FDA Announces Modifications to iPLEDGE REMS Program

The Food and Drug Administration has approved system changes to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program for isotretinoin products.

The system changes will go into effect starting December 13, 2021 for health care professionals, pharmacies, and patients. Prior to the modification, the iPLEDGE website and iPLEDGE REMS Contact Center will undergo maintenance and will be unavailable on December 11 and 12, 2021. Any patient whose isotretinoin prescription risk management authorization (RMA) (eg, iPLEDGE authorization) expires on these dates must obtain their prescription before 11:59pm on Friday, December 10, 2021. 

The modified iPLEDGE REMS will require health care professionals to assign and confirm their currently enrolled patients’ risk category upon their first login into the iPLEDGE REMS website on or after December 13, 2021. Patient risk categories will be reduced from 3 to 2 options: patients who can get pregnant and patients who cannot get pregnant. To determine the reproductive potential of a patient, health care professionals can access the iPLEDGE REMS Prescriber Guide which describes the qualification criteria.

Additionally, pharmacies will no longer be able to use the switch pharmacy management system to obtain a pre-dispense authorization. Starting December 13, 2021, all pharmacists will be required to obtain an RMA prior to dispensing isotretinoin through the iPLEDGE REMS website or the iPLEDGE REMS Contact Center.

For patients, the modified iPLEDGE REMS program allows for use of a unique QR code at the pharmacy rather than the iPLEDGE identification number. The QR code will be available on each patient’s account on the iPLEDGE REMS website.

Reference

iPLEDGE Risk Evaluation and Mitigation Strategy (REMS). News release. US Food and Drug Administration. Accessed October 12, 2021. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/ipledge-risk-evaluation-and-mitigation-strategy-rems.