MAUI, HAWAII -- SMART, the new teratogenicity management program for Accutane, does not go far enough because too many of the provisions are voluntary, Dr. Kenneth L. Jones said at the annual Hawaii dermatology seminar sponsored by the Skin Disease Education Foundation.
"I think there are many positive aspects to the SMART (System to Manage Accutane-Related Teratogenicity) program, but I think it has not gone far enough," said Dr. Jones, a professor of pediatrics at the University of California, San Diego, and a member of the Teratology Society, which has argued for greater restrictions on Accutane.
Many pregnancies continue to occur in women on Accutane, and many of these exposures are not reported, either to the Food and Drug Administration's MedWatch program or to the Slone Epidemiologic Survey maintained by the Boston University School of Public Health. These exposures need to be recorded in order to know how many there truly are because the results can be so devastating, he said.
Dr. Jones said that he sees many children in his practice who were exposed to Accutane in utero, but have never been reported in any manner.
As with the previous pregnancy prevention program, patient enrollment in the Slone registry is voluntary under SMART. However, the FDA has set as a 1-year performance goal for the program of 60% enrollment of female patients, according to Eileen Enny Leach, R.N., medical director of dermatology for Roche Pharmaceuticals in Nutley, N.J., which manufactures Accutane.
The current experience with the Slone registry suggests that encouraging reporting and registry but not making it required will not work, he said. It is estimated that at present only 30%-40% who receive an Accutane prescription enroll in the registry.
Dr. Jones also said that one cannot expect SMART to reduce the number of pregnancy exposures to any degree. Some 60% of all pregnancies are unplanned, and the number of prescriptions written for Accutane has risen dramatically over the years, from fewer than 750,000 in 1989 to more than 1.9 million in 2000.
COPYRIGHT 2002 International Medical News Group
COPYRIGHT 2002 Gale Group
Contact
Home
A
8-Hour Bayer