全面触发工具在肾移植受者免疫抑制药品不良事件监测中的运用

目的 运用全面触发工具(global trigger tool,GTT)初步建立新疆某医院肾移植受者免疫抑制药品不良事件(adverse drug events,ADE)的主动监测模型.方法 采用触发器进行回顾性审查病例324份,对病例中ADE及其分类、分级进行判定,并采用Logistic分析探讨与ADE发生可能相关的...     

全面触发工具在老年住院患者药品不良事件监测中的研究

目的 验证全面触发工具(global trigger tool,GTT)在老年住院患者药品不良事件(adverse drug event,ADE)监测中的可行性.方法 根据《IHI global trigger tool for measuring adverse events》中推荐的触发器和国内其他研究使用的触发器...     

ADE触发工具在药品不良事件监测中的应用

目的：探索ADE触发工具在医院药品不良事件（ADE）监测中的应用。方法：根据医疗保健研究所（IHI）推出的ADE触发工具及医院具体用药情况,选择19项触发器。自医院电子病历系统随机抽取2015年第三季度出院病历共967份（肿瘤患者和18岁以下患者除外）,回顾性研究患者的用药情况、检验检查指标及病程记录,对触发器显示阳性的患者进行ADE判定和分析,并进行数据统计和分析,评估各触发器信号与ADE发生的相关性。结果：967位患者中触发器阳性者达到417例次,涉及319位患者,确定33位患者发生ADE,ADE检出率为10.34%（33/319）。33例ADE中E级ADE为31例,F级为2例。同时间段医院ADE自愿上报率为0.67%（147/21897）,与经触发器检出的ADE发生率相比,有统计学差异;且在医院ADE自愿上报系统中未检查到此33例ADE患者信息。结论：ADE触发工具对发现ADE具有较强的敏感性,与自愿上报系统相比,可发现更多的ADE,但触发器需要进一步修正。     

全面触发工具回顾性监测与自愿上报的药品不良事件比较

摘 要比较应用美国健康促进研究所推出的全面触发工具（GTT）主动监测药品不良事件（ADE）与采用自愿报告系统上报的ADE,为更好地应用两种监测方法预防和减少药品不良事件提供参考。方法：回顾性分析某院2014年应用GTT监测的成年住院患者的ADE与同期医院自愿报告的ADE的特点。结果：自愿上报ADE的可预防率为4.08%,GTT监测为18.75%。ADE相关患者中内科明显多于外科。自愿上报ADE中E级为主,且有F级、H级事件,GTT监测的ADE中E级与F级事件较多。ADE涉及的给药途径以静滴、口服和皮下给药为主,涉及的药品中频率最高的是中药、抗肿瘤药和胰岛素。结论：GTT监测与自愿上报两种方法监测到的ADE类型有一定互补性,建议医疗机构同时应用两种方法,以更好地预防和减少ADE的发生。     

全面触发工具用于住院儿童药品不良事件主动监测

目的采用全面触发工具(GTT)建立儿童住院患者药品不良事件(ADE)的主动监测方法,评价住院患儿的ADE发生情况。方法用专家咨询法建立儿童ADE触发器,采用等距随机抽样方法抽取本院2014年10月至2015年9月住院患儿归档病历600份,按GTT法进行回顾性病历审查。对触发器阳性所涉及情况进一步审查以确定或排除ADE,审查中发现的无触发器阳性但确定发生的ADE一并记录。所有ADE进行严重程度分级、类型分布及相关药物分析,计算ADE检出率及触发器阳性预测值(PPV)等。结果最终纳入587例病历,共检出119例患儿共计159例次ADE。GTT检出105例患儿共计120例次ADE,检出率17.9%(105/587),无触发器阳性但确定为ADE的39例次。建立的36项触发器,实际应用中有26项呈阳性(72%);触发器总阳性频次905次,检出ADE的有143次,触发器PPV 15.8%(143/905)。159例次ADE中暂时性伤害占98.7%(E级77.4%、F级20.8%),最常累及胃肠系统,相关药物以抗菌药物为主(36.9%)。结论 GTT对儿童ADE的监测及评价具有积极作用,但尚需进一步改进。     

