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Pharmacy general policies and

procedures manual
Last updated: Month/Day/Year

Last reviewed: Month/Day/Year

Links and references updated: January 1, 2022

Page 1 of 38
Table of Contents

1.0 Introduction..................................................................................................................................... 3

2.0 General operations......................................................................................................................... 4

3.0 Dispensary operations.................................................................................................................... 7

4.0 Providing virtual care to patients................................................................................................... 19

5.0 Laboratory and point-of-care testing (POCT)................................................................................20

5.0 Pharmacy compounding of non-sterile preparations.....................................................................21

6.0 Patient concerns........................................................................................................................... 25

7.0 Privacy policy ............................................................................................................................... 26

8.0 Pharmacy signage........................................................................................................................ 27

9.0 Pharmacy website........................................................................................................................ 28

10.0 Reference library.......................................................................................................................... 29

11.0 Code of Ethics.............................................................................................................................. 30

12.0 Human resources......................................................................................................................... 31

13.0 Business operations..................................................................................................................... 33

14.0 Contacts........................................................................................................................................ 35

15.0 Definitions .................................................................................................................................... 37

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[Pharmacy Name]: Policies and procedures manual
Updated: mm/dd/yyyy

1.0 Introduction
These operational procedures are specific to the provision of pharmacy services by [insert pharmacy
name here]. All other activities are encompassed in separate policies and procedures, sections of which
are complementary to these.

These procedures apply to all pharmacy employees who provide services on behalf of [insert pharmacy
name here].

These procedures will be reviewed every [insert time period].

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2.0 General operations


2.1. Pharmacy information
Pharmacy name:

Pharmacy license #:

Address:

City:

Postal code:

Hours of operation:

Pharmacy licensee:

Pharmacy proprietor(s) (e.g. owner, regional pharmacy director, director of operations):

Pharmacy website(s) (including all social media platforms):

2.2. Staff information


Pharmacists





Pharmacy technicians





Pharmacy assistants


Other staff


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2.3. Security

2.3.1. Pharmacy access

2.3.2. Mandatory pharmacist presence

2.3.3. Opening and closing procedures


Opening:

Closing:

2.3.4. Keys
Procedure for key holders:

Procedure for relief pharmacists:

2.3.5. Alarm
Procedure:

Alarm Contacts:

2.3.6. Lock and leave


Procedure:

Securing Schedule 2 products:

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Securing Schedule 3 products:

Safe:

Shared premises:

2.3.7. Hardware and software security


Procedure:

2.3.8. Time-delay safe


Procedure:

2.3.9. Armed robbery


Procedure:

2.3.10. Pharmacy break-ins or burglaries


Procedure:

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3.0 Dispensary operations


3.1. Systems and software
Computer information:

3.1.1. Data backup


Procedure:

Repair contact:

Supplies contact:

Dispensary software contact:

3.1.2. Netcare user ID and password security (DO NOT list user IDs and
passwords here)
Systems User ID and Password Security

Security Procedure:

Netcare User ID and Password Security

Security procedure:

3.1.3. Affiliate agreements


Insert list of agreements with affiliate IT providers:

3.1.4. Systems and software training

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3.2. Stock layout or planogram

Supplies:

3.3. Workflow (text and diagram)


Role of pharmacy technician:

Role of pharmacy assistant:

3.4. Retention of prescription and patient records

3.4.1. Retention of prescriptions (written, electronic)


A prescription for a Schedule 1 drug may legally be filled for 12 months from the date on
which the prescription was written and may be refilled for 18 months past the date on
which the prescription was first filled.

Written prescriptions and transaction records for schedule 1 drugs that have been
dispensed should be filed systematically and retained for at least two years past the
completion of therapy with regard to the prescription or for 42 months, whichever is
greater.

Procedure (including backup plan):

3.4.2. Retention of patient records (written, electronic)


The patient record must provide a history of all interactions required to be documented for
a patient under the Standards of Practice for Pharmacist and Pharmacy Technicians and
must be maintained for a period not less than 10 years after the last pharmacy service or
two years past the age of majority, whichever is greater.

