New restrictions on Accutane
Beginning next year, Accutane (isotretinoin, Roche) prescriptions must bear a special yellow sticker attached by the physician or the pharmacist should refuse to fill them. The stickers are part of the latest risk management plan by the Food & Drug Administration and Roche Laboratories to prevent fetal exposure to Accutane.
Brochures and letters about the new SMART (System to Manage Accutane-Related Teratogenicity) programeach designed for a specific audiencewill be sent to R.Ph.s, primary care physicians and dermatologists, and patients in January. SMART, developed by Roche and the FDA, is supposed to enhance the existing pregnancy prevention program. Both have the same goals: No woman should start taking Accutane if she is pregnant, and no woman should get pregnant while taking the drug.
While the drug is a highly effective treatment for severe recalcitrant nodular acne, it also is a potent human teratogen. The risks of birth defects and fetal death have been known since the drug's introduction in 1982, and pregnancy prevention education programs have been required by the FDA since 1988. Warnings about the risk of depression, suicide, and other psychiatric events have been repeatedly strengthened over the years. Accutane now is one of the few drugs to require a Medication Guide and two patient information/consent forms.
Physicians who want to prescribe Accutane next year must study Roche's "Guide to Best Practices" and then sign a "letter of understanding" to Roche, certifying their knowledge of the pregnancy prevention rules. Those include two negative urine or serum pregnancy tests before an Rx is written and the use of two effective forms of contraception for females who are or may become sexually active.
Registered prescribers then will get the yellow, self-adhesive Accutane Qualification Stickers from Roche to attach to the regular prescription form. "This sticker indicates ... the patient is 'qualified' according to the new package insert, which means that the female patient has had negative pregnancy tests ... as well as education and counseling about pregnancy prevention," the FDA said. The pregnancy test will be repeated monthly throughout the treatment course, and Rxs will be limited to a one-month supply at a time.
In addition, R.Ph.s must fill Rxs within seven days of the date written on the qualification sticker, and no refills or phoned-in Rxs are authorized.
"This is a very reasonable, safe, efficient, practical way for handling additional patient safety concerns," said Edward Staffa, director of pharmacy practice and communications for the National Association of Chain Drug Stores, which worked on concepts of the program with Roche and the FDA.
Mike Conlan. No sticker on prescription, no dispensing of Accutane.