重点短缺药品及供应保障措施探讨

目的：分析我国重点短缺药品品种,探讨供应保障措施,为缓解药品短缺和实施相关政策提供参考。方法：检索我国政府网站,收集整理短缺药品监测报告,从监测哨点角度、省级监测平台角度和短缺药品来源角度,总结归纳出我国重点短缺药品品种,分析其短缺原因,提出措施建议。结果与结论：我国短缺药品中,国产药品、化学药品占比较高,抗肿瘤药短缺问题突出,基本药物目录、医保目录内品种占比高。为做好短缺药品综合供应保障,应在落实已有政策的基础上,学习国外管理经验,着力解决重点短缺药品、完善监测平台、发挥政策引导作用,加强企业社会责任意识,做好数据挖掘和信息公开,多举措保障药品的可及性。     

陕西省基层医疗机构药品短缺现状、造成的影响及对策研究

目的：调查和探讨陕西省基层医疗机构药品短缺现状、造成的影响和对策,为保障药品供应提供依据。方法：采用自行设计的药品短缺调查问卷,于2017年3-6月期间对陕西省基层医疗机构的全科医生进行调查。问卷内容包括基本信息、药品短缺现状、影响和应对策略等4个部分。结果：共发放问卷235份,回收有效问卷193份,有效回收率为82.1%。其中,92.1%的全科医生曾遇到药品短缺情况,短缺品种数共为139种,不同医疗机构和不同经济发展水平地区短缺情况存在差异;短缺药品一般为低价药和基本药物,种类覆盖面较广,其中呼吸系统用药、心血管系统用药短缺较为严重;药品短缺主要给医生的工作带来不便,影响医患关系,影响医院的声誉以及增加了患者经济负担;为应对药品短缺问题,大部分全科医生对患者使用次优疗法或替代药物。结论：陕西省基层医疗机构药品短缺现状比较严峻,影响了医务人员的日常工作,增加了患者治疗负担。建议政府部门加强对药品短缺的监测,强化政策引导,建立针对药品供应企业的奖惩制度。     

我国部分省市药品短缺现状研究及相关建议

目的： 通过对我国部分省（市）近年短缺药品有关数据的整理,分析我国药品短缺的现状,提出相关意见和建议,为我国进一步提高药品供应保障能力提供依据和参考。方法： 通过国家药品供应保障综合管理信息平台,查询全国有关短缺药品的公开信息,以及检索部分省（市）药品短缺相关资料,统计对比部分省（市）短缺药品数据,分析短缺药品供应保障现状。结果与结论： 我国目前短缺药品多为省内短缺,全国性短缺情况较少见;短缺药品中,基本药物、低价药物短缺比较常见,各省（市）根据自身特点完善了短缺药品供应保障措施,但是,还需要进一步创新和改进。     

我国部分临床短缺药品供应保障措施探讨

目的：分析部分药品短缺的原因,探讨药品供应信息平台的建立,为完善我国部分临床短缺药品供应保障措施提供参考。方法：采用文献研究法,了解我国药品短缺的原因,初步探索短缺药品的应急处理措施与长期保障措施。结果与结论：通过建立短缺药品信息平台,从生产供应调节与临床使用调节两方面进行应急处理;对于短缺药品的长期保障,可从短缺药品的遴选环节、生产流通环节、储备调剂环节和定价支付环节着手,减少药品短缺事件的发生。     

陕西省药品不良反应报告主体工作现状的实证研究

摘 要 目的:调查研究陕西省药品不良反应报告主体工作开展的现状,探讨目前存在的问题和不足,从组织体系建设、制度政策等方面提供切实可行的建议。方法：以陕西省药品不良反应报告主体（药品生产企业、药品经营企业、医疗机构）为研究对象对其进行整群抽样,使用SPSS 19.0统计软件,运用描述性统计分析等方法对回收问卷进行分析处理,得出相应统计结果。结果：陕西省药品不良反应报告主体工作现状、制度建设、上报情况良好,但工作人员满意度方面有待进一步加强。结论：针对研究结果,提出以下建议：完善药品不良反应监测工作组织建设;优化办公条件;保证药品不良反应监测经费;加强工作交流;加强制度建设。     

从生产者角度分析药品临床供应短缺的原因

目的：从生产者角度分析药品短缺原因,提出应对药品短缺问题的政策建议。方法：采用文献综述法和归纳总结法,分析药品短缺原因;在此基础上提出相关建议。结果与结论：对于药品生产企业来说,药品短缺原因分为生产原因和非生产原因。生产性原因分为主观原因和客观原因。主观原因主要有价格太低、需求量少、成本上升等造成企业不愿生产;客观原因主要有原料获取困难、生产条件不符合规定等。非生产性原因主要有流通环节利润太低、流通垄断、意外情况等。应进一步调动生产企业积极性、净化原料和流通环节、落实保障政策,提高相应药品的可及性。     

