药品集中招标采购的几点思考

本文对药品集中招标采购做了客观的评价,要求进一步严格操作、规范操作行为,加强监督、明确检查重点,并对药品集中招标采购工作的法制化、代理制、配送制、电子商务制等趋势做了探讨.     

新医改背景下药品代理模式的发展趋势

药品代理制因其利益均兼、风险共担的特征,受到广大中小医药企业的青睐,目前约60%的中小医药企业主要采取这种营销模式作为企业营销战略.然而,随着市场竞争越来越激烈,药品代理的弊端已日益凸显.面对即将全面实施的新医改方案,药品代理的变革已迫在眉睫,对于部分＂依赖＂药品代理为生的企业来说,如何科学理性地审视药品代理与企业自身生存与发展之间的关系,合理运用药品代理制是亟待解决的问题.     

上海市药品市场变动趋势研究

现有的药品市场更新换代迅速,甚至处于销售顶峰的药品很快被更有竞争力的药品代替,这种药品市场中的快速更替现象是值得研究的。药品市场的变动率及趋势等数据不仅为药品生产厂家提供了必要的市场变化信息,而且新药的迅速上市也使得医生、患者等药品消费的决定者对于药品信息有了更多的要求。另外,药品市场的变动情况和整个医疗保健体系有着密切联系,它可以为卫生政策的制定提供依据。无论是医生、患者、药品生产厂商还是药品政策的决策者都很需要药品市场变化的研究信息,但是,目前对于药品市场变动趋势的研究还比较少。为了测量药品市场的…     

药品集中招标采购过程中常见问题及解决方法

药品集中招标采购是推进医疗改革的重要环节,是降低药品价格、减轻患者负担,建立和谐社会的重要举措。分析了药品集中招标采购过程中存在药品招标代理收费问题;厂商的价格垄断,使药品竞争机制弱化;药品替代问题;招标药品的采购工作不规范的问题,并针对问题,提出了严格新药的审批和管理,规范药品招标采购行为;改进药品招标代理收费标准;合理制定招标药品组合,增强药品招标采购的科学性;加强医院用药规范管理;推广网上采购工作的解决方法。     

21世纪吃什么药

在即将到来的21世纪,为了自身的健康,人们更加关注未来将会有哪些新药品问世。 一、蓝色药品 浩瀚的海洋不仅为人类提供了丰富的食品、能源和矿产资源,而且还成为人类未来的大“药房”。据统计,未来将从海洋中提制的药品将达2万种以上。海洋药物按其用途大体可分为心脑血管药物、抗癌药物、抗微生物感染药物、愈合伤口药物、保健药物等。 当今,世界各国正在加紧对海洋药物进行研究和开发,且竞争日趋激烈。我国已从海洋生物中分离出数百种海洋活性物质。己开发的海洋药物有藻酸双酯钠、甘糖脂、海豚     

中国药品集中采购的演变以及与医保支付的逻辑关系

本文主要通过政策梳理和文献回顾的方法,详细阐述了药品集中采购政策的发展演变及其与医保支付的逻辑关系。文章首先梳理了药品集中采购的三个发展阶段,并分析了当前药品集中招标采购的特点和趋势;进而重点探讨了药品集中采购与医保支付体系的关系以及两者配套改革对于解决药品问题的现实可行性。研究认为,药品集中招标采购已经演变为省级平台限价下的议价、最低价联动采购方式;药品集中招标采购可为医保支付标准的形成提供依据,但国家药品谈判以及省级医保特药谈判存在功能重叠;药品招标采购、医保支付等制度安排可助推医药分开,配套相关改革可为解决"药价虚高"提供一种思路。     

特征价格模型在药品定价中的应用

在分析我国药品定价现状的基础上,提出了将特征价格模型应用于药品定价的思路。同时,借鉴特征价格模型的基本理论,将药品特征分为安全性特征、有效性特征和创新性特征,对三个特征向量进一步量化,给出了药品特征价格模型的基本形式。     

