Frequency and cost of serious adverse drug reactions in a department of general medicine

Aims To assess the frequency and cost of drug reactions causing or prolonging hospitalization.
Methods All patients admitted to an internal medicine ward over 6 months were evaluated to identify serious adverse reactions. The number of drug classes on admission or at the time of the adverse drug reaction (ADR) was counted. Excess ADR-related hospital stay was computed using a) raw excess duration of hospital stay, b) correction of duration of hospital stay by age, sex, and number of drug classes, and c) estimation by investigator of excess hospital stay.
Results Three hundred and twenty-nine patients were evaluated: 212 male, 117 female, mean age 57.2 (males: 52.2, females: 66.2 ( P <0.05)), range 17–95 years. They stayed a total of 3720 hospital days (mean stay 11.3 days). 298 had no ADR (mean age 55.8, taking a mean of 2.7 drug classes, 10.7 days hospital stay); 31 had ADRs: in 10, the ADR caused admission in patients with a mean age of 84 ( P <0.01 vs the two other groups), taking 6.3 drug classes, who stayed a mean of 15.1 days; 21 occurred in hospital in patients with a mean age of 63.6, taking 4.2 drug classes ( P <0.01), who stayed a mean of 19.2 days ( P <0.01 vs patients without ADRs). In four the ADR was fatal (13% of ADRs, 40% of deaths). Raw ADR-related excess hospital stay was 318 days (8.6% of all hospital days), after multivariate correction 282 days (7.6% of all hospital days), and with investigator estimation 197 days (5.3% of all hospital days). Point prevalence of ADRs at admission was 3%, incidence rate in hospital was 5.6/1000 patient-days.
Conclusions 3% of the admissions were related to ADRs. In addition, 6.6% of hospitalized patients had significant ADRs. Between 5 and 9% of hospital costs were related to ADRs. In 24 of the 31 patients with ADRs (77%), these were related to the pharmacological properties of the involved drugs, and may possibly have been avoidable.     

临床常见不合理用药的干预与建议

目的了解我院临床输液中发生药品不良反应的情况,以促进合理用药。方法对我院2005～2006年临床126例输液中的药物不良反应进行分析。结果不良反应发生和很多因素有关:抗菌药物不良反应,药物相互作用,药效学和药化动力学的改变等有关。结论应重视临床药物不良反应的监测。     

基于药品不良反应严重度指数的171例儿童严重药品不良反应分析

目的：结合药品不良反应（ADR）严重度指数分析湖南省儿童医院上报的儿童严重ADR发生情况,为临床合理用药及严重不良反应预警提供参考。方法：对湖南省儿童医院2006年1月至2020年12月上报的171例儿童药物严重ADR报告进行回顾性分析,计算各类药物ADR严重度指数（SIADR）,并对其进行评价。结果：171例儿童严重ADR中,男119例（69.59%）,女52例（30.41%）。以SIADR排序,SIADR最高的三类药物分别为血液系统用药、中药注射剂和电解质、维生素及营养药,其中葡萄糖酸钙注射液以5.00位列第一。全身性损害是严重ADR的最主要表现。结论：在临床用药时应警惕SIADR较大的药物,加强儿童ADR监测及采用多种措施促进安全合理用药,以减少和避免严重ADR的发生。     

Company observational post-marketing studies: drug risk assessment and drug research in special populations – a study-based analysis

Objectives: Company observational post-marketing studies (COPS) claim to provide essential data about drug risks and effectiveness in special populations not admitted to pre-approval clinical trials. Since COPS are often mainly regarded as a marketing activity, this study-based analysis tries to evaluate the scientific contributions of COPS. Material and methods: Thirty-five COPS were identified by hand-searching through medical journals, writing to pharmaceutical manufacturers and using MEDLINE. Fourteen COPS evaluated cardiovascular drugs, 9 evaluated NSAIDs and 12 evaluated various other indications. Results: Thirty-five COPS listed effectiveness, 31 listed safety and 8 listed patient compliance as principal objectives. Not a single COPS included a control group. Seventeen of 21 evaluable COPS mentioned extensive exclusion criteria similar to those in clinical trials. Median observation time was 8 weeks, too short for chronic diseases and for adverse drug reactions with longer latency periods. One new adverse event was regarded. Global assessments of the outcomes by physicians dominated and were not based on objective clinical findings. None of the studies specified any details concerning the standardisation of observations or quality-control procedures. Discussion and conclusion: The current COPS scheme does not contribute significantly to our knowledge of drug safety and the effects in special populations. Despite serious criticism over the past 20 years, the poor quality of COPS – compared with dramatic improvements of pre-approval trials – implies a need for detailed guidelines for non-experimental phase IV research, similar to the Good Clinical Practice-Guideline of the European Community. Received: 13 June 1997 / Accepted in revised form: 4 August 1997     

