iPledge Requirements for Men and Women

Because isotretinoin medications (like Absorica, Claravis, etc.) can cause severe birth defects when taken during pregnancy, the iPledge program was created to help reduce the number of babies born with birth defects caused by isotretinoin. The goat of the program is to ensure no woman gets pregnant while using this medication.

Does this mean men, and women who can't get pregnant, have to participate in the iPledge Program too?  Yes! Anyone taking isotretinoin must be enrolled in and meet the requirements of iPledge.

But men and women who can't get pregnant have different requirements than women who can get pregnant.

Women of non-childbearing potential include post-menopausal women, women who had their ovaries removed, and women who are otherwise physically unable to bear children.

Women who have had their tubes tied are considered to be of childbearing potential, because of the very slight chance of pregnancy even after the procedure. So, ladies, even if you have had a tubal ligation you will still have to follow the iPledge requirements for women who can get pregnant (including using two forms of birth control).

If you are male, or you are a woman who can't get pregnant, you are required by iPledge to:

Talk to Your Doctor

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Before enrolling in the program, you'll need to get counseling from your doctor regarding the proper use possible side effects of isotretinoin use.

Isotretinoin is a powerful drug that can be a wonderful treatment for those with severe acne, but it does come with side effects and some risks. The goal is for you to understand what these risks are before beginning treatment.

Read and Sign Patient Information/Informed Consent

Your doctor will have you read and sign documents stating you understand the risks involved with isotretinoin treatment. You also need to understand what your responsibilities are during treatment.

Before you sign the forms, your physician will explain everything you need to know about treating acne with isotretinoin: how it's used, potential side effects, and how to minimize them.

Your doctor will also talk to you about warning signs to watch out for, and give you an idea of how long your treatment will take.

Make sure to ask your doctor if you have any questions, or if there is anything you don't understand.

See Your Doctor Every Month

You and your doctor will get to know each other very well during your isotretinoin treatment. You'll be seeing each other every month.

During these visits, you'll be able to talk about any side effects you may be experiencing, ask questions and voice concerns, and have blood tests done as needed.

Then you'll be on your way to getting your next 30-day supply of medication.

Pick up Your Prescription within a 30-Day Window

Unlike women who can get pregnant (who must pick up their medication within a 7-day window) you will have a 30-day window in which to fill and pick up your prescription.

Count Day 1 as the day of your doctor's appointment. If for some reason, you can't pick up your medication within this window, you will have to go through the authorization process again.

Not Donate Your Blood

While it's admirable to want to donate blood for those who may need it, you can't donate while taking isotretinoin. If your blood is given to a woman who is pregnant, her unborn child could be exposed to the drug and be at risk for severe birth defects.

You will be able to donate blood 1 month after you've finished your last course of isotretinoin.

Once You've Completed These Requirements You Can Fill Your Prescription

Once you have completed all of these requirements, and they are entered into the iPledge computer system, you will be able to fill your prescription. Your pharmacist will access this system to receive authorization to give you your medication.

This isn't just a one-and-done process, though. Remember, you will have to meet these requirements each month that you are taking isotretinoin.

Sources:

"About iPledge." iPledge. 2005. Web.

"Blood Donor Eligibility Requirements." American Red Cross. 2016. Web.

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