Pharmacovigilance in France: Role of the Regional Centers
Nicholas Moore, M.D., Ph.D., Department of Pharmacology, University of Bordeaux 2, Bordeaux, France
Spontaneous reporting of adverse drug reactions (eg, medwatch) is the mainstay of regulatory pharmacovigilance. Typical spontaneous reporting, however, may be hinderd by a number of problems such as lack of knowledge of the existence of a reporting system, misunderstanding of the need to report, uncertainty as to what to report, poor quality of reports, triviality of reports, or lack of interaction with a distant administration. In such a context, the establishment of local or regional centers may be profitable. In France, a network of 31 regional centers was progressively established from 1972 to 1995. These centers are in clinical pharmacology departments of university hospitals, and are staffed by medical doctors and pharmacists. They receive spontaneous reports from health professionals. They also act as drug information centers, answering health professionals' questions about the use and risks of drugs, and can participate in the clinical management of adverse drug reactions, at the physicians' request. This has double consequence: physicians perceive the regional center as a useful resource for information and patient management rather than as a distant administration, and the centers retrieve high-quality data on clinically significant and often novel adverse drug reactions. By early interaction and participation in case management, more information on cases can be generated as needed, such as relevant lab tests. Some centers have consultation services, to which physicians can address their patients. Being within reference hospitals, center personnel can interact directly with the departments receiving the more serious cases, such as dermatology, intensive care, hematology or hepatology, for systematic retrieval of incident cases. Additionally, since center personnel participate in medical and pharmaceutical curricula, they can teach future physicians the management of ADRs, and further the awareness of the existence of and need for such structures and reporting. They are also involved in research on ADRs. This research ranges from the fundamental, eg pharmacokinetics or pharmacogenetics, to epidemiological studies, using reporting data or adhoc studies. Centers receive yearly 18000 reports, up from about 9000 ten years ago, for a population of 55 million inhabitants. 30 to 40 % qualify as serious reports. This represents about half the reports generated yearly in the country, the other half being reported to industry. Every report transmitted to a regional center is reviewed for completeness and causality using a common method, before being input locally into a common database accessible by all centers, and by the central drug agency. Centers provide the National Medicines Agency with a pool of experts for commissions and boards, and to review alerts. Nearly 200 peer-reviewed papers are published each year by the centers. Regionalisation of pharmacovigilance represents an effective use of local resources, involving clinical pharmacologists in routine regulatory activity and research. It result in the creation of a population of clinical pharmacologists trained for drug safety assessment.