ObjectivesPharmacovigilance education is essential since adverse drug reactions (ADRs) are a serious health problem and contribute to unnecessary patient burden and hospital admissions. Healthcare professionals have little awareness of pharmacovigilance and ADR reporting, and only few educational interventions had durable effects on this awareness. Our future healthcare providers should therefore acquire an adequate set of pharmacovigilance competencies to rationally prescribe, distribute, and monitor drugs. We investigated the pharmacovigilance and ADR-reporting competencies of healthcare students to identify educational interventions that are effective in promoting pharmacovigilance.MethodsThe PubMed, EMBASE, Cochrane, CINAHL, PsycINFO, and ERIC databases were searched using the terms “pharmacovigilance,” “students,” and “education.”.ResultsTwenty-five cross-sectional and 14 intervention studies describing mostly medical and pharmacy students were included. Intentions and attitudes on ADR reporting were overall positive, although most students felt inadequately prepared, missed the training on this topic, and lacked basic knowledge. Although nearly all students observed ADRs during clinical rounds, only a few had actually been involved in reporting an ADR. Educational interventions were predominately lectures, sometimes accompanied by small interactive working groups. Most interventions resulted in a direct increase in knowledge with an unknown long-term effect. Real-life learning initiatives have shown that healthcare students are capable of contributing to patient care while increasing their ADR-reporting skills and knowledge.ConclusionsThere is an urgent need to improve and innovate current pharmacovigilance education for undergraduate healthcare students. By offering real-life pharmacovigilance training, students will increase their knowledge and awareness but can also assist current healthcare professionals to meet their pharmacovigilance obligations.Electronic supplementary materialThe online version of this article (10.1007/s00228-018-2500-y) contains supplementary material, which is available to authorized users.

Pharmacovigilance centres monitor the safety of drugs, based on adverse drug reactions (ADRs) reported by doctors, pharmacists and pharmaceutical companies. However, the under-reporting of ADRs remains a major problem. Our aim was to investigate preparedness of future doctors for their role in pharmacovigilance, by assessing their pharmacovigilance awareness, skills and knowledge. The study was a nationwide e-survey among medical students (third to sixth year) of all eight medical schools in the Netherlands. The survey consisted of questions regarding pharmacovigilance awareness, skills and knowledge. Overall, 874 students provided informed consent and participated (response 12%). Almost all students (96%) intended to report serious ADRs in their future practice. Almost half (44%) of the students did not know where to report an ADR, and 78% did not know which items were necessary for a good-quality ADR report. While more than 78% of the students agreed that pharmacovigilance is an important topic in their medical education, only 26% found that their current curriculum covered pharmacovigilance adequately. Although ADR reporting is considered relevant and important among future doctors, many do not know where and what to report. This is highly undesirable and should have consequences for pharmacotherapy teaching.

IntroductionPharmacovigilance, 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.MethodsIn 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.ResultsFrom 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.ConclusionThe 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.Electronic supplementary materialThe online version of this article (doi:10.1007/s40264-016-0502-1) contains supplementary material, which is available to authorized users.

Aims The involvement of an inter-professional healthcare student team in the review of medications used by geriatric patients could not only provide patients with optimized therapy but also provide students with a valuable inter-professional learning experience. We describe and evaluate the clinical and learning outcomes of an inter-professional student-run mediation review program (ISP). Subject and method A variable team consisting of students in medicine, pharmacy, master advanced nursing practice, and master physician assistant reviewed the medication lists of patients attending a specialized geriatric outpatient clinic. Results During 32 outpatient visits, 188 medications were reviewed. The students identified 14 medication-related problems, of which 4 were not recognized by healthcare professionals. The ISP team advised 95 medication changes, of which 68 (71.6%) were directly implemented. Students evaluated this pilot program positively and considered it educational (median score 4 out of 5) and thought it would contribute to their future inter-professional relationships. Conclusion An inter-professional team of healthcare students is an innovative healthcare improvement for (academic) hospitals to increase medication safety. Most formulated advices were directly incorporated in daily practice and could prevent future medication-related harm. The ISP also offers students a first opportunity to work in an inter-professional manner and get insight into the perspectives and qualities of their future colleagues.

