Pharmacy Technician Certification Exam Practice Question

Correct Answer: D

Rationale: A REMS (Risk Evaluation and Mitigation Strategy) program is designed to ensure that the benefits of a medication outweigh its risks, particularly when serious safety concerns arise. This may include elements like restricted distribution or patient monitoring.

MedWatch reports (A) are used for reporting adverse events but do not impose specific safety measures on manufacturers. Failure modes and effects analysis (B) is a proactive risk management tool used during product development, not a regulatory requirement. Root-cause analysis (C) investigates issues after they occur, rather than preventing them through regulatory measures. Thus, only a REMS program directly addresses serious safety concerns with mandated actions.