Detection, verification, and quantification of adverse drug reactions

Abstract

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.