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.     

左氧氟沙星不良反应148例分析

目的探讨左氧氟沙星不良反应（ADR）发生的规律和特点,为临床合理使用提供参考。方法对148例使用左氧氟沙星患者的不良反应报告进行汇总和统计分析。结果左氧氟沙星的不良反应主要有变态反应、神经系统损害、关节软组织损害、循环系统损害以及低血糖等,并且不良反应的发生与患者年龄、用药方法、给药时间有一定的关系。结论为减少左氧氟沙星不良反应的发生,应合理使用,严格掌握左氧氟沙星的临床适应症,尽量使用口服途径给药,必须采用静脉给药时,静滴过程中要严格控制滴速和滴注浓度,并密切观察。     

致心律失常不良反应药物信号的检测与评价

目的检测和评价致心律失常药品不良反应( adverse drug reaction，ADR)药物信号，为临床安全用药提供参考。方法收集 2004年第 1季度至 2020年第 4季度美国食品药品监督管理局不良事件报告系统自发呈报系统中接收到的致心律失常 ADR信号，采用比例报告比法( proportional reporting ratios，PRR)和报告比值比法( proportional reporting odds ratio，ROR)对进行信号检测，分析 ADR报告中对应病人的基本信息(包括性别、年龄、上报年份、上报国家、严重 ADR)和安全警告信号。结果收集到的 65 536份 ADR报告中，排除重复，保留首要怀疑药物和伴随药物的 ADR报告有 20 401份。除性别未知和年龄缺失的 ADR报告外，纳入报告病人的性别分布女性稍高于男性(9 918比 8 401)，年龄范围 50～75岁比例较高，其余分布较均衡，上报数量最多的年份分别是 2005年、 2011年、 2012年、 2018年和 2019年，主要上报国家为美国、德国等。严重的 ADR报告有 11 158份(占 54.7％)“住院或住院时间延长”为主，导致死亡占 16.88%。共挖掘得到 ADR信号 478个，累及心血管系统( 122个)、内分泌系统(48个)、以，抗精神病( 43个)、神经系统( 32个)、抗感染( 22个)、呼吸系统( 22个)、血液系统( 17个)、抗肿瘤( 16个)等 19个系统用药。致心律失常 ADR信号频数排序前 10位的药物分别为罗非考昔(频数 1 795)、罗非昔布(频数 1 792)、对乙酰氨基酚(频数 1 393)、左甲状腺素(频数 912)、美托洛尔(频数 879)、缬沙坦(频数 805)、罗格列酮(频数 798)、丙氧酚(频数 776)、呋塞米(频数 687)、氢氯噻嗪(频数 635)。头孢噻吩信号强度值最高，对乙酰氨基酚次之。结论心血管系统、抗精神     

Retrospective analysis of the frequency and recognition of adverse drug reactions by means of automatically recorded laboratory signals

AIMS: To estimate the frequency of adverse drug reactions (ADRs) identified through the use of automatic signals generated from laboratory data (ALS) in hospitalised patients. To determine the frequency of spontaneous recognition of these ADRs by the attending physicians and to assess the potential value of ALS for detection of ADRs. METHODS: Laboratory results of patients hospitalised in a nine bed medical ward were automatically recorded over a period of 17 months. Values exceeding defined boundaries were used as ALS. Charts of every third patient were analysed retrospectively with regard to adverse drug related reactions and causality was evaluated as well as whether the ADR had been recognised during the period of hospitalisation. RESULTS: The charts and ALS of 98 patients were analysed. In 18 cases a drug-related adverse reaction was probable. Awareness to the reaction by the treating physicians was evident in 6 out of these 18 ADRs. Approximately 80% of the ADRs were considered predictable. Three ADRs were regarded as serious. CONCLUSIONS: Adverse drug reactions are common and often preventable. Only one third of ADRs which could have been detected through ALS were recognised by the attending physicians. An increased doctor's awareness of the frequency of drug related abnormal laboratory results by means of ALS is likely to increase the recognition rate of ADRs and might help to prevent them.     

