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J R Soc Med. 1991 June; 84(6): 341–344.
PMCID: PMC1293280

Spontaneous adverse drug reaction reporting vs event monitoring: a comparison.

Abstract

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.

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Selected References

These references are in PubMed. This may not be the complete list of references from this article.
  • Griffin JP, Weber JC. Voluntary systems of adverse reaction reporting--Part I. Adverse Drug React Acute Poisoning Rev. 1985 Winter;4(4):213–230. [PubMed]
  • Griffin JP, Weber JC. Voluntary systems of adverse reaction reporting--Part II. Adverse Drug React Acute Poisoning Rev. 1986 Spring;5(1):23–55. [PubMed]
  • Griffin JP, Weber JC. Voluntary systems of adverse reaction reporting--Part III. Adverse Drug React Acute Poisoning Rev. 1989 Winter;8(4):203–215. [PubMed]

Articles from Journal of the Royal Society of Medicine are provided here courtesy of Royal Society of Medicine Press