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

Metformin

Answer

Lisinopril

Answer

Atorvastatin

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

One form of contraception; no pregnancy test required

Answer

No contraception required if patient is unmarried

Answer

One form of contraception; one pregnancy test before starting only

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

Dietary Supplement Health and Education Act (DSHEA)

Answer

Controlled Substances Act (CSA)

Answer

Prescription Drug Marketing Act (PDMA)

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

To advertise the drug's benefits to prescribers

Answer

To notify patients about drug pricing and coverage

Answer

To update a drug's FDA-approved labeling

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

Only when specifically requested by the patient

Answer

Only for the first dispensing of a new prescription

Answer

Only when the prescriber includes a written request

Question 6

Which of the following is an example of an ETASU (Elements to Assure Safe Use) requirement within a REMS program?

Accepted Answer

Requiring pharmacies to be specially certified before dispensing the drug

Answer

Including the standard FDA package insert in the drug packaging

Answer

Sending a one-time Dear Healthcare Provider letter

Answer

Creating a public website with general drug information