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PITMAN, NJ – The Dermatology Nurses’ Association (DNA) today announced its support of the American Academy of Dermatology Association’s (AAD) efforts to resolve inconsistencies and shortcomings with the iPLEDGE program for isotretinoin patients, scheduled for a March 1, 2006, start date.
Isotretinoin (Accutane and its generics) is a highly effective drug for severe acne, but it carries a significant risk of birth defects if taken during pregnancy. The iPLEDGE program was designed by the Isotretinoin Product Manufacturers Group (IPMG) and its chosen vendor, Covance, under the direction of the U.S. Food and Drug Administration (FDA), to prevent use of the drug during pregnancy. iPLEDGE, a mandatory risk-management system, tracks doctors, patients, wholesalers and pharmacies to ensure women of childbearing age do not become pregnant while taking isotretinoin.
DNA has worked with AAD, the Inflammatory Skin Diseases Institute and the Society of Dermatology Physician Assistants to alert the FDA to significant flaws with the iPLEDGE program and encouraged the FDA to postpone the March 1 start date. The FDA recently announced the March 1 start date would remain in effect.
DNA members and others have repeatedly reported serious flaws, inconsistencies and confusion with the system, resulting in concerns that iPLEDGE will not work as intended and likely affect patient access to isotretinoin. DNA believes there isn’t enough time to resolve these problems prior to the mandatory start date, jeopardizing the health, safety and welfare of isotretinoin patients and others who are qualified to receive this valuable medication.
“We have worked together with other dermatology groups to make the FDA aware of the significant problems we’ve had with the iPLEDGE program, and it is disappointing to know that the program is moving forward as scheduled on March 1,” said DNA President Cathy Boeck, RN, CCRC, DNC. “The safety of our patients is a major concern, and we have not been assured that the program’s flaws will be corrected prior to the program’s launch.”
DNA members are very experienced with the drug and see firsthand the significant and often life-altering benefits isotretinoin offers. At the same time, DNA recognizes the importance of ensuring women of childbearing age do not become pregnant while taking the drug, and members work carefully to educate patients and prescribe the drug accordingly.
DNA is committed to promoting excellence in dermatologic care and will continue to work with AAD in hopes that the FDA, the IPMG and Covance will correct the serious problems with the iPLEDGE program. Maintaining patient safety remains of utmost importance, and correcting these issues will ensure that patients taking isotretinoin continue to receive safe, high-quality care.
Members of the media: Please contact Linda Alexander or Janet D’Alesandro (information at top of release) to set up interviews with DNA President Cathy Boeck.
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The Dermatology Nurses’ Association (DNA) is a professional nursing organization comprised of a diverse group of individuals committed to quality care through sharing knowledge and expertise. DNA’s core purpose is to promote excellence in dermatologic care.