2013-2018年西安市各级医院第一批国家重点监控药品不良反应/不良事件分析

目的 总结、分析西安市各级医院第一批国家重点监控药品(以下简称重点监控药品)不良反应/事件(ADR/ADE)发生的情况,以促进重点监控药品合理化使用.方法 对西安市各级医院2013-2018年上报的重点监控药品ADR/ADE报告进行统计分析,包括患者性别、年龄、ADR/ADE发生的时间、产生ADR/ADE的重点监控药品...     

Inequality in science and the case for a new agenda

The history of the scientific enterprise demonstrates that it has supported gender, identity, and racial inequity. Further, its institutions have allowed discrimination, harassment, and personal harm of racialized persons and women. This has resulted in a suboptimal and demographically narrow research and innovation system, a concomitant limited lens on research agendas, and less effective knowledge translation between science and society. We argue that, to reverse this situation, the scientific community must reexamine its values and then collectively embark upon a moonshot-level new agenda for equity. This new agenda should be based upon the foundational value that scientific research and technological innovation should be prefaced upon progress toward a better world for all of society and that the process of how we conduct research is just as important as the results of research. Such an agenda will attract individuals who have been historically excluded from participation in science, but we will need to engage in substantial work to overcome the longstanding obstacles to their full participation. We highlight the need to implement this new agenda via a coordinated systems approach, recognizing the mutually reinforcing feedback dynamics among all science system components and aligning our equity efforts across them.     

创新药价值评估的国际经验比较及启示

随着我国医药卫生体制改革的不断深入,以价值为导向的创新药医保谈判准入模式已经逐步确立,如何科学开展创新药的价值评估已成为政府决策部门和社会各界关注的重要问题。本文对英国、德国、法国、加拿大四个国家的创新药价值评估体系与评估流程进行了系统梳理与对比,总结了英国关于药物经济学评价以及德国、法国、加拿大关于附加临床收益评估的过往经验;在此基础上,针对我国的创新药价值评估流程,在构建创新药附加临床收益评估体系、完善创新药医保准入的谈判规则、完善创新药医保准入的决策依据三个方面提出了相关建议。     

域外典型国家药品使用环节仿制药替代促进政策的经验及启示

目的：从药品使用环节为完善我国仿制药替代促进政策提供建议。方法：采用文献研究法探究欧、美、日等国外促进仿制药替代的思路与典型措施,结合我国仿制药替代使用过程存在的问题,提出完善我国药品使用环节仿制药替代促进政策的具体建议。结果和结论：通过欧、美、日等国外经验研究,发现域外典型国家在促进仿制药替代过程中形成了“接受仿制药—科学合理替代—持续反馈与改进”的思路,建议我国将医患主体的意见纳入仿制药替代决策、基于风险建立仿制药替代规则、加强仿制药可替代性真实世界数据研究和监测评估、加强仿制药信息公开与政策宣传力度,进一步完善我国药品使用环节仿制药替代促进政策,促进仿制药替代使用。     

国谈抗肿瘤药配备机构的空间可达性评价研究——以武汉市为例

目的：本研究旨在评估武汉市中心城区国谈抗肿瘤药配备机构的空间可达性水平,为优化药物供应与配置提供经验证据。方法：以武汉市为例,采用基于高斯衰减函数的两步移动搜索法(2-Step Floating Catchment Area, 2SFCA)评估研究区域内各个需求单元在不同交通出行方式下的国谈抗肿瘤药配备机构的可达性,同时运用空间自相关分析和K-means聚类分析识别需求单元可达性的分布态势和分类模式。结果：在驾车或公交出行的情况下,武汉市中心城区各需求单元的配药定点机构的可达性呈现出明显的空间分异特征。江汉区、汉阳区等可达性水平较高且均衡,而青山区和洪山区可达性水平较低且内部存在明显分层。此外,各需求单元呈现显著正相关空间分布,区域内高值集聚与分区内部分化现象并存。结论：武汉市中心城区配药机构可达性整体较高,但存在从核心城区向边缘城区递减的趋势;多数辖区的可达性良好且较为均衡,但少数辖区的可达性较差且存在明显的内部等级分层。     

