Females prescribed Accutane must have what

• A. Two negative pregnancy tests before starting
• B. Must use two forms of contraception
• C. Enroll in a risk management program to ensure these are followed
• D. All of the above

Answer: (D)

Isotretinoin is highly teratogenic, so strict safety measures are required for females of reproductive potential. Because the risk of birth defects is so great, there is a risk management program that all patients must enter to ensure pregnancy prevention and monitoring. Specifically, before starting isotretinoin, there must be two negative pregnancy tests, and during treatment, two forms of contraception must be used. Enrollment in the risk management program ensures ongoing education, verification of compliance, and regular pregnancy testing. Because all of these steps are required to prevent fetal harm, the correct answer is that all of the above.