A cross-sectional analysis of mifepristone, misoprostol, and combination mifepristone-misoprostol package inserts obtained in 20 countries
A cross-sectional analysis of mifepristone, misoprostol, and combination mifepristone-misoprostol package inserts obtained in 20 countries
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DOI：
10.1016/j.contraception.2020.01.011
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发表时间：
2020-05-01
期刊：
影响因子：
2.9
通讯作者：
Winikoff, Beverly
中科院分区：
文献类型：
--
作者：
Frye, Laura J.;Kilfedder, Catherine;Winikoff, Beverly
目的：评估在低收入和中等收入国家收集的药物流产商品包装说明书中的特征、临床信息和储存说明。研究设计：从2017年11月至2018年2月收集米非司酮、米索前列醇和米非司酮-米索前列醇联合（组合）产品，以填充药物流产商品数据库。我们从获得的每个包装说明书中提取了说明的使用适应症、储存说明和上次修订日期。对于那些将药物流产列为适应症的说明书，我们还提取了资格标准、推荐方案、副作用和禁忌适应症。结果：我们鉴定了来自20个国家的41份说明书；19人（46%）将药物流产列为适应证，包括所有7种组合包、所有7种米非司酮产品和5/27（19%）米索前列醇产品。上次插入修订的日期为1991年至2016年。早期药物流产的胎龄限制从49天到“妊娠早期”不等。三种（43%）米非司酮产品推荐600毫克口服剂量，两种（29%）推荐与吉美前列素联合使用。十八种（67%）米索前列醇和一种（14%）组合式插入物推荐防潮。结论：低收入和中等收入国家各种实地设置的药物流产产品包装说明书的特点、临床信息和储存说明包括储存说明不足和胎龄限制和方案过时。(C) 2020爱思唯尔公司版权所有。
Objectives: To evaluate the characteristics, clinical information, and storage instructions contained in package inserts from medical abortion commodities collected in low- and middle-income countries.Study design: From November 2017 to February 2018 mifepristone, misoprostol, and combined mifepristone-misoprostol (combipack) products were collected to populate the Medical Abortion Commodities Database. We extracted stated indications for use, storage instructions, and date of last revision from each package insert obtained. For those inserts listing medical abortion as an indication, we also extracted eligibility criteria, recommended regimens, side effects, and contra indications.Results: We identified 41 package inserts from 20 countries; 19 (46%) listed medical abortion as an indication including all 7 combipacks, all 7 mifepristone products, and 5/27 (19%) misoprostol products. Date of last insert revision ranged from 1991 to 2016. Gestational age limits for early medical abortion ranged from 49 days to "first trimester." Three (43%) mifepristone products recommended a 600 mg oral dose and two (29%) recommended regimens with gemeprost. Eighteen (67%) misoprostol and one (14%) combipack inserts recommended protection from moisture.Conclusions: The characteristics, clinical information, and storage instructions in medical abortion product package inserts from a variety of field settings in low- and middle-income countries included inadequate storage instructions and outdated gestational age limits and regimens. (C) 2020 Elsevier Inc. All rights reserved.