Undergraduate and postgraduate pharmacovigilance education: A proposal for appropriate curriculum content.

BACKGROUND: Adverse drug reactions (ADRs) are common, often preventable, and a leading cause of morbidity and mortality. Pharmacovigilance (PV) involves detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. Education of healthcare professionals (HCPs) involved in drug prescription, dispensing and administration is essential to help prevent and mitigate both ADRs and medication errors and has to be focused on 3 pivotal aspects: •Awareness: All medicines can produce adverse effects. ADRs should always be considered as part of the differential diagnosis if any new adverse condition, symptoms or signs appear after a drug administration or during or after pharmacological treatment. •Knowledge: HCPs must have a sound understanding of the most frequently prescribed drugs and over-the-counter medications, factors that make patients more likely to benefit or more susceptible to harm, as well as of causes of medication errors. •Reporting: HCPs should know how to report ADRs and the role of reporting on regulatory aspects and scientific knowledge. Undergraduate curricula must provide, at a minimum, sufficient skills that warrant the appropriate and safe prescription/dispensing/administration of medications in clinical practice, focusing both on therapeutic effects and prevention of harm. Clinical appraisal skills must include ADRs as differential diagnosis, taking accurate medication history, basic individual causality assessment, identification and proper management of ADRs, and informing patients of possible ADRs. Postgraduate periodic PV training should be mandatory as part of continuing education. Specialised postgraduate education should include advanced contents.