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July 1988

Adverse Drug Event ReportingImproving the Low US Reporting Rates

Author Affiliations

Division of Epidemiology School of Public Health Stadium Gate 27 611 Beacon St SE Minneapolis, MN 55455

Arch Intern Med. 1988;148(7):1499-1503. doi:10.1001/archinte.1988.00380070017005

The United States has low adverse drug event (ADE) spontaneous reporting rates compared with those of other developed countries (1983). Although slightly lower reporting rates are experienced in the Netherlands, France, Germany, and Belgium, US reporting rates are on the average approximately 25% of those in Denmark, 40% of those in Canada, and 50% of those in the United Kingdom.1 This is despite demonstrated successes in identifying potentially dangerous and ineffective drugs by the spontaneous reporting system (SRS), regular distribution of reporting forms to health providers by the Food and Drug Administration (FDA), and frequent periodic articles in scientific journals and presentations at national and international meetings explaining and promoting spontaneous reporting.

See also p 1596.

The FDA's SRS began in 1960 and was computerized in 1969. Since 1969, over 360000 reports have been computerized.2 The 1984 ADE reporting rate was approximately 15 reports per million prescriptions dispensed

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