Procedure (including access, retention and backup plan):

3.4.3. Retention of disclosure of health information


When a custodian discloses a record containing individually identifying diagnostic,
treatment and care information without consent, the disclosing custodian must make a
notation of the name of the recipient, the date and purpose of the disclosure and a
description of the information disclosed. The disclosure notation may be in paper or

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electronic form, may be put on the individual’s health or drug record or in a book or
“disclosure log.” This record is to be kept for 10 years following the date of disclosure.

Procedure:

3.4.4. Offsite storage

Storage Procedure:

3.5. Audit trail - general (text and diagram)

3.6. Record of disclosure form


Procedure:

[insert form(s) here or location of documentation in database]

3.7. Electronic transmission of prescriptions

3.7.1. Fax standards compliance

3.7.2. Electronic signatures

3.8. Transfer of care

3.9. Sale of Schedule 2 and 3 products


Procedure and accompanying documentation:

3.10. Repackaging prescriptions


Refer to Standards 7 and 21 in the Standards of Practice for Pharmacists and Pharmacy
Technicians.

Procedure and accompanying documentation:

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Patient records:

Repackaging area:

Labeling requirements:

Audit trail:

Quality assurance:

Storage:

3.11. Delivery and mailing of prescriptions


Section 12.1 of the Pharmacy and Drug Regulations requires that where a prescription is not
picked up at the pharmacy by the patient or the patient’s agent, the pharmacy must document
“the method of delivery of the drug to the patient and the method of dealing with environmental
concerns where appropriate.”

Procedure and accompanying documentation:

Audit trail:

3.12. Long term care pharmacy


Policies:

Procedure:

Patient assessments:

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Collaboration with other health care providers:

Confidentiality agreements:

Patient records:

Labels:

Audit trail:

Delivery:

Storage:

Disposal:

Contracts:

Quality assurance:

Billing:

3.13. Narcotics and controlled substances


Procedure for narcotic signing authority:

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Prescription regulations chart:

3.13.1. TPP Alberta


Pharmacy resources (information for the pharmacist)

Procedure:

Stolen TPP pads

Information for the prescriber

Handling logged prescriptions and refills

Procedure:

3.13.2. Narcotics and controlled substances receipts report

Purchase record:

3.13.3. Narcotics and controlled substances security and inventory


management

Procedure for narcotic and controlled substances counts:

Procedure for storage of narcotics and controlled substances:

3.13.4. Managing expired or returned stock

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Procedure for return and disposal (include template for documenting returned products
from patients and expired products in the pharmacy):

3.13.5. Loss or theft form

Procedure:

3.13.6. Suspected forgery

Procedure:

3.13.7. Forgery reporting form

Procedure:

3.13.8. Opioid Agonist Therapy (OAT)

3.13.8.1. General
Prescription authentication procedure:

Prescriber exemption verification:

Patient verification procedure:

Patient assessment and documentation:

New patient agreement (i.e. expectations, obligations, pick up schedule,


identification):

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3.13.8.2. Administration
Witnessing administration:

Process:

Initial dosing of buprenorphine/naloxone:

Missed dose:

Lost/stolen dose:

Spoiled dose:

Vomited dose (methadone and Suboxone):

Withholding dose:

Administration records:

Insert a template here:

Physician collaboration:

Dispensing container:

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3.13.8.3. Preparation
Methadone preparation (equipment, audit trail, and documentation):

Storage location of medications:

Disposal:

3.13.8.4. Carries
Patient eligibility:

Requirements and restrictions:

Agreement:

Labelling and packaging:

Sample Label

Signature and documentation:

Delivery and documentation:

Bottle return and documentation:

Alternative witness agreement:

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3.14. Benzodiazepines and other targeted substances

3.15. Child resistant containers

3.16. Administration of drugs by injection


Procedure:

3.16.1. Multi-dose medications


Store Policy on multi-dose medications:

