德国、日本和我国台湾地区药品价格规制经验及启示

目的:为完善我国药品价格规制政策提供参考。方法:运用文献研究、制度比较等方法,归纳总结德国、日本和我国台湾地区药品价格规制政策的共性和特色,借鉴其成功经验。结果与结论:德国、日本和我国台湾地区药品价格管理各有特色。德国实行参考价格制度和新药定价机制,是最早实行参考价格制度的国家;日本采用新药创新性加价、仿制药递减定价和药品价格再调整体制;我国台湾地区实行分类分组差别定价、鼓励竞争议价并定期对药价调查与调价。德国、日本和我国台湾地区均将医保支付价作为药价管理的核心,采取综合手段规制药品价格,同时也都注重对市场价格的监测和定期调整,价格谈判和药物经济学等多种定价方法被广泛应用。以价值为基础的定价是目前药品价格政策改革的趋势,我国在完善药品价格管理制度时可有所借鉴。     

发展和应用监管科学: 中国、美国、欧盟和日本的药品监管机构的经验

目的:本文旨在使用逻辑模型分析特定国家推行发展监管科学的实际执行经验.方法:中国、美国、欧盟和日本的药品监管机构因正式启动了监管科学计划而被选为目标研究对象,对其政府文件和相关文献进行分析和审查以收集数据.结果与结论:关于监管科学的定义尚无共识,但发展和应用监管科学的愿景却是相同的,即开发新的工具、标准和指南以提高评估...     

日本药品专利期限补偿制度对中国新药研发的启示

由于新药的研究和开发时间较长,未经安全性、有效性严格审查的药品不能上市,审查时间过长从而导致新药研发成本过高.日本实行药品专利期限补偿制度,给予药品一定专利保护期限的延长,有效减少了新药和仿制药的矛盾.本文通过对日本2017-2019年的药品专利期延长申请数据进行分析,结合2020年10月17日第十三届全国人民代表大会...     

An observational study of intravenous medication errors in the United Kingdom and in Germany

Objectives: To investigate the incidence and the severity of intravenous (i.v.) drug preparation and administration errors in two countries and three pharmacy services. Method: A disguised observational method was used to record details of the preparation and administration of prescribed i.v. drugs on two wards in each of three teaching hospitals: one with a traditional British ward pharmacy service (TBP) and two hospitals in Germany, one with a traditional ward stock supply (TGP) and one with a satellite pharmacy service (GSP) with unit dose system. Main outcome measures: Errors in i.v. drug preparation and administration and their potential significance. Results: The number of observed preparations/administrations were: TBP 77/63, TGP 126/109 and GSP 134/106. The preparation error rates were: TBP 22% (95% confidence interval: 1331%), TGP 23% (1630%) and GSP 31% (2339%). The administration error rates were TBP 27% (1638%), TGP 49% (3958%) and GSP 22% (1430%). The percentage of administration errors on the wards with TGP was statistically significantly higher than in the other two services. Common errors at the study sites with TBP and GSP were omissions. Wrong rate of administration occurred most frequently on the wards with TGP. The majority of errors were likely to be of 'moderate' to 'severe' outcome. Careful drug chart reading could possibly reduce omission errors on the wards with TBP. A change of the German nursing law ('Krankenpflegegesetz') to legally entitle nurses to administer i.v. drugs could probably result in better training, national guidelines and standards. Conclusion: This study found a high rate of i.v. medication errors of moderate to severe significance. Changes in practice should be considered to make i.v. therapy safer for patients.     

