Which statement best describes a Risk Evaluation and Mitigation Strategy (REMS)?

• A. A marketing plan required by the FDA.
• B. A drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits outweigh the risks.
• C. A training program for pharmacists about general drug safety.
• D. A labeling guideline for all medications.

Answer: (B)

REM S are FDA-required safety programs for certain medicines with serious safety concerns to ensure the benefits outweigh the risks. They’re not marketing plans, general pharmacist training, or universal labeling guidelines. REMS may include elements like restricted distribution, specialized prescriber or pharmacy training, and patient monitoring to manage risks. This description best fits how REMS function as a regulatory, risk-mitigation tool for high‑risk drugs.