Health

Dermatologists complain about risk management program for acne drug

NEWS IN BRIEF — Posted Sept. 25, 2006

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The system established to reduce the chance that a woman will become pregnant while taking isotretinoin is confusing, onerous and disruptive, according to an American Academy of Dermatology Assn. survey released this month to mark the six-month anniversary of the program.

According to the survey carried out by Doane Marketing Research, more than 90% of physicians who prescribe this drug have had at least some problems with the iPLEDGE program, which requires registration of everyone involved with dispensing and using this medication. More than 50% had problems getting help from iPLEDGE call center staff, and more than 35% said the system was confusing.

To make this system less of a burden, many survey respondents want the 30-day requirement between appointments scrapped and an allowance that prescriptions can be rewritten if a patient is unable to pick up their medications within a seven-day window. Nearly 13% want to see the program eliminated, and 10% would like to see male patients and women who are unable to have children exempt.

Isotretinoin is a known teratogen. The iPLEDGE system is the latest attempt to keep it available while reducing the risk of fetal exposure.

A Food and Drug Administration spokeswoman acknowledged that there have been problems with the system, particularly in the first month of operation, but that many had been addressed.

Note: This item originally appeared at http://www.ama-assn.org/amednews/2006/09/25/hlbf0925.htm.

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