全面触发工具对住院患者药品不良事件检出率影响的系统评价

摘要：目的:系统评价全面触发工具(GTT)与自愿呈报系统(VRNS)对住院患者药品不良事件(ADE)检出率影响。方法:计算机检索PubMed、Embase、the Cochrane Library(2019年第8期)、SinoMed、CNKI、WanFang Data和VIP数据库,搜集同时采用GTT对住院患者进行ADE主动监测和VRNS进行监测的回顾性队列研究,检索时限均为从建库至2019年8月。由两名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.3软件进行Meta分析。结果:共纳入17项研究,共计144 740例患者。Meta分析结果显示:①成年住院患者中,GTT组ADE检出率相较VRNS组明显增加,差异有统计学意义[RR=7.80,95%CI(2.89,21.03),P<0.000 1];②儿童住院患者中,相比VRNS组,GTT组ADE检出率明显增加[RR=5.66,95%CI(1.96,16.38),P=0.001];③ICU住院患者中,GTT组ADE检出率高于VRNS组,差异有统计学意义[RR=5.28,95%CI(4.12,6.76),P<0.000 01]。结论:当前证据表明,与VRNS相比,GTT在住院患者中的应用能够明显提高成年、儿童与ICU患者的ADE检出率,通过主动监测帮助医生及早地发现与处理可疑的安全事件,降低患者病死率与风险。受纳入研究数量和质量的限制,上述结论尚需开展更多高质量研究予以验证。     

全面触发工具在药品不良事件检测中的应用初探

目的：探讨全面触发工具（ GTT）在我国医疗机构检测药品不良事件（ ADE）的可行性。方法调取1013年1月1日至11月31日首都医科大学宣武医院出院患者的信息,按照出院时间排序后,使用Microsoft Excel 1007软件中的随机抽样工具,每半个月随机抽取30例患者的病历。根据入选标准（患者年龄≥18岁,1013年住院次数为1次,住院时间﹥1 d）、排除标准（入住产科、计划生育科、康复科、肿瘤科、日间病房、儿科的患者）剔除不合格病历,使用GTT推荐以及根据国外相关研究和首都医科大学宣武医院自身经验确定的35项触发器（包含实验室指标、解救剂、临床症状和处理措施等）按样本随机顺序每半个月审查10份病历（若符合入选标准者不足10份则全部纳入）,检测到触发器者标记为触发器阳性,对触发器阳性所涉及情况进一步审查以确定或排除 ADE,对确定为ADE者进行分级。使用Microsoft Excel 1007软件对阳性触发器和ADE进行整理分析,计算阳性触发器的阳性预测值。结果审查病历共465份,涉及465例患者,其中男性156例,女性109例,年龄19~91岁,平均57岁,住院时间1~37 d,平均10 d。465例患者中触发器阳性者108例（44.7%）。35项触发器中有11项触发器呈阳性（61.9%）,共检出341例次。确定ADE 18例次,涉及16例患者,ADE检出率为3.4%（16/465）。18例次ADE中13例次有相对应的触发器,涉及8项触发器。11项阳性触发器的总体阳性预测值为3.8%。18例次ADE包括肺炎、肝损伤、寒战和皮疹各1例次,抗菌药物相关性腹泻、头痛、头晕、恶心呕吐、低血糖、过度镇静、谵妄、出血、白细胞减少症和兴奋各1例次;14例次为E级,4例次为F级;涉及药物11种,包括抗菌药物5种,血液系统药物和精神系统药物各3种,心血管系统药物、激素类药物和中成药各1种,调脂药、影响骨代?     

利用全面触发工具建立住院患儿头孢菌素类药品不良反应主动监测预警模型

目的 应用全面触发工具建立住院患儿头孢菌素类药品不良反应(ADR)主动预警监测模型,为患儿使用头孢菌素类ADR的监测、防治提供参考.方法 收集2017～2018年某院使用头孢菌素类药物发生过敏反应病例102例作为试验组,并随机抽取同期使用该药未发生过敏反应的病例269例作为对照组,利用全面触发工具对危险因素进行单因素分...     

