中药注射剂医院集中监测“三位一体”模式的建立

目的: 建立以研究护士为主体的医院中药注射剂上市后安全性监测"三位一体"模式。 方法: 以研究护士为主采集科研数据,完成CRF表(A表)的填写;中药注射剂使用发生不良反应或事件时则由临床医师、临床药师、临床护士共同完成CRF表(B表)的填写;形成了以研究护士为主线,临床医师、临床药师、临床护士相互配合的三位一体中药上市后医院监测模式。建立以研究护士为主体"中药注射剂安全性监测"参研医院从事该项研究工作的组织机构、监测流程与过程质量控制。 结果: 通过实施中药注射剂"三位一体"的医院集中监测模式,监测过程质量得到有效控制,经临床实践,误差率、漏报率均为零。 结论: 研究护士为主体的医院中药注射剂上市后安全性监测"三位一体"模式的应用,保证了该项科研采集到的科研数据具有真实性、准确性、及时性、整体性的特点,杜绝了数据采集过程中的误差。经医院实践证明,可操作性强,监测效果良好。

Establishment of model of traditional Chinese medicine injections post-marketing safety monitoring

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.