仿制药与原研药的比价及其管理策略研究

目的:通过对仿制药与原研药的比价的实证研究,探讨其管理策略。方法:采用2014年上海医院购药信息系统的数据,获取276对仿制药及其对应原研药的配对样本,把配对样本的价格转换成可比价格进行比较。结果:仿制药与原研药的全部比价在0.01~1.41之间,均值为0.54±0.26,均值的95%置信区间为0.51~0.57,第一四分位数为0.34,中位数为0.57,第三四分位数为0.73。结论:对仿制药与原研药价格管理策略的建议是把比价的第一和第三四分位数之间的区间作为过渡性合理区间,将来结合仿制药质量一致性评价结果,引导仿制药与原研药的比价向更加合理的区间移动,最终基本实现由市场决定仿制药与原研药的比价,同时,要出台鼓励使用仿制药的配套措施。     

我国相关省份原研药及仿制药价格比较

目的:通过对相关省份原研药与仿制药价格比较,明确两类药品价格水平。方法:通过WHO-HAI标准化价格比较方法,从原研药与仿制药的价格比较和相关省份仿制药价格比较两个方面比较2016年相关省份常用药品采购价格。结果:整体上我国原研药价格相对仿制药较高,且两者价格高于国际参考价。相关省份同一仿制药产品的价格水平差异性明显,有些省份整体价格相对较低。结论:仿制药价格比原研药低,且同一药品在不同省份间有差异。相关部门应支持鼓励仿制药质量的提高,完善各省市药品集中采购政策,建立全国性公开透明的药品价格数据库。     

优质仿制药加速上市 原研药市场或将生变

正9月11日,国家食药监管总局药品审评中心(CDE)发布新一批拟纳入优先审评审批品种名单,涉及15个品种,9个品种为仿制药,占比超过60%。江苏恒瑞的格隆溴铵注射液申请理由为"与现有治疗手段相比具有明显治疗优势"。格隆溴铵注射液可直接用于肌内或静脉注射,用于胃肠道疾病或麻醉,目前已在美国、英国、加拿大、澳大利亚等国家上市,2016年格隆溴铵注射液全球市场销售额约为2.35亿美元。齐鲁制药的注射用培美曲塞二钠的申请理由则是同一产线在美国2017年上     

仿制药/原研药的比价与仿制药生产厂家数量的关系研究

目的:探索仿制药/原研药的比价(PR)与仿制药的生产厂家数量(QM)的关系。方法:采用上海医院购药信息系统(HPDIS)的数据,筛选出仿制药及其对应的原研药,计算两者有效成份最小计量单位的PR,同时,统计每个仿制药的QM,并对PR与QM进行相关和回归分析。结果:PR的均值为0.54±0.26,中位数为0.57;QM的均值为3.07±2.46,中位数为2.00;两者的相关系数为-0.36,线性回归方程为PR=-0.04QM+0.66。结论:本研究结果可以为有关管理部门合理控制PR和QM提供参考。     

药品实行专利后的合法仿制

药品实行专利后的合法仿制熊梦辉，周增桓，黄震从１９９３年１月１日起，药品在我国实行专利保护。这样，我国的制药企业再也不能“随心所欲”地仿制他人的专利药品了。但这并不意味着不能仿制，而是强调要“合法”仿。仿制药品在我国制药工业仍然是一条不可缺少的重要途...     

论仿制药的利益平衡机制及其发展

仿制药由于涉及巨大的经济利益和社会利益而倍受关注,而作为促进创新,推动社会进步的药品专利制度更多的是从利益平衡角度出发。因此,作为关系人体健康最重要的药品发展走向,必然会是社会公共利益与现有制度均衡下的理性选择的结果。     

仿制药的春天还有多远

正近日,国务院办公厅发布《关于改革完善仿制药供应保障及使用政策的意见》。文件安排可谓事无巨细,既体现了国家对创新的珍惜、重视和扶持,又表达了对民生的关切、对医疗医保事业的实质性支持和对产业升级的期盼。虽然该文件仍是一种两难的平衡、两难的折中,但也释放出一个信号——仿制药在顶层制度设计层面已得到充分认可和重视。优质仿制药的腾笼换鸟原研药在中国售价昂贵,但市场占有率奇高。这是由于国内仿制药总体质     

美国鼓励仿制药替代使用政策与措施研究

目的：分析美国鼓励仿制药替代使用的立法过程、政策措施以及关键要素，为我国仿制药经一致性评价后制定替代使用政策提供建议。方法：通过查阅美国联邦法律、各州法律、指南文件、国内外文献等，全面分析美国鼓励仿制药替代使用的基本原则、监管理念和实施挑战。结论：美国仿制药替代法律的制定经历探索、发展和调整三个阶段。医师、药师和患者是美国各州法律鼓励仿制药替代的关键要素，联邦政府和FDA通过橙皮书、分级医保支付和开展认知教育的途径指导和影响仿制药替代。建议我国以尊重患者为基本原则，将鼓励仿制药替代写入法律，明确界定仿制药替代使用范围；建立具有替代决策支持工具的电子处方系统；加强宣传教育提高仿制药认知度。     

