Evaluation of Need and Distribution of National Essential Medicines List in Village Clinics:A Cross-sectional Study Based on the Perspective of Village Doctors in China

This study aimed to evaluate the satisfaction of village doctors to essential medicines list (EML) and accessibility of essential medicines (EMs) distribution to improve the implementation of EML in village clinics.A total of 422 village doctors from five counties in three provinces of China were surveyed by questionnaires.Logistic regression analysis was conducted to identify the main factors associated with village doctors' evaluation of EML.The results showed that village doctors had a negative evaluation in satisfaction level of EML to village-based care and accessibility of EM distribution.The government should adjust EML regularly based on the actual health status of local villagers in China and focus on adding appropriate drugs that meet the needs of villagers with chronic disease.The local government should also attach importance to the distribution of EMs and maintain their supply in village clinics.

Effects of China's National Essential Medicines Policy on the Use of Injection in Primary Health Facilities

The overuse of injection exists more than 20 years since economic reform in China.It is a persistent problem and seems becoming a new challenge in the new health reform period.This study was designed to assess the effect of national essential medicines policy(NEMP) on injection use at primary health facilities in China by investigating their prescription information.Questionnaires were designed and disseminated to collect empirical data on injection use at 120 primary health facilities in 6 provinces from January to September in 2010 and 2011.The injection use was measured as the indicator as the percentage of prescriptions with one or more injections.The results showed that the percentage of prescriptions with one or more injections was decreased from 38.91% to 36.82%(2 =11.158,P=0.001) in the all survey areas during the NEMP reform.The difference in level of the injection use in 2011 was significant among the eastern,central and western regions(2 =223.584,P=0.000);level of the injection use in western region was the lowest(27.73%),while that in the central region was the highest(43.10%).The level of the injection use in 2011 among different provinces was also of great difference(26.00%-58.25%,range:32.25%).The level of the injection use in 2011 was still much higher than the standard suggested by WHO for developing countries(13.4%-24.1%).It was concluded that NEMP has improved injection use in China,but the injection abuse situation remains serious,indicating that one of the priorities to the next stage of NEMP is to promote the rational use of drugs,especially the injection use.

Research on the Linkage Mechanism between Essential Medicine List and Healthcare Insurance List

Objective: To put forward suggestions to improve the linkage mechanism between China’s essential medicine list and healthcare insurance medicine list. Methods: Comparative study of the organization setting, selection criteria, adjustment procedures, and reimbursement of essential medicine list and healthcare insurance medicine list, containing both the foreign experience and China’s status quo. Results: When two lists exist at the same time, they are often managed separately abroad, setting more selection criteria for the essential medicine, and giving the essential medicine a higher payment ratio. The two lists in China are managed and adjusted separately, but lack of connection. As a result, some essential medicines cannot be reimbursed. Conclusion: The two lists’ linkage mechanism needs to be improved. It is recommended to make it clear that essential medicines should be selected from the healthcare insurance medicine list, and enhance the consistency of medicine evaluation through mutually scientific evidence.

Development of radiation countermeasure agents for acute radiation syndromes

The risk of internal and external exposure to ionizing radiation(IR)has increased alongside the development and implementation of nuclear technology.Therefore,serious security issues have emerged globally,and there has been an increase in the number of studies focusing on radiological prevention and medical countermeasures.Radioprotective drugs are particularly important components of emergency medical preparedness strategies for the clinical management of IR-induced injuries.However,a few drugs have been approved to date to treat such injuries,and the related mechanisms are not entirely understood.Thus,the aim of the present review was to provide a brief overview of the World Health Organization's updated list of essential medicines for 2023 for the proper management of national stockpiles and the treatment of radiological emergencies.This review also discusses the types of radiation-induced health injuries and the related mechanisms,as well as the development of various radioprotective agents,including Chinese herbal medicines,for which significant survival benefits have been demonstrated in animal models of acute radiation syndrome.

