麻醉药品和精神药品批发企业风险分析与对策建议

Risk Analysis and Countermeasures of Narcotic Drugs and Psychotropic Substances Wholesale Enterprises

目的:通过分析山东省麻醉药品和精神药品批发企业许可情况及现场检查发现的问题,提出对策与建议,为规范麻醉药品和精神药品经营秩序提供参考。方法:对山东省麻醉药品和精神药品批发企业许可检查的缺陷项目进行统计,分析存在的问题,并提出相应的对策。结果:现场检查缺陷项目集中在质量管理体系文件(63,19.94%)、储存与养护(60,18.99%)、人员与培训(42,13.29%)、设施与设备(38,12.03%)、机构和质量管理职责(36,11.39%)等方面。结论:麻精药品批发企业应落实企业主体责任,及时修订质量管理体系文件,有效开展教育培训工作,加强承运方审计,定期进行风险自查;监管部门应强化麻精药品监管,提高药品检查员能力,严厉打击违法违规行为。

Objective:To provide reference for standardizing the operation order of narcotic drugs and psychotropic drugs by analyzing the licensing situation of narcotic drugs and psychotropic drugs wholesale enterprises in Shandong Province and the problems found in on-site inspection.Methods:Statistics were made on defective items of licensing inspection of the narcotic drugs and psychotropic substances wholesale enterprises in Shandong Province,the existing problems were analyzed to put forward countermeasures.Results:The defective items in the on-site inspection mainly focus on quality management system documents(63,19.94%),storage and maintenance(60,18.99%),personnel and training(42,13.29%),facilities and equipment(38,12.03%),and organization and quality management responsibilities(36,11.39%).Conclusion:The narcotic drugs and psychotropic substances wholesale enterprises should implement the main responsibility of the enterprise,timely revise the quality management system documents,effectively carry out education and training work,strengthen the audit of carriers,and conduct regular risk self-examination.Regulatory authorities should strengthen the supervision of narcotic drugs and psychotropic substances,improve the ability of drug inspectors,and crack down on illegal activities.