If you are currently taking Isotretinoin, you are probably well aware how the new iPledge System frustrates users. Accessing the iPledge system has never been easy for prescribers or patients. The December 16th 2021 launch of the new system proved to be even more frustrating than anyone could imagine. A laundry list of issues has accompanied the update, including the inability of providers to confirm patients in the system, patient access to complete the FDA-required confirmation questions, and difficulty for pharmacies to fill prescriptions.
Background
- Formerly known as Accutane, Isotretinoin is a prescription medication used to treat moderate to severe acne. Because of the risks involved with taking this drug while pregnant, patients are required to sign into the iPledge Risk Evaluation and Mitigation Strategy (REMS) monthly and answer questions.
- The iPledge REMS is one of many drug safety programs required by the U.S. Food and Drug Administration (FDA) to ensure a drug’s benefits outweigh its risks. To learn more about the risks and benefits of Isotretinoin visit our blog post Attacking Acne with Accutane.
- Providers began prescribing Isotretinoin, the generic form of Absorica®, Amnesteem®, Claravis®, Myorisan®, and Zenatane™, in 1982, but the first REMS program was not required until 2010.
- Female patients are required to have a negative pregnancy test, state their forms of birth control, and prove they understand the risks of the medication every month. If these steps are not taken, patients are locked out of the system and unable to receive their medication for 30 days.
- In 2018, the FDA decided to update the program and remove the gender-specific labels. These updates launched on December 13, 2021.
Post-Launch
- Since the new iPledge REMS system launched in December, patients, prescribers, and pharmacists throughout the country have had difficulties with the program.
- A recent article from Dermatology Times® reported that as of January 6th, nearly two-thirds of their survey-takers were still locked out of the system.
- Because of these glitches, the American Academy of Dermatology (AAD) is urging Isotretinoin manufacturers and the FDA to either “halt the program, fix its platform, or find reasonable workarounds to restore patient access to isotretinoin.”
What You Can Do
While the AAD and FDA work to resolve these issues, here are a few things you can do:
- Try another pharmacy: To date, our practice has found two pharmacies in Virginia that can fill Isotretinoin prescriptions: Coastal Pharmacy in Norfolk and RVA Pharmacy in Richmond.
- Access the site from a desktop computer: Some of our patients and staff members are able to login to and use the new IPldege website on desktop computers. We do not recommend using a phone or tablet as the smaller screen hides buttons and other features.
- Share your story: The AAD offers a portal on their website where patients anonymously share their experience with the new system. This feedback helps the stakeholders understand how best to restore access to treatment and maintain patient safety.
Until these issues are resolved, please know that we understand your frustrations as we are experiencing them too. We appreciate your patience as we work together to access and navigate the iPledge platform. We are doing our very best to help our patients get their medication as quickly as possible.
