) values from the USHIK Master Table
(RIMKUK0_USHIK_MSTR) where:
The USHIK Category (USHIK_CATEGORY) equals Medication.
The USHIK Code System (USHIK_CODE_SYSTEM) equals RXNORM.

USHIK_CATEGORY USHIK_CODE_SYSTEM USHIK_CONCEPT

Medication RXNORM 215868

Medication RXNORM 215869

Medication RXNORM 215870

Medication RXNORM 218571

Medication RXNORM 749830

Medication RXNORM 749834

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The above example represents only a partial list of the retrieved values. Actual results will be
numerous.

2. Retrieve the EVD External Previous Vocabulary Identifier (EVD_EXT_PREV_VOCAB_ID), EVD External
Change Date (EVD_EXT_CHANGE_DT), EVD External Replacement Vocabulary Identifier (
EVD_EXT_REP_VOCAB_ID), and EVD External Ultimate Replacement Vocabulary Identifier (
EVD_EXT_ULT_REP_VOCAB_ID) values from the Vocabulary Replacement History Table
(REVDRH0_RXCUI_REP_HIST) where:
The EVD External Previous Vocabulary Identifier (EVD_EXT_PREV_VOCAB_ID) column equals
the USHIK Concept (USHIK_CONCEPT) value retrieved in the previous step.
The EVD External Change Date (EVD_EXT_CHANGE_DT) is greater than or equal to the time
period in question (20130101).

EVD_EXT_PREV_V EVD_EXT_CHANG EVD_EXT_REP_V EVD_EXT_ULT_RE EVD_EXT_PREV_V

OCAB_ID E_DT OCAB_ID P_VOCAB_ID OCAB_DESC

215868 20130319 20173 20173 Capozide 25/15

215869 20130319 20173 20173 Capozide 25/25

215870 20130319 20173 20173 Capozide 50/15

215871 20130319 20173 20173 Capozide 50/25

749830 20130319 284780 284780 Micardis-HCT

40/12.5

749834 20130319 284780 284780 Micardis-HCT

80/12.5

The above example represents only a partial list of the retrieved values. Actual results will be
numerous.

The EVD External Previous Vocabulary Description (EVD_EXT_PREV_VOCAB_DESC) column,

located in the Vocabulary Replacement History Description Table
(REVDRHD0_RXCUI_REP_DESC), provides text descriptions that may be useful to the end user.
Results are displayed here for example purposes only.

3. Display results to user.

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Structured & Codified Sig Applications

Retrieving an External Interoperable Concept for a Given FDB Interoperable Concept

Retrieving an HL7 Concept for a Given Frequency and Interval ID

Retrieving a UCUM Code for a Given FDB Master Unit of Measure Identifier

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Retrieving an External Interoperable Concept for a Given FDB Interoperable Concept

This application illustrates how to retrieve an external interoperable concept for a given FDB concept, such as
routes (ROUTE_MSTR_ID), units of measure (UOM_MSTR_ID), PRN reasons (PRN_ID), and administration
methods (ADMIN_METHOD_CD).

This application assumes the user is supplying a known FDB Unit of Measure Identifier.

Use this application to retrieve a specified vocabulary constraint to support specific structured representation of
medication instructions .

1. Retrieve the following values from the SIG FDB to External Vocabulary Link Table
(RIMKSSE0_SIG_FDB_TO_EXT_LINK):
IMK FDB Vocabulary Identifier (IMK_FDB_VOCAB_NO_ID)
IMK FDB Vocabulary Description (IMK_FDB_VOCAB_DESC)
EVD FDB Vocabulary Type ID Description (EVD_FDB_VOCAB_TYPE_ID_DESC)
IMK External Vocabulary Identifier (IMK_EXT_VOCAB_ID)
IMK External Vocabulary Description (IMK_EXT_VOCAB_DESC)
EVD External Vocabulary Type ID Description (EVD_EXT_VOCAB_TYPE_ID_DESC)
IMK Preferred Indicator (IMK_PREFERRED_IND)
IMK Related Indicator (IMK_RELATED_IND)
where:
The IMK FDB Vocabulary Identifier (IMK_FDB_VOCAB_NO_ID) equals the given FDB concept
identifier.
The EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) equals the FDB concept
type identifier.
The EVD External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) equals the External
concept type identifier.
The Link Active Date (LINK_INACTIVE_DT) is null.

2. If more than one row is returned from the previous step, select the row where the IMK Preferred Indicator (
IMK_PREFERRED_IND) equals 1 and the IMK Related Indicator (IMK_RELATED_IND) equals 0.

ExampleRetrieving an External Interoperable Concept for a Given FDB Interoperable Concept

For purposes of demonstrating this application, the following scenario is used: A user is trying to retrieve
the SNOMED CT code and NCIt Terminology Code for the Sublingual route (IMK_FDB_VOCAB_NO_ID = 219).
These external concepts can be provided when creating an electronic prescription using the NCPDP Structured
Sig format.

1. Retrieve the following values from the SIG FDB to External Vocabulary Link Table
(RIMKSSE0_SIG_FDB_TO_EXT_LINK):
IMK FDB Vocabulary Identifier (IMK_FDB_VOCAB_NO_ID)

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IMK FDB Vocabulary Description (IMK_FDB_VOCAB_DESC)

EVD FDB Vocabulary Type ID Description (EVD_FDB_VOCAB_TYPE_ID_DESC)
IMK External Vocabulary Identifier (IMK_EXT_VOCAB_ID)
IMK External Vocabulary Description (IMK_EXT_VOCAB_DESC)
EVD External Vocabulary Type ID Description (EVD_EXT_VOCAB_TYPE_ID_DESC)
IMK Preferred Indicator (IMK_PREFERRED_IND)
IMK Related Indicator (IMK_RELATED_IND)
where:
The IMK FDB Vocabulary Identifier (IMK_FDB_VOCAB_NO_ID) equals 219 (Sublingual).
The EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) equals 131
(ROUTE_MSTR_ID).
The EVD External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) equals 570
(SNOMED-CT) or 810 (NCIt Terminology Code).
The Link Active Date (LINK_INACTIVE_DT) is null.

EVD_FDB_VOCAB_TYPE_ID 131 131

EVD_FDB_VOCAB_TYPE_ID_D ROUTE_MSTR_ID ROUTE_MSTR_ID

ESC

IMK_FDB_VOCAB_NO_ID 219 219

IMK_FDB_VOCAB_DESC Sublingual Sublingual

EVD_EXT_VOCAB_TYPE_ID 570 810

EVD_EXT_VOCAB_TYPE_ID_D SNOMED-CT NCIt Terminology Code

ESC

IMK_EXT_VOCAB_ID 000000000037839007 C38300

IMK_EXT_VOCAB_DESC Sublingual route (qualifier value) SUBLINGUAL

2. If more than one row for each external vocabulary type is returned from the previous step, select the row
where the IMK Preferred Indicator (IMK_PREFERRED_IND) equals 1 and the IMK Related Indicator (
IMK_RELATED_IND) equals 0. In this example, one row for each vocabulary type was returned, so
filtering is not required.

In this example, the IMK External Vocabulary Identifier (IMK_EXT_VOCAB_ID) 000000000037839007

could potentially be used in the NCPDP Structured Sig Segment 070-S028, Route Of Administration,
where the route of administration code is constrained to a value spanning either a SNOMED-CT
vocabulary or Federal Medication Terminologies code (NCIt). Note that leading zeros are typically removed
when included in messaging.

SC Element Number SC Element Name Route of Administration Example

Description

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SIG-070-01 <RouteofAdministrationTe The textual representation Sublingual route (qualifier

xt> of the Route of value)
Administration

SIG-070-02 <RouteofAdministrationCo Qualifier to identify the 1

deQualifier> code system being used
ECL REF: 7935 1 =
SNOMED, 2 = FMT

SIG-070-03 <RouteofAdministrationCo The code representing the 37839007

de> Route of Administration

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Retrieving an External HL7 Concept for a Given Frequency and Interval ID

This application illustrates how to retrieve an external HL7 concept for a given Frequency and Interval ID. Use this
translation in HL7 C-CDA messaging.

1. Retrieve the following values from the SIG Frequency Interval Table (RIMKHFI0_SIG_FREQ_INT_LINK):
Frequency and Interval Identifier (FREQ_INT_ID)
HL7 Institution Specified (HL7_FI_INSTITUTION_SPECIFIED)
HL7 Period Value (HL7_FI_PERIOD_VALUE)
HL7 Period Type (HL7_FI_PERIOD_TYPE)
HL7 Period Low Value (HL7_FI_LOW_VALUE)
HL7 Period High Value (HL7_FI_HIGH_VALUE)
HL7 Interval Unit (HL7_FI_UOM)
HL7 Effective Time Type (HL7_FI_EFFECTIVE_TIME_TYPE)
where:
The Frequency and Interval Identifier (FREQ_INT_ID) equals the given Frequency and Interval ID
value.
The Link Inactive Date (HL7_FI_INACTIVE_DT) is null.

2. (Left join:) Retrieve the following values from the SIG Frequency Interval Event Table
(RIMKHIE0_FREQ_INT_EVENT_LINK):
HL7 Event Code (HL7_FI_EVENT_CD)
HL7 Event Sequence Number (HL7_FI_EVENT_SN)

where:
The Frequency and Interval Identifier (FREQ_INT_ID) equals the given Frequency and Interval ID
value in the SIG Frequency Interval Table (RIMKHFI0_SIG_FREQ_INT_LINK).
The Link Inactive Date (LINK_INACTIVE_DT) is null.

The HL7_FI_PERIOD_VALUE column will not be populated if the HL7_FI_PERIOD_TYPE column

is populated.

The HL7_FI_UOM value is applicable to the following fields (when populated):

HL7_FI_PERIOD_VALUE
HL7_FI_LOW_VALUE
HL7_FI_HIGH_VALUE

ExampleRetrieving an External HL7 Concept for a Given Frequency and Interval ID

For purposes of demonstrating this application, the following scenario is used: A user is trying to
translate the frequency and interval information associated with after meals and at bedtime

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(FREQ_INT_TEXT_SHORT = qpchs, FREQ_INT_ID = 94) for use in a HL7 C-CDA message.

1. Retrieve the following values from the SIG Frequency Interval Table (RIMKHFI0_SIG_FREQ_INT_LINK):
Frequency and Interval Identifier (FREQ_INT_ID)
HL7 Institution Specified (HL7_FI_INSTITUTION_SPECIFIED)
HL7 Period Value (HL7_FI_PERIOD_VALUE)
HL7 Period Type (HL7_FI_PERIOD_TYPE)
HL7 Period Low Value (HL7_FI_LOW_VALUE)
HL7 Period High Value (HL7_FI_HIGH_VALUE)
HL7 Interval Unit (HL7_FI_UOM)
HL7 Effective Time Type (HL7_FI_EFFECTIVE_TIME_TYPE)
where:
The Frequency and Interval Identifier (FREQ_INT_ID) equals 94.
The Link Inactive Date (HL7_FI_INACTIVE_DT) is null.

FREQ_INT_ID 94

FREQ_INT_TEXT_SHORT qpchs

HL7_FI_INACTIVE_DT

HL7_FI_INSTITUITION_SPECIFIED 1

HL7_FI_PERIOD_VALUE

HL7_FI_PERIOD_TYPE

HL7_FI_LOW_VALUE

HL7_FI_HIGH_VALUE

HL7_FI_UOM

HL7_FI_EFFECTIVE_TIME_TYPE EIVL_TS

2. (Left join:) Retrieve the following values from the SIG Frequency Interval Event Table
(RIMKHIE0_FREQ_INT_EVENT_LINK):
HL7 Event Code (HL7_FI_EVENT_CD)
HL7 Event Sequence Number (HL7_FI_EVENT_SN)

where:
The Frequency and Interval Identifier (FREQ_INT_ID) equals 94.
The Link Inactive Date (LINK_INACTIVE_DT) is null.

FREQ_INT_ID 94

FREQ_INT_TEXT_SHORT qpchs

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HL7_FI_INACTIVE_DT

HL7_FI_INSTITUTION_SPECIFIED 1

HL7_FI_EFFECTIVE_TIME_TYPE EIVL_TS

HL7_FI_EVENT_CD PC

HL7_FI_EVENT_SN 1

HL7_FI_EVENT_CD HS

HL7_FI_EVENT_SN 2

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Retrieving a UCUM Code for a Given FDB Master Unit of Measure Identifier
This application illustrates how to retrieve a Unified Code for Units of Measure (UCUM) Code for a given FDB
Master Unit of Measure Identifier. Use this translation in HL7-based transmittals that require a UCUM value in the
context of a unit of measure (for use with the Quantity data type).

This application assumes the user is supplying a known FDB Unit of Measure Identifier.

1. Retrieve the following values from the Master FDB Unit of Measure to UCUM Link Table
(RIMKUCM0_MSTRUOM_TO_UCUM_LINK):
UCUM Concept Code (UCUM_CD)
IMK External Vocabulary Description (IMK_EXT_VOCAB_DESC)

where:

The IMK FDB Vocabulary Identifier (IMK_FDB_VOCAB_NO_ID) equals the given FDB Master Unit
of Measure Identifier (UOM_MSTR_ID).
The EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) equals 130
(UOM_MSTR_ID).
The External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) equals 600 (UCUM
Code).
The Link Inactive Date (LINK_INACTIVE_DT) is null.

ExampleRetrieving a UCUM Code for a Given FDB Master Unit of Measure Identifier

For purposes of demonstrating this application, the following scenario is used: A user is trying to retrieve
the UCUM code for million units/kilogram (IMK_FDB_VOCAB_NO_ID = 445). The user is using FHIR and a value
set with an identifier of http://unitsofmeasure.org/vs/[expression], and must conform to a template where
[expression] is a valid UCUM expression.

1. Retrieve the UCUM Concept Code (UCUM_CD) from the Master FDB Unit of Measure to UCUM Link
Table (RIMKUCM0_MSTRUOM_TO_UCUM_LINK) where:
The IMK FDB Vocabulary Identifier (IMK_FDB_VOCAB_NO_ID) equals 445 (million units/kilogram).
The EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_TYPE_ID) equals 130
(UOM_MSTR_ID).
The External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) equals 600 (UCUM
Code).
The Link Inactive Date (LINK_INACTIVE_DT) is null.

IMK_FDB_VOCAB_NO_ID 445

IMK_FDB_VOCAB_DESC million units/kilogram

EVD_FDB_VOCAB_TYPE_ID 130

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EVD_EXT_VOCAB_TYPE_ID 600

UCUM_CD 10*6.[U]/kg

2. Use the UCUM_CD retrieved in the previous step in the electronic health record. An extract of a sample
template is provided below.

<compose>
<include>
<system value="http://unitsofmeasure.org"/>
<filter>
<property value="comparable"/>
<op value="="/>
<value value="10*6.[U]/kg"/>
</filter>
</include>
</compose>

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Interoperability ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

FDB Interoperability Module Tables

FDB Interoperability Module ERD
FDB Interoperability Module: Immunization Interoperability ERD
FDB Interoperability Module: Clinical Interoperability ERD
FDB Interoperability Module: SNOMED CT ERD

FDB Interoperability Module Tables

Clinical Module Code Description Table
CPT to CVX Link Table
CVX to MVX Link Table
CVX Usage Table
DXID to SNOMED CT Best Fit History Table
DXID to SNOMED CT Best Fit Table
External Allergen to FDB Link Table
External Vocabulary CVX Description Table
External Vocabulary Description Table
External Vocabulary Link Table
External Vocabulary Link Type Description Table
External Vocabulary MVX Description Table
External Vocabulary Note Table
FDB to External Allergen Link Table
HL7 Standard Code Set CVX-VIS Mapping Table
HL7 Standard Code Set Mapping CVX to Vaccine Groups Table
IMK Status Code Description Table
Master FDB Unit of Measure to UCUM Link Table
Navigation Code Description Table
NDC to CVX-MVX Link Table
NLM SNOMED CT Concept Description Table
NLM SNOMED CT Concept Table
NLM SNOMED CT Language Table
NLM SNOMED CT Relationship Table
RXCUI Ultimate Replacement Table
RxNorm Concept Description Table

Copyright 2017 First Databank, Inc. 1943

FDB MedKnowledge U.S. Documentation August 2017

RxNorm Concept Master Table

RxNorm Concept Source Table
RxNorm to FDB Clinical Screening Exception Table
RxNorm to FDB Clinical Screening Link Table
SIG FDB to External Vocabulary Link Table
SIG Frequency Interval Event Table
SIG Frequency Interval Table
SNOMED CT Concept Type Description Table
SNOMED CT to DXID Search Exclusion History Table
SNOMED CT to DXID Search Exclusion Table
SNOMED CT to DXID Search History Table
SNOMED CT to DXID Search Table
SNOMED CT to FDB Link Table
SNOMED CT Type Description Table
SNOMED CT Value Set Description Table
SNOMED CT Value Set Table
Source Description Table
USHIK History Table
USHIK Master Table
Vaccine Information Statement (VIS) Lookup Table
Vocabulary Data Version Table
Vocabulary Replacement History Description Table
Vocabulary Replacement History Table
Vocabulary Type Definition Table
Vocabulary Type to HL7 OID Link Table

FDB Interoperability Module ERD

Copyright 2017 First Databank, Inc. 1944

FDB MedKnowledge U.S. Documentation August 2017

FDB Interoperability Module: Immunization Interoperability ERD

Copyright 2017 First Databank, Inc. 1945

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FDB Interoperability Module: Clinical Interoperability ERD

Copyright 2017 First Databank, Inc. 1946

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FDB Interoperability Module: SNOMED CT ERD

Copyright 2017 First Databank, Inc. 1947

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Copyright 2017 First Databank, Inc. 1948

FDB MedKnowledge U.S. Documentation August 2017

Clinical Module Code Description Table

Table Name RIMKCMD0_CLIN_MOD_DESC

Revision Activity add.06-02-2013

Purpose Relates the Clinical Code to its text description.

Key Column Name Column Format Length Picture

Description

P CLIN_CD Clinical Code AN 2 X(2)

CLIN_CD_DESC Clinical Code AN 50 X(50)

Description

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FDB MedKnowledge U.S. Documentation August 2017

CPT to CVX Link Table

Table Name REVDCPT0_EXT_CPT_CVX_LINK

Revision Activity add.06-30-2011

Purpose Provides the CDC's mapping of CPT codes to CVX codes.

This table is not intended to be a definitive source for a CPT
code, description, or status. The table includes both current
and historical CPT-CVX mapping records. Active CPT
codes, inactive CPT codes and pre-release CPT codes are
also included.

Key Column Name Column Format Length Picture

Description

P EVD_CPT_CD EVD CPT Code AN 10 X(10)

from CDC

P EVD_CVX_CD EVD CVX Code AN 10 X(10)

from CDC

EVD_CPT_CD_D EVD CPT Code AN 255 X(255)

ESC Description from
CDC

EVD_VACCINE_ EVD Vaccine AN 100 X(100)

NAME Name from CDC

EVD_CPT_STAT EVD CPT Status AN 30 X(30)

US from CDC

EVD_CPT_CVX_ EVD CPT to CVX AN 255 X(255)

NOTE Notes from CDC

EVD_CPT_CVX_ EVD CPT to CVX N 8 9(8)

LAST_UPDATE_ Last Update Date
DT from CDC

Copyright 2017 First Databank, Inc. 1950

FDB MedKnowledge U.S. Documentation August 2017

CVX to MVX Link Table

Table Name REVDCM0_CVX_MVX_LINK

Revision Activity add.06-30-2011

Purpose Relates CVX codes to their associated MVX codes and

attributes.

Key Column Name Column Format Length Picture

Description

P EVD_CVX_CD EVD CVX Code AN 10 X(10)

from CDC

P EVD_MVX_CD EVD MVX Code AN 10 X(10)

from CDC

EVD_CVX_CD_D EVD CVX Code AN 100 X(100)

ESC_SHORT Short Description

EVD_CVX_CD_D EVD CVX Code AN 255 X(255)

ESC_LONG Long Description

F EVD_CVX_CD_U EVD CVX Code N 2 9(2)

SAGE Usage

EVD_CVX_CD_U EVD CVX Code AN 100 X(100)

SAGE_DESC_SH Usage Short
ORT Description

EVD_CVX_CODE EVD CVX Code AN 30 X(30)

_STATUS Status from CDC

EVD_MVX_CD_D EVD CVX Code AN 100 X(100)

ESC Description from
CDC

EVD_MVX_CD_S EVD CVX Code AN 30 X(30)

TATUS Status from CDC

Copyright 2017 First Databank, Inc. 1951

FDB MedKnowledge U.S. Documentation August 2017

CVX Usage Table

Table Name REVDUSE0_EXT_VOCAB_CVX_USAGE

Revision Activity add.06-30-2011

Purpose Provides the recommended usage for the CVX codes.

Key Column Name Column Format Length Picture

Description

P EVD_CVX_CD_U EVD CVX Code N 2 9(2)

SAGE Usage

EVD_CVX_CD_U EVD CVX Code AN 100 X(100)

SAGE_DESC_SH Usage Short
ORT Description

EVD_CVX_CD_U EVD CVX Code AN 255 X(255)

SAGE_DESC_LO Usage Long
NG Description

Copyright 2017 First Databank, Inc. 1952

FDB MedKnowledge U.S. Documentation August 2017

DXID to SNOMED CT Best Fit History Table

Table Name RIMKBFH0_DXID_SCT_BEST_FIT_HX

Revision Activity add.06-20-2013

Purpose Provides historical view of Best Fit links between FDB DXID
and SNOMED CT Concept ID.

Key Column Name Column Format Length Picture

Description

PF DXID FML Disease N 8 9(8)

Identifier

P SCT_CONCEPT_ SNOMED CT N 18 9(18)

ID Concept Identifier

PF SCT_CONCEPT_ SNOMED CT AN 2 X(2)

ID_TYPE Concept Identifier
Type

PF LINK_FIRST_AC Link First Active N 8 9(8)

TIVE_DT Date

LINK_IND DXID to SNOMED AN 1 X(1)

CT Concept ID
Link Indicator

LINK_LAST_ACTI Link Last Active N 8 9(8)

VE_DT Date

Copyright 2017 First Databank, Inc. 1953

FDB MedKnowledge U.S. Documentation August 2017

DXID to SNOMED CT Best Fit Table

Table Name RIMKBF0_DXID_SCT_BEST_FIT

Revision Activity add.06-20-2013

Purpose Provides Best Fit links between FDB DXID and SNOMED
CT Concept ID.

Key Column Name Column Format Length Picture

Description

PF DXID FML Disease N 8 9(8)

Identifier

P SCT_CONCEPT_ SNOMED CT N 18 9(18)

ID Concept Identifier

PF SCT_CONCEPT_ SNOMED CT AN 2 X(2)

ID_TYPE Concept Identifier
Type

LINK_IND DXID to SNOMED AN 1 X(1)

CT Concept ID
Link Indicator

Copyright 2017 First Databank, Inc. 1954

FDB MedKnowledge U.S. Documentation August 2017

External Allergen to FDB Link Table

Table Name RIMKEAF0_EXT_ALG_FDB_VOCAB_LNK

Revision Activity add.10-18-2012

Purpose Links external allergen concepts to FDB allergen concepts.

Key Column Name Column Format Length Picture

Description

P IMK_EXT_VOCA IMK External AN 50 X(50)

B_ID Vocabulary
Identifier

PF EVD_EXT_VOCA EVD External N 4 9(4)

B_TYPE_ID Vocabulary Type
Identifier

P IMK_FDB_VOCA IMK FDB External N 8 9(8)

B_NO_ID Vocabulary
Identifier

PF EVD_FDB_VOCA EVD FDB N 4 9(4)

B_TYPE_ID External
Vocabulary Type
Identifier

IMK_EXT_VOCA IMK External AN 255 X(255)

B_DESC Vocabulary
Description

F IMK_EXT_VOCA IMK External N 1 9(1)

B_STATUS_CD Vocabulary Status
Code

F EVD_RXN_RXCU RxNorm RXCUI AN 8 X(8)

I

IMK_FDB_VOCA IMK FDB AN 255 X(255)

B_DESC Vocabulary
Description

F IMK_FDB_VOCA FDB Vocabulary N 1 9(1)

B_STATUS_CD Status Code

IMK_PREFERRE IMK Preferred AN 1 X(1)

D_IND Indicator

IMK_RELATED_I IMK Related AN 1 X(1)

ND Indicator

LINK_ADD_DATE Link Add Date N 8 9(8)

LINK_INACTIVE_ Link Inactive Date N 8 9(8)

DATE

Copyright 2017 First Databank, Inc. 1955

FDB MedKnowledge U.S. Documentation August 2017

External Vocabulary CVX Description Table

Table Name REVDCVX0_EXT_VOCAB_CVX_DESC

Revision Activity add.06-30-2011

Purpose Provides attributes of the CVX Codes.

Key Column Name Column Format Length Picture

Description

P EVD_CVX_CD EVD CVX Code AN 10 X(10)

from CDC

EVD_CVX_CD_D EVD CVX Code AN 100 X(100)

ESC_SHORT Short Description

EVD_CVX_CD_D EVD CVX Code AN 255 X(255)

ESC_LONG Long Description

F EVD_CVX_CD_U EVD CVX Code N 2 9(2)

SAGE Usage

EVD_CVX_CODE EVD CVX Code AN 30 X(30)

_STATUS Status from CDC

EVD_CVX_CD_N EVD CVX Code AN 30 X(30)

ONVACCINE Non-Vaccine from
CDC

EVD_CVX_CD_A EVD CVX Code N 8 9(8)

DD_DT Add Date

EVD_CVX_CD_O EVD CVX Code N 8 9(8)

BS_DT Obsolete Date

EVD_CVX_LAST EVD CVX Last N 8 9(8)

_UPDATE_DT Update Date

Copyright 2017 First Databank, Inc. 1956

FDB MedKnowledge U.S. Documentation August 2017

External Vocabulary Description Table

Table Name REVDEV0_EXT_VOCAB_DESC

Revision Activity add.10-15-2009

Purpose Relates the external vocabulary identifier to its text

description.

Key Column Name Column Format Length Picture

Description

P EVD_EXT_VOCA EVD External AN 50 X(50)

B_ID Vocabulary
Identifier

PF EVD_EXT_VOCA EVD External N 4 9(4)

B_TYPE_ID Vocabulary Type
Identifier

P EVD_SEQ_SN EVD Sequence N 4 9(4)

Number

EVD_EXT_VOCA EVD External AN 255 X(255)

B_DESC Vocabulary
Description

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FDB MedKnowledge U.S. Documentation August 2017

External Vocabulary Link Table

Table Name REVDEL0_EXT_VOCAB_LINK

Revision Activity add.10-15-2009

Purpose Relates First Databank (FDB) concepts to external

vocabulary concept identifiers.

Key Column Name Column Format Length Picture

Description

PF EVD_FDB_VOCA EVD FDB AN 20 X(20)

B_ID Vocabulary
Identifier

PF EVD_FDB_VOCA EVD FDB N 4 9(4)

B_TYPE_ID Vocabulary Type
Identifier

PF EVD_EXT_VOCA EVD External AN 50 X(50)

B_ID Vocabulary
Identifier

PF EVD_EXT_VOCA EVD External N 4 9(4)

B_TYPE_ID Vocabulary Type
Identifier

F EVD_LINK_TYPE EVD Link Type N 4 9(4)

_ID Identifier

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FDB MedKnowledge U.S. Documentation August 2017

External Vocabulary Link Type Description Table

Table Name REVDLT0_LINK_TYPE_DESC

Revision Activity add.10-15-2009

Purpose Relates the link methodology to its source and text

description.

Key Column Name Column Format Length Picture

Description

P EVD_LINK_TYPE EVD Link Type N 4 9(4)

_ID Identifier

F EVD_SOURCE_I EVD Source N 4 9(4)

D Identifier

EVD_LINK_TYPE EVD Link Type AN 50 X(50)

_DESC Description

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FDB MedKnowledge U.S. Documentation August 2017

External Vocabulary MVX Description Table

Table Name REVDMVX0_EXT_VOCAB_MVX_DESC

Revision Activity add.06-30-2011

Purpose Provides attributes of the MVX codes.

Key Column Name Column Format Length Picture

Description

P EVD_MVX_CD EVD MVX Code AN 10 X(10)

from CDC

EVD_MVX_CD_D EVD MVX Code AN 100 X(100)

ESC Description from
CDC

EVD_MVX_CD_S EVD MVX Code AN 30 X(30)

TATUS Status from CDC

EVD_MVX_LAST EVD MVX Last N 8 9(8)

_UPDATE_DT Update Date

Copyright 2017 First Databank, Inc. 1960

FDB MedKnowledge U.S. Documentation August 2017

External Vocabulary Note Table

Table Name REVDEVN0_EXT_VOCAB_NOTE

Revision Activity add.06-30-2011

Purpose Provides instructional notes associated with an external

vocabulary concept, when available.

Key Column Name Column Format Length Picture

Description

PF EVD_EXT_VOCA EVD External AN 50 X(50)

B_ID Vocabulary
Identifier

PF EVD_EXT_VOCA EVD External N 4 9(4)

B_TYPE_ID Vocabulary Type
Identifier

P EVD_SEQ_SN EVD Sequence N 4 9(4)

Number

EVD_EXT_VOCA EVD External AN 255 X(255)

B_NOTE Vocabulary Note

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FDB MedKnowledge U.S. Documentation August 2017

FDB to External Allergen Link Table

Table Name RIMKFAE0_FDB_ALG_EXT_VOCAB_LNK

Revision Activity add.10-18-2012

Purpose Links FDB allergen concepts to external allergen concepts.

Key Column Name Column Format Length Picture

Description

P IMK_FDB_VOCA IMK FDB N 8 9(8)

B_NO_ID Vocabulary
Identifier

PF EVD_FDB_VOCA EVD FDB N 4 9(4)

B_TYPE_ID Vocabulary Type
Identifier

P IMK_EXT_VOCA IMK External AN 50 X(50)

B_ID Vocabulary
Identifier

PF EVD_EXT_VOCA IMK External N 4 9(4)

B_TYPE_ID Vocabulary Type
Identifier

IMK_FDB_VOCA IMK External AN 255 X(255)

B_DESC Vocabulary
Description

F IMK_FDB_VOCA FDB Vocabulary N 1 9(1)

B_STATUS_CD Status Code

FDB_DAM_PICK FDB DAM Picklist AN 1 X(1)

LIST_IND Indicator

FDB_VOCAB_ID_ FDB Vocabulary AN 1 X(1)

MULTI_SET_IND ID Multiple Set
Indicator

IMK_EXT_VOCA IMK External AN 255 X(255)

B_DESC Vocabulary
Description

F IMK_EXT_VOCA IMK External N 1 9(1)

B_STATUS_CD Vocabulary Status
Code

F EVD_RXN_RXCU RxNorm RXCUI AN 8 X(8)

I

LINK_ADD_DATE Link Add Date N 8 9(8)

LINK_INACTIVE_ Link Inactive Date N 8 9(8)

DATE

Copyright 2017 First Databank, Inc. 1962

FDB MedKnowledge U.S. Documentation August 2017

HL7 Standard Code Set CVX-VIS Mapping Table

Table Name REVDVL0_CDC_CVX_VIS_LINK

Revision Activity add.02-27-2014

Purpose Provides the mapping of CVX codes to associated Vaccine

Information Statements (VIS).

Key Column Name Column Format Length Picture

Description

PF CDC_CVX_CD CDC CVX Code AN 10 X(10)

PF CDC_VIS_FULLY CDC VIS Fully AN 24 X(24)

_ENCODED_TEX Encoded Text
T Code

F CDC_CVX_VACC CDC CVX AN 100 X(100)

INE_DESC Vaccine
Description

F CDC_VIS_DOCU CDC VIS AN 100 X(100)

MENT_NAME Document Name

F CDC_VIS_EDITI CDC VIS Edition N 8 9(8)

ON_DT Date

CDC_VIS_EDITI CDC VIS Edition AN 30 X(30)

ON_STATUS Status

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FDB MedKnowledge U.S. Documentation August 2017

HL7 Standard Code Set Mapping CVX to Vaccine Groups Table

Table Name REVDVG0_CDC_CVX_VG_LINK

Revision Activity add.02-27-2014

Purpose Supports mapping of CVX codes to vaccine groups.

Key Column Name Column Format Length Picture

Description

PF CDC_DATA_ID CDC Data N 8 9(8)

Identifier

F CDC_CVX_CD CDC CVX Code AN 10 X(10)

F CDC_SHORT_DE CDC Short AN 100 X(100)

SC Description

CDC_VACCINE_ CDC Vaccine AN 30 X(30)

STATUS Status

CDC_VACCINE_ CDC Vaccine AN 100 X(100)

GROUP_NAME Group Name

CDC_UNCERTAI CDC Uncertain AN 10 X(10)

N_FORM_CVX Formulation CVX
Code

Copyright 2017 First Databank, Inc. 1964

FDB MedKnowledge U.S. Documentation August 2017

IMK Status Code Description Table

Table Name RIMKSCD0_STATUS_DESC

Revision Activity add.10-18-2012

Purpose Relates the IMK Vocabulary Status code to its text

description.

Key Column Name Column Format Length Picture

Description

P IMK_VOCAB_ST IMK Vocabulary N 1 9(1)

ATUS_CD Identifier Status
Code

IMK_VOCAB_ST IMK Vocabulary AN 50 X(50)

ATUS_CD_DESC Identifier Status
Code Description

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FDB MedKnowledge U.S. Documentation August 2017

Master FDB Unit of Measure to UCUM Link Table

Table Name RIMKUCM0_MSTRUOM_TO_UCUM_LINK

Revision Activity add.05-05-2016

Purpose Links an FDB Master Unit of Measure Identifier to a UCUM

Code.

Key Column Name Column Format Length Picture

Description

P IMK_FDB_VOCA IMK FDB N 8 9(8)

B_NO_ID Vocabulary
Identifier

PF EVD_FDB_VOCA EVD FDB N 4 9(4)

B_TYPE_ID Vocabulary Type
Identifier

P LINK_ADD_DT Link Active Date N 8 9(8)

IMK_FDB_VOCA IMK FDB AN 255 X(255)

B_DESC Vocabulary
Description

UCUM_CD UCUM Concept AN 255 X(255)

Code

F EVD_EXT_VOCA EVD External N 4 9(4)

B_TYPE_ID Vocabulary Type
Identifier

LINK_INACTIVE_ Link Inactive Date N 8 9(8)

DT

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FDB MedKnowledge U.S. Documentation August 2017

Navigation Code Description Table

Table Name RIMKNVD0_NAVIGATION_DESC

Revision Activity add.06-20-2013

Purpose Relates the Navigation Code to its text description.

Key Column Name Column Format Length Picture

Description

P NAV_CD Navigation Code AN 2 X(2)

NAV_CD_DESC Navigation Code AN 50 X(50)

Description

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FDB MedKnowledge U.S. Documentation August 2017

NDC to CVX-MVX Link Table

Table Name REVDNCM0_NDC_CVX_MVX_LINK

Revision Activity add.06-30-2011

Purpose Relates NDCs and associated attributes to their single best

CVX and MVX codes.

Key Column Name Column Format Length Picture

Description

P NDC National Drug AN 11 X(11)

Code

F LBLRID Labeler Identifier AN 6 X(6)

MFG Manufacturer AN 15 X(15)

Name

F GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

BN Brand Name AN 30 X(30)

NDCFI NDC Format AN 1 X(1)

Indicator

OBSDTEC Obsolete Date N 8 9(8)

REPACK Repackaged AN 1 X(1)

Indicator

LN60 Label Name-60 AN 60 X(60)

F MEDID MED Medication N 8 9(8)

Identifier

MED_MEDID_DE MED Medication AN 70 X(70)

SC Description

F GENERIC_MEDI MED Generic N 8 9(8)

D Medication
Identifier

GENERIC_MEDI Generic AN 70 X(70)

D_DESC Medication
Description

F EVD_CVX_CD EVD CVX Code AN 10 X(10)

from CDC

EVD_CVX_CD_D EVD CVX Code AN 100 X(100)

ESC_SHORT Short Description

EVD_CVX_CD_D EVD CVX Code AN 255 X(255)

ESC_LONG Long Description

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FDB MedKnowledge U.S. Documentation August 2017

F EVD_CVX_CD_U EVD CVX Code N 2 9(2)

SAGE Usage

EVD_CVX_CD_U EVD CVX Code AN 100 X(100)

SAGE_DESC_SH Usage Short
ORT Description

EVD_CVX_CODE EVD CVX Code AN 30 X(30)

_STATUS Status from CDC

F EVD_MVX_CD EVD MVX Code AN 10 X(10)

from CDC

EVD_MVX_CD_D EVD MVX Code AN 100 X(100)

ESC Description from
CDC

EVD_MVX_CD_S EVD MVX Code AN 30 X(30)

TATUS Status from CDC

Copyright 2017 First Databank, Inc. 1969

FDB MedKnowledge U.S. Documentation August 2017

NLM SNOMED CT Concept Description Table

Table Name RIMKSD0_NLM_SCT_CONCEPT_DESC

Revision Activity add.06-20-2013

Purpose Relates a list of SNOMED CT Concept Description within

the SNOWMED CT Release Format 2.

Key Column Name Column Format Length Picture

Description

P NLM_DESCRIPTI NLM Description N 18 9(18)

ON_ID Identifier

P NLM_EFFECTIVE NLM Effective N 8 9(8)

_TIME Time

NLM_ACTIVE_IN NLM Active AN 1 X(1)

D Indicator

NLM_MODULE_I NLM Module N 18 9(18)

D Identifier

NLM_CONCEPT_ NLM Concept N 18 9(18)

ID Identifier

NLM_LANGUAGE NLM Language AN 50 X(50)

_CD Code

NLM_TYPE_ID NLM Type N 18 9(18)

Identifier

NLM_TERM NLM Terminology AN 255 X(255)

NLM_CASE_SIG NLM Case N 18 9(18)

NIFICANCE_ID Significance
Identifier

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FDB MedKnowledge U.S. Documentation August 2017

NLM SNOMED CT Concept Table

Table Name RIMKSC0_NLM_SCT_CONCEPT

Revision Activity add.06-20-2013

Purpose Provides a list of SNOMED CT Concepts within the

SNOMED CT Release Format 2.

Key Column Name Column Format Length Picture

Description

P NLM_CONCEPT_ NLM Concept N 18 9(18)

ID Identifier

P NLM_EFFECTIVE NLM Effective N 8 9(8)

_TIME Time

NLM_ACTIVE_IN NLM Active AN 1 X(1)

D Indicator

NLM_MODULE_I NLM Module N 18 9(18)

D Identifier

NLM_DEFINITIO NLM Definition N 18 9(18)

N_STATUS_ID Status Identifier

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NLM SNOMED CT Language Table

Table Name RIMKSLG0_NLM_SCT_LANGUAGE

Revision Activity add.06-20-2013

Purpose Provides language description and preference within a

particular context.

Key Column Name Column Format Length Picture

Description

P NLM_LANGUAGE NLM Language AN 36 X(36)

_ID Identifier

P NLM_EFFECTIVE NLM Effective N 8 9(8)

_TIME Time

NLM_ACTIVE_IN NLM Active AN 1 X(1)

D Indicator

NLM_MODULE_I NLM Module N 18 9(18)

D Identifier

NLM_REFSET_ID NLM Reference N 18 9(18)

Set Identifier

NLM_REFERENC NLM Referenced N 18 9(18)

ED_COMPONEN Component
T_ID Identifier

NLM_ACCEPTAB NLM Acceptability N 18 9(18)

ILITY_ID Identifier

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NLM SNOMED CT Relationship Table

Table Name RIMKSRS0_NLM_SCT_RELATIONSHIP

Revision Activity add.06-20-2013

Purpose Provides relationships between SNOMED CT Concepts

within the SNOMED CT Release Format 2.

Key Column Name Column Format Length Picture

Description

P NLM_RELATION NLM Relationship N 18 9(18)

SHIP_ID Identifier

P NLM_EFFECTIVE NLM Effective N 8 9(8)

_TIME Time

NLM_ACTIVE_IN NLM Action AN 1 X(1)

D Indicator

NLM_MODULE_I NLM Module N 18 9(18)

D Identifier

NLM_SOURCE_I NLM Source N 18 9(18)

D Identifier

NLM_DESTINATI NLM Destination N 18 9(18)

ON_ID Identifier

NLM_RELATION NLM Relationship AN 50 X(50)

SHIP_GROUP Group

NLM_TYPE_ID NLM Type N 18 9(18)

Identifier

NLM_CHARACTE NLM N 18 9(18)

RISTIC_TYPE_ID Characteristic
Type Identifier

NLM_MODIFIER_ NLM Modifier N 18 9(18)

ID Identifier

Copyright 2017 First Databank, Inc. 1973

FDB MedKnowledge U.S. Documentation August 2017

RXCUI Ultimate Replacement Table

Table Name REVDUR0_RXCUI_ULT_REPL

Revision Activity add.03-10-2011

Purpose Provides a list of replaced RXCIUs and their ultimate

replacements.

Key Column Name Column Format Length Picture

Description

P EVD_EXT_VOCA EVD External AN 50 X(50)

B_ID Vocabulary
Identifier

P EVD_EXT_ULT_ EVD External AN 50 X(50)

REP_VOCAB_ID Ultimate
Replacement
Vocabulary
Identifier

Copyright 2017 First Databank, Inc. 1974

FDB MedKnowledge U.S. Documentation August 2017

RxNorm Concept Description Table

Table Name REVDCD0_RXN_CONCEPT_DESC

Revision Activity add.02-09-2012

Purpose Provides descriptions for RxNorm concepts.

Key Column Name Column Format Length Picture

Description

P EVD_RXN_CON RxNorm Concept N 8 9(8)

CEPT_DESC_KE Description Key
Y

P EVD_RXN_SEQ_ RxNorm N 4 9(4)

SN Sequence
Number

F EVD_RXN_CON RxNorm Concept N 8 9(8)

CEPT_SOURCE_ Source Key
KEY

EVD_RXN_STR RxNorm Concept AN 255 X(255)

Description

Fields with column names that end with _KEY are not persistent in that any change to corresponding
fields within the record will result in the regeneration of the key.

Copyright 2017 First Databank, Inc. 1975

FDB MedKnowledge U.S. Documentation August 2017

RxNorm Concept Master Table

Table Name REVDRC0_RXN_CONCEPT_MSTR

Revision Activity add.02-09-2012

Purpose Provides the ability to apply the following options to RxNorm

Concept Unique Identifiers (RXCUIs).

View RxNorm concepts that are mapped to FDB

concepts using the Shared RXCUI Indicator (EVD_
SHARED_RXCUI_IND).
View RxNorm concepts that are not mapped to
FDB Concepts.
Filter for RxNorm concepts that are inculded in the
subset of RxNorm Current Prescribable Content
using the Prescribable RXCUI Indicator (EVD_PRE
SCRIBABLE_RXCUI_IND).
View Unique Ingredient Identifier (UNII) Codes that
are associated to RxNorm concepts (if available).

Key Column Name Column Format Length Picture

Description

P EVD_RXN_RXCU RxNorm Concept AN 8 X(8)

I Unique Identifier
(RXCUI)

EVD_SHARED_R Shared RXCUI AN 1 X(1)

XCUI_IND Indicator

EVD_PRESCRIB Prescribable AN 1 X(1)

ABLE_RXCUI_IN RXCUI Indicator
D

UNII_CODE Unique Ingredient AN 10 X(10)

Identifier (UNII)
Code

Copyright 2017 First Databank, Inc. 1976

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RxNorm Concept Source Table

Table Name REVDCS0_RXN_CONCEPT_SOURCE

Revision Activity add.02-09-2012

Purpose Provides information about an RxNorm concept including its

related Source Abbreviations (SAB), Term Types (TTY),
and Codes (CODE). This information is derived from the
National Library of Medicine (NLM)'s Concept and Source
Information Table (RXNCONSO).

Key Column Name Column Format Length Picture

Description

P EVD_RXN_CON RxNorm Concept N 8 9(8)

CEPT_SOURCE_ Source Key
KEY

F EVD_RXN_RXCU RxNorm Concept AN 8 X(8)

I Unique Identifier
(RXCUI)

EVD_RXN_SAB RxNorm Source AN 20 X(20)

Abbreviation

EVD_RXN_TTY RxNorm Term AN 20 X(20)

Type

EVD_RXN_CODE RxNorm Code AN 50 X(50)

EVD_RXN_CODE RxNorm Source N 8 9(8)

_NO Vocabulary
Numeric Identifier
(FDB Codes Only)

EVD_RXN_SUPP RxNorm AN 1 X(1)

RESS Suppressible Flag

EVD_FDB_EXCL FDB Excluded AN 1 X(1)

UDE_RXCUI_IND RXCUI Indicator

Fields with column names that end with _KEY are not persistent in that any change to corresponding
fields within the record will result in the regeneration of the key.

Copyright 2017 First Databank, Inc. 1977

FDB MedKnowledge U.S. Documentation August 2017

RxNorm to FDB Clinical Screening Exception Table

Table Name RIMKCSE0_RXN_FDB_CS_EXCEPT

Revision Activity add.01-24-2013

Purpose Provides RxNorm RXCUIs from the RxNorm to FDB Clinical

Screening Link Table (RIMKCS0_RXN_FDB_CS_LNK) that
could not be mapped to an FDB ingredient concept.

Key Column Name Column Format Length Picture

Description

PF EVD_RXN_RXCU RxNorm RXCUI AN 8 X(8)

I_SCREENED Screened

PF EVD_RXN_RXCU RxNorm RXCUI AN 8 X(8)

I_UNSCREENED Unscreened

EVD_RXN_RXCU RxNorm RXCUI AN 255 X(255)

I_UNSCREENED Unscreened
_DESC Description

Copyright 2017 First Databank, Inc. 1978

FDB MedKnowledge U.S. Documentation August 2017

RxNorm to FDB Clinical Screening Link Table

Table Name RIMKCS0_RXN_FDB_CS_LNK

Revision Activity add.01-24-2013

Purpose Relates RxNorm ingredient concepts to FDB ingredient

concepts for clinical screening purposes.

Key Column Name Column Format Length Picture

Description

P EVD_RXN_RXCU RxNorm RXCUI AN 8 X(8)

I

PF EVD_EXT_VOCA EVD External N 4 9(4)

B_TYPE_ID Vocabulary Type
Identifier

P IMK_FDB_VOCA IMK FDB N 8 9(8)

B_NO_ID Vocabulary
Identifier

PF EVD_FDB_VOCA EVD FDB N 4 9(4)

B_TYPE_ID Vocabulary Type
Identifier

EVD_RXN_RXCU RxNorm RXCUI AN 255 X(255)

I_DESC Description

F EVD_RXN_RXCU RxNorm RXCUI N 1 9(1)

I_STATUS_CD Status Code

IMK_FDB_VOCA IMK FDB AN 255 X(255)

B_DESC Vocabulary
Description

F IMK_FDB_VOCA FDB Vocabulary N 1 9(1)

B_STATUS_CD Status Code

IMK_PREFERRE IMK Preferred AN 1 X(1)

D_IND Indicator

IMK_PARTIAL_IN IMK Partial AN 1 X(1)

D Indicator

LINK_ADD_DATE Link Add Date N 8 9(8)

LINK_INACTIVE_ Link Inactive Date N 8 9(8)

DATE

Copyright 2017 First Databank, Inc. 1979

FDB MedKnowledge U.S. Documentation August 2017

SIG FDB to External Vocabulary Link Table

Table Name RIMKSSE0_SIG_FDB_TO_EXT_LINK

Revision Activity add.05-05-2016

Purpose Relates First Databank (FDB) concepts to external

vocabulary concept identifiers to support interoperable
translation of codified components for electronic
transmissions.

Key Column Name Column Format Length Picture

Description

P IMK_FDB_VOCA IMK FDB N 8 9(8)

B_NO_ID Vocabulary
Identifier

PF EVD_FDB_VOCA EVD FDB N 4 9(4)

B_TYPE_ID Vocabulary Type
Identifier

P IMK_EXT_VOCA IMK External AN 50 X(50)

B_ID Vocabulary
Identifier

PF EVD_EXT_VOCA EVD External N 4 9(4)

B_TYPE_ID Vocabulary Type
Identifier

P LINK_ADD_DT Link Add Date N 8 9(8)

IMK_FDB_VOCA IMK FDB AN 255 X(255)

B_DESC Vocabulary
Description

EVD_FDB_VOCA EVD FDB AN 50 X(50)

B_TYPE_ID_DES Vocabulary Type
C Description

IMK_EXT_VOCA IMK External AN 255 X(255)

B_DESC Vocabulary
Description

EVD_EXT_VOCA EVD External AN 50 X(50)

B_TYPE_ID_DES Vocabulary Type
C Description

IMK_PREFERRE IMK Preferred AN 1 X(1)

D_IND Indicator

IMK_RELATED_I IMK Related AN 1 X(1)

ND Indicator

LINK_INACTIVE_ Link Inactive Date N 8 9(8)

DT

Copyright 2017 First Databank, Inc. 1980

FDB MedKnowledge U.S. Documentation August 2017

SIG Frequency Interval Event Table

Table Name RIMKHIE0_SIG_FREQ_INT_EVENT

Revision Activity add.05-05-2016

Purpose Relates First Databank (FDB) frequency and interval

concepts to HL7 concepts when the instructions are related
to a specific event (for example, at bedtime or after meals)
and not a specific time period or interval. Links are created
and maintained editorially.

Key Column Name Column Format Length Picture

Description

PF FREQ_INT_ID Frequency and N 8 9(8)

Interval ID

P HL7_FI_EVENT_ HL7 Event Code AN 10 X(10)

CD

P HL7_FI_EVENT_ HL7 Event N 8 9(8)

SN Sequence
Number

P LINK_ADD_DT Link Add Date N 8 9(8)

HL7_FI_LOW_EV HL7 Low Event N 10 9(6).9(3)

ENT_OFFSET_TI Offset Time
ME

HL7_FI_LOW_EV HL7 Low Event AN 50 X(50)

ENT_OFFSET_U Offset Unit of
OM Measure

HL7_FI_HIGH_E HL7 High Event N 10 9(6).9(3)

VENT_OFFSET_ Offset Time
TIME

HL7_FI_HIGH_E HL7 High Event AN 50 X(50)

VENT_OFFSET_ Offset Unit of
UOM Measure

LINK_INACTIVE_ Link Inactive Date N 8 9(8)

DT

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FDB MedKnowledge U.S. Documentation August 2017

SIG Frequency Interval Table

Table Name RIMKHFI0_SIG_FREQ_INT_LINK

Revision Activity add.05-05-2016

Purpose Relates First Databank (FDB) frequency and interval

concepts to HL7 concepts.

Key Column Name Column Format Length Picture

Description

PF FREQ_INT_ID Frequency and N 8 9(8)

Interval ID

P HL7_FI_ADD_DT Link Add Date N 8 9(8)

FREQ_INT_TEXT Frequency and AN 50 X(50)

_SHORT Interval Short Text

HL7_FI_INSTITU HL7 Institution AN 1 X(1)

TION_SPECIFIED Specified

HL7_FI_PERIOD HL7 Period Value N 10 9(6).9(3)

_VALUE

HL7_FI_PERIOD HL7 Period Type AN 50 X(50)

_TYPE

HL7_FI_LOW_VA HL7 Period Low N 10 9(6).9(3)

LUE Value

HL7_FI_HIGH_V HL7 Period High N 10 9(6).9(3)

ALUE Value

HL7_FI_UOM HL7 Period Unit of AN 50 X(50)

Measure

HL7_FI_EFFECTI HL7 Effective AN 50 X(50)

VE_TIME_TYPE Time Type

HL7_FI_INACTIV Link Inactive Date N 8 9(8)

E_DT

Copyright 2017 First Databank, Inc. 1982

FDB MedKnowledge U.S. Documentation August 2017

SNOMED CT Concept Type Description Table

Table Name RIMKSID0_SCT_TYPE_DESC

Revision Activity add.06-20-2013

Purpose Relates the SNOMED CT Concept Type Identifier to its text

description.

Key Column Name Column Format Length Picture

Description

P SCT_CONCEPT_ SNOMED CT AN 2 X(2)

ID_TYPE Concept Identifier
Type

SCT_CONCEPT_ SNOMED CT AN 50 X(50)

ID_TYPE_DESC Concept Identifier
Type Description

Copyright 2017 First Databank, Inc. 1983

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SNOMED CT to DXID Search Exclusion History Table

Table Name RIMKSXH0_SCT_DXID_SRCH_EXCL_HX

Revision Activity add.06-20-2013

Purpose Provides historical view of links between SNOMED CT

Concept and FDB DXID within specific clinical/drug group
codes that are excluded from the main search result set of
Related DXIDs.

Key Column Name Column Format Length Picture

Description

P SEARCH_SCT_C Search SNOMED N 18 9(18)

ONCEPT_ID CT Concept
Identifier

PF SCT_CONCEPT_ SNOMED CT AN 2 X(2)

ID_TYPE Concept Identifier
Type

PF RELATED_DXID FML Related N 8 9(8)

DXID

PF CLIN_CD Clinical Code AN 2 X(2)

P CLIN_DRUG_GR Clinical Drug N 5 9(5)

P Group

P LINK_FIRST_AC Link First Active N 8 9(8)

TIVE_DT Date

LINK_LAST_ACTI Link Last Active N 8 9(8)

VE_DT Date

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SNOMED CT to DXID Search Exclusion Table

Table Name RIMKSX0_SCT_DXID_SRCH_EXCL

Revision Activity add.06-20-2013

Purpose Provides links between SNOMED CT Concept and FDB

DXID within specific clinical/drug group codes that are
excluded from the main search result set of Related DXIDs.

Key Column Name Column Format Length Picture

Description

PF SEARCH_SCT_C Search SNOMED N 18 9(18)

ONCEPT_ID CT Concept
Identifier

PF SCT_CONCEPT_ SNOMED AN 2 X(2)

ID_TYPE Concept Identifier
Type

PF RELATED_DXID FML Related N 8 9(8)

DXID

PF CLIN_CD Clinical Code AN 2 X(2)

P CLIN_DRUG_GR Clinical Drug N 5 9(5)

P Group

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FDB MedKnowledge U.S. Documentation August 2017

SNOMED CT to DXID Search History Table

Table Name RIMKSRH0_SCT_DXID_SRCH_HX

Revision Activity add.06-20-2013

Purpose Provides historical view of links between SNOMED CT

Concept and FDB DXID within specific clinical content.

Key Column Name Column Format Length Picture

Description

P SEARCH_SCT_C Search SNOMED N 18 9(18)

ONCEPT_ID CT Concept
Identifier

PF SCT_CONCEPT_ SNOMED CT AN 2 X(2)

ID_TYPE Concept Identifier
Type

PF RELATED_DXID Related FML N 8 9(8)

DXID

PF CLIN_CD Clinical Code AN 2 X(2)

P LINK_FIRST_AC Link First Active N 8 9(8)

TIVE_DT Date

F NAV_CD Navigation Code AN 2 X(2)

LINK_LAST_ACTI Link Last Active N 8 9(8)

VE_DT Date

Copyright 2017 First Databank, Inc. 1986

FDB MedKnowledge U.S. Documentation August 2017

SNOMED CT to DXID Search Table

Table Name RIMKSR0_SCT_DXID_SRCH

Revision Activity add.06-20-2013

Purpose Provides links between SNOMED CT Concept and FDB

DXID within specific clinical content.

Key Column Name Column Format Length Picture

Description

P SEARCH_SCT_C Search SNOMED N 18 9(18)

ONCEPT_ID CT Concept
Identifier

PF SCT_CONCEPT_ SNOMED CT AN 2 X(2)

ID_TYPE Concept Identifier
Type

PF RELATED_DXID FML Related N 8 9(8)

DXID

PF CLIN_CD Clinical Code AN 2 X(2)

F NAV_CD Navigation Code AN 2 X(2)

Copyright 2017 First Databank, Inc. 1987

FDB MedKnowledge U.S. Documentation August 2017

SNOMED CT to FDB Link Table

Table Name RIMKSVF0_SCT_FDB_VOCAB_LINK

Revision Activity add.10-18-2012

Purpose Supports allergy filing for non-medication reconciliation.

Key Column Name Column Format Length Picture

Description

PF IMK_SCT_VALUE IMK SNOMED CT N 4 9(4)

_SET_ID Value Set
Identifier

P SCT_CONCEPT_ SNOMED CT N 18 9(18)

ID Concept Identifier

P IMK_FDB_VOCA IMK FDB N 8 9(8)

B_NO_ID Vocabulary
Identifier

PF EVD_FDB_VOCA EVD FDB N 4 9(4)

B_TYPE_ID Vocabulary Type
Identifier

IMK_EXT_VOCA IMK External AN 255 X(255)

B_DESC Vocabulary
Description

F IMK_EXT_VOCA IMK External N 1 9(1)

B_STATUS_CD Vocabulary Status
Code

IMK_FDB_VOCA IMK FDB AN 255 X(255)

B_DESC Vocabulary
Descrition

F IMK_FDB_VOCA FDB Vocabulary N 1 9(1)

B_STATUS_CD Status Code

IMK_PREFERRE IMK Preferred AN 1 X(1)

D_IND Indicator

IMK_RELATED_I IMK Related AN 1 X(1)

ND Indicator

LINK_ADD_DATE Link Add Date N 8 9(8)

LINK_INACTIVE_ Link Inactive Date N 8 9(8)

DATE

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SNOMED CT Type Description Table

Table Name RIMKTD0_SCT_TYPE_DESC

Revision Activity add.10-18-2012

Purpose Relates the SNOMED CT Type Identifier to its text

description.

Key Column Name Column Format Length Picture

Description

P SCT_TYPE_ID SNOMED CT N 1 9(1)

Description Type
Identifier

SCT_TYPE_DES SNOMED CT AN 50 X(50)

C Type Description

Copyright 2017 First Databank, Inc. 1989

FDB MedKnowledge U.S. Documentation August 2017

SNOMED CT Value Set Description Table

Table Name RIMKVSD0_SCT_VALUE_SET_DESC

Revision Activity add.10-18-2012

Purpose Provides the name and definition for an associated

SNOMED CT value set.

Key Column Name Column Format Length Picture

Description

P IMK_SCT_VALUE IMK SNOMED CT N 4 9(4)

_SET_ID Value Set
Identifier

IMK_SCT_VALUE IMK SNOMED CT AN 255 X(255)

_SET_DESC Value Set
Description

IMK_SCT_VALUE IMK SNOMED CT AN 255 X(255)

_SET_COMMENT Value Set
Comment

F EVD_EXT_VOCA EVD External N 4 9(4)

B_TYPE_ID Vocabulary Type
Identifier

IMK_ADD_DATE IMK Add Date N 8 9(8)

IMK_INACTIVE_ IMK Inactive Date N 8 9(8)

DATE

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SNOMED CT Value Set Table

Table Name RIMKVS0_SCT_VALUE_SET

Revision Activity add.10-18-2012

Purpose Provides the name and definition for an associated

SNOMED CT value set.

Key Column Name Column Format Length Picture

Description

PF IMK_SCT_VALUE IMK SNOMED CT N 4 9(4)

_SET_ID Value Set
Identifier

P SCT_CONCEPT_ SNOMED CT N 18 9(18)

ID Concept Identifier

P SCT_DESCRIPTI SNOMED CT N 18 9(18)

ON_ID Description
Identifier

F SCT_TYPE_ID SNOMED CT N 1 9(1)

Description Type
Identifier

SCT_TERM SNOMED CT AN 255 X(255)

Description

IMK_ADD_DATE IMK Add Date N 8 9(8)

IMK_INACTIVE_ IMK Inactive Date N 8 9(8)

DATE

Copyright 2017 First Databank, Inc. 1991

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Source Description Table

Table Name REVDVS0_SOURCE_DESC

Revision Activity add.10-15-2009

Purpose Relates the EVD source identifier to its text description.

Key Column Name Column Format Length Picture

Description

P EVD_SOURCE_I EVD Source N 4 9(4)

D Identifier

EVD_SOURCE_D EVD Source AN 50 X(50)

ESC Description

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USHIK History Table

Table Name RIMKUKH0_USHIK_HIST

Revision Activity add.09-24-2015

Purpose Supports Meaningful Use Value Sets for the most recent
NLM published version and previous four CMS reporting
years.
Some attribute columns in this table have a Not Null
constraint. If FDB receives CQM value set information in
which certain data fields are reported with no information:

The word NULL is passed through for alphanumeric

columns.
A 0 value is passed through for numeric columns.
The content in this table uses the USHIK format, but is
compiled by FDB.

Key Column Name Column Format Length Picture

Description

P USHIK_MEASUR USHIK Measure N 8 9(8)

E_IDENTIFIER Identifier

P USHIK_QUALITY USHIK Quality AN 255 X(255)

_DATA_ELEMEN Data Element
T

P USHIK_VALUE_S USHIK Value Set AN 100 X(100)

ET_OID Object Identifier

P USHIK_CODE_S USHIK Code AN 50 X(50)

YSTEM System

P USHIK_CODE_S USHIK Code AN 50 X(50)

YSTEM_VERSIO System Version
N

P USHIK_CONCEP USHIK Concept AN 50 X(50)

T

P CMS_REPORTIN CMS Reporting N 4 9(4)

G_YEAR Year

USHIK_MEASUR USHIK Measure AN 255 X(255)

E_TITLE Title

USHIK_NQF_ID USHIK NQF AN 50 X(50)

Identifier

USHIK_VERSION USHIK Version N 8 9(8)

USHIK_ELIGIBILI USHIK Eligibility AN 100 X(100)

TY

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USHIK_CATEGO USHIK Category AN 100 X(100)

RY

USHIK_VALUE_S USHIK Value Set AN 255 X(255)

ET_NAME Name

USHIK_VALUE_S USHIK Value Set N 8 9(8)

ET_VERSION Version

USHIK_CONCEP USHIK Concept AN 1000 X(1000)

T_DESCRIPTION Description

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USHIK Master Table

Table Name RIMKUK0_USHIK_MSTR

Revision Activity add.03-21-2013

Purpose Supports USHIK Meaningful Use Value Sets. Some

attrubute comumns in this table have a Not Null constraint.
If FDB receives CQM value set information in which certain
data fields are reported with no information:

The "NULL" is passed through for alphanumeric

columns.
A "0" value is passed through for numeric columns.

Key Column Name Column Format Length Picture

Description

P USHIK_MEASUR USHIK Measure N 8 9(8)

E_IDENTIFIER Identifier

P USHIK_QUALITY USHIK Quality AN 255 X(255)

_DATA_ELEMEN Data Element
T

P USHIK_VALUE_S USHIK Value Set AN 100 X(100)

ET_OID Object Identifier

P USHIK_CODE_S USHIK Code AN 50 X(50)

YSTEM System

P USHIK_CODE_S USHIK Code AN 50 X(50)

YSTEM_VERSIO Sytem Version
N

P USHIK_CONCEP USHIK Concept AN 50 X(50)

T

USHIK_MEASUR USHIK Measure AN 255 X(255)

E_TITLE Title

USHIK_NQF_ID USHIK NQF AN 50 X(50)

Identifier

USHIK_VERSION USHIK Version N 8 9(8)

USHIK_ELIGIBILI USHIK Eligibility AN 100 X(100)

TY

USHIK_CATEGO USHIK Category AN 100 X(100)

RY

USHIK_VALUE_S USHIK Value Set AN 255 X(255)

ET_NAME Name

USHIK_VALUE_S USHIK Value Set N 8 9(8)

ET_VERSION Version

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USHIK_CONCEP USHIK Concept AN 1000 X(1000)

T_DESCRIPTION Description

Copyright 2017 First Databank, Inc. 1996

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Vaccine Information Statement (VIS) Lookup Table

Table Name REVDVB0_CDC_VIS_LOOKUP

Revision Activity add.02-27-2014

Purpose Provides a two-dimensional "data matrix" barcode for a

given Vaccine Information Statement (VIS).

Key Column Name Column Format Length Picture

Description

PF CDC_VIS_GDTI_ CDC VIS Global AN 13 9(13)

DOCUMENT_CD Document Type
Identifier
Document Code

PF CDC_VIS_FULLY CDC VIS Fully AN 24 X(24)

_ENCODED_TEX Encoded Text
T

PF CDC_VIS_EDITI CDC VIS Edition N 8 9(8)

ON_DT Date

F CDC_VIS_DOCU CDC VIS AN 100 X(100)

MENT_TYPE_DE Document Type
SC Description

CDC_VIS_EDITI CDC VIS Edition AN 30 X(30)

ON_STATUS status

F CDC_VIS_LAST_ CDC VIS Last N 8 9(8)

UPDATED_DT Updated Date

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Vocabulary Data Version Table

Table Name REVDVD0_VOCAB_DATA_VERSION

Revision Activity add.03-10-2011

Purpose Provides a version date associated with an external

vocabulary data set.

Key Column Name Column Format Length Picture

Description

P EVD_DATA_ID EVD Data N 4 9(4)

Identifier

EVD_DATA_DES EVD Data AN 50 X(50)

C Description

EVD_SOURCE_I EVD Source N 4 9(4)

D Identifier

EVD_SOURCE_D EVD Source AN 50 X(50)

ESC Description

EVD_DATA_VER EVD Data Version N 8 9(8)

SION_DT Date

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Vocabulary Replacement History Description Table

Table Name REVDRHD0_RXCUI_REP_DESC

Revision Activity add.02-27-2014

Purpose Relates the EVD External Previous Vocabulary Identifier to

its text description.

Key Column Name Column Format Length Picture

Description

PF EVD_EXT_PREV EVD External AN 50 X(50)

_VOCAB_ID Previous
Vocabulary
Identifier

PF EVD_EXT_CHAN EVD External N 8 9(8)

GE_DT Change Date

PF EVD_EXT_SEQ_ EVD External N 4 9(4)

SN Previous
Vocabulary
Description
Sequence

F EVD_EXT_PREV EVD External AN 255 X(255)

_VOCAB_DESC Previous
Vocabulary
Description

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Vocabulary Replacement History Table

Table Name REVDRH0_RXCUI_REP_HIST

Revision Activity add.02-27-2014

Purpose Provides a historical view of replaced RXCUIs and their

ultimate replacements.

Key Column Name Column Format Length Picture

Description

PF EVD_EXT_PREV EVD External AN 50 X(50)

_VOCAB_ID Previous
Vocabulary
Identifier

PF EVD_EXT_CHAN EVD External N 8 9(8)

GE_DT Change Date

PF EVD_EXT_REP_ EVD External AN 50 X(50)

VOCAB_ID Replacement
Vocabulary
Identifier

PF EVD_EXT_ULT_ EVD External AN 50 X(50)

REP_VOCAB_ID Ultimate
Replacement
Vocabulary
Identifier

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Vocabulary Type Definition Table

Table Name REVDVT0_VOCAB_TYPE_DEF

Revision Activity add.10-15-2009

Purpose Relates the vocabulary type to its description and source.

Key Column Name Column Format Length Picture

Description

P EVD_VOCAB_TY EVD Vocabulary N 4 9(4)

PE_ID Type Identifier

EVD_VOCAB_TY EVD Vocabulary AN 50 X(50)

PE_DESC Type Description

F EVD_SOURCE_I EVD Source N 4 9(4)

D Identifier

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Vocabulary Type to HL7 OID Link Table

Table Name RIMKVHO0_VOCAB_TYP_HL7_OID_LNK

Revision Activity add.10-18-2012

Purpose Links a Vocabulary Type Identifier to its Health Level Seven

International (HL7) Object Identifier (OID) and description.

Key Column Name Column Format Length Picture

Description

PF EVD_VOCAB_TY EVD Vocabulary N 4 9(4)

PE_ID Type Identifier

HL7_OID HL7 OID AN 200 X(200)

HL7_OID_DESC HL7 OID AN 100 X(100)

Description

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FDB State and Federal Controlled Substances Module

FDB State and Federal Controlled Substance Module Editorial Policies
Applications
ERD and Technical Specifications

Copyright 2017 First Databank, Inc. 2003

FDB MedKnowledge U.S. Documentation August 2017

FDB State and Federal Controlled Substance Module Editorial

Policies
Overview
Definitions
Data Elements
Inclusion Criteria
Rule Sets
Maintenance
Resources

Copyright 2017 First Databank, Inc. 2004

FDB MedKnowledge U.S. Documentation August 2017

SFCSM Overview
The FDB State and Federal Controlled Substances Module facilitates compliance with complex state and
federal laws and regulations aimed at reducing abuses associated with the prescription and dispensing of
controlled substances. State and federal standards may diverge, and the Module assists providers in determining
the most restrictive controlled substance schedule applicable in a jurisdiction. Use of the Module permits
prescribers, pharmacies, intermediaries, claims processors, auditors, drug wholesalers, manufacturers, and their
system application vendors to:

Comply with state and federal regulations associated with the purchasing, storing, and prescribing of
controlled substances.
Determine NDC and drug concept level effective dates for reporting and auditing of controlled substances
using the federal or state assigned schedules.
Establish the proper electronic prescribing of controlled substances (EPCS) work flows and employ
mandated safeguards required for compliance with state and federal regulations.
Track and report on each states Prescription Drug Monitoring Program (PDMP) list of monitored
substances.
Perform drug utilization reviews and auditing on claims.
Ensure that prescribing of controlled substances is within the prescriptive authority of the prescriber.
Report the inventories, acquisitions and distributions of controlled substances to state boards of pharmacy
and the DEA.
Manage and maintain state and federal controlled substance schedules over time.

The FDB State and Federal Controlled Substances Module includes the following state and federal controlled
substance information:

Federal Controlled Substance Schedule Information by NDC and drug concept.

State Controlled Substance Schedule Information by NDC and drug concept.
State PDMP Lists of Monitored Substances by NDC and drug concept.
Links from the Controlled Substance Schedule to the SCRIPT 10.6 DEA Schedule Code.Indicator for
Narcotic and Non-Narcotic NDCs and drug concepts.

Copyright 2017 First Databank, Inc. 2005

FDB MedKnowledge U.S. Documentation August 2017

SFCSM Definitions
This section defines important terms related to the module that users should understand. Some industry terms
relating to state and federal controlled substances are also defined.

State Controlled Substances

Drug of Concern
Electronic Prescribing of Controlled Substances (EPCS)
Prescription Drug Monitoring Program (PDMP)
Prescriptive Authority
NCPDP SCRIPT
DEA Exemption Lists

State Controlled Substances

Through enactment of the state-level Uniform Controlled Substances Act, each state has the authority to enact
state controlled substance regulations. However, the Controlled Substances Act is grounded in federal commerce
power and states explicitly that any state law that is in positive conflict with the Act is preempted by federal
law.The State and Federal Controlled Substances Module output for its state value the most stringent schedule,
state or federal, that can be applied to a product in a given state, and state-specific scheduling will therefore only
be reported when it exceeds DEA scheduling

Drug of Concern
For purposes of this module, a drug of concern is any NDC or drug concept identified by a state for prescription
drug monitoring that is not scheduled by the state.

Electronic Prescribing of Controlled Substances (EPCS)

EPCS is the process in which pharmacies, hospitals, and practitioners use modern technology for transmitting
controlled substance prescriptions while maintaining the closed system of controls required by the DEA. Effective
June 1, 2010, the DEA's Final Rule, titled Electronic Prescriptions for Controlled Substances, revised DEA
regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically.
The regulations also permit pharmacies to receive, dispense, and archive these electronic prescriptions.

Prescription Drug Monitoring Program (PDMP)

Prescription Drug Monitoring Programs (PDMPs) are statewide electronic databases that collect designated data
on substances dispensed in that state. The PDMP is housed by a specified statewide regulatory, administrative or
law enforcement agency and can be accessed by authorized users. Although programmatic details differ among
states, in general, all PDMPs are designed to assist in detecting and preventing abuse, misuse, and diversion of
controlled substances.

Prescriptive Authority
Prescribers of controlled substances are required to obtain prescriptive authority from their state to prescribe

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controlled substances. They must also register for licensure with the DEA. Prescriptive authority for controlled
substances is granted for drug schedules 2, 2N, 3, 3N, 4, and 5. The N that follows the numeric schedule value
indicates that prescriber authority is for non-narcotic drugs in that schedule. Prescriber authorizations are limited
to specific schedules, and authorization to prescribe products on one schedule does not constitute authorization
for products on any other schedule.

NCPDP SCRIPT
NCPDP SCRIPT is a standard created to facilitate the electronic transfer of prescription data between
pharmacies, prescribers, intermediaries, and payers. Version 10.6 of the NCPDP SCRIPT standard was
recognized by the Centers for Medicare and Medicaid Services (CMS) regulation, effective for use July 1, 2010.
Use of the NCPDP SCRIPT is a requirement of e-Prescribing standards in order to receive e-Prescribing
certification.

DEA Exemption Lists

The US Drug Enforcement Agency has the authority to exempt certain non-narcotic drug products from controlled
substance scheduling, as described in 21 CFR 1308.31-1308.34. These exemptions, which are NDC-specific, are
listed on the DEA website. The Module will apply federal controlled substances exemptions as if they were
adopted by the states, unless there is controlling state authority to the contrary.

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SFCSM Data Elements

This section contains additional information about the tables and codes contained in the module. The tables
included in this section are organized by NDC, Drug Concept, and shared (both NDC and Drug Concept)
categories.

