我院门诊435种中成药说明书信息调查与分析
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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.
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.
引文
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[12]王建,张桂芬,卢虹,等.240份中成药说明书的调查分析[J].中国医院用药评价与分析,2011,11(3):277-279.
[13]沈文超,丁艳.我院促进临床合理用药的信息化实践[J].中国药房,2015,26(10):1426-1428.
[14]方顺干,沈浓儿,吴祖帅.336份药品说明书缺项统计分析[J].中国药房,2012,23(45):4315-4316.
[15]张冰,林志健,张晓朦,等.国产中成药说明书现状调研与修订完善建议[J].药物流行病学杂志,2017,26(8):561-564.
[2]国家食品药品监督管理局.药品说明书和标签管理规定[S].2006-03-10.
[3]孙雪林,穆林,谭玲,等.我院老年病患者常用药品说明书缺项调查分析[J].中国药房,2015,26(33):4623-4625.
[4]张艳华,赵庆军.中成药说明书内容分析与药学服务[J].实用药物与临床,2014,17(2):252-255.
[5]周祖萍,刘洋志,邵寅.某院212种口服中成药处方药说明书调查[J].药物流行病学杂志,2012,21(8):393-395.
[6]国家食品药品监督管理局.关于印发中药、天然药物处方药说明书格式内容书写要求及撰写指导原则的通知[S].2006-06-02.
[7]田硕,郭晖,苗明三.中成药说明书完善的思考及实践[J].中华中医药杂志,2018,33(6):2225-2229.
[8]张晓朦,林志健,周伟龙,等.中成药说明书[禁忌]项的修订完善思考与建议[J].药物流行病学杂志,2017,26(9):634-637.
[9]杨冬梅,刘俊,蒋磊.501种口服药品说明书用药时间和方法的统计分析[J].中国医院药学杂志,2018,38(17):1841-1845.
[10]国家食品药品监督管理局.中成药规格表述技术指导原则[S].2017-10-11.
[11]姜晓燕,马道南.藤黄健骨片致不良反应1例[J].中国中药杂志,2001,26(5):776.
[12]王建,张桂芬,卢虹,等.240份中成药说明书的调查分析[J].中国医院用药评价与分析,2011,11(3):277-279.
[13]沈文超,丁艳.我院促进临床合理用药的信息化实践[J].中国药房,2015,26(10):1426-1428.
[14]方顺干,沈浓儿,吴祖帅.336份药品说明书缺项统计分析[J].中国药房,2012,23(45):4315-4316.
[15]张冰,林志健,张晓朦,等.国产中成药说明书现状调研与修订完善建议[J].药物流行病学杂志,2017,26(8):561-564.