The iPLEDGE program is a risk evaluation and mitigation strategy (REMS). The Food and Drug Administration (FDA) may require a REMS to help ensure that a medication’s benefits outweigh its risks.
A REMS requires certain actions on the part of drug manufacturers, doctors, consumers, and pharmacists to ensure that people taking a medication understand its potential risks.
The iPLEDGE program is a REMS for isotretinoin, a prescription medication used to treat severe acne. It was put in place to prevent pregnancy in people taking isotretinoin. Taking this drug while pregnant can lead to a range of birth defects and health issues.
Everyone taking isotretinoin, regardless of sex or gender, is required to register for iPLEDGE. But people capable of becoming pregnant must take extra steps.
The purpose of the iPLEDGE program is to prevent pregnancy in people taking isotretinoin. Taking isotretinoin while pregnant can cause birth defects. It also increases your risk for complications, such as miscarriage or preterm birth.
Taking isotretinoin at any time during your pregnancy can result in external issues for your baby, including:
- an abnormally shaped skull
- abnormal looking ears, including small or absent ear canals
- eye abnormalities
- facial disfigurements
- cleft palate
Isotretinoin can also cause severe, life-threatening internal problems in your baby, such as:
- severe brain damage, possibly affecting the ability to move, talk, walk, breathe, speak, or think
- severe intellectual disability
- heart issues
You must register for the iPLEDGE program before your healthcare provider prescribes you isotretinoin. They’ll have you complete the registration in their office while they go over the risks. To complete the process, you’ll be asked to sign a series of documents.
If you have female reproductive organs, your registration will need to contain the names of two forms of birth control you agree to use while taking isotretinoin.
Once you complete these steps, you’ll be given instructions on how to sign in to the iPLEDGE system online. Your pharmacist will also have access to this system.
Each month, before your prescription can be refilled, you’ll need to answer a few questions and resubmit your pledge to use two forms of birth control.
iPLEDGE requirements depend on whether or not it’s possible for you to become pregnant.
If you can become pregnant
If it’s biologically possible for you to become pregnant, iPLEDGE requires you to agree to using two forms of birth control. This is usually required regardless of your sexual orientation, gender identity, or level of sexual activity.
People generally opt for a barrier method, such as a condom or cervical cap, and hormonal birth control. You’ll need to use both methods for one month before you can get your prescription.
Before they can register you for iPLEDGE, your healthcare provider is required to give you an in-office pregnancy test. Your registration can move forward after a negative test result.
You’ll need to follow up with a second pregnancy test at an approved lab before you can pick up your isotretinoin prescription. You must pick up your prescription within seven days of this second test.
To refill your prescription each month, you’ll need to take a pregnancy test at an approved lab. The lab will send the results to your pharmacist, who will fill your prescription. You must pick up your prescription within seven days of taking the pregnancy test.
You’ll also need to log in to your iPLEDGE account every month to answer a few questions about birth control. If you don’t take the pregnancy test and follow the steps in the online system, your pharmacist won’t be able to fill your prescription.
If you can’t become pregnant
If you have a male reproductive system or a condition that prevents you from becoming pregnant, your requirements are a bit simpler.
You’ll still need to meet with your healthcare provider and sign some forms before they enter you into the iPLEDGE system. Once you’re set up, you’ll need to follow up with monthly visits to discuss your progress and any side effects you’re having. You’ll have to pick up your prescription refill within 30 days of these appointments.
iPLEDGE has received a good deal of criticism from both medical professionals and consumers since its introduction. It requires a lot of monitoring for those who can become pregnant, so much so that some view it as an invasion of privacy.
Others are critical of the fact that non-menstruating and abstinent young women are being put on birth control.
Some doctors and members of the transgender community are also concerned about the challenges (emotional and otherwise) associated with asking trans men to use two forms of birth control. This is of particular concern because severe acne is a common side effect of testosterone therapy.
Some also question the effectiveness of iPLEDGE and its many requirements.
Despite the program’s requirements, an average of 150 women taking isotretinoin get pregnant every year. This is often due to improper use of birth control.
If you take isotretinoin and have the potential to become pregnant, iPLEDGE can feel like a major inconvenience. Keep in mind the program was put in place for good reason.
Still, it’s not a perfect system, and many take issue with some of the program’s requirements.
If the iPLEDGE program is making you reconsider taking isotretinoin, consider that treatment typically only lasts for about six months, so you won’t need to follow it for very long.