Evaluation of Spontaneous Reports of Adverse Reactions to Drugs
- 23 September 1972
- Vol. 3 (5829) , 746-749
- https://doi.org/10.1136/bmj.3.5829.746
Abstract
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.Keywords
This publication has 3 references indexed in Scilit:
- ROLE OF DRUG-REACTION MONITORING IN THE INVESTIGATION OF THROMBOSIS AND “THE PILL”British Medical Bulletin, 1970
- Recognition of unwanted drug effects.BMJ, 1969
- Adverse reactions to drugs.BMJ, 1965