控制药品费用总量 促使药品市场有序发展的理论依据和实施效果概述

针对药品市场混乱状况，该课题组经过系统研究形成了“促使药品市场有序发展的政策思路和逻辑顺序”。其中逻辑顺序第一步为：以实施“医疗资源最优利用模型”为前提．控制药品利用总量．该步骤综合分析了药品市场混乱的根源、医院与药品市场的互动关系、药品收益对医院补偿的作用、药品总量和药品扣率间关系等，并在此基础上，得出了上述第一步思路。实践检验表明，该步骤的实施可有效控制药品费用与医院业务收入的过快增长，在促使医院补偿机制进步趋向争理完善的同时，带动了药品数量、品种、价格等适宜性的提高，制药业开始进行结构调整．为避步规范药品市场创造了有利的条件。     

解决药品市场混乱的宏观策略研究

文章依据政策制定科学化程序,在逻辑推论“药品市场混乱”的直接相关因素和间接促发因素基础上,总结出药品市场混乱问题的根源和作用机制模型,即医疗机构补偿机制恶性循环模型,针对根源研制并论证了相应的政策思路模型,即医疗资源最优利用模型。提出实施该政策思路并能取得成效的前提条件是在政府统一的领导下,各有关部门通力协作,总结出从医疗机构入手,解决药品市场混乱政策思路实施的逻辑顺序依次为：控制药品费用总量;逐步控制药品毛利,摆脱医疗机构对药品的依赖性;加强药品市场的管理,完善市场“游戏规则”并研制了各相应步骤中的关键技术。逻辑推论的政策方案实施效果的评价表明,上述政策思路具有科学性、合理性和可操作性,政策方案切实可行。     

医药分业的利益驱动分析

文章认为,在现有条件下,如果我国实行“医药分业”政策,医疗机构表面上是直接的利益受损者,而广大的药品消费者或支付者将是最终的利益受损者,也就是说消费者或支付者将为“医药分业”埋单;药品流通渠道(批发和零售)和生产商是政策受益者。政府将面临提高医疗服务收费标准或增加医疗机构补偿的压力,也将面临着是让医疗机构发展停顿还是医疗服务费用非常规增长的两难抉择,还将面临着通过牺牲医疗机构利益、消费者利益或政府加大投入来扶持药品流通渠道的道义上指责。日前我国药品监督管理机构正在实行的“渐进性的医药分业”政策,这些问题已然显现雏形。实施医药分业政策的理想境界是:药品价格总体下降26％～30％,将469亿元～547亿元的药品毛利化作医疗服务收费标准的调整幅度,以后,医疗服务收费标准按物价指数逐年调整。     

从国际经验看医药分业

20世纪80年代以来，医疗费用持续高涨，并日益成为广大国民关注的焦点。为此，各地政府采取了多项政策措施：调整药品价格，严格限定药品收入占整个医疗业务收入的比例、实行药品收支两条线、药品集中招标采购，以期控制医疗费用的上涨，但是收效甚微。于是，一些专家学者和政府部门转而寄希望于“医药分业”。但是“医药分业”是否真能解决困扰多年的医疗费用持续上涨的难题?本文试图通过对日本、韩国医药分业的经验和教训，以及美国医疗卫生市场的演化进行比较、分析、探讨，总结医疗卫生发展的内在规律，以期对我国的医药分业提供有益的借鉴和指导。     

谈医疗机构"医药分开核算、分别管理"

医疗机构实行“医药分开核算、分别管理”,旨在规范医疗行为,促进医疗机构收入结构的调整,优化医疗机构补偿机制,控制医院医药费用过快增长,降低药品收入在医院收入中的比重,促使医疗机构为群众提供质优、价廉的医疗服务。 医疗机构实行“医药分开核算”就是按照新的《医院会计制度》(以下简称《制度》),对医疗成本和药品成本分别核算。医疗服务和药品经销各项直接费用,要分别列入医疗支出和药品支出。医疗机构的管理费用,要按《制度》要求合理分摊到医疗成本和药品成本。要依照有关规定严格控制费用支出?严禁乱摊费用、扩大成本。 医疗机构要实行医药分别管理,笔者认为应实行“核定收     

