Evaluation of spontaneous reports of adverse reactions to drugs.
An adverse drug-reaction monitoring system based on spontaneous reporting to a central register of adverse reactions has been in operation for eight years. As a test of the validity of the reports and of the probability of causal relationship between drug and reaction a random sample of 82 cases were followed up in detail. The sample included 17 deaths, 26 serious reactions, and 39 reactions of moderate or only minor severity. Altogether 78% of the reactions were considered to be "probably" drug related and 13% "possibly" drug related. It is concluded that the reports are of value in the detection and evaluation of drug safety.
D000328:Adult; D004335:Drug and Narcotic Control; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D012042:Registries; D006113:United Kingdom