论药品不良反应监测信息与科学决策

药品不良反应信息报告在医院安全用药决策中的作用越来越受到重视。通过药品不良反应监测,更好地提高医院安全用药决策成为各家医院的共同做法。通过药品不良反应信息报告在医院安全用药决策中的作用进行阐述,为加强医院药品不良反应监测工作提供借鉴。     

药品不良反应监测工作初探

药品不良反应监测是药品监督管理的科学依据，是百姓用药的重要屏障。为提高全县药品不良反应报告和监测工作水平，做好信息收集工作，我局在县级药品不良反应监测工作开展方面进行了探索。     

我院药品不良反应报告信息利用分析

目的提高医院药品不良反应(ADR)信息利用能力。方法分析医院药品不良反应信息利用情况,探讨影响药品不良反应信息利用的因素。结果与结论药品不良反应报告的质量影响分析其信息利用。医疗机构加强药品不良反应监测工作,并有医生、护士、药师等密切配合,才能做好药品不良反应信息分析工作,从而促进临床安全用药。     

医院药品不良反应监测模式的探讨

药品不良反应监测是医院药学的重要组成部分。对医院药品不良反应监测工作模式进行探讨，以完善医院药品不良反应监测组织体系，推动医院药品不良反应监测工作的深入开展。     

关爱生命珍惜健康

浅谈我院3年来药品不良反应监测工作的体会,强调药品不良反应监测工作的重要性和有针对性地开展监测工作,为医院合理用药、安全用药提供信息,促进医院的整体用药水平.     

某院2009年药品不良反应报表分析

目的分析2009年丹东市第一医院药品不良反应报表申报情况。方法根据2009年丹东市第一医院收集、上报的药品不良反应报表数,按照患者性别、年龄、药品类型、不良反应涉及系统等进行统计分析。结果男女病例数比为1∶1,抗感染类药物引起的ADR占40.5%。皮肤系统的损伤最为常见,共20例;药品经注射给药造成的ADR较多,为75%。结论药品不良反应监测工作在丹东市第一医院仍未全面展开。广大医务工作者在提高对药品不良反应认知的基础上,结合临床用药的品种、剂量、疗程及特殊人群用药,更加积极地开展药品不良反应信息的收集和报告工作,督促临床合理用药。     

加强药品不良反应监测力度，拓宽监测网络，夯实工作基础

近年来,药品安全问题已经成为社会关注的焦点.而药品不良反应(ADR)监测工作是收集药品不良反应/不良事件信息的主要来源,是食品药品监督管理体系的重要组成部分;同时,药品不良反应监测是药品上市后再评价的主要途径,也是确保药品安全、保障公众健康的主要手段.     

药品不良反应信息通报(第4期)

<正> 根据《中华人民共和国药品管理法》、《药品不良反应监测管理办法(试行)》的规定,为进一步加强药品不良反应监测工作,及时反馈收集到药品安全隐患的信息,经国家食品药品监督管理局批准,国家药品不良反应监测中心负责不定期     

利用信息技术开展临床药学服务

针对新形势下医院药学工作发展的要求,借助医院网络平台,引进和开发适合本院特色的药学服务软件,帮助药师收集、整理各类药品信息,开展如药物咨询、治疗药物监测、药物不良反应监测等多种形式的药学服务,为药学人员与医护人员之间提供信息交流平台,促进临床安全、有效、合理、经济的使用药品,以提高药学服务的整体水平。     

浅谈医院如何开展药品不良反应监测

我国药品不良反应病例报告数据近90％来源于医疗卫生机构,但目前,我国医院药品不良反应监测工作并没有统一模式,各家医院多根据相关法规要求制定监测工作方案,开展监测工作。通过从医院开展药品不良反应监测工作的优势、监测模式及存在问题等方面探讨医院药品不良反应监测工作,以期为相关从业人员提供参考。     

我院药品不良反应监测网络系统的建设与应用

目的：弥补国家级药品监测系统的不足,正确指导医生临床合理用药,提高医院药品不良反应（ADR）监测工作的质量和效率,减轻患者经济负担。方法：在医院局域网基础上,采用异步JavaScript和XML（AJAX）前台开发模式,运用ASP.NET编程语言、数据库（SQL Server）等主流的计算机技术,开发基于医院局域网的ADR监测系统。结果：与系统应用前比较,系统具备同时跟踪国家已披露信息、医院已上报未披露信息以及未上报信息等3个层次的ADR报告,并集成医院已有的医院信息管理（HIS）系统,功能明显增强。同时ADR报告数量明显增加,工作效率明显提高。结论 ：该系统实现了医院ADR报告实时性与网络化管理,提高了ADR报告水平,值得推广。     