新医改背景下我国城镇地区医疗机构的药品配备及使用情况分析

目的 :从不同级别医疗机构出发,旨在分析新医改下我国城镇地区医疗机构的药品配备和使用情况。方法 :采用结构化的医疗机构调查表,在杭州市和宝鸡市分别调查了20家不同级别医疗机构,收集其基本情况、药品配备种类、药品收入等信息。结果 :整体而言,两市的医疗资源分布略有差异,杭州市医疗机构配备的药品种类数远高于宝鸡。2009—2013年间,杭州市基层医疗机构总体配备的药品种类数、基本药物配备种类数和抗生素种类都呈下降趋势;除抗生素外,二级和三级医院的配备药品总数、基本医疗保险目录内药品总数略有上升。杭州市医疗机构药品费用占机构总收入的比例高于宝鸡市,调查年份内不同级别医疗机构超过一半以上的收入来源于药品收入。此外,虽然基层医疗机构药品收入占比高于三级和二级医院,但可以观察到该指标呈现较为明显的下降趋势。宝鸡市不同级别医疗机构除抗生素外,药品配备总数、目录内药品总数整体呈现上升趋势。结论 :国家基本药物制度和基层医疗机构改革对城镇地区基层医疗机构的药品配备起到了决定性作用,药品收入的增长也得到了控制。但如何在不影响医疗服务质量的基础上,改善二级和三级医疗机构的合理用药,降低药品费用占医疗机构总收入的比例,仍然是需要研究的问题。     

灰色模型GM(1,1)结合Excel实现药品销售预测

目的:预测医院药品销售趋势.方法:利用灰色模型GM(1,1)的预测原理,在Excel电子表格中实现数据的自动计算和处理,实时得出预测结果.结果:根据拟合公式得出的预测值与实际值比较,预测精度大于97%,后验差比值C=0.0538.结论:灰色模型GM(1,1)是一种预测医院药品销售趋势的简便易行的方法,易推广,有较强的实用性.     

医疗机构不能承受的"生命之重"——论医疗机构提供假药劣药的民事责任归责原则

假药、劣药存在的根源在于药品生产厂商对于商业利润的追求,医疗机构外购药品导致人身损害的民事责任归责原则是过错责任原则,政府、生产厂商、医疗机构和患者应共同努力承担起药品安全的生命保障。     

Guía metodológica para la evaluación de la eficacia y la seguridad de nuevos fármacos: implementación de las recomendaciones de EUnetHTA

The European network for Health Technology Assessment (EUnetHTA) is the network of public health technology assessment (HTA) agencies and entities from across the EU. In this context, the HTA Core Model^®, has been developed. The Andalusian Agency for Health Technology Assessment (AETSA) is a member of the Spanish HTA Network and EUnetHTA collaboration In addition, AETSA participates in the new EUnetHTA Joint Action 3 (JA, 2016–2019). Furthermore, AETSA works on pharmaceutical assessments. Part of this work involves drafting therapeutic positioning reports (TPRs) on drugs that have recently been granted marketing authorisation, which is overseen by the Spanish Agency of Medicines and Medical Devices (AEMPS). AETSA contributes by drafting “Evidence synthesis reports: pharmaceuticals” in which a rapid comparative efficacy and safety assessment is performed for drugs for which a TPR will be created. To create this type of report, AETSA follows its own methodological guideline based on EUnetHTA guidelines and the HTA Core Model^®. In this paper, the methodology that AETSA has developed to create the guideline for “Evidence synthesis reports: pharmaceuticals” is described. The structure of the report itself is also presented.     

Have Regulatory Efforts to Reduce Organophosphorus Insecticide Exposures Been Effective?

