PTCB Certified Pharmacy Technician (PTCE)MedicationsMedium
A pharmacy technician is entering a new prescription for 'isotretinoin 40 mg, take 1 capsule by mouth daily'. The patient is a female of childbearing potential. Which of the following is a mandatory requirement that the technician should be aware of for dispensing this medication?
- AThe patient must use a single form of birth control for the duration of treatment.
- BThe patient must be enrolled in the iPLEDGE program and have two negative pregnancy tests.
- CThe patient must agree to monthly blood tests to monitor for liver function abnormalities.
- DThe patient must have a documented history of severe acne for at least 5 years.
Show answer & explanationAnswer & explanation
Correct answer: B. The patient must be enrolled in the iPLEDGE program and have two negative pregnancy tests.
Isotretinoin is a potent teratogen, meaning it can cause severe birth defects. The iPLEDGE program is a mandatory risk management program designed to prevent fetal exposure to isotretinoin. For females of childbearing potential, this includes enrollment in the program, two negative pregnancy tests prior to starting treatment, and using two forms of contraception.
Why the other options are wrong
- A. Two forms of contraception are required, not just one, for females of childbearing potential.
- C. Monthly blood tests for liver function are common but not a dispensing prerequisite like iPLEDGE.
- D. While used for severe acne, a 5-year history is not a mandatory dispensing requirement.
Isotretinoin (iPLEDGE)
A severe acne medication with significant teratogenic risk, requiring strict adherence to the iPLEDGE risk management program.
- Mandatory for all patients, prescribers, pharmacies, and wholesalers.
- Females of childbearing potential need two negative pregnancy tests and two forms of contraception.
- Medication must be dispensed within 7 days of the pregnancy test.
Memory trick: iPLEDGE: Prevent Pregnancy, Protect Patients