妊娠期妇女用药安全性探讨

目的:探讨妊娠期妇女的用药安全性。方法:比较本院妊娠期妇女所使用药品的说明书与专业参考书、《中国药典.临床用药须知》中适应证及孕期用药安全性等内容的异同。结果:3种资料的相关内容不统一,专业参考书的适应证范围比药品说明书和《中国药典.临床用药须知》广,《中国药典.临床用药须知》的"孕妇禁用"范围比药品说明书宽松。妊娠期妇女存在使用适应证范围以外药品和"孕妇禁用"药品现象。药品生产企业为规避风险,局限了妊娠期妇女的用药范围。结论:妊娠期妇女用药存在安全隐患,有关部门应统一规范,建立健全相关法律法规,保障妊娠期妇女用药安全、合理。

On Medication Safety of Pregnant Women

OBJECTIVE:To discuss the medication safety of pregnant women.METHODS:The package inserts of drugs used for the pregnant women in our hospital was compared with the reference books and China Pharmacopeia-Clinical Medication Notice in respect of the indications and medication safety and so on.RESULTS:The relative contents in are not unified in the above 3 documents.The indications defined in reference books cover a wider range than those in drug package inserts and China Pharmacopeia-Clinical Medication Notice,and the condition about contraindication in pregnancy in China Pharmacopeia-Clinical Medication Notice is looser than in drug package inserts.Drugs which fall out of the scope of indications or contraindicated were used in pregnant women.The drug manufacturing enterprises had confined the medication indications for pregnant women to evade risks.CONCLUSIONS:There are hidden risks for the medication of pregnant women. The concerned government departments ought to unify the medication for pregnant women so as to ensure their medication safety and rational drug use.