iPLEDGE now under way, despite objections

April 1, 2006

National report - Despite objections from the American Academy ofDermatology (AAD) and others, the Food and Drug Administration(FDA) is moving forward with the iPLEDGE risk management programfor isotretinoin.

In early February, FDA officials said they were considering postponing iPLEDGE's mandatory March 1 start date (which already had been delayed from Jan. 1). On Feb. 23, however, the FDA nixed the idea, citing in a press release "rapid and significant progress" in addressing users' concerns.

While no sources contacted by Dermatology Times dispute the rationale for the registry - to prevent the exposure of unborn children to isotretinoin, which can cause serious birth defects - many worry about the logistical and operational challenges the program poses.

"Members of the Academy believe that flaws and inefficiencies in the program have not been sufficiently addressed prior to its launch," Dr. Cockerell writes.

Diane Thiboutot, M.D., calls the system a "disaster" because, she says, it gives providers only about half the information required to use it. Guidebooks fail to explain such elements as how to perform data entry and when to schedule patients for visits and follow-up appointments, says Dr. Thiboutot, chairwoman of the AAD's isotretinoin task force and professor of dermatology at Pennsylvania State University College of Medicine.

"The way the system is designed," she says, "patients are going to have to go without medication for a few days every month."

At press time, Dr. Thiboutot said providers just learned that they must wait 30 days after a patient's prior visit to schedule a follow-up or refill a prescription.

"There's no leeway prior to that," she says, "and it's tough to schedule patients back exactly 30 days later," particularly for practices that might not be open daily.

Hampering care?

For such reasons, forging ahead as planned is "absolutely crazy," says Emil Tanghetti, M.D., a dermatologist in Sacramento, Calif., and clinical professor of medicine at the University of California, Davis. He says that requiring a patient to pass a Clinical Laboratory Improvement Amendments (CLIA)-certified pregnancy test before getting a prescription will mean an extra, uncompensated office visit for dermatologists.

Many doctors already are abandoning isotretinoin, says Leon Kircik, M.D., clinical associate professor of dermatology at Indiana University and medical director of Derm Research P.L.L.C. in Louisville, Ky.

"I'm already getting one or two acne patients a week from other dermatologists," he says.