药品不良反应简报系统软件及应用

目的利用计算机、网络技术开展药品不良反应(ADR)监测。方法设计药品不良反应临床简报系统软件,利用简报系统监测药品不良反应具有方便快捷、效率高等优点。结果药品不良反应上报率明显增加。结论医院加强ADR监测工作有助于提高医疗质量和安全合理用药。     

开展药品不良反应监测的意义

目的 为了积极推动药品不良反应监测工作，保障广大人民群众用药安全性。方法通过查阅有关资料，分析药品不良反应的危害性，制订相应防范措施，依照有关法规开展了药品不良反应监测。结果 药品不良反应监测提高了广大医务工作者对药品不良反应的认知，促进了临床正确合理用药，药品生产和经营企业增强了对防范药品安全性隐患的高度责任意识，积极开展药品不良反应信息的收集和报告工作，以及药品上市后的安全性评价工作。结论 开展药品不良反应监测对保证患者用药安全性起了积极的作用，具有重要的意义。     

健康医疗大数据研究热点与前沿的可视化分析

目的梳理健康医疗大数据领域相关文献并进行可视化分析,为开展进一步研究提供参考。方法以Web of Science核心合集为数据源,利用VOSviewer对关键词进行共现聚类,采用Citespace探测研究前沿。结果共检索到相关文献2 818篇。聚类分析得到5个研究主题,分别为健康医疗大数据技术研究、在精准医学及靶向治疗中的应用、在疾病危险因素识别及监测中的应用、电子健康记录相关研究、健康医疗大数据发展面临的挑战。研究前沿包括健康医疗大数据管理、数据挖掘、生物信息学、患者安全与隐私问题,以及疾病监测等。结论我国应追踪该领域研究热点与前沿,采取一定措施促进国内健康医疗大数据研究的进一步发展。     

基于电子病历的ADR知识发现与应用模型研究

利用电子病历数据提高药品不良反应(ADR)的主动监测水平,为药品上市后的安全监测和个性化预警服务提供可借鉴的方法。首先提出了基于电子病历的ADR知识发现与应用模型的总体框架,然后分别对模型中涉及的基本要素和信息活动进行详细的解释和阐述;最后以痰热清注射液为例,运用DIKW层级体系探讨引起疚热清注射液疑似过敏反应的影响因素,揭示了药物不良反应“数据一信息一知识一智慧”信息链中的信息活动规律,为药品不良反应的研究与管理提供决策支持。     

开展药品不良反应监测的意义

目的为了积极推动药品不良反应监测工作,保障广大人民群众用药安全性。方法通过查阅有关资料,分析药品不良反应的危害性,制订相应防范措施,依照有关法规开展了药品不良反应监测。结果药品不良反应监测提高了广大医务工作者对药品不良反应的认知,促进了临床正确合理用药,药品生产和经营企业增强了对防范药品安全性隐患的高度责任意识,积极开展药品不良反应信息的收集和报告工作,以及药品上市后的安全性评价工作。结论开展药品不良反应监测对保证患者用药安全性起了积极的作用,具有重要的意义。     

医院药品质量管理工作的几点体会

药品质量是医院生存的命脉，医院必须保证所用药品的质量，确保医疗安全、有效，所以加强药品管理工作的有效性和科学性是非常必要的。如何贯彻执行《药品管理法》，有效和科学地开展药品管理工作，根据几年来我们的药品质量管理工作的实际体会，谈几点看法。     

基于电子病历的医疗质量控制与安全管理策略

电子病历是临床信息的集成平台,可以提供完整、安全、可交换、可挖掘的临床信息源,同时也可以改变传统的医疗质量监控与安全管理方式,提高质量和安全管理水平.介绍了基于电子病历的医疗质量控制与安全管理的一系列策略,主要包括数字化医疗质量监控管理平台、单病种临床路径管理系统、合理用药监测与处方点评系统、医疗过程控制与任务管理、危急值提醒与医疗安全警示、院内感染管理系统、重症病人监护管理系统、基于电子病历的无线移动技术和物联网技术的应用等.     

疫苗上市后安全性的准实时主动监测

疫苗上市后安全性监测是及时发现风险信号以确保疫苗安全的必要措施,包括被动监测与主动监测。其中,主动监测能够全面、持续的收集免疫接种后不良事件,及时发现并验证疫苗安全性信号,已经成为未来上市后安全性监测的主要发展趋势。随着信息时代的到来,主动监测可通过纵向链接多源电子医疗数据库开展分析,数据的快速传输与定期更新,使得接近实时的发现疫苗安全性信号成为可能,这种主动、及时、快速识别免疫接种后不良事件的准实时主动监测方法逐渐在国际上兴起。本文通过梳理既往文献,对目前疫苗准实时主动监测的发展现状与方法学原理进行综述,以期为我国开展疫苗安全性的准实时主动监测提供借鉴。     

