Spontaneous adverse drug reaction reporting vs event monitoring: a comparison.
Spontaneous adverse drug reaction (ADR) reporting is the mainstay of national and international drug safety evaluation in the post-approval phase. A major criticism of the method has been a high, but essentially unquantifiable, level of under-reporting by doctors. A direct comparison has been made between spontaneous ADR reporting and an observational event monitoring system for a group of more than 44,000 patients receiving one or other of a group of seven new drugs. The data suggests that under-reporting by the spontaneous system may be as high as 98% for several clinical events believed to be associated with drug treatment.
Fletcher
A P
AP
Post Marketing Surveillance Unit, IMS International Ltd, London.
D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D015588:Observer Variation; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000706:statistics & numerical data