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 wer...

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Bibliographic Details
Published in:BMJ 1972-09, Vol.3 (5829), p.746-749
Main Authors: Inman, William H. W., Evans, David A. Price
Format: Article
Language:English
Subjects:
Adult
Adverse drug reactions
Aplastic anemia
Causality
Coroners
Drug and Narcotic Control
Drug-Related Side Effects and Adverse Reactions
Exanthema
Female
Follow-Up Studies
Humans
Male
Medical Practice
Middle Aged
Oral contraceptives
Overdose
Proportions
Reactions To Drugs
Registries
Subcommittees
Thrombocytopenia
United Kingdom
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Summary: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.
ISSN:0007-1447
0959-8138
1468-5833
DOI:10.1136/bmj.3.5829.746