Pharmacoepidemiology is the study of effects of drugs in large numbers of people. Epidemiologic Study Designs, Reasons to perform Pharmacoepidemiology studies, Users of pharmacoepidemiology and Role of Pharmacists & other Public Health Practitioners in Pharmacoepidemiology are discussed in this presentation.

1. Pharmacoepidemiology
Dr. P.Naina Mohamed
Pharmacologist

2. Introduction
 Pharmacoepidemiology is the study of the uses and effects of
drugs in large numbers of people.
Pharmacoepidemiology
Pharmakon
- Drug
Epi – upon or
among
Demos –
People or
district
Logos -
Study
 Pharmacovigilance is an area unique to pharmacoepidemiology
and it is a type of continual monitoring of unwanted effects and
other safety-related aspects of drugs.

3. Pharmacoepidemiological Research
 Pharmacoepidemiological studies focus on
 Global trends in prescribing
 Appropriateness of drug use
 Medication adherence
 Identification of predictors for medication use
Lifestyle effects on drug therapy
Special population (Elderly, Pediatric, etc.) drug
therapy
Drug Interactions
 Predictable ADRs
 Uncommon and unpredictable ADRs

4. Epidemiologic Study Designs
 Case Reports:
A case report describes the effects of the drug a single
patient experiencing.
Case reports are easy and cheap method for generating
hypothesis about drug effects.
 Case Series:
Case series are collection of patients who had single
exposure.
 Case series are useful in quantifying the incidence of ADRs.
 Analyses of secular trends (Ecological Studies):
Analysis of data from a single region and examine how it
changes over time.
They are useful to provide rapid evidence for hypotheses.

5. Epidemiologic Study Designs
 Case-control study:
 These studies compare cases with disease to controls without
disease.
 Useful to study multiple possible causes of a single disease.
 Useful to study uncommon diseases.
 It is easier and faster to conduct Case-control study.
 It is less expensive.
 Cohort study:
 Cohort studies identify subsets of a defined population and
follow them over time, looking for differences in their
outcome.
 They are useful to compare exposed patients to unexposed
patients.
 Can study multiple outcomes.
 Can study uncommon exposures.

6. Epidemiologic Study Designs
 Randomized clinical trials (Experimental
Studies):
In randomized clinical trials, the
investigator controls the therapy to be
received by each participant.
Most convincing design.
Most expensive design.
It is an artificial design.
Logistically most difficult.

7. Reasons to perform
Pharmacoepidemiology studies
 Regulatory reasons:
To obtain earlier approval for marketing
 As a response to a question raised by regulatory agency
To assist application for marketing elsewhere
 Marketing reasons:
To assist market penetration by documenting the safety of
the drug
To increase name recognition
To assist repositioning the drug
To protect the drug from accusations about adverse effects

8. Reasons to perform
Pharmacoepidemiology studies
 Legal reasons:
 In anticipation of future product liability litigation
 Clinical reasons:
Hypothesis testing
o Problem hypothesized based on the structure of the
drug
o Problem suspected on the basis of preclinical or
premarketing human data
o Problem suspected on the basis of spontaneous
reports
Hypothesis generating (for new chemical entity, etc.)

9. Users of Pharmacoepidemiology
 Government agencies & Health care plans:
Pharmacoepidemiology research is important for the
government agencies like the Agency for Healthcare
Research and Quality (AHRQ) and the Centers for Medicare
and Medicaid Services (CMS) and Healthcare plans.
 Pharmaceutical industries:
The pharmaceutical industry want to understand how a
drug is prescribed, used and what are all the positive and
negative outcomes.
 Practitioners:
Pharmacoepidemiological studies can help Pharmacists,
Physicians, Nurses and other Public health care practitioners
to make informed decisions about treatment for patients.

10. Users of Pharmacoepidemiology
 Academicians:
Academicians often conduct
pharmacoepidemiological studies to find answers to practice
related questions.
 Attorneys:
Findings from pharmacoepidemiological studies can
be used as evidence that a drug product did or didn’t cause
an event.
 Consumers and Patients:
To learn about safety and effectiveness of drug
products, patients and consumers rely on
pharmacoepidemiological studies.

11. Role of Pharmacists & other Public Health
Practitioners in Pharmacoepidemiology
 Pharmacists are considered drug experts and naturally
they play an important role in Pharmacoepidemiology.
 A pharmacist may identify and report an adverse event to a
hospital drug safety committee, Medwatch, or a
pharmaceutical company.
 Physicians and pharmacists have the highest rate of
adverse event reporting among other health care
practitioners.
 Pharmacists and other health care practitioners may serve
on Pharmacy Therapeutic Committee, Patient Safety
Committees or other groups deciding health care plans.

12. References
 Pharmacoepidemiology, 5th Edition
Brian L. Strom, Stephen E Kimmel, Sean
Hennessy
Understanding Pharmacoepidemiology
Yi Yang, Donna West-Strum
Pharmacoepidemiology
Stanley A. Edlavitch
http://www.pharmacoepi.org/about/about.cf
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