Aim In‐hospital prescribing errors (PEs) may result in patient harm, prolonged hospitalization and hospital (re)admission. These events are associated with pressure on healthcare services and significant healthcare costs. To develop targeted interventions to prevent or reduce in‐hospital PEs, identification and understanding of facilitating and protective factors influencing in‐hospital PEs in current daily practice is necessary, adopting a Safety‐II perspective. The aim of this systematic review was to create an overview of all factors reported in the literature, both protective and facilitating, as influencing in‐hospital PEs. Methods PubMed, http://EMBASE.com and the Cochrane Library (via Wiley) were searched, according to the Preferred Reporting Items for Systematic Reviews and Meta‐Analysis (PRISMA) statement, for studies that identified factors influencing in‐hospital PEs. Both qualitative and quantitative study designs were included. Results Overall, 19 articles (6 qualitative and 13 quantitative studies) were included and 40 unique factors influencing in‐hospital PEs were identified. These factors were categorized into five domains according to the Eindhoven classification (‘organization‐related’, ‘prescriber‐related’, ‘prescription‐related’, ‘technology‐related’ and ‘unclassified’) and visualized in an Ishikawa (Fishbone) diagram. Most of the identified factors (87.5%; n = 40) facilitated in‐hospital PEs. The most frequently identified facilitating factor (39.6%; n = 19) was ‘insufficient (drug) knowledge, prescribing skills and/or experience of prescribers’. Conclusion The findings of this review could be used to identify points of engagement for future intervention studies and help hospitals determine how to optimize prescribing. A multifaceted intervention, targeting multiple factors might help to circumvent the complex challenge of in‐hospital PEs.

Managing adverse drug reactions (ADRs) is a challenge, especially because most healthcare professionals are insufficiently trained for this task. Since context-based clinical pharmacovigilance training has proven effective, we assessed the feasibility and effect of a creating a team of Junior-Adverse Drug Event Managers (J-ADEMs). The J-ADEM team consisted of medical students (1st–6th year) tasked with managing and reporting ADRs in hospitalized patients. Feasibility was evaluated using questionnaires. Student competence in reporting ADRs was evaluated using a case-control design and questionnaires before and after J-ADEM program participation. From Augustus 2018 to Augustus 2019, 41 students participated in a J-ADEM team and screened 136 patients and submitted 65 ADRs reports to the Netherlands Pharmacovigilance Center Lareb. Almost all patients (n = 61) found it important that “their” ADR was reported, and all (n = 62) patients felt they were taken seriously by the J-ADEM team. Although attending physicians agreed that the ADRs should have been reported, they did not do so themselves mainly because of a “lack of knowledge and attitudes” (50%) and “excuses made by healthcare professionals” (49%). J-ADEM team students were significantly more competent than control students in managing ADRs and correctly applying all steps for diagnosing ADRs (control group 38.5% vs. intervention group 83.3%, p < 0.001). The J-ADEM team is a feasible approach for detecting and managing ADRs in hospital. Patients were satisfied with the care provided, physicians were supported in their ADR reporting obligations, and students acquired relevant basic and clinical pharmacovigilance skills and knowledge, making it a win-win-win intervention.

The Junior Adverse Drug Event Manager (J-ADEM) team is a multifaceted intervention focusing on real-life education for medical students that has been shown to assist healthcare professionals in managing and reporting suspected adverse drug reactions (ADRs) to the Netherlands Pharmacovigilance Centre Lareb. The aim of this study was to quantify and describe the ADRs reported by the J-ADEM team and to determine the clinical potential of this approach. The J-ADEM team consisted of medical students tasked with managing and reporting ADRs in hospitalized patients.All ADRs screened and reported by J-ADEM team were recorded anonymously, and categorized and analysed descriptively. From August 2018 through January 2020, 209 patients on two wards in an academic hospital were screened for ADR events.The J-ADEM team reported 101 ADRs. Although most ADRs (67%) were first identified by healthcare professionals and then reported by the J-ADEM team, the team also reported an additional 33 not previously identified serious ADRs. In 10% of all reported ADRs, the J-ADEM team helped optimize ADR treatment. The ADR reports were largely well-documented (78%), and ADRs were classified as type A (66%), had a moderate or severe severity (85%) and were predominantly avoidable reactions (69%). This study shows that medical students are able to screen patients for ADRs, can identify previously undetected ADRs and can help optimize ADR management.They significantly increased (by 300%) the number of ADR reports submitted, showing that the J-ADEM team can make a valuable clinical contribution to hospital care.

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