CLINICAL DRUG LITERATURE

Medical informatics
• science that deals with

“the storage, retrieval, and optimal use

of biomedical information, data, and knowledge for

problem-solving and decision-making”.

Blois MS, Shortliffe EH. The computer meets medicine: emergence of a discipline. In Shortliffe EH, Perreault
LE, Wiederhold G, et al, eds. Medical Informatics: Computer Applications in Health Care. Reading, MA:
 Role of Pharmacist
pharmacists are information specialists and must be knowledgeable about:
information resources available . locate complete, up-to-date information.
how and why to use them. develop recommendations based on the best
critically analyze, evaluate, and interpret the available data.
information. Providing seminars and lectures.
differentiating good from poor quality provide verbal and written information to
information. patients.
Strengths and limitations. Participation in clinical research trials
applying the information they obtain to patient Drug information centers.
care.
respond to drug information questions.

Types of drug information needed

side/adverse effects/toxic effects. Availability.

drug interactions. Dosages and administration.
Uses Pharmacokinetics.
Teratogenicity. Pharmacodynamics.
Stability. pharmacogenomics.
Compatibility. Pharmacoeconomics.
comparative Efficacy.
 DRUG INFORMATION
Pharmacist must
RESOURCES
A. Primary sources… Ensure that they are valid to produce useful information.

Journal articles. Special care must be exercised when reviewing promotional

literature.
provide the most current
information. pharmacy practitioner must draw their own conclusions based
on a study’s merits, rather than simply relying upon the authors’
conclusions.
B. Secondary sources indexing and abstracting services.
C. Tertiary sources Textbook databases .
References:
Villaneuva P, Peiro S, Libero J, et al. Lancet 2003; 361:27–32. Ziegler MG, Lew P, Singer BC. JAMA
1995; 273:1296–1298.
 A. Primary sources…Journal articles
• Original studies, reports and published conference
proceedings and symposia.
• Journals enable pharmacists for:
– making recommendations concerning the optimal
therapy.
– Disease state.(how another clinician handled a particular
problem)
– Adverse events, drug interactions.
– Information about new or investigational drugs.
– Keep up with new developments in pathophysiology,
diagnostic agents, and therapeutic regimens
– Enhance communication with other HCP’s.
 Types of clinical studies
two broad general types……….descriptive and explanatory
1)Descriptive record data from 1) case reports
Studies observations. observations of individual patients.

describe an adverse event following the use of

a particular drug or to report a possible drug
draws conclusions as to interaction.
possible reasons for the (2) case series.
events witnessed. observations from a group of patients

describe unusual or new for estimating the incidence of an adverse

events. event of a newly marketed drug.
to help ensure that a certain adverse event is
not associated with the use of a drug

2) Explanatory To determine the efficacy of (1) observational.

Studies medications.
2) experimental.
identify whether there is a
true relationship between
the use of a drug and the
occurrence of an outcome.
 Explanatory Studies
Observational CASE one group with disease condition (the cases) compared with
CONTROL another group without the disease (the controls).
study of rare diseases that take many years to develop
not suited to the evaluation of therapy because there is no
comparison to other drugs
COHORT Follow-up Studies.
patients who have not yet experienced the outcome.
patients are then followed over time to identify the causes of
the outcome of interest.
CROSS- Prevalence Studies.
SECTIONAL Makes simultaneous assessments of both the outcome and
potential predictors.
to evaluate:
a new laboratory test or a new application of an existing Test.
risk factors and etiological agents of a disease or condition
the prevalence of a disease or condition
Experimental Controlled Use a comparison group in addition to the group receiving the
studies drug being investigated.
is the strongest type of experimental study.
 Parts of study
Introduction Author(s) has/have expertise in subject?
Background. Background, Relevant previous work cited.
Objective(s) clearly stated.
Methods. Inclusion and exclusion criteria clearly defined and appropriate for objective.
Study design, Treatment considerations, Outcome measures, Data analysis
End points defined clearly.
Measurements valid, reliable.
Results. Statistical tests and analyses used for key outcome measures.
Discussion. Study limitations addressed and Significance of findings discussed.

