药品价格规制的比较与借鉴

药品价格水平的高与低,合理与否,直接涉及到用药者和经营者的合法权益。为此应当让规制机构官员、专家、药品生产和经营者、消费者协力合作,从而调和在不同的利益、立场与目标下,所掩藏的时有冲突的各种价值。     

Estimating Local and National Problem Drug Use Prevalence from Demographics

Objective:?To assess the applicability and validity of the Multiple Indicator Method for combining sparsely available local prevalence estimates of problem drug use into a national estimate. Method?:?Local estimates of problem drug use were available in seven out of the 27 addiction treatment regions in the Netherlands. Using demographic variables as predictors and under varying regression model specifications estimates were obtained for the remaining 20 regions and aggregated into national ones. These outcomes were compared with one obtained with the methodologically unrelated Treatment Multiplier Method. Results:?All results point to a prevalence of 0.32% in the population of 15–55 years (or 0.27% in the population aged 15–64). Discussion:?The applicability and validity of the Multiple Indicator Method – and adaptations thereof – for getting regional and national prevalence estimates from incomplete data remains subject of further research. However, the results found here and elsewhere more than justify an interest in future research efforts.     

加拿大药品费用及药品价格管理介绍

目的:介绍加拿大药品费用及药品价格管理概况,以供我国借鉴。方法:采用文献研究和描述性分析方法。结果与结论:加拿大2007年药品费用占卫生总费用的比例估计为16.8%,2007年的人均药品费用估计为818加元。加拿大药品价格管理包括专利药和非专利药的价格管理,其中对专利药价格管理采取了参考定价的方式,并就药品价格的国际比较和国内比较的方法学进行了明确设计。     

Local Drug Abuse Needs and Priorities

Abstract

Insomnia is a problem that extends beyond the nighttime. People who experience sleep disturbances complain that they stay awake for a long time before they fall asleep. They may wake up several times during the night and cannot return to sleep and/or they wake up early in the morning. As a result, they feel sleepy during the day and are less alert. Various forms of insomnia are described that require—as much as possible—an individualized treatment approach. Besides sleeping hygiene, benzodiazepines certainly occupy a place in thetreatment of insomnia. Triazolam, a triazclobenzodiazepine, closely approaches the characteristics of an ideal hypnotic: pharmacological activity at the level of the receptors, moderate absorption, short-acting, and rapid elimination. It is effective and safe if prescribed correctly and at the appropriate dosage.     

美国药品召回规制对我国的借鉴意义

目的：思考完善我国药品召回规制的方式。方法：对缺陷药品相关概念进行阐述,分析我国药品召回规制现状及问题,并对美国药品召回规制现状进行介绍。结果与结论：我国可借鉴美国药品召回规制措施,进一步完善我国政府规制。     

关于药物创新与药品管理关系的思考

在建设创新型国家的主旋律下,每一种角度的论述都给予药物创新神圣的使命,使得药物创新具有越来越高的势能,但同时,我们距离药物创新的客观规律和现实性似乎有了越来越高深的鸿沟,药物创新也越来越缺乏具有中国特色的可操作性。     

Decision-Taking in Drug Regulation: Doublethink,Regret Avoidance,and Other Matters

Abstract

Much of the behavior of both drug regulators and drug developers is affected by the concepts of doublethink, regret avoidance, natural justice, and open government, and by lack of foresight on the part of developers. Some of these are counterproductive. Drug developers would be wise to apprise themselves more fully of psychological factors so they are prepared to answer the questions and challenges of the regulators in an appropriate manner, and so ease the process of drug development considerably.     

搞好批发企业经营管理规范药品流通秩序

药品批发企业经营管理混乱是药品购销渠道混乱的重要原因之一。必须健全法律、法规，加大执法力度，切实加强药品市场的监督管理。     

The Politics of Drug Regulation

Abstract

The issue of who decides which drugs an individual may take is political. The politics of drug regulation differ from other areas in that such regulation is seldom of high political visibility, yet proposals for change receive considerable attention. Although there are substantial economic stakes in the politics of drugs, the contest is generally over the non-economic issue of whose expertise should be entrusted with the final decision. Unlike other areas of politics, the FDA has not been “captured” by the industry, nor is there a closed club of bureaucrats, drug manufacturers, and doctors controlling the process of drug regulation. Finally, drug regulatory policy changes very slowly. In order to modify this situation a group of hardworking, persistent policymakers in Congress must be convinced that public welfare requires change, academia must make the changes respectable, the administration must make them possible, industry must help, and, most importantly, a dramatic drug-related crisis must arise to motivate the system.     

