410份药品说明书中孕妇及哺乳期妇女用药标注浅谈

Annotation for pregnant and lactant women in 410 package inserts of drug

目的整理本院常用药品说明书中【孕妇及哺乳期妇女用药】项的标注情况,浅析该类人群用药现状,旨在探讨正确标注该项的重要性。方法选取本院目前使用频率较高的药品说明书410份,按照有无标注【孕妇及哺乳期妇女用药】项,以及是否有相关警示语进行统计分析。结果 410份说明书按口服制剂、外用制剂、注射剂分类标项率分别为40.7%、40.0%、99.0%,按西药和中成药分类标项率分别为84.1%和0,按国产药、外资(合资)药分类标项率分别为63.8%和91.0%。结论药品说明书中【孕妇及哺乳期妇女用药】项无标注或内容不全面,建议进一步完善该项内容,为孕产妇合理用药提供依据。

Objective To analyze the annotation of commonly used medicines for pregnant and lactant women in our hospital and label the utilization of drugs properly. Methods Totally 410 frequently used package inserts were investigated and the drugs with warning remarks for pregnant and lactant women were collected. Results All the 410 package inserts were investigated according to dosage forms, with 40.7%, 40.0% and 99.0% for oral preparation, external preparation and injection, respectively. Then the package inserts were studied according to their medicine properties, and the annotation ratio of application for pregnant and lactant women was 84.1% in western medicines but 0 in Chinese patent medicines. The package inserts were also classified according to the manufacturers, and the annotation ratio of application from foreign and domestic manufacturers was 91.0% and 63.8%, respectively. Conclusion The annotation for pregnant and lactant women in the package inserts has either no markings or incomplete contents. Great importance should be attached to the incomplete medication items.