BMJ  2004;329:44-47 (3 July), doi:10.1136/bmj.329.7456.44

Education and debate

Detection, verification, and quantification of adverse drug reactions

¹ Pharmacoepidemiology Unit, Department of Epidemiology and Biostatistics, Erasmus Medical Center, PO Box 1738, 3000 DR Rotterdam, ² Cardiovascular Health Research Unit, Departments of Medicine and Epidemiology, University of Washington, Seattle, USA

The current system of verifying and quantifying adverse reactions to new drugs is too disparate. Epidemiological studies for testing a hypothesis have a part to play in protecting the public from the harmful effects of new drugs

The first 150 words of the full text of this article appear below.

Introduction

Although some will question the use of the term experiment on formal grounds, most experts will likely agree that the widespread marketing of a new drug is in fact a large experiment on a population. This is especially the case when it concerns a novel molecular entity with potentially a new set of clinical experiences. As the marketing of new drugs includes the discovery of adverse effects, the public's health would be best protected by a complementary set of techniques for the detection, verification, and quantification of safety issues. Yet the current approach to this is scattered and disappointing. We discuss why healthcare professionals are not aware of all safety problems of a drug at its introduction and why pharmacoepidemiology should complement the indispensable observational method of case reporting.

Sources and selection criteria

Our review is based on a search of PubMed using the terms adverse effect, adverse reaction, ADR, adverse event, adverse reaction . . . [Full text of this article]

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Limitations of clinical trials

Adverse drug reactions

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Detect adverse reactions before the drug goes on the market

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