2021-2023年山西省药品监督抽检质量分析  

Analysis of sampling quality of drug supervision in Shanxi province from 2021 to 2023

作　　者：赵向东 曹志伟 Zhao Xiangdong;Cao Zhiwei(Department of Drug Risk Monitoring,Shanxi Provincial Drug Safety Risk Monitoring Center,Taiyuan 030033,China;Department ofMedical Device Evaluation and Review,Shanxi Provincial,Drug Evaluation Center(Shanxi Academy of Medicine and Life Sciences),Taiyuan030051,China)

机构地区：[1]山西省药品安全风险监测中心药品风险检测部,太原030033 [2]山西省药品审评中心(山西省医药与生命科学研究院)医疗器械审评部,太原030051

出　　处：《实用医技杂志》2025年第4期302-304,共3页Journal of Practical Medical Techniques

摘　　要：目的通过统计分析2021—2023年药品质量抽检情况,为药品抽检工作提供建议和参考。方法采用数据统计软件对山西省2021—2023年药品质量抽检结果进行统计分析。结果2021—2023年共抽检8325批次,不合格药品总计38批次,抽检药品的不和合格率由0.54%降低至0.40%,不合格药品类别主要为中药饮片,不合格药品抽样环节主要出现在使用环节中的民营医院、个体诊所。结论我省药品质量总体安全形势平稳可控,药品质量处于较高水平,不合格药品率逐年降低,药品监管部门应加强对中药饮片的抽检力度,增加使用环节的抽样比例,提升药品抽检的靶向性和精准性,保障人民群众用药安全,推动我省医药产业健康持续发展。Objective Through the collection,sorting and statistical analysis of drug quality sampling from 2021 to 2023,suggestions and references were provided for drug sampling.Methods The results of drug quality sampling in Shanxi province from 2021 to 2023 were analyzed by descriptive statistics software.Results From 2021 to 2023,a total of 8325 batches were sampled,with a total of 38 batches of non-compliant drugs.The non-compliance rate of sampled drugs decreases from 0.54%to 0.40%.The main category of unqualified sample drugs are Chinese herbal medicine slices.And the sampling of non-compliant drugs mainly occurred in private hospitals and individual clinics in the usage stage.Conclusion The overall safety situation of drug quality in Shanxi province is stable and controllable.The drug quality is at a comparatively high level with the rate of non-compliant drug decreasing year by year.Drug regulatory authorities should strengthen the sampling inspection of Chinese herbal medicine slices,increase the sampling proportion at drug usage stage,improve the targeting and accuracy of the drug sampling,ensure the safety of drug use of the people,and promote the healthy and sustainable development of the pharmaceutical industry in Shanxi province.

关 键 词：药品质量管理 不合格药品 产品监测 售后 

分 类 号：R95[医药卫生—药学]