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How does the iPLEDGE program work?

The iPLEDGE system automatically checks patient qualification criteria for you. Prescriptions will be authorized only for those patients who meet all criteria. Additional fills for the prescription to achieve the desired dosage can be entered by the pharmacist immediately after the prescription is authorized.

Why was iPLEDGE created?

The iPLEDGE Program was instituted as a replacement for the failed SMART program (System to Manage Related Teratogenicity). Instituted in April 2002, SMART aimed to eliminate -induced birth defects by preventing exposure to the drug during pregnancy.

What happens if I miss my iPLEDGE window?

If you missed the window during your first month of treatment, you will need to wait another 19 days before the iPledge system will allow us to enter another negative pregnancy test.

What is the purpose of iPLEDGE?

The iPLEDGE Program was originally implemented in early 2005 and approved as the iPLEDGE REMS in 2010. The goals of the iPLEDGE REMS are to prevent fetal exposure to and to inform prescribers, pharmacists, and patients about isotretinoins serious risks and safe-use conditions.

Does iPLEDGE collect information on pregnancies?

The iPLEDGE REMS is a, shared (includes multiple manufacturers) Risk Evaluation and Mitigation Strategy (REMS) with requirements for prescribers, pharmacies, patients, and wholesalers. The iPLEDGE REMS also includes a pregnancy registry for patients who get pregnant.

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