3.16.2. Anaphylaxis management


Procedure:

Anaphylaxis kit item list:

Policy on stock rotation:

3.17. Cold chain management


Procedure:

3.17.1. Refrigerator temperature log


Procedure:

3.18. Ordering
Procedure:

Wholesalers:

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Special order:

3.19. Prescription balances or owing


Procedure:

3.20. Prescriptions not picked up


Procedure:

3.21. Inventory management


Maintenance:

Short-dated/expired stock:

3.22. Special Access Programs (SAPs)


Procedure:

3.23. Waste management

3.23.1. Expired drugs/returned stock


Procedure:

3.23.2. Sharps disposal


Procedure:

3.23.3. Needlestick injury


Prevention:

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Procedure for managing injuries:

3.24. Quality assurance and safety

3.24.1. Drug error (drug incident) reporting


Procedure for preventing, reporting, investigating, documenting and evaluating drug
errors (drug incidents):

Procedure for dealing with complaints or concerns:

3.24.2. Drug error (drug incident) follow-up process


Procedure to conduct regular review of procedures to prevent drug errors (drug
incidents):

3.24.3. Adverse event reporting

Side Effect Reporting


Procedure:

Adverse Event Following Immunization (AEFI) Reporting

Procedure:

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4.0 Providing virtual care to patients


4.1. Virtual care technology

4.2. Virtual assessment procedures

4.3. Documentation for virtual assessments

4.4. OIPC approval

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5.0 Laboratory and point-of-care testing (POCT)


5.1. Ordering laboratory tests

5.2. Point-of-care testing (POCT)

5.3. Standard operating procedures

5.4. Quality assurance process

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5.0 Pharmacy compounding of non-sterile


preparations
5.1. General operations and pharmacy information

5.1.1. Standards for Pharmacy Compounding of Non-Sterile Preparations


Standards for Pharmacy Compounding of Non-Sterile Preparations

5.1.2. Guidance Document for Pharmacy Compounding of Non-sterile


Preparations
Guidance Document for Pharmacy Compounding of Non-Sterile Preparations

5.1.3. Other applicable standards and legislation

5.1.4. Current copy of completed ACP non-sterile compounding self-


assessment
Non-Sterile Compounding Self Assessment

5.1.5. Staff information


Compounding Supervisor:

Other individuals involved in compounding:





5.1.6. Compounding references

5.1.7. Compounding and repackaging agreements

5.2. Personnel and facilities

5.2.1. Obligations of personnel

5.2.1.1. Attire and dress code

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5.2.1.2. Health conditions (reasons for temporary withdrawal from


compounding activities)

5.2.1.3. Expected behaviour in compounding areas

5.2.2. Training and assessment of personnel

5.2.2.1. Initial training and assessment program

5.2.2.2. Program to assess maintenance of competency

5.2.2.3. Training and assessment of cleaning and disinfecting personnel

5.2.2.4. Additional training in all aspects of handling and compounding


complex or hazardous products

5.2.2.5. Staff log of initial and ongoing competency

5.2.3. Delegation and appropriate supervision of activities

5.2.3.1. Delegation and supervision considerations for compounding activities


by unregulated pharmacy staff

5.2.4. Facilities and equipment

5.2.4.1. Access to controlled area or room

5.2.4.2. Overview of facilities and equipment

5.2.4.3. Maintenance of facilities and equipment

5.2.4.4. Cleaning activities for compounding room

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5.3. Compounded non-sterile preparations

5.3.1. SDS, risk assessments, compounding formulas and MFR

5.3.2. Determining beyond use dates of ingredients and final preparations

5.3.3. Hand hygiene procedures

5.3.4. Personal protective equipment in compounding areas

5.3.5. Deactivation, decontamination, and cleaning of the C-PEC

5.3.6. Receipt, unpacking, and storage of hazardous products

5.3.7. Verification of the compounding process and final preparations

5.3.8. Labelling of final preparations

5.3.9. Packaging of final preparations

5.3.10. Storage of products and final preparations

5.3.11. Transport of final preparations to destination (patient, pharmacy,


facility)

