With three dermatologists in his office and about 15 patients on Accutane, Dr. Rusonis says it is going to be a lot of additional time and work for the office staff.
One entity that seems to find ways to impact practices on a regular basis is the government.
"It's just another example of how every year or two, staff looks at things as a big crisis. This one is dealing with the Accutane iPledge Program. It's huge. It's ugly. I'm afraid a lot of dermatologists will just not bother with Accutane anymore because of the FDA intervention."
Dr. Rusonis says that the imposition of the new rules was
"The AAD tried to hold the new rules back - or tried to get them to compromise - and they were just bulls in the china shop. They went ahead and did what they darn well pleased, just implementing the rules with no more hearings.
Dr. Rusonis says dermatologists have to do more than to start registering every patient. In addition to the pregnancy tests that were already being given, there have to be double pregnancy tests, confirmations called in and/or registered online, and women have to have two negative tests within a set 19-day period in exact timing with their menstrual cycle.
"The first time I saw the regulations, I just shook my head, handed them to my nurse and said, 'See if you can make any sense of this nightmare.'"
Dr. Rusonis says the office is very aware of the need to avoid pregnancy during Accutane use, but doesn't see how following the government's "little list" of things that must be said to
patients every month is going to help.
With three dermatologists in his office and about 15 patients on Accutane, Dr. Rusonis says it is going to mean a lot of additional time and work for the office staff. He adds that he can imagine some dermatologists, particularly part-time practitioners or those who do not treat many young adults, will stop prescribing Accutane to avoid the hassles.
Not only will practices potentially be dealing with extra work from the Accutane, Shelley W. Russell, M.D., who has a dermatology practice with her husband in Conway, Ark., says the time it takes to obtain coverage from insurance companies is on the rise.
Even when doctors think they've gotten a system down for dealing with managed-care requirements, the parameters change and the offices have to develop entirely new paradigms for working with third-party payers.
She says formulary regulations have caused more problems this year than in the past, and she finds she needs to call insurance companies more often to get needed drugs approved for her patients. In particular, she finds that retinoids and antifungal, such as Lamisil, tie up her nurses' time.Although she understands that third-party payers like to question the possibility of a cosmetic factor in the retinoids, she says now they are doing the same with the antifungals. Having practiced for more than five years, she is not sure what has caused the added hassle factor.
"Once patients see the commercials with the little creepy bugs crawling around, everybody thinks they need to be treated. As a result, insurance companies are saying 'no, no, no - we don't want to pay for that.' In some regard they are actually considering fungus a cosmetic issue now. We have to first of all prove there is a fungus, and, secondly, we have to prove that it is symptomatic, and not just a thickening issue. That turns into a lot of battles."