我国微生态制剂儿童用药信息的调查分析

Investigation and Analysis of Pediatric Medication Information of Microecological Preparations in China

目的:为进一步完善我国微生态制剂药品说明书儿童用药信息提供建议。方法:采用文本分析法,对我国上市的36个批准文号微生态制剂(共来自于23家企业的29个品种)的儿童用药信息进行统计分析。结果:在36个微生态制剂产品中,有2个产品为儿童专用药品(占5.56%);包含颗粒剂2个(占5.56%),散剂9个(占25.00%),片剂9个(占25.00%),胶囊剂16个(占44.44%);国家基本药物6个(占16.67%);国家基本医疗保险目录内药品13个(占36.11%);非处方药品22个(占61.11%)。标注了儿童适应证、儿童用法用量、儿童相关不良反应、禁忌和注意事项的药品说明书分别占19.44%、55.56%、2.77%、5.56%和8.33%,在“儿童用药”项标注了具体的儿童用药信息的占25.00%。结论:我国现有微生态制剂药品说明书儿童用药信息缺乏,且存在用法用量不明确、儿童用药信息标注位置分散、内容缺乏实用性等问题。建议医疗机构应加强对医务人员的合理用药指导,落实超说明书用药科学管理流程;相关部门应出台更多的激励政策,鼓励企业完善儿童用药依据,并详细规定药品说明书中儿童用药信息的标注规范;此外,还可建立儿童用药信息数据库,从而为儿科安全、合理用药提供参考。

OBJECTIVE:To provide suggestions for improving pediatric medication information in drug instructions of microecological preparations in China.METHODS:Using text analysis method,the pediatric medication information in the instructions of 36 approval number of microecological(29 varieties from 23 enterprises)is statistically analyzed.RESULTS:Among the 36 microecological preparations,there were 2 medicines for children(5.56%).There were 2 granules(5.56%),9 dispersants(25.00%),9 tablets(25.00%)and 16 capsules(44.44%);there were 6 national essential medicines(16.67%);there were 13 products in the list of national essential medical insurance(36.11%);there were 22 OTC products(61.11%).The proportion of children’s indications,children’s usage and dosage,child-related adverse reactions,taboos and matters needing attention in the drug instructions for children were 19.44%,55.56%,2.77%,5.56% and 8.33%,respectively.The proportion of specific information about children’s drug use marked in the item of“children’s drug use”was 25.00%.CONCLUSIONS:There is a lack of information on pediatric medication in the instructions of microecologial preparations in China,and there are some problems such as unclear wording,scattered labeling position of the medication information for children,and the content is not practical.It is recommended that medical institutions should strengthen the rational use of medical guidance for medical personnel,implement the scientific management process of over-instruction medications;the relevant departments should introduce more incentive policies,encourage enterprises to improve the basis of children’s medications,and make standardized labeling of children’s medication information in drug specifications.In addition,a database of information on children’s medications can be established to provide a reference for rational use of pediatric drugs.