REMS Programs and Risk Mitigation Strategies Flashcards
7 cards from real CSP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 REMS Programs and Risk Mitigation Strategies flashcards as text
The TIRF REMS Access program applies to which class of medications?
Answer: Transmucosal immediate-release fentanyl products
TIRF REMS Access covers transmucosal immediate-release fentanyl products (e.g., lozenges, buccal films, nasal sprays) due to serious risk of misuse, abuse, and fatal overdose.
Under the clozapine REMS, absolute neutrophil count (ANC) monitoring is required because clozapine can cause which life-threatening condition?
Answer: Severe neutropenia (agranulocytosis)
Clozapine can cause severe neutropenia (agranulocytosis), which can be fatal; the REMS mandates ANC monitoring before dispensing each prescription.
A patient enrolled in the mycophenolate (CellCept/Myfortic) REMS program must be counseled about which primary risk?
Answer: Teratogenicity and pregnancy loss
The mycophenolate REMS focuses on teratogenicity; the drug causes pregnancy loss and congenital malformations, requiring females to use contraception and avoid pregnancy.
Which REMS program was established specifically for thalidomide (Thalomid)?
Answer: S.T.E.P.S. (System for Thalidomide Education and Prescribing Safety)
The S.T.E.P.S. program was created for thalidomide due to its severe teratogenicity (historically causing phocomelia) and requires strict pregnancy prevention measures.
Under most REMS programs with ETASU, a specialty pharmacy may NOT dispense a REMS medication if which condition exists?
Answer: The prescriber is not enrolled in the REMS program
If a REMS program requires prescriber certification, a pharmacy cannot legally dispense the medication unless the prescriber is enrolled and authorized under that REMS.
Which of the following REMS programs uses a shared system that combines multiple manufacturers' products under one program?
Answer: TIRF REMS Access
TIRF REMS Access is a shared REMS system that covers multiple manufacturers' transmucosal immediate-release fentanyl products under a single unified program.
In a REMS program that requires a Medication Guide, which party is responsible for distributing it to the patient?
Answer: The dispensing pharmacist or pharmacy
The dispensing pharmacist or pharmacy is responsible for providing the FDA-approved Medication Guide to patients each time a REMS medication is dispensed.