5.3.12. Recording of preparation in patient file

5.3.13. Hazardous waste management

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5.3.14. Exposure to hazardous products

5.3.15. Spills and spill management

5.3.16. Recall of ingredients or compounded medications

5.4. Quality assurance program

5.4.1. Verification and maintenance of equipment and facilities

5.4.2. Environmental monitoring of chemical contamination of hazardous


products

5.4.3. Drug error processes

5.5. Additional resources

5.5.1. Policies and procedure template

5.5.2. Risk assessment procedure and examples


Sample risk assessments may be found on the ACP website.

5.5.3. Master Formulation Record template


The master formulation record template may be found on the ACP website.

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6.0 Patient concerns


Complaints procedure:

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7.0 Privacy policy


7.1. Custodians of health information
Custodians of health information (list and define where appropriate):

 Pharmacists
o
 Pharmacy Managers
o
 Affiliates (specify)
o
 Others (specify)
o

7.2. Use and disclosure of health information


Procedure (define limitations on type, access and use of health information):

Procedure for disclosure:

Procedure for documentation and retention of record of disclosure:

7.3. Privacy impact assessment

7.4. Disposal of health information


Procedure:

Shredding:

7.5. Mandatory privacy breach reporting


Procedure:

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8.0 Pharmacy signage


 Pharmacy hours posted (must be posted in public view)
 Council-approved signage as per SOLP 4.7(e)
 Pharmacy License (must be posted in public view)
 Code of Ethics Poster (must be posted in public view)
 Patient Concerns Poster (must be posted in public view)
 Patient Information Collection Poster
 Returned Medication Cards
 Relevant Certification (e.g. CDE, CGP)

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9.0 Pharmacy website


Section 23 of the Pharmacy and Drug Regulation outlines the information that a licensee must
ensure is displayed on the pharmacy website:
 A copy (scanned is sufficient) of the pharmacy licence.
 The location, mailing address, e-mail address and telephone number of the licensed
pharmacy.
 The name, pharmacist practice permit number, and business address of the licensee.
 A statement that the licensee is required to provide, on the request of a patient, the
name and practice permit number of any regulated member who provides a pharmacy
service to the patient or who engages in the practice of pharmacy with respect to a
patient.
 The name and business address of the proprietor.
 If the proprietor is a corporation, the name of the proprietor’s representative.
 A copy (scanned is sufficient) of the patient concerns poster.

Procedure for updating:

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10.0 Reference library

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11.0 Code of Ethics


The Code of Ethics must be posted in public view.

Policy to disclose services not available because of conscientious objection (Principle V. Respect
each patient’s right to healthcare):

A pharmacist shall assist each patient to obtain appropriate pharmacy services from another
pharmacist or health professional within a timeframe fitting the patient’s needs if that pharmacist
is unable to provide the pharmacy service or will not provide the service due to a conscientious
objection. A pharmacist will arrange the condition of his/her practice so that the care of his/her
patients will not be jeopardized when he/she will not provide certain pharmacy services due to a
conscientious objection.

Procedure:

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12.0 Human resources


12.1. Job descriptions
Pharmacy Manager:

Pharmacist:

Regulated Pharmacy Technician:

Pharmacy Assistant:

Pharmacy Intern:

Pharmacy Student:

Other Staff:

Volunteers:

12.2. Supervision
Policy:

Procedure:

12.3. Staffing levels


Qualifications of staff:

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Number of staff:

12.4. Dress code

12.5. Performance appraisal

12.6. Sick leave


Procedure:

12.7. Leaves of absence


Procedure:

12.8. Vacation requests


Procedure:

12.9. Pandemic preparedness plan


Plan for staff:

Plan for store:

12.10. Harassment in the workplace

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13.0 Business operations


13.1. Internet and electronic communication
Procedure:

13.2. Opening and closing cash


Procedure:

