REMS (Risk Evaluation and Mitigation Strategies) are drug safety programs that the FDA (Food and Drug Administration) can require for certain medications with potential for serious adverse side effects to help ensure the benefits of the medication outweigh its risks. REMS allows the prescribing of drugs that otherwise would not be available because of safety issues. Only a few drugs require REMS. REMS required actions vary with each drug or drug class (e.g., opioid).
FDA is championing and actively exploring innovative technologies to facilitate the completion of REMS requirements within the prescribers and pharmacists’ workflows. Under the auspices of the public HL7 CodeX FHIR Accelerator Community and through the REMS Integration Use Case, FDA is supporting the use of standardized application programming interfaces (APIs), like the open source and freely available HL7® FHIR® APIs, with pharmacy data standards, i.e., National Council for Prescription Drug Programs (NCPDP) SCRIPT, to integrate REMS into prescriber and pharmacy workflows. The use case ultimately aims to reduce REMS implementation burden, improve the quality of REMS data for feedback and evaluation, and optimize safe medication use and health outcomes.
For more background information about REMS, please see the following resources:
- Risk Evaluation and Mitigation Strategies | REMS | FDA
- Approved Risk Evaluation and Mitigation Strategies (REMS) (fda.gov)
- FDA REMS Public Dashboard
REMS Workflow Diagram