Risk Communication and Patient Safety: Recent Learnings and New Approaches
Meredith Y. Smith, PhD, MPA
Global Risk Management Officer, Global Patient Safety
Amgen Inc., United States
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.
Learning Objective : Describe recent efforts by a major regulatory authority (the European Medicines Agency) to improve the quality of therapeutic risk communication via partnership and engagement with patients and healthcare professionals; Identify how to implement therapeutic risk communication programs; Discuss new types of risk communication tools that the FDA has developed for sponsors to use when communicating medicinal product risks to healthcare professionals and patients.
Engaging Patients and Healthcare Professionals in Evaluating Risk Minimization Measures: How Can Regulators Best Listen to Medicine Users for Improved Regulatory Decision Making and Risk Communication
European Medicines Agency (EMA), United Kingdom
New Risk Communication Approaches for Patients: The FDA's Benefit-Risk Counseling Framework and Other Tools
Michael S. Wolf
Associate Professor, Medicine and Learning Sciences, Associate Division Chief
Northwestern University, United States