U.S. Food and Drug Administration approves changes to iPLEDGE program

The U.S. Food and Drug Administration has approved a modification to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program. Beginning December 13, 2021, system changes for health care professionals and patients will go into effect.

Please note that prior to this modification, the iPLEDGE website and iPLEDGE REMS Contact Center phone service will undergo maintenance starting Friday, December 10 at 11:59 p.m. EST until Sunday, December 12 at 11:59 p.m. EST. During this time, iPLEDGE will be completely unavailable.

Important changes for Patients:

Starting on December 13, 2021, patients will be assigned to one of two risk categories: patients who can get pregnant and patients who cannot get pregnant. Patients will also have the option of presenting a unique QR code at the pharmacy on their smartphone instead of providing their iPLEDGE identification number. Patients can access their unique QR code by logging into their account on the iPLEDGE REMS website.

Any patient whose isotretinoin prescription RMA (i.e., iPLEDGE authorization) expires during the weekend of December 11-12, 2021 must obtain their prescription before 11:59 p.m. (Eastern) on Friday, December 10, 2021. If the RMA expires before the prescription is picked up from the pharmacy, the patient must go back to their prescriber and start the authorization process again.

Important changes for Health Care Providers:

Patient risk categories in the REMS will be reduced from three options to two. The new risk category options are: patients who can get pregnant and patients who cannot get pregnant. Health care providers must assign and confirm their currently enrolled patients’ risk category for each patient upon their first login into the iPLEDGE REMS website on or after December 13, 2021. The iPLEDGE REMS Prescriber Guide describes the qualification criteria for determining the reproductive potential of a patient.

Prescribers and their designees should ensure that any patient whose isotretinoin prescription RMA (i.e., iPLEDGE authorization) expires on December 11-12, 2021 is instructed to obtain their prescription before 11:59 p.m. (Eastern) on December 10, 2021.

Important changes for Pharmacies:

The REMS administrator has changed, and the current “switch” pharmacy management system is being removed as a method to verify authorization to dispense isotretinoin. With the changes to the pharmacy management system, pharmacists will no longer use the switch system to obtain a pre-dispense authorization, known as a risk management authorization (RMA). Starting on December 13, 2021, all pharmacists must obtain an RMA prior to dispensing isotretinoin by accessing the iPLEDGE REMS website or the iPLEDGE REMS Contact Center.

Pharmacies will not be able to obtain an RMA number to dispense isotretinoin between December 11-12, 2021. Isotretinoin manufacturers anticipate the phone and internet systems for the modified iPLEDGE will be available on December 13, 2021.

For complete information on the new 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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