近年国外药物流行病学研究的特点

药物流行病学(Pharmacoepidemiology)是一门研究药物在人群中的应用及效应的学科[1],即是将流行病学的理论、方法与知识应用于研究药物的应用与效应的一门学科."药物流行病学是科学方法的自然杂交.流行病学研究的是疾病的存在,药理学则通过生物化学方面的干预,降低疾病的发生率和患病率”[2].药物流行病学的核心在于临床药理学与临床流行病学二条途径的交叉点[3].     

药物流行病学与电子健康档案数据库

1前言 自发不良事件报告已成为上市后药品安全信息的主要来源之一。对于通过自发报告鉴别出的具体事件,经常会开展一些有选择的研究以便更加严格地评估药物与事件之问的相互关系。在过去的20年里,通过采用书面或电子形式的数据库等已有的健康档案,大部分这样的研究变得具有可观察性（流行病学）。健康数据库数量的增长致使此类研究不断增加;另外,人们对于电子数据库应用于系统的药物安全警戒活动方面的兴趣也大增。     

用于药物警戒研究的自动化医疗保健数据库简介

上市后药品的安全性分析主要依赖于自发性不良事件/不良反应报告数据库,该数据库对成本要求和人员需要相对较低,能覆盖所有的患者人群,在药物上市后即开始发挥监测作用,能发现那些罕见且临床意义重要的药物毒性。但是该系统为被动性药物监测,漏报率高,不能准确计算发生率,而且报告     

药物流行病学研究进展

药物流行病学是研究药物在广泛人群中的应用及其效应的科学,是将流行病学的方法用于临床药理学研究的科学。近年来,无论国际国内,药物流行病学在各个领域都取得了明显的发展和进步。本文介绍了药物流行病学国际国内的研究进展,同时,对该学科的研究趋势和发展方向提出预测和建议。     

药物流行病学在中药上市后安全性研究中的应用

目的：探讨药物流行病学在中药上市后安全性研究中的应用,为中药上市后的安全性研究提供参考。方法：结合药物流行病学研究方法与相关实例,概述各种研究方法的特点及在中药上市后安全性研究中的应用。结果与结论：药物流行病学的各种研究方法在中药上市后安全性研究中发挥了重要作用,其中描述性研究是药物上市后研究的起点;分析性研究可以筛选与检验病因假设;实验性研究尤其随机对照试验是评价药物疗效的金标准,但通常不能专门用于药品不良反应的确证;二次研究可用于汇总证据,强化因果关系论证的力度;多种药物流行病学的新方法,在中药上市后安全性研究中具有广阔的应用前景。应灵活运用多种药物流行病学研究方法对中药的安全性实施科学、客观的评价。     

药物流行病学及其数据库应用简介

人类应用药物已有几千年的历史，但是真正自觉地把安全性放在重要的位置，不过是近几十年的事。这是本世纪以来历次药害事件中，成千上万致残、致死惨痛教训换来的。20世纪80年代以来，由药物上市后的安全性监测研究发展形成的一门新学科——药物流行病学（Pharmacoepidemiology），是临床药理学和流行病学相互渗透形成的。目前，国际上对药物流行病学的定义描述不尽一致。1995年4月，我国首届全国药物流行病学学术会议建议将药物流行病学定义为：药物流行病学是运用流行病学的原理和方法，研究人群中药物利用及其效应的应用科学。     

药物流行病学数据库现状与前景展望

介绍了药物流行病学和数据库的定义以及它们之间的相互关系，以及药物流行病学数据库的作用、类型、现状、发展趋势和展望。     

Use of the UK General Practice Research Database for pharmacoepidemiology

The last decade has seen a surge in the use of computerized health care data for pharmacoepidemiology. Of all European databases, the General Practice Research Database (GPRD) in the UK, has been the most widely used for pharmacoepidemiological research. Since 1994, this database has belonged to the UK Department of Health, and is maintained by the Office of National Statistics (ONS). Currently, around 1500 general practitioners with a population coverage in excess of 3 million, systematically provide their computerized medical data anonymously to ONS. Validation studies of the GPRD have documented the recording of medical data into general practitioners' computers to be near to complete. The GPRD collects truly population-based data, has a size that makes it possible to follow-up large cohorts of users of specific drugs, and includes both outpatient and inpatient clinical information. The access to original medical records is excellent. Desirable improvements to the GPRD would be additional computerized information on certain variables and linkage to other health care databases. Most published studies to date have been in the area of drug safety. The General Practice Research Database has proved that valuable data can be collected in a general practice setting. The full potential of this rich computerized database has yet to come. This experience should serve to encourage others to develop similar population-based data in other countries.     

