Challenges and Opportunities for REMS Integration, Innovation, and Modernization

Background

The U.S. Food and Drug Administration (FDA) requires Risk Evaluation and Mitigation Strategies (REMS) for certain medications to ensure that the benefits of the medication outweigh the risks. A REMS is a drug safety program designed to reinforce medication use behaviors and actions that support the safe use of that medication.  REMS requirements can be burdensome for prescribers, pharmacists, and patients. Completion of REMS requirements is often done outside of standard clinical workflows (in some cases manual processes are used), which can be costly and time-consuming for stakeholders and can create delays or barriers to medication access for patients. In addition, each REMS program is slightly different and not standardized, which makes it difficult to exchange information across REMS systems, electronic health records, and pharmacy management systems for REMS implementation and evaluation.

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. 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.  This in turn could improve REMS program design, creating a learning REMS ecosystem.

Workshop Description

On October 11, 2022, the Duke-Margolis Center for Health Policy and FDA will be hosting a virtual public workshop to solicit feedback from key stakeholders on the REMS integration prototype. 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 that focus on how the prototype can address challenges associated with integrating REMS requirements into clinical workflows to facilitate safe medication use.