49. USA only - iPLEDGE Program for isotretinoin

Doctor Jacob here, and we're talking about the iPLEDGE Program, which is a program instituted in 2006 by the Food and Drug Administration of the United States to control who may receive isotretinoin. The goal is to minimize the chance of a female patient becoming pregnant while taking this drug.

All patients who receive isotretinoin in the United States must participate in the iPLEDGE Program; there are no exceptions.

As required by the program, patients who receive isotretinoin may not receive more than a 30-day supply. This means that isotretinoin patients must plan on monthly appointments with their dermatologist. Just to be clear, not refills are given with isotretinoin prescriptions. Monthly visits are required. Patients may not donate blood during therapy or for one month after discontinuation.

Once a woman has had her first menstrual period, she is considered to be of child-bearing potential. Women patients who have passed menopause, or have had surgical removal of the reproductive organs are treated like male patients under the iPLEDGE Program. However, females who have had their tubes tied are still considered to be of reproductive potential.

All patients have a specific period of time in which their prescription is valid; this is called the prescription window. For women with reproductive potential, the prescription window is seven days. For men it's 30 days, and for women of non-reproductive potential it's also 30 days.

Once the prescription window is over, the prescription is automatically expired and a new prescription will be needed. Additionally, females patients of child-bearing potential who do not fill and pick up their first prescription in the first seven-day window must wait at least 19 days from their most recent pregnancy test until getting their next pregnancy test. This is based on the requirement that the most recent pregnancy test prior to starting therapy must be collected in the first five days of a woman's menstrual cycle.

To receive monthly prescriptions, a female patient must also answer questions in the iPLEDGE system, basically going and logging in and then answering comprehension questions. For example, "May I share my medication with a friend?" and the answer would be no. Or for example, "How many days do I have until the prescription expires?" in which case the answer would be seven.

For females of child-bearing potential, it is mandated that two forms of contraception be used, if sexually active. Abstinence is acceptable, however many women do not know if they will be sexually active within the next 6 to 8 months, even if they're not active today.

Typically, women choose a form of birth control or hormonal contraception as one method, using a back-up method such as a male latex condom.

Prior to getting started with this drug, female patients of child-bearing potential must have two negative pregnancy tests using either urine or blood before receiving the initial prescription. These two tests have to be at least 19 days apart, and the second test should fall within the first five days after the start of the menstrual period. For each month of therapy thereafter and one month after completing, female patients of child-bearing potential must return to their physician for evaluation, counseling, education, as well as a pregnancy test.

To summarize, the system is a pain in the butt for women who can get pregnant. Basically, you can't start the medicine right away; you have to have a 30-day waiting period where you at first get some negative pregnancy tests, wait 30 days, go back in, get another negative pregnancy test and then you can start. Before you actually pick up your medicine, every month you have to go back to your doctor and then go home, log into your iPLEDGE account, answer some comprehension questions, then you can go to the pharmacy and then they can give you your medicine.

It's a pain in the butt for women. For men it's a lot easier, but still it requires coming back every 30 days.

That's all for today. I'm Doctor Jacob, we'll see you next time.