上海市不同专业医务人员药品不良反应报告质量分析

目的研究不同专业医务人员药品不良反应自愿报告情况及医务人员对药品不良反应及其报告制度的认知情况。方法收集2006年1月至2007年12月上海市药品不良反应报告数据库中医务人员的报告数据,导入ACCESS软件,用EXCEL统计分析报告情况及质量。结果本组资料中,来自医师的报告占总报告数的65．87％,高于药师（26．13％）和护士（8．00％）。根据世界卫生组织（WHO）和我国质量分级标准,医务人员ADR报告的级别99％以上达到3级,但报告的基本信息存在缺失,如病历号缺失率高于10％、联系方式高于5％。2006年,医师、药师、护士上报的新的和严重的药品不良反应分别为3．54％、4．20％、5．85％,2007年分别为5．55％、6．33％和12．28％。关联性评价中,护士的评价与市中心的评价一致比例最高。结论医务人员对药品不良反应关注的角度和报告技术要点的掌握并不一致,要提高对药品不良反应的监测效率,必须调动和发挥医务人员的积极性,持续不断地进行教育和培训。     

The Need for Nationwide Electronic Cigarette Smoking Cessation Curricula Across the Healthcare Spectrum

Using electronic nicotine delivery systems (ENDS) has become a stepping stone for smokers in their cessation of tobacco use. Students within Doctor of Pharmacy and other health care programs have expressed varying responses as to how likely they are to recommend ENDS based on their knowledge of these devices. Because the amount of education on these products provided by PharmD programs varies, one study shows student pharmacists were less likely to recommend the use of ENDS to current cigarette smokers. This commentary suggests why some student pharmacists support such recommendations and therefore require more adequate ENDS education to better equip themselves for future patient education counseling sessions.     

The role of electronic healthcare record databases in paediatric drug safety surveillance: a retrospective cohort study

Aim

Electronic healthcare record (EHR)-based surveillance systems are increasingly being developed to support early detection of safety signals. It is unknown what the power of such a system is for surveillance among children and adolescents. In this paper we provide estimates of the number and classes of drugs, and incidence rates (IRs) of events, that can be monitored in children and adolescents (0–18 years).

Methods

Data were obtained from seven population-based EHR databases in Denmark, Italy, and the Netherlands during the period 1996–2010. We estimated the number of drugs for which specific adverse events can be monitored as a function of actual drug use, minimally detectable relative risk (RR) and IRs for 10 events.

Results

The population comprised 4 838 146 individuals (25 575 132 person years (PYs)), who were prescribed 2170 drugs (1 610 631 PYs drug-exposure). Half of the total drug-exposure in PYs was covered by only 18 drugs (0.8%). For a relatively frequent event like upper gastrointestinal bleeding there were 39 drugs for which an association with a RR ≥4, if present, could be investigated. The corresponding number of drugs was eight for a rare event like anaphylactic shock.

Conclusion

Drug use in children is rare and shows little variation. The number of drugs with enough exposure to detect rare adverse events in children and adolescents within an EHR-based surveillance system such as EU-ADR is limited. Use of additional sources of paediatric drug exposure information and global collaboration are imperative in order to optimize EHR data for paediatric safety surveillance.     

药品安全“十二五”规划框架下的电子监管政策研究

目的为完善我国药品电子监管制度提出建议。方法通过系统比较中美两国药品电子监管制度的实施绩效与监管范围、流程、措施等方面的政策内容,在此基础上借鉴美国经验,结合我国实际情况提出建议。结果与结论我国应尽快完善药品电子监管制度,更好地发挥其效能,达到国家药品安全＂十二五＂规划的要求。