Purpose: Evaluate whether a 15 minute lecture intervention will improve ADR reporting quality on standard MedWatch forms. Methods: 100 4th year medical students were randomized to intervention "B" or non-intervention "A" groups on the first day of a required 5 day clinical pharmacology rotation. The "B" group attended a 15 minute lecture on completing a MedWatch form with quality information considered by the FDA critical to ADR reporting. The "A" group did not. After watching a standardized-patient interview for documentation of a recognizable ADR, both groups completed MedWatch forms. Four blinded, FDA Safety Evaluators rated student responses in 7 domains and overall global quality using a standardized data quality analysis form. Results: 76 MedWatch forms were evaluated (B-n=38, A-n=38). Overall form quality scores for the intervention group were significantly higher than the nonintervention group (p<.0001). Six of seven domain analyses were also statistically significant (p=0.009 or less) favoring the intervention group. Conclusion: A 15 minute intervention can significantly improve the quality of ADR reporting by 4th year medical students. ADRs have a significant impact on public health and the FDA relies on quality physician reporting. All academic medical centers should consider incorporating ADR reporting intervention curriculum into the clinical training of medical students.
|Original language||English (US)|
|Journal||Clinical Pharmacology and Therapeutics|
|State||Published - Jan 1 2001|
ASJC Scopus subject areas
- Pharmacology (medical)