“医药分业”方案的利弊、动力阻力和前提条件研究

本文系从药品市场的需方─—医院的院长角度，论证了“医药分业”方案的利弊得失、动力阻力以及实施的前提条件。     

对医药分业的思考

近年来，不断有媒体和文章提出“医药分业”的观点，主张医疗单位与药剂科脱离关系，来解决医疗单位“以药养医”及群众吃药贵的问题。他们简单地把医疗单位药剂科看成是以营利为目的、买卖药品的药店，认为把药剂科从医疗单位剥离出去变成自负营亏、照章纳税、具有独立法人资格的药店，就可以解决医疗单位“以药养医”及群众吃药贵的问题。作为一个医药工作者，笔者认为，在当前的医药市场情况下，“医药分业”是不可行的。     

"乡村卫生机构药品购销体制研究"总报告

通过不同地区乡村卫生机构药品购销体制调查发现：农村药品生产经营企业过多，药品资源比较充足；传统的农村药品购销体系已遭破坏，药品价格十分混乱；农村医疗机构不合理用药令人担忧，假劣药品充斥市场。针对上述问题，笔者提出了农村医药改革必须同步，加强农村基层用药监管，提高农村医疗服务劳务价格等政策建议。     

再论"医药分业"

分析我国“医药分业”的历史背景和西方国家及韩国“医药分业”的进程、教训，认为商业零售药品市场竞争的加剧，导致的医院处方外配是一种正在成长中的市场力量，可能是我国“医药分业”的前奏。     

“医药分业”势在必行

医药分业是城镇职工基本医疗保险改革中配套改革的重要措施之一,但却步履蹒跚?“医药分业”,究竟有着几道“坎”? 医院:有得也有失 医药分业后,医院不再是药品经营者,可以一门心思搞好医疗服务,树立医疗单位的良好形象。然而,医药分业后也出现了许多新的矛盾。首先,医药分业后利益如何分配?过去,医院从药品采购和销售中获得的利润一般占医院总收入的     

The importance of being first: evidence from Canadian generic pharmaceuticals

This paper uses pooled cross-section data on Canadian ethical drug sales to examine the effect of entry timing on sales of generic drugs. The data is for all drugs for which the first generic competitor entered during the years 1994-1997. It is found that the first generic entrant has a lasting competitive advantage: being first into the market appears to lead to an increase of around 30% in market share (among generics) over a period of at least 4 years. This finding has considerable implications for the current policy of allowing brandname drug companies to issue pseudo-generic equivalents as a preemptive strike against true generic competitors.     

Entry time effects and follow-on drug competition

Pharmaceutical firms have been criticized for concentrating efforts of R&D on the so-called me-too or follow-on drugs. There have been many comments for and against the dissemination of these incremental innovations but few papers have broached the subject from an econometric point of view, possibly because identification of me-too or follow-on drugs is not so obvious. This paper focuses on the impact of entry order on follow-on drug competition in the French market between the years 2001 and 2007. More precisely, this study examines the effects on market share of first entrants in the follow-on drug market and how this possible competitive advantage changes over time. First results are coherent with theoretical microeconomic issues concerning the importance of being first. We find evidence that first movers in the follow-on drug market have the ability to capture and maintain greater market share for a long period of time. The hierarchical market position of follow-on drugs does not seem to be affected by generic drug emergence. From a dynamic perspective, our analysis shows that market share is positively correlated with the ability of follow-on drugs to set prices higher than the average follow-on drug prices in a specific therapeutic class, which means that market power remains considerably important for first movers. Moreover, we found that the optimum level of innovation to maximize market share is the highest one.     

