我院抗菌药物不良反应／事件报告分析

目的通过对我院428例抗菌药品不良反应／事件（ADR／ADE）报告相关因素分析,了解抗菌药物ADR／ADE发生特点及规律,为临床安全、有效、合理用药提供参考。方法对我医院2009年1月113至2013年12月3113收集到的428例抗菌药物ADR／ADE报告数据进行回顾性统计分析。结果428例抗菌药品ADR／ADE报告中,女性多于男性;0—14岁的儿童61例（占14．26％）;50～83岁的患者264例（占61．68％）;头孢菌素类居首位239例（占55．85％）;给药途径以静脉点滴所占比例最大385例（占89．96％）;抗菌药物ADR／ADE主要临床表现为皮肤及其附件、消化系统、全身性损害等。结论加强抗菌药物ADR／ADE监测工作,减少或者避免ADR／ADE的发生,确保临床安全、有效、合理用药。     

144例双黄连注射剂不良反应/事件报告分析

目的 探讨双黄连注射剂不良反应/事件发生的一般规律和特点.方法 采用回顾性研究方法,对我市药品不良反应监测中心2005-2012年收集的144例双黄连注射剂不良反应/事件自发报告进行分析.结果 144例报告给药途径均为静脉滴注;14岁以下儿童患者74例,占报告总数的51.39％;不良反应以皮肤及其附件损害为主,主要表现为皮疹、荨麻疹等;临床存在不合理用药情况.结论 临床应严格按照药品说明书用药,并加强不良反应监测,以减少药品不良反应的发生.     

克林霉素致不良反应215例临床分析

目的探讨克林霉素致药物不良反应(ADR)的一般规律及特点,为临床合理用药提供参考.方法对近11年国内医药期刊报道的克林霉素所致不良反应215例进行分类统计、分析.结果 215例ADR病例涉及15个器官/系统类型,前3位是皮肤及其附件损害、胃肠系统损害及中枢和外周神经系统损害.结论临床应重视克林霉素的合理使用,警惕可能因药物的相互作用诱发严重ADR的潜在危害性.     

38例抗结核药物所致不良反应临床分析

目的了解抗结核化学药物引起不良反应（ADR）的发生现状,为进一步完善抗结核药品的合理使用提供科学依据。方法对2007年10月～2008年3月收治的涂阳肺结核病人进行前瞻性调查。结果2007年10月～2008年3月共收治涂阳肺结核病人89例（男性66例,女性23例）,发生不良反应38例,占42．7％,其中男性32例,不良反应发生率48．5％,女性6例,不良反应发生率26．1％,合并多种不良反应10例,总的不良反应发生50例次。结论服用抗结核药物常常引起肺结核病人的不良反应,是患者不能完成疗程的原因之一。但通过医生治疗前和治疗过程中的宣教。树立治疗信心;督导医生及时发现不良反应,及时正确处理,适当调整化疗方案,可较好地减轻或消除病人的不良反应,减少中断治疗情况的发生。     

