PTCB Certified Pharmacy Technician (PTCE)Federal RequirementsEasy
A pharmacy technician is assisting a patient who is picking up a prescription for isotretinoin. The technician knows this medication requires specific monitoring and dispensing restrictions due to severe potential side effects, particularly concerning pregnancy. Which federal program is designed to manage such risks?
- AMedWatch Program
- BNational Drug Code (NDC) System
- CDrug Utilization Review (DUR) Program
- DRisk Evaluation and Mitigation Strategy (REMS)
Show answer & explanationAnswer & explanation
Correct answer: D. Risk Evaluation and Mitigation Strategy (REMS)
REMS programs are mandated by the FDA for certain medications with serious safety concerns to ensure that the benefits of the drug outweigh its risks.
Why the other options are wrong
- A. MedWatch is an FDA program for voluntary reporting of adverse events, not a risk management strategy itself.
- B. NDC is a unique product identifier for drugs, unrelated to risk management programs.
- C. DUR programs review prescribing patterns and patient drug regimens for safety and efficacy, but are not specific drug-risk management programs.
REMS Program
Risk Evaluation and Mitigation Strategy (REMS) is an FDA-mandated program to ensure that the benefits of certain drugs with serious safety concerns outweigh their risks.
- Required for drugs with significant potential for adverse effects (e.g., teratogenicity).
- May include elements like patient registries, specific training for prescribers/pharmacies, and patient counseling.
- Isotretinoin (for severe acne) is a well-known example.
Memory trick: Risk Evaluation Mitigates Serious (drug) harm.