药品不良事件自动监测系统的研究状况

药品不良事件自动监测系统可以高效发现、实时监测、减少或避免不良事件,但受到医疗活动的复杂性、技术和高假阳性率的限制,故自动监测系统的性能仍需进一步提升。为此,本文综述国内外药品不良事件自动监测系统的现状,以期为相关的研究者提供一定的参考。     

基于全面触发工具构建DPP-4抑制剂药品不良反应主动监测模型

目的 本研究基于全面触发工具(GTT)对二肽基肽酶-4(DPP-4)抑制剂药品不良反应(ADR)构建主动监测模型,为医疗机构对患者使用DPP-4抑制剂ADR主动监测和防治提供参考。方法 参考《IHI Global Trigger Tool for Measuring Adverse Events》(后称GTT白皮书)、采用德尔菲专家咨询法(Delphi method)建立DPP-4抑制剂ADR主动监测触发器,应用中国医院药物警戒系统(CHPS)构建监测模型并对其验证,主动监测2021年3月9日～2022年3月8日某三级甲等医院所有使用DPP-4抑制剂的住院病例,统计分析相关ADR情况。结果 495份病例中,经触发器检出阳性条目及例次分别为158条、85例患者,经人工审查,最终判定与DPP-4抑制剂相关的ADR条目及例次分别为46条、32例患者,总体触发器阳性预测值(PPV)为29.11%(46/158)。ADR共累及7个系统-器官,受损害系统最严重的是代谢和营养障碍,占比32.61%。主动监测检出率为6.46%(32/495),该医疗机构同期自主上报率为1.01%(5/495),两者差...     

全面触发工具在药品不良事件分析中的应用

目的验证全面触发工具用于检测药品不良事件的可行性。方法利用临床药学管理系统(2.1)随机抽取本院2014年10—12月500份住院患者病历进行回顾性分析,评价病历记录中可能存在的药品不良事件。结果在调查的500份住院病历中,39项触发器有25项触发器显阳性,触发器阳性频次为459次。其中抗过敏应用药物项(编号:33)触发频次最多,71次,占15.5%。确定药品不良事件77次,涉及53例患者,ADE检出率为16.8%(77/459)。阳性预测值以血钾异常项(编号:7、8)较其他高,分别占34.8%和30.0%。不良事件伤害分级集中在"轻微伤害"与"中度伤害"级别。结论全面触发工具在防范药品不良事件方面具有积极作用,但尚待完善。     

Development of a trigger tool for the detection of adverse drug events in Chinese geriatric inpatients using the Delphi method

International Journal of Clinical Pharmacy - Background The global trigger tool is a method of retrospective medical record review that identifies possible harm in hospitalized patients using...     

Suspected adverse drug events requiring emergency department visits or hospital admissions

Objective: To analyse the contribution of adverse drug events (ADEs) to the overall number of referrals or visits at an emergency department, to determine the proportion of more severe episodes requiring hospital admission and to characterize the different causes of drug-related visits or admissions. Methods: A 1-year prospective collection of data on visits performed at an emergency department. All visits, observed during 1 week every month, were analyzed in order to identify suspected ADEs. The effects of age and sex on the frequency of ADE-related visits and admissions were evaluated. All patients hospitalized because of an ADE were followed up in order to collect information about progress and outcome of the events, which were also assessed in terms of avoidability. Results: Among the 5497 patients who visited the Emergency Department over 1 year, 235 (4.3%) experienced an ADE, 45 of these (19.1%) were subsequently hospitalized, among whom there were five deaths. Dose-related therapeutic failures were the main causes of drug-related admissions (55.6%), whereas adverse drug reactions caused the most frequent drug-related visits to the Emergency Department (63.8%). Although the frequency of drug-drug interactions leading to a visit to the Emergency Department was small (3.8%), this type of event was more severe, because most of these patients were hospitalized. No age/sex effect was observed in the proportion of ADE-related hospital admissions. Twenty-five (1.4% of the total admissions) of the 45 ADE-related admissions were evaluated as preventable, contributing by more than 61% of the overall length of hospital stay. Conclusion: The high proportion of drug therapeutic failures leading to an admission highlights the need for public education, particularly to prevent non-compliance. Received: 14 April 1998 / Accepted in revised form: 5 October 1998     

Implementing a clinical pharmacy survey of adverse drug events in a French emergency department

