Dermatologists wary of isotretinoin hassles

January 1, 2005

With tighter restrictions now a reality, many dermatologists could stop prescribing isotretinoin altogether.

Miami Beach, Fla. - The advent of generic isotretinoin has left a void in terms of manufacturer support for the drug at a time when many dermatologists already had been dreading the prospect of tighter safety restrictions, a dermatologist based here says.

"When we had brand-name Accutane (isotretinoin, Hoffmann-LaRoche), we had a lot of industry support behind it," says Hilary E. Baldwin, M.D., an associate professor of clinical dermatology at the State University of New York Downstate, Brooklyn. "Roche was very interested in educational support. They gave us pregnancy tests for our patients and were really helpful. But in the first two months of generic substitution, they lost 60 percent of their business, promptly fired all their drug reps and basically closed up shop. Although Accutane is still made, Roche has no drug reps; they don't call on us. "

Picking up ball Attempting to pick up where Roche left off, Ranbaxy Pharmaceuticals has begun sending its reps to dermatologists and providing them with needed support, which includes plans for an indigent program.

Under this scenario, "a patient would come to see me a couple days prior to their menstrual cycle," Dr. Baldwin says. "I would order a urine or blood pregnancy test. The patient would go get it done. The lab would sign off on the fact that it had been done. A couple days later, I would sign off to indicate that I had looked at it and it was negative, thereby allowing the pharmacy to release the drug to the patient when she showed up with a prescription. The bottom line is that this is going to be very complicated. It's going to take an awful lot of paperwork. For those of us who prescribe a lot of isotretinoin, it's going to be a considerable headache because we're going to have to have somebody on staff basically devoted just to filling out forms and checking pregnancy tests. And that's a tall order for small mom-and-pop practices."

Total halt?

With tighter restrictions now a reality, many dermatologists could stop prescribing isotretinoin altogether.

"What a shame that would be, considering it's the best medication for acne that any of us have ever seen or and perhaps will ever see, " she says.

To gauge how likely dermatologists are to abandon isotretinoin, and how they felt about previously existing restrictions, Dr. Baldwin informally polled attendees about these matters at two recent conferences. One measure that prompted discussion was a survey in which patients taking isotretinoin were required to enroll.

Although the FDA set the bar for participation in this survey at 60 percent, "We only came up with about 28 percent, which is one of the reasons why we're in the mess we're in now," she tells Dermatology Times. "But part of the issue with the survey is that you can't really judge what the survey outcomes were. Since there are four separate branded generics now, it's possible that a patient might have started out on Accutane then got switched to another drug - Amnesteem (Bertek Pharmaceuticals), Claravis (Barr Laboratories) or Sotret (Ranbaxy). And since there are no refills permitted on the prescriptions now, when patients show up at the pharmacy it's always with a new prescription. It's unclear if that new prescription, without a survey enrollment form to go along with it, was counted as a failure to fill out the form."

Restriction burdens Opinions regarding the burden created by already-existing restrictions vary.