What is REMS?

• A. A drug safety program required by the FDA for certain medications to ensure benefits outweigh risks
• B. A general labeling requirement for all medications
• C. A marketing plan to promote high-risk drugs
• D. A penalty system for unsafe drugs

Answer: (A)

REM stands for risk evaluation and mitigation strategy, a drug safety program the FDA requires for certain medications when their risks are significant. The goal is to ensure that the drug’s benefits outweigh its risks by adding safety measures beyond ordinary labeling. These measures can include restricted distribution, required education and certification for prescribers, patient enrollment, and ongoing safety monitoring. It’s not a general labeling rule for all drugs, not a marketing plan, and not a penalty system. In practice, you’ll encounter REMS with specific medicines, and you may need to verify that the patient has received required education or that the dispensing pharmacy is authorized to handle the drug.