我院超说明书用药管理体系构建的实践与探索
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摘要
目的:构建医疗机构超说明书用药管理体系,规范医疗机构超说明书用药行为,提升合理用药水平。方法:建立我院基于循证研究的超说明书用药管理制度,并开展临床实践,以超说明书用药的备案条数、审批通过率等指标评价所建管理体系的运行效果。结果:自2011年起,我院逐步建立并完善了超说明书用药管理制度,建立了多学科团队参与、以药品临床证据质量分级为基础的院内超说明书用药的备案与审批模式。至2016年底,共提交超说明书备案252条,其中儿科159条(占59.77%)、妇产科93条(占34.96%);在提交的超说明书备案药品中,有181个通过审批,通过率为64.29%;专项处方点评提示住院医嘱中超说明书用药医嘱呈下降趋势,已备案的超说明书用药医嘱比率从2013年的17.33%提升到2016年的84.00%。结论:构建的医疗机构超说明书用药管理体系能有效促进临床对超说明书用药的认识,规范超说明书用药行为。
OBJECTIVE: To establish the management system for off-label drug use in a medical institutions, and to standardize the behaviors of off-label drug use and improve the rational drug use. METHODS:Based on evidence-based researches for off-label drug use, management system of off-label drug use was established in our hospital, and off-label drug use management was carried out. The effects of management system were evaluated with the number of records for off-label drug use and pass rate of approval as indexes. RESULTS:Since the year of 2011,the management system for off-label drug use had gradually established and improved in our hospital;the mode of registration and approval for off-label drug use was established by based on a multi-disciplinary team management and quality classification for clinical evidence. Up to 2016,a total of 252 records for off-label use were submitted,among which 159 (accounting for 59.77%) were for pediatrics and 93(accounting for 34.96%) were for gynecology and obstetrics. Among the submitted records,181 had passed the examination and approval,and the pass rate was 64.29%. Special prescription comments indicated that the numbers of off-label use medical orders in inpatient medical orders showed a downward trend,and the proportion of recorded medical orders of off-label use had increased from 17.33% in 2013 to 84.00% in 2016. CONCLUSIONS:The management system for off-label drug use in medical institutions can effectively improve the clinical understanding of off-label drug use,standardize the behavior of off-label drug use.
OBJECTIVE: To establish the management system for off-label drug use in a medical institutions, and to standardize the behaviors of off-label drug use and improve the rational drug use. METHODS:Based on evidence-based researches for off-label drug use, management system of off-label drug use was established in our hospital, and off-label drug use management was carried out. The effects of management system were evaluated with the number of records for off-label drug use and pass rate of approval as indexes. RESULTS:Since the year of 2011,the management system for off-label drug use had gradually established and improved in our hospital;the mode of registration and approval for off-label drug use was established by based on a multi-disciplinary team management and quality classification for clinical evidence. Up to 2016,a total of 252 records for off-label use were submitted,among which 159 (accounting for 59.77%) were for pediatrics and 93(accounting for 34.96%) were for gynecology and obstetrics. Among the submitted records,181 had passed the examination and approval,and the pass rate was 64.29%. Special prescription comments indicated that the numbers of off-label use medical orders in inpatient medical orders showed a downward trend,and the proportion of recorded medical orders of off-label use had increased from 17.33% in 2013 to 84.00% in 2016. CONCLUSIONS:The management system for off-label drug use in medical institutions can effectively improve the clinical understanding of off-label drug use,standardize the behavior of off-label drug use.
引文
[1]张伶俐,李幼平,梁毅,等.全球门诊儿童超说明书用药现状的系统评价[J].中国循证医学杂志,2012,12(3):305-313.
[2]张伶俐,李幼平,梁毅,等.全球住院儿童超说明书用药现状的系统评价[J].中国循证医学杂志,2012,12(2):176-187.
[3]张伶俐,李幼平,黄亮,等.四川大学华西第二医院儿科门诊处方超药品说明书用药情况调查[J].中国循证医学杂志,2011,11(10):1120-1124.
[4]张伶俐,李幼平,黄亮,等.四川大学华西第二医院2010年儿科门诊患儿超说明书用药情况调查[J].中国循证医学杂志,2012,12(3):267-273.
