美国FDA新孕妇用药规则的实行及影响被引量：17

Publication and Effects of FDA's New Rule for Pregnant and Lactational Women

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摘要目的解读2015年美国食品药品监督管理局(FDA)孕妇用药规则的相关资料,为我国孕妇用药安全提供借鉴。方法分析美国FDA孕妇用药规则发展历史、原有规则及缺陷、FDA所做准备、现行新孕妇用药规则及特点、现行新孕妇用药规则的影响,总结其改革经验。结果新规则除去了ABCDX字母分类,并将原有相关内容做出合并,同时增加了"潜在生育人群"部分。结论新规则可以更好指导临床用药,我国孕妇用药规则应借鉴相关先进经验,进一步提升我国孕妇用药安全。 OBJECTIVE To investigating the Pregnancy,Lactation,and Reproductive Potential：Labeling for Human Prescription Drug and Biological Products-Content and Format,and we provide lessons for China＇s future revolution for the use of drug for pregnant women.METHODS We analyzed and summarized the materials about the new system,and discussed history,letter risk categorization system,the preparation,new system,the effects of new rule.RESULTS The new rule eliminates letter risk categorization system（ABCDX）.The new system not only combines different parts of the previous rule but also adds a new part-＂Females and Males of Reproductive Potential＂.CONCLUSION Clinical pharmacists will work better with the new rule,thus should take lessons of FDA＇s revolutions for rules on pregnancy,and take steps to improve the safety measures for pregnant women.

作者杜博冉冯欣史湘君

机构地区首都医科大学附属北京妇产医院北京清华长庚医院

出处《中国药学杂志》 CAS CSCD 北大核心 2016年第12期1049-1054,共6页 Chinese Pharmaceutical Journal

关键词美国食品药品监督管理局孕妇用药 ABCDX字母风险分类 FDA pregnancy ABCDX letter risk categorization system

分类号 R951 [医药卫生—药学]

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