title: Quality of adverse drug experience reports submitted by pharmacists and physicians to the FDA.
abstract: The US Food and Drug Administration (FDA)'s Spontaneous Adverse Experience Reporting System is a computerized database with over one million adverse drug experience (ADE) reports. In 1992, the FDA received over 100,000 ADE reports and pharmacists were major contributors to these reports. In 1993, the FDA launched MEDWatch, a new initiative to enhance direct reporting of adverse events by health professionals. thus far, majority of reports to MEDWatch are from pharmacists. Drug regulatory agencies of some countries do not accept reports submitted by pharmacists. We performed a study to assess the quality of information in ADE reports submitted directly to the FDA by pharmacists and physicians and compared that with manufacturer-channelled 15-day reports. We evaluated 589 ADE reports with serious outcomes associated with nine new molecular entities. Data were analysed using Epi Info. Our results showed no substantial difference in a subjective assessment of the quality of information in the reports submitted by pharmacists or physicians, irrespective of whether these reports were submitted directly or via manufacturers. This study suggests that reports from hospital pharmacists are valuable and of comparable quality. We believe that all health professionals contribute to the success of FDA's MEDWatch programme and thereby play an important part in protecting public health by promptly reporting serious adverse events.
authors.affiliation: Clinical Pharmacology Division, Department of Medicine, Georgetown University Medical Center, Washington, DC, USA.
authors.forename: S R
authors.initials: SR
authors.lastname: Ahmad
authors.forename: J P
authors.initials: JP
authors.lastname: Freiman
authors.forename: D J
authors.initials: DJ
authors.lastname: Graham
authors.forename: R C
authors.initials: RC
authors.lastname: Nelson