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 exponentially in the next decade both in developed and in developing countries. Within Europe, a common market of over 350 million consumers, regulations and guidelines related to drug use were formulated, especially with respect to post-marketing surveillance and the detection, interpretation and management of rare but serious drug related adverse events. The activities of international organizations like the World Health Organization in this context are briefly addressed. In the European Union a choice has been made by the regulatory authorities for spontaneous reporting systems as a minimal requirement for post marketing surveillance in all member states. The French pharmacovigilance system has to some extend functioned as a blueprint for a common European post marketing surveillance system. Therefore the organization of this French system is explained in some detail. Also in this context the need for drug utilization studies to get quantitative information about drug use is stressed. For the creation of the databases needed for case control and cohort studies a variety of approaches is used in different countries, all with their own advantages and shortcomings. Some examples from England and the Netherlands are given. The efforts of the European Commission and various scientific organizations aiming to promote the harmonization of pharmacovigilance actions in Europe are discussed. Finally, some guidelines for good pharmacovigilance practice are suggested.
van Boxtel
C J
CJ
Department of Clinical Pharmacology and Pharmacotherapy, Academic Medical Centre, Amsterdam, Netherlands.
Wang
G
G
D019992:Databases as Topic; D004345:Drug Industry / Q000331:legislation & jurisprudence; D005062:European Union; D005544:Forecasting; D017408:Guidelines as Topic; D006801:Humans; D017891:Pharmacoepidemiology / Q000592:standards* / Q000639:trends; D011358:Product Surveillance, Postmarketing