浅谈医疗机构药械监管中存在的问题及对策

目的:探讨医疗机构药品、医疗器械监督管理中存在的问题并提出相应的对策。方法:检索近年来国内文献资料,总结医疗机构药械监管存在的问题,分析其发生的原因,并对解决问题的方法进行探讨。结果与结论:医疗机构药品、医疗器械管理中存在一些突出问题亟待解决,药品监督管理部门及相关部门应加强协作,加大监管力度,规范医疗机构药械的使用,确保广大患者应用药品及医疗器械安全、有效。     

医院门诊药房与零售药店药品品种及价格的比较

目的了解医院门诊药房与零售药店药品品种与价格,知晓其差异,提出相关政策建议.方法对4个省的7家药店和8家医院门诊药房的药品品种和价格进行调查和比较分析.结果医院门诊药房和零售药店经营药品的种类差异较大;患者持医院处方到零售药店有60%的可能购不到所开药品;医院门诊药房与零售药店药品的质量、价格管理方式不同;医院门诊药房和零售药店药品同类品种的零售价格水平不同;单独定价药品价格虚高较为严重;医院药剂部门在拥有高中级药学人才方面占有绝对优势,其药事服务能力零售药店难以企及.结论医院门诊药房和零售药店具有较大差异性.目前情况下,出台剥离医院门诊药房,或者鼓励门诊病人到零售药店进行处方调剂的政策性规定,条件尚不成熟.医疗机构要进一步规范药品采购行为;要规范医疗机构医生的处方行为.     

江苏全面推行医疗机构药品使用规范化管理

《江苏省医疗机构药品使用质量管理规范》近日出台，对各类医疗机构建立药品采购、储存、调配全过程质量管理体系以及药房（柜）、药库设立等均作出了明确规定，特别规定“将医疗机构纳入药品安全远程监管”，“达不到规定条件的医疗机构不得设立药房”。据悉，医疗机构是最主要的药品消费终端，     

医药团结合作 建设放心药房

总结了全国放心药店现场交流会后,全国各地放心药房建设的情况。强调了建设放心药房工作的意义,指出建设放心药房是中医医疗机构精神文明建设的重要部分,是落实中央指示,加强药品管理的具体行动,是加强中医医疗机构内涵建设的重要内容,是保证中医医疗质量的关键环节。对进一步做好放心药房建设工作提出了要求:规范进货行为,把好药品进货关;不断深化改革,加强内部管理;认真贯彻国家有关法规,继续整治药品回扣违法行为;加强医药团结合作,建立稳定的供需关系;加强领导,务求实效,使“放心药房”建设深入持久地开展下去。     

基层医疗机构实行药房托管后药学人员的安置与配备

《全国药品流通行业发展规划纲要（2011—2015）》关于“鼓励连锁药店积极承接医疗机构药房服务和其他专业服务”的规定,将药房托管推向了关注的焦点。目前,河南某市积极探索基层医疗机构药房托管模式,希望以点带面,逐步实现医药分开。但从实施情况看,在维护医疗机构原药学人员的合法权益及药品经营企业引进和配备新的药学工作人员上存在一些缺陷。     

农村基本药物流通安全研究

采用专家讨论、实地调研、统计分析等方法,对农村药品流通进行了为期7年的深入研究,总结我国农村药品流通存在的主要问题:边远地区药品配送直配不到位、对药品销售员的监管法律依据缺乏、药品流通中"过票"行为猖獗、农村医疗机构药品经营不规范、农村药品流通监管人员和设施严重不足.为落实国家基本药物制度,提出农村地区药品流通应重点应对:流通新范式的产生、现代物流的引入、"过票"行为的遏制、农村医疗机构基本药物经营的规范化等问题.提出农村基本药物流通安全全过程监管的新模式.     

