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

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?

Accepted Answer

Severe neutropenia (agranulocytosis)

Answer

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?

Accepted Answer

Teratogenicity and pregnancy loss

Answer

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)?

Accepted Answer

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

Answer

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?

Accepted Answer

The prescriber is not enrolled in the REMS program

Answer

If a REMS program requires prescriber certification, a pharmacy cannot legally dispense the medication unless the prescriber is enrolled and authorized under that REMS.

CSP - Certified Specialty Pharmacist Practice Test

CSP - Certified Specialty Pharmacist Practice Test

CSP REMS Programs and Risk Mitigation Strategies 2