State and Federal Controlled Substances Information

NDC Based Tables
Drug Concept Based Tables
NDC and Drug Concept Shared Tables
NCPDP SCRIPT DEA Information
NDC and Drug Concept Shared Tables
State Master Information
NDC and Drug Concept Shared Tables
State Prescription Drug Monitoring Program (PDMP) Information
NDC Based Tables
Drug Concept Based Tables
NDC and Drug Concept Shared Tables
Drug Concept Source and Type Information
Drug Concept Based Tables

State and Federal Controlled Substances Information

The state and federal controlled substance schedule information appears in the following tables:

NDC Based Tables

Federal Controlled Substance NDC Link Table (RCSFL0_FEDERAL_CS_LIN)

State Controlled Substance NDC Link Table (RCSSTL0_STATE_CS_LINK)
State Controlled Substance Difference Code NDC Table (RCSDIF0_STATE_CS_DIFF)
Controlled Substance NDC Attribute Table (RCSNA0_NDC_ATTRIBUTE)

Drug Concept Based Tables

Federal Controlled Substance Drug Concept (MEDID or RXCUI) Link Table

(RCSCFS0_CONCEPT_FEDERAL_SCHED)
State Controlled Substance Drug Concept (MEDID or RXCUI) Attribute Table
(RCSCAS0_CONCEPT_STATE_ATTR)
State Controlled Substance Difference Code Drug Concept (MEDID or RXCUI) Table
(RCSCSD0_CONCEPT_STATE_CS_DIFF)
Controlled Substance Drug Concept (MEDID or RXCUI) Attribute Table (RCSCA0_CONCEPT_ATTR)
State Controlled Substance Drug Concept (MEDID or RXCUI) Link Table
(RCSCSS0_CONCEPT_STATE_SCHED)

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NDC and Drug Concept Shared Tables

State Controlled Substance Difference Code Description Table (RCSSTD0_STATE_DIFF_DESC)

Controlled Substance Attribute Description Table (RCSAD0_ATTRIBUTE_DESC)
Controlled Substance Attribute Type Description Table (RCSATD0_ATTRIBUTE_TYPE_DESC)
Controlled Substance Attribute Value Description Table (RCSAVD0_ATTRIBUTE_VALUE_DESC)

NDC Based Tables

Federal Controlled Substance NDC Link Table (RCSFL0_FEDERAL_CS_LINK)

The federal controlled substance schedule is represented in the Federal Controlled Substance NDC Link Table
(RCSFL0_FEDERAL_CS_LINK). This table links National Drug Codes (NDCs) to their controlled substance
schedule as assigned by the Drug Enforcement Agency (DEA).

Current, historical and future effective dates are provided to identify when an NDC was on the DEA's list of
controlled substances at the stated schedule.
New records will be added to this table when:
A non-scheduled NDC becomes a scheduled substance.
An NDC is added that is federally controlled.
An NDC changes from one schedule to another.
The start date for an NDC that is federally controlled will be the later of:
The date the NDC was added to the database.
The current or future date that the affected NDC is scheduled to change.
The end date will be set upon proper notification that the NDC is no longer a federally scheduled product.

The Federal Controlled Substance Schedule Code (FEDERAL_CS_SCHEDULE_CD) that is currently in

effect for an NDC will match the DEA code provided in FDB MedKnowledge within the NDC Table
(RNDC14_NDC_MSTR). For more information on this table, please refer to the FDB MedKnowledge
documentation.

State Controlled Substance NDC Link Table (RCSSTL0_STATE_CS_LINK)

An individual state's controlled substance schedule can be found in the State Controlled Substance NDC Link
Table (RCSSTL0_STATE_CS_LINK). This table links the National Drug Codes (NDC) to the state controlled
substance schedule as assigned by their governing controlled substance authority or to the federal schedule,
whichever is more stringent.

Current, historical, and future effective dates are provided to identify an NDCs schedule on a state's list of
controlled substances.
New records will be added to this table when:
A non-scheduled NDC becomes scheduled within the state.
An NDC changes from one schedule to another within the state.

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A new NDC that is state-controlled is added to FDB's database.

The start date for an NDC that is state controlled will be the later of:
The date the NDC was added to the database.
The current or future date that the affected NDC is scheduled to change.
The end date will be set upon proper notification that the current state schedule for an NDC is ending.
If a state or territory specific controlled substance schedule does not exist, the federal schedule will be
reported. In these instances the state schedule in this table will match the federal schedule in the Federal
Controlled Substance NDC Link Table (RCSFL0_FEDERAL_CS_LINK).
Some states define their controlled substances beyond the five schedules defined by the DEA. When this
occurs, FDB will provide the schedule as defined by the state.

Neither the FDB State and Federal Controlled Substances Module nor the FDB MedKnowledge database
includes Schedule 1 controlled substances.

State Controlled Substances Difference Code NDC Table (RCSDIF0_STATE_CS_DIFF)

The State Controlled Substance Difference Code NDC Table (RCSDIF0_STATE_CS_DIFF) provides a
convenient method to determine if the schedule code for an NDC in a particular state is identical to the federal
schedule, is more stringent than the federal schedule, or does not exist on the federal schedule. When a state
adopts the federal controlled substance schedule, the list of NDCs for that state will be identical to the federal list
and all of the State Controlled Substance Difference Codes (STATE_CS_DIFF_CD) for that state will be a 1,
indicating the state schedule is the same as the federal schedule.

Controlled Substance NDC Attribute Table (RCSNA0_NDC_ATTRIBUTE)

The Controlled Substance NDC Attribute Table (RCSNA0_NDC_ATTRIBUTE) contains NDC-level attributes for
controlled substances. Each Controlled Substance NDC Attribute is identified by its Controlled Substance
Attribute Code (CS_ATTRIBUTE_CD). The value of the attribute for a given NDC is contained in the Controlled
Substance Attribute Value (CS_ATTRIBUTE_VALUE). Currently this table provides the following NDC-level
controlled substance attribute:

Controlled Substance Narcotics Indicator

A Controlled Substance Narcotics Indicator will be provided for every NDC in the State Controlled
Substance NDC Link Table. (RCSSTL0_STATE_CS_LINK).

Drug Concept Based Tables

Federal Controlled Substance Drug Concept (MEDID or RXCUI) Link Table (RCSCFS0_CONCEPT_FEDERAL_SCHED)

The federal controlled substance schedule at the drug concept (MEDID or RXCUI) level is represented in the
Federal Controlled Substance Drug Concept (MEDID or RXCUI) Link Table

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(RCSCFS0_CONCEPT_FEDERAL_SCHED). This table links drug concepts (MEDID or RXCUI) to their

controlled substance schedule as assigned by the Drug Enforcement Agency (DEA). The controlled substance
schedule is aggregated from the NDCs that are related to the MEDID or RXCUI.

Current, historical, and future effective dates are provided to identify when NDCs related to a drug concept
appeared on the DEA's list of controlled substances at the stated schedule.
New records will be added to this table when:
A drug concept has a related non-scheduled NDC which became a scheduled substance.
A new drug concept has a related NDC added that is federally controlled.
A drug concept has one or more related NDCs whose most restrictive federal schedule changes
from one schedule to another.
The start date for a drug concept that is federally controlled will be the later of:
The date the drug concept was added to the database.
The current or future date that the affected drug concept is scheduled to change.

The end date will be set when:

The drug concept no longer has any related NDCs which are federally scheduled.
The federal schedule, which is set by aggregating the federal schedules from related NDCs, changes to a
different schedule.
The federal schedule, which is set by aggregating the federal schedules from related NDCs, has been set
obsolete for more than three years.
The Federal Controlled Substance Schedule Code (FEDERAL_CS_SCHEDULE_CD) that is currently in
effect for a drug concept will match the most restrictive federal schedule code of related NDCs.

State Controlled Substance Difference Code Drug Concept (MEDID or RXCUI)

Table (RCSCAS0_CONCEPT_STATE_ATTR)

The State Controlled Substance Drug Concept (MEDID or RXCUI) Attribute Table
(RCSCAS0_CONCEPT_STATE_ATTR) contains state specific drug concept (MEDID or RXCUI)-level attributes
for controlled substances. Each Controlled Substance Drug Concept Attribute is identified by its Controlled
Substance Attribute Code (CS_ATTRIBUTE_CD). The value of the attribute for a given drug concept is contained
in the Controlled Substance Attribute Value (CS_ATTRIBUTE_VALUE). Currently this table provides the following
drug concept-level controlled substance attributes:

Current List of Available Attributes

State Schedule Multi-Value Indicator A State Schedule Multi-Value Indicator will be provided
for every drug concept (MEDID or RXCUI) in the State
Controlled Substance Drug Concept (MEDID or RXCUI)
Link Table (RCSCSS0_CONCEPT_STATE_SCHED).
The State Schedule Multi-Value Indicator denotes when
a drug concept has related NDCs whose current
controlled substance schedules span more than one
schedule.

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State Controlled Substance Difference Code Drug Concept (MEDID or RXCUI) Table
(RCSCSD0_CONCEPT_STATE_CS_DIFF)

The State Controlled Substance Difference Code Drug Concept (MEDID or RXCUI) Table
(RCSCSD0_CONCEPT_STATE_CS_DIFF) provides a convenient method to determine if the schedule code for a
drug concept (MEDID or RXCUI) in a particular state is identical to the federal schedule, is more or less stringent
than the federal schedule, or does not exist on the federal schedule. When a state adopts the federal controlled
substance schedule, the list of drug concepts for that state will be identical to the federal list and all of the State
Controlled Substance Difference Codes (STATE_CS_DIFF_CD) for that state will be a 1, indicating the state
schedule is the same as the federal schedule.

Controlled Substance Drug Concept (MEDID or RXCUI) Attribute Table (RCSCA0_CONCEPT_ATTR)

The Controlled Substance Drug Concept (MEDID or RXCUI) Attribute Table (RCSCA0_CONCEPT_ATTR)
contains drug concept (MEDID or RXCUI) level attributes for controlled substances. Each Controlled Substance
Drug Concept Attribute is identified by its Controlled Substance Attribute Code (CS_ATTRIBUTE_CD). The value
of the attribute for a given drug concept is contained in the Controlled Substance Attribute Value (
CS_ATTRIBUTE_VALUE). Currently this table provides the following drug concept-level controlled substance
attributes:

Current List of Available Attributes

Controlled Substance Narcotics Indicator A Controlled Substance Narcotics Indicator will be

provided for every drug concept (MEDID or RXCUI) in
the State Controlled Substance Drug Concept (MEDID
or RXCUI) Link Table (RCSCSS0_CONCEPT_STATE_
SCHED).

Federal Schedule Multi-Value Indicator A Federal Schedule Multi-Value Indicator will be

provided for every drug concept (MEDID or RXCUI) in
the Federal Controlled Substance Drug Concept
(MEDID or RXCUI) Link Table (RCSCFS0_CONCEPT_
FEDERAL_SCHED).
The Federal Schedule Multi-Value Indicator denotes
when a drug concept has related NDCs whose current
controlled substance schedules span more than one
schedule.

State Controlled Substance Drug Concept (MEDID or RXCUI) Link Table (RCSCSS0_CONCEPT_STATE_SCHED)

An individual state's controlled substance schedule for drug concepts (MEDID or RXCUI) can be found in the
State Controlled Substance Drug Concept (MEDID or RXCUI) Link Table
(RCSCSS0_CONCEPT_STATE_SCHED). This table links the drug concept (MEDID or RXCUI) to their state
controlled substance schedule as assigned by the State Board of Pharmacy in their given state. The controlled
substance schedule is aggregated from the NDCs that are related to the MEDID or RXCUI for the state.

Current, historical, and future effective dates are provided to identify a drug concept schedule on a state's
list of controlled substances.
New records will be added to this table when:

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A drug concept has related non-scheduled NDCs which become scheduled substances within the
state.
A new drug concept has a related NDC added that is a scheduled substance within the state.
A drug concept has one or more related NDCs whose most restrictive state schedule changes from
one schedule to another within the state.
The start date for a drug concept that is state controlled will be the later of:
The date the drug concept was added to the database.
The current or future date that the affected drug concept is scheduled to change.
The end date will be set when:
The drug concept no longer has any related NDCs which are state scheduled.
The state schedule, which is set by aggregating the state schedules from related NDCs, changes to
a different schedule.
The state schedule, which is set by aggregating the state schedules from related NDCs, has been
set obsolete for more than three years.
If a state or territory specific controlled substance schedule does not exist, the federal schedule will be
reported. In these instances the state schedule in this table will match the federal schedule in the Federal
Controlled Substance Drug Concept (MEDID or RXCUI) Link Table
(RCSCFS0_CONCEPT_FEDERAL_SCHED).
Some states define their controlled substances beyond the five schedules defined by the DEA. When this
occurs, FDB will provide the schedule as defined by the state.
The State Controlled Substance Schedule Code (STATE_CS_SCHEDULE_CD) that is currently in effect
for a drug concept will match the most restrictive state schedule code of related NDCs.

NDC and Drug Concept Shared Tables

Neither the FDB State and Federal Controlled Substances Module nor the FDB MedKnowledge database
includes Schedule 1 controlled substances.

State Controlled Substance Difference Code Description Table (RCSSTD0_STATE_DIFF_DESC)

The State Controlled Substance Difference Code Description Table (RCSSTD0_STATE_DIFF_DESC) contains
the descriptions for comparisons between the current state and federal control substances schedules. This table
contains a set of State Controlled Substance Difference Codes (STATE_CS_DIFF_CD) and their descriptions,
that are represented as the following valid values:

1 - Same as Federal Schedule

2 - More Stringent than Federal Schedule
3 - Diff Code no longer in use
4 - Not on Federal Schedule

Controlled Substance Attribute Description Table (RCSAD0_ATTRIBUTE_DESC)

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The Controlled Substance Attribute Description Table (RCSAD0_ATTRIBUTE_DESC) provides a full text
description that describes the controlled substance attribute being provided in the Controlled Substance Attribute
Code (CS_ATTRIBUTE_CD) within the Controlled Substance NDC Attribute Table
(RCSNA0_NDC_ATTRIBUTE), the Controlled Substance Drug Concept (MEDID or RXCUI) Attribute Table
(RCSCA0_CONCEPT_ATTR), the State Controlled Substance Drug Concept (MEDID or RXCUI) Attribute Table
(RCSCAS0_CONCEPT_STATE_ATTR), and the State PDMP Drug Concept (MEDID or RXCUI) Attribute Table
(RCSCAP0_CONCEPT_PDMP_ATTR). A Controlled Substance Attribute Type Code (
CS_ATTRIBUTE_TYPE_CD) is also provided as a link to the Controlled Substance Attribute Type Description
Table (RCSATD0_ATTRIBUTE_TYPE_DESC).

Controlled Substance Attribute Type Description Table (RCSATD0_ATTRIBUTE_TYPE_DESC)

The Controlled Substance Attribute Type Description Table (RCSATD0_ATTRIBUTE_TYPE_DESC) provides a

full text description, length, and precision for each attribute contained within the Controlled Substance NDC
Attribute Table (RCSNA0_NDC_ATTRIBUTE), the Controlled Substance Drug Concept (MEDID or RXCUI)
Attribute Table (RCSCA0_CONCEPT_ATTR), the State Controlled Substance Drug Concept (MEDID or RXCUI)
Attribute Table (RCSCAS0_CONCEPT_STATE_ATTR), and the State PDMP Drug Concept (MEDID or RXCUI)
Attribute Table (RCSCAP0_CONCEPT_PDMP_ATTR). This metadata is used to convey the intended content of
the Controlled Substance Attribute Value (CS_ATTRIBUTE_VALUE) for a given Controlled Substance Attribute.

Controlled Substance Attribute Value Description Table (RCSAVD0_ATTRIBUTE_VALUE_DESC)

The Controlled Substance Attribute Value Description Table (RCSAVD0_ATTRIBUTE_VALUE_DESC) contains a

full text description of the Controlled Substance Attribute Value (CS_ATTRIBUTE_VALUE) within the Controlled
Substance NDC Attribute Table (RCSNA0_NDC_ATTRIBUTE), the Controlled Substance Drug Concept (MEDID
or RXCUI) Attribute Table (RCSCA0_CONCEPT_ATTR), the State Controlled Substance Drug Concept (MEDID
or RXCUI) Attribute Table (RCSCAS0_CONCEPT_STATE_ATTR), and the State PDMP Drug Concept (MEDID
or RXCUI) Attribute Table (RCSCAP0_CONCEPT_PDMP_ATTR). Controlled Substance Attribute Value
Descriptions (CS_ATTRIBUTE_VALUE_DESC) will only be provided when the Controlled Substance Attribute
Values (CS_ATTRIBUTE_VALUE) for a Controlled Substance Attribute Code (CS_ATTRIBUTE_CD) represent a
discrete set of codes when providing a description to describe the Controlled Substance Attribute Value (
CS_ATTRIBUTE_VALUE) is useful.

NCPDP SCRIPT DEA Information

National Cancer Institute (NCI) codes for NCPDP-compliant schedule terminology can be accessed by using the
following tables:

NDC and Drug Concept Shared Tables

Controlled Substance Schedule to NCPDP SCRIPT DEA Code Link Table

(RCSSDEL0_SCRIPT_DEA_LINK)
NCPDP SCRIPT DEA Master Table (RCSSDEA0_SCRIPT_DEA_MSTR)

NDC and Drug Concept Shared Tables

Controlled Substance Schedule to NCPDP SCRIPT DEA Code Link Table (RCSSDEL0_SCRIPT_DEA_LINK)

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The Controlled Substance Schedule to NCPDP SCRIPT DEA Code Link Table
(RCSSDEL0_SCRIPT_DEA_LINK) is provided to link a Federal Controlled Substance Schedule Code (
FEDERAL_CS_SCHEDULE_CD) to an FDB-assigned SCRIPT DEA Identifier (SCRIPT_DEA_ID). The SCRIPT
DEA Identifier is used for linking to the NCPDP SCRIPT DEA Master Table (RCSSDEA0_SCRIPT_DEA_MSTR)
in order to retrieve the valid SCRIPT DEA Code (SCRIPT_DEA_CD).

NCPDP SCRIPT DEA Master Table (RCSSDEA0_DEA_MSTR)

The NCPDP SCRIPT DEA Master Table (RCSSDEA0_SCRIPT_DEA_MSTR) provides mappings between FDB's
Federal Controlled Substance Schedule Code (FEDERAL_CS_SCHEDULE_CD) and the NCPDP DEA value
sets as required in the DRU (Drug) segment of the SCRIPT 10.6 (DRU segment Field Number 010-I013-17-7996
DEA Schedule Code) and later electronic prescribing standards. All records in the NCPDP SCRIPT DEA Master
Table(RCSSDEA0_SCRIPT_DEA_MSTR) are extracted from the National Cancer Institute Thesaurus (NCIt)
Subset C89507 (NCPDP DEASchedule Terminology). This table contains the actual codes and related
descriptions that are required for use in e-Prescribing to represent DEA controlled substance schedules.

Today there is only a single subset used to define the controlled substance schedule within the NCPDP SCRIPT
standard. To represent this subset, an FDB assigned identifier of 0004 is used in the NCPDP SCRIPT DEA
Code Subset ID (SCRIPT_DEA_SUBSET_ID) column. The subset ID 0004is used to define the NCIt Subset
C89507 (NCPDP DEA Schedule Terminology). Should additional subsets be supported in current or later
electronic prescribing standards, a new subset ID will be added.

State Master Information

NDC and Drug Concept Shared Tables

State and Territory Master Table (RCSSTMA0_STATE_MSTR)

NDC and Drug Concept Shared Tables

State and Territory Master Table (RCSSTMA0_STATE_MSTR)

A list of the 50 U.S. states, the District of Columbia, and five U.S. territories (American Samoa, Guam, the
Northern Mariana Islands, Puerto Rico, and the Virgin Islands) can be found in the State and Territory Master
Table (RCSSTMA0_STATE_MSTR). This table provides the two-character postal code and its associated text
description.

State Prescription Drug Monitoring Program (PDMP) Information

The State PDMP lists of monitored substances are contained in the following tables:

NDC Based Tables

State PDMP NDC Link Table (RCSPDL0_STATE_PDMP_LINK)

State PDMP Drug Source NDC Table (RCSSRC0_STATE_PDMP_DRUG_SOURCE)

Drug Concept Based Tables

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State PDMP Drug Concept (MEDID or RXCUI) Link Table (RCSCSP0_CONCEPT_STATE_PDMP)

State PDMP Drug Source Concept (MEDID or RXCUI) Table (RCSCPS0_CONCEPT_PDMP_SOURCE)
State PDMP Drug Concept (MEDID or RXCUI) Attribute Table (RCSCAP0_CONCEPT_PDMP_ATTR)

NDC and Drug Concept Shared Tables

State PDMP Drug Source Description Table (RCSPDSD0_PDMP_DRUG_SOURCE_DESC)

State PDMP List Type Description Table (RCSPTYP0_PDMP_LIST_TYPE_DESC)

NDC Based Tables

State PDMP NDC Link Table (RCSPDL0_STATE_PDMP_LINK)

The State PDMP NDC Link Table (RCSPDL0_STATE_PDMP_LINK) provides a list by state of all NDCs required
to be reported and monitored as part of a Prescription Drug Monitoring Program.

Monitored substances may consist of both controlled and non-controlled substances.

Current, historical, and future effective dates are provided to identify when an NDC is on a state's list of
monitored substances.
New records will be added to this table when:
An NDC goes from being non-scheduled to scheduled within the state and the schedule is
monitored by the state.
An NDC changes from one state schedule to another and the new state schedule is monitored by
the state.
A new state scheduled NDC is added to FDB's database and the state schedule is monitored by the
state.
An NDC is added to a states PDMP drug of concern list.
An NDC is added to FDBs database and the drug exists on a states PDMP drug of concern list.
The start date of an NDC on the state PDMP list will be the later of:
The date the NDC was added to the database.
The date that monitoring for the NDC is to go into effect.
The end date will be set when the current state PDMP monitoring for an NDC has ended.

Effective dates represent when a drug is on a states list of monitored substances, regardless of the
source of the information. If a drug is on a states PDMP list of monitored substances and the source
code changes, effective dates will not be affected.

State PDMP Drug Source NDC Table (RCSSRC0_STATE_PDMP_DRUG_SOURCE)

The State PDMP Drug Source NDC Table (RCSSRC0_STATE_PDMP_DRUG_SOURCE) contains a source
code to indicate if FDB placed a drug on a state's list of monitored substances because:

The drug is state-scheduled and is either on a schedule that the state monitors or is identified individually
by the state to be monitored, or

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The drug is not state-scheduled, but is on the state PDMP's drug of concern list.

Drug Concept Based Tables

State PDMP Drug Concept (MEDID or RXCUI) Link Table (RCSCSP0_CONCEPT_STATE_PDMP)

The State PDMP Drug Concept (MEDID or RXCUI) Link Table (RCSCSP0_CONCEPT_STATE_PDMP) provides
a list by state of all drug concepts (MEDID or RXCUI) required to be reported and monitored as part of a
Prescription Drug Monitoring Program (PDMP).

Monitored substances may consist of both controlled and non-controlled substances.

Current, historical, and future effective dates are provided to identify when a drug concept (MEDID or
RXCUI) is on a state's list of monitored substances.
New records will be added to this table when:
A drug concept goes from being non-scheduled to scheduled within the state and the schedule is
monitored by the state.
A drug concept changes from one state schedule to another and the new state schedule is
monitored by the state.
A new state scheduled drug concept is added to FDB's database and the state schedule is
monitored by the state.
A drug concept is added to a state's PDMP drug of concern list.
A drug concept is added to FDB's database and the drug exists on a state's PDMP drug of concern
list.
The start date of a drug concept on the state PDMP list will be the later of:
The date the drug concept was added to the database.
The date that monitoring for the drug concept is to go into effect.
The end date will be set when the current state PDMP monitoring for a drug concept has ended.

State PDMP Drug Source Concept (MEDID or RXCUI) Table (RCSCPS0_CONCEPT_PDMP_SOURCE)

The State PDMP Drug Source Concept (MEDID or RXCUI) Table (RCSCSP0_CONCEPT_STATE_PDMP)
contains a source code to indicate if FDB placed a drug concept (MEDID or RXCUI) on a state's list of monitored
substances because:

The drug concept is state-scheduled and is either on a schedule that the state monitors or is identified
individually by the state to be monitored, or
The drug concept is not state-scheduled, but is on the state PDMP's drug of concern list.

State PDMP Drug Concept (MEDID or RXCUI) Attribute Table (RCSCAP0_CONCEPT_PDMP_ATTR)

The State PDMP Drug Concept (MEDID or RXCUI) Attribute Table (RCSCAP0_CONCEPT_PDMP_ATTR)
contains state specific drug concept (MEDID or RXCUI)-level attributes for controlled substances. Each
Controlled Substance Drug Concept Attribute is identified by its Controlled Substance Attribute Code (

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CS_ATTRIBUTE_CD). The value of the attribute for a given drug concept is contained in the Controlled
Substance Attribute Value (CS_ATTRIBUTE_VALUE). Currently this table provides the following drug
concept-level controlled substance attributes:

Current List of Available Attributes

State PDMP Schedule Multi-Value Indicator A State PDMP Drug Source Multi-Value Indicator will be
provided for every drug concept (MEDID or RXCUI) in the S
tate PDMP Drug Concept (MEDID or RXCUI) Link Table (R
CSCSP0_CONCEPT_STATE_PDMP).
The State PDMP Drug Source Multi-Value Indicator
denotes whether a drug concept has more than one related
NDCs which have multiple State Prescription Drug
Monitoring Program List Type Code (STATE_PDMP_LIST_
TYPE_CD) values. When the State PDMP Drug Source
Multi-Value Indicator is equal to 1, the drug concept has
related NDCs with a differing State Prescription Drug
Monitoring Drug Source Code (STATE_PDMP_DRUG_SO
URCE_CD) values within a particular state. When the State
PDMP Drug Source Code Multi-Value Indicator is equal to
0, the NDCs related to the drug concept have only one
State Prescription Drug Monitoring Drug Source Code (STA
TE_PDMP_DRUG_SOURCE_CD) value within a particular
state.

NDC and Drug Concept Shared Tables

State PDMP Drug Source Description Table (RCSPDSD0_PDMP_DRUG_SOURCE_DESC)

The State PDMP Drug Source Description Table (RCSPDSD0_PDMP_DRUG_SOURCE_DESC) contains the
descriptions for the source used to identify that a drug is on a state's PDMP list. The source codes are
represented using the following valid values:

1 - Monitored Drug of Concern

2 - Monitored State Scheduled Drug

State PDMP List Type Description Table (RCSPTYP0_PDMP_LIST_TYPE_DESC)

The State PDMP List Type Description Table (RCSPTYP0_PDMP_LIST_TYPE_DESC) contains the descriptions
of the types of state PDMP drug lists included in the module.

Currently, the State and Federal Controlled Substances Module contains lists of monitored substances
intended to support the reporting requirements of each state's PDMP. A State PDMP List Type Code (
STATE_PDMP_LIST_TYPE_CD) has been included in the module to allow flexibility for identification of
additional state specific controlled substance driven requirements in the future.

Drug Concept Source and Type Information

Drug Concept Based Tables

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Controlled Substance Concept Source Description Table (RCSSD0_CONCEPT_SOURCE_DESC)

Controlled Substance Concept Type Description Table (RCSCT0_CONCEPT_TYPE_DESC)

Drug Concept Based Tables

Controlled Substance Concept Source Description Table (RCSSD0_CONCEPT_SOURCE_DESC)

The Controlled Substance Concept Source Description Table (RCSSD0_CONCEPT_SOURCE_DESC) provides

the source description for the Controlled Substance Concept Type Identifier ( CS_CONCEPT_TYPE_ID) in the
Controlled Substance Concept Type Description Table (RCSCT0_CONCEPT_TYPE_DESC).

Controlled Substance Concept Type Description Table (RCSCT0_CONCEPT_TYPE_DESC)

The Controlled Substance Concept Type Description Table (RCSCT0_CONCEPT_TYPE_DESC) provides the
identifier type and source of a given drug concept.

CS_CONCEPT_TYPE_ID CS_CONCEPT_TYPE_DESC CS_CONCEPT_SOURCE_ID

3 MEDID 1 (First Databank)

501 Semantic Clinical Drug (SCD) 2 (National Library of Medicine)

502 Semantic Branded Drug (SBD) 2 (National Library of Medicine)

503 Generic Pack (GPCK) 2 (National Library of Medicine)

504 Brand Back (BPACK) 2 (National Library of Medicine)

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SFCSM Inclusion Criteria

This module encompasses NDCs from First Databanks (FDB) MedKnowledge database that are active or have
been obsolete for less than three years.

Inclusion - Database Product

The FDB State and Federal Controlled Substances Module will include those controlled substances that meet
the MedKnowledge database inclusion policy (see page 153). Neither the FDB State and Federal Controlled
Substances Module nor the FDB MedKnowledge database includes Schedule 1 controlled substances.

The FDB State and Federal Controlled Substances Module will include NDCs and drug concepts from
MedKnowledge when:

The NDC or drug concept has a past, present, or future federal controlled substance schedule.
The NDC or drug concept has a past, present, or future state controlled substance schedule.
The NDC or drug concept has existed in past, present, or future state PDMP lists of monitored substances.

Each state will minimally have a record for every NDC or drug concept that has a federal schedule and may have
records for additional NDCs or drug concepts if the state has deviated from the federal schedule.

The FDB State and Federal Controlled Substances Module includes the selected RxNorm Term Type values
listed below:

SBD (Semantic Branded Drug)Ingredient, strength, and dose form, brand name. For example,
Fluoxetine 4 MG/ML Oral Solution [Prozac].
SCD (Semantic Clinical Drug)Ingredients, strength and dose form. For example, Fluoxetine 4 MG/ML
Oral Solution.
BPCK (Branded Pack)Branded Drug Delivery Device (a pack that contains multiple clinical drugs or
clinical drugs designed to be administered in a specified sequence); for example, {12 (Ethinyl Estradiol
0.035 MG / Norethindrone 0.5 MG Oral Tablet)/ 9 (Ethinyl Estradiol 0.035 MG/ Norethindrone 1 MG Oral
Tablet)/ 7 Inert Ingredients 1 MG Oral Tablet)} Pack [Leena 28 Day]).
GPCK (Generic Pack)Generic Drug Delivery Device; for example, {11 [varenicline 0.5 MG Oral Tablet] /
42 (varenicline 1 MG Oral Tablet)} Pack.

This module will only include active RXCUIs which are represented in the FDB Interoperability Module and has
associated NDCs in the FDB State and Federal Controlled Substances Module.

The FDB State and Federal Controlled Substances Module includes select MED Medication ID ( MEDID) values
where:

The MED Medication Status Code (MED_STATUS_CD) is Active (equal to 0) and

The MED Medication ID (MEDID) has associated NDCs in the FDB State and Federal Controlled
Substances Module.

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SFCSM Rule Sets

This section provides rules that the clinical team uses in regard to creating the module's data, both general rules
and rules specific to data elements.

The history of federal controlled substance schedules, state controlled substance schedules, and state PDMP
lists of monitored substances will begin with the release of the product. FDB will not provide a history of this
information prior to the release date.

FDB will report for each NDC, the more stringent of state or federal scheduling. When rolling up the state
schedule from NDCs to related drug concepts, if multiple schedule assignments exist, the most restrictive
schedule will be reported.

FDB will, whenever possible, provide up to two months advance notice of drug schedule and PDMP reporting
changes to licensed customers who are registered to receive notifications through the FDB Community.

21 CFR 1308.31 authorizes the exemption of designated nonnarcotic prescription drugs from controlled
substances scheduling, and 21 CFR 1308.32 identifies the exempted NDCs. Exemptions are specific to individual
NDCs, and not their therapeutic equivalents, FDB will consider an NDC to be exempt from scheduling if the NDC
is listed on the DEA's exemption list (http://www.deadiversion.usdoj.gov/schedules/) or if the manufacturer
provides FDB with a letter from the DEA granting the exemption for the NDC.

The start date for the federal exempt NDCs will be equal to the date of the DEA exemption list or the date
stamped on the DEA exemption letter.

FDB will notify the appropriate regulatory entity in an attempt to resolve any questions or inconsistencies that
arise through our review of state and federal regulations. Corrections will be made upon written notification from
the regulatory agency.

Setting of the Start Date for NDC Based Schedules

The start date for the federal schedule will be set at product release for each NDC as follows:

If the NDC Date of Add was... If the Most Recent Federal Schedule The Default Start Date becomes...
Change was...

More than three years ago More than three years ago January 28, 2010 (this date represents
the product release date of January
28, 2013 minus three years)

More than three years ago Less than three years ago Most recent federal schedule change
date

Less than or equal to three years ago No federal schedule changes have NDC date of add
occurred

Less than or equal to three years ago More recent than the NDC date of add Most recent federal schedule change
date

The start date for the state schedules and the PDMP lists of monitored substances for NDCs has been set to the
product release date of January 28, 2013 for each NDC.

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Setting of the Start Date for Drug Concept Based Schedules

The start date for the federal controlled substance schedules, state schedules, and the PDMP lists of monitored
substances for drug concepts will be set to the release date of November 14, 2013 for each MEDID or RXCUI
concept.

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SFCSM Maintenance
This section contains information regarding the ongoing maintenance of the module's data. First Databank uses
State Net - A Lexis Nexis Company (http://www.statenet.com) and NABPLaw Online (
http://www.nabp.net/programs/member-services/nabplaw/) as our primary sources to monitor changes in state
controlled substance schedules and PDMP program additions. Additional sources used as references for state
specific information are listed at the end of this document. Updates to relevant controlled substance information
within State Net and NABPLaw will be identified and reviewed by FDB staff prior to being incorporated into the
module. Any potential updates to state controlled substances discovered in sources other than State Net and
NABPLaw will be reviewed using appropriate regulatory sources prior to being incorporated into the module.

External Triggers for Clinical Review

The external triggers that prompt the clinical editors to add or review data are the following:

FDA-approved documentation from manufacturers or distributors

State Net
NABPLaw
Introduction of new drug products to the U.S. market
Notification of changes from documented sources listed in the Resources section below

Internal Triggers for Clinical Review

The internal trigger that prompts the clinical editors to add or review data is a new Clinical Formulation ID (
GCN_SEQNO).

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SFCSM Resources
This section lists sources used by First Databank to compile the information contained in the module.

FDB utilizes many reference sources including, but not limited to, the primary medical literature (for example,
published journal articles), medical reference texts, published expert treatment guidelines, and manufacturer
product package inserts. FDB uses current source editions or versions when coding and updating data, as well as
when researching questions about data. However, a formal data review does not occur for every new release of
source editions or versions.

Additional sources include:

U.S. Food and Drug Administration. FDA MedWatch. [Newsletter].

U.S. Food and Drug Administration. The National Drug Code Directory. Available at
http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm.
NCPDP, Public Documents for Prescription Monitoring Programs. Available at
http://www.ncpdp.org/Resources/Hot-Topics.
State Net - A Lexis Nexis Company. Available at http://www.statenet.com.
National Association of Boards of Pharmacy, NABPLaw Online. Available at http://nabplaw.net/.
National Association of State Controlled Substances Authorities. Available at
http://www.nascsa.org/stateProfiles.htm.
National Alliance for Model State Drug Laws. Available at http://www.namsdl.org/.
Alliance of States with PMP Monitoring Programs. Available at http://www.pmpalliance.org.
DEA Controlled Substances Act: http://www.deadiversion.usdoj.gov/schedules/index.html.
NCPDP Subset Terminology Files: http://evs.nci.nih.gov/ftp1/NCPDP/NCPDP.xls.
NCPDP RxReconn Regulatory Reports.
Individual State Boards of Pharmacy.
Individual State PDMP Administrators.

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SFCSM Applications
This section provides information about the practical application of data contained in this module.

Finding the More Restrictive State or Federal Narcotic or Non-Narcotic Schedule for an NDC

Finding the State Schedule for an NDC that is Not Federally Controlled

Finding the NCPDP SCRIPT 10.6 DEA Code for an EPCS Transaction

Identifying the NDCs That Require Reporting to a PDMP

Finding the More Restrictive State or Federal Schedule for an NDC

Finding the More Restrictive State or Federal Schedule for a Controlled Substance Concept

Finding the State Schedule for a Controlled Substance Concept that is Not Federally Controlled

Identifying the Controlled Substance Concepts That Require Reporting to a PDMP

Identifying Controlled Substance Concepts with Multiple Values from Related NDCs

Finding the More Restrictive State of Federal Narcotic or Non-Narcotic Schedule for a Concept

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Finding the More Restrictive State or Federal Narcotic or Non-Narcotic

Schedule for an NDC
This application illustrates how to retrieve the more restrictive state or federal drug schedule for an NDC.

1. Retrieve the State Code (STATE_CD) value from the State and Territory Master Table
(RCSSTMA0_STATE_MSTR) where the State Description (STATE_DESC) value equals the state of the
prescriber.

2. Retrieve the current State Controlled Substance Schedule Code (STATE_CS_SCHEDULE_CD) value
from the State Controlled Substance NDC Link Table (RCSSTL0_STATE_CS_LINK) where:
The National Drug Code (NDC) value equals the NDC of the product.
The State Code (STATE_CD) value equals the value from the previous step.
The State Controlled Substance Start Date (STATE_CS_START_DT) is less than or equal to the
current date.
The State Controlled Substance End Date (STATE_CS_END_DT) value is either null or the State
Controlled Substance End Date (STATE_CS_END_DT) value is greater than or equal to today.

3. Retrieve the State Controlled Substance Difference Code (STATE_CS_DIFF_CD) from the State
Controlled Substance Difference Code Description Table (RCSDIF0_STATE_CS_DIFF) where:
The National Drug Code (NDC) value equals the NDC of the product.
The State Code (STATE_CD) value equals the value obtained in step 1.

4. To determine the actual federal schedule, retrieve the Federal Controlled Substance Schedule Code (
FEDERAL_CS_SCHEDULE_CD) value from the Federal Controlled Substance NDC Link Table
(RCSFL0_FEDERAL_CS_LINK) where:
The National Drug Code (NDC) value equals the NDC of the product.
The Federal Controlled Substance Start Date (FEDERAL_CS_START_DT) value is less than or
equal to the current date.
The Federal Controlled Substance End Date (FEDERAL_CS_END_DT) is either null or the Federal
Controlled Substance End Date (FEDERAL_CS_END_DT) is greater than or equal to today.

ExampleDetermining the More Restrictive State or Federal Schedule for an NDC

For purposes of demonstrating this application, the following scenario is used: A physician in the state of
Minnesota is sending an e-Prescription for CHERATUSSIN AC SYRUP (NDC 00603107554) and his application
must determine if the state or federal schedule is more restrictive.

1. Retrieve the State Code (STATE_CD) value from the State and Territory Master Table
(RCSSTMA0_STATE_MSTR) where the State Description (STATE_DESC) value equals the state of the
prescriber (in this case, Minnesota). In this example, the State Code (STATE_CD) equals a value of MN.

2. Retrieve the current State Controlled Substance Schedule Code (STATE_CS_SCHEDULE_CD) value
from the State Controlled Substance NDC Link Table (RCSSTL0_STATE_CS_LINK) where:
The National Drug Code (NDC) value equals the NDC of the product.

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The State Code (STATE_CD) value equals the value from the previous step.
The State Controlled Substance Start Date (STATE_CS_START_DT) is less than or equal to the
current date.
The State Controlled Substance End Date (STATE_CS_END_DT) value is either null or the State
Controlled Substance End Date (STATE_CS_END_DT) value is greater than or equal to today.

NDC STATE_CD STATE_CS_STA STATE_CS_END_ STATE_CS_SCH

RT_DT DT EDULE_CD

00603107554 MN 20130128 3

The State Controlled Substance Schedule Code (STATE_CS_SCHEDULE_CD) value of 3 is

retrieved.

3. Retrieve the State Controlled Substance Difference Code (STATE_CS_DIFF_CD) from the State
Controlled Substance Difference Code Description Table (RCSDIF0_STATE_CS_DIFF) where:
The National Drug Code (NDC) value equals the NDC of the product.
The State Code (STATE_CD) value equals the value obtained in step 1.

NDC STATE_CD STATE_CS_DIFF_CD

00603107554 MN 2

The State Controlled Substance Difference Code (STATE_CS_DIFF_CD) value of 2 is retrieved,

indicating the state schedule is more restrictive than the federal schedule.

4. To determine the actual federal schedule, retrieve the Federal Controlled Substance Schedule Code (
FEDERAL_CS_SCHEDULE_CD) value from the Federal Controlled Substance NDC Link Table
(RCSFL0_FEDERAL_CS_LINK) where:
The National Drug Code (NDC) value equals the NDC of the product.
The Federal Controlled Substance Start Date (FEDERAL_CS_START_DT) value is less than or
equal to the current date.
The Federal Controlled Substance End Date (FEDERAL_CS_END_DT) is either null or the Federal
Controlled Substance End Date (FEDERAL_CS_END_DT) is greater than or equal to today.

NDC STATE_CD FEDERAL_CS_S FEDERAL_CS_E FEDERAL_CS_S

TART_DT ND_DT CHEDULE_CD

00603107554 MN 20100128 5

In this example, the Federal Controlled Substance Schedule Code (

FEDERAL_CS_SCHEDULE_CD) value of 5 is retrieved, confirming that the state schedule is more
restrictive than the federal schedule.

Depending on your implementation, steps 2-4 may be combined into a single step. Please
note that every NDC in the State Controlled Substance NDC Link Table

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(RCSSTL0_STATE_CS_LINK) may not have a matching NDC in the Federal Controlled

Substance NDC Link Table (RCSFL0_FEDERAL_CS_LINK). This occurs when an NDC is
state scheduled but not federally scheduled.

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Finding the State Schedule for an NDC that is Not Federally Controlled
This application illustrates how to retrieve the state schedule for an NDC that is not federally controlled.

1. Retrieve the State Code (STATE_CD) value from the State and Territory Master Table
(RCSSTMA0_STATE_MSTR) where the State Description (STATE_DESC) value equals the state of the
pharmacy.

2. Retrieve the current State Controlled Substance Schedule Code (STATE_CS_SCHEDULE_CD) value
from the State Controlled Substance NDC Link Table (RCSSTL0_STATE_CS_LINK) where:
The National Drug Code (NDC) value equals the NDC of the product.
The State Code (STATE_CD) value equals the value from the previous step.
The State Controlled Substance Start Date (STATE_CS_START_DT) is less than or equal to the
current date.
The State Controlled Substance End Date (STATE_CS_END_DT) is either empty or the State
Controlled Substance End Date (STATE_CS_END_DT) is greater than or equal to today.

3. Retrieve the State Controlled Substance Difference Code (STATE_CS_DIFF_CD) from the State
Controlled Substance Difference Code Description Table (RCSDIF0_STATE_CS_DIFF) where:
The National Drug Code (NDC) value equals the NDC of the product.
The State Code (STATE_CD) value equals the value obtained in step 1.

ExampleFinding the State Schedule for an NDC that is Not Federally Controlled
For purposes of demonstrating this application, the following scenario is used: A pharmacy in the state of
Tennessee is dispensing Tramadol HCl 50 MG Tablet (NDC 68387090030) to a patient.

1. Retrieve the State Code (STATE_CD) value from the State and Territory Master Table
(RCSSTMA0_STATE_MSTR) where the State Description (STATE_DESC) value equals the state of the
pharmacy (in this case, Tennessee). In this example, the State Code ( STATE_CD) equals a value of TN.

2. Retrieve the current State Controlled Substance Schedule Code (STATE_CS_SCHEDULE_CD) value
from the State Controlled Substance NDC Link Table (RCSSTL0_STATE_CS_LINK) where:
The National Drug Code (NDC) value equals the NDC of the product.
The State Code (STATE_CD) value equals the value from the previous step.
The State Controlled Substance Start Date (STATE_CS_START_DT) is less than or equal to the
current date.
The State Controlled Substance End Date (STATE_CS_END_DT) is either empty or the State
Controlled Substance End Date (STATE_CS_END_DT) is greater than or equal to today.

NDC STATE_CD STATE_CS_STA STATE_CS_END_ STATE_CS_SCH

RT_DT DT EDULE_CD

68387090030 TN 20130128 5

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In this example, the State Controlled Substance Schedule Code (STATE_CS_SCHEDULE_CD)

value of 5 is retrieved.

3. Retrieve the State Controlled Substance Difference Code (STATE_CS_DIFF_CD) from the State
Controlled Substance Difference Code Description Table (RCSDIF0_STATE_CS_DIFF) where:
The National Drug Code (NDC) value equals the NDC of the product.
The State Code (STATE_CD) value equals the value obtained in step 1.

NDC STATE_CD STATE_CS_DIFF_CD

68387090030 TN 4

In this example, the State Controlled Substance Difference Code (STATE_CS_DIFF_CD) value of 4
, indicating the drug is not on the federal schedule, is retrieved.

Since the NDC is Not on the Federal Schedule, the NDC in this example will not be found in
the Federal Controlled Substance NDC Link Table (RCSFL0_FEDERAL_CS_LINK).

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Finding the NCPDP SCRIPT 10.6 DEA Code for an EPCS Transaction
This application illustrates how to retrieve the NCPDP SCRIPT 10.6 DEA Code using the more restrictive state or
federal controlled substance schedule code. The NCPDP SCRIPT 10.6 DEA Code is required to be sent as part
of the SCRIPT 10.6 messaging standard for an e-Prescription of a Controlled Substance (EPCS).

This application assumes that your application has already determined the more restrictive state or
federal schedule code. The more restrictive state or federal schedule code should be used to determine
the SCRIPT 10.6 DEA Code for an EPCS transaction.

1. Retrieve the FDB SCRIPT DEA ID (SCRIPT_DEA_ID) from the Controlled Substance Schedule to NCPDP
SCRIPT DEA Code Link Table (RCSSDEL0_SCRIPT_DEA_LINK) by matching the more restrictive state
or federal schedule code to the Federal Controlled Substance Schedule Code (
FEDERAL_CS_SCHEDULE_CD) in the Controlled Substance Schedule to NCPDP SCRIPT DEA Code
Link Table (RCSSDEL0_SCRIPT_DEA_LINK).

2. Retrieve the NCPDP SCRIPT DEA Code (SCRIPT_DEA_CD) from the NCPDP SCRIPT DEA Master
Table (RCSSDEA0_SCRIPT_DEA_MSTR) where:
The FDB SCRIPT DEA ID (SCRIPT_DEA_ID) value equals the value from the previous step.
The SCRIPT DEA Code Subset ID (SCRIPT_DEA_SUBSET_ID) equals the value specifying the
NCPDP Script 10.6 DEA Code Subset

ExampleFinding the NDPDP SCRIPT DEA 10.6 Code for an EPCS Transaction
For purposes of demonstrating this application, the following scenario is used: In this example, the more
restrictive state or federal schedule code for the NDC being prescribed is a value of 3.

NCPDP SCRIPT 10.6 DEA Code values may be retrieved for NDCs and Controlled Substance Concepts.

1. Retrieve the FDB SCRIPT DEA ID (SCRIPT_DEA_ID) from the Federal Controlled Substance Schedule to
NCPDP SCRIPT DEA Code Link Table (RCSSDEL0_SCRIPT_DEA_LINK) where the Federal Controlled
Substance Schedule Code (FEDERAL_CS_SCHEDULE_CD) is a value of 3. In this example, the FDB
SCRIPT DEA ID (SCRIPT_DEA_ID) equals a value of 00000115.

FEDERAL_CS_SCHEDULE_CD SCRIPT_DEA_ID

3 00000115

2. Retrieve the NCPDP SCRIPT DEA Code (SCRIPT_DEA_CD) from the NCPDP SCRIPT DEA Master
Table (RCSSDEA0_SCRIPT_DEA_MSTR) where:
The FDB SCRIPT DEA ID (SCRIPT_DEA_ID) value equals the value from the previous step
(00000115).
The SCRIPT DEA Code Subset ID (SCRIPT_DEA_SUBSET_ID) equals a value of 0004 (indicating
the NCPDP Script 10.6 DEA Code Subset).

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SCRIPT_DEA_ID SCRIPT_DEA_SUBSET_ID SCRIPT_DEA_CD

00000115 0004 C48676

In this example, the NCPDP SCRIPT DEA Code (SCRIPT_DEA_CD) equals a value of C48676
indicating a Schedule III Substance is retrieved.

When a drug is not federally scheduled there will not be a Federal Controlled Substance
Code (FEDERAL_CS_SCHEDULE_CD). In these instances, the C38046 NCPDP SCRIPT
DEA Code (SCRIPT_DEA_CD), which indicates Unspecified, can be sent as part of the
SCRIPT 10.6 EPCS transaction.

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Identifying the NDCs That Require Reporting to a PDMP

This application illustrates how to retrieve a list of NDCs that must be reported to a given state's Prescription Drug
Monitoring Program (PDMP).

1. Retrieve the State Code (STATE_CD) value from the State and Territory Master Table
(RCSSTMA0_STATE_MSTR) where the State Description (STATE_DESC) value equals the state of the
pharmacy.

2. Select all National Drug Code (NDC) values from the State PDMP NDC Link Table
(RCSPDL0_STATE_PDMP_LINK) where:
The State Code (STATE_CD) value equals the value from the previous step.
The State PDMP List Type Code (STATE_PDMP_LIST_TYPE_CD) is equal to 1, indicating that the
drug list used is for reporting to the state.
The State PDMP Start Date (STATE_PDMP_START_DT) is less than or equal to the start of the
desired reporting period.
The State PDMP End Date (STATE_PDMP_END_DT) is either empty or the State PDMP End Date
(STATE_PDMP_END_DT) is greater than or equal to the end of the desired reporting period.

ExampleIdentifying the NDCs That Require Reporting to a PDMP

For purposes of demonstrating this application, the following scenario is used: A pharmacy in the state of
Ohio needs to submit its weekly report of prescriptions dispensed for the prior week to its state PDMP.

1. Retrieve the State Code (STATE_CD) value from the State and Territory Master Table
(RCSSTMA0_STATE_MSTR) where the State Description (STATE_DESC) value equals the state of the
pharmacy (in this case, Ohio). In this example the State Code (STATE_CD) equals a value of OH.

2. Select all National Drug Code (NDC) values from the State PDMP NDC Link Table
(RCSPDL0_STATE_PDMP_LINK) where:
The State Code (STATE_CD) value equals the value from the previous step.
The State PDMP List Type Code (STATE_PDMP_LIST_TYPE_CD) is equal to 1, indicating that the
drug list used is for reporting to the state.
The State PDMP Start Date (STATE_PDMP_START_DT) is less than or equal to the start of the
desired reporting period.
The State PDMP End Date (STATE_PDMP_END_DT) is either empty or the State PDMP End Date
(STATE_PDMP_END_DT) is greater than or equal to the end of the desired reporting period.

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Finding the More Restrictive State or Federal Schedule for an NDC

This application illustrates how to retrieve the more restrictive state or federal narcotic or non-narcotic (2N or 3N)
schedule for an NDC.

1. Retrieve the State Code (STATE_CD) value from the State and Territory Master Table
(RCSSTMA0_STATE_MSTR) where the State Description (STATE_DESC) value equals the state of the
prescriber.

2. Retrieve the State Controlled Substance Schedule Code (STATE_CS_SCHEDULE_CD) from the State
Controlled Substance NDC Link Table (RCSSTL0_STATE_CS_LINK) where
The National Drug Code (NDC) value equals the NDC of the product.
The State Code (STATE_CD) column equals the value from the previous step.
The State Controlled Substance Start Date (STATE_CS_START_DT) is prior to or equal to the
current date.
The State Controlled Substance End Date (STATE_CS_END_DT) value is either null or the State
Controlled Substance End Date (STATE_CS_END_DT) value is greater than or equal to today.

3. Retrieve the State Controlled Substance Difference Code (STATE_CS_DIFF_CD) from the State
Controlled Substance Difference Code Description Table (RCSDIF0_STATE_CS_DIFF) where:
The National Drug Code (NDC) column equals the NDC of the product.
The State Code (STATE_CD) column equals the value obtained from step 1.

4. To determine the actual federal schedule, retrieve the Federal Controlled Substance Schedule Code (
FEDERAL_CS_SCHEDULE_CD) value from the Federal Controlled Substance NDC Link Table
(RCSFL0_FEDERAL_CS_LINK) where:
The National Drug Code (NDC) value equals the NDC of the product.
The Federal Controlled Substance Start Date (FEDERAL_CS_START_DT) value is less than or
equal to the current date.
The Federal Controlled Substance End Date (FEDERAL_CS_END_DT) is either null or the Federal
Controlled Substance End Date (FEDERAL_CS_END_DT) is greater than or equal to today.

5. If the more restrictive state or federal schedule is a 2 or a 3, determine if the drug is a narcotic or a
non-narcotic. Retrieve the Narcotic Indicator by selecting the Controlled Substance Attribute Value (
CS_ATTRIBUTE_VALUE) from the Controlled Substance NDC Attribute Table
(RCSNA0_NDC_ATTRIBUTE) where:
The National Drug Code (NDC) value equals the NDC of the product.
The Controlled Substance Attribute Code (CS_ATTRIBUTE_CD) is equal to 1.
The Controlled Substance Attribute Sequence Number (CS_ATTRIBUTE_SN) is equal to 1.
The Controlled Substance Attribute Value Sequence Number (CS_ATTRIBUTE_VALUE_SN) is
equal to 1.

6. If the Controlled Substance Attribute Value (CS_ATTRIBUTE_VALUE) is a Y, then the drug is a narcotic
and the more restrictive state or federal schedule of 2 or 3 is applied. If the Controlled Substance Attribute

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6.

Value (CS_ATTRIBUTE_VALUE) is an N, then the drug is classified as a non-narcotic. Append the

Controlled Substance Attribute Value (CS_ATTRIBUTE_VALUE) of N to the more restrictive state or
federal schedule. The more restrictive state schedule would be categorized as 2N, and the more restrictive
federal schedule would be categorized as 3N.

ExampleFinding the More Restrictive State or Federal Narcotic or Non-Narcotic Schedule for an
NDC
For purposes of demonstrating this application, the following scenario is used: A pharmacy in the state of
Minnesota is filling a prescription and must determine if the physician's assistant who prescribed the drug (and
who is authorized in the state of Minnesota to prescribe drugs in schedules 3N, 4, and 5) has the prescriptive
authority to prescribe the drug PROMETHAZINE-CODEINE SYRUP (NDC 00472162716).

1. Retrieve the State Code (STATE_CD) value from the State and Territory Master Table
(RCSSTMA0_STATE_MSTR) where the State Description (STATE_DESC) value equals the state of the
pharmacy (in this case, Minnesota). In this example the State Code (STATE_CD) equals a value of MN.

2. Retrieve the current State Controlled Substance Schedule Code (STATE_CS_SCHEDULE_CD) from the
State Controlled Substance NDC Link Table (RCSSTL0_STATE_CS_LINK) where:
The National Drug Code (NDC) is a value of 00472162716.
The State Code (STATE_CD) is a value of MN.
The State Controlled Substance Start Date (STATE_CS_START_DT) is less than or equal to today.
The State Controlled Substance End Date (STATE_CS_END_DT) value is either null or the State
Controlled Substance End Date (STATE_CS_END_DT) value is greater than or equal to today.

NDC STATE_CD STATE_CS_STA STATE_CS_END_ STATE_CS_SCH

RT_DT DT EDULE_CD

00472162716 MN 20130128 3

In this example, the State Controlled Substance Schedule Code (STATE_CS_SCHEDULE_CD)

value of 3 is retrieved.

3. Retrieve the State Controlled Substance Difference Code (STATE_CS_DIFF_CD) from the State
Controlled Substance Difference Code Description Table (RCSDIF0_STATE_CS_DIFF) where:
The National Drug Code (NDC) is a value of 00472162716.
The State Code (STATE_CD) is a value of MN.

NDC STATE_CD STATE_CS_DIFF_CD

00472162716 MN 2

In this example, a State Controlled Substance Difference Code (STATE_CS_DIFF_CD) value of 2 is

retrieved, indicating that the state schedule is more restrictive than the federal schedule.

4.

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4. To determine the actual federal schedule, retrieve the Federal Controlled Substance Schedule Code (
FEDERAL_CS_SCHEDULE_CD) value from the Federal Controlled Substance NDC Link Table
(RCSFL0_FEDERAL_CS_LINK) where:
The National Drug Code (NDC) is a value of 00472162716.
The Federal Controlled Substance Start Date (FEDERAL_CS_START_DT) is greater than or equal
to today.
The Federal Controlled Substance End Date (FEDERAL_CS_END_DT) is either null or the Federal
Controlled Substance End Date (FEDERAL_CS_END_DT) is greater than or equal to today.

NDC FEDERAL_CS_START FEDERAL_END_DT FEDERAL_CS_SCHED

_DT ULE_CD

00472162716 20130128 5

In this example, a Federal Controlled Substance Schedule Code (FEDERAL_CS_SCHEDULE_CD)

value of 5 is retrieved, confirming that the state schedule is more restrictive than the federal
schedule.

5. Since the state schedule is more restrictive and the state schedule is a 3, determine if the drug is a
narcotic or a non-narcotic. Retrieve the Narcotic Indicator by selecting the Controlled Substance Attribute
Value (CS_ATTRIBUTE_VALUE) from the Controlled Substance NDC Attribute Table
(RCSNA0_NDC_ATTRIBUTE) where:
The National Drug Code (NDC) is a value of 00472162716.
The Controlled Substance Attribute Code (CS_ATTRIBUTE_CD) is a value of 1.
The Controlled Substance Attribute Sequence Number (CS_ATTRIBUTE_SN) is equal to 1.
The Controlled Substance Attribute Value Sequence Number (CS_ATTRIBUTE_VALUE_SN) is
equal to 1.

NDC CS_ATTRIBUTE_ CS_ATTRIBUTE_ CS_ATTRIBUTE_ CS_ATTRIBUTE_

CD SN VALUE_SN VALUE

00472162716 1 1 1 Y

In this example, the Controlled Substance Attribute Value (CS_ATTRIBUTE_VALUE) of Y is

retrieved.

6. Since the Controlled Substance Attribute Value (CS_ATTRIBUTE_VALUE) is a Y, the drug is a narcotic
and the schedule that the prescriber should be validated against is a 3. The physician's assistant in this
scenario is only licensed to prescribe drugs in schedules 3N, 4, and 5 and therefore is not authorized to
prescribe this drug in the state of Minnesota.

During your implementation, you may choose to include the Controlled Substance Attribute Value (
CS_ATTRIBUTE_VALUE) (Narcotic Indicator) in a distinct database column to simplify data

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retrieval. If so, your method for retrieving the Narcotic Indicator may vary from what's listed in step
5. In this instance, you would still complete steps 5 and 6 using the data from your Narcotic
Indicator source.

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Finding the More Restrictive State or Federal Schedule for a Controlled

Substance Concept
This application illustrates how to retrieve the more restrictive state or federal drug schedule for a controlled
substance concept.

1. Retrieve the State Code (STATE_CD) value from the State and Territory Master Table
(RCSSTMA0_STATE_MSTR) where the State Description (STATE_DESC) value equals the state of the
prescriber.

2. Retrieve the current State Controlled Substance Schedule Code (STATE_CS_SCHEDULE_CD) value
from the State Controlled Substance Drug Concept (MEDID or RXCUI) Link Table
(RCSCSS0_CONCEPT_STATE_SCHED) where:
The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) value equals:
3, if the drug concept identifier is a MEDID.
501, if the drug concept identifier is a Semantic Clinical Drug (SCD)
502, if the drug concept identifier is a Semantic Branded Drug (SBD)
503, if the drug concept identifier is a Generic Pack (GPCK).
504, if the drug concept identifier is a Brand Pack (BPCK).

Specifying the Controlled Substance Concept Type Identifier (

CS_CONCEPT_TYPE_ID) is optional if the Controlled Substance Concept Type
Identifier is unknown and the drug concept identifier is not a MEDID.

The Controlled Substance Concept Identifier (CS_CONCEPT_ID) value equals the identifier
of the concept.
The State Code (STATE_CD) value equals the value from the previous step.
The State Controlled Substance Concept Start Date (CONCEPT_STATE_CS_START_DT) is
less than or equal to the current date.
The State Controlled Substance Concept End Date (CONCEPT_STATE_CS_END_DT)
value is either null or the State Controlled Substance Concept End Date (
CONCEPT_STATE_CS_END_DT) value is greater than or equal to today.

3. Retrieve the State Controlled Substance Difference Code (STATE_CS_DIFF_CD) from the State
Controlled Substance Difference Code Drug Concept (MEDID or RXCUI) Table
(RCSCSD0_CONCEPT_STATE_CS_DIFF) where:
The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) value equals the
value obtained in step 2.
The Controlled Substance Concept Identifier (CS_CONCEPT_ID) value equals the value obtained
in step 2.
The State Code (STATE_CD) value equals the value obtained in step 1.

4. To determine the actual federal schedule, retrieve the Federal Controlled Substance Schedule Code (

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4.
FEDERAL_CS_SCHEDULE_CD) value from the Federal Controlled Substance Drug Concept (MEDID or
RXCUI) Link Table (RCSCFS0_CONCEPT_FEDERAL_SCHED) where:
The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) value equals the
value obtained in step 2.
The Controlled Substance Concept Identifier (CS_CONCEPT_ID) value equals the value obtained
in step 2.
The Federal Controlled Substance Start Date (FEDERAL_CS_START_DT) value is less than or
equal to the current date.
The Federal Controlled Substance Concept End Date (CONCEPT_FEDERAL_CS_END_DT) is
either null or the The Federal Controlled Substance Concept End Date (
CONCEPT_FEDERAL_CS_END_DT) is greater than or equal to today.

ExampleDetermining the More Restrictive State or Federal Schedule for a MEDID

For purposes of demonstrating this application, the following scenario is used: A physician in the state of
Minnesota is sending an e-Prescription for codeine 10 mg-guaifenesin 100 mg/5 mL Oral Liquid (MEDID 266139),
and his application must determine if the state or federal schedule is more restrictive.

1. Retrieve the State Code (STATE_CD) value from the State and Territory Master Table
(RCSSTMA0_STATE_MSTR) where the State Description (STATE_DESC) value equals the state of the
prescriber (in this case, Minnesota). In this example, the State Code (STATE_CD) equals a value of MN.

2. Retrieve the current State Controlled Substance Schedule Code (STATE_CS_SCHEDULE_CD) value
from the State Controlled Substance Drug Concept (MEDID or RXCUI) Link Table
(RCSCSS0_CONCEPT_STATE_SCHED) where:
The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) value equals the
Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) for the drug concept type
being used (in this case, a value of 3, indicating a MEDID).
The Controlled Substance Concept Identifier (CS_CONCEPT_ID) value equals the identifier of the
concept (in this case, MEDID 266139).
The State Code (STATE_CD) value equals a value of MN.
The State Controlled Substance Concept Start Date (CONCEPT_STATE_CS_START_DT) is less
than or equal to the current date.
The State Controlled Substance Concept End Date (CONCEPT_STATE_CS_END_DT) value is
either null or the State Controlled Substance Concept End Date (CONCEPT_STATE_CS_END_DT)
value is greater than or equal to today.

CS_CONCEPT CS_CONCEPT STATE_CD CONCEPT_ST CONCEPT_ST STATE_CS_S

_TYPE_ID _ID ATE_CS_STA ATE_CS_END CHEDULE_CD
RT_DT _DT

3 MEDID 266139 20131114 3

In this example, the State Controlled Substance Schedule Code (STATE_CS_SCHEDULE_CD)

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value equals 3.

3. Retrieve the State Controlled Substance Difference Code (STATE_CS_DIFF_CD) from the State
Controlled Substance Difference Code Drug Concept (MEDID or RXCUI) Table
(RCSCSD0_CONCEPT_STATE_CS_DIFF) where:
The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) value equals the
value obtained in step 2 (in this case, a value of 3).
The Controlled Substance Concept Identifier (CS_CONCEPT_ID) value equals the value obtained
in step 2 (in this case, a value of MEDID 266139).
The State Code (STATE_CD) is a value of MN.

CS_CONCEPT_TYPE_I CS_CONCEPT_ID STATE_CD STATE_CS_DIFF_CD

D

3 MEDID 266139 MN 2

The State Controlled Substance Difference Code (STATE_CS_DIFF_CD) value of 2 is retrieved,

indicating the state schedule is more restrictive than the federal schedule.

4. To determine the actual federal schedule, retrieve the Federal Controlled Substance Schedule Code (
FEDERAL_CS_SCHEDULE_CD) value from the Federal Controlled Substance Drug Concept (MEDID or
RXCUI) Link Table (RCSCFS0_CONCEPT_FEDERAL_SCHED) where:
The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) value equals the
value obtained in step 2 (in this case, a value of 3).
The Controlled Substance Concept Identifier (CS_CONCEPT_ID) value equals the value obtained
in step 2 (in this case, a value of MEDID 266139).
The Federal Controlled Substance Concept Start Date (CONCEPT_FEDERAL_CS_START_DT)
value is less than or equal to the current date.
The Federal Controlled Substance Concept End Date (CONCEPT_FEDERAL_CS_END_DT) is
either null or the The Federal Controlled Substance Concept End Date (
CONCEPT_FEDERAL_CS_END_DT) is greater than or equal to today.

CS_CONCEPT_T CS_CONCEPT_ID CONCEPT_FEDE CONCEPT_FEDE FEDERAL_CS_S

YPE_ID RAL_CS_START_ RAL_CS_END_D CHEDULE_CD
DT T

3 MEDID 266139 20131114 5

In this example, the Federal Controlled Substance Schedule Code (

FEDERAL_CS_SCHEDULE_CD) value of 5 is retrieved, confirming that the state schedule is more
restrictive than the federal schedule.

Depending on your implementation, steps 2-5 may be combined into a single step. Please
note that every drug concept in the State Controlled Substance Drug Concept (MEDID or
RXCUI) Link Table (RCSCSS0_CONCEPT_STATE_SCHED) may not have a matching

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Concept Identifier in the Federal Controlled Substance Drug Concept (MEDID or RXCUI)
Link Table (RCSCFS0_CONCEPT_FEDERAL_SCHED). This occurs when a drug concept
is state scheduled but not federally scheduled.

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Finding the State Schedule for a Controlled Substance Concept that is Not
Federally Controlled
This application illustrates how to retrieve the state schedule for a controlled substance concept that is not
federally controlled.

1. Retrieve the State Code (STATE_CD) value from the State and Territory Master Table
(RCSSTMA0_STATE_MSTR) where the State Description (STATE_DESC) value equals the state of the
pharmacy.

2. Retrieve the current State Controlled Substance Schedule Code (STATE_CS_SCHEDULE_CD) value
from the State Controlled Substance Drug Concept (MEDID or RXCUI) Link Table
(RCSCSS0_CONCEPT_STATE_SCHED) where:
The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) value equals:
3, if the drug concept identifier is a MEDID.
501, if the drug concept identifier is a Semantic Clinical Drug (SCD)
502, if the drug concept identifier is a Semantic Branded Drug (SBD)
503, if the drug concept identifier is a Generic Pack (GPCK).
504, if the drug concept identifier is a Brand Pack (BPCK).

Specifying the Controlled Substance Concept Type Identifier (

CS_CONCEPT_TYPE_ID) is optional if the Controlled Substance Concept Type
Identifier is unknown and the drug concept identifier is not a MEDID.

The Controlled Substance Concept Identifier (CS_CONCEPT_ID) value equals the identifier of the
product.
The State Code (STATE_CD) value equals the value from the previous step.
The State Controlled Substance Concept Start Date (CONCEPT_STATE_CS_START_DT) is less
than or equal to the current date.
The State Controlled Substance Concept End Date (CONCEPT_STATE_CS_END_DT) value is
either null or the State Controlled Substance Concept End Date (CONCEPT_STATE_CS_END_DT)
value is greater than or equal to today.

3. Retrieve the State Controlled Substance Difference Code (STATE_CS_DIFF_CD) from the State
Controlled Substance Difference Code Drug Concept (MEDID or RXCUI) Table
(RCSCSD0_CONCEPT_STATE_CS_DIFF) where:
The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) value equals the
value obtained in step 2.
The Controlled Substance Concept Identifier (CS_CONCEPT_ID) value equals the value obtained
in step 2.
The State Code (STATE_CD) value equals the value obtained in step 1.

ExampleFinding the State Schedule for an RXCUI that is Not Federally Controlled

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For purposes of demonstrating this application, the following scenario is used: A physician in the state of
Tennessee is sending an e-prescription for tramadol hydrochloride 50 MG Oral Tablet (RXCUI 835603) to a
pharmacy.

1. Retrieve the State Code (STATE_CD) value from the State and Territory Master Table
(RCSSTMA0_STATE_MSTR) where the State Description (STATE_DESC) value equals the state of the
prescriber (in this case, Tennessee). In this example, the State Code (STATE_CD) equals a value of TN.

2. Retrieve the current [State Controlled Substance Schedule Code (STATE_CS_SCHEDULE_CD) value
from the State Controlled Substance Drug Concept (MEDID or RXCUI) Link Table
(RCSCSS0_CONCEPT_STATE_SCHED) where:
The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) values equal the
selected Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) for the drug
concept type being used (in this case, 501, 502, 503 or 504).
The Controlled Substance Concept Identifier (CS_CONCEPT_ID) value equals the identifier of the
product (in this case, a value of 835603).
The State Code (STATE_CD) value equals the value from the previous step.
The State Controlled Substance Concept Start Date (CONCEPT_STATE_CS_START_DT) is less
than or equal to the current date.
The State Controlled Substance Concept End Date (CONCEPT_STATE_CS_END_DT) value is
either null or the State Controlled Substance Concept End Date (CONCEPT_STATE_CS_END_DT)
value is greater than or equal to today.

CS_CONCEPT CS_CONCEPT STATE_CD CONCEPT_ST CONCEPT_ST STATE_CS_S

_TYPE_ID _ID ATE_CS_STA ATE_CS_END CHEDULE_CD
RT_DT _DT

501 835603 TN 20131114 4

In this example, the State Controlled Substance Schedule Code (STATE_CS_SCHEDULE_CD)

equals a value of 4.

3. Retrieve the State Controlled Substance Difference Code (STATE_CS_DIFF_CD) from the State
Controlled Substance Difference Code Drug Concept (MEDID or RXCUI) Table
(RCSCSD0_CONCEPT_STATE_CS_DIFF) where:
The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) values equals the
values obtained in step 2 (in this case, 501).
The Controlled Substance Concept Identifier (CS_CONCEPT_ID) value equals the value obtained
in step 2 (in this case, a value of 835603).
The State Code (STATE_CD) value equals the value obtained in step 1.

CS_CONCEPT_TYPE_I CS_CONCEPT_ID STATE_CD STATE_CS_DIFF_CD

D

501 835603 TN 4

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The State Controlled Substance Difference Code (STATE_CS_DIFF_CD) value of 4 is retrieved,

indicating the drug is not on the federal schedule, is retrieved. Since the RXCUI is Not on the
Federal Schedule, the RXCUI in this example will not be found in the Federal Controlled Substance
Drug Concept (MEDID or RXCUI) Link Table (RCSCFS0_CONCEPT_FEDERAL_SCHED).

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Identifying the Controlled Substance Concepts That Require Reporting to a

PDMP
This application illustrates how to retrieve a list of Controlled Substance Concepts that must be reported to a
given state's Prescription Drug Monitoring Program (PDMP).

1. Retrieve the State Code (STATE_CD) value from the State and Territory Master Table
(RCSSTMA0_STATE_MSTR) where the State Description (STATE_DESC) value equals the state of the
pharmacy.

2. Retrieve the current State Controlled Substance Schedule Code (STATE_CS_SCHEDULE_CD) value
from the State Controlled Substance Drug Concept (MEDID or RXCUI) Link Table
(RCSCSS0_CONCEPT_STATE_SCHED) where:
The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) value equals
3, if the drug concept identifier is a MEDID.
501, if the drug concept identifier is a Semantic Clinical Drug (SCD)
502, if the drug concept identifier is a Semantic Branded Drug (SBD)
503, if the drug concept identifier is a Generic Pack (GPCK).
504, if the drug concept identifier is a Brand Pack (BPCK).

Specifying the Controlled Substance Concept Type Identifier (

CS_CONCEPT_TYPE_ID) is optional if the Controlled Substance Concept Type
Identifier is unknown and the drug concept identifier is not a MEDID.

The State Code (STATE_CD) value equals the value from the previous step.
The State PDMP List Type Code (STATE_PDMP_LIST_TYPE_CD) is equal to 1, indicating that the
drug list used is for reporting to the state.
The State Prescription Drug Monitoring Program Concept Start Date (
CONCEPT_STATE_PDMP_START_DT) is less than or equal to the start of the desired reporting
period.The State Prescription Drug Monitoring Program Concept End Date (
CONCEPT_STATE_PDMP_END_DT) is either empty or the State Prescription Drug Monitoring
Program Concept End Date (CONCEPT_STATE_PDMP_END_DT) is greater than or equal to the
end of the desired reporting period.

ExampleIdentifying the MEDIDs That Require Reporting to a PDMP

For purposes of demonstrating this application, the following scenario is used: A pharmacy in the state of Ohio
needs to submit its weekly report of prescriptions dispensed for the prior week to its state PDMP.

1. Retrieve the State Code (STATE_CD) value from the State and Territory Master Table
(RCSSTMA0_STATE_MSTR) where the State Description (STATE_DESC) value equals the state of the
pharmacy. In this example the State Code (STATE_CD) equals a value of OH.

