Six months ago the FDA launched iPLEDGE, a mandatory registry for users of Isotretinoin (commonly prescribed as Accutane), designed to keep its users pregnancy free. Given that the powerful acne medication that's prescribed to 5 million Americans has been linked to serious birth defects and mental health problems, precautionary steps are understandable.
The FDA, caught in a tussle between patients wanting this extremely effective acne drug and those wanting it off the market, accepted iPLEDGE as a compromise to essentially improve behavior while taking a dangerous drug. But the requirements of the "computer-based risk management program" are so daunting it turns out people might be avoiding the drug altogether.
Women on the medication take mandatory pregnancy tests each month (two, one in a clinic), and have to take two forms of birth control at the same time. Or, they can pledge to "abstain from intercourse for one month prior to treatment, during treatment and for one month after treatment has ended." Every month patients must repledge the two forms of birth control they are using. Those who get pregnant anyway must "agree to be queried by an agent of iPLEDGE."
Male users have to sign on as well, and all users have to sign a document acknowledging that Accutane can increase risk for birth defects, depression, and suicidal thoughts.
Doctors and patients alike are complaining about the complicated $80 million system that requires everyone, patients plus all the people involved in the distribution of the drug to register: doctors, pharmacists and drug wholesalers included.
Each month prescribers must enter a female patient's pregnancy test results into the system and the two forms of contraception she is using. The system then authorizes the doctor to prescribe, and the pharmacist to dispense, the drug. Yesterday, the Washington Post reported that the 15,000-member American Academy of Dermatology (AAD) released a survey finding:
-90% of 378 physicians are having problems with the program.
-Nearly 52% said patients' treatments had been delayed because they were unable to pick up a prescription within seven days.
-39% said their patients encountered technical problems using the website.
The website itself is a curious sight. The tagline, "Committed to Pregnancy Prevention" has an icon that is a red stop sign with a big hand in the middle. The website features a big red arrow with the words "The Only Way" running across each page. Of the women on Accutane, 80% are under 30, "females of childbearing potential" and given the hoops women have to go through abstinence may be the best policy when taking the drug, or finding another drug. One outgrowth of the system is that, if it survives, it will creates a national database tracking birth control use and behavior, as well as pregnancies and abortions, of Isotretinoin users. Somewhat far afield of treating acne. We'll stay tuned to see how it plays out.