Risk Evaluation and Mitigation Strategies (REMS)areFDA-required programsto ensure that thebenefits of certain medications outweigh their risks. REMS programsrestrict prescribing, dispensing, and monitoringdue to the potential for serious side effects or misuse.
Suboxoneis used foropioid dependenceand containsbuprenorphine, apartial opioid agonist, which can causeaddiction, misuse, and respiratory depressionif used improperly.
REMS Requirements for Suboxone:
Prescriber Certification:Only specially certified providers can prescribe Suboxone.
Patient Education:Patients must be informed about the risks of misuse, overdose, and dependence.
Limited Dispensing:Pharmacists must ensure prescriptions meet REMS criteria before dispensing.
A. Xarelto (Rivaroxaban).→ Incorrect. While Xarelto is an anticoagulant, it isnot under REMS.
C. Warfarin.→ Incorrect. Warfarin requires monitoring butdoes not have a REMS program.
D. Haloperidol.→ Incorrect. Haloperidol is an antipsychotic, but itdoes not have a REMS program.
FDA REMS Program List (www.accessdata.fda.gov).
Suboxone REMS Guidelines (www.suboxonerems.com).
PTCB PTCE Exam Content Outline – REMS and Medication Safety.
Mosby’s Pharmacy Technician: Principles and Practice – REMS Regulations.
Why Is Suboxone (Buprenorphine/Naloxone) Under REMS?Why the Other Answer Choices Are Incorrect:Pharmacy Technician References:
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