国际医疗器械安全性信息适时监测和分析研究

本课题是上海市食品药品安全研究中心、上海市药品不良反应监测中心接受国家药品不良反应监测中心、国家食品药品监督管理局药品评价中心委托开展的“全球医疗器械安全性信息适时监测和分析”研究。旨在通过研究国外,特别是欧美发达国家医疗器械监管部门发布的医疗器械召回、医疗器械警戒等信息,借鉴这些发达国家在医疗器械安全性信息监测方面的经验,为我国医疗器械的安全性监测、安全评价、医疗器械警戒以及风险管理等提供相关的参考数据,推动我国上市后医疗器械监管水平的提高。     

药剂科药品不良反应监测管理问题与对策

随着新医改的不断深入和药品行业的持续发展,关于药品使用的医疗事故屡有发生,药品的安全使用和管理不断引起广泛的关注和重视。因此加强药品安全监测管理,促进合理用药成为医疗工作的关键。而药剂科作为为医疗机构负责药品供应工作的部门,同时也对药品不良反应有监测管理责任和义务。本文结合药剂科药品不良反应监测管理中存在的问题,对药剂科药品不良反应监测管理提出相应对策。     

Simulation study comparing exposure matching with regression adjustment in an observational safety setting with group sequential monitoring

Sequential methods are well established for randomized clinical trials (RCTs), and their use in observational settings has increased with the development of national vaccine and drug safety surveillance systems that monitor large healthcare databases. Observational safety monitoring requires that sequential testing methods be better equipped to incorporate confounder adjustment and accommodate rare adverse events. New methods designed specifically for observational surveillance include a group sequential likelihood ratio test that uses exposure matching and generalized estimating equations approach that involves regression adjustment. However, little is known about the statistical performance of these methods or how they compare to RCT methods in both observational and rare outcome settings. We conducted a simulation study to determine the type I error, power and time‐to‐surveillance‐end of group sequential likelihood ratio test, generalized estimating equations and RCT methods that construct group sequential Lan–DeMets boundaries using data from a matched (group sequential Lan–DeMets‐matching) or unmatched regression (group sequential Lan–DeMets‐regression) setting. We also compared the methods using data from a multisite vaccine safety study. All methods had acceptable type I error, but regression methods were more powerful, faster at detecting true safety signals and less prone to implementation difficulties with rare events than exposure matching methods. Method performance also depended on the distribution of information and extent of confounding by site. Our results suggest that choice of sequential method, especially the confounder control strategy, is critical in rare event observational settings. These findings provide guidance for choosing methods in this context and, in particular, suggest caution when conducting exposure matching. Copyright © 2014 John Wiley & Sons, Ltd.     

Pharmacoepidemiological perspectives.

Parallel with increasing concerns about drug safety, the importance of drug surveillance and the application of epidemiologic techniques have grown rapidly during the past decades. The increasing use of computerized health care data facilitates the establishment of populations large enough (millions) to allow epidemiological studies. Such extensive studies are now being done routinely in North America. By the use of computerized pharmacy or billing records, drug exposure is linked to files which include diagnoses. These record-linkage systems provide "objective" drug histories for pharmacoepidemiological cohort and case-control studies and these large databases offer powerful tools for drug evaluation. A number of new drug-disease associations, many of potential importance for European populations, will be discovered through the increased use of large databases in North America. The European community needs to develop a strategy to respond to these overseas findings to protect society from either overreaction or underreaction to drug safety issues.     

PMD17 Surveillance of a New Drug in the United Kingdom

Reports of adverse events often surface shortly after a new drug is introduced and in many cases provoke governmental regulatory action. Deaths pose a particular challenge, because drug takers may have excess mortality risk relative to nontakers for reasons unrelated to drug use. Aside from the implications for safety surveillance, a spurious association between drug use and mortality also can confound economic comparisons based on drug use.
OBJECTIVE: To investigate, at the request of the U.K. Medicines Control Agency, safety and health-care resource utilization related to use of a new drug.
METHODS: A postmarketing surveillance program was implemented at major medical schools in England and Scotland to monitor mortality, morbidity, and healthcare resource utilization associated with use of a new drug for treating gastrointestinal conditions. The study employs a longitudinal design that identified 18,000 drug takers through automated pharmacy listings at 700+ general practitioner offices located within a one-hour drive from the medical schools. In addition to drug taking patterns and adverse event occurrences, use of ambulatory and hospital health-care resources is recorded. Instead of employing a reference group of nontakers, national death rates will serve as "historical controls."
RESULTS: Morbidity and mortality experience among drug takers will be assessed by reviewing whether incidents occurred concomitantly with use of the medicine, by examining relationships with dose and duration of use, and other evidence to establish "biologic plausibility." These experiences will be related in turn to selected measures of health-care resource utilization.
CONCLUSION: This study provides a useful template for future research to establish the safety and health care resource utilization profiles of a new drug.     

