Under-reporting of adverse drug reactions by UK family doctors

November 29, 2001

N.B. Please note that if you are outside North America the embargo for Lancet Press material is 0001 hours UK Time Friday 30th November 2001

A research letter in this week's issue of THE LANCET highlights how family doctors in England under-report suspected adverse drug reactions (from newly marketed drugs) to the Committee on Safety of Medicines (CSM). The study shows that around 10% of adverse drug reactions are reported, increasing to over 50% for serious events.

Newly marketed drugs in the UK are marked with a black triangle. For medicines showing the black triangle symbol, the Medicines Control Agency and the CSM require all suspected adverse drug reactions to be reported through the yellow-card scheme; however, under-reporting of adverse reactions is frequent. Emma Heeley and colleagues from the Drug Safety Research Unit, Southampton, UK, aimed to establish what types of adverse reactions are under-reported to the CSM by family doctors in England. The investigators used prescription-event monitoring data obtained for 15 newly marketed drugs.

Only 9% (376) of events recorded as adverse drug reactions in these prescription-event monitoring studies were said to have been reported to the CSM. However, 53% (27) of the 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. The authors noted that reporting of serious suspected adverse reactions has improved since a previous study done in 1998.

Saad Shakir (one of the investigators) comments: "Our results suggest that family doctors are five times more likely to report serious events on black-triangle drugs than non-serious labelled events, irrespective of whether the serious event is labelled or not. This finding raises the question of whether doctors are fully aware of the meaning of the black triangle, whereby all suspected adverse drug reactions should be reported to the CSM. What is apparent is that the yellow card scheme run by the CSM has been improved in its effectiveness to detect serious reactions. Prescription-event monitoring continues to show its effectiveness to detect all kinds of adverse reactions (serious and non-serious), especially adverse events that the doctor does not necessarily attribute to the drug."
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Contact: Dr Saad Shakir, Director, Drug Safety Research Unit, Bursledon Hall, Southampton SO31 1AA, UK; T) +44 (0)2380 40600; F) +44 (0)2380 40609; E) saad.shakir@dsru.org

Lancet

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