体外诊断试剂能力验证应用策略探讨

目的：探讨体外诊断检测领域能力验证策略,为能力验证提供者组织能力验证活动提供参考,推动实验室质量体系持续改进。方法：通过对组织体外诊断检测领域能力验证活动的工作进行总结,从方案设计到结果分析所涉及的关键环节进行梳理剖析,只有将这些关键环节进行有效的质量控制,才能成功地开展能力验证活动。结果与结论：能力验证提供者持续改进质量体系建设,为实验室提供质量评价保障的同时,推动了实验室间结果的一致性和标准化。     

化妆品中地塞米松检测能力验证研究

目的：设计组织化妆品中地塞米松测定能力验证项目,评价实验室检测化妆品中地塞米松的技术能力和水平,促进各参加实验室对该类测试项目检测能力的提高。方法：通过实施能力验证计划,获得各参加实验室化妆品中地塞米松含量的测定结果,对结果进行稳健统计分析,通过Z比分数评价实验室检测能力。结果：样品通过分析,在P<0.05显著水平,制备的300瓶样品均匀性符合要求且在整个计划周期内保持稳定,满足能力验证计划要求。40家参加能力验证的实验室中39家结果为满意结果,满意率为97.5%。结论：多数参加实验室检测能力评价为满意,表明化妆品中地塞米松检测水平总体良好。实验操作误差是造成个别实验室结果离群的主要原因。     

人血白蛋白的蛋白质含量测定能力验证结果与分析

目的：对全国血液制品批签发授权药检机构及相关生产企业或单位实验室的人血白蛋白蛋白质含量检测能力进行评价。方法：选择符合要求的人血白蛋白产品作为原料进行合并、除菌、分装。制备后按照《中国药典》2015年版三部蛋白质含量（凯式定氮）测定,组织协作标定后确立指定值。均一性和稳定性监测合格后按能力验证要求发放样品。以多中心协作标定结果作为评价参加者能力验证结果的依据。结果：能力验证样品确立的指定值及其参考范围为（193.30±5.08） g·L^-1,参加本次能力验证的药检机构或企业实验室共13家,10家实验室结果为优秀,1家实验室为合格,2家实验室为不满意。整体满意率为84.6%,优秀率76.9%,不合格率15.4%。结论：国内血液制品的7家批签发授权药检机构能力验证结果均为优秀,部分企业实验室能力验证结果为满意,但也有个别实验室测定结果出现偏差,参加者应调查并改进。     

实验室化学药品熔点测定能力验证研究

摘 要 目的：评价参加能力验证的实验室测定药品熔点的能力和水平。方法: 制备两个考核样品,各实验室自愿报名参加,按照中国药典2015年版四部通则0612测定两个考核样品的熔点,对各参加实验室的结果回收后进行稳健统计分析,用Z比分数法评价实验室检测能力。结果: 样品通过检验是均匀稳定的,满足能力验证计划要求。有31 个实验室的检测结果为满意,占83.8%。结论: 参加本次能力验证的实验室大多数可以准确测定化学药品的熔点,该信息为下一次能力验证计划的开展实施奠定了基础。     

实验小鼠肾匀浆中肽酶-3能力验证结果评价

目的：通过实验小鼠肾匀浆中肽酶-3检测能力验证计划，了解实验动物检测机构检验能力，提高实验动物质量检测水平。方法：按照CNAS批准的能力验证方案，通过样品制备，经过稳定性和均匀性检验合格，作为能力验证样品。采用随机编号，发样给参加单位，并附作业指导书。在规定时限提交检验报告和原始记录复印件，其结果与样品标准结果一致的判为满意结果，不一致或未能提交结果的判为不满意结果。结果：共有11个实验室参加本次能力验证项目，其中提交满意结果的实验室有9个，占总参加机构的81.8%，不满意的实验室有2个，占18.2%。结论：实验动物质量检测机构在实验小鼠肾匀浆中肽酶-3的检测能力较高，实施能力验证计划能够反映实验室的检测水平。     

