抗菌药物实施国家集中带量采购的政策效果分析*

目的：分析国家药品集中采购政策对中选抗菌药物销售额、销量、用药厂牌、用药频度、仿制药替代率、药品价格、日均费用和潜在节省费用的影响,探究抗菌药物国家药品集中采购实施效果并提出政策建议,为完善抗菌药物集采规则和配套政策提供参考。方法：选取第3批国家药品集中采购6个中选抗菌药物2020—2021年1~3季度的销售数据,描述性统计分析抗菌药物集采实施效果。结果：国家药品集中采购显著影响抗菌药物市场规模并重塑抗菌药物市场竞争格局;改变抗菌药物的用药行为和调整用药结构;影响中选品种各厂牌价格并显著降低用药费用。结论：抗菌药物集采取得了显著的政策效果,同时基于抗菌药物的特殊性需要重点关注国家药品集中采购政策效果与抗菌药物合理用药的关系。     

基于价格指数的安徽省药品集采政策实施效果比较研究

目的：比较不同药品集采政策对安徽省药品价格下降的影响。方法：利用安徽省医保局成立前后5年的药品采购数据,采用链式拉氏价格指数模型比较了不同采购政策下的省级药品价格指数和不同采购政策对价格指数的贡献率。结果：实现了2018—2022年安徽省药品集中采购价格的动态分析和预测,固定了安徽省药品采购指数数据样本,以此作为后续 5年常态化指数测算样本。医保局成立后组织实施的药品集中带量采购政策,与传统的药品集中招标采购政策比较,价格指数有显著下降,不同政策对价格下降的影响程度依次为：国家集中采购、集中采购扩围品种梯度降价、省级集中采购、国家医保目录入围谈判和省级重点药物监控政策,最主要的影响因素在于承诺采购量和谈判目录范围的大小。结论：药品带量采购政策有利于控制药品费用,节约医保基金,有必要通过省市联盟等方式扩大承诺采购量和增加集中采购药品目录范围,尤其是扩大中成药和生物制品的集中采购范围和地区覆盖。     

集中带量采购对公立医疗机构约定采购周期及续约期药品采购的影响*

目的：分析集中带量采购对公立医疗机构约定采购周期及续约期药品采购的影响,以期为政策协同提供科学依据。方法：基于两干预点间断时间序列模型,分析2018年1月—2020年12月7个试点城市公立医疗机构药品采购量、采购金额及日均费用的变化特征。结果：集中带量采购品种中原研药、未过评仿制药试点期采购量及其占比水平变化均为下降(P＜ 0.05)。集中带量采购品种中原研药(β₂=-0.58,P=0.043)、过评仿制药(β₂=-3.18,P＜0.001)、未过评仿制药(β₂=5.83, P＜0.001)试点期日均费用水平变化均具有统计学意义。可替代品种中过评仿制药在试点期政策干预后采购量(β₃=19.69, P=0.025)及采购量占比均呈上升趋势,但在续约期政策干预后采购量及采购量占比均呈下降趋势。抗感染药、抗肿瘤药及免疫用药试点期采购量水平变化均具有统计学意义(P＜0.05)。结论：加强药品使用监测和合理用药管理,制定并完善挂网采购审核、价格监测、医保支付标准调整等相关配套措施。     

我国各省医用耗材集中带量采购政策比较分析

目的:为完善我国医用耗材集中带量采购工作提供参考和建议.方法:检索收集2019年7月1日—2020年10月1日我国各省出台的医用耗材集中带量采购相关政策,采用文献分析法和比较分析法进行归纳总结.结果:各省在采购品种、采购量、分组规则、评审方法、价格降幅等方面存在差异.结论:采购品种遴选标准应透明化;应统一分组规则,并构...     

佛山市第二类疫苗集中采购的实践与思考

目的探索新形势下有序的第二类疫苗流通管理模式。方法根据有关法律法规,对佛山市第二类疫苗集中采购管理改革的做法进行总结分析结果佛山市第二类疫苗集中采购管理改革符合有关法律法规精神,切合实际,成功运作,具有一定的借鉴意义。结论各级疾病预防控制机构把握第二类疫苗管理的市场规律,找准定位,发挥现有的冷链、人员、技术等优势,在第二类疫苗管理中应继续发挥应有的作用。     