柴胡注射液不良反应或不良事件的系统评价

背景：柴胡注射液是柴胡（Radix Bupleuri Chinensis,又名“北柴胡”）或狭叶柴胡（Radix Bupleuri Scorzonerifolii,又名“南柴胡”）经水蒸气蒸馏法制成的水溶液,广泛应用于临床各类发热性疾病的治疗。目的：本研究基于现有证据了解造成柴胡注射液不良反应或不良事件（adversedrugreactionoradverseevent,ADR／AE）的可能原因,并评价其安全性。检索策略：本研究未进行手工检索。电子检索的数据库为中国学术期刊全文数据库（CNKI）和中国科技期刊全文数据库（重庆维普,VIP）。检索时间截止至2009年6月30日。纳入标准：全面收集使用柴胡注射液致ADR／AE的研究,语种和结局指标不限。患者的年龄、性别、种族、原发病不限。干预措施为单独使用柴胡注射液或柴胡注射液与其他药物（含柴胡的中药汤剂或其他制剂除外）联用。资料提取与分析：由两位研究者独立提取资料。采用MicrosoftExcel软件制定数据提取表。由于各研究异质性较大,此处仅做描述性分析。结果：本研究共纳入83篇文献203例柴胡注射液ADR／AE。由于无法计算ADR／AE的发生率,因此无法准确评估ADR／AE发生的危险度和柴胡注射液的安全性。研究发现儿童和老人重型病例构成比高于其他年龄段;大部分肌注病例ADR／AE均发生在注射后30min内（30min累计发生构成比93．8％）;静滴病例的ADR／AE,4例发生在滴注过程中;初次使用者,其ADR／AE30min累计发生构成比和重型病例30min累计发生构成比均高于有柴胡注射液使用既往史的病例。不少柴胡注射液ADR／AE病例存在不当使用,如大剂量使用（5例）、静脉给药（6例）、违反配伍禁忌（7例）。重、轻型病例中,ADR、AE之比分别为1．7：1和1．1：1;肯定有关、很可能有关、可能有关3个关联程度等级,重、轻型病例中3个等级病例数之比依次为25：14：5和44：9：16。结论：目前低强度的证据表明柴胡注射液ADR／AE病例中不当使用情况严重,部分柴胡注射液的适应人群有待进一步的研究,如老人和儿童。应加强对各级医务人员规范使用柴胡注射液的教育,鼓励和支持各级医护人员如实上报ADR／AE的同时规范发表ADR／AE。     

360例儿科药物不良反应综合分析

通过对国内4种儿科杂志360例个例报道性药物不良反应的综合分析，发现儿科药物不良反应发生的某些特征。表现在抗菌药物不良反应多；引起中枢神经系统损害者多；误服过量中毒病例多；过敏性休克和肝肾功能衰竭是药物致死的重要原因；药物通过皮肤粘膜吸收可引起严重毒性反应；妇女孕期哺乳期用药对胎儿或婴儿可造成危害等。期望医务工作者能认识到儿科病人药物不良反应的严重性和特殊性，掌握儿科药物不良反应发生的规律，尽量避免不良反应的发生。     

运用我院信息系统建立药物不良反应的监测模式在药学监护中的应用

目的：根据我院的医疗特点研究建立规范化药物不良反应监测模式,提高药物不良反应监测的申报效率,促进临床合理用药。方法：依据住院患者病历及用药信息,运用我院信息系统建立规范化药物不良反应监测模式。结果：所建立药物不良反应监测模式达到医院药学监护药历规范化、统一化,从而方便医院对患者药物不良反应情况的进一步了解。结论：本法能提高临床药学的工作效率,避免药物不良反应的重复发生,使临床用药更加有效、合理、经济。     

上海市药品不良反应自发呈报数据库定量信号检测系统的建立

目的建立上海市药品不良反应自发呈报数据库定量信号检测系统。方法借鉴目前国际上五种针对自发呈报数据库的定量信号检测方法,采用PowerBuilder与SQL2000编程,建立了信息编码、信号检测和报表生成三个模块,并应用于上海市2003—2004年自发呈报数据库．验证其检测效果。结果1．该系统能准确检出已知信号;2．不同定量信号检测方法联合使用能够提高信号检测的准确性;3．本系统可以早期检出两种新的药品不良反应信号（莲必治致急性肾功能衰竭,头孢拉定致血尿）。结论不良反应定量信号检测系统的建立可以极大地提高药品不良反应监测工作的效率。     

Awareness and attitudes of healthcare professionals in Wuhan, China to the reporting of adverse drug reactions

