By John Carruthers, staff writer, May 1, 2012
The use and regulation of isotretinoin has been a significant issue in dermatology since the strong link between the drug and birth defects came to light, and ramped up further when the media took to the issue in the early 2000s. Women of childbearing age taking oral isotretinoin were said to have a fetal exposure risk of up to one in every 300-450 courses of therapy, according to the CDC. After a 250 percent increase in isotretinoin prescriptions from 1992 to 2000, widespread fear of perceived risks led to a decline in prescriptions of 23 percent between 2002 and 2003.
As a result, the FDA began efforts to ensure safe use in patients of childbearing age while still protecting patient access to the vital drug. Following the widely perceived failure of the FDA’s original System to Manage Accutane-Related Teratogenicity (SMART) program, the FDA instituted the iPLEDGE program in March 2006. Under the program, patients and their physicians and pharmacists were required to register on the FDA’s iPLEDGE website and follow a set of regulations designed to minimize the risk of fetal exposure. More than six years after the program’s implementation, dermatologists say the program has set a number of good prescribing practices while paradoxically failing to significantly decrease the annual number of fetal exposures.
iPledge and patient registration
Controversial at the outset, the iPLEDGE program, with its strict prescribing windows, blackout periods, and mandatory registration for both female and male patients, has been called “a logistical nightmare,” with loopholes “sealed with a wall of bureaucratic red tape,” by Danbury, Conn., physician Graeme Lipper, MD, in an isotretinoin column published on MedScape. Yet over the years, some of the program’s rougher edges have been smoothed away thanks to physician and patient advocacy.
According to dermatologist Mary Maloney, MD, who chairs the American Academy of Dermatology Association’s Regulatory Policy Committee, there is still room for the program to improve, becoming more consumer-friendly, though it’s doubtful that this will happen soon.
“One of the things that I question is the validity of continuing to register men. And I think that there is absolutely no question about the fact that there’s no indication for the registration of men. It doesn’t provide us any detail on the epidemiology of the use of istotretinoin, they’re at no risk of getting pregnant, and whether or not we register them, they can still give their medicine away if they want to,” Dr. Maloney said. “Some of the logic was letting men know that they couldn’t give their medicine to their girlfriend, for example. But it has significant costs to the health care system to register men, so I think that’s an area where we should continue to work and see if we can somehow eliminate some of those costs.”
Former Academy President Stephen P. Stone, MD, who co-authored an editorial on iPLEDGE with Dr. Maloney in the Journal of the American Academy of Dermatology (2011;65:418-9), said that at present, the iPLEDGE program is running with relative smoothness, especially compared to the furor that met its launch during his presidential year. From the perspective of those in charge of the program, he said, it may not prove worthwhile to significantly alter it at present.
“I think there are still some dermatologists who feel it should be changed and liberalized a great deal,” Dr. Stone said. “But I’m not sure that it will be done. There is certainly a vested interest on the part of people who participate in the program to maintain it running smoothly. And I think that quite frankly there is a concern if we change too much, it will increase the risk of pregnancies. Another question is how much it will cost to make these changes. Still, it makes no sense to include males in the program at this point.”