我院临床常用药物代谢规律、相互作用及不良反应简表的建立

目的：对我院临床常用药物的代谢规律、相互作用和不良反应相关资料进行统计,为预测个体患者药物治疗效果和不良反应的发生提供参考。方法：对临床各科室的用药情况进行调查,统计和归纳。结果：各科室用药特点不一,统计简表的建立可在很大程度上减少潜在的用药风险和不良反应。结论：药物使用的统计资料能为临床治疗方案的制定提供参考,可提高患者的依从性,避免可能发生的不良反应和事件。     

Adverse drug reactions in elderly patients

Many studies from around the world show a correlation between increasing age and adverse drug reaction (ADR) rate, at least for some medical conditions. More than 80% of ADRs causing admission or occurring in hospital are type A (dose-related) in nature, and thus predictable from the known pharmacology of the drug and therefore potentially avoidable. Frail elderly patients appear to be particularly at risk of ADRs and this group is also likely to be receiving several medicines. The toxicity of some drug combinations may sometimes be synergistic and be greater than the sum of the risks of toxicity of either agent used alone. In order to recognize and to prevent ADRs (including drug interactions), good communication is crucial, and prescribers should develop an effective therapeutic partnership with the patient and with fellow health professionals. Undergraduate and postgraduate education in evidence-based therapeutics is also vitally important. The use of computer-based decision support systems (CDSS) and electronic prescribing should be encouraged, and when problems do occur, health professionals need to be aware of their professional responsibility to report suspected adverse drug events (ADEs) and ADRs. "Rational" or "obligatory" polypharmacy is becoming a legitimate practice as increasing numbers of individuals live longer and the range of available therapeutic options for many medical conditions increases. The clear risk of ADRs in this situation should be considered in the context that dose-related failure of existing therapy to manage the condition adequately may be one of the most important reasons for admission of the elderly to hospital. Thus, age itself should not be used as a reason for withholding adequate doses of effective therapies.     

我院2011年767例药品不良反应分析

目的了解肿瘤专科医院药品不良反应（ADR）发生的最新特点及规律。方法对2011年1月至12月收集并上报的767例ADR报告,分别从报告人、患者性别及年龄、引发ADR的药品种类、给药途径、ADR涉及器官或系统及临床表现等方面进行统计分析。结果767例ADR报告中,50～60岁者ADR发生率最高,占32．99％;以抗肿瘤药居多,占72．40％;静脉滴注给药方式是引发ADR的主要给药途径,占79．92％;最常见的临床表现为恶心、呕吐以及骨髓抑制。结论应加强化疗监护,综合考量患者身体状况,优化给药剂量,并重视ADR的监测工作,以减少ADR的发生。     

Intensive monitoring of adverse drug reactions in infants and preschool children

Summary Intensive monitoring of adverse drug reactions (ADR) in infants and preschool children in the paediatric outpatient unit covering the town of Karlovac (150000 inhabitants) was performed over a period of three months. Data were obtained by physical examination of children and the history given by their parents. In all 2359 children were examined. ADR were recorded in 63 children and were reported to the National ADR monitoring centre in Zagreb. Using the algorithm of Hutchinson et al. (1979), all ADR were classified as definite, probable, possible and unlikely. Drugs were prescribed in 97.3% of children, 60.24% received an antimicrobial agent (43% of them on the basis of a sensitivity test), and an antipyretic was given to 1878 children, mostly paracetamol. ADR were most frequently caused by antibiotics (49 reactions to penicillin V, and 15 to amoxycillin) and secretolytics (7 reactions). ADR were followed by complete recovery and not a single child was hospitalized because of an ADR.The results, when compared with the very small number of broadly comparable studies, indicate that the incidence of ADR in this population is rather small and of minor importance.     