Background A voluntary procedure for reporting adverse drug reactions (ADRs) was formally put in place in 1989. However, only a small proportion of ADR reports are actually forwarded to the national monitoring center. To identify the reasons for underreporting, the authors investigated the awareness and attitudes of healthcare professionals (doctors, nurses, and administrators) toward the ADR system in China. In addition, the authors sought to formulate approaches to improve the current ADR reporting system.Methods Structured interviews were carried out in 16 hospitals selected from 27 municipal hospitals in Wuhan, Hubei Province, China. A questionnaire survey of a stratified random sample of approximately 15% of healthcare professionals in each selected hospital was conducted during February to March 2003.Results The response rate of this survey was 85%. One thousand six hundred and fifty-three questionnaires were used in the final analysis. Only 2. 7% of the healthcare professionals had a correct understanding to the definition of ADR. Eighty-nine point two percent of the healthcare professionals had encountered ADRs. Ninety-four percent of them were aware of the need to report these to the ADR monitoring center. However, only 28.5% of doctors, 22. 8% of nurses, and 29. 7% of administrators actually submitted a report. For the most part, they reported ADRs to the hospital pharmacy (66.0%), to other departments in the hospital (72.5%), and to the pharmaceutical industry (23.0%), rather than to the national monitoring center (2.9%) or regional monitoring center (9.5%). Severe or rare ADRs and ADRs to new products were generally perceived to be significant enough to report. Sixty-two point one percent of the healthcare professionals had encountered ADRs,yet not reported them to anybody. The major reasons for not reporting included no knowledge of the reporting procedure (71.4%), unavailability of the reporting center mailing address (67. 9%),unavailability of the ADR report form (60.4%), lack of knowledge of the existence of a national ADR reporting system (52.2%), and belief that the ADR in question was already well known (44. 1% ).Conclusions Healthcare professionals in Wuhan, China have little basic knowledge of ADR and of the voluntary reporting system. The main reasons for underreporting were lack of basic knowledge about ADRs and the voluntary reporting procedure. Education and training of healthcare professionals is needed to improve the current ADR reporting system.     

我院中药注射剂不良反应分析及合理使用方法探讨

目的了解北京市大兴区人民医院（以下简称＂我院＂）中药注射剂不良反应（ADR）发生情况,为临床安全合理使用中药注射剂提供参考依据。方法对我院2009年1月～2011年12月上报的180例中药注射剂ADR病例报告进行分析。结果中药注射剂ADR发生率为46.8%,其中男女比例为1.57∶1,男性多于女性,年龄分布为4～88岁,60岁以上年龄段占46.54%,中老年患者ADR发生率相对较高,临床表现涉及消化系统、血液系统、循环系统等,以全身性过敏反应最为多见。结论严格掌握适应证和说明书,规范中药注射剂的使用,避免ADR的发生,促进临床合理用药。     

630例药品不良反应调查分析

目的了解医院药品不良反应（ADR）发生的情况及特点,为临床合理用药及药物安全性评价提供参考。方法对2008~2010年收集的630例不良反应报告表,分别从患者年龄、给药途径、药品种类、抗微生物药物类别、累及的器官或系统及临床表现等方面进行统计分析。结果 ADR多发生在大于60岁年龄组（23.81%）;静脉滴注导致的ADR发生率最高,占71.59%;ADR发生率最高的为抗微生物药物,为62.54%,其中头孢菌素类药物最多,占118例;ADR的临床表现以皮肤及其附件损害最为常见,占44.76%。结论引起ADR的因素有多方面,应加强ADR监测,促进临床合理用药,减少ADR的发生。     

《侵权责任法》对药品不良反应法律责任的影响

目的探讨《侵权责任法》实施后对药品不良反应侵权责任的法律适用及法律责任带来的影响。方法运用文献研究的方法、案例研究的方法、归纳等逻辑研究的方法,研究《侵权责任法》的法律规定。结果证明了常见且可预期之外的药品不良反应是药品缺陷,发生药品不良反应侵害时,药品生产者、销售者和医疗机构应当承担侵权责任。结论确定药品不良反应侵权责任时,应当区分不承担责任和减轻责任的情形,同时要对关键细节进行司法解释以明确法律责任,也可以更好地体现《侵权责任法》的立法宗旨。     

Drug related medical emergencies in the elderly: role of adverse drug reactions and non-compliance

