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

Tim Schutte (), Jelle Tichelaar, Michael O. Reumerman, Rike Eekeren, Leàn Rolfes, Eugène P. Puijenbroek, Milan C. Richir and Michiel A. Agtmael
Additional contact information
Tim Schutte: VU University Medical Center
Jelle Tichelaar: VU University Medical Center
Michael O. Reumerman: VU University Medical Center
Rike Eekeren: The Netherlands Pharmacovigilance Centre Lareb
Leàn Rolfes: The Netherlands Pharmacovigilance Centre Lareb
Eugène P. Puijenbroek: The Netherlands Pharmacovigilance Centre Lareb
Milan C. Richir: VU University Medical Center
Michiel A. Agtmael: VU University Medical Center

Drug Safety, 2017, vol. 40, issue 5, No 6, 409-418

Abstract: 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

Keywords: Medical Student; Adverse Drug Reaction; Adverse Drug Reaction Reporting; Pharmacy Student; Undergraduate Medical Student (search for similar items in EconPapers)
Date: 2017
References: View complete reference list from CitEc
Citations:

Downloads: (external link)
http://link.springer.com/10.1007/s40264-016-0502-1 Abstract (text/html)
Access to the full text of the articles in this series is restricted.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:spr:drugsa:v:40:y:2017:i:5:d:10.1007_s40264-016-0502-1

Ordering information: This journal article can be ordered from
http://www.springer.com/adis/journal/40264

DOI: 10.1007/s40264-016-0502-1

Access Statistics for this article

Drug Safety is currently edited by Nitin Joshi

More articles in Drug Safety from Springer
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().