2. Select all Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) values from the State

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2.

PDMP Drug Concept (MEDID or RXCUI) Link Table (RCSCSP0_CONCEPT_STATE_PDMP) where:

The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) value equals the
Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) for the drug concept type
being used (in this case, a value of 3, indicating a MEDID).
The State Code (STATE_CD) value equals the value from the previous step (in this case, OH).
The State PDMP List Type Code (STATE_PDMP_LIST_TYPE_CD) is equal to 1, indicating that the
drug list used is for reporting to the state.
The State Prescription Drug Monitoring Program Concept Start Date (
CONCEPT_STATE_PDMP_START_DT) is less than or equal to the start of the desired reporting
period.
The State Prescription Drug Monitoring Program Concept End Date (
CONCEPT_STATE_PDMP_END_DT) is either empty or the State Prescription Drug Monitoring
Program Concept End Date (CONCEPT_STATE_PDMP_END_DT) is greater than or equal to the
end of the desired reporting period.

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Identifying Controlled Substance Concepts with Multiple Values from

Related NDCs
This application illustrates how to verify whether Controlled Substance Concepts have multiple values based
upon related NDCs. When a Controlled Substance Concept has multiple values, the most restrictive value is
populated in the Controlled Substance Concepts tables and a multiple value indicator will indicate that multiple
values are present on related NDCs.

1. If retrieving values from the State Controlled Substance Difference Code Drug Concept (MEDID or RXCUI)
Table (RCSCSS0_CONCEPT_STATE_SCHED) or State PDMP Drug Concept (MEDID or RXCUI) Link
Table (RCSCSP0_CONCEPT_STATE_PDMP), retrieve the State Code (STATE_CD) value from the State
and Territory Master Table (RCSSTMA0_STATE_MSTR) where the State Description (STATE_DESC)
value equals the state.

2. Select the Controlled Substance Concept information from one of the following tables:
Federal Controlled Substance Drug Concept (MEDID or RXCUI) Link Table
(RCSCFS0_CONCEPT_FEDERAL_SCHED) where:
The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) value equals:
3, if the drug concept identifier is a MEDID.
501, if the drug concept identifier is a Semantic Clinical Drug (SCD).
502, if the drug concept identifier is a Semantic Branded Drug (SBD).
503, if the drug concept identifier is a Generic Pack (GPCK).
504, if the drug concept identifier is a Brand Pack (BPCK).

Specifying the Controlled Substance Concept Type Identifier (

CS_CONCEPT_TYPE_ID) is optional if the Controlled Substance Concept
Type Identifier is unknown and the drug concept identifier is not a MEDID.

The Controlled Substance Concept Identifier (CS_CONCEPT_ID) value equals the identifier
of the concept.
The Federal Controlled Substance Concept Start Date (
CONCEPT_FEDERAL_CS_START_DT) value is less than or equal to the current date.
The Federal Controlled Substance Concept End Date (CONCEPT_FEDERAL_CS_END_DT)
is either null or the Federal Controlled Substance Concept End Date (
CONCEPT_FEDERAL_CS_END_DT) is greater than or equal to today.
The State PDMP Drug Concept (MEDID or RXCUI) Link Table
(RCSCSP0_CONCEPT_STATE_PDMP) where:
The State Code (STATE_CD) value equals the values from the previous step.
The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) value equals:
3, if the drug concept identifier is a MEDID.
501, if the drug concept identifier is a Semantic Clinical Drug (SCD)

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502, if the drug concept identifier is a Semantic Branded Drug (SBD)

503, if the drug concept identifier is a Generic Pack (GPCK).
504, if the drug concept identifier is a Brand Pack (BPCK
The Controlled Substance Concept Identifier (CS_CONCEPT_ID) value equals the identifier
of the concept.
The State Prescription Drug Monitoring Program Concept Start Date (
CONCEPT_STATE_PDMP_START_DT) is less than or equal to the start of the desired
reporting period.
The State Prescription Drug Monitoring Program Concept End Date (
CONCEPT_STATE_PDMP_END_DT) is either empty or the State Prescription Drug
Monitoring Program Concept End Date (CONCEPT_STATE_PDMP_END_DT) is greater
than or equal to the end of the desired reporting period.
The State Controlled Substance Drug Concept (MEDID or RXCUI) Link Table
(RCSCSS0_CONCEPT_STATE_SCHED) where:
The State Code (STATE_CD) value equals the value from the previous step.
The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) value equals:
3, if the drug concept identifier is a MEDID.
501, if the drug concept identifier is a Semantic Clinical Drug (SCD)
502, if the drug concept identifier is a Semantic Branded Drug (SBD)
503, if the drug concept identifier is a Generic Pack (GPCK).
504, if the drug concept identifier is a Brand Pack (BPCK)
The Controlled Substance Concept Identifier (CS_CONCEPT_ID) value equals the identifier
of the concept.
The State Controlled Substance Concept Start Date (CONCEPT_STATE_CS_START_DT) is
less than or equal to the current date.
The State Controlled Substance Concept End Date (CONCEPT_STATE_CS_END_DT)
value is either null or the State Controlled Substance Concept End Date (
CONCEPT_STATE_CS_END_DT) value is greater than or equal to today.

3. Retrieve any controlled substance attribute values associated to the concept from the previous step from
one of the following tables:
Controlled Substance Drug Concept (MEDID or RXCUI) Attribute Table
(RCSCA0_CONCEPT_ATTR) if the previously selected table is the Federal Controlled Substance
Drug Concept (MEDID or RXCUI) Link Table (RCSCFS0_CONCEPT_FEDERAL_SCHED) where:
The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) value is equal
to the previously selected value.
The Controlled Substance Concept Identifier (CS_CONCEPT_ID) value equals the identifier
of the concept.
The State PDMP Drug Concept (MEDID or RXCUI) Attribute Table

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(RCSCAP0_CONCEPT_PDMP_ATTR) if the previously selected table is the State PDMP Drug

Concept (MEDID or RXCUI) Link Table (RCSCSP0_CONCEPT_STATE_PDMP) where:
The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) value is equal
to the previously selected value.
The State Code (STATE_CD) value is equal to the previously selected value.
The State Prescription Drug Monitoring Program List Type Code (
STATE_PDMP_LIST_TYPE_CD) value is equal to the previously selected value.
The Controlled Substance Concept Identifier (CS_CONCEPT_ID) value equals the identifier
of the concept.
State Controlled Substance Drug Concept (MEDID or RXCUI) Attribute Table
(RCSCAS0_CONCEPT_STATE_ATTR) if the previously selected table is the State Controlled
Substance Drug Concept (MEDID or RXCUI) Link Table (RCSCSS0_CONCEPT_STATE_SCHED)
where:
The Concept Type Identifier (CS_CONCEPT_TYPE_ID) value is equal to the previously
selected value.
The State Code (STATE_CD) value is equal to the previously selected value.
The Controlled Substance Concept Identifier (CS_CONCEPT_ID) value equals the identifier
of the concept.

4. Filter attribute values to only include multiple value indicators returned by the previous step:
The State Controlled Substance Drug Concept (MEDID or RXCUI) Attribute Table
(RCSSD0_CONCEPT_SOURCE_DESC) where the Controlled Substance Attribute Code (
CS_ATTRIBUTE_CD) equals 2 (for Federal Schedule Multi-Value Indicator).
The State PDMP Drug Concept (MEDID or RXCUI) Attribute Table
(RCSCAP0_CONCEPT_PDMP_ATTR) where the Controlled Substance Attribute Code (
CS_ATTRIBUTE_CD) equals 4 (for State PDMP Drug Source Code Multi-Value Indicator).
The State Controlled Substance Drug Concept (MEDID or RXCUI) Attribute Table
(RCSCAS0_CONCEPT_STATE_ATTR) where the Controlled Substance Attribute Code (
CS_ATTRIBUTE_CD) equals 3 (for State Schedule Multi-Value Indicator).

5. Evaluate whether multiple values are present.

If the Controlled Substance Attribute Value (CS_ATTRIBUTE_VALUE) from the previous step is
equal to 1 (indicating that multiple values are present at the NDC level), then the concept has
multiple values present on related NDCs. Continue to the next step.
If the Controlled Substance Attribute Value (CS_ATTRIBUTE_VALUE) from the previous step is
equal to 0 (indicating that only a single value is present at the NDC level), then the concept has a
single value present on all related NDCs. The application is complete.

6. Retrieve NDCs related to the Controlled Substance Concept Identifier (CS_CONCEPT_ID) where:
If the Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) equals 3 (indicating
a MEDID):

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Select the National Drug Code (NDC) values from the MED NDC to Medication ID
Cross-Reference Table (RMINDC1_NDC_MEDID) where the MED Medication ID (MEDID)
column equals the MEDID value of the previous step.
Select the NDC (NDC) values from the MED NDC to Generic Medication ID Cross-Reference
Table (RMEDNGM0_NDC_GEN_MEDID) where the MEDID column equals the MEDID
values from the previous step.
Remove duplicates from the list of NDCs returned in the previous step.
If the Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) is equal to 501, 502
, 503, or 504, indicating Semantic Clinical Drug (SCD), Semantic Brand Drug (SBD), Generic Pack
(GPCK), or Brand Pack (BPCK), select the EVD FDB Vocabulary Identifier ( EVD_FDB_VOCAB_ID)
from the MTL External Vocabulary Link Table (REVDEL0_EXT_VOCAB_LINK) where:
The EVD FDB Vocabulary Type Identifier (EVD_FDB_VOCAB_ID) value is equal to 100
(indicating an NDC).
The EVD External Vocabulary Identifier (EVD_EXT_VOCAB_ID) is equal to the Controlled
Substance Concept Identifier (CS_CONCEPT_ID) value from the previous step.
The EVD External Vocabulary Type Identifier (EVD_EXT_VOCAB_TYPE_ID) is equal to the
Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) of the previous
step.

7. When available, retrieve the NDC-level controlled substance information from one of the following tables:
If the Federal Controlled Substance Drug Concept (MEDID or RXCUI) Link Table
(RCSCFS0_CONCEPT_FEDERAL_SCHED) was selected in the previous step, then select the
Federal Controlled Substance NDC Link Table (RCSFL0_FEDERAL_CS_LINK) where:
The NDC values from the previous step are equal to the NDC value in the Federal Controlled
Substance NDC Link Table (RCSFL0_FEDERAL_CS_LINK).
The Federal Controlled Substance Start Date (FEDERAL_CS_START_DT) value is less than
or equal to the current date.
The Federal Controlled Substance End Date (FEDERAL_CS_END_DT) is either null or the
Federal Controlled Substance End Date (FEDERAL_CS_END_DT) is greater than or equal
to today.
If the previously selected table is the State PDMP Drug Concept (MEDID or RXCUI) Link Table
(RCSCSP0_CONCEPT_STATE_PDMP) was selected in the previous step, then select the State
PDMP NDC Link Table (RCSPDL0_STATE_PDMP_LINK) where:
The NDC values from the previous step are equal to the NDC values in the State PDMP NDC
Link Table (RCSPDL0_STATE_PDMP_LINK).
The State Code (STATE_CD) value is equal to the previously selected value.
State Prescription Drug Monitoring Program List Type Code (
STATE_PDMP_LIST_TYPE_CD) value is equal to the previously selected value.
The State PDMP Start Date (STATE_PDMP_START_DT) is less than or equal to the start of
the desired reporting period.

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The State PDMP End Date (STATE_PDMP_END_DT) is either empty or the State PDMP
End Date (STATE_PDMP_END_DT) is greater than or equal to the end of the desired
reporting period.
If the previously selected table is the State Controlled Substance Drug Concept (MEDID or RXCUI)
Link Table (RCSCSS0_CONCEPT_STATE_SCHED) was selected in the previous step, then select
the State Controlled Substance NDC Link Table (RCSSTL0_STATE_CS_LINK) where:
The NDC values from the previous step are equal to the NDC values in the State Controlled
Substance NDC Link Table (RCSSTL0_STATE_CS_LINK).
The State Code (STATE_CD) value is equal to the previously selected value.
The State Controlled Substance Start Date (STATE_CS_START_DT) is less than or equal to
the current date.
The State Controlled Substance End Date (STATE_CS_END_DT) is either empty or the
State Controlled Substance End Date (STATE_CS_END_DT) is greater than or equal to
today. If an NDC which is related to a drug concept (MEDID or RXCUI) is not available in the
Federal Controlled Substance Drug Concept (MEDID or RXCUI) Link Table
(RCSCFS0_CONCEPT_FEDERAL_SCHED), State PDMP Drug Concept (MEDID or RXCUI)
Link Table (RCSCSP0_CONCEPT_STATE_PDMP), or State Controlled Substance Drug
Concept (MEDID or RXCUI) Link Table (RCSCSS0_CONCEPT_STATE_SCHED), then the
NDC is not controlled at the state or federal level or does not require reporting to a state's
PDMP.

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Finding the More Restrictive State of Federal Narcotic or Non-Narcotic

Schedule for a Concept
This application illustrates how to retrieve the more restrictive state or federal narcotic or non-narcotic (2N or 3N)
schedule for a concept.

1. Retrieve the State Code (STATE_CD) value from the State and Territory Master Table
(RCSSTMA0_STATE_MSTR) where the State Description (STATE_DESC) value equals the state of the
prescriber.

2. Retrieve the current State Controlled Substance Schedule Code (STATE_CS_SCHEDULE_CD) value
from the State Controlled Substance Drug Concept (MEDID or RXCUI) Link Table
(RCSCSS0_CONCEPT_STATE_SCHED) where:
The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) value equals:
3, if the drug concept identifier is a MEDID.
501, if the drug concept identifier is a Semantic Clinical Drug (SCD)
502, if the drug concept identifier is a Semantic Branded Drug (SBD)
503, if the drug concept identifier is a Generic Pack (GPCK).
504, if the drug concept identifier is a Brand Pack (BPCK).

Specifying the Controlled Substance Concept Type Identifier (

CS_CONCEPT_TYPE_ID) is optional if the Controlled Substance Concept Type
Identifier is unknown and the drug concept identifier is not a MEDID.

The Controlled Substance Concept Identifier (CS_CONCEPT_ID) value equals the identifier of the
concept.
The State Code (STATE_CD) value equals the value from the previous step.
The State Controlled Substance Concept Start Date (CONCEPT_STATE_CS_START_DT) is less
than or equal to the current date.
The State Controlled Substance Concept End Date (CONCEPT_STATE_CS_END_DT) value is
either null or the State Controlled Substance Concept End Date (CONCEPT_STATE_CS_END_DT)
value is greater than or equal to today.

3. Retrieve the State Controlled Substance Difference Code (STATE_CS_DIFF_CD) from the State
Controlled Substance Difference Code Drug Concept (MEDID or RXCUI) Table
(RCSCSD0_CONCEPT_STATE_CS_DIFF) where:
The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) value equals the
value obtained in step 2.
The Controlled Substance Concept Identifier (CS_CONCEPT_ID) value equals the value obtained
in step 2.
The State Code (STATE_CD) value equals the value obtained in step 1.

4. To determine the actual federal schedule, retrieve the Federal Controlled Substance Schedule Code (

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4.
FEDERAL_CS_SCHEDULE_CD) value from the Federal Controlled Substance Drug Concept (MEDID or
RXCUI) Link Table (RCSCFS0_CONCEPT_FEDERAL_SCHED) where:
The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) value equals the
value obtained in step 2.
The Controlled Substance Concept Identifier (CS_CONCEPT_ID) value equals the value obtained
in step 2.
The Federal Controlled Substance Concept Start Date (CONCEPT_FEDERAL_CS_START_DT)
value is less than or equal to the current date.
The Federal Controlled Substance Concept End Date (CONCEPT_FEDERAL_CS_END_DT) is
either null or the Federal Controlled Substance Concept End Date (
CONCEPT_FEDERAL_CS_END_DT) is greater than or equal to today.

5. If the more restrictive schedule is a 2 or a 3, determine if the drug is a narcotic or a nonnarcotic. Retrieve
the Narcotic Indicator by selecting the Controlled Substance Attribute Value ( CS_ATTRIBUTE_VALUE)
from the Controlled Substance Drug Concept (MEDID or RXCUI) Attribute Table
(RCSCA0_CONCEPT_ATTR) where:
The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) value equals the
value obtained in step 2.
The Controlled Substance Concept Identifier (CS_CONCEPT_ID) value equals the value obtained
in step 2.
The Controlled Substance Attribute Code (CS_ATTRIBUTE_CD) is equal to 1 (for Controlled
Substance Narcotics Indicator).
The Controlled Substance Attribute Sequence Number (CS_ATTRIBUTE_SN) is equal to 1.
The Controlled Substance Attribute Value Sequence Number (CS_ATTRIBUTE_VALUE_SN) is
equal to 1.

6. If the Controlled Substance Attribute Value (CS_ATTRIBUTE_VALUE) is a Y, then the drug is a narcotic
and the more restrictive state or federal schedule of 2 or 3 is applied. If the Controlled Substance Attribute
Value (CS_ATTRIBUTE_VALUE) is an N, then the drug is classified as a non-narcotic. Append the
Controlled Substance Attribute Value (CS_ATTRIBUTE_VALUE) of N to the more restrictive state or
federal schedule. The more restrictive state schedule would be categorized as 2N, and the more restrictive
federal schedule would be categorized as 3N.

ExampleFinding the More Restrictive State or Federal Narcotic or Non-Narcotic Schedule for a
Concept
For purposes of demonstrating this application, the following scenario is used: A pharmacy in the state of
Minnesota is filling a prescription and must determine if the physician's assistant who prescribed the drug (and
who is authorized in the state of Minnesota to prescribe drugs in schedules 3N, 4, and 5) has the prescriptive
authority to prescribe the drug promethazine-codeine 6.25 mg-10 mg/5 mL Syrup (MEDID 195297).

1. Retrieve the State Code (STATE_CD) value from the State and Territory Master Table
(RCSSTMA0_STATE_MSTR) where the State Description (STATE_DESC) value equals the state of the

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1.

pharmacy (in this case, Minnesota).In this example the State Code (STATE_CD) equals a value of MN.

2. Retrieve the current State Controlled Substance Schedule Code (STATE_CS_SCHEDULE_CD) value
from the State Controlled Substance Drug Concept (MEDID or RXCUI) Link Table
(RCSCSS0_CONCEPT_STATE_SCHED) where:
The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) value equals the
selected Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) for the drug
concept type being used (in this case, a value of 3).
The Controlled Substance Concept Identifier (CS_CONCEPT_ID) value equals the identifier of the
concept (in this case, a value of 195297).
The State Code (STATE_CD) value equals the value from the previous step (in this case, a value of
MN).
The State Controlled Substance Concept Start Date (CONCEPT_STATE_CS_START_DT) is less
than or equal to the current date.
The State Controlled Substance Concept End Date (CONCEPT_STATE_CS_END_DT) value is
either null or the State Controlled Substance Concept End Date (CONCEPT_STATE_CS_END_DT)
value is greater than or equal to today.

CS_CONCEPT CS_CONCEPT STATE_CD CONCEPT_ST CONCEPT_ST STATE_CS_S

_TYPE_ID _ID ATE_CS_STA ATE_CS_END CHEDULE_CD
RT_DT _DT

3 195297 MN 20131114 3

In this example, the State Controlled Substance Schedule Code (STATE_CS_SCHEDULE_CD)

value equals 3.

3. Retrieve the State Controlled Substance Difference Code (STATE_CS_DIFF_CD) from the State
Controlled Substance Difference Code Drug Concept (MEDID or RXCUI) Table
(RCSCSD0_CONCEPT_STATE_CS_DIFF) where:
The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) value equals the
value obtained in step 2 (in this case, a value of 3).
The Controlled Substance Concept Identifier (CS_CONCEPT_ID) value equals the value obtained
in step 2 (in this case, a value of 195297).
The State Code (STATE_CD) value equals the value obtained in step 1 (in this case, MN).

CS_CONCEPT_TYPE_I CS_CONCEPT_ID STATE_CD STATE_CS_DIFF_CD

D

3 195297 MN 3

The State Controlled Substance Difference Code (STATE_CS_DIFF_CD) value of 2 is retrieved,

indicating the state schedule is more restrictive than the federal schedule.

4.

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4. To determine the actual federal schedule, retrieve the Federal Controlled Substance Schedule Code (
FEDERAL_CS_SCHEDULE_CD) value from the Federal Controlled Substance Drug Concept (MEDID or
RXCUI) Link Table (RCSCFS0_CONCEPT_FEDERAL_SCHED) where:
The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) value equals the
value obtained in step 2 (in this case, a value of 3).
The Controlled Substance Concept Identifier (CS_CONCEPT_ID) value equals the value obtained
in step 2.
The Federal Controlled Substance Concept Start Date (CONCEPT_FEDERAL_CS_START_DT)
value is less than or equal to the current date.
The Federal Controlled Substance Concept End Date (CONCEPT_FEDERAL_CS_END_DT) is
either null or the Federal Controlled Substance Concept End Date (
CONCEPT_FEDERAL_CS_END_DT) is greater than or equal to today.

CS_CONCEPT_T CS_CONCEPT_ID CONCEPT_FEDE CONCEPT_FEDE FEDERAL_CS_S

YPE_ID RAL_CS_START_ RAL_CS_END_D CHEDULE_CD
DT T

3 195297 20131114 3

In this example, the Federal Controlled Substance Schedule Code (

FEDERAL_CS_SCHEDULE_CD) value of 5 is retrieved, confirming that the state schedule is more
restrictive than the federal schedule.

5. If the more restrictive schedule is a 2 or a 3, determine if the drug is a narcotic or a non-narcotic. Retrieve
the Narcotic Indicator by selecting the Controlled Substance Attribute Value ( CS_ATTRIBUTE_VALUE)
from the Controlled Substance Drug Concept (MEDID or RXCUI) Attribute Table
(RCSCA0_CONCEPT_ATTR) where:
The Controlled Substance Concept Type Identifier (CS_CONCEPT_TYPE_ID) value equals the
value obtained in step 2 (in this case, a value of 3).
The Controlled Substance Concept Identifier (CS_CONCEPT_ID) value equals the value obtained
in step 2 (in this case, a value of 195297).
The Controlled Substance Attribute Code (CS_ATTRIBUTE_CD) is equal to 1 (for Controlled
Substance Narcotics Indicator).
The Controlled Substance Attribute Sequence Number (CS_ATTRIBUTE_SN) is equal to 1.
The Controlled Substance Attribute Value Sequence Number (CS_ATTRIBUTE_VALUE_SN) is
equal to 1.

CS_CONCEPT CS_CONCEPT CS_ATTRIBU CS_ATTRIBU CS_ATTRIBU CS_ATTRIBU

_TYPE_ID _ID TE_CD TE_SN TE_VALUE_S TE_VALUE
N

3 195297 1 1 1 Y

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In this example, the Controlled Substance Attribute Value (CS_ATTRIBUTE_VALUE) of Y is

retrieved.

6. If the Controlled Substance Attribute Value (CS_ATTRIBUTE_VALUE) is a Y, then the drug is a narcotic
and the more restrictive state or federal schedule of 2 or 3 is applied. If the Controlled Substance Attribute
Value (CS_ATTRIBUTE_VALUE) is an N, then the drug is classified as a non-narcotic. Append the
Controlled Substance Attribute Value (CS_ATTRIBUTE_VALUE) of N to the more restrictive state or
federal schedule. The more restrictive state schedule would be categorized as 2N, and the more restrictive
federal schedule would be categorized as 3N.
Since the Controlled Substance Attribute Value (CS_ATTRIBUTE_VALUE) is a Y, the drug is a narcotic
and the schedule that the prescriber should be validated against is a 3. The physician's assistant in this
scenario is only licensed to prescribe drugs in schedules 3N, 4, and 5 and therefore is not authorized to
prescribe this drug in the state of Minnesota.

During your implementation, you may choose to include the Controlled Substance Attribute Value (
CS_ATTRIBUTE_VALUE) (Narcotic Indicator) in a distinct database column to simplify data
retrieval. If so, you would still complete steps 5 and 6 using the data from your Narcotic Indicator
source.

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State and Federal Controlled Substances Module ERD and

Technical Specifications
This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

FDB State and Federal Controlled Substances Module Tables

FDB State & Federal Controlled Substances Module (NDC Concept Level) ERD
FDB State & Federal Controlled Substances Module (MEDID and RXCUI Concept Level) ERD

FDB State and Federal Controlled Substances Module Tables

Controlled Substance Attribute Description Table
Controlled Substance Attribute Type Description Table
Controlled Substance Attribute Value Description Table
Controlled Substance Concept Source Description Table
Controlled Substance Concept Type Description Table
Controlled Substance Drug Concept (MEDID or RXCUI) Attribute Table
Controlled Substance NDC Attribute Table
Controlled Substance Schedule to NCPDP SCRIPT DEA Code Link Table
Federal Controlled Substance Drug Concept (MEDID or RXCUI) Link Table
Federal Controlled Substance NDC Link Table
NCPDP SCRIPT DEA Master Table
State and Territory Master Table
State Controlled Substance Difference Code Description Table
State Controlled Substance Difference Code Drug Concept (MEDID or RXCUI) Table
State Controlled Substance Difference Code NDC History Table
State Controlled Substance Difference Code NDC Table
State Controlled Substance Drug Concept (MEDID or RXCUI) Attribute Table
State Controlled Substance Drug Concept (MEDID or RXCUI) Link Table
State Controlled Substance NDC Link Table
State PDMP Drug Concept (MEDID or RXCUI) Attribute Table
State PDMP Drug Concept (MEDID or RXCUI) Link Table
State PDMP Drug Source Concept (MEDID or RXCUI) Table
State PDMP Drug Source Description Table
State PDMP Drug Source NDC Table
State PDMP List Type Description Table
State PDMP NDC Link Table

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FDB State & Federal Controlled Substances Module (NDC Concept Level)
ERD

FDB State & Federal Controlled Substances Module (MEDID and RXCUI
Concept Level) ERD

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Controlled Substance Attribute Description Table

Table Name RCSAD0_ATTRIBUTE_DESC

Revision Activity add.4-29-2013

Purpose Provides information about a given Controlled Substance

attribute and type.

Key Column Name Column Format Length Picture

Description

P CS_ATTRIBUTE_ Controlled N 8 9(8)

CD Substance
Attribute Code

CS_ATTRIBUTE_ Controlled AN 100 X(100)

DESC Substance
Attribute
Description

F CS_ATTRIBUTE_ Controlled N 8 9(8)

TYPE_CD Substance
Attribute Type
Code

CS_ATTRIBUTE_ Controlled N 8 9(8)

GROUP_CD Substance
Attribute Group
Code

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Controlled Substance Attribute Type Description Table

Table Name RCSATD0_ATTRIBUTE_TYPE_DESC

Revision Activity add.4-29-2013

Purpose Provides a text description and optional length and

precision describing the data type of the attribute being
provided.

Key Column Name Column Format Length Picture

Description

P CS_ATTRIBUTE_ Controlled N 8 9(8)

TYPE_CD Substance
Attribute Type
Code

CS_ATTRIBUTE_ Controlled AN 100 X(100)

TYPE_DESC Substance
Attribute Type
Description

CS_ATTRIBUTE_ Controlled N 8 9(8)

TYPE_LENGTH Substance
Attribute Type
Length

CS_ATTRIBUTE_ Controlled N 8 9(8)

TYPE_PRECISIO Substance
N Attribute Type
Precision

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Controlled Substance Attribute Value Description Table

Table Name RCSAVD0_ATTRIBUTE_VALUE_DESC

Revision Activity add.4-29-2013

Purpose Provides text descriptions of coded values for controlled

substance attributes that have a discrete set of values.

Key Column Name Column Format Length Picture

Description

PF CS_ATTRIBUTE_ Controlled N 8 9(8)

CD Substance
Attribute Code

P CS_ATTRIBUTE_ Controlled AN 255 X(255)

VALUE Substance
Attribute Value

CS_ATTRIBUTE_ Controlled AN 255 X(255)

VALUE_DESC Substance
Attribute Value
Description

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Controlled Substance Concept Source Description Table

Table Name RCSSD0_CONCEPT_SOURCE_DESC

Revision Activity add.11-14-2013

Purpose Relates the Controlled Substance Concept Source Identifier

to its text description.

Key Column Name Column Format Length Picture

Description

P CS_CONCEPT_S Controlled N 4 9(4)

OURCE_ID Substance
Concept Type
Source Identifier

CS_CONCEPT_S Controlled AN 50 X(50)

OURCE_DESC Substance
Concept Type
Source
Description

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Controlled Substance Concept Type Description Table

Table Name RCSCT0_CONCEPT_TYPE_DESC

Revision Activity add.11-14-2013

Purpose Relates the Controlled Substance Concept Type Identifier

to its text description.

Key Column Name Column Format Length Picture

Description

P CS_CONCEPT_T Controlled N 4 9(4)

YPE_ID Substance
Concept Type
Identifier

F CS_CONCEPT_S Controlled N 4 9(4)

OURCE_ID Substance
Concept Type
Source Identifier

CS_CONCEPT_T Controlled AN 50 X(50)

YPE_DESC Substance
Concept Type
Description

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Controlled Substance Drug Concept (MEDID or RXCUI) Attribute Table

Table Name RCSCA0_CONCEPT_ATTR

Revision Activity add.11-14-2013

Purpose Provides attributes related to controlled substances at the

drug concept (MEDID or RXCUI) level.

Key Column Name Column Format Length Picture

Description

P CS_CONCEPT_I Controlled AN 50 X(50)

D Substance
Concept Identifier

PF CS_CONCEPT_T Controlled N 4 9(4)

YPE_ID Substance
Concept Type
Identifier

PF CS_ATTRIBUTE_ Controlled N 8 9(8)

CD Substance
Attribute Code

P CS_ATTRIBUTE_ Controlled N 4 9(4)

SN Substance
Attribute
Sequence
Number

P CS_ATTRIBUTE_ Controlled N 4 9(4)

VALUE_SN Substance
Attribute Value
Sequence
Number

CS_ATTRIBUTE_ Controlled AN 255 X(255)

VALUE Substance
Attribute Value

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Controlled Substance NDC Attribute Table

Table Name RCSNA0_NDC_ATTRIBUTE

Revision Activity add.4-29-2013

Purpose Provides attributes related to controlled substances at the

NDC level.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

PF CS_ATTRIBUTE_ Controlled N 8 9(8)

CD Substance
Attribute Code

PF CS_ATTRIBUTE_ Controlled N 4 9(4)

SN Substance
Attribute
Sequence
Number

P CS_ATTRIBUTE_ Controlled N 4 9(4)

VALUE_SN Substance
Attribute Value
Sequence
Number

CS_ATTRIBUTE_ Controlled AN 255 X(255)

VALUE Substance
Attribute Value

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Controlled Substance Schedule to NCPDP SCRIPT DEA Code Link Table

Table Name RCSSDEL0_SCRIPT_DEA_LINK

Revision Activity add.1-28-2013

Purpose Links a Controlled Substance Schedule Code to an FDB

SCRIPT DEA ID.

Key Column Name Column Format Length Picture

Description

P FEDERAL_CS_S Federal Controlled AN 2 X(2)

CHEDULE_CD Substance
Schedule Code

PF SCRIPT_DEA_ID FDB SCRIPT N 8 9(8)

DEA ID

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Federal Controlled Substance Drug Concept (MEDID or RXCUI) Link Table

Table Name RCSCFS0_CONCEPT_FEDERAL_SCHED

Revision Activity add.11-14-2013

Purpose Links a drug concept (MEDID) or RXCUI) to its federal

controlled substance schedule.

Key Column Name Column Format Length Picture

Description

P CS_CONCEPT_I Controlled AN 50 X(50)

D Substance
Concept Identifier

PF CS_CONCEPT_T Controlled N 4 9(4)

YPE_ID Substance
Concept Type
Identifier

P CONCEPT_FEDE Federal Controlled N 8 9(8)

RAL_CS_START Substance
_DT Concept Start
Date

FEDERAL_CS_S Federal Controlled AN 2 X(2)

CHEDULE_CD Substance
Schedule Code

CONCEPT_FEDE Federal Controlled N 8 9(8)

RAL_CS_END_D Substance
T Concept End Date

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Federal Controlled Substance NDC Link Table

Table Name RCSFL0_FEDERAL_CS_LINK

Revision Activity add.1-28-2013

Purpose Links an NDC to its federal controlled substance schedule.

This table provides current, historical, and future federal
schedule information for an NDC.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

P FEDERAL_CS_S Federal Controlled N 8 9(8)

TART_DT Substance Start
Date

FEDERAL_CS_S Federal Controlled AN 2 X(2)

CHEDULE_CD Substance
Schedule Code

FEDERAL_CS_E federal Controlled N 8 9(8)

ND_DT Substance End
Date

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NCPDP SCRIPT DEA Master Table

Table Name RCSSDEA0_SCRIPT_DEA_MSTR

Revision Activity add.1-28-2011

Purpose Provides SCRIPT DEA 10.6 DEA Schedule Code values

and their related attributes.

Key Column Name Column Format Length Picture

Description

P SCRIPT_DEA_ID FDB SCRIPT N 8 9(8)

DEA ID

SCRIPT_DEA_C NCPDP SCRIPT AN 10 X(10)

D DEA Code

SCRIPT_DEA_C NCPDP SCRIPT AN 50 X(50)

D_DESC DEA Code
Description

SCRIPT_DEA_S NCPDP SCRIPT N 4 9(4)

UBSET_ID DEA Code Subset
ID

SCRIPT_DEA_O NCPDP SCRIPT N 8 9(8)

BSOLETE_DT DEA Code
Obsolete Date

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State and Territory Master Table

Table Name RCSSTMA0_STATE_MSTR

Revision Activity add.1-28-2013

Purpose Relates the State Code to its text description.

Key Column Name Column Format Length Picture

Description

P STATE_CD State Code AN 2 X(2)

STATE_DESC State Code AN 50 X(50)

Description

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State Controlled Substance Difference Code Description Table

Table Name RCSSTD0_STATE_DIFF_DESC

Revision Activity add.1-28-2013

Purpose Relates the State Controlled Substance Difference Code to

its text description.

Key Column Name Column Format Length Picture

Description

P STATE_CS_DIFF State Controlled AN 2 X(2)

_CD Substance
Difference Code

STATE_CS_DIFF State Controlled AN 100 X(100)

_CD_DESC Substance
Difference Code
Description

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State Controlled Substance Difference Code Drug Concept (MEDID or

RXCUI) Table
Table Name RCSCSD0_CONCEPT_STATE_CS_DIFF

Revision Activity add.11-14-2013

Purpose Provides a comparison between the current federal

schedule and the current state schedule for a given drug
concept (MEDID or RXCUI).

Key Column Name Column Format Length Picture

Description

P CS_CONCEPT_I Controlled AN 50 X(50)

D Substance
Concept Identifier

PF CS_CONCEPT_T Controlled N 4 9(4)

YPE_ID Substance
Concept Type
Identifier

PF STATE_CD State Code AN 2 X(2)

F STATE_CS_DIFF State Controlled AN 2 X(2)

_CD Substance
Difference Code

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State Controlled Substance Difference Code NDC History Table

Table Name RCSDFH0_STATE_CS_DIFF_HIST

Revision Activity add.11-03-2016

Purpose Provides a history of the state controlled substance

difference codes.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

PF STATE_CD State Code AN 2 X(2)

P STATE_CS_DIFF State Controlled N 8 9(8)

_CD_START_DT Substance
Difference Code
Start Date

F STATE_CS_DIFF State Controlled AN 2 X(2)

_CD Substance
Difference Code

STATE_CS_DIFF State Controlled N 8 9(8)

_CD_END_DT Substance
Difference Code
End Date

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State Controlled Substance Difference Code NDC Table

Table Name RCSDIF0_STATE_CS_DIFF

Revision Activity add.1-28-2013

Purpose Provides a comparison between the current federal

schedule and the current state schedule for a given NDC.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

PF STATE_CD State Code AN 2 X(2)

F STATE_CS_DIFF State Controlled AN 2 X(2)

_CD substance
Difference Code

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State Controlled Substance Drug Concept (MEDID or RXCUI) Attribute

Table
Table Name RCSCAS0_CONCEPT_STATE_ATTR

Revision Activity add.11-14-2013

Purpose Provides attributes related to controlled substances at the

drug concept (MEDID or RXCUI) and state levels.

Key Column Name Column Format Length Picture

Description

P CS_CONCEPT_I Controlled AN 50 X(50)

D Substance
Concept Identifier

PF CS_CONCEPT_T Controlled N 4 9(4)

YPE_ID Substance
concept Type
Identifier

PF STATE_CD State Code AN 2 X(2)

PF CS_ATTRIBUTE_ Controlled N 8 9(8)

CD Substance
Attribute Code

P CS_ATTRIBUTE_ Controlled N 4 9(4)

SN Substance
Attribute
Sequence
Number

P CS_ATTRIBUTE_ Controlled N 4 9(4)

VALUE_SN substance
Attribute Value
Sequence
Number

CS_ATTRIBUTE_ Controlled AN 255 X(255)

VALUE Substance
Attribute Value

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State Controlled Substance Drug Concept (MEDID or RXCUI) Link Table

Table Name RCSCSS0_CONCEPT_STATE_SCHED

Revision Activity add.11-14-2013

Purpose Links a drug concept (MEDID or RXCUI) to its state

controlled substance schedule.

Key Column Name Column Format Length Picture

Description

P CS_CONCEPT_I Controlled AN 50 X(50)

D Substance
concept Identifier

PF CS_CONCEPT_T Controlled N 4 9(4)

YPE_ID Substance
concept Type
Identifier

PF STATE_CD State Code AN 2 X(2)

P CONCEPT_STAT State Controlled N 8 9(8)

E_CS_START_D Substance
T concept Start
Date

STATE_CS_SCH State Controlled AN 2 X(2)

EDULE_CD Substance
Schedule Code

CONCEPT_STAT State Controlled N 8 9(8)

E_CS_END_DT Substance
concept End Date

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State Controlled Substance NDC Link Table

Table Name RCSSTL0_STATE_CS_LINK

Revision Activity add.1-28-2013

Purpose Links an NDC to its state controlled substance schedule.

This table provides current, historical, and future state
schedule information for an NDC.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

PF STATE_CD State Code AN 2 X(2)

P STATE_CS_STA State Controlled N 8 9(8)

RT_DT Substance Start
Date

STATE_CS_SCH State Controlled AN 2 X(2)

EDULE_CD Substance
Schedule Code

STATE_CS_END State Controlled N 8 9(8)

_DT Substance End
Date

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State PDMP Drug Concept (MEDID or RXCUI) Attribute Table

Table Name RCSCAP0_CONCEPT_PDMP_ATTR

Revision Activity add.11-14-2013

Purpose Provides attributes related to PDMP lists of monitored

substances at the drug concept (MEDID or RXCUI), State,
and List Type levels.

Key Column Name Column Format Length Picture

Description

P CS_CONCEPT_I Controlled AN 50 X(50)

D Substance
Concept Identifier

PF CS_CONCEPT_T Controlled N 4 9(4)

YPE_ID Substance
Concept Type
Identifier

PF STATE_CD State Code AN 2 X(2)

PF STATE_PDMP_LI State Prescription AN 2 X(2)

ST_TYPE_CD Drug Monitoring
Program List Type
Code

PF CS_ATTRIBUTE_ Controlled N 8 9(8)

CD Substance
Attribute Code

P CS_ATTRIBUTE_ Controlled N 4 9(4)

SN Substance
Attribute
Sequence
Number

P CS_ATTRIBUTE_ Controlled N 4 9(4)

VALUE_SN Substance
Attribute Value
Sequence
Number

CS_ATTRIBUTE_ Controlled AN 255 X(255)

VALUE Substance
Attribute Value

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State PDMP Drug Concept (MEDID or RXCUI) Link Table

Table Name RCSCSP0_CONCEPT_STATE_PDMP

Revision Activity add.11-14-2013

Purpose Links a drug concept (MEDID or RXCUI) to its state

Prescription Drug Monitoring Program (PDMP) list of
monitored substances.

Key Column Name Column Format Length Picture

Description

P CS_CONCEPT_I Controlled AN 50 X(50)

D Substance
Concept Identifier

PF CS_CONCEPT_T Controlled N 4 9(4)

YPE_ID Substance
Concept Type
Identifier

PF STATE_CD State Code AN 2 X(2)

PF STATE_PDMP_LI State Prescription AN 2 X(2)

ST_TYPE_CD Drug Monitoring
Program List Type
Code

P CONCEPT_STAT State Prescription N 8 9(8)

E_PDMP_START Drug Monitoring
_DT Program Start
Date

CONCEPT_STAT State Prescription N 8 9(8)

E_PDMP_END_D Drug Monitoring
T Program End
Date

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State PDMP Drug Source Concept (MEDID or RXCUI) Table

Table Name RCSCPS0_CONCEPT_PDMP_SOURCE

Revision Activity add.11-13-2013

Purpose Identifies the source used by FDB to place a drug concept

(MEDID or RXCUI) on a state's PDMP list of monitored
substances.

Key Column Name Column Format Length Picture

Description

P CS_CONCEPT_I Controlled AN 50 X(50)

D substance
Concept Identifier

PF CS_CONCEPT_T Controlled N 4 9(4)

YPE_ID substance
Concept Type
Identifier

PF STATE_CD State Code AN 2 X(2)

PF STATE_PDMP_LI State Prescription AN 2 X(2)

ST_TYPE_CD Drug Monitoring
Program List Type
Code

F STATE_PDMP_D State Prescription AN 2 X(2)

RUG_SOURCE_ Drug Monitoring
CD Program Source
Code

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State PDMP Drug Source Description Table

Table Name RCSPDSD0_PDMP_DRUG_SOURCE_DESC

Revision Activity add.1-28-2013

Purpose Relates the State PDMP Drug Source Code to its text
description.

Key Column Name Column Format Length Picture

Description

P STATE_PDMP_D State Prescription AN 2 X(2)

RUG_SOURCE_ Drug Monitoring
CD Program Source
Code

STATE_PDMP_D State Prescription AN 100 X(100)

RUG_SOURCE_ Drug Monitoring
CD_DESC Program Source
Code Description

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State PDMP Drug Source NDC Table

Table Name RCSSRC0_STATE_PDMP_DRUG_SOURCE

Revision Activity add.1-28-2013

Purpose Identifies the source used by FDB to place an NDC on a

state's PDMP list of monitored substances.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

PF STATE_CD State Code AN 2 X(2)

PF STATE_PDMP_LI State Prescription AN 2 X(2)

ST_TYPE_CD Drug Monitoring
Program List Type
Code

F STATE_PDMP_D State Prescription AN 2 X(2)

RUG_SOURCE_ Drug Monitoring
CD Program Source
Code

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State PDMP List Type Description Table

Table Name RCSPTYP0_PDMP_LIST_TYPE_DESC

Revision Activity add.1-28-2013

Purpose Relates the State PDMP List Type Code to its text
description.

Key Column Name Column Format Length Picture

Description

P STATE_PDMP_LI State Prescription AN 2 X(2)

ST_TYPE_CD Drug Monitoring
Program List Type
Code

STATE_PDMP_LI State Prescription AN 100 X(100)

ST_TYPE_CD_D Drug Monitoring
ESC Program List Type
Code Description

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State PDMP NDC Link Table

Table Name RCSPDL0_STATE_PDMP_LINK

Revision Activity add.1-28-2013

Purpose Links an NDC to its state Prescription Drug Monitoring

Program (PDMP) list of monitored substances.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

PF STATE_CD State Code AN 2 X(2)

PF STATE_PDMP_LI State Prescription AN 2 X(2)

ST_TYPE_CD Drug Monitoring
Program List Type
Code

P STATE_PDMP_S State Prescription N 8 9(8)

TART_DT Drug Monitoring
Program Start
Date

STATE_PDMP_E State Prescription N 8 9(8)

ND_DT Drug Monitoring
Program End
Date

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Medicaid Module 1.0

Medicaid Module General Information
ERD and Technical Specifications

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Medicaid Module General Information

Overview
Medicaid Drug Rebate (MDR) Program
Available Data for Each State

Overview
The Medicaid Module provides state Medicaid pricing. Effective May 5, 2016 FDB discontinued population of
Medicaid formulary information for all states except California. Users should refer to the individual state medicaid
websites for current state formulary data.

Effective May 5, 2016 FDB discontinued support of all Medicaid data for the state of Massachusetts.

All formulary, rebate, and DESI restrictions have been removed from the Medicaid Data Price Table
(RMDP0_MEDICAID_PRICE), and the Medicaid Data Table (RMD2_MEDICAID_MSTR) will contain all NDCs
added to the Medicaid Data Price Table for a given state. The Formulary Indicator (MDT_FI) value will default to
"0" for all states, except for the State of California. Customers may consult the Federal Financing Participation
table in conjunction with the NSDE file to determine a drug's eligibility for reimbursement in the Medicaid program.
The Medicaid Data Price Table (RMDP0_MEDICAID_PRICE) includes state MAC prices (MDPT_TYP = 01) only
if the state MAC list has been made available by the state in its entirety and is in a usable data-processing format.
The Medicaid Module cannot accommodate the publication of MAC prices greater than $9,999.99.

If a state MAC price exceeds $9,999.99 and there has been no previously published price for the product,
no price will be published and this will be announced in Medicaid Highlights.
If a state MAC price value exceeds $9,999.99 and there has been a previously published a price, a zero (0
) value will be assigned to it and this will be announced in Medicaid Highlights.
If a state stops publishing a MAC Price for a product, a zero ( 0) value appears in the MAC price field.

The states of Alabama, Colorado, Idaho, Iowa, Louisiana, Maryland, Montana, Oregon, and Tennessee publish
Average Acquisition Cost (AAC) prices for their state Medicaid pharmacy claims. The Medicaid Data Price Table
(RMDP0_MEDICAID_PRICE) consequently includes (MDPT_TYP = 06) when an AAC value has been made
available by states. When a state begins publishing an AAC price, any previous MAC price type eliminated by the
state will be output with a zero (0) value. If a state publishes an AAC for a product and then later removes it, the
module will reflect an AAC price of $0.00 with the date of removal as the effective date. The zero is not to be
understood as a price but as an indicator that no AAC price has been published by the state.

FDB publishes Medicaid pricing for medical devices for a limited number of states: Arkansas, New York, South
Carolina and Utah.

For Californias Medicaid plan, medical supplies are required to be billed using Healthcare Common Procedure
Coding System (HCPCS) Level II codes. However, California local codes are used for diabetic supplies, inhalers,
peak flow meters, Family PACT medical supplies, and enteral nutritional products. As a result, Medicaid Data
Table - State Billing Code (MDT_BC) field may contain either a HCPCS code or a state-specific billing code.

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The Medicaid data does not include NDCs that have been obsolete for longer than three (3) years. The obsolete
date for an NDC appears in the Obsolete Date (OBSDTEC) column in the NDC Table.

Medicaid Drug Rebate (MDR) Program

The Federal Financing Participation Data Table (RFFP0_FED_FIN_PARTICIPATION) provides Rebate
Manufacturer, Medical Supply, and Permitted Exclusion indicators for use in determining Federal Medicaid
coverage. These indicators are applied to NDCs regardless of obsolete date. The obsolete date for an NDC
appears in the Obsolete Date (OBSDTEC) column in the NDC Table.

A Rebate Manufacturer Indicator (FFP_TYP = RM) value ( FFP_IND) of 1 is applied to all NDCs from a
manufacturer or a labeler that is participating in the Medicaid Drug Rebate (MDR) program as reported by the
Centers for Medicare and Medicaid Services (CMS). FDB will only exclude products or categories from receiving
the Rebate Manufacturer Indicator when specified by CMS. If an NDC, a manufacturer, or a labeler is terminated
from the MDR program, a Rebate Manufacturer Indicator value of 0 will be reported with the effective date (
FFP_DATEC) provided by CMS.

On September 30, 2014, CMS announced that NDCs not listed with the FDA's comprehensive NDC Structured
Product Labeling (SPL) Data Elements (NSDE) file will not be eligible for coverage under the MDR program.
Customer may consult the NSDE file to determine Medicaid program drug eligibility.

A Medical Supply Indicator (FFP_TYP = MS) value (FFP_IND) of 1 is applied to products identified as medical
supplies and to certain products that do not meet the covered outpatient drug standard as defined in the Social
Security Act Sec. 1927 (SSA Sec. 1927) even if the labeler is participating in the MDR program. NDCs that have
a Rebate Manufacturer Indicator value of 0 may be filtered with the Medical Supply Indicator to identify products
that may be included for coverage by the state.

A Permitted Exclusion Indicator (FFP_TYP = PX) value (FFP_IND) of 1 is applied to NDCs that are in categories
that may be excluded or otherwise restricted from Medicaid coverage as specified in SSA Sec. 1927. If a drug
category is no longer subject to restriction or exclusion, a Permitted Exclusion Indicator of 0 will appear with the
effective date provided by CMS. NDCs that have a Rebate Manufacturer Indicator value of 1 may be filtered with
the Permitted Exclusion Indicator to identify products that may be excluded or restricted from coverage by the
state.

Available Data for Each State

The following Charts indicate the data that is currently available for each state. Data is expressed in terms of the
Column Names that appear in the Medicaid Data Table and Medicaid Data Price Table.
Chart 1: Available Data for California
Chart 2: Available Data for Alabama Illinois (excluding California)
Chart 3: Available Data for Indiana - Missouri
Chart 4: Available Data for Montana - Oregon
Chart 5: Available Data for Pennsylvania - Wyoming

Refer to ERD and Technical Specifications for more information about the Medicaid Data Table and Medicaid

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Data Price Table.

All formulary, rebate, and DESI restrictions have been removed from the Medicaid Data Price Table
(RMDP0_MEDICAID_PRICE) and the Medicaid Data Table (RMD2_MEDICAID_MSTR) will contain all
NDCs added to the Medicaid Data Price Table for a given state.

Except for the State of California, the Formulary Indicator (MDT_FI) will default to 0 (VALUE
DISCONTINUED) values for all unsupported states. Customers may consult the Federal Financing
Participation Data Table in conjunction with the NSDE file to determine Medicaid program drug eligibility.

Chart 1: Available Data for California

Column Name CA

MDPT_DATEC X

MDPT_ID X

MDPT_PRICE X

MDPT_TYP X

MDT_BC X

MDT_BCDTE

MDT_BU

MDT_CODE1 X

MDT_COP

MDT_COV X

MDT_FEE X

MDT_FI X

MDT_FIDTE

MDT_FREQ X

MDT_GBC

MDT_GBCDTE

MDT_ID X

MDT_LTC X

MDT_MAX X

MDT_MAXC

MDT_MIN X

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MDT_MINC X

MDT_PA

MDT_PS

MDT_QBU

MDT_RFL

MDT_SLC10

MDT_SUB

NDC X

Chart 2: Available Data for Alabama Illinois (excluding California)

Colu AK AL AR CO CT DC DE FL GA HI IA ID IL
mn
Nam
e

MDPT X X X X X X X X X X X X X
_DAT
EC

MDPT X X X X X X X X X X X X X
_ID

MDPT X X X X X X X X X X X X X
_PRIC
E

MDPT X X X X X X X X X X X X X
_TYP

MDT_I X X X X X X X X X X X X X
D

NDC X X X X X X X X X X X X X

Chart 3: Available Data for Indiana - Missouri

Column IN KS KY LA MD ME MI MN MO MS
Name

MDPT_D X X X X X X X X X X
ATEC

MDPT_I X X X X X X X X X X
D

MDPT_P X X X X X X X X X X
RICE

MDPT_T X X X X X X X X X X
YP

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MDT_ID X X X X X X X X X X

NDC X X X X X X X X X X

Chart 4: Available Data for Montana - Oregon

Colum MT NC ND NE NH NJ NM NV NY OK OR
n

MDPT_ X X X X X X X X X X X
DATEC

MDPT_I X X X X X X X X X X X
D

MDPT_ X X X X X X X X X X X
PRICE

MDPT_ X X X X X X X X X X X
TYP

MDT_ID X X X X X X X X X X X

NDC X X X X X X X X X X X

Chart 5: Available Data for Pennsylvania - Wyoming

Colu PA RI SC SD TN TX UT VA VT WA WI WV WY
mn

MDPT X X X X X X X X X X X X X
_DAT
EC

MDPT X X X X X X X X X X X X X
_ID

MDPT X X X X X X X X X X X X X
_PRIC
E

MDPT X X X X X X X X X X X X X
_TYP

MDT_I X X X X X X X X X X X X X
D

NDC X X X X X X X X X X X X X

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Medicaid Module ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

Medicaid Module Tables

Medicaid Module ERD

Medicaid Module Tables

Federal Financing Participation Data Table
Medicaid Copay Description Table
Medicaid Coverage Code Description Table
Medicaid Data Price Table
Medicaid Data Table
Medicaid Maximum Quantity Code Description Table
Medicaid Minimum Quantity Code Description Table
Medicaid Prior Authorization Code Description Table
Medicaid Refill Description Table

Medicaid Module ERD

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Federal Financing Participation Data Table

Table Name RFFP0_FED_FIN_PARTICIPATION

Revision Activity add.04-01-1995

Purpose Links a product to various Federal Financing Participation

categories.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

P FFP_TYP Federal Financing AN 2 X(2)

Participation
Indicator Type
Code

P FFP_DATEC Federal Financing N 8 9(8)

Participation
Indicator Effective
Date

FFP_IND Federal Financing AN 1 X(1)

Participation
Indicator

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Medicaid Copay Description Table

Table Name RMDCOPD0_MEDICAID_COPAY_DESC

Revision Activity add.08-11-2000 (discontinued)

Purpose Relates a State Copay Indicator to its text description.

Please note that this table is no longer supported. All
records contain a default value of 0 (VALUE
DISCONTINUED).

Key Column Name Column Format Length Picture

Description

P MDT_ID Medicaid Data AN 2 X(2)

Table - State ID

P MDT_COP Medicaid Data AN 1 X(1)

Table - State
Copay Indicator

MDT_COPD Medicaid Data AN 50 X(50)

Table - State
Copay Descriptor

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Medicaid Coverage Code Description Table

Table Name RMDCOV0_MEDICAID_COV_DESC

Revision Activity rev.02-01-1998 (discontinued)

Purpose Relates the State Coverage Code to its text description.

Please note that this table is no longer supported for any
state except California. All records for unsupported states c
ontain a default value of 0 (VALUE DISCONTINUED).

Key Column Name Column Format Length Picture

Description

P MDT_ID Medicaid Data AN 2 X(2)

Table - State ID

P MDT_COV Medicaid Data AN 1 X(1)

Table - State
Coverage Code

MDT_COVD Medicaid Data AN 50 X(50)

Table - State
Coverage Code
Description

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Medicaid Data Price Table

Table Name RMDP0_MEDICAID_PRICE

Revision Activity rev.01-21-1992

Purpose Provides state Medicaid price data for a packaged product.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

P MDPT_ID Medicaid Data AN 2 X(2)

Price Table -
State ID

P MDPT_TYP Medicaid Data AN 2 X(2)

Price Table -
State Price Type
Code

P MDPT_DATEC Medicaid Data N 8 9(8)

Price Table -
State Price
Effective Date

MDPT_PRICE Medicaid Data N 10 9(4).9(5)

Price Table -
State Unit Price

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Medicaid Data Table

Table Name RMD2_MEDICAID_MSTR

Revision Activity rev.03-31-1996

Purpose Provides Medicaid attributes for a packaged product.

Please note that this table is no longer supported for any
state except California. All records for unsupported
states contain a default value of 0 (VALUE
DISCONTINUED) or blank.
Note: Not all columns are supported for California. Please
see individual columns for current valid values.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

P MDT_ID Medicaid Data AN 2 X(2)

Table - State ID

MDT_BC Medicaid Data AN 11 X(11)

Table - State
Billing Code

MDT_BCDTE This column is not N 8 9(8)

currently being
used

MDT_FI Medicaid Data AN 1 X(1)

Table - State
Formulary
Indicator

MDT_FIDTE This column is not N 8 9(8)

currently being
used

MDT_GBC This column is not AN 11 X(11)

currently being
used

MDT_GBCDTE This column is not N 8 9(8)

currently being
used

MDT_COV Medicaid Data AN 1 X(1)

Table - State
Coverage Code

MDT_PA Medicaid Data AN 1 X(1)

Table - State Prior
Authorization

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MDT_RFL Medicaid Data AN 1 X(1)

Table - State Refill
Indicator

MDT_COP Medicaid Data AN 1 X(1)

Table - State
Copay Indicator

MDT_BU Medicaid Data AN 2 X(2)

Table - State
Billing Units

MDT_PS Medicaid Data AN 12 9(8).9(3)

Table - State
Package Size
Divisor

MDT_QBU Medicaid Data AN 10 X(10)

Table - State
Quantity Bill Units

MDT_MINC Medicaid Data AN 1 X(1)

Table - State
Minimum Quantity
Code

MDT_MIN Medicaid Data AN 12 9(8).9(3)

Table - State
Minimum Quantity

MDT_MAXC Medicaid Data AN 1 X(1)

Table - State
Maximum
Quantity Code

MDT_MAX Medicaid Data AN 12 9(8).9(3)

Table - State
Maximum
Quantity

MDT_FEE Medicaid Data AN 1 X(1)

Table - State Fee
Indicator

MDT_SLC10 Medicaid Data AN 10 X(10)

Table - State
Specific &
Limitation Codes

MDT_LTC Medicaid Data AN 1 X(1)

Table - State Long
Term Care Code

MDT_FREQ Medicaid Data AN 1 X(1)

Table - State
Frequency Code

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MDT_CODE1 Medicaid Data AN 1 X(1)

Table - State
Code 1 Restriction

MDT_SUB Medicaid Data AN 1 X(1)

Table - State
Substitutable Drug
Indicator

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Medicaid Maximum Quantity Code Description Table

Table Name RMDMAXC0_MEDICAID_MAX_QTY_DESC

Revision Activity rev.02-01-1998 (discontinued)

Purpose Relates the State Maximum Quantity Code to its text

description.
Please note that this table is no longer supported. All
records contain a default value of 0 (VALUE
DISCONTINUED).

Key Column Name Column Format Length Picture

Description

P MDT_ID Medicaid Data AN 2 X(2)

Table - State ID

P MDT_MAXC Medicaid Data AN 1 X(1)

Table - State
Maximum
Quantity Code

MDT_MAXCD Medicaid Data AN 50 X(50)

Table - State
Maximum
Quantity Code
Description

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Medicaid Minimum Quantity Code Description Table

Table Name RMDMINC0_MEDICAID_MIN_QTY_DESC

Revision Activity rev.02-01-1998 (discontinued)

Purpose Relates the State Minimum Quantity Code to its text

description.
Please note that this table is no longer supported for any
state except California. All records for unsupported states c
ontain a default value of 0 (VALUE DISCONTINUED).

Key Column Name Column Format Length Picture

Description

P MDT_ID Medicaid Data AN 2 X(2)

Table - State ID

P MDT_MINC Medicaid Data AN 1 X(1)

Table - State
Minimum Quantity
Code

MDT_MINCD Medicaid Data AN 50 X(50)

Table - State Mini
mum Quantity
Code Description

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Medicaid Prior Authorization Code Description Table

Table Name RMDPA0_MEDICAID_PA_DESC

Revision Activity rev.02-01-1998 (discontinued)

Purpose Relates the State Prior Authorization Code to its text

description.
Please note that this table is no longer supported. All
records contain a default value of 0 (VALUE
DISCONTINUED).

Key Column Name Column Format Length Picture

Description

P MDT_ID Medicaid Data AN 2 X(2)

Table - State ID

P MDT_PA Medicaid Data AN 1 X(1)

Table - State Prior
Authorization
Code

MDT_PAD Medicaid Data AN 50 X(50)

Table - State Prior
Authorization
Code Description

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Medicaid Refill Description Table

Table Name RMDRFLD0_MEDICAID_REFILL_DESC

Revision Activity add.08-11-2000 (discontinued)

Purpose Relates the State Refill Indicator to its text description.

Please note that this table is no longer supported. All
records contain a default value of 0 (VALUE
DISCONTINUED).

Key Column Name Column Format Length Picture

Description

P MDT_ID Medicaid Data AN 2 X(2)

Table - State ID

P MDT_RFL Medicaid Data AN 1 X(1)

Table - State Refill
Indicator

MDT_RFLD Medicaid Data AN 50 X(50)

Table - State Refill
Indicator
Description

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Medicare Module-HCPCS Select

Medicare Module - HCPCS Select Editorial Policies
Medicare Part B Applications
ERD and Technical Specifications

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Medicare Module - HCPCS Select Editorial Policies

Overview
Definitions
Concepts
Inclusion Criteria
Data Elements
Rule Sets
Maintenance
Resources

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Overview
Medicare is the U.S. national health insurance program for people 65 or older. It also provides benefits for some
people under 65 with disabilities, and for those with special circumstances such as end-stage renal disease. The
Center for Medicare & Medicaid Services (CMS) is the federal agency that administers the Medicare Program.
Currently, Medicare provides coverage to over 40 million Americans.

Benefits provided by Medicare are categorized as belonging to Parts A, B, C, or D. The various Medicare Parts
address the following healthcare areas:

Part A Helps cover inpatient care in hospitals, including critical

access hospitals, and skilled nursing facilities (not custodial
or long-term care). It also helps cover hospice care and
some home health care. Beneficiaries must meet certain
conditions to get these benefits.

Part B Helps cover doctors' services and outpatient care. It also

covers some other medical services that Part A doesn't
cover, such as some of the services of physical and
occupational therapists, and some home health care. Part B
helps pay for these covered services and supplies when
they are medically necessary.

Part C Known as the Medicare+Choice (M+C). M+C plans typically

provide health care coverage that exceeds the coverage of
original fee-for-service Medicare at a lower cost to Medicare
beneficiaries. The primary goal of the M+C program is to
provide Medicare beneficiaries with a wider range of health
plan choices through which to obtain their Medicare
benefits. As part of the M+C program, CMS can contract
with public or private organizations offering a variety of
health plan options for beneficiaries, including both
traditional managed care plans and new options that were
not previously authorized.

Part D Allows everyone under Medicare, regardless of income,

health status, or prescription drugs used, to get prescription
drug coverage.

FDBs Medicare ModuleHCPCS Select is an integratable data product that lets you access national Medicare
Part B drug pricing and coverage information. Although the focus of the module is Medicare Part B, the HCPCS
codes and their linked drug identifiers can also be used in applications related to Medicare Parts A, C, and D. In
this document the term Medicare module is used interchangeably with Medicare ModuleHCPCS Select.

The Medicare module includes National Drug Codes (NDCs) linked to Healthcare Common Procedure Coding
System (HCPCS) Level II and some Level I codes. Each included NDC has both current and historical Part B
pricing information.

The information in the Medicare module allows you to periodically assess and adjust billing amounts for covered
drugs, enables the updating of administrative records, facilitates the creation of accurate fee sheets, and provides
information for efficient billing and claims processing for private carriers.

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What the Medicare Module Can Do

The Medicare module can be used to provide the following functionality or information:

Determine candidate HCPCS codes for a given NDC

Determine the date that a HCPCS code becomes valid
Determine the coverage status (coverage code) of a HCPCS code
Determine the meaning of a coverage code for a HCPCS code
Determine the meaning of a HCPCS code
Determine the current Part B payment allowance limit for a HCPCS code
Determine the current NOC payment allowance limit (PAL) for an NDC code
Given a past date, determine what Part B PAL was in effect for a HCPCS code
Given a past date, determine what NOC payment allowance limit was in effect for a HCPCS code

What the Medicare Module Cannot Do

The Medicare module cannot provide the following information or functionality:

Assist in calculating billing units such as those used in the CMS 1500 claim form because billing units per
NDC are not part of the module
Create a complete billing sheet because the module does not include all HCPCS codes, only HCPCS
codes and descriptions for drug and diabetic/ostomy supplies
Provide past HCPCS code definition and drug associations

Product Role Within a Customer Application

The role of the Medicare module is to provide viable HCPCS candidates for selection.

FDB uses algorithms that may expand the selections identified in the CMS Crosswalk publications to include
additional NDC-to-HCPCS linkages. It is the responsibility of the end-user to apply professional judgment to make
an appropriate selection from that list of candidates.

CMS provides the source information on payment allowances and Medicare coverage. FDB incorporates this
information into the Medicare module to assist end-users in the planning and execution of Medicare
reimbursements as part of their business.

Presentation of an NDC, assignment of a specific coverage code, or the indication of a PAL amount does not
guarantee coverage or that reimbursement will be a specific amount.

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Definitions
This section defines important terms related to the module that users should understand. Some industry terms
that have a specific connotation in regards to the module are also defined.

ASP
Billing Code
Billing Sheet
Billing Unit
CMS
CPT
Coverage
DMERC
Effective Date
HCPCS Code
J Code
Modifier Codes
NOC
PAL
Reference Codes
Service Date

ASP
CMS determines the average sale price (ASP) by calculating the average of all reported prices for an item. These
prices are confidentially provided by manufacturers to CMS.

Billing Code
See HCPCS Code.

Billing Sheet
A record of billing codes and their related patient charges. It is used by medical practitioners and clinicians to
complete and submit the procedure(s) and diagnosis to a billing person or department.

Billing Unit
The administration amount specified by the HCPCS code. For example, if the code specifies 5 mg is to be
administered, then each 5 mg is a billing unit. These frequently vary from Medicaid Billing Units because Medicaid
uses quantities based on a portion or multiple of NDC units (grams, mililiters, eaches) rather than based on
amounts measured in units used for dosing or administration amounts.

CMS

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The Center for Medicare & Medicaid Services. This is the federal agency that administers the Medicare Program.

CPT
Current Procedural Terminology. The American Medical Association maintains the CPT code set. The CPT code
set describes medical, surgical, and diagnostic services and is designed to communicate uniform information
about medical services and procedures among physicians, coders, patients, accreditation organizations, and
payers for administrative, financial, and analytical purposes.

Coverage
The extent to which a drug, service, or supply item is reimbursable. There is no information in the Medicare
module, nor any information published by CMS, guaranteeing coverage. The Medicare module provides coverage
codes that indicate the existence of any restrictions or conditional requirements impacting potential Medicare
reimbursement.

DMERC
Durable Medical Equipment Regional Carrier. Payer for durable medical equipment (DME).

Effective Date
The date when the Medicare reimbursement process recognizes a HCPCS code as valid. Once valid, providers
can use the code to identify and report drug administration within Medicare claims processing. Even though a
code is valid, this does not imply or guarantee reimbursement (coverage).

HCPCS Code
A HCPCS code, sometimes called a billing code, is five characters in length and is used to standardize the
reporting of drugs, services, and supplies for Medicare reimbursement. Often, these codes are listed with the
description of a diagnosis or treatment on a fee sheet or reimbursement form.

The HCPCS code category used for most drugs is category J. Usually a J code refers to a drug administered
non-orally, for example by injection, and includes chemotherapy drugs.

Drug-related HCPCS codes typically specify a quantity of drug administered, where the quantity is used to
calculate billing units on a claim. For example, the code J3260 is used to report the administration of 80 MG of
Tobramycin by injection:

J3260 = Tobramycin sulfate injection, 80 MG

If the total amount administered is 160 MG, that constitutes two (2) billing units.

J Code
See HCPCS Code.

Modifier Codes
Modifier codes are two characters that provide additional information about a HCPCS code. For example:

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G6 ESRD PATIENT FOR WHOM LESS THAN SIX DIALYSIS

SESSIONS HAVE BEEN PROVIDED IN A MONTH

H9 COURT-ORDERED

Modifiers can be situational or patient specific. The Medicare module does not include modifier codes.

NOC
Not Otherwise Classified. An NDC without an assigned HCPCS code, but is considered reimbursable by CMS.

PAL
Payment Allowance Limit. Drug costs reimbursed under Medicare Part B are capped at a specific amount, known
as a Payment Allowance Limit (PAL). The PAL enables consistent reimbursement, regardless of region or
HCPCS Code. FDB publishes a Part B Price, which is the Medicare PAL. The PAL is set by CMS based on their
calculated Average Sale Price (ASP) plus a specified markup.

Reference Codes
The Medicare module uses a reference code in place of a HCPCS code when more than one HCPCS code is
linked to an NDC within the HCPCS code column.

Service Date
The date on which the drug was administered, the service was performed, or the supplies were used.

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Medicare Concepts
Medicare Part B Benefits
Medicare Part D Benefits
Billing
Claims Submission
HCPCS Codes Categories and Groupings
Multiple Price Types for NDCs
Medicare Module Usage Example

Medicare Part B Benefits

Because traditional Medicare provided for inpatient hospital services, a Medicare Part B program was created to
cover physician and outpatient services with limited coverage for outpatient drugs. Part B coverage includes the
following:

Physician and nursing service

X-rays
Laboratory and diagnostic tests
Influenza and pneumonia vaccinations
Blood transfusions
Renal dialysis
Outpatient hospital procedures
Limited ambulance transportation
Immunosuppressive drugs for organ transplant recipients
Chemotherapy
Hormonal treatments such as lupron
Other outpatient medical treatments administered in a doctors office

The Medicare Part B prices contained in the Medicare modules Part B Price Data File correspond to the prices
posted on the CMS website at http://www.cms.hhs.gov/McrPartBDrugAvgSalesPrice/. Since January 1, 2005
CMS has provided these prices based on the Average Sales Price (ASP) plus 6%. FDB passes through this
pricing information as it is made available from CMS.

Any exceptions to the standard CMS pricing methodology can be viewed on the CMS website.

Medicare Part D Benefits

Although Part D benefits provide insurance for prescription drug costs, and FDB is a leading provider of drug
information, the Medicare module does not provide functionality to meet any needs specific to Medicare Part D.

Unlike original Medicare (Part A and B,) Part D coverage is not standardized. Individual plans determine which
drugs (or even classes of drugs) are covered or not covered and at what level (or tier) they are covered.

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Billing

Healthcare providers bill commercial insurance companies, Medicare, and patients with expectations of receiving
payment. The providers bill Medicare for drugs subject to Medicare Part B reimbursement at an amount that is at
the discretion of the provider.

The provider is then reimbursed an amount up to, but not more than, the limit (PAL) established by CMS when
covered. Any remainder is billed to the insurance company or the patient.

Detailed written records are normally kept as healthcare services are rendered. Providers can streamline billing
and claims processing by listing HCPCS codes (and codes from other coding schemes) on these documents to
classify products and services in advance, rather than entering them at a later time in the billing cycle. These
documents can be referred to as billing sheets, fee sheets, or super bills.

Claims Submission

CMS prescribes the CMS-1500 form, shown in part below, as the form for the Medicare program for claims from
physicians and suppliers. When submitting paper or electronic claims, Medicare requires the proper classification
of the procedure, service, or supplies through the use of CPT/HCPCS codes. Providers use the codes to report
services rendered and are accompanied by a quantity expressed in billing units.

For example, if 160 MG of Tobramycin is administered, but 80 MG is the billing quantity for the code, a billing unit
of 2 is entered in the claim, indicating that two 80 MG amounts were administered.

HCPCS Codes Categories and Groupings

Most HCPCS codes in the Medicare module begin with a letter (A-V) and are followed by four digits. These are
sometimes called Level II codes. The letter prefix groups like code classifications. Codes beginning with A, J, P,
and Q are used to classify drug-related reporting.

However, drug-related HCPCS codes also span a series of codes beginning with 9. These codes are sometimes
called Level I codes. They are special in that they are Current Procedural Terminology codes and are proprietary
to the American Medical Association. The Medicare module contains some CPT codes, which are handled just
like Level II HCPCS codes, related to drug administration.

Multiple Price Types for NDCs

In rare cases, NDCs can have both Part B pricing and NOC pricing. The price used when filing a claim is
dependent on the circumstances of administration. To determine whether an NDC has both types of pricing
available, you must retrieve pricing information using both Retrieving the Current Part B Price for an NDC and
Retrieving Current or Previous NOC Pricing for an NDC applications for the NDC.

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Medicare Module Usage Example

The following diagram illustrates how you might use the Medicare module information in a general healthcare
application.

The example application provides four potential outputs:

A detailed printout of the drugs, services, and supplies related to the office visit to be given to the patient at
the time of the office visit.
A completed CMS-1500 claim form that is ready to be submitted for Medicare reimbursement.
A final bill that can be mailed to the patient after the provider receives reimbursements from Medicare.
An audit report comparing actual reimbursements against PALs.

The Medicare module can provide drug-related information for all four of these outputs.

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Inclusion Criteria
This section provides information detailing the criteria that guides the inclusion of the data contained within the
module as well as information pertaining to limitations or exclusions when appropriate to the discussion.

The HCPCS universe of codes contains over 6,000 classifications - from codes to identify Ambulance Services or
Abutment Supported Porcelain/Ceramic Crowns to those for Zinc Paste Impregnated Bandages. It is important to
understand that not all of these HCPCS codes are supported with NDCs in the Medicare module. The Medicare
module primarily provides HCPCS codes for drug products, with limited support for specific non-drug items
related to diabetic and ostomy supplies.

HCPCS Codes Provided by CMS

HCPCS Codes Not Found in CMS Published Sources
HCPCS Codes With a Not Covered or Not Valid Status
HCPCS Code Exceptions
Exclusions for HCPCS-NDC Associations Provided by CMS
HCPCS Codes with Part B Pricing - Inclusion and Exclusion

HCPCS Codes Provided by CMS

The chart below defines each of the Level II HCPCS categories. Highlighted items represent codes provided by
CMS and are included in the Medicare module as noted. Prefixes that are not highlighted are presented only for
information purposes.

