Patients and prescribers must be enrolled in which program before using Accutane?

Enrollment in the iPledge program is a requirement for patients and prescribers before they can prescribe or use Accutane (isotretinoin). iPledge is a risk management program mandated by the FDA due to the potential severe teratogenic effects of isotretinoin, which can cause serious birth defects if taken during pregnancy. The program is designed to prevent fetal exposure to the drug by ensuring that patients understand the risks and adhere to specific precautions, such as using effective contraception while on the medication.

To participate in the iPledge program, patients must complete various requirements, including signing a consent form and undergoing regular pregnancy tests. Prescribers must also fulfill certain obligations, such as verifying the enrollment of their patients in the program and providing education on the risks associated with isotretinoin.

Altogether, iPledge functions as a safeguard aimed at minimizing the risk of harmful outcomes while allowing access to a medication that can be vital for treating severe acne. The other programs listed do not specifically relate to the regulation of isotretinoin usage, which underscores the importance of the iPledge program in ensuring safe and responsible prescribing practices.