塑料薄膜氧气透过量测定能力验证研究

目的：组织实施塑料薄膜氧气透过量测定能力验证项目,评价检验机构对氧气透过量的检测能力。方法：制备单一水平样品,采用单因素方差分析对样品均匀性进行检验。对能力验证结果进行统计分析,以z比分数评价实验室检测能力。结果：样品均匀性符合要求,满足能力验证计划要求。38家实验室参加塑料薄膜氧气透过量能力验证项目,满意数为34家,满意率为89.5%。结论：多数实验室检测结果满意,部分实验室检测能力有待提高。     

奶粉中四环素检测能力验证研究

目的：设计并实施奶粉中四环素检测能力验证计划,评价实验室检测奶粉中四环素的技术能力和水平,促进各参加实验室对该类测试项目检测能力的提高。方法：参照CNAS-GL02,对参加该计划的21家食品药品检验实验室及第三方实验室的21份奶粉中的四环素测定结果进行稳健统计分析,用Z比分数评价实验室检测能力,并对离群数据从实验仪器、操作步骤、原始记录等方面进行技术分析。结果：在P<0.05显著水平,制备的300瓶样品均匀性符合要求且在整个计划周期内保持稳定,满足能力验证计划要求。21家参加验证的实验室中20家结果为满意结果,满意率为95.2%。结论：多数参加实验室检测能力评价为满意,表明奶粉中四环素检测水平总体良好。实验操作误差是造成个别实验室结果离群的主要原因。     

国家药品标准物质管理系统的建立及介绍

目的：实现国家药品标准物质全过程的信息化管理。方法：建立“国家药品标准物质管理系统”,对国家药品标准物质的计划立项、原料登记、制备、标定、报告审核、仓储及分发供应等全部流程进行信息化、自动化管理。结果与结论：通过该系统的应用,能及时掌握动态信息,为保障标准物质供应提供了现代化的管理手段。     

品管圈在规范我院住院药房拆零药品质量管理的作用探析

目的：探究开展品管圈（Quality control circle,QCC）实践活动对住院药房拆零药品质量管理的影响。方法：回顾性分析我院开展QCC活动前后住院药房拆零药品质量管理数据资料,统计实施QCC的成果和影响。结果：通过QCC活动,拆零药品质量管理情况有较大改善,药品变质、过期、调剂差错次数均大幅下降,达到预期效果;圈员各项活动成长值均为正值。结论：开展QCC可有效降低住院药房拆零药品质量管理中的差错事件,提高拆零药品质量管理,亦能有效提高药师的工作积极性、解决问题的能力及团队凝聚力。     

实验室人员能力数字化生态管理探索

目的： 减少实验室人员能力管理质量风险点,探究新的管理理念和模式。方法： 结合实验室认定认可准则及相关法律法规要求,分析目前实验室人员能力管理中常见多发的问题。对比提出数字化生态管理模式的优势及创建方式。结果： 通过应用生态思维、数字思维、用户思维,实验室人员能力数字化生态管理模式能有效地实现完备、及时、共建共享的管理效果。结论： 实验室人员能力管理难度大,为适用新的准则法规要求,必须转变理念、改进方法。本文提出的数字化生态管理通过模块体系、流程体系、时效体系和可视化体系有效地实现系统、科学、高效的人员能力管理效果,进而推动实验室质量管理工作的整体改进。     

Use of Normalization Process Theory to explore key stakeholders’ perceptions of the facilitators and barriers to implementing electronic systems for medicines management in hospital settings

BackgroundLimited data exist on the facilitators and barriers to implementing electronic systems for medicines management in hospitals. Whilst numerous studies advocate system use in improved patient safety and efficiency within the health service, their rate of adoption in practice has been slow.ObjectiveTo explore the perceptions of key stakeholders towards the facilitators and barriers to implementing electronic prescribing systems, robotic pharmacy systems, and automated medication storage and retrieval systems in public hospital settings using Normalization Process Theory as a theoretical framework.MethodsIndividual face-to-face semi-structured interviews were conducted in three public hospitals in Ireland with 23 consenting participants: nine nurses; four pharmacists; two pharmacy technicians; six doctors; and two Information Technology managers.ResultsEnhanced patient safety and efficiency in healthcare delivery emerged as key facilitators to system implementation, as well as the need to have clinical champions and a multi-disciplinary implementation team to promote engagement and cognitive participation. Key barriers included inadequate training and organisational support, and the need for ease and confidence in system use to achieve collective action.ConclusionsMany themes that are potentially transferable to other national settings have been identified and extend the evidence base. This will assist organisations around the world to better plan for implementation of medication-related eHealth systems.     

