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

Author

Listed:
  • Tim Schutte

    (VU University Medical Center
    RECIPE (Research and Expertise Center In Pharmacotherapy Education))

  • Jelle Tichelaar

    (VU University Medical Center
    RECIPE (Research and Expertise Center In Pharmacotherapy Education))

  • Michael O. Reumerman

    (VU University Medical Center)

  • Rike Eekeren

    (The Netherlands Pharmacovigilance Centre Lareb
    University of Groningen
    The Netherlands Pharmacovigilance Centre Lareb)

  • Leàn Rolfes

    (The Netherlands Pharmacovigilance Centre Lareb
    University of Groningen
    The Netherlands Pharmacovigilance Centre Lareb)

  • Eugène P. Puijenbroek

    (The Netherlands Pharmacovigilance Centre Lareb
    University of Groningen
    The Netherlands Pharmacovigilance Centre Lareb)

  • Milan C. Richir

    (VU University Medical Center
    RECIPE (Research and Expertise Center In Pharmacotherapy Education))

  • Michiel A. Agtmael

    (VU University Medical Center
    RECIPE (Research and Expertise Center In Pharmacotherapy Education))

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

Suggested Citation

  • Tim Schutte & Jelle Tichelaar & Michael O. Reumerman & Rike Eekeren & Leàn Rolfes & Eugène P. Puijenbroek & Milan C. Richir & Michiel A. Agtmael, 2017. "Feasibility and Educational Value of a Student-Run Pharmacovigilance Programme: A Prospective Cohort Study," Drug Safety, Springer, vol. 40(5), pages 409-418, May.
    • Handle: RePEc:spr:drugsa:v:40:y:2017:i:5:d:10.1007_s40264-016-0502-1
    DOI: 10.1007/s40264-016-0502-1
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