我国儿童药研制的制约因素分析及政策建议——基于医药企业的视角

目的：为完善我国儿童药供应保障政策提供依据。方法：基于医药企业视角通过文献综述、问卷调研梳理药品全生命周期中儿童药研制的制约因素,分析其集中和迫切程度。结果：儿童药的主要制约因素包括：儿童临床试验开展难度大;注册审批规则中缺乏对儿童药特殊性的考虑和专门的材料要求;生产激励政策落地缺乏实施细则和措施;市场利益机制尚不完善等。其中,研发和使用支付是问题相对集中的环节。讨论及建议：建议我国开拓并合理使用儿童临床试验资源,多举措增加儿童药研发投入;制定儿童药申报的专项指南,鼓励成人药品注册时提交儿童研究计划;基于典型案例探索儿童药生产供应优化路径;在药品使用与支付规则中给予儿童药更多空间。     

基于全周期管理的中美日仿制药替代促进政策对比研究

目的:基于全周期管理理念,从仿制药研发注册、市场准入、临床使用和上市后再评价多个环节为我国仿制药替代促进政策的制定和完善提供建议。方法:采用文献研究法和对比分析法,对我国和美日的仿制药替代促进政策现状进行对比分析。结论:仿制药替代是涉及多个环节的系统工程,美国和日本通过在研发注册环节不断完善技术标准和数据指南,在市场准入环节合理定价和医保激励,在临床使用环节管理医师药师处方行为、加强宣传教育,在上市后再评价环节对仿制药进行再评价和替代效果评估,构建了全周期的仿制药替代促进政策体系,实现了仿制药替代目标。     

我国专利药品医疗保险价格谈判的演化博弈研究

利用演化博弈理论,结合我国专利药价格谈判现状,建立专利药品价格谈判博弈的演化模型,并进行仿真模拟分析,探究对演化博弈稳定状态产生影响的因素及其作用路径。结果发现,谈判前后专利药品的销售额、谈判双方的谈判初始意愿和变化方向以及对于社会声誉的考量均能够对演化稳定结果产生影响,最终从上述角度提出谈判双方优化专利药品价格谈判的相关建议。     

Health Technology Assessment Process for Oncology Drugs: Impact of CADTH Changes on Public Payer Reimbursement Recommendations

Public reimbursement systems face the challenge of balancing provision of needed treatments and the reality of limited resources. Canada has a complex system for drug approval and public reimbursement, with jurisdiction divided between the federal government and the provinces/territories. A pivotal role is that of health technology assessment (HTA), which relies primarily on health economic principles to analyze the value of drugs on a population health basis and make recommendations about public reimbursement. The Canadian Agency for Drugs and Technologies in Health (CADTH) provides recommendations to all provinces but Quebec. This article provides an overview of Canada’s approval and public reimbursement pathway, including the role of HTA and the economic principles on which it relies. Starting in late 2020, CADTH reduced the cost per quality-adjusted life year (QALY) threshold, the metric relied upon in making recommendations to public payers. An analysis of all 56 oncology drug final recommendations issued from January 2020 to January 2022 was conducted and confirms this reduction in the cost per QALY threshold. As a result of this threshold reduction, recommendations to the provinces include, in a number of cases, substantially greater price reductions. The potential implications for successful price negotiation with the pan-Canadian Pharmaceutical Alliance (pCPA), the public negotiating body for the provinces, are discussed.     

The Importance of Prisons in Achieving Hepatitis C Elimination: Insights from the Australian Experience

Following the availability of highly effective direct-acting antivirals (DAAs) to treat hepatitis C infection, the uptake of treatment by people living with hepatitis C rose dramatically in high- and middle-income countries but has since declined. To achieve the World Health Organization’s (WHO) 2030 target to eliminate hepatitis C as a public health threat among people who inject drugs, an increase in testing and treatment is required, together with improved coverage of harm reduction interventions. The population that remains to be treated in high- and middle-income countries with high hepatitis C prevalence are among the most socially disadvantaged, including people who inject drugs and are involved in the criminal justice system, a group with disproportionate hepatitis C prevalence, compared with people in the wider community. Imprisonment provides an unrivalled opportunity for screening and treating large numbers of people for hepatitis C, who may not access mainstream health services in the community. Despite some implementation challenges, evidence of the efficacy, acceptability, and cost-effectiveness of in-prison hepatitis treatment programs is increasing worldwide, and evaluations of these programs have demonstrated the capacity for treating people in high numbers. In this Perspective we argue that the scale-up of hepatitis C prevention, testing, and treatment programs in prisons, along with the investigation of new and adapted approaches, is critical to achieving WHO elimination goals in many regions; the Australian experience is highlighted as a case example. We conclude by discussing opportunities to improve access to prevention, testing, and treatment for people in prison and other justice-involved populations, including harnessing the changed practices brought about by the COVID-19 pandemic.