Which REMS program is specifically used for thalidomide to prevent birth defects?

• A. S.T.E.P.S.
• B. REMS for Thalidomide
• C. ThaliCare Plan
• D. STEP-Thalidomide

Answer: (A)

Thalidomide’s serious teratogenic risk requires a tightly controlled approach to prevent fetal exposure, so a dedicated REMS program is used. The program specifically for thalidomide is S.T.E.P.S.— System for Thalidomide Education and Prescribing Safety. It ensures safety through prescriber and patient enrollment and certification, strict education requirements, and irreversible limits on how the drug is dispensed—restricted to certified pharmacies and approved distributors. Women of childbearing potential must use two forms of contraception and undergo regular pregnancy testing (typically monthly) before and during each dispensing, along with ongoing education and monitoring. These safeguards are unique to this thalidomide REMS and are not found in generic-sounding or misnamed options, which is why S.T.E.P.S. is the correct program.