Level II HCPCS Code Categories and Their Scope

Code Scope

A Transportation Services, Chiropractic Services, Medical and

Surgical Supplies, Miscellaneous and Experimental
Note: Limited to NDCs for Diabetic and Ostomy Supplies in
the Medicare module

B Enteral and Parenteral Therapy

C Items that may qualify for pass through payments under the
hospital outpatient prospective payment system (OPPS)

D Dental Procedures

E Durable Medical Equipment

Note: Limited to NDCs for Diabetic and Ostomy Supplies in
the Medicare module

G Procedures/Services Temporary

H Rehabilitation Services

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J Drugs administered other than oral method and

Chemotherapy drugs
Note: Most are included in the Medicare module; See
HCPCS Code Exceptions, page 1960 for those that are not
included

K Used by DMERCs in situations when the national

permanent HCPCS level II codes do not include codes
needed to implement a DMERC medical review policy
K codes are no longer being actively used.

L Orthotic and Prosthetic Procedures

M Medical Services

P Pathology and Laboratory

Note: Partially covered and included in the Medicare
module for drug-related HCPCS codes

Q Temporary Codes
Note: Partially covered and included in the Medicare
module for drug-related HCPCS codes

R Diagnostic Radiology Services

S Private Payer Codes

T State Medicaid agency codes for Medicaid Program

administration

V Vision and Hearing Services

The Medicare module primarily provides NDCs for HCPCS codes related to drug utilization. These codes include
J, P, and Q codes. For example J0128 is linked to PLENAXIS 100 MG Vial (NDC 68158014951).

The Medicare module also includes NDCs linked to a series of CPT codes beginning with 9 that are used to
report vaccine administration.

In addition to drugs, the Medicare module provides linkages to HCPCS codes related to the reimbursement of
Diabetic and Ostomy supplies. HCPCS codes beginning with the letters A and E are typically used by CMS for
this type of categorization.

HCPCS Codes Not Found in CMS Published Sources

Although the majority of drug-related HCPCS codes are provided through CMS published sources, there are
additional drug-related HCPCS codes that are active (non-terminated) that do not have Part B payment limits and
are not linked to NDCs in any CMS Crosswalk publications.

FDB provides appropriate NDCs for these drug-related HCPCS codes to facilitate classification and reporting of
these drugs in areas outside of Medicare.

HCPCS Codes With a Not Covered or Not Valid Status

The Medicare module includes NDCs associated with HCPCS codes considered Not Valid or Non-Covered for

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Medicare, as specified by the HCPCS coverage code (see "Mapping CMS Coverage Codes to FDB Coverage
Codes" in the Rule Sets section). This facilitates NDC-to-HCPCS identification for applications outside of
Medicare and provides information on non-reimbursable items within Medicare.

HCPCS Code Exceptions

FDBs goal is to provide appropriate NDCs that can be used to report administration covered by Medicare. The
Medicare Region Master Table contains HCPCS code-to-NDC mappings for most J and drug-related Q codes.

The Medicare Region Master Table does not have HCPCS code-to-NDC mappings for the following situations:

CMS has terminated the HCPCS code. A HCPCS code is considered terminated when CMS has
designated a termination date in the Alpha-Numeric HCPCS codes file. However, HCPCS codes having
termination dates in the future (with respect to the FDB publication date) are not considered terminated
until the termination date has passed.
The HCPCS code does not represent a specific drug, but instead defines a category of unclassified, not
otherwise classified, or not otherwise specified drugs. See the following table.

The following HCPCS codes do not have mappings in the Medicare Region Master Table:

Codes Not Found in the Medicare Region Master Table

HCPCS Code Description

A9270 NON-COVERED ITEM OR SERVICE

C9399 UNCLASSIFIED DRUGS OR BIOLOGICALS

J3490 UNCLASSIFIED DRUGS

J3530 NASAL VACCINE INHALATION

J3535 DRUG ADMINISTERED THROUGH A METERED DOSE

INHALER

J3590 UNCLASSIFIED BIOLOGICS

J7599 IMMUNOSUPPRESSIVE DRUG, NOT OTHERWISE

CLASSIFIED

J7699 NOC DRUGS, INHALATION SOLUTION ADMINISTERED

THROUGH DME

J7799 NOC DRUGS, OTHER THAN INHALATION DRUGS,

ADMINISTERED THROUGH DME

J8498 ANTIEMETIC DRUG, RECTAL/SUPPOSITORY, NOT

OTHERWISE SPECIFIED

J8499 PRESCRIPTION DRUG, ORAL, NON

CHEMOTHERAPEUTIC, NOS

J8597 ANTIEMETIC DRUG, ORAL, NOT OTHERWISE

SPECIFIED

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J8999 PRESCRIPTION DRUG, ORAL, CHEMOTHERAPEUTIC,

NOS

J9999 NOT OTHERWISE CLASSIFIED, ANTINEOPLASTIC

DRUGS

Q0181 UNSPECIFIED ORAL DOSAGE FORM, FDA APPROVED

PRESCRIPTION ANTI-EMETIC, FOR USE AS A
COMPLETE THERAPEUTIC SUBSTITUTE FOR A IV
ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY
TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE
REGIMEN

Exclusions for HCPCS-NDC Associations Provided by CMS

The Medicare module includes all HCPCS code-to-NDC mappings electronically published by CMS with the
following exceptions:

HCPCS-NDC associations in CMS data that appear inappropriate

When a CMS Crosswalk association between a HCPCS code and an NDC seems inappropriate, FDB excludes
that association. For example, the association of an injectable drug with an oral HCPCS description or an oral
drug associated with a HCPCS description for an injection.

Bulk powders

Editorial policy excludes NDCs for bulk powder forms of drugs in the module data, unless CMS provides at least
one NDC for the HCPCS code that is in bulk powder form.

Unmapped NDCs

Associations to obsolete NDCs not found in MedKnowledge or associations to NDCs that are incorrectly
formatted or cannot be reliably interpreted using CMS published information are excluded

HCPCS Codes with Part B Pricing - Inclusion and Exclusion

Not all HCPCS codes related to drug administration have predetermined, national reimbursement amounts. As a
result, they do not appear in the CMS ASP (PAL) pricing publication or in the CMS Crosswalk publications. Yet
many can be linked to appropriate NDCs that could be used to report administration.

Therefore, the Medicare Region Master Table includes HCPCS-to-NDC mappings when the HCPCS code relates
to drug administration (all J Codes and drug-related Q Codes), with the following exceptions:

The drugs do not meet the criteria stated in this section

FDB clinical staff does not have sufficient information to accurately assign NDCs to the HCPCS Code.

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Data Elements
This section contains additional information about particularly important tables and codes contained within the
module, as well as concepts about the data that the reader must understand in order to understand the module.

Medicare Region Master Table

Medicare Region Reference Description Table
Medicare Coverage Code Description Table
Medicare HCPC Part B Price Data File

Medicare Region Master Table

The Medicare Region Master Table provides a formulary of Medicare drug products including NDCs, coverage
codes, regions, and HCPCS codes. The table includes the NDC and effective date, HCPC or reference code, and
coverage code which indicates if or how reimbursement is obtained.

Medicare Region Reference Description Table

The Medicare Region Reference Description Table provides a list of HCPCS codes and their text descriptions for
a reference code. This table associates a reference code for the Master Table with a HCPC code or codes and
their descriptions.

Medicare Coverage Code Description Table

The Medicare Coverage Code Description Table relates the Medicare Coverage Code to its text description.

Medicare HCPC Part B Price Data File

The Medicare HCPC Part B Price Data File table provides the current HCPC Part B price or not otherwise
covered (NOC) price with its effective date and up to seven historical price/date pairs. This table provides
payment limits for HCPC codes and NOC drugs that do not have HCPC codes. The table also includes: HCPC
codes, NDCs for NOCs, current price and effective date, and previous price and effective date.

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Rule Sets
This section provides rules that the clinical team uses in regard to creating the module's data, both general rules
and rules specific to data elements.

Rules of General Applicability

General Referential Data Integrity
HCPCS, NOC, and Part B Pricing Histories
Modifying HCPCS Code Descriptions to Include Administration Amounts
Impact of MedKnowledge Data on the Medicare Module
Collecting NDCs Associated with HCPCS Codes Through CMS
Establishing HCPCS-NDC Associations Not Provided By CMS
Rules for Data Elements
Mapping CMS Coverage Codes to FDB Coverage Codes
Effective Dates for NDCs that Span Multiple HCPCS Codes

Rules of General Applicability

This section describes editorial policies that have a broad impact on the module data or by nature are less
specific than those policies in other sections.

HCPC code descriptions drive the content of the module. The module focuses primarily on Medicare Part B drugs
and some biologics and vaccines. Diabetic and ostomy supplies are also included. The HCPC codes are linked to
active NDCs that are on the FDB database. HCPC codes that do not represent a specific drug but instead define
a category of unclassified, not otherwise defined, or specified are not linked to NDCs.

General Referential Data Integrity

HCPCS codes appearing in the Medicare HCPC Part B Price Data File will always have a description in the
Medicare Region Reference Description Table.

HCPCS, NOC, and Part B Pricing Histories

FDB does not maintain the history of HCPCS codes as they change over time. However, the Medicare module
does provide up to seven previous Part B reimbursement limits and NOC prices.

Modifying HCPCS Code Descriptions to Include Administration Amounts

Short HCPCS code descriptions published by CMS are used as the Medicare Billing Code Description in the
Medicare Region Reference Description Table (RMCRRD1_MEDICARE_REG_REF_DESC). If the CMS short
description does not include the amount to administer, FDB programmatically adds the HCPCS amount to the
description when appropriate.

Impact of MedKnowledge Data on the Medicare Module

The function of an NDC in the Medicare module is to provide an association to an appropriate HCPCS code. This
association is dependent on the NDC being available in MedKnowledge. If a drug is excluded from

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MedKnowledge by editorial policy, FDB cannot create NDC-to-HCPCS linkages for that drug in the Medicare
module.

Collecting NDCs Associated with HCPCS Codes Through CMS

FDB provides those HCPCS to NDC associations currently published by CMS and made available electronically.

The process used to identify Drug-related HCPCS codes is as follows:

1. FDB collects all HCPCS codes published by CMS in their Alpha-Numeric HCPCS list.

2. All J codes are treated as drug-related based on the CMS classification policies.

3. An algorithm extracts the short and long descriptions for all Q codes. Clinical editors identify all Q codes for
inclusion that are drug-related.

4. FDB includes all HCPCS codes found in the CMS Crosswalk publications and ASP Part B publications.

The process used to identify HCPCS codes associated with Diabetic and Ostomy supplies is as follows:

1. FDB collects all HCPCS codes published by CMS in their Alpha-Numeric HCPCS list.

2. All codes beginning with A or E are extracted and examined by Editorial staff to determine which codes are
related to Diabetic and Ostomy supplies.

3. Clinical editors, using the previously extracted list of Q codes, identify all Q codes for inclusion that are
related to Diabetic and Ostomy supplies.

Establishing HCPCS-NDC Associations Not Provided By CMS

The CMS HCPCS-NDC sources do not provide links to all available NDCs in the marketplace. FDB extends the
linkages to all MedKnowledge NDCs that satisfy the HCPCS code description. Using this approach results in
linkages to the following:

All NDCs that can be used to administer the drug

Editorial policy is to include all NDCs that could be used to administer the drug amount identified in the
HCPCS code description. However, some NDCs that could possibly supply this amount may not be
practical to administer. FDB does not restrict the assignment of HCPCS codes to NDCs based on any
guidelines regarding practical or economic considerations such as ampule volume, package size, or other
packaging details.
NDCs from repackagers
NDCs are published with HCPCS codes without regard to repackaging status.
NDCs that may or may not be eligible for rebates
NDCs are published with HCPCS codes regardless of the Manufacturer Rebate status.

Rules for Data Elements

This section describes editorial policies that are more specific towards their effect on the data elements contained
in the module.

The following is a list of rules for data elements:

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HCPC codes having Part B pricing and published by CMS.

Part B pricing published by CMS.
Short HCPC code descriptions published by CMS.
NDCs on FDBs database that satisfy HCPC code descriptions.
NDCs on FDBs database for selected diabetic and ostomy supplies.
Coverage code values and their descriptions from CMS and FDB.

Mapping CMS Coverage Codes to FDB Coverage Codes

CMS uses the following codes to indicate the level of coverage for a HCPCS code:

CMS Code CMS Definition of Coverage

I Not valid for Medicare

M Non-covered by Medicare

S Non-covered by Medicare Statute

D Special coverage instructions apply

C Carrier judgement

However, FDB maps the CMS coverage codes to internal codes as follows:

CMS Code FDB Code* FDB Definition

I, M, S 0 Non-covered by Medicare

D 2 Covered with special instructions

C 4 Covered with carrier discretion

8 Coverage Information not available

9 Coverage information varies within

reference code

* FDB codes 1 and 3 are no longer used when mapping CMS codes.

FDB assigns a coverage code of 8 when there is not sufficient information to determine Medicare coverage. A
coverage code of 9 is assigned when one or more HCPCS codes in a referenced group has different coverage
codes. See "Reference Codes" in Definitions for additional information.

Effective Dates for NDCs that Span Multiple HCPCS Codes

On rare occasions, an NDC can span multiple HCPCS codes where the Medicare Billing Code Effective Date
(MCR_DATEC) for one or more codes is different. When this occurs, FDB editorial policy is to publish the earliest
effective date of any of the codes in the Medicare Region Master Table.

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Maintenance
This section contains information regarding the ongoing maintenance of the module's data.

Updates and Deliveries

HCPCS Code Removal by CMS
CMS Annual and Quarterly Updates
CMS Mid-Quarter Revisions
FDB Delivery of New NDCs

This section contains information regarding the ongoing maintenance of the module's data.

Updates and Deliveries

The two areas covered are as follows:

CMS published policies and schedules

FDB policies for Medicare module data updates

A comprehensive HCPC code update occurs annually in December with an effective date of January 1st. Data is
obtained from CMS as well as from the PMIC (Practice Management Information Corporation) annual HCPC
manual. The updates include adds, deletes, and changes.

Minor updates may occur throughout the year and are monitored by checking the CMS website.

Part B pricing is obtained from CMS and updated quarterly. Price changes made by CMS during a given quarter
are also updated. Price changes extending beyond the current quarter are not changed.

HCPCS Code Removal by CMS

HCPCS procedure and modifier codes remain in the CMS electronic source materials for four (4) years to
facilitate claims processing. After that, CMS removes the codes. Those codes will not be present in the
subsequently updated Medicare module data. Usually CMS performs HCPCS code adds and deletes in their
yearly update file.

CMS Annual and Quarterly Updates

CMS updates HCPCS Level II codes, their long and short descriptions, and applicable Medicare administrative,
coverage, and pricing data annually. In addition, CMS issues quarterly updates to the codes that are generally the
result of updated ASP data from drug manufacturers. FDB processes all annual and quarterly updates as soon as
they are made available (usually two weeks prior to the effective date) with the goal of inclusion in the next
scheduled weekly or monthly data build. For quarterly updates to weekly distributions, this means that the Part B
limits should always be in place on or before the effective date.

When receiving year-end Medicare module updates containing the annual CMS changes, customers must
manage the timing of the update to make sure that the correct HCPCS codes are in place for the year in which a
service is performed.

Because it is possible for a HCPCS code to be valid on the last day of the current year and invalid on the first day

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of the next year, FDB recommends that customers keep a HCPCS history to facilitate any year-end billing that
isnt performed until the following year.

Conversely, because CMS can reactivate a HCPCS code, it is possible to have a code that is invalid on the last
day of the current year and valid on the first day of the following year. While this situation is rare, to reduce the
possibility of having erroneous data FDB recommends that customers subscribe to a weekly product update cycle
and to apply all updates as soon as possible.

CMS Mid-Quarter Revisions

FDB will revise the current quarter's limits in the HCPCS Part B pricing file should CMS make revisions to limits
during the quarter in which they are effective.

FDB Delivery of New NDCs

FDB follows a Thursday-to-Thursday production cycle. Any new NDCs added that are applicable to the Medicare
module are included in the next weekly data build and distributed in the next customer update. Because the
NDCs must be in the main MedKnowledge data, there may be some lag time between a drug coming to market
and that drug being mapped to appropriate HCPCS codes.

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Resources
This section lists sources used by FDB to compile the information contained in the Medicare module.

CMS Alpha-Numeric HCPCS File, http://www.cms.gov/HCPCSReleaseCodeSets/ANHCPCS/list.asp

CCYY Table of Drugs, http://www.cms.hhs.gov/HCPCSReleaseCodeSets/
CMS Pricing Files and NDC/HCPCS Crosswalks, http://www.cms.hhs.gov/McrPartBDrugAvgSalesPrice/
Practice Management Information Corporation (PMIC): HCPCS Health Care Procedure Coding System,
National Level II Medicare Codes, Coder's Choice

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Medicare Part B Applications

This section provides information about the practical application of data contained in this module.

Retrieving Candidate HCPCS Codes for an NDC

Retrieving Information About a HCPCS Code

Retrieving the Description of an HCPCS Code

Retrieving the Current Part B Price for an NDC

Retrieving a Historical Part B Price for an NDC

Retrieving Current or Previous NOC Pricing for an NDC

Retrieving an NDC Linked to a HCPCS Code

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Retrieving Candidate HCPCS Codes for an NDC

This application describes how to obtain the group of candidate HCPCS (billing) codes associated with a given
NDC. The user can then select from the candidates the HCPCS code that best represents the NDC administered.

1. Select the Medicare Reference Code (MCR_REF) values from the Medicare Region Master Table
(RMCRMA1_MEDICARE_MSTR) where the NDC column equals the NDC value of the drug product.

2. Select the Medicare Billing Code (MCR_BC) and Medicare Billing Code Description (MCR_BCDESC)
values from the Medicare Region Reference Description Table
(RMCRRD1_MEDICARE_REG_REF_DESC) where the MCR_REF column equals the MCR_REF value
from the previous step.

3. Select the appropriate HCPCS code from the candidates.

ExampleRetrieve Candidate HCPCS Codes for an NDC

In this example, a health care provider administers Aranesp, 100 mcg/ml vial to an end-stage renal disease
patient and needs to determine the appropriate HCPCS code. The associated NDC is 55513000501.

1. Select the Medicare Reference Code (MCR_REF) values from the Medicare Region Master Table
(RMCRMA1_MEDICARE_MSTR) where the NDC column equals the NDC value of the drug product.

NDC MCR_REGION MCR_DATEC MCR_REF MCR_COV

55513000501 N 20060101 00045 2

2. Select the Medicare Billing Code (MCR_BC) and Medicare Billing Code Description (MCR_BCDESC)
values from the Medicare Region Reference Description Table
(RMCRRD1_MEDICARE_REG_REF_DESC) where the MCR_REF column equals the MCR_REF value
from the previous step.

MCR_REF MCR_REFSN MCR_BC MCR_BCDESC

00045 0001 J0881 Darbepoetin alfa,

non-esrd, 1 MCG

00045 0002 J0882 Darbepoetin alfa, esrd use,

1 MCG

3. Select the appropriate HCPCS/billing code from the candidates. In this example, the appropriate code is
J0882.

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Retrieving Information About a HCPCS Code

This application describes how to retrieve information about a specific HCPCS code to determine the following
items:

When the HCPCS code became valid for use with an NDC
The HCPCS coverage code and its associated reimbursement restrictions

The following steps assume that the NDC is known and the HCPCS code has already been selected as illustrated
in Retrieving Candidate HCPCS Codes for an NDC.

1. Select the Medicare Billing Code Effective Date (MCR_DATEC) values from the Medicare Region Master
Table (RMCRMA1_MEDICARE_MSTR) where the NDC column equals the NDC value of the product.
This step determines if the NDC is valid for reimbursement. The returned date usually reflects the date the
linked HCPCS code was initially valid for use in reporting. However, if the MCR_REF field contains a
reference code instead of a HCPCS code, the date placed in the field is the earliest date that any HCPCS
code in the reference group was valid. In either case, the returned date must be older-than or equal-to the
service date to be valid for possible reimbursement.

2. Select the Medicare Coverage Code (MCR_COV) values from the Medicare Region Master Table
(RMCRMA1_MEDICARE_MSTR) where the NDC column equals the NDC of the drug product.

3. Select the Medicare Coverage Code Description (MCR_COVD) values from the Medicare Coverage Code
Description Table (RMCRCOD1_MEDICARE_COV_DESC) where the MCR_COV column equals the
MCR_COV value from the previous step.

ExampleRetrieve Information About a HCPCS Code

In this example, a healthcare provider needs to determine whether an administered drug is reimbursable under
Medicare and what, if any, restrictions apply. The following steps use the NDC 55513000501.

1. Select the Medicare Billing Code Effective Date (MCR_DATEC) values from the Medicare Region Master
Table (RMCRMA1_MEDICARE_MSTR) where the NDC column equals the NDC value of the product.
This step determines if the NDC is valid for reimbursement. The returned date usually reflects the date the
linked HCPCS code was initially valid for use in reporting. However, if the MCR_REF field contains a
reference code instead of a HCPCS code, the date placed in the field is the earliest date that any HCPCS
code in the reference group was valid. In either case, the returned date must be older-than or equal-to the
service date to be valid for possible reimbursement.

NDC MCR_REGION MCR_DATEC MCR_REF MCR_COV

55513000501 N 20060101 00045 2

Note that in this example, the MCR_REF contains a reference code instead of a HCPCS code indicating
that the returned date is the oldest date linked to any of the related HCPCS codes.

2. Select the Medicare Coverage Code (MCR_COV) values from the Medicare Region Master Table
(RMCRMA1_MEDICARE_MSTR) where the NDC column equals the NDC of the drug product.

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2.

NDC MCR_REGION MCR_DATEC MCR_REF MCR_COV

55513000501 N 20060101 00045 2

3. Select the Medicare Coverage Code Description (MCR_COVD) value from the Medicare Coverage Code
Description Table (RMCRCOD1_MEDICARE_COV_DESC) where the MCR_COV column equals the
MCR_COV value from the previous step.

MCR_COV MCR_COVD

2 COVERED WITH SPECIAL INSTRUCTIONS

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Retrieving the Description of an HCPCS Code

This application describes how to retrieve the text description of a specific HCPCS code linked to an NDC.

1. Select the Medicare Reference Code (MCR_REF) values from the Medicare Region Master Table
(RMCRMA1_MEDICARE_MSTR) where the NDC column equals the NDC value of the product.

2. Select the Medicare Billing Code (MCR_BC) and the Medicare Billing Code Description (MCR_BCDESC)
values from the Medicare Region Reference Description Table
(RMCRRD1_MEDICARE_REG_REF_DESC) where the MCR_REF column contains the MCR_REF value
from the previous step. Allow the end user to choose the correct description.

ExampleRetrieve the Description of a HCPCS Code

In this example, a healthcare provider has administered Aranesp, 100 mcg/ml vial with an NDC of 55513000501
to an end-stage renal disease patient. The provider wants to retrieve the description of the associated HCPCS
code.

1. Select the Medicare Reference Code (MCR_REF) values from the Medicare Region Master Table
(RMCRMA1_MEDICARE_MSTR) where the NDC column equals the NDC value of the product.

NDC MCR_REGION MCR_DATEC MCR_REF MCR_COV

55513000501 N 20060101 00045 2

2. Select the Medicare Billing Code (MCR_BC) and the Medicare Billing Code Description (MCR_BCDESC)
values from the Medicare Region Reference Description Table
(RMCRRD1_MEDICARE_REG_REF_DESC) where the MCR_REF column contains the MCR_REF value
from the previous step.

MCR_REF MCR_REFSN MCR_BC MCR_BCDESC

00045 0001 J0881 Darbepoetin alfa,

non-esrd, 1 MCG

00045 0002 J0882 Darbepoetin alfa, esrd use,

1 MCG

In this example, the correct description is linked to HCPCS code J0882.

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Retrieving the Current Part B Price for an NDC

This application illustrates how to obtain the current Part B price for an NDC. The application consists of two
parts:

Retrieving an HCPCS Code for an NDC (steps 1 and 2)

Retrieving the current Part B price for a HCPCS Code (steps 3 and 4)

1. Select the Medicare Reference Code (MCR_REF) values from the Medicare Region Master Table
(RMCRMA1_MEDICARE_MSTR) where the NDC column equals the NDC value of the product.

2. Select the Medicare Billing Code (MCR_BC) values from the Medicare Region Reference Description
Table (RMCRRD1_MEDICARE_REG_REF_DESC) where the MCR_REF column equals the MCR_REF
value from the previous step. The MCR_BC column represents the HCPCS code.

3. Select the HCFA Common Procedure Code (HCPC) values from the Medicare HCPC Part B Price Data
File (RMCRPB0_MEDICARE_HCPC_PB_PRICE) where the HCPC column equals the MCR_BC values
from the previous step.

4. Select the HCPC Part B Price (HCPC_PBP1) and the HCPC Part B Price Effective Date (HCPC_PBC1)
values where the HCPC column matches the HCPC value from the previous step.

ExampleRetrieving the Medicare Part B price for an NDC

In this example, a claims processor wants to retrieve the current Part B price (PAL) for Itraconazole (NDC
50458029801):

1. Select the Medicare Reference Code (MCR_REF) values from the Medicare Region Master Table
(RMCRMA1_MEDICARE_MSTR) where the NDC column equals the NDC value of the product.

NDC MCR_DATEC MCR_REF

50458029801 20020101 J1835

2. Select the Medicare Billing Code (MCR_BC) values from the Medicare Region Reference Description
Table (RMCRRD1_MEDICARE_REG_REF_DESC) where the MCR_REF column equals the MCR_REF
value from the previous step.
The MCR_BC column represents the HCPCS code:

MCR_REF MCR_BC MCR_BCDESC

J1835 J1835 Itraconazole injection, 50 MG

In this example, the Reference Code (MCR_REF) and the Billing Code (MCR_BC) are the same, which is
often the case. However, the Reference Code differs from the Billing Code when there is more that one
HCPCS code associated with an NDC. When that occurs, the Reference Code represents a group number
instead of the HCPCS code.

Never use a Reference Code (MCR_REF) for billing. Use the Billing Code (MCR_BC) because it

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always contains a valid HCPCS code.

3. Select the HCFA Common Procedure Code (HCPC) values from the Medicare HCPC Part B Price Data
File (RMCRPB0_MEDICARE_HCPC_PB_PRICE) where the HCPC column equals the MCR_BC values
from the previous step.

HCPC HCPC_PBC1 HCPC_PBP1 HCPC_PBC2 HCPC_PBP2 HCPC_PBC3 HCPC_PBP3

J1835 20110101 0 20100401 42.281 20100101 42.2813

The HCPC Part B Price Data File contains the current Part B price and up to seven previous Part
B prices, each with its own associated effective date.

4. Select the HCPC Part B Price (HCPC_PBP1) and the HCPC Part B Price Effective Date (HCPC_PBC1)
values where the HCPC column matches the HCPC value from the previous step.

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Retrieving a Historical Part B Price for an NDC

This application illustrates how to obtain the current Part B price for an NDC. The application consists of two
parts:

Retrieving an HCPCS Code for an NDC (steps 1 and 2)

Retrieving the Historical Part B price for a HCPCS Code (steps 3 and 4)

1. Select the Medicare Reference Code (MCR_REF) values from the Medicare Region Master Table
(RMCRMA1_MEDICARE_MSTR) where the NDC column equals the NDC value of the product.

2. Select the Medicare Billing Code (MCR_BC) values from the Medicare Region Reference Description
Table (RMCRRD1_MEDICARE_REG_REF_DESC) where the MCR_REF column equals the MCR_REF
value from the previous step. The MCR_BC column represents the HCPCS code.

3. Select the HCFA Common Procedure Code (HCPC) values from the Medicare HCPC Part B Price Data
File (RMCRPB0_MEDICARE_HCPC_PB_PRICE) where the MCR_BC column equals the MCR_BC
values from the previous step.

4. Evaluate each historical date (HCPC_PBCN, where N= 2 through 8) until you find the first effective date
preceding the service date. Then select the associated HCPC_PBPN value.
If the historical price field contains a zero (0), the HCPCS code did not have a payment allowance limit in
effect on the service date.

ExampleRetrieve a historical Medicare Part B price for an NDC

In this example, a claims processor wants to retrieve the Part B price for Itraconazole (NDC 50458029801) that
was administered to a patient on February 3rd, 2008:

1. Select the Medicare Reference Code (MCR_REF) values from the Medicare Region Master Table
(RMCRMA1_MEDICARE_MSTR) where the NDC column equals the NDC value of the product.

NDC MCR_DATEC MCR_REF

50458029801 20020101 J1835

2. Select the Medicare Billing Code (MCR_BC) values from the Medicare Region Reference Description
Table (RMCRRD1_MEDICARE_REG_REF_DESC) where the MCR_REF column equals the MCR_REF
value from the previous step.
The MCR_BC column represents the HCPCS codes:

MCR_REF MCR_BC MCR_BCDESC

J1835 J1835 Itraconazole injection, 50 MG

In this example, the Reference Code (MCR_REF) and the HCPCS code (MCR_BC) are the same, which is

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often the case. However, the Reference Code differs from the HCPCS code when there is more that one
HCPCS code associated with an NDC. When that occurs, the Reference Code represents a group number
instead of the HCPCS code.

Never use the Reference Code for billing. Use the HCPCS code because it always contains a valid
HCPCS code.

3. Select the HCFA Common Procedure Code (HCPC) values from the Medicare HCPC Part B Price Data
File (RMCRPB0_MEDICARE_HCPC_PB_PRICE) where the HCPC column equals the MCR_BC values
from the previous step.

HCPC HCPC_PBC1 HCPC_PBP1 HCPC_PBC2 HCPC_PBP2 HCPC_PBC3 HCPC_PBP3

J1835 20110101 0 20100401 42.281 20100101 42.2813

The HCPC Part B Price Data File contains the current Part B price and up to seven previous Part
B prices, each with their own associated effective date.

4. Evaluate each historical date (HCPC_PBCN, where N= 2 through 8) until you find the first effective date
preceding the service date. Then select the associated HCPC_PBPN value.
If the historical price field contains a zero (0), the HCPCS code did not have a payment allowance limit in
effect on the service date.
In this example, the date immediately preceding February 3rd, 2010 is 20100101 ( HCPC_PBC3). The Part
B price (HCPC_PBP3) in effect on February 3rd, 2008 was $42.2813 for each 50MG administered.

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Retrieving Current or Previous NOC Pricing for an NDC

This application illustrates how to retrieve the current NOC pricing for an NDC.

The Medicare HCPC Part B Price Data File includes Not Otherwise Classified (NOC) pricing. These are prices for
NDCs to which CMS has not assigned a HCPCS code. FDB identifies these items by populating the HCPC field
with all zeroes in the Medicare HCPC Part B Price Data File. Users must navigate to a NOC price contained in
the Part B file using an NDC, not the HCPCS code.

To retrieve NOC pricing for an NDC, do the following:

1. Select all record values from the Medicare HCPC Part B Price Data File
(RMCRPB0_MEDICARE_HCPC_PB_PRICE) where the NDC column equals the NDC value of the
product.

2. Select the current Part B price (HCPC_PBP1) and effective date (HCPC_PBC1) values or evaluate the
historical effective dates to find the one just previous to the service date.

ExampleRetrieving NOC Pricing for an NDC

In this example, a claims processor wants to retrieve the current NOC pricing for NDC 59730560101:

1. Select all record values from the Medicare HCPC Part B Price Data File
(RMCRPB0_MEDICARE_HCPC_PB_PRICE) where the HCPC column equals 00000 and the NDC
column equals the NDC value of the product. A sample of retrieved data is displayed below:

HCPC NDC HCPC_PBC1 HCPC_PBP1 HCPC_PBC2 HCPC_PBP2

00000 59730560101 20110101 334.92499 20101001 363.965

The HCPC Part B Price Data File contains the current Part B price and seven previous Part B prices. The
sample shows the current Part B price associated to the NDC is contained in the HCPC_PBP1 column with
its associated effective date contained in the HCPC_PBC1 column.
The first previous, or historical, Part B price associated with the NDC and its effective date are shown in
the remaining columns. The other six previous prices associated with the NDC that are available in the
Part B File are not shown in the sample above.

2. Select the current Part B price ( HCPC_PBP1) and effective date (HCPC_PBC1) values or evaluate the
past effective dates to find the one just previous to the service date.

3. Result: $334.92499 is the current Part B price (PAL) and its effective date is January 1, 2011.
To determine a historical NOC price, you must evaluate each historical date against the service date, then
select the effective date immediately preceding that date. For example, if the service date was February
3rd, 2008:

HCPC NDC HCPC_PBC2 HCPC_PBP2 HCPC_PBC3 HCPC_PBP3

00000 59730560101 20101001 363.965 20100701 374.55899

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In this example, the historical price in effect on that date was $374.55899 with an effective date of July 1,
2010.

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Retrieving an NDC Linked to a HCPCS Code

This application describes how to retrieve all the NDCs that are linked to a specific reference code and then
select a specific NDC based on the billing (HCPCS) code.

1. Select the following values from the Medicare Region Reference Description Table
(RMCRRD1_MEDICARE_REG_REF_DESC) where the Medicare Billing Code Description (
MCR_BCDESC) column equals the desired drug name or procedure.
Medicare Reference Code (MCR_REF)
Medicare Reference Code Sequence Number (MCR_REFSN)
Medicare Billing Code (MCR_BC)

2. Select the National Drug Code (NDC) values from the Medicare Region Master Table
(RMCRMA1_MEDICARE_MSTR) where the MCR_REF column matches the MCR_REF values selected
from the previous step.

3. Choose an NDC from the results.

ExampleRetrieve an NDC Linked to a HCPCS Code

This example retrieves the code for Hydralazine hcl injection, 20 MG, then retrieves the linked NDCs.

1. Select the following values from the Medicare Region Reference Description Table
(RMCRRD1_MEDICARE_REG_REF_DESC) where the Medicare Billing Code Description (
MCR_BCDESC) column equals the desired drug name or procedure.
Medicare Reference Code (MCR_REF)
Medicare Reference Code Sequence Number (MCR_REFSN)
Medicare Billing Code (MCR_BC)

MCR_REF MCR_REFSN MCR_BC MCR_BCDESC

J0360 1 J0360 Hydralazine hcl injection,

20 MG

2. Select the National Drug Code (NDC) values from the Medicare Region Master Table
(RMCRMA1_MEDICARE_MSTR) where the MCR_REF column matches the MCR_REF values selected
from the previous step.

NDC MCR_REGION MCR_DATEC MCR_REF MCR_COV

00469249000 N 19970101 J0360 2

00517090125 N 19970101 J0360 2

00517091125 N 19970101 J0360 2

00703820101 N 19970101 J0360 2

00703820104 N 19970101 J0360 2

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00703820194 N 19970101 J0360 2

17478093401 N 19970101 J0360 2

39769002101 N 19970101 J0360 2

55081085700 N 19970101 J0360 2

55081100700 N 19970101 J0360 2

63323061401 N 19970101 J0360 2

63323061455 N 19970101 J0360 2

3. Choose the desired NDC from the resulting list. Note that in this example if the actual injection is 60 MG,
that represents three (3) billing units at the specified billing quantity (20MG x 3 = 60MG).

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Medicare Module-HCPCS Select ERD and Technical

Specifications
This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

Medicare ModuleHCPCS Select Tables

Medicare ModuleHCPCS Select ERD

Medicare ModuleHCPCS Select Tables

Medicare Coverage Code Description Table
Medicare HCPC Part B Price Data File
Medicare Region Master Table
Medicare Region Reference Description Table

Medicare ModuleHCPCS Select ERD

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Medicare Coverage Code Description Table

Table Name RMCRCOD1_MEDICARE_COV_DESC

Revision Activity add.07-01-2003

Purpose Relates the Medicare Coverage Code to its text description.

Key Column Name Column Format Length Picture

Description

P MCR_COV Medicare AN 1 X(1)

Coverage Code

MCR_COVD Medicare AN 60 X(60)

coverage Code
Description

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Medicare HCPC Part B Price Data File

Table Name RMCRPB0_MEDICARE_HCPC_PB_PRICE

Revision Activity add.01-27-2004

Purpose Provides the current HCPC Part B price or NOC price with
its effective date and up to seven historical price/date pairs.

Key Column Name Column Format Length Picture

Description

PF HCPC HCFA Common AN 5 X(5)

Procedure Code
Note: The HCPC
column contains
zeroes when the
NDC column is
populated. A
non-zero value in
this field indicates
the row contains
Part B prices
linked to a
HCPCS code.

PF NDC National Drug AN 11 X(11)

Code
Note: The NDC
column is blank
when the HCPC
column contains a
non-zero value.
The presence of
an NDC in this
field indicates the
row contains Not
Otherwise
Classified (NOC)
price

HCPC_PBC1 HCPC Part N 8 9(8)

B/NOC Price
Effective Date

HCPC_PBP1 HCPC Part N 12 9(6).9(5)

B/NOC Price

HCPC_PBC2 HCPC Part N 8 9(8)

B/NOC Previous
Price Effective
Date

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HCPC_PBP2 HCPC Part N 12 9(6).9(5)

B/NOC Previous
Price

HCPC_PBC3 HCPC Part N 8 9(8)

B/NOC 2nd
Previous Price
Effective Date

HCPC_PBP3 HCPC Part N 12 9(6).9(5)

B/NOC 2nd
Previous Price

HCPC_PBC4 HCPC Part N 8 9(8)

B/NOC 3rd
Previous Price
Effective Date

HCPC_PBP4 HCPC Part N 12 9(6).9(5)

B/NOC 3rd
Previous Price

HCPC_PBC5 HCPC Part N 8 9(8)

B/NOC 4th
Previous Price
Effective Date

HCPC_PBP5 HCPC Part N 12 9(6).9(5)

B/NOC 4th
Previous Price

HCPC_PBC6 HCPC Part N 8 9(8)

B/NOC 5th
Previous Price
Effective Date

HCPC_PBP6 HCPC Part N 12 9(6).9(5)

B/NOC 5th
Previous Price

HCPC_PBC7 HCPC Part N 8 9(8)

B/NOC 6th
Previous Price
Effective Date

HCPC_PBP7 HCPC Part N 12 9(6).9(5)

B/NOC 6th
Previous Price

HCPC_PBC8 HCPC Part N 8 9(8)

B/NOC 7th
Previous Price
Effective Date

HCPC_PBP8 HCPC Part N 12 9(6).9(5)

B/NOC 7th
Previous Price

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Medicare Region Master Table

Table Name RMCRMA1_MEDICARE_MSTR

Revision Activity add.07-01-2003

Purpose Provides a formulary of Medicare drug products including

NDCs, coverage codes, regions, and HCPCS codes.

Key Column Name Column Format Length Picture

Description

P NDC National Drug AN 11 X(11)

Code

P MCR_REGION Medicare Region AN 1 X(1)

P MCR_DATEC Medicare Billing N 8 9(8)

Code Effective
Date

MCR_REF Medicare AN 5 X(5)

Reference Code

F MCR_COV Medicare AN 1 X(1)

coverage Code

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Medicare Region Reference Description Table

Table Name RMCRRD1_MEDICARE_REG_REF_DESC

Revision Activity add.07-01-2003

Purpose Provides a list of HCPCS codes and their text descriptions

for a Reference Code.

Key Column Name Column Format Length Picture

Description

P MCR_REF Medicare AN 5 X(5)

Reference Code

P MCR_REFSN Medicare N 4 9(4)

Reference Code S
equence Number

MCR_BC Medicare Billing AN 5 X(5)

Code

MCR_BCDESC Medicare Billing AN 50 X(50)

Code Description

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FDB Medicare Part D Module

Introduction
FDB Medicare Part D Module Editorial Policies
Applications
ERD and Technical Specifications

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Introduction
The Centers for Medicare and Medicaid Services (CMS) has introduced a series of coverage and participation
rules for Medicare Part D sponsors for the management of beneficiaries' drug therapy from a cost and quality of
care perspective. These rules may directly impact sponsor reimbursement rates.

The FDB Medicare Part D Module is designed to provide information that assists Part D sponsors in complying
with CMS coverage rules. It is therefore aimed at regulatory compliance and should not be used as a proxy
source for the clinical information to be found in MedKnowledge clinical modules. The content in the FDB
Medicare Part D Module is designed to be integrated into systems that prescribe covered drugs, dispense
prescriptions, adjudicate the prescription drug claims, report on various coverage and quality of care
measurements, and otherwise promote efficient implementation of the Medicare Part D program. The FDB
Medicare Part D Module allows plan sponsors to apply certain real-time claim edits to enforce the various CMS
coverage rules, minimize PDE rejections, assist plan sponsors in identifying drugs related to quality measures,
and facilitate the generation of dash-board reports. Sponsors can also evaluate their Medicare Part D adherence,
improve their claim processing procedures, and provide updated listings for CMS evaluation. In addition, the
module is intended to be used in non-Medicare Part D applications, such as Medicaid, Accountable Care
Organizations, Health Insurance Exchanges, and in commercial payment programs.

The FDB Medicare Part D Module is organized by NDCs to support any NDC-based drug file application or
system. Access points to the FDB Medicare Part D Module are also available through the FDB Product Identifiers
tables. National Drug Codes (NDC) in the FDB Medicare Part D Module are not limited to NDCs specifically
identified for coverage under Medicare Part D. Therefore, records are not excluded because Medicare Part D will
not cover a product. Customers using the contents of this FDB Medicare Part D Module may want to add their
own Part D coverage filters when implementing within Medicare Part D plans.

The FDB Medicare Part D Module allows for excluding specific categories for the Morphine Equivalent Dose
Measure and the Opioid and Concurrent Drug Therapy Measure. For example, cough and cold products, narcotic
withdrawal agents, and injectables.

The FDB Medicare Part D Module provides NDC level information for the following:

Acetaminophen Quantity (mg per dosage unit): Aids in the calculation of the maximum daily dose of
acetaminophen.
Morphine Equivalent Doses: Aids in the calculation of the total morphine equivalent dose for
opioid-containing drug products and helps determine if the morphine daily quantity threshold set by CMS is
exceeded. This module is not designed and should not be used as a tool for a conversion of one opioid to
another opioid. Given the focus of the Module on Medicare Part D population, the drugs covered are
primarily those used in an ambulatory outpatient setting. Drugs whose Medicare Part D conversion values
are not available, e.g., injectable formulations of some opioids, and opioids that are otherwise not
dispensed in an outpatient ambulatory setting, are not included in the Module.
Opioids and Concurrent Drug Therapy Categories: CMS has expressed concerns with the concurrent use
of opioids and benzodiazepines which can exacerbate the risk for respiratory depression. Opioids and
Concurrent Drug Therapy checks allow for screening of:

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Opioid and benzodiazepine and/or non-benzodiazepine sedative/hypnotics

Opioid and benzodiazepine and/or non-benzodiazepine sedative/hypnotic AND muscle relaxants
Comprehensive NDC SPL Data Elements (NSDE) Information: Identifies drugs eligible for coverage under
Medicare Part D using the following elements: NDC, Marketing Category, Marketing Start Date and
Marketing End Date.
Short Cycle Dispensing: Facilitates the identification of drugs that are subject to the 14-day dispensing
rules for pharmacies providing services to Long Term Care facilities.
Drugs that Indicate Core Medication Therapy Management (MTM) Medical Conditions: Helps identify
candidates for enrollment in a plans MTM program.
Display Measures: Assists in monitoring and serves as a staging area for measures prior to future
inclusions in CMS Star Ratings.
Star Ratings: Provides medication listings that support CMS Medicare Part D quality of care initiatives and
plan ratings.

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FDB Medicare Part D Module Editorial Policies

The policies and criteria that apply to the inclusion criteria, processes, and references used in creation of module
information are provided in the following sections:

Overview
Concepts
Data Elements
Additional Editorial Policies

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Overview
The FDB Medicare Part D Module currently covers the following:

Acetaminophen Quantity (mg per dosage unit)

Morphine Equivalent Doses
Opioids and Concurrent Drug Therapy Categories
Comprehensive NDC SPL Data Elements (NSDE) Information
Short Cycle Dispensing
Drugs that indicate Core MTM Medical Conditions
Display Measures
Star Ratings

The FDB Medicare Part D Module is designed to provide information that assists Part D participants in
complying with CMS coverage rules. It is therefore aimed at regulatory compliance and should not be
used as a proxy source for the clinical information to be found in MedKnowledge clinical modules.

The module is intended to be used in Medicare Part D applications and non-Medicare Part D
applications, such as Medicaid, Accountable Care Organizations, Health Insurance Exchanges, and in
commercial payment programs. NDCs in the FDB Medicare Part D Module are not limited to NDCs
specifically identified for coverage under CMS Medicare Part D. Customers using the contents of the FDB
Medicare Part D Module may want to add their own Part D coverage filters when implementing within
Medicare Part D plans.

The FDB Medicare Part D Module will link National Drug Codes (NDC) and First Databank Product
Identifiers (FDB_PRODUCT_ID) to associated measures. Additionally, it can be used for linking product
attribute information used to determine adherence to Medicare Part D requirements. The FDB Medicare
Part D Module also identifies whether the measure is continuous or associated to a specific benefit year.

Customers whose internal drug files are NDC-based should use the NDC access path for entry to the
FDB Medicare Part D Module.

FDB MedKnowledge customers who want use the product design table (External Product Code Table
[RPRDPC0_EXT_PRODCUT_CD]) need to consider External Product Code + External Product +
Timeframe in exception cases. This combination is used to retrieve the exact product information
required in exception cases, such as when an NDC has been reused.

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Concepts
This section describes concepts and database elements that are important for understanding the module.

Measures
Timeframes
Inclusion Reasons
Product Attribute
Star Ratings
Display Measures

Measures
The FDB Medicare Part D Module identifies requirements and measures that can facilitate the accurate
submission of claims and improve beneficiary care. These measures are identified and linked to an associated
drug product, and inclusion reason, and the measure timeframe. Associated description information is included in
the example below:

MC_MEASURE_ID MC_MEASURE_DESC FDB Solution Identifies...

1 Acetaminophen Quantity NDCs that contain Acetaminophen, the

milligrams of Acetaminophen in each
dosage unit, and the dosage unit

2 Morphine Equivalent Dose NDCs that contain specific opiates, the

total morphine equivalent strength in
milligrams contained in each dosage
unit, and the dosage unit

3 NSDE Information NDC marketing category, marketing

start date, and marketing end date

4 Short Cycle Dispensing NDCs that are subject to the CMS

short cycle dispensing rules

7 High Risk Medications NDCs for high risk medications

8 Diabetes Treatment NDCs for recommended types of blood

pressure medications for diabetic
patients

9 Medication Adherence for Diabetes NDCs belonging to four classes of

Medications diabetes medications: biguanides,
sulfonylureas, thiazolidinediones, and
DiPeptidyl Peptidase (DPP)-IV
Inhibitors for reporting members who
adhere to their prescribed drug therapy

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10 Medication Adherence for NDCs for renin angiotensin system

Hypertension (RAS antagonists) (RAS) antagonists (angiotensin
converting enzyme inhibitor (ACEI),
angiotensin receptor blocker (ARB), or
direct renin inhibitor medications) for
reporting members who adhere to their
prescribed drug therapy

11 Medication Adherence for Cholesterol NDCs for statin cholesterol

(Statins) medications for reporting members
who adhere to their prescribed drug
therapy

12 Atypical Antipsychotic NDCs that are classified as Atypical

Antipsychotics

13 Diabetes Medication Dosing NDCs for CMS recommended

maximum dose unit(s) for specified
diabetic medications

14 Drug-Drug Interactions NDC level drug interactions as

specified in CMS Display Measures

15 MTM: Alzheimers Disease NDCs used in the management of

Alzheimer's Disease

16 MTM: Chronic Heart Failure NDCs used in the management of

Chronic Heart Failure

17 MTM: Diabetes NDCs used in the management of

Diabetes

18 MTM: Dyslipidemia NDCs used in the management of

Dyslipidemia

19 MTM: End-Stage Renal Disease NDCs used to treat complications

associated with End-Stage Renal
Disease

20 MTM: Hypertension NDCs used in the management of

Hypertension

21 MTM: Respiratory Disease NDCs used in the management of

Respiratory Disease

22 MTM: Bone Disease-Arthritis NDCs used in the management of

Bone Disease-Arthritis

23 MTM: Mental Health NDCs used in the management of

Mental Health disorders

24 Opioids and Concurrent Drug Therapy NDCs used in the management of

opioid and concurrent drug therapies

Timeframes

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Each measure has an associated timeframe. The Medicare Measure Timeframe Identifier (
MC_MEASURE_TIMEFRAME_ID) column is used to present this information. If the timeframe is a benefit year,
the benefit year will be added to the data. Measures that have a on-going timeframe are categorized as
Continuous.

Inclusion Reasons
The First Databank Inclusion Reason Identifier (FDB_INCLUSION_REASON_ID) specifies how an NDC or FDB
Product ID was associated to a Medicare Part D requirement or quality measure. Associated descriptions and
definitions information are provided below.

FDB_INCLUSION_REASON_DESC FDB_INCLUSION_REASON_DEF

Pass-Thru Information provided came directly from an external source.

Clinical Formulation Extension Information was added by First Databank using the clinical
formulation to identify additional NDCs that have the same
Clinical Formulation (products that have the same route,
dosage form, strength, strength unit of measure, and set of
ingredients) that were not included in the pass-thru
information.

Unreconciled Product information as found in the source is not congruent

with First Databank's drug file information or NDC is greater
than 3 years obsolete on RNDC14_NDC_MSTR.

FDB Information was calculated or derived directly from First

Databank's drug file information or a combination of
externally sourced information and data that was calculated
using First Databank data.

Product Attribute
There are three main categories of product attributes:

Product Attribute: The unit qualifier that is associated to a specific measure, such as dosage unit,
marketing category, or date. Note that a drug product can have multiple product attributes if it is associated
to multiple measures.
Product Attribute Value: The actual value of the product (for example, 10, capsule, NDA, 01/01/2013)
Product Attribute Type: Additional information about the field, such as data type, field length, and number
of decimals.

For product attributes, the Medicare Product Attribute ID (MC_PRODUCT_ATTR_ID) and Medicare Product
Attribute Description (MC_PRODUCT_ATTR_DESC) columns are used. These columns identify and describe the
product attributes used to quantify measures. For example:

Measure MC_PRODUCT_ATTR_ID MC_PRODUCT_ATTR_DESC

Acetaminophen Quantity 1 Strength in milligrams per Dosage Unit

Acetaminophen Quantity 2 Dosage Unit

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NSDE Information 3 FDA Current NSDE Marketing Start

Date

NSDE Information 4 FDA Current NSDE Marketing End

Date

NSDE Information 5 FDA Current NSDE Marketing

Category

For product attribute values, the Medicare Product Attribute Value (MC_PRODUCT_ATTR_VALUE) provides the
specific value for an NDC and NDC attribute combination. Use the Medicare Product Attribute Value Description (
MC_PRODUCT_ATTR_VALUE_DESC) for additional text descriptions. Products that are associated to multiple
quality measures can have multiple attributes and attribute values. To accommodate this, the following sequence
number attributes have been added to the module to allow for ordering:

Medicare Product Attribute Sequence Number (MC_PRODUCT_ATTR_SN): Orders the Medicare product
attribute
Medicare Product Attribute Value Sequence Number (MC_PRODUCT_ATTR_VALUE_SN): Orders the
Medicare product attribute value

For product attribute types, additional information about the product attribute is provided. For example, the
Medicare product attribute values for dose amount, date, and dose unit of measure have different data types and
length requirements. This allows a developer to correctly present the values to the end user. The type values are:

Medicare Product Attribute Type Identifier (MC_PRODUCT_ATTR_TYPE_ID): Numerical identifier

Medicare Product Attribute Type Description (MC_PRODUCT_ATTR_TYPE_DESC): Description (for
example, character or numeric)
Medicare Product Attribute Type Length (MC_PRODUCT_ATTR_TYPE_LENGTH): Character length of
the field
Medicare Product Attribute Type Precision (MC_PRODUCT_ATTR_TYPE_PRECISION): Number of
decimals

Star Ratings
CMS created the Five-Star Quality Rating System to drive Medicare quality improvement and to assist consumers
in comparing plans based on quality and performance. Medicare utilizes information from member satisfaction
surveys, health and drug plans, quality data collected by CMS and healthcare providers to assign a rating
between 1 and 5 stars. A 5-star rating is considered excellent.

CMS Star Ratings Criteria, which are used in calculating their Star Ratings, are updated annually each fall.
Additional CMS Prescription Drug Coverage Performance Data is available at:
https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn/PerformanceData.html.
There may be a two-year lag between the time CMS uses the measures in their calculations and when the
measures are published in the performance data on the CMS enrollment website. For example, CMS will use the

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measures in 2015 that will appear in the 2017 performance data. FDB will obtain the data directly from a source
organization whenever possible. Customers may need concurrent licensing agreements. In the FDB Medicare
Part D Module, data will be identified as External or FDB.

The current CMS Prescription Drug Coverage Performance Data is available on the CMS website. This content is
usually restricted to Medicare Part D sponsors. Although CMS only publishes performance data once a year,
CMS obtains semi-annually updated content from the Pharmacy Quality Alliance (PQA). PQA is an organization
that improves the quality of medication management and use across healthcare settings with the goal of
improving patients health through a collaborative process to develop and implement performance measures and
recognize examples of exceptional pharmacy quality. To obtain more current information, FDB has entered into a
contractual agreement to receive a semi-annual update directly from the PQA. This semi-annual data is the
source of the Star Ratings data.

Display Measures
Display measures are information that could be used in Medicaid applications, Accountable Care Organizations,
Health Insurance Exchanges, and in commercial payment programs. Display Measures listings provided by CMS
are generated annually and may be updated as deemed necessary per CMS. These listings from CMS provide
metrics similar to Star Ratings, but they do not count as part of the reward/penalty structure of the Star Measure
system. For more information, see
https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn/PerformanceData.html.

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FDB Medicare Part D Data Elements

This section contains additional information about particularly important tables and codes contained within the
module, as well as concepts about the data that the reader must understand in order to understand the module.

Product Measure Tables

Description Tables
Product Attribute Tables

Product Measure Tables

There are two product measure tables. One links to the First Databank Product Identifier ( FDB_PRODUCT_ID)
and the other to the National Drug Code (NDC):

Medicare FDB Product ID Measure Table (RMRDPM0_PRODUCT_MEASURE)

Medicare NDC Product Measure Table (RMRDNM0_PRODUCT_MEASURE)

Both tables link the drug product to a:

Medicare Measure Identifier (MC_MEASURE_ID)

Medicare Measure Timeframe Identifier (MC_MEASURE_TIMEFRAME_ID)
First Databank Inclusion Reason Identifier (FDB_INCLUSION_REASON_ID)

Description Tables
There are several tables that contain the definitions of various data elements used in the FDB Medicare Part D
Module. These tables are used to link the identifier to its description:

Medicare Measure Table (RMRDM0_MEASURE)

Medicare Measure Timeframe Table (RMRDMT0_MEASURE_TIMEFRAME)
First Databank Inclusion Reason Table (RMRDFIR0_FDB_INCLUSION_REASON)
Medicare Product Attribute Value Description Table (RMRDAVD0_PROD_ATTR_VALUE_DESC)
Medicare Product Attribute Description Table (RMRDPAD0_PRODUCT_ATTR_DESC)
Medicare Product Attribute Type Description Table (RMRDAVD0_PROD_ATTR_VALUE_DESC)

See the table technical specifications for a list of columns contained in each table.

End users may need to make adjustments to allow for the number of characters used in the definition column if a
system has character limits

Product Attribute Tables

Similar to the product measure tables, there are two product attribute tables. One links to the First Databank
Product Identifier (FDB_PRODUCT_ID) and the other to the National Drug Code (NDC):

Medicare FDB Product ID Product Attribute Table (RMRDPA0_PRODUCT_ATTR)

Medicare NDC Product Attribute Table (RMRDNA0_PRODUCT_ATTR)

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Both tables link the product to:

Medicare Measure Identifier (MC_MEASURE_ID)

Medicare Measure Timeframe Identifier (MC_MEASURE_TIMEFRAME_ID)
Medicare Product Attribute ID (MC_PRODUCT_ATTR_ID)
Medicare Product Attribute Sequence Number (MC_PRODUCT_ATTR_SN)
Medicare Product Attribute Value Sequence Number (MC_PRODUCT_ATTR_VALUE_SN)
Medicare Product Attribute Value (MC_PRODUCT_ATTR_VALUE)

The tables are used to associate a product to a timeframe and to product attribute information. These tables are
used to determine when a measure for a specific product should be tracked and the type, order, and value of the
product attribute.

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FDB Medicare Part D Module Additional Editorial Policies

First Databank utilizes many reference sources including, but not limited to, government sources, primary medical
literature (for example, published journal articles), medical reference texts, published expert treatment guidelines,
and manufacturer product package inserts.

NDCs in the FDB Medicare Part D Module are not limited to NDCs specifically identified for coverage
under Medicare Part D. The module is also intended to be used in non-Medicare Part D applications.
Therefore, records are not excluded because Medicare Part D will not cover a product, allowing the file to
be used in Medicaid applications, Accountable Care Organizations, Health Insurance Exchanges, and in
commercial payment programs. Customers using the contents of this FDB Medicare Part D Module may
want to add their own Part D coverage filters when implementing within Medicare Part D plans.

Acetaminophen Quantity
Morphine Equivalent Dose
NSDE Information
Short Cycle Dispensing
CMS Measures
Drugs that Indicate Core MTM Medical Conditions
Opioid and Concurrent Drug Therapy

Acetaminophen Quantity
The Final CY 2013 CMS Call Letter stated CMS expectation that all sponsors would implement edits in their
systems that prevent the dispensing of unsafe daily doses of Acetaminophen to any beneficiary.

In the Final Calendar Year 2013 (CY2013) Medicare Part D Call Letter on April 2, 2012, CMS offered clarification
on how Medicare Part D sponsors can comply with the drug utilization management (DUM) requirements of 42
C.F.R 423.153(c)(2) to prevent overutilization of prescribed covered Part D drugs. CMS expects all sponsors to
consider edits in their systems that prevent the dispensing of unsafe daily doses of APAP (greater than 4
gm/day as recommended by the FDA).

Maintenance

This section contains information regarding the ongoing maintenance of the module's data.

As new Acetaminophen-containing products are added to the First Databank database, the total amount of
Acetaminophen in each dosage unit will be calculated in milligrams.

FDB will provide the dosage unit for Acetaminophen containing NDCs, excluding bulk powders. The dosage unit
will be assigned the drug product's drug form (DF) if it is 'milliliter' (output as 'mL'). If it is not 'milliliter', the MED
Dosage Form Description will be assigned (for example, tablet or capsule).

The Acetaminophen Quantity timeframe is continuous.

Inclusion Criteria

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This section provides information detailing the criteria that guided the inclusion of the data contained within the
module as well as information pertaining to limitations or exclusions when appropriate to the discussion.

This quality measure includes active or less than three years obsolete NDCs on First Databank's U.S. file.

This quality measure will include Acetaminophen-containing products and excludes bulk powder products.

Morphine Equivalent Dose

The Final CY 2013 CMS Call Letter stated CMS' expectation that all sponsors would implement edits in their
systems to prevent the overutilization of opioids. The morphine equivalent conversion factors used in this
measure were based on information provided by the Centers for Disease Control and Prevention, Morphine
equivalent conversion factors for opioids, 2011 version CDC, Atlanta, GA, 2013.

Maintenance

This section contains information regarding the ongoing maintenance of the module's data.

As new opioid products are added to the First Databank database, the morphine equivalent strength will be
calculated in milligrams contained in each dosage unit.

First Databank will provide the dosage unit for each of the opioid NDCs being evaluated. The dosage unit will be
assigned the drug product's drug form (DF) if it is 'milliliter' (output as 'mL'). If it is not 'milliliter', the MED Dosage
Form Description will be assigned (for example, tablet or capsule).

The Morphine Equivalent Dose timeframe is continuous.

Inclusion Criteria

This section provides information detailing the criteria that guided the inclusion of the data contained within the
module as well as information pertaining to limitations or exclusions when appropriate to the discussion.

This quality measure includes active or less than five years obsolete NDCs on First Databank's U.S. File.

Information supporting this data is based on the CMS/CDC-generated list of opioid ingredients and conversion
factors. FDB is restricting the list of products to the opioid ingredients specifically on the CMS/CDC list.

This quality measure includes non-injectable products containing opioid ingredients on FDB's database and
excludes bulk powder products.

The morphine equivalent dose measure is limited to ingredients listed on the CDC opioid conversion list.
Injectable medications are not included. MedKnowledge Core customers can identify if a specific opioid
product has a morphine equivalent dose using FDB's NDC Attribute Table
(RNDCAT0_NDC_ATTRIBUTE) by selecting NDC Attribute Type Code (NDC_ATTRIBUTE_TYPE_CD)
"61" (Morphine Equivalence Code). For records with:

An NDC Attribute Value (NDC_ATTRIBUTE_VALUE) of "1" indicates that an Opioid Morphine

Equivalent Dose is Available and will have an associated record in the Part D Module to indicate
the morphine equivalent quantity.

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An NDC Attribute Value (NDC_ATTRIBUTE_VALUE) of "2" indicates than an Opioid Morphine

Equivalent Dose is Not Available.

NSDE Information
NDC Structured Product Labeling (SPL) Data Elements File (NSDE) file is generated from SPL documents sent
to the FDA for inclusion in the FDA Online Label Repository at labels.fda.gov.

The NSDE File is CMS's authoritative source of NDC information used in developing the CMS Medicare Part D
Formulary Reference File and validating NDC information on PDE submission. Data elements on the NSDE file
are used to make coverage determinations and distinguish brand and generic products as defined by Medicare
Part D. The NSDE file is available at:
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm240580.htm

Maintenance

This section contains information regarding the ongoing maintenance of the module's data.

For NDCs on the First Databank file that are active or less than three years obsolete, the following NSDE data
elements are provided:

NDC
Marketing Category
Marketing Start Date
Marketing End Date

The NSDE Information timeframe is continuous.

Inclusion Criteria

This section provides information detailing the criteria that guided the inclusion of the data contained within the
module as well as information pertaining to limitations or exclusions when appropriate to the discussion.

This quality measure will include active or obsolete less than three years NDCs on First Databank's U.S. file.

NSDE Data is considered pass-thru and is not editorially reviewed or updated by FDB.

Short Cycle Dispensing

This measure relates to CMS: 423.154 (Appropriate dispensing of prescription drugs in long-term care facilities
under PDPs and MA-PD plans).

Maintenance

This section contains information regarding the ongoing maintenance of the module's data.

NDCs on the First Databank database that meet the criteria below will be added to the Medicaid Measure for
Short Cycle Dispensing. Changes in NDC attributes may result in changes to the Short Cycle Dispensing list.

The Short Cycle Dispensing timeframe is continuous.

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Inclusion Criteria

This section provides information detailing the criteria that guided the inclusion of the data contained within the
module as well as information pertaining to limitations or exclusions when appropriate to the discussion.

This measure includes active or obsolete less than three years NDCs on First Databank's U.S. file.

This measure also includes:

Solid, oral dosage form drugs identified using the Dosage Form Attribute Table
(RPEIDFA0_DOSAGE_FORM_ATTRIBUTE) and the Route of Administration Description Table
(RROUTED3_ROUTE_DESC)
Prescription Drugs (prescription) identified using NDC Table (RNDC14_NDC_MSTR)
CMS defined Brand name drugs identified using the NSDE Marketing category equal to NDA (New Drug
Application) and NDA Authorized Generic

This measure will exclude:

Products that are obsolete greater than three years using the Obsolete Date in the RNDC14_NDC_MSTR
table
Products that are required to be dispensed in their original container, using the Unit of Use indicator on the
RNDC14_NDC_MSTR table
Oral Contraceptives using AHFS codes
Anti-Infective Agents using the FDB Enhanced Therapeutic Classification (ETC) Table
(RETCTBL0_ETC_ID)

CMS Measures
CMS created over 50 Star Rating and Display Measures to drive Medicare quality improvement and to assist
consumers in comparing plans based on quality and performance.

. FDB will address Part D measures that relate to medication therapy. The following are currently included in this
module.

High Risk Medications: To identify high risk medications to determine the number of patients who received
prescriptions for medications with a high risk of side effects as published by PQA.
Diabetes Treatment: To identify the types of blood pressure medications recommended for diabetic
patients. This can be used to determine the number of patients dispensed at least one prescription for an
oral hypoglycemic agent or insulin and at least one prescription for a recommended antihypertensive
agent, as published by PQA. Note: Effective 2016 CMS removed this measure from Star Ratings
requirements.
Medication Adherence for Diabetes Medications: To identify diabetes medications in the following classes:
biguanides, sulfonylureas, thiazolidinediones, and DiPeptidyl Peptidase (DPP)-IV Inhibitors, as published
by PQA. This is used to determine patient adherence to prescribed diabetes drug therapy. This measure
excludes patients who are receiving insulin.
Medication Adherence for Hypertension (RAS antagonists): To identify renin angiotensin system (RAS)

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antagonists to determine patient adherence to their prescribed antihypertensive drug therapy, as published
by PQA.
Medication Adherence for Cholesterol (Statins): To identify statin cholesterol medications to determine
patient adherence to their prescribed cholesterol lowering drug therapy, as published by PQA.

Atypical Antipsychotic (Data based on an FDB interpretation of a CMS listing of drug names that are
included in the measure)
Diabetes Medication Dosing (Data based on information from the Pharmacy Quality Alliance)
Drug-Drug Interactions (Data based on information from the Pharmacy Quality Alliance)

Maintenance

This section contains information regarding the ongoing maintenance of the module's data.

For the measures identified above, FDB will publish NDCs and associated attributes for each measure on the
source document. FDB will provide an extended list of NDCs derived from common clinical formulations. The
PQA measures NDC lists are reviewed and incorporated into the module when published.

FDB delivers updated extended records as part of the customers' weekly or monthly production file. NDC records
will change from extended to pass-thru status if included in the next Pharmacy Quality Alliance (PQA) data list.
For this reason, plan years are attached to the PQA data lists.

Inclusion Criteria

This section provides information detailing the criteria that guided the inclusion of the data contained within the
module as well as information pertaining to limitations or exclusions when appropriate to the discussion.

The therapeutic category descriptions are provided by CMS and are not part of FDB MedKnowledge mapping.

These measures will include:

NDCs listed on the source documents

FDB NDCs that are not on the source documents but are derived from common clinical formulation
extensions for products that are active or obsolete less than three years
Source document NDCs not congruent with First Databank's drug file information will be marked as
Unreconciled
Source document NDCs that are greater than three years obsolete will be marked as Unreconciled

Drugs that Indicate Core MTM Medical Conditions

Maintenance

This section contains information regarding the ongoing maintenance of the module's data.

First Databank will assign newly added NDCs that have both FDA-approved indications and are highly indicative
or commonly used for the treatment/management of the MTM diseases listed below.

The Medication Therapy Management (MTM) Medical Conditions timeframe is continuous.

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Effective 2016 CMS reporting year MTM measures are included in the Star Ratings.

Inclusion Criteria

This section provides information detailing the criteria that guided the inclusion of the data contained within the
module as well as information pertaining to limitations or exclusions when appropriate to the discussion.

This quality measure includes active or obsolete less than three years NDCs on First Databank's U.S. file.

Medications will only be included if they have both FDA-approved indications and are highly indicative or
commonly used for the treatment/management of the MTM diseases listed below.

MTM: Alzheimer's Disease

MTM: Chronic Heart Failure
MTM: Diabetes
MTM: Dyslipidemia
MTM: Hypertension
MTM: Mental Health
MTM: Respiratory Disease
MTM: Bone Disease-Arthritis
MTM: End-Stage Renal Disease

The MTM drug listings are:

Intended for inferring disease states, in the absence of specific diagnosis data
Not intended to be used as treatment algorithms
Limited to medications and will not include medical supplies (for example, glucometers, syringes, lancets)

Opioid and Concurrent Drug Therapy

In the 2017 Final Call Letter, CMS has expressed concern with the high prevalence of concurrent use of opioids
and benzodiazepines as well as the instances of extended duration of use CMS encouraged Part D sponsors to
evaluate their claims data and use available drug utilization management tools to help address the concurrent use
of these drug classes. The Opioids and Concurrent Drug Therapy module faciliates screening for the concurrent
use of opioids, benzodiazepines, non-benzodiazepine sedative hypnotics and muscle relaxants

Maintenance

This section contains information regarding the ongoing maintenance of the module's data.

As new opioids, benzodiazepines, muscle relaxants, non-benzodiazepine sedative hypnotics products are added
to FDB's database, they will be assigned to the appropriate attribute value. This assignment is based on FDB's
therapeutic classification of the ingredients and/or their corresponding clinical formulation. The Medicare Product
Attribute Identifier (MC_PRODUCT_ATTR_ID) for Opioids and Concurrent Drug Therapy Categories are
associated to the following Medicare Product Attribute Values (MC_PRODUCT_ATTR_VALUE):

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MC_PRODUCT_ATTR_ID MC_PRODUCT_ATTR_DE MC_PRODUCT_ATTR_VA MC_PRODUCT_ATTR_VA

SC LUE LUE_DESC

13 Opioids and Concurrent 1 Opioids

Drug Therapy Categories

13 Opioids and Concurrent 2 Benzodiazepine

Drug Therapy Categories

13 Opioids and Concurrent 3 Non-benzodiazepine

Drug Therapy Categories sedative/hypnotics

13 Opioids and Concurrent 4 Muscle Relaxants

Drug Therapy Categories

Additional parameters have been provided to allow exclusions for:

MC_PRODUCT_ATTR_ID MC_PRODUCT_ATTR_DE MC_PRODUCT_ATTR_VA MC_PRODUCT_ATTR_VA

SC LUE LUE_DESC

12 Exclusion Code 1 Cough and Cold

Preparations

12 Exclusion Code 2 Agents for Narcotic

Withdrawal

12 Exclusion Code 3 Injectable Opioid

12 Exclusion Code 4 Injectable benzodiazepine

12 Exclusion Code 5 Injectable

non-benzodiazepine
sedative/hypnotics

12 Exclusion Code 6 Injectable muscle relaxant

12 Exclusion Code 7 Bulk opioids,

benzodiazepine,
non-benzodiazepine
sedative/hypnotics, muscle
relaxant

The Opioid and Concurrent Drug Therapy Measurement timeframe is continuous.

Inclusion Criteria

This section provides information detailing the criteria that guided the inclusion of the data contained within the
module as well as information pertaining to limitations or exclusions when appropriate to the discussion.

This quality measure includes active and less than three years obsolete NDCs on First Databank's U.S. File.

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FDB Medicare Part D Applications

This section provides information about the practical application of the data contained in this module.

Determining Claim Eligibility Using Specific NDC SPL NSDE Attributes

Determining the Acetaminophen Quantity Contained in One Dosage Unit

Determining the Morphine Equivalent Strength in Milligrams Contained in One Dosage Unit

Identifying NDCs that Should Adhere to the CMS Short Cycle Dispensing Rules

Identifying Concepts for CMS Reporting

Identifying Medication Therapy Management Categories for NDCs on a Patient Claim History

Identifying CMS Concepts

Identifying NDCs for Screening Opioid and Concurrent Drug Therapy Risk

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Determining Claim Eligibility Using Specific NDC SPL NSDE Attributes

In some instances, validating the FDA's NDC Structured Product Labeling (SPL) Data Elements File (NSDE)
information may be the first check made on any NDC before additional "edit checks" are made during the claim
submission process. This application illustrates one method to validate if an "obsolete date" NDC adheres to the
CMS reimbursement requirements.

For purposes of demonstrating this application, the following scenario is used: A processor has received a
claim from a pharmacy on May 1, 2014 for NDC 00093528601 (ROPINIROLE HCL 3 MG TABLET) and wants to
validate if it could be considered eligible for CMS reimbursement. The obsolete date provided by manufacturer to
the referenced compendia is July 26, 2013.

1. Retrieve the National Drug Code (NDC) value from the Medicare Medicare NDC Product Measure Table
(RMRDNM0_PRODUCT_MEASURE) where the:
Medicare Measure Identifier (MC_MEASURE_ID) value equals 3 (NSDE Information)
First Databank Inclusion Reason Identifier (FDB_INCLUSION_REASON_ID) equals 0 (Pass-Thru)
Medicare Measure Timeframe Identifier (MC_MEASURE_TIMEFRAME_ID, page 1830) value
equals 1 (Continuous)

MC_MEASURE_ID FDB_INCLUSION_REA MC_MEASURE_TIMEF NDC

SON_ID RAME_ID

3 0 1 00093528601

2. Retrieve the NDC, MC_MEASURE_ID, Medicare Product Attribute ID (MC_PRODUCT_ATTR_ID),

Medicare Product Attribute Sequence Number, (MC_PRODUCT_ATTR_SN), Medicare Product Attribute
Value Sequence Number (MC_PRODUCT_ATTR_VALUE_SN) and the Medicare Product Attribute Value (
MC_PRODUCT_ATTR_VALUE) values from the Medicare NDC Product Attribute Table
(RMRDNA0_PRODUCT_ATTR) where the:
NDC equals the value retrieved in step 1
MC_MEASURE_ID equals the value entered in step 1
MC_MEASURE_TIMEFRAME_ID equals the value entered in step 1
MC_PRODUCT_ATTR_SN is sorted in ascending order
MC_PRODUCT_ATTR_VALUE_SN is sorted in ascending order

NDC MC_MEASUR MC_PRODUC MC_PRODUC MC_PRODUC MC_PRODUC

E_ID T_ATTR_ID T_ATTR_SN T_ATTR_VAL T_ATTR_VAL
UE_SN UE

00093528601 3 3 1 1 20080507

00093528601 3 4 1 1 20140531

00093528601 3 5 1 1 ANDA

The MC_PRODUCT_ATTR_ID value of 3 represents the FDA Current NSDE Marketing

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Start Date, the value 4 represents the FDA Current NSDE Marketing End Date, and the
value 5 represents the FDA Current NSDE Marketing Category.

