title: Prescription-event monitoring and reporting of adverse drug reactions.
abstract: Newly marketed drugs in the UK are marked with a black triangle, indicating that doctors should report all adverse drug reactions associated with them to the Committee on Safety of Medicines (CSM). However, under-reporting of adverse reactions is frequent. Our aim was to establish what types of adverse reactions are under-reported to the CSM by family doctors who work in England. We used prescription-event monitoring data obtained for 15 newly marketed drugs. Only 9% (376) of 4211 events found on prescription-event monitoring were reported to the CSM. However, 53% (27) of 51 events classified as serious adverse drug reactions were reported. Overall, serious events were five times more likely to be reported to the CSM than non-serious events. Our results should not be extrapolated to calculate incidence rates of adverse drug reactions in the community from spontaneous reports.
authors.affiliation: Drug Safety Research Unit, Bursledon Hall, SO31 1AA, Southampton, UK. emma.heeley@dsru.org
authors.forename: E
authors.initials: E
authors.lastname: Heeley
authors.forename: J
authors.initials: J
authors.lastname: Riley
authors.forename: D
authors.initials: D
authors.lastname: Layton
authors.forename: L V
authors.initials: LV
authors.lastname: Wilton
authors.forename: S A
authors.initials: SA
authors.lastname: Shakir
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D004348:Drug Labeling; D016903:Drug Monitoring / Q000379:methods*; D006801:Humans; D011795:Surveys and Questionnaires; D006113:United Kingdom