Doctors and their patients continue to face problems with a program designed to limit use of an acne medication that can cause birth defects if taken by pregnant women, a dermatology group said Monday.
Nine out of 10 dermatologists report having problems with the registry, put in place to control access to isotretinoin, according to a survey commissioned by the American Academy of Dermatology. The group has been critical of the iPledge program.
About 80 percent of the 378 doctors surveyed who prescribe the drug said their patients also have experienced problems, including mandatory lockout periods that interrupt treatment.
"Basically, the problem is that patients are having denial of access and delayed access to the drug, and that continues," said the group's president, Dr. Stephen Stone of the Southern Illinois University School of Medicine. The group unsuccessfully sought to delay iPledge's Dec. 30, 2005, debut.
As of March 1, doctors and patients, along with wholesalers and pharmacies, had to be registered and activated in the computerized iPledge system to lawfully sell, prescribe or take isotretinoin. Isotretinoin is sold as Accutane and in three generic versions: Amnesteem, Claravis and Sotret.
The registry program is the latest in 20 years of FDA efforts to limit the exposure of fetuses to the drug.
"Every time they try to accommodate the dermatologists, it doesn't work," said Rep. Bart Stupak (news, bio, voting record), D-Mich., whose teenage son committed suicide while using Accutane.
The program is meant to limit the exposure of fetuses to isotretinoin. It requires women to use birth control and regularly take pregnancy tests. If a woman uses the drug during pregnancy, or becomes pregnant within a month of taking it, her baby runs a significant risk of brain and heart defects or mental retardation.
The FDA said it received no reports between Dec. 30 and March 31 of women becoming pregnant while on the drug and enrolled in iPledge. The Organization of Teratology Information Services has received a "handful" of reports of pregnancies, said Christina Chambers, director of the California chapter of the clearinghouse on birth defects linked to drugs and chemicals.
Since Accutane sales began in 1982, the FDA has received reports of more than 2,000 pregnancies among users. Most ended in abortion or miscarriage, but the FDA counts more than 160 babies born with drug-caused defects.
The telephone survey of Academy members found that among those who reported problems, a little more than half had difficulties with the program's call center. An equal proportion said their patients had to interrupt taking the drug because they failed to fill their prescriptions within a required seven-day window. That forces patients to wait a month before they can revisit their doctors for a new prescription.
Stone said that lockout should be eliminated. He acknowledged that there have been some improvements to the iPledge call center, including more operators, but said navigating the semi-automated system can be frustrating.
The FDA continues to work with Covance Inc., which runs iPledge, and drug companies on enhancements to the program, agency spokeswoman Susan Cruzan said without elaborating.
A spokeswoman for Covance had no immediate reply to questions sent by e-mail. A message left with Hoffman-La Roche Inc., the manufacturer of Accutane, was not returned.
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On the Net:
Food and Drug Administration isotretinoin information: http://www.fda.gov/cder/drug/infopage/accutane/default.htm