中国与不同国家和地区的畅销药比较分析

本文对１９９２年中国、台湾、日、美、意、法、德、英共８个国家和地区及全世界汇总的前１５位畅销药进行横向对比分析，包括品种的地域分布，与世界总市场的比较，按治疗学分类的研究等，同时也分析了各国家和地区用药模式的差异。     

中国内地及港澳台地区药事管理研究动态介绍

为了解内地、台湾、香港和澳门药事管理研究动态，采用网络数据库检索的方法，对万方数据库、台湾博硕士论文数据库、香港各大学图书馆硕博论文数据库、澳门各大学图书馆硕博论文数据库中有关药事管理的研究文题进行分析。研究结果显示：内地与港澳台药事管理研究主题既有相同点，又各具特色；内地与港澳台药事管理研究方法差异较大；内地药事管理论文常常较宏观，而港澳台药事管理论文较微观。     

我国进口药品监督检验制度的研究

目的调研我国进口药品监督检验制度及执行中的有关问题,为修订我国《药品管理法》及相关法律法规提供调查结果和建议。方法采取问卷调查和实地调研的方法,掌握我国食品药品稽查机构和相关进口药品检验所在日常工作中遇到的问题,对信息进行综合分析。结果我国对进口药品和国产药品的监督检验存在着很多差别。结论进口药品涉及到国与国之间、海关与海关之间、进口商和国外生产商之间的关系和利益,为保证进口药品安全、有效、质量可控,对进口药品的监督检验应有明确的法律规定。     

中国与西太平洋地区发展中国家公立药品采购系统基本药物价格比较及启示

目的:为制定和调整我国基本药物价格和采购监管政策提供参考。方法:对我国黑龙江省、马来西亚、蒙古和越南的公立药品采购系统相关政策,及其2009年5～9月31个基本药物的公立采购价格进行国家间和与国际及世界卫生组织西太平洋地区中位数价格的比较、分析。结果与结论:我国黑龙江省公立药品采购系统多数只采购国产通用名药,价格水平与健康管理科学组织(MSH)和世界卫生组织西太平洋地区相当,但与印度通用名药、甚至是品牌通用名药相比偏高。某些同时采购通用名药和原研药的品种价差与他国相比过大,但一些原研药仍能在公立药品采购系统中有一席之地。原研药和通用名药"共生"的品种,价格与印度相比没有优势,国产通用名药的价格甚至高于印度品牌通用名药。     

Comparison of different exposure assessment methods to estimate the long-term dietary exposure to dioxins and ochratoxin A

Long-term exposures to dioxins (PCCD/F and dioxin-like PCBs) and ochratoxin A were calculated using food consumption data of the European concise database combined with concentration data of the Netherlands (NL) using a deterministic approach. To refine these assessments, exposures were also calculated using three long-term exposure models, observed individual means (OIM), Iowa State University Foods (ISUF), and betabinomial-normal (BBN) models, combined with individual food consumption data of NL. BBN and ISUF correct the variation in long-term exposure for the within-person variation, whereas OIM calculates the mean exposure over the days in the food consumption survey. Exposures obtained with the concise database were highest, and those obtained with OIM higher than with BBN and ISUF. Contribution of the major sources of exposure differed between the concise database and the three models. Given the constraints of the concise database, exposures obtained with this database should be interpreted as a first tier assessment. Preferably, refined assessments using models that correct the variation in long-term exposure for the within-person variation combined with individual food consumption data and national concentration data should be used to assess the long-term exposure. We recommend the use of BBN since it can model exposure distributions that depend on covariates.     

Timely awareness and prevention of emerging chemical and biochemical risks in foods: Proposal for a strategy based on experience with recent cases

A number of recent food safety incidents have involved chemical substances, while various activities aim at the early identification of emerging chemical risks. This review considers recent cases of chemical and biochemical risks, as a basis for recommendations for awareness and prevention of similar risks at an early stage. These cases include examples of unapproved genetically modified food crops, intoxications with botanical products containing unintentionally admixed toxic herbs, residues of unapproved antibiotics and contaminants in farmed aquaculture species such as shrimp and salmon; and adverse effects of chemical and biological pesticides of natural origin. Besides case-specific recommendations for mitigation of future incidents of the same nature, general inferences and recommendations are made. It is recommended, for example, to establish databases for contaminants potentially present within products. Pro-active reconnaissance can facilitate the identification of products potentially contaminated with hazardous substances. In international trade, prevention and early identification of hazards are aided by management systems for product quality and safety, rigorous legislation, and inspections of consignments destined for export. Cooperation with the private sector and foreign authorities may be required to achieve these goals. While food and feed safety are viewed from the European perspective, the outcomes also apply to other regions.