BACKGROUND—Adverse drug reactions and non-compliance are important causes of admissions in the elderly to medical clinics. The contribution of adverse drug reactions and non-compliance to admission by the medical emergency department was analysed.
METHODS—A total of 578 consecutive elderly patients admitted to the medical emergency department were interviewed to determine the percentage of admissions due to adverse drug reactions or non-compliance with medication regimens, their causes, consequences, and predictors.
RESULTS—Eighty three (14.4%) of the 578 admissions were drug related: 39 (6.7%) caused by adverse drug reactions and 44 (7.6%) caused by non-compliance with medication. One hundred ninety two (33.2%) patients had a history of non-compliance. Factors associated with an increased risk of admission because of an adverse drug reaction were patients with diabetes or neoplasms, and patients using numerous different medications. Factors associated with a higher risk of hospitalisation because of non-compliance were poor recall of the medication regimen, seeing numerous physicians, female sex, polypharmacy, drug costs, and switching over to non-conventional forms of treatment.
CONCLUSION—Many elderly admissions are drug related, with non-compliance accounting for a substantial fraction of these. Elderly people at high risk of suffering a drug related medical emergency are identified and suitable interventions may be planned by the healthcare policymakers to target them.


     

我院严重老年人药品不良反应300例分析

目的：总结老年人严重药品不良反应的主要表现,为用药安全提供指导。方法：对我院2004年1月～2009年12月诊治的老年人严重药品不良反应（ADR）300例进行统计分析。结果：本组ADR涉及的药品居首位的是抗感染药,病例数83例（27．67％）。注射给药共263例（87．67％）,其中静脉滴注发生严重ADR最多,为238例（79．33％）。由中药制剂引起的严重ADR有49例,占总例数的16．33％,其中涉及中药注射制剂达22种之多。281例（93．67％）存在联合用药的情况,其中4种及4种以上药物联用的有188例（62．67％）。结论：加强老年人严重药品不良反应监测工作,并根据老年人的特点合理选择药物,简化用药品种,合理治疗剂量,提高对用药的依从性。     

Cognitive work analysis to evaluate the problem of patient falls in an inpatient setting

Objective

To identify factors in the nursing work domain that contribute to the problem of inpatient falls, aside from patient risk, using cognitive work analysis.

Design

A mix of qualitative and quantitative methods were used to identify work constraints imposed on nurses, which may underlie patient falls.

Measurements

Data collection was done on a neurology unit staffed by 27 registered nurses and utilized field observations, focus groups, time–motion studies and written surveys (AHRQ Hospital Survey on Patient Culture, NASA-TLX, and custom Nursing Knowledge of Fall Prevention Subscale).

Results

Four major constraints were identified that inhibit nurses'' ability to prevent patient falls. All constraints relate to work processes and the physical work environment, opposed to safety culture or nursing knowledge, as currently emphasized. The constraints were: cognitive ‘head data’, temporal workload, inconsistencies in written and verbal transfer of patient data, and limitations in the physical environment. To deal with these constraints, the nurses tend to employ four workarounds: written and mental chunking schemas, bed alarms, informal querying of the previous care nurse, and informal video and audio surveillance. These workarounds reflect systemic design flaws and may only be minimally effective in decreasing risk to patients.

Conclusion

Cognitive engineering techniques helped identify seemingly hidden constraints in the work domain that impact the problem of patient falls. System redesign strategies aimed at improving work processes and environmental limitations hold promise for decreasing the incidence of falls in inpatient nursing units.     

A method for systematic discovery of adverse drug events from clinical notes

Objective Adverse drug events (ADEs) are undesired harmful effects resulting from use of a medication, and occur in 30% of hospitalized patients. The authors have developed a data-mining method for systematic, automated detection of ADEs from electronic medical records.Materials and Methods This method uses the text from 9.5 million clinical notes, along with prior knowledge of drug usages and known ADEs, as inputs. These inputs are further processed into statistics used by a discriminative classifier which outputs the probability that a given drug–disorder pair represents a valid ADE association. Putative ADEs identified by the classifier are further filtered for positive support in 2 independent, complementary data sources. The authors evaluate this method by assessing support for the predictions in other curated data sources, including a manually curated, time-indexed reference standard of label change events.Results This method uses a classifier that achieves an area under the curve of 0.94 on a held out test set. The classifier is used on 2 362 950 possible drug–disorder pairs comprised of 1602 unique drugs and 1475 unique disorders for which we had data, resulting in 240 high-confidence, well-supported drug-AE associations. Eighty-seven of them (36%) are supported in at least one of the resources that have information that was not available to the classifier.Conclusion This method demonstrates the feasibility of systematic post-marketing surveillance for ADEs using electronic medical records, a key component of the learning healthcare system.     

