INTRODUCTION
Since its approval by the Food and Drug Administration (FDA) in 1982, Accutane (isotretinoin) has been contraindicated
during pregnancy due to its known teratogenicity
in animals.1 Unfortunately, despite a designated "Category X" drug label, reports of fetal exposure and resulting
birth defects ensued, forcing the FDA and Accutane's manufacturer, Hoffman La-Roche, to devise a series of risk management programs (RMP) to heighten awareness about fetal malformation and to minimize the number of pregnancies
during treatment.1,2 With each new RMP, including the Pregnancy Prevention Program (PPP) and System to Manage
Accutane-Related Teratogenicity (SMART), additional requirements
were placed on both the physician and patient, making the prescription of isotretinoin more rigorous and burdensome (Table 1).
In February 2004, the Drug Safety and Risk Management and Dermatologic and Ophthalmic Advisory Committees created
iPLEDGE in order to reduce fetal exposure to isotretinoin and monitor the prescribing, dispensing, and distribution of all isotretinoin brands.3 The main goals of iPLEDGE are to prevent pregnancies in females taking isotretinoin and to prevent pregnant females from taking isotretinoin.4 Using a performance-linked access system, the responsibility for achieving these goals are distributed among patients, physicians,
pharmacies, manufacturers, and wholesalers, all of whom are required to register with iPLEDGE online or by telephone.
1,2,5 As a result of the increasing demands placed on the physician, many dermatologists viewed iPLEDGE as an assault on their freedom to practice medicine, and believed that the isotretinoin registry would hinder their patients' access to this drug and breed select "isotretinologists."5
Despite these concerns, iPLEDGE became mandatory on March 1, 2006. Many greeted the web-based system with frustration as faulty program databases and glitches, coupled with inadequate
telephone support, resulted in lengthy wait times and registration delays.2,6 However, dermatologists continued to register with iPLEDGE despite these administrative burdens as there was no alternative way to legally prescribe isotretinoin in the United States.5
Successful use of iPLEDGE requires substantial coordination. Only after the web-based system verifies that physician and patient are compliant with all iPLEDGE requirements are pharmacists
allowed to dispense the drug.2,4
