加拿大药物经济学评价准则的发展及其启示

目的 :提出规范药物经济学研究的建议。方法 :对加拿大药物经济学评价准则制定的背景和主要内容进行了介绍 ,并阐述了其最新发展状况 ,同时对我国药物经济学评价标准的初步建构提出了自己的设想。结果与结论 :应建立一套为国家社会保障部门、药品监督管理部门、卫生行政部门所认可的药物经济学的评价准则 ,规范药物经济学研究。同时 ,政府应出台相应政策 ,将药物经济学评价和药品价格、临床合理用药、《药品分类管理目录》、《社会医疗保险用药目录》等问题联系起来 ,建构起符合中国国情的药物经济学政府管制框架     

浅谈药物经济学研究方法的比较分析

药物经济学是近年来发展起来的一门新兴的边缘学科 ,其基本理论和基本概念已为广大的药物经济学研究人员所熟悉 ,广大的研究人员也已开展了药物经济学的实际研究。药物经济学作为一门应用性的学科 ,其研究的结果应能反映临床实际情况 ,这就要求研究人员在进行药物经济学研究时尽可能从实际出发设计研究方法。目前在进行药物经济学研究时 ,一般常采用 3种研究方法 ,一是随机临床试验 (ｒａｎ ｄｏｍｉｓｅｄｃｏｎｔｒｏｌｌｅｄｔｒｉａｌ,简称ＲＣＴ) ;二是观察性研究 (ｏｂｓｅｒｖａｔｉｏｎｓｔｕｄｙ) ;三是实际临床试验(ｐｒａｇｍａ…     

比较国产与进口辛伐他汀的药物经济学评价

目的 比较国产与进口辛伐他汀的药物经济学评价，指导临床医师合理使用经济有效的办法。方法 将118例病人随机分为国产辛伐他汀组及进口辛伐他汀组分别口服国产及进口辛伐他汀，观察用药4周和8周病人血脂的变化，并进行了两组的期望成本比较。结果 两组临床疗效及不良反应无显著性差异，国产组治疗原发性高胆固醉血症的药价为进口组的1／5。结论 国产的辛伐他汀对治疗原发性高胆固醇血症的临床疗效与进口辛伐他汀一样有效，且成本低。     

抗精神病药物的药物经济学评价（上）

本研究旨在通过回顾性的药物经济学研究,在抗精神病药使用调查和回顾性收集文献的基础上,计算其疗效、不良反应和治疗经济学的平均水平,建立药物经济学评价模型,一方面为临床合理用药提供指导,另一方面为同类药物的价格水平提供衡量标准。     

2010年国内药物经济学评价文献的系统评估和质量评价

目的:了解国内药物经济学评价研究现状,分析研究中存在的主要问题并提出建议。方法:检索2010年国内专业期刊上发表的药物经济学评价文献,根据制定的质量评价标准对纳入研究文献进行系统评估和质量评价。结果与结论:共纳入药物经济学评价文献117篇,主要研究机构为医疗机构,总体质量不高,大部分研究角度不明确、研究设计不合理、对照选择不恰当;成本计算差异大;健康产出指标、效果指标及评价方法都较单一;敏感性分析不合理;结果缺少对普适性、外推性和伦理性的讨论。     

药物经济学评价与临床试验

随机临床试验在药物经济学评价中应用广泛。尤其在澳大利亚药物经济学评价指南中,临床试验更是被作为首选的评价方法来推荐。但对于在随机临床试验中进行药物经济学评价的结果是否具有普遍意义,始终存在很大的争议。本丈讨论了在随机临床试验中进行药物经济学评价可能产生的偏差。建议在Ⅲ期临床试验、Ⅳ期临床试验中都实行药物经济学评价。Ⅳ期临床试验是开放性的观测研究,在Ⅳ期临床试验中都实行药物经济学评价可有效地避免评价偏差。     

药物经济学评价与参考价格制度的比较分析

目的:了解世界各国为解决药品费用快速上涨问题而采取的药品定价制度,重点比较分析以澳大利亚为代表的药物经济学评价体系和以德国为代表的参考价格体系。方法:根据药物经济学和参考价格体系的基本原理,结合实践进行理论分析。结果:运用参考价格体系存在一定的风险,而采用药物经济学评价体系则可以有效地避免这些风险。结论:运用药物经济学确实更有优势,但是具体实施的效果还有赖于具体国家的国情。     

国家基本药物目录与药物经济学的相关问题分析

我国现行《国家基本药物目录》存在诸多问题,其中目录品种过多和遴选过程的不够科学影响了基本药物制度在我国的施行。在基本药物目录遴选过程中引入药物经济学评价方法,将有利于提高遴选过程的科学性和临床用药的合理性,提高我国的医疗保障水平。     

药物经济学文献资料的评价与应用

本文通过对药物经济学文献资料特点的分析,以及药物经济学文献评价的指导原则及标准的考察,提出应用药物经济学文献的几种方法,以期推动医院药房和公共药房的药物经济学研究和应用.     

