Lu Liang promoted the construction of the information traceability system of key varieties of medicines

Last year, Lu Liang City's blood products, anesthesia drugs, psychiatric drugs, and national collection of key varieties and other key varieties and medical institutions and medical institutions basically completed the construction of the drug traceability system, realizing traceability management.

In order to further promote the intelligent supervision of drugs, improve the ability of drug supervision and supervision, and ensure the safety of the people's medication, the Luliang Market Supervision Bureau has deployed to further promote the construction of the information traceability system for key varieties of drugs. Municipal bureaus, such as blood products, special drugs, selected varieties in the national collection, and other biological products (except reagents) and other pharmaceutical varieties operating enterprises and medical institutions above the second level, in accordance The system promotes the "one thing, one code, and the code" through the code and scan code, and forms the data chain of interconnected drugs to trace the data chain, and realize the source of the entire process of key varieties.

Regarding the management requirements of pharmaceutical business enterprises: First, we must establish and improve the pharmaceutical traceability management system, and incorporate the traceability of drugs into the quality management system. Essence Second, it is necessary to establish a drug information traceability system in accordance with national standards or choose a third -party platform, and configure the code scanning equipment that is compatible with the scale of the drug. Encourage the convenience, normality, and accuracy of traceability data entry through software fusion and hardware upgrade. Third, when the drug enters the warehouse, it is necessary to obtain relevant traceability information from upstream companies, check the traceability code according to the acceptance requirements, check the information feedback from upstream enterprises, and when there is inconsistent amount of goods and traceability information or the number of traceability codes. Disposal is strictly forbidden to get traceable information and the pharmaceuticals that do not match the physical objects. Fourth, in terms of pharmaceutical terminal sales, the drug is confirmed to be updated after the sale. Fifth, we must save the pharmaceutical traceability information and provide the drug traceability data to the drug regulatory department. When quality and safety problems and risks occur, rely on the drug traceability system to completely record the recall of drug recall. Management requirements for traceability of medical institutions: First, the second and above medical institutions of key varieties must be self -built in accordance with the relevant standards of the State Drug Administration or selected a third -party platform to establish a pharmaceutical information traceability system. Adapt to code scanning device. Second, when the drug enters the warehouse, it is necessary to obtain relevant traceability information from upstream companies, check the traceability code according to the acceptance requirements, check the information feedback from upstream enterprises, and when there is inconsistent amount of goods and traceability information or the number of traceability codes. Disposal is strictly forbidden to enter the warehouse that does not match information and the real objects. Third, when the drug is out of the warehouse, the pharmaceutical scan traceability code should be updated according to the sales packaging scan.

For the traceability management of hemp essence drugs, the drugs that are sent to the inpatient pharmacy will scan the traceability code according to the sales packaging scanning codes when the pill out of the drug library is out; ID card, update the drug status, trace back to people. Fourth, the drug traceability information should be preserved in accordance with the requirements, and the drug traceability data is provided to the drug regulatory department. When the quality and safety of drugs and risks occur, cooperate with the drug listing license holder (manufacturer) and upstream suppliers to record and provide the flow of drug recall flows. information. The Municipal Bureau requires county bureaus to strictly implement the responsibility of territorial regulatory supervision, accelerate the deployment and promote the specific work of the construction of the pharmaceutical information traceability system, ensure that the tasks are completed by the end of 2022, and do a good job of supervision, publicity, management, inspection and inspection and inspection and inspection and inspection and inspection. Service work. The second is to improve work execution, urge the implementation of traceability responsibility, and incorporate the construction of the information traceability system into the daily supervision and inspection project. Requires to complete.三是积极推进信息化追溯向其他品种和基层医疗机构、民营医院延伸，逐步实现全品种生产、经营到使用全过程的追溯管理，不断探索和发挥药品“大数据”在问题追溯、统计分析、 The technical support role of risk research, prediction and early warning, etc., and improve the level of smart supervision.

Source: Shanxi Provincial Drug Administration

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