SOME OBSERVATIONS ON PHARMACOEPIDEMIOLOGY IN EUROPE

The need for pharmacoepidemiology, defined as the study of the use of and the effects of drugs in large numbers of people, will increase exp onentially in the next decade both in developed and in developing coun tries, Within Europe, a common market of over 350 million consumers, r egulations and guidelines related to drug use were formulated, especia lly with respect to post-marketing surveillance and the detection, int erpretation and management of rare but serious drug related adverse ev ents. The activities of international organizations like the World Hea lth Organization in this context are briefly addressed. In the Europea n Union a choice has been made by the regulatory authorities for spont aneous reporting systems as a minimal requirement for post marketing s urveillance in all member states. The French pharmacovigilance system has to some extend functioned as a blueprint for a common European pos t marketing surveillance system. Therefore the organization of this Fr ench system is explained in some detail. Also in this context the need for drug utilization studies to get quantitative information about dr ug use is stressed. For the creation of the databases needed for case control and cohort studies a variety of approaches is used in differen t countries, all with their own advantages and shortcomings. Some exam ples from England and the Netherlands are given, The efforts of the Eu ropean Commission and various scientific organizations aiming to promo te the harmonization of pharmacovigilance actions in Europe are discus sed. Finally, some guidelines for good pharmacovigilance practice are suggested. (C) 1997 Elsevier Science B.V.