2018—2022年中国药物经济学评价文献质量评估

目的 分析我国药物经济学评价研究目前存在的问题,提高药物经济学评价研究的规范性与科学性,从而为政府决策提供更高质量的证据。方法 检索中国知网、万方数据库、维普数据库、PubMed、Web of Science等数据库2018-2022年收录的中国药物经济学评价文献,利用Excel 2016软件对符合纳入标准的文献进行关键信息提取,通过卫生经济学研究质量评价（QHES）量表对纳入文献进行质量评价。结果 共纳入113篇文献,其中中文文献85篇、英文文献28篇。文献整体质量的平均得分为65.7分,其中中文文献平均得分62.0分,英文文献平均得分76.9分。2018、2019、2020、2021、2022年文献质量评分的中位数分别为62.0、70.5、59.3、71.0、73.0分。65篇文献明确报告了研究角度,36篇文献未明确说明贴现率,25篇文献未对阈值的定义明确说明,53篇文献同时使用了2种敏感性分析方法。在QHES量表不同条目下,条目2（研究角度）、条目8（时间范围及贴现）、条目14（潜在偏倚）、条目16（资金来源）的得分占比较低。结论 2018-2022年我国学者发表药物经济学评价的...     

国外脑卒中药物经济学研究概况

目的：了解国外在脑卒中防治方面的药物经济学研究,为我国在相关领域开展药物经济学研究提供参考。方法：从脑卒中的预防、诊断、治疗、康复、护理及模型研究方法等方面,概述了国外药物经济学研究的进展。结果：国外注重对脑卒中二级预防的药物经济学研究,普遍采用模型研究方法,注重敏感性分析。结论：国外药物经济学研究方法和技术日益完善和成熟,为我国开展高质量的脑卒中药物经济学研究提供了借鉴。     

The Social Consequences of Binge Drinking: A Comparison of Young Adults in Six European Countries

ABSTRACT

A considerable amount of survey information was available from general population surveys carried out in six countries between 2000 and 2005. These studies were conducted under the auspices of Gender, Alcohol and Culture: An International Study (GENACIS). A total of 1,446 adults between 18 and 23 years of age and 2,482 adults between 24 and 32 years of age from the Czech Republic, Denmark, the Isle of Man, Spain, Sweden, and the United Kingdom responded to questions about their drinking habits and the social consequences directly resulting from their drinking. Survey methods varied from quota sampling with face-to-face interviewing in Spain and the United Kingdom to telephone surveys in Denmark and Sweden. Response rates varied from 50% to 72%. “Binge” or “heavy episodic” drinking was defined as a usual amount on one occasion of more than 8 UK “units” for men and more than 6 units for women. Consequences investigated comprised relationship, health and financial problems, being asked to cut down on drinking, and being involved in a fight. In Denmark and Sweden, the group aged 24 to 32 years was less likely to be binge drinkers than the 18 to 23 year olds. In the other countries, there was little difference. There was also little difference between the age groups in frequency of drinking, but there were considerable variations in this respect between countries. People in the United Kingdom, Sweden, the Czech Republic, and Denmark were more likely to suffer at least one consequence than those in Spain and the Isle of Man. In Spain, there was little change between the age groups in this respect. Fights were most common in the United Kingdom. Being asked to cut down one's drinking was less common in Spain and Sweden than it was elsewhere. Findings are discussed in terms of the varied drinking cultures in the different countries.     

Comparison of Noncancer Risk Assessment Approaches for Use in Deriving Drinking Water Criteria

The development and promulgation of drinking water regulations to protect exposed human populations from contaminants that may occur in public drinking water supplies has been a major regulatory concern and effort of the United States Environmental Protection Agency for decades. Risk assessment, as applied in the development of drinking water regulations, involves the quantification of the level below which adverse health effects are not expected to occur. Traditionally, the oral reference dose (RfD) has been the preferred approach for characterizing these noncancer health risks. The benchmark dose approach to derive RfDs has increasingly gained scientific and regulatory acceptance as a risk assessment methodology since its introduction in 1984. Similarly, the use of categorical regression techniques were introduced at about the same time. The objective of this paper is to present an evaluation of the strengths and weaknesses of each risk assessment method as related to the development of drinking water criteria for noncarcinogenic chemicals. The data base requirements, performance record, mathematical or statistical basis, and other parameters are described and compared.     

Pharmacoeconomic Spotlight on Rotavirus Vaccine RIX4414 (Rotarix?) in Developed Countries

