Updated November 25, 2014.

Question: What is iPledge?

What is iPledge? Do I have to enroll in the iPledge program if I use isotretinoin?

Answer:

Before you take Accutane or another isotretinoin medication like Claravis, Sotret, or Amnesteem, you'll learn a lot about the iPledge program. iPledge is a computer-based system for patients and healthcare providers, whose primary goal is to ensure no woman gets pregnant while using isotretinoin.


Isotretinoin can cause severe, life-threatening birth defects in babies whose mothers take isotretinoin while pregnant. Even a single dose can be enough to harm an unborn child. iPledge was developed, along with the U.S. Food and Drug Administration, to protect isotretinoin users as well as their developing fetuses. With everyone working together, the iPledge program provides a system of checks and balances to reduce the chance of fetal exposure to this drug.

Everyone who uses isotretinoin, regardless of age or gender, is required to enroll in the iPledge program. Doctors who prescribe isotretinoin, and pharmacies that dispense it also must be registered in iPledge.

Before your doctor can write you a prescription for isotretinoin, he will explain how this medication is used, and tell you the risks and possible side effects. Your doctor will also explain in detail the iPledge program. You must understand and agree to all terms of the program before you can receive a prescription.

But learning about isotretinoin and its side effects is just the beginning.

You must meet certain requirements before you will be qualified to receive your medication. Requirements of the iPledge program includes using two methods of contraception or practicing 100% abstinence during treatment, having negative pregnancy tests each month (for women of childbearing potential), seeing your doctor monthly, and submitting to regular blood tests as needed.

Once you have completed the necessary steps to enroll in the program, you will receive an iPledge card with an identification number. You will need this number each time you pick up your medication.

You'll also have some criteria you'll have to meet each month to get your refill. Each month you'll have an appointment with your doctor, who will enter your information into the iPledge database and verify your negative pregnancy test (for women of childbearing potential). Then, your doctor will write your prescription. You will only get enough medication to last one month.

The pharmacist filling your prescription must also verify through the iPledge system website (or over the phone) that all criteria has been met. Your pharmacist must obtain authorization before giving you the medication. The iPledge program also requires your prescription to be picked up within a certain time frame. If you're a woman of childbearing potential and you miss this window, you'll have to go through the monthly qualification process again.

Although the process may seem like an inconvenience, the iPledge program works and ultimately protects you.

iPledge Requirements for Women of Childbearing Potential

iPledge Requirements for Men and Women of Non-Childbearing Potential

Visit the iPledge Program website