[5]张伶俐,李幼平,胡蝶,等.四川大学华西第二医院2010年儿科住院患儿超说明书用药情况调查[J].中国循证医学杂志,2012,12(2):161-167.
[6]张伶俐,李幼平,曾力楠,等.15国超说明书用药政策的循证评价[J].中国循证医学杂志,2012,12(4):426-435.
[7]American Society of Hospital Pharmacists.ASHP statement on the use of medications for unlabeled uses[J].Am J Hospital Pharm,1992,49(8):2006-2008.
[8]NCBI.Mesh:off-label use[EB/OL].(2010-11-08)[2018-11-02].https://www.ncbi.nlm.nih.gov/mesh/?term=off+label+drug+use.
[9]杨悦,何畔,邹韵,等.推荐分级的评估、制定与评价方法以及WHO在基本药物遴选中的应用[J].中国药房,2011,22(32):2977-2981.
[10]黄亮,申向黎,张伶俐,等.正确认识并有效规范超说明书用药行为[J].中国医院药学杂志,2009,29(11):949-951.
[11]Wold Medical Association.WMA declaration of Helsinki-ethical principles for medical research involving human subjects[EB/OL].(2013-10-30)[2018-11-02].https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/.
[12]广东省药学会.药品未注册用法专家共识[EB/OL].(2010-03-08)[2018-11-02].http://www.sinopharmacy.com.cn/download/1.html
[13]KATHLEEN K,TERRY G.药物和治疗学委员会实践指南:中文版[S].中国医院协会药事管理专业委员会译,北京:2006.
[14]中国药理学会治疗药物监测研究专业委员会药品风险管理学组.超说明书用药专家共识[J].药物不良反应杂志,2015,7(2):101-103.
[15]中华医学会儿科学分会临床药理学组.中国儿科超说明书用药专家共识[J].中华儿科杂志,2016,54(2):101-103.
[2]张伶俐,李幼平,梁毅,等.全球住院儿童超说明书用药现状的系统评价[J].中国循证医学杂志,2012,12(2):176-187.
[3]张伶俐,李幼平,黄亮,等.四川大学华西第二医院儿科门诊处方超药品说明书用药情况调查[J].中国循证医学杂志,2011,11(10):1120-1124.
[4]张伶俐,李幼平,黄亮,等.四川大学华西第二医院2010年儿科门诊患儿超说明书用药情况调查[J].中国循证医学杂志,2012,12(3):267-273.
[5]张伶俐,李幼平,胡蝶,等.四川大学华西第二医院2010年儿科住院患儿超说明书用药情况调查[J].中国循证医学杂志,2012,12(2):161-167.
[6]张伶俐,李幼平,曾力楠,等.15国超说明书用药政策的循证评价[J].中国循证医学杂志,2012,12(4):426-435.
[7]American Society of Hospital Pharmacists.ASHP statement on the use of medications for unlabeled uses[J].Am J Hospital Pharm,1992,49(8):2006-2008.
[8]NCBI.Mesh:off-label use[EB/OL].(2010-11-08)[2018-11-02].https://www.ncbi.nlm.nih.gov/mesh/?term=off+label+drug+use.
[9]杨悦,何畔,邹韵,等.推荐分级的评估、制定与评价方法以及WHO在基本药物遴选中的应用[J].中国药房,2011,22(32):2977-2981.
[10]黄亮,申向黎,张伶俐,等.正确认识并有效规范超说明书用药行为[J].中国医院药学杂志,2009,29(11):949-951.
[11]Wold Medical Association.WMA declaration of Helsinki-ethical principles for medical research involving human subjects[EB/OL].(2013-10-30)[2018-11-02].https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/.
[12]广东省药学会.药品未注册用法专家共识[EB/OL].(2010-03-08)[2018-11-02].http://www.sinopharmacy.com.cn/download/1.html
[13]KATHLEEN K,TERRY G.药物和治疗学委员会实践指南:中文版[S].中国医院协会药事管理专业委员会译,北京:2006.
[14]中国药理学会治疗药物监测研究专业委员会药品风险管理学组.超说明书用药专家共识[J].药物不良反应杂志,2015,7(2):101-103.
[15]中华医学会儿科学分会临床药理学组.中国儿科超说明书用药专家共识[J].中华儿科杂志,2016,54(2):101-103.