10/02/2006iPledge risk management program for isotretinoin did not begin officially until December 30, 2005, pharmacies began "registering" and "activating" in the program as early as September 2005. Under the program, all registered entities, including pharmacies are required to "re-activate" on an annual basis in order to remain in the program. Therefore, pharmacies should be receiving reminder letters via mail soon… instructing them to "reactivate" their pharmacies. Reactivation is easy and can be done at any time via the website (
www.ipledgeprogram.com) or help desk at 1-866-495-0654. Pharmacies that do not reactivate will not be able to continue to order isotretinoin products.
Starting 11/1/05 there is a new process for dispensing the Accutane/isotretinoin products. You must be pre-registered with iPledge (which means committed to pregnancy prevention). Each pharmacy can and must be registered at no cost, but it must be done in order to allow you to dispense the prescriptions after Oct.31
The website for information is www.ipledgeprogram.com. Each pharmacy can register on line.
From the iPLEDGE Site:
"Because of isotretinoin's teratogenicity and to minimize fetal exposure, isotretinoin is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPledge. Isotretinoin must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Isotretinoin must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE (see PRECAUTIONS).
The goal of the iPLEDGE program is to prevent pregnancies in females taking isotretinoin and to prevent pregnant females from taking isotretinoin.
The iPLEDGE program is a computer-based risk management system that uses verifiable, trackable links between prescriber, patient, pharmacy, and wholesaler to control prescribing, using, dispensing and distribution of isotretinoin."
