IPLEDGE

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The iPLEDGE program is a mandatory distribution program in the United States for isotretinoin (commonly sold as Accutane), intended to prevent the use of the drug during pregnancy due to the high risk of birth defects (see Isotretinoin#Teratogenicity (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 only known long term-inhibitor for severe cystic acne vulgaris, a condition 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.

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Process

The program is intended to work as follows: first, the doctor prescribing the drug enters patient information on the iPLEDGE website. 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.

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.

Recently the iPLEDGE program has been relaxed for males and women of non-childbearing age. Doctors can issue prescriptions a few days early if appointments do not happen to line-up with the 30 day window. A lost or unfilled prescription can also be rewritten within 30 days. Mandatory patient counseling and reporting in the online system is still required for all patients.

Criticisms

Criticisms of the iPLEDGE program include the following:

Difficulty of compliance

The time and expense of compliance with iPLEDGE is significant, and may pose a barrier to treatment if doctors do not wish to expend the effort required.

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."

For many patients, the iPLEDGE program has caused delays in receiving isotretinoin. Doctors may not prescribe more than a 30 day supply. A new prescription may not be written for at least 30 days. Pharmacies are also under similar restriction. No more than a 30 day supply may be filled. There is also a 7 day window in which the medication must be picked up at the pharmacy. If the original prescription is lost, or pick-up window is missed, the patient must wait 30 days without any medication. Doctors and pharmacists must also verify written prescriptions in an online system before patients may fill the prescription. This sequence of requirements can make it very difficult for patients to receive and take isotretinoin on the prescribed schedule. Many patients are forced to wait several days without medication.

Privacy

Some patients complain of the requirements of the iPLEDGE program and say patients must choose between privacy or treatment. Some requirements of the program include regular blood testing every thirty days and regular pregnancy tests every thirty days.

Medicare part D

Another criticism is that pharmacists are already taxed with compliance with Medicare Part D.

Criticisms of the iPLEDGE website

Some criticisms of the iPLEDGE website include the website provides no information about who administers the site or how patients' private information is secured. Another criticism is that a website is not an effective pregnancy prevention program

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

Although the goal of the program is to prevent pregnancies, male patients must also use the same program even though the questions and "Pledge" are geared towards females. This includes promising that they will not get pregnant as part of the iPLEDGE questioning. There has been no link to birth defects from Accutane associated with males using the drug.