Removal of Isotretinoin Gender-Based Guidelines: Inclusivity Takes Precedence
The iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) system recently underwent major structural changes. After many years of advocacy by physicians and patients, the program has changed to reflect more inclusivity in the enrollment process. Specifically, the risk categories of females of reproductive potential, females not of reproductive potential, and males were replaced by 2 categories: (1) people who can get pregnant, and (2) people who cannot get pregnant. The importance of this change is detailed here along with proposed questions we can ask patients to understand their pregnancy-related risks with isotretinoin. As allies to our patients, we strive to create an environment of equal care for all, and this change moves us in a more inclusive, patient-centered direction.
Resident Pearls
- Major changes in the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) system recently took place, including simplifying registration categories while making the process more inclusive for patients.
- It is important to practice culturally sensitive language when discussing subjects regarding gender identification and sexual practices. Sample questions have been provided to help familiarize practitioners with optimal ways to approach these patient encounters.
- There likely will be more changes with iPLEDGE REMS in the future as the American Academy of Dermatology Association continues to work on solutions regarding decreasing monthly qualifications for patients who cannot get pregnant and possible removal of patient attestation requirements.
Transgender patients have unique and unmet needs that often are overlooked and prevent them from equitable, gender-affirming health care. For example, in a prospective study following 20 transgender men starting hormone replacement therapy, the percentage of patients with facial acne increased from 35% to 82% after 6 months of therapy.5 In addition, the increased psychosocial burden of acne may be especially difficult in these patients, as they already report higher rates of depression and suicidal ideation compared with their heterosexual cisgender peers.4 Further, the primary patient populations receiving isotretinoin typically are adolescents and young adults who are undergoing major physical, mental, and hormonal changes. Self-discovery and self-actualization develop over time, and our role as physicians is to advocate for all aspects of our patients’ health and eliminate barriers to optimal care.
Inclusive Language in iPLEDGE Categories
It is important to streamline access to care for all patients, and gender-affirming, culturally sensitive language is essential to building trust and understanding between patients and providers. Howa Yeung, MD, MSc, a dermatologist at Emory University (Atlanta, Georgia) who advocated for gender-neutral iPLEDGE registration, welcomes the change and stated it “will make my job easier. I no longer have to struggle between respecting the patient’s gender identity and providing medically necessary care for patients with severe acne.”3
Sanchez et al6 provided a list of structured questions providers can ask their patients to assess their risk regarding pregnancy: (1) Do you have a uterus and/or ovaries?, (2) Are you engaging in sexual intercourse with a person who has a penis?, and (3) If yes to these questions, what form(s) of birth control are you using? Providers should preface these questions with the following statement: “It is important that I ask these questions to assess your risk for becoming pregnant on this medication because isotretinoin can cause very serious birth defects.” It is important to review these questions and practice asking them so residents can operate from the same place of openness and understanding when caring for their patients.
Final Thoughts
The landscape of isotretinoin prescribing currently is changing on a day-to-day basis. As residents, it is important we stay up to date with the changes regarding our regularly dispensed medications. The main modification made to the iPLEDGE REMS system was switching the risk categories from 3 (females who can get pregnant, females who cannot get pregnant, males) to 2 (people who can get pregnant, people who cannot get pregnant). This change will make registration for iPLEDGE less complex and more inclusive for all patients. It is important for residents to stay at the forefront of these patient health issues and barriers to equal care, and this change represents a step in the right direction.
