Adverse drug events in an intensive care unit of a university hospital

Purpose  

Adverse drug events (ADEs) are harmful and occur with alarming frequency in critically ill patients. Complex pharmacotherapy with multiple medications increases the probability of a drug interaction (DI) and ADEs in patients in intensive care units (ICUs). The objective of the study is to determine the frequency of ADEs among patients in the ICU of a university hospital and the drugs implicated. Also, factors associated with ADEs are investigated.     

我院药品不良反应/事件主动监测系统构建

目的：构建药品不良反应/事件主动监测系统,为临床提供用药安全信息,及时发现并快速上报药品不良反应（adverse drug reaction,ADR）/事件（adverse drug event,ADE）,实现基于该系统的ADR/ADE真实世界研究条件。方法：联合"触发器原理"与"贝叶斯置信传播神经网络法"挖掘医院信息系统的ADR/ADE信号,由药师负责建立规则、布局功能模块以及对效果进行评估验证,由软件工程师负责编写计算机程序实现。结果：建立了较全面的监测规则,实现了实时预警与回顾性研究数据快速提取,完成了ADR/ADE主动监测平台的搭建。结论：ADR/ADE实时预警有利于及时处置,减少药品危害,并提高上报效能,快速筛选数据的功能为上市后药品安全性再评价提供便利,对建立药品安全性监测与评价信息技术平台有重要意义。     

Fatal adverse events during hospital stays

A study of the frequency and severity of adverse events during hospital stays, based on a sample of US Medicare beneficiaries, was published in late 2010. Medicare provides healthcare coverage for people aged 65 and over, the disabled, and patients with renal impairment. One in 7 patients (13.5%) experienced a serious adverse event, and nearly half of these events were considered preventable. When extrapolated to the entire Medicare population in the United States, this corresponds to an estimated 15 000 deaths every month among the disabled and the elderly. About half of these deaths were due to drugs, especially anticoagulants. There are no studies of this type in France.     

某院重点监控药品的药事管理实践

目的：探索对重点监控药品合理使用的有效药事管理措施。方法：建立重点监控药品的药事管理措施,通过对比监管前后某院医疗指标以及重点监控药品目录的变化情况,对管理效果进行参考性评价。结果：对比监管前后数据,发现收治人数增加了53.0%;但药占比从34.4%下降至24.5%;人均药费从8 492.5元降至6 078.3元;而平均住院天数、诊断疾病种类数、治愈率均无显著性差异。对比全院重点监控药品目录前20位药品,亦明显可见非针对性治疗用药明显减少,针对疾病的治疗用药明显增加,而且监管后非针对性治疗用药的使用不合理率也大幅度下降。结论：某院通过建立重点监控药品的药事管理措施,对重点监控药品实施的药事管理效果初具成效,在一定程度上规范了医疗机构药物使用管理,减轻了患者医药费用负担,保障医疗质量和医疗安全。     

Developing a model to determine the effects of adverse drug events in hospital inpatients.

PURPOSE: A study was conducted to develop a model to identify adverse drug events (ADEs) and quantify their effect on quality and cost in a large tertiary care hospital. METHODS: The drug-ADE relationship between unfractionated heparin and heparin-induced bleeding was studied for all inpatients receiving heparin infusions at the hospital between January 1 and December 31, 2004. Activated partial thromboplastin time (aPTT) values were used to help determine if the patients received blood products in response to excessive anticoagulation with heparin. The number of aPTT values of > or =150 seconds and the last aPTT value before discharge were evaluated. The key outcome measures were length of stay, cost per admission, and mortality. Of the 1455 admissions to the hospital, 122 patients received blood products before receiving heparin infusion only, 264 received blood products after receiving the drug only, 221 received blood products both before and after, and 848 who received the drug never received blood products. RESULTS: Differences in full cost and length of stay between the group receiving heparin infusion only and the groups receiving both blood products were significant. Differences in mortality between the group only receiving heparin infusion and the groups receiving both heparin infusion and blood products were also significant. CONCLUSION: Using the model developed to study the effect of heparin-induced bleeding, we found that the cost per patient day was highest for patients receiving blood products after heparin infusion treatment. There was a positive correlation between one or more aPTT values of > or =150 seconds and undesirable patient outcomes.     

System for voluntary reporting of adverse drug reactions in a university hospital

The development and implementation of a system to improve voluntary reporting of adverse drug reactions (ADRs) is described. A preliminary study comparing three concurrent voluntary reporting systems at a 327-bed university teaching hospital demonstrated the ability of medical records personnel to identify ADRs that were documented in the medical record but not reported under the voluntary system. It was concluded that a concurrent voluntary reporting system would be coupled with a medical record review process that would focus reporting on clinically important and unexpected ADRs. Failures to report ADRs would be handled through existing procedures of staff privilege allocation and peer review. The baseline ADR rate was determined. A telephone reporting system was established for the medical staff. After review of reported reactions by pharmacy, feedback was provided to ADR reporters and the medical staff. During the first three months under the new system, 9 of 114 documented ADRs were reported, compared with none in the three months before the program began. All ADRs defined as reportable were reported. An ADR-reporting system designed to encourage voluntary reporting of selected reactions, monitor the baseline rate of ADR occurrence, and assess compliance with reporting criteria appears to operate satisfactorily.     

