The general practice research database: role in pharmacovigilance.
The General Practice Research Database (GPRD) is the world's largest computerised database of anonymised longitudinal clinical records from primary care. The database already has an international reputation in the field of drug safety signal evaluation where the results of GPRD-based pharmacoepidemiological studies have been used to inform regulatory pharmacovigilance decision making. The characteristics and richness of the data are such that the GPRD is likely to prove a key data resource for the proactive pharmacovigilance anticipated in risk management and pharmacovigilance plans. An update of recent developments to the database and new data available from it -- including spontaneously recorded suspected adverse drug reactions -- is presented in the article, with a description of how the data can be used to support a variety of pharmacovigilance applications. The possibility of using the GPRD in signal detection and assessment of the impact of pharmacovigilance activities in the future is also discussed.
Wood
Louise
L
General Practice Research Database Division, Medicines and Healthcare products Regulatory Agency, London, UK. louise.wood@gprd.com
Martinez
Carlos
C
D016907:Adverse Drug Reaction Reporting Systems / Q000941:ethics / Q000592:standards / Q000639:trends*; D003219:Confidentiality / Q000941:ethics / Q000592:standards / Q000639:trends; D016208:Databases, Factual / Q000592:standards / Q000706:statistics & numerical data / Q000639:trends*; D005194:Family Practice / Q000592:standards / Q000639:trends*; D006801:Humans; D008137:Longitudinal Studies; D016347:Medical Records Systems, Computerized / Q000941:ethics / Q000592:standards / Q000706:statistics & numerical data; D011320:Primary Health Care / Q000379:methods / Q000592:standards; D012308:Risk Management / Q000379:methods / Q000592:standards / Q000639:trends; D006113:United Kingdom / Q000453:epidemiology