NEW YORK (Reuters Health) – Hoffmann-La Roche on Monday began distributing to physicians and pharmacists updated requirements aimed at preventing pregnancy in women who take the company's acne drug Accutane (isotretinoin).
Accutane is known to cause birth defects, and for 13 of the last twenty years the drug has been on the market, Roche has continually instituted and revised restrictions on its use. Despite the company's efforts, 2,000 pregnancies had occurred in women taking Accutane from 1982 to 2000, the Centers for Disease Control and Prevention reported last August.
Roche and the US Food and Drug Administration (FDA) worked together to come up with a new plan, and the System to Manage Accutane Related Teratogenecity (SMART) program was approved in October.
Under SMART, which was mailed to 375,000 dermatologists, primary care physicians and pharmacists beginning Monday, female patients will now be required to submit to a pregnancy test every month before receiving a 30-day refill of the medication. Before, the test was optional.
Also before receiving an initial prescription, women must have two negative pregnancy tests, one as a screen and the second during the first five days of the next menstrual period. They also must select and commit to using two forms of birth control simultaneously for one month before treatment, continue use during treatment, and for a month afterwards. Patients also have to read and sign an informed consent about the risk of birth defects and participate in the Accutane Survey, a questionnaire about their use of the drug.
If a woman has complied with these criteria, the physician places a yellow sticker on the paper prescription. The sticker acts as a certification, and pharmacists will be warned to only fill prescriptions with a sticker, said Roche spokesperson Gail Safian.
Women will not be allowed to request refills by phone — they must return to the physician for the pregnancy test and certification, Safian said.
"It's a much more conscious and conscientious process," she said.
Safian claimed that despite increasing numbers of prescriptions for Accutane, the numbers of pregnancies were declining.
About 550,000 prescriptions are written for Accutane each year, and some 15 million have been issued since the drug came on the market, she said.