本院药品不良反应自发报告模式探讨
详细信息 查看官网全文
- 英文论文题名：Pattern of adverse drug reactions notified by spontaneous reporting in a Chinese tertiary care teaching hospital
- 论文作者：何娟 ; 陈冰 ; 杨婉花
- 英文论文作者：HE Juan ; CHEN Bing ; YANG Wan-hua ; Department of Pharmacy ; Ruijin Hospital Affiliated to Shanghai Jiao-tong University School of Medicine
- 年：2016
- 作者机构：上海交通大学医学院附属瑞金医院药剂科;
- 论文关键词：药物不良反应 ; 抗菌药 ; 回顾性研究 ; 自发报告模式
- 英文论文关键词：adverse drug reactions ; anti-bacterial agents ; retrospective studies ; pattern ; spontaneous reporting
- 会议召开时间：2016-09-27
- 会议录名称：中国药学会第十三届青年药学科研成果交流会论文集
- 语种：中文
- 分类号：R95
- 学会代码：YYWS
- 会议名称：中国药学会第十三届青年药学科研成果交流会
- 会议地点：中国江西南昌
- 主办单位：中国药学会
- 学会名称：中国药学会
- 页数：7
- 文件大小：470k
- 原文格式：O
- 会议级别：全国
摘要
目的:通过对本院药品不良反应信息汇总,分析药品不良反应的发生情况,并对药品不良反应自发报告模式进行探讨。方法采用病例回顾性研究的方法,总结不良反应发生状况,包括患者的基本资料,药品及其不良反应的特点,发生率,严重度等因素。结果:本院药品不良反应的发生率为0.0077%,住院患者药品不良反应的发生率为0.0517%,门诊发生率为0.0067%,老年患者药品不良反应的发生率较高,A型药品不良反应的发生率较高,抗生素类药物不良反应的发生率较高。轻度和中度药品不良反应的发生率分别为50.0%和46.8%。27.7%的药品不良反应是可预防的。71.4%的药品不良反应至少存在一种易感因素,最常见的易感因素为多种药物合并使用和多种合并症。对患者特征与药品不良反应特征进行相关性分析发现,A型药品不良反应在老年患者的发生率较高,B型药品不良反应在中青年患者的发生率较高。结论:本院药品不良反应自发报告发生情况与其他医院相似。避免药品不良反应常见的易感因素可显著减少或预防药品不良反应的发生,从而保证临床用药安全有效。
Objective AIM To characterize the pattern of ADRs reported in a tertiary teaching hospital in China.METHODS Retrospective evaluation was done for various parameters including patient demographics,drug and reaction characteristics,outcome,causality,severity,preventability,and predisposing factors.RESULTS A total of 220 ADRs were evaluated.The overall incidence of ADR was 0.0077%.At least one ADR was reported in 0.0517%of the hospitalized patients and in 0.0067%of me oulpatients.Incidence of ADRs among elderly adults and older adults were significantly higher than other age groups.Type A reactions accounted for majority of the reports.Antibacterials were the drug class most commonly involved.Upon causality assessment,majority of the reports were rated as probable.Mild and moderate reactions accounted for 50.0%and 46.8%,respectively.In 27.7%of the reports,the reaction was considered to be preventable.At least one predisposing factor was present in 71.4%of the reports and the most common predisposing factors associated were polypharmacy and multiple disease state.Evaluating the relationship between patient characteristics and reaction characteristics,type A reactions were more common among older and elderly adults and type B reactions more common in adults compared to other age groups.CONCLUSION The pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital set up elsewhere.Our evaluations revealed opportunities for interventions especially for the preventable ADRs to ensure safer drug use.
