National report - Sources say glitches in the Food and DrugAdministration's online registry for limiting pregnancy exposuresto isotretinoin have resulted in overburdened office staffs,locked-out patients and end runs around the system.
Since registration became mandatory March 1, "There have been many reasons that patients may be having problems," says Diane Thiboutot, M.D., chairwoman of the American Academy of Dermatology's isotretinoin task force and professor of dermatology at Penn State University.
Dr. Thiboutot tells Dermatology Times that if patients register but miss subsequent office visits, "Trying to re-establish those patients within the iPLEDGE system involves a call to the call center, and approval from someone at a higher level there. In some cases, that's been taking up to a couple weeks to accomplish."
"The iPLEDGE program is basically locked up and says that the patient can't get it, even though one does everything properly," says Dr. Hughes, who practices in San Antonio, Texas, with his daughter, Elizabeth Tichy, M.D.
"I have enrolled six patients in the silly program, and every one has been denied for various reasons," Dr. Tichy says.
"We have people with a disfiguring disease that is both uncomfortable and socially disabling, especially for teenagers," Dr. Tichy says.
She adds that although she supports the program's goals, "I believe it's unethical to deny somebody a treatment when one knows they need it."
A representative for the company, who declined to be identified, says its isotretinoin orders have risen 60 percent in recent weeks, though it's impossible to say if iPLEDGE accounts for the entire increase.