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

Curtis J. Rosebraugh, Yi Tsong, Feng Zhou, Min Chen, Ann Corken Mackey, Charlene Flowers, Denise Toyer, David A. Flockhart, Peter K. Honig

Research output: Contribution to journalArticle

18 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)97-101
Number of pages5
JournalPharmacoepidemiology and Drug Safety
Issue number2
StatePublished - Mar 1 2003



  • Adverse drug reaction
  • Adverse drug reaction reporting
  • Food and drug administration
  • MedWatch
  • Standardize patient

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

Rosebraugh, C. J., Tsong, Y., Zhou, F., Chen, M., Mackey, A. C., Flowers, C., Toyer, D., Flockhart, D. A., & Honig, P. K. (2003). Improving the quality of adverse drug reaction reporting by 4th-year medical students. Pharmacoepidemiology and Drug Safety, 12(2), 97-101.