北京市顺义区基层医药人员对药品不良反应认知程度调研

[目的]通过对北京市顺义区一级医疗机构的150名医生进行药品不良反应认知度的调查,分析目前基层医疗机构药品不良良应监测工作中存在的问题,为提高基层医疗机构药品不良反应监测水平提供依据和参考。[方法]利用SPSS统计软件对调查问卷结果进行统计分析。[结果与结论]基层医药人员对药品不良反应认知程度较差,基层医疗机构药品监测体制不健全,监测力度不够。建议对基层医务人员积极开展药品不良反应监测的宣传、教育工作,加强药品监管力度。     

安徽省医改试点地区药品零差率销售的调查及探讨

目的:通过对安徽省医改试点地区亳州市的药品零差率销售工作开展调查,发现问题并对问题提出探索性的建议。方法:实地调查、走访群众及开展座谈会。结果:基层医疗机构药品费用降低,人均门诊费用、住院费用下降,居民基本用药费用负担有所降低;存在乡村医生收入偏低、部分药品无法采购使用以及部分目录药品不齐等问题。结论:有关部门要加强对药品生产配送企业的监管,确保零差率销售工作的正常运行。     

北京市基层医务人员药品不良反应认知现状与对策研究

目的:了解基层医务人员对药品不良反应的认知情况,查找问题并分析原因,为提高基层医疗机构药品不良反应监测水平提供依据和参考.方法:对150名医务人员进行问卷调查,利用手工筛选以及统计软件对调查问卷结果进行统计分析,比较不同特征医务人员对药品不良反应基本知识的掌握情况.结果:药品不良反应基本知识满分为14分,138名医务人员平均得分为(8.23±3.21).不同学历的医务人员得分间差别有统计学意义(P< 0.05).结论:基层医务人员药品不良反应知识缺乏;基层医疗机构药品监测体制不健全,监测力度不够;应提高监测人员的业务水平,加强日常监测和评价工作,加强药品监管力度.     

医院门诊药房改为药品零售企业的思路探讨

国务院体改办等8部门《关于城镇医药卫生体制改革的指导意见》明确指出;“……把医院的门诊药房改为药品零售企业,独立核算、照章纳税。各地区要选择若干所医院积极进行门诊药房改为药品零售企业的试点,取得经验后普遍推广。”卫生部部长张文康在2002年全国卫生工作会议上,谈到2002年卫生工作重点时指出:“在理顺医疗机构补偿机制的基础上,选择几个中等城市实施把门诊药房改为零售药店的试点。”为积极、稳妥地推行医院门诊药房改为药品零售企业这项工作,我们认为,在此项改革措施未全面推广之前,有必要从理论上对其相关政策作一些有益的研究和探索。     

The impact of supervision on stock management and adherence to treatment guidelines: a randomized controlled trial

Ensuring the availability of essential drugs and using them appropriately are crucial if limited resources for health care are to be used optimally. While training of health workers throughout Zimbabwe in drug management (including stock management and rational drug use) resulted in significant improvements in a variety of drug use indicators, these achievements could not be sustained, and a new strategy was introduced based on the supervision of primary health care providers. This was launched in 1995 with a training course in supervisory skills for district pharmacy staff. In order to evaluate the impact of the supervision and the effectiveness of the training programme, adherence to standard treatment guidelines (STG) and stock management protocols was evaluated in a randomized controlled trial. The study compared three different groups of health facilities: those that received supervision for either use of STG (n = 23) or stock management (n = 21) - each facility acting as control for the other area of supervision - and a comparison group of facilities which received no supervision (n = 18). On-the-spot supervision by a specially trained pharmacy staff, based around identified deficiencies, took place at the start of the study and 3 months later. The evaluation compared performance on a variety of drug management indicators at baseline and 6-8 months after the second supervisory visit. The results of the study showed that, following supervision, overall stock management improved significantly when compared with the control and comparison groups. Similar improvements were demonstrated for adherence to STG, although the effect was confounded by other interventions. The study also showed that supervision has a positive effect on improving performance in areas other than those supervised, and demonstrated that pharmacy technicians with limited clinical skills can be trained to influence primary health care workers to positively improve prescribing practices. Allocating resources to supervision is likely to result in improved performance of health workers with regard to the rational use of essential drugs, resulting in improved efficiency and effectiveness.     

