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A Student-Run Pharmacovigilance Programme

Date: 1 September 2017

A programme in which students assess real life reports of adverse drug reactions (ADRs) seems effective to increase knowledge and awareness about ADR reporting. In addition, these students’ high quality assessment are valuable for the pharmacovigilance centre. The Lareb staff indicated that the students assessment saved time in 33% of the case and time was neutral for 56%. For only 11% of the cases it cost them extra time.

In the Netherlands, the VU University Medical Center (VUmc) of Amsterdam carried out a student-run pharmacovigilance programme in collaboration with the Netherlands Pharmacovigilance Centre Lareb. In this programme, teams of medical students carried out a case-by-case assessment of a ADR-report which had been submitted to Lareb. The medical students are first- to fifth-year students who have volunteered at the learner-centered student-run clinic, which is based on the conceptual framework of ‘learning by doing’. The student assessment was verified and evaluated by Lareb staff, before feedback was sent back to the reporter.

Evaluation of 43 students assessments by Lareb staff indicated that they were useful (93%), scientifically sustained (90%), accurate (92%) and complete (92%). Verification and evaluation of the assessment did not cost Lareb staff did not cost Lareb staff more time that assessing reports themselves. Medical students were also positive about the programme. After participation they intended to reports serious ADRs in their future practice. The assignment increased their knowledge of pharmacovigilance, ADR reporting and overall pharmacological understanding.

The student-run pharmacovigilance programme has mutual benefits for pharmacovigilance and the medical students. Future research is needed to determine the additional value of this novel approach, compared with, for instance an ADR reporting assignment or a lecture, on students’ pharmacovigilance skills, and to explore the long-term effect of this novel approach.

To read the article:
Schutte T, Tichelaar J, Reumerman MO, van Eekeren R, Rolfes L, van Puijenbroek EP, Richir MC, van Agtmael MA. Feasibility and Educational Value of a Student-Run Pharmacovigilance Programme: A Prospective Cohort Study. Drug Saf. 2017 May;40(5):409-418.

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