Role of Pharmacovigilance in India: An overview

Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human. Pharmaceutical and biotechnological medicines are designed to cure, prevent or treat diseases; however, there are also risks particularly adverse drug reactions (ADRs) can cause serious harm to patients. Thus, for safety medication ADRs monitoring required for each medicine throughout its life cycle, during development of drug such as pre-marketing including early stages of drug design, clinical trials, and post-marketing surveillance. PV is concerns with the detection, assessment, understanding and prevention of ADRs. Pharmacogenetics and pharmacogenomics are an indispensable part of the clinical research. Variation in the human genome is a cause of variable response to drugs and susceptibility to diseases are determined, which is important for early drug discovery to PV. Moreover, PV has traditionally involved in mining spontaneous reports submitted to national surveillance systems. The research focus is shifting toward the use of data generated from platforms outside the conventional framework such as electronic medical records, biomedical literature, and patient-reported data in health forums. The emerging trend in PV is to link premarketing data with human safety information observed in the post-marketing phase. The PV system team obtains valuable additional information, building up the scientific data contained in the original report and making it more informative. This necessitates an utmost requirement for effective regulations of the drug approval process and conscious pre and post approval vigilance of the undesired effects, especially in India. Adverse events reported by PV system potentially benefit to the community due to their proximity to both population and public health practitioners, in terms of language and knowledge, enables easy contact with reporters by electronically. Hence, PV helps to the patients get well and to manage optimally or ideally, avoid illness is a collective responsibility of industry, drug regulators, clinicians and other healthcare professionals to enhance their contribution to public health. This review summarized objectives and methodologies used in PV with critical overview of existing PV in India, challenges to overcome and future prospects with respect to Indian context.     

Evaluating the safety of medicines, with particular reference to contraception.

Toxicological studies and clinical trials cannot be expected to predict all important adverse effects of medicines and contraceptives. Post-marketing surveillance is essentially an epidemiological task that involves detecting associations between drugs and events. The first alerts about drug safety problems have often come from case reports, but epidemiological studies are needed to confirm adverse (or beneficial) effects and to provide quantitative information. This article illustrates methodological principles by considering three examples from the field of contraceptive safety: oral contraceptives and breast cancer, intrauterine contraception and pelvic inflammatory disease, and newer oral contraceptives and venous thromboembolism. Key issues that emerge include bias and confounding, the place of subgroup analyses, random error, and the use of computerized databases. In research on contraceptive and drug safety, conclusions usually need to be based on careful assessment of multiple observational studies.     

Use of larger versus smaller drug-safety databases before regulatory approval: the trade-offs

Although efforts to revamp the drug-safety system have been directed at strengthening postmarketing surveillance, strategies for the preapproval stage may be useful. One strategy would be to require larger sample sizes in preapproval safety databases. To evaluate the potential benefits and costs of this approach, we developed a hypothetical model to estimate the expected incremental number of adverse drug events that could be avoided in a postapproval population. We found that the potential to limit adverse events can be an important consideration in sample-size determinations for preapproval trials. Requiring larger preapproval databases could be a cost-effective means of reducing adverse events in postapproval populations.     

Comparison of hospital databases on antibiotic consumption in France,for a single management tool

Context

The surveillance of antibiotic use in hospitals and of data on resistance is an essential measure for antibiotic stewardship. There are 3 national systems in France to collect data on antibiotic use: DREES, ICATB, and ATB RAISIN. We compared these databases and drafted recommendations for the creation of an optimized database of information on antibiotic use, available to all concerned personnel: healthcare authorities, healthcare facilities, and healthcare professionals.

Methodology

We processed and analyzed the 3 databases (2008 data), and surveyed users.

Results

The qualitative analysis demonstrated major discrepancies in terms of objectives, healthcare facilities, participation rate, units of consumption, conditions for collection, consolidation, and control of data, and delay before availability of results. The quantitative analysis revealed that the consumption data for a given healthcare facility differed from one database to another, challenging the reliability of data collection. We specified user expectations: to compare consumption and resistance data, to carry out benchmarking, to obtain data on the prescribing habits in healthcare units, or to help understand results.

Conclusions

The study results demonstrated the need for a reliable, single, and automated tool to manage data on antibiotic consumption compared with resistance data on several levels (national, regional, healthcare facility, healthcare units), providing rapid local feedback and educational benchmarking.     

A comprehensive approach to percutaneous injury prevention during phlebotomy: results of a multicenter study, 1993-1995.

OBJECTIVE: To examine a comprehensive approach for preventing percutaneous injuries associated with phlebotomy procedures. DESIGN AND SETTING: From 1993 through 1995, personnel at 10 university-affiliated hospitals enhanced surveillance and assessed underreporting of percutaneous injuries; selected, implemented, and evaluated the efficacy of phlebotomy devices with safety features (ie, engineered sharps injury prevention devices [ESIPDs]); and assessed healthcare worker satisfaction with ESIPDs. Investigators also evaluated the preventability of a subset of percutaneous injuries and conducted an audit of sharps disposal containers to quantify activation rates for devices with safety features. RESULTS: The three selected phlebotomy devices with safety features reduced percutaneous injury rates compared with conventional devices. Activation rates varied according to ease of use, healthcare worker preference for ESIPDs, perceived "patient adverse events," and device-specific training. CONCLUSIONS: Device-specific features and healthcare worker training and involvement in the selection of ESIPDs affect the activation rates for ESIPDs and therefore their efficacy. The implementation of ESIPDs is a useful measure in a comprehensive program to reduce percutaneous injuries associated with phlebotomy procedures.