Learning by doing in the student-run pharmacovigilance program

Background: Medication safety is an important topic in healthcare nowadays. Pharmacovigilance, the monitoring of drug safety after approval for marketing, depends mainly on the quality and quantity of reported adverse drug reactions (ADR). To increase pharmacovigilance awareness among medical students, we developed and evaluated a Student-run Pharmacovigilance program, together with pharmacovigilance centre Lareb. Method: A pilot study was performed in which teams of (1st-4th year) medical students assessed real ADR-reports from patients/healthcare professionals reported to Lareb. After assessment on causality, students searched for a pharmacological explanation and wrote a feedback letter to the reporter and a summary for the pharmacovigilance- databases of the European Medicines Agency and WHO. This student-assessment was then verified by Lareb staff, who evaluated student-handling it in an e-questionnaire. Results: From May to December 2014, 89 different ADR-reports selected by Lareb staff were handled, with the top 3 reported ADRs being; palpitations, urinary retention and agitation. Thirty-five students and 3 Lareb staff members participated. Lareb staff rated the student assessments (very) useful (> 92%), scientifically substantiated (> 88%), complete (not lacking information) and without inaccuracies (both > 92%). Altogether the student-assessments were rated mean 8.3 (1-10; min-max). Compared to self-handling, Lareb staff indicated student-assessment cost less time in 33% assessments, neutral in 55%, and cost extra time in 11%. Conclusion: The Student-run pharmacovigilance program is a win-win venture. It offers students a valuable “pharmacovigilance experience”, creates awareness in future doctors with the potential to increase ADR-reporting, and didn't cost Lareb staff extra time overall. The learner effects need to be investigated in future studies