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The U.S. Food and Drug Administration (FDA) and Duke-Margolis are collaborating to host a virtual public workshop to solicit feedback from key stakeholders on a Risk Evaluation and Mitigation Strategies (REMS) integration prototype. A REMS is a drug safety program designed to reinforce medication use behaviors and actions that support the safe use of that medication. The FDA requires REMS for certain medications to ensure that the benefits of the medication outweigh the risks.

The FDA, under a contract with the MITRE Corporation and with stakeholders through an open community under the health data standards development organization Health Level Seven (HL7), is working to reduce the burden of REMS implementation and optimize patient outcomes by integrating REMS into prescribers’ and pharmacists’ clinical workflows. By using contemporary health data standards, prescribers and pharmacists could complete REMS requirements without having to go outside of their workflows, and many steps could be automated, increasing efficiency of implementation and reducing burden of these programs. The FDA has supported the development of a proof-of-concept prototype that will allow certain REMS activities to be integrated into standard health information technologies. Such REMS integration could not only reduce burden but also promote timely and safe medication access for patients and improve data quality to optimize timely feedback on patient outcomes, enabling more robust REMS program evaluations.

During this workshop, speakers from FDA and MITRE will provide an overview of the prototype’s aims, core functions, and role in FDA’s ongoing efforts to modernize REMS. Patients, prescribers, pharmacists, health system representatives, informaticists, and other key stakeholders will participate in a series of moderated panel discussions focusing on how the prototype can address challenges associated with integrating REMS requirements into clinical workflows to facilitate safe medication use.

Funding for this workshop was made possible in part by a cooperative agreement from the U.S. Food and Drug Administration Center for Drug Evaluation and Research. The views expressed in written workshop materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services nor does mention of trade names, commercial practices, or organizations imply endorsements by the U.S. Government.