Improving the quality of adverse drug reaction reporting by 4th-year medical students.
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.
Rosebraugh
Curtis J
CJ
United States Food and Drug Administration, Room 10B-45, HFD-570, 5600 Fishers Lane, Rockville, MD 20857, USA. RosebraughC@cder.fda.gov
Tsong
Yi
Y
Zhou
Feng
F
Chen
Min
M
Mackey
Ann Corken
AC
Flowers
Charlene
C
Toyer
Denise
D
Flockhart
David A
DA
Honig
Peter K
PK
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