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目的:推动浙江省构建上下统一的食品药品安全应急管理处置体系,为建立合理、有效的应急管理体系提供实证依据。方法:通过抽样调查,对该省市县级食品药品监督管理机构的应急管理现状、人力资源、硬件设备资源进行实证调查与分析。结果:当前浙江省市、区(县)级食品药品监督管理机构的应急管理人员数量相对不足,专业知识培训较为薄弱;在应急管理设备配备方面,基本硬件设施与设备的配备率较低,应急管理的相关软件或系统建设较为落后。结论:应增加食品药品安全应急管理的人力资源投入,加强对应急管理人员的在岗培训,优化知识结构。逐步提高应急管理基本设备的配备水平,完善应急管理信息系统,实施食品药品应急管理协同计划,增强各部门的协同能力。 相似文献
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摘 要为进一步守住药品安全防线,做好药品安全事件快速预警和应急处置,有效防范和应对药品安全事件提供参考。回顾药用胶囊铬超标系列事件的处置过程,通过剖析药用胶囊铬超标系列事件的特点,探讨我国药品安全应急处置与预警机制。建立药品安全突发事件监测机制、风险分析与评估机制、程序启动机制、危机终止及善后评估机制、适当的舆情引导机制、明确药品安全突发事件处置中快速检测的法律地位是完善药品安全突发事件快速预警与应急处置的有效手段,可为我国的药品安全监管提供必要保障。 相似文献
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目的:梳理新型冠状病毒感染疫情应对过程中我国药械应急管理的情况与不足,提出新形势下突发公共卫生事件中药械应急管理的建议和启示,提升药械应急管理水平。方法:采取文献查阅法,对新冠疫情防控中的药械应急管理进行回顾,通过访谈调研进行补充完善,分析应对中存在的薄弱点。结果:相关部门采取了积极的应对保障措施,但在法规建设、预案体系、审评机制等方面还存在不足。结论:我国药械应急管理应进一步完善立法,优化应急体系,建立决策平台,强化应急技术储备,科学开展应急培训演练。 相似文献
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摘 要模拟演练是基于某种特定场景下的应对处置实践,它是基于“情景模拟教学法”创新实践的产物。为了提高教学质量,快速提升食药监管领导干部沟通、决策、指挥等能力,本文介绍了模拟演练的概念与理论基础、模拟演练的影响因子,在此基础上丛模拟演练的设计、模拟演练的准备、模拟演练的组织与控制以及模拟演练的总结评估与考核等方面探讨了模拟演练在干部教育培训中的实施,并提出了模拟演练在干部教育培训中应用的关键控制点。结合国家食品药品监督管理总局高级研修学院(安全应急演练中心)开展多次演练式教学,食药系统人员结构特点,讨论如何更有效将模拟演练运用于干部教育培训当中,具有重要作用。 相似文献
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目的探讨提高食品药品安全突发事件应急处置能力的方式和方法。方法从组织工作、资源调配、部门协调等方面探讨应急检验的实施程序。结果与结论应急检验是食品药品检验机构必须履行的职责,应通过不断完善预案、科学组织实施、强化人员素质、定期演练来不断提高应急检验工作的水平。 相似文献
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目的:探索我国食品药品安全监管的粗放式监管方式,向精准化监管转变的制度设计和实施路径。方法:采用文献回顾和数据分析方法,分析我国食品药品安全管理制度及其分类和分级监管措施,探索监管资源配置现状及精准监管的设计思路。结果与结论:当前,我国食品药品监管存在监管人员缺口较大、监管力量相对薄弱的问题。食品药品安全精准监管设计思路应从企业产品分类分级、信息化大数据和基层分类分级的三维度考虑;精准监管实施路径,包括加大监管资源投入力度、属地统筹协调、综合治理网格化管理、政府购买服务、强化大数据分析等。 相似文献
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公共卫生事件中医疗机构中药制剂应急管理探讨 总被引:3,自引:0,他引:3
目的 回顾与总结新型冠状病毒肺炎疫情下医疗机构中药制剂应急管理措施,为进一步改进和完善我国应对突发公共卫生事件中药品应急管理体系建设提供参考。方法 结合本次新型冠状病毒肺炎疫情中各省医疗机构中药制剂应急管理工作实践,梳理开展医疗机构中药制剂应急管理工作流程,探讨突发公共卫生事件中医疗机构中药制剂管理策略及措施。结果 目前,19个省份发布新型冠状病毒肺炎防控用医疗机构中药制剂应急管理文件,25个省份完成百余种医疗机构中药制剂备案审批并投入临床使用。结论 建立完善的药品应急管理体系,可以提高监管效率,协调指导相关工作有序进行,进一步提高突发公共卫生事件应对能力。 相似文献
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目的:探讨非战争军事救援行动中通过信息化手段构建药材模块化设计的保障体系。方法:依据遂行任务易致疾病的特点、分类及严重程度等,将药材保障模块划分为通用保障模块、专用保障模块和补充保障模块,再根据保障任务不同进行任意组合形成新的保障单元。结果:引入药材模块化管理,可以有效提高非战争军事救援行动药材快速保障的能力。结论:非战争军事救援行动中药材保障是非战争军事行动卫勤保障的重要组成部分,传统的药材保障模式有局限性,通过药材模块化管理、信息化维护,可实现药材保障的灵活性、适应性、精确性和有效性,并通过信息化的设计,规范药材的轮换更新。 相似文献
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目的:制定全市急(抢)救药品供应保障体系,探讨其对全市医疗机构急(抢)救药品缺乏以及费用的影响。方法:在全市16家各级不同医疗机构建立急(抢)救药品监测网络,通过制定急(抢)救药品储备目录、采购与调用管理规定、费用结算管理规定,以及建立常备化的储备点等多项措施构建供应保障体系。分别选取2017年1月至6月和2018年1月至6月全市医疗机构急(抢)救药品保障供应情况为对照组和试验组。观察保障体系实施前后,全市各级医疗机构急(抢)救药品缺乏的品种数、报损的品种数和费用以及采购费用。结果:实施该保障体系后,与对照组相比,试验组急(抢)救药品缺乏的品种数显著下降(P < 0.05),而报损品种数、报损费用和采购费用也均显著下降(P < 0.05)。结论:急(抢)救药品供应保障体系,可有效改善医疗机构急(抢)救药品缺乏的状况,降低了报损费用和采购费用,具有进一步推广应用的价值。 相似文献
