[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).


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Shijiazhuang City Chinese Medicine Hospital Affiliated to Hebei Medical University, Shijiazhuang 050000, China. mitianci@163.com
Xin-E
XE
Guo
Shijiazhuang City Chinese Medicine Hospital Affiliated to Hebei Medical University, Shijiazhuang 050000, China.
Yu-Bin
YB
Zhao
Chinese Basic Research in Clinical Medicine of Chinese Academy of Sciences, Beijing 100700, China.
Yan-Ming
YM
Xie
Shijiazhuang City Chinese Medicine Hospital Affiliated to Hebei Medical University, Shijiazhuang 050000, China.
Li-Cai
LC
Zhao
Shijiazhuang City Chinese Medicine Hospital Affiliated to Hebei Medical University, Shijiazhuang 050000, China.
Yan-Feng
YF
Li
Shijiazhuang Third Hospital, Shijiazhuang 050011, China.
Zhe
Z
Hao
D002681:China / Q000453:epidemiology; D016903:Drug Monitoring / Q000379:methods* / Q000592:standards; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006282:Health Personnel; D006801:Humans; D008297:Male; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000592:standards
D004365:Drugs, Chinese Herbal