Risk Evaluation and Mitigation Strategy (REMS)
Definition
A Risk Evaluation and Mitigation Strategy (REMS) is an FDA-required safety program for drugs with serious safety concerns that cannot be adequately managed through standard labeling. REMS programs impose specific requirements on manufacturers, distributors, prescribers, pharmacies, and patients to ensure that the benefits of the drug outweigh its risks.
In the 340B context, REMS programs are relevant because they can restrict how and where drugs are distributed and dispensed. Drugs with REMS programs may only be available through limited distribution networks, which can complicate 340B purchasing and dispensing arrangements. Contract pharmacies may not be able to participate in REMS programs, limiting the channels through which covered entities can dispense these drugs to eligible patients.
Covered entities that have patients who require REMS drugs should understand the specific distribution and dispensing requirements for each REMS program and ensure their 340B arrangements are compatible with those requirements.
Frequently Asked Questions
Why Risk Evaluation and Mitigation Strategy (REMS) Matters
REMS programs can limit the channels through which covered entities can access and dispense certain drugs, affecting their ability to realize 340B savings on high-cost specialty medications. Understanding REMS requirements is essential for managing specialty drug programs.
How Virtue 340B Uses It
Virtue 340B helps covered entities understand how REMS requirements interact with their 340B purchasing and dispensing arrangements, particularly for specialty drugs with significant savings potential.