Only partial results have been displayed for illustrative purposes, including some of the columns and
values previously retrieved in step 1.

3. Display the results to the user.

In this example, the claim transaction date is between the FDA Marketing Start and End Dates (potentially
eligible for additional processing).

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Determining the Acetaminophen Quantity Contained in One Dosage Unit

This application illustrates one method to determine at the NDC level how many milligrams of acetaminophen are
contained in the dosage unit.

For purposes of demonstrating this application, the following scenario is used: A processor has received a
claim for NDC 50458051360 (Tylenol with Codeine #3 Tablet) from a pharmacy for one of their beneficiaries. Part
of processors patient safety edits include identifying medications containing acetaminophen to allow their internal
programming to review the beneficiarys claim history to determine the daily amount of acetaminophen
accumulated.

1. Retrieve the National Drug Code (NDC), Medicare Measure Identifier (MC_MEASURE_ID), and Medicare
Measure Timeframe Identifier (MC_MEASURE_TIMEFRAME_ID) values from the Medicare NDC Product
Measure Table (RMRDNM0_PRODUCT_MEASURE) where the:
(MC_MEASURE_ID) value equals 1 (Acetaminophen Quantity)
First Databank Inclusion Reason Identifier (FDB_INCLUSION_REASON_ID) equals 4 (FDB)
MC_MEASURE_TIMEFRAME_ID value equals 1 (Continuous)

MC_MEASURE_ID FDB_INCLUSION_REA MC_MEASURE_TIMEF NDC

SON_ID RAME_ID

1 4 1 50458051360

2. Retrieve the NDC, MC_MEASURE_ID, Medicare Product Attribute ID (MC_PRODUCT_ATTR_ID),

Medicare Product Attribute Sequence Number (MC_PRODUCT_ATTR_SN), Medicare Product Attribute
Value Sequence Number (MC_PRODUCT_ATTR_VALUE_SN) and the Medicare Product Attribute Value (
MC_PRODUCT_ATTR_VALUE) the from the Medicare NDC Product Attribute Table
(RMRDNA0_PRODUCT_ATTR) where the:
NDC equals the value retrieved in step 1
MC_MEASURE_ID equals the value entered in step 1
MC_MEASURE_TIMEFRAME_ID equals the value entered in step 1
MC_PRODUCT_ATTR_SN is sorted in ascending order
MC_PRODUCT_ATTR_VALUE_SN is sorted in ascending order

NDC MC_MEASUR MC_PRODUC MC_PRODUC MC_PRODUC MC_PRODUC

E_ID T_ATTR_ID T_ATTR_SN T_ATTR_VAL T_ATTR_VAL
UE_SN UE

50458051360 1 1 1 1 300

50458051360 1 2 1 1 TABLET

The Medicare Product Attribute ID (MC_PRODUCT_ATTR_ID) value of 1 represents the

Strength in milligrams per Dosage Unit; the value 2 represents the Dosage Unit.

Only partial results have been displayed for illustrative purposes, including some of the columns and

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values previously retrieved in step 1.

3. Display the results to user

Final steps will be dependent upon the dosing instructions for the NDC.

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Determining the Morphine Equivalent Strength in Milligrams Contained in

One Dosage Unit
This application illustrates one method to determine at the NDC the morphine equivalent strength in milligrams
that are contained in a single dosage unit.

For purposes of demonstrating this application, the following scenario is used: A processor has received a
claim for NDC 50458051360 (Tylenol with Codeine #3 Tablet) from a pharmacy for one of their beneficiaries. Part
of processors patient safety edits include identifying medications containing opioids to allow their internal
programming to review the beneficiarys claim history to determine the daily amount of opioids accumulated.

1. Retrieve the National Drug Code (NDC), Medicare Measure Identifier (MC_MEASURE_ID), and Medicare
Measure Timeframe Identifier (MC_MEASURE_TIMEFRAME_ID) values from the Medicare NDC Product
Measure Table (RMRDNM0_PRODUCT_MEASURE) where the:
MC_MEASURE_ID value equals 2 (Morphine Equivalent Dose)
First Databank Inclusion Reason Identifier (FDB_INCLUSION_REASON_ID) equals 4 (FDB)
MC_MEASURE_TIMEFRAME_ID value equals 1 (Continuous)

MC_MEASURE_ID FDB_INCLUSION_REA MC_MEASURE_TIMEF NDC

SON_ID RAME_ID

2 4 1 50458051360

2. Retrieve the NDC, MC_MEASURE_ID, Medicare Product Attribute ID (MC_PRODUCT_ATTR_ID),

Medicare Product Attribute Sequence Number (MC_PRODUCT_ATTR_SN), Medicare Product Attribute
Value Sequence Number (MC_PRODUCT_ATTR_VALUE_SN) and the Medicare Product Attribute Value (
MC_PRODUCT_ATTR_VALUE) values from the Medicare NDC Product Attribute Table
(RMRDNA0_PRODUCT_ATTR) where the:
NDC equals the value retrieved in step 1
MC_MEASURE_ID equals the value entered in step 1
MC_MEASURE_TIMEFRAME_ID equals the value entered in step 1
MC_PRODUCT_ATTR_SN is sorted in ascending order
MC_PRODUCT_ATTR_VALUE_SN is sorted in ascending order

NDC MC_MEASUR MC_PRODUC MC_PRODUC MC_PRODUC MC_PRODUC

E_ID T_ATTR_ID T_ATTR_SN T_ATTR_VAL T_ATTR_VAL
UE_SN UE

50458051360 2 1 1 1 4.5

50458051360 2 2 1 1 TABLET

The Medicare Product Attribute ID (MC_PRODUCT_ATTR_ID) value of 1 represents the

Morphine Equivalent Strength in milligrams per Dosage Unit; the value 2 represents the
Dosage Unit.

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3. Display the results to user.

Final steps will be dependent upon the dosing instructions for the NDC.

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Identifying NDCs that Should Adhere to the CMS Short Cycle Dispensing
Rules
This application illustrates one method to validate if a solid oral brand-named NDC has been identified to adhere
to the CMS Short Cycle Dispensing requirements.

For purposes of demonstrating this application, the following scenario is used: A pharmacy supplying
medications to a Long Term Care (LTC) facility has an order for a brand solid oral dosage form and needs to
determine if the product selected meets the CMS Short Cycle Dispensing exception policy.

1. Retrieve the National Drug Code (NDC) values from the Medicare NDC Product Measure Table
(RMRDNM0_PRODUCT_MEASURE) where the:
Medicare Measure Identifier (MC_MEASURE_ID) value equals 4 (Short Cycle Dispensing)
First Databank Inclusion Reason Identifier (FDB_INCLUSION_REASON_ID) equals 4 (FDB)
Medicare Measure Timeframe Identifier (MC_MEASURE_TIMEFRAME_ID) value equals 1
(Continuous)

MC_MEASURE_ID FDB_INCLUSION_REA MC_MEASURE_TIMEF NDC

SON_ID RAME_ID

4 4 1 54868520001

Only records that have a NDA or NDA Authorized Generic marketing category are identified
as eligible NDCs and included in the MC_MEASURE_ID.

2. Display the results to the user.

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Identifying Concepts for CMS Reporting

This application illustrates how to retrieve the concepts identified for Medicare Part D Reporting.

1. Retrieve the National Drug Code (NDC), Medicare Measure Identifier (MC_MEASURE_ID), and Medicare
Measure Timeframe Identifier (MC_MEASURE_TIMEFRAME_ID) values from the Medicare NDC Product
Measure Table (RMRDNM0_PRODUCT_MEASURE) where the:
MC_MEASURE_ID value equals:
7 (High Risk Medication)
8 (Diabetes Treatment)
9 (Medication Adherence for Diabetes Medications)
10 (Medication Adherence for Hypertension [RAS antagonists])
11 (Medication Adherence for Cholesterol [Statins])
First Databank Inclusion Reason Identifier (FDB_INCLUSION_REASON_ID) value equals:
0 if the reason identifier is Pass-Thru
1 if the reason identifier is Clinical Formulation Extension
3 if the reason identifier is Unreconciled
4 If the reason identifier is FDB
MC_MEASURE_TIMEFRAME_ID value equals 2 (2014)

2. Retrieve the NDC, MC_MEASURE_ID, Medicare Product Attribute ID (MC_PRODUCT_ATTR_ID),

Medicare Product Attribute Sequence Number (MC_PRODUCT_ATTR_SN), Medicare Product Attribute
Value Sequence Number (MC_PRODUCT_ATTR_VALUE_SN) and the Medicare Product Attribute Value (
MC_PRODUCT_ATTR_VALUE) values from the Medicare NDC Product Attribute Table
(RMRDNA0_PRODUCT_ATTR) where the:
NDC equals the value retrieved in step 1
MC_MEASURE_ID equals the value entered in step 1
MC_MEASURE_TIMEFRAME_ID equals the value entered in step 1
MC_PRODUCT_ATTR_SN is sorted in ascending order
MC_PRODUCT_ATTR_VALUE_SN is sorted in ascending order

3. Display the results to the user.

ExampleIdentifying High Risk Medication Concepts

ExampleIdentifying Diabetes Treatment Concepts
ExampleIdentifying Medication Adherence for Diabetes Medication Concepts
ExampleIdentifying Medication Adherence for Hypertension (RAS Antagonists) Concepts
ExampleIdentifying Medication Adherence for Cholesterol (Statins) Concepts

ExampleIdentifying High Risk Medication Concepts

For purposes of demonstrating this application, the following scenario is used: A Medicare Part D Plan
Sponsor wants to create a list of NDCs to identify Medicare Advantage members who were dispensed multiple

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ambulatory prescriptions for identified High Risk Medications containing the same active ingredient(s) during the
reporting period. Customers would use this data to identify high risk medications.

1. Retrieve the National Drug Code (NDC), Medicare Measure Identifier (MC_MEASURE_ID), and Medicare
Measure Timeframe Identifier (MC_MEASURE_TIMEFRAME_ID) values from the Medicare NDC Product
Measure Table (RMRDNM0_PRODUCT_MEASURE) where the:
MC_MEASURE_ID value equals 7 (High Risk Medication)
First Databank Inclusion Reason Identifier (FDB_INCLUSION_REASON_ID) value equals 0
(Pass-Thru)
MC_MEASURE_TIMEFRAME_ID value equals 2 (2014)

MC_MEASURE_ID FDB_INCLUSION_REA MC_MEASURE_TIMEF NDC

SON_ID RAME_ID

7 0 2 00378113401

7 0 2 00115104201

Only partial results have been displayed for illustrative purposes.

2. Retrieve the NDC, MC_MEASURE_ID, Medicare Product Attribute ID (MC_PRODUCT_ATTR_ID),

Medicare Product Attribute Sequence Number (MC_PRODUCT_ATTR_SN), Medicare Product Attribute
Value Sequence Number (MC_PRODUCT_ATTR_VALUE_SN) and the Medicare Product Attribute Value (
MC_PRODUCT_ATTR_VALUE) values from the Medicare NDC Product Attribute Table
(RMRDNA0_PRODUCT_ATTR) where the:
NDC equals the value retrieved in step 1
MC_MEASURE_ID equals the value entered in step 1
MC_MEASURE_TIMEFRAME_ID equals the value entered in step 1
MC_PRODUCT_ATTR_SN is sorted in ascending order
MC_PRODUCT_ATTR_VALUE_SN is sorted in ascending order

NDC MC_MEASUR MC_PRODUC MC_PRODUC MC_PRODUC MC_PRODUC

E_ID T_ATTR_ID T_ATTR_SN T_ATTR_VAL T_ATTR_VAL
UE_SN UE

00378113401 7 8 1 1 Ketorolac

00115104201 7 8 1 1 Promethazine

Only partial results have been displayed for illustrative purposes.

The MC_PRODUCT_ATTR_ID value 8 indicates that the NDC is associated to a CMS

Ingredient Classification.

3. Display the results to the user.

ExampleIdentifying Diabetes Treatment Concepts

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For purposes of demonstrating this application, the following scenario is used: A Medicare Part D Plan
Sponsor wants to create a list of NDCs to identify Medicare Advantage members who were dispensed a
medication for diabetes (oral hypoglycemic agent or insulin) and a medication for hypertension whose treatment
included a renin angiotensin system (RAS) antagonist (an angiotensin converting enzyme inhibitor (ACEI),
angiotensin receptor blocker (ARB), or a direct renin inhibitor) medication. Note that RAS antagonists are a
subset of hypertensions. The listing will be limited to CMS identified Diabetes Treatment NDCs for the CMS
Plan 2014 reporting period.

1. Retrieve the National Drug Code (NDC, page 1968), Medicare Measure Identifier ( MC_MEASURE_ID),
and Medicare Measure Timeframe Identifier (MC_MEASURE_TIMEFRAME_ID) values from the Medicare
NDC Product Measure Table (RMRDNM0_PRODUCT_MEASURE) where the:
MC_MEASURE_ID value equals 8 (Diabetes Treatment)
First Databank Inclusion Reason Identifier (FDB_INCLUSION_REASON_ID) value equals 0
(Pass-Thru)
MC_MEASURE_TIMEFRAME_ID value equals 2 (2014)

MC_MEASURE_ID FDB_INCLUSION_REA MC_MEASURE_TIMEF NDC

SON_ID RAME_ID

8 0 2 54868521002

8 0 2 00078048815

8 0 2 00088222033

Only partial results have been displayed for illustrative purposes.

2. Retrieve the NDC, MC_MEASURE_ID, Medicare Product Attribute ID (MC_PRODUCT_ATTR_ID),

Medicare Product Attribute Sequence Number (MC_PRODUCT_ATTR_SN), Medicare Product Attribute
Value Sequence Number (MC_PRODUCT_ATTR_VALUE_SN) and the Medicare Product Attribute Value (
MC_PRODUCT_ATTR_VALUE) values from the Medicare NDC Product Attribute Table
(RMRDNA0_PRODUCT_ATTR) where the:
NDC equals the value retrieved in step 1
MC_MEASURE_ID equals the value entered in step 1
MC_MEASURE_TIMEFRAME_ID equals the value entered in step 1
MC_PRODUCT_ATTR_SN is sorted in ascending order
MC_PRODUCT_ATTR_VALUE_SN is sorted in ascending order

NDC MC_MEASUR MC_PRODUC MC_PRODUC MC_PRODUC MC_PRODUC

E_ID T_ATTR_ID T_ATTR_SN T_ATTR_VAL T_ATTR_VAL
UE_SN UE

54868521002 8 9 1 1 Sulfonylureas

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00078048815 8 9 1 1 Angiotensin II
Receptor Antag
& Ca Channel
Blocker Comb

00088222033 8 9 1 1 Human Insulin

Only partial results have been displayed for illustrative purposes.

The MC_PRODUCT_ATTR_ID value 9 indicates that the NDC is associated to a CMS

Therapeutic Category.

3. Display the results to the user.

4. A sponsor uses an internal algorithm to separate data needed to identify patients taking medications for
diabetes and hypertension and a separate listing to identify patients taking medications for diabetic and
hypertension whose treatment included taking renin angiotensin system (RAS) antagonist medications.

There has been a change within Pharmacy Quality Alliance (PQA) to provide methodology to
indicate whether an NDC should exist on the diabetes medication list, hypertension list, and a RAS
list. The methodology is expected to be incorporated in future release of the FDB data.

Diabetic Therapeutic Categories

Alpha-Glucosidase Inhibitors

Antidiabetic - Amylin Analogs

Antidiabetic Combinations

Biguanides

Dipeptidyl Peptidase-4 Inhibitors

Dipeptidyl Peptidase-4 Inhibitor-Biguanide Combinations

Human Insulin

Incretin Mimetic Agents (GLP-1 Receptor Agonists)

Meglitinide Analogues

Meglitinide-Biguanide Combinations

Sulfonylurea-Biguanide Combinations

Sulfonylureas

Sulfonylurea-Thiazolidinedione Combinations

Thiazolidinedione-Biguanide Combinations

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Thiazolidinediones

ANTIHYPERGLYCEMC-SOD/GLUC COTRANSPORT2(SGT2)INHIB

Hypertension Therapeutic Categories

ACE Inhibitor & Calcium Channel Blocker Combinations

ACE Inhibitors & Thiazide/Thiazide-Like

ACE Inhibitors

Alpha-Beta Blockers

Angiotensin II Receptor Antag & Ca Channel Blocker Comb

Angiotensin II Receptor Antagonists & Thiazides

Angiotensin II Receptor Antagonists

Angiotensin II Receptor Ant-Ca Channel Blocker-Thiazides

Antihypertensive Combinations

Beta Blocker & Diuretic Combinations

Beta Blockers Cardio-Selective

Beta Blockers Non-Selective

Calcium Channel Blocker & HMG CoA Reductase Inhibit Comb

Calcium Channel Blockers

Direct Renin Inhibitors & Angiotensin II Receptor Antag

Direct Renin Inhibitors & Thiazide/Thiazide-Like Comb

Direct Renin Inhibitors

Renin Angiotensin System (RAS) Antagonist Categories

ACE Inhibitor & Calcium Channel Blocker Combinations

ACE Inhibitors & Thiazide/Thiazide-Like

ACE Inhibitors

Angiotensin II Receptor Antag & Ca Channel Blocker Comb

Angiotensin II Receptor Antagonists & Thiazides

Angiotensin II Receptor Anatagonists

Angiotensin II Receptor Ant-Ca Channel Blocker-Thiazides

Antihypertensive Combinations

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Direct Renin Inhibitors & Angiotensin II Receptor Antag

Direct Renin Inhibitors & Thiazide/Thiazide-Like Comb

Direct Renin Inhibitors

ExampleIdentifying Medication Adherence for Diabetes Medication Concepts

For purposes of demonstrating this application, the following scenario is used: A Medicare Part D Plan
Sponsor wants to create a list of NDCs to identify Medicare Advantage members who adhere to their prescribed
drug therapy across any of the CMS identified classes of diabetes medications (biguanides, sulfonylureas,
thiazolidinediones, and DiPeptidyl Peptidase (DPP)-IV Inhibitors) who are not taking insulin. The listing will be
limited to CMS identified Part D Medication Adherence for Oral Diabetes Medications NDCs for the CMS Plan
2014 reporting period.

1. Retrieve the National Drug Code (NDC), Medicare Measure Identifier (MC_MEASURE_ID), and Medicare
Measure Timeframe Identifier (MC_MEASURE_TIMEFRAME_ID) values from the Medicare NDC Product
Measure Table (RMRDNM0_PRODUCT_MEASURE) where the:
MC_MEASURE_ID value equals 9 (Medication Adherence for Diabetes Medications)
First Databank Inclusion Reason Identifier (FDB_INCLUSION_REASON_ID) value equals 0
(Pass-Thru)
MC_MEASURE_TIMEFRAME_ID value equals 2 (2014)
Medicare Product Attribute Value (MC_PRODUCT_ATTR_VALUE) from the Medicare NDC Product
Attribute Table (RMRDNA0_PRODUCT_ATTR) does not equal Human Insulin

NDC MC_PRODUCT_A MC_MEASURE_I FDB_INCLUSION MC_MEASURE_T

TTR_VALUE D _REASON_ID IMEFRAME_ID

55289021160 Biguanides 9 0 2

58864068760 Thiazolidinediones 9 0 2

00009034101 Sulfonylureas 9 0 2

This listing will be used to identify patients taking biguanides, sulfonylureas, thiazolidinediones, and
DiPeptidyl Peptidase (DPP)-IV Inhibitors.

2. Retrieve the NDC, MC_MEASURE_ID, Medicare Product Attribute ID (MC_PRODUCT_ATTR_ID),

Medicare Product Attribute Sequence Number (MC_PRODUCT_ATTR_SN), Medicare Product Attribute
Value Sequence Number (MC_PRODUCT_ATTR_VALUE_SN) and MC_PRODUCT_ATTR_VALUE
values from the RMRDNA0_PRODUCT_ATTR table where the:
MC_MEASURE_ID value equals 9 (Medication Adherence for Diabetes Medications)
FDB_INCLUSION_REASON_ID value equals 0 (Pass-Thru)
MC_MEASURE_TIMEFRAME_ID value equals 2 (2014)
MC_PRODUCT_ATTR_VALUE equals Human Insulin

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NDC MC_MEASUR MC_PRODUC MC_PRODUC MC_PRODUC MC_PRODUC

E_ID T_ATTR_ID T_ATTR_SN T_ATTR_VAL T_ATTR_VAL
UE_SN UE

00002751601 9 9 1 1 Human Insulin

00002831501 9 9 1 1 Human Insulin

00169183702 9 9 1 1 Human Insulin

This listing will be used to identify patients taking insulin.

3. Sponsor will use an internal algorithm to identify patients that have medications on both listings; these
patients are exempt from the edit.

ExampleIdentifying Medication Adherence for Hypertension (RAS Antagonists) Concepts

For purposes of demonstrating this application, the following scenario is used: A Medicare Part D Plan
Sponsor wants to create a list of drugs to identify Medicare Advantage members who adhere to their prescribed
drug therapy across Renin Angiotensin System (RAS) antagonists (angiotensin converting enzyme inhibitor
(ACEI), angiotensin receptor blocker (ARB), or direct renin inhibitor medications). The listing will be limited to
CMS identified Part D Medication Adherence for Hypertension Medications (RAS Antagonists) NDCs for the
CMS Plan 2014 reporting period.

1. Retrieve the National Drug Code (NDC), Medicare Measure Identifier (MC_MEASURE_ID), and Medicare
Measure Timeframe Identifier (MC_MEASURE_TIMEFRAME_ID) values from the Medicare NDC Product
Measure Table (RMRDNM0_PRODUCT_MEASURE) where the:
MC_MEASURE_ID value equals 10 (Medication Adherence for Hypertension [RAS Antagonists])
First Databank Inclusion Reason Identifier (FDB_INCLUSION_REASON_ID) value equals 0
(Pass-Thru)
MC_MEASURE_TIMEFRAME_ID value equals 2 (2014)

MC_MEASURE_ID FDB_INCLUSION_REA MC_MEASURE_TIMEF NDC

SON_ID RAME_ID

10 0 2 00093512401

10 0 2 00172503470

10 0 2 00078052415

Only partial results have been displayed for illustrative purposes.

2. Retrieve the NDC, MC_MEASURE_ID, Medicare Product Attribute ID (MC_PRODUCT_ATTR_ID),

Medicare Product Attribute Sequence Number (MC_PRODUCT_ATTR_SN), Medicare Product Attribute
Value Sequence Number (MC_PRODUCT_ATTR_VALUE_SN) and the Medicare Product Attribute Value (
MC_PRODUCT_ATTR_VALUE) values from the Medicare NDC Product Attribute Table
(RMRDNA0_PRODUCT_ATTR) where the:
NDC equals the value retrieved in step 1

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MC_MEASURE_ID equals the value entered in step 1

MC_MEASURE_TIMEFRAME_ID equals the value entered in step 1
MC_PRODUCT_ATTR_SN is sorted in ascending order
MC_PRODUCT_ATTR_VALUE_SN is sorted in ascending order

NDC MC_MEASUR MC_PRODUC MC_PRODUC MC_PRODUC MC_PRODUC

E_ID T_ATTR_ID T_ATTR_SN T_ATTR_VAL T_ATTR_VAL
UE_SN UE

00093512401 10 9 1 1 ACE Inhibitors

00172503470 10 9 1 1 ACE Inhibitors

&
Thiazide/Thiazi
de-Like

00078052415 10 9 1 1 Direct Renin

Inhibitors &
Thiazide/Thiazi
de-Like Comb

Only partial results have been displayed for illustrative purposes.

The MC_PRODUCT_ATTR_ID value 9 indicates that the NDC is associated to a CMS

Therapeutic Category.

3. Display the results to the user.

ExampleIdentifying Medication Adherence for Cholesterol (Statins) Concepts

For purposes of demonstrating this application, the following scenario is used: A Medicare Part D Plan
Sponsor wants to create a list of drugs to identify Medicare Advantage members who adhere to their prescribed
drug therapy for statin cholesterol medications. The listing will be limited to CMS identified Part D Medication
Adherence for Cholesterol Medications (Statins) NDCs for the CMS Plan 2014 reporting period.

1. Retrieve the National Drug Code (NDC), Medicare Measure Identifier (MC_MEASURE_ID), and Medicare
Measure Timeframe Identifier (MC_MEASURE_TIMEFRAME_ID) values from the Medicare NDC Product
Measure Table (RMRDNM0_PRODUCT_MEASURE) where the:
MC_MEASURE_ID value equals 11 (Medication Adherence for Cholesterol [Statins])
First Databank Inclusion Reason Identifier (FDB_INCLUSION_REASON_ID) value equals 0
(Pass-Thru)
MC_MEASURE_TIMEFRAME_ID value equals 2 (2014)

MC_MEASURE_ID FDB_INCLUSION_REA MC_MEASURE_TIMEF NDC

SON_ID RAME_ID

11 0 2 00378201505

11 0 2 54868525000

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11 0 2 00069225030

Only partial results have been displayed for illustrative purposes

2. Retrieve the NDC, MC_MEASURE_ID, Medicare Product Attribute ID (MC_PRODUCT_ATTR_ID),

Medicare Product Attribute Sequence Number (MC_PRODUCT_ATTR_SN), Medicare Product Attribute
Value Sequence Number (MC_PRODUCT_ATTR_VALUE_SN) and the Medicare Product Attribute Value (
MC_PRODUCT_ATTR_VALUE) values from the Medicare NDC Product Attribute Table
(RMRDNA0_PRODUCT_ATTR) where the:
NDC equals the value retrieved in step 1
MC_MEASURE_ID equals the value entered in step 1
MC_MEASURE_TIMEFRAME_ID equals the value entered in step 1
MC_PRODUCT_ATTR_SN is sorted in ascending order
MC_PRODUCT_ATTR_VALUE_SN is sorted in ascending order

NDC MC_PRODUC
MC_MEASURE_ID MC_PRODUC MC_PRODUC MC_PRODUC
T_ATTR_ID T_ATTR_SN T_ATTR_VAL T_ATTR_VAL
UE_SN UE

00378201505 11 9 1 1 HMG CoA

Reductase
Inhibitors

54868525000 11 9 1 1 Intest Cholest

Absorp
Inhib-HMG CoA
Reductase
Inhib Comb

00069225030 11 9 1 1 Calcium
Channel
Blocker & HMG
CoA Reductase
Inhibit Comb

Only partial results have been displayed for illustrative purposes.

The MC_PRODUCT_ATTR_ID value 9 indicates that the NDC is associated to a CMS

Therapeutic Category.

3. Display the results to the user

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Identifying Medication Therapy Management Categories for NDCs on a

Patient Claim History
This application illustrates how to retrieve NDCs identified for Medication Therapy Management (MTM).

For purposes of demonstrating this application, the following scenario is used: A Medicare Part D Plan
Sponsor has a list of NDCs from a Medicare members pharmacy claim history. The Medicare Part D Plan
Sponsor covers five of the MTM categories and wants to see if the member has pharmacy claims that span three
or more of those categories.

1. Retrieve the National Drug Code (NDC), Medicare Measure Identifier (MC_MEASURE_ID), First Databank
Inclusion Reason Identifier (FDB_INCLUSION_REASON_ID), and Medicare Measure Timeframe Identifier
(MC_MEASURE_TIMEFRAME_ID) values from the Medicare Medicare NDC Product Measure Table
(RMRDNM0_PRODUCT_MEASURE) where the:
MC_MEASURE_ID value equals the value for the MTM to include in the search. In this example, the
value equals:
15 (MTM: Alzheimers Disease)
16 (MTM: Chronic Heart Failure)
18 (MTM: Dyslipidemia)
20 (MTM: Hypertension)
21 (MTM: Respiratory Disease)
FDB_INCLUSION_REASON_ID value equals 4 (FDB)
MC_MEASURE_TIMEFRAME_ID) value equals 1 (Continuous)
NDC equals the values obtained in the patient's pharmacy claim history

MC_MEASURE_ID FDB_INCLUSION_REA MC_MEASURE_TIMEF NDC

SON_ID RAME_ID

15 4 1 62856024730

18 4 1 68382007105

20 4 1 58864062014

Only partial results have been displayed for illustrative purposes.

2. Display the results to the user.

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Identifying CMS Concepts

This application illustrate how to retrieve CMS concepts identified for Medicare Part D.

Example 1Identifying Atypical Antipsychotics NDCs

Example 2Identifying Maximum Dose Units for Diabetes Medication Dosing
Example 3Identifying a CMS Display Measure Drug-Drug Interaction

Example 1Identifying Atypical Antipsychotics NDCs

This application illustrates one method to validate if an NDC has been identified by the CMS as an Atypical
Antipsychotic.

For purposes of demonstrating this application, the following scenario is used: To ensure the appropriate
use of the medications, a Long Term Care (LTC) facility medical director wants to identify and review medical
records for all patients currently being administered atypical antipsychotic medications. Identifying the atypical
antipsychotic NDCs is just one step in the process.

1. Retrieve the National Drug Code (NDC), Medicare Measure Identifier (MC_MEASURE_ID), First Databank
Inclusion Reason Identifier (FDB_INCLUSION_REASON_ID), and Medicare Measure Timeframe Identifier
(MC_MEASURE_TIMEFRAME_ID) values from the Medicare NDC Product Measure Table
(RMRDNM0_PRODUCT_MEASURE) where the:

MC_MEASURE_ID value equals 12 (Atypical Antipsychotic).

FDB_INCLUSION_REASON_ID value equals 4 (FDB)
MC_MEASURE_TIMEFRAME_ID value equals 2 (2014)

MC_MEASURE_ID FDB_INCLUSION_REA MC_MEASURE_TIMEF NDC

SON_ID RAME_ID

12 4 2 50458056101

2. Display the results to the user.

Example 2Identifying Maximum Dose Units for Diabetes Medication Dosing

For purposes of demonstrating this application, the following scenario is used: A Medicare Part D Plan
sponsor wants to create a report to analyze the percentage of patients who were dispensed a dose higher than
the daily recommended CMS Maximum Diabetes Medication Dosing. To accomplish this, the NDC on this patient
pharmacy claim history will be compared against the NDCs Calculated Maximum Dosage Units in the Medicare
NDC Product Attribute Table (RMRDNA0_PRODUCT_ATTR).

1. Retrieve the National Drug Code (NDC), Medicare Measure Identifier (MC_MEASURE_ID), First Databank
Inclusion Reason Identifier (FDB_INCLUSION_REASON_ID), and Medicare Measure Timeframe Identifier
(MC_MEASURE_TIMEFRAME_ID) values from the Medicare NDC Product Measure Table
(RMRDNM0_PRODUCT_MEASURE) where the:
MC_MEASURE_ID value equals 13 (Diabetes Medication Dosing)

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FDB_INCLUSION_REASON_ID value equals 0 (Pass-Thru), 1 (Clinical Formulation Extension), or

3 (Unreconciled)
MC_MEASURE_TIMEFRAME_ID value equals 2 (2014)

MC_MEASURE_ID FDB_INCLUSION_REA MC_MEASURE_TIMEF NDC

SON_ID RAME_ID

13 0 2 00003421411

13 0 2 00003421411

13 0 2 00003421411

Only partial results have been displayed for illustrative purposes.

2. Retrieve the Medicare Product Attribute ID (MC_PRODUCT_ATTR_ID) and the Medicare Product Attribute
Value (MC_PRODUCT_ATTR_VALUE) values from the Medicare NDC Product Attribute Table
(RMRDNA0_PRODUCT_ATTR) where the:
MC_MEASURE_ID value equals the value obtained in step 1
MC_MEASURE_TIMEFRAME_ID value equals the value obtained in step 1
NDC equals the value obtained in step 1

MC_MEASUR MC_MEASUR NDC MC_PRODUC MC_PRODUC MC_PRODUC

E_ID E_TIMEFRAM T_ATTR_ID T_ATTR_VAL T_ATTR_DES
E_ID UE C

13 2 00003421411 10 2 Calculated Max

Dosage Unit

13 2 00003421411 2 tablet Dosage Unit

13 2 00003421411 9 Dipeptidyl External

Peptidase-4 Therapeutic
(DPP-4) Category
Inhibitors

Only partial results have been displayed for illustrative purposes. In addition, the Medicare Product
Attribute Description (MC_PRODUCT_ATTR_DESC) column has only been added for illustrative
purposes as well.

3. Display the results to the user.

Example 3Identifying a CMS Display Measure Drug-Drug Interaction

For purposes of demonstrating this application, the following scenario is used: A Medicare Part D Plan
Sponsor wants to create a report to analyze the percentage of patients who were dispensed a target (CMS
identified medication) with at least one day overlap with a CMS identified contraindicated medication. The NDCs
in patients medication claim histories will be compared against the NDCs provided from the Display Measures
Drug-Drug Interactions in Medicare NDC Product Attribute Table (RMRDNA0_PRODUCT_ATTR).

Part 1: Identifying CMS Target Medications

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1. Retrieve the National Drug Code (NDC), Medicare Measure Identifier (MC_MEASURE_ID), First Databank
Inclusion Reason Identifier (FDB_INCLUSION_REASON_ID), and Medicare Measure Timeframe Identifier
(MC_MEASURE_TIMEFRAME_ID) values from the Medicare Medicare NDC Product Measure Table
(RMRDNM0_PRODUCT_MEASURE) where the:
MC_MEASURE_ID value equals 14 (Drug-Drug Interaction).
FDB_INCLUSION_REASON_ID value equals 0 (Pass-Thru)
MC_MEASURE_TIMEFRAME_ID value equals 2 (2014)

MC_MEASURE_ID FDB_INCLUSION_REA MC_MEASURE_TIMEF NDC

SON_ID RAME_ID

14 0 2 00054306844

14 0 2 00054356699

14 0 2 00054485851

Only partial results have been displayed for illustrative purposes.

2. Retrieve the Medicare Product Attribute ID (MC_PRODUCT_ATTR_ID) and the Medicare Product Attribute
Value (MC_PRODUCT_ATTR_VALUE) values from the Medicare NDC Product Attribute Table
(RMRDNA0_PRODUCT_ATTR) where the:
MC_MEASURE_ID value equals the value obtained in step
MC_MEASURE_TIMEFRAME_ID value equals the value obtained in step 1
NDC equals the value obtained in step 1
MC_PRODUCT_ATTR_ID value equals 11 (Category and Step)
MC_PRODUCT_ATTR_VALUE value contains 1

MC_MEASUR MC_MEASUR NDC MC_PRODUC MC_PRODUC MC_PRODUC

E_ID E_TIMEFRAM T_ATTR_ID T_ATTR_VAL T_ATTR_DES
E_ID UE C

14 2 00054306844 11 A1 Category and

Step

14 2 00054356699 11 A1 Category and

Step

The Medicare Product Attribute Description (MC_PRODUCT_ATTR_DESC) has been added for
illustration purposes only and is available in the Medicare Product Attribute Description Table
(RMRDPAD0_PRODUCT_ATTR_DESC). In this example, A represents category and 1 represents
a step.Only partial results have been displayed for illustrative purposes.

For additional context, the following values are associated to the same values as appear in
the above table:

MC_PRODUCT_ATTR_ID = 9

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MC_PRODUCT_ATTR_DESC = External Therapeutic Category

MC_PRODUCT_ATTR_VALUE = Benzodiazepines (for NDC 00054306844)
MC_PRODUCT_ATTR_VALUE = Benzodiazepine Hypnotics (for NDC 00054356699)

Part 2: Identifying CMS "Interaction" Medications

1. Retrieve the NDC, MC_MEASURE_ID, FDB_INCLUSION_REASON_ID, and

MC_MEASURE_TIMEFRAME_ID values from the Medicare NDC Product Measure Table
(RMRDNM0_PRODUCT_MEASURE) where the:
MC_MEASURE_ID value equals 14 (Drug-Drug Interaction)
FDB_INCLUSION_REASON_ID value equals 0 (Pass-Thru)
MC_MEASURE_TIMEFRAME_ID value equals 2 (2014)

MC_MEASURE_ID FDB_INCLUSION_REA MC_MEASURE_TIMEF NDC

SON_ID RAME_ID

14 0 2 00054306844

14 0 2 00054356699

14 0 2 00054485851

Only partial results have been displayed for illustrative purposes.

2. Retrieve the MC_PRODUCT_ATTR_ID and the MC_PRODUCT_ATTR_VALUE values from the Medicare
NDC Product Attribute Table (RMRDNA0_PRODUCT_ATTR) where the:
MC_MEASURE_ID value equals the value obtained in step 1
MC_MEASURE_TIMEFRAME_ID value equals the value obtained in step 1
NDC equals the value obtained in step 1
MC_PRODUCT_ATTR_ID value equals 11 (Category and Step)
MC_PRODUCT_ATTR_VALUE value contains 2

MC_MEASUR MC_MEASUR NDC MC_PRODUC MC_PRODUC MC_PRODUC

E_ID E_TIMEFRAM T_ATTR_ID T_ATTR_VAL T_ATTR_DES
E_ID UE C

14 2 00049316044 11 A2 Category and

Step

14 2 68462010230 11 A2 Category and

Step

MC_PRODUCT_ATTR_DESC has been added for illustration purposes only and is available in the
Medicare Product Attribute Description Table (RMRDPAD0_PRODUCT_ATTR_DESC). In this
example, A represents category and 1 represents a step. Only partial results have been displayed.

For additional context, the following values are associated to the same values as appear in

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the above table:

MC_PRODUCT_ATTR_ID = 9

MC_PRODUCT_ATTR_DESC = External Therapeutic Category

MC_PRODUCT_ATTR_VALUE = Triazoles

Please be advised that for MC_MEASURE_ID 14, all drugs with a

MC_PRODUCT_ATTR_VALUE of I are considered to react with other class I drugs.

Part 3: Comparing the Result

1. If the patient profile identifies NDCs found in Part 1 and Part 2 where the category is the same (for
example, A) there is a potential drug-drug interaction.

2. Display the results to the user. Actual results will be dependent on the patient's prescription history.

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Identifying NDCs for Screening Opioid and Concurrent Drug Therapy Risk
This application illustrates one method to validate if an NDC has been identified for screening for potential opioid
and concurrent drug risk therapy risk. Screening does not always begin with an opioid, it can begin with a
medication in a concurrent drug therapy list as demonstrated in this application.

For purposes of demonstrating this application, the following scenario is used: A pharmacy has received a
prescription from a patient for temazepam 30mg to treat a sleep disorder. The medication claim for temazepam
30mg (NDC 67877014705) is sent to a processor where screening for opioid double and triple threat is part of the
adjudication process. The processor checks the patient claim history file as part of the screening process (this
patient also has a recent Vicodin prescription from dentist on file).

Part 1: Identifying Opioid and Concurrent Drug Therapy Risk

Retrieve the Medicare Measure Identifier (MC_MEASURE_ID), Medicare Measure Timeframe Identifier
(MC_MEASURE_TIMEFRAME_ID), and First Databank Inclusion Reason Identifier
(FDB_INCLUSION_REASON_ID) values from the Medicare NDC Product Measure Table
(RMRDNM0_PRODUCT_MEASURE) where the National Drug Code (NDC) value equals 67877014705.

NDC MC_MEASURE_ID MC_MEASURE_TIMEFRA FDB_INCLUSION_REASO

ME_ID N_ID

67877014705 24 1 4

In this scenario, the NDC has a MC_MEASURE_ID value of 24 (Opioids and Concurrent Drug Therapy) and
requires additional screening steps. Proceed to Part 2.

If the given NDC does not have a MC_MEASURE_ID value of 24 (Opioids and Concurrent Drug
Therapy), no risk is present and screening for this measure is stopped.

Part 2: Screening Patient History for the Presence of Opioids and Concurrent Drug Therapy Risks

Retrieve the Medicare Product Attribute ID (MC_PRODUCT_ATTR_ID), Medicare Measure Timeframe Identifier
(MC_MEASURE_TIMEFRAME_ID), and Medicare Product Attribute Value (MC_PRODUCT_ATTR_VALUE)
values from the Medicare NDC Product Attribute Table (RMRDNA0_PRODUCT_ATTR) where:

the NDC(s) equals the value(s) from the patient history file (period used for lookup based on user
specific parameters)
the MC_MEASURE_ID equals the value retrieved in the previous step (24):

In this example, the patient has a historical record for NDC 00074304153 (VICODIN 5-300 MG
TABLET) as prescribed by a dentist.

NDC MC_MEASURE_ID MC_MEASURE_TI MC_PRODUCT_AT MC_PRODUCT_AT

MEFRAME_ID TRIBUTE_ID TR_VALUE

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00074304153 24 1 13 (Opioids and 1 (Opioids)

Concurrent Drug
Therapy Categories)

In this scenario, an history file NDC is represented in Opioids and Concurrent Drug Therapy Categories
(13) with a Medicare Product Attribute value indicating presence of an opioid (1) and requires additional
screening steps are required. Proceed to Part 3.

If the given NDC(s) are not represented in Opioids and Concurrent Drug Therapy Categories (13)
with a Medicare Product Attribute value indicating presence of an opioid (1) ), no risk is present
and screening for this measure is stopped.

Part 3: Presence of Opioids and Concurrent Drug Therapy with Presence of Non-benzodiazepine Sedative/hypnotics

Retrieve the Medicare Product Attribute Value (MC_PRODUCT_ATTR_VALUE) value(s) from the Medicare NDC
Product Attribute Table (RMRDNA0_PRODUCT_ATTR) where:

NDC equals the value of submitted NDC and patient history NDC(s)
MC_MEASURE_ID equals the value retrieved in step 1
MC_PRODUCT_ATTRIBUTE_ID equals the values retrieved in the previous steps
MC_MEASURE_TIMEFRAME_ID equals the value retrieved in step 1

NDC MC_MEASURE_ID MC_MEASURE_TI MC_PRODUCT_AT MC_PRODUCT_AT

MEFRAME_ID TRIBUTE_ID TR_VALUE

00074304153 24 1 13 (Opioids and 1 (Opioids)

Concurrent Drug
Therapy Categories)

67877014705 24 1 13 (Opioids and 3

Concurrent Drug (Non-benzodiazepin
Therapy Categories) e sedative/hypnotics)

If Medicare Product Attribute Values (MC_PRODUCT_ATTR_VALUE) obtained by review of newly submitted or

historic claims contains a NDC with the value of 1 (opioids) and a second NDC with the value of either 2 or 3, a
potential Opioid and Concurrent Drug Therapy Risk could exist. Processor specific messaging returned to
pharmacy.

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FDB Medicare Part D Module ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

FDB Medicare Part D Tables

FDB Medicare Part D Module ERD: NDC Focused
FDB Medicare Part D Module ERD: FDB_PRODUCT_ID Focused

FDB Medicare Part D Tables

First Databank Inclusion Reason Table
Medicare FDB Product ID Measure Table
Medicare FDB Product ID Product Attribute Table
Medicare Measure Table
Medicare Measure Timeframe Table
Medicare NDC Product Attribute Table
Medicare NDC Product Measure Table
Medicare Product Attribute Description Table
Medicare Product Attribute Type Description Table
Medicare Product Attribute Value Description Table

FDB Medicare Part D Module ERD: NDC Focused

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FDB Medicare Part D Module ERD: FDB_PRODUCT_ID Focused

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First Databank Inclusion Reason Table

Table Name RMRDRIR0_FDB_INCLUSION_REASON

Revision Activity add.11-18-2014

Purpose Provides the reason that First Databank included a product

in this module for a particular CMS Medicare Quality
measurement.

Key Column Name Column Format Length Picture

Description

P FDB_INCLUSION First Databank N 4 9(4)

_REASON_ID Inclusion Reason
Identifier

FDB_INCLUSION First Databank AN 50 X(50)

_REASON_DESC Inclusion Reason
Description

FDB_INCLUSION First Databank AN 2000 X(2000)

_REASON_DEF Inclusion Reason
Definition

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Medicare FDB Product ID Measure Table

Table Name RMRDPM0_PRODUCT_MEASURE

Revision Activity add.11-18-2014

Purpose Provides a drug product identifier in the form of a

proprietary product identifier controlled by First Databank
that is being tracked in a particular CMS quality measure
and explains the reason that particular product was
included by First Databank in that measurement. This
product identifier will help manage reused NDCs.
If a product is not listed by FDB, the FDB_INCLUSION_RE
ASON_ID, MC_MEASURE_ID, and MC_MEASURE_TIME
FRAME_ID will not be provided.

Key Column Name Column Format Length Picture

Description

PF FDB_PRODUCT_ First Databank N 11 9(11)

ID Product Identifier

PF MC_MEASURE_I Medicare N 8 9(8)

D Measure Identifier

PF MC_MEASURE_T Medicare N 8 9(8)

IMEFRAME_ID Measure
Timeframe
Identifier

F FDB_INCLUSION First Databank N 4 9(4)

_REASON_ID Inclusion Reason
Identifier

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Medicare FDB Product ID Product Attribute Table

Table Name RMRDPA0_PRODUCT_ATTR

Revision Activity add.11-18-2014

Purpose Provides associates a drug product identifier using the FDB

_PRODUCT_ID and that product's measure to any
attributes of that product that are used to help report on or
to track that measure.

Key Column Name Column Format Length Picture

Description

PF FDB_PRODUCT_ First Databank N 11 9(11)

ID Product Identifier

PF MC_MEASURE_I Medicare N 8 9(8)

D Measure Identifier

PF MC_MEASURE_T Medicare N 8 9(8)

IMEFRAME_ID Measure
Timeframe
Identifier

PF MC_PRODUCT_ Medicare Product N 8 9(8)

ATTR_ID Attribute Identifier

P MC_PRODUCT_ Medicare Product N 4 9(4)

ATTR_SN Attribute
Sequence
Number

P MC_PRODUCT_ Medicare Product N 4 9(4)

ATTR_VALUE_S Attribute Value
N Sequence
Number

MC_PRODUCT_ Medicare Product AN 255 X(255)

ATTR_VALUE Attribute Value

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Medicare Measure Table

Table Name RMRDM0_MEASURE

Revision Activity add.11-18-2014

Purpose Provides a full text description of the CMS quality

measurement and optional definition that CMS uses for the
tracking of quality measures to improve beneficiary care
related to submission of Medicare Part D claims.

Key Column Name Column Format Length Picture

Description

P MC_MEASURE_I Medicare N 8 9(8)

D Measure Identifier

MC_MEASURE_ Medicare AN 255 X(255)

DESC Measure
Description

MC_MEASURE_ Medicare AN 2000 X(2000)

DEFINITION Measure
Definition

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Medicare Measure Timeframe Table

Table Name RMRDMT0_MEASURE_TIMEFRAME

Revision Activity add.11-18-2014

Purpose Provides a description and an optional definition of the

reporting timeframe that can be used to filter a particular
Medicare Product Measure (for current or retrospective
reporting purposes)

Key Column Name Column Format Length Picture

Description

P MC_MEASURE_T Medicare N 8 9(8)

IMEFRAME_ID Measure
Timeframe
Identifier

MC_MEASURE_T Medicare AN 255 X(255)

IMEFRAME_DES Measure
C Timeframe
Description

MC_MEASURE_T Medicare AN 2000 X(2000)

IMEFRAME_DEF Measure
Timeframe
Definition

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Medicare NDC Product Attribute Table

Table Name RMRDNA0_PRODUCT_ATTR

Revision Activity add.11-18-2014

Purpose Associates a drug product identifier in the form of an

11-digit NCPDP formatted NDC and that product's quality
measure to any attributes for that product that are used to
help report or to track that measure.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

PF MC_MEASURE_I Medicare N 8 9(8)

D Measure Identifier

PF MC_MEASURE_T Medicare N 8 9(8)

IMEFRAME_ID Measure
Timeframe
Identifier

PF MC_PRODUCT_ Medicare Product N 8 9(8)

ATTR_ID Attribute Identifier

P MC_PRODUCT_ Medicare Product N 4 9(4)

ATTR_SN Attribute
Sequence
Number

P MC_PRODUCT_ Medicare Product N 4 9(4)

ATTR_VALUE_S Attribute Value
N Sequence
Number

MC_PRODUCT_ Medicare Product AN 255 X(255)

ATTR_VALUE Attribute Value

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Medicare NDC Product Measure Table

Table Name RMRDNM0_PRODUCT_MEASURE

Revision Activity add.11-18-2014

Purpose Provides a drug product identifier in the form of an 11-digit

NCPDP formatted NDC that is being tracked in a particular
CMS quality measure and also explains the reason that
particular product was included by First Databank in that
measurement.

The NDC product codes in this file with

FDB_INCLUSION_REASON_IDs of 0 (Pass-Thru), 1
(Clinical Formulation Extension), or 4 (FDB) are limited to
active or less than three years obsolete NDCs. If the NDC is
being passed through from other sources, this active or
three years obsolete restriction does not apply.

Key Column Name Column Format Length Picture

Description

P NDC National Drug AN 11 X(11)

Code

PF MC_MEASURE_I Medicare N 8 9(8)

D Measure Identifier

PF MC_MEASURE_T Medicare N 8 9(8)

IMEFRAME_ID Measure
Timeframe
Identifier

F FDB_INCLUSION First Databank N 4 9(4)

_REASON_ID Inclusion Reason
Identifier

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Medicare Product Attribute Description Table

Table Name RMRDPAD0_PRODUCT_ATTR_DESC

Revision Activity add.11-18-2014

Purpose Provides a full text description and an attribute type

describing the data type for a Medicare Product Attribute
Identifier (MC_PRODUCT_ATTR_ID)

Key Column Name Column Format Length Picture

Description

P MC_PRODUCT_ Medicare Product N 8 9(8)

ATTR_ID Attribute Identifier

MC_PRODUCT_ Medicare Product AN 100 X(100)

ATTR_DESC Attribute
Description

F MC_PRODUCT_ Medicare Product N 8 9(8)

ATTR_TYPE_ID Attribute Type
Identifier

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Medicare Product Attribute Type Description Table

Table Name RMRDATD0_PROD_ATTR_TYPE_DESC

Revision Activity add.11-18-2014

Purpose Provides a description of the data type, optional length, and

optional precision for a Medicare Product Attribute Type

Key Column Name Column Format Length Picture

Description

P MC_PRODUCT_ Medicare Product N 8 9(8)

ATTR_TYPE_ID Attribute Type
Identifier

MC_PRODUCT_ Medicare Product AN 100 X(100)

ATTR_TYPE_DE Attribute Type
SC Description

MC_PRODUCT_ Medicare Product N 8 9(8)

ATTR_TYPE_LE Attribute Type
NGTH Length

MC_PRODUCT_ Medicare Product N 8 9(8)

ATTR_TYPE_PR Attribute Type
ECISION Precision

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Medicare Product Attribute Value Description Table

Table Name RMRDAVD0_PROD_ATTR_VALUE_DESC

Revision Activity add.11-18-2014

Purpose Provides additional values for a Medicare Product Attribute

when that attribute can in turn have multiple codified values.

Key Column Name Column Format Length Picture

Description

PF MC_PRODUCT_ Medicare Product N 8 9(8)

ATTR_ID Attribute Identifier

P MC_PRODUCT_ Medicare Product AN 255 X(255)

ATTR_VALUE Attribute Value

MC_PRODUCT_ Medicare Product AN 500 X(500)

ATTR_VALUE_D Attribute Value
ESC Description

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Patient Education Module (PEM) 2.0

Patient Education Module Editorial Policies
Applications
ERD and Technical Specifications

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Patient Education Module Editorial Policies

Overview
Inclusion Criteria
Data Elements
Rule Sets
Maintenance
Resources

Overview
The Patient Education Module (PEM) provides monographs that contain drug information for use by patients, in
conjunction with verbal counseling from a healthcare professional. PEM provides practical information in a format
that is easy to read and remember. Patient information is available in the following printed formats:

First Databank (FDB) Standard Monographs (XML and ASCII File Formats)
ASHP MedTeach Monographs (Version 3.0)

PEM is a reporting mechanism that is supported by a master and monograph table. There is no patient profile
interface. PEM monograph files are referenced by patient education monograph codes found in the master table
or in the GCN_SEQNO/Patient Education Monograph Code Relation Table
(RPEMOGC0_MONO_GCNSEQNO_LINK). Patient education codes are assigned sequentially. The monograph
files (ASCII files only) also contain print codes/text identifiers, which are used to identify specific monograph text
sections. These monographs are based on an Editorial Policy which is in compliance with the Action Plan for the
Provision of Useful Prescription Medicine Information (Keystone Guidelines).

PEM is designed to convey drug information that is specific to dosage form and route of administration (and as
applicable, strength) to the patient so that the most beneficial therapeutic response is achieved with minimization
of preventable adverse effects. Information is presented in non-scientific terms, so patients will find it easy to
comprehend. When professional terms are useful in order to clarify or specify information, they will be included in
parentheses following the consumer term. This module, in combination with effective verbal counseling, provides
state-of-the-art comprehensive patient drug education at the point of care.

PEM consists of the following formats:

FDB Standard Monographs (available in English, Spanish, and French languages)

FDB Standard Monographs in XML format (available in English, Spanish, and French languages)
ASHP MedTeach Monographs

Drug knowledge is aggregated at the Clinical Formulation ID (GCN_SEQNO), Routed Medication ID (

ROUTED_MED_ID), and the Routed Generic ID (ROUTED_GEN_ID) levels in the FDB knowledge base.

Inclusion Criteria

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This section provides information detailing the criteria that guided the inclusion of the data contained within the
module as well as information pertaining to limitations or exclusions when appropriate to the discussion.

PEM monographs serve as an adjunct to professional oral counseling, not a substitute for oral counseling. PEM
monographs are not intended to be comprehensive, but instead are a summary of key information (presented in
lay language) related to drug products

In synchronization with the PKBS Inclusion policy, PEM can include the following products:

Rx products with a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologic
License Application (BLA)
Over-the-counter (OTC) products registered with the FDA and possessing an FDA OTC Monograph
Herbal products consistent with the FDB list of covered herbal products (see Herbal Products Inclusion List
)
Single and multi-vitamins containing iron and folic acids in specified strengths
Combination products in which all components meet the criteria for individual inclusion
Health-Canada approved and marketed Rx and OTC products

PEM includes consumer drug monographs written for specific ingredients and routes of administration, and as
necessary, specific dosage forms and ingredient strengths. Monographs are primarily based on high-volume-use
ambulatory care drug products which include (but are not limited to) oral, topical or inhaled dosage forms used for
common disease conditions.

Exclusion Criteria

PEM does not include monographs covering medical supplies or devices, or bulk chemical products. PEM does
not include monographs related to drug products that are administered and monitored solely by a healthcare
professional (as opposed to a patient or lay caregiver). An example would be general anesthetic gases or
parenteral products.

Data Elements
This section contains additional information about particularly important tables and codes contained within the
module, as well as concepts about the data that the reader must understand in order to understand the module.

FDBs Standard Monograph

The FDB Standard Monograph provides an in-depth discussion of a drug. It contains practical, clinically significant
information needed to assist in safe and effective drug use. This monograph is strongly recommended since it is
an excellent tool for providing useful patient education and risk management in conjunction with verbal counseling
via a healthcare professional. These monographs are based on an Editorial Policy which is in compliance with the
Action Plan for the Provision of Useful Prescription Medicine Information (Keystone Guidelines).

FDB provides ASCII format monographs in English, Spanish, and French languages. All monographs are also
available in eXtensible Markup Language (XML) format (PEM-XML). PEM-XML offers the same patient drug
education content as the traditional FDB standard monographs but is formatted for use in internet applications.

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FDB also provides a default monograph that can be used to present a message when a monograph is not
available for a given product. FDB does not recommend displaying the full default monograph. See Displaying the
Patient Education Standard Monograph for more information.

Finding Standard Monograph ASCII Text

FDB associates PEM monographs with drugs at the Clinical Formulation ID (GCN_SEQNO) level and the Routed
Generic Identifier (ROUTED_GEN_ID) level. Multiple monographs may be associated with the Routed Generic
Identifier, for example if the different dosage forms require separate monographs.

The Patient Education Code (PEC) is used to identify a drug with its available standard monograph text for patient
drug education. Monograph text is accessed using the following codes:

Patient Education Monograph Code (PEMONO)

Patient Education French Language Monograph Code (PEMONOFRA)
Patient Education Spanish Language Monograph Code (PEMONOS)

Understanding the Standard Monograph Elements

The FDB Standard Monograph consists of the following sections, described in detail below:

Disclaimer (Important Note)

This section provides a statement that the monograph is intended to supplement, not substitute for, professional
medical advice. It also indicates that patients should consult with their healthcare professionals when questions
arise.

Title

The monograph title consists of the formulation drug name and route of administration.

Phonetic Spelling

This section provides a phonetic spelling to assist in the pronunciation of drug product generic names. This allows
for greater accuracy and ease of communication between healthcare professionals and patients. The phonetic
spelling criteria include consideration of standard medical and pharmacy references conventions, consensus of
clinical practitioners, and especially the easy to recognize phonetic phrases. Phonetic terms are consistent from
one generic entity to the next. The phonetic terms are practical and consistent with the text for a sixth-grade level
of understanding. Therefore, traditional phonetic didactic rules are not used. This feature appears directly below
the monograph title.

Common Brand Names

This section lists the common product names of the drug, which allow for the rapid and accurate identification of
generic drug products. The list of brand names is alphabetized and is not necessarily comprehensive where
multiple brands exist.

Warning

This section is included in the monograph when applicable to convey consumer-friendly translations and

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distillation of important warning information from the professional drug labeling (such as black box warnings).
This includes relevant symptoms that the patient can report to a healthcare professional.

Uses

This section does not list all possible FDA-approved indications, however, it does list those indications that are
the most commonly used in the vast majority of patients. The Uses section also provides valuable information
regarding the benefits obtained from the medication in question, as well as how the drug works, and the drug
classification.

Other Uses

This section lists the commonly accepted unlabeled uses that are of interest to a patient. These uses are derived
from secondary compendia sources.

How to Use

This section deals with the method of ingesting, injecting, inserting, or applying each medication. Drug
interactions may be included in this section as well, when the interaction relates logically to medication dosing,
such as interactions involving foods or nonprescription products such as vitamins. Any special circumstances or
adjuncts related to administration of medication are explained including disposal of syringes, as applicable. Also
included are onsets of effect and dependence/tolerance/addiction information as necessary.

Side Effects

This section includes common side effects as well as uncommon side effects that would be especially deleterious
or life threatening. An example of this case is the antifungal agent ketoconazole. Although hepatotoxicity occurs in
only one in 10,000 cases (0.01%) and is reversible upon discontinuation of treatment, its potential side effect of
liver toxicity is mentioned in the monograph. The monograph informs the patient which parameters need to be
monitored or reported in reference to side effects. Again, using ketoconazole as an example, these parameters
would include symptoms of liver compromise (such as dark urine, yellowing eyes or skin, abdominal pain,
extreme fatigue, fever, and nausea).

Minor or transient adverse effects are listed separately. The more serious and/or life-threatening adverse effects
are listed at two levels of frequency:

unlikely (greater than 1% if frequency is available)

rare and/or life-threatening effects (less than 1% if frequency available)

A statement precedes the serious side effects section which indicates that the majority of people do not develop
serious side effects, and that their physician has determined that the benefits of using the medication outweigh
the risk of side effects. This statement is intended to help balance the considerable amount of risk information
present in the professional literature and the PEM monographs.

The urgency of reporting specific symptoms as well as advice to mitigate adverse effects (as applicable) are also
conveyed in this section.

Precautions

This section contains all common therapeutic contraindications, along with selected cautions that may preclude

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the use of the medication by the patient. Included are disease contraindications/cautions, allergy contraindications
(including cross-sensitivity reactions), relevant drug-specific advisories such as photosensitivity precautions, and
drug-alcohol information. Additionally, pregnancy and lactation information (standardized to FDA categories) is
provided, and relevant gender-specific, pediatric, or geriatric precautions are also included.

Drug Interactions

This section warns of significant drug interactions. Drug interaction contraindications and certain cautions are
included. An example of this relates to the patient about to take erythromycin or ketoconazole products while
taking the antiarrhythmic agent dofetilide. Since a rare but life-threatening interaction can occur, this information
would fall under the QT prolongation subsection of Drug Interactions. Pharmacokinetic (in vitro) drug interactions
are included should the data reach the cutoff criteria delineated by the PEM clinical editors.

Drug-food and drug-laboratory interactions are also included. Detailed descriptions of drug interactions are found
in other clinical knowledge bases.

Overdose

This section includes valuable advice on what action to take should an overdose be suspected, as well as
relevant overdose symptoms.

Notes

This section includes general and/or customized information (for example, lifestyle modification as appropriate for
specific diseases) as it applies to specific classes of drugs. The information is practical and complements the
other sections. Included in this section are antibiotic-specific information statements and medical
appointment/laboratory monitoring recommendations. Some of these monitoring advisories relate to critical drug
adverse effects.

Missed Dose

This section provides specific directions and protocols to follow when a dose is omitted. For example, in the case
of birth control medication, a specific sequence of steps must be followed when one or two tablets are missed in
succession.

Storage

This section addresses proper storage of a medication. For example, the requirement that certain antibiotic
suspensions need to be refrigerated is specified in this section, as well as what to do with any unused or outdated
portion. Also included is information about odor, color, and appearance changes and the toxicity of certain drugs
after the expiration date.

Medical Alert

As a public service, we have included a MedicAlert statement in selected drug monographs. The drugs were
selected on the basis of the seriousness of the condition for which the drug is being used, and whether the patient
may be unresponsive to emergency personnel due to the condition. MedicAlert is a non-profit organization.

Document Information

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This section provides the last revised date and the copyright year associated with each PEM monograph. This
information should be placed uniformly at the end of the final PEM section and does not have a title.

Understanding Standard Monograph PEM-XML Format

The FDB Standard Monograph is also available in eXtensible Markup Language (XML) format (PEM-XML).
PEM-XML is an optional offering of the Patient Education Module. XML monographs provide the same patient
drug education content as the traditional FDB Standard Monographs, formatted for use in Internet applications.
These monographs provide optimal formatting customization, as well as bullet-point format for easier readability
and patient recall. Such formats are recommended within the Keystone Guidelines.
PEM-XML requires Microsoft Internet Explorer 5.0 or higher for viewing the monographs. FDB delivers the
approximate 2400 XML monograph files (representing all of the FDB Standard Monographs) on CD or via FTP,
which includes one DTD file, four XSL files, and 12 icon files in JPEG format.

Updating PEM-XML content requires a total file replacement. Each update cycle you will receive all XML files,
XSL files, and the DTD file.

PEM-XML DTD File

The Document Type Definition (DTD) file for PEM-XML provides the structure and usage guidelines for the
information contained in the XML monographs. It identifies the mandatory and optional sections within each
monograph. The DTD file is read-only and must be placed in the root directory with the XML files to allow the
monographs to display properly. The following table explains the DTD in PEM-XML.

The XML monograph MUST contain The XML monograph CAN contain

Monograph Number Phonetic Spelling

Disclaimer Common Names

Monograph Title Warning

Uses Other Uses

How to Use Medical Alert

Side Effects

Precautions

Storage

Drug Interactions

Overdose

Notes

Missed Dose Information

PEM-XML Stylesheets (XSL Files)

FDB provides four monograph stylesheets (XSL files) with PEM-XML. Each stylesheet contains unique

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formatting, graphic representation, and functionality. Each of the four stylesheets (XSL files) is described below.

Default Monograph Stylesheet (MONOGRAPH.xsl)

MONOGRAPH.xsl is the default monograph stylesheet. It displays section headings in blue with section text
appearing directly below each heading.

Drop-Down Monograph Stylesheet (MONODropDown.xsl)

The Drop-Down Monograph Stylesheet displays section headings in blue. The section text is hidden in the
monograph. Click a heading to make the corresponding section text appear directly below the heading. Click the
section heading to hide the section text.

Icon Monograph Stylesheet (MONOIcon.xsl)

The Icon Monograph Stylesheet displays icons on the first page that represent each monograph section. Section
headings appear below the icons on the same page. The section text appears sequentially in the monograph.
Click either the icon or the heading to go to the corresponding section of the monograph. Click the section
heading to return to the first page of icons and headings.

Slide Monograph Stylesheet (MonoSlide.xsl)

The Slide Monograph Stylesheet displays a list of the section headings in blue on the first monograph page. The
section text appears sequentially in the monograph. Click a heading to go directly to the corresponding section of
the monograph. Click the heading to return to the first page.

ASHP MedTeach Monograph (v3.0)

The ASHP MedTeach Monograph is authored by the American Society of Health-System Pharmacists (ASHP). It
provides detailed information about certain aspects of prescription drug use, and contains instructions for dosage
forms of each drug within one monograph. According to ASHP, this monograph meets the criteria set forth in the
Action Plan for the Provision of Useful Prescription Medicine Information (Keystone Guidelines). There are over
790 ASHP MedTeach Monographs.

ASHP MedTeach Monograph (v3.0)

The ASHP MedTeach Monograph is authored by the American Society of Health-System Pharmacists (ASHP). It
provides detailed information about certain aspects of prescription drug use, and contains instructions for dosage
forms of each drug within one monograph. According to ASHP, this monograph meets the criteria set forth in the
Action Plan for the Provision of Useful Prescription Medicine Information (Keystone Guidelines). There are over
790 ASHP MedTeach Monographs.

MedTeach Monograph Disclaimer

Any use of MedTeach monographs must include the following notice, which must appear on any computer screen
for a sufficient period of time to be read by an average person:

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MedTeach Version 3.0 is copyrighted by the American Society of Health-System Pharmacists, Inc. 2007 , ASHP,
Bethesda, Maryland 20814. All Rights Reserved. Duplication must be authorized by ASHP. The American Society of
Health-System Pharmacists, Inc. represents that the database provided hereunder was formulated with a reasonable
standard of care, and in conformity with professional standards in the field. The American Society of Health-System
Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied
warranty of merchantability and/or fitness for a particular purpose, with respect to such database and specifically disclaims
all such warranties and representations. Users are advised that decisions regarding drug therapy are complex medical
decisions requiring the independent, informed decision of an appropriate health care professional, and the database is
provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough
understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does
not endorse or recommend the use of any drug in the database. The information contained in the database is not a
substitute for medical care.
In addition, any time any part of a MedTeach monograph is displayed, the copyright notice must be displayed as shown
below with the year changed to correspond to the date of the most recent update:
Copyright 2007, American Society of Health-System Pharmacists, Inc., Bethesda, Maryland. All rights reserved.

Rule Sets
This section provides rules that the clinical team uses in regard to creating the module's data, both general rules
and rules specific to data elements.

Rules of General Applicability

This section describes editorial policies that have a broad impact on the module data or by nature are less
specific than those policies in other sections.

The monograph authorship/editing function is accomplished via the following approach:

The primary reference source for monograph authorship and routine clinical updates/edits (from FDA
Medwatch or Health Canada) is the professional labeling (this includes FDA/Health Canada safety alert
letters).
AHFS Drug Information compendium may also be consulted.
Consensus Guidelines can be consulted regarding clinical information relevant to PEM monographs.
Primary literature may be consulted when necessary to resolve a customer's specific clinical question.

Rules for Data Elements

This section describes editorial policies that are more specific towards their effect on the data elements contained
in the module.

The following are a list of rules for data elements:

PEM monographs are linked to clinical formulations meeting PEM inclusion criteria and further linked to
NDCs or DINs which are active, or those that have been inactive less than two years.
Clinical formulations consisting of products without NDA, ANDA, BLA, or an OTC Monograph are
excluded.
PEM monographs are linked to ingredient(s), route of administration, dosage form, and ingredient strength
(i.e., a clinical formulation). The PEMONO numeric value is the same as the first four bytes of the Patient

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Education Code value.

Monographs are retired and stored in an archive database if all attached products (NDCs and/or DINs)
become greater than two years obsolete, or the products have been officially withdrawn from the U.S. and
Canadian markets for greater than one year.
PEM Spanish and French monographs utilize the same Patient Education Code and Patient Education
Monograph Code numeric value as the corresponding English monograph.
ASHP MedTeach monographs are linked to clinical formulations via the associated PEM(s) if at least one
associated PEM exists.

Maintenance
This section contains information regarding the ongoing maintenance of the module's data.

External Triggers for Clinical Review

The external triggers that prompt the clinical editors to add or review data are the following:

MedEffects Alerts from Health Canada are reviewed and if such information meets inclusion criteria, PEM
data is updated on a weekly basis.
Ad hoc customer or manufacturer clinical inquiries are reviewed daily and the database is updated weekly
as appropriate.
FDA MedWatch Safety Alerts are reviewed and if such information meets inclusion criteria, PEM data is
updated on a weekly basis.
FDA MedWatch Safety Datamonthly professional labeling changes are reviewed and if such information
meets inclusion criteria, PEM data is updated on a monthly basis.

Internal Triggers for Clinical Review

The internal triggers that prompt the clinical editors to add or review data are the following:

New clinical formulations are reviewed against the PEM inclusion criteria on a daily basis. Monographs are
authored and attached to clinical formulations meeting inclusion criteria.
Changes to existing clinical formulations that result in potential PEM linkage changes are reviewed on a
daily basis.

Resources
This section lists sources used by FDB to compile the information contained in the Medicare module.

Briggs G. Drugs in Pregnancy and Lactation.

Food and Drug Administration. MedWatch: The FDA Safety Information and Adverse Event Reporting
Program. Available at: http://www.fda.gov/Safety/MedWatch/default.htm.
Health Canada Safety Alerts. Available at: http://www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php.
Medical Economics Staff. Physicians Desk Reference.
Published by authority of the Board of Directors of the American Society of Health-System Pharmacists.

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American Hospital Formulary Service (AHFS) Drug Information.

XML Resources

The references below were used in the development of FDBs PEM-XML. These references provide introductory
and expert-level information about the technology of XML.

Howard ER. XML Bible. 2nd ed. New York, NY: John Wiley & Sons; 2003.
XML 101. Available at: http://www.xmlfiles.com. Accessed June 30, 2003.
TopXML. Available at: http://www.vbxml.com. Accessed June 30, 2003.

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PEM Applications
This section provides information about the practical application of data contained in this module.

Displaying the Patient Education Standard Monograph

Displaying the ASHP MedTeach Monograph
Implementing a PEM-XML Stylesheet
Changing Icons in the PEM-XML Icon Monograph Stylesheet

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Displaying the Patient Education Standard Monograph

This application illustrates how to display the full standard ASCII Patient Education monograph in the desired
language (English, Spanish, or French).

FDB associates PEM monographs with drugs at the Clinical Formulation ID (GCN_SEQNO) level and the Routed
Generic Identifier (ROUTED_GEN_ID) level. If a monograph is not available for a given FDB identifier, the title of
the FDB default monograph should be displayed to the end user. FDB does not recommend displaying the full
FDB default monograph.

This application assumes familiarity with the various drug concepts and their identifiers. (See Multiple
Access Points (MAPs) for more information.)

The following examples demonstrate this application by retrieving U.S. monograph information with the Clinical
Formulation ID (GCN_SEQNO):

ExampleDisplaying the Patient Education Standard Monograph

ExampleWhat to Display When There is No Monograph

1. Do one of the following:

a. Select the Patient Education Monograph Code (PEMONO) from the GCN_SEQNO/Patient
Education Monograph Code Relation Table (RPEMOGC0_MONO_GCNSEQNO_LINK) where the
GCN_SEQNO column equals the Clinical Formulation ID (GCN_SEQNO) value of the drug product.

b. Select the Patient Education French Language Monograph Code (PEMONOFRA) from the
GCN_SEQNO/Patient Education French Monograph Code Relation Table (
FPEMOGC0_FRENCH_GCNSEQNO_LINK) where the GCN_SEQNO column equals the Clinical
Formulation ID (GCN_SEQNO) value of the drug product.

c. Select the Patient Education Spanish Language Monograph Code (PEMONOS) from the
GCN_SEQNO/Patient Education Spanish Monograph Code Relation Table
(SPEMOGC0_SPNSH_GCNSEQNO_LINK) where the GCN_SEQNO column equals the Clinical
Formulation ID (GCN_SEQNO) value of the drug product.

Proceed as follows:
If no monograph value is returned, proceed to step 2 to display the FDB default monograph title.
Otherwise, proceed to step 3 to retrieve monograph information.

2. Do one of the following to display the FDB default monograph title:

a. Select the Patient Education Text (Standard) (PEMTXTE) value from the Patient Education
Standard Monograph Text U.S. Brand Names Table (RPEMMOE2_MONO) where the PEMONO
column equals 0000 (zeroes) and the Patient Education Text Identifier (Standard) (PEMTXTEI)
column equals T.

b.

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b. Select the PEMTXTE value from the Patient Education French Language Standard Monograph Text
Table (FPEMMOE1_FRENCH_MONO) where the PEMONOFRA column equals 0000 (zeroes) and
the PEMTXTEI column equals T.

c. Select the PEMTXTE value from the Patient Education Spanish Language Standard Monograph
Text Table (SPEMMOE1_SPNSH_MONO) where the PEMONOS column equals 0000 (zeroes) and
the PEMTXTEI column equals T.

