34家儿童医疗机构镇咳祛痰药品说明书信息标注情况分析  

Analysis of information labeling in instructions of antitussive and expectorant drugs in 34 children’s medical institutions

作　　者：丁臻 梁海[2] 阮文懿 蔡和平 DING Zhen;LIANG Hai;RUAN Wenyi;CAI Heping(Dept.of Clinical Pharmacy,Anhui Provincial Children’s Hospital,Hefei 230022,China;Dept.of Pharmacy,Bozhou People’s Hospital,Anhui Bozhou 236800,China)

机构地区：[1]安徽省儿童医院临床药学部,合肥230022 [2]亳州市人民医院药学部,安徽亳州236800

出　　处：《中国药房》2024年第5期607-611,共5页China Pharmacy

基　　金：安徽省重点研究与开发计划项目(No.2022e07020066)。

摘　　要：目的了解儿童医疗机构常用镇咳祛痰药药品说明书中儿童用药信息标注情况,并提出相关建议。方法收集我国具有区域代表性的20家三级儿童医院(中心)和14家妇幼保健院(中心)的100种常用镇咳祛痰药的说明书,对药品说明书中儿童用药信息标注情况进行调查分析。结果专用儿童镇咳祛痰药只有7种,其他均为非儿童专用药;镇咳祛痰药中片剂占18.00%,注射剂占18.00%,胶囊剂占4.00%;100种镇咳祛痰药中72种(占72.00%)标注了儿童用法用量,63种(占63.00%)标注了儿童用药项,59种(占59.00%)注意事项中注明了儿童信息,均未标注儿童药动学参数;对比进口或合资的镇咳祛痰药,国产药品儿童用药信息标注缺失较多;63种标注有儿童用药项的药品说明书中,多种说明书标注信息指导意义不大。结论镇咳祛痰药说明书中儿童用药信息存在标注缺乏的情况,儿童专用药品占比低,说明书中儿童用药项标注信息对儿童用药指导意义不大。相关部门应进一步推进镇咳祛痰药的药品说明书中儿童用药信息的完善,保障儿童用药的合理使用。OBJECTIVE To understand the information labeling of children’s medication in the instructions of antitussive and expectorant drugs commonly used in children’s medical institutions,analyze the existing problems,and propose relevant suggestions.METHODS The instructions for 100 antitussive and expectorant drugs commonly used in 20 tertiary children’s hospitals(centers)and 14 maternal and child health hospitals(centers)with regional representativeness in China were collected,and the information labeling of children’s medication in the instructions was investigated and analyzed.RESULTS There were only 7 kinds of antitussive and expectorant drugs for children,and the others were non-specific drugs for children.Among antitussive and expectorant drugs,tablets accounted for 18.00%,injections for 18.00%,and capsules for 4.00%.Among 100 antitussive and expectorant drugs,72(72.00%)labeled the usage and dosage for children,63(63.00%)labeled the medication items for children,59(59.00%)indicated the information of children in the precautions,and pharmacokinetic parameters for children were absent.Compared with imported antitussive and expectorant drugs or the drugs manufactured by joint ventures,there were many missing labeling of medication information for children with Chinese drugs.Among 63 kinds of drug instructions labeled with medication items for children,various instructions information had little guiding significance.CONCLUSIONS There is a lack of labeling in the instructions of antitussive and expectorant drugs for children,and the proportion of special drugs for children remains low.Pediatric drug information in the instructions has little guiding significance for pediatric medication.Relevant departments should further promote the completeness of pediatric medication information in the instructions of antitussive and expectorant drugs to ensure the rational use of children’s medication.

关 键 词：镇咳祛痰药 儿童 药品说明书 用药信息标注 调查 

分 类 号：R974.1[医药卫生—药品] R985[医药卫生—药学]