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New Requirement to Dispense Accutane

Pregnancy Prevention Program for Women on Accutane enhanced.

New Requirement to Dispense Accutane
Teresa Clement,
B.S. Candidate, University of Cincinnati, and OPA extern

Roche, the manufacturer of Accutane® (isotretinoin), has enhanced the Pregnancy Prevention Program for Women on Accutane with a new program called System to Manage Accutane Related Teratogenicity (SMARTTM). Accutane is an effective treatment for severe recalcitrant nodular (cystic) acne that has not responded to other therapies. Accutane is teratogenic; therefore SMART is designed to ensure that female patients are not pregnant while taking this medication.

Prescribing physicians are required to enroll in the SMART program. Upon agreement to the terms, they will receive yellow Accutane Qualification Stickers. As of April 10, 2002, only prescriptions with the yellow stickers will be in compliance with the product label. The prescription must be filled within seven days of the qualification date on the sticker. Therefore, telephone or computerized Accutane prescriptions are invalid. Refills require a new prescription with the yellow Accutane Qualification Sticker attached, and no more than a 30-day supply can be dispensed at a time. Also, included with the product label, pharmacists must provide a copy of the Accutane Medication Guide to all patients with each prescription.

For the female patient to receive her first Accutane prescription, she must:
1. have two negative pregnancy tests - the first as a screening test and the second as a confirmatory test that will be administered during the first five days of her next menstrual period;
2. select and commit to using two effective forms of birth control simultaneously one month prior to treatment, during treatment, and for one month after stopping treatment;
3. read and sign an informed consent agreement explaining the risk of potential birth defects associated with Accutane;
4. learn about and be encouraged to enroll in the Accutane Survey, a system to track female Accutane patients, learn about their experiences with pregnancy prevention efforts and determine their pregnancy status.

For each of the following months of therapy, the female patient must have a negative pregnancy test and receive contraception counseling from the physician.

Male patients must also sign consent agreements and have a yellow Accutane Qualification Sticker attached to their Accutane prescription.
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