门诊药房退药现状分析及对策

目的促进临床合理用药,保证患者用药安全。方法对医院2011年7月1日至9月30日门诊患者625例退药登记进行回顾性统计分析。结果药品不良反应(ADR)是主要退药原因,大处方过度用药、特殊人群禁忌及药品供应短缺是次要原因。所退药品主要为价格较贵的抗生素、消化系统用药及治疗辅助用药。结论合理用药,个性化用药,加强医患沟通,增强患者用药依从性,制订退药规范等,是降低门诊药房患者退药率的关键。     

536例头孢菌素类抗生素不良反应报告分析

目的 通过监测分析2004年1月-2005年12月山西省药品不良反应中心收到的药品不良反应报告中头孢菌素类抗生素所致不良反应及其相关因素，提示应正确使用头孢素类抗生素，以减少不良反应的发生。方法 采用回顾性调查方法对收到的头孢菌素类抗生素所致536例不良反应报告进行统计分折。结果 不良反应涉及药品18种，排前3位的是头孢曲松、头孢哌酮、头孢噻肟。药品不良反应累及人体的9个系统，比例最高的不良反应为变态反应。分析头孢菌素类抗生素的主要不良反应发生机制，为临床正确使用提供理论依据。结论 应关注头孢菌素类抗生素的不良反应，提高合理用药水平。     

2014年马鞍山市基本药物不良反应报告分析

摘 要 目的:探讨基本药物不良反应（ADR）的发生特点,为促进临床安全用药提供参考。方法：对马鞍山市2014年收集的3 061例基本药物的不良反应报告作回顾性分析,分别按患者性别、年龄、药品种类、剂型、给药途径、报告类型、ADR累及系统 器官等项目统计并分析。结果：3 061例ADR报告中,性别比例基本相当;50～59岁、60～69岁、40～49岁3个年龄段ADR构成比居于前三位;引起ADR的药物以化学药物最多（63.38%）;剂型分布以注射剂（53.15%）和片剂（33.00%）为主;给药途径以静脉注射引发ADR最多,共1 605例（52.44%）;新的严重不良反应23例（0.75%）; ADR累及的系统器官以消化系统最多见（31.88%）。结论：提示临床应用应进一步加强基本药物重点监测及高发群体不良反应的监控,尽量减少ADR的发生。     

108例儿童药物不良反应分析

[摘要]目的：分析我院儿童药物不良反应（ADR）的发生特点,为临床合理用药提供参考。方法：对我院2015年1月至2017年6月收集的108份儿童药物ADR进行分析、总结。结果：108例儿童ADR中,男62例（57.4%）,女46例（42.6%）;静脉给药者居多（94例,占87.04%）;抗感染药物引起的ADR居首位,涉及19种抗感染药物共79例（73.14%）,中成药4种共11例（10.18%）;皮肤及其附件损害是ADR最主要的表现,共82例（75.93%）。结论：增强对药物不良反应的防范意识,加强不良反应监测,确保临床安全、有效、合理用药。     

2010年我院160例药品不良反应报告分析

目的 了解医院药品不良反应(ADR)发生的规律和特点,促进临床合理用药,提高药物治疗安全性.方法 采用回顾性调查方法,对2010年上报的167例药品不良反应报告,按患者年龄、性别,给药途径,涉及药品种类,累及器官和临床表现、转归与评价等进行分析.结果 167例报告中,7例为皮肤过敏试验阳性,有效报告160例.其中患者女47.50%(76/160),男52.50%(84/160),平均年龄54.37岁;静脉给药145例(90.63%),口服给药ll例(6.88%),皮下注射给药4例(25.00%);涉及药品12类73种,列前3位的药品是抗感染药物83例(51.88%),中药制剂40例(25.00%),消化系统用药9例(5.63%);以皮肤及其附件损害为主;药品不良反应多为一般性的(97.50%),严重的4例(2.50%),并且转归良好,无死亡病例.结论 药品不良反应发生无明显年龄和性别差异.抗感染药物、中药制剂及静脉给药途径是引发药品不良反应的主要因素.应加强合理用药监管,保障患者用药安全.     