基于CHPS的全国药品不良反应监测哨点联盟的研究

目的：为政府部门、医院、制药企业等机构的相关人员对基于CHPS的全国药品不良反应监测哨点联盟的认识和了解提供参考。方法：采用基于文献调查和实践观察的规范研究方法,对比分析中美两国的药品不良反应监测哨点联盟的监测方法,并对我国药品不良反应监测哨点联盟建立的作用、意义及其运行情况进行阐述和分析。结果：CHPS在哨点联盟中可以及时、准确、完整地收集药品不良反应信息,促进哨点联盟成员高效率、低成本、高质量地完成药物上市后的研究。结论：哨点医院联盟的建立,为建设和完善我国药品上市后科学评价体系以及药品安全的智能监管体系,提供了新的实现平台。     

2014至2016年安徽省药品注册现状分析

目的：总结安徽省2014至2016年药品注册情况,为本省的药品研发、申报、审批提供参考。方法：通过梳理药品企业在2014至2106年新药、仿制药、补充申请和再注册申请的情况,对安徽省药品注册申请进行统计分析与评价。结果：近3年,安徽省药品注册申请数量主要集中在药品再注册和补充申请。新药申请中,97%的药品申报临床试验,化学药品占新药申请的90%。仿制药申报品种均为化学药品。结论：安徽省药品注册申报类别分布合理,在生物制品的新药研发上取得进步,中药研发方面有待加强。     

美国药品短缺应对机制及其对我国的启示

目的：对美国药品短缺应对机制进行研究,总结其经验,为我国药品短缺应对提供借鉴和思路。方法：采用文献研究法了解美国处理药品短缺的具体情况,运用对比分析法寻找我国可以采纳的优点。结果：美国的药品短缺应对机制相对完善,有专门的管理机构,并且通过政策法规等文件明确规定了药品短缺的解决流程,能够有效地改善药品短缺问题。结论：我国可以参考美国的处理方式,明确药品短缺的具体概念,完善药品短缺管理法律法规,设立专门的管理机构,建立短缺信息监测机制等。     

1989年—2021年6月国内药品短缺研究可视化分析

目的 基于文献分析中国药品短缺问题的研究现状，探讨中国药品短缺原因及特点，为完善中国药品短缺应对措施提供参考。方法 检索中国知网、万方数据库和维普数据库中1989年—2021年6月中国药品短缺相关中文文献，利用可视化分析软件CiteSpace，对文献的发表时间、作者、研究机构、关键词，以及药品短缺原因等进行统计分析。结果 共有400篇文献纳入研究，中国药品短缺的研究文献数量从2011年起呈现出明显的增长趋势，作者和研究机构合作网络分散，研究团队以高校和研究所为主；关键词“药品供应链”“国家基本药物”政策以及“药品价格”方面是药品短缺领域的研究重点，“监测预警”是该领域新的研究趋势。结论 针对中国药品短缺问题研究的系统性尚需提高。现有研究文献提示，供应链中的生产环节是引起中国药品短缺的主要环节，药品价格是重要的影响因素，国家基本药物在短缺药品中占比较高，这些问题需要关注并值得进一步研究。     

医疗机构廉价基本药物短缺现象研究

目的:为处理医疗机构廉价基本药物短缺问题提供建议。方法:结合医疗机构廉价基本药物短缺的现状,分析其产生的原因。结果:医疗机构廉价基本药物短缺的主要原因在于作为理性经济人的医疗机构不使用廉价基本药物、医师处于博弈优势地位、医药企业的合理利润没有保障、医疗保险支付方式存在缺陷。结论:政府应明确负责处理廉价基本药物短缺问题的行政机构,加大对廉价基本药物的投入,保障医药企业生产、配送廉价基本药物的合理利润,同时完善医疗保险制度。     

The role of outsourcing facilities in overcoming drug shortages

BackgroundThe Drug Quality and Security Act passed in 2013 created a new voluntary category of compounders, referred to as outsourcing facilities. The regulatory landscape allows these facilities to compound on a larger scale in comparison with the typical compounding pharmacies, which positions them to potentially serve a role in overcoming drug shortages.ObjectiveThe purpose of this article is to identify the number of drug products on shortage as reported by the Food and Drug Administration (FDA) that were also compounded by outsourcing facilities.MethodsAll current and resolved drug shortages through January 27, 2020, as reported by FDA, were compared with the 503B product reports from July 2018 through June 2019 submitted to FDA by outsourcing facilities. The active pharmaceutical ingredient (API) and dosage form for each product on shortage were compared with the 503B product reports to identify similarities.ResultsThere were 344 unique APIs on the FDA drug shortage list and 774 unique APIs on the 503B product reports. After comparison of the APIs on the drug shortage list with those on the product reports, 27% of unique APIs (74 of 272) were included on both lists, and of these, 18% (50 of 272) of the APIs on the drug shortage list were compounded by outsourcing facilities in the same dosage form as what was on shortage.ConclusionThe regulatory landscape positions outsourcing facilities to play an important role in providing access to medications while on shortage. However, when comparing the drugs on shortage as reported by FDA with the 503B product reports, there was minimal overlap. Additional research into why outsourcing facilities are not taking on a larger role in overcoming drug shortages should be explored.     

