| 引用本文: | 徐润龙,陈仲永,吴晖,王慧群.浙江省药品安全智慧监管“黑匣子”应用建设研究[J].中国现代应用药学,2022,39(21):2721-2725. |
| XU Runlong,CHEN Zhongyong,WU Hui,WANG Huiqun.Research on the Construction of the Intelligent Drug Safety Supervision “Black Box” Application in Zhejiang Province[J].Chin J Mod Appl Pharm(中国现代应用药学),2022,39(21):2721-2725. |
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| 摘要: |
| 目的 为有效落实“四个最严”，履行地方政府药品安全监管责任，通过数字化改革，提高“技术成熟度”和“管理成熟度”，构建从实验室到医院的每一道防线。方法 浙江省药品监督管理局针对药品生产经营环节的监管，重点建设药品安全智慧监管“黑匣子”应用，借鉴民航“黑匣子”理念，利用药品生产经营企业自身信息化系统，在企业安装用于接收存储关键数据的数据仓(“黑匣子”)，自动收集企业生产源头采集的物料管理、生产工艺、质量检验、产品放行等影响药品质量的关键参数。结果 药品安全智慧监管“黑匣子”应用把药品监管的数字化触角深入到企业生产线，已接入4 752家药品生产、经营企业，采集29 340批药品、7 655万条数据。结论 应用实现药品全覆盖、全天候、全自动的非现场智能化监管，实现全受控严格管理、全链条严格监管、全时空严格执法，构建“无处不在、无时不在、无感监测，无事不扰、小事预警、大事严查”的药品安全在线智控新模式。 |
| 关键词: 药品安全 智慧监管 黑匣子 浙江 |
| DOI：10.13748/j.cnki.issn1007-7693.2022.21.002 |
| 分类号:R95 |
| 基金项目: |
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| Research on the Construction of the Intelligent Drug Safety Supervision “Black Box” Application in Zhejiang Province |
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XU Runlong, CHEN Zhongyong, WU Hui, WANG Huiqun
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Zhejiang Medical Products Administration, Hangzhou 310012, China
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| Abstract: |
| OBJECTIVE To effectively implement the “four strictest” and fulfill the drug safety supervision responsibility of local governments, improve “technical maturity” and “management maturity” through digital reform, and build defense line from laboratory to hospital. METHODS Drawing lessons from the “black box” concept of civil aviation, the Zhejiang Medical Products Administration focused on building the “black box” application of intelligent drug safety supervision for the supervision of drug manufacturing and supply. Used the drug production and marketing enterprise’s own information system, install a data warehouse (“black box”) in the enterprise for receiving and storing key data, and automatically collect the key parameters affecting drug quality, such as material management, production process, quality control, product release, etc. RESULTS The application of the “black box” of intelligent drug safety supervision had deepened the digital tentacles of drug supervision into the enterprise production line. The 4 752 drug production and marketing enterprises had been connected, and 29 340 batches of drugs and 76.55 million pieces of data had been collected. CONCLUSION The application realizes full coverage, all day long, full automatic off-site intelligent supervision of drugs. Fully controlled and strict management, full chain supervision, and strict law enforcement in all time and space were implemented. A new online intelligent control mode for drug safety were built that is “Everywhere, Everytime, Non inductive monitoring. Non bothering, Early warning of minor matters, Strict investigation of major events”. |
| Key words: drug safety intelligent supervision black box Zhejiang |