Objective AIM To characterize the pattern of ADRs reported in a tertiary teaching hospital in China.METHODS Retrospective evaluation was done for various parameters including patient demographics,drug and reaction characteristics,outcome,causality,severity,preventability,and predisposing factors.RESULTS A total of 220 ADRs were evaluated.The overall incidence of ADR was 0.0077%.At least one ADR was reported in 0.0517%of the hospitalized patients and in 0.0067%of me oulpatients.Incidence of ADRs among elderly adults and older adults were significantly higher than other age groups.Type A reactions accounted for majority of the reports.Antibacterials were the drug class most commonly involved.Upon causality assessment,majority of the reports were rated as probable.Mild and moderate reactions accounted for 50.0%and 46.8%,respectively.In 27.7%of the reports,the reaction was considered to be preventable.At least one predisposing factor was present in 71.4%of the reports and the most common predisposing factors associated were polypharmacy and multiple disease state.Evaluating the relationship between patient characteristics and reaction characteristics,type A reactions were more common among older and elderly adults and type B reactions more common in adults compared to other age groups.CONCLUSION The pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital set up elsewhere.Our evaluations revealed opportunities for interventions especially for the preventable ADRs to ensure safer drug use.
引文
[1]JOSE J,RAO PG.Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital[J].Pharmacol Res,2006,54(3):226-233.
[2]MARTIN RM,KAPOOR KV,WILTON LV,et al.Under-reporting of suspected adverse drug reactions to newly marketed("black triangle")drugs in general practice:observational study[J].BMJ,1998,317(7151):119-120.
[3]ALVAREZ-REQUEJO A,CARVAJAL A,BEGAUD B,et al.Under-reporting of adverse drug reactions.Estimate based on a spontaneous reporting scheme and a sentinel system[J].Eur J Clin Pharmacol,1998,54(6):483-488.
[4]GALLELLI L,FERRERI G,COLOSIMO M,et al.Retrospective analysis of adverse drug reactions to bronchodilators observed in two pulmonary divisions of Catanzaro,Italy[J].Pharmacol Res,2003,47(6):493-499.
[5]GALLELLI L,FERRERI G,COLOSIMO M,el al.Adverse drug reactions to antibiotics observed in two pulmonology divisions of catanzaro,Italy:a six-year retrospective study[J].Pharmacol Res,2002,46(5):395-400.
[6]M.D.Rawlins,T.J.W.Textbook of adverse drug reactions(1st ed.)[M].Oxford:Oxford University Press,1977:332-335.
[7]European Commission.A guideline on summary of product characteristics[M].European Union Commission,2005:F2.
[8]WHO Collaborating Centre for Drug Statistics Methodology.Completed ATC Index.2005:http://www.whocc.no/atcddd/.
[9]NARANJO CA,BUSTO U,SELLERS EM,et al.A method for estimating the probability of adverse drug reactions[J].Clin Pharmacol Ther,1981,30(2):239-245.
[10]LAU PM,STEWART K,DOOLEY MJ.Comment:hospital admissions resulting from preventable adverse drug reactions[J].Ann Pharmacother,2003,37(2):303-305.
[11]HARTWIG SC,SIEGEL J,SCHNEIDER PJ.Preventability and severity assessment in reporting adverse drug reactions[J].Am J Hosp Pharm,1992,49(9):2229-2232.
[12]G.Parthasarathi O.S.A text book of clinical pharmacy practice-essential concepts and skills(1st ed.)[M].Chennai:Orient Longman Private Limited,2004:86-102.
[13]VEEHOF L,STEWART R,HAAIJER-RUSKAMP F,et al.The development of polypharmacy.A longitudinal study[J].Fam Pract,2000,17(3):261-267.
[14]LAZAROU J,POMERANZ BH,COREY PN.Incidence of adverse drug reactions in hospitalized patients:a meta-analysis of prospective studies[J].JAMA,1998,279(15):1200-1205.
[15]SUH DC,WOOD ALL BS,SHIN SK,et al.Clinical and economic impact of adverse drug reactions in hospitalized patients[J].Ann Pharmacother,2000,34(12):1373-1379.
[16]MURPHY BM,FRIGO LC.Development,implementation,and results of a successful multidisciplinary adverse drug reaction reporting program in a university teaching hospital[J].Hosp Pharm,1993,28(12):1199-1204.
[17]GONZALEZ-MARTIN G,CAROCA CM,PARIS E.Adverse drug reactions(ADRs)in hospitalized pediatric patients.A prospective study[J].Int J Clin Pharmacol Ther,1998,36(10):530-533.
