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8/11/2019 PHARMACOEPIDEMIOLOGY andri.pptx
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PHARMACOEPIDEMIOLOGY
Andriani Noerlita N., M. Sc., Apt.
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What Are Your Drugs Really Doing To
Your Patients?
Epidemiological Approaches To StudyingDrug-induced Disease
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Introduction
Current System
Premarketing
Postmarketing/
Pharmacoepidemiology
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Introduction
Current System
Premarketing
Postmarketing/
Pharmacoepidemiology
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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
4PC 1 2 3
Drug Approval
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Limitations of
Pre-marketing Trials
Carefully selected subjects may not reflectreal-life patients in whom drug will be used
Study subjects may receive better carethan real-life patients
Short duration of treatment
No info on comparative effectiveness
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Limitations of
Pre-marketing Trials
development costs lead to need for
immediate huge sales (“blockbuster
drugs”), and aggressive marketingpractices
Yet, development programs with 3000patients cannot reliably detect adverse
events with an incidence of < 1 per 1000,
even if severe
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Introduction
Current System
Premarketing
Postmarketing/
Pharmacoepidemiology
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Definition
Pharmacology is the study of the effects ofdrugs
Epidemiology is the study of thedistribution and determinants of diseasesin populations
Pharmacoepidemiology is the study of theuse of and the effects (good and bad) ofdrugs in populations
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Purpose
Describe
Explain
ControlPredict
The use and effects of drugs in a defined time,
place and population
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Purpose
Determine how a drug performs in clinicalpractice (effectiveness, safety)
Frequently used for postmarketing
surveillance Identify rare adverse events or events that
occur in “special” populations
Document new uses of approved drugs
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Purpose
Determine long term effects of drugs, oreffects on ultimate vs. intermediateoutcomes
Used by the FDA to allow priority drugs inshorter time
Used by the FDA to modify product
labeling or approval status
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Types of Pharmacoepidemiologic
Investigation
Adverse and beneficial drug effects
Medication utilization patterns
Drug effects on quality of life
Economic impact of medication use
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