我院252例药品不良反应报告分析

目的：了解我院药品不良反应（ADR）发生的规律与特点,为临床安全用药提供参考。方法：对我院2009年1月1日。2009年12月20日收集到的252例ADR报告,从报告数量、报告来源、药品种类、给药途径、涉及器官或系统及临床表现等方面进行统计、分析。结果：不良反应报告女性多于男性,60以上患者为敏感人群。静脉滴注是发生ADR的主要给药途径,252例ADR涉及120种药品,其中主要是抗菌药（133例,41个品种）和中药制剂（30例,20个品种）,损及皮肤及附件的ADR构成比为46．82％。结论：医院应进一步加强ADR监测与医疗监管工作,促进合理用药。     

我院207例药品不良反应报告分析

目的:了解我院药品不良反应(ADR)发生的特点及规律.方法:对我院2010年上报国家和省药品不良反应监测中心的207例ADR报告进行回顾性分析.结果:207例ADR中,女性多于男性;≥60岁的患者占38.65％;抗感染药引起的ADR最多见,占48.79％,其次为抗肿瘤及辅助治疗用药;给药途径以静脉给药引起的ADR为主;皮肤及其附件损害最多,占35.42％.结论:医务人员应强化合理用药意识,开展和加强临床ADR监测,保证临床用药的安全、有效.     

Adverse drug reactions in liver cirrhosis

Summary Impaired liver function may increase susceptibility to drug toxicity. In a prospective drug surveillance study of 1280 patients the frequency of adverse drug reactions (ADR) was higher in 333 patients with clinical and/or histopathological evidence of liver cirrhosis than in 188 with other liver diseases (p<0.01) and than in 759 without liver disease (p<0.0001). The 128 cirrhotics had 339 events considered definitely or probably related to drug therapy by consensus of the monitoring team and the attending physicians. ADR were 93.8% dose-related, 11.2% were severe but only one was fatal. ADR were most commonly associated with diuretics (32.6% of patients administered the drugs), potassium salts (6.5%), antimicrobials (3.9%) and sedatives (3.5%). Most common manifestations were metabolic (62.6%), gastrointestinal (13.2%) and neurologic (11.9%). The frequency of ADR was higher in females (p<0.05), patients receiving more drugs (p<0.001), those with longer hospital stay (p<0.001) and those with ascites (p<0.0001), portal hypertension (p<0.0001), prior hepatic encephalopathy (p<0.02) or prolonged prothrombin time (p<0.0001). Adverse reactions were more common for drugs biotransformed greater than 50% by the liver (p<0.005). These findings show that ADR are more frequent in severe hepatic dysfunction.     

2009年我院药品不良反应报告分析

目的：分析我院不良反应发生的规律和特点,为临床合理使用药品提供参考。方法：采取回顾性研究方法对我院2009年不良反应报告进行汇总分析。结果：由抗微生物药引起的ADR所占比例最高（48.75%）,其次为中药注射剂（25.00%）;临床表现以皮肤及其附件的损害最常见（53.75%）;静脉给药是引起ADR的主要给药途径（87.50%）。结论：应以抗微生物药、中药注射剂为重点,加强药品不良反应监测,提高临床安全用药意识,确保患者用药安全。     

某中医院225例药品不良反应报告综合分析

目的 分析药品不良反应（ADR）的发生特点,促进临床合理用药。方法对2006年1月至2008年12月收集的225例ADR报告进行回顾性分析。结果静脉给药引发的ADR最多（87．11％）,涉及药品13类71个品种,最易引起ADR的药物为抗感染药物（50．67％）和注射用中药制剂（16．89％）;ADR造成皮肤和附件损害最多（54．67％）,新的ADR24例（10．67％）,严重的ADR19例（8．44％）。结论加强医院ADR监测报告工作,规范干预措施,可以降低ADR重复发生率,提高临床用药水平。     

儿童中常见的药物不良反应

病人特别是儿童常发生药物不良反应,在新生儿监护室中发生的不良反应高达30％。甲氧氟普胺引起的肌张力障碍,抗惊厥药引起嗜睡,氯霉素引起灰婴综合征以及皮质类固醉造成的发育障碍都可在儿童中出现。药物有关不良反应在儿童中发生率比成人高的主要原因可能是儿童代谢功能不成熟之故。