Pills in paradise: Exploring international lifestyle and retirement migrants’ perceptions of the pharmaceutical sector on Cozumel Island,Mexico

International lifestyle and retirement migration is a growing phenomenon, yet little is known about migrants’ experiences of health care in destination countries. This includes use of and access to pharmaceutical selling establishments. This article explores international lifestyle and retirement migrants’ experiences and perceptions of the local pharmaceutical sector on Cozumel Island, Mexico. Qualitative data, collected through semi-structured interviews (n = 26), finds that participants are concerned with accessibility, quality and communication within the island's pharmaceutical sector. Subsequent analysis suggests that these concerns arise through comparison with previous health care environments and that migrants attempt to remedy them by spatially reorganising their pharmacy engagements through practices which may contribute to adverse health outcomes.     

Future European health care: cost containment, health care reform and scientific progress in drug research

The cost of the development of a new pharmaceutical product from its conception and synthesis through to the regulatory approval process has more than quadrupled in the last 20 years. Both clinical and total development times have increased substantially. To amortize the costs incurred, the pharmaceutical industry has taken an international dimension. The incentives for pharmaceutical firms to discover and develop new drugs depend on the length of the development and regulatory review process plus the potential market size. Recent regulatory, economic and political changes may have significant implications for the future of new drug developments in Europe. The European Union industrial policy felt that there is a need for convergence in the area of pricing. It is recommended that the policy should aim to contain growth in pharmaceutical expenses by means specific to reimbursement rather than direct price controls. By encouraging doctors to prescribe and customers to use generics, competition is enhanced to bring down drug prices. More emphasis is being laid by government in educating customers to cost-awareness and cost-benefit ratios with regard to pharmaceuticals. Concerning clinical trials, European harmonization has been achieved by significant developments: the rights and integrity of the trial subjects are protected; the credibility of the data is established; and the ethical, scientific and technical quality of the trials has improved. Future European health care forecasts a whole change in the pharmaceutical business. Important issues in cost and outcome measurement should be carefully planned and considered in drug development. Due to important mergers and acquisitions, the pharmaceutical sector will consist mainly of important multinational corporations. In this way, valuable new products may be brought to the market.     

Pharmaceutical regulation in context: the case of Lao People's Democratic Republic

An explosive development of private pharmacies in the Lao People's Democratic Republic (Lao P.D.R.) has led to 80% of pharmaceuticals being provided by the private sector. In order to achieve the goal of access to good quality health care for all citizens, the Lao government is making an effort to regulate the private pharmaceutical sector using the emerging legal system of laws, decrees, and regulations. The aim of this paper is to describe and analyze the system of drug regulation in Lao P.D.R. in relation to the public social goals. Relevant official documents at the central, provincial and district levels have been reviewed, interviews were held with 30 key informants and 15 pharmacies were surveyed. The public social goals have been expressed in terms of equity and quality of care. However, total drug expenditure may be as low as US$1 per person per year which is far below any minimum standard and does not make it possible to achieve reasonable access to drugs for all. The regulatory system has so far been focused on entry into the pharmaceutical retail market and dealing with basic issues of product quality and conditions of sale. An enforcement system including sanctions is being developed; other policy instruments such as information and economic means are hardly being used at all. The government presently faces a trade-off between quality of pharmaceutical services and geographical equity of access. The study shows that regulation is strongly influenced by the general socioeconomic context.     