Progress in New Drug Regulation

Abstract

Since the enactment of the Drug Amendments of 1962, there has been no progress in reform of new drug regulation for three reasons. The recommendations for reform have come from outside FDA, and thus have had no leverage or clout. Congress has no interest in reforming drug regulation. The FDA bureaucracy has no incentive to reform the system. Progress in new drug regulation will therefore be extremely difficult in the future and may not be achievable.     

对药品贮藏规定的调查与分析

药品是否能够规范储存直接关系到药品质量，关系到人民的用药安全。我国现行药品储藏环境问题严峻，医院药库、药房的药品储存条件令人担忧，拆零药品管理制度缺失，药品说明书和包装存在多种问题，药监部门应加强对药品贮藏的监督管理。     

从世界前沿进展分析药物研发和企业发展的未来

随着全球GDP的稳健增长,全球医药市场更是表现出了迅猛的增长势头,并且远远超过了GDP的增长速度。全球医药市场的价值也从1982年的10亿美元,增长到2005年的6000亿美元。为何全球医药市场会有如此的快速增长?GDP的增长无疑是一个推动力,人口的老龄化也刺激了市场的需求,药品开发链的不断充实更是全球医药市场增长的强劲推动力(CSFB预测,IMSHealth,WEFA)。但是,全球医药市场的辉煌还能否以及如何得以继续,药物的研发和企业的发展应该何去何从,中国的制药市场应选择怎样的出路,这些都是值得深刻思考的问题。     

Science vs. Food Drug Regulation

Abstract

Science is less helpful to the regulation of drugs than most would wish because there is an unfortunate antagonism between scientists and regulators which stems not from any inherent conflict between science and law, or from an inadequacy of science in meeting the demands of law, but from a confusion as to what science is and is not, what science can and cannot do, and who is and is not a scientist. In order to address the drug regulation process intelligently, careful attention must be paid to two points: a distinction must be made between questions of science and questions of public policy over which science has no sway; and the public must be educated as to what science is, what science can do, and who scientists are.     

全球儿童合理用药国家药物政策现状分析

目的:评价全球儿童合理用药国家药物政策现状及实施情况,为建立适合我国国情的儿童合理用药国家药物政策提供决策依据。方法:检索国内外相关数据库,查阅世界卫生组织(WHO)、欧盟以及多个国家和地区的药品管理相关网站,用预先设计的数据提取表收集儿童合理用药政策相关信息,并进行归纳、总结和分析。结果:最终纳入45篇文献,涉及WHO和欧盟、美国、加拿大、英国、爱尔兰、荷兰、德国、西班牙、法国、澳大利亚、新西兰、中国、印度、韩国、日本、南非等多个国家和地区。各国儿童合理用药国家药物政策共同关注的要点包括促进儿童药物临床试验的开展,制定和推广儿童基本药物目录,制定和推广国家儿童处方集、标准治疗指南等用药标准,促进儿童药物上市后的监测等4个方面。美国、欧盟和日本制定了儿童药物临床试验的国家法规政策,WHO、南非和印度制定了儿童基本药物目录,WHO、英国和我国制定了儿童处方集。结论:建议相关部门参考美国和欧盟等国家和地区的经验,建立适合我国儿童疾病负担和用药情况的国家药物政策。     

用科学监管来鼓励药物创新——解读新《药品注册管理办法》

新<药品注册管理办法>(以下简称新办法)于2007年7月1日颁布,2007年10月1日正式施行,得到了社会各界的高度关注.新办法实施以来,我们国家药品注册申报的总量明显减少,新药的比例明显提高.     

Drug Regulation Reform Act of 1978

Provisions of the Drug Regulation Reform Act of 1978 are discussed. Included in the discussion are drug monographs and product licenses, investigations and approvals of drugs, drug information, labeling, promotion and education, penalties, and the National Center for Clinical Pharmacology. The Act eliminates the individual NDA approach to regulation and replaces it with a system of monographs on "drug entities" and "drug product" licenses. It amplifies and redefines the investigational process to facilitate and promote research while protecting patients' rights. It also divides the commercial investigation process into two phases: drug innovation investigations and drug development investigations.