The iPLEDGE Risk Assessment and Mitigation Strategy (REMS) has undergone changes approved by the FDA, including system changes for healthcare professionals and patients that took effect on December 13, 2021. Changes to the website were announced by the FDA on October 8, 2021, indicating that it had approved a modification of the REMS iPLEDGE that would take effect on that date of December 13, 2021. This has resulted in many people not being able to dispense or receive their drug based on isotretinoin.
In the weeks following the change, many healthcare professionals and patients struggled to access the site. A recent survey conducted on Dermatology Time® found that two-thirds of survey respondents were excluded from the system, while an additional survey found that over 95% of respondents agreed that the iPLEDGE system should be discontinued.
A statement from the American Academy of Dermatology Association (AADA), presented below, explained how the organization worked with the IPMG to “shut down the program, fix their platform, or find reasonable workarounds for restore patients’ access to isotretinoin “.
The ADA published a letter yesterday stating in its tweet that “The ADA continues to pressure the #I promise Product Manufacturers Group (IPMG) to terminate the program, repair its platform, or find reasonable workarounds to restore patient access to isotretinoin. Learn more and find out how patients can submit their stories.
Some have tried to find workarounds in the system. One such workaround, created by isotretinoin patient Meghan Keating, and retweeted by John Barbieri, MD, MBA, AADA iPLEDGE task force member, lists instructions for helping patients unable to connect. to the site. The instructions present 5 optional ways for patients to attempt to log into the system.
There is also a Change.org petition titled “Cancel the REMS iPLEDGE program so accutane patients can get their prescription drugs,” which is circulating as many have been prevented from getting drugs for weeks.
As of yet, no new information from the FDA has been announced on stopping or stopping the program as patients are still trying to get their isotretinoin medication.
Stay tuned for continued coverage of The Dermatology Times® as this situation evolves.
Engagement Risk Assessment and Mitigation Strategy (REMS). FDA. Published online December 14, 2021. Accessed January 4, 2021. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/ipledge-risk-evaluation-and-mitigation- strategy -rems