Monitoring of adverse drug reactions in the pharmaceutical industry--the scene in the United Kingdom.
In the United Kingdom, all suspected reactions to newly marketed drugs and serious, suspected reactions to established drugs are reported by doctors, dentists, coroners and pharmaceutical companies to the Medicines Control Agency. The information is entered onto the Agency database and analysed before being made available in regular reports. Post-marketing surveillance of newly licensed drugs is carried out in a number of ways: protocolled studies involving up to 10,000 patients, prescription tracing, and databases using input from general practitioners or hospitals. European Community pharmacovigilance requirements were due to become effective in 1992, or soon after. These may involve companies in a review of the structures of their reporting department and, without care on the part of the Community, could result in duplication of reporting. Risk/benefit analysis of drug use is led by the International Foundation based in Geneva. The aim is to improve the management of drug safety, both within the industry and the medical profession. In the UK, a risk assessment group has grown up which includes, among others, all interested UK companies and representation from the Medicines Control Agency.
Whitmarsh
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Clinical Safety and Pharmacoeconomics, SmithKline Beecham Pharmaceuticals, Reigate, Surrey, United Kingdom.
D016208:Databases, Factual; D004345:Drug Industry; D016903:Drug Monitoring; D005060:Europe; D006801:Humans; D012307:Risk Factors; D006113:United Kingdom