DIA 2018 Global Annual Meeting

While the product label represents the primary source of information about a medicine’s risks, numerous other types of risk communication measures have been used or required by regulatory authorities to date, including Dear Healthcare Provider Letters, Medication Guides, educational brochures, monographs, reminder and/or alert cards, and checklists. Such materials are typically intended for a diverse audience (e.g., healthcare professionals, patients, informal care providers, general public) and for use in a diverse array of settings, ranging from hospital and outpatient clinics to home-based. Increasingly, regulatory authorities are seeking to incorporate new learnings from the science of risk communication to support more effective tools and methods for reaching these audiences, including patient-centered approaches, shared decision-making techniques, electronic medical records, and other digital-based forms of communication.
The purpose of this session is present highlights from recent risk communication initiatives at the European Medicines Agency (EMA) and US Food and Drug Administration (FDA), and to illustrate how learnings from the emerging field of implementation science can be used to enhance the effectiveness of risk communication by both regulators as well as sponsors.