CSP REMS Programs and Risk Mitigation Strategies 2

Question 1

The TIRF REMS Access program applies to which class of medications?

Accepted Answer

Transmucosal immediate-release fentanyl products

Answer

Topical immunosuppressive fentanyl formulations

Answer

Timed-release intrathecal fentanyl devices

Answer

Transdermal intermediate-release fentanyl patches

Question 2

Under the clozapine REMS, absolute neutrophil count (ANC) monitoring is required because clozapine can cause which life-threatening condition?

Accepted Answer

Severe neutropenia (agranulocytosis)

Answer

Aplastic anemia

Answer

Thrombocytopenic purpura

Answer

Hemolytic anemia

Question 3

A patient enrolled in the mycophenolate (CellCept/Myfortic) REMS program must be counseled about which primary risk?

Accepted Answer

Teratogenicity and pregnancy loss

Answer

QT interval prolongation

Answer

Hepatic veno-occlusive disease

Answer

Serotonin syndrome

Question 4

Which REMS program was established specifically for thalidomide (Thalomid)?

Accepted Answer

S.T.E.P.S. (System for Thalidomide Education and Prescribing Safety)

Answer

T-SAFE (Thalidomide Safety and Fertility Education)

Answer

SUPPORT (Systematic Utilization Program for Pregnancy and Outcomes Reporting)

Answer

T-REMS (Thalidomide Risk Evaluation and Monitoring System)

Question 5

Under most REMS programs with ETASU, a specialty pharmacy may NOT dispense a REMS medication if which condition exists?

Accepted Answer

The prescriber is not enrolled in the REMS program

Answer

The patient has a prior authorization denial pending appeal

Answer

The prescription is written for a quantity exceeding a 90-day supply

Answer

The patient is currently hospitalized

Question 6

Which of the following REMS programs uses a shared system that combines multiple manufacturers' products under one program?

Accepted Answer

TIRF REMS Access

Answer

iPLEDGE

Answer

Clozapine REMS

Answer

S.T.E.P.S.

Question 7

In a REMS program that requires a Medication Guide, which party is responsible for distributing it to the patient?

Accepted Answer

The dispensing pharmacist or pharmacy

Answer

The prescribing physician

Answer

The drug manufacturer

Answer

The FDA MedWatch program