Factors Affecting Physician Reporting of Adverse Drug Reactions

Abstract

A survey was performed to ascertain which factors influence physicians to directly report adverse drug reactions to the FDA. Eighty-two percent of the 190 physicians reporting reactions during an 11-week period responded to the survey. Reporters were disproportionately in primary care compared to all US physicians and tended to spend a larger amount of time in teaching and research than the average physician. More than half of the respondents were under 40 years of age. The major reporting influences found were the severity of the reaction and the newness of the drug. Patient attribution of the reaction to the drug was a strong influence on reporting of nonserious reactions. Concern for legal implications was a relatively infrequently (11%) noted influence on reporting physicians. No single reporting influence was unique to reporters of serious unlabeled reactions.