Risk factors for the development of adverse drug events in hospitalized patients

Adverse drug events in hospitalized patients lead to increased morbidity, mortality and costs. Early detection of adverse drug events could aid in the prevention of these adverse outcomes. A costeffective system for the early detection of adverse drug events should focus on high risk patients. A study was set up with the primary aim to identify characteristics that are associated with the development of adverse drug events (ADEs) in hospitalized patients.ADE reports were gathered from physicians and nurses (spontaneous reports) and from patients after intensive ward interviews by hospital pharmacists. All patients admitted to the internal medicine wards of two Dutch hospitals, during a two month period, were included.The following characteristics were analyzed for their potential relationship to the occurence of ADEs: age (categorized), gender, number of drugs prescribed during hospital stay, types of drugs used and changes in drug use on admission.Age was found to be inversely associated with the development of ADEs (OR 0.36, CI 0.210.61 for age category > 80 years; OR 0.56; CI 0.311.02 for age category 7580 years and OR 0.69; CI 0.421.11 for age category 6074 years). Furthermore, statistically significant associations were found for the number of drugs prescribed per hospitalized patient (for the class of 46 drugs per patient OR 2.61, CI 1.325.18), for newly prescribed drugs (OR 6.65, CI 2.6316.81) and for the cessation of drugs on hospital admission (OR 1.50, CI 1.022.20). The use of gastrointestinal drugs (OR 2.13, CI 1.323.45), central nervous system drugs (OR 1.66, CI 1.072.57) and antibiotics (OR 2.44, CI 1.653.60) were associated with the development of ADEs, when compared to all other drugs taken by the patients.In this study, the most important risk factors are the number of drugs used per patient and the starting of a new drug during hospitalization. As most hospitalized patients start new drug therapies while in hospital, this seems an inappropriate focus. However, careful monitoring of patients using more than 7 drugs at a time may be possible in a costeffective system for the early detection of ADEs.     

住院患者药品不良反应报告分析

目的:了解住院患者发生药品不良反应(ADRs)的情况。方法:按患者的年龄、性别、用药情况及ADRs的主要表现、严重程度等进行统计分析。结果:185例报表中,男性87例,女性98例,涉及药品82种,主要为抗感染药物(46.49%),其次为中药制剂(16.76%),ADRs主要表现是皮肤及附件损害,其次是循环系统、消化系统。结论:应加强对住院患者ADRs的监测工作,以保证用药安全性。     

Adverse drug reactions in hospitalized pediatric patients of Saudi Arabian University Hospital and impact of pharmacovigilance in reporting ADR

ObjectivesChildren are more vulnerable to ADRs, and this susceptibility is compounded due to hospitalization. There is a lack of local data regarding the potential risk of ADRs in hospitalized pediatric patients. Therefore, this study is designed to identify the frequent nature, severity of adverse drug reactions, drugs implicated and factors influencing ADRs.MethodsIntensive monitoring study of ADRs was done in hospitalized pediatric patients of King Abdulaziz University Hospital, Jeddah from January to December 2011, with an analogous retrospective study for the preceding year to determine incidence rate, demographic aspects, causality appraisal, polypharmacy, body organs/systems involved and drugs implicated in ADR. Comparison of the two data was done to determine the impact of pharmacovigilance.ResultsIncidence rate of ADRs in retrospective study was (4.50%) and (8.2%) in prospective study. ADR was more in patients who received 5–6 drugs, which was (15.5%) in retrospective study and (22.1%) in prospective study. Regarding age, it was the highest in patients of 0–1 year of age which was (40.7%) in retrospective study and (38.8%) in prospective study. Anti-infective agents were the most frequently involved in ADR (40.8%) in prospective study and (48.2%) and retrospective study. This study also demonstrated that, there was high susceptibility of the skin to the ADR which was (37%) in retrospective study and (42.9%) in prospective study. None of the ADRs proved to be fatal.ConclusionWell premeditated intensive monitoring approach in pharmacovigilance amplifies the ADR detection, which can persuade healthcare providers into more drug safety.     