新一轮药品集中采购价格10省份间对比研究

目的研究我国10省份新一轮药品集中采购药品中标价格差异,为进一步完善我国各省份药品集中采购工作提供参考。方法基于"2015年全国样本医院药品采购排行榜"和各省份新一轮集中采购目录选择15种药品,通过对比研究法对15种药品的省份间价格、国产药与进口药的价格进行分析,在借鉴世界卫生组织/国际卫生行动组织药品价格标准调查法的基础上,将各省份的药品价格与国际参考价格进行对比分析。结果同种药品在各省份的采购价格不相同,福建省价格明显低于其他省份价格,少数进口药价格明显高于国产药价格,部分药品的中位价格比值超过了合理区间。结论建议各省份参考福建在药品集中采购方面的有益经验,完善各自的集中采购方案;各省份应对国产通过一致性评价的仿制药、进口专利或原研药一视同仁,给予两者公平竞价的机会;将国际参考价格纳入限价参考体系中,制定更加合理的限价标准。     

浙江省实施二类疫苗省级政府集中采购的管理效果分析

目的探讨并评估浙江省二类疫苗省级政府集中采购方式的实施效果,为《疫苗流通和预防接种管理条例》(新《条例》)颁布后落实二类疫苗政府集中采购提供依据。方法对2012年以来浙江省实施二类疫苗政府集中采购的流程及特点进行描述。结果自2012年以来,浙江省二类疫苗采购工作纳入政府集中采购管理,委托浙江省政府采购中心组织招标。政府集中采购具有公开、公平、公正的特点,程序规范,过程透明,不仅降低了企业投标成本,也达到了控制采购价格,让利于民的效果。新《条例》确定的二类疫苗供应新模式要求浙江省完善采购细节,指导县级疾病预防控制机构履行采供职责,按照统一的储存运输收费标准向接种单位供应疫苗。结论浙江省实施政府集中采购后,二类疫苗供应有序、服务及时,采购成效显著;县级疾病预防控制机构应提高相关业务能力,以确保新《条例》能够在浙江省规范、有序实施。     

2015－2018年我国登革热暴发流行病学特征分析

目的 分析2015-2018年我国登革热暴发流行病学特征,为制定登革热防控策略提供参考。方法 收集和分析中国疾病预防控制信息系统、突发公共卫生事件报告管理信息系统及病媒生物监测系统上报的登革热发病及媒介监测数据,描述登革热暴发流行病学特征。应用Excel 2010和SPSS 20.0软件整理数据和分析,采用ArcGIS 10.5软件绘制地图。结果 2015-2018年全国累计报告登革热暴发111起,共涉及病例12 490例,占全国病例总数的73.7%。暴发集中在广东（77起）、云南（14起）、浙江（8起）和福建（8起）4省份,共累及85个县（区）。暴发集中在5-11月,病例≤ 10例的小规模暴发多于30 d内终止（28/34,82.4%）,较大规模暴发多持续数月,于10-11月终止。登革病毒1型和2型为我国登革热暴发的主要流行株。疫情主要发生在人口密度大、卫生环境差的区域。主要暴发省份病例的年龄和职业构成差异有统计学意义。结论 我国登革热暴发呈地域扩散、甚至向高纬度扩散态势,不同省份暴发特征各异,总体分为口岸型、乡村型和城市型,各省份应针对性调整防控策略。     

我国各省新一轮集中招标采购政策对比分析

目的:研究各省份新一轮药品集中招标采购政策,为完善各省份集中招标采购工作提供借鉴和参考。方法:检索收集《关于完善公立医院药品集中采购工作的指导意见》和《关于落实完善公立医院药品集中采购工作指导意见的通知》发布以来各省份出台的最新集中采购文件,运用文献分析法、对比分析法以及专家咨询法对其中的集中招标采购内容进行分析,归纳总结各省集中招标采购工作的差异。结果:各省份的工作进展不尽相同,在带量采购、限价规定、双信封评审等方面存在较大差异。结论:实行分层限价以体现药品质量差异,基于参考价的平均值确定限价范围,设置合理的经济技术指标,综合经济技术评分和价格确定中标药品,增加中标药品数量以保障药品供应。     

肠道病毒71型疫苗上市后疫苗保护效果和免疫原性分析

目的 分析肠道病毒71型（EV-A71）疫苗上市接种后的疫苗保护效果和免疫原性。方法 采用队列研究于2017年10－12月在上海市静安区招募符合纳入标准的预防接种门诊受种者为研究对象,按0、30 d程序接种疫苗者纳入接种组,不接种疫苗者纳入对照组,随访观察1年,评估疫苗保护效果和接种2剂次疫苗后抗体水平及阳转率。结果 共纳入3 018名8~20月龄的儿童,接种组1 211人,对照组1 807人,经过1年随访,EV-A71疫苗对EV-A71感染引起的手足口病保护率为100.00%（95% CI：-66.99%~100.00%）。接种组中124人检测了中和抗体,接种首剂疫苗后60 d抗体几何平均滴度（GMT）为41.76（95% CI：35.60~49.34）,接种后365 d GMT为28.44（95% CI：23.59~34.54）。结论 EV-A71疫苗对于儿童有良好的免疫应答,EV-A71感染引起的手足口病病例较少,需进一步观察。     

