National report — This month begins the Food and Drug Administration (FDA)-mandated iPLEDGE system for patients, physicians and providers of isotretinoin.
National report - This month begins the Food and Drug Administration (FDA)-mandated iPLEDGE system for patients, physicians and providers of isotretinoin.
The computerized registry is designed to prevent fetal exposure to isotretinoin, known to have teratogenic effects.
The FDA set Nov. 1 as the date by which wholesalers and pharmacies were required to register to obtain isotretinoin from manufacturers. Patients and prescribers have until Dec. 31 to register and comply with requirements in areas including office visits, counseling and birth control.
The registry process gives women seven days from the date their prescriptions are written to fill them. Additionally, women must submit evidence of a negative pregnancy test monthly before they can get a refill. The system will also schedule female patients for pregnancy tests at the conclusion of therapy and 30 days later.
"Enhancing and combining the previous risk management programs into one collaborative program minimizes possible confusion from having multiple equivalent programs, and further tightens existing links between pregnancy testing and dispensing of the drug through mandatory registration of all parties and other mechanisms. The enhancements to the programs strive to prevent, to the extent possible, the risk of fetal exposure to isotretinoin," says a spokesperson for iPLEDGE, whose sponsors include Hoffman-LaRoche (Accutane), GenPharm (Amnesteem), Ranbaxy Pharmaceuticals (Sotret) and Barr Laboratories (Claravis).
In an editorial in the October issue of Dermatology Times, editorial adviser Ronald G. Wheeland, M.D., warned, "If sufficient numbers of physicians don't register, or if the number of pregnancies occurring while female patients are receiving this drug doesn't dramatically decline, it is my opinion that the Food and Drug Administration will remove it from the market and we will lose this drug from our armamentarium. If access to this important drug is eliminated, it will be our patients with scarring cystic acne who will lose the most."