The iPLEDGE program is a mandatory distribution program in the United States for isotretinoin ("Accutane"), intended to prevent the use of the drug during pregnancy due to the high risk of birth defects. As of March 1, 2006, patients and their doctors and pharmacists are required by the US Food and Drug Administration to register and use a web site^* in order to receive this medication.

Isotretinoin is the drug of choice for severe cystic acne vulgaris, which often causes scarring and depression from disfigurement. It has been called "the greatest medical advance of the 1980's." A majority of patients with acne are permanently cleared after a 4 to 5 month course of treatment.

The program is intended to work as follows: first, the doctor prescribing the drug enters patient information on the iPLEDGE website. The dispensing pharmacist then interviews the patient about her sexual practices and checks the website before filling the prescription. The stated goal is to prevent female patients "of childbearing potential" from receiving the drug if they are pregnant, and to prevent them from becoming pregnant if they are taking the drug.

The program was mandated by the FDA despite criticism from practicing medical doctors that its cumbersome nature would make the drug unavailable to deserving patients. In practice, the website has presented many problems to physicians; once information is entered, it can be difficult or impossible to change or correct it. If there is an error, the patient is locked out for 30 days and cannot receive the medication. Problems are common and take days to correct. Technical assistance by phone is available, but callers report waiting "on hold" for 2 hours or more. Criticisms of the iPLEDGE program include the following:

• intrusive and byzantine requirements; patients must choose between privacy or treatment
• the time and expense of compliance is significant, and may pose a barrier to treatment if doctors do not wish to expend the effort required
• pharmacists are already taxed with compliance with part D
• the website provides no information about who administers the site or how patients' private information is secured
• a website is not an effective pregnancy prevention program

In the RxDerm dermatology user group, a physician said, "It will be easier to get a firearm, an abortion or Thalidomide, than to obtain this safe and important medication." He went on to say that this program requires the pharmacist, the physician, and the patient to get online, answer personal and sensitive questions about the patients' sexual practices, urine tests, and menstrual cycles to a faceless governmental confessor, all according to a very tight schedule, just so that a patient may have her acne treated. If any of the numerous requirements are not met, the drug cannot be dispensed and further activity for the patient is delayed for 30 days.

Some Canadian pharmacies will honor US prescriptions, thus providing an alternate source of isotretinoin if US patients are unable to obtain it through FDA-approved procedures.

External links

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• ipledgeprogram.com The official iPledge program web site.
• FDA press release about the program
• Information from the CDC CDC and the March of Dimes^* about Accutane and birth defects
• Medscape Medical News, Dermatologists Frustrated With Problematic iPledge Program, AAD 64th Annual Meeting. Focus session, March 6, 2006