Medication Guides may be required as part of REMS.

• A. Medication Guides may be required as part of REMS.
• B. All Medication Guides are included as part of REMS.
• C. Medication Guides are never part of REMS.
• D. Medication Guides replace REMS entirely.

Answer: (A)

Medication Guides may be required as part of REMS. REMS, or Risk Evaluation and Mitigation Strategy, is a FDA-directed plan for managing serious safety concerns with certain drugs. Some REMS programs include a Medication Guide—a patient-facing document that explains a drug’s risks and how to use it safely—to help patients understand important safety information at the point of dispensing or use. But not all Medication Guides are tied to REMS, and not every REMS requires a Medication Guide; REMS can include other elements like communication plans, training, or monitoring systems. So, saying that Medication Guides may be required as part of REMS is accurate.