氟康唑不良反应的文献分析

目的了解氟康唑不良反应的发生的一般规律及特点,为临床合理用药提供参考。方法检索1999～2010年国内医药学术期刊中有关氟康唑所致的不良反应,进行整理,归纳和分析。结果氟康唑所致不良反应临床表现复杂多样,其中以过敏反应,肝、肾功能异常,神经系统反应等为主。结论应重视氟康唑在临床应用中的不良反应,以保证用药的安全性。     

米卡芬净临床不良反应及合理用药

目的分析并探讨米卡芬净不良反应(ADR)发生的类型及特点,为临床安全、合理用药提供参考。方法检索国内外有关米卡芬净不良反应的病例报道,对其不良反应发生类型及特点进行分析和总结。结果米卡芬净的不良反应以皮疹、胃肠道反应及肝损害最为多见,另外可见心血管疾病、溶血及过敏反应等。结论鉴于米卡芬净可造成患者多个器官和系统的不良反应,医药人员在临床治疗过程中应加强不良反应的监测,减少和防止ADR的发生率,以确保患者的用药安全。     

他汀类66例药品不良反应报告分析

目的 为促进临床更合理地使用他汀类药品,为其临床安全用药提供参考依据.方法 汇总徐州市2015年1月—2016年6月66例他汀类药品的不良反应报告进行回顾性分析和总结.结果 60岁以上病人服用他汀类药品不良反应发生率最高,其中以胃肠道反应最为常见,使用辛伐他汀发生不良反应发生率最高.结论 他汀类药品应从小剂量开始服用,加强监测,确保病人用药安全、有效.     

骨瓜提取物致不良反应文献分析

目的分析讨论骨瓜提取物所致不良反应的临床特点及发生规律,为临床合理用药提供参考。方法检索1983年至2012年医药学期刊报道的有关骨瓜提取物致不良反应的文献进行统计分析。结果共检索到骨瓜提取物所致不良反应27例,均为静脉滴注给药,其中男20例,女7例;年龄0～19岁1例（3．7％）,20～29岁3例（11．1％）,30—39岁8例（29．6％）,40—59岁8例（29．6％）,≥60岁7例（25．9％）;原患疾病以不同部位不同程度的骨折为主,共23例（85．2％）;多在用药10min内发生,其中1—5min13例（48．1％）。27例药物不良反应中,骨瓜提取物均采取静脉滴注给药,其中21例（77．8％）为50、75、100mg骨瓜提取物＋0．9％氯化钠注射液或5％葡萄糖注射液250—500ml;20例（74．1％）为单独使用骨瓜提取物过程中出现,7例为联合使用药物过程中出现。不良反应累及多个系统和器官,临床表现复杂多样,主要为速发型变态反应,临床表现主要为瘙痒、皮疹、红斑疹、无力、寒战、头痛、发热、多汗、胸闷、心悸、呼吸困难、呼吸急促、抽搐、腹痛、恶心呕吐、皮肤潮红等,严重者可致过敏性休克。结论临床医师、药师应了解骨瓜提取物所致不良反应的规律和特点,加强其应用的监测,以减少不良反应的发生。     

药物不良反应的分析、预防与监测

药物不良反应是临床用药中常遇到的现象,成为危害人类健康的主要杀手,在我国引起了越来越多的关注和研究。本文对引起药物不良反应的原因进行了多方面的分析,同时提出了相应的预防措施,加强对药物不良反应的监测和防范,减少和避免药物不良反应的发生。     

氟喹诺酮类药物致不良反应128例分析

目的 了解氟喹诺酮类药致不良反应（ADR）发生特点和规律.方法 收集医院2009年1月-2012年12月住院患者128例氟喹诺酮类药致ADR报表进行汇总分析.结果 128例ADR报表中,60～70岁发生率最高,6～30min时间段多见,涉及的5种氟喹诺酮类药以加替沙星为主,累及的6个系统以神经系统损害明显,静脉给药容易引起ADR,多数ADR转归良好.结论 应高度重视氟喹诺酮类药ADR的报告和监测,提高临床合理用药水平,减少ADR的发生.     

Correlations between in vitro affinity of antipsychotics to various central neurotransmitter receptors and clinical incidence of their adverse drug reactions