AHA environmental assessment.

The first step in planning is to assess your environment. Ask the long-range questions: What does your current market look like? What are the demographic trends that will influence your community? How will the workforce issue and the regulatory environment affect your hospital? Hospitals & Health Networks presents the American Hospital Association's environmental assessment, which may help you to conduct your own.     

Nurse migration: a challenge for the profession and health-care systems

Introduction and questions of exploration  

In a first step this paper outlines the global context of and international influences on nurse migration. Liberalization of health markets is identified as a trigger point steering movements of nurses globally. Facts and figures concerning nurse migration are highlighted in a second section focusing on developments in the USA and UK, which are recruiting nurses from Europe and overseas on a large scale, and adding the latest European approaches and policies concerning this issue. Projections are presented that highlight growing demands for the next 2 decades. The third part explores the impact of nurse migration on nursing care and professional standards.     

“两票制”政策对山东省药品供应状况影响分析

目的:探究“两票制”政策对山东省药品供应状况的影响,为保障政策进一步实施提供科学依据和政策建议。方法:对比政策实施前后山东省药品集中采购平台数据,采用企业集中度分析药品供应市场的集中状况,采用间断时间序列方法分析政策对药品到货率和订单完成率的影响。结果:药品供应企业数量逐步减少,由政策实施前的627家降为565家;市场集中度逐步提升,由316.42提高到366.29;大型企业市场份额逐步提升,份额占比前75%的企业数量由54家降为47家。政策实施后,山东省总体到货率呈下降趋势,经济发达地区、相对较弱地区和欠发达地区的药品到货率也相应呈下降趋势。结论:“两票制”政策的实施,使得山东省药品供应市场集中度逐步提升,供应市场秩序逐步规范。但政策实施后,有部分地区医疗机构反映出药品供应下降的趋势,不利于患者用药可及性的提升。     

Drug interchangeability: clinical approach and consumer's point of view

The rational construction of an essential drug list, considering the patient's need, drug safety, availability and the best cost-benefit ratio, is based on drug safety, efficacy and quality. However, in daily practice, the prescriber's decision is mostly influenced by drug effectiveness, following criteria that increase adherence to the treatment, such as relative drug toxicity, convenience, cost and prescriber's experience. In addition, frequent launching of new molecules for the same therapeutic indication, together with wide publicity targeting prescribers, interferes with the decision-making process. Similarly, the bonuses offered by the industry for over-the-counter drug sales interfere with the consumer's choice. The confrontation between known human biological variability and the knowledge that there is no absolute similarity between drugs of the same therapeutic class, or even generic drugs, has an impact on the prescriber's drug list, which should include the concept of first and second choice drugs. Prescribers' unfamiliarity with these subjects is a determinant factor for irrational drug use: a public health issue. The objective of this study was to introduce to drug prescribers information that can help them building up a rational drug list for their patients, based on the National Health Surveillance Agency (Anvisa) experience of drug regulation.     

On the concept of eugenics: preliminaries to a critical appraisal

This paper's main issue is linked to what can be foreseen as the increasing capability of medical genetics to modify the genetic composition of the human species through direct interventions in the human genome for medical and non-medical purposes, i.e., the "risk" of a resurgence of eugenics. In current discussions on the topic (briefly presented in the first section), the "phantom of eugenics" is raised several times, but there is a great deal of confusion on what counts as eugenics, partly because of broad conceptual disagreement over the notion itself. Furthermore, according to some scholars there is no hope of overcoming this unsatisfactory conceptual uncertainty. Partly challenging this opinion, the second and third sections of this paper attempt to identify some basic features which could be seen as intrinsically linked to the notion of eugenics, with the aim of reducing the range of conceptual disagreement as a preliminary step in bringing into focus what exactly is wrong with practicing eugenics. The subsequent sections deal with the substantive issue of whether or not to practice eugenics from the point of view of the interest of future generations in the human species' genetic composition. The main moral arguments for and against eugenics are examined from the point of view of our obligations towards future generations, and the conclusion is in favor of a cautious "open-door" position.     

