中美药物临床试验中的药品管理现状比较
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摘要
目的:为完善我国药物临床试验中的药品管理提出建议。方法:以"药物临床试验质量管理规范""临床试验药物""临床试验用药品""GCP""Investigational drug products"等为关键词,组合查询中国知网、万方数据、PubMed、OVID等数据库2014年7月-2018年7月收录的相关文献,对中美药物临床试验中的药品管理指南、管理体系(包括管理模式、人员配置、预算评估)的差异进行归纳总结,并对我国临床试验用药品管理过程中的不足提出建议。结果与结论:共检索到相关文献154篇,其中有效文献33篇。美国临床试验用药品管理指南较为完善,比如有美国医院药师学会颁布的《临床试验药品管理指南》,而我国尚未出台此类全国性指南。美国临床试验用药品管理包括医院药事部门药师兼职管理和多名专职药师与药学技术员管理2种模式,由药师或药学技术人员参与管理的全流程,且对临床试验用药品管理预算评估开展了较多研究;我国临床试验用药品管理包括专职药师管理、专职药师与兼职护士管理、兼职药师与兼职护士管理3种模式,由药师和护士共同参与管理但尚未做到全流程管理,且对临床试验用药品管理预算评估研究较少。建议我国临床试验用药品管理可通过细化临床试验用药品管理制度、规范临床试验用药品管理模式以及开展管理预算评估等方式,提高临床试验用药品的管理效率和水平,促进我国药物临床试验管理质量的提升。
OBJECTIVE:To put forward the suggestions for improving drug management in clinical drug trials in China.METHODS:"Good clinical practice""Clinical trials drug""Drugs for clinical trials""GCP""Investigational drug products"as search terms,searching CNKI database,Wanfang database,PubMed database and OVID electronic journal full-text database during Jul.2014-Jul.2018.The differences of drug management guidelines and management systems(including management model,staffing and budget evaluation)in clinical drugs between China and the United States were summarized.The suggestions were put forward to the shortage of drugs management of clinical trials in China.RESULTS&CONCLUSIONS:A total of 154literatures were retrieved,including 33 valid literatures.The guidelines for drug management in clinical trials in the United States were relatively perfect,such as the Guidelines for Drug Management in Clinical Trials promulgated by the American Society of Hospital Pharmacists,while China had not yet published such national guidelines.The drug management in clinical trials in the United States had two modes which is the management of part-time pharmacists in hospital pharmacy department and the management of several full-time pharmacists and pharmacy technicians.Pharmacists or pharmaceutical technicians participated in the whole process of management,and a lot of research was carried out on the budget evaluation of clinical trials drug management.Domestic clinical trials drug management included three modes which is full-time pharmacist management,full-time pharmacist and part-time nurse management,part-time pharmacist and part-time nurse management.Pharmacists and nurses jointly participated in the management,but the whole process management had not yet been achieved,and there were few studies on budget evaluation of clinical trials drug management.It is suggested that the management of clinical trials drug in China can improve the management efficiency and level of clinical trials drug by refining the management system of clinical trials drug,standardizing the management mode of clinical trials drug and carrying out management budget evaluation.
OBJECTIVE:To put forward the suggestions for improving drug management in clinical drug trials in China.METHODS:"Good clinical practice""Clinical trials drug""Drugs for clinical trials""GCP""Investigational drug products"as search terms,searching CNKI database,Wanfang database,PubMed database and OVID electronic journal full-text database during Jul.2014-Jul.2018.The differences of drug management guidelines and management systems(including management model,staffing and budget evaluation)in clinical drugs between China and the United States were summarized.The suggestions were put forward to the shortage of drugs management of clinical trials in China.RESULTS&CONCLUSIONS:A total of 154literatures were retrieved,including 33 valid literatures.The guidelines for drug management in clinical trials in the United States were relatively perfect,such as the Guidelines for Drug Management in Clinical Trials promulgated by the American Society of Hospital Pharmacists,while China had not yet published such national guidelines.The drug management in clinical trials in the United States had two modes which is the management of part-time pharmacists in hospital pharmacy department and the management of several full-time pharmacists and pharmacy technicians.Pharmacists or pharmaceutical technicians participated in the whole process of management,and a lot of research was carried out on the budget evaluation of clinical trials drug management.Domestic clinical trials drug management included three modes which is full-time pharmacist management,full-time pharmacist and part-time nurse management,part-time pharmacist and part-time nurse management.Pharmacists and nurses jointly participated in the management,but the whole process management had not yet been achieved,and there were few studies on budget evaluation of clinical trials drug management.It is suggested that the management of clinical trials drug in China can improve the management efficiency and level of clinical trials drug by refining the management system of clinical trials drug,standardizing the management mode of clinical trials drug and carrying out management budget evaluation.
引文
[1]沈玉红,张正付,李正奇.药物临床试验中试验药物管理存在的问题与对策[J].中国药房,2011,22(22):2093-2094.
[2]ICH.Integrated addendum to ICH E6(R1):guideline for good clinical practice E6(R2)[EB/OL].(2016-12-15)[2018-04-03].www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6.
