AAD Suggests Halting iPLEDGE Program

A scheduled change to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) has led to a delay in isotretinoin prescriptions. Physicians and their teams have been unable to access the iPLEDGE site during an update to incorporate an FDA-approved modification to the iPLEDGE REMS that took effect December 13, 2021.

iPLEDGE Program was implemented in early 2005 and approved as the iPLEDGE REMS in 2010 with the goal of preventing fetal exposure to isotretinoin. It also aims to inform prescribers, pharmacists, and patients about isotretinoin’s serious risks and safe-use conditions.

The American Academy of Dermatology (AAD) had sent Syneos Health and the iPLEDGE sponsors correspondence about their concerns with the modifications of the program. The letter can be found here. The AAD also sent a letter to Patrizia Cavazzoni, the director of the Center for Drug Evaluation and Research at the FDA.

For more details on how this issue began, read our article here.

John Barbieri, MD, MBA, FAAD, speaking in his capacity as a member of the AAD iPLEDGE Workgroup, explained that an emergency meeting will be taking place Thursday, December 16, 2021, to discuss how to handle the situation.

The AAD will be asking the FDA to halt the iPLEDGE RMS at the emergency meeting so patients can receive their prescriptions. “The most important priority is identifying a solution so that patients can continue to get their prescriptions, and so that everyone understands how this program works going forward. It seems unlikely that the administrators are going to be able to fix these substantial issues… in a timely manner,” Barbieri said.

Barbieri continued to explain that the decision to halt the program should be strongly considered by the FDA to provide acute relief to this problem so that patients can access their isotretinoin medication. The most important goal, Barbieri said, was that patients can safely access isotretinoin, whether that be through halting the program or administrators quickly fixing the issues.

The FDA is separate from the management of the iPLEDGE program and the vendors running the website and call center. Barbieri said there are 2 issues: how best to run the program and the lack of access to the website right now.

Informing patients about the risks of isotretinoin is a part of what physicians do, Barbieri continued, and is at the core of taking care of patients. The includes providing counseling and informing the patient about preventing pregnancy. Barbieri said this accomplishes the goal of what iPLEDGE is aiming for.

“Physicians have always been empowered and are always capable in their efforts to prevent fetal exposure to isotretinoin and, and can continue to use this medication safely,” Barbieri said.

Also, he talked about how some issues with iPLEDGE, like patients who aren't of childbearing potential having to go through some of the same logistical challenges that patients who are childbearing potential, “And that doesn’t make sense with the goals of iPLEDGE in mind,” Barbieri said.

Right now, the AAD’s top priority is advocating for a solution so patients can get access to their prescriptions, Barbieri emphasized. Some patients may be concerned about how to move forward without access to their medications.

Isotretinoin has a half-life of about a day, Barbieri continued, so the medication builds up over time. This means if a patient misses a week of treatment, it will not necessarily have a major impact on outcome, but it is not optimal, he said, and can lead to other issues.

“One thing I worry about is these breaks related to programmatic issues, where patients may not be able to resume it,” Barbieri said. “I think it's important that the iPLEDGE sponsors think about a clear and efficient pathway so that everyone can get back on board to the system and communicate this effectively to everyone.”

He gave an example of a patient not being able to pick up their first prescription of isotretinoin within 7 days of their pregnancy tests which may cause them to be “locked out” of the system for a month. This leads to them not being able to be prescribed again until that period passes. He also mentioned that there may be patients who get locked out and cannot get back into the system. Therefore, Barbieri urges the patients and dermatologists to work together to find a solution.

The AAD will be continuing to communicate information about this situation. For more resources about isotretinoin, please visit https://www.aad.org.

Reference:

1. Ipledge risk evaluation and mitigation strategy (REMS). FDA. Published online December 14, 2021. Accessed December 14, 2021. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/ipledge-risk-evaluation-and-mitigation-strategy-rems