Accutane pregnancy prevention rules revised. (Negative Pregnancy Test Mandatory).

The risk management program to prevent Accutane-exposed pregnancies has been revised.

Announced in October and effective this month, SMART (System to Manage Accutane-Related Teratogenicity) is designed to enhance the safe and appropriate use of Accutane by strengthening the existing pregnancy prevention program, according to the Food and Drug Administration and Roche Pharmaceuticals, the drug's manufacturer. (See box.)

Although the system does add minor administrative hassles, for the most part, these efforts are what physicians "should have been doing all along," said Dr. David M. Pariser, chief of dermatology at Eastern Virginia Medical School, Norfolk.

Mandatory physician, patient, and pharmacy registries could be implemented if SMART does not live up to expectations, the FDA warned.

The SMART program was developed to address two main goals set forth at a September 2000 meeting of the FDA's advisory panel on dermatologic drugs:

* No woman should start Accutane if she is pregnant.

* No woman should become pregnant during Accutane therapy