REMS
Pronunciation: REMZ
Also written as: REMS — Risk Evaluation and Mitigation Strategies
Risk Evaluation and Mitigation Strategies required by FDA for certain addiction medications with abuse potential.
Full Definition
Risk Evaluation and Mitigation Strategies (REMS) are regulatory requirements imposed by the FDA on specific medications used in addiction treatment that have significant safety concerns or abuse potential. REMS programs may include elements such as medication guides, communication plans for healthcare providers, elements to assure safe use (ETASU), and implementation systems. For addiction medicine, REMS commonly apply to opioid analgesics and certain addiction treatment medications. Healthcare providers must comply with REMS requirements, and documentation must reflect adherence to these safety protocols.
Usage
Usage note: Always use as acronym in clinical documentation; spell out on first use in educational materials.
In Context
- "The prescriber completed all required REMS training before initiating the new opioid formulation." — Provider credentialing documentation
- "Patient counseling documentation must reflect compliance with REMS communication requirements." — Quality assurance review