3. Select the Patient Education Text Sequence Number (Standard) PEMONOE_SN), PEMTXTEI, and
PEMTXTE columns from the monographs text table where one of the following is true:

a. Where the PEMONO column from the RPEMMOE2_MONO table equals the PEMONO value of the
patient education monograph.

b. Where the PEMONOFRA column from the FPEMMOE1_FRENCH_MONO table equals the
PEMONOFRA value from step 1.

c. Where the PEMONOS column from the SPEMMOE1_SPNSH_MONO column equals the
PEMONOS value from step 1.

4. Display monograph details to the end-user in the order indicated by the sequence number column.

ExampleDisplaying the Patient Education Standard Monograph

A clinician wishes to generate a patient education ASCII monograph for Simethicone Drops (GCN_SEQNO
002815).

1. Select the Patient Education Monograph Code (PEMONO) value from the GCN_SEQNO/Patient
Education Monograph Code Relation Table (RPEMOGC0_MONO_GCNSEQNO_LINK) value where the
GCN_SEQNO column equals the Clinical Formulation ID (GCN_SEQNO) value of the drug product.
Proceed as follows:
If no monograph value is returned, proceed to step 2 to display the FDB default monograph title.
Otherwise, proceed to step 3 to retrieve monograph information.

GCN_SEQNO PEMONO

002815 0265

In this example, a monograph is returned. The application proceeds to step 3.

2. Select the Patient Education Text (Standard) (PEMTXTE) value from the Patient Education Standard
Monograph Text U.S. Brand Names Table (RPEMMOE2_MONO) where the PEMONO column equals
0000 (zeroes) and the Patient Education Text Identifier (Standard) (PEMTXTEI) column equals T.

3. Select the Patient Education Text Sequence Number (Standard) (PEMONOE_SN), Patient Education Text
Identifier (Standard) (PEMTXTEI), and Patient Education Text (Standard) (PEMTXTE) columns from the
Patient Education Standard Monograph Text U.S. Brand Names Table (RPEMMOE2_MONO) where the

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3.

PEMONO column equals the PEMONO value of the patient education monograph.
A sample of the monograph is shown below:

PEMONO PEMONOE_SN PEMTXTEI PEMTXTE

0265 001 Z IMPORTANT: HOW TO

USE THIS
INFORMATION: This is a
summary and

0265 002 Z does NOT have all

possible information about
this product. This

0265 003 Z information does not

assure that this product is
safe, effective,

0265 004 Z or appropriate for you. This

information is not
individual

0265 005 Z medical advice and does

not substitute for the
advice of your

0265 006 Z health care professional.

Always ask your health
care

0265 007 Z professional for complete

information about this
product and your

0265 008 Z specific health needs.

0265 009 B

0265 010 T SIMETHICONE DROPS -

ORAL

0265 011 F (sye-METH-i-kone)

0265 012 B

0265 013 C COMMON BRAND

NAME(S): Mylicon

0265 014 B

4. Display monograph details to the end-user in the order indicated by the PEMONOE_SN value. The
example below provides a sample display of the monograph text.

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FDB MedKnowledge U.S. Documentation August 2017

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all
possible information about this product. This information does not assure that this product is safe,
effective,or appropriate for you. This information is not individual medical advice and does not
substitute for the advice of your health care professional. Always ask your health care professional for
complete information about this product and your specific health needs.

SIMETHICONE DROPS (sye-METH-i-kone)

COMMON BRAND NAMES: Mylicon

USES: This product is used to relieve symptoms of extra gas caused by air swallowing or certain
foods/infant formulas. Simethicone helps break up gas bubbles in the gut.

HOW TO USE: Shake the container well before each use. Give this product by mouth as needed,
usually after meals and at bedtime, or as directed by the doctor. Follow all directions on the product
package. If you are uncertain about any of the information, consult the doctor or pharmacist.

Fill the dropper to the correct usage and squeeze the liquid slowly into the babys mouth, towards the
inner cheek. You can also measure the correct dosage with the dropper and mix it in 1 ounce of cool
water, infant formula, or juice. Mix well and give the solution to your baby. The proper dosage is based
on your childs age and weight.

If you are treating the child yourself (without direction from a doctor), do not use more than 12 doses of
simethicone per day.

Clean the dropper well after each use and close the bottle tightly.

If your childs condition persists or worsens, or if you think there may be a serious medical problem,
seek immediate medical attention.

SIDE EFFECTS: There are no reports of any side effects due to this medication. However, tell the
doctor if your child experiences any unpleasant effects while taking this medication.

A very serious allergic reaction to this product is rare. However, seek immediate medical attention if
you notice any of the following symptoms of a serious allergic reaction: rash, itching, swelling
(especially of throat/face), severe dizziness, trouble breathing.

If you notice other effects not listed above, contact your doctor or pharmacist.

ExampleWhat to Display When There is No Monograph

A hospital nurse, wishing to provide information on Digoxin Ampul (Clinical Formulation ID ( GCN_SEQNO)
000015) to a patient's family, attempts to generate a patient education ASCII monograph.

1. Select the Patient Education Monograph Code (PEMONO) from the GCN_SEQNO/Patient Education
Monograph Code Relation Table (RPEMOGC0_MONO_GCNSEQNO_LINK) where the GCN_SEQNO

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1.

column equals the Clinical Formulation ID (GCN_SEQNO) value of the drug product.
Proceed as follows:
If no monograph value is returned, proceed to step 2 to display the FDB default monograph title.
Otherwise, proceed to step 3 to retrieve monograph information.
In this example, no monograph was returned. The application proceeds to step 2.

2. Select the Patient Education Text (Standard) (PEMTXTE) value from the Patient Education Standard
Monograph Text U.S. Brand Names Table (RPEMMOE2_MONO) where the PEMONO column equals
0000 (zeroes) and the Patient Education Text Identifier (Standard) (PEMTXTEI) column equals T.

PEMONO PEMTXTEI PEMTXTE

0000 T NO MONOGRAPH AVAILABLE AT

THIS TIME

The example below provides a sample display of the monograph text. The application ends.

NO MONOGRAPH AVAILABLE AT THIS TIME FOR ONDANSETRON HCL POWDER.

3. Select the Patient Education Text Sequence Number (Standard) (PEMONOE_SN), PEMTXTEI, and
PEMTXTE columns from the monographs text table where one of the following is true:

a. Where the PEMONO column from the RPEMMOE2_MONO table equals the PEMONO value of the
patient education monograph.

b. Where the PEMONOFRA column from the FPEMMOE1_FRENCH_MONO table equals the
PEMONOFRA value from step 1.

c. Where the PEMONOS column from the SPEMMOE1_SPNSH_MONO column equals the
PEMONOS value from step 1.

4. Display the monograph in the order indicated by the sequence number column.

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Displaying the ASHP MedTeach Monograph

This application illustrates how to display the ASHP MedTeach monographs.

The following application begins at the Clinical Formulation level with the Clinical Formulation ID (GCN_SEQNO)
and assumes familiarity with the various drug concepts and their identifiers. See Multiple Access Points
(MAPs) for more information.

1. Select the Patient Education Code (PEC) column from the GCN_SEQNO/Patient Education Code Relation
Table (RPEMGC0_GCNSEQNO_LINK) where the GCN_SEQNO column equals the Clinical Formulation
ID (GCN_SEQNO) value of the drug product.

2. Select the Patient EducationAmerican Society of Health-System Pharmacists Monograph Code Version
3 (ASHPCDE3) from the Patient Education Master Table (RPEMMA5_MSTR) where the PEC column
equals the PEC value from the previous step.

3. Select the following columns from the Patient Education (ASHP MedTeach) Monograph Text Table
(RPEMMOA2_MEDTCH_MONO) where the ASHPCDE3 column equals the ASHPCDE3 value from the
previous step.

a. Patient EducationAmerican Society of Health-System Pharmacists Monograph Text Sequence

Number (ASHPCDE_SN)

b. Special Print Character (SPCHAR)

c. Patient Education Text (ASHP) (PEMTXTA)

4. Display monograph details to the end-user in the order indicated by the ASHPCDE_SN column.

ExampleDisplaying the ASHP MedTeach Monograph

A clinician wishes to generate a U.S. patient education monograph for Simethicone Drops (Clinical Formulation ID
(GCN_SEQNO) 002815).

1. Select the Patient Education Code (PEC) column from the GCN_SEQNO/Patient Education Code Relation
Table (RPEMGC0_GCNSEQNO_LINK) where the GCN_SEQNO column equals the Clinical Formulation
ID (GCN_SEQNO) value of the drug product.

GCN_SEQNO PEC

004308 608113

2. Select the Patient Education American Society of Health-System Pharmacists Monograph Code Version 3
(ASHPCDE3) from the Patient Education Master Table (RPEMMA5_MSTR) where the PEC column equals
the PEC value from the previous step.

PEC ASHPCDE3

608113 601023

3. Select the following columns from the Patient Education (ASHP MedTeach) Monograph Text Table (

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3.
RPEMMOA2_MEDTCH_MONO) where the ASHPCDE3 column equals the ASHPCDE3 value from the
previous step.

a. Patient EducationAmerican Society of Health-System Pharmacists Monograph Text Sequence

Number (ASHPCDE_SN)

b. Special Print Character (SPCHAR)

c. Patient Education Text (ASHP) (PEMTXTA)

ASHPCDE3 ASHPCDE_SN SPCHAR PEMTXTA

601023 001 T Aspirin, Butalbital, and

Caffeine

601023 002 T (as' pir in) (byoo tal' bi

tal) (kaf' een)

601023 003 B

601023 004 N Brand Name(s):

Farbital(R) (as a
combination product
containing Aspirin,

601023 005 N Butalbital, Caffeine),

Fiorinal(R) (as a
combination product
containing

601023 006 N Aspirin, Butalbital,

Caffeine), Fiormor(R) (as
a combination product

601023 007 N containing Aspirin,

Butalbital, Caffeine),
Fiortal(R) (as a
combination

601023 00 N product containing

Aspirin, Butalbital,
Caffeine), Fortabs(R) (as
a

601023 009 N combination product

containing Aspirin,
Butalbital, Caffeine),
Idenal(R)

601023 010 N (as a combination

product containing
Aspirin, Butalbital, and
Caffeine),

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601023 011 N Isollyl(R) (as a

combination product
containing Aspirin,
Butalbital,

601023 012 N Caffeine), Laniroif(R) (as

a combination product
containing Aspirin,

601023 013 N Butalbital, Caffeine); also

available generically

601023 014 B

601023 015 U WHY is this medicine

prescribed?

601023 016 U This combination of

drugs is used to relieve
tension headaches.

601023 017 U This medication is

sometimes prescribed
for other uses; ask your
doctor or

601023 018 U pharmacist for more

information.

601023 019 B

601023 020 U HOW should this

medicine be used?

601023 021 U The combination of

aspirin, butalbital, and
caffeine comes as a
capsule

601023 022 U and tablet to take by

mouth. It usually is taken
every 4 hours as
needed.

601023 023 U Follow the directions on

your prescription label
carefully, and ask your

601023 024 U doctor or pharmacist to

explain any part you do
not understand. Take

601023 025 U aspirin, butalbital, and

caffeine exactly as
directed. Do not take
more

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FDB MedKnowledge U.S. Documentation August 2017

601023 026 U than six tablets or

capsules in 1 day. If you
think that you need more
to

601023 027 U relieve your symptoms,

call your doctor.

601023 028 U This medication can be

habit-forming. Do not
take a larger dose, take
it

601023 029 U more often, or for a

longer time than your
doctor tells you to.

601023 030 B

601023 031 U What SPECIAL

PRECAUTIONS should I
Follow?

601023 032 U Before taking aspirin,

butalbital, and caffeine,

601023 033 U * tell your doctor and

pharmacist if you are
allergic to aspirin,

601023 034 U butalbital, caffeine, other

pain relievers such as
ibuprofen (Motrin), or

601023 035 U any other drugs.

601023 036 U * tell your doctor and

pharmacist what
prescription and
nonprescription

601023 037 U medications you are

taking, especially
acetazolamide (Diamox);

601023 038 U anticoagulants ('blood

thinners') such as
warfarin (Coumadin);

601023 039 U antidepressants;

antihistamines;
corticosteroids such as
prednisone;

601023 040 U medications for arthritis,

gout, diabetes, or pain;
methotrexate;

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601023 041 U sedatives; sleeping pills;

tranquilizers; and
vitamins.

601023 042 U * tell your doctor if you

have or have ever had
kidney disease,
porphyria,

601023 043 U bleeding problems, nasal

polyps, ulcers, or a
history of depression.

601023 044 U * tell your doctor if you

are pregnant, plan to
become pregnant, or are

601023 045 U breast-feeding. If you

become pregnant while
taking this medication,
call

601023 046 U your doctor.

601023 047 U * you should know that

this drug may make you
drowsy. Do not drive a
car

601023 048 U or operate machinery

until you know how this
drug affects you.

601023 049 U * remember that alcohol

can add to the
drowsiness caused by
this drug.

601023 050 B

601023 051 U What SPECIAL

DIETARY instructions
should I follow?

601023 052 U Aspirin, butalbital, and

caffeine may cause an
upset stomach. Take this

601023 053 U medicine with food or

milk.

601023 054 B

601023 055 U What should I do IF I

FORGET to take a
dose?

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601023 056 U Take the missed dose as

soon as you remember
it. However, if it is almost

601023 057 U time for the next dose,

skip the missed dose
and continue your
regular

601023 058 U dosing schedule. Do not

take a double dose to
make up for a missed
one.

601023 059 B

601023 060 U What SIDE EFFECTS

can this medicine
cause?

601023 061 U Aspirin, butalbital, and

caffeine may cause side
effects. Tell your doctor

601023 062 U if any of these symptoms

are severe or do not go
away:

601023 063 U * drowsiness

601023 064 U * upset stomach

601023 065 U * vomiting

601023 066 U * stomach pain

601023 067 U * lightheadedness

601023 068 U * confusion

601023 069 U If you experience any of

the following symptoms,
call your doctor

601023 070 U immediately:

601023 071 U * skin rash

601023 072 U * itching

601023 073 U * difficulty breathing

601023 074 U * ringing in the ears

601023 075 U * bloody or black stools

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601023 076 U If you experience a

serious side effect, you
or your doctor may send
a

601023 077 U report to the Food and

Drug Administration's
(FDA) MedWatch
Adverse Event

601023 078 U Reporting program

online (at http://www.fda.
gov/Safety/MedWatch)
or by

601023 079 U phone (1-800-332-1088).

601023 080 B

601023 081 U What should I know

about STORAGE and
DISPOSAL of this
medication?

601023 082 U Keep this medication in

the container it came in,
tightly closed, and out

601023 083 U of reach of children.

Store it at room
temperature, away from
excess heat

601023 084 U and moisture (not in the

bathroom). Throw away
any medication that is

601023 085 U outdated or no longer

needed. Talk to your
pharmacist about the
proper

601023 086 U disposal of your

medication.

601023 087 B

601023 088 U What should I do in case

of OVERDOSE?

601023 089 U In case of overdose, call

your local poison control
center at

601023 090 U 1-800-222-1222. If the

victim has collapsed or is
not breathing, call

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601023 091 U local emergency services

at 911.

601023 092 B

601023 093 U What OTHER

INFORMATION should I
know?

601023 094 U Keep all appointments

with your doctor.

601023 095 U Do not let anyone else

take your medication.
This medication is a

601023 096 U controlled substance.

Prescriptions may be
refilled only a limited
number

601023 097 U of times; ask your

pharmacist if you have
any questions.

601023 098 U It is important for you to

keep a written list of all
of the prescription

601023 099 U and nonprescription

(over-the-counter)
medicines you are
taking, as well

601023 100 U as any products such as

vitamins, minerals, or
other dietary
supplements.

601023 101 U You should bring this list

with you each time you
visit a doctor or if you

601023 102 U are admitted to a

hospital. It is also
important information to
carry with

601023 103 U you in case of

emergencies.

601023 104 B

601023 105 U This report on

medications is for your
information only, and is
not

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601023 106 U considered individual

patient advice. Because
of the changing nature

601023 107 U of drug information,

please consult your
physician or pharmacist
about

601023 108 U specific clinical use.

601023 109 U The American Society of

Health-System
Pharmacists, Inc.
represents that

601023 110 U the information provided

hereunder was
formulated with a
reasonable

601023 111 U standard of care, and in

conformity with
professional standards in
the

601023 112 U field. The American

Society of Health-System
Pharmacists, Inc. makes
no

601023 113 U representations or

warranties, express or
implied, including, but
not

601023 114 U limited to, any implied

warranty of
merchantability and/or
fitness for

601023 115 U a particular purpose, with

respect to such
information and
specifically

601023 116 U disclaims all such

warranties. Users are
advised that decisions

601023 117 U regarding drug therapy

are complex medical
decisions requiring the

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601023 118 U independent, informed

decision of an
appropriate health care
professional,

601023 119 U and the information is

provided for
informational purposes
only.

601023 120 U The entire monograph

for a drug should be
reviewed for a thorough

601023 121 U understanding of the

drug's actions, uses and
side effects. The

601023 122 U American Society of

Health-System
Pharmacists, Inc. does
not endorse

601023 123 U or recommend the use of

any drug. The
information is not a
substitute

601023 124 U for medical care.

601023 125 U AHFS Consumer

Medication Information.
(c) 2012. The American
Society of

601023 126 U Health-System

Pharmacists, Inc., 7272
Wisconsin Avenue,
Bethesda,

601023 127 U Maryland 20814. All

Rights Reserved.
Duplication for
commercial use must

601023 128 U be authorized by ASHP.

601023 129 U Last Reviewed:

09/01/2010

In addition, you must provide the copyright notice. See "MedTeach Monograph Disclaimer"
in the PEM Data Elements section for more information.

4. Display monograph details to the end-user in the order indicated by the ASHPCDE_SN column. The
example below provides a sample display of the monograph text.

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Aspirin, Butalbital, and Caffeine (as' pir in) (byoo tal' bi tal) (kaf' een)

BRAND NAME(S): Axotal, B-A-C, Butalbital Compound, Fiorgen PF, Fiorinal, Isollyl Improved,
Lanorinal, Marnal

WHY is this medicine prescribed? This combination of drugs is used to relieve tension headaches. This
medication is sometimes prescribed for other uses; as your doctor or pharmacist for more information.

HOW should this medicine be used? The combination of aspirin, butalbital, and caffeine comes as a
capsule and tablet to take by mouth. It usually is taken every 4 hours as needed. Follow the directions on
your prescription label carefully and ask your doctor or pharmacist to explain any part you do not understand.
Take aspirin, butalbital, and caffeine exactly as directed. Do not take more than six tablets or capsules in 1
day. If you think that you need more to relieve your symptoms, call your doctor. This medication can be habit
forming. Do not take a larger dose, take it more often, or for a longer time than your doctor tells you to.

What SPECIAL PRECAUTIONS Should I Follow? Before taking aspirin, butalbital, and caffeine,

tell your doctor and pharmacist if you are allergic to aspirin, butalbital, caffeine, other pain relievers
such as ibuprofen (Motrin), or any other drugs.
tell your doctor and pharmacist what prescription and nonprescription medications you are taking,
especially acetazolamide (Diamox); anticoagulants ('blood thinners') such as warfarin (Coumadin);
antidepressants; antihistamines; corticosteroids such as prednisone; medications for arthritis, gout,
diabetes, or pain; methotrexate; sedatives; sleeping pills; tranquilizers; and vitamins.
tell your doctor if you have or have ever had kidney disease, porphyria, bleeding problems, nasal
polyps, ulcers, or a history of depression.
tell your doctor is you are pregnant, plan to become pregnant, or are breast-feeding. If you become
pregnant while taking this medication, call your doctor.
you should know that this drug may make you drowsy. Do not drive a car or operate machinery until
you know how this drug affects you.
remember that alcohol can add to the drowsiness caused by this drug.

What SPECIAL DIETARY Should I Follow? Take the missed dose as soon as you remember it. However, if
it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not
take a double dose to make up for a missed one.

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Implementing a PEM-XML Stylesheet

This application illustrates how to change an XML stylesheet.

The Default Monograph stylesheet is found in the CD root directory with the XML files. To use a different
stylesheet, you must copy the desired stylesheet (XSL) file from the XSL_FILES folder into the root directory. See
"Understanding Standard Monograph PEM-XML Format" in the PEM Data Elements for more information on the
available stylesheets.

1. In the root directory, rename Monograph.xsl to monograph_def.xsl. folder.

2. In the XSL_FILES folder, click the XSL file that you wish to use as your stylesheet.

3. Select Edit/Copy to copy the selected XSL file.

4. Paste the selected XSL file into the root directory.

5. Change the name of the pasted XSL file to MONOGRAPH.xsl.

6. Click an XML file to open the monograph in the new stylesheet format.

The icon JPEG files must be moved into the root directory with the XML files when implementing
the Icon Monograph stylesheet.

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Changing Icons in the PEM-XML Icon Monograph Stylesheet

This application illustrates how to change the icons in the Icon monograph stylesheet.

The MONOIcon.xsl file displays the Icon Monograph stylesheet. FDB supplies dummy icons as placeholders in
the stylesheet; you must replace these with your own icons.

1. Move the placeholder JPEG files out of the XSL_FILES folder. (Do not delete the files.)

2. Copy the new JPEG files into the XSL_FILES folder.

3. Rename the new JPEG files, using the names of the placeholder JPEG files they replace. (Be sure to use
the same capitalization and spelling when renaming the files.)

4. Implement the Monograph Icon stylesheet with the new JPEG files.

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PEM ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

PEM Tables
PEM ERD

PEM Tables
GCN_SEQNO/Patient Education Code Relation Table
GCN_SEQNO/Patient Education French Monograph Code Relation Table
GCN_SEQNO/Patient Education Monograph Code Relation Table
GCN_SEQN/Patient Education Spanish Monograph Code Relation Table
Patient Education (ASHP MedTeach) Monograph Text Table
Patient Education French Language Standard Monograph Text Table
Patient Education Master Table
Patient Education Spanish Language Standard Monograph Text Table
Patient Education Standard Monograph Text U.S. Brand Names Table
PEM French Mono Routed Generic Table
PEM Mono Routed Generic Table
PEM Routed Generic Table
PEM Spanish Mono Routed Generic Table

PEM ERD

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GCN_SEQNO-Patient Education Code Relation Table

Table Name RPEMGC0_GCNSEQNO_LINK

Revision Activity original

Purpose Links a clinical formulation to patient education information.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID

PF PEC Patient Education N 6 9(6)

Code

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GCN_SEQNO-Patient Education French Monograph Code Relation Table

Table Name FPEMOGC0_FRENCH_GCNSEQN0_LINK

Revision Activity original

Purpose Links a clinical formulation directly to a French-language

patient education monograph.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF PEMONOFRA Patient Education N 4 9(4)

French Language
Monograph Code

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GCN_SEQNO-Patient Education Monograph Code Relation Table

Table Name RPEMOGC0_MONO_GCNSEQNO_LINK

Revision Activity add.10-01-1995

Purpose Links a clinical formulation directly to the FDB patient

education monograph.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF PEMONO Patient Education N 4 9(4)

Monograph Code

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GCN_SEQN-Patient Education Spanish Monograph Code Relation Table

Table Name SPEMOGC0_SPNSH_GCNSEQNO_LINK

Revision Activity add.10-01-1995

Purpose Links a clinical formulation directly to a Spanish-language

patient education monograph.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF PEMONO Patient Education N 4 9(4)

Spanish
Language
Monograph Code

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Patient Education (ASHP MedTeach) Monograph Text Table

Table Name RPEMMOA2_MEDTCH_MONO

Revision Activity rev.10-03-2002

Purpose Provides attributes for the ASHP MedTeach monographs.

Key Column Name Column Format Length Picture

Description

P ASHPCDE3 Patient N 6 9(6)

EducationAmeri
can Society of
Health - System
Pharmacists
Monograph Code
Version 3

P ASHPCDE_SN Patient N 3 9(3)

EducationAmeri
can Society of
Health - System
Pharmacists
Monograph Text
Sequence
Number

SPCHAR Special Print AN 1 X(1)

Character

PEMTXTA Patient Education AN 76 X(76)

Text (ASHP)

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Patient Education French Language Standard Monograph Text Table

Table Name FPEMMOE1_FRENCH_MONO

Revision Activity original

Purpose Provides attributes for the FDB Standard French-language

monographs.

Key Column Name Column Format Length Picture

Description

P PEMONOFRA Patient Education N 4 9(4)

French Language
Monograph Code

P PEMONOE_SN Patient Education N 3 9(3)

Text Sequence
Number
(Standard)

PEMTXTEI Patient Education AN 1 X(1)

Text Identifier
(Standard)

PEMTXTE Patient Education AN 76 X(76)

Text (Standard)

PEMGNDR This column is not AN 1 X(1)

currently being
used

PEMAGE This column is not AN 1 X(1)

currently being
used

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Patient Education Master Table

Table Name RPEMMA5_MSTR

Revision Activity rev.02-25-2000

Purpose Associates the drug or drug class with the available

monographs for patient drug education.

Key Column Name Column Format Length Picture

Description

P PEC Patient Education N 6 9(6)

Code

DGNAME Drug Name AN 30 X(30)

LBLMSG1 Patient Education AN 27 X(27)

Message Line #1

LBLMSG2 Patient Education AN 27 X(27)

Message Line #2

F PEMONO Patient Education N 4 9(4)

Monograph Code

AMACDE This column is not AN 3 X(3)

currently being
used

PHMXCDE This column is not AN 3 X(3)

currently being
used

USPCDE This column is not AN 4 X(3)

currently being
used

NARDCDE This column is not AN 3 X(3)

currently being
used

F ASHPCDE3 Patient N 6 9(6)

EducationAmeri
can Society of
Health-System
Pharmacists
Monograph Code
Version 3

F PEMONOS Patient Education N 4 9(4)

Spanish
Language
Monograph Code

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F PEMONOFRA Patient Education N 4 9(4)

French Language
Monograph Code

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Patient Education Spanish Language Standard Monograph Text Table

Table Name SPEMMOE1_SPNSH_MONO

Revision Activity rev.08-11-2000

Purpose Provides attributes for the FDB Standard Spanish-language

monographs.

Key Column Name Column Format Length Picture

Description

P PEMONOS Patient Education N 4 9(4)

Spanish
Language
Monograph Code

P PEMONOE_SN Patient Education N 3 9(3)

Text Seqence
Number
(Standard)

PEMTXTEI Patient Education AN 1 X(1)

Text Identifier
(Standard)

PEMTXTE Patient Education AN 76 X(76)

Text (Standard)

PEMGNDR This column is not AN 1 X(1)

currently being
used

PEMAGE This column is not AN 1 X(1)

currently being
used

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Patient Education Standard Monograph Text U.S. Brand Names Table

Table Name RPEMMOE2_MONO

Revision Activity rev.05-01-1999

Purpose Provides attributes for the FDB standard monographs.

Key Column Name Column Format Length Picture

Description

P PEMONO Patient Education N 4 9(4)

Monograph Code

P PEMONOE_SN Patient Education N 3 9(3)

Text Sequence
Number
(Standard)

PEMTXTEI Patient Education AN 1 X(1)

Text Identifier
(Standard)

PEMTXTE Patient Education AN 76 X(76)

Text (Standard)

PEMGNDR This column is not AN 1 X(1)

currently being
used

PEMAGE This column is not AN 1 X(1)

currently being
used

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PEM French Mono Routed Generic Table

Table Name FPEMRG0_ROUTED_GEN_FRENCH_LINK

Revision Activity original

Purpose Links a routed generic to a FDB standard French-language

monograph.

Key Column Name Column Format Length Picture

Description

PF ROUTED_GEN_I Routed Generic N 8 9(8)

D Identifier

PF PEMONOFRA Patient Education N 4 9(4)

French Language
Monograph Code

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PEM Mono Routed Generic Table

Table Name RPEMORG0_ROUTED_GEN_LINK

Revision Activity original

Purpose Links a routed generic to the FDB patient education

monograph.

Key Column Name Column Format Length Picture

Description

PF ROUTED_GEN_I Routed Generic N 8 9(8)

D Identifier

PF PEMONO Patient Education N 4 9(4)

Monograph Code

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PEM Routed Generic Table

Table Name RPEMRG0_ROUTED_GEN_LINK

Revision Activity original

Purpose Links a routed generic to patient education information.

Key Column Name Column Format Length Picture

Description

PF ROUTED_GEN_I Routed Generic N 8 9(8)

D Identifier

PF PEC Patient Education N 6 9(6)

Code

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PEM Spanish Mono Routed Generic Table

Table Name SPEMRG0_RTD_GEN_SPNSH_LINK

Revision Activity original

Purpose Links a routed generic to a FDB Standard

Spanish-language monograph.

Key Column Name Column Format Length Picture

Description

PF ROUTED_GEN_I Routed Generic N 8 9(8)

D Identifier

PF PEMONOS Patient Education N 4 9(4)

Spanish
Language
Monograph Code

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Prescriber Order Entry Module (POEM) 2.0

General Information
Prescriber Order Entry Module Editorial Policies
POEM Applications
ERD and Technical Specifications

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General Information
The General Information section contains high-level information about the module.

Overview
Definitions
Data Elements
Concepts
ExampleRetrieving a Default Dosage Order String Text
Inclusion and Exclusion Criteria
Maintenance

Overview
The Prescriber Order Entry Module (POEM) provides common orders (order strings and orders components)
in a format that can be transmitted for e-prescribing for a specific drug, strength, and dosage form (specific to a
Clinical Formulation ID) as well as route-of-administration and indication in adults that may apply to an inpatient
and/or outpatient practice setting. POEM is restricted to dosing for adults only. Dosing that pertains to specific
patient clinical situations (e.g., organ/renal failure, pharmacogenetics, concomitant tobacco use, and/or
gender-specific) is not explicitly represented in POEM.

POEM can be implemented within:

an inpatient order-entry system, allowing for the creation of convenient lists of drug dosage orders
an outpatient prescription-writing system, allowing for the creation of convenient lists of prescriptions

In either case, provided lists consist of common dosage orders specific to the drug formulation and intended route
of administration. If desired, the prescribers system can allow the list of orders to be filtered using known patient
information, such as medical condition (indication) and age. Filtering the list of dosing orders by information
known about the patient (such as age and medical condition) presents the prescriber with a smaller, more
patient-specific set of orders, reducing the possibility of a prescribing error and simplifying the dosage order
process.

Drug knowledge is aggregated at the Clinical Formulation ID (GCN_SEQNO), Routed Medication ID (

ROUTED_MED_ID), and the Routed Generic ID (ROUTED_GEN_ID) levels in the FDB knowledge base.
Under certain circumstances, aggregated drug knowledge may not apply to all related packaged
products; more specific information may be found within product labels.

Definitions
This section defines important terms related to the module that users should understand. Some industry terms
that have a specific connotation in regards to the module may also be defined.

Dose Type

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Dose type is defined by its purpose for being administered to a patient. For example, a loading dose is the initial
total dose required to rapidly achieve a desired plasma concentration.

Dose type is identified by the POEM Dose Type Code (POEDOSETYP). Only the Maintenance Dose Type (
POEDOSETYP=02) is used in the POEM Order Set data.

Indication
A condition that can be treated or alleviated by drug therapy; a reason a drug is prescribed, whether its use is
approved or off-label.

The relationship between Clinical Formulation IDs (GCN_SEQNO) and indicationsthe DXID and FDBDX
columnsin POEM resides in the POEM GCN_SEQNO POEM Source Table
(RPOEGSQ2_GCNSEQNO_MSTR).

Route of Administration
The route of administration refers to the normal site or method by which a drug is administered in the body, such
as oral, injection, or topical. A Route of Administration Code (GCRT) is associated to each Clinical Formulation ID
(GCN_SEQNO) to identify that component of the clinical formulation.

For example, intramuscular and continuous infusion are examples of route of administration.

Data Elements
Order/order string formatting includes the following elements: Standard content and Optional content (if
appropriate).

Standard Content
Verb (e.g., "take")
Dosage form and/or Dosage amount
Frequency and/or Interval
Route

Example

Standard content and formatting:

Take 2 tablets (600 mg) by oral route once daily

Place 1 tablet (10 mg) under the tongue and allow to dissolve by sublingual route 2 times daily
Inject 1 milliliter (50 mg) by intramuscular route every 6 hours
Infuse 400 mg over 60 minutes by intravenous route every 12 hours

Optional Content (if appropriate)

PRN
Duration

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Additional Instructions

Examples

Content including PRN attribute and range for frequency and/or interval:

Take 1 tablet (1 mg) by oral route 3 times daily as needed for nausea
Insert 1 suppository (25 mg) by rectal route every 4 hours as needed for fever
Inject 25 mg IV push over 1-2 minutes by intravenous route every 4-6 hours as needed for pain

Content including therapy duration:

Insert 1 suppository (100 mg) by vaginal route once daily at bedtime for 7 days
Apply a small amount to the affected area by topical route 3 times per day for 14 days
Instill 2 drops into affected eye(s) by ophthalmic route 3 times per day and at bedtime for 10 days

Content including additional administration instruction(s)/site:

Place 1 tablet (2.5 mg) on top of tongue, allow to dissolve then swallow by translingual route once; may
repeat after 2hrs, max 10 mg/24hrs
Inject 10 mcg by subcutaneous route once 30-60 minutes before anesthesia induction
Apply 1 pump (30 mg) by transdermal route once daily in the morning to each underarm for a total dose of
60 mg

Concepts
This section describes concepts and database elements that are important for understanding the module.

Clinical Formulation Identifier (GCN_SEQNO)

A Clinical Formulation Identifier (GCN_SEQNO) represents a drug formulation, which is the combination of the
ingredient list, route of administration, dosage form, and strength.

The POEM GCN_SEQNO POEM Source Table (RPOEGSQ2_GCNSEQNO_MSTR) and the POEM
GCN_SEQNO Standard Order Table (RPOEGCS1_STANDARD_ORDER) associate Clinical Formulation IDs
(GCN_SEQNOs) to POEM Order Set Identifiers (POEOSETID).

A Clinical Formulation ID (GCN_SEQNO) is a requirement for retrieving dosage orders from the POEM database.

Dosage Orders
POEM contains two types of dosage orders:

Dosage Orders are associated with indications. These orders have been determined by FDB clinicians to
be the common Dosage Orders for the Clinical Formulation ID (GCN_SEQNO)/indication combinations in
question. A Clinical Formulation ID (GCN_SEQNO) can have several Dosage Orders associated with it
based on the different indications associated with it.
Default Dosage Orders are independent of indications and have been determined by FDB clinicians to be
the most commonly used order for a specified Clinical Formulation ID (GCN_SEQNO). Some Clinical

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Formulation IDs (GCN_SEQNOs) may not have a Default Dosage Order available since, in some
instances, a drug may not yet have enough adequate common dosage research available from which to
determine a default. By definition, a Clinical Formulation ID (GCN_SEQNO) can have only one Default
Dosage Order in the database.

Dosage orders are provided in two formats. The first is as a pre-constructed text string and the second is as
individual data elements.

POEM Standard Order Table

The source table for Default Dosage Orders. The linkage between a Clinical Formulation ID (GCN_SEQNO) and
a Default Dosage POEOSETID, independent of indication, resides in the RPOEGCS1_STANDARD_ORDER
table.

The source information linked to a Clinical Formulation ID (GCN_SEQNO) in the

RPOEGCS1_STANDARD_ORDER table are:

POEM Order Set Identifier (POEOSETID)

POEM Clinical Context Identifier (POECLINID)

Refer to the Common Usage Example below for more information about Default Dosage Orders.

POEM GCN_SEQNO POEM Source Table

The source table for Dosage Orders. Unlike Default Dosage Orders, Dosage Orders are associated to medical
conditions (indications). The linkage between a Clinical Formulation ID (GCN_SEQNO), a POEOSETID, and
indication resides in the RPOEGSQ2_GCNSEQNO_MSTR table.

The source information linked to a Clinical Formulation ID (GCN_SEQNO) in the

RGCNSEQ4_GCNSEQNO_MSTR table is:

First Databank Disease Code (FDBDX)

POEM Order Set Identifier (POEOSETID)
POEM Clinical Context Identifier (POECLINID)
Disease Identifier (DXID)

POEM Order String Table

The POEM Order String Table (RPOEOSR1_ORDER_STRING) contains most of the parsed data available for
use in creating custom dosage orders.

There are two specialized tables that also contain parsed data: The POEM Administration Rate Table
(RPOEAR1_ADMINISTRATION_RATE) and the POEM Context Table (RPOECL1_CLIN_CONTEXT).
Refer to ERD and Technical Specifications for more information about these tables.

Parsed data includes dosage data elements such as route, doses, intervals, frequencies, etc.

A POEM Order String Identifier (POEOSTRID) identifies a row of parsed data in the

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RPOEOSR1_ORDER_STRING table. All of the data elements contained in the identified row correspond to the
specified Clinical Formulation ID (GCN_SEQNO)and any other parameters specified, such as indicationused
as input to the database.

Some data elements in a row may not contain data. For example, a High Frequency value ( POEHIGHF)
may not be available for some Clinical Formulation IDs (GCN_SEQNOs).

Unit code columns and route columns contained in the POEM Order String Table
([RPOEOSR1_ORDER_STRING) table are populated with unit codes that identify from which table rows in the
POEM Code Definition Table (RPOECD1_DEFINITION) unit descriptions are retrieved.

High Dose Units Code column, containing unit codes that identify the table rows in the POEM Code Definition
Table (RPOECD1_DEFINITION) table from which unit descriptions are being retrieved.

POEROUTE and POEROUTE_D, the route columns, also contain unit codes that identify which
descriptions are retrieved from the RPOECD1_DEFINITION table.

The following diagram illustrates the relationship between unit code columns and route columns in the
RPOEOSR1_ORDER_STRING table and description columns in the RPOECD1_DEFINITION table:

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POEM Code Definition Table

The POEM Code Definition Table (RPOECD1_DEFINITION) contains definitions for all of the parsed data route
and unit code columns that are contained primarily in the RPOEOSR1_ORDER_STRING table.

There are two specialized tables that also contain parsed data: The POEM Administration Rate Table
(RPOEAR1_ADMINISTRATION_RATE) and the POEM Context Table (RPOECL1_CLIN_CONTEXT).
Refer to ERD and Technical Specifications for more information about these tables.

Most of the unit code columns in the POEM Order String Table (RPOEOSR1_ORDER_STRING) have a U at
the end of their name. For example, POELOWDU is the POEM Low Dose Units Code column, containing unit
codes that identify the table rows in the RPOECD1_DEFINITION table from which unit descriptions are being
retrieved.

POEROUTE and POEROUTE_D, the route columns, also contain unit codes that identify which
descriptions are retrieved from the RPOECD1_DEFINITION table.

The descriptions for the unit code columns in the RPOEOSR1_ORDER_STRING table are accessed via the
POEM Unit Code (POEUNITCDE) column in the RPOECD1_DEFINITION table. To access a description, you
must create a relationship between the unit code column in the RPOEOSR1_ORDER_STRING table and the
POEUNITCDE column in the RPOECD1_DEFINITION table.

In the table shown below, the POEM Low Dose Units Code (POELOWDU) contains the number 0080 in its field in
the row of parsed data for the POEM Order String Identifier (POEOSTRID) value of 0000018195 in the
RPOEOSR1_ORDER_STRING table. The POEM Low Dose (POELOWD) column is also shown since the POEM
Low Dose Units Code (POELOWDU) column defines the unit of measure for the low dose.

RPOEOSR1_ORDER_STRING Table

POEOSTRID POELOWD POELOWDU

0000018195 0000000000195 0080

In the RPOECD1_DEFINITION table, the POEM Unit Code (POEUNITCDE) 0080 identifies the row from which
the unit description for POELOWDU is retrieved. For example:

RPOECD1_DEFINITION Table

POEUNITCDE POEUNITTYP POEDESC1 POEDESC2 POEDESC3

0080 2 MG

The POEUNITTYP 2 indicates the row contains Unit of Measure information. The POEDESC1 column is the only
description column populated in Unit of Measure table rows and is the description column that is retrieved. (See
"POEM Compliance with TJC and ISMP" below.)

Once a relationship between the POELOWDU column in the RPOEOSR1_ORDER_STRING table and the

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POEUNITCDE column in the RPOECD1_DEFINITION table is created, querying the RPOECD1_DEFINITION

table and retrieving the POEDESC1 column description produces the results as shown in the table below:

POEOSTRID POELOWD POEDESC1

0000018195 0000000000195 MG

How you create a relationship between the POELOWDU column, or any unit column, and the POEUNITCDE
column depends on the tool being used to manipulate the data. For example, if using Microsoft Access, creating a
relationship would require adding a Join Line from one table to the other, linking the two columns.

The example above explains how to retrieve a single unit code column definition in a row of parsed data in the
RPOEOSR1_ORDER_STRING table. For instructions on how to create a full custom dosage order consisting of
multiple unit code columns, refer to Creating Custom Dosage Orders in the POEM Applications section.

POEM Compliance with TJC and ISMP

The POEM Description 1 (POEDESC1) column contains a text description for dosage form unit, unit of measure,
or route, depending on the value in the POEM Unit Code Type ( POEUNITTYP) column. The information in the
PEODESC1 column might include dosage form abbreviations (POEUNITTYPE = 1) or unit of measure
abbreviations (POEUNITTYP = 2) considered inappropriate by The Joint Commission (TJC) and Institute for Safe
Medication Practices (ISMP).

To comply with TJC and ISMP requirements, use the Units Description Table (RUNITSD0_UNITS_DESC), which
provides the TJC-compliant alternatives to the dosage form or unit of measure abbreviations in the PEODESC1
column.

The RUNITSD0 table provides both an appropriate TJC-compliant abbreviation and a fully expanded description
with no abbreviations at all. For example, POEM uses MMU/KG as a unit in the POEDESC1 column where
POEUNITTYP = 2. The RUNITSD0 table contains the following corresponding unit descriptions:

A TJC-compliant abbreviation (million units/kg) in the Unit Description Abbreviation (

UNIT_DESC_ABBREV) column
An expanded unit description (million units per kilogram) in the Units Description Expanded (
UNIT_DESC_EXPANDED) column

Unit Code Type (POEUNITTYP)

The POEM Unit Code Type (POEUNITTYP) column in the RPOECD1_DEFINITION table identifies the type of
information the table row contains.

Clinical Context Identifier (POECLINID)

The POEM Clinical Context Identifier (POECLINID) identifies clinical patient parameters which affect dosage.

Currently, POEM has one clinical context identifier (01) which indicates Age. All of the dosages currently
contained in POEM are for the age category Adult.

Order Set Identifier (POEOSETID)

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The POEM Order Set Identifier (POEOSETID) identifies a drug/indication/clinical context combination that links to
a POEM Order String Identifier (POEOSTRID) in the POEM database.

Currently, POEOSETIDs and POEOSTRIDs have a one-to-one relationship; each POEOSETID links to a single
POEOSTRID. POEM has the potential to expand order sets to contain multiple links to order strings in future
iterations of POEM. Once order sets contain multiple links to order strings, the relationship between order sets
and order strings will change from a one-to-one to a one-to-many.

The relationship between a POEOSETID and a POEOSTRID, the identifier for parsed data in the
RPOEOSR1_ORDER_STRING table and the POEM Text Code (POETEXTCDE) in the POEM Order String to
Text Table (RPOEOSX1_TEXT_LINK), resides in the POEM Order Set Table (RPOEOS1_ORDER_SET).

Order String Identifier (POEOSTRID)

POEM Order String Identifier (POEOSTRID) identifies parsed data elements and the POETEXTCDE in the
RPOEOSX1_TEXT_LINK table.

The Order String Identifier has different uses, depending on what type of information you are attempting to
retrieve from the database.

For example, in the RPOEOSR1_ORDER_STRING table, the POEOSTRID is linked to parsed data elements. In
the POEM Order String to Text Table (RPOEOSX1_TEXT_LINK), the POEOSTRID is linked to a POEM Text
Code (POETEXTCDE), which identifies text contained in the POEM Text Table (RPOETXT1_TEXT).

Text Code (POETEXTCDE)

POEM Text Code (POETEXTCDE) identifies a line of text that resides in the POEM Text Table
(RPOETXT1_TEXT).

There are two types of text residing in the text table: Order String Texts and Additional Instructions text. Text type
is identified with the POEM Text Type Code (POETEXTTYPE).

Text Type (POETEXTTYP)

POEM Text Type Code (POETEXTTYP) identifies text as one of the two types of text contained in the POEM
Text Table (RPOETXT1_TEXT).

This column can indicate the text is order string text (a value of 80) or additional instructions text (a value of 90).
Order string text is pre-constructed, clinically validated drug dosage order. For example, take 1 capsule (200mg)
by oral route 2 times per day is an available Order String Text in the POEM database.

Additional instructions text is a small bit of text that contributes to a Parsed Data Drug Dosage Order. For
example, in the morning is an available piece of Additional Instructions text in the POEM database.

Input Data Elements

Data input that can be used to filter/qualify the list of dosage orders that are presented to the prescriber. This
information can be found in the patients electronic medical record (EMR) or can be acquired by prompting the
prescriber through the application user interface at the time of order entry.

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Input Data Elements Description Table

Input Description Database Column Names

Drug The minimum input into POEM is a GCN_SEQNO

drug formulation identifier for which
dosing information is being requested.

Indication Dosing instructions for the same drug FDBDX

may differ depending on the medical DXID
condition (indication) being treated.
Therefore, POEM further qualifies drug
dosing information by indication. In the
absence of indication information, a list
of common orders with their indications
can be presented to the prescriber for
selection.

Dose Type Dosing may vary based on the dose POEDOSETYP

type. For example, glipizide given as
an initial dose for the treatment of
diabetes mellitus is 5MG/day, whereas
the maintenance dose ranges from
5MG to 40MG/DAY. Fluconazole given
for the treatment of disseminated
candidiasis is given as a single 800MG
loading dose followed by a
maintenance dose of 200MG/DAY.
The design of POEM assigns the dose
type as an attribute of an individual
order string.
Only the Maintenance Dose Type (PO
EDOSETYP=02) is used in the POEM
Order Set data.

Route of Administration The method of administering a drug to POEROUTE

the patient.

Patient Parameter Dosing may differ by patient variables, POECLINTYP

such as age and organ function.
POEM currently supports limited
filtering of dosing order sets by age,
indication, and route of administration.
In applications designed without age
information, the prescriber can be
presented with all order sets specific to
the ordered drug, regardless of
indication and patient age.

Custom Dosage Orders

Custom dosage orders consist of a combination of:

Parsed data, which resides in the POEM Order String Table (RPOEOSR1_ORDER_STRING), POEM
Administration Rate Table (RPOEAR1_ADMINISTRATION_RATE), POEM Context Table

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(RPOECL1_CLIN_CONTEXT)
Additional Instructions text, which resides in the POEM Text Table (RPOETXT1_TEXT).

The parsed data elements consist of individual dosing attributes useful in building custom dosage orders and
conducting related calculations. Many of the data elements are contained in the RPOEOSR1_ORDER_STRING
table: their columns contain actual data used for custom dosage orders.

However, parsed data unit code columns and the route columns contained in the RPOEOSR1_ORDER_STRING
table contain unit codes that identify from which table row in the POEM Code Definition Table
(RPOECD1_DEFINITION) descriptions are being retrieved. The descriptions are accessed via the
POEUNITCDE column in the RPOECD1_DEFINITION table.

Most of the unit code columns in the RPOEOSR1_ORDER_STRING table have a U at the end of their name.
For example, POELOWDU is the POEM Low Dose Units Code and contains a unit code.

POEROUTE and POEROUTE_D, the route columns, also contain unit codes that identify which
descriptions are retrieved from the RPOECD1_DEFINITION table.

The descriptions in the RPOECD1_DEFINITION table are retrieved via the POEUNITCDE column. To access
descriptions, you must create a relationship between the desired unit code column in the
RPOEOSR1_ORDER_STRING table and the POEM Unit Code (POEUNITCDE) column in the
RPOECD1_DEFINITION table.

For example, the POEM Low Dose Units Code (POELOWDU) contains the number 0080 in the field for a row of
parsed data for POEOSTRID 0000018195 in the RPOEOSR1_ORDER_STRING table as shown below. The
POEM Low Dose (POELOWD) column is also shown since the POELOWDU column defines the unit of measure
for the low dose.

RPOEOSR1_ORDER_STRING Table

POEOSTRID POELOWD POELOWDU

0000018195 0000000000195 0080

195 is the low dose value, but in order to obtain the low dose unit, the RPOECD1_DEFINITION table must be
queried. In the RPOECD1_DEFINITION table, the POEUNITCDE 0080 identifies the row from which the
description is retrieved, as shown below.

RPOECD1_DEFINITION Table

POEUNITCDE POEUNITTYP POEDESC1 POEDESC2 POEDESC3

0080 2 MG

The POEUNITTYP 2 indicates the row contains Unit of Measure information. The POEDESC1 column is the only
description column populated in Unit of Measure table rows. Always retrieve POEDESC1 for units of measure.
(See "POEM Compliance with TJC and ISMP" above.)

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Once a relationship between the POELOWDU column in the RPOEOSR1_ORDER_STRING table and the
POEUNITCDE column in the RPOECD1_DEFINITION table is created, querying the RPOECD1_DEFINITION
table and retrieving the POEDESC1 column description produces the results as shown in the example below.

POEOSTRID POELOWD POEDESC1

0000018195 0000000000195 MG

How you create a relationship between the POELOWDU column, or any unit column, and the POEUNITCDE
column depends on the tool being used to manipulate the data. For example, if using Microsoft Access, creating a
relationship would require adding a Join Line from one table to the other, linking the two columns.

The preceding example is dealing with how to retrieve a single unit code column description. For instructions on
how to create a full custom dosage order with multiple unit code columns, refer to Creating Custom Dosage
Orders in the POEM Applications section.

An example of a custom dosage order, consisting of multiple parsed data elements, is shown below. Brackets ([])
are used to illustrate the individual pieces of data. Note that the 195 MG in the dosage order is the same low
dose information used for the example on the preceding pages, only presented here as part of a complete custom
dosage order.

Parsed Data columns

Parsed data columns are defined in the following table. Column names marked with an asterisk (*) indicate the
columns are unit code columns containing unit codes that identify from which table rows in the
RPOECD1_DEFINITION table the unit descriptions are retrieved:

Parsed Data Columns

Parsed Data Output Description Database Column Names

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Clinical Route* Clinical route of administration. For POEROUTE

example, Oral is the clinical route for
Potassium Iodide. The POEROUTE
column in the
RPOEOSR1_ORDER_STRING table
contains a unit code that corresponds
to the POEUNITCDE column in the
RPOECD1_DEFINITION table,
identifying the proper row from which
the route is retrieved. For example, a 2
064 in the POEROUTE column
identifies the row in the
RPOECD1_DEFINITION table
containing the POEUNITCDE 2064.
Always retrieve POEDESC1 for the
route. Retrieving POEDESC1 for the
example above results in Oral being
retrieved as the clinical route for
Potassium Iodide.

Route Description* Indicates which of the two description POEROUTE_D

columnsPOEDESC2 or POEDESC3
to retrieve from the
RPOECD1_DEFINITION table for the
route description. For example, take
and chew are two possible words that
can be retrieved for dosage orders
involving drugs taken by oral route.
The POEROUTE_D column always
contains a numeral 2 or 3.

The numeral 2 indicates retrieval

of the POEDESC2 column in the
RPOECD1_DEFINITION table.
The numeral 3 indicates retrieval
of the POEDESC3 column in the
RPOECD1_DEFINITION table.

Dose Form Amount Represents the number of dose form POELOWDFA

units required for each dose (for POEHIGHDFA
example, 2 tablets or 5 milliliters).

Dose Form Amount Units* Describes the dose form unit used for POELOWDFU
the Dose Form Amount (such as 2 tabl POEHIGHDFU
ets or 5 milliliters).

Dose Amount Numeric value for the dose. The dose POELOWD
can be represented as a fixed dose POEHIGHD
(for example, 500MG) or as a dose
that requires further calculation based
upon patient weight or body surface
area (for example, 0.06MG/kg or 1.2 G
/M2).

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Dose Amount Units* Describes the dose unit of measure POELOWDU

(such as 500MG, 0.06MG/KG, or 1.2 POEHIGHDU
G/M2).

Frequency Indicates how often to give the dose POELOWF

within a specified time interval (for POEHIGHF
example, 1 time every 8 hours or 3
times every 1 day).

Second Frequency Available if a second frequency is POESLOWF

applicable to a dosage order. POESHIGHF

Interval Describes numeric value for the period POELOWI

of time that each dose is to be POEHIGHI
administered (for example, 1 time
every 8 hours or 3 times every 1 day).

Interval Units* Representative of the unit of measure POELOWIU

used to describe each dose interval POEHIGHIU
(for example, 1 time every 8 hours or
3 times every 1 day).

Second Interval Available if a second interval is POESLOWI

applicable to a dosage order. POESHIGHI

Second Interval Units* Available if a second interval is POESLOWIU

applicable to a dosage order. POESHIGHIU

Duration Defines numeric value of the length of POELOWDR

therapy when applicable (for example, POEHIGHDR
7 days or 3 months).

Duration Units* Describes the unit of measure for the POELOWDRU

duration of therapy (for example, 7 day POEHIGHDRU
s or 3 months).

Additional parsed data can be presented for a custom drug dosage order using the POEM Administration Rate
Table (RPOEAR1_ADMINISTRATION_RATE) and the POEM Context Table (RPOECL1_CLIN_CONTEXT).
Highlighted rows indicate the columns are unit code columns containing unit codes that identify from which table
rows in the RPOECD1_DEFINITION table the unit descriptions are retrieved. The additional parsed data columns
include:

Parsed Data Output Description Database Column Name

Administration Rate Numeric value of the rate of POEADRT

administration (for example, over 20 mi (RPOEAR1_ADMINISTRATION_RAT
nutes or over 12 hours) E table)

Admin Rate Units* Describes the unit of measure for the POEADRTUNT
administration rate (for example, over (RPOEAR1_ADMINISTRATION_RAT
20 minutes or over 12 hours) E table)

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Clinical Context Range* Describes the unit of measure for the POERANGUNT
clinical context range. (for example, (RPOECL1_CLIN_CONTEXT)
between 5475 and 23724 days for age
range).

Common Usage Example

The example presented in this section has been created to illustrate some important relationships between tables
and columns within the tables. The example shows common pathways through some of the POEM database
tables. The example is presented through the use of a Microsoft Access Query for two primary reasons:

A precedent exists in the Sample Database section of this documentation for using Microsoft Access to
provide screen shots of database tables and queries.
To provide a visual representation of table/column relationships. Past feedback has indicated the POEM
database structure is one of the more complex database structures of all of the available modules in the
product. A high-level visual representation of a common pathway through the database may aid in
developing an understanding of table/column relationships in conjunction with the POEM Technical
Specifications and Entity Relationship Diagrams.

This example is not intended for use as an application algorithm. Refer to POEM Applications for detailed
POEM application algorithms.

ExampleRetrieving a Default Dosage Order String Text

The example is broken up into five parts that extend over the next several pages:

A Pathway Through the Database

Specifying a Clinical Formulation ID (GCN_SEQNO)
From Order Set ID to Order String ID
From Order String ID to Order String Text
Output

Part 1: A Pathway Through the Database

Figure 1. Default Dosage Order Pathway shows the Select Query window containing all of the tables involved in
the example. The tables and the Join Lines linking the tables represent a database pathway to a Default Dosage
Order String Text.

Figure 1 shows the high level, big picture representation of the pathway.

Parts 2-4 begin to move you step by step through the pathway, focusing on individual tables and their
relationships to one another.

Part 5 shows the resultant output after running the Select Query.

As Figure 1 illustrates, two tables have been included in the example that are not defined as a part of the POEM
module: the Ingredient List Identifier Description Table(RHICLSQ2_HICLSEQNO_MSTR)and the Clinical

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Formulation ID Table (RGCNSEQ4_GCNSEQNO_MSTR). However, all you need to know for the purposes of this
example is that those tables have been introduced here to provide a short version of the generic drug name in the
Select Query output.

For a better understanding of these two tables as they relate to modules, refer to Clinical Formulation and
Ingredient Data.

Figure 1: Default Dosage Order Pathway

Continue to Specifying a Clinical Formulation ID (GCN_SEQNO).

Part 2: Specifying a Clinical Formulation ID (GCN_SEQNO)

The Clinical Formulation ID (GCN_SEQNO) is a vital piece of data input that is required for retrieving any output
from the POEM database.

Figure 2: Specifying a Clinical Formulation ID (GCN_SEQNO) shows that the first two Select Query destination
fields retrieve information from the GNN column in theRHICLSQ2_HICLSEQNO_MSTRtable, which will provide a
short version of the generic drug name in the output, and the GCN_SEQNO column in the POEM GCN_SEQNO
Standard Order Table (RPOEGCS1_STANDARD_ORDER). GCN_SEQNO 1266 [potassium chloride] is
specified as the Criteria.

Join Line 1 in Figure 2 was created to link the HICL_SEQNO columns in

theRHICLSQ2_HICLSEQNO_MSTRtable and the RGCNSEQ4_GCNSEQNO_MSTR table, establishing the
relationship between the two tables.

Join Line 2 in Figure 2 was created to link the GCN_SEQNO columns in the RGCNSEQ4_GCNSEQNO_MSTR
table and the RPOEGCS1_STANDARD_ORDER table, establishing the relationship between those two tables.

The RPOEGCS1_STANDARD_ORDER table is the table in POEM from which the pathway between all Clinical
Formulation IDs (GCN_SEQNOs) and their Default Dosage Order String Texts, which are contained in the POEM
Text Table (RPOETXT1_TEXT), originates. The source information linked to a Clinical Formulation ID
(GCN_SEQNO) in the RPOEGCS1_STANDARD_ORDER table are:

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POEM Clinical Context Identifier (POECLINID)

POEM Order Set Identifier (POEOSETID)

Figure 2: Specifying a Clinical Formulation ID (GCN_SEQNO)

Continue to From Order Set ID to Order String ID.

Part 3: From Order Set ID to Order String ID

Figure 3: From Order Set ID to Order String ID shows that the next three destination fields specified for the Select
Query are retrieving information from the POEOSETID, POEM Order String Identifier (POEOSTRID), and POEM
Text Type Code (POETEXTTYP) columns.

Join Line 3 in Figure 3 was created to link the POEOSETID columns in the RPOEGCS1_STANDARD_ORDER
table and the POEM Order Set Table (RPOEOS1_ORDER_SET) to each other. In this example, the one-to-one
relationship between the POEOSETID and the POEOSTRID resides in the RPOEOS1_ORDER_SET table.

Join Line 4 in Figure 3 was created to link the POEOSTRID columns in the RPOEOS1_ORDER_SET and the
POEM Order String to Text Table (RPOEOSX1_TEXT_LINK) to each other.
The relationship between the POEOSTRID and the POEM Text Code ( POETEXTCDE) resides in the
RPOEOSX1_TEXT_LINK table.

The POETEXTTYP column also resides in the RPOEOSX1_TEXT_LINK table and it identifies to which type of
text the POETEXTCDE is linking. There are two types of text contained in POEM: Order String Text and
Additional Instructions text. This example is linking to Order String Text, which are text lines of pre-constructed,

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clinically validated dosage orders. Order String Text has a POETEXTTYP of 80. In Figure 2, the Criteria for
POETEXTTYP field is specified as 80, since the purpose of this example is to retrieve a Default Dosage Order
String Text.

Additional Instructions text, which have a POETEXTTYP of 90, are assigned their own POETEXTCDEs
and are available for use as part of custom dosage orders. For example, in the morning is an available
piece of Additional Instructions text.

Figure 3: From Order Set ID to Order String ID

Continue to From Order String ID to Order String Text.

Part 4: From Order String ID to Order String Text

Figure 4 (shown below) shows the final three Select Query destination fields are retrieving information from the
POETEXTCDE, POEM Text Line Number (POETXTNUM), and POEM Text Line (POETXLINE) columns.

Join Line 5 in Figure 4 was created to link the POETEXTCDE columns in the RPOE0SX1_TEXT_LINK table and
the POEM Text Table (RPOETXT1_TEXT) to each other. The relationship between the POETEXTCDEs and the
POETXLINEs resides in the RPOETXT1_TEXT table.

Within the RPOETXT1_TEXT table, POETEXTCDEs and POETXLINEs are linked to one another. The
POETXLINEs are the table rows that contain the two types of text in the RPOETXT1_TEXT table: Order String
Text and Additional Instructions text.

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The table also contains the POEM Language Code (POELANGCDE) and POEM Country Code (POECOCDE),
which identify the language and country for the text, respectively. Currently, POEM contains only one
POELANGCDE (01English) and one POECOCDE (01USA).

The POETXTNUM column sequentially numbers multiple table rows of the same Order String Text. Because of
spacing restrictions, some Order String Texts require multiple table rows. The multiple rows have the same
POETEXTCDE, but their existence creates a requirement that each row be sequentially identified for its proper
sequence in output.

In Figure 4, the Sort for POETEXTNUM field is specified as Ascending. The Order String Text for Clinical
Formulation ID (GCN_SEQNO) 001678 (Potassium Iodide) is contained in four separate table rows in the
RPOETXT1_TEXT table. Thus, the table rows sort in ascending order from 1-4 in the output.

Figure 4: From Order String ID to Order String Text

Continue to Output.

Part 5: Output
Running the Select Query for Clinical Formulation ID (GCN_SEQNO) 001678, with the specified information
discussed in Parts 2-4, produces the output as shown in Figure 5 below.

Output

Inclusion and Exclusion Criteria

POEM provides orders for prescription drug products while over-the-counter formulations are generally excluded.

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If a drug has prescription and over-the-counter dosage forms available in the same strength, POEM provides only
the prescription dosing for that compound.

A common dose may be represented by a partial tablet dosing (e.g., 0.5 tablet) if that strength is not available.
For example, if a drug is manufactured as 5 and 10MG tablets, 5MG (0.5 tablet) dosing of the 10MG tablet is not
generally provided but can be requested.

The default order string length/character count is intended for most drugs to meet e-prescribing standards (less
than or equal to 140 character count). When constructing Order Strings, additional administration instructions that
represent auxiliary label type additional instructions will not be added to stay within character limits (see LBLW
content).

Summary of POEM Inclusions:

FDA-approved prescription drugs (NDA/ANDA) or grand-fathered drugs

Non-FDA approved products that are designated as RX per FDB and have approved indications
Orders for FDA-approved indications
Orders with FDA-approved routes of administration
Drugs with FDA-approved dosage forms (e.g., tablets, capsules, milliliter, cream, ointment, etc.)
Dosing that applies to adults only (ages >=18 and <65 years) with normal organ function
Common maintenance dosing may include dosing adjusted for specific clinical conditions when the
adjusted dosing replaces the usual maintenance dosing, such as in patients experiencing Adverse Drug
Events (ADE).
Usual maintenance dose: infuse 15 mg/kg over 60 minute(s) by intravenous route on days 1 and 8
of a 21 day cycle
Adjusted maintenance dose for ADE: infuse 12 mg/kg over 60 minute(s) by intravenous route on
days 1 and 8 of a 21 day cycle
Orders that are loading/initial dosing that is required as a part of a complete dosing regimen
Inject 160 mg by subcutaneous route once on Day 1 of therapy; administer as 4 separate 0.4 mL
(40 mg) injections into abdomen or upper thigh
Inject 0.8 milliliter (80 mg) by subcutaneous route once on Day 15 of therapy; administer as 2
separate 0.4 mL (40 mg) injections into abdomen or upper thigh
Inject 0.4 milliliter (40 mg) by subcutaneous route every 2 weeks into abdomen or upper thigh
Single dose/Once: orders that are exclusively part of a dosing regimen for the medication and/or may be
commonly administered in an ambulatory setting
Medication administered annually: inject 0.5 mL by intramuscular route once
Medication administered as one-time dose: insert 1 applicatorful by vaginal route once
Medication administered every 3 months: inject 11.25 mg by intramuscular route once
Drug product strengths that only represent non-maintenance dosing used for drug titration or as adjusted
dose for drug toxicity
Example of dose titration:

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Usual maintenance dose is 100 mg once daily; include orders for 50 mg tablet:
take 1 tablet (50 mg) by oral route once daily at bedtime
take 1 tablet (50 mg) by oral route once daily at bedtime for 7 days
Example of dose adjustment for toxicity:
Usual maintenance dose is 250 mg twice daily; 100 mg tablet represents adjustment dose for
toxicity (e.g., neutropenia); include orders for 100 mg tablet:
take 1 tablet (100 mg) by oral route once daily
Orders that are limited to a maximum number of dosage units depending on dosage form, unless the only
maintenance dosing is a number of dosage form units greater than the usual maximum (example dosage 2
tabs/20 mL):
Solid oral dosage form limit: 2 tablets/2 capsules
Oral liquids dosage form limit: 20 mL
Intramuscular injectables: an appropriate dose and volume based on the strength of the product
able to be administered by the given route: 30 mg (3 mL) by IM route
Subcutaneous injectables: an appropriate dose and volume based on the strength of the product
able to be administered by the given route: 20 mg (2 mL) by SQ route
Product requiring reconstitution: if there is no volume of dilution given, there will be no volume in the
string: inject 0.2 mg by intramuscular route 1/2-1 hour before induction of anesthesia
Pen-injector dosing can be represented by the pen markings only and/or the usual dose and volume
representations
Inject 1.2 mg by subcutaneous route once daily
Inject 0.5 milliliter (1.5 mg) by subcutaneous route once weekly in the abdomen, thigh, or upper arm
rotating injection sites
Dose packs/Starter packs may be included in POEM using usual pack dosing directions if the order string
is <=140 characters; if the 140-character count is exceeded by required directions, dosing directions of
take by oral route as directed per package directions may be utilized
Example: Dose pack: take by oral route as directed per package instructions

Summary of generally Excluded orders/drugs that may be ADDED UPON REQUEST:

Orders for common, unlabeled/off-labeled indications

Orders for common, unlabeled/off-labeled routes of administration
Over-the-counter medications
Partial tablet dosing (e.g., 0.5 tab) for a dosage-form strength when a lower strength representing that "1/2
tab" dose amount is available as a distinct strength

Summary of Exclusions:

Orders explicitly for pediatric patients (age <18 years)

Orders explicitly for geriatric patients (age >=65 years)
Orders adjusted for organ impairment (examples: renal disease, hepatic disease)

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Non-FDA approved, compounded drug products (example: Marys Magic Potion, fentanyl
citrate/ropivacaine HCl 4 mcg/mL-0.2 % iso-osmtc Epidural Plastic Bag)
Medical devices (examples: insulin pump, PCA pump)
Medical supplies (examples: bandages, diabetic test kits, and contraceptive devices)
Large and small volume parenterals that are categorized as maintenance fluids (examples: dextrose in
water, 0.9% sodium chloride, amino acids/other base solutions and additives used for compounding TPNs)
Diluents (example: sterile water for injection)
Nutritional and Dietary supplements (e.g., enteral feeding products)
Anesthetic gases (examples: isoflurane, nitrous oxide)
Radiologic contrast media products (examples: gadobenate dimeglumine, gadobutrol)
Drugs that are exclusively dosed based upon a laboratory-determined variable (examples: Digoxin Immune
FAB based on digoxin levels, antihemophilic factors based on current vs. target factor levels)
Homeopathic, and/or herbal containing products (examples: red yeast rice, black cohosh)
Drugs in kits and combination packages that contain more than one drug formulation and/or dosage form
(examples: Helidac, Prevpac)
Orders for pediatric dosage forms not traditionally used or labeled for use in the adult population (example:
pediatric drops)
Drugs available as bulk powders, ointment bases, and other products categorized/used exclusively for
compounding (examples: hydrocortisone bulk powder, lipophilic ointment base)

Maintenance
FDB utilizes a variety of sources to identify and update dosing data, including manufacturer product information,
regulatory agency notifications, and clinical references. Drug products are added to and/or updated in POEM
based upon both external and internal review triggers.

Triggers for Clinical Review

External Triggers for Clinical Review:

The external triggers that prompt data review and adds include, but are not limited to the following:

MedWatch Safety Alerts

CDERnew
MedWatch label changes (monthly)
Customer inquiries

Internal Triggers for Clinical Review:

The internal triggers that prompt data review and adds to module(s) include, but are not limited to the following:

new or updated Clinical Formulation ID (GCN_SEQNO)

changes/additions to FDBs Indications Module
updates performed to other FDB dosing content

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Sources
FDB utilizes many reference sources including, but not limited to, manufacturer product package inserts,
medical/pharmacy reference texts, published expert treatment guidelines, and primary medical literature
(published medical journal articles). FDB uses current source editions when adding/updating data and
researching questions related to the module data.

References commonly consulted for dosing information included in POEM are:

Manufacturer Product Labeling (US FDA-approved)

American Hospital Formulary Service Drug Information (AHFS)
APhA Drug Information Handbooks

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Prescriber Order Entry Module Editorial Policies

The policies and criteria that apply to the scope, processes, and sources of the Prescriber Order Entry
Module are provided in the following sections:

Scope
Editorial Process
Maintenance

Scope
As part of the implementation of POEM, alternative dosage orders based on related medical conditions can be
programmed to be presented to end users when knowledge of a patients age and/or medical condition is limited.
However, implementation of POEM should be designed to allow the prescriber to apply personal knowledge of
patient clinical status and diagnosis when selecting the appropriate dosage order.

Figure 1 provides a high level representation of data required as input and information provided as output within
POEM.

POEM Data Flow Representation

POEM data is linked to the GCN_SEQNO, one of the important FDB Multiple Access Points (MAPs), page
42. MAPs provide access to other FDB clinical modules, supporting a range of applications using MedKnowledge
data.

Limitations

Healthcare professionals are expected to use manufacturers packaging information and dosage reference texts
when prescribing medications for pediatric or geriatric patients. They should also consult these sources if dosing
can be affected by tobacco or alcohol use, gender, or organ failure. FDBs Dosage Range Check Module

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(DRCM) 3.1 and Neonatal and Infant Dosage Range Check Module (NEOM) 1.1 are also available as
dosing information sources (see Dosing).

POEM provides dosage information for prescription formulations of drug products. If a drug has prescription and
over-the-counter dosage forms available in the same strength, POEM provides only the prescription dosing for
that compound.

Additionally, partial tablet dosing (such as tablet or tablet) is not available when a tablet dosage form is
available from the manufacturer in several strengths and dose amount can be represented by a single tablet of a
lower strength. For example, if a drug is manufactured in 5 and 10MG tablets, 5MG ( tablet) dosing of the 10MG
tablet is not provided.

Editorial Process
The following section describes the processes and criteria the clinical editors use to add or review database
elements.

External Triggers for Clinical Review

The external triggers that prompt the clinical editors to add or review data are the following:

MedEffects Alerts from Health Canada

MedWatch Safety Alerts

Internal Triggers for Clinical Review

The internal trigger that prompts the clinical editors to add or review data is a new Clinical Formulation ID
(GCN_SEQNO).

Duration Range Guidelines

When standard references report length of therapy as a range, the duration of therapy described in POEM varies
depending on the type of drug.

POEM Duration Range Example 1

For an antibiotic... POEM provides the following Order String Texts...

Take 250mg every 8 hours for 7-14 days Take 1 capsule (250mg) every 8 hours for 7 days.
Take 1 capsule (250mg) every 8 hours for 14 days.
Take 1 capsule (250mg) every 8 hours.

The string with no designated duration is provided so that the prescriber may decide on a duration less than,
greater than, or between the usual duration range.

POEM Duration Range Example 2

For drugs such as pain medications... POEM provides the following Order String Text...

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Take 1 tablet every 4 hours as needed for pain for 7-10 Take 1 tablet (325mg) every 4 hours as needed for pain for
days 7-10 days

Since pain medications are usually given on an as needed basis, the duration range is not separated. The
prescriber can decide on a quantity.

Frequency and Interval Guidelines

Order String Texts within POEM reflect dosage frequencies and intervals as reported in the literature for the
majority of agents.

POEM Order String Text Example 1

For this dose... POEM provides the following Order String Texts...

Take 250mg every 6 hours. Take 1 capsule (250mg) every 6 hours.

Take 250mg 4 times daily. Take 1 capsule (250mg) 4 times daily.

However, for some agents, more consistent dosing may be required to achieve desired drug levels and
therapeutic effects. If the frequency for such an agent is reported as a non-specific interval, then both the
non-specific interval and the specific interval are provided. If the frequency for such an agent is reported as a
specific interval, then only the specific interval is provided.

POEM Order String Text Example 2

For an antibiotic... POEM provides the following Order String Texts...

Take 1 capsule 4 times daily. Take 1 capsule (250mg) 4 times daily.

Take 1 capsule (250mg) every 6 hours.

Take 1 capsule every 6 hours. Take 1 capsule (250mg) every 6 hours.

Inclusion and Exclusion Criteria

Drug dosage orders offered in POEM are for adults (18 years <= 64 years) with normal organ function. Dosing is
added only for labeled indications and within labeled amounts. Uses and doses outside of this criteria will not be
added.