The most common cause of severe diarrhea in infants and young children is rotavirus gastroenteritis (RVGE), which is associated with significant morbidity, healthcare resource use, and direct and indirect costs in industrialized nations. The monovalent rotavirus vaccine RIX4414 (Rotarix™) is administered as a two-dose oral series in infants and has demonstrated protective efficacy against RVGE in clinical trials conducted in developed countries. In addition, various naturalistic studies have demonstrated ‘real-world’ effectiveness after the introduction of widespread rotavirus vaccination programs in the community setting.Numerous cost-effectiveness analyses have been conducted in developed countries in which a universal rotavirus vaccination program using RIX4414 was compared with no universal rotavirus vaccination program. There was a high degree of variability in base-case results across studies even when the studies were conducted in the same country, often reflecting differences in the selection of data sources or assumptions used to populate the models. In addition, results were sensitive to plausible changes in a number of key input parameters. As such, it is not possible to definitively state whether a universal rotavirus vaccination program with RIX4414 is cost effective in developed countries, although results of some analyses in some countries suggest this is the case. In addition, international guidelines advocate universal vaccination of infants and children against rotavirus. It is also difficult to draw conclusions regarding the cost effectiveness of rotavirus vaccine RIX4414 relative to that of the pentavalent rotavirus vaccine, which is administered as a three-dose oral series. Although indirect comparisons in cost-effectiveness analyses indicate that RIX4414 provided more favorable incremental cost-effectiveness ratios when each vaccine was compared with no universal rotavirus vaccination program, results were generally sensitive to vaccine costs. Actual tender prices of a full vaccination course for each vaccine were not known at the time of the analyses and therefore had to be estimated.     

从中美对比看如何推进我国药物经济学的应用

目的指出我国适合开展药物经济学研究及应用的基础条件和存在的缺陷。方法对我国与美国药物经济学研究及应用的实际情况进行对比分析。结果与结论我国具有较好的开展药物经济学研究及应用的基础条件,但也存在教育与研究水平不高、应用范围不广且不规范等问题。     

Comparison of Robust Criteria for D-Optimal Designs

This study compared the performance of a local and three robust optimality criteria in terms of the standard error for a one-parameter and a two-parameter nonlinear model with uncertainty in the parameter values. The designs were also compared in conditions where there was misspecification in the prior parameter distribution. The impact of different correlation between parameters on the optimal design was examined in the two-parameter model. The designs and standard errors were solved analytically whenever possible and numerically otherwise.     

Confidence Interval Criteria for Assessment of Dose Proportionality

Purpose. The aim of this work was a pragmatic, statistically sound and clinically relevant approach to dose-proportionality analyses that is compatible with common study designs. Methods. Statistical estimation is used to derive a (1-)% confidence interval (CI) for the ratio of dose-normalized, geometric mean values (R_dnm) of a pharmacokinetic variable (PK). An acceptance interval for R_dnm defining the clinically relevant, dose-proportional region is established a priori. Proportionality is declared if the CI for R_dnm is completely contained within the critical region. The approach is illustrated with mixed-effects models based on a power function of the form PK = ₀ Dose¹; however, the logic holds for other functional forms. Results. It was observed that the dose-proportional region delineated by a power model depends only on the dose ratio. Furthermore, a dose ratio (₁) can be calculated such that the CI lies entirely within the pre-specified critical region. A larger ratio (₂) may exist such that the CI lies completely outside that region. The approach supports inferences about the PK response that are not constrained to the exact dose levels studied. Conclusion. The proposed method enhances the information from a clinical dose-proportionality study and helps to standardize decision rules.     

Assessment of Communications-related Admissions Criteria in a Three-year Pharmacy Program

Objective. To determine if there is a correlation between TOEFL and other admissions criteria that assess communications skills (ie, PCAT variables: verbal, reading, essay, and composite), interview, and observational scores and to evaluate TOEFL and these admissions criteria as predictors of academic performance.Methods. Statistical analyses included two sample t tests, multiple regression and Pearson’s correlations for parametric variables, and Mann-Whitney U for nonparametric variables, which were conducted on the retrospective data of 162 students, 57 of whom were foreign-born.Results. The multiple regression model of the other admissions criteria on TOEFL was significant. There was no significant correlation between TOEFL scores and academic performance. However, significant correlations were found between the other admissions criteria and academic performance.Conclusion. Since TOEFL is not a significant predictor of either communication skills or academic success of foreign-born PharmD students in the program, it may be eliminated as an admissions criterion.     

Pharmacoeconomic considerations in anaesthetic use

Healthcare costs are rising in all areas of medicine, especially in high technology specialities such as anaesthesia. Therefore, cost containment and reduction have become major goals in many hospitals and anaesthesia departments. One area that has received substantial attention is the cost of pharmaceutical products, in particular the cost of newer, shorter-acting inhaled and intravenous anaesthetics, analgesics and neuromuscular blocking agents. Numerous pharmacoeconomic studies have been published on the theoretical analysis of anaesthetic drug costs and the potential benefit of various anaesthesia techniques. However, the results are not conclusive and anaesthesia departments continue to seek ways to reduce costs. In this review, we intend to discuss cost terminology, common areas of cost containment in anaesthesia and the relationship of anaesthesia care costs to total perioperative costs.     

Stakeholders in Opioid Substitution Treatment Policy: Similarities and Differences in Six European Countries

Based on the research papers within this special issue, this overview discusses similarities and differences in stakeholding in drug user opioid substitution treatment policy in Britain, Denmark, Italy, Austria, Poland, and Finland. It explores factors that have influenced stakeholder activity, including the importance of crisis, the impact of evidence, the availability of resources, the wider political context, the influence of moral frameworks and ideologies, and the pressure of external influences. The paper highlights the important differences in the emergence and evolution of stakeholder groups and in the political, cultural, and economic circumstances, which both constrain and enable their activities.