摘要
目的:调查分析我院门诊中成药说明书现状及存在问题,为完善中成药说明书提供建议。方法:收集我院门诊药房2018年正在使用的中成药药品说明书435份,统计说明书中用法用量标注不明确、其他项目标注不明确和缺项内容。结果:435份药品说明书中,用法用量不明确的情况包括用法用量只标注克数或毫升数(54种,12.4%)、每日给药剂量不明确(165种,37.9%)、包含"或遵医嘱"的字样(86种,19.8%)、特殊人群用法用量标注模糊(34种,7.8%)和未标注给药时间(365种,83.9%);其他项目标注不明确包括药物相互作用不明确(121种,27.8%)、注意事项不明确(12种,2.8%)、不良反应不明确(307种,70.6%)、禁忌不明确(257种,59.1%)、适应证不明确(1种,0.2%),缺项内容包括无特殊人群用药剂量(41种,94.5%)、无药理毒理项(305种,70.1%)、无临床试验数据(395种,90.8%)、未标识贮藏温度(377种,86.7%)。结论:中成药说明书普遍存在缺项与安全用药信息不明确现象,其项目内容的修订、完善需从多方面开展,以便为临床合理用药提供依据,保障患者用药安全。
OBJECTIVE:To investigate and analyze the current status and existing problems of Chinese patent medicine instructions in outpatient department of our hospital,and to provide suggestions for the improvement of Chinese patent medicine instructions. METHODS:A total of 435 copies of Chinese patent medicines instructions using in the outpatient pharmacy of our hospital were collected in 2018. The labeling of usage and dosage of the instructions and other items were not clear and missing items were analyzed statistically. RESULTS:In 435 copies of drug instructions,unclear usage and dosage included usage and dosage were marked only in grams or milliliters(54 kinds,12.4%);daily dosage was not clear(165 kinds,37.9%);the words “or follow the doctor’s advice”were involved in drug instructions(86 kinds,19.8%);the labeling of usage and dosage for special population were not clear(34 kinds,7.8%);medication time was not labeled(365 kinds,83.9%). Unclear labeling of other items included unclear drug interaction(121 kinds,27.8%),unclear matters needing attention(12 kinds,2.8%),unclear ADR(307 kinds,70.6%),unclear contraindications (257 kinds,59.1%) and unclear indications (1 kind,0.2%). The missing items included that drug dosage for special population (41 kinds,94.5%),pharmacological and toxicological items (305 kinds, 70.1%),clinical trial data(395 kinds,90.8%),storage temperature label(377 kinds,86.7%). CONCLUSIONS:Missing items and unclear information on safe medication are common in Chinese patent medicine instructions,which need to be standardized and perfected in order to provide reference for rational drug use and guarantee the safety of drug use in patients.
作者
王文青
韩仙鸽
刘津
杜闻伟
李智荣
高善荣
WANG Wenqing;HAN Xiange;LIU Jin;DU Wenwei;LI Zhirong;GAO Shanrong(Dept. of Pharmacy,Xiyuan Hospital,China Academy of Chinese Medicine Sciences,Beijing 100091,China)
出处
《中国药房》
CAS
北大核心
2019年第9期1288-1292,共5页
China Pharmacy
基金
国家中医药管理局全国中药特色技术传承人才培训项目(No.国中医药人教函〔2015〕168号)
关键词
中成药
药品说明书
合理用药
缺项
不规范
调查与分析
Chinese patent medicine
Medicine instruction
Rational drug use
Missing items
Non-standardized
Investigation and analysis
