REMS

Also known as: Risk Evaluation and Mitigation Strategy

An FDA-required safety plan for drugs with significant risks (e.g. teratogenicity, addiction).

Definition

A Risk Evaluation and Mitigation Strategy is an FDA-required risk-management programme imposed on drugs with serious safety risks. REMS elements can include medication guides, communication plans, restricted distribution (e.g. iPLEDGE for isotretinoin, TIRF REMS for transmucosal fentanyl), and prescriber/patient/pharmacy enrollment requirements.

See also

• Boxed warning — The strongest FDA warning, displayed in a black border at the top of a drug label.
• Adverse event — Any untoward medical occurrence in a patient receiving a drug, regardless of causality.

Other safety terms

• Drug interaction
• Adverse event
• Boxed warning
• FAERS
• PV