iPledge Requirements for Females Who Can Get Pregnant

If you're going to take isotretinoin, prepare to get really familiar with the iPledge program. This program was put in place to prevent birth defects caused by isotretinoin.

You'll need to enroll in iPledge to get your prescription; it's a requirement for everyone who is prescribed isotretinoin medications like Absorica, Amnesteem, Claravis, and Sotret.

Because of the high risk of birth defects in babies whose mothers take isotretinoin, any woman who can become pregnant—no matter how remote the chances—have certain criteria to meet in order to receive this medication.

This includes young people who have not started menstruating yet, and even those assigned female at birth who have had their tubes tied. (Men have their own set of iPledge requirements, by the way.)

As these steps are completed, they are entered into the computer-based iPledge system. Your pharmacist will access this system to receive authorization to give you your medication. You must re-qualify with iPledge every month prior to refilling your prescription.

If you are a person who can get pregnant, no matter how slight the chances, you are required to:

Talk to Your Healthcare Provider

Cropped shot of young woman holding medicine capsule and glass of water
Maria Fuchs / Getty Images

First things first, before starting treatment your healthcare provider will talk to you about the proper use of this medication. You'll also go over possible side effects of isotretinoin.

It's important you understand all the risks involved before committing to treatment. Take this time to ask questions. If you're unsure about something or don't understand something, let your healthcare provider know.

Read and Sign the Patient Information/Informed Consent

Your healthcare provider will give you documents outlining patient information/informed consent to review and sign. These documents are basically a review of what you and your healthcare provider have talked about regarding isotretinoin use.

Read through the information. The goal of the patient information/informed consent is to ensure you fully understand how isotretinoin works, its side effects, and your responsibilities while taking this drug.

After reading, you'll sign the documents. Again, if you're not clear on something, don't be afraid to ask before you sign.

Submit to Regular Pregnancy Testing

You must have two negative pregnancy tests before you receive your first month's supply of isotretinoin. The first pregnancy test will be done by your healthcare provider before you're accepted into the program; the second must be done by a Clinical Laboratory Improvement Amendments-certified laboratory (CLIA).

You'll also need a negative pregnancy test each month before getting your refill, and one last pregnancy test one month after stopping treatment.

Going forward, monthly pregnancy tests must be done by a CLIA-certified lab. Your healthcare provider will give you information on approved labs in your area.

Use Two Forms of Contraception at All Times

You must use two forms of contraception one month prior to receiving your medication, the entire time during treatment, and for one month after stopping treatment. Birth control forms must be used together, at the same time (i.e. condoms along with oral contraceptives).

Not all forms of birth control are approved by the iPledge program. Talk to your healthcare provider about accepted forms of contraception. This appointment may be paid for by the program.

See Your Healthcare Provider Every Month

You'll be seeing a lot of your healthcare provider during your isotretinoin treatment. You'll have an appointment every month to discuss your questions and concerns, fill them in on the side effects you're experiencing, and take blood tests as needed.

Answer Questions in the iPledge System

Each month, before you pick up your medication, you'll need to access the iPledge system via your computer. Once there, you will be asked random questions about the iPledge program. You will also confirm the two birth control methods you are using.

And no, you can't skip this step. Your pharmacist can't fill your prescription until you have completed all necessary steps.

Pick up Your Prescription within a 7-Day Window

Count Day 1 as the day of your pregnancy test. You will have to pick up your prescription within the next seven days.

If, for some reason, you can't get your isotretinoin within this window, you will have to re-qualify to receive your medication. This means you will have to do another pregnancy test, and answer questions in the iPledge system again. Unless this is your first prescription, you can immediately begin the qualifying process.

If you miss the 7-day window to pick up your very first prescription, you will have to wait 19 days before you can start the qualification process again. You will be locked out of the system during this time, no exceptions. Neither your pharmacist, healthcare provider , nor the iPledge call center can "unlock" you.

Don't Donate Blood

Do not donate blood while taking isotretinoin. If your blood is given to a woman who is pregnant, the fetus could be exposed to the drug and develop birth defects.

A Word From Verywell

While complying with iPledge requirements are cumbersome, these safeguards have drastically reduced the number of babies born with birth defects due to isotretinoin exposure. Yes, the whole process can feel tedious but once you've done it a few times you'll see it isn't incredibly complicated.

Also remember that you won't, in the vast majority of cases, be taking isotretinoin long-term. So it will only be a few months of inconvenience. Once you've been off isotretinoin for a month, you may be transitioned over to another acne medication and be done with iPledge requirements. Most likely with clear skin!

And if isotretinoin isn't the right treatment for you, there are plenty of other options. Your dermatologist will help you find the best acne treatment medication for you.

1 Source
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Choi JS, Koren G, Nulman I. Pregnancy and isotretinoin therapy. CMAJ. 2013;185(5):411-3. doi:10.1503/cmaj.120729

Additional Reading

By Angela Palmer
Angela Palmer is a licensed esthetician specializing in acne treatment.