Exclusions

Clinical Formulations that belong to the following therapeutic categories are excluded from POEM due to the
great degree of variability in dosing dependent upon clinical situation and patient factors:

Large and small volume parenterals, including dextrose in water, sodium chloride, amino acids for TPNs,
lipids, sterile water for injection, and other diluents.
Dietary supplements, including those for enteral feeding.
Anesthetic gases.
Drugs such as Digoxin Immune FAB and MESNA, which are dosed based upon the dose/serum level of

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another drug.
Medical supplies, including IV pumps, bandages, diabetic test kits, and contraceptive supplies are
excluded because they do not have dosage ranges.
Natural or homeopathic products are excluded because of the challenges associated with products not
approved by the FDA, such as the lack of FDA-approved labeling.
Kits and other individual products packaged together in a combination package, such as Helidac and
Prevpac, are excluded because of the complexity related to multiple dosage forms and units. Individual
products, which make up the kit or combination package are included if appropriate.
Obsolete products in a newly-included category are excluded. Products that are included and then become
obsolete will continue to carry doses.
Dosage forms not traditionally used in the adult population. For example, pediatric acetaminophen drops.
Although over-the-counter medications are also normally excluded, they can be considered for inclusion
upon customer request.

Dosage Form Attributes

Dosage Form Attributes are dosage form components by which Master Dosage Forms may be identified,
delineated, or grouped. It is possible to group associated drug products by using dosage form attributes as
components of the search. For example, it is possible to search for and locate Medication Concepts which are
oral liquid formulations with a specific ingredient list by limiting the search to dosage forms with an attribute of
liquid and a route of oral. See Dosage Form for more information.

Maintenance
The Dosing Editors review a variety of sources to identify and update dosing data, including manufacturer product
information, regulatory agency notifications and clinical references. Such a review may be initiated by events such
as creation of a new Clinical Formulation ID, FDA approval for a new chemical entity, receipt of a
MedWatch/Health Canada Med Effects alert, change in manufacturer labeling, and/or customer inquiries.

Reference Data Evaluation

FDB clinical editors compare, review, and compile the clinical information contained within these and other clinical
data sources to identify the dosing content for a given age, clinical route, indication and dose type.

Sources
This section lists sources that may be used by FDB Editors to compile the dosing information considered for
inclusion within dosing modules.

Manufacturer Product Labeling (country-specific based on product approval/availability)

AAP Pediatric Care Online
AAP Redbook
American Hospital Formulary Service Drug Information (AHFS)
APhA Drug Information Handbook

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APhA Geriatric Dosage Handbook

APhA Pediatric and Neonatal Dosage Handbook
British National Formulary
British National Formulary for Children
Drug Prescribing In Renal Failure
Harriet Lane Handbook
Martindale: The Complete Drug Reference
Natural Medicines Comprehensive Database
Neonatology-Gomella
Pediatric Dosing Expert Panel (PDEP), convened by FDB
Primary Medical Literature (when appropriate)
Specialty References/Textbooks
Specialty Guidelines, Consensus
The Renal Drug Handbook

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POEM Applications
This section provides information about the practical application of data contained in this module. All of the
dosage information in the POEM database is formatted as either Order String Text or parsed data. The
applications in this section explain how to retrieve both Default Dosage Orders and Dosage Orders in either the
Order String Text format or the parsed data format. In addition, a formula for calculating prescription quantities is
covered.

A Clinical Formulation ID (GCN_SEQNO) is required as input for using POEM.

Using the POEM GCN_SEQNO POEM Source Table (RPOEGSQ2_GCNSEQNO_MSTR), information systems
can gain access to specific dosage information. An Order String Text is presented or parsed data is retrieved
based on the specified Clinical Formulation ID (GCN_SEQNO) and the patient data, including age and indication
being treated. The POEM Order String Table (RPOEOSR1_ORDER_STRING) contains the dosage data in a
parsed format which can be used to perform calculations or display alternative text.

In order entry systems integrated with a patient record, dosage order sets specific to patient diagnosis, age, and
other clinical parameters can be presented to the healthcare provider.

Retrieving Default Dosage Order String Text

Retrieving Dosage Order String Text

Creating Custom Dosage Orders

Calculating Prescription Quantity

Retrieving Dosage Orders for Related Disease States

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Retrieving Default Dosage Order String Text

The POEM GCN_SEQNO Standard Order Table (RPOEGCS1_STANDARD_ORDER) offers the prescriber a
Default Dosage Order, independent of indication. Once the end-user application displays the drugs Default
Dosage Order for the prescriber, the prescriber may then choose to accept or reject the default. Depending on
the implementation, the end-user application can then display a list of Dosage Orders, which are indication
specific, should the prescriber reject the default.

Default Dosage Orders are also available in a parsed data format. Refer to Creating Custom Dosage Orders for
more information.

A Clinical Formulation ID (GCN_SEQNO) is required as input for retrieving a Default Dosage Order. The patient
age (in days) is also recommended for input.

For purposes of demonstrating this application, the following scenario is used: The following application
provides steps to retrieve the Default Dosage Order String Text for a 13,000-day old (35-year old) patient with
normal organ function. Input for the retrieval is Clinical Formulation ID (GCN_SEQNO) 029968 (atorvastatin
calcium).

To retrieve Default Dosage Order String Text, complete the following steps:

1. Query the RPOEGCS1_STANDARD_ORDER table and retrieve the POEM Order Set Identifier (
POEOSETID) and the Clinical Context Identifier (POECLINID) associated with the specified Clinical
Formulation ID (GCN_SEQNO). For example:

GCN_SEQNO POECLINID POEOSETID

029968 000001 000634

Only one POEOSETID is associated with any given Clinical Formulation ID (GCN_SEQNO) in the
RPOEGCS1_STANDARD_ORDER table. The table is the source for linkage to the one dosage
order determined by FDB clinicians to be the most common dosage order for a given Clinical
Formulation ID (GCN_SEQNO), independent of indication.

If a POEOSETID is not retrieved, display this message to the end-user: Dosage information is not
available.

2. For each retrieved POEOSETID linked to a POECLINID with a value of 000001 (Age), query the POEM
Context Table (RPOECL1_CLIN_CONTEXT) and retrieve the POEM Minimum Range (POEMINRANG)
and POEM Maximum Range (POEMAXRANG) values and compare the calculated patient age in days to
the ranges. For example:

POEOSETID POECLINID POEMINRANG POEMAXRANG

000634 000001 000005475 000023724

If the patient age is less than the POEMINRANG or greater than the POEMAXRANG, remove the
POEOSETID from the queue of retrieved POEOSETIDs. If the patient age is unknown or unavailable,

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include range information when displaying dosage text to the end user. In this scenario, the patient is
13,000 days old, which falls within the minimum and maximum age range.

3. Query the POEM Order Set Table (RPOEOS1_ORDER_SET) and retrieve the POEM Order String
Identifier (POEOSTRID) associated to the retrieved POEOSETID. For example:

POEOSETID POEOSTRID

000634 000634

4. Query the POEM Order String to Text Table (RPOEOSX1_TEXT_LINK) and retrieve the POEM Text Code
(POETEXTCDE) associated to the retrieved POEOSTRID. Specify 80 for the POEM Text Type Code (
POETEXTTYP), which specifies the retrieval is for Order String Text. For example:

POEOSTRID POETEXTTYP POETEXTCDE

000634 80 0000000634

5. Query the POEM Text Table (RPOETXT1_TEXT) and retrieve the POEM Text Line ( POETXLINE), which
is the Order String Text, associated to the retrieved POETEXTCDE. For example:

POETEXTCDE POETXLINE

000634 take 1 tablet (20mg) by oral route once daily

6. Display the retrieved Order String Text, allowing end user to select or reject the default dosage order. For
example:

7. The end user selects or rejects the Default Dosage Order.

If the end user rejects the Default Dosage Order, offer the option for the user to view orders
specific to the drugs indications. Refer to Retrieving Dosage Order String Text for more
information.

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Retrieving Dosage Order String Text

With a Clinical Formulation ID (GCN_SEQNO) and drug indication, Dosage Orders specific to each Order Set
Identifier can be retrieved and presented to the prescriber.

A Clinical Formulation ID (GCN_SEQNO) is required as input for retrieving Dosage Orders. Indication and patient
age (in days) are also recommended for input.

Dosage Orders are associated with indication. A single Clinical Formulation ID (GCN_SEQNO) can have multiple
orders based on the different indications associated with it. For example, the following table shows a sampling of
the data for Clinical Formulation ID (GCN_SEQNO) 008995 taken from the POEM GCN_SEQNO POEM Source
Table (RPOEGSQ2_GCNSEQNO_MSTR):

GCN_SEQNO FDBDX DXID

008995 01.088810 00000244

008995 01.099550 00000297

008995 06.382000 00001378

The DxID and FDBDX values (indications) and descriptions in the following table are found for the sampling of
data for Clinical Formulation ID (GCN_SEQNO) 008995.

DXID FDBDX Description

00000244 01.088810 Lyme Disease

00000297 01.099550 Genitourinary Chlamydia Trachomatis

00001378 06.382000 Acute Otitis Media, H. Influenzae

As shown, it is possible for a wide variety of indications to be associated with a single Clinical Formulation ID
(GCN_SEQNO), each of which can substantially alter the details of a Dosage Order.

When retrieving Dosage Orders, all of the orders for all of the indications associated with a Clinical Formulation ID
(GCN_SEQNO) can be retrieved, which, in some cases, can be quite large. However, a more common use is to
retrieve orders for a Clinical Formulation ID (GCN_SEQNO) based on any indications associated with the patient
for which the order is being retrieved.

Dosage Orders are also available in a parsed data format. Refer to Creating Custom Dosage Orders for more
information.

Refer to Retrieving Default Dosage Order String Text for information about Default Dosage Orders which are
dosage orders independent of indication.

For purposes of demonstrating this application, the following scenario is used: The following application
provides steps to retrieve Dosage Order String Text for a 13,000-day old (35-year old) patient with normal organ

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function. Input for the retrieval is Clinical Formulation ID (GCN_SEQNO) 008995 (amoxicillin trihydrate). In
addition, the patient has been diagnosed with Genitourinary Chlamydia Trachomatis, which has a DxID of
00000297 and an FDBDX of 01.099550.

When creating Dosage Orders, use either the DxID or the FDBDX column for specifying indication. FDB
recommends using the DxID column.

To retrieve Dosage Order String Text, complete the following steps:

1. Query the POEM GCN_SEQNO POEM Source Table (RPOEGSQ2_GCNSEQNO_MSTR) and retrieve all
POEM Order Set Identifiers (POEOSETID) and Clinical Context Identifiers (POECLINID) associated to the
Clinical Formulation ID (GCN_SEQNO), along with either a specified DxID or FDBDX value. For example:

GCN_SEQNO POEOSETID POECLINID DXID

008995 000373 000001 00000297

008995 000375 000001 00000297

008995 008192 000001 00000297

008995 008194 000001 00000297

008995 009300 000001 00000297

008995 009301 000001 00000297

2. For each retrieved POEOSETID associated to a POECLINID with a value of 000001 (Age), query the
POEM Context Table (RPOECL1_CLIN_CONTEXT) and retrieve the POEM Minimum Range (
POEMINRANG) and POEM Maximum Range (POEMAXRANG) values and compare the calculated patient
age in days to the ranges. For example:

POEOSETID POECLINID POEMINRANG POEMAXRANG

000373 000001 000005475 000023724

000375 000001 000005475 000023724

008192 000001 000005475 000023724

008194 000001 000005475 000023724

009300 000001 000005475 000023724

009301 000001 000005475 000023724

If the patient age is less than the POEMINRANG or greater than the POEMAXRANG, remove the
POEOSETID from the queue of previously retrieved POEOSETIDs. If the patient age is unknown or
unavailable, include range information when displaying dosage text to the end user. In this scenario, the
patient is 13,000 days old, which falls within the minimum and maximum age range.

3. Query the POEM Order Set Table (RPOEOS1_ORDER_SET) and retrieve the POEM Order String

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3.

Identifiers (POEOSTRID) associated to the retrieved POEOSETIDs. For example:

POEOSETID POEOSTRID

000373 0000000373

000375 0000000375

008192 0000008192

008194 0000008194

009300 0000009300

009301 0000009301

4. Query the POEM Order String to Text Table (RPOEOSX1_TEXT_LINK) and retrieve the POEM Text
Codes (POETEXTCDE) associated to the retrieved POEOSTRIDs. Specify 80 for the POEM Text Type
Code (POETEXTTYP), which specifies the retrieval is for Order String Text. For example:

POEOSTRID POETEXTTYP POETEXTCDE

0000000373 80 0000000373

0000000375 80 0000000375

0000008192 80 0000008192

0000008194 80 0000008194

0000009300 80 0000009300

0000009301 80 0000009301

5. Query the POEM Text Table (RPOETXT1_TEXT) and retrieve the POEM Text Lines (POETXLINE)
associated to the retrieved POETEXTCDEs. For example:

POETEXTCDE POETXTNUM POETXLINE

0000000373 001 take 2 capsules (500mg) by oral

route 3 times per day for 10 days

0000000375 001 take 2 capsules (500mg) by oral

route every 8 hours for 10 days

0000008192 001 take 2 capsules (500mg) by oral

route 3 times per day

0000008194 001 take 2 capsules (500mg) by oral

route every 8 hours

0000009300 001 take 2 capsules (500mg) by oral

route 3 times per day for 7 days

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0000009301 001 take 2 capsules (500mg) by oral

route every 8 hours for 7 days

If a retrieved POETXLINE consists of multiple table rows, sort the results in ascending order using
the POETXTNUM column.

6. Display the retrieved Order String Text, allowing the end user to select the desired dosage:

ORDER STRING TEXT

Take 2 capsules (500mg) by oral route 3 times per day for 10 days.

Take 2 capsules (500mg) by oral route every 8 hours for 10 days.

Take 2 capsules (500mg) by oral route 3 times per day.

Take 2 capsules (500mg) by oral route every 8 hours.

Take 2 capsules (500mg) by oral route 3 times per day for 7 days.

Take 2 capsules (500mg) by oral route every 8 hours for 7 days.

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Creating Custom Dosage Orders

Users can create custom dosage orders using parsed data for any of their special needs. Parsed data can be
presented using the POEM Order String Table (RPOEOSR1_ORDER_STRING) and the POEM Code Definition
Table (RPOECD1_DEFINITION).

All of the dosage information in the POEM database is formatted as both Order String Text and parsed data. In
order to illustrate the parsed data concept and how the database tables relate to one another, the application
presented in this section focuses on how to retrieve the parsed data to match the Order String Text shown below.

Order String Text [POETEXTCDE: 0000018195, POETEXTTYP: 80]

Parsed Data

The words by and route in the parsed data are suggested additions to the order for displaying POEROUTE that
the user supplies through the application which is being used to create the dosage orders. Refer to Suggestions
for Displaying Parsed Data for more suggestions for displaying the different types of parsed data.

For purposes of demonstrating this application, the following scenario is used: The following application
provides steps to retrieve parsed data to match the Order String Text pictured on the previous page. The patient
for the scenario is a 13,000-day old (35-year old) patient with normal organ function. Input for the retrieval is
Clinical Formulation ID (GCN_SEQNO) 001678 (potassium iodide). In addition, Thyroid Gland Radiation
Protection is an associated indication, which has a DxID of 593 and an FDBDX of 03.246903.

When creating Dosage Orders, use either the DxID or the FDBDX column for specifying indication. FDB
recommends using the DxID column.

1. Query the POEM GCN_SEQNO POEM Source Table (RPOEGSQ2_GCNSEQNO_MSTR) and retrieve all
POEM Order Set Identifiers (POEOSETID) and Clinical Context Identifiers (POECLINID) associated to the
Clinical Formulation ID (GCN_SEQNO), along with either a specified DxID or FDBDX value. For example:

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GCN_SEQNO POEOSETID POECLINID DXID

001678 018195 000001 00000593

Substitute the POEM GCN_SEQNO Standard Order Table (RPOEGCS1_STANDARD_ORDER)

in place of the RPOEGSQ2_GCNSEQNO_MSTR table to retrieve parsed data for Default Dosage
Orders.

2. For each retrieved POEOSETID associated to a POECLINID with a value of 000001 (Age), query the
POEM Context Table (RPOECL1_CLIN_CONTEXT) and retrieve the POEM Minimum Range (
POEMINRANG) and POEM Maximum Range (POEMAXRANG) values and compare the calculated patient
age in days to the ranges. For example:

If the patient age is less than the POEMINRANG or greater than the POEMAXRANG, remove the
POEOSETID from the queue of retrieved POEOSETIDs. If the patient age is unknown or unavailable,
include range information when displaying dosage text to the end user. In this scenario, the patient is
13,000 days old, which falls within the minimum and maximum age range.

3. Query the POEM Order Set Table (RPOEOS1_ORDER_SET) and retrieve the POEM Order String
Identifiers (POEOSTRID) associated to the retrieved POEOSETIDs. For example:

POEOSETID POEOSTRID

018195 0000018195

If there are multiple returns, sort the POEOSETID and POEOSTRID columns in ascending order.

4. Query the POEM Order String Table (RPOEOSR1_ORDER_STRING) and retrieve the same
POEOSTRIDs that were retrieved in the previous step. Each POEOSTRID identifies a table row of parsed
data from which you can retrieve desired values. The following example shows results for a retrieval for
POESTRID 000018195:

POEOSTRID POEROUTE POEROUTE_ POELOWD POELOWDU POELOWDF POELOWDF

D A U

0000018195 2064 2 00000000001 0080 0000003 3006

95

The POEM Low Dose (POELOWD) and POEM Low Dose Form Amount (POELOWDFA) columns contain
the retrievable values for the custom drug order, 195 and 3, as shown. However, all of the Unit Code
columns in the RPOEOSR1_ORDER_STRING table contain unit codes that identify from which table rows
in the POEM Code Definition Table (RPOECD1_DEFINITION) the unit description is retrieved.

Most of the Unit Code columns have names that end with a U. POEROUTE and POEROUTE_D,
although they dont end in a U, also contain unit codes that identify which descriptions are
retrieved from the RPOECD1_DEFINITION table.

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Unit Code columns contain POEM Unit Codes and these codes correspond to a table row in the
RPOECD1_DEFINITION table. Each row in the RPOECD1_DEFINITION table begins with the POEM Unit
Code (POEUNITCDE) column, which is the primary key into the table. The POEUNITCDE columns contain
a matching Unit Code for the Unit Code columns in the Order String table. For example, the POELOWDU
column contains Unit Code 0080. A table row in the RPOECD1_DEFINITION table begins with
POEUNITCDE 0080, which is the row from which the description for the low dose unit is retrieved.

5. Query the RPOECD1_DEFINITION table and retrieve the descriptions for all of the desired Unit Code
columns, including POEROUTE and POEROUTE_D. Create a relationship between the Unit Code
columns in the RPOEOSR1_ORDER_STRING table and the POEUNITCDE column in the
RPOECD1_DEFINITION table for each description being retrieved. The following example shows the
results for a retrieval for descriptions for the POEROUTE, POEROUTE_D, POELOWDU, and
POELOWDFU columns. Sub-steps 5A-5C explain how these results are retrieved column by column.

POEOSTRID POEDESC1 POEDESC2 POELOWD POEDESC1 POWLOWDF POEDESC2

A

0000018195 Oral take 00000000001 MG 0000003 milliliters

95

The RPOEOSR1_ORDER_STRING and RPOECD1_DEFINITION tables have a unique and complex

relationship in the POEM database. In order to illustrate how the results pictured in Step 4 were achieved,
the table row of parsed data for POEOSTRID 0000018195 in the RPOEOSR1_ORDER_STRING table
shown in Step 4 is repeated below, along with all of the associated RPOECD1_DEFINITION table rows
from which descriptions are being retrieved. Note that within each row in the Definition table, the POEM
Unit Code Type (POEUNITTYP) identifies the type of information contained in that row.
RPOEOSR1_ORDER_STRING Table

POEOSTRID POEROUTE POEROUTE_ POELOWD POELOWDU POELOWDF POELOWDF

D A U

0000018195 2064 2 00000000001 0080 0000003 3006

95

RPOECD1_DEFINITION Table

POEUNITCDE POEUNITTYP POEDESC1 POEDESC2 POEDESC3

2064 3 oral take chew

0080 2 MG

3006 1 milliliter milliliters

a. Create a relationship between the POEROUTE column in the RPOEOSR1_ORDER_STRING table

and the POEUNITCDE column in the RPOECD1_DEFINITION table and then query the
RPOECD1_DEFINITION table and retrieve the descriptions for the POEROUTE and
POEROUTE_D columns.

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As shown, the POEROUTE column contains the Unit Code 2064, which identifies the table row in
the Definition table the route for the dosage order is retrieved via POEUNITCDE 2064. The
POEUNITTYP in that row is 3, which indicates that the row contains Route of Administration
information. The POEDESC1 column always contains the route in Route of Administration table
rows. Always retrieve the POEDESC1 column for route. The POEROUTE_D column is the route
description and is directly associated with the POEROUTE column. The route description is always
retrieved from the same table row as the route. The POEROUTE_D column identifies which route
description should be retrieved, either the POEDESC2 or POEDESC3 column, based on the
numeral it contains. The POEROUTE_D column always contains a numeral 2 or 3. If a 2, retrieve
POEDESC2. If a 3, retrieve POEDESC3. Since POEROUTE_D contains a 2, retrieve POEDESC2.
Retrieving POEDESC1 results in Oral for the route and retrieving POEDESC2 results in take for the
route description.

b. Create a relationship between the POELOWDU column in the RPOEOSR1_ORDER_STRING table

and the POEUNITCDE column in the RPOECD1_DEFINITION table and then query the
RPOECD1_DEFINITION table and retrieve the description for the POELOWDU column.
The POELOWDU column contains the Unit Code 0080, which identifies the table row in the
Definition table from which the description for the low dose unit of measure is retrieved via
POEUNITCDE 0080. The POEUNITTYP in that row is 2, which indicates the row contains Unit of
Measure information. The POEDESC1 column is the only description column populated in Unit of
Measure table rows. Always retrieve the POEDESC1 column for units of measure. Retrieving
POEDESC1 results in MG for the low dose unit of measure.

The POEDESC1 column may contain a text description for dosage form unit, unit of
measure, or route, depending on the POEUNITTYP. If the POEDESC1 column contains
Dosage Form abbreviations (POEUNITTYP = 1) or Unit of Measure abbreviations
(POEUNITTYP = 2), the PEODESC1 column might be considered inappropriate by The
Joint Commission (TJC) and Institute for Safe Medication Practices (ISMP) contain. To
retrieve the corresponding TJC-compliant unit descriptions for the given unit in the
PEODESC1 column, query the Units Description Table. Create a relationship between the
POEDESC1 column and the DOSING_MODULE_UNIT_ABBREV column in the Units
Description Table.

c. Create a relationship between the POELOWDFU column in the RPOEOSR1_ORDER_STRING

table and the POEUNITCDE column in the RPOECD1_DEFINITION table and then query the
RPOECD1_DEFINITION table and retrieve the description for the POELOWDFU column.
The POELOWDFU column contains the Unit Code 3006 which identifies the table row from which
the low dose form unit description is retrieved in the Definition table via POEUNITCDE 3006. The
POEUNITTYP in that table row is 1, which indicates the row contains Dosage Form information.
The POEDESC1 and POEDESC2 columns are populated in the Dosage Form rows with the same
dosage form in each column. However, POEDESC1 always contains the singular form and
POEDESC2 always contains the plural form. If the dosage form amount is a 1, always retrieve

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POEDESC1. If the dosage form amount is 2 or more, retrieve POEDESC2. The POELOWDFA
column contains a 3, so retrieving POEDESC2 results in the plural milliliters for the low dosage
form unit.
Once again, the results after retrieving the descriptions in steps 5a-c are shown in the following
table:

POEOSTRID 0000018195

POEDESC1 oral

POEDESC2 take

POELOWD 0000000000195

POEDESC1 MG

POELOWDFA 0000003

POEDESC2 milliliters

6. If you want to retrieve Additional Instructions text associated with the parsed data, query the POEM Order
String to Text Table (RPOEOSX1_TEXT_LINK) and retrieve all POEM Text Codes (POETEXTCDE)
associated to the retrieved POESTRIDs. Specify 90 for the POEM Text Type Code (POETEXTTYP), which
indicates the retrieval is for Additional Instructions text. For example:

POEOSTRID POETEXTTYP POETXTSTRL POETEXTCDE

0000018195 90 1 1000018195

0000018195 90 2 1000018195

The POETXTSTRL column suggests where in the custom dosage order the Additional Instructions
text should appear.

7. Query the POEM Text Table (RPOETXT1_TEXT) and retrieve the POEM Text Lines ( POETXLINE)
associated to the retrieved POETEXTCDEs. Sort the POETEXTCDE and POETXTNUM columns in
ascending order. For example:

POETEXTCDE POETXTNUM POETXLINE

1000018195 1 diluted in a full glass (240ml) of

water, fruit juice, milk, or broth

2000018195 1 24 hours prior to and once daily for

10 days following administration

2000018195 2 of, or exposure to, radioactive

isotopes of iodine

The parsed data retrieved in the preceding application is shown below:

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Suggestions for Displaying Parsed Data

The following sections contain suggestions for displaying the different types of parsed data.

Displaying Route

Column: POEROUTE

The following tables contain a sample of route data:

RPOEOSR1_ORDER_STRING TABLE

POEROUTE

2064

RPOECD1_DEFINITION TABLE

POEUNITCDE POEDESC1

2064 ORAL

Display Suggestion

by + POEDESC1 (retrieved from the RPOECD1_DEFINITION table) + route

For example: by oral route

Displaying Dose

Low Dose Columns: POELOWD and POELOWDU

High Dose Columns: POEHIGHD and POEHIGHDU

The following tables contain a sample of dose data:

RPOEOSR1_ORDER_STRING TABLE

POELOWD POELOWDU POEHIGHD POEHIGHDU

0000000000200 0080 0000000000400 0080

RPOECD1_DEFINITION TABLE

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POEUNITCDE POEDESC1

0080 MG

Display Suggestion

POELOWD + POEDESC1 (retrieved from the RPOECD1_DEFINITION table) to + POEHIGHD

(RPOEOSR1_ORDER_STRING table) + POEDESC1 (retrieved from the RPOECD1_DEFINITION table)

For example: 200 MG to 400 MG

Display to and High Dose values only if POEHIGHD is not 0.

If you wish to display TJC-compliant unit descriptions for dosage form information (POEUNITTYP = 1) or unit of
measure information (POEUNITTYP = 2), query the Units Description Table (RUNITSD0_UNITS_DESC) using
the values from the POEDESC1 column.

Displaying Low Frequency/Interval

Columns: POELOWF, POELOWI, and POELOWIU

The following tables contain a sample of low frequency/interval data:

RPOEOSR1_ORDER_STRING TABLE

POELOWF POELOWI POELOWIU

004 001 3003

RPOECD1_DEFINITION TABLE

POEUNITCDE POEDESC1

3003 day

Display Suggestion

If POELOWF (RPOEOSR1_ORDER_STRING table) is not 0: POELOWF + POELOWI

(RPOEOSR1_ORDER_STRING table) + POEDESC1 (retrieved from the RPOECD1_DEFINITION table).

For example: 4 times per day

For POELOWI, POESLOWI, and POEHIGHI codes, if the value is 1, display the words times per instead
of the value 1; for interval values greater than 1, display the value.

Displaying Second Low Frequency/Interval

Columns: POESLOWF, POESLOWI, and POESLOWIU

The following tables contain a sample of second low frequency/interval data:

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RPOEOSR1_ORDER_STRING TABLE

POESLOWF POESLOWI POESLOWIU

001 006 3004

RPOECD1_DEFINITION TABLE

POEUNITCDE POEDESC1

3004 hours

Display Suggestion

If POESLOWF (RPOEOSR1_ORDER_STRING table) is not 0: POESLOWF + POESLOWI

(RPOEOSR1_ORDER_STRING table) + POEDESC2 (retrieved from the RPOECD1_DEFINITION table)

For example: every 6 hours

For POELOWF, POESLOWF, and POEHIGHF codes, if the value is 1, display the word every instead of
the value 1; for frequency values greater than 1, display the value.

Displaying High Frequency/Interval

Columns: POEHIGHF, POEHIGHI, POEHIGHIU

The following tables contain a sample of high frequency/interval data:

RPOEOSR1_ORDER_STRING TABLE

POESHIGHF POEHIGHI POEHIGHIU

002 001 3003

REPOECD1_DEFINITION TABLE

POEUNITCDE POEDESC1

3003 day

Display Suggestion

If POEHIGHF (RPOEOSR1_ORDER_STRING table) is not 0: POEHIGHF + POEHIGHI

(RPOEOSR1_ORDER_STRING table) + POEDESC1 (retrieved from the RPOECD1_DEFINITION table)

For example: 2 times per day

For POELOWI, POESLOWI, and POEHIGHI codes, if the value is 1, display the words times per instead
of the value 1; for interval values greater than 1, display the value.

Displaying Duration

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Columns: POELOWDR, POELOWDRU, POEHIGHDR, and POEHIGHDRU

The following tables contain a sample of duration data:

RPOEOSRT1_ORDER_STRING TABLE

POELOWDR POELOWDRUS POEHIGHDR POEHIGHDRU

014 3003 021 3003

RPOECD1_DEFINITION TABLE

POEUNITCDE POEDESC2

3003 days

Display Suggestion

If POELOWDR (RPOEOSR1_ORDER_STRING table) is not 0: for + POELOWDR + POELOWDRU (retrieve

description from RPOECD1_DEFINITION table) + to + POEHIGHDR (RPOEOSR1_ORDER_STRING table) +
POEDESC2 (retrieved from the RPOECD1_DEFINITION table)

For example: for 14 days to 21 days

Display to and High Duration values only if POEHIGHDR is not 0.

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Calculating Prescription Quantity

A prescription quantity is required when prescribing a drug in an ambulatory setting. A prescription quantity is
calculated using the following formula:

The interval is usually days. The intervals in the equations must match in order for the equation to calculate the
correct prescription quantity. For example, in the following equation the same interval (day) appears in the
variables 3 times per day and 10 days.

For maintenance drugs (drugs taken for an indefinite period of time), the prescriber must provide as input the
number of intervals to use the drug.

The system can calculate the prescription quantity for dosage orders that do not require additional dosage
calculation (such as weight or body surface area) and do not include a dose range (for example, 1-2 tablets every
4-6 hours).

Prescription quantities for dosage orders can be calculated when all of the following conditions are met. All
columns are located in the POEM Order String Table (RPOEOSR1_ORDER_STRING) unless otherwise noted.

The POEM Calculation Required (POECALCREQ) value in the POEM Order Set Table
(RPOEOS1_ORDER_SET) is 0.
The POEM Low Dose Form Amount (POELOWDFA) value is not 0.
The POEM Dispensable Quantity Code (POEDISPQTY) value in the POEM Code Definition Table
(RPOECD1_DEFINITION) associated with the POEM Low Dose Form Units Code ( POELOWDFU) is 1.
The POEM High Dose Form Amount (POEHIGHDFA) value is 0.
The POEM High Frequency (POEHIGHF) value is 0.
The POEM Low Duration (POELOWDR) value is not 0 or the end-user provides the number of intervals as
input.
The POEM Low Duration Units Code (POELOWDRU) value is the same as the POEM Low Interval Units (
POELOWIU) value, or the end-user provides the number of intervals as input.
The POEM High Duration (POEHIGHDR) value is 0, or the end-user provides the number of intervals as
input.

The total prescription quantity is the sum of the total number of dosage form units calculated for each
Order String Identifier linked to the Order Set Identifier.

When the POELOWDFU is linked within the RPOECD1_DEFINITION table to an mL Conversion value

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that is not 0, multiply the total prescription quantity by the mL Conversion value to express the total
prescription quantity in terms of milliliters.

When the dosage form unit in POEM is in terms of mL and the Drug Form Code ( DF) in the NDC Table
(RNDC14_NDC_MSTR) is equal to 1 (each), the system will need to look at the volume per each in the
Clinical Formulation Ingredient Strength Component Table (RGCNSTR0_INGREDIENT_STRENGTH)
and divide the calculated volume (total dose) by the volume per each to get the number of eaches to
dispense. In cases where the ingredient strength is expressed as a percent, the percent value must be
converted to a strength per volume. For example, 1% is expressed as 1g (strength)/100mL (volume). In
other cases where there is no volume per each, the calculation cannot be performed. For more
information, please see the Clinical Formulation Ingredient Strength Component Table.

Using information found in the RPOEOSR1_ORDER_STRING and the RPOECD1_DEFINITION tables, the
following formula is used to calculate the total number of dosage form units for an order string:

Formula Abbreviation Table

Column Name Column Description

POELOWDFA Low Dose Form Amount

POELOWF Low Frequency

POELOWIU_POEPERDAYC Low Interval Units Code_Per Day Conversion (located in

the RPOECD1_DEFINITION table)

POELOWI Low Interval

POELOWDR Low Duration or Days Supply

POEM Calculation of Prescription Quantity

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Example 1Prescription Quantity Calculation

The Order String Text Take 1 tablet (250mg) by oral route 4 times per day for 10 days has the following values.
All values are located in the RPOEOSR1_ORDER_STRING table unless otherwise noted.

Column Name Column Description Value

POELOWDFA Low Dose Form Amount 1

POELOWF Low Frequency 4

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POELOWIU_POEPERDAYC Low Interval Units Code _Per Day 1

Conversion
In this example, the POELOWIU
column in the
RPOEOSR1_ORDER_STRING table
contains Unit Code 3003. To obtain the
Per Day Conversion value, locate
POEUNITCDE 3003 in the
RPOECD1_DEFINITION table,
identifying the table row from which the
value is retrieved. In that table row, the
POEPERDAYC column contains the
value 1.

POELOWI Low Interval 1

POELOWDR Low Duration or Days Supply 10

Refer to the following diagram which illustrates Example 1.

POEM Calculation of Prescription Quantity, Example 1

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Example 2Prescription Quantity Calculation

The Order String Text Take 1 tablet (250mg) by oral route every 6 hours for 10 days has the following values.
All values are located in the RPOEOSR1_ORDER_STRING table unless otherwise noted.

Column Name Column Description Value

POELOWDFA Low Dose Form Amount 1

POELOWF Low Frequency 1

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POELOWIU_POEPERDAYC Low Interval Units Code _Per Day 24

Conversion
In this example, the POELOWIU
column in the
RPOEOSR1_ORDER_STRING table
contains Unit Code 3004. To obtain the
Per Day Conversion value, locate
POEUNITCDE 3004 in the
RPOECD1_DEFINITION table,
identifying the table row from which the
value is retrieved. In that table row, the
POEPERDAYC column contains the
value 24.

POELOWI Low Interval 6

POELOWDR Low Duration or Days Supply 10

Refer to the following diagram which illustrates Example 2.

POEM Calculation of Prescription Quantity, Example 2

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Example 3Prescription Quantity Calculation

The Order String Text Take 10 milliliters (250mg) by oral route every 8 hours with an end-user defined days
supply of 30 days has the following values. All values are located in the RPOEOSR1_ORDER_STRING table
unless otherwise noted.

Column Name Column Description Value

POELOWDFA Low Dose Form Amount 10

POELOWF Low Frequency 1

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POELOWIU_POEPERDAYC Low Interval Units Code _Per Day 24

Conversion
In this example, the POELOWIU
column in the
RPOEOSR1_ORDER_STRING table
contains Unit Code 3004. To obtain the
Per Day Conversion value, locate
POEUNITCDE 3004 in the
RPOECD1_DEFINITION table,
identifying the table row from which the
value is retrieved. In that table row, the
POEPERDAYC column contains the
value 24.

POELOWI Low Interval 8

POELOWDR Low Duration or Days Supply 30

Refer to the following diagram which illustrates Example 3.

POEM Calculation of Prescription Quantity, Example 3

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Example 4Prescription Quantity Calculation

The Order String Text Instill 1 drop into right eye by ophthalmic route every 2-3 hours during the day and less
frequently at night with an end-user defined days supply of 30 days has the following values. All values are
located in the RPOEOSR1_ORDER_STRING table unless otherwise noted.

Column Name Column Description Value

POELOWDFA Low Dose Form Amount 1

POELOWF Low Frequency 1

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POELOWIU_POEPERDAYC Low Interval Units Code _Per Day 24

Conversion

POELOWI Low Interval 2

POELOWDR Low Duration or Days Supply 30

POEHIGHF High Frequency 1

Quantity cannot be calculated because the High Frequency value is not 0. In this situation, prompt the end-user
to input a prescription quantity.
Refer to the following diagram which illustrates Example 4.

POEM Prescription Quantity Calculation, Example 4

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Example 5Prescription Quantity Calculation

The Order String Text Instill 1 drop into affected eye(s) by ophthalmic route every 2 hours during the day and
less frequently at night with an end-user defined days supply of 30 days has the following values. All values are
located in the RPOEOSR1_ORDER_STRING table unless otherwise noted.

Column Name Column Description Value

POELOWDFA Low Dose Form Amount 1

POELOWF Low Frequency 1

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POELOWIU_POEPERDAYC Low Interval Units Code _Per Day 24

Conversion

POELOWI Low Interval 2

POELOWDR Low Duration or Days Supply 30

POELOWDFU_POEDISPQTY Low Dose Form Units 0

Code_Dispensable Quantity
In this example, the POELOWDFU
column in the
RPOEOSR1_ORDER_STRING table
contains Unit Code 3017. To obtain the
Dispensable Quantity Code value,
locate POEUNITCDE 3017 in the
RPOECD1_DEFINITION table,
identifying the table row from which the
value is retrieved. In that table row, the
POEDISPQTY column contains the
value 0.

Quantity cannot be calculated because the Dispensable Quantity Code value is 0. In this situation, prompt the
end-user to input package size and quantity into the appropriate prescription fields.

Packaging information can be presented to the end user via a pick list.MedKnowledge end users can search the
National Drug Code (NDC) table for distinct packaging information linked to the Clinical Formulation ID
(GCN_SEQNO).Refer to the following diagram which illustrates Example 5.

POEM Calculation of Prescription Quantity, Example 5

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Example 6Prescription Quantity Calculation

The Order String Text Take 1 tablet (500mg) or 2 tablets (1000mg) by oral route every 6 hours as needed with
an end-user defined days supply of 30 days has the following values. All values are located in the
RPOEOSR1_ORDER_STRING table unless otherwise noted.

Column Name Column Description Value

POELOWDFA Low Dose Form Amount 1

POELOWF Low Frequency 2

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POELOWIU_POEPERDAYC Low Interval Units Code _Per Day .1429

Conversion

POELOWI Low Interval 1

POELOWDR Low Duration or Days Supply 4

POEHIGHDFA High Dose Form Amount 2

Quantity cannot be calculated because the High Dose Form Amount value is not 0. In this situation, prompt the
end-user to input a prescription quantity.
Refer to the following diagram which illustrates Example 6.

POEM Calculation of Prescription Quantity, Example 6

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Example 7Prescription Quantity Calculation

The Order String Text Take 4 teaspoonsful (20mL) by oral route every 12 hours with an end-user defined days
supply of 5 days has the following values. All values are located in the RPOEOSR1_ORDER_STRING table
unless otherwise noted.

Column Name Column Description Value

POELOWDFA Low Dose Form Amount 4

POELOWF Low Frequency 1

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POELOWIU_POEPERDAYC Low Interval Units Code _Per Day 24

Conversion
In this example, the POELOWIU
column in the
RPOEOSR1_ORDER_STRING table
contains Unit Code 3004. To obtain the
Per Day Conversion value, locate
POEUNITCDE 3004 in the
RPOECD1_DEFINITION table,
identifying the table row from which the
value is retrieved. In that table row, the
POEPERDAYC column contains the
value 24.

POELOWI Low Interval 12

POELOWDR Low Duration or Days Supply 5

POELOWDFU_POEMLCNVRS POEM Low Dose Form Units 1

Code_POEM mL Conversion
(RPOECD1_DEFINITION table)

In this example, the POELOWDFU column in the RPOEOSR1_ORDER_STRING table contains Unit Code 3008.
To obtain the POEM mL Conversion value, locate POEUNITCDE 3008 in the RPOECD1_DEFINITION table,
identifying the table row from which the value is retrieved. In that table row, the POEMLCNVRS column contains
the value 5.

Refer to the following diagram which illustrates Example 7.

POEM Calculation of Prescription Quantity, Example 7

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Retrieving Dosage Orders for Related Disease States

The following applications use the First Databank Medical Lexicon DxID and ICD Search Tables to retrieve
dosage orders that are specific to a particular diagnosis or disease state. These applications are dependent upon
the following:

Familiarity with the First Databank Medical Lexicon Module and the Disease Identifier (DxID).
Assignment of a DxID or ICD Code to a given disease state.

Refer to the FDB Medical Lexicon (FML) 2.0 for more information.

Retrieving Dosage Orders Using an ICD Code

POEM does not allow ICD Codes as input for retrieving Dosage Orders. The following applications explain how to
locate a related DxID, which can be used in POEM to access Dosage Orders in combination with a specified
Clinical Formulation ID (GCN_SEQNO).

The FML ICD Search Table (RFMLISR1_ICD_SEARCH) is used to locate related DxIDs. Related DxIDs have
three ratings in the RFMLISR1_ICD_SEARCH table, each of which is indicated by a value in the
FML_NAV_CODE column. The three values are:

FML_NAV_CODE DESCRIPTION

01 Equal

02 Broader

03 Narrower

There are two possible query results when conducting a search for a related DxID using the applications below
and querying the RFMLISR1_ICD_SEARCH table. The possible results are:

A related DxID rated equal. Some broader and/or narrower related DxIDs may also be included in the
results because the FML_NAV_CODE is not specified for either of the application queries.
Broader and/or narrower related DxIDs, but none rated equal.

Two applications are provided in this section for the handling of the two types of results when querying the
RFMLISR1_ICD_SEARCH table for related DxIDs:

Using an ICD Code to Retrieve Dosage Orders With a DxID Rated Equal

Using an ICD Code to Retrieve Dosage Orders With DxIDs Rated Broader and/or Narrower

Using an ICD Code to Retrieve Dosage Orders With a DxID Rated Equal
For purposes of demonstrating this application, the following scenario is used: Input for for this application
is Clinical Formulation ID (GCN_SEQNO) 008995 (amoxicillin trihydrate). In addition, the patient has been
diagnosed with Genitourinary Chlamydia Trachomatis, which has an ICD-9-CM of 099.55.

1. Given the ICD-9-CM, query the FML ICD Search Table (RFMLISR1_ICD_SEARCH) for FML Related
DxIDs (RELATED_DXID) and FML Navigation Codes (FML_NAV_CODE), specifying the following:

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1.

The ICD Code for the Search ICD Code (SEARCH_ICD_CD) column.
05 for the FML Clinical Module Code (FML_CLIN_CODE) column, which specifies the query is for
POEM. For example:

SEARCH_ICD_CD RELATED_DXID FML_CLIN_CODE FML_NAV_CODE

099.55 00000297 05 01

099.55 00002321 05 03

Results with FML_NAV_CODE 01 indicate the RELATED_DXID is equal.

2. Query the POEM GCN_SEQNO POEM Source Table (RPOEGSQ2_GCNSEQNO_MSTR) for POEM
Order Set Identifiers (POEOSETID) associated with the specified Clinical Formulation ID (GCN_SEQNO)
and the RELATED_DxIDs with FML_NAV_CODE 01.

3. Depending on the query results, do one of the following:

If POEOSETIDs are retrieved, retrieve the Dosage Orders associated to the retrieved POEOSETIDs
and present the Dosage Orders to the end user. Refer to Retrieving Dosage Order String Text and
Creating Custom Dosage Orders for more information about retrieving Dosage Orders. In this
example, POEOSETIDs are retrieved for DxID 00000297, as shown below:

GCN_SEQNO POEOSETID DXID

008995 000373 00000297

008995 000375 00000297

008995 008192 00000297

008995 008194 00000297

008995 009300 00000297

008995 009301 00000297

If no POEOSETIDs are retrieved using the DxID rated equal, continue to Step 4.
For the example shown above, the combination of Clinical Formulation ID (GCN_SEQNO) 008995
and DxID 00000297 retrieves POEOSETIDS. However, the remaining steps explain what to do in a
case where POEOSETIDs are not retrieved for a GCN_SEQNO/DxID combination where the DxID
is rated equal.

4. If no POEOSETIDs are retrieved using the DxID rated equal, query the RPOEGSQ2_GCNSEQNO_MSTR
table for POEOSETIDs associated to the specified Clinical Formulation ID (GCN_SEQNO) and any
RELATED_DxIDs with FML_NAV_CODE 02 and/or 03, which indicates a rating of broader and/or
narrower.

5. Depending on the query results, do one of the following:

If POEOSETIDs are retrieved using DxIDs rated broader and/or narrower, retrieve the Dosage
Orders associated to the retrieved POEOSETIDs and present the Dosage Orders to the end user.

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Preface all Dosage Orders retrieved using DxIDs rated broader and/or narrower with the following
statement: Dosage Orders for [Diagnosis ICD_CD] are not available. Dosage Orders for the
associated term [Related DxID name], have been retrieved.
If no POEOSETIDs are returned for DxIDs rated broader and/or narrower, continue to Step 6.

6. Retrieve the Default Dosage Order for the Clinical Formulation ID (GCN_SEQNO), independent of
indication, and present it to the end user. Preface the Default Dosage Order with the following statement:
Dosage Orders for [Diagnosis ICD_CD] are not available. The Default Dosage Order, independent of
diagnosis, has been retrieved. Refer to Retrieving Default Dosage Order String Text and Creating Custom
Dosage Orders for more information.

Using an ICD Code to Retrieve Dosage Orders With DxIDs Rated Broader and/or Narrower
When querying the RFMLISR1_ICD_SEARCH table to retrieve RELATED_DXIDs for an ICD Code, it is possible
to retrieve only RELATED_DXIDs that are rated broader and/or narrower, indicating there are no
RELATED_DXIDs that are rated equal. This application explains how to use this type of query result in POEM.

For purposes of demonstrating this application, the following scenario is used: Input for this application is
Clinical Formulation ID (GCN_SEQNO) 011668 (cimetidine). In addition, the patient has been diagnosed with a
Chronic Gastric Ulcer with Hemorrhage Without Obstruction, which has an ICD-9-CM of 531.40.

1. Given the ICD-9-CM, query the FML ICD Search Table (RFMLISR1_ICD_SEARCH) for FML Related
DxIDs (RELATED_DXID) and FML Navigation Codes (FML_NAV_CODE), specifying the following:
The ICD-9-CM for the Search ICD Code (SEARCH_ICD_CD) column.
05 for the FML Clinical Module Code (FML_CLIN_CODE) column, which specifies the query is for
POEM. For example:

SEARCH_ICD_CD RELATED_DXID FML_CLIN_CODE ML_NAV_CODE

531.40 00002013 05 03

531.40 00002015 05 03

531.40 00003545 05 03

531.40 00004638 05 03

Results with FML_NAV_CODE 01 indicate the RELATED_DXID is equal. As shown, results for
ICD-9-CM 531.40 contain no RELATED_DXIDs with FML_NAV_CODE 01. All of the results shown
have an FML_NAV_CODE of 03, which indicates the RELATED_DXIDs are rated narrower.

2. Query the POEM GCN_SEQNO POEM Source Table (RPOEGSQ2_GCNSEQNO_MSTR) for POEM
Order Set Identifiers (POEOSETID) associated with the specified Clinical Formulation ID (GCN_SEQNO)
and each of the RELATED_DxIDs with FML_NAV_CODE 02 and/or 03. For example:

GCN_SEQNO POEOSETID DXID

011668 001834 00002013

3.

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3. Do one of the following:

If POEOSETIDs are retrieved using DxIDs rated broader and/or narrower, retrieve the Dosage
Orders associated to the retrieved POEOSETIDs and present the Dosage Orders to the end user.
Preface all Dosage Orders retrieved using DxIDs rated broader and/or narrower with the following
statement: Dosage Orders for [Diagnosis ICD_CD] are not available. Dosage Orders for the
associated term [Related DxID name], have been retrieved.
If no POEOSETIDs are retrieved for DxIDs rated broader and/or narrower, continue to Step 4.
For the example shown above, the combination of Clinical Formulation ID (GCN_SEQNO) 011668
and DxID 00002013 results in a returned POEOSETID. However, Step 4 explains what to do in the
case where POEOSETIDs are not returned for GCN_SEQNO/DxID combinations where the DxID
is rated broader and/or narrower.

4. Retrieve the Default Dosage Order for the Clinical Formulation ID (GCN_SEQNO), independent of
indication, and present it to the end user. Preface the Default Dosage Order with the following statement:
Dosage Orders for [Diagnosis ICD_CD] are not available. The Default Dosage Order, independent of
diagnosis, has been retrieved.
Refer to Retrieving Default Dosage Order String Text and Creating Custom Dosage Orders for more
information.

Retrieving Dosage Orders Using DxIDs Related To DxIDs

Given a Clinical Formulation ID (GCN_SEQNO) and a DxID, Dosage Orders can be retrieved using POEM.
However, in some cases, a Clinical Formulation ID (GCN_SEQNO) and DxID combination may not have any
Dosage Orders available. For instances where this occurs, the end user can be presented with Dosage Orders for
the same Clinical Formulation ID (GCN_SEQNO), but associated with DxIDs that are rated as broader and/or
narrower than the original DxID. Use the FML Disease Identifier (DxID) Search Table
(RFMLDSR0_DXID_SEARCH) to access related DxIDs for a given DxID.

Scenario: Input for the retrieval is Clinical Formulation ID (GCN_SEQNO) 006646 (levothyroxine sodium). In
addition, the patient has been diagnosed with Congenital Hypothyroidism, which has a DxID of 00000583. In
this scenario, the user has already queried the POEM GCN_SEQNO POEM Source Table
(RPOEGSQ2_GCNSEQNO_MSTR) using the Clinical Formulation ID (GCN_SEQNO) 006646/DxID 00000583
combination, and no results were retrieved.

1. Given the DxID, query the RFMLDSR0_DXID_SEARCH table for FML Related DxIDs ( RELATED_DXID)
and FML Navigation Codes (FML_NAV_CODE), specifying the following:
The DxID for the FML Search DxID (SEARCH_DXID) column.
05 for the FML Clinical Module Code (FML_CLIN_CODE) column, which specifies the query is for
POEM. For example:

SEARCH_DXID RELATED_DXID FML_CLIN_CODE FML_NAV_CODE

00000583 00000578 05 03

00000583 00000584 05 03

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00000583 00000587 05 03

00000583 00000588 05 03

2. Query the RPOEGSQ2_GCNSEQNO_MSTR table for POEOSETIDs associated with the specified Clinical
Formulation ID (GCN_SEQNO) and any RELATED_DxIDs with FML_NAV_CODE 02 and/or 03. The
combined results for queries for each of the RELATED_DXIDs retrieved in the previous step are shown
below:

GCN_SEQNO POEOSETID DXID

006646 009083 00000584

006646 009084 00000584

006646 009085 00000584

006646 009086 00000584

006646 009084 00000587

006646 009086 00000587

006646 009087 00000587

3. Do one of the following:

If POEOSETIDs are retrieved using DxIDs rated broader and/or narrower, retrieve the Dosage
Orders associated to the retrieved POEOSETIDs and present the Dosage Orders to the end user.
Preface all Dosage Orders retrieved using DxIDs rated broader and/or narrower with the following
statement: Dosage Orders for [Diagnosis DxID name] are not available. Dosage Orders for the
associated term [Related DxID name], have been retrieved.
Refer to Retrieving Retrieving Default Dosage Order String Text and Creating Custom Dosage
Orders for more information about retrieving Dosage Orders.
If no POEOSETIDs are retrieved, continue to Step 4.

4. Retrieve the Default Dosage Order for the Clinical Formulation ID (GCN_SEQNO), independent of
indication, and present it to the end user. Preface the Default Dosage Order with the following statement:
Dosage Orders for [Diagnosis DxID name] are not available. The Default Dosage Order, independent of
diagnosis, has been retrieved.
Refer to Retrieving Default Dosage Order String Text and Creating Custom Dosage Orders for more
information about retrieving dosage orders.

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POEM ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

POEM Tables
POEM ERD

POEM Tables
Dosage Form Master to POEM Dosage Form Link Table
POEM Administration Rate Table
POEM Calculation Required Type Code Description Table
POEM Clinical Context Type Description Table
POEM Clinical Context Value Description Table
POEM Code Definition Table
POEM Context Table
POEM Country Code Description Table
POEM Dose Type Code Description Table
POEM GCN_SEQNO POEM Source Table
POEM GCN_SEQNO Standard Order Table
POEM Language Code Description Table
POEM Order Set Table
POEM Order String Table
POEM Order String to Text Table
POEM Route Description Code Description Table
POEM Text String Location Code Description Table
POEM Text Table
POEM Text Type Code Description Table
POEM Unit Code Type Description Table

POEM ERD

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Dosage Form Master to POEM Dosage Form Link Table

Table Name RPEIPF0_POEM_DF_MSTR_LINK

Revision Activity add.07-1-2013

Purpose Relates dosage forms in the Dosage Form Master Table to

dosage forms in the POEM Code Definition Table (RPOEC
D1_DEFINITION).

Key Column Name Column Format Length Picture

Description

PF DOSAGE_FORM Dosage Form N 8 9(8)

_ID Identifier

PF POEUNITCDE POEM Unit Code N 4 9(4)

PREFERRED_D Preferred Dosage N 1 9(1)

OSAGE_FORM_I Form Indicator
ND

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POEM Administration Rate Table

Table Name RPOEAR1_ADMINISTRATION_RATE

Revision Activity add.08-11-2000

Purpose Links an order string to administration rate information.

Key Column Name Column Format Length Picture

Description

P POEOSTRID POEM Order N 10 9(10)

String Identifier

P POEADMINSQ POEM N 2 9(2)

Administration
Rate Sequence
Code

POEADRT POEM N 9 9(5).9(3)

Administration
Rate

POEADRTUNT POEM N 4 9(4)

Administration
Rate Unit Code

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POEM Calculation Required Type Code Description Table

Table Name RPOECRD0_CALC_REQ_TYPE_DESC

Revision Activity add.03-14-2002

Purpose Relates the Calculation Required Type Code to its text

description.

Key Column Name Column Format Length Picture

Description

P POECALCRTC POEM Calculation AN 1 X(1)

Required Type
Code

POECALCRTC_D POEM Calculation AN 60 X(60)

ESC Required Type
Code Description

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POEM Clinical Context Type Description Table

Table Name RPOECTD0_CLIN_CONTEXT_TYP_DESC

Revision Activity add.03-14-2002

Purpose Relates the Clinical Context Type to its text description.

Key Column Name Column Format Length Picture

Description

P POECLINTYP POEM Clinical N 2 9(2)

Context Type

POECLINTYP_D POEM Clinical AN 39 X(30)

ESC Context Type
Description

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POEM Clinical Context Value Description Table

Table Name RPOECVD0_CLIN_CONTEXT_VAL_DESC

Revision Activity add.03-14-2002

Purpose Relates the Clinical Context Value to its text description.

Key Column Name Column Format Length Picture

Description

P POECLINVAL POEM Clinical AN 2 X(2)

Context Value

POECLINVAL_D POEM Clinical AN 30 X(30)

ESC Context Value
Description

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POEM Code Definition Table

Table Name RPOECD1_DEFINITION

Revision Activity add.08-11-2000

Purpose Relates the Unit Code to its text description and provides
attributes of that relationship.

Key Column Name Column Format Length Picture

Description

P POEUNITCDE POEM Unit Code N 4 9(4)

PF POELANGCDE POEM Language N 2 9(2)

Code

PF POECOCDE POEM Country N 2 9(2)

Code

F POEUNITTYP POEM Unit Code N 1 9(1)

Type

POEDESC1 POEM Description AN 30 X(30)

1

POEDESC2 POEM Description AN 20 X(20)

2

POEDESC3 POEM Description AN 20 X(20)

3

POEPERDAYC POEM Per Day N 9 9(4).9(4)

Conversion

POEDISPQTY POEM N 1 9(1)

Dispensable
Quantity Code

POEMLCNVRS POEM mL N 4 9(4)

Conversion

F POECALCRTC POEM Calculation AN 1 X(1)

Required Type
Code

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POEM Context Table

Table Name RPOECL1_CLIN_CONTEXT

Revision Activity add.08-11-2000

Purpose Provides attributes for a set of specific patient parameters

(such as renal function) necessary for a given dose.

Key Column Name Column Format Length Picture

Description

P POECLINID POEM Clinical N 6 9(6)

Context Identifier

PF POECLINTYP POEM Clinical N 2 9(2)

Context Type

F POECLINVAL POEM Clinical AN 2 X(2)

Context Value

POEMINRANG POEM Minimum N 9 9(6).9(2)

Range

POEMAXRANG POEM Maximum N 9 9(6).9(2)

Range

POERANGUNT POEM Range Unit N 4 9(4)

Code

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POEM Country Code Description Table

Table Name RPOECOD0_COUNTRY_DESC

Revision Activity add.03-14-2002

Purpose Relates the Country Code to its text description.

Key Column Name Column Format Length Picture

Description

P POECOCDE POEM Country N 2 9(2)

Code

POECOCDE_DE POEM Country AN 30 X(30)

SC Code Description

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POEM Dose Type Code Description Table

Table Name RPOEDTD0_DOSE_TYPE_DESC

Revision Activity add.03-14-2002

Purpose Relates the Dose Type Code to its text description.

Key Column Name Column Format Length Picture

Description

P POEDOSETYP POEM Dose Type AN 2 X(2)

Code

POEDOSETYP_D POEM Dose Type AN 60 X(60)

ESC Code Description

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POEM GCN_SEQNO POEM Source Table

Table Name RPOEGSQ2_GCNSEQNO_MSTR

Revision Activity rev.03-14-2002

Purpose Links a clinical formulation to a specific dosage order set,

based on indication.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF FDBDX First Databank AN 9 X(9)

Disease Code

PF POEOSETID POEM Order Set N 6 9(6)

Identifier

PF POECLINID POEM Clinical N 6 9(6)

Context Identifier

F DXID FML Disease N 8 9(8)

Identifier (Stable
ID)

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POEM GCN_SEQNO Standard Order Table

Table Name RPOEGCS1_STANDARD_ORDER

Revision Activity add.08-01-2001

Purpose Links a clinical formulation to a standard (default) dosage

order set, independent of indication.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF POECLINID POEM Clinical N 6 9(6)

Context Identifier

PF POEOSETID POEM Order Set N 6 9(6)

Identifier

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POEM Language Code Description Table

Table Name RPOELGD0_LANGUAGE_DESC

Revision Activity add.03-14-2002

Purpose Relates the Language Code to its text description.

Key Column Name Column Format Length Picture

Description

P POELANGCDE POEM Language N 2 9(2)

Code

POELANGCDE_ POEM Language AN 30 X(30)

DESC Code Description

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POEM Order Set Table

Table Name RPOEOS1_ORDER_SET

Revision Activity add.08-11-2000

Purpose Links one specific dosage order set to one or more specific
order strings and provides attributes of that relationship.

Key Column Name Column Format Length Picture

Description

PF POEOSETID POEM Order Set N 6 9(6)

Identifier

P POEOSTRSEQ POEM Order N 2 9(2)

String Sequence
Code

PF POEOSTRID POEM Order N 10 9(10)

String Identifier

F POEDOSETYP POEM Dose Type AN 2 X(2)

Code

POECALCREQ POEM Calculation AN 1 X(1)

Required

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POEM Order String Table

Table Name RPOEOSR1_ORDER_STRING

Revision Activity add.08-11-2000

Purpose Associates dosing concepts within order string text to

specific columns.

Key Column Name Column Format Length Picture

Description

P POEOSTRID POEM Order N 10 9(10)

String Identifier

POEROUTE POEM Route N 4 9(4)

Code

F POEROUTE_D POEM Route N 1 9(1)

Description Code

POELOWD POEM Low Dose N 13 9(8).9(4)

POELOWDU POEM Low Dose N 4 9(4)

Units Code

POEHIGHD POEM High Dose N 13 9(8).9(4)

POEHIGHDU POEM High Dose N 4 9(4)

Units Code

POELOWDFA POEM Low Dose N 7 9(4).9(2)

Form Amount

POELOWDFU POEM Low Dose N 4 9(4)

Form Units Code

POEHIGHDFA POEM High Dose N 6 9(4).9(2)

Form Amount

POEHIGHDFU POEM High Dose N 4 9(4)

Form Units Code

POELOWF POEM Low N 3 9(3)

Frequency

POELOWI POEM Low N 3 9(3)

Interval

POELOWIU POEM Low N 4 9(4)

Interval Units
Code

POEHIGHF POEM High N 3 9(3)

Frequency

POEHIGHI POEM High N 3 9(3)

Interval

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POEHIGHIU POEM High N 4 9(4)

Interval Units
Code

POESLOWF POEM Second N 3 9(3)

Low Frequency

POESLOWI POEM Second N 3 9(3)

Low Interval

POESLOWIU POEM Second N 4 9(4)

Low Interval Units
Code

POESHIGHF This column is not N 3 9(3)

currently being
used

POESHIGHI This column is not N 3 9(3)

currently being
used

POESHIGHIU This column is not N 4 9(4)

currently being
used

POELOWDR POEM Low N 3 9(3)

Duration

POELOWDRU POEM Low N 4 9(4)

Duration Units
Code

POEHIGHDR POEM High N 3 9(3)

Duration

POEHIGHDRU POEM High N 4 9(4)

Duration Units
Code

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POEM Order String to Text Table

Table Name RPOEOSX1_TEXT_LINK

Revision Activity add.08-11-2000

Purpose Links an order string to a dosage order set and provides

attributes of that relationship.

Key Column Name Column Format Length Picture

Description

PF POEOSTRID POEM Order N 10 9(10)

String Identifier

PF POETEXTTYP POEM Text Type N 2 9(2)

Code

P POETXTSTRL POEM Text String N 1 9(1)

Location Code

F POETEXTCDE POEM Text Code N 10 9(10)

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POEM Route Description Code Description Table

Table Name RPOERDD0_ROUTE_DESC

Revision Activity add.03-14-2002

Purpose Relates the Route Description Code to its text description.

Key Column Name Column Format Length Picture

Description

P POEROUTE_D POEM Route N 1 9(1)

Description Code

POEROUTE_D_D POEM Route AN 60 X(60)

ESC Description Code
Description

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POEM Text String Location Code Description Table

Table Name RPOETSD0_TEXT_STR_LOC_DESC

Revision Activity add.03-14-2002

Purpose Relates the Text String Location Code to its text description.

Key Column Name Column Format Length Picture

Description

P POETXTSTRL POEM Text String N 1 9(1)

Location Code

POETXTSTRL_D POEM Text String AN 60 X(60)

ESC Location Code
Description

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POEM Text Table

Table Name RPOETXT1_TEXT

Revision Activity add.08-11-2000

Purpose Associates text to an order string, and provides attributes of

that relationship.

Key Column Name Column Format Length Picture

Description

P POETEXTCDE POEM Text Code N 10 9(10)

PF POELANGCDE POEM Language N 2 9(2)

Code

PF POECOCDE POEM Country N 2 9(2)

Code

P POETXTNUM POEM Text Line N 3 9(3)

Number

POETXLINE POEM Text Line AN 70 X(70)

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POEM Text Type Code Description Table

Table Name RPOETTD0_TEXT_TYPE_DESC

Revision Activity add.03-14-2002

Purpose Relates the Text Type Code to its text description.

Key Column Name Column Format Length Picture

Description

P POETEXTTYP POEM Text Type N 2 9(2)

Code

POETEXTTYP_D POEM Text Type AN 30 X(30)

ESC Code Description

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POEM Unit Code Type Description Table

Table Name RPOEUTD0_UNIT_TYPE_DESC

Revision Activity add.03-14-2002

Purpose Relates the Unit Code Type to its text description.

Key Column Name Column Format Length Picture

Description

P POEUNITTYP POEM Unit Code N 1 9(1)

Type

POEUNITTYP_D POEM Unit Code AN 30 X(30)

ESC Type Description

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Prioritized Label Warnings Module (LBLW) 1.0

General Information
Prioritized Label Warnings Module Editorial Policies
Applications
ERD and Technical Specifications

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General Information
The General Information section contains high-level information about the module.

Overview
Concepts

Overview
The Prioritized Label Warnings Module (LBLW) provides clinical formulation (CFID)-specific, prioritized auxiliary
label warning sets created and updated by First Databank (FDB) clinical pharmacists. The label selection and
stratification schema is based on the relative importance of a label in the context of the product's ingredient list,
dosage form, route of administration and as necessary - its strength. This process provides a clinical formulation
(CFID)-specific linking of the set of essential labels (see USP Chapter 17 Guidance as noted below). The FDB
LBLW labels are then mapped to four major commercial auxiliary label vendors' data for ease of label printing or
display by FDB customers within their proprietary pharmacy systems.

Note that the LBLW sets as a whole will be gradually streamlined in response to this revised Editorial Policy - i.e.,
on average, fewer labels will be attached per CFID as are attached currently. The focus will be on essential
auxiliary label information only. Moreover, revised inclusion/exclusion criteria will focus label attachment on
products used primarily by patients or caregivers - as well as a variety of healthcare professionals. Bulk chemical
products, for example, will now be excluded from LBLW.

In addition, note that certain packaged product-based information (such as NDC, DIN or NPN-specific storage
information) cannot always be represented at the CFID level. Therefore in such situations product packaging data
needs to be consulted.

Drug knowledge is aggregated at the Clinical Formulation ID (GCN_SEQNO), Routed Medication ID (

ROUTED_MED_ID), and the Routed Generic ID (ROUTED_GEN_ID) levels in the FDB knowledge base.
Under certain circumstances (e.g., storage information), aggregated drug knowledge may not apply to all
related packaged products; more specific information may be found within product labels.

Concepts
Label Selection and Prioritization
This LBLW Editorial Policy draws from the recent United States Pharmacopoeia (USP) Chapter 17 Prescription
Container Label Guidance - which emphasizes utilization of only the essential auxiliary labels as a component of
the overall prescription container label. Once the essential labels are selected by FDB clinical pharmacists via
criteria-based assessment, the prioritization schema is applied and the auxiliary label set is associated with the
CFID(s). These processes are executed via a review and evaluation of CFID-specific clinical data by FDB clinical
pharmacists. A primary source for the clinical data is the professional labeling (aka package insert).

For example - the label priority order for a particular CFID may be as follows:

Patient safety-related auxiliary labels - addressing issues such as pregnancy, lactation, and selected

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adverse effects
Site-of-administration labels
How-to-use labels
Storage labels

Black Box Warning Indicator label or Medication Guide Indicator label

The priority order of auxiliary labels may be further customized so as to be appropriate for associated CFID(s).
For example, the order in which similar or identical labels appear may vary from product to product based on the
relative clinical importance of the ingredients in the product, the route of administration, the dosage form - and as
necessary, the strength. Consider two therapeutically-similar drug products - they may have a significantly
different incidence and severity of drowsiness, leading to a differing priority order for the drowsiness label within
the respective label sets. Labels are attached to products utilizing these data elements: Clinical Formulation (
GCN_SEQNO), ingredient (HIC_SEQN), dosage form, route and strength.

Lowest Priority Labels

The Black Box Warning Indicator Label and the Medication Guide Indicator Label are always assigned the lowest
priorities (with the Medication Guide Label Warning always being the lowest priority of all) to ensure that specific
clinical or storage-based labels are not supplanted. These two Indicator Labels provide a flag to health care
providers, pointing them to important information from the Food and Drug Administration (FDA) for that specific
clinical formulation.

The Black Box Warning label indicates when the highest-level safety-related information (i.e., Black Box Warning
information) from the FDA exists for a product and can be used to alert the user to the presence of a Black Box
Warning. This label is assigned the Prioritized Label Warning Code ( LBL_WARN) #0298 and has the Prioritized
Label Warning Code Description (LBL_DESC), Read the boxed warning information for this medication. This
label is always assigned the lowest priority unless a Medication Guide Label Warning also exists for a product.

The Medication Guide Label Warning indicates when a FDA Medication Guide is available for a product and can
be used to alert the user to the presence of a Med Guide - or to print the Med Guide automatically. This label is
assigned the Prioritized Label Warning Code (LBL_WARN) #0230 and has the Prioritized Label Warning Code
Description (LBL_DESC), Read the Medication Guide that comes with this medicine. This label is always
assigned the absolute lowest priority.

Maximum Label Number

The auxiliary label limit per Clinical Formulation is ten. A ten label limit is reasonable because USP Chapter 17
Guidance recommends only essential auxiliary label information be applied to products. Moreover, there are
practical limitations to how many labels will fit on a prescription bottle, other types of packaging - or other
space-constrained education materials.

FDB does not recommend setting a more restrictive label limit than 10. FDB recommends
printing/affixing all the labels attached to a Clinical Formulation. Exceptions are labels 0230 and 0298 -
the Medication Guide and Black Box Warning Indicator labels, respectively.

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FDB does not recommend printing auxiliary label warnings in lieu of PEM monographs.

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Prioritized Label Warnings Module Editorial Policies

The policies and criteria that apply to the inclusion and maintenance of the Prioritized Label Warnings Module are
provided in the following sections:

Editorial Process

Editorial Process
The following section describes the processes and criteria the clinical editors use to add or review database
elements.

External Triggers for Clinical Review

The external triggers that prompt the clinical editors to add or review data are the following:

MedWatch Safety Alerts

New product labeling
Product labeling changes
New clinical information in the primary literature
FDA Med Guide announcements

Internal Triggers for Clinical Review

The internal triggers that prompt the clinical editors to add or review data are the following:

New Clinical Formulation ID (GCN_SEQNO)

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Applications
This section provides information about the practical application of data contained in this module.

Considerations for Using Prioritized Label Warnings

Retrieving Prioritized Label Warnings for a Drug

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Considerations for Using Prioritized Label Warnings

Consider the following items before implementing this module.

Application of Labels to Active Products and a Limited Obsolete Product Set

This module includes warning labels for active products in the United States and Canada.

Vendor Label Codes

Label codes are available from multiple label manufacturers or vendors, including but not limited to:

Architext
Intercon
Pharmex
Printed Solutions

Programming Notes for RDBMS Format

The Clinical Formulation ID (GCN_SEQNO) links to the GCN_SEQNO/Prioritized Label Warning Code Relation
Table (RLBLWGC0_GCNSEQNO_LINK).

The Clinical Formulation ID (GCN_SEQNO) + the Prioritized Label Warning Code (LBL_WARN) links to the
descriptive information in the Prioritized Label Warning Code Description Table (RLBLWD0_DESC).

Table Data Structure Description

RLBLWGCO_GCNSEQNO_LINK RLBLWGCx GCN_SEQNO/Prioritized Label

Warning Relation

RLBLWD0_DESC RLBLWDx Prioritized Label Warning Descriptions

(Also available in Spanish and French)

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Retrieving Prioritized Label Warnings for a Drug

This application illustrates how to retrieve and sort label warnings for a drug.

1. Select these columns from the GCN_SEQNO/Prioritized Label Warning Code Relation Table
(RLBLWGC0_GCNSEQNO_LINK) where the Clinical Formulation ID (GCN_SEQNO) equals the
GCN_SEQNO value of the drug product:
Prioritized Label Warning Code (LBL_WARN)
Prioritized Label Warning Relative Priority (LBL_PRTY)

2. Select these columns from the Prioritized Label Warning Code Description Table (RLBLWD0_DESC)
where the Prioritized Label Warning Code (LBL_WARN) equals the LBL_WARN retrieved in the previous
step:
Prioritized Label Warning Text Sequence Number (LBL_TEXTSN)
Prioritized Label Warning Code Description (LBL_DESC)

3. Sort the labels by sequence number and priority.

a. Use the Prioritized Label Warning Text Sequence Number (LBL_TEXTSN) column to sort the
results by sequence number. This determines the order in which each line of each label will appear.

b. Use the Prioritized Label Warning Relative Priority (LBL_PRTY) column to sort the results by
priority. This determines the order in which the labels will be printed.

4. Present the results to the end user for printing.

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Prioritized Label Warnings ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

Prioritized Label Warnings Tables

Prioritized Label Warnings ERD

Prioritized Label Warnings Tables

French Prioritized Label Warning Code Description Table
GCN_SEQNO/Prioritized Label Warning Code Relation Table
Prioritized Label Warning Code Description Table
Prioritized Label Warning Vendor Description Table
Prioritized Label Warning Vendor Type Relation Table
Spanish Prioritized Label Warning Code Description Table

Prioritized Label Warnings ERD

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French Prioritized Label Warning Code Description Table

Table Name FLBLWD0_FRENCH_DESC

Revision Activity original

Purpose Relates the Prioritized Label Warning Code to its

French-language text description and provides attributes of
that relationship.

Key Column Name Column Format Length Picture

Description

P LBL_WARN Prioritized Label AN 4 X(4)

Warning Code

P LBL_TXTSNF Prioritized Label N 2 9(2)

Warning Text
Sequence
Number (French)

LBL_DESCF Prioritized Label AN 55 X(55)

Warning Code
Description
(French)

LBLGNDR This column is not AN 1 X(1)

currently being
used

LBLAGE This column is not AN 1 X(1)

currently being
used

LBLPREG This column is not AN 1 X(1)

currently being
used

LBLINFO This column is not AN 1 X(1)

currently being
used

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GCN_SEQNO Prioritized Label Warning Code Relation Table

Table Name RLBLWGC0_GCNSEQNO_LINK

Revision Activity rev.02-01-1998

Purpose Links a clinical formulation to an associated label warning.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF LBL_WARN Prioritized Label AN 4 X(4)

Warning Code

LBL_PRTY Prioritized Label N 2 9(2)

Warning Relative
Priority

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Prioritized Label Warning Code Description Table

Table Name RLBLWD0_DESC

Revision Activity add.09-01-1997

Purpose Relates the Prioritized Label Warning Code to its text

description and provides attributes of that relationship.

