PHARMACOEPIDEMIOLOGY

Andriani Noerlita N., M. Sc., Apt.

What Are Your Drugs Really Doing To
Your Patients?



Epidemiological Approaches To Studying
Drug-induced Disease
Introduction
Current System
Premarketing
Postmarketing/
Pharmacoepidemiology
Introduction
Current System
Premarketing
Postmarketing/
Pharmacoepidemiology
Phases of Drug Development
PC: Preclinical studies
1: Dose escalation in normals
2: Dose ranging, first time in patients
3: Pivotal trials for registration
4: Post-marketing, not always required

4
PC 1 2 3
Drug Approval
Limitations of
Pre-marketing Trials
Carefully selected subjects may not reflect
real-life patients in whom drug will be used

Study subjects may receive better care
than real-life patients

Short duration of treatment

No info on comparative effectiveness

Limitations of
Pre-marketing Trials
development costs lead to need for
immediate huge sales (blockbuster
drugs), and aggressive marketing
practices

Yet, development programs with 3000
patients cannot reliably detect adverse
events with an incidence of < 1 per 1000,
even if severe

Introduction
Current System
Premarketing
Postmarketing/
Pharmacoepidemiology
Definition
Pharmacology is the study of the effects of
drugs

Epidemiology is the study of the
distribution and determinants of diseases
in populations

Pharmacoepidemiology is the study of the
use of and the effects (good and bad) of
drugs in populations

Purpose
Describe
Explain
Control
Predict
The use and effects of drugs in a defined time,
place and population

Purpose
Determine how a drug performs in clinical
practice (effectiveness, safety)
Frequently used for postmarketing
surveillance
Identify rare adverse events or events that
occur in special populations
Document new uses of approved drugs


Purpose
Determine long term effects of drugs, or
effects on ultimate vs. intermediate
outcomes
Used by the FDA to allow priority drugs in
shorter time
Used by the FDA to modify product
labeling or approval status
Options in Research Design
(Methods)
Observational Method Reseach
Cohort study
Cross sectional
Case control study
Case series
Case report
Experimental study
RCT (Randomized Controlled clinical Trial)
Quasi experimental study


Types of Pharmacoepidemiologic
Investigation
Adverse and beneficial drug effects
Medication utilization patterns
Drug effects on quality of life
Economic impact of medication use