基于知识图谱的国家基本药物制度研究进展分析

目的 运用知识图谱的可视化方法对我国基本药物制度领域的研究进展进行探究,为该领域后续发展提供参考依据。方法 采用文献计量学方法,借助CiteSpace软件,从研究者、研究机构、关键词等角度对基本药物制度相关文献进行分析,并绘制可视化知识图谱。结果 该领域有众多学者开展相关研究,研究学者之间合作度较低;高校是研究的主要力量,研究机构之间合作不够密切;国家基本药物目录、基层医疗卫生机构、药品零差率、合理用药等是该领域的研究热点;药品零差率销售、补偿机制、乡村医生等高强度突现词反映该领域不同时段的研究前沿。结论 需进一步加强研究者之间的科研合作;促进该领域各类研究机构之间的协作互动机制;基本药物制度领域的研究热点与国家深化医药卫生体制改革进程中的阶段性目标一致;新时期,基本药物制度领域研究侧重点从关注供给端向需求端倾斜。

The impacts of national essential medicine policies on the rational use of medicines in China: A cross-sectional study in primary health care institution

Irrational use of medicines is a major problem worldwide, and it is believed there would be positive correlation between the National Essential Medicines Policies(NEMPs) and the level of rational use of medicines(RUMs). Though there is some early evidence on the NEMPs’ effects on RUMs in China, the evidence is scarce, and conclusions vary. In the present study, we aimed to evaluate the impacts of the NEMPs of China on the RUMs in the primary health care institutions(PHCs). A cross-sectional survey was conducted in 2010. A total of 201 PHCs from six provinces of China were selected, and 39 181 prescriptions were extracted from January to June, 2010. Six indicators were used and tested by independent-samples T test. We found that the average number of drugs per prescription in PHCs with NEMP implementation(the treatment group) was significantly higher than that of the group without NEMP implementation(the control group)(3.37 vs. 2.83, P<0.01). There was no significant difference in the average cost per prescription(81.43 vs. 75.02). The percentage of prescriptions, including an antibiotic(53.40% vs. 36.48%, P<0.01) or an injection(40.54% vs. 27.94%, P<0.01), was higher in the treatment group, and the percentage of drugs prescribed by general name was significantly lower(83.71% vs. 93.11%, P<0.01). For the percentage of drugs prescribed from essential medicines list, the treatment group exhibited the higher ratio(76.12% vs. 53.45%, P<0.01). From this study, the NEMPs were not likely to have a positive impact on RUMs. China still needed efforts to improve the selection, the absence of physicians’ active involvement, and the patients’ habits of irrational medication use.

《国家基本药物目录》(2012年版和2018年版)与《世界卫生组织基本药物标准清单》(2023版)中眼科用药的比较和分析

目的为我国《国家基本药物目录》中的眼科用药提供改进建议。方法采用描述性分析方法,将《国家基本药物目录》(2012年版和2018年版)与《世界卫生组织基本药物标准清单》(2023版)中眼科用药部分进行对比,重点比较药品种类、剂型、规格和备注等方面的差异。结果与2012年版相比,2018年版的《国家基本药物目录》在西药和中药方面都有药物的增减和调整。《国家基本药物目录》(2018年版)与《世界卫生组织基本药物标准清单》(2023版)在药品分类、剂型和规格等方面存在差异。《世界卫生组织基本药物标准清单》(2023版)提供了详细的药物功能介绍和补充说明,以及可替代方案(药物)。结论《国家基本药物目录》(2018年版)根据我国眼科疾病的特点和需求进行了调整,但仍有改进的空间。借鉴《世界卫生组织基本药物标准清单》(2023版)的分类方法、制定替代药物清单,完善备注和适应证,可以更好地为不同级别医疗机构提供指导,提高眼科用药的安全性和适用性。

国家集中采购药品与基本药物目录收录药品比较

目的比较第1~8批国家组织集中采购(集采)药品与2018年版国家基本药物(基药)目录的差异,分析药品品种差异的原因,为更新和完善我国基药目录以及国家集采药品政策提供参考。方法收集并整理集采药品目录与基药目录中药品类别、品种、规格、剂型等信息,通过归类比较找出其中差异,分析原因。结果39%集采药品为基药;按药理学分类,基药中有40种药品集采药品未涉及;抗凝血药及溶栓药类药品中,同时属于基药和集采的药品品种占比小于品规占比。结论集采药品与基药目录存在差异,具有一定的合理性,同时也存在待完善的问题。

