What to Know About the iPledge Program

Before you take isotretinoin medication like Claravis, Sotret, or Amnesteem, you will learn about the iPledge program. iPledge is a computer-based system for patients and healthcare providers whose primary goal is to ensure you do not get pregnant before starting therapy or while using isotretinoin.

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Why Pregnancy Must Be Avoided While Taking 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. According to the iPledge website, birth defects caused by isotretinoin exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. There is also an increased risk of miscarriage. Premature births also have been reported.

Isotretinoin and iPledge Program Registration Basics

iPledge was developed by the Food and Drug Administration (FDA) in an effort to protect against preventable birth defects and other pregnancy-related side effects of isotretinoin. The intent of the iPledge program is to provide 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. Healthcare providers who prescribe isotretinoin and pharmacies that dispense it also must be registered in iPledge.

Before your practitioner can write you a prescription for isotretinoin, they will explain how this medication is used and tell you the risks and possible side effects. Your healthcare provider 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.

Meeting the Requirements for Qualification

Learning about isotretinoin and its side effects is just the beginning of the iPledge program. You must also meet certain requirements before you will be qualified to receive your medication. Requirements of the iPledge program include using two methods of contraception or practicing 100 percent abstinence during treatment, having negative pregnancy tests each month (for people of childbearing potential), seeing a healthcare provider 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 will also have some criteria you must meet each month to get your refill. Each month, you will have an appointment with your healthcare provider who will enter your information into the iPledge database and verify your negative pregnancy test using a CLIA-certified laboratory for women of childbearing potential. Then, your practitioner will write your prescription. You will only get enough medication to last the one month between the required visits.

The pharmacist filling your prescription must also verify through the iPledge system website (or over the phone) that all criteria have 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 person of childbearing potential and you miss this window (seven days starting from the date of a pregnancy test), you will have to go through the monthly qualification process again.

Criticism of the Program

There has been some criticism of the iPledge program, with some patients viewing the monthly pregnancy test requirement as unnecessarily intrusive and a potential disruption of their privacy. Healthcare providers have raised concerns that the program is too cumbersome and difficult for patients to adhere to, particularly the monthly pregnancy tests. Very little information is available on how patient data is stored in the iPledge program, which has also raised patient privacy concerns.

The Bottom Line

Despite concerns raised about the iPledge program, the current rules still require anyone taking isotretinoin to register and submit to this monitoring. Ultimately, the program has been a proven system for preventing devastating birth defects and harmful side effects of Accutane (before it was discontinued in 2009) and other isotretinoin drugs.

2 Sources
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  1. iPLEDGE. iPledge.

  2. FDA. Accutane label.

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