Recently, the drug administration of Shanxi Province issued the work plan for the construction of drug information traceability system. By the end of 2020, the basic development of drug traceability and supervision system in Shanxi Province will be completed, the drug marketing license holders (production enterprises) will establish the drug information traceability system, and complete the data docking with the national drug traceability collaborative service platform, so as to basically realize narcotic drugs, psychotropic drugs and drugs Category of precursor chemicals, blood products, centralized procurement of bid winning varieties, the whole process of traceability.
At the same time, it is required to gradually promote the traceability of high-risk varieties such as traditional Chinese medicine injections and Chinese herbal pieces. Before the completion of the "fourteenth five year plan", it is necessary to realize the information traceability of the whole drug varieties and the whole process, so as to ensure that the drugs with quality and safety risks can be recalled and the responsibility can be investigated.
According to the plan, pharmacies and other drug distribution enterprises should establish their own traceability system or select a third-party platform to establish a traceability system. Medical institutions should establish a traceability system that meets the national drug traceability standards and requirements. Each city should select at least one public secondary or above medical institution to carry out the retrospective pilot project, which will be completed by the end of 2021. By the end of 2025, all medical institutions in the province will have an information traceability system.
Drugs are special commodities, and their quality and safety are closely related to human health. It is of great significance to promote the construction of drug information traceability, which can realize the "source can be traced, the destination can be traced, the risk can be controlled, and the responsibility can be traced", which is conducive to improving the level of accurate and scientific drug supervision, and effectively protecting the health and life safety of the people.
At present, in addition to Shanxi Province, Shandong, Yunnan and other provinces are also in action. On November 27, Yunnan Provincial Drug Administration issued the notice on implementing the construction of drug information traceability system, which clearly required drug marketing license holders, manufacturers, trading enterprises and users to establish drug traceability system through information technology, record and save drug traceability data timely and accurately, and form an interconnected drug traceability data chain Before that, the traceability of selected varieties, narcotic drugs, psychotropic drugs, blood products and other key varieties in the national centralized drug procurement was basically realized.
According to the notice issued by Yunnan Province, the provincial drug administration is responsible for the overall promotion of the construction of drug information traceability system in the whole province, including promoting the construction of traceability system in production links, promoting the construction of traceability system in wholesale link, building provincial drug traceability supervision system, investigating and dealing with illegal drug tracing activities, etc.; the municipal and county market supervision and management departments are responsible for promoting the retail use link in the jurisdiction Drug traceability system construction.
Shandong Province has established a whole process drug information traceability system with "traceable source, traceable destination, controllable risk and traceable responsibility". It is reported that the drug traceability management platform of Shandong Province includes one data center and four subsystems. The platform aims to promote the "one thing, one code, and the same tracking" to build the whole process drug traceability system. The manufacturer generates the supervision code of each package through the serialization service of "one thing, one code" and uploads it to the data center; the drug circulation and user units collect the data by scanning the code, compare and verify the traceability data with the platform, analyze and record the nature and status of the drug; the regulatory department collects the whole flow traceability data of drugs through the platform to realize the whole process supervision of the drug traceability supply chain To ensure that the source can be checked and the whereabouts can be traced. If quality and safety problems are found, drug recall and accountability can be carried out.
Up to now, the product information of 238
Pharmaceutical enterprises in Shandong Province has been included in the drug traceability management platform, with 158600 drug delivery and warehousing documents, 37.501400 boxes of single box drugs with code scanning, and 3.8575 million inquiries from the public.
December 08, 2020
