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
What is the primary consequence for a specialty pharmacy that dispenses a REMS-required medication without complying with REMS requirements?
Answer: The pharmacy may face FDA enforcement action, including warning letters, injunctions, or civil monetary penalties
Non-compliance with REMS requirements can subject a pharmacy to FDA enforcement actions including warning letters, injunctions, seizures, and civil monetary penalties.
When a new REMS element is added to an existing REMS program, how should a specialty pharmacy respond?
Answer: Update internal SOPs and staff training to reflect the new requirements before continuing to dispense
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.
A specialty pharmacist is reviewing a prescription for lenalidomide (Revlimid). What REMS program governs its dispensing?
Answer: REVLIMID REMS (formerly RevAssist)
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.
Under iPLEDGE, how many forms of contraception must females of childbearing potential who are not abstinent use while taking isotretinoin?
Answer: Two forms of contraception simultaneously
iPLEDGE requires females of childbearing potential to use two simultaneous forms of contraception starting one month before, during, and one month after isotretinoin therapy.
What is a key pharmacist responsibility related to REMS documentation in a specialty pharmacy setting?
Answer: Maintaining records of REMS-required patient counseling, monitoring data, and dispense confirmations for FDA audit purposes
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.
Which term describes a REMS requirement that restricts dispensing to only specially certified pharmacies?
Answer: Restricted distribution system
A restricted distribution system is an ETASU element that limits dispensing to certified specialty pharmacies, preventing dispensing at retail or non-enrolled outlets.
A patient calls the specialty pharmacy saying they cannot afford the required pregnancy test before their next REMS medication refill. What is the pharmacist's most appropriate response?
Answer: Assist the patient in finding low-cost or free testing resources and explain the prescription cannot be dispensed without a confirmed negative test
REMS pregnancy testing requirements are mandatory and cannot be waived; the pharmacist must help the patient access resources while withholding the medication until the test is completed.