查看文章

Pharmacoepidemiology studies the use and effects, both beneficial and adverse, of medicines in large numbers of people. It applies the methods of Epidemiology to the area of Clinical Pharmacology (Strom, 2005a). This field seeks to further the knowledge and science underlying post marketing drug surveillance (studies conducted after a medicine has been released into the market).

The raison d’être of these studies is to bridge the gap between the information generated by clinical pre-marketing trials and the real-world drug usage, since drugs often do not perform as well in routine clinical practice as in clinical trials. Clinical trials may not provide an accurate picture of drug effects. At the time of authorization, we have evidence from clinical trials which demonstrate efficacy, but only for a specific indication and only within the original test population. At this stage, we have evidence of adverse reactions, but only the most common ones (Black, 1996; Strom, 2005a).