Program coordinated by a drug information service to improve adverse drug reaction reporting in a hospital

A program coordinated by a drug information service to improve adverse drug reaction (ADR) reporting in a hospital is described. At a 520-bed teaching hospital, the drug information service was asked to design a new adverse drug reaction reporting system that would encourage clinicians to report ADRs. A new system was implemented on a general medical unit: A physician, pharmacist, or nurse telephoned the drug information service when an adverse drug reaction was suspected, and drug information personnel followed up on the report, completing all subsequent investigation and documentation. A standard algorithm was used to evaluate causality of the reported reactions. Pertinent data were entered on a form and retained in the drug information service. The primary physician's approval was obtained before a reaction could be reported on an FDA drug-experience form. Drug information service personnel reviewed the ADR data monthly to detect any trends that clinicians should be aware of and to prepare a report for the pharmacy and therapeutics committee. Nurses, physicians, and pharmacy personnel were oriented to the new system before its implementation and were subsequently informed about reported ADRs and use of the system through newsletters and meetings. In the initial three-month period, 23 ADRs involving 19 drugs were reported from the medical unit; in a six-month period before development of the new system, no ADRs had been reported. This ADR reporting system developed and implemented by the drug information service was effective in improving reporting of adverse drug reactions.     

药师在我院药品安全性监测中的作用

目的探讨药师在医院药品不良反应(ADR)监测和药品安全警戒中的责任和作用。方法采集医院2006年至2009年的药品不良反应报表数据、合理用药监测(PASS)软件审查数据和处方评价数据,并进行汇总分析。结果医院药品不良反应报表数量和质量呈逐年上升趋势,上报形式得到改进,医院对此项工作的重视程度提高,及时发布药物警戒信息,有效预防了药品不良事件的发生,提高了临床医师合理用药水平。结论药师应发挥更大的作用,有效促进药品安全监测工作的开展,推动医院的安全合理用药。     

我院药品不良反应报告的回顾性分析

目的分析评价我院药品不良反应（ADR）呈报的基本情况和填报质量，为深入开展ADR监测工作及合理用药提供参考。方法从广东省ADR监测中心数据库下载我院上报且省中心已做出评价的ADR报告表，进行患者年龄、性别、药品类别、ADR过程描述、关联评价统计、分析。结果360份ADR报告涉及的药品有16类共98种药品，其中抗微生物药品31种和中药制剂13种，位居前列（依次为203例、28例）。ADR所累及的器官、系统主要为皮肤及其附件（63％），其次为消化系统（21％）。绝大多数ADR的转归良好。静脉给药导致的ADR例数为235例（65％）；新的、严重的不良反应上报较少；报告质量有待提高。结论应强化培训工作，增强ADR呈报意识和责任感，以提高ADR报告质量。     

213例药物不良反应回顾性分析

目的了解本院药品不良反应(ADR)现状及发生ADR相关信息,以引起医务人员重视ADR,促进临床合理用药。方法收集本院2010～2011年度ADR213例报告信息,按来源、报告类型、药品类别、按给药途径、患者性别、年龄、涉及器官或系统进行分类统计和分析。结果给药途径以静脉用药为主;ADR的临床表现以皮肤及其附件损害最常见。结论应加强合理用药及ADR监测,减少甚至避免ADR的发生,最终达到安全有效的用药。     

Pharmacy-coordinated program that encourages physician reporting of adverse drug reactions

A pharmacy-coordinated program for encouraging physician reporting of adverse drug reactions (ADRs) is described. The ADR surveillance program at the Medical Center Hospital of Vermont, a 500-bed tertiary-care hospital, is in its fifth year. Key elements are close interaction between physicians and pharmacists, feedback, program promotion, and financial incentive. The program is promoted chiefly to house staff physicians. A physician may identify a suspected ADR, or he or she may be alerted by a pharmacist. The physician completes the first part of a form, which requests information on the patient, the severity of the reaction, the actions taken, and any predisposing factors. A pharmacist reviews the incident independently and in consultation with the reporter and then completes the second part of the form, which asks the pharmacists to assess the probability that the drug caused the ADR and to classify the reaction. A summary is sent to the physician and may be reported to the FDA and the manufacturer. Each report earns the reporter a $5 stipend. Information from the ADR forms is entered into a dBASEIII PLUS computer program for later retrieval and analysis. During a 12-month period, 175 ADR reports (out of a total of 249 reports) were received from house staff members, compared with about 4 voluntary reports received annually before the program began. The ADR surveillance program has increased physician reporting of ADRs and produced a reliable database that can be used to influence hospital policy and promote education.     