13.3. Charge accounts


Procedure:

13.4. Cheques
Procedure:

13.5. Staff purchases


Procedure:

Pricing policies:

13.6. Telephones
Procedure:

13.7. Accounts receivable


Procedure:

13.8. Accounts payable


Procedure:

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13.9. Banking
Procedure:

13.10. Pricing policies

13.11. Return policies


Prescription drugs:

Non-prescription drugs:

Other health care products:

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14.0 Contacts
14.1. Manager
 Name:
 Phone Number:
 E-Mail:

14.2. Staff
 Name:
 Phone Number:
 E-Mail:

14.2.1. Relief pharmacists


 Name:
 Phone Number:
 E-Mail:

14.3. Wholesaler(s)
 Name:
 Address:
 Phone Number:
 E-Mail:

14.4. Supplier(s)
 Name:
 Address:
 Phone number:
 E-mail:

14.5. Local physicians


 Name:
 Address:
 Phone number:
 Fax number:

14.6. Third party


 Name:
 Phone number:
 Provider number:

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14.7. Alarm company


 Name:
 Address:
 Phone Number:
 E-Mail:

14.8. Emergency services


 Police:
 Fire/Ambulance:

14.8.1. Staff with CPR and First Aid Training


 Name:
 Phone number:
 E-mail:

 Name:
 Phone number:
 E-mail:

14.9. Software support


 Name:
 Phone number:
 Account number:

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15.0 Definitions
a) “adverse drug event” means an unexpected and undesired incident that results in patient
injury or death or an adverse outcome for a patient, including injury or complication.
b) “drug error” means an adverse drug event or a drug incident where the drug has been
released to the patient.
c) “drug incident” means any preventable event that may cause or lead to inappropriate drug
use or patient harm. Drug incidents may be related to professional practice, drug products,
procedures or systems, and include:
i. prescribing;
ii. order communications;
iii. product labeling, packaging, nomenclature;
iv. compounding;
v. dispensing;
vi. distribution;
vii. administration;
viii. education;
ix. monitoring; and
x. use.
d) “drug therapy” means
i. dispensing a Schedule 1 drug or blood product,
ii. selling a Schedule 2 or Schedule 3 drug, or
iii. prescribing a Schedule 1 drug or blood product.
e) “individual” means a person employed in a pharmacy, including a volunteer relationship.
f) “patient” means any person to whom a pharmacist provides a service that is within the
practice of pharmacy.
g) “patient’s agent” means a family member, caregiver or another person who has a close
personal relationship with the patient.
h) “pharmacist” means a clinical pharmacist, a provisional pharmacist, a courtesy pharmacist or
a student pharmacist, unless the context requires otherwise.
i) “pharmacist service” means any service that falls within the practice of pharmacy.
j) “practice of pharmacy” and “pharmacy practice” mean the scope of practice described in
section 3 of schedule 19 to the Health Professions Act.
k) “prescriber” means a regulated health professional who is authorized to prescribe schedule 1
drugs or blood products.
l) “professional relationship” means a relationship formed with a patient for the purpose of
optimizing the patient’s health and drug therapy.
m) “proprietor” means a person who owns, manages or directs the operation of a facility in which
a licensed pharmacy is located and exercises a significant degree of control over the
management and policies of the licensed pharmacy, or the conduct of the pharmacists and
pharmacy interns, if any, who are employed by the licensed pharmacy.
n) “regulated health professional” means a health professional who practises under the terms of
the Health Professions Act or similar legislation that governs a profession in Alberta.
o) “restricted activity” means any restricted activity referred to in section 16 of the Pharmacists
Profession Regulation.
p) “Schedule 1 drug” means a Schedule 1 drug within the meaning of the Pharmacy and Drug Act.
q) “Schedule 2 drug” means a Schedule 2 drug within the meaning of the Pharmacy and Drug Act.
r) “Schedule 3 drug” means a Schedule 3 drug within the meaning of the Pharmacy and Drug Act.

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