[3]国家食品药品监督管理总局.药物临床试验质量管理规范[EB/OL].(2003-08-06)[2018-07-05].http://samr.cfda.gov.cn/WS01/CL1031/24473.html.
[4]BARTON A.Handbook for good clinical research practice:guidance for implementation[J].J Epidemiol Community Health,2007,61(6):559.
[5]AGARWAL DR SP.Good clinical practices for clinical research in India[EB/OL].(2007-05-03)[2018-07-09].http://www.cdsco.nic.in/html/GCP1.html.
[6]田少雷,邵庆翔.药物临床试验与GCP实用指南[M].2版.北京:北京大学医学出版社,2010:20-35.
[7]KAY SC,LUKE DG,TAMER HR.ASHP:guidelines for the management of investigational drug products[J].Am JHealth Syst Pharm,2018,75(8):561-573.
[8]杨忠奇,赖育健,吴波林,等.药物临床试验药物管理·广东共识[J].今日药学,2015,25(2):75-76.
[9]STOLAR MH,GABRIEL T,GRANT KL,et al.Pharmacy-coordinated investigational drug services[J].Am JHosp Pharm,1982,39(3):232.
[10]JEON JE,MIGHTY J,LANE K,et al.Participation of a coordinating center pharmacy in a multicenter international study[J].Am J Health Syst Pharm,2016,73(22):1859-1868.
[11]CRUZ JL,BROWN JN.Safety risks with investigational drugs:pharmacy practices and perceptions in the veterans affairs health system[J].Ther Adv Drug Saf,2015,6(3):103-109.
[12]何晓宇.澳洲监察员浅谈药剂师在临床试验中的作用[J].中国处方药,2013,11(6):91-92.
[13]WERMELING DP.Clinical research:regulatory issues[J].Am J Health Syst Pharm,1999,56(3):252-256.
[14]LAFLEUR J,TYLER LS,SHARMA RR.Economic benefits of investigational drug services at an academic institution[J].Am J Health Syst Pharm,2004,61(1):27-32.
[15]IDOATE A,ORTEGA A,CARRERA FJ,et al.Cost-evaluation model for clinical trials in a hospital pharmacy service[J].Pharm World Sci,1995,17(5):172-176.
[16]ASHP.Budget estimate for investigational drug services[EB/OL].[2018-11-04].https://www.ashp.org/-/media/assets/pharmacy-practice/resource-centers/investigationaldrug-services/articles-and-guidelines-example-investigational-drug-budget-form.ashx.
[17]张斅琳.临床试验用药物管理模式的现状调查和存在问题分析[D].广州:暨南大学,2015.
[18]肖忠革,周礼明,田卓平,等.以GCP原则指导医院药物临床试验机构的建设和管理[J].中国药房,2007,18(10):733-735.
[19]赵彤芳,元唯安,郁韶明,等.信息化管理系统在试验药物中心化管理中的应用[J].药物评价研究,2016,39(5):881-884.
[20]马颖,彭朋,元唯安.关于临床试验药物中心药房的管理和思考[J].中国卫生产业,2016,13(33):177-179.
[21]林颖,黄盛超.某院GCP药房的管理体会[J].中国处方药,2014,12(10):4-6.
[22]刘业娜,王艺,刘韬,等.某临床试验研究中心GCP药房的运作管理[J].今日药学,2016,26(3):213-216.
[23]王彦荣,张丽娟,陈桂玲,等.我院临床试验用药品管理模式的建立[J].中国药房,2014,25(5):408-410.
[24]罗翠霞,梁小帆.临床试验标准操作规程之药房管理[J].实用药物与临床,2009,12(4):302-303.
[25]王槐芾.我院药物临床试验机构药房药品管理实践体会[J].中国药房,2015,26(28):3909-3911.
[26]王露,黄淑萍,张洁.我院药物临床试验药品管理过程中的实践体会[J].天津药学,2016,28(6):48-49.
[27]张朝欣,陈硕.医疗机构药物临床试验经费管理中存在的若干问题及对策研究[J].中国卫生产业,2016,13(24):177-179.
[28]国家食品药品监督管理总局药品审评中心.2017年度药品审评报告[EB/OL].(2018-03-23)[2018-04-03].www.cde.org.cn/news.do?method=view Info Common&id=314402.
[29]谢婷,王子寿,何韦静,等.临床试验药物管理规范性要点探讨[J].中药与临床,2015,6(1):45-47.
[30]肖妤,曾代文,严晓梁,等.由我国临床试验用药物管理存在的问题引发的思考[J].实用医院临床杂志,2012,9(1):167-169.
[31]刘峰,邓贵新,李雪芹,等.试验药物管理中存在的问题及对策探讨[J].中国医药导报,2017,14(20):128-131.
[32]王白璐.药物临床试验质量管理评价研究[D].济南:山东大学,2012.
[33]管海燕,宋丹,徐靖.临床试验静脉用药调配中心的应用可行性研究[J].中国医院药学杂志,2018,38(3):305-308.