质量考核标准在医院药学管理工作中的成效研究

目的：完善药学管理制度,促进药学事业的高质量发展,提高医院药学服务水平。方法：根据《三级妇幼保健院评审标准实施细则（2016年版）》和《JCI医院评审标准（第6版）》查找医院药学服务在运行过程中出现的质量管理方面的问题,并依此建立我院药学质量考核体系。结果：质量考核标准的执行,使我院药学管理工作取得一定成效,完善了药学相关制度,促进信息化平台的建设,提高了药学服务质量,从而保障了患者的用药安全。结论：质量考核标准的建立和实施有利于规范医院药学管理,提高药学服务质量,保障患者用药安全。     

医疗机构个体化药物治疗实验室质量管理体系的构建与效果评价

目的 建立药学服务转型模式下医疗机构个体化药物治疗实验室（PDTL）质量管理制度,规范和标准化使用PDTL,强化运行与效能,提高药学检验临床工作实效。方法 以目标管理为核心,采用实证研究与调查相结合,综合评价管理体系的合理性、可及性、适宜性、推广性,以工作实效和便宜执行并重的原则,制定管理制度与相关评价量表供决策与管理。结果 结合PDTL实际管理执行情况,制定了4级管理要求,涵盖管理制度及质量控制2大体系,包括实验室计划（规划）、总则、实验人员、实验室财务、实验室设备与器材、实验室环境监测、设备器材运行使用检测、样本登记接收、标准操作规程（SOP）及评估与认证等10大模块为具体执行内容,实施效果评价为可操作性强。结论 建立的PDTL质量管理体系客观可行,可达到医疗机构PDTL规范和标准化运行管理的目的,对提高医疗机构个体化药物治疗技术与平台建设、转型药学服务模式均具有重要意义。     

基于六西格玛管理构建医院药学服务流程

目的 运用六西格玛管理形成一套系统、切实可行的标准化流程,提升医院药学服务质量。方法 按照六西格玛的五步法（DMAIC）实施,即定义-测量-分析-改进-控制,重组和优化药学服务流程。结果 形成98个标准流程,涵盖药事管理各个方面。结论 应用六西格玛管理,使医院药学流程标准化和规范化,以低资源成本、低缺陷的质量水平、优质的服务水准整体上实现医院药学服务质量的提升,实现六西格玛水准,满足患者多层次的需求,顺利接轨新医改。     

Pharmacotherapeutics knowledge of some nonemergency and emergency conditions among medical undergraduates in an Indian medical college

Objectives:To assess pharmacotherapeutics (PT) knowledge of second professional medical undergraduates.Results:MCQs related with PT of nonemergency conditions were responded correctly by 9.8–77.7% of participants. MCQs related with PT of some emergency conditions were responded correctly by 17–66.1% of participants. No statistically significant association was observed in PT knowledge with respect to mode of admission.Conclusion:Gross deficiency in the PT knowledge can potentially and adversely affect future rational prescribing skills. PT knowledge about common medical conditions should be emphasized during undergraduate training program.KEY WORDS: Knowledge, medical, pharmacotherapeutics, undergraduates     

欧盟DCP/MRP药品市场监督抽检策略研究

目的：研究欧盟分散审批与互认审批药品（DCP/MRP）市场监督抽检策略,为我国完善省级药品抽检,进一步探索国抽与省抽统筹模式提供参考。方法：采用文献研究法,汇总欧盟分散审批与互认审批药品（DCP/MRP）市场监督抽检相关法规框架、程序性文件等信息,讨论并分析关键措施。结果：欧盟建立了风险评估制度框架与指导通则,形成了基于互评制度的计划管理模式,制定了针对检验协作网络的专项质管体系,搭建了单点协作的假劣药品管控平台以及多元开放的转化应用链条。结论：研究欧盟分散审批与互认审批药品（DCP/MRP）市场监督抽检采取的关键措施,对我国完善省级药品抽检管理,具有一定参考价值。     

