对375份药品说明书中“孕妇用药”项的调查分析

Analysis of 375 Drug Package Inserts on "Drug Use for Pregnant Women"

目的:了解药品说明书中"孕妇用药"项的情况,为规范药品说明书提供参考。方法:收集我院常用药品的药品说明书375份,对其"孕妇用药"项进行统计、分析。结果:注有孕妇禁用或忌用的134份、慎用的51份、尚不明确的40份,未列此项的23份。结论:建议国家相关部门加强对药品说明书的安全监管,定期组织专家对上市药品进行再评价,督促药品生产厂家对其药品说明书及时更新,制定和完善药品说明书的标准格式,以保证临床用药安全。

OBJECTIVE： To investigate the ＂drug use for pregnant women＂ in drug package inserts and to provide reference in standarding the drug package inserts. METHODS： 375 package inserts of common drugs collected in our hospital were analyzed statistically in terms of the item of ＂drug use for pregnant women＂. RESULTS： Among the 375 drug package insert, 134 stated ＂forbidden or contraindicated for pregnant women＂ ; 51 stated ＂to be used with caution for pregnant women＂, 40 had indefinite explanation about the drug use for pregnant women, and 23 had no explanation for drug use for pregnant women. CONCLUSIONS： It is advisable for the related department in our country tighten control on the safety of drug package inserts by organizing experts to conduct a regular post- marketing reevaluation on the drugs, urging drug manufactures to timely update the drug package inserts, setting and improving the standard format of drug package inserts to ensure the safety of clinical drug use.