Key Column Name Column Format Length Picture

Description

P LBL_WARN Prioritized Label AN 4 X(4)

Warning Code

P LBL_TEXTSN Prioritized Label N 2 9(2)

Warning Text
Sequence
Number

LBL_DESC Prioritized Label AN 55 X(55)

Warning Code
Description

LBLGNDR This column is not AN 1 X(1)

currently being
used

LBLAGE This column is not AN 1 X(1)

currently being
used

LBLPREG This column is not AN 1 X(1)

currently being
used

LBLINFO This column is not AN 1 X(1)

currently being
used

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Prioritized Label Warning Vendor Description Table

Table Name RLBLWVD0_VENDOR_TYPE_DESC

Revision Activity add.08-11-2000

Purpose Relates the Prioritized Label Warning Vendor Type to its

text description.

Key Column Name Column Format Length Picture

Description

P LBLW_VTYPE Prioritized Label N 3 9(3)

Warning Vendor
Type

LBLW_VDESC Prioritized Label AN 50 X(50)

Warning Vendor
Description

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Prioritized Label Warning Vendor Type Relation Table

Table Name RLBLWV0_VENDOR_LINK

Revision Activity add.08-11-2000

Purpose Links a label warning to an external vendor.

Key Column Name Column Format Length Picture

Description

P LBL_WARN Prioritized Label AN 4 X(4)

Warning Code

PF LBLW_VTYPE Prioritized Label N 3 9(3)

Warning Vendor
Type

LBLW_VCODE Prioritized Label AN 10 X(10)

Warning Vendor
Code

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Spanish Prioritized Label Warning Code Description Table

Table Name SLBLWD0_SPNSH_DESC

Revision Activity add.02-25-2000

Purpose Relates the Prioritized Label Warning Code to its

Spanish-language text description and provides attributes of
that relationship.

Key Column Name Column Format Length Picture

Description

P LBL_WARN Prioritized Label AN 4 X(4)

Warning Code

P LBL_TXTSNS Prioritized Label N 2 9(2)

Warning Text
Sequence
Number (Spanish)

LBL_DESCS Prioritized Label AN 55 X(55)

Warning Code
Description
(Spanish)

LBLGNDR This column is not N 1 X(1)

currently being
used

LBLAGE This column is not N 1 X(1)

currently being
used

LBLPREG This column is not N 1 X(1)

currently being
used

LBLINFO This column is not N 1 X(1)

currently being
used

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MedGuides Module 1.0

MedGuides Module Editorial Policies
Applications
ERD and Technical Specifications

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MedGuides Module Editorial Policies

Overview
Definitions
Inclusion Criteria
Data Elements
Rule Sets
Maintenance
Resources

Overview
Since 1998, the FDA has required that Medication Guides (MedGuides) be created and distributed by drug
manufacturers for certain prescribed drugs and biologic products. The FDA determines which products will need a
MedGuide and requires manufacturers to submit their MedGuides for FDA approval prior to usage. Additionally,
pharmacies are required by the FDA to provide patients with MedGuides for these products when they dispense
them.

The MedGuides Module enables the automated distribution of FDA-mandated MedGuides that have been
provided by the manufacturers to the FDA with properly coded Structured Product Labels (SPLs) and posted on
the official National Library of Medicines (NLMs) DailyMed website. Using the MedGuide data, pharmacists can
easily print Medication Guides from within their existing workflow.

MedGuides are available in both PDF and XML formats. Both versions offer the same patient drug information
content. Use of the XML formatting provides users with optimal customization capabilities such as embedding
additional content or tailoring the look and feel of the MedGuide prior to printing.

The MedGuides Module provides a list of National Drug Codes (NDCs) derived from the FDA-approved SPLs
posted on the official DailyMed repository. The module also provides the most current version of each MedGuide
made available by the FDA within the SPLs posted to DailyMed. File names for the MedGuides are linked to
NDCs, and these file names correspond to the individual PDF or XML files for the MedGuides.

Definitions
This section defines important terms related to the module that users should understand. Some industry terms
that have a specific connotation in regards to the module are also be defined.

MedGuide
A MedGuide, or Medication Guide, is an FDA-approved document created and distributed by manufacturers in
order to provide specific patient medication information for products that the FDA has designated as high risk.
The FDA requires that these Medication Guides be delivered to patients at the time the underlying drug is
dispensed. See below for a table adapted from the final FDA Guidance on the Distribution of MedGuides.

Adapted Table for Medication Guide Enforcement Discretion Policy from the FDA

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Setting Patient/Patients Each Time Drug At Time of First MedGuide ETASU REMS4
Agent Requests is Dispensed Dispensing Materially
MedGuide Changes

Inpatient1 Provide Need not provide Need not provide Need not provide Provide5

(HCP to patient)2 Provide Need not provide Provide Provide Provide5

Outpatient Provide Provide Provide Provide Provide5

(directly to patient)
3

1 Example settings: Hospitals, hospice inpatient services, skilled nursing facilities

2Drug dispensed to healthcare professional (HCP) for administration to patient. Example settings: clinic, infusion
center, emergency department, outpatient surgery
3Drug dispensed directly to patient or caregiver. Example settings: retail pharmacy, hospital ambulatory
pharmacy, patient samples
4 Drug is subject to Elements to Assure Safe Use (ETASU) and Risk Evaluation and Mitigation Strategy (REMS)
that included specific requirements for providing and reviewing a MedGuide
5 Provide as specified in REMS

Inclusion Criteria
This section provides information detailing the criteria that guided the inclusion of the data contained within the
module as well as information pertaining to limitations or exclusions when appropriate to the discussion.

MedGuides are updated weekly and supplied to First Databank (FDB) by the American Society of Health System
Pharmacists (ASHP), which extracts MedGuide information directly from the FDA-approved Structured Product
Labels (SPLs) posted on the NLMs DailyMed website. Information posted on the DailyMed website and supplied
by ASHP is the sole source for the MedGuides Module.

The MedGuides Module encompasses all drugs included in MedKnowledge that can be identified in SPLs filed
with the FDA, including related package sizes (via the NDC9) that have been omitted from a filed SPL. While FDB
does not editorially modify the content of the published MedGuides or independently validate DailyMed
NDC-to-MedGuide linkages, we will exclude incorrect linkages that are uncovered in routine data processing.

FDB provides MedGuides, when applicable, for NDCs that are active and NDCs up to three years past their
obsolete date. While original manufacturers and repackagers of products requiring MedGuides are obliged to file
them with the FDA, compliance with this standard is not currently universal. Consequently, the research by FDB
that generates Prioritized Label Warning Code (LBL_WARN) 0230 (Read the Medication Guide that comes with
this medicine.) in the Prioritized Label Warnings Module (LBLW) 1.0 provides a listing of those NDCs that
require MedGuides but have not been submitted by the manufacturer to the DailyMed website.

To increase the number of MedGuides available to pharmacists in this module, FDB uses an FDA-approved class
or original source NDC MedGuide in two key areas:

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Repackaged drug products that require a MedGuide per the FDA will be assigned an original source NDC
MedGuide if one exists and if a MedGuide was not provided by the manufacturer. These original source
NDC MedGuides were created by the manufacturer of the original drug product and can be used for
repackaged versions of the same drug product.
Drug products that require a MedGuide per the FDA will be assigned an FDA-approved class MedGuide (if
available) when a MedGuide was not provided by the manufacturer.

Please direct inquiries regarding the use of MedGuides data to the FDB Customer Service Department.

Exclusion Criteria
FDB publishes MedGuides content as received from the DailyMed website through ASHP and does not editorially
modify the MedGuide content. Failure by a manufacturer to properly file a Medication Guide within an SPL with
the FDA precludes the corresponding NDCs from having a MedGuide linked.

The NDCs linked to MedGuides that are submitted to the DailyMed website are dependent upon the labelers
compliance to submit MedGuide information to the FDA through the SPL.

Data Elements
This section contains additional information about particularly important tables and codes contained within the
module, as well as concepts about the data that the reader must understand in order to understand the module.
NDC to PDF MedGuides Link Table
NDC to XML MedGuides Link Table
MedGuide File Replacement
XML File Directory
XML Associated Files

NDC to PDF MedGuides Link Table

The NDC to PDF MedGuides Link Table (RNDCMDG0_NDC_MEDGUIDE_LINK) serves two main purposes: for
determining if an NDC requires a MedGuide and for obtaining the MedGuide file name.

To determine if an NDC requires a MedGuide, users would search the table for the NDC in question.

If the NDC is present in the table, the MedGuide is required.

If the NDC is not found in the table, a MedGuide is not required for the NDC.
If the NDC is present in the table, but the title, file name, and version date columns are blank, the
FDA-required MedGuide was not provided by the manufacturer and is unavailable for printing.

The MedGuide File Name (MEDGUIDE_FILE_NAME) column is used to know which PDF file to present to the
end user. The MedGuide Version Date (MEDGUIDE_VERSION_DATE) provides the last date that updates were
made to the content within the Medication Guide.

ExamplePDF MedGuide files for Cymbalta

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NDC MEDGUIDE_TITLE MEDGUIDE_FILE_NAME MEDGUIDE_VERSION_DA

TE

00002323560 Cymbalta (Duloxetine) 2f7d4d67-10c1-4bf4-a7f2-c1 20100113

85fbad64ba.pdf

00002323701 Cymbalta (Duloxetine) 2f7d4d67-10c1-4bf4-a7f2-c1 20100113

85fbad64ba.pdf

00002323704 Cymbalta (Duloxetine) 2f7d4d67-10c1-4bf4-a7f2-c1 20100113

85fbad64ba.pdf

NDC to XML MedGuides Link Table

The NDC to XML MedGuides Link Table (RNDCMDX0_NDC_MEDGUIDE_LINK) serves two main purposes for
users: determining if an NDC requires a MedGuide and obtaining the directory location and file name of the
MedGuide.

To determine if an NDC requires a MedGuide, users would search the table for the NDC in question.

If the NDC is present in the table, a MedGuide is required.

If the NDC is not found in the table, a MedGuide is not required for the NDC.
If the NDC is present in the table, but the title, directory name, file name, and version date columns are
blank, the FDA-required MedGuide was not provided by the manufacturer and is unavailable for printing.

Unlike PDF MedGuides, which are stored in a single folder, XML MedGuides require a directory folder structure
with separate subfolders that each contain one XML MedGuide. Therefore, both the directory name (
MEDGUIDE_DIRECTORY_NAME) and file name (MEDGUIDE_FILE_NAME) are needed to locate the correct
XML file to present to the end user. See XML File Directory for additional information.

ExampleXML MedGuide Files for Cymbalta

NDC MEDGUIDE_TITLE MEDGUIDE_DIRECTORY_NAME

MEDGUIDE_FILE_NAME
MEDGUIDE_VERSION_DATE

00002323560 Cymbalta (Duloxetine) 2f7d4d67-10c1-4bf4-a 2f7d4d67-10c1-4bf4-a 20100113

7f2-c185fbad64ba 7f2-c185fbad64ba.xml

00002323701 Cymbalta (Duloxetine) 2f7d4d67-10c1-4bf4-a 2f7d4d67-10c1-4bf4-a 20100113

7f2-c185fbad64ba 7f2-c185fbad64ba.xml

00002323704 Cymbalta (Duloxetine) 2f7d4d67-10c1-4bf4-a 2f7d4d67-10c1-4bf4-a 20100113

7f2-c185fbad64ba 7f2-c185fbad64ba.xml

MedGuide File Replacement

Customers must perform a total file replacement for the PDF or XML MedGuides. Each update cycle, all of
the MedGuides (for both XML or PDF) are sent to users. Customers need to extract the MedGuide files from the
NDDF PLUS DB.zip file to completely replace the previous versions of the MedGuides in their systems
environment.

For XML, extract all of the XML MedGuides and associated files (see XML Associated Files) from the

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following path within the NDDF PLUS DB.zip file:

NDDF Plus DB\MedGuides\MedGuide XML.
For PDF, extract all of the PDF MedGuide files from the following path within the NDDF PLUS DB.zip file:
NDDF Plus DB\MedGuides\MedGuide PDF.

Customers can choose to apply either the full database version or the incremental version of either the NDC to
PDF MedGuides Link Table (RNDCMDG0_NDC_MEDGUIDE_LINK) or the NDC to XML MedGuides Link Table
(RNDCMDX0_NDC_MEDGUIDE_LINK).

XML File Directory

To ensure the correct MedGuide can be located, maintain the folder directory structure as provided by FDB in the
MedGuide product deliverable. In this structure, each XML MedGuide file and any supporting image files are
stored in a separate folder in the directory, and XML associated files (such as style sheets) are stored in the root
directory along with the folders.

ExampleNDC 00002323560 XML MedGuide File

NDC MEDGUIDE_TITLE MEDGUIDE_DIRECTORY_NAME

MEDGUIDE_FILE_NAME
MEDGUIDE_VERSION_DATE

00002323560 Cymbalta (Duloxetine) 2f7d4d67-10c1-4bf4-a 2f7d4d67-10c1-4bf4-a 20100113

7f2-c185fbad64ba 7f2-c185fbad64ba.xml

For the above example, the file location for the XML MedGuide would be \[system path to XML
directory]\2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba\2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba.xml, where:

\[system path to XML directory] is the example system path where the directory is located. This will be
different for each users system.
2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba is the MEDGUIDE_DIRECTORY_NAME
2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba.xml is the MEDGUIDE_FILE_NAME.

XML Associated Files

For the XML files to be rendered correctly, place all of the XML associated files listed below in the root directory
that also stores the XML MedGuide folders.

XML
XSL Style Sheets
Cascading Style Sheets
Java Script

Rule Sets
This section provides rules that the clinical team uses in regard to creating the module's data, both general rules
and rules specific to data elements.

Linking Methodology

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FDB updates MedGuides information weekly using the following methodology:

1. ASHP extracts FDA-approved MedGuides on a daily basis from properly coded SPLs posted on the NLMs
DailyMed website, which is located at http://dailymed.nlm.nih.gov/dailymed/about.cfm.

2. On a weekly basis, FDB acquires the MedGuides and associated NDCs from ASHP. This information is
comprised of:
Manufacturer supplied and FDA approved NSAID and anti-depressant class MedGuides (PDF and
XML formats)
List of NDCs linked to MedGuides
List of NDCs that require a MedGuide but are missing a manufacturer-supplied MedGuide
XML associated files provided by the FDA needed to properly render the XML formats
Title and version date of each MedGuide

3. Once the data is acquired, it is loaded into FDB internal database structures and then delivered to
customers on a weekly or monthly basis.

Maintenance
This section contains information regarding the ongoing maintenance of the module's data.

On a weekly basis, FDB compiles MedGuides information from ASHP. FDB publishes the MedGuides information
and provides MedGuides in PDF or XML formats to customers on a weekly and monthly frequency, regardless of
whether new or updated MedGuides are available.

Resources
This section lists sources used by FDB to compile the information contained in the MedGuides Module.

DailyMed: Current Medication Information, http://dailymed.nlm.nih.gov/dailymed/about.cfm

MedGuides data is supplied to First Databank by the American Society of Health-System Pharmacists
(ASHP)
U.S. Food and Drug Administration, Medication Guides for Prescription Drug Products, Code of Federal
Regulations, Title 21, Part 208.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=208&showFR=1
U.S. Food and Drug Administration, Guidance, Medication Guides -- Distribution Requirements and
Inclusion in Risk Evaluation and Mitigation Strategies (REMS), November 2011.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM244570.pdf

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Applications MedGuides
This section provides information about the practical application of data contained in this module.

Retrieving a PDF MedGuide for a Prescribed Packaged Product

Retrieving an XML MedGuide for a Prescribed Packaged Product

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Retrieving a PDF MedGuide for a Prescribed Packaged Product

This application illustrates how to retrieve a PDF MedGuide for an NDC.

1. Search the NDC to PDF MedGuides Link Table (RNDCMDG0_NDC_MEDGUIDE_LINK) for the NDC in
question.
If the NDC is found in the table, a MedGuide is required. Continue to Step 2.
If the NDC is not found in the table, a MedGuide is not required and no further action needs to be
taken.

2. Retrieve the MedGuide Title (MEDGUIDE_TITLE), MedGuide File Name (MEDGUIDE_FILE_NAME), and
MedGuide Version Date (MEDGUIDE_VERSION_DATE) from the NDC to PDF MedGuides Link Table
(RNDCMDG0_NDC_MEDGUIDE_LINK).

If a MedGuide has not yet been provided by the manufacturer, all columns except the NDC will be
left empty.

3. Using the MedGuide File Name (MEDGUIDE_FILE_NAME) from Step 2, access the MedGuide PDF from
the directory on your system where the PDF MedGuides reside.

4. Present the PDF to the end user according to your business needs.

ExampleRetrieving a PDF MedGuide for a Prescribed Packaged Product

For purposes of demonstrating this application, the following scenario is used: While filling a prescription, a
pharmacist needs to provide a copy of the associated MedGuide to the patient. In this example, a pharmacist
dispenses a prescription for Cymbalta 20 mg Capsules (NDC 00002323560) to be taken orally two times per day
for 30 days.

1. Search the NDC to PDF MedGuides Link Table (RNDCMDG0_NDC_MEDGUIDE_LINK) for the NDC in
question.
If the NDC is found in the table, a MedGuide is required. Continue to Step 2.
If the NDC is not found in the table, a MedGuide is not required and no further action needs to be
taken.

In this example, the NDC is found.

NDC MEDGUIDE_TITLE MEDGUIDE_FILE_NAME MEDGUIDE_VERSION_D

ATE

00002323560 Cymbalta (Duloxetine) 2f7d4d67-10c1-4bf4-a7f2- 20100113

c185fbad64ba.pdf

2. Retrieve the MedGuide Title (MEDGUIDE_TITLE), MedGuide File Name (MEDGUIDE_FILE_NAME), and
MedGuide Version Date (MEDGUIDE_VERSION_DATE) from the NDC to PDF MedGuides Link Table
(RNDCMDG0_NDC_MEDGUIDE_LINK).

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NDC MEDGUIDE_TITLE MEDGUIDE_FILE_NAME MEDGUIDE_VERSION_D

ATE

00002323560 Cymbalta (Duloxetine) 2f7d4d67-10c1-4bf4-a7f2- 20100113

c185fbad64ba.pdf

If a MedGuide has not yet been provided by the manufacturer, all columns except NDC will be left
empty.

3. Using the MedGuide File Name (MEDGUIDE_FILE_NAME) from Step 2, access the MedGuide PDF from
the directory on your system where the PDF MedGuides reside.

4. Present the PDF to the end user according to your business needs.
In this example, the pharmacist prints the MedGuide and presents it to the patient.

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Retrieving an XML MedGuide for a Prescribed Packaged Product

This application illustrates how to retrieve an XML MedGuide for an NDC.

1. Search the NDC to XML MedGuides Link Table (RNDCMDX0_NDC_MEDGUIDE_LINK) for the NDC in
question.
If the NDC is found in the table, a MedGuide is required. Continue to Step 2.
If the NDC is not found in the table, a MedGuide is not required and no further action needs to be
taken.

2. Retrieve the MedGuide Title (MEDGUIDE_TITLE), MedGuide Directory Name

MEDGUIDE_DIRECTORY_NAME), MedGuide File Name (MEDGUIDE_FILE_NAME), and MedGuide
Version Date MEDGUIDE_VERSION_DATE) from the NDC to XML MedGuides Link Table
(RNDCMDX0_NDC_MEDGUIDE_LINK).

If a MedGuide has not yet been provided by the manufacturer, all columns except for NDC will be
left empty.

3. In the XML directory on your system, locate the folder with the same name as the MedGuide Directory
Name (MEDGUIDE_DIRECTORY_NAME) found in Step 2.

4. Using the MedGuide File Name (MEDGUIDE_FILE_NAME) from Step 2, access the MedGuide XML from
the directory found in Step 3.

5. Present the XML to your end user according to your business needs.

ExampleRetrieving an XML MedGuide for a Prescribed Packaged Product

For purposes of demonstrating this application, the following scenario is used: While filling a prescription, a
pharmacist needs to provide a copy of the associated MedGuide to the patient. In this example, a pharmacist
dispenses a prescription for Cymbalta 20 mg Capsules (NDC 00002323560) to be taken orally two times per day
for 30 days.

1. Search the NDC to XML MedGuides Link Table (RNDCMDX0_NDC_MEDGUIDE_LINK) for the NDC in
question.
If the NDC is found in the table, a MedGuide is required. Continue to Step 2.
If the NDC is not found in the table, a MedGuide is not required and no further action needs to be
taken.

In this example, the NDC is found.

NDC MEDGUIDE_TITLE MEDGUIDE_FILE_

MEDGUIDE_DIRECTORY_NAME MEDGUIDE_VERSI
NAME ON_DATE

00002323560 Cymbalta 2f7d4d67-10c1-4bf4- 2f7d4d67-10c1-4bf4- 20100113

(Duloxetine) a7f2-c185fbad64ba a7f2-c185fbad64ba.
pdf

2.

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2. Retrieve the MedGuide Title (MEDGUIDE_TITLE), MedGuide File Name (MEDGUIDE_FILE_NAME), and
MedGuide Version Date (MEDGUIDE_VERSION_DATE) from the NDC to XML MedGuides Link Table
(RNDCMDX0_NDC_MEDGUIDE_LINK).

NDC MEDGUIDE_TITLE MEDGUIDE_DIREC MEDGUIDE_FILE_ MEDGUIDE_VERSI

TORY_NAME NAME ON_DATE

00002323560 Cymbalta 2f7d4d67-10c1-4bf4- 2f7d4d67-10c1-4bf4- 20100113

(Duloxetine) a7f2-c185fbad64ba a7f2-c185fbad64ba.
pdf

If a MedGuide has not yet been provided by the manufacturer, all columns except NDC will be left
empty.

3. In the XML directory on your system, locate the folder with the same name as the MedGuide Directory
Name (MEDGUIDE_DIRECTORY_NAME) found in Step 2.

4. Using the MedGuide File Name (MEDGUIDE_FILE_NAME) from Step 2, access the MedGuide XML from
the directory found in Step 3.
In this example, the location will be: \[system path to XML
directory]\2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba\2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba.xml.

5. Present the XML to your end user according to your business needs.
In this example, the pharmacist prints the MedGuide and presents it to the patient.

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MedGuides ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

MedGuides Tables
MedGuides ERD

MedGuides Tables
NDC to PDF MedGuides Link Table
NDC to XML MedGuides Link Table

MedGuides ERD

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NDC to PDF MedGuides Link Table

Table Name RNDCMDG0_NDC_MEDGUIDE_LINK

Revision Activity rev. 07-24-2013

Purpose Links NDCs to related MedGuides in PDF format.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

MEDGUIDE_TITL MedGuide Title AN 200 X(200)

E

MEDGUIDE_FILE MedGuide File AN 50 X(50)

_NAME Name

MEDGUIDE_VER MedGuide N 8 9(8)

SION_DATE Version Date

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NDC to XML MedGuides Link Table

Table Name RNDCMDX0_NDC_MEDGUIDE_LINK

Revision Activity add. 07-24-2013

Purpose Links NDCs to related MedGuides in XML format.

Key Column Name Column Format Length Picture

Description

PF NDC National Drug AN 11 X(11)

Code

MEDGUIDE_TITL MedGuide Title AN 200 X(200)

E

MEDGUIDE_DIR MedGuide AN 50 X(50)

ECTORY_NAME Directory Name

MEDGUIDE_FILE MedGuide File AN 50 X(50)

_NAME Name

MEDGUIDE_VER MedGuide N 8 9(8)

SION_DATE Version Date

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Therapeutic Classification Systems

First Databank Enhanced Therapeutic Classification System (ETC) 1.0
Therapeutic Classification Data ERD and Technical Specifications
Universal System of Classification (USC) 1.0

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First Databank Enhanced Therapeutic Classification System

(ETC) 1.0
First Databank Enhanced Therapeutic Classification System Editorial Policies
Applications
ERD and Technical Specifications

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First Databank Enhanced Therapeutic Classification System Editorial

Policies
The policies and criteria that apply to the inclusion criteria, processes, and references used in creation of the ETC
module are provided in the following sections:

Overview
Inclusion Criteria
Data Elements
Rule Sets
Maintenance
Resources

Overview
The First Databank Enhanced Therapeutic Classification System (ETC) is a hierarchical class system that groups
medical products and formulations at both highly defined levels and within broader drug categories.

Drug knowledge is aggregated at the Clinical Formulation ID (GCN_SEQNO), Medication ID (MEDID),

Routed Medication ID (ROUTED_MED_ID), and the Routed Generic ID (ROUTED_GEN_ID) levels in the
First Databank (FDB) knowledge base. Under certain circumstances, aggregated drug knowledge may
not apply to all related packaged products; more specific information may be found within product labels.

Inclusion Criteria
This section provides information detailing the criteria that guide the inclusion of data contained within the module
as well as information pertaining to limitations or exclusions when appropriate to the discussion.
All Clinical Formulations (GCN_SEQNO) associated with products in the U.S. have Enhanced Therapeutic Class
(ETC) associations. Therefore all products in the U.S. have ETCs.

Data Elements
This section contains additional information about particularly important tables and codes contained within the
module, as well as concepts about the data that the reader must understand in order to understand the module.

ETC Identifier

The ETC identifier is an eight-character numeric column that identifies a unique therapeutic classification. This
number is a stable identifier permanently associated with the ETC description.

ETC_ID ETC_NAME

00000225 Angiotensin II Receptor Blockers (ARBs)

00000224 ACE Inhibitors

00005991 Renin Inhibitor, Direct

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00002718 Central Alpha-2 Receptor Agonists

00000248 Diuretics

00000250 Diuretic - Loop

00000252 Diuretic - Osmotic

00000253 Diuretic - Potassium Sparing

00000263 Antihyperlipidemics

00000267 Alternative Therapy - Natural HMG CoA Reductase

Inhibitors

00000264 Antihyperlipidemic - Bile Acid Sequestrants

00000265 Antihyperlipidemic - Fibric Acid Derivatives

Associated Data Elements

Key Column Name Column Format Length Picture

Description

P ETC_ID ETC IdentifierA N 8 9(8)

permanent
numeric identifier
that represents a
unique therapeutic
classification.
(Stable ID)

ETC_NAME ETC NameA AN 70 X(70)

unique mixed
case descriptive
name for a
therapeutic
classification

ETC_ULTIMATE_ ETC Ultimate AN 1 X(1)

CHILD_IND Child
IndicatorIndicat
es that the given
ETC_ID has no
lower-level
classifications
associated to it.

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ETC_DRUG_CO ETC Drug AN 1 X(1)

NCEPT_LINK_IN Concept Link
D IndicatorIndicat
es that at least
one Clinical
Formulation ID
(GCN_SEQNO) is
associated to the
given ETC_ID.

ETC_PARENT_E ETC Parent ETC N 8 9(8)

TC_ID IdentifierIdentifi
es the ETC_ID
that is one level
higher than the
given ETC_ID.

ETC_FORMULAR ETC Formulary AN 1 X(1)

Y_LEVEL_IND Level
IndicatorIdentifi
es a suggested
level for building
formularies.

ETC_PRESENTA ETC Presentation N 5 9(5)

TION_SEQNO Sequence
NumberProvide
s a sort order for
sequencing
ETC_IDs with the
same parent.

ETC_ULTIMATE_ ETC Ultimate N 8 9(8)

PARENT_ETC_ID Parent ETC
IdentifierIdentifi
es the therapeutic
classification that
is at the top of the
hierarchy from the
given ETC_ID.

ETC_HIERARCH ETC Hierarchy N 2 9(2)

Y_LEVEL LevelProvides
the position of the
given therapeutic
classification in
the hierarchical
structure.

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ETC_SORT_NUM ETC Sort N 5 9(5)

BER NumberProvide
s a sort order for
sequencing the
ETC_ID when
printing or
displaying a list;
changes with
each product
update and should
not be used as a
class identifier.

ETC_RETIRED_I ETC Retired AN 1 X(1)

ND IndicatorIndicat
es that the given
ETC_ID has been
retired.

ETC_RETIRED_ ETC Retired N 8 9(8)

DATE DateProvides
the date on which
the ETC_ID was
retired.

Related Tables

ETC to GCN_SEQNO Assignment Table

ETC to GCN_SEQNO Change History Table

ETC to HICL_SEQNO Assignment Table

ETC to HICL_SEQNO Assignment History Table

ETC to HIC_SEQN Assignment Table

ETC to HIC_SEQN Assignment History Table

ETC to MedID Assignment Table

ETC to MedID Change History Table

ETC to Med Name ID Assignment Table

ETC to Med Name ID Assignment History Table

ETC to NDC Assignment Table

ETC to NDC Change History Table

ETC HIC3 to ETC Cross Reference Table

Rule Sets
This section provides rules that the clinical team uses in regards to creating the module's data, both general rules
and rules specific to data elements.

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Enhanced Therapeutic Class (ETC)

Therapeutic classes, in general, are a mixture of structural (tricyclic antidepressants), mechanism of action
(beta-blockers), and functional (medical supplies) grouping terms. While initial class terms may be derived from
specific functional descriptions, the terms and expressions that are adopted over time are terms which are the
most popular and recognizable to clinicians. Some have long, mechanism-based names which have been
abbreviated in pragmatic ways in common practice (for example, ACE inhibitors).

Multi-ingredient formulations are represented with a single class description (for example, ACE Inhibitor and
Calcium Channel Blocker Combinations). Since the individual drugs in such combinations are often included
alone in different branches of the hierarchy, it is necessary to determine which branch of the hierarchy will be
selected for a given combination.

For example, the combination class description "ACE Inhibitor and Calcium Channel Blocker" is listed once under
"Ace Inhibitors" in the hierarchy rather than "Calcium Channel Blockers." The order of display and the branch of
the hierarchy chosen are determined by the editors based on a combination of factors that include innovator
ingredient order, clinical relevance, and as with other class descriptions, clinician adopted terminology.

Formulary Level Indicator

The Formulary Class Level is an indicator applied to an ETC Class in the class tree at a level that clinicians may
find more useful and appropriate than the most granular and often directly linked class for display in a Formulary
Listing of drugs.

For example, non-selective NSAIDs Classes include the following list of drug-structure based classes:

NSAIDs, COX Non-Specific Inhibitors - Anthranilic Acid Derivatives

NSAIDs, COX Non-Specific Inhibitors - Indole Acetic Acid Derivatives
NSAIDs, COX Non-Specific Inhibitors - Phenylacetic Acid Derivatives
NSAIDs, COX Non-Specific Inhibitors - Propionic Acid Derivatives
NSAIDs, COX Non-Specific Inhibitors - Pyrazolone Derivatives
NSAIDs, COX Non-Specific Inhibitors - Oxicam Derivatives

These classes are directly associated with drugs fitting these structural descriptions. However, listing these drugs
under a single, broader class would better suit most instances in which these drugs are displayed with associated
ETC classes.

The ETC class one level above these granular classes is the Formulary Level Class, and it is an alternative option
for display in lieu of the more granular classes below it.

NSAIDs, Cyclooxygenase Inhibitors-Non-Selective Inhibitors

NSAIDs, COX Non-Specific Inhibitors - Anthranilic Acid Derivatives
NSAIDs, COX Non-Specific Inhibitors - Indole Acetic Acid Derivatives
NSAIDs, COX Non-Specific Inhibitors - Phenylacetic Acid Derivatives
NSAIDs, COX Non-Specific Inhibitors - Propionic Acid Derivatives
NSAIDs, COX Non-Specific Inhibitors - Pyrazolone Derivatives

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NSAIDs, COX Non-Specific Inhibitors - Oxicam Derivatives

The Formulary Level Indicator may be used in conjunction with the search table to "roll-up" or group drugs at the
Formulary Level Class.

Search Table Functionality

The search table is designed to facilitate grouping and display of drug formulations at the desired class level
depending on customer need.

Creation and Maintenance of ETC Class Associations

Enhanced Therapeutic Classes (ETCs) are associated directly to Clinical Formulations and Ingredients. All other
ETC associations: Medication Concept to ETC; Product to ETC; Ingredient List (HICL_SEQNO) to ETC are
derived from the initial association to a Clinical Formulation. Ingredient to the ETC class associations may differ
from ETC classes assigned to the Clinical Formulation level.

Special Class Associations

The ETC Class of 5904 "Medical Supply, FDB Superset" is applied as a secondary class, not the default class, to
all medical supplies without active drug ingredients that participate in clinical screening modules. This association
can be and is intended to be used to exclude these formulations from clinical screening, thereby saving
processing time for customers.

Default Class Indicator

Each Formulation assigned an ETC has one and only one default ETC class designated by the Default Class
Indicator. If two ETC classes are assigned to a formulation, the default indicator may be used to prevent
double-counting of formulations associated with multiple ETC Classes.

Common Class Indicator

As described above, when two classes are assigned to a formulation, one of those two classes will be the default
indicator. When applied, the Common Class indicator represents that the Default ETC Class is the better
representation of the class for the formulation to which it is applied, than the "non-default" class. When a single
class is the only class assigned to a formulation, that class association is automatically assigned both the
Common and Default indicators.

Maintenance
This section contains information regarding the ongoing maintenance of the module's data.

Triggers for Clinical Review

Assignment of ETCs to newly created Clinical Formulations requires review of existing ETC associations
for similar formulations or classes. This "new product review" may trigger further review to determine if
ETC class and formulation associations require enhancement.
Customer or manufacturer clinical inquiries are reviewed daily and the database is updated weekly as
appropriate.
FDA MedWatch Safety Alerts.

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Resources
This section lists sources used by FDB to compile the information contained in the module.

FDB utilizes many reference sources including, but not limited to, the primary medical literature (for example,
published journal articles), medical reference texts, published expert treatment guidelines, and manufacturer
product package inserts. FDB uses current source editions or versions when coding and updating data, as well as
when researching questions about data. However, a formal data review does not occur for every new release of
source editions or versions. Additional sources include:

Gilman AG, Hardman JG, Limbird LE. Goodman & Gilman's The Pharmacological Basis of Therapeutics.
Treatment Guidelines
PubMed.gov. Available at: http://www.ncbi.nlm.nih.gov/pubmed.
Product labeling:
Manufacturer websites

FDA sources:
Daily Med: Structured Product Labels (SPL). Available at:
http://dailymed.nlm.nih.gov/dailymed/rsshome.cfm.
FDA Approved Drug Products. Available at:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.
National Drug Code Directory. Available at:
http://www.accessdata.fda.gov/scripts/cder/ndc/default.cfm.

ChemIDpluslite, an NLM sponsored ingredient structure and synonym look-up:

http://chem2.sis.nlm.nih.gov/chemidplus/chemidlite.jsp.
USP Dictionary online: U.S. naming standard and ingredient structure look-up:
http://www.uspusan.com/usan/.

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ETC Applications
This section provides information about the practical application of data contained in the First Databank
Enhanced Therapeutic Classification System (ETC). The following applications are included:

Building a Formulary

Presenting Product Substitution Candidates

Performing Comparative Product Analysis

Reporting Ingredient-Based Classifications

Displaying or Selecting the Default ETC Class from Various Drug Concept Levels

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Building a Formulary
The ETC is designed primarily for formulary building, maintenance, and reporting. Using the ETC hierarchy, you
can define your desired therapeutic classifications, using formulary rules to choose the products in each
classification that will be included in the formulary.

Building a formulary is simplified with the ETC_SEARCH_ETC_ID and the ETC_PRODUCT_RELATED_ETC_ID.

Use of these identifiers retrieves only classifications that have Clinical Formulation IDs (GCN_SEQNOs) linked to
them.

There are two parts to building a formulary with the ETC:

Assembling the ETC Hierarchy

Defining the Formulary Rules

These processes are described below.

Assembling the ETC Hierarchy

Before defining the formulary rules, assemble the ETC hierarchy for review. The hierarchy can be loaded into a
database and/or printed. The following application provides the steps for assembling the ETC hierarchy:

1. Retrieve all ETC Identifier (ETC_ID) and ETC Name (ETC_NAME) values from the ETC Table
(RETCTBL0_ETC_ID) that have an ETC Ultimate Parent ETC Identifier (
ETC_ULTIMATE_PARENT_ETC_ID) value of 0. These are the top-level classifications.
In the example below, the top-level classification is ETC_ID = 2549, Anti-Infective Agents.

ETC_ULTIMATE_PARENT_ETC_I ETC_ID ETC_NAME

D

0000 2549 Anti-Infective Agents

2. Retrieve all ETC Identifier (ETC_ID) and ETC Name (ETC_NAME) values that have ETC Parent ETC
Identifier (ETC_PARENT_ETC_ID) values that match the ETC_ID values retrieved in the previous step.
These are the immediate children of the ultimate parent identifiers.
This example retrieves the immediate children of the Anti-Infective Agents (ETC_ID = 2549).

ETC_PARENT_ETC_ID ETC_ID ETC_NAME

2549 40 Antifungals

2549 44 Antivirals

2549 2504 Antiparasitics

2549 2526 Misc Anti-Infectives and

Combinations

2549 2620 Antibacterial Agents

2549 2644 Antiprotozoal-Antibacterial Agents

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2549 3808 Anti-Infective - Immunologic

Adjuvants

Retired ETC_ID values can be excluded by excluding all ETC_ID values with an ETC Retired
Indicator (ETC_RETIRED_IND) value of 1.

3. Retrieve all ETC Identifier (ETC_ID) and ETC Name (ETC_NAME) values that have ETC Parent ETC
Identifier (ETC_PARENT_ETC_ID) values that match the ETC_ID values retrieved in the previous step.
These are the immediate children of the classes retrieved in the previous step.
This example retrieves the immediate children of the Antibacterial Agents (ETC_ID = 2620).

ETC_ID ETC_NAME ETC_PARENT_ETC_ID ETC_ULTIMATE_CHILD

_IND

16 Macrolide Antibiotics and 2620 0

Combinations

20 Lincosamide Antibiotics 2620 1

27 Tetracycline Antibiotics 2620 0

and Combinations

34 Aminoglycoside Antibiotic 2620 1

37 Antimycobacterial Agents 2620 0

69 Polymyxin Antibiotics and 2620 0

Derivatives

71 Streptogramin Antibiotics 2620 1

74 Folate Antagonist 2620 0

Antibiotics

1268 Quinolone Antibiotics 2620 0

2510 BetaLactam Antibiotics 2620 0

2515 Glycopeptide Antibiotics 2620 1

2517 Chloramphenicol 2620 0

Antibiotics and Derivatives

2518 Antibacterial Adjuvants 2620 1

2519 Steroidal Antibiotics 2620 1

2636 Monobactam Antibiotics 2620 1

2646 Antibacterial Nitrofuran 2620 0

Derivatives and
Combinations

2700 Antibacterial Other 2620 1

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2835 Oxazolidinone Antibiotics 2620 1

4545 Aminocyclitol Antibiotics 2620 1

5742 Cyclic Lipopeptide 2620 0

Antibiotics

5841 Ketolide Antibiotics 2620 0

5844 Rifamycins and Related 2620 0

Derivative Antibiotics

5890 Glycylcycline Antibiotics 2620 0

6055 Quaternary protoberberine 2620 0

alkaloid Antibiotics

ETC_IDs with an ETC Ultimate Child Indicator (ETC_ULTIMATE_CHILD_IND) value of 1 have no

lower-level classifications associated to them.

4. Continue to retrieve immediate children of each subclass until all ultimate children are retrieved.

5. Retrieve the ETC Presentation Sequence Number (ETC_PRESENTATION_SEQNO) and the ETC
Hierarchy Level (ETC_HIERARCHY_LEVEL) for each ETC_ID. Use these fields to organize the hierarchy
with different levels of indentation to represent the parent/child relationships and to sequence the classes
at each hierarchical level.
The example below shows a sample of the ETC class hierarchy for Anti-Infective Agents (ETC_ID = 2549).

ETC_ID ETC_NAME ETC_PARENT_ET ETC_PRESENTATI ETC_HIERARCHY_

C_ID ON_SEQNO LEVEL

2549 Anti-Infective Agents 0000 40 1

2620 Antibacterial Agents 2549 10 2

4545 Aminocyclitol 2620 5 3

Antibiotics

34 Aminoglycoside 2620 10 3
Antibiotic

74 Folate Antagonist 2620 30 3

Antibiotics

2646 Antibacterial 2620 40 3

Nitrofuran
Derivatives and
Combinations

37 Antimycobacterial 2620 50 3
Agents

2510 BetaLactam 2620 60 3

Antibiotics

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1 Penicillin Antibiotics 2510 10 4

10 Cephalosporin 2510 20 4
Antibiotics

11 Cephalosporin 10 10 5
Antibiotics - 1st
Generation

12 Cephalosporin 10 20 5
Antibiotics - 2nd
Generation

13 Cephalosporin 10 30 5
Antibiotics - 3rd
Generation

14 Cephalosporin 10 40 5
Antibiotics - 4th
Generation

6184 Cephalosporin 10 60 5
Antibiotics - 5th
Generation

15 Cephalosporin 10 100 5
Antibiotics
Combinations

2630 Cephalosporin 15 10 6
Antibiotic &
Beta-lactamase
Inhibitor
Combinations

2631 Cephalosporin 15 20 6
Antibiotic
Combinations Other

2511 Carbapenem 2510 40 4

Antibiotics
(Thienamycins) and
Combinations

2520 Carbacephem 2510 50 4

Antibiotics

2517 Chloramphenicol 2620 70 3

Antibiotics and
Derivatives

5742 Cyclic Lipopeptide 2620 75 3

Antibiotics

2515 Glycopeptide 2620 80 3

Antibiotics

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5890 Glycylcycline 2620 82 3

Antibiotics

5841 Ketolide Antibiotics 2620 85 3

20 Lincosamide 2620 90 3
Antibiotics

16 Macrolide Antibiotics 2620 100 3

and Combinations

2636 Monobactam 2620 110 3

Antibiotics

2835 Oxazolidinone 2620 120 3

Antibiotics

69 Polymyxin Antibiotics 2620 130 3

and Derivatives

6055 Quaternary 2620 135 3

protoberberine
alkaloid Antibiotics

1268 Quinolone Antibiotics 2620 140 3

5844 Rifamycins and 2620 145 3

Related Derivative
Antibiotics

2519 Steroidal Antibiotics 2620 150 3

71 Streptogramin 2620 160 3

Antibiotics

27 Tetracycline 2620 170 3

Antibiotics and
Combinations

2700 Antibacterial Other 2620 180 3

2518 Antibacterial 2620 190 3

Adjuvants

40 Antifungals 2549 20 2

44 Antivirals 2549 30 2

2504 Antiparasitics 2549 40 2

2644 Antiprotozoal-Antiba 2549 50 2

cterial Agents

3808 Anti-Infective - 2549 60 2

Immunologic
Adjuvants

2526 Misc Anti-Infectives 2549 70 2

and Combinations

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Defining the Formulary Rules

Rules can be defined using particular ETC_IDs and attributes in combination with selected attributes of the drug
concepts associated to those ETC_IDs. There are many ways to define formulary rules. The following application
provides steps for defining a sample formulary rule:

ExampleAll Prescription Non-Sedating Antihistamines, No Repackagers

1. Review the hierarchy to identify the ETC_ID representing Non-Sedating Antihistamines. Refer to
Assembling the ETC Hierarchy, above, for more information. In this example, Non-Sedating Antihistamines
is ETC_ID 290.

2. Use selected ETC_IDs as the ETC_SEARCH_ETC_IDs in the ETC Search Table to retrieve all lower-level
classifications that have Clinical Formulation IDs (GCN_SEQNOs) attached. In this example, ETC_ID 290
(Non-Sedating Antihistamines) is used as the ETC_SEARCH_ETC_ID to retrieve
ETC_PRODUCT_RELATED_ETC_ID (Antihistamine Non-Sedating - Piperazines) and 3948 (Antihistamine
Non-Sedating - Piperidines).

Alternately, the ETC_DRUG_CONCEPT_LINK_IND may be used to determine which ETC_IDs

have Clinical Formulation IDs (GCN_SEQNOs) linked.

3. Use ETC_PRODUCT_RELATED_ETC_ID as the ETC_ID in the ETC to GCN_SEQNO Assignment

Table (or the ETC to NDC Assignment Table, the ETC to Med Name ID Assignment History Table,
the ETC to HICL_SEQNO Assignment Table, or the ETC to Med Name ID Assignment History Table) to
retrieve desired Clinical Formulation IDs (GCN_SEQNOs) (or NDCs, Med IDs, HICL_SEQNOs,
or MED_NAME_IDs). For purposes of this example, NDCs linked to ETC_IDs 3947 (Antihistamine
Non-Sedating - Piperazines) and 3948 (Antihistamine Non-Sedating - Piperidines) are retrieved, using the
ETC to NDC Assignment Table. A sampling of NDCs is shown below:

NDCs linked to ETC_ID 3947 NDCs linked to ETC_ID 3948

54569-4509-00 (Zyrtec 1MG/ML syrup) 54569-2467-01 (Hismanal 10MG tablet)

00069-5530-47 (Zyrtec 1MG/ML syrup) 55175-0148-00 (Hismanal 10MG tablet)

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54569-4290-00 (Zyrtec 10MG tablet) 54569-4388-06 (Allegra 60MG capsule)

55175-6040-04 (Zyrtec 10MG tablet) 54569-4479-01 (Claritin 10MG/10MG syrup)

00069-5500-66 (Zyrtec 5MG tablet) 00085-0612-02 (Claritin 10MG/10MLsyrup)

4. Validate NDC List.

5. Set up formulary rule as All NDCs in ETC_ID 3947 and 3948 with REPACK = 0.

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Presenting Product Substitution Candidates

The ETC can be used to find the following types of substitution candidates:

Therapeutically-equivalent products are products with the same GCN/Labeler Code combination and the
same ETC_ID that have an A Orange Book Code rating.
Products in the same therapeutic classification are products that are associated to the same ETC_ID.

The final decision to substitute must also include a review of State Board of Pharmacy regulations relative
to drug substitution and the dispensing pharmacists best professional judgment.

Please note that the ETC is not a substitute for the Indications Module (INDM) 2.0.

FDB is not a laboratory and is not equipped to do a laboratory analysis of pharmaceutical products. FDB
depends on the pharmaceutical manufacturer to provide all relevant information accurately and
completely in the package insert. FDB relies on the information in the package insert in determining how
to enter a particular drug into the database.

The applications for finding each type of substitution candidate are presented below.

Finding Therapeutically-Equivalent Products

To find therapeutically-equivalent candidates for substitution, use the following application:

1. Use the product NDC to query the NDC Table and retrieve its associated Clinical Formulation ID (
GCN_SEQNO), Labeler Code (last five characters of the LBLRID), and Orange Book Code (OBC).

NDC LN GCN_SEQNO Labeler Code OBC

00016010105 AZULFIDINE 500 9402 00013 AB

MG TABLET

2. Use the retrieved Clinical Formulation ID (GCN_SEQNO) to query the GCN_SEQNO/GCN Relation Table
and retrieve the associated GCN. At this point you should have the product NDCs OBC, Labeler Code,
and GCN.

NDC LN OBC Labeler Code GCN

00016010105 AZULFIDINE 500 AB 00013 41611

MG TABLET

3. Use the product NDC to retrieve its associated ETC_IDs from the ETC to NDC Assignment Table.

NDC LN ETC_ID ETC Name

00016010105 AZULFIDINE 500 MG 3013 Inflammatory Bowel

TABLET Agents - Mesalamine
Derivatives

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4. Use the retrieved ETC_IDs to query the ETC to NDC Assignment Table and retrieve all associated NDCs.
(Please note that only a sampling of NDCs are shown in the following example).

ETC_ID ETC Name NDC LN

3013 Inflammatory Bowel 00013010120 AZULFIDINE 500 MG

Agents - Mesalamine TABLET
Derivatives

00032192482 ROWASA 4 GM/60 ML

ENEMA

00013010201 AZULFIDINE ENTAB 500

MG

00013010501 DIPENTUM 250 MG

CAPSULE

54569007200 AZULFIDINE 500 MG

TABLET

00032206001 S.A.S.-500 TABLET

00088201046 PENTASA 250 MG

CAPSULE

00102275501 SULFASALAZINE 500 MG

TABLET

00149075202 ASACOL 400 MG TABLET

EC

00016010105 AZULFIDINE 500 MG

TABLET

00150115240 SULFASALAZINE 500 MG

TABLET

00150115260 SULFASALAZINE 500 MG

TABLET

00016010101 AZULFIDINE 500 MG

TABLET

5. Use each of the retrieved NDCs to query the NDC Table and retrieve associated Clinical Formulation IDs (
GCN_SEQNO), Labeler Codes (last five characters of the LBLRID) and OBCs. Proceed only with NDCs
that have A-rated OBCs, and exclude all other NDCs.

NDC LN GCN_SEQNO OBC Labeler Code

00013010120 AZULFIDINE 500 9402 AB 00009

MG TABLET

00032192482 ROWASA 4 GM/60 4444 ZC 00032

ML ENEMA

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00013010201 AZULFIDINE 9403 AB 00009

ENTAB 500 MG

00013010501 DIPENTUM 250 MG 15514 ZC 00009

CAPSULE

54569007200 AZULFIDINE 500 9402 ZA 54569

MG TABLET

00032206001 S.A.S.-500 TABLET 9402 ZA 00053

00088201046 PENTASA 250 MG 19863 ZC 54092

CAPSULE

00102275501 SULFASALAZINE 9402 ZA 00102

500 MG TABLET

00149075202 ASACOL 400 MG 15237 ZC 00149

TABLET EC

00150115240 SULFASALAZINE 9402 ZA 00150

500 MG TABLET

00150115260 SULFASALAZINE 9402 ZA 00150

500 MG TABLET

00016010101 AZULFIDINE 500 9402 AB 00013

MG TABLET

6. Use the retrieved Clinical Formulation IDs (GCN_SEQNO) to query the GCN_SEQNO/GCN Relation Table
(RGCN0_GCN_GCNSEQNO_LINK) and retrieve the associated GCN for each Clinical Formulation ID (
GCN_SEQNO). At this point you should have the OBC, Labeler Code, and GCN for each A rated NDC.

NDC LN OBC Labeler Code GCN

00013010120 AZULFIDINE 500 AB 00009 41611

MG TABLET

00013010201 AZULFIDINE AB 00009 41620

ENTAB 500 MG

00016010101 AZULFIDINE 500 AB 00013 41611

MG TABLET

7. Compare the GCN and Labeler Code of the product NDC to the list of NDCs with their associated GCNs
and Labeler Codes. NDCs that have the same GCN and Labeler Code as the product NDC are
therapeutically equivalent.

NDC LN OBC Labeler Code GCN

00016010105 AZULFIDINE 500 AB 00013 41611

MG TABLET

NDC LN OBC Labeler Code GCN

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00013010120 AZULFIDINE 500 AB 00009 41611

MG TABLET

00013010201 AZULFIDINE AB 00009 41620

ENTAB 500 MG

00016010101 AZULFIDINE 500 AB 00013 41611

MG TABLET

Finding Products in the Same Therapeutic Classification

To find products in the same therapeutic classification, use the following application:

1. Use the product NDC to retrieve its associated ETC_ID from the ETC to NDC Assignment Table.

NDC LN ETC_ID ETC Name

00013010120 AZULFIDINE 500 MG 3013 Inflammatory Bowel

TABLET Agents - Mesalamine
Derivatives

2. Use the retrieved ETC_ID to query the ETC to NDC Assignment Table and retrieve all associated NDCs.
These NDCs are in the same therapeutic classification as the product NDC. (Please note that only a
sampling of NDCs are shown in the following example).

ETC_ID ETC Name NDC LN

3013 Inflammatory Bowel 00013010120 AZULFIDINE 500 MG

Agents - Mesalamine TABLET
Derivatives

00032192482 ROWASA 4 GM/60 ML

ENEMA

00013010201 AZULFIDINE ENTAB 500

MG

00013010501 DIPENTUM 250 MG

CAPSULE

54569007200 AZULFIDINE 500 MG

TABLET

00032206001 S.A.S.-500 TABLET

00088201046 PENTASA 250 MG

CAPSULE

00102275501 SULFASALAZINE 500 MG

TABLET

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Performing Comparative Product Analysis

The flexibility of the ETC makes it suitable for many different types of comparative analyses. For purposes of
demonstrating this application, the following scenario is used:

ExampleProduct Comparison Analysis for Antianginal - Coronary Vasodilators (Nitrates)

1. For each therapeutic classification (ETC_ID), query the ETC to NDC Assignment Table
(RETCNDC0_ETC_NDC) and retrieve all associated NDCs. For purposes of this example, a sampling of
the NDCs associated to ETC_ID 206 (Antianginal - Coronary Vasodilators [Nitrates]) were retrieved, as
shown below:

ETC_ID NDC

206 54868153801

206 00008416101

206 62584076301

206 00310085310

206 62794020493

206 57866394601

206 39822995002

2. For each NDC, query the NDC Table and retrieve the Package Size ( PS), Label Name (LN), and Labeler
ID (LBLRID), as shown in the example below:

NDC PS LN LBLRID

54868153801 100.000 NITROSTAT 0.3 MG A54868

TABLET SL

00008416101 100.000 ISORDIL 10 MG TABLET A00008

SL

62584076301 100.000 ISOSORBIDE DN 10 MG A62584

TABLET

00310085310 100.000 SORBITRATE 2.5 MG B00310

TABLET SL

62794020493 30.000 NITREK 0.4 MG/HR A62794

PATCH

57866394601 30.000 ISOSORBIDE MN 120 MG A57866

TAB SA

39822995002 .300 AMYL NITRITE AMPUL A39822

3.

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3. For each LBLRID, query the Labeler Identifier Description Table (RLBLRID3_LBLR_DESC) and retrieve
the associated Manufacturer Name (MFG), as shown in the example below:

LBLRID MFG

A54868 Physicians TC

A00008 Wyeth Pharm

A62584 AHP

B00310 Zeneca Inc.

A62794 Bertek Pharm

A57866 Direct Dispense

A39822 Pharma-Tek

4. At this point in the example, the following elements for each NDC have been retrieved:
Package Size (PS)
Label Name (LN)
Manufacturer Name (MFG)

The following table illustrates these elements formatted into a product comparison report:

ExampleProduct Comparison Report for Antianginal - Coronary Vasodilators (Nitrates)

NDC LN Manufacturer Package Size

54868153801 NITROSTAT 0.3 MG Physicians TC 100.000

TABLET SL

00008416101 ISORDIL 10 MG TABLET SL Wyeth Pharm 100.000

62584076301 ISOSORBIDE DN 10 MG AHP 100.000

TABLET

00310085310 SORBITRATE 2.5 MG Zeneca Inc 100.000

TABLET SL

62794020493 NITREK 0.4 MG/HR PATCH Bertek Pharm 30.000

57866394601 ISOSORBIDE MN 120 MG Direct Dispense 30.000

TAB SA

39822995002 AMYL NITRITE AMPUL Pharma-Tek .300

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Reporting Ingredient-Based Classifications

HIC_SEQN associations to ETC_IDs can be used to report on all products containing ingredients classified in a
particular therapeutic classification, whether or not the product containing the ingredient belongs to that
classification. In the following example, the application retrieves products containing ingredients classified as
Analgesic or Antipyretic Non-Narcotic:

1. Using a given ETC_ID, query the ETC to HIC_SEQN Assignment Table and retrieve all HIC_SEQNs. For
purposes of this example, a sampling of the HIC_SEQNs associated to ETC_ID 577 is retrieved (Analgesic
or Antipyretic Non-Narcotic), as shown below:

ETC_ID HIC_SEQN

577 1605

2. For each HIC_SEQN, query the HICL_SEQNO/HIC Relation Table and retrieve associated
HICL_SEQNOs, as shown in the example below:

HIC_SEQN HICL_SEQNO

1605 1866

1605 1871

1605 21273

3. For each HICL_SEQNO, query the Clinical Formulation ID Table, page 100 and retrieve associated
Clinical Formulation IDs (GCN_SEQNOs), as shown in the example below:

HICL_SEQNO GCN_SEQNO

1866 4473

1871 48520

21273 45404

4. For each Clinical Formulation ID (GCN_SEQNO), query the NDC Table and retrieve all associated NDCs,
as shown in the example below:

GCN_SEQNO NDC LN ETC_ID ETC Name

4473 00045049475 TYLENOL EXTRA 577 Analgesic or

STRENGTH CAP Antipyretic
Non-Narcotic

48520 00086012005 MIDRIN CAPSULE 3745 Migraine Therapy -

Analgesic/Vasoconst
rictor/Sedative
Combinations

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45404 19810003206 EXCEDRIN P.M. 547 Sedative/Hypnotic -

CAPLET Antihistamine
Combinations

Clinical Formulation IDs (GCN_SEQNOs) and/or NDCs listed above do not necessarily belong to
ETC_ID 577.

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Displaying or Selecting the Default ETC Class from Various Drug Concept Levels
A given medication may be linked to more than one ETC class. However, the end user may only desire one ETC
class to describe a particular medication. In such cases, the default class indicator ( ETC_DEFAULT_USE_IND)
could be used as a filter to specify which ETC class would be most commonly used to describe the given
medication.

The ETC_DEFAULT_USE_IND and ETC_COMMON_USE_IND have been synchronized to contain the

same values. FDB recommends using the ETC_DEFAULT_USE_IND for consistency, and considers
ETC_COMMON_USE_IND to be a legacy field.

The ETC_DEFAULT_USE_IND is assigned at the Clinical Formulation ID (GCN_SEQNO), Medication ID (MEDID

), or National Drug Code (NDC) level.

A GCN_SEQNO, NDC, or MEDID is associated with one (and only one) default ETC (derived from the
associated GCN_SEQNO relationship). Some MEDIDs may be associated with more than one
GCN_SEQNO; thus, the default ETC may differ between GCN_SEQNOs associated to the same MEDID.
For example, carbamazepine (GCN_SEQNO) may be prescribed either as an anticonvulsant for the
treatment of epilepsy (which represents one ETC class) or for the treatment of bipolar disorder (which
represents another). FDB has assigned a representative ETC as the default ETC class to resolve that
issue. Limiting the display of the ETC class to just the default class may limit recognition that other
classifications may apply.

The ETC_DEFAULT_USE_IND may be transferred from the MEDID to less specific levels of the Med
Name concepts; for example, Routed Dosage Form Med, Routed Med, or Med Name to facilitate the
display of a single primary ETC if desired (and where possible).

Find the Default ETC from the MED_NAME

To determine the default ETC class for a Medication Name (MED_NAME), navigate to the Medication ID (MEDID
).

1. Select the MED Medication Name ID (MED_NAME_ID) from the MED Medication Name Table
(RMINMID1_MED_NAME) where the Medication Name (MED_NAME) equals the Medication Name of the
drug.

2. Select the MED Routed Medication ID (Stable ID) (ROUTED_MED_ID) from the MED Routed Medication
Table (RMIRMID1_ROUTED_MED) where the MED_NAME_ID equals the MED_NAME_ID from the
previous step.

3. Select the MED Routed Dosage Form Medication ID (Stable ID) ( ROUTED_DOSAGE_FORM_MED_ID)
from the MED Routed Dosage Form Medication Table (RMIDFID1_ROUTED_DOSE_FORM_MED
RMIDFID2_ROUTED_DOSE_FORM_MED) where the ROUTED_MED_ID equals the ROUTED_MED_ID
from the previous step.

4.

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4. Select the MEDID from the MED Medication Table (RMIID1_MED) where the
ROUTED_DOSAGE_FORM_MED_ID equals the ROUTED_DOSAGE_FORM_MED_ID from the previous
step with a MED Medication Status Code (MED_STATUS_CD) of 0 (Active) or 1 (Inactive).

5. Select the ETC_ID value from the ETC to MedID Assignment Table (RETCMED0_ETC_MEDID) for the
MEDIDs from the previous step where the ETC Default Use Indicator ( ETC_DEFAULT_USE_IND) equals
1.

An ETC class can be identified as the Default Use Class for a MEDNAME when the associated MEDIDs have
only one ETC class with the ETC_DEFAULT_USE_IND set to 1. Not every MED_NAME will have a default ETC
class, however.

If the MEDIDs associated with the MEDNAME have more than one ETC class with an
ETC_DEFAULT_USE_IND of 1, you will not be able to derive a single default ETC for a MEDNAME, but
there may still be value in displaying results with default indicators which are transferred from the
associated MEDIDs.

As a reminder, one drug may be prescribed for a variety of indications. As in the examples above,
carbamazepine may be prescribed for epilepsy, bipolar disorder, or trigeminal neuralgia, and other drugs,
such as bupropion, may be prescribed as an antidepressant or as a smoke deterrent. Though the default
ETC class (such as Tricyclic Antidepressant) may imply a broader reason or indication that a patient is
taking a medication, precautions should be taken that the actual reason or indication for which a drug is
administered should be specified, and not just inferred from the ETC class.

This application is useful in a number of settings, including medication reconciliation. The following example
demonstrates this application.

ExampleDisplaying or Selecting the Default ETC Class from Various Drug Concept Levels for Purposes of
Medication Reconciliation

For purposes of demonstrating this application, the following scenario is used: A patient is being released from
the hospital, and the discharge system will generate a report listing the medications administered to the patient at
the hospital and the medications already regularly taken by the patient at home. The list will be organized by
therapeutic class, so that the hospital physician can determine which medications should be additionally
prescribed for the patient to take at home.

For this example, the medication taken by the patient at home is identified by the MED Medication Name (
MED_NAME). The information was collected during preregistration when the patient recited the names of his
current medications from memory. The medication taken by the patient at home (derived from the MED
Medication Name Table [RMINMID1_MED_NAME]) is:

MED_NAME_ID MED_NAME

10289 Epitol

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The list of medications administered in the hospital is pulled from the CPOE system, and therefore are identified
by the MED Medication ID (MEDID). The medications administered to the patient in the hospital (derived from the
MED Medication Table [RMIID1_MED]) are:

MEDID MED_MEDID_DESC

170880 diphenhydramine 50 mg tablet

243574 diphenhydramine 25 mg tablet

472543 lactulose 10 gram/15 mL Oral Soln

472869 carbamazepine ER 200 mg capsule, extended release

mphase12hr

472870 carbamazepine ER 300 mg capsule, extended release

mphase12hr

Part 1: Find the Default ETC for Each Medication Taken by the Patient at Home

The medications on the home list are identified by MED_NAME. To determine the default ETC class for a
MED_NAME, navigate to the MEDID.

1. Select the MED Medication Name ID (MED_NAME_ID) from the MED Medication Name Table
(RMINMID1_MED_NAME) where the Medication Name equals the Medication Name of the medication.

MED_NAME MED_NAME_ID

Epitol 10289

2. Select the MED Routed Medication ID (Stable ID) (ROUTED_MED_ID) from the MED Routed Medication
Table (RMIRMID1_ROUTED_MED) where the MED_NAME_ID equals the MED_NAME_ID from the
previous step.

MED_NAME MED_NAME_ID ROUTED_MED_ID

Epitol 10289 10962

3. Select the MED Routed Dosage Form Medication ID (Stable ID) ( ROUTED_DOSAGE_FORM_MED_ID)
from the MED Routed Dosage Form Medication Table
(RMIDFID1_ROUTED_DOSE_FORM_MED RMIDFID2_ROUTED_DOSE_FORM_MED) where the
ROUTED_MED_ID equals the ROUTED_MED_ID from the previous step.

MED_NAME MED_NAME_ID ROUTED_MED_ID ROUTED_DOSAGE_FO

RM_MED_ID

Epitol 10289 10962 1241

4. Select the MEDID from the MED Medication Table (RMIID1_MED) where the
ROUTED_DOSAGE_FORM_MED_ID equals the ROUTED_DOSAGE_FORM_MED_ID from the previous

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4.

step with a MED Medication Status Code (MED_STATUS_CD) of 0 (Active) or 1 (Inactive).

MED_NAME MED_NAME ROUTED_M ROUTED_D MEDID MED_MEDID MED_STATU

_ID ED_ID OSAGE_FO _DESC S_CD
RM_MED_ID

Epitol 10289 10962 12412 265451 Epitol 200 mg 0

tablet

5. Select the ETC_ID value from the ETC to MedID Assignment Table (RETCMED0_ETC_MEDID) for the
MEDIDs from the previous step where the ETC Default Use Indicator ( ETC_DEFAULT_USE_IND) equals
1.

MED_NAME MED_NAME_ID MEDID ETC_ID ETC_COMMON ETC_NAME

_USE_IND

Epitol 10289 265451 2687 1 Anticonvulsant -

Iminostilbene
Derivatives

6. The default ETC class for Epitol is Anticonvulsant - Iminostilbene Derivatives.

Part 2: Find the Default ETC Class for Each Medication Administered to the Patient at the Hospital

1. Select the ETC Identifier (ETC_ID) value from the ETC to MedID Assignment Table
(RETCMED0_ETC_MEDID) for each given MED Medication ID (MEDID) where the ETC Default Use
Indicator (ETC_DEFAULT_USE_IND) equals 1.

MEDID MED_MEDID_DES ETC_ID ETC_DEFAULT_U ETC_NAME

C SE_IND

170880 diphenhydramine 50 3152 1 Antihistamines - 1st

mg tablet Generation

243574 diphenhydramine 25 3152 1 Antihistamines - 1st

mg tablet Generation

472543 lactulose 10 gram/15 409 1 Laxative - Saline and

mL Oral Soln Osmotic

472869 carbamazepine ER 2687 1 Anticonvulsant -

200 mg capsule, Iminostilbene
extended release Derivatives
mphase12hr

472870 carbamazepine ER 2687 1 Anticonvulsant -

300 mg capsule, Iminostilbene
extended release Derivatives
mphase12hr

These are the default classifications for each MEDID administered to the patient at the hospital.

Part 3: Compare ETC Classes for Medication Reconciliation

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1. Record the list of medications and default classifications for each MEDID administered to the patient in the
hospital:

MEDID MED_MEDID_DESC ETC_ID ETC_NAME

170880 diphenhydramine 50 mg 3152 Antihistamines - 1st

tablet Generation

243574 diphenhydramine 25 mg 3152 Antihistamines - 1st

tablet Generation

472543 lactulose 10 gram/15 mL 409 Laxative - Saline and

Oral Soln Osmotic

472869 carbamazepine ER 200 2687 Anticonvulsant -

mg capsule, extended Iminostilbene Derivatives
release mphase12hr

472870 carbamazepine ER 300 2687 Anticonvulsant -

mg capsule, extended Iminostilbene Derivatives
release mphase12hr

2. Record the medications and default classifications taken at home:

MED_NAME_ID MED_NAME ETC_ID ETC_NAME

10289 Epitol 2687 Anticonvulsant -

Iminostilbene Derivatives

3. In comparing the two lists, we see that the patient was prescribed an Anticonvulsant in the hospital, and is
also regularly taking one at home. Prescribing this medication at discharge is desirable in providing
continued care along with counseling to ensure that the patient doesn't take both prescriptions
simultaneously.

As a reminder, one drug may be prescribed for a variety of indications. As in the examples above,
carbamazepine may be prescribed for epilepsy, bipolar disorder, or trigeminal neuralgia, and other
drugs, such as bupropion, may be prescribed as an antidepressant or as a smoke deterrent.
Though the default ETC class (such as Tricyclic Antidepressant) may imply a broader reason or
indication that a patient is taking a medication, precautions should be taken that the actual reason
or indication for which a drug is administered should be specified, and not just inferred from the
ETC class.

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ETC ERD and Technical Specifications

This section provides the Entity-Relationship Diagram (ERD) and technical specifications for each of the tables
contained in this module.

ETC Tables
ETC ERD

ETC Tables
ETC Change Type Code Description Table
ETC HIC3 to ETC Cross Reference Table
ETC Search Table
ETC Table
ETC to GCN_SEQNO Assignment Table
ETC to GCN_SEQNO Change History Table
ETC to HIC_SEQN Assignment History Table
ETC to HIC_SEQN Assignment Table
ETC to HICL_SEQNO Assignment History Table
ETC to HICL_SEQNO Assignment Table
ETC to MedID Assignment Table
ETC to MedID Change History Table
ETC to Med Name ID Assignment History Table
ETC to Med Name ID Assignment Table
ETC to NDC Assignment Table
ETC to NDC Change History Table

ETC ERD

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ETC Change Type Code Description Table

Table Name RETCCTD0_ETC_CHANGE_TYPE_DESC

Revision Activity add.09-05-2002

Purpose Relates the ETC_CHANGE_TYPE_CODE to its text

description.

Key Column Name Column Format Length Picture

Description

PF ETC_CHANGE_T ETC Change AN 1 X(1)

YPE_CODE Type
Codeidentifies
the type of history
record.

ETC_CHANGE_T ETC Change AN 90 X(90)

YPE_CODE_DES Type Code
C Descriptionthe
text description for
an
ETC_CHANGE_T
YPE_CODE.

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ETC HIC3 to ETC Cross Reference Table

Table Name RETCXRF0_ETC_HIC3_ETC

Revision Activity add.09-05-2002

Purpose Provides a link to all ETCs that are equal to or narrower

than a given Hierarchical Ingredient Code 3 Specific
Therapeutic Classification (HIC3).

Key Column Name Column Format Length Picture

Description

PF ETC_ID ETC Identifiera N 8 9(8)

permanent
numeric identifier
that represents a
unique therapeutic
classification.
(Stable ID)

PF HIC3_SEQN Hierarchical N 6 9(6)

Specific
Therapeutic Class
code Sequence

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ETC Search Table

Table Name RETCSCH0_ETC_SEARCH

Revision Activity add.09-05-2002

Purpose Provides the association between a ETC_ID and related

child ETC_IDs with associations to Clinical Formulation IDs
(GCN_SEQNOs).

Key Column Name Column Format Length Picture

Description

PF ETC_SEARCH_E ETC Search ETC N 8 9(8)

TC_ID Identifierthe
ETC_ID used to
search for related
ETC_IDs.

PF ETC_PRODUCT_ ETC Product N 8 9(8)

RELATED_ETC_I Related ETC
D IdentifierETC_I
D that is the child
of an
ETC_SEARCH_E
TC_ID and is
associated to
Clinical
Formulation IDs
(GCN_SEQNOs).

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ETC Table

Table Name RETCTBL0_ETC_ID

Revision Activity add.09-05-2002

Purpose Provides attributes for the therapeutic classification and

associates it to its parent therapeutic classification.

Key Column Name Column Format Length Picture

Description

PF ETC_ID ETC Identifiera N 8 9(8)

permanent
numeric identifier
that represents a
unique therapeutic
classification.
(Stable ID)

ETC_NAME ETC Namea AN 70 X(70)

unique mixed
case descriptive
name for a
therapeutic
classification.

ETC_ULTIMATE_ ETC Ultimate AN 1 X(1)

CHILD_IND Child
Indicatorindicat
es that the given
ETC_IC has no
lower-level
classifications
associated to it.

ETC_DRUG_CO ETC Drug AN 1 X(1)

NCEPT_LINK_IN Concept Link
D Indicatorindicat
es that at least
one Clinical
Formulation ID
(GCN_SEQNO) is
associated to the
given ETC_ID.

F ETC_PARENT_E ETC Parent ETC N 8 9(8)

TC_ID Identifieridentifi
er the ETC_ID
that is one level
higher than the
given ETC_ID.

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ETC_FORMULAR ETC Formulary AN 1 X(1)

Y_LEVEL_IND Level
Indicatoridentifi
es a suggested
level for building
formularies.

ETC_PRESENTA ETC Presentation N 5 9(5)

TION_SEQNO Sequence
Numberprovide
s a sort order for
sequencing
ETC_IDs with the
same parent.

F ETC_ULTIMATE_ ETC Ultimate N 8 9(8)

PARENT_ETC_ID Parent ETC
Identifieridentifi
es the therapeutic
classification that
is at the top of the
hierarchy from the
given ETC_ID.

ETC_HIERARCH ETC Hierarchy N 2 9(2)

Y_LEVEL Levelprovides
the position of the
given therapeutic
classification in
the hierarchical
structure.

ETC_SORT_NUM ETC Sort N 5 9(5)

BER Numberprovide
s a sort order for
sequencing the
ETC_ID when
printing or
displaying a list;
changes with
each product
update and should
not be used as a
class identifier.

ETC_RETIRED_I ETC Retired AN 1 X(1)

ND Indicatorindicat
es that the given
ETC_ID has been
retired.

ETC_RETIRED_ ETC Retired N 8 9(8)

DATE Dateprovides
the date on which
the ETC_ID was
retired.

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ETC to GCN_SEQNO Assignment Table

Table Name RETCGC0_ETC_GCNSEQNO

Revision Activity add.09-05-2002

Purpose Links the clinical formulation to a therapeutic classification

and provides the attributes of that association.

Key Column Name Column Format Length Picture

Description

PF GCN_SEQNO Clinical N 6 9(6)

Formulation ID
(Stable ID)

PF ETC_ID ETC Identifiera N 8 9(8)

permanent
numeric identifier
that represents a
unique therapeutic
classification.
(Stable ID)

ETC_COMMON_ ETC Common AN 1 X(1)

USE_IND Use
Indicatoridentifi