What program is required for the dispensing of isotretinoin?

The program required for the dispensing of isotretinoin is iPledge. iPledge is a specialized risk management program mandated by the FDA for isotretinoin due to the serious risks associated with the medication, particularly the potential for severe birth defects if taken during pregnancy.

The iPledge program is designed to ensure that both healthcare providers and patients understand the risks and follow specific guidelines to mitigate them. It requires participation from prescribers, patients, and pharmacists, coordinating their responsibilities to ensure patients do not conceive while taking this medication.

For a patient to receive isotretinoin, they must be enrolled in the iPledge program, which includes pregnancy testing and the use of effective contraception to reduce the risk of teratogenic effects. The management framework instilled by iPledge is critical for the safe administration of isotretinoin and is a requirement that healthcare professionals must adhere to when dispensing this medication.