Background: The Food Quality Protection Act (FQPA) was signed into law in 1996 to strengthen the regulation of pesticide tolerances in food. Organophosphorus (OP) insecticides were the first group of pesticides reviewed by the U.S. Environmental Protection Agency (EPA) under the new law.Objective: Our goal was to determine whether urinary concentrations of dialkylphosphate (DAP) metabolites of OP pesticides declined between the National Health and Nutrition Examination Survey (NHANES) III and NHANES 1999–2004.Methods: Using mass spectrometry–based methods, we analyzed urine samples from a nationally representative sample of 2,874 adults 20–59 years of age in NHANES 1999–2004 and samples from a non-nationally representative sample of 197 adult participants for NHANES III (1988–1994) for six common DAP metabolites of OP pesticides.Results: Median urinary DAP concentrations decreased by more than half between NHANES III and NHANES 2003–2004. Reductions of about 50%–90% were also observed for 95th percentile concentrations of five of the six metabolites. Frequencies of detection (FODs) decreased in all six metabolites (< 50% reduction). On average, median and 95th percentile concentrations and FODs showed a larger decrease in diethylphosphate metabolites than dimethylphosphate metabolites.Conclusions: Human exposure to OP insecticides as assessed by urinary DAP concentrations has decreased since the implementation of the FQPA, although we cannot be certain that U.S. EPA actions in response to the FQPA directly caused the decrease in DAP concentrations.     

Adolescent smoking and exposure to tobacco marketing under a tobacco advertising ban: findings from 2 Norwegian national samples

OBJECTIVES: We examined the extent to which adolescents in Norway have been exposed to tobacco marketing despite an existing ban, and whether exposure is related to their current smoking or expectations they will smoke in the future. METHODS: Questionnaires were administered to nationally representative systematic samples of Norwegian youths aged 13 to 15 years in 1990 (n = 4282) and 1995 (n = 4065). RESULTS: About half in each cohort reported exposure to marketing. Youths reporting exposure were significantly more likely to be current smokers and to expect to be smokers at 20 years of age, after control for important social influence predictors. CONCLUSIONS: Adolescents' current smoking and future smoking expectations are linked to marketing exposure even in limited settings, suggesting the need for comprehensive controls to eliminate the function of marketing in promoting adolescent smoking.     

One Key Question® and the Desire to Avoid Pregnancy Scale: A comparison of two approaches to asking about pregnancy preferences

ObjectiveTo facilitate assessment of patients’ pregnancy preferences, we compared responses to One Key Question® with the validated Desire to Avoid Pregnancy (DAP) scale and assessed their relationships to patient-reported reproductive health behaviors.MethodsIn this after-visit survey in primary care and obstetrics-gynecology practices, women ages 18–49 (n = 177) answered “Would you like to become pregnant in the next year?” and the 14-item DAP scale. We performed one-way ANOVA to compare DAP scores (0–4 scale, 4 = highest preference to avoid pregnancy) across One Key Question® responses (“Yes,” “Unsure,” “Ok either way,” “No but sometime in the future,” “No never”). We used logistic regression to test association of One Key Question® and DAP with contraceptive and folic acid use.ResultsMost patients did not want to become pregnant in the next year, based on One Key Question® (7% “Yes,” 4% “Unsure,” 11% “Ok either way,” 53% “In the future,” 25% “Never”). The mean DAP score overall was 2.52 (SD = 1.03, Range: 0–4, Cronbach’s α = 0.96). Scores differed by One Key Question® response (“Yes” mean DAP = 0.84, “Unsure” 1.64, “Ok” 1.42, “In the future” 2.94, “Never” 2.78, p < 0.001) yet varied markedly within each One Key Question® response group. Contraceptive use was lower among those who answered “Yes” (46%; OR = 0.14, 95% CI 0.04–0.48) vs. “No, future” (86%). Similarly, odds of contraceptive use increased with DAP score (OR = 1.69, 9% CI 1.18–2.42; predicted 51% for DAP = 0, 90% for DAP = 4).ConclusionOne Key Question® responses correlate with DAP scores, and contraceptive use correlates with not desiring pregnancy by both approaches.Implications StatementOne Key Question® and the Desire to Avoid Pregnancy scale can both identify women wishing to avoid pregnancy to help clinicians address patients’ contraceptive needs. Given the range of preferences associated with One Key Question® responses, clinicians who use it should proceed with further discussion to fully understand patients’ feelings.     

