Thalomid REMS Program (formerly STEPS) requires what prior to dispensing EACH prescription?

• A. Negative pregnancy test required prior to dispensing EACH prescription
• B. Annual pregnancy test
• C. No pregnancy test required
• D. Only for women of childbearing age

Answer: (A)

Thalidomide’s severe birth-defect risk makes strict pregnancy screening essential. The REMS program requires a negative pregnancy test before dispensing each prescription to ensure there is no pregnancy at the time of dispensing, preventing fetal exposure with every use. An annual test wouldn’t catch a new pregnancy that could occur between renewals, and the requirement isn’t limited to a narrow group—it applies to any woman capable of pregnancy. So the correct requirement is a negative pregnancy test prior to every dispensing.