CSP REMS Programs and Risk Mitigation Strategies 2 — Questions and Answers
Question 1: The TIRF REMS Access program applies to which class of medications?
- Transmucosal immediate-release fentanyl products (Correct answer)
- Topical immunosuppressive fentanyl formulations
- Timed-release intrathecal fentanyl devices
- Transdermal intermediate-release fentanyl patches
Correct 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.
Question 2: Under the clozapine REMS, absolute neutrophil count (ANC) monitoring is required because clozapine can cause which life-threatening condition?
- Severe neutropenia (agranulocytosis) (Correct answer)
- Aplastic anemia
- Thrombocytopenic purpura
- Hemolytic anemia
Correct answer: Severe neutropenia (agranulocytosis)
Clozapine can cause severe neutropenia (agranulocytosis), which can be fatal; the REMS mandates ANC monitoring before dispensing each prescription.
Question 3: A patient enrolled in the mycophenolate (CellCept/Myfortic) REMS program must be counseled about which primary risk?
- Teratogenicity and pregnancy loss (Correct answer)
- QT interval prolongation
- Hepatic veno-occlusive disease
- Serotonin syndrome
Correct 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.
Question 4: Which REMS program was established specifically for thalidomide (Thalomid)?
- S.T.E.P.S. (System for Thalidomide Education and Prescribing Safety) (Correct answer)
- T-SAFE (Thalidomide Safety and Fertility Education)
- SUPPORT (Systematic Utilization Program for Pregnancy and Outcomes Reporting)
- T-REMS (Thalidomide Risk Evaluation and Monitoring System)
Correct 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.
Question 5: Under most REMS programs with ETASU, a specialty pharmacy may NOT dispense a REMS medication if which condition exists?
- The prescriber is not enrolled in the REMS program (Correct answer)
- The patient has a prior authorization denial pending appeal
- The prescription is written for a quantity exceeding a 90-day supply
- The patient is currently hospitalized
Correct 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.
Question 6: Which of the following REMS programs uses a shared system that combines multiple manufacturers' products under one program?
- TIRF REMS Access (Correct answer)
- iPLEDGE
- Clozapine REMS
- S.T.E.P.S.
Correct 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.
Question 7: In a REMS program that requires a Medication Guide, which party is responsible for distributing it to the patient?
- The dispensing pharmacist or pharmacy (Correct answer)
- The prescribing physician
- The drug manufacturer
- The FDA MedWatch program
Correct 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.
CSP REMS Programs and Risk Mitigation Strategies 2
The TIRF REMS Access program applies to which class of medications?