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: