MPJE Drug Recalls, Adverse Event Reporting, and Risk Management 3

Question 1

Which drug requires enrollment in the iPLEDGE REMS program due to severe teratogenicity risks?

Accepted Answer

Isotretinoin

Answer

Isotretinoin requires the iPLEDGE REMS program because it is highly teratogenic and can cause severe birth defects if taken during pregnancy.

Question 2

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?

Accepted Answer

Two forms of contraception; monthly negative pregnancy tests required throughout therapy

Answer

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.

Question 3

Under which federal legal authority did the FDA gain explicit power to require a REMS program for a drug?

Accepted Answer

FDCA Section 505-1, added by the FDA Amendments Act of 2007 (FDAAA)

Answer

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.

Question 4

Which of the following best describes the purpose of a REMS Communication Plan element?

Accepted Answer

To inform healthcare providers about serious drug risks and safe-use requirements

Answer

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.

Question 5

A pharmacist dispensing a drug with a REMS Medication Guide requirement must provide the Medication Guide at which point?

Accepted Answer

Each time the drug is dispensed, including refills

Answer

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.

MPJE - Multistate Pharmacy Jurisprudence Examination Practice Test

MPJE - Multistate Pharmacy Jurisprudence Examination Practice Test

MPJE Drug Recalls, Adverse Event Reporting, and Risk Management 3