Risk Evaluation and Mitigation Strategy (REMS)
An FDA-required safety programme for drugs with known serious risks, ensuring benefits outweigh risks. REMS range from medication guides to restricted distribution systems with prescriber certification and patient registries. Some peptide drugs with significant safety concerns have REMS programmes.
Technical Context
REMS categories (escalating restrictiveness): Medication Guide (patient-directed information dispensed with each fill — simplest REMS), Communication Plan (materials to educate healthcare providers about serious risks), and Elements to Assure Safe Use (ETASU — the most restrictive, may include: prescriber certification, pharmacy certification, dispensing only in specific healthcare settings, patient monitoring requirements, and patient registries). REMS are required when the FDA determines that a drug's benefits outweigh risks only if certain risk mitigation measures are in place. REMS assessments are submitted periodically to the FDA evaluating whether the programme is meeting its goals. The FDA can modify or remove REMS requirements based on these assessments. Shared REMS (covering multiple products in a class) can reduce administrative burden on healthcare providers and pharmacies.