南京地区医务人员对药品不良反应报告认知情况的调查

目的了解南京医务人员对药品不良反应的认识情况，找出药品不良反应报告率低的原因。方法采取分层随机抽样方法，对选定医院内的医务人员通过自填式问卷调查的形式进行关于药品不良反应知识的调查。结果共调查960人，获有效问卷为791份，有效应答率为82.4％。医务人员对药品不良反应概念答对率为28．4％。67．8％的医务人员曾遇到过不良反应，76．6％的医务人员认为报告临床所见的药品不良反应是自己的职责，然而仅有38．8％的医务人员曾经报告过药品不良反应，主要报告机构为地方药品不良反应监测中心，没有报告的原因主要是不知道报告程序（53．3％）。97．6％的被调查对象认为有必要加强药品不良反应知识的教育。结论医务人员对药品不良反应认知情况不容乐观，对药品不良反应上报意识还不够强、对报告体系还不够了解，应加强宣传教育。提高药品不良反应的认知水平。     

Cost-effectiveness analysis of a hospital electronic medication management system

Objective To conduct a cost–effectiveness analysis of a hospital electronic medication management system (eMMS).Methods We compared costs and benefits of paper-based prescribing with a commercial eMMS (CSC MedChart) on one cardiology ward in a major 326-bed teaching hospital, assuming a 15-year time horizon and a health system perspective. The eMMS implementation and operating costs were obtained from the study site. We used data on eMMS effectiveness in reducing potential adverse drug events (ADEs), and potential ADEs intercepted, based on review of 1 202 patient charts before (n = 801) and after (n = 401) eMMS. These were combined with published estimates of actual ADEs and their costs.Results The rate of potential ADEs following eMMS fell from 0.17 per admission to 0.05; a reduction of 71%. The annualized eMMS implementation, maintenance, and operating costs for the cardiology ward were A$61 741 (US$55 296). The estimated reduction in ADEs post eMMS was approximately 80 actual ADEs per year. The reduced costs associated with these ADEs were more than sufficient to offset the costs of the eMMS. Estimated savings resulting from eMMS implementation were A$63–66 (US$56–59) per admission (A$97 740–$102 000 per annum for this ward). Sensitivity analyses demonstrated results were robust when both eMMS effectiveness and costs of actual ADEs were varied substantially.Conclusion The eMMS within this setting was more effective and less expensive than paper-based prescribing. Comparison with the few previous full economic evaluations available suggests a marked improvement in the cost–effectiveness of eMMS, largely driven by increased effectiveness of contemporary eMMs in reducing medication errors.     

DeepADEMiner: a deep learning pharmacovigilance pipeline for extraction and normalization of adverse drug event mentions on Twitter

ObjectiveResearch on pharmacovigilance from social media data has focused on mining adverse drug events (ADEs) using annotated datasets, with publications generally focusing on 1 of 3 tasks: ADE classification, named entity recognition for identifying the span of ADE mentions, and ADE mention normalization to standardized terminologies. While the common goal of such systems is to detect ADE signals that can be used to inform public policy, it has been impeded largely by limited end-to-end solutions for large-scale analysis of social media reports for different drugs.Materials and MethodsWe present a dataset for training and evaluation of ADE pipelines where the ADE distribution is closer to the average ‘natural balance’ with ADEs present in about 7% of the tweets. The deep learning architecture involves an ADE extraction pipeline with individual components for all 3 tasks.ResultsThe system presented achieved state-of-the-art performance on comparable datasets and scored a classification performance of F₁ = 0.63, span extraction performance of F₁ = 0.44 and an end-to-end entity resolution performance of F₁ = 0.34 on the presented dataset.DiscussionThe performance of the models continues to highlight multiple challenges when deploying pharmacovigilance systems that use social media data. We discuss the implications of such models in the downstream tasks of signal detection and suggest future enhancements.ConclusionMining ADEs from Twitter posts using a pipeline architecture requires the different components to be trained and tuned based on input data imbalance in order to ensure optimal performance on the end-to-end resolution task.