REMS Programs and Risk Mitigation Strategies Flashcards
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What does REMS stand for in the context of the FDA?
Answer: Risk Evaluation and Mitigation Strategy
REMS stands for Risk Evaluation and Mitigation Strategy, which are FDA-required programs to ensure certain drugs with serious safety risks are used appropriately.
Under which federal law did the FDA gain formal authority to require REMS programs?
Answer: Food and Drug Administration Amendments Act (FDAAA) of 2007
The FDAAA of 2007 granted the FDA explicit statutory authority to require REMS when necessary to ensure benefits of a drug outweigh its risks.
Which of the following is a required component of ALL REMS programs?
Answer: Timetable for submission of REMS assessments
A timetable for submission of REMS assessments to the FDA is required in every REMS program; all other elements are optional and included only when needed.
What are ETASU in the context of REMS programs?
Answer: Elements to Assure Safe Use
ETASU (Elements to Assure Safe Use) are the most restrictive REMS components that can include requirements such as prescriber certification, pharmacy certification, and patient monitoring.
Which specialty pharmacy action is required when a REMS program with ETASU mandates pharmacist certification?
Answer: The pharmacy must enroll in the REMS program before dispensing the medication
When ETASU require pharmacy certification, the specialty pharmacy must formally enroll in the specific REMS program before it is authorized to dispense that medication.
Which of the following medications is managed under the iPLEDGE REMS program?
Answer: Isotretinoin
Isotretinoin is managed under iPLEDGE due to its severe teratogenicity; the program requires pregnancy testing, contraception, and monthly confirmations for females of childbearing potential.
How frequently must a REMS sponsor typically submit the first REMS assessment to the FDA after approval?
Answer: At 18 months, 3 years, and 7 years after approval
The standard REMS assessment timetable requires submissions at 18 months, 3 years, and 7 years after approval, unless the FDA specifies otherwise.