July 1988

Physician Knowledge, Attitudes, and Behavior Related to Reporting Adverse Drug Events

Author Affiliations

From The Johns Hopkins University School of Medicine, Baltimore (Drs Rogers, Smith, and Levine); State of Maryland Department of Health and Mental Hygiene, Baltimore (Dr Israel); The Johns Hopkins University School of Hygiene and Public Health, Baltimore (Dr McBean); The Center for Health Education, Baltimore (Dr Valente); and the Department of Epidemiology and Biostatistics, Food and Drug Administration, Rockville, Md (Dr Faich).

Arch Intern Med. 1988;148(7):1596-1600. doi:10.1001/archinte.1988.00380070090021

• Voluntary physician reporting of adverse drug events (ADEs) in their patients remains the single most important source of information on serious and rare ADEs. Yet, substantial underreporting exists and the factors producing it are unclear. We surveyed 3000 randomly chosen physicians by mailed questionnaire to determine their knowledge about the reporting system, attitudes toward reporting, and their past behavior in reporting the ADEs they had detected. Responses numbered 1121. Only 57% were aware of the Food and Drug Administration's reporting system. While 418 physicians had detected an ADE in their practices during the previous year, only 21 physicians reported these events directly to the Food and Drug Administration. The physicians appear to appreciate the safety issues involved in prescription drug use and view reporting as a professional obligation; however, the current reporting system is considered inconvenient.

(Arch Intern Med 1988;148:1596-1600)