iPLEDGE

iPLEDGE is a distribution program designed to prevent pregnancies in patients taking isotretinoin and to prevent pregnant people from taking isotretinoin. Isotretinoin is sometimes used by dermatologists to treat severe acne, but it is teratogenic and must not be used by pregnant people. There is an extremely high risk of birth defects if pregnancy occurs while a patient is taking isotretinoin, even for a short period of time. iPLEDGE is mandated by the FDA.

Important updates to the iPLEDGE program

Please note, that although the FDA has approved the changes below, the Academy continues to advocate on behalf of its members to reduce the burden of these changes on dermatologists.

Nov. 30, 2023

Thanks to the AADA’s strong advocacy the FDA will require modifications to the iPLEDGE Program that would minimize burdens on patients and dermatologists while maintaining the safe use of isotretinoin.

The FDA will require the Isotretinoin Product Manufacturers Group (IPMG) to implement the following changes to the iPLEDGE program:

• Remove the waiting period requirement (or the 19-day lockout) for patients if they do not obtain isotretinoin within the first seven-day prescription window. Before initiating isotretinoin treatment, a repeat confirmatory pregnancy test must be completed in a medical setting without any required waiting period.

• Revise the pregnancy registry requirement to remove the objective to document pregnancy and fetal outcomes (and associated data collection) for each pregnancy.

• Revise the requirement for prescribers to document patient counseling in patients who cannot become pregnant from monthly to only at enrollment.

• Remove the requirement that pregnancy tests must be performed in a CLIA-certified laboratory. However, all pregnancy testing before isotretinoin treatment initiation must be completed in a medical setting (e.g., prescriber’s office, clinic laboratory).

• Allow prescribers the option of using home pregnancy testing for their patients during and after isotretinoin treatment.

The IPMG will be required to implement these changes six months from the date of the FDA’s notification. Then, the FDA has six months to review and approve the changes. Therefore, these changes may take up to a year or more to be fully implemented.

The AADA has already requested to participate in the next phase of this process and will continue to advocate for other iPLEDGE program recommendations.

The AADA long advocated for this flexibility to remain and testified in March at an FDA advisory committee hearing, coordinated with several stakeholder societies, sent numerous letters, and engaged members who sent nearly 600 letters to the FDA.

When visiting the iPLEDGE REMS website, what should Prescribers and Designees do to comply?

Update your account: There are security standards to confirm your identity and update your password. You will need your DOPS.

• Prescribers: Login to iPLEDGE Program website to make sure you know your identifiers required to access the new system [NPI & DOPS]. The National Provider Identification (NPI) number, can be found online via the National Plan and Provider Enumeration System.

• Designees: Login to iPLEDGE Program website to ensure you have your identifiers required to access the new system [Username and DOPS].

Update patient categories for existing patients: Providers will have to review their current patients on the Manage Patients Screen and confirm the patient category (that is, patients who can get pregnant or patients who cannot get pregnant). This must be done upon acting on an individual patient NOT all at once for existing patients.

• Patients who can get pregnant must follow the Risk Evaluation and Mitigation Strategy (REMS) guidelines to prevent pregnancy during isotretinoin treatment.

• Any patient without a confirmed patient category will not be able to receive their prescription.

Complete new patient enrollment either electronically or on a downloadable paper form. The enrollment will include completing patient risk categorization, registration, and signed informed consent.

• In-office: Consent may be signed electronically in the office on the iPLEDGE REMS website or a paper copy may be downloaded from the web site, signed by the patient. Prescriber must indicate via a checkbox that the signed paper consent has been completed, and the consent form should be kept in the patient’s medical record.

• Telehealth: If the Prescriber chooses to complete the informed consent(s) process electronically, the patient will be able to electronically sign remotely. During the enrollment process, the “Type It” option will send the patient a link, via e-mail or text, to log into the iPLEDGE REMS web site to sign electronically.

What does the modernized program look like?

Patient enrollment must be completed electronically including patient risk categorization and program registration.

Informed consent may be completed electronically or via a downloadable paper form that the patient must sign.

Patients completed informed consent(s) will be available online to download and print. Patients will also have access to their iPLEDGE profile.

Educational materials have been revised and unassigned Patient IDs preprinted on legacy materials will no longer work to enroll new patients after Dec. 10, 2021. Practices should discard any current inventory of iPLEDGE materials and download or order new materials online.

For complete details visit the FDA page on iPLEDGE.

How is electronic enrollment completed?

First time users will need their NPI and Date of Personal Significance (DOPS) to login.

Designees (such as office staff) will need a prescriber’s username and DOPS.

Prescribers (medical professionals such as doctor, physician assistant, or nurse practitioner who has prescribing privileges) may login to ipledgeprogram.com on or before Dec. 10 and review their profile to know obtain the DOPS.

Are there exemptions?

Patients with serious medical reasons, including non-pregnant female patients, can request to bypass the initial 30-day waiting period and obtain quicker access to isotretinoin. This process must be completed by the prescriber as noted in the Prescriber Isotretinoin Educational Kit (PDF).

Questions or feedback?

For questions or to provide feedback on issues with the iPLEDGE program, please contact us.

All new materials can be downloaded or ordered by visiting ipledgeprogram.com.

For complete information on iPLEDGE REMS requirements and to learn more about the new QR code for patients, please visit the iPLEDGE REMS website or contact the iPLEDGE REMS Contact Center at 866-495-0654.

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