EVALUATING A CLINICAL STUDY.

A. objective of the study? Goal, aim of study.
B. Subjects of the study. profile of the study population
C. Administration of the drug treatment. Details of treatment
D. Setting of the study. Hospital?? Clinic??
E. Methods and design of the study. Retrospective versus prospective ,Blind assessment
F. Analysis of the study.
 B. Secondary sources
• Used to identify and locate primary and other resources………
– Abstracting services
• Used when
when the most recent information concerning a topic is required
when a topic is new enough that it is not likely to be included in
standard reference sources.

Whenever primary literature is needed.

Pharmacists should evaluate the original article because

abstracts may not include enough information to critically
evaluate the study.
– Medline/PubMed.
 C. Tertiary sources…….
When basic information on Pharmacotherapeutic, toxicology,
or drug interactions is required, a tertiary literature source
may be the best means.
Merits De Merits
provides easy access to a information available in textbooks might not include the most
related topics. recent developments in the field.

Background information is Other resources should be used to supplement information

often available. obtained from textbooks.

Author might have misinterpreted the primary or secondary

literature.
textbooks and databases as sources of drug information should include
The author , publisher areas of expertise?
The year of publication.
The edition of the text.
References published?
PHARMACEUTICAL INDUSTRY/PUBLISHED
INFORMATION….
• pharmaceutical industry generate and analyze
medical information.

• Drug manufacturers compile results from clinical

trials conducted.

• Drug companies realize the value of publications of

studies of their drugs as a means of influencing
medical practice.
Promotional Information/Print advertisements ………….DIL

Advertisements have educational value as well .

Drug advertisements information are related to side

effects, contraindications, and effectiveness.

Full prescribing information or the package insert.

Pharmacists should be cautious when assessing

information that is contained in pharmaceutical
advertisements.
 INTERNET
• Patients/health-care providers are increasingly turning
to the Internet as a drug information resource.
• An Internet search may be required for the following:
– Company-specific information.
– Issues currently in the news.
– Alternative medicine.
– Government information.
Karp S, Monroe AF. Manag Care Quart 2002; 10(2):3–8.
Pharmacist and Internet
Should critically evaluate internet’s medical information to be accurate and reliable.
Search therapies that have been recently published.
should be knowledgeable about criteria to use to help determine the quality of Internet
information.
 Selected Web Sites
American Association of Colleges of www.aacp.org
Pharmacy
American Diabetes Association www.diabetes.org
American Heart Association www.americanheart.org
Clincal Trials www.clinicaltrials.gov
Mayo Clinic College of Medicine www.mayo.edu
Medscape www.medscape.com
National Institutes of Health www.nih.gov
WebMD www.webmd.com
U.S. Food and Drug Administration www.fda.gov
DRUG INFORMATION REQUESTS
Determine the reason for the inquiry.
Clarify the drug's identification and availability.
Do not guess.
Response is not necessary if the inquirer intends to misuse or abuse information.
Organize information before attempting to communicate the response to the
inquirer .
Tailor the response to the inquirer 's background.
Tell the inquirer where the information was found.
Use more than abstracts to answer drug information questions.
Alert the inquirer of a possible delay when it takes longer than anticipated to
answer the question.
Ask if the information that is provided answers the inquirer 's questions.
 Determine the answers to the following
questions:
1. What is the indication for the prescribed drug?
2. Is the drug's use approved or unapproved?
3. What are the age, sex, and weight of the patient in question?
4. Does the patient have any other medical conditions or renal or hepatic disease?
5. Is the patient taking any other medications?
6. What drugs has the patient taken during the past 6 months, and what were the
dosages?
7. Did the patient experience any signs or symptoms of a possible adverse drug
reaction?
8. Did the patient experience any signs or symptoms of a drug interaction?
9. How severe was the reaction?
10. When did the reaction appear?
11. Has the patient experienced any allergic or adverse reactions to medications in
the past?