Feasibility and Educational Value of a Student-Run Pharmacovigilance Programme: A Prospective Cohort Study

Drug Saf. 2017 May;40(5):409-418. doi: 10.1007/s40264-016-0502-1.

Abstract

Introduction: Pharmacovigilance, the monitoring of drug safety after marketing approval, highly depends on the adequate reporting of adverse drug reactions (ADRs). To improve pharmacovigilance awareness and future ADR reporting among medical students, we developed and evaluated a student-run pharmacovigilance programme.

Methods: In this project, teams of medical students (first- to fifth-year) assessed real ADR reports, as submitted to the national pharmacovigilance centre. After assessment of causality, including identification of a potential pharmacological explanation for the ADR, the students wrote a personalized feedback letter to the reporter, as well as a summary for the European Medicines Agency (EMA) and World Health Organization (WHO) pharmacovigilance databases. This student assessment was then verified and evaluated by staff from The Netherlands Pharmacovigilance Centre Lareb (Lareb), using an e-questionnaire. Student attitudes, intentions, skills, and knowledge of ADR reporting were evaluated using the e-questionnaire, before and after participation in the programme.

Results: From May 2014 to January 2015, a total of 43 students assessed 100 different ADR reports selected by Lareb staff (n = 3). Student assessments were rated as useful (93%), scientifically substantiated (90%), accurate (92%), and complete (92%), and, on average, did not cost Lareb staff extra time. Medical students were positive about ADR reporting, and their awareness of ADR reporting increased significantly following participation in the programme (p < 0.05). After participation in the programme, the students intended to report serious ADRs in their future practice, and their knowledge of pharmacovigilance and ADR reporting showed they had a high overall level of pharmacological understanding.

Conclusion: The student-run pharmacovigilance programme is a win-win venture. It offers students a valuable 'pharmacovigilance experience', creates awareness in future doctors, and has the potential to increase pharmacovigilance skills and knowledge.

MeSH terms

  • Adverse Drug Reaction Reporting Systems*
  • Clinical Competence
  • Cohort Studies
  • Drug-Related Side Effects and Adverse Reactions / epidemiology*
  • Education, Medical
  • Educational Measurement
  • Health Knowledge, Attitudes, Practice
  • Humans
  • Netherlands
  • Pharmacovigilance*
  • Product Surveillance, Postmarketing / methods
  • Prospective Studies
  • Students, Medical*