IPLEDGE offers benefits some may not have considered

Scottsdale, Ariz. - For many dermatologists, the new iPLEDGE registry has brought hassles and headaches, but there are plenty of benefits to be considered that could ultimately make the initial ordeal worthwhile, said Hilary Baldwin, M.D., at a recent meeting of the Skin Disease Education Foundation.

The iPLEDGE program, which lays down a number of strict guidelines for prescribing isotretinoin, has not met the warmest of receptions since it was implemented last winter, but that appears to be easing a bit.

"It's been a remarkably steep learning curve," says Dr. Baldwin, an associate professor of dermatology at the State University of New York, Brooklyn. "We're frustrated, annoyed and we're moaning, but I think we're reaching acceptance."

But Dr. Baldwin reports that the wait time at the call center, as of late June, was down to less than two minutes, and the fact that the calls are letting up is a good sign.

"The number of calls going into the call center has decreased, and it's not because people aren't prescribing anymore, but because we're getting the hang of it and learning to do it."

In fact, dermatologists should find that the registry has only a minimal impact on time spent with patients, especially for the initial visit, which was already very long. Subsequent visits should be easy and don't even need to involve the doctor as much.

In addition, the iPLEDGE program can make life easier for dermatologists in ways they don't yet realize, Dr. Baldwin says.

iPLEDGE advantages

For one thing, the program wraps the four manufacturers of isotretinoin under one plan. That means no more dealing with yellow stickers and other hassles, and prescriptions can now be issued by phone, e-mail or fax.

Dermatologists also now have the power to "hold a prescription hostage" until a patient complies with their instructions.

"In the past, especially with male patients, I would insist they get, for instance, a triglyceride and liver function test before the next time they saw me, and they would show up later and say they forgot," Dr. Baldwin says.

Now, under iPLEDGE, patients have seven days from the office visit to comply with the doctor's instructions. If they don't comply, the seven-day clock expires and patients won't be able to get the drug for the remainder of the month because they will have been closed out of the system.

Importantly, under iPLEDGE, doctors actually have less medicolegal exposure. The responsibilities extend beyond the doctor, as the patient has to attest, on a monthly basis, to understanding the instructions.

Previously, if a woman got pregnant on isotretinoin, for instance, she could go to court and say the doctor never told her to use birth control or that there was a risk in pregnancy, Dr. Baldwin says. But now, female patients have to supply their signature every month, indicating that they understand that they must be on two forms of birth control.

"Somebody else other than our chart is recording this," Dr. Baldwin says. "(Female patients) can no longer say they didn't get it."

Dermatologists are also relieved of the legal exposure of caring for patients who are too far away to come in for regular visits; for instance, if they go off to college. That's because the registry requires that students or others who relocate on a temporary basis are required to transfer to another doctor who is on the registry and who can continue to see them on a monthly basis.

Finally, in terms of managing patients, the mandatory monthly visits mean no more missed appointments - and missed co-pays.