The Small- and Medium-sized Enterprises Office (SME Office) at the European Medicines Agency

On 15 December 2005, the European Medicines Agency (EMEA) launched an “SME Office” to provide financial and administrative assistance to micro-, small- and medium-sized enterprises (SMEs), with the aim of promoting innovation and the development of new human and veterinary medicinal products by SMEs. According to current EU definition of an SME, companies with fewer than 250 employees, and an annual turnover of not more than €50 million or an annual balance sheet total of not more than €43 million, are eligible for assistance from the SME Office. Incentives available from the EMEA for SMEs, include:

Administrative and procedural assistance from SME Office within the Agency.

Fee reductions (90%) for scientific advice and inspections.

Fee exemptions for certain administrative services (excluding parallel distribution).

Deferral of the fee payable for an application for marketing authorisation or related inspection until after the grant of the marketing authorisation.

Conditional fee exemption where scientific advice followed and marketing application is unsuccessful.

Assistance with translations of the product information documents.

At the end of May 2009, more than 380 companies from 21 countries across the European Economic Area (EEA) had SME status assigned by the EMEA. The large majority of companies are developing medicinal products for human use, 16 are veterinary companies, 15 companies are developing products for both human and veterinary use and 38 are regulatory consultants. Since the SME initiative started the Agency has processed more than 130 requests for scientific advice with fee reductions totalling of €6.9 million. Regulatory assistance has been provided to more than 170 companies and 12 companies have benefited from the SME translation service. Stakeholders have acknowledged the significant role the SME Office now plays as a service provider. In the period between January 2006 and June 2009, 34 applications for marketing authorization from SME applicants were filed for medicinal products for human use. Current analysis shows SMEs to have a lower success rate compared to non-SME companies. Major objections for SMEs are particularly high in the area of quality. Although the SME initiative is still at an early stage, it is apparent from the experience gained with applications for marketing authorisation to date that it is important for companies to open up an early dialogue with the EMEA. Scientific advice should be sought early, proactively and comprehensively on key issues in development (quality, non-clinical, clinical) and follow-up advice should be sought as development proceeds. For advanced therapy medicinal products, the assistance available to SMEs will be reinforced in 2009, with the introduction of the certification process.     

Experiences with the Accreditation of the Institute for Medical Research and Occupational Health,Zagreb, Croatia

Accreditation in accordance with the international General Requirements for the Competence of Testing and Calibration Laboratories (HRN EN ISO/IEC 17025 standard) has become a widely accepted method of quality management and objective evidence of technical competence, knowledge, and skills of testing and calibration laboratories. In 2010, the Institute for Medical Research and Occupational Health (IMROH) had its management system accredited against the HRN EN ISO/IEC 17025 standard for the following scopes: determination of radioactivity, testing of ambient air quality, and testing in the scope of ionising radiation protection. This accreditation encompassed three laboratories: Radiation Protection Unit, Environmental Hygiene Unit, and the Radiation Dosimetry and Radiobiology Unit. In accordance with the rules of the Croatian Accreditation Agency, the second re-accreditation is due in 2020. This paper describes and discusses the quality management system at IMROH over the ten years of its implementation. We share our experiences about non-conformities discovered during regular work, internal audits, and external audits performed by the Croatian Accreditation Agency. The accredited management system significantly improved the performance of the accredited units, and the Institute increased its visibility and marketing advantage, consequently improving its market position.Key words: ISO norms, measurement traceability, quality management, testing laboratories     

Hospital administrator's perspectives regarding the health care industry.