我国仿制药发展存在的问题及对策探究

目的:研究我国仿制药发展存在的问题及对策.方法:运用文献及数据分析方法从发展仿制药品制度及技术层面进行分析,总结出我国发展仿制药的必要性以及发展策略.结果:为我国发展仿制药的研究、监管以及发展策略提供了大量的数据以及方法参考,并且总结出我国目前在发展仿制药中存在的一些问题,提出解决对策.结论:伴随着医学药品的大力发展,发展仿制药已经具有非常重要的意义了,针对于这一形势,我国应当大幅度加强对于仿制药的质量管理,积极的借鉴国外的发展经验,大幅度提高药品质量标准,并且应当对所采取的政策进行及时的调整,保证我国仿制药的用药安全.     

无症状胆囊结石综述

无症状胆囊结石常见于临床,近年来检出率呈上升趋势.其发病机制复杂,预后无明确规律,且影响因素众多.目前有保守治疗及预防性胆囊切除手术2种治疗方案,但选择上存有争议.本文就无症状胆囊结石的发病机制、预后及影响因素、治疗方案的选择进行综述.     

An Overview of Cholesterol Management

Cardiovascular disease is the leading cause of death worldwide. Elevated cholesterol (hypercholesterolemia) and abnormal lipid profiles (dyslipidemia) are important risk factors for the development of cardiovascular disease. This article discusses the role of cholesterol in the body and the relationship between different cholesterol fractions and the risk of cardiovascular disease. The guidelines for assessment and treatment of dyslipidemia from the National Cholesterol Education Program are outlined, and cholesterol targets and goals of therapy are discussed. The mechanism of action, place in therapy (eg, first-line, second-line, or add-on), and common side effects are also discussed for each of the available classes of drugs used in the treatment of dyslipidemia.Cardiovascular (CV) disease (CVD) is the leading cause of mortality and one of the leading causes of disability worldwide.1 In the United States alone, more than 80 million adults have at least one type of CVD, with hypertension, coronary heart disease (CHD), stroke, and heart failure among the most common forms of the disease. Elevated levels of cholesterol (hypercholesterolemia) and abnormal lipid profiles (dyslipidemia) are important risk factors for CVD. The American Heart Association (AHA) estimates that more than 100 million Americans have elevated cholesterol levels (>200 mg/dL) and 34 million have cholesterol levels that necessitate treatment.2Cholesterol is an essential component of cell membranes and steroid hormones. The body synthesizes most of its required cholesterol with the remainder coming from the diet. Since cholesterol is mostly insoluble in blood, it is packaged with proteins and phospholipids to form lipoprotein complexes that circulate in the bloodstream. The types of cholesterol-containing lipoproteins are high-density lipoproteins (HDL-C), low-density lipoproteins (LDL-C), very low-density lipoproteins (VLDL-C), and chylomicrons.High levels of LDL-C are associated with increased CV risk in epidemiologic studies. In addition, numerous clinical studies using a variety of therapies have demonstrated decreased CV events and mortality with LDL reduction. Therefore, the first goal of therapy is reduction of LDL-C levels for the most common forms of dyslipidemia. Conversely, high levels of HDL-C are associated with decreased risk of CV events. However, clinical trials assessing the morbidity and mortality benefits of drug therapies that raise HDL-C levels have had varied results. HDL-C–modifying trials with niacin have demonstrated CV event reduction.3,4 Conversely, other treatments that raise HDL-C, including hormone replacement therapy5 and torcetrapib,6 have not decreased CV events. Because of this, in the absence of large clinical outcome trials, therapies that elevate HDL cannot be assumed to produce clinical event reduction.     

An Overview of Livestock-Associated MRSA in Agriculture

ABSTRACT

Researchers, veterinary and health care practitioners, and agricultural producers gathered in Johnston, Iowa, to attend the eighth annual Midwest Rural Agricultural Safety and Health Forum (MRASH), November 2009. Among several focus areas, four plenary talks were given on the current research being conducted examining methicillin-resistant Staphylococcus aureus (MRSA) on swine farms in the United States. These focused on prevalence of MRSA on farms, both in swine and in human workers; the presence of MRSA in air samples and in swine barn shower facilities; and the presence of methicillin-resistant and methicillin-sensitive S. aureus in retail meats. These findings begin to elucidate the overall picture of livestock-associated MRSA in the Midwestern United States.