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美国食品药品监督管理局米非司酮法规的更新:对临床实践及堕胎服务可及性的影响

Updates to the US Food and Drug Administration Regulations for Mifepristone: Implications for Clinical Practice and Access to Abortion.

作者信息

Simmonds Katherine E, Beal Margaret W, Eagen-Torkko Meghan K

出版信息

J Midwifery Womens Health. 2017 May;62(3):348-352. doi: 10.1111/jmwh.12636.

Abstract

This article provides information on recent changes in the US Food and Drug Administration (FDA) labeling and safety regulations for mifepristone (Mifeprex). The revised label now permits midwives, advanced practice nurses, and physician assistants to order and prescribe mifepristone, eliminating the requirement for physician supervision. The updated label also extends eligibility for use from 49 to 70 days' gestation and decreases the number of required visits from 3 to 2. The recommended dose of mifepristone has been reduced, and the dosage, timing, and route of administration for misoprostol have also been changed to reflect current research. These changes have implications for clinical practice and may lead to expanded access for women in the United States.

摘要

本文提供了关于美国食品药品监督管理局(FDA)对米非司酮(米非普明)标签及安全规定近期变化的信息。修订后的标签现在允许助产士、高级执业护士和医师助理订购和开处米非司酮,不再要求医生监督。更新后的标签还将使用资格从妊娠49天延长至70天,并将所需就诊次数从3次减少到2次。米非司酮的推荐剂量已降低,米索前列醇的剂量、给药时间和途径也已改变以反映当前研究。这些变化对临床实践有影响,可能会扩大美国女性获得该药物的途径。

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