title: Improving the quality of adverse drug reaction reporting by 4th-year medical students.
abstract: OBJECTIVE
  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.
authors.affiliation: United States Food and Drug Administration, Room 10B-45, HFD-570, 5600 Fishers Lane, Rockville, MD 20857, USA. RosebraughC@cder.fda.gov
authors.forename: Curtis J
authors.initials: CJ
authors.lastname: Rosebraugh
authors.forename: Yi
authors.initials: Y
authors.lastname: Tsong
authors.forename: Feng
authors.initials: F
authors.lastname: Zhou
authors.forename: Min
authors.initials: M
authors.lastname: Chen
authors.forename: Ann Corken
authors.initials: AC
authors.lastname: Mackey
authors.forename: Charlene
authors.initials: C
authors.lastname: Flowers
authors.forename: Denise
authors.initials: D
authors.lastname: Toyer
authors.forename: David A
authors.initials: DA
authors.lastname: Flockhart
authors.forename: Peter K
authors.initials: PK
authors.lastname: Honig
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D064420:Drug-Related Side Effects and Adverse Reactions; D004501:Education, Medical; D005260:Female; D006801:Humans; D008297:Male; D011785:Quality Assurance, Health Care; D013337:Students, Medical / Q000706:statistics & numerical data; D011795:Surveys and Questionnaires; D014481:United States; D014486:United States Food and Drug Administration