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性别中立术语在风险评估和缓解战略计划中的重要性:呼吁采取行动

Colin Burnette¹, William Smithy¹, Daniel Strock²

¹Nova Southeastern University College of Osteopathic Medicine, Davie, FL, United States.

JMIR dermatology

|August 26, 2023

概括

风险评估和缓解策略 (REMS) 计划,如对异三胺的iPLEDGE,正在更新基于怀孕潜力的性别中立类别. 这改善了多样化的患者的获取,并维持了出生缺陷预防的目标.

科学领域:

皮肤病学皮肤病学
药理学药理学是指药理学的学科.
公共卫生公共卫生

背景情况:

风险评估和缓解策略 (REMS) 计划对于具有原性潜力的药物至关重要,例如异二胺.
之前根据性别和生殖潜力对患者进行分类的iPLEDGE系统,对性别多样化的个体造成了痛苦.
对于thalidomide,acitretin和mycophenolate mofetil,现有的REMS程序使用类似的过时分类.

研究的目的:

评估修订后的iPLEDGE指导方针对性别多样性人口的异丁氨酸可访问性的影响.
倡导在其他REMS项目中采用性别中立的注册标准.
通过将REMS协议与生殖潜力相协调,而不是性别或性别来提高患者安全和治疗可访问性.

主要方法:

分析更新的iPLEDGE系统的注册类别.
审查之前的 iPLEDGE 患者分类及其局限性.
对iPLEDGE的新框架与其他原药物REMS计划的比较评估.

主要成果:

新的iPLEDGE指南根据怀孕潜力 (可以或不能怀孕) 将患者分类,取代了基于性别的类别.
这一变化通过减少处方障碍,改善了性别多样性个体对异丁的可访问性.
虽然系统转换带来了最初的挑战,但基于生殖潜力的方法支持了预防出生缺陷的首要目标.

结论:

修订后的iPLEDGE系统有效地解决了性别多样性问题,并改善了异丁的可访问性.
建议对thalidomide,acitretin和mycophenolate mofetil等药物进行基于生殖潜力的性别中立术语的REMS程序的标准化.
未来的REMS协议应该优先考虑出生缺陷预防,而不是性别或性别考虑,以最大限度地增加入学率并最大限度地减少患者的痛苦.

关键词:

雷姆斯是一种REMS.可访问性可访问性屏障障碍物屏障障障碍物屏障障障碍物生物学上的性别.呼吁采取行动的呼吁.评估和缓解战略的评估和缓解策略.性别性别性别性别性别性别多样性性别多样性性别形症是什么意思性别形症是什么意思这就是 iPLEDGE 的原因.个人身份身份身份身份.医疗社区医疗社区这是一种口服的视网类药物.护理的质量护理质量跨性别患者的患者.治疗治疗治疗治疗治疗治疗

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