Objective: This study was performed to determine whether in vitro affinities of currently available antipsychotics toward dopamine or other neuronal receptor systems are associated with their in vivo incidence of central and peripheral adverse drug reactions (ADRs). Methods: For 17 antipsychotic drugs available in Japan, the clinical incidences of 7 different types of drug-induced ADRs (i.e., akathisia, dyskinesia, tremor, rigidity, drowsiness, hypotension and dry mouth) were obtained from both post-marketing ADR databases and the investigational clinical trials of eight pharmaceutical companies. Affinity constants (K _i) of the respective drugs toward dopamine D₁ and D₂ receptors, α₁-adrenoceptors, histamine H₁ receptors, serotonin 5-HT₂ receptors and muscarinic cholinoceptors, determined using rat brain synaptosomes, were obtained from the literature. Relationships between in vitro receptor-binding properties and in vivo incidences of the respective types of antipsychotic-related ADRs were analyzed using Spearman's rank correlation. Results: Significant (P < 0.05) correlations were observed between the K _i values for dopamine D₂ receptor and the clinical incidences of akathisia and dyskinesia (r _s = −0.68 and −0.66, respectively). Significant (P < 0.05) correlations were also observed between the K _i values for α₁-adrenoceptor and histamine H₁ receptor and the incidence of drowsiness (r _s=−0.65 and −0.55, respectively), and between the K _i values for three receptor systems (i.e., dopamine D₁ receptor, α₁-adrenoceptor and histamine H₁ receptor) and the incidence of dry mouth (r _s = −0.50, −0.81 and −0.62, respectively). Conclusion: Preclinical receptor-binding data of antipsychotic drugs toward central dopamine and other ancillary neurotransmitter systems may be useful for predicting not only in vivo antipsychotic potency but also clinical incidence of akathisia and dyskinesia for this class of agents. Newly developed antipsychotic drugs with more potent and selective antagonistic activity against the dopamine D₂ receptor may not necessarily be associated with a lower incidence of extrapyramidal ADRs. Received: 21 December 1998 / Accepted in revised form: 21 July 1999     

葛根素注射液的不良反应及相关因素分析的研究

目的探究葛根素注射液使用中发生不良反应（adverse drug reactions,ADR）的规律和特点,为临床更合理用药提供一定的参考。方法收集徐州矿务集团第二医院2007年1月至2008年1月间葛根素注射液所致ADR的病例196例,进行统计分析。结果196例中有31例出现ADR,ADR的发生率为15.8%。结论ADR的发生主要与年龄、生产厂家、制剂、剂量、疗程及合并用药等因素有关。     

Some patient experiences with drugs and adverse drug reactions in an African teaching hospital

One hundred and seventy patients regularly attending a general medical outpatients' clinic at the Parirenyatwa Central Hospital (PCH) in Harare, Zimbabwe were interviewed about their knowledge of their present drug therapy and possible adverse drug reactions (ADRs), history of previous ADRs and action taken on experiencing them, information source and satisfaction with their therapy. Sixty seven patients knew what drugs they were taking and this level of awareness was associated with age, occupation and level of education of the patient. Only 19 patients knew about the possible ADRs of their drugs and this knowledge was associated with language ability, disease knowledge and knowledge of what drugs they were taking. Seventy eight patients had experienced ADRs and this was linked to age and knowledge of ADRs. Eighty one patients said that they would continue their drug treatment on experiencing ADRs, and this behaviour was associated with knowledge of disease and ADRs. More than half of the patients were not satisfied with the information given about their drugs, and very few had read about this subject. These results suggest that overall knowledge of drugs and ADRs amongst patients at the PCH is low, and that there is a need to increase patient education regarding therapy. This training should take into account the patient's demographic and socioeconomic background. Knowledge of ADRs was shown to increase the potential for compliance.     

Under-reporting of adverse drug reactions Estimate based on a spontaneous reporting scheme and a sentinel system

Objective: Spontaneous reporting is the most common method used in pharmacovigilance and the best one to generate signals on new or rare adverse drug reactions (ADRs). Under-reporting is a major drawback of this system. The objective of this study was to quantify the extent of under-reporting in general practice and to assess the factors which influence it. Methods: Details of ADRs collected through a short intensive survey were compared with primary care spontaneous reports received by the Castilla y Leon Regional Pharmacovigilance Centre during a 12-month reference period. The survey was undertaken by a random sample of 146 general practitioners (GPs), providing care to 149 487 people. The pharmacovigilance centre received reports concerning the whole regional population (2.5 million) covered by primary health care. The under-reporting coefficient (U) was estimated as the ratio between the number of effects observed by physicians in the survey and those spontaneously reported to the pharmacovigilance centre. Results: The overall under-reporting rate was 1144 [95% confidence interval (CI): 928–1409]. Under-reporting was greater for psychiatric (2119; 945–4752) and gastrointestinal (1946; 1424–2659) disorders. Severe effects were more reported (U=605; 151–2431) than moderate (863; 473–1575) and mild (1209; 973–1503) ones. The under-reporting rate was lower for drugs recently marketed (706; 406–1230) and slightly lower for unlabelled effects (1031; 641–1657). Conclusion: The under-reporting rate of ADRs is considerable, though not homogeneous for the different cases. This should be taken into account when comparing adverse effects (AEs) for different drugs. Under-reporting seems to be positively selective, as it involves mainly the less severe and better-known effects, preserving the value of spontaneous reporting for signal detection. Received: 21 November 1997 / Accepted in revised form: 28 April 1998     

