中药注射剂医院集中监测“三位一体”模式的建立(4)
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Establishment of model of traditional Chinese medicine injections
post-marketing safety monitoring
GUO Xin-e1， ZHAO Yu-bin1， XIE Yan-ming3*， ZHAO Li-cai1， LI Yan-feng1， HAO Zhe2
(1.Shijiazhuang City Chinese Medicine Hospital Affiliated to Hebei Medical University， Shijiazhuang 050000， China；
2. Shijiazhuang Third Hospital， Shijiazhuang 050011， China；
3. Chinese Basic Research in Clinical Medicine of Chinese Academy of Sciences， Beijing 100700， China)
[Abstract] Objective： To establish a nurse based post-marketing safety surveillance model for traditional Chinese medicine injections(TCMIs). Method： A TCMIs safety monitoring team and a research hospital team engaged in the research， monitoring processes， and quality control processes were established， in order to achieve comprehensive， timely， accurate and real-time access to research data， to eliminate errors in data collection. Result： A triage system involving a study nurse， as the first point of contact， clinicians and clinical pharmacists was set up in a TCM hospital. Following the specified workflow involving labeling of TCM injections and using improved monitoring forms it was found that there were no missing reports at the ratio of error was zero. Conclusion： A research nurse as the first and main point of contact in post-marketing safety monitoring of TCM as part of a triage model， ensures that research data collected has the characteristics of authenticity， accuracy， timeliness， integrity， and eliminate errors during the process of data collection. Hospital based monitoring is a robust and operable process.
[Key words] traditional Chinese medicine injections； safety monitoring； post-marketing drug assessment； study nurse
doi：10.4268/cjcmm20131811, 百拇医药(郭新娥 赵玉斌 谢雁鸣 赵丽彩 李燕峰 郝哲)
Establishment of model of traditional Chinese medicine injections
post-marketing safety monitoring
GUO Xin-e1， ZHAO Yu-bin1， XIE Yan-ming3*， ZHAO Li-cai1， LI Yan-feng1， HAO Zhe2
(1.Shijiazhuang City Chinese Medicine Hospital Affiliated to Hebei Medical University， Shijiazhuang 050000， China；
2. Shijiazhuang Third Hospital， Shijiazhuang 050011， China；
3. Chinese Basic Research in Clinical Medicine of Chinese Academy of Sciences， Beijing 100700， China)
[Abstract] Objective： To establish a nurse based post-marketing safety surveillance model for traditional Chinese medicine injections(TCMIs). Method： A TCMIs safety monitoring team and a research hospital team engaged in the research， monitoring processes， and quality control processes were established， in order to achieve comprehensive， timely， accurate and real-time access to research data， to eliminate errors in data collection. Result： A triage system involving a study nurse， as the first point of contact， clinicians and clinical pharmacists was set up in a TCM hospital. Following the specified workflow involving labeling of TCM injections and using improved monitoring forms it was found that there were no missing reports at the ratio of error was zero. Conclusion： A research nurse as the first and main point of contact in post-marketing safety monitoring of TCM as part of a triage model， ensures that research data collected has the characteristics of authenticity， accuracy， timeliness， integrity， and eliminate errors during the process of data collection. Hospital based monitoring is a robust and operable process.
[Key words] traditional Chinese medicine injections； safety monitoring； post-marketing drug assessment； study nurse
doi：10.4268/cjcmm20131811, 百拇医药(郭新娥 赵玉斌 谢雁鸣 赵丽彩 李燕峰 郝哲)