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BackgroundDrug-related overdoses were declared a public health emergency in British Columbia, Canada in April, 2016 facilitating the scale-up of responses including rapid sanctioning and implementation of overdose prevention sites (OPSs). OPSs are a health service providing supervised injection and immediate overdose response. In BC, OPSs were operational within weeks of sanctioning. In the first year of operation over 20 OPSs were established with approximately 550,000 visits and no overdose deaths at any site. In this paper, we examine the implementation of OPSs as a novel and nimble response to prevent overdose deaths as a result of injection drug use.MethodsA multiple case study design was used with the Consolidated Framework for Implementation (CFIR) informing the analysis. Three sites in a single city were included with each site constituting a case. In this paper, we focus on qualitative interviews with 15 staff and their perceptions of the implementation of the OPSs as well as provincial and local documents.ResultsThe legislative process to implement OPSs was unprecedented as it sanctioned supervised injection services as an extraordinary measure under a declared public health emergency. Innovative and inclusionary practices were possible within state-sanctioned OPSs, as the sites were government-directed yet community-developed, with PWUD centred in service design, implementation and delivery. OPSs lack permanency and may be limited to the duration of the public health emergency.ConclusionThe rapid implementation of OPSs provides an international example of an alternative to lengthy and often onerous sanctioning processes for supervised consumption services (SCSs). Overdose prevention sites provide an example of a novel service design and nimble implementation process that combines the benefits of state-sanctioned injection services with community-driven implementation. Such evidence questions the continued acceptability of governments’ restrictive sanctioning processes, which have limited expansion of SCSs internationally and the implementation of services that are not necessarily aligned with the needs of PWUD. 相似文献
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《Expert opinion on drug delivery》2013,10(4):499-509
Introduction: Gene delivery from hydrogel biomaterials provides a fundamental tool for a variety of clinical applications including regenerative medicine, gene therapy for inherited disorders and drug delivery. The high water content and mild gelation conditions of hydrogels support their use for gene delivery by preserving activity of lentiviral vectors and acting to shield vectors from any host immune response. Areas covered: Strategies to control lentiviral entrapment within and retention/release from hydrogels are reviewed. The authors discuss the ability of hydrogel design parameters to control the transgene expression profile and the capacity of hydrogels to protect vectors from (and even modulate) the host immune response. Expert opinion: Delivery of genetic vectors from scaffolds provides a unique opportunity to capitalize on the potential synergy between the biomaterial design for cell processes and gene delivery. Hydrogel properties can be tuned to directly control the events that determine the tissue response to controlled gene delivery, which include the extent of cell infiltration, preservation of vector activity and vector retention. While some design parameters have been identified, numerous opportunities for investigation are available in order to develop a complete model relating the biomaterial properties and host response to gene delivery. 相似文献