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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