2023年版WHO基本药物示范目录特点分析及启示

对2023年版世界卫生组织的基本药物示范目录(第23版)与儿童基本药物示范目录(第9版)进行分析,首先梳理目录调整的工作流程与递交申请所需的材料;接着归纳新版目录的调整依据和特点,目录内的药物数量创历史新高、广泛纳入创新药、审慎遴选儿童药、重视临床获益证据与公共卫生可负担性。建议参考WHO经验,结合国情尽快对我国基本药物目录进行更新,注意基药目录与医保目录的区别与联系,做好目录衔接,满足基本用药需求,确保药品可及性,优化卫生资源配置。

淮南地区5家公立医院国家基本药物采购情况研究

目的为新医改政策下促进国家基本药物的推广及相关政策的制定提供建议。方法对5家公立医院国家基本药物品种、采购金额占比、系统分类情况以及国家医保谈判(以下简称国谈)药品、国家集中带量采购药品(以下简称国家集采)的采购情况利用Excel软件进行数据汇总分析。结果5家医院国家基本药物平均品种数和金额占比分别为43.15%、39.12%,其中中成药品种和金额仅占20.9%、20.35%;从系统分类来看,中成药及儿科、眼科用药和抗寄生虫药配备比低下;国谈涉及的国家基本药物品种数和采购金额平均占比分别为14.63%、26.77%,且逐年减少;2020年第一批国家集采涉及的国家基本药物采购数量较上一周期增长32.3%,采购金额下降73.88%,占同期国家基本药物采购总额的19.28%,品种数和采购金额占比呈下降趋势。结论医院中成药、儿科用药及抗寄生虫药等品种配备不足,部分国家基本药物短缺,国谈品种大量落地等原因导致国家基本药物品种和金额占比降低。建议完善儿科用药目录,将中成药纳入国家集采以提高基本药物比例,医院应完善儿科、眼科等科室基本药物品种,加强短缺药品预警和储备等措施,促进国家基本药物的推广。

《国家基本药物临床应用指南(2018版)》孕妇禁用中成药收载情况分析

目的:了解《国家基本药物临床应用指南(2018版)》中孕妇禁用中成药的情况,为进一步完善基本药物目录品种及促进临床合理用药提供参考。方法:对《国家基本药物临床应用指南(2018版)》含孕妇禁用中成药的收载情况进行汇总和分析。结果:书中共收载孕妇禁用中成药112种,其中内科、外科、妇科、眼科、耳鼻喉科、骨伤科类分别有64、12、14、2、5、15种;含土鳖虫成药10种(占8.92%);含麝香(人工麝香)成药8种(占7.14%);含朱砂、雄黄成药7种(占6.25%);含附子、制川乌、制草乌成药5种(占4.46%);含马钱子、细辛成药9种(8.04%);含罂粟壳成药2种(占1.79%);其他饮片成药71种(65.19%);按剂型分类注射剂、口服剂、外用剂、其他剂型分别有5、98、8、1种。结论:孕妇禁用中成药品种、剂型分布合理,但存在剂量、标注不规范等问题,仍需进一步完善。研究结果可为下一步整理其他特殊人群用药提供借鉴,为临床合理用药提供更加准确的理论指导。

我国基本药物制度现状、问题与展望

2009年以来,国家卫生行政管理部门通过颁布系列法规制度,遴选并调整了多版基本药物目录,初步建立了我国基本药物制度,为提升药品供应保障能力发挥了重要作用。随着医疗卫生体制改革的不断深入,人民群众用药需求也发生了较大变化,药品供应保障体系相关政策相继颁布实施,我国基本药物制度也面临新的问题与挑战。本文回顾了2009年以来我国基本药物制度建立与实施的基本情况,通过分析基本药物制度当前面临的形势与问题,对未来该制度的优化与调整提出建议。

