What is Pharmacoepidemiology BRIAN L. STROM University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA a desire to take medicine is, perhaps, the great fields. The history of drug regulation will then be feature which distinguishes man from other ani. briefly and selectively reviewed, focusing on the Sir william Osler. 1891 US experience as an example, demonstrating how it has led to the development of this new field In recent decades, modern medicine has been bles- Next the current regulatory process for the sed with a pharmaceutical armamentarium which approval of new drugs will be reviewed, in order is much more powerful than what it had before. to place the use of pharmacoepidemiology and Although this has given us the ability to provide postmarketing drug surveillance into proper much better medical care for our patients, it has spective. Finally, the potential scientific and per- also resulted in the ability to do much greater ical contributions of pharmacoepidemiology harm. It has also generated an enormous number be discussed of product liability suits against pharmaceutical manufacturers, some appropriate and others inap- propriate.In fact, the history of drug regulation parallels the history of major adverse drug reac- DEFINmION OF tion"disasters. "Each change in pharmaceutical PHARMACOEPIDEMIOLOGY law was a political reaction to an epidemic of Pharmacoepidemiology is the study of the use/of adverse drug reactions. The harm that drugs can and the effects of drugs in large numbers of cause has also led to the development of the field people. The term pharmacoepidemiology con- of pharmacoepidemiology, which is the focus of tains two components: "pharmaco"and"epide this book. More recently, the field has begun to miology "In order to better appreciate and expand its focus to include issues other than understand what is and what is not included in adverse reactions, as well this new field, it is useful to compare its scope to To clarify what is, and what is not, included that of other related fields. The scope of pharma within the discipline of pharmacoepidemiology, coepidemiology will first be compared to that of this chapter will begin by defining pharmacoepi- clinical pharmacology, and then to that of epide- demology, differentiating it from other related molo Pharmacoepidemiology(Second edition). Edited by Brian L Strom 第169页第 169 页