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Comparative Study
. 1991 Jun;84(6):341-4.
doi: 10.1177/014107689108400612.

Spontaneous adverse drug reaction reporting vs event monitoring: a comparison

A P Fletcher  1
Affiliations
Comparative Study

Spontaneous adverse drug reaction reporting vs event monitoring: a comparison

A P Fletcher. J R Soc Med. 1991 Jun.

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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References

    1. Adverse Drug React Acute Poisoning Rev. 1985 Winter;4(4):213-30 - PubMed
    1. Adverse Drug React Acute Poisoning Rev. 1989 Winter;8(4):203-15 - PubMed
    1. Adverse Drug React Acute Poisoning Rev. 1986 Spring;5(1):23-55 - PubMed

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