Accutane

VICTORIA, B.C. -- An initial audit shows that physicians and pharmacists are adhering to the Food and Drug Administration-mandated System to Manage Accutane-Related Teratogenicity.

Among 783 pharmacies nationwide that were monitored after SMART went into effect in April, 754 (96.3%) were in full compliance with the new rules, which permit pharmacists to fill only those prescriptions that bear physicians' stickers verifying that patients have undergone required pregnancy risk counseling and pregnancy tests.

"We're certainly encouraged by these results," according to Dr. Ronald Gottschalk, who is medical director for dermatology at Roche Laboratories, Nutley, NJ.

Although the new regulations are "somewhat cumbersome," adherence to them will diminish the chances of a mandatory registry for all physicians and patients using the category X known teratogen, Dr. Gottschalk said at the annual meeting of the Pacific Northwest Dermatological Society.

Dr. Gottschalk shared with the meeting a number of Roche-sponsored studies shedding light on the need for better pregnancy prevention efforts among Accutane users.

For example, one survey of mall shoppers found that 91% believed they were well versed in facts about contraception, but 37% chose the least effective birth control method, withdrawal, he commented.

To be sure, Accutane users appear to be far better informed than the general public.

While the number of patients initiating Accutane therapy increased fourfold over 10 years to 250,000 in 2000, the number of Accutane pregnancies has remained steady at about 150 per year, he said at the conference.

Over the years, Accutane-related pregnancies have most often been due to the following factors:

* Patients failing to adhere to absolute abstinence, using ineffective or inconsistent contraception, experiencing contraceptive failure, or having unexpected sexual activity.

* Confusion over the timing of pregnancy tests.

* False-negative pregnancy tests.

* Patients failing to wait until the correct day of the menstrual cycle to begin taking Accutane.

* Misinformation about contraceptive methods.

* Patients receiving more than a 1-month supply of the drug.

* Failure of practitioners to perform monthly pregnancy tests and/or contraception counseling.

RELATED ARTICLE: Accutane-Related Pregnancies

Among 150 pregnancies per year:

* 64% occurred while patient was established on Accutane therapy.

* 14% were pregnant at the time of the first office visit.

* 12% didn't wait to begin prescription until next menstrual cycle.

* 10% complete information was unavailable.

Average age of the woman who becomes pregnant on Accutane is 26.3 years.

Percentage of women who become pregnant on Accutane but recall physician's warnings about birth defects is 90%.

Source: Dr. Ronald Gottschalk of Roche Laboratories

COPYRIGHT 2002 International Medical News Group
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