Washington, D.C. - While dermatologists welcome proposed changes to FDA's iPLEDGE isotretinoin risk management program, they say iPLEDGE needs further tweaking in areas including physician and patient convenience, data security and drug access for low-income patients.
Washington - While dermatologists welcome proposed changes to the Food and Drug Administration's iPLEDGE isotretinoin risk management program, they say iPLEDGE needs further tweaking in areas such as physician and patient convenience, data security and drug access for low-income patients.
In August, an FDA advisory panel suggested eliminating the 23-day lockout for females of childbearing potential (FCBP) who have been denied a prescription, and tying the seven-day window to get a prescription filled to the date of a negative pregnancy test rather than the dermatologist visit that preceded it.
"Those are both useful and positive steps," which the American Academy of Dermatology (AAD) has advocated since iPLEDGE began, says David M. Pariser, M.D., AAD president-elect.
Although the FDA said at press time it wouldn't comment while the changes were under review, Ms. Terrell tells Dermatology Times the changes are expected to take effect in early November.
The changes "continue to be a step in the right direction. They're going to make the program easier to use in a way that is not going to add to the risk of exposed pregnancies," says Stephen P. Stone, M.D., chairman of the AAD's ad hoc task force on isotretinoin.
Covance data show that during iPLEDGE's first year, 122 pregnancies occurred in registered patients, and another 37 occurred in the four months that followed.
"We expected the number of pregnancies to go up, since the reporting is finally accurate for the first time," says Hilary E. Baldwin, M.D., vice chairwoman and associate professor, department of dermatology, State University of New York-Downstate.
According to the FDA, 120 women on isotretinoin became pregnant during the first year of iPLEDGE's predecessor, the System to Manage Accutane Related Teratogenicity (SMART).
"The important number is the number of patients pregnant before starting the drug, which was only 10," Dr. Baldwin says. Short of being in the bedroom with patients, she says, "These results show that doctors were behaving appropriately, and the system was working as well as it can."
"We have no control over that," he says. Dr. Silverman is a dermatologist in private practice in Fairfax, Va.
According to an FDA briefing, most of the pregnancies that occurred during isotretinoin therapy involved patient noncompliance with birth control methods. Reasons cited for the 10 pregnancies that commenced before isotretinoin therapy include contraceptive failure, unsuccessful abstinence and falsification of test results by prescribers or prescriber designees, according to Covance and the FDA.
"Some patients (two) were only using one method of birth control as opposed to the required two," Dr. Stone adds. Overall, Covance data show that "Nearly all women - both those who became pregnant and those who didn't - did admit to being counseled by their dermatologists" regarding the need for two birth control methods, he says.
Working the phones
Operationally, Dr. Stone adds, "There are still some inconveniences in getting to a human being to restore patients who have been dropped from the program as 'lost to follow-up.'"