[2]ICH.Integrated addendum to ICH E6(R1):guideline for good clinical practice E6(R2)[EB/OL].(2016-12-15)[2018-04-03].www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6.
[3]国家食品药品监督管理总局.药物临床试验质量管理规范[EB/OL].(2003-08-06)[2018-07-05].http://samr.cfda.gov.cn/WS01/CL1031/24473.html.
[4]BARTON A.Handbook for good clinical research practice:guidance for implementation[J].J Epidemiol Community Health,2007,61(6):559.
[5]AGARWAL DR SP.Good clinical practices for clinical research in India[EB/OL].(2007-05-03)[2018-07-09].http://www.cdsco.nic.in/html/GCP1.html.
[6]田少雷,邵庆翔.药物临床试验与GCP实用指南[M].2版.北京:北京大学医学出版社,2010:20-35.
[7]KAY SC,LUKE DG,TAMER HR.ASHP:guidelines for the management of investigational drug products[J].Am JHealth Syst Pharm,2018,75(8):561-573.
[8]杨忠奇,赖育健,吴波林,等.药物临床试验药物管理·广东共识[J].今日药学,2015,25(2):75-76.
[9]STOLAR MH,GABRIEL T,GRANT KL,et al.Pharmacy-coordinated investigational drug services[J].Am JHosp Pharm,1982,39(3):232.
[10]JEON JE,MIGHTY J,LANE K,et al.Participation of a coordinating center pharmacy in a multicenter international study[J].Am J Health Syst Pharm,2016,73(22):1859-1868.
[11]CRUZ JL,BROWN JN.Safety risks with investigational drugs:pharmacy practices and perceptions in the veterans affairs health system[J].Ther Adv Drug Saf,2015,6(3):103-109.
[12]何晓宇.澳洲监察员浅谈药剂师在临床试验中的作用[J].中国处方药,2013,11(6):91-92.
[13]WERMELING DP.Clinical research:regulatory issues[J].Am J Health Syst Pharm,1999,56(3):252-256.
[14]LAFLEUR J,TYLER LS,SHARMA RR.Economic benefits of investigational drug services at an academic institution[J].Am J Health Syst Pharm,2004,61(1):27-32.
[15]IDOATE A,ORTEGA A,CARRERA FJ,et al.Cost-evaluation model for clinical trials in a hospital pharmacy service[J].Pharm World Sci,1995,17(5):172-176.
[16]ASHP.Budget estimate for investigational drug services[EB/OL].[2018-11-04].https://www.ashp.org/-/media/assets/pharmacy-practice/resource-centers/investigationaldrug-services/articles-and-guidelines-example-investigational-drug-budget-form.ashx.
[17]张斅琳.临床试验用药物管理模式的现状调查和存在问题分析[D].广州:暨南大学,2015.
[18]肖忠革,周礼明,田卓平,等.以GCP原则指导医院药物临床试验机构的建设和管理[J].中国药房,2007,18(10):733-735.
[19]赵彤芳,元唯安,郁韶明,等.信息化管理系统在试验药物中心化管理中的应用[J].药物评价研究,2016,39(5):881-884.
[20]马颖,彭朋,元唯安.关于临床试验药物中心药房的管理和思考[J].中国卫生产业,2016,13(33):177-179.
[21]林颖,黄盛超.某院GCP药房的管理体会[J].中国处方药,2014,12(10):4-6.
[22]刘业娜,王艺,刘韬,等.某临床试验研究中心GCP药房的运作管理[J].今日药学,2016,26(3):213-216.
[23]王彦荣,张丽娟,陈桂玲,等.我院临床试验用药品管理模式的建立[J].中国药房,2014,25(5):408-410.
[24]罗翠霞,梁小帆.临床试验标准操作规程之药房管理[J].实用药物与临床,2009,12(4):302-303.
[25]王槐芾.我院药物临床试验机构药房药品管理实践体会[J].中国药房,2015,26(28):3909-3911.
[26]王露,黄淑萍,张洁.我院药物临床试验药品管理过程中的实践体会[J].天津药学,2016,28(6):48-49.
[27]张朝欣,陈硕.医疗机构药物临床试验经费管理中存在的若干问题及对策研究[J].中国卫生产业,2016,13(24):177-179.
[28]国家食品药品监督管理总局药品审评中心.2017年度药品审评报告[EB/OL].(2018-03-23)[2018-04-03].www.cde.org.cn/news.do?method=view Info Common&id=314402.
[29]谢婷,王子寿,何韦静,等.临床试验药物管理规范性要点探讨[J].中药与临床,2015,6(1):45-47.
[30]肖妤,曾代文,严晓梁,等.由我国临床试验用药物管理存在的问题引发的思考[J].实用医院临床杂志,2012,9(1):167-169.
[31]刘峰,邓贵新,李雪芹,等.试验药物管理中存在的问题及对策探讨[J].中国医药导报,2017,14(20):128-131.
[32]王白璐.药物临床试验质量管理评价研究[D].济南:山东大学,2012.
[33]管海燕,宋丹,徐靖.临床试验静脉用药调配中心的应用可行性研究[J].中国医院药学杂志,2018,38(3):305-308.