我国药品说明书中老年人用药事项说明的分析

Analysis of medication instructions for elderly people in dru~ labels in China

目的了解我国常用口服药品说明书中关于老年人用药事项的说明情况。方法利用首都医科大学宣武医院门诊药品出入库信息电子管理系统，统计2013年1至12月发放给患者的口服西药药品，计算不同种类药品的构成比。收集并阅读这些药品的说明书，先按有、无“老年人用药”项分类，再从标注“老年人用药”项的药品说明书中提取该项中记载的具体内容，并与2012版Beers标准中相应药品老年人的使用建议（风险点）进行比较。结果门诊西药房共使用368种口服药物，其中作用于中枢神经系统的药物品种数居首位（93，25．3％），其次为作用于心血管系统的药物（62，16．8％），作用于消化系统的药物居第3位（38，10．3％）。368种药品中，说明书中有“老年人用药”项标注者259种（70．4％）；“老年人用药”项仅注明“未进行该项试验且无可靠参考文献／尚不明确”者75种（20．4％）；无“老年用药”项标注者34种（9．2％）。门诊西药房2013年使用的药品中有80种为2012版Beers标准收录的药品，其中说明书中未标注“老年人用药”项的药品有8种（10．0％），标注该项的药品有72种（90．0％）。标注该项的72种药品与2012版Beers标准比较，结果分为4种情况：未标注具体风险点（52．5％，42／80）；风险点不一致（25．0％，20／80）；说明书中“老年用药”项标注的风险点比Beers标准少（6．3％，5／80）；风险点一致（6．3％，5／80）。结论我国常用口服药品说明书中关于老年人用药事项的说明尚不完善，应予改进，以提高老年患者用药的安全性。

Objective To analyze the contents related to elderly people in medication instructions of oral drugs commonly used in China. Methods Oral medicines in Department of Outpatient Pharmacy, Xuanwu Hospital of Capital Medical University were recorded using Electronic Management System of drugs and composition ratio of different kinds of drugs were calculated. The notes for elderly people in medicine instructions were extracted and compared with administration suggestion （ risk points） of the same drugs described in 2012 edition of Beers Criteria. Results A total of 368 kinds of oral drugs in Department of Outpatient Pharmacy were collected. Of them, varieties of drugs for central nervous system ranked first （93 kinds, 25.3% ）, varieties of drugs for cardiovascular system ranked second （62, 16.8% ）, varieties of drugs for digestive system ranked third （38, 10. 3% ）o Of the 368 kinds of oral drugs, medication instructions of 259 drugs （70.4%） were marked with notes for elderly people; medication instructions of 75 drugs （20.4%） were marked that no related tests were performed, no reliable references were provided or not clear; medication instructions of 34 drugs （9.2%） were not marked. Eighty kinds of drugs which were used in Department of Outpatient Pharmacy in 2013 were included in 2012 Beers Criteria. Of them, 8 kinds of drugs （ 10.0% ） were not marked notes for elderly people and other 72 kinds of drugs （90.0%） were marked. Compared with the 2012 edition of Beers Criteria, the 72 kinds of drugs used in Department of Outpatient Pharmacy were divided into 4 kinds of results： risk points were not marked （52.5% ,42/80） , risk points were different （25.0% , 20/80 ） , risk points were less than those marked in Beers Criteria （6.3% ,5/80）, and risk points were identical （6.3%, 5/80）. Conclusion The notes for elderly people in medication instructions of commonly used oral drugs in China need further improvement to ensure medication safety in elderly patients.