Vaccine bidding,procurement and distribution management practices in mainland China: A nationwide study

ObjectiveTo conduct a nationwide evaluation of vaccine bidding, procurement and distribution management for understanding and improving the current situation well in mainland China.MethodsAn institution survey was carried out to collect information on tendering, procurement, distribution and related issues to vaccines by structured questionnaires administered to 31 provinces in mainland China from April to July 2019.ResultsIn 13 (41.9%) of 31 provinces, centralized bidding of National Immunization Program (NIP) vaccines was accomplished, and others conducted independent tendering and purchasing in 2018. For non-NIP vaccines, all provinces implemented unified bidding at the provincial level and over half (18, 58.1%) of them chose provincial public resource trading platforms, but their modes varied over provinces. Then procurement was undertaken by the district-level centers for disease control and prevention (CDC) while they were unable to choose the best option of too many vaccines targeted by the province-level CDC for local populations. The distribution modes of NIP and non-National Immunization Program (non-NIP) vaccines were similar overall in a province but very different over provinces. Main mode was that CDCs at different levels delivered about two thirds (64.5%) of NIP vaccines distribution and more than one third (35.5%) of non-NIP vaccines. Another distribution mode was occupied as fully buying the service from third parties in 3 municipalities. Some provinces mixed both modes, too. The total distribution volume of vaccines was 430.7 million doses in 2018. The top five non-NIP vaccines delivered in 2018 were human rabies vaccine, varicella vaccine, EV71 hand foot mouth disease vaccine, hepatitis B vaccine and influenza vaccine.ConclusionThe vaccine biding, procurement and distribution management varied over provinces in mainland China in 2018, especially for non-NIP vaccines. Specific policies and measures should be developed for different regions to improve the immunization management better.     

药品集中带量采购中药品短缺风险及防范对策

为减少在药品集采工作中可能会面临的短缺风险,从经济学角度剖析了药品集采的本质,利用供需模型从理论上探讨药品集采可能存在的供给短缺。同时,从不同利益相关者角度深入挖掘集采引起的药品短缺风险来源,并系统梳理英国、美国、德国以及世界卫生组织在药品集采方面所采取的风险控制措施,归纳总结其经验及对我国的启示。借鉴各国遵循“物有所值”原则制定的集采方针并结合各项集采法律法规和监管方法,吸取减少集采药品短缺风险的经验,我国可以通过出台集采药品法律法规、建立药品信息平台和改革现有医疗机构体制等措施,进一步完善集采药品短缺风险防范对策。     

心脏起搏器类高值医用耗材省级带量采购现状分析

目的:分析心脏起搏器类高值医用耗材省级带量采购实践情况,为完善高值医用耗材带量采购工作提供建议。方法:收集2019—2023年省级(包括省级联盟)心脏起搏器类耗材带量采购政策文件,运用文献分析法和专家咨询法对采购规则进行分析。结果:心脏起搏器采购品种均为双腔类产品,分组依据以市场份额为主,多数样本并未选取代表品报价,评标规则主要采用最低价拟中选结合其他拟中选方式。结论:各地在组织心脏起搏器带量采购时应扩大联盟范围,完善分组规则,制定符合产品特点的评标规则。     

Vaccine vial monitor availability and use in low- and middle-income countries: A systematic review

