Dr. Baldwin

As program managers begin penalizing noncompliant prescribers, however, some dermatologists question whether the registry warrants the time and money spent satisfying its requirements.

Since the FDA approved the program in 2005 (it became mandatory in March 2006), iPLEDGE managers have deactivated 23 of the system's 14,500 enrolled prescribers — meaning they can no longer prescribe the drug, says Christian Germain, senior manager, Life Sciences, BearingPoint Management & Technology Consultants, a spokesman for iPLEDGE program manager Covance.

Dr. Baldwin says these penalties signify that, "We've learned how to deal with iPLEDGE, and now the teeth are setting in."

iPLEDGE was created by the FDA and several drug manufacturers (Roche, Accutane; Genpharm, Amnesteem; Barr, Claravis; Ranbaxy, Sotret) to minimize the incidence of birth defects, a significant risk for pregnant women who take isotretinoin.

Dr. Taub

The program took effect March 1, 2006, despite protests by the American Academy of Dermatology (AAD) and other organizations contending that its requirements would impact physicians' ability to deliver top-quality care.

Considered by many doctors to be time-consuming, cumbersome and overly restrictive, iPLEDGE was later amended. In late 2006, the FDA announced that the program would no longer require a 23-day lockout for males and females of non-childbearing potential who failed to fill their prescriptions within seven days.

In 2007, the program also eliminated a 30-day lockout for females of childbearing age who miss that seven-day window, although they are still required to return to the office to receive another pregnancy test.

These and other tweaks addressed the program's major glitches, Dr. Baldwin says, allowing iPLEDGE officials to focus on culling underperformers, the most blatant of them first.

Reporting improves

Dr. Baldwin says iPLEDGE has improved the reporting of pregnancy exposures compared to its predecessor, the System to Manage Accutane Related Teratogenicity (SMART), based on data from iPLEDGE administrator Covance. However, some dermatologists question iPLEDGE's value.

"The only data I have seen said it wasn't effective at preventing pregnancies," says Amy Forman Taub, M.D., director of Advanced Dermatology in Lincolnshire, Ill., and assistant clinical professor of dermatology at Northwestern University, Chicago.

Dr. Poggioli

"Statistically, it appears the number of reported pregnancies has remained constant since iPLEDGE was initiated," says Lawrence J. Green, M.D., assistant clinical professor of dermatology, George Washington University, Washington, D.C.

Specifically, Covance data on file with the FDA show that 122 pregnancies occurred in registered patients during iPLEDGE's first year, versus 123 pregnancies during SMART's final year.

However, Dr. Baldwin says that SMART was voluntary, and "Few doctors would voluntarily report a pregnancy and open themselves up to further scrutiny."

So, while the number of pregnancies recorded has held steady, she says, "What changed was the number of patients for whom pregnancy status was known. Mathematically, the numerator is the same, but the denominator has (grown) four- to fivefold."

Furthermore, Dr. Baldwin says, "If iPLEDGE prevents even one isotretinoin baby, it's worth all this effort."

Dr. Hanson