Drug Recalls, Adverse Event Reporting, and Risk Management Flashcards
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Which drug requires enrollment in the iPLEDGE REMS program due to severe teratogenicity risks?
Answer: Isotretinoin
Isotretinoin requires the iPLEDGE REMS program because it is highly teratogenic and can cause severe birth defects if taken during pregnancy.
Under the iPLEDGE REMS program, females of childbearing potential must use how many forms of contraception and obtain monthly pregnancy tests for how long before receiving isotretinoin?
Answer: Two forms of contraception; monthly negative pregnancy tests required throughout therapy
iPLEDGE requires females of childbearing potential to use two forms of contraception simultaneously and obtain a negative pregnancy test each month before a prescription can be dispensed.
Under which federal legal authority did the FDA gain explicit power to require a REMS program for a drug?
Answer: FDCA Section 505-1, added by the FDA Amendments Act of 2007 (FDAAA)
FDCA Section 505-1, added by FDAAA 2007, explicitly grants the FDA authority to require a REMS when necessary to ensure a drug's benefits outweigh its risks.
Which of the following best describes the purpose of a REMS Communication Plan element?
Answer: To inform healthcare providers about serious drug risks and safe-use requirements
A REMS Communication Plan is designed to inform healthcare providers—such as physicians and pharmacists—about a drug's serious risks and the steps required for safe use.
A pharmacist dispensing a drug with a REMS Medication Guide requirement must provide the Medication Guide at which point?
Answer: Each time the drug is dispensed, including refills
FDA regulations require that a Medication Guide be dispensed with every fill of the applicable drug, including refills, to ensure patients have consistent access to safety information.
Which of the following is an example of an ETASU (Elements to Assure Safe Use) requirement within a REMS program?
Answer: Requiring pharmacies to be specially certified before dispensing the drug
ETASU can require pharmacies to be specially certified, patients to be enrolled in registries, and providers to complete special training before the drug may be prescribed or dispensed.