The U.S. Food and Drug Administration agreed with panel recommendations that it should start a national registry of women of child-bearing age who are prescribed Accutane (isotretinoin, Roche). The decision may have generated more questions than answers for dermatologists who prescribe the acne medication and patients who take Accutane — or are thinking about taking it.
On Call asked several dermatologists around the country how they view the idea of a registry and what effect they think it will have - if any - on use of what's been described as the most effective acne drug ever developed.
"The patient will be filling out questionnaires, dealing with literature and data, and mailing that in on a monthly basis. Certainly, that is not an impossibility for patients to manage; it is just another layer of responsibility that some patients will find a little bit over the top.
"Another thing is that some physicians and some providers will not be as readily willing to provide the drug and write the script if there's going to be too much more effort and energy expended by their practice or their patient. That's one of the limiting steps on these drugs when you have registry. The level of work begins to increase and your level of motivation for writing the drug decreases with that."
In Sacramento, Calif., Emil A. Tanghetti, M.D., prescribes Accutane all of the time.
"It has become a key ingredient of our therapy. What's really difficult is that the whole issue really stems from a few people not doing their job - and the overuse in patients, especially women, with mild to moderate acne. Patients come in demanding the therapies because they have no tolerance for anything other than clearing their acne as quickly and as efficaciously as possible. That's where Accutane is probably being misused."
Call for regulation But does that indicate that physicians have brought this call for regulation upon themselves?
"The physician is always in an uncomfortable position when people come in demanding things. We don't want to see patients leave unhappy. We are put in a quandary. This is a very difficult position to be in. ..."
"... Patient pressure is fairly great. That's why sometimes these advertisements create the issue as well - patients come in demanding the drug and they can have a substantial impact," Dr. Tanghetti says.
But, overall, Dr. Tanghetti, a practitioner for 25 years and a clinical professor at the University of California Davis, Davis, Calif., says the changing rules will make it onerous to use the drug.
"This can be an impediment to the use of the drug, and it will be effective in that regard. It will discourage physicians from prescribing the drug and I don't think patients are going to quite get it until they come in and are faced with a doctor who tells them that they have to register if they want the drug."