Reducing the Burden of Drug Safety Risk Minimization Programs on the Healthcare System: How Do We Do So and What Has Been Learned to Date?
Meredith Y. Smith, PhD, MPA
Global Risk Management Officer, Global Patient Safety
Amgen Inc., United States
As part of its REMS integration initiative under the Prescription Drug User Fee Act V, the FDA committed to improving the integration of risk evaluation and mitigation strategies (REMS) into the healthcare system. A designated team (the Design and Standardization Work Group) was established to identify best practices to incorporate into REMS design, as well as appropriate ways to standardize REMS tools and integrate REMS into the healthcare delivery system. Results of this workstream have important implications for how industry designs its REMS programs moving forward as well as for the efficiency of the healthcare system. This session will discuss how it remains unclear as to how to accomplish this goal from a practical perspective.
Learning Objective : Describe the nature of FDA’s commitment to reduce the burden of REMS on the healthcare system and to provide an update on the design and standardization workstream; Discuss a REMS program that was successfully integrated into the clinical workflow; Identify policy options for integrating REMS into the healthcare system.
An Update on the FDA's Design and Standardization Workstream in Regard to Integrating REMS Into the Health Care System
FDA, United States
What Are the Factors That Faciilitate Integration Within the Health Care Delivery System: A Case Study of the Vandetanib Risk Minimization Program
Sarah A. Frise, PhD, MSc
Global Director Risk Management