Adverse drug reaction reporting by nurses in Sweden

AIM: To investigate whether nurses could be a useful tool for improving the reporting rate of adverse drug reactions (ADRs). Furthermore, we wanted to study how physicians working at the study departments would respond to nurses as reporters of ADRs and if the reporting from the nurses affected the reporting rate from the physicians. METHOD: Three departments of internal medicine and one unit for orthopaedics were selected for the study. Nurses with special drug responsibilities were invited to participate. At the start of the study period, the nurses received an introduction with background, objective, method and other practical issues concerning the study. After this, an education programme about ADR reporting, definitions, and ADR classification according to mechanism and organ system was given. To study their knowledge about and attitude towards ADRs, a questionnaire was handed out to the nurses. A questionnaire was also handed out to all physicians at the participating departments in order to investigate their attitude towards nurses as reporters of ADRs. RESULTS: Fifty-four nurses participated in the study. During the study period, a total number of 23 reports with 39 ADRs were sent to the regional centres by the nurses. Seventeen (74%) of the reports were assessed as serious. Eight of the 39 ADRs were unlabelled and all reports were considered appropriate. The reporting rate from the physicians during the study period was similar to the previous year, indicating that the nurses contributed with additional reports. At the end of the study, the nurses thought that they had enough knowledge to report ADRs. Sixty-eight percent of the physicians did not object to nurses being included as reporters of suspected ADRs. CONCLUSION: Adverse drug reaction reporting by nurses could improve the overall safety of drugs.     

Adverse drug reactions: a cohort study in internal medicine units at a university hospital

Objectives Adverse drug reactions (ADRs) are important causes of hospitalization, morbidity and mortality in hospitalized patients. In addition to the impact they have on human life, they also significantly influence health costs. This study intended to (1) identify suspected ADRs and establish their frequency of development, (2) establish a causal relationship with the suspected drug(s) and (3) verify if there is an association between the development of an ADR and factors such as age, gender, number of diagnoses and number of prescribed medications. Methods This cohort study considered hospitalized patients at five inpatient internal medicine units in a university hospital located in southern Brazil. Patients were intensively monitored in order to identify suspected ADRs during hospitalization. The types of reactions were classified and a causal relationship was established using an algorithm. Results The cohort study followed 333 patients and approximately 43% of them presented at least one suspected ADR. Three hundred and sixty suspected ADRs were identified, with 19.7% manifesting before the patient was admitted and 80.3% during hospitalization. Medications that were most commonly involved in these suspected cases were anti-infectious agents followed by drugs that act on the central nervous system (CNS). The follow-up length and number of medications in use were independent risk factors for the development of an ADR. The same relationship was not observed for age, gender and number of diagnoses. Conclusion ADRs are a major problem in our setting and measures must be adopted to minimize them. Financial support: Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq), Fundo de Incentivo à Pesquisa do HCPA (FIPE), Brazil.     

中药注射剂不良反应/事件 95例的相关因素分析

目的分析中药注射剂不良反应/事件的发生情况及相关因素,为临床合理用药提供参考。方法对该院2006～2008年上报的95例中药注射剂不良反应/事件报告表进行回顾性分析。结果本组不良反应/事件以药物热和皮肤及其附件损害为主,共76例占80.0%;涉及27个注射剂品种,其中冠心宁注射液、银杏达莫注射液、血塞通注射液、生脉注射液、香丹注射液等5种注射剂共诱发63例不良反应/事件占66.3%。结论提倡中药口服途径给药,慎用中药注射剂,加强对中药注射剂不良反应/事件的监测和相关研究,提高临床用药的安全性。     

28例GLP-1受体激动药不良反应/事件分析

摘 要 目的：探讨GLP 1受体激动药不良反应/事件（ADR/ADE）的发生特点。方法：计算机检索CNKI、万方数据、PubMed等数据库,对艾塞那肽、利拉鲁肽、贝那鲁肽、利司那肽、阿必鲁肽、度拉糖肽、索马鲁肽等7种GLP 1受体激动药所致ADR/ADE个例报道文献进行整理分析,分别统计ADR/ADE的患者因素、药物因素和ADR/ADE相关特征等信息。结果：收集文献31篇,获取病例32例,剔除3例用药差错事件,1例阴性报道,纳入分析报道28例。GLP 1受体激动药ADR/ADE女性多于男性,ADR/ADE发生多发生在用药后2个月内,主要涉及消化系统、泌尿生殖系统、皮肤及其附件系统等,其中以胰腺炎与急性肾损伤较为严重。肾功能不全、合并使用血管紧张素受体抑制药±利尿药者可能是急性肾损伤的危险因素,可能机制为严重呕吐、脱水导致低血压、肾血流量不足所致。结论：GLP 1受体激动药较为安全,对于有胰腺炎及急性肾损伤高危因素者用药前2个月内,药师应加强监护与随访,注意患者有无腹痛、严重呕吐、脱水、无尿等症状,以防严重ADR/ADE发生。     