我院2006年至2007年药品不良反应报告分析

目的了解我院2006至2007年药品不良反应的总体情况、分析原因,促进临床合理用药,减少ADR发生。方法对我院2006年至2007年记录的77例ADR数据进行列表,作回顾性分析。结果我院抗感染用药的ADR为59.74%;中成药ADR为22.28%;循环系统用药ADR10.39%。ADR的症状以皮肤及其附件损害为主占45.45%;其次为消化系统损害的ADR占28.57%,严重的ADR3例;缺少与生化指标有关的ADR报告;各种给药途径中以静脉给药发生的ADR最高占59.74%。结论强化药物使用的监督与管理制度,减少多药联用比例;合理选用给药方式;重视用药前病史、用药史的查询及用药后的药学服务;完善药物ADR监测的制度,医、护、药三方共同努力可减少我院药物ADR的发生。     

基层药品不良反应监测报告现状及评价难点分析

目的 完善药品不良反应(ADR)报告内容,为药品不良事件的准确评价提供依据.方法 对基层ADR报告内容进行梳理分析.结果 大量不良反应报告录入信息不完备、使用剂量和给药方法不规范、药品说明书查询比对不到位,给不良事件的认定和评价造成很大困难.结论 完善ADR报告表的栏目,增加必须填写的内容,建立规范的药品说明书快捷查询系统,加大培训力度,提升基层监测评价人员的水平.     

A survey on factors that could affect adverse drug reaction reporting according to hospital pharmacists in Great Britain.

INTRODUCTION: Since April 1997, UK hospital pharmacists have been invited to submit reports of suspected adverse drug reactions (ADRs) to the Committee on Safety of Medicines (CSM) and Medicines Control Agency. Three studies have investigated the involvement of hospital pharmacists in ADR reporting; however, they did not investigate the possible factors that could affect ADR reporting. OBJECTIVES: (i) To analyse the extent to which hospital pharmacists think that specified factors could affect reporting ADRs; (ii) to identify any additional factors that could hinder reporting; and (iii) to recommend possible methods to improve reporting. METHODS: Piloted questionnaires were sent to 548 hospital pharmacists in Great Britain randomly selected by the Royal Pharmaceutical Society of Great Britain (RPSGB) from their computer database. 346 questionnaires were returned and 280 were included in this study. RESULTS: 46% of the pharmacists had identified ADRs that were considered to be reportable according to the CSM criteria in the 6 months prior to the survey. 39% did not report these ADRs either to the CSM or the manufacturers. Only 8.2% reported that their hospitals had a written policy; conversely, 73.7% agreed that such a policy could enhance ADR reporting. Although not statistically significant, the result showed an increasing tendency to report ADRs by pharmacists who had received training. Furthermore, there was an increasing tendency to report ADRs with increasing seniority. DISCUSSION: The results show that hospital pharmacists say they are more likely to report serious and rare ADRs and ADRs associated with newly marketed drugs. Factors that could reduce ADR reporting included being busy at work, lack of confidence in recognising ADRs and the fear of breaching patient confidentiality. Most common suggestions on methods to improve ADR reporting were to provide ADR training and meetings (34%) and a hospital written policy (24%). RECOMMENDATIONS: ADR training and meetings would be a useful step in improving hospital pharmacist ADR reporting. Therefore, we recommend that the CSM and the RPSGB liaise with regional drug information centres and schools of pharmacy to provide more study days and training programmes for hospital pharmacists. Furthermore, the CSM should write to the 'Drugs and Therapeutics Committee' of each hospital and encourage them to develop a written local policy for pharmacist ADR reporting. Further studies should be conducted to test the recommendations noted here, assessing the response of the pharmacists in terms of absolute numbers of reports made. It would be particularly interesting to study the need for a written hospital policy and education.     

我院近3年药品不良反应报告表质量分析

目的分析评估我院近3年来药品不良反应(adverse drug reactions,ADR)报告质量状况。方法根据《药品不良反应报告和监测管理办法》及"药品不良反应/事件报告表"规范分级标准,对我院512份ADR报告质量进行分析,包括报表的规范性、完整性、加分项的正确率分析,同时对ADR的上报科室和上报类型进行了统计。结果我院ADR报告表数量逐年上升,报表的完整性和规范性亦呈逐年上升趋势,主要是一般的不良反应,但总体报告表的质量仍偏低,主要体现在完整性不高。且ADR报表大部分由所在科室的临床药师上报,主要集中于抗生素和中成药注射液。结论 ADR上报应提高规范性、完整性及正确率。发挥临床药师的专业优势是提高ADR报告表质量的一个重要因素。