The Economics of Biosimilars

Background

The high cost of pharmaceuticals, especially biologics, has become an important issue in the battle to control healthcare costs. The Hatch-Waxman Act encourages generic competition but still provides incentives for pioneers to develop new drugs. The Biologics Price Competition and Innovation Act is intended to do the same for biologics and biosimilars.

Objective

To examine information related to biosimilars to determine their potential impact on competition in the biologic market.

Method

Using information concerning the European Union (EU) and the pharmaceutical industry, this article reviews and analyzes the experience of biosimilars in the EU, as well as the obstacles and opportunities that biosimilars face in the United States. Much of the analysis is based on examining current trends in biologic drugs and the potential implications on the future of biosimilars.

Discussion

This article reviews the mixed success of biosimilars in the EU and the implications for the United States. Because biologics are produced from living organisms, manufacturing issues are more important than in the chemical drug market. The barriers to biosimilar entry into the marketplace are much more difficult to overcome than challenges generic manufacturers typically face and are similar to obstacles specialty injectable producers encounter. The competitive responses by pioneers are also likely to be more important. The capital costs and risk issues with biosimilars make alliances and partnering arrangements very likely. Biosimilars often enter emerging markets, where the barriers to entry are easier to overcome. Nevertheless, the United States represents the greatest opportunity for biosimilar producers, in part because it is the largest biologics market and has high prices for biologics. As the United States enters the biosimilar market, the pharmaceutical industry is likely to grow at an accelerated pace. Automatic substitution is likely to be slow to develop, because of safety and quality concerns. The beneficial impact of biosimilars is likely to take a long time to be realized and to be fraught with more difficulties than was the case for small-molecule generics.

Conclusion

Various factors, such as safety, pricing, manufacturing, entry barriers, physician acceptance, and marketing, will make the biosimilar market develop different from the generic market. The high cost to enter the market and the size of the biologic drug market make entry attractive but risky.The high cost of pharmaceuticals, especially biologics, has become an important issue in the battle concerning ever-increasing healthcare costs. The average daily cost of a biologic in the United States is $45 compared with only $2 for chemical (small-molecule) drugs.1 The Hatch-Waxman Act encourages generic competition but still provides incentives for pharmaceutical innovators to develop new drugs. The Biologics Price Competition and Innovation Act (BPCIA) of 2009 is intended to do the same for biologics and biosimilars. Now that the US Food and Drug Administration (FDA) can approve biosimilars, it is important to consider whether biosimilars are likely to have the same impact in the biologic drug market that generics have had in the chemical drug market.The experience in the European Union (EU), where biosimilars were first marketed in 2007, is instructive. This article reviews the obstacles that biosimilar manufacturers face, as well as the opportunities, and evaluates the probable impact of biosimilars on the healthcare market. The potential impact of the BPCIA on prices and access in the biologic market are addressed.     

Individualizing drug dosage with longitudinal data

We propose a two‐step procedure to personalize drug dosage over time under the framework of a log‐linear mixed‐effect model. We model patients' heterogeneity using subject‐specific random effects, which are treated as the realizations of an unspecified stochastic process. We extend the conditional quadratic inference function to estimate both fixed‐effect coefficients and individual random effects on a longitudinal training data sample in the first step and propose an adaptive procedure to estimate new patients' random effects and provide dosage recommendations for new patients in the second step. An advantage of our approach is that we do not impose any distribution assumption on estimating random effects. Moreover, the new approach can accommodate more general time‐varying covariates corresponding to random effects. We show in theory and numerical studies that the proposed method is more efficient compared with existing approaches, especially when covariates are time varying. In addition, a real data example of a clozapine study confirms that our two‐step procedure leads to more accurate drug dosage recommendations. Copyright © 2016 John Wiley & Sons, Ltd.