CSP REMS Programs and Risk Mitigation Strategies 3

Question 1

What is the primary consequence for a specialty pharmacy that dispenses a REMS-required medication without complying with REMS requirements?

Accepted Answer

The pharmacy may face FDA enforcement action, including warning letters, injunctions, or civil monetary penalties

Answer

Non-compliance with REMS requirements can subject a pharmacy to FDA enforcement actions including warning letters, injunctions, seizures, and civil monetary penalties.

Question 2

When a new REMS element is added to an existing REMS program, how should a specialty pharmacy respond?

Accepted Answer

Update internal SOPs and staff training to reflect the new requirements before continuing to dispense

Answer

Pharmacies must update their SOPs and train staff on any modifications to a REMS program before continuing to dispense, as new requirements are binding upon implementation.

Question 3

A specialty pharmacist is reviewing a prescription for lenalidomide (Revlimid). What REMS program governs its dispensing?

Accepted Answer

REVLIMID REMS (formerly RevAssist)

Answer

Lenalidomide is dispensed under the REVLIMID REMS (formerly RevAssist), which requires patient enrollment, pregnancy prevention for females, and confirmation of negative pregnancy tests before each dispense.

Question 4

Under iPLEDGE, how many forms of contraception must females of childbearing potential who are not abstinent use while taking isotretinoin?

Accepted Answer

Two forms of contraception simultaneously

Answer

iPLEDGE requires females of childbearing potential to use two simultaneous forms of contraception starting one month before, during, and one month after isotretinoin therapy.

Question 5

What is a key pharmacist responsibility related to REMS documentation in a specialty pharmacy setting?

Accepted Answer

Maintaining records of REMS-required patient counseling, monitoring data, and dispense confirmations for FDA audit purposes

Answer

Specialty pharmacies must maintain complete REMS-related records—including counseling documentation, monitoring data, and dispense confirmations—that demonstrate compliance and are available for FDA audits.

CSP - Certified Specialty Pharmacist Practice Test

CSP - Certified Specialty Pharmacist Practice Test

CSP REMS Programs and Risk Mitigation Strategies 3