What is the name of the REMS program associated with thalidomide?

• A. IPLEDGE
• B. STEPS
• C. REMS
• D. ThalSafe

Answer: (B)

Thalidomide’s use is tightly controlled because of its high risk of birth defects, so its safety framework is a specific REMS designed for this drug. That program is STEPS, the System for Thalidomide Education and Prescription Safety. It requires everyone involved—prescribers, pharmacies, and patients—to be enrolled and to follow strict safeguards. These safeguards include ensuring appropriate patient eligibility, mandatory pregnancy testing for women of childbearing potential, and the use of effective contraception to prevent pregnancy during treatment, along with thorough counseling on risks. IPLEDGE is the REMS for isotretinoin, not thalidomide, and REMS is the general term for these programs, not a specific name. ThalSafe isn’t the official program. So STEPS is the correct name.