Risk Evaluation and Mitigation Strategies (REMS) programs
Risk Evaluation and Mitigation Strategies (REMS) programs are used by the FDA and drug manufacturers to help monitor medication safety during postmarketing. REMS programs may be mandated by FDA as a requirement of marketing. Specific requirements of individual REMS programs vary, and may include distribution of Patient Medication Guides, risk management programs for monitoring and responding to specific adverse effects, or restricted distribution programs. Information about REMS programs is available from several sources, including:
- FDA List of Approved REMS programs
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ ucm111350.htm - Federal Register
http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-6201.pdf - ASHP Risk Evaluation and Mitigation Strategies Resource Center
http://www.ashp.org/REMS - Society for Hospital Medicine / ASHP REMS education initiative
http://www.remsupdates.org/
