对于iPLEDGE的避孕咨询及其对皮肤科医生的负担
Kelly E Owens1, Simon W Jiang2, Matilda W Nicholas3,4
1Duke University School of Medicine, Durham, NC, USA.
Archives of dermatological research
|May 28, 2024
概括
风险评估和缓解策略 (REMS) 的 iPLEDGE 计划旨在防止胎儿暴露于异二胺,但给胎儿带来很大的负担. 基于证据的调整,包括共享决策和LARC豁免,可以改善患者护理和医生经验.
科学领域:
- 皮肤病学 皮肤病学
- 公共卫生 公共卫生
- 药物监督 药物监督 药物监督
背景情况:
- 风险评估和缓解策略 (REMS) 的 iPLEDGE 计划要求严格控制异二胺,以防止胎儿暴露.
- 对于iPLEDGE的要求,有效性和可访问性存在批评,理由是对医生,患者和工作人员造成重大负担.
研究的目的:
- 评估iPLEDGE计划所造成的负担.
- 提出基于证据的调整,以改善异丁的处方经验和患者护理.
主要方法:
- 审查iPLEDGE程序的要求和批评.
- 在避孕咨询中通过共享决策进行潜在改善的分析.
- 根据避孕疗法的有效性,适应REMS协议的建议.
主要成果:
- 该iPLEDGE计划造成了相当大的行政和临床负担,可能会限制异丁的处方.
- 共同决策和对长效可逆避孕药 (LARC) 的患者教育可以加强咨询.
- 建议从某些要求中豁免LARC和绝育等高效避孕药.
结论:
- 对iPLEDGE程序进行调整是必要的,以减轻负担,同时保持安全.
- iPLEDGE 和皮肤科医生之间的合作可以带来持续的改进.
- 实施共享决策和认识到避孕措施的可变性可以优化异氨酸治疗.
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