ADVERSE DRUG-REACTIONS IN A HOSPITAL-GENERAL MEDICAL UNIT MERITING NOTIFICATION TO THE COMMITTEE ON SAFETY OF MEDICINES

1 We have retrospectively analysed data collected by a local adverse d rug reactions reporting scheme in an acute hospital medical setting an d have determined the numbers and types of reactions that would have m erited notification as yellow card reports according to the guidelines of the Committee on Safety of Medicines. 2 The data related to 20 695 consecutive acute general medical admissions on seven general medical wards (140 beds) and were collected over 3 years, from April 1990 to March 1993. 3 Over 3 years there were 1420 reports of suspected advers e drug reactions, a rate of 68.7 per 1000 admissions. 4 If the guideli nes for reporting issued by the Committee on Safety of Medicines had b een strictly followed, 477 yellow cards would have been sent (23.1 per 1000 admissions). In 357 of these reports (74.8%), the reaction had c aused admission to hospital. Only 31 of the 477 potential cards (6.5%) involved black triangle drugs and 10 of these were for minor reaction s. 5 Only 30 of the 477 potential yellow cards (6.3%) were known to ha ve been sent. The majority of those reactions not reported were for dr ug-related admissions, most of which were for well-known reactions to established drugs. 6 We have confirmed and quantified the extent of un der-reporting of serious suspected adverse drug reactions to the Commi ttee on Safety of Medicines from our hospital medical unit.