CPGP · Question #479
What does REMS stand for in pharmaceutical surveillance? Response:
The correct answer is B. Risk Evaluation and Mitigation Strategy. REMS stands for Risk Evaluation and Mitigation Strategy (B), a program required by the FDA when a drug's benefits only outweigh its risks if specific safety measures are in place - think thalidomide or isotretinoin programs. Why the distractors fail: A swaps "Mitigation" for…
Question
What does REMS stand for in pharmaceutical surveillance? Response:
Options
- ARisk Evaluation and Management Strategy
- BRisk Evaluation and Mitigation Strategy
- CRegulatory Evaluation and Management Scheme
- DRegulatory Evaluation and Mitigation Scheme
How the community answered
(66 responses)- A11% (7)
- B82% (54)
- C3% (2)
- D5% (3)
Explanation
REMS stands for Risk Evaluation and Mitigation Strategy (B), a program required by the FDA when a drug's benefits only outweigh its risks if specific safety measures are in place - think thalidomide or isotretinoin programs.
Why the distractors fail:
- A swaps "Mitigation" for "Management" - REMS is specifically about mitigating risk, not generically managing it.
- C & D replace "Risk" with "Regulatory" - REMS is centered on the risk profile of the drug itself, not a regulatory process category.
Memory tip: Think M for Mitigation = M for Medicine - REMS exists to mitigate the danger of a high-risk medicine before it reaches patients.
Community Discussion
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