单唾液酸四己糖神经节苷脂钠注射液不良事件及其救护措施

目的 探讨单唾液酸四己糖神经节苷脂钠注射液(GM1)致药品不良事件(ADE)的相关因素及其救护措施,为临床合理用药提供依据.方法 对湖南中医药大学第一附属医院2019年1月至2020年12月发生的12例GM1致ADE报告进行回顾性分析.结果 GM1致ADE多在用药后5 min～12 d内,主要表现为寒战、发热等全身性损...     

104例肿瘤病人药品不良反应发生特点分析

目的 探讨肿瘤病人住院期间药品不良反应(ADR)的发生规律和特点,为临床安全、合理用药提供依据.方法 对104例肿瘤病人发生ADR的病例按病人年龄、性别、给药途径、药品类型、ADR 涉及器官和(或)系统及临床表现等进行分类统计与分析.结果 104例药品不良反应报告中,静脉给药导致药品不良反应为96.15%;由抗肿瘤药物引起的药品不良反应最多,占48.08%;不良反应临床表现以皮肤及附件损害最为常见,占24.41%.结论 医院应加强与重视肿瘤病人药品不良反应的监测工作,保证肿瘤病人用药的安全性.     

我院2002年~2005年311例药品不良反应报告分析

目的:了解我院药品不良反应(ADR)的发生特点及评价ADR报告填写质量,促进临床合理用药。方法:制作Excel表,对2002年~2005年收集到的311例ADR根据患者性别、年龄及药品种类、ADR临床表现等分类,并进行统计分析。结果:由抗菌药物导致的ADR所占比例最高;皮肤及其附件损害的ADR约为总报告例次的50%;ADR报告总数偏少。结论:应加强专业人员的业务和素质培养,合理使用抗菌药物,以减少和避免ADR的发生。     

2012年某院药品不良反应的分析

目的分析药物不良反应发生的特点,促进药品不良反应监测的进一步完善。方法对我院2012年全年上报的61例不良反应报告进行回顾性分析。结果引起不良反应的药物主要为抗菌药物和中药制剂,不良反应上报率低、漏报率高。结论通过多种途径改进不良反应上报工作,提高全体医务人员的重视,保障患者用药安全、有效。     

59例抗真菌药物不良反应分析

目的了解我院抗真菌药物不良反应(ADR)发生的情况和特点,为临床安全、合理用药提供参考。方法收集我院2007-2012年抗真菌药物ADR报告59例,按患者年龄、性别、涉及药品种类、给药方式、ADR损害器官及主要临床表现等进行统计分析。结果 59例报告中,男33例,女26例。59岁以上发生率最高(23例,占38.98%)。涉及4类抗真菌药,以吡咯类为主(45例,占76.27%)。引起ADR的主要给药途径为静脉给药(43例,占72.29%)。ADR主要损害器官为皮肤及其附件损害(23.53%)和肝损害(23.53%)。结论合理应用抗真菌药,使用中应密切监测,避免严重ADR的发生。     

Investigation of the characteristics of medication errors and adverse drug reactions using pharmacovigilance data in China

The aim of this study was to investigate the characteristics of medication errors (MEs) and adverse drug reactions (ADRs) using data from the spontaneous reporting system, which is helpful to understand the actual situation of MEs in China. Data from 2015 in a south distinct in Shanghai were gathered from the spontaneous reporting system and analyzed. The general information, cause of errors, severity, primary diseases, involved system and organs, symptoms, and suspected drugs were investigated. A total of 1290 adverse drug events (ADEs), including 1079 ADRs and 211 MEcs (MEs causing ADE), were reported. Older patients suffered from both ADRs and MEcs (age distribution and dosage form were different between ADRs and MEcs). The main causes of errors were inappropriate usage and dosage of drugs and inappropriate indication selection. Most ADR and MEc cases were mild; the possibility of developing a severe adverse event was quite low. The distribution of the top 10 system and organs, and symptoms involved was significantly different between ADRs and MEcs, with J01 drugs (antibacterials for systemic use) being the leading cause in both. Our results suggested that a direct analysis of data from the spontaneous reporting system is a reliable, and convenient method to investigate MEs and ADRs, despite the existing limitations, and contributes to further understanding the current situation of MEs and ADRs in China.     

