Improving the quality of adverse drug reaction reporting by 4th-year medical students

Abstract

Purpose Evaluate whether a 15‐minute lecture intervention will improve adverse drug reaction reporting quality on standard MedWatch forms. Methods Seventy‐eight 4th‐year medical students were randomized to intervention ‘Group‐A’ or non‐intervention ‘Group‐B’ on the first day of a required five‐day clinical pharmacology rotation. Group‐A participants attended a 15‐minute lecture on completing a MedWatch form with quality information considered by the Food and Drug Administration as critical to adequate adverse drug reaction reporting. Group‐B participants did not attend this lecture. Both groups then watched a standardized patient interview of a recognizable adverse drug reaction and completed MedWatch forms. Four Safety Evaluators from the Food and Drug Administration (FDA) rated student responses in a blinded fashion for the primary efficacy variable of Overall Impression and six informational domins using a standardized data quality analysis form that was developed within the Office of Postmarketing Drug Risk Assessment of the FDA. Results Seventy‐eight MedWatch forms were evaluated (Group‐A=40, Group‐B = 38). Overall MedWatch information quality scores for the intervention group were significantly higher than the non‐intervention group (p < 0.004). Conclusions As little as a 15‐minute intervention can significantly improve the quality of adverse drug reaction reporting by 4th‐year medical students. Academic medical centers should consider incorporating adverse drug reaction reporting curriculum into the clinical training of medical students. Copyright © 2003 John Wiley & Sons, Ltd.