我国医疗器械标准法规解读和思考

目的：为我国医疗器械标准化管理工作提供参考。方法：总结分析我国医疗器械标准管理法规的基本架构,重点解读深化标准化工作改革方案出台后部分相继修订的法规内容,并对其中的差异性变化及标准化发展趋势进行分析。结果与结论：行业标准和国家标准保持了较好的衔接,后续工作建议进一步完善医疗器械标准法规体系架构,建立科学合理的技术标准体系,优化医疗器械标准组织管理体系,研究落实医疗器械标准实施评价机制,逐步实现标准全生命周期的管理。     

Perspectives of pharmacists about collaborative asthma care model in primary care

BackgroundThe newly recognized General Practice Pharmacist (GPP) model in Australia, where non-dispensing pharmacists work in collaboration with general practitioners (primary care physicians) within their general practice/clinics represent an efficient yet novel approach for the management of chronic diseases. In chronic conditions, such as asthma, these models can help achieve optimal health outcomes, given current gaps between guidelines and practice.ObjectiveThe aim of this study was to elicit pharmacists’ views and recommendations about pragmatic models of collaboration between GPPs and general practitioners in providing asthma management services in future service delivery models.MethodsCommunity pharmacists were recruited via convenience sampling and passive snowballing techniques. Qualitative, semi-structured, in-depth interviews were conducted. Recorded interviews were transcribed verbatim and analyzed utilizing NVivo® 11 software. Obtained data were content analyzed for emergent themes using the Braun and Clarke framework.ResultsTwenty-five interviews were conducted. Asthma management challenges in current practice and the implementation practicality of asthma care GPP models comprised the two major emerging themes. Pharmacists' time and workload constraints and patients' reluctance to seek pharmacists’ assistance to dispel misconceptions about asthma control were reported to be major barriers for the implementation of optimal asthma management services in community pharmacy. While a GPP dependent on several criteria. The development of specified channels for inter-professional communication for sharing of patient information and the willingness of stakeholders to accept and access such a model were reported. Funding and remuneration were considered critical factors by most participants. The professional self-autonomy of each healthcare professional involved in the GPP model was also highlighted as pertinent issue.ConclusionsThis study provides significant insights to create pragmatic scalable versions of a GPP care model that could facilitate better asthma care after key barriers and facilitators identified by participants are carefully addressed.     

Service providers’ perceptions of barriers to the implementation of trauma-focused substance use services for women in Cape Town,South Africa

BackgroundA substantial number of South African women with substance use disorders also report psychological trauma related to experiences of physical and sexual abuse. Trauma-focused substance use programmes may support recovery from co-occurring substance use disorders and psychological trauma, yet integrated programmes are not widely available in South Africa. As part of the process of developing a trauma-focused substance use programme for South African women, we explored service providers’ views of the feasibility of implementing trauma-focused substance use interventions within usual care settings in Cape Town, including potential barriers that need to be considered when planning for implementation.MethodsWe conducted 16 in-depth interviews with key informants responsible for planning or delivering substance use, psychological trauma or gender-based violence services to women in Cape Town. Guided by Extended Normalisation Process Theory, interviews explored participants’ perceptions of the potential value of trauma-focused substance use programmes, the feasibility of their implementation, and factors that may facilitate or hinder the implementation of trauma-focused substance use programmes. Qualitative data were analysed using the framework approach.ResultsThree themes emerged: (1) Potential for the implementation of trauma-focused substance use programmes, describing participants’ views of the acceptability of these programmes; (2) Capacity for intersectoral collaboration, which participants considered necessary for limiting barriers to implementation; and (3) Co-operation with community structures to enhance capability for implementation.ConclusionFindings show potential for implementing trauma-focused substance use interventions in South Africa, however context-specific capacity and capability barriers need to be considered and addressed for implementation to be successful.     

地市级药品安全监测数据综合管理平台构建研究

目的：通过构建药品安全监测数据综合管理平台,实现对药品安全监测数据的管理与分析利用。方法：运用信息化手段,以国家药品不良反应监测系统为依托,将数据采集检索、报告质量管理、数据统计分析、实时风险预警、风险信号挖掘五大功能融为一体,实现一站式服务。以“机器换人”为导向,将人工难以实现的计算任务转为机器计算功能,并引入可视化模型用于数据分析和信号挖掘,体现基于数据的价值创造。结果：利用数据综合管理平台,可有效管理和分析全市药品安全监测信息,极大提高了监测效率及风险预警能力。结论：数据综合管理平台体现了药品安全的智慧监测,具有较好的应用前景。