地舒单抗不良反应信号挖掘与分析

目的通过对地舒单抗相关药品不良反应( ADR)进行挖掘与分析,为临床安全合理用药提供依据。方法采用比例失衡分析法中的报告比值比法( ROR)和比例报告比值比法( PRR)对美国食品药品监督管理局( FDA)不良事件报告系统(FAERS)中地舒单抗 2010年第 3季度至 2021年第 3季度中发生的 ADR进行挖掘及分析。结果提取到 28 823例以地舒单抗为首要怀疑药物的 ADR报告,共检测出有效信号 256例,涉及 19个器官系统分类。主要涉及肌肉骨骼及结缔组织疾病,胃肠系统疾病,各类检查和感染及侵染类疾病等。在信号强度排序前 50的 ADR中不仅包括说明书中已知的口腔相关 ADR、颌骨坏死、各种类型骨折、外耳道骨坏死、钙离子相关 ADR等。还包括说明书中未提及的 ADR 9种,分别是颌骨外生骨疣,高钙性肾病,免疫介导的肾上腺功能不全,脊柱畸形,纵隔纤维化,甲状腺钙化,椎间盘环形撕裂,下颌骨肿块,关节杂音。结论地舒单抗使用过程中,医务人员不仅要重点关注肌肉骨骼及结缔组织疾病、胃肠系统疾病、各类检查和感染及侵染类疾病,对于信号挖掘发现的新的 ADR也应该提高警惕,积极预防和治疗,以减少 ADR对病人的危害。     

加强药品不良反应认识

护理安全是防范和减少医疗事故与纠纷的重要工作，从患者入院到出院，护理人员监护患者的药物治疗全过程，认识、发现和上报药物不良反应（ADR），对配合救治ADR病例和减少同类事件的发生有着举足轻重的意义和作用。     

临床应用头孢菌素类抗生素的不良反应及合理用药研究

目的探讨临床应用头孢菌素类抗生素产生的不良反应及合理用药措施。方法通过回顾性分析法对68例采取头孢菌素类抗生素治疗出现不良反应的患者的临床资料进行收集、分析、整理,对头孢菌素类抗生素不良反应出现的原因、具体类型、头孢菌素类抗生素药物应用类型进行归纳总结,同时制定头孢菌素类抗生素药物的合理应用措施。结果头孢菌素类抗生素引起的不良反应药物类型包括头孢哌酮、头孢曲松、头孢唑林、头孢西丁、头孢呋辛、头孢他啶、头孢地嗪,占比分别为14.71%、13.24%、11.76%、7.35%、13.24%、20.59%、19.12%。常见不良反应类型包括血液系统反应、变态反应、胃肠道反应、肾肝毒性反应,占比分别为11.76%、26.47%、57.35%和7.35%;头孢菌素类抗生素不良反应发生的主要原因包括超剂量用药、未进行药敏试验、无指征用药、重复用药,占比分别为32.35%、4.41%、23.53%和39.71%。结论临床应用头孢菌素类抗生素过程中,应保证药物应用的合理性及安全性,利用合理用药方法可降低不良反应发生率。     

某三甲综合医院346例抗肿瘤药物致不良反应报告分析

目的:分析抗肿瘤药物相关的药品不良反应(adverse drug reaction,ADR)发生的特点及规律,为临床安全使用抗肿瘤药物提供参考。方法:对我院2013–2018年抗肿瘤药物致ADR报告进行回顾性分析,共计346例,对患者性别、年龄、给药途径、引起ADR的药品种类分布、ADR累及系统/器官和临床表现、给药途径与发生时间、ADR分级与转归情况、关联性评价、报告主体等进行分析。结果:346例ADR报告中,女性患者占61.27%,男性患者占38.73%;年龄以45~59岁组占比最高(43.64%);药物种类占比最高的依次为抗代谢类(21.21%)、铂类(20.98%)和植物来源类(20.51%);累及系统/器官最常见的为血液系统(36.86%)、消化系统(16.80%);引发ADR最多的给药途径为静脉给药(85.08%);发生时间主要为用药后2 h(37.06%);严重ADR为64例(18.50%),新的ADR为6例(1.73%)。结论:抗肿瘤药物致ADR较多且严重,应加强监测高危品种、长期用药、严重ADR、新的ADR;药师应从多方面发挥作用,注重对特殊人群的药学监护,促进抗肿瘤药物在临床合理用药。