BCPS Regulatory Practice Test

REMS programs are required for drugs with serious safety concerns to ensure that benefits outweigh risks by controlling how the drug is prescribed, dispensed, and monitored. The thalidomide program, known as S.T.E.P.S., is a classic example. It creates a tightly controlled system with patient and prescriber registration, certification of prescribers and distributors, and strict requirements for contraception and pregnancy testing to prevent fetal exposure. This history and structure make it the best exemplification of a REMS beyond isotretinoin’s iPLEDGE. While other drugs may have risk-management strategies, the S.T.E.P.S. framework for thalidomide is one of the best-known, long-standing REMS models.