Abstract
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.
Highlights
Managing adverse drug reactions (ADRs) remains a challenge given the increasing complexity of therapeutics, the aging population, and the growing number of patients with multimorbidity and polypharmacy (Coleman and Pontefract 2016)
Sixty-two (86%) patients returned the questionnaire, 61 of whom (98%) found it relevant to report an ADR to Lareb if the suspected ADR led to hospital admission
This study shows that medical students can play an important role in the detection and management of serious and unknown ADRs in hospitalized patients while at the same time acquiring basic and clinical pharmacovigilance skills and knowledge
Summary
Managing adverse drug reactions (ADRs) remains a challenge given the increasing complexity of therapeutics, the aging population, and the growing number of patients with multimorbidity and polypharmacy (Coleman and Pontefract 2016). Multiple determinants for low ADR detection and reporting rates have been found, most of which are related to the awareness and pharmacological knowledge of attending healthcare professionals (Dormann et al 2003; Hazell and Shakir 2006; Lopez-Gonzalez and Figueiras 2009). While most healthcare professionals recognize the importance of ADR management, they lack the skills and knowledge to do so (Pagotto et al 2013) This is not surprising since healthcare students receive almost no education on this topic, and the educational activities that do exist are mainly outdated and lecture based (Reumerman et al 2018; Jenny Hartman 2017; Schutte et al 2017a) and few have clinical and or long-term effects (Reumerman et al 2020a; Arici et al 2015). Context-based clinical pharmacovigilance training, such as reporting ADRs in clinical practice (Reumerman et al 2018; Reumerman et al 2020a; Schutte et al 2018a; Sullivan and Spooner 2008) or assessing real ADR reports (Schutte et al 2017b), has proven effective in increasing students’ pharmacovigilance skills and knowledge (Reumerman et al 2018)
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