Although medical and pharmacy students may recognise the importance of adverse drug reaction reporting and express their intention to report ADRs, they may be insufficiently prepared to do so, or lack the requisite pharmacovigilance competencies.
Currently there is no international standard for pharmacovigilance education at universities and, in many countries, pharmacovigilance education is not embedded in the curriculum. This hampers optimal patient care and the safe use of drugs. As WHO and others have recognised, more education is needed for future healthcare professionals to build competence in both handling ADRs in clinical practice and reporting them during their undergraduate studies.
Over the past two years, two expert meetings were held on behalf of WHO, by the Netherlands Pharmacovigilance Centre Lareb – the WHO Collaborating Centre for Pharmacovigilance in Education and Patient Reporting. Representatives from both pharmacovigilance centres and academia participated.
One outcome of the first meeting was a draft framework of the WHO core curriculum for university teaching, including the five key aspects of pharmacovigilance with a focus on clinical practice. These are: the importance of pharmacovigilance in pharmacotherapy and preventing, recognising, managing, and reporting adverse drug reactions. The proposed content of the undergraduate core curriculum was approved by the 14th WHO Advisory Committee on Safety of Medicinal Products (ACSoMP) Meeting at the WHO.
In the second meeting, participants discussed how these five key aspects could best be introduced at universities. Because there is generally lack of extra time in medical and pharmacy studies to implement a new curriculum, it was proposed to integrate aspects of pharmacovigilance in existing courses. In this way, students learn about medicines safety in several contexts. To make this work, a “teach-the-teacher” course has also been developed.
The materials were piloted in the Netherlands, where 23 teachers from medical and pharmacy schools of seven different universities participated in a five-hour teach-the-teacher course. During the course, teachers discussed what aspects of pharmacovigilance and ADR education could be implemented or improved in their own curricula and prepared action plans. The instructors also demonstrated practical examples of assignments and exercises that could be used. All participants agreed on the need for improvement of pharmacovigilance education at their schools and were enthusiastic about practical assignments on monitoring ADRs and reporting them during internships.
Lareb will continue working to advance pharmacovigilance education for students. Currently, the researchers are planning a pilot study of the teach-the-teacher course in other countries. This pilot should give insight into success factors and points of concern for implementing medicines safety education in existing curricula and courses. A web portal is also being developed to present and share teaching materials and supporting materials will be available as part of the WHO PV Toolkit.
Hussain Al Ramimmy, Director of Pharmacovigilance and Drug Information in the Oman Ministry of Health, and one of the authors of the paper published about this project, says there is much to be gained from ADR “harmonisation at regional global levels,” and he encourages others to take part in developing the curriculum by “involving teachers and institutions in research related to pharmacovigilance”.
Anyone who wants to share educational materials is encouraged to contact email@example.com. The aim of this project is that university teachers will be sufficiently equipped to teach their students about pharmacovigilance and ADRs. To that end, this work can also help pharmacovigilance centres support university teachers in their countries.
- R van Eekeren, L Rolfes, A S Koster, L Magro, G Parthasarathi, H Al Ramimmy, T Schutte, D Tanaka, E van Puijenbroek, L Härmark, "What Future Healthcare Professionals Need to Know About Pharmacovigilance: Introduction of the WHO PV Core Curriculum for University Teaching with Focus on Clinical Aspects", Drug Safety, 2018.