摘要
目的提高药品标准管理水平。方法总结传统药品标准管理的内容与不足,分析实验室信息管理系统(LIMS)在某院药品标准信息化管理中的应用效果与优势,并提出相关建议。结果传统药品标准管理内容主要包括标准的收集、整理、受控编号、勘误、查新、查询与发放、回收作废标准;不足有查询困难且费时,标准受控编号过程烦琐,标准有效性难以判定,无法实施分权限管理。LIMS药品标准管理内容主要包括标准收集、整理,受控编号,纸质单篇标准转为电子标准并导入LIMS中的药品标准库,查询,勘误与修订,查新,作废标准状态标识管理,分权限管理;其优势为提高查询效率,可控溯源,权限分配管理灵活,降低成本。应用LIMS管理药品标准时,建议成册标准无需扫描为.pdf文件,建立相应的电子目录即可查询;纸质标准原件按要求存放于标准管理科,编号采用三编号定位法;完善电子流程,增强电子标准的保密性;加快推进相关法规、制度的发布与实施。结论LIMS在药品标准管理中的应用,可有效解决传统药品标准管理的不足,规范业务流程和管理体制,提高药品标准管理水平。
Objective To improve the drug standard management.Methods The contents and shortcomings of traditional drug standard management were summarized,and the application effect and advantages of laboratory information management system(LIMS)in drug standard information management of a hospital were analyzed to put forward relevant suggestions.Results The contents of traditional drug standard management mainly included standard collection,sorting,controlled numbering,correction,novelty search,query,distribution and recovery of invalid standards.The shortcomings of this method were as follows:it was difficult and time-consuming to query,the process of controlled numbering was cumbersome,the validity of the standard was difficult to determine,and the sub-authority management could not be implemented.The contents of drug standards management by LIMS mainly included standard collection,sorting,controlled numbering,conversion of single paper standard into electronic standard and import into the drug standard library in LIMS,query,correction and revision,novelty search,status identification management of invalid standard and sub-authority management.The advantages of this method were as follows:improvement of query′s efficiency,controllable traceability,flexible authority allocation and management and diminish of cost.When LIMS was used to manage drug standards,it was suggested that the standards in volumes did not need to be scanned into a electronic file in pdf format,and a corresponding electronic catalogue could be established for query,the original paper standard could be stored in the Department of Standard Management as required and numbered by the three-number positioning method,the electronic process should be improved to enhance the confidentiality of electronic standards,the issue and implementation of relevant laws and regulations should be accelerated.Conclusion The application of LIMS in drug standard management can effectively solve the shortcomings of traditional drug standard management,standardize business process and management system,and improve the level of drug standard management.
作者
赵艳霞
马克民
周维利
华逢彪
孙铜
程春雷
ZHAO Yanxia;MA Kemin;ZHOU Weili;HUA Fengbiao;SUN Tong;CHENG Chunlei(Shandong Institute for Food and Drug Control,Jinan,Shandong,China 250101;Chengdu Kanghong Biological Technology Co.,Ltd.,Chengdu,Sichuan,China 610036)
出处
《中国药业》
CAS
2022年第11期14-16,共3页
China Pharmaceuticals
关键词
实验室信息管理系统
药品标准
标准管理
药品监管
laboratory information management system
drug standard
standard management
drug administration