贵阳医学院附属医院2008至2012年药品不良反应报告质量分析

目的探讨医院药品不良反应（ADR）上报工作中存在的问题及对策。方法收集贵阳医学院附属医院2008年1月至2012年12月上报国家ADR监测中心并被接收的ADR报告,重点就ADR报告是否符合国家卫生和计划生育委员会2011年关于“个例药品不良反应”上报的要求进行分析。新药监测期内药品（新药）和监测期外药品（老药）分别按批准文号计算上市〈5和≥5年统计。结果纳入分析的ADR报告共485例,其中2012年242例（49．9％）,2008至2011年243例（50．1％）。2012年上报数量明显增多与贵阳市自2012年实施ADR上报指标量化等措施有关。485例ADR报告中,符合上报要求者107例（22．1％）,其中新药所致ADR22例,老药所致新的或严重的ADR共85例。新药所致22例ADR中严重ADR5例,一般ADR17例,涉及18种新药;老药所致ADR共463例,符合上报要求者85例（18．4％）,其中新的ADR9例,严重ADR76例,涉及药品384种。结论医院ADR上报工作中存在的主要问题是质量不高。量化上报措施对改善报告质量的作用有限。建议细化ADR定义,明确上报范围,完善报告制度,实施可行的新药监测制度,提高ADR报告质量及其可利用价值。     

某院162例药品不良反应报告调查分析

目的：了解某院药品不良反应（ADR）发生的特点及规律,促进临床合理用药。方法对某院2012年收集的162例ADR报告,分别从患者性别及年龄、出现不良反应时间、给药途径、ADR涉及器官或系统及临床表现、引发ADR的药品种类、ADR的转归及报告人职业等进行统计和分析。结果162例ADR报告中70岁以上者所占比例最大（44.44%,72/162）;引起ADR的主要药品种类为抗菌药物（23.76％,48/202）,其次为心血管系统药物（12.38％,25/202）;静脉滴注给药方式是引发ADR的主要给药途径（80.86%,131/162）;ADR临床表现以皮肤及其附件损害为主（29.67%,73/246）;多数患者发生ADR经停药及对症处理后好转或治愈,对原患疾病影响不明显（51.23%,83/162）;ADR上报人员以医生和护士为主,分别为29.01%（47/162）、69.75%（113/162）。结论医护人员应加强对老年患者的用药监护,密切观察患者用药后0.5 h内的反应;除静脉给药外,还应考虑其他给药方式;更加关注用药后患者皮肤及其附件的变化;对抗菌药物的使用应加强管理;对于不良反应的处理得当,可继续保持;应增加药师的ADR上报率。     

Adverse drug events in two emergency departments in Naples, Italy: an observational study

The aims of this study, conducted in the emergency departments of two hospitals of Naples (Italy), which differ in type of catchment area and in the number of daily visits, were to determine: (1) the percent of emergency department visits due to adverse drug events (ADEs); (2) the percent of visits requiring hospitalisation due to acute ADEs; (3) the drugs implicated in ADEs; and (4) the types of ADEs and their frequency. We studied all emergency department visits at the A. Cardarelli and Incurabili hospitals between 8.00 a.m. and 8.00 p.m. (prospectively), and between 8.00 p.m. and 8.00 a.m. (retrospectively) for two 10-day periods. When possible, a form was completed for each subject. Patients were asked if they had taken a drug (name, dosage and reason for its use) in the previous 2 weeks. Of the 2442 emergency visits considered, 34 (1.3%) were drug related. Of the 480 patients who were subsequently hospitalised 17 (3.6%) had an ADE. The number increased to 34 (8.9%) in the 379 patients who took drugs in the 2 previous weeks. Non-steroidal anti-inflammatory drugs accounted for 26.5% of cases, antibiotics 23.6%, and antihypertensive agents 17.7%. The most frequent ADEs were gastrointestinal diseases (diarrhea, vomiting and haemorrhagic gastritis) and cutaneous rash (erythema, dermatitis). This study shows that ADEs account for a large percent of hospital admissions and confirms that drug-induced disorders is a notable public health problem.