pharmacoepidemiology andri.pptx

8/11/2019 PHARMACOEPIDEMIOLOGY andri.pptx

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PHARMACOEPIDEMIOLOGY

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



What Are Your Drugs Really Doing To

Your Patients?

Epidemiological Approaches To StudyingDrug-induced Disease



Introduction

Current System

Premarketing

Postmarketing/

Pharmacoepidemiology



Introduction

Current System

Premarketing

Postmarketing/




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



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



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



Introduction

Current System

Premarketing

Postmarketing/




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



Purpose

Describe

Explain

ControlPredict

The use and effects of drugs in a defined time,

place and population



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



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



Types of Pharmacoepidemiologic

Investigation

Adverse and beneficial drug effects

Medication utilization patterns

Drug effects on quality of life

Economic impact of medication use

pharmacoepidemiology andri.pptx

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