Title : Medication errors: Detection, impact, and risk reduction through pharmacovigilance
Abstract:
Medication errors are a leading cause of preventable harm in healthcare systems worldwide, with significant implications for patient safety and therapeutic outcomes. Within the European Union (EU), addressing medication errors has become a key priority to enhance public health and ensure safe use of medicines. To support this goal, the European Medicines Agency (EMA), in collaboration with national competent authorities, developed the EU Good Practice Guide on Medication Errors. This guide offers a comprehensive framework for identifying, reporting, evaluating, and preventing medication errors within the EU pharmacovigilance system. This presentation will delve into the essential elements of the Good Practice Guide, including its definitions, classification of errors, the role of risk minimisation measures, and integration with adverse event reporting systems. Emphasis will be placed on the distinction between medication errors and adverse drug reactions, and on how marketing authorisation holders and healthcare professionals should manage such events in compliance with EU regulatory requirements. Case studies and real-world scenarios will be presented to illustrate how proactive error identification and reporting can prevent recurrence and reduce patient harm. Furthermore, the broader impact of medication errors—ranging from patient trust and treatment outcomes to regulatory action and healthcare costs—will be examined. By fostering awareness and promoting consistent practices, the Guide aims to support a culture of safety and continuous improvement in medication use. This presentation will equip attendees with the practical insights needed to align with regulatory expectations and contribute effectively to medication error prevention efforts.
