药品说明书中特殊人群用药标注情况统计分析  

Statistical Analysis on Tagging in Medication of Special Population according to Package Inserts

作　　者：杨冬梅[1] 蒋磊[1] 张雪芹[2] 

机构地区：[1]安徽医学高等专科学校附属医院,合肥市230022 [2]安徽中医学院,合肥市230022

出　　处：《中国药房》2010年第17期1630-1632,共3页China Pharmacy

摘　　要：目的:了解药品说明书中有关特殊人群用药内容的标注情况,为特殊人群合理用药提供参考。方法:随机抽取我院住院药房、门诊药房常用中、西药药品说明书389份,对特殊人群包括孕妇及哺乳期妇女、儿童、老年人用药内容进行统计分析。结果:部分药品说明书中特殊人群用药项目存在缺失。其中,按剂型大类分类,注射剂标注率高于其它剂型,除关于儿童用药项外,注射剂的标注率均超过90%,而口服制剂只有"禁忌"和"注意事项"2项标注率超过90%;按生产厂家分类,国产药品标注率较低,进口药品标注率均超过90%。结论:药品监督管理部门、药品生产部门、药品使用人群等需共同努力完善药品说明书,保障特殊人群用药安全。OBJECTIVE： To investigate the tagging condition in medication of special population in package inserts in order to give reference for rational drug use of special population. METHODS： 389 pieces of common Chinese and western medicine package inserts of our inpatient and out-patient dispensaries were randomly collected and analyzed statistically in terms of the content of package inserts for special population, including pregnant and lactant women, children and the aged. RESULTS： A part of medication items of special population in package inserts had deficiency. According to the classification of dosage form, the tagging rate of injection exceeded other dosage forms reached to more than 90%, except of medication items for children. The tagging rate of oral formulation arrived at more than 90% only in terms of contraindications and cautions. According to the classification of manufacturer, the tagging rate of domestic drugs was kept at the low level while that of imported drugs exceeded 90%. CONCLUSIONS： Package inserts need to be improved with the effort of drug supervision management department, drug production department and population of using drugs to guarantee the safety of drug use in special population.

关 键 词：药品说明书 特殊人群 用药安全 标注率 

分 类 号：R95[医药卫生—药学]