目的 了解药品说明书中关于妊娠期及哺乳期妇女用药的标注情况，为进一步规范药品说明书提供参考。 方法: 依据《药品说明书和标签管理规定》、《化学药品非处方药说明书规范细则》、《化学药品和生物制品说明书规范细则》及其他参考资料对我院门诊药房常用的490种药品的说明书中有关妊娠期及哺乳期妇女用药的标示情况进行调查分析。 结果:在处方药中，准确标注妊娠期及哺乳期妇女用药占53.91%；标注妊娠期及哺乳期妇女用药“尚不明确”或“尚无资料”占13.28%；未进行标注妊娠期及哺乳期妇女用药情况占32.81%。在非处方药中，准确标注妊娠期及哺乳期妇女用药占46.23%；未进行标注妊娠期及哺乳期妇女用药情况占53.77%。结论:药品说明书中还存在“妊娠期及哺乳期妇女用药”相关内容缺失的问题，需要引起各方面重视，加强管理，不断完善。
Abstract
To investigate the instruction for drug use for pregnant and lactating women and to provide reference for standardizing drug package inserts METHODSFour hundred and ninty drug instructions sampled from the pharmacy in our hospital were investigated and analyzed on the part for pregnant and lactating women medication by Provisions for Drug Insert Sheets and Labels，Regulatory Guidelines for the chemicals nonprescription drug， Regulatory Guidelines for chemicals and living creature product and other references RESULTSIn prescription medicines， The rate of pregnant and lactating women to use the medicine circumstance marked was 53.91%， and that of "not yet clear"or "still have no data”was 13.28%， and the other 32.81% have never carried on to mark In nonprescription medicines， The rate of pregnant and lactating women to use the medicine circumstance marked was 46.23%， 53.77% have never carried on to mark CONCLUSIONThe contents of pregnant and lactating women medication are far from perfect，Which should draw attention to better management.
关键词
药品说明书 /
妊娠期 /
哺乳期 /
调查分析
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Key words
drug package insert /
lactating women /
research analysis
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参考文献
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