Medical Economics Feature - May 2006
By Ken Ortolon
It's rare when a situation arises to which several clichés apply equally well: The road to Hell is paved with good intentions. The devil is in the details. We're from the government, and we're here to help you.
But they all seem to fit the U.S. Food and Drug Administration's (FDA's) new iPLEDGE program to prevent birth defects associated with the anti-acne drug isotretinoin (a.k.a. Accutane).
Just ask Austin dermatologist Zoltan Trizna, MD, PhD.
"The iPLEDGE program is government bureaucracy on steroids," Dr. Trizna said. "It's unbelievable."
Despite its good intentions, dermatologists say iPLEDGE was plagued with problems even before it officially began March 1. Faulty program databases and glitches in the online registration software make it difficult for physicians to register themselves or their patients. What's more, support services from the FDA-approved contractor running the program, Covance Inc., are lacking. And FDA and the drug company sponsors, who hired Covance to design and run the program, have been slow to act on myriad complaints lodged by the American Academy of Dermatology (AAD).
Dermatologists say they are frustrated and angry because iPLEDGE interferes with their ability to care for their patients.
"Everybody accepts a few glitches here and there with any start-up program, but this has been of mammoth proportions" said Texas Dermatology Society President Ron Davis, MD, of Tyler. "It has really been difficult not only for the physicians, but also very difficult, frustrating, and harmful for the patients themselves."
Doctors have long known that isotretinoin carries significant risks of birth defects if taken during pregnancy. However, it is highly effective against the most serious form of acne, recalcitrant nodular acne. About 200,000 Americans use Accutane or generic isotretinoin annually.
Access to Accutane, manufactured by Roche Laboratories, and isotretinoin, produced by three other pharmaceutical companies, has been restricted since 2002. Despite that, roughly 200 women annually become pregnant while using the drug, about the same rate as before the program was implemented.
An FDA advisory committee recommended a stricter program in 2004. In August 2005, the agency and the drug manufacturers announced iPLEDGE would be implemented Dec. 31, 2005. Intervention by AAD and the national chain drug store association pushed the deadline to March 1.
"This stronger program is a major step in protecting against inadvertent pregnancy exposure by tightly linking negative pregnancy testing with dispensing of isotretinoin," Steven Galson, MD, MPH, director of FDA's Center for Evaluation and Research, said in announcing the program. "iPLEDGE, using a computer-based telephone system, will provide health care professionals with the real-time information necessary to effectively manage the risks of isotretinoin."
iPLEDGE requires physicians, pharmacies, drug wholesalers, and patients to register to prescribe, dispense, or take isotretinoin. Patients receive educational materials, an identification number, and a password to get their prescriptions. Women also must take pregnancy tests before being prescribed the drug, have monthly negative pregnancy test results, and use two forms of contraception while taking it. A final negative pregnancy test is required one month after completing therapy.
It was obvious the system was full of bugs when physicians and pharmacies began registering last fall. For starters, not all dermatologists were in the iPLEDGE database even though many of them registered at the earliest possible point in an attempt to become compliant with the program in advance of the March 1 effective date.
Even Dr. Davis, a member of the AAD Board of Directors, was left out of the database. Because his name, licensure, and board certification information were not in the system, he could not register and participate in the program online. Instead, he had to fax paper forms to Covance. He had done that three times, but was still not in the system when the program began.
"Fortunately, I am in practice with another physician, so she has been able to write the prescriptions for Accutane," he said.
Numerous glitches with the patient registration system also have bedeviled physicians and their staff. Some complain it frequently rejects the patient identification numbers. Also, there is no way to correct a mistake on the registration information once it is submitted. Physicians or their staff members must phone the iPLEDGE call center for help.
Dr. Trizna says one day in early March his staff was on hold for an hour and 42 minutes to register one patient, and then waited another hour and 20 minutes to register a second patient.
Relying on Snail Mail
Another problem is iPLEDGE sends the patients' passwords via regular mail rather than e-mail, which complicates filling a patient's initial prescription. Patients must fill prescriptions within seven days after they are written, and a prescription cannot be filled if the password has not arrived. The patient must wait 30 days to get another prescription because they are limited to one a month. That, Dr. Davis says, can cause permanent harm.
"Typically these are patients who have either been on other medications or they've got such severe acne you know nothing but Accutane is going to work," he said. "And in a fairly short time, within a few weeks, acne that is explosive like this can cause significant scarring that's going to last their entire life."
Not only is treatment of new patients delayed, but continued treatment of patients already on isotretinoin has been disrupted because of registration problems. Dr. Trizna says the iPLEDGE software rejected one patient's prescription even though she was registered and her data was properly entered.
Physicians also complain that iPLEDGE requires them to register women who are not of childbearing age and men, even though the program is designed to avoid birth defects.
Full Speed Ahead
FDA ignored AAD's plea to delay iPLEDGE so problems could be corrected and said it was working with the drug manufacturers and Covance to find a solution.
"Going forward with a flawed program, in our mind, wasn't putting your best foot forward," said Laura Edwards, director of federal affairs for the American Academy of Dermatology Association.
"FDA has ensured that rapid and significant progress has been made by the sponsors and Covance to address them," the agency said in a Feb. 23 statement. "Specific measures undertaken have included an increase in iPLEDGE call center staffing to handle the expected increases in call volume and user questions in the coming weeks, as well as an enhanced system to process requests for new passwords by users who have forgotten or lost their original passwords."
Covance spokesperson Laurene Isip says it made its Web site more user-friendly, including adding frequently asked questions to its prescriber, pharmacy, and patient home pages.
By early March, when AAD held its annual meeting in San Francisco, physicians were still having problems with the system. Dr. Davis says he stood in a long line to get help with his registration problem from Covance officials at the meeting.
Ms. Edwards says the FDA, Covance, and the drug companies are listening to the complaints, "but they're moving slowly and it's frustrating because we've been telling them this stuff for months."
She also says AAD wants Congress to pressure FDA and Covance to move faster.
Ken Ortolon can be reached by telephone at (800) 880-1300, ext. 1392, or (512) 370-1392; by fax at (512) 370-1629; or by email at Ken Ortolon.
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