基于学术论文及药品说明书信息构建药品不良反应风险指数
|
摘要
根据药品的说明书及学术论文中涉及药品不良反应发生率的相关信息设计了药品不良反应风险指数的指标体系,包括由药品说明书所对应的实际部分指标、学术论文所对应的潜在部分指标和相关学术论文总量独立指标三部分,对提升用药的规范程度、减少因药品不良反应而产生的医疗资源浪费,具有现实意义。
This article designs the index system of adverse drug reaction risk index based on the dispensatory and the related information in the research paper about adverse drug reaction incidence. In this index system,the index target includes three parts such as the actual part's index of the dispensatory,the potential part's index of the research paper and the total independent index of related research paper. This index has the practical significance to improve the standard of drug using and reduce the waste of medical resources caused by adverse drug reactions.
This article designs the index system of adverse drug reaction risk index based on the dispensatory and the related information in the research paper about adverse drug reaction incidence. In this index system,the index target includes three parts such as the actual part's index of the dispensatory,the potential part's index of the research paper and the total independent index of related research paper. This index has the practical significance to improve the standard of drug using and reduce the waste of medical resources caused by adverse drug reactions.
引文
[1]赵克健.现代药学名词手册[M].北京:中药医药科技出版社,2004.
[2]刘敏豪,邬倩倩.我院药品说明书现状调查及其相关风险分析[J].中国药房,2012,23(17):1619-1621.
[3]陈东伟.药品说明书的调查与分析[J].中国实用医药,2013,8(08):271-273.
[4]龚海虹,林志强.原研与国产仿制抗菌药物药品说明书的对比分析[J].中国药房,2015,26(01):141-144.
[5]Morikawa K.Analysis of drug safety information using largescale adverse drug reactions database[J].Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku,2011(1):1-26.
[6]副作用/有害事象が疑われる症例報告に関する情報について(平成16年度以降の報告)[EB/OL].(2015-06-30)[2018-01-04].http://www.info.pmda.go.jp/fsearchnew/jsp/menu_fukusayou_base.jsp.
[7]Nakamura M,Umetsu R,Abe J,Matsui T,Ueda N,Kato Y,et al.Analysis of the time-to-onset of osteonecrosis of jaw with bisphosphonate treatment using the data from a spontaneous reporting system of adverse drug events[J].Pharm Health Care Sci,2015(1):34.
[8]Abe J,Umetsu R,Mataki K,et al.Analysis of Stevens-Johnson syndrome and toxic epidermal necrolysis using the Japanese Adverse Drug Event Report database[J].Journal of Pharmaceutical Health Care&Sciences,2016,2(1):1-10.
[9]国家药品不良反应监测年度报告(2016年)[EB/OL].(2017-04-28)[2018-01-04].http://www.sda.gov.cn/WS01/CL0844/172167.html.
[10]杨延音,董志,夏永鹏.新《药品不良反应报告和监测管理办法》重点解读及应对模式探讨[J].中国药学杂志,2012,47(15):1263-1264.
[11]基本概念:如何表示不良反应发生率[EB/OL].(2011-07-05)[2018-01-04].http://www.sda.gov.cn/WS01/CL0747/63723.html.
[2]刘敏豪,邬倩倩.我院药品说明书现状调查及其相关风险分析[J].中国药房,2012,23(17):1619-1621.
[3]陈东伟.药品说明书的调查与分析[J].中国实用医药,2013,8(08):271-273.
[4]龚海虹,林志强.原研与国产仿制抗菌药物药品说明书的对比分析[J].中国药房,2015,26(01):141-144.
[5]Morikawa K.Analysis of drug safety information using largescale adverse drug reactions database[J].Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku,2011(1):1-26.
[6]副作用/有害事象が疑われる症例報告に関する情報について(平成16年度以降の報告)[EB/OL].(2015-06-30)[2018-01-04].http://www.info.pmda.go.jp/fsearchnew/jsp/menu_fukusayou_base.jsp.
[7]Nakamura M,Umetsu R,Abe J,Matsui T,Ueda N,Kato Y,et al.Analysis of the time-to-onset of osteonecrosis of jaw with bisphosphonate treatment using the data from a spontaneous reporting system of adverse drug events[J].Pharm Health Care Sci,2015(1):34.
[8]Abe J,Umetsu R,Mataki K,et al.Analysis of Stevens-Johnson syndrome and toxic epidermal necrolysis using the Japanese Adverse Drug Event Report database[J].Journal of Pharmaceutical Health Care&Sciences,2016,2(1):1-10.
[9]国家药品不良反应监测年度报告(2016年)[EB/OL].(2017-04-28)[2018-01-04].http://www.sda.gov.cn/WS01/CL0844/172167.html.
[10]杨延音,董志,夏永鹏.新《药品不良反应报告和监测管理办法》重点解读及应对模式探讨[J].中国药学杂志,2012,47(15):1263-1264.
[11]基本概念:如何表示不良反应发生率[EB/OL].(2011-07-05)[2018-01-04].http://www.sda.gov.cn/WS01/CL0747/63723.html.