Under the iPledge Risk Evaluation and Mitigation Strategy (REMS) for isotretinoin, what is the maximum number of refills authorized on a prescription?

Under the iPledge Risk Evaluation and Mitigation Strategy (REMS) for isotretinoin, the protocol is designed to manage the risks associated with the medication, particularly the risk of severe birth defects if taken during pregnancy. One of the key elements of iPledge is to ensure that patients are closely monitored throughout their treatment, which involves regular follow-ups and verification of the patient's eligibility to receive the medication.

Due to the stringent requirements and monitoring necessary with isotretinoin, prescriptions issued under this program are limited to a single fill, meaning no refills are allowed. This approach ensures that healthcare providers can reassess the patient's status and continue to educate them on the risks associated with isotretinoin before allowing them to obtain more of the medication. The limitation on refills is crucial for maintaining patient safety and timely interventions if any issues arise during treatment.

Consequently, the maximum number of refills authorized on a prescription for isotretinoin under the iPledge REMS is set at zero, compelling patients to return to their prescriber for a new prescription after the one-time fill, thus supporting ongoing management of the therapy and adherence to safety protocols.