Background The prevalence of adverse drug events (ADEs) occurring in the ambulatory setting is high, requiring the development of a coherent and comprehensive patient-safety policy framework. Former experiences demonstrated that emergency department (ED) surveillance can help characterise the burden of outpatient ADEs. We developed a clinical pharmacy programme called the clinical pharmacy survey of adverse drug events (CPSA) to support interventions and research projects in the area of ADE prevention and management. Objective To design a survey to identify and describe ADEs in patients visiting the medical ED of our tertiary care hospital. We report the results of the first 2?years of CPSA implementation and an assessment of its performance. Setting The medical ED of a French 3,000-bed tertiary care hospital. Method Between January 2008 and December 2009, adult patients visiting our medical ED were included during randomised time slots. Data were collected by pharmacy students. ADEs were documented by a trained physician pharmacist team using the chart review method. Main outcome measure The primary outcome was the number of patients visiting our ED with an ADE. The CPSA attributes were assessed on the basis of the Centers for Disease Control and Prevention??s 2001 updated guidelines for evaluating public health surveillance systems. Results Of the 1,035 included patients, 201 experienced an ADE at the ED visit (19.4?%; 95?% confidence interval 15.8?C23.0?%). Forty-seven ADEs (23.4?%) were unrelated to the patient??s chief complaint. An ADE was the leading cause of 154 in the 1,035 admissions (14.9?%). The assessment of our method on the basis of the Centers for Disease Control and Prevention guidelines showed good performances in terms of data quality, stability, flexibility, timeliness, and acceptability, but not in terms of simplicity and representativeness. The profile of patients with an ADE at admission and detected ADEs did not significantly differ between years 2008 and 2009. Conclusion Our experience demonstrates that clinical pharmacists can successfully implement a survey process of ADEs in an ED over time. Our method seems basic enough to suit most health care facilities with pharmacy students.     

The burden of adverse drug events

Drug safety should be considered as part of the balance between benefit and risk, and represents a burden to the patient, the healthcare professional, the regulator and industry. Each of these has a different view on adverse drug reactions and these are discussed in this article.     

Emergency department visits caused by adverse drug events: results of a French survey.

BACKGROUND: Adverse drug events (ADEs) are a substantial cause of hospital admissions. However, little is known about the incidence, preventability and severity of ADEs resulting in emergency department visits. To address this issue, we conducted a prospective survey in emergency departments of French public hospitals. METHODS: This study was performed over two periods of 1 week each, one in June 1999 and one in December 1999, in emergency departments of five university hospitals and five general hospitals throughout France. All patients aged>or=15 years presenting with medical complaints were included in the study. Trauma patients, those with gynaecological conditions and those with alcohol intoxication or intentional drug poisoning were excluded from the study. Each patient was assessed by two local emergency physicians to determine whether the visit was the result of an ADE. All medical records were subsequently validated by an independent group of medical lecturers in iatrogenic disorders. RESULTS: Out of a total of 1937 patients consulting, 1562 were taking at least one drug during the previous week and were included for analysis; 328 (21%; 95% CI 19, 23) of these patients consulted an emergency physician because of an ADE. Patients with ADEs were older than those without (mean age 63.5 vs 54.8 years; p<0.0001). Furthermore, ADE patients were more likely to have a higher severity presentation than the non-ADE group (p=0.019). The number of drug exposures was significantly higher in patients with an ADE than in those without (mean number of medications 5.17 vs 3.82; p<0.0001). On multivariate analysis, only age and the number of medications taken were significantly associated with adverse events. In total, 410 drugs were incriminated in the occurrence of 328 ADEs. The most frequently incriminated drug classes were: (i) psychotropic agents (n=84; 20.5%); (ii) diuretics (n=48; 11.7%), anticoagulants (n=38; 9.3%) and other cardiovascular drugs (n=63; 15.4%); and (iii) analgesics, including NSAIDs (n=57; 13.9%). Preventability could be assessed in 280 of the 328 cases. In 106 cases (37.9%), the ADE was judged to be preventable. CONCLUSION: ADEs leading to emergency department visits are frequent, and many are preventable, confirming that there is a need to develop prevention strategies.