IntroductionThe vaccine vial monitor (VVM) registers cumulative heat exposure on vaccines over time. As low- and lower-middle-income countries transition beyond support from the Global Alliance for Vaccines and Immunization (Gavi), they will assume full responsibility for vaccine financing and procurement. It is unclear to what extent countries transitioning out of Gavi support will continue to include VVMs on their vaccines. This paper aims to systematically review evidence on VVM availability and use in low- and middle-income countries to document factors behind global access to and country demand for VVMs. Such results could help identify actions needed to ensure continued use of VVMs in countries that transition out of Gavi support.MethodsWe performed a systematic review of electronic databases, reference lists, and grey literature in English and French languages with publication dates from 2005 onwards. The studies included were analyzed for the following outcomes: (1) availability and deployment of VVM-labeled vaccines; (2) VVM practices and perceptions in the immunization system; (3) vaccine introduction and decision-making processes; (4) Gavi graduation and vaccine program sustainability.ResultsThe study found that VVM availability and use was affected by multiple sourcing of vaccines and the extent to which VVM was included in the vaccine specification in the tendering documents when procuring vaccines. Knowledge about VVM and its impact on the EPI program was found to be high among health workers as well as decision-makers. However, the study also found that weak capacity in key national institutions such as NRA and NPA might impact on demand for VVM. As countries take decisions regarding the adoption of new vaccines, factors such as disease burden and vaccine price may assume greater importance than vaccine characteristics and presentation. Finally, the study found that countries rely largely on the advice and recommendations from technical partners such as WHO and PAHO.ConclusionThe study concludes that global access to and country demand for VVM are dependent on policy statements and recommendations about VVM by key policy institutions such as WHO and UNICEF. The study also concludes that despite Gavi-eligible countries having access to VVM-labeled vaccines, inclusion is often below 100%. Weak institutional capacity in key national agencies such as NRA and NPA seems to be a contributing factor, while other factors include the procurement of clear national policies on the inclusion of VVM on vaccines, along with the capacity to enforce the policy. Finally, the study concludes that knowledge about VVM and its impact on vaccine program efficiency, safety, and cost is critical for transitioning countries’ continuous demand for VVM.     

0~12月龄儿童联合疫苗使用和同时接种专家共识

随着扩大国家免疫规划的实施和非免疫规划疫苗种类的增加，儿童可接种的疫苗种类和剂次不断增加，其中0~12月龄儿童接种疫苗种类和剂次较多的问题更为突出，影响其及时完成疫苗全程接种。使用联合疫苗或多种疫苗同时接种，可以简化免疫程序，提高接种率，给儿童提供更多的保护，也是未来发展趋势。在对国内外最新文献、免疫程序和疫苗说明书等进行整理和研究的基础上，汇总我国0~12月龄儿童免疫策略面临的问题和挑战，同时探讨解决路径，以期为基层预防接种人员合理安排接种提供参考。     

新疫苗纳入国家免疫规划的评价维度及指标分析

目的 对新疫苗纳入国家免疫规划涉及的决策要素相关的文献进行系统梳理。方法 通过8个中英文文献数据库检索国内外相关文献,归纳各国进行免疫决策时的评价维度及核心指标等。结果 纳入41篇文献,内容以案例研究为主,实证研究较少。各文献基本遵循疾病、疫苗、卫生系统的评价框架,但有不同程度的延伸。疾病死亡率、疫苗安全性及有效性、成本效果评价等为高频评价指标。本研究梳理出基于“疾病-疫苗-能力-效益评价”的4维度13个要素43个指标的评价体系。结论 国内外关于疫苗决策的研究处于发展阶段,我国应增强疫苗纳入免疫规划的评价框架的可操作性及广度,注重本土的流行病学、卫生经济学数据收集,进一步发挥国家免疫规划技术工作组在疫苗循证决策中的作用。     

National vaccine coverage trends and funding in Latin America and the Caribbean

BackgroundFrom 2006 to 2011 nearly 174,000 deaths were prevented in Latin America and the Caribbean through vaccination of children under five, which is widely attributed to the Expanded Program on Immunization (EPI). Despite near global adoption of EPI recommendations, vaccination coverage shows substantial variation across world regions. Causes for low immunizations within regions are multifaceted and include vaccination program costs. To date, publications regarding vaccine coverage across Latin America and the Caribbean are not readily available. This study aimed to: (1) compare vaccine coverage trends across nations within the region; and (2) assess whether national immunization program expenditures are correlated with vaccine coverage.MethodsCoverage for nine vaccines were collected by nation using publicly available data from WHO. National immunization program expenditures for each country were collected from the World Bank Index. The proportion of countries achieving 90% coverage in the years 2013 and 2017 for each vaccine were compared. Pearson correlation coefficients were calculated to measure the relationship between financing variables and DTP3 coverage for 2017.ResultsIn 2017, fewer Latin American and Caribbean nations were able to achieve 90% vaccine coverage for five vaccines compared to 2013. Mostly weak to moderate positive relationships were found between national immunization program expenditures and DTP3 coverage for 2017. Excluding Haiti, a weak negative relationship was found between total government expenditure on vaccines per infant and DTP3 coverage for 2017. Countries across Latin America and the Caribbean were largely self-reliant in funding vaccine expenditures.ConclusionsFewer countries across Latin America and the Caribbean are currently achieving optimum national vaccine coverage and weak to moderate relationships between routine immunization and vaccine expenditures and coverage were observed. Additional factors contributing to national vaccine coverage should be concomitantly examined to implement strategies which optimize delivery of childhood immunizations.     