中成药医保准入的影响因素分析

目的分析影响中成药在国家医保目录准入的因素,助力中成药在医保准入中充分体现实际价值。方法从国家医保局官网获取2021-2023年通过形式审查的目录外中成药的申报材料,包括药品的基本信息、安全性、有效性、创新与传承信息,并参考药典和药智网等进行补充;经济性信息和企业信息通过药智网等网站获取。对药品的首次申报信息和准入结果进行单因素分析、多因素Logistic回归分析和逐步回归分析;并将在不同年份进行多次申报的药品均作为独立样本进行敏感性分析。结果与结论2021-2023年通过形式审查的目录外中成药有27个,涉及37次申报。单因素分析结果显示,药品说明书中适应证/功能主治描述中含有中医证型、有明确的特殊人群用药方案调整信息、上市时间短、注册类型为1~6类中成药或Ⅰ类中药创新药/Ⅲ类古代经典名方中药复方制剂、生产企业申报当年在“中国医药工业百强企业榜单”的中成药更有可能进入国家医保目录(P<0.05);多因素Logistic回归分析结果显示差异暂不显著,逐步回归与单因素分析的结果显示出较好的一致性。敏感性分析结果与基础分析呈现出相同趋势。建议中成药企业进一步明确对产品说明书内容的描述,增强创新能力,传承发展古代经典名方,并及时完善临床试验证据。

云南省边境县某乡镇卫生院2018—2021年国家基本药物使用情况分析

目的:分析云南省边境县某乡镇卫生院2018—2021年国家基本药物使用情况。方法:对2018—2021年该院国家基本药物的种类、名称、剂型、销售额、使用情况等数据进行统计、分析、排名,并评价销量排名前20的国家基本药物的可负担性。结果:该院2018—2021年使用国家基本药物种类及销售额逐年增加,配备的国家基本药物品种数占该院药物品种总数的比例分别为67.57%、72.42%、73.97%和76.63%,销售额占该院当年药品总销售额的比例分别为63.86%、65.84%、66.15%和70.23%。筛选出的销量前20种国家基本药物可负担性较好,且可负担性逐年改善。在国家基本药物合理用药方面,不合理处方占比为17.62%。结论:该院国家基本药物制度实施情况较为良好,但与卫生行政部门的要求还有一定差距,需进一步加强基本药物的配备和合理用药。

Can health technology assessments assist the global campaign against poverty?

Although a key tenant of the Sustainable Development Goals is to achieve universal health coverage,the global drug gap persists-cver a third of the global population lack access to essential medicines.Without access to affordable drugs,people have worse health outcomes,higher medical expenses,and productivity loss,pushing them into poverty.Health technology assessments(HTAs)offer an opportunity to decrease the global drug gap and increase access to essential medicines by overcoming barriers to medicine access.These barriers include drug procurement,drug affordability for payers and patients,a patienfs ability to obtain essential medicines,and health system capacity.Using HTAs can therefore close the global drug gap by increasing access to affordable essential medicines.In turn,people have better health outcomes,spend less money on medical care,and can have better productivity.Ultimately,use of HTAs can lift the population out of poverty and force fewer people into poverty by creating better health outcomes at affordable prices.

《国家医保目录》待谈判中成药药物经济学研究系统评价

目的探讨《2023年国家基本医疗保险、工伤保险和生育保险药品目录调整通过初步形式审查的申报药品名单》(简称《申报药品名单》)中待谈判中成药的经济性。方法系统检索PubMed、中国知网、万方、中国生物医学文献服务系统,获取各数据库自建库起至2023年8月公开发表的《申报药品名单》中待谈判中成药的药物经济学文献,汇总文献的基本情况、研究概况、药物经济学评价方法与内容,并使用卫生经济学评价报告标准共识(CHEERS)清单评价文献质量。结果共纳入31篇文献,均为中文文献,涉及《申报药品名单》中7个待谈判中成药(参一胶囊、丹红注射液、复方丹参滴丸、银杏二萜内酯葡胺注射液、银杏内酯注射液、注射用丹参多酚酸和注射用益气复脉),其中14项研究表明待评价药品具有良好的经济性。CHEERS清单评价,纳入文献的平均得分为13.3分,中位得分为11.5分。结论现有研究表明,《申报药品名单》中待谈判中成药缺乏高质量的药物经济学研究支持,亟需高质量的中成药药物经济学研究来支撑其纳入《国家基本医疗保险、工伤保险和生育保险药品目录》(简称《国家医保目录》)。

