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iPLEDGE Update
March 23, 2006
iPLEDGE, a risk management program to reduce the risk of fetal exposure
to isotretinoin (a drug to treat severe recalcitrant nodular acne), was fully implemented on March 1, 2006. This comprehensive program seeks to reduce the risk of inadvertent pregnancy exposure by tightly linking negative pregnancy testing with dispensing of isotretinoin.
iPLEDGE is a risk management program that is unprecedented in size and scope. It requires that all participants in the healthcare system using isotretinoin (wholesalers, pharmacies, physicians and patients) participate in the program. iPLEDGE was developed through a cooperative effort of the manufacturers of isotretinoin, a drug that has been marketed for several decades. Isotretinoin
is highly effective in the treatment of severe recalcitrant nodular
acne, but has known serious side effects, such as its potential to
cause birth defects when pregnant women are exposed to the drug, and
more recent concerns regarding its association with severe
depression. Isotretinoin is available as the branded drug, Accutane, or as a generic (Amnesteem, Claravis, Sotret).
Registration in iPLEDGE is increasing rapidly with over 22,000 prescribers and 71,700 patients registered. Patient registration levels have tripled since late February.
iPLEDGE statistics show that program controls are working. Of the prescriptions written, over 29,000 have been filled through iPLEDGE; however, a large number of prescriptions were denied as they did not comply with the risk management program requirements. The primary reasons for prescription denial include presentation of the prescription prior to completion of the initial 30-day period necessary to establish use of two forms of contraception and obtain confirmatory pregnancy testing, absence of confirmation of contraceptive counseling, absence of pregnancy test results, and patient failure to complete their responses to the monthly questions.
FDA is working closely with the isotretinoin sponsors and their vendor, Covance Inc., to maintain a critical balance between access and safety for patients who need this important drug. As concerns have been raised regarding operational aspects of the program, we have ensured that the sponsors and Covance address them rapidly. We take these concerns very seriously and will continue to work with the iPLEDGE program sponsors to find practical solutions. For example, to address the volume of calls being received, Covance is further increasing their center staffing. We also continue to encourage the medical community and patients to ensure that iPLEDGE objectives, avoidance of fetal exposure to isotretinoin and safe use of the drug, are achieved.
iPLEDGE seeks to prevent exposure to isotretinoin during pregnancy. To obtain the drug, patients must comply with a number of key requirements that include being registered with iPLEDGE, completing an informed consent form, obtaining counseling about the risks and requirements for safe use of the drug, and, for women of childbearing age, complying with necessary pregnancy testing. We encourage prescribers and patients to thoroughly review the iPLEDGE education materials.
Prescribers and patients who have questions about the iPLEDGE program should contact the iPLEDGE call center at 1-866-495-0654 (8 AM – midnight EST, Monday through Saturday) or on line at https://www.ipledgeprogram.com/. Additionally, Covance advises that during the times of high call volume that the caller either calls back again or checks the website. Covance
has provided answers to frequently asked questions.
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Date created: March 23, 2006 |