2012-2018年甘肃省药品集中采购情况分析

目的:评价甘肃省药品集中采购政策实施的效果,总结药品集中采购取得的成绩和不足,为甘肃省进一步完善药品集中采购政策提供参考。方法:从甘肃省药品集中招标采购平台上导出2012-2018年药品采购相关统计数据,使用Ex-cel软件进行描述性统计分析。使用指标主要有均数、百分比、集中度等。结果:2012-2018年甘肃省药品集中采购的药物金额总体上逐年增加、药品价格以中低价格为主、市场集中度较低,各级医院基本药物的采购金额大体上呈增加趋势。结论:甘肃省药品集中采购政策总体上实施效果良好,但还应有针对性地规范完善。     

Vaccine events raising public concern and associated immunization program policy and practice changes,China, 2005–2021

IntroductionSeveral vaccine events causing public concern have occurred in China that were investigated and responded to by the central government. We describe causes, influences, and policy or practice changes associated with vaccine events that occurred between 2005 and 2021. We make recommendations to foster resilience in China’s Expanded Program of Immunization (EPI) system and vaccination enterprises and to sustain vaccine and program confidence.MethodsOur study included all vaccine events since 2005 that were investigated and responded to by the central government of China. We verified mainstream and social media visibility of the events through Internet search. We extracted event times, causes, investigation processes, results, actions, and policy or practice regulation changes from official reports of government meetings and from official websites with media briefings.ResultsSeven vaccine events were identified, each of which caused more than 100,000 mainstream or social media reports nationally or nationally and internationally. The events ranged in magnitude from 145 children receiving out-of-date oral poliovirus vaccine to a measles supplementary immunization activity involving 103 million children. Few, if any, children were directly harmed by vaccines in the events. Government responded to each event with program or policy changes, and in one case, with legislation. Responses affected the conduct of campaigns and supplementary immunization activities, use of schools as vaccination venues, financial incentives for vaccinating with non-program vaccines, vaccine procurement and distribution, and program policy making. The most fundamental response was enacting the country’s first vaccine law, the 2019 Vaccine Administration Law, which guides virtually all aspects of vaccination work, from vaccine development through regulation, program implementation, and safety and impact monitoring.ConclusionsAll seven events generated substantial national and international mainstream and social media criticism and discussion, most commonly expressed through concerns of vaccine safety or vaccine effectiveness. Most had temporally associated temporary declines in vaccine confidence and coverage, jeopardizing decades of vaccination effort. The central government responded to each event by attempting to address root causes. Faithful implementation of the Vaccine Administration Law is fundamental to program strengthening and sustaining confidence of families, stakeholders, and government in vaccines and immunization in China.     

A cost comparison of introducing and delivering pneumococcal,rotavirus and human papillomavirus vaccines in Rwanda

BackgroundDetailed cost evaluations of delivery of new vaccines such as pneumococcal conjugate, human papillomavirus (HPV), and rotavirus vaccines in low and middle-income countries are scarce. This paper differs from others by comparing the costs of introducing multiple vaccines in a single country and then assessing the financial and economic impact at the time and implications for the future. The objective of the analysis was to understand the introduction and delivery cost per dose or per child of the three new vaccines in Rwanda to inform domestic and external financial resource mobilization.MethodsStart-up, recurrent, and capital costs from a government perspective were collected in 2012. Since pneumococcal conjugate and HPV vaccines had already been introduced, cost data for those vaccines were collected retrospectively while prospective (projected) costing was done for rotavirus vaccine.ResultsThe financial unit cost per fully immunized child (or girl for HPV vaccine) of delivering 3 doses of each vaccine (without costs related to vaccine procurement) was $0.37 for rotavirus (RotaTeq^®) vaccine, $0.54 for pneumococcal (Prevnar^®) vaccine in pre-filled syringes, and $10.23 for HPV (Gardasil ^®) vaccine. The financial delivery costs of Prevnar^® and RotaTeq^® were similar since both were delivered using existing health system infrastructure to deliver infant vaccines at health centers. The total financial cost of delivering Gardasil^® was higher than those of the two infant vaccines due to greater resource requirements associated with creating a new vaccine delivery system in for a new target population of 12-year-old girls who have not previously been served by the existing routine infant immunization program.ConclusionThe analysis indicates that service delivery strategies have an important influence on costs of introducing new vaccines and costs per girl reached with HPV vaccine are higher than the other two vaccines because of its delivery strategy. Documented information on financial commitments for new vaccines, particularly from government sources, is a useful input into country policy dialogue on sustainable financing and co-financing of new vaccines, as well as for policy decisions by donors such as Gavi, the Vaccine Alliance.