医疗不良事件报告体系评述

医疗不良事件报告体系对于促进患者安全、提高医疗质量具有重要作用,但各国的报告体系模式有所不同。借鉴国外报告体系的成功经验,为建立和完善适合我国国情的医疗不良事件报告体系提供理论依据。     

医疗安全不良事件报告的现状调查及影响因素分析

?????? 目的 调查医务人员参与不良事件报告的现状及主要影响因素。方法 采用分层随机整群抽样方法,调查全院24个科室321名医务人员对不良事件报告制度实施的态度、知晓及执行情况。结果 85.9%的医务人员对不良事件报告制度的实施持积极态度,但10.3%的人员不知道医院实施不良事件报告制度,近一半的人员不知道报告程序,不良事件发现率仅为31.5%,报告率为13.4%。医务人员的个人认知、医院安全文化氛围、报告系统设计是影响医务人员参与报告的重要因素。结论 提高医务人员认知程度,强化不良事件报告责任,发挥管理者的重要作用,构建医院公正的安全文化,进而提高医务人员参与不良事件报告的积极性和主动性。     

我国医疗不良事件报告系统研究与应用现状述评

Reporting of medical adverse events is an important measure to prevent recurrence of adverse events and improve the quality of medical care. Through starting with policies about medical adverse event reporting system, existing medical adverse event reporting system is summarized and analyzed, the characteristics and defects are summed up, and the prospect of improving the reporting system of adverse events is made.     

医院不良事件报告制度的实施效果探析

目的 探讨和分析不良事件报告制度在医院内部的实施效果及存在问题。方法 对医院不良事件报告制度的实施进行资料回顾和报告数据分析。结果 不良事件报告例数呈逐年递增趋势,报告事件以未造成后果事件为主,急诊、重症医学科的报告比例明显高于其他科室,护理人员的报告比例相对较高。结论 不良事件报告对医院风险防范和医疗系统改进具有重要作用。     

医疗不良事件和病人安全隐患报告系统的构建

通过介绍北京协和医院进行医疗不良事件和病人安全隐患事件报告系统工作实务,论述了在大型综合医院如何结合具体实际情况,探索有效的病人安全实践措施,旨在对医疗机构进行医疗不良事件报告系统和制度的建立、正常运行和完善有所借鉴。     

综合医院医疗不良事件报告的障碍因素以及改进策略分析

????? 医疗不良事件的分析总结对保证医疗质量起着促进作用,而医疗不良事件的报告存在着许多障碍因素。通过调查湖北省、江苏省、浙江省12家医院的医疗不良事件的报告情况,分析阻碍医疗不良事件报告的原因,并提出相应建议。

     

手术室非惩罚性护理不良事件报告制度的建立

手术室护理不良事件发生率影响因素较多,建立非惩罚性护理不良事件报告制度是非常有效的控制不良事件的方法。通过在本院手术室建立非惩罚性护理不良事件报告制度,对上报的护理不良事件分析发生的根本原因并提出修正方案及预防措施,提升护理质量,完善护理流程及管理制度。     

上海市医疗安全监控系统研究框架

大量的研究显示国内外病人安全面临着严峻的挑战，为此上海市卫生监督所与复旦大学公共卫生学院于2006年开展了医疗安全监控系统的研究，在前期课题研究的基础上，将进一步对课题研究背景和意义、研究目标、研究方法、资料来源、质量控制和统计工具作详细介绍。     

可疑医疗器械不良事件上报管理的实践探索

PDCA循环圈理念是广泛应用于质量管理的科学管理工具。运用其管理理念,通过对医院医疗器械不良事件上报工作联络员的知识、态度、行为等情况进行调查,了解医院工作现状及存在的问题,制定干预措施;干预后再次进行评价。旨在提高医院可疑医疗器械不良事件上报管理工作的质量。     

Torsadogenic Risk of Antipsychotics: Combining Adverse Event Reports with Drug Utilization Data across Europe

Background

Antipsychotics (APs) have been associated with risk of torsade de Pointes (TdP). This has important public health implications. Therefore, (a) we exploited the public FDA Adverse Event Reporting System (FAERS) to characterize their torsadogenic profile; (b) we collected drug utilization data from 12 European Countries to assess the population exposure over the 2005-2010 period.

Methods

FAERS data (2004-2010) were analyzed based on the following criteria: (1) ≥4 cases of TdP/QT abnormalities; (2) Significant Reporting Odds Ratio, ROR [Lower Limit of the 95% confidence interval>1], for TdP/QT abnormalities, adjusted and stratified (Arizona CERT drugs as effect modifiers); (3) ≥4 cases of ventricular arrhythmia/sudden cardiac death (VA/SCD); (4) Significant ROR for VA/SCD; (5) Significant ROR, combined by aggregating TdP/QT abnormalities with VA and SCD. Torsadogenic signals were characterized in terms of signal strength: from Group A (very strong torsadogenic signal: all criteria fulfilled) to group E (unclear/uncertain signal: only 2/5 criteria). Consumption data were retrieved from 12 European Countries and expressed as defined daily doses per 1,000 inhabitants per day (DID).

Results

Thirty-five antipsychotics met at least one criterium: 9 agents were classified in Group A (amisulpride, chlorpromazine, clozapine, cyamemazine, haloperidol, olanzapine, quetiapine, risperidone, ziprasidone). In 2010, the overall exposure to antipsychotics varied from 5.94 DID (Estonia) to 13.99 (France, 2009). Considerable increment of Group A agents was found in several Countries (+3.47 in France): the exposure to olanzapine increased across all Countries (+1.84 in France) and peaked 2.96 in Norway; cyamemazine was typically used only in France (2.81 in 2009). Among Group B drugs, levomepromazine peaked 3.78 (Serbia); fluphenazine 1.61 (Slovenia).

Conclusions

This parallel approach through spontaneous reporting and drug utilization analyses highlighted drug- and Country-specific scenarios requiring potential regulatory consideration: levomepromazine (Serbia), fluphenazine (Slovenia), olanzapine (across Europe), cyamemazine (France). This synergy should be encouraged to support future pharmacovigilance activities.     

Adverse Drug Reaction Reporting Program of the Ontario Medical Association: the first 3 years.

This paper describes the Adverse Drug Reaction Reporting Program developed and operated by the Committee on Drugs and Pharmaco-therapy of the Ontario Medical Association. Analyses were done to demonstrate some of the trends derived from the reports. Some of the clinical observations based on the reports, which are published quarterly and circulated to physicians and to pharmacy, nursing and hospital organizations, are also reviewed.