2010年某医院药品不良反应监测结果分析

目的：了解我院药品不良反应的报告情况及其特点,促进临床安全用药。方法：回顾性分析2010年1月～12月我院各科室呈报的287例ADR,对其性别、年龄、药品种类、给药途径、所涉及的器官及临床表现等方面数据进行统计分析。结果：287例ADR患者中,女性例数（占55.05%）高于男性（占44.95%）;引发ADR的主要途径是静脉滴注,占总例数的73.87%;引起ADR药物共有118种,其中抗感染药物最多,占60.63%;以皮肤及其附件及消化系统相关临床表现为主。结论：加强ADR知识宣传、培训,扩大呈报范围,降低漏报率,对提高临床用药安全,保障人们生命健康有重要意义。     

Risk of adverse drug events by patient destination after hospital discharge.

PURPOSE: The prevalence of risk factors for adverse drug events (ADEs) in patients discharged from the hospital to various care settings was studied. METHODS: Data on patient risk characteristics for ADEs were collected for hospital discharges for 2000. Differences in the prevalence of 10 risk characteristics among home health care (HHC), self-care (SC), and long-term-care (LTC) patients at the point of discharge were determined. RESULTS: Data for 4250 discharges were analyzed. The three groups differed significantly in the distribution of risk characteristics. HHC patients had the highest prevalence of heart failure, cardiovascular medication use, and polypharmacy, and LTC patients had the highest prevalence of hypoalbuminemia, cognitive impairment, and psychiatric drug use. CONCLUSION: The risk of ADEs in patients discharged to HHC appeared to be comparable to or higher than that in patients discharged to LTC.     

我院开展药品不良反应监察工作的体会

药品不良反应监察(Adverse Drug Reations Monitoring, ADRM)工作已得到世界卫生组织和各国医药界的重视,一致认为它对于研制安全有效的药物、减少药源性疾病、提高医疗质量都具有十分重要的意义[1]. 近年我院每年经审批采购的新药品种有100多种,临床药品不良反应发生率比较高,需要认真开展ADR监察工作,为选择质优、价廉、安全的药品供应临床提供依据.现将我院开展ADR监察工作的做法和措施介绍如下.     

某院重点监控中成药的管理实践

目的：探索对中成药重点监控药品合理使用的有效药事管理措施。方法：基于药品销售金额、DDDs，和DUI为评价指标，通过四步筛选法确定中成药重点监控目录，结合用药合理性评价结果进行药事管控。通过对比监管前后某院医疗指标变化情况，对管理效果进行参考性评价。结果：在疗效相同的前提下，重点监控中成药的金额占比持续下降，中成药的药占比由24.4%下降至15.8%；中成药的人均药费由1 492.5元降至878.3元；而病种类数、收治人数、治愈率均无显著性差异。中成药的用药不合理使用率也大幅度下降。结论：通过建立重点监控中成药的管理措施，规范医疗机构药物使用并取得一定成效。为中成药的管理提供新的思路。     

Preventing adverse drug events in hospital practice: an overview

Adverse drug events (ADEs) are a considerable cause of morbidity and mortality in hospital practice. The precise frequency is unknown, but studies give an incidence number ranging from 2 until 52 ADEs per 100 patients. There are many different methods for definition, causality assessment, severity classification and detection which make it difficult to compare the different studies. A substantial part (in some studies up to 70%) of ADEs can be prevented and it is important to, besides their detection, focus on the prevention of these ADEs. In this literature review we give an overview of methods for preventing ADEs. There are many different tools with different impact on a particular part of the distribution system which has the potential to prevent ADEs. A multifaceted approach is needed. Two interesting strategies of prevention, pharmacist participation on ward rounds and computerised physician order entry with clinical decision support systems (CDSS), are highlighted. Moreover, two promising CDSS are discussed in more detail, namely computer-based monitoring systems and information systems which link laboratory and pharmacy data.     

Utilization of fluconazole in an intensive care unit at a university hospital in Brazil

Background Fungi have been developing resistance and merit greater attention because these microorganisms are among the major causes of hospital infection. Objective The aim of the present study was to characterize the pattern of fluconazole use in an adult intensive care unit. Setting The setting was an intensive care unit at a university hospital in Brazil. Method An observational retrospective study was performed between 2007 and 2010. The use of antifungal drugs was calculated as the defined daily dose per 1,000 patient-days. The pattern of fluconazole use was determined by analyzing patient charts. Results Fluconazole accounted an average of 66.6 % of the antifungal agents prescribed. All of the patients exhibited important risk factors for the development of fungal infection. Treatment was empirical in 45.2 % of the cases and therapeutic in 54.8 % of the cases. The dose interval was inadequate in 51.1 % of the treatments. Fluconazole at doses ≥400 mg/day was related to a greater likelihood of survival. C. albicans was the most prevalent species (31.3 %). Urine was the biological material with the greatest number of positive mycological exams (71.9 %). Conclusion This study found a high utilization of fluconazole and, in most cases, its administration at intervals that were different from the recommended intervals.     

医院药品不良反应监测工作感悟

近年来,我院药品不良反应监测工作,在省、市食品药品监督管理局的正确领导和帮助支持下,不断强化思想意识、提高检测认识、提升管理水平、加大措施、健全组织、完善制度、强化督导,促进了ADR监测工作的顺利开展,取得了一定成绩。为做好药品不良反应监测工作,做出了积极努力。我院开展药品不良反应监测工作的具体做法是.     

Design, monitoring, and analysis issues relative to adverse events.

In the clinical development of new drugs for market approval, it is frequently impossible to design trials to provide definitive information about safety--particularly about adverse events. It is possible, however, to design most trials to provide definitive information about efficacy. Efficacy trials with new drugs should therefore be monitored for safety, and the safety profile described within and across trials. Confidence intervals are recommended as the appropriate statistical methodology for doing this. Such intervals provide an interval estimate on the unknown incidences of adverse experiences among patients who could be treated with each regimen, as well as permit a conclusion that two regimens are different.