Drug shortages in Saudi Arabia: Root causes and recommendations

Drug shortages are a multifaceted problem that has been recurring in Saudi Arabia over the past decade with its significant negative impact on patient care. However, there is a dearth of evidence about possible domestic reasons, if any, behind this recurring problem. Recently, the Pharmacy Education Unit at King Saud University College of Pharmacy has called for a meeting with multiple stakeholders from academia, pharmaceutical care, pharmaceutical industry, purchasing and planning, and regulatory bodies to unveil the root domestic causes of the drug shortages in the Kingdom. Four major topics were used to guide the discussion in this meeting, including: current situation of drug shortages in Saudi Arabia, major factors contributing to drug shortages, challenges and obstacles to improve drug supply, and stakeholders’ recommendations to manage drug shortages. The meeting was audio-recorded and transcribed into verbatim by five authors. The text was then reviewed and analyzed to identify different themes by the first and third authors. Multiple causes were identified and several recommendations were proposed. The main domestic causes of drug shortages that were explored in this study included poor medication supply chain management, lack of government regulation that mandates early notification of drug shortages, a government procurement policy that does not keep pace with the changes in the pharmaceutical market, low profit margins of some essential drugs, weak and ineffective law-violation penalties against pharmaceutical companies and licensed drug importers and distributors, and overdependence on drug imports. The participants have also proposed multiple recommendations to address drug shortages. Policy makers should consider these factors that contribute to drug shortages in Saudi Arabia as well as the recommendations when designing future initiatives and interventions to prevent drug shortages.     

医疗机构药品短缺原因分析与防范

目的分析医疗机构药品短缺原因,采取相应的防范措施,保障药品供应。方法对2012年药品出库单进行回顾性分析,追溯短缺药品采购计划时间、供应商交货时间,并结合供应商无法供货的情况说明,利用Excel对短缺药品信息进行分类、统计,总结医疗机构药品短缺的外因与内因。结果 2012年调剂部门请领计划共46 862条,短缺药品1 423条,药品短缺率为3.0%,外因导致的药品短缺共计643次,占45.2%;内因导致的药品短缺780次,占54.8%。在导致药品短缺的外因中,价格倒挂占40.7%,居药品短缺外因之首,低价小品种及普药占外因导致的药品短缺的71.2%;药品短缺的内因中,控制库存占45.0%,排首位。结论如果药品定价合理,完善招标政策及药品供应链,加强短缺药品的预警与管理,可减少药品短缺状况。     

2013～2016年国家药品不良反应监测年度报告统计分析

摘 要 目的：了解我国近年来药品不良反应/事件监测情况,分析其原因,提出建议,为加强药品不良反应/事件监测、降低药品质量风险、保障公众安全用药提供参考。方法：收集2013～2016年《国家药品不良反应监测年度报告》,对我国药品不良反应/事件报告的总体情况、基本药物监测情况、抗感染药物监测情况以及中药注射剂监测情况进行统计分析。结果：药品不良反应监测网络覆盖率逐年增加;收集的不良反应/事件报告数量也逐年增多;医疗机构是药品不良反应/事件报告的主要来源;抗感染药物不良反应报告数量仍居首位。结论：药品不良反应/事件监测事业的稳定运行是公众安全用药的有力保障,应当形成全员参与的意识,药品生产经营企业提高对上市药品的不良反应/事件监测力度;重视抗感染药物和中药注射剂的药品不良反应;关注老年人和儿童用药不良反应。     

Drug shortages in hospitals: Actors’ perspectives

BackgroundDespite an increasing focus on drug shortages, no standardized global definition of a drug shortage seems to exist. This raises the question of whether healthcare actors are discussing the same phenomenon, which may influence their actions when managing, solving and preventing drug shortages. Further, the literature reports a lack of national contingency plans for managing drug shortages in hospitals.ObjectiveTo explore national-level communication, decision-making and collaboration on drug shortage management carried out in Denmark by secondary healthcare actors.MethodsSeven semi-structured interviews were conducted with actor representatives from Amgros, the procurement department of the hospital pharmacy in the Capital Region of Denmark, two medicine suppliers, two pharmaceutical wholesalers and distributors, and the Danish Medicines Agency. Data was analyzed using a social constructivist approach.ResultsNo common definition of a drug shortage exists among the actors, but referential definitions related to “contract” and delivered “as expected” were identified. Additionally, actors initiate drug shortage procedures differently, and, as efforts are minimally coordinated, the work procedures are often needlessly duplicated. Further, discrepancies in available drug shortage information arise, as information is distributed through different electronic systems, unavailable to all actors. Besides, Amgros (a national organization responsible for tendering and procuring medicines in hospitals) and the procurement department of the hospital pharmacy in the Capital Region of Denmark make joint decisions regarding the choice of alternative drugs. However, the study found that actors had diverse collaborative relationships, especially those with the Danish Medicines Agency, and that these were limited to contact regarding medicine regulations and unlicensed medicine.ConclusionThe study provided insight into national-level communication, decision-making and collaboration on drug shortage management by different actors in hospitals. This knowledge is useful in the development of a national contingency plan for drug shortage management.