[18]KANJANARAT P,WINTERSTEIN AG,JOHNS TE,et al.Nature of preventable adverse drug events in hospitals:a literature review[J].Am J Health Syst Pharm,2003,60(17):1750-1759.
[19]EVANS RS,LLOYD JF,STODDARD GJ,et al.Risk factors for adverse drug events:a 10-year analysis[J].Ann Pharmacother,2005,39(7-8):1161-1168.
[2]MARTIN RM,KAPOOR KV,WILTON LV,et al.Under-reporting of suspected adverse drug reactions to newly marketed("black triangle")drugs in general practice:observational study[J].BMJ,1998,317(7151):119-120.
[3]ALVAREZ-REQUEJO A,CARVAJAL A,BEGAUD B,et al.Under-reporting of adverse drug reactions.Estimate based on a spontaneous reporting scheme and a sentinel system[J].Eur J Clin Pharmacol,1998,54(6):483-488.
[4]GALLELLI L,FERRERI G,COLOSIMO M,et al.Retrospective analysis of adverse drug reactions to bronchodilators observed in two pulmonary divisions of Catanzaro,Italy[J].Pharmacol Res,2003,47(6):493-499.
[5]GALLELLI L,FERRERI G,COLOSIMO M,el al.Adverse drug reactions to antibiotics observed in two pulmonology divisions of catanzaro,Italy:a six-year retrospective study[J].Pharmacol Res,2002,46(5):395-400.
[6]M.D.Rawlins,T.J.W.Textbook of adverse drug reactions(1st ed.)[M].Oxford:Oxford University Press,1977:332-335.
[7]European Commission.A guideline on summary of product characteristics[M].European Union Commission,2005:F2.
[8]WHO Collaborating Centre for Drug Statistics Methodology.Completed ATC Index.2005:http://www.whocc.no/atcddd/.
[9]NARANJO CA,BUSTO U,SELLERS EM,et al.A method for estimating the probability of adverse drug reactions[J].Clin Pharmacol Ther,1981,30(2):239-245.
[10]LAU PM,STEWART K,DOOLEY MJ.Comment:hospital admissions resulting from preventable adverse drug reactions[J].Ann Pharmacother,2003,37(2):303-305.
[11]HARTWIG SC,SIEGEL J,SCHNEIDER PJ.Preventability and severity assessment in reporting adverse drug reactions[J].Am J Hosp Pharm,1992,49(9):2229-2232.
[12]G.Parthasarathi O.S.A text book of clinical pharmacy practice-essential concepts and skills(1st ed.)[M].Chennai:Orient Longman Private Limited,2004:86-102.
[13]VEEHOF L,STEWART R,HAAIJER-RUSKAMP F,et al.The development of polypharmacy.A longitudinal study[J].Fam Pract,2000,17(3):261-267.
[14]LAZAROU J,POMERANZ BH,COREY PN.Incidence of adverse drug reactions in hospitalized patients:a meta-analysis of prospective studies[J].JAMA,1998,279(15):1200-1205.
[15]SUH DC,WOOD ALL BS,SHIN SK,et al.Clinical and economic impact of adverse drug reactions in hospitalized patients[J].Ann Pharmacother,2000,34(12):1373-1379.
[16]MURPHY BM,FRIGO LC.Development,implementation,and results of a successful multidisciplinary adverse drug reaction reporting program in a university teaching hospital[J].Hosp Pharm,1993,28(12):1199-1204.
[17]GONZALEZ-MARTIN G,CAROCA CM,PARIS E.Adverse drug reactions(ADRs)in hospitalized pediatric patients.A prospective study[J].Int J Clin Pharmacol Ther,1998,36(10):530-533.
[18]KANJANARAT P,WINTERSTEIN AG,JOHNS TE,et al.Nature of preventable adverse drug events in hospitals:a literature review[J].Am J Health Syst Pharm,2003,60(17):1750-1759.
[19]EVANS RS,LLOYD JF,STODDARD GJ,et al.Risk factors for adverse drug events:a 10-year analysis[J].Ann Pharmacother,2005,39(7-8):1161-1168.