Baek Peter, Shah Nidhi, Kirkorian A Yasmine
The George Washington University School of Medicine and Health Sciences, Washington, DC, USA.
Division of Dermatology, Children's National Hospital, Washington, DC, USA.
Pediatr Dermatol. 2025 Mar-Apr;42(2):413-414. doi: 10.1111/pde.15765. Epub 2024 Sep 23.
Isotretinoin, the standard treatment for severe nodular acne, is subject to stringent iPLEDGE regulations due to its teratogenic risks, requiring monthly assessments for patients of childbearing potential. Analysis of the iPLEDGE Comprehension Assessment (iPCA) revealed an average readability score of grade 8.5, exceeding the recommended grade 6 level for optimal patient comprehension. The complex language of iPCA may hinder patients from accessing treatment, contributing to delays and potential discontinuation, especially among female patients. While the overall number of isotretinoin-exposed pregnancies has decreased since the inception of iPledge, several hundred pregnancies continue to be reported, and simplification of iPCA presents one avenue to improve patient comprehension, safety, and ensuring equitable access to isotretinoin.
异维A酸是重度结节性痤疮的标准治疗药物，因其致畸风险而受到严格的iPLEDGE法规监管，要求对有生育潜力的患者进行每月评估。对iPLEDGE理解评估（iPCA）的分析显示，平均可读性得分相当于八年级半的水平，超过了为实现最佳患者理解而建议的六年级水平。iPCA复杂的语言可能会阻碍患者接受治疗，导致治疗延误和潜在的停药情况，尤其是在女性患者中。虽然自iPledge实施以来，异维A酸暴露导致的妊娠总数有所下降，但仍有数百例妊娠报告，简化iPCA是提高患者理解度、安全性并确保公平获得异维A酸的一条途径。