Based on responses from 52 hospital administrators, four areas of managerial concern have been addressed, including: (1) decision-making factors; (2) hospital service offerings: current and future; (3) marketing strategy and service priorities; and (4) health care industry challenges. Of the total respondents, 35 percent indicate a Director of Marketing has primary responsibility for making marketing-related decisions in their hospital, and 19 percent, a Vice-President of Marketing, thus demonstrating the increased priority of the marketing function. The continued importance of the physician being the primary market target is highlighted by 70 percent of the administrators feeling physician referrals will be more important regarding future admissions than in the past, compared to only two percent feeling the physicians' role will be less important. Of primary importance to patients selecting a hospital, as perceived by the administrators, are the physician's referral, the patient's previous experience, the hospital's reputation, and the courtesy of the staff. The clear majority of the conventional-care hospitals surveyed offer out-patient surgery, a hospital pharmacy, obstetrics/maternity care, and diabetic services. The future emphasis on expanding services is evidenced by some 50 percent of the hospital administrators indicating they either possibly or definitely plan to offer long-term nursing care, out-patient substance abuse programs, and cancer clinics by 1990. In addition, some one-third of the respondents are likely to expand their offerings to include wellness/fitness centers, in-patient substance abuse programs, remote or satellite primary care clinics, and diabetic services. Other areas having priority for future offerings include services geared specifically toward women and the elderly. Perceived as highest in priority by the administrators regarding how their hospital can achieve its goals in the next three years are market development strategies, followed by product/service development and finally, market penetration strategies. Clearly, the role of marketing will increase as new targets and new offerings dominate future, strategic decision-making. Specific hospital services having the highest future priority include out-patient services, in-patient care, cardiology, cancer/oncology, obstetrics, and services geared specifically to women and the elderly. Finally, when asked to identify the three most significant challenges facing the health care/hospital industry over the next five years, 12 challenges emerged, with five being mentioned by the majority of the administrators and seven by the minority.(ABSTRACT TRUNCATED AT 400 WORDS)     

Determinants of organophosphate pesticide exposure in pregnant women: A population-based cohort study in the Netherlands

Background

In the Netherlands organophosphate (OP) pesticides are frequently used for pest control in agricultural settings. Despite concerns about the potential health impacts of low-level OP pesticides exposure, particularly in vulnerable populations, the primary sources of exposure remain unclear. The present study was designed to investigate the levels of DAP metabolites concentrations across pregnancy and to examine various determinants of DAP metabolite concentrations among an urban population of women in the Netherlands.

Workshop on funding opportunities within the Food Standards Agency

During this workshop, held as part of a joint Nutrition Society and Food Standards Agency (Agency) meeting on Micronutrient interactions and public health, several precepts for a successful funding application to the Agency were discussed. These precepts, many of which can be used as guiding principles for project proposals to other funding bodies, are summarised as follows: remember that the Agency only supports research that will help them formulate or change human food policy; read the research requirements document thoroughly and plan your project to answer the call; remember that the Agency issues contracts, not grants; your project will be just one project within a focused and coordinated programme; collaborative work is encouraged, but this type of approach is not a licence to double or treble your costs; write a one-page executive summary and attach it to the front of the form;the statistical basis for your experimental design and proposed statistical analysis of your results are important criteria in the evaluation of your proposal; your plans for dissemination and exploitation are very important;match your project duration against your research plan; abide by the Agency plan for quality assurance for the management of research; make full use of the programme adviser and the Agency policy contact and the 'feedback' stage to refine your scientific ideas in line with Agency policy.     

'No decision about me, without me': a place for social marketing within the new public health architecture?

July 2011 marked the 40th anniversary of social marketing. However, while the previous Labour administration dedicated sustained resources and support to developing the field of social marketing, this was followed by a time of uncertainty during the Coalition Government's ascent to power. This paper explores the potential future position of social marketing within David Cameron's evolving public health landscape, outlining areas of synergy between social marketing's key features, and the coalition's emergent public health architecture. The paper concludes with an exploration of the development opportunities nascent within social marketing, suggesting that support for the new commissioners (GP and local authority), and an enhanced emphasis on evaluation of financial and social outcomes, will be required if the evidence base for strong practice is to continue to grow and evolve.