Which statement best describes Thalidomide REMS?

• A. Maximum 60 DS, with auto refills
• B. Maximum 28 DS, auto refills allowed
• C. Maximum 12 DS, auto refills allowed
• D. Maximum 28 DS, no auto refills

Answer: (D)

Thalidomide REMS is designed to tightly control how the drug is dispensed because of its birth defect risk. The program requires a limited quantity per prescription and prohibits auto-refills to ensure ongoing safety checks each cycle. The standard arrangement is a 28-day supply per prescription with no auto-refills, so that every refill prompts re-evaluation of pregnancy status, use of contraception, and adherence to REMS requirements. This is why the statement describing a 28-day supply with no auto-refills is the best match. Options suggesting a longer supply or allowing auto-refills would undermine the necessary safeguards, and a shorter or nonstandard quantity wouldn’t align with the established REMS protocol.