我国儿童基本药物目录药品备选库形成机制设计及路径模拟

目的建立儿童国家基本药物目录药品备选库形成机制,设计适用于我国国情的儿童药品备选库遴选方案。方法在借鉴典型国家和地区儿童目录遴选经验的基础上,结合现阶段我国推进儿童基本药物目录调整的可操作性,围绕其指导临床合理用药的定位,及其与医保政策的衔接,从理论和实际用药层面出发,设计药品备选库形成机制;利用现有公开资料和江苏省2020年儿童医院药品采购情况,对备选库形成机制进行路径模拟,验证该方案的可行性。结果我国儿童基本药物目录药品备选库可形成以临床诊疗指南中儿童用药、《中国国家处方集(化学药品与生物制品卷·儿童版)》中推荐药品以及《鼓励研发申报儿童药品清单》为主导、医保药品和儿童医院中儿童用药为重要补充的儿童药品备选库形成机制。结论该机制既体现循证决策理念,又充分尊重临床意见,并且实现基本药物政策与医保政策间的衔接,对于形成科学、权威、适宜的儿童国家基本药物目录具有重要意义。

国家基本药物目录中COPD治疗药品的调整建议

目的为慢性阻塞性肺疾病(COPD)的规范化治疗和国家基本药物目录中COPD治疗药品的调整提供参考。方法邀请相关临床专家、药学专家、医保专家共同梳理国内外COPD临床指南、国家基本药物目录、WHO基本药物标准清单、国家医保目录等收录的COPD治疗药品,并进行比较分析。结果与结论相较于国内临床治疗指南,国外临床指南多收录了1种COPD三联复合制剂,但后者收录的祛痰药及抗氧化剂种类较少;WHO基本药物标准清单收录的COPD治疗药品仅有12种,而我国基本药物目录收录了18种,后者包含更多的茶碱类、祛痰药及抗氧化剂。有15种COPD治疗药品被我国临床指南和国家医保目录收录,但未被国家基本药物目录收录,包括特布他林、盐酸左沙丁胺醇、沙美特罗、福莫特罗、茚达特罗、倍氯米松、糠酸莫米松、沙丁胺醇异丙托溴铵、格隆溴铵福莫特罗、乌美溴铵维兰特罗、茚达特罗格隆溴铵、倍氯米松福莫特罗、布地奈德/格隆溴铵/富马酸福莫特罗(布地格福)、糠酸氟替卡松/维兰特罗/乌美溴铵(氟替美维)、福多司坦,主要为长效β2受体激动剂和三联复合制剂。这些药品具有一定的循证医学证据,其疗效和经济性均有一定优势,且对医保基金预算的影响可控,建议后续基本药物目录更新调整时可考虑纳入。

WHO和典型国家基本药物目录的框架结构设计对我国的启示

目的梳理国内外基本药物目录框架常见的呈现形式和构成要素,以期为我国基本药物目录框架优化提供参考。方法对比WHO和中国、南非、印度、马来西亚等典型国家的最新版基本药物目录,分析其目录框架呈现形式和构成要素的共性与差异。结果与结论WHO和典型国家常见的目录呈现形式包括分册、分类和符号注释,不同形式的管理思路、发挥作用和实施难度有所不同;常见的框架构成要素包括目标人群、医疗机构级别、药品使用条件、核心与补充目录、采购优先等级。对比发现,我国基药目录所涵盖的信息较为单薄,框架设计尚未充分发挥出基药目录指导临床合理用药和优化医疗卫生资源配置的理想作用,仍有一定的完善空间。建议我国明确目录不同呈现形式的特点和作用,基于国情和发展需求合理设定目录框架;在目录中补充药品临床使用、经济性、政策属性等多维度的药品信息,保障基本药物合理使用;在基药目录框架中增加“医疗机构级别”要素,细化基本药物配备使用的管理要求,优化医疗卫生资源配置。

价格规制降低药品招标价格了吗?——基于基本药物制度和取消药品加成政策准自然实验的研究

为了回答我国政府能否通过药品价格规制来解决“以药养医”这一问题,本文首先构建理论模型分析药企面对价格规制的策略性反应。理论结果表明,药企会针对价格规制来调整药品投标价格和返利额度,以保证医生处方选择的激励;这种调整会提高招标价格,从而部分抵消价格规制对药价的抑制作用。在实证部分,本文将药品中标数据与国家基本药物目录、国家和各省的医保目录中的药物名单进行匹配构建数据样本,并使用此数据分析基本药物制度和取消药品加成政策对药品招标价格的影响。结果表明,基本药物制度导致招标价格提高约8%,而取消药品加成制度则导致招标价格提高约9%。可以看出,药企的策略性定价行为部分抵消了价格规制对药品价格的影响。