Schaumburg, Ill. -- The American Academy of Dermatology (AAD) hopes results of its recent iPLEDGE survey will prompt changes in the federal isotretinoin registry, which doctors and patients say is cumbersome and frustrating and hampers the delivery of quality medical care.
"Part of the problem is that dermatologists weren't in on the original formulation of the program, which is why we've been submitting a list of concerns about iPLEDGE to the sponsoring companies, Covance and the FDA (Food and Drug Administration)," says AAD President Stephen P. Stone, M.D., a professor of clinical medicine at the Southern Illinois University School of Medicine.
iPLEDGE is a mandatory, computer-based registry and tracking system designed to control the prescribing, usage, dispensing and distribution of isotretinoin, used to treat severe acne and various rarer dermatologic diseases. Because isotretinoin has been found to cause birth defects when taken by pregnant women, iPLEDGE was created to minimize such incidents.
iPLEDGE was approved by the four companies and the FDA a year ago and went into effect March 1, 2006 - but not without substantial protest by the AAD and other organizations on behalf of physicians concerned that the registry's rigorous requirements and restrictions were hampering the way they practice medicine.
The AAD and others began submitting their concerns about and proposed changes to iPLEDGE to Covance and the FDA early, but the AAD believes critical issues still must be addressed.
iPLEDGE is now in what the ADD spokeswoman calls a Phase II stage - that is, changes proposed by the sponsoring companies and Covance, with input from the AAD and other organizations, have been submitted to the FDA for approval.
"The FDA is looking at these proposed changes right now, but the specifics of the changes are not being made available to the public at this point," the spokeswoman says. "There is no timetable as to when the FDA will announce whether it's approved the changes or what the proposed changes were - it could be tomorrow, it could be six months from now."
The "major concerns" to which Dr. Stone refers include iPLEDGE's mandate that an isotretinoin prescription must be picked up within seven days. If it isn't, the patient must wait another 23 days to get another prescription (and, if that patient is a woman of childbearing potential, she must get another pregnancy test to show she's not pregnant).