Isotretinoin: Navigating one medicine through turbulent times
Novel and timely nuances must be part of the equation.
P007 – Advanced and Quandaries in Isotretinoin Management: Cases and Discussions With the Experts
Friday, Aug. 11 | 10 a.m.– 12 p.m.
Patient storytelling will be the foundation for discussing important updates and considerations in modernizing treatment for serious acne with isotretinoin. In particular, today’s session, “P007 – Advanced and Quandaries in Isotretinoin Management: Cases and Discussions With the Experts,” will cover a range of topics, from evidence-based dosing and monitoring to billing tips in the current health care climate.
Severe and recalcitrant acne is a difficult condition to manage and mitigate. Although isotretinoin can improve a patient’s symptoms immensely, it also can cause serious birth defects if not monitored appropriately, which puts it in an exclusive class of prescriptions. Session director Lorraine L. Rosamilia, MD, FAAD, a dermatologist in State College, Pennsylvania, said experts will share a “toolbox” for guidance.
“We want to provide a toolbox, using evidence and experience, on how to handle these issues prudently, safely, and sensitively,” Dr. Rosamilia said.
Panelist Hilary E. Baldwin, MD, FAAD, will focus on the nuances and intricacies of prescribing isotretinoin, including dosing, laboratory monitoring, and surgical timelines. Fellow panelists Jon Klint Peebles, MD, FAAD, and Trilokraj Tejasvi, MD, MBBS, will delve into recent regulatory, technological, environmental, and social developments.
The iPLEDGE REMS (Risk Evaluation and Mitigation Safety) program for isotretinoin launched 20 years ago, and serves as an intermediary safety program for patients, prescribers, and pharmacists. The centralized system closely monitors required data points to assess drug risk, monitor symptoms, and approve prescriptions, which only come in 30-day supplies due to the medicine’s potential critical side effects.
iPLEDGE was created with drug safety as its pinnacle, but recent events have uncovered flaws in its infrastructure and relevance, said Dr. Rosamilia. Most notably was when the iPLEDGE platform crashed during the COVID-19 pandemic and everything that was established to aid in isotretinoin management was put in jeopardy. Dr. Rosamilia referred to this as “a painfully transparent moment.”
“When [iPLEDGE] doesn’t work, either from a technology standpoint or from a medically relevant one, the entire prescribing process fails, and that further reveals its shortcomings,” she said.
Not only did this capture people’s attention, but it compelled those close to the matter to act. According to Dr. Rosamilia, a committee of AAD members are collaborating closely with the FDA to review iPLEDGE’s parameters, benefits, and inadequacies.
The gender spectrum
One example of where iPLEDGE falls short is it requires people of all genders to have monthly visits, even though patients who have female reproductive organs and can bear children comprise the population that carries the potential risk of birth defects.
“iPLEDGE is very rigid and [physicians] are required to place patients in reproductive categories, but it does not outline these categories completely, or accurately, yet,” said Dr. Rosamilia. “iPLEDGE does not consider the spectrum of our patients’ social norms.”
A possible scenario could be a transgender patient who has female reproductive organs but identifies as male. He, too, said Dr. Rosamilia, would be confined to the strict parameters of iPLEDGE and be required to provide negative pregnancy tests each month to receive his prescription refill. This is only one example of where a patient may not receive medication in the appropriate timeline or may not take it at all because they may not be comfortable going to a lab or pharmacy to take a pregnancy test.
“Our discussions about gender preferences and how we communicate with and care for patients are always evolving,” she said. “It’s impossible to prescribe isotretinoin without having these sensitive conversations, which require building trust with patients.”
Dr. Rosamilia emphasized that iPLEDGE is a work in progress that needs constant assessment and revision to successfully maintain its primary goal of assisting physicians in safely prescribing isotretinoin and providing access to patients with severe acne. She said that if it cannot meet this objective, then there should be a different course for prescribing isotretinoin.
“If you think about this as a new era of personalizing care for these patients, we need to ask specific questions and not assume that we know what the answer is,” Dr. Rosamilia said. “Patients want to do what’s most efficient and safe to obtain this medicine on time, but gender preference and reproductive health are anything but simple to streamline.”