试验药物管理中存在的问题及对策探讨
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摘要
在药物临床试验过程中,研究药物的管理是试验过程中的重要组成部分。本文根据广东省中山市人民医院药物临床试验机构试验药物管理中存在的主要问题,如试验药物管理疏漏,登记表格复杂;专业科室药物管理混乱,不能规范管理药物;手写处方增加研究者工作量;无温湿度监控系统,难以保证药物有效性和安全性等,通过修订、完善试验药物管理制度及标准操作规程,成立机构药房,进行免费药物编码,使用温湿度监控系统,加强试验药物监控等措施提高了试验药物的管理。强调各机构应根据实际情况,制订适合自己机构的药物管理制度及标准操作规程,并不断完善,以提高试验药物管理的可操作性,从而保证试验药物的安全、有效。
In the process of drug clinical trials, the experimental drug management is an important part in the process of study. According to the main problems in the management of experimental drugs in Drug Clinical Trial Institution,Zhongshan People's Hospital, such as management oversight in experimental drugs, the registration form is complicated;the drug management of professional department is so disorder that it can not be managed normatively; the hand-written prescription increases the workload of researchers; there is no monitoring system of temperature and humidity, so it is difficult to guarantee the drug efficacy and safety, and so on, through using the measures of revising and perfecting experimental drug management system and standard operation procedure, establishing institutional pharmacy, taking free drug coding, using the temperature and humidity monitoring system to strengthen the experimental drug monitoring.It is emphasized that the institutions should formulate the experimental drug management system and standard operation procedure for their own institutions and continue to improve base on the actual situation, in order to improve the operability of experimental drug management, so as to ensure the safety and efficacy of experimental drugs.
In the process of drug clinical trials, the experimental drug management is an important part in the process of study. According to the main problems in the management of experimental drugs in Drug Clinical Trial Institution,Zhongshan People's Hospital, such as management oversight in experimental drugs, the registration form is complicated;the drug management of professional department is so disorder that it can not be managed normatively; the hand-written prescription increases the workload of researchers; there is no monitoring system of temperature and humidity, so it is difficult to guarantee the drug efficacy and safety, and so on, through using the measures of revising and perfecting experimental drug management system and standard operation procedure, establishing institutional pharmacy, taking free drug coding, using the temperature and humidity monitoring system to strengthen the experimental drug monitoring.It is emphasized that the institutions should formulate the experimental drug management system and standard operation procedure for their own institutions and continue to improve base on the actual situation, in order to improve the operability of experimental drug management, so as to ensure the safety and efficacy of experimental drugs.
引文
[1]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)[2014-12-01].http://www.sfda.gov.cn/WS01/CL0053/24473.html.
[2]国家食品药品监督管理总局.《药物临床试验机构资格认定检查细则(试行)》征求意见稿[S].2014-09-05.
[3]国家食品药品监督管理局.关于印发《药物临床试验机构资格认定办法(试行)》的通知[S].2004-02-19.
[4]袁培明.临床科室药物管理存在的问题及对策探讨[J].中国卫生产业,2015,4(15):65-66.
[5]余元龙,苏韶生,程敏婷,等.数字化医院数据资源开发研究和实践[J].中国数字医学,2012,8(15):108-110.
[6]杨樱,容颖慈,喻丽元,等.临床科室药物管理存在的问题及对策探讨[J].中国卫生产业,2015,4(15):65-66.
[7]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.
[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(2014年)[J].今日药学,2015,25(2):75-76.
[9]刘畅,宁华.临床试验药品细节管理[J].基层医学论坛,2009,13(2):158-159.
[10]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.
[11]刘侃,王东文,王小玲,等.特殊药品电子处方系统的设计与应用[J].中国数字医学,2015,10(7):62-64.
[12]洪东升,杨志海,卢晓阳,等.试验用药物管理信息系统的设计与实现[J].现代医院管理,2013,11(4):70-72.
[13]王晨静,柳艳平,李欣,等.药物临床试验过程中研究药物的管理特点[J].中国临床药理学杂志,2016,32(9):858-860.
[14]李树婷,杨丽,张黎,等.临床研究药物中心化管理现场评估标准[J].药物评价研究,2016,39(3):335-344.
[15]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.
[2]国家食品药品监督管理总局.《药物临床试验机构资格认定检查细则(试行)》征求意见稿[S].2014-09-05.
[3]国家食品药品监督管理局.关于印发《药物临床试验机构资格认定办法(试行)》的通知[S].2004-02-19.
[4]袁培明.临床科室药物管理存在的问题及对策探讨[J].中国卫生产业,2015,4(15):65-66.
[5]余元龙,苏韶生,程敏婷,等.数字化医院数据资源开发研究和实践[J].中国数字医学,2012,8(15):108-110.
[6]杨樱,容颖慈,喻丽元,等.临床科室药物管理存在的问题及对策探讨[J].中国卫生产业,2015,4(15):65-66.
[7]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.
[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(2014年)[J].今日药学,2015,25(2):75-76.
[9]刘畅,宁华.临床试验药品细节管理[J].基层医学论坛,2009,13(2):158-159.
[10]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.
[11]刘侃,王东文,王小玲,等.特殊药品电子处方系统的设计与应用[J].中国数字医学,2015,10(7):62-64.
[12]洪东升,杨志海,卢晓阳,等.试验用药物管理信息系统的设计与实现[J].现代医院管理,2013,11(4):70-72.
[13]王晨静,柳艳平,李欣,等.药物临床试验过程中研究药物的管理特点[J].中国临床药理学杂志,2016,32(9):858-860.
[14]李树婷,杨丽,张黎,等.临床研究药物中心化管理现场评估标准[J].药物评价研究,2016,39(3):335-344.
[15]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.