PTCB Certified Pharmacy Technician (PTCE)Federal RequirementsMedium
A pharmacy technician is tasked with stocking a new shipment of medications. One of the medications is mifepristone, which is subject to a Risk Evaluation and Mitigation Strategy (REMS) program. Which of the following is a key characteristic of a REMS program?
- AIt limits the sale of certain OTC medications to specific quantities per transaction.
- BIt categorizes medications into schedules based on their abuse potential.
- CIt requires specific training or certifications for prescribers and/or dispensers.
- DIt mandates a minimum of 6 months validity for all prescriptions.
Show answer & explanationAnswer & explanation
Correct answer: C. It requires specific training or certifications for prescribers and/or dispensers.
REMS programs are FDA-mandated strategies to manage serious risks associated with certain medications and often include requirements for healthcare providers, such as specialized training or certification, and patient-specific elements like enrollment or monitoring.
Why the other options are wrong
- A. This describes pseudoephedrine sales limits, not a general characteristic of REMS programs.
- B. This describes the scheduling of controlled substances, not REMS programs.
- D. Prescription validity periods are not a characteristic of REMS programs, but rather federal/state laws.
REMS Program Characteristics
Risk Evaluation and Mitigation Strategy (REMS) programs are FDA requirements for certain medications with serious safety concerns, ensuring that the benefits outweigh the risks.
- FDA-mandated.
- Designed to mitigate serious risks.
- Can include Medication Guides, communication plans, ETASU (Elements to Assure Safe Use).
- ETASU often involve prescriber/dispenser training or patient monitoring.
Memory trick: REMS: Risk Education Means Safety.