Ten recommendations to improve use of medicines in developing countries

Inappropriate prescribing reduces the quality of medical care and leads to a waste of resources. To address these problems, a variety of educational and administrative approaches to improve prescribing have been tried. This article reviews the experiences of the last decade in order to identify which interventions have proven effective in developing countries, and suggests a range of policy options for health planners and managers. Considering the magnitude of resources that are wasted on inappropriately used drugs, many promising interventions are relatively inexpensive. Simple methods are available to monitor drug use in a standardized way and to identify inefficiencies. Intervention approaches that have proved effective in some settings are: standard treatment guidelines; essential drugs lists; pharmacy and therapeutics committees; problem-based basic professional training; and targeted in-service training of health workers. Some other interventions, such as training of drug sellers, education based on group processes and public education, need further testing, but should be supported. Several simplistic approaches have proven ineffective, such as disseminating prescribing information or clinical guidelines in written form only. Two issues that will require a long-term strategic approach are improving prescribing in the private sector and monitoring the impacts of health sector reform. Sufficient evidence is now available to persuade policy-makers that it is possible to promote rational drug use. If such effective strategies are followed, the quality of health care can be improved and drug expenditures reduced.     

探讨新医改模式下的医院药学服务

目的：介绍中国新医改的主要内容及其对医院药学服务的影响,探讨医院药学适应新医改要求的具体做法。方法：综合国内外的文献,结合作者单位的工作实际,从多方面论述医院药学服务的发展方向。结果：新医改对医院药学服务提出了更高的要求,医院药学服务人员要从加强自身学习、优化管理模式、发挥临床药师作用、引入药物经济学方法等多个方面加强医院药学服务,为患者提供安全、有效、经济的药疗服务。结论：医院药学服务人员要根据本地区、本单位的实际,探索适应新医改要求的医院药学服务发展之路。     

Economic evaluation of task-shifting approaches to the dispensing of anti-retroviral therapy

ABSTRACT: BACKGROUND: A scarcity of human resources for health has been identified as one of the primary constraints to the scale-up of the provision of Anti-Retroviral Treatment (ART). In South Africa there is a particularly severe lack of pharmacists. The study aims to compare two task-shifting approaches to the dispensing of ART: Indirectly Supervised Pharmacist's Assistants (ISPA) and Nurse-based pharmaceutical care models against the standard of care which involves a pharmacist dispensing ART. METHODS: A cross-sectional mixed methods study design was used. Patient exit interviews, time and motion studies, expert interviews and staff costs were used to conduct a costing from the societal perspective. Six facilities were sampled in the Western Cape province of South Africa, and 230 patient interviews conducted. RESULTS: The ISPA model was found to be the least costly task-shifting pharmaceutical model. However, patients preferred receiving medication from the nurse. This related to a fear of stigma and being identified by virtue of receiving ART at the pharmacy. CONCLUSIONS: While these models are not mutually exclusive, and a variety of pharmaceutical care models will be necessary for scale up, it is useful to consider the impact of implementing these models on the provider, patient access to treatment and difficulties in implementation.     

医疗卫生行业综合监管制度体系构建——基于扎根理论的质性分析

目的：运用扎根理论方法研究医疗卫生行业综合监管制度体系框架并提出相应对策，为完善医疗卫生行业综合监管制度提供科学依据。方法：2018年9-12月对北京市各级卫生行政部门、卫生监督机构以及医疗机构、相关行业协会负责人、领域内专家、高校教师共计27人进行访谈，结合文献资料和小组研讨等内容，采用三级编码将原始资料逐级浓缩并分类、归纳。结果：经过三级编码提炼出42个初始范畴、11个主范畴及5个核心范畴，最终形成综合监管制度体系框架，应构建“四位一体”相互协作的综合监管格局，建立信息平台实现技术上的严密管控，同时完善定期督察机制和法律法规的制定。结论：实施医疗卫生行业综合监管必须坚持政府主导，完善多元主体协调机制，创新监管机制、完善保障制度，构建科学合理的综合监管体系。     

开展药学监护 提高用药水平

探讨临床药学监护（%&）的概念及其产生和发展，提出实施药学监护（%&）的必要性和可 行性，有利于医院提高用药水平，减轻医药费用负担，是完善医药体制改革的重要举措之一。药学 监护是一种全新的药学服务模式，“以病人为中心，提供全优的药学服务”是今后医院药学工作的核 心内容，而合理用药则是这项工作的重点，我们必须接受新的药学服务理念，创造条件付诸实施。