TY - JOUR
T1 - Review of adverse reactions to injections of Chinese materia medica
AU - BIAN, Zhaoxiang
AU - Shang, Hongcai
AU - Cheng, Chungwah
AU - Wu, Taixiang
AU - Li, Youping
AU - Zhang, Boli
N1 - Copyright:
Copyright 2011 Elsevier B.V., All rights reserved.
PY - 2010/5
Y1 - 2010/5
N2 - Using Chinese Materia Medica (CM) as injections is an innovation that is proving effective in extensive clinical use in Mainland China. However, recent reports have focused on adverse reactions, ignoring the considerable successes of these preparations. In order to achieve balance in the media and in theminds of the public, we suggest the first step is to clarify the concepts of and differences between adverse drug reactions (ADR) and adverse events (AE) for all concerned-the public, medical practitioners, government officials, and lawmakers. Second, the State Food andDrugAdministration should raise the requirements for Chinese Materia Medica Injection (CMI) registration and license approval and emphasize the importance of evidence-based CMI development and evidence-based CMI license approval. Thirdly, drug companies and institutions should reinforce basic research about the quality control of herbs and CMI-drug interactions. Fourth, the Government should clarify the legal responsibilities for CMI approval agencies, CMI developers, medical doctors, and patients. Fifth, themedical association and Government should enhance training for health care professionals concerning the usage of CMIs. And finally sixth, State Food and Drug Administration should monitor the content and quality of the directions for use of CMI.
AB - Using Chinese Materia Medica (CM) as injections is an innovation that is proving effective in extensive clinical use in Mainland China. However, recent reports have focused on adverse reactions, ignoring the considerable successes of these preparations. In order to achieve balance in the media and in theminds of the public, we suggest the first step is to clarify the concepts of and differences between adverse drug reactions (ADR) and adverse events (AE) for all concerned-the public, medical practitioners, government officials, and lawmakers. Second, the State Food andDrugAdministration should raise the requirements for Chinese Materia Medica Injection (CMI) registration and license approval and emphasize the importance of evidence-based CMI development and evidence-based CMI license approval. Thirdly, drug companies and institutions should reinforce basic research about the quality control of herbs and CMI-drug interactions. Fourth, the Government should clarify the legal responsibilities for CMI approval agencies, CMI developers, medical doctors, and patients. Fifth, themedical association and Government should enhance training for health care professionals concerning the usage of CMIs. And finally sixth, State Food and Drug Administration should monitor the content and quality of the directions for use of CMI.
KW - Chinese materia medica injection
KW - Confidence
KW - Crisis
KW - Retrospection
UR - http://www.scopus.com/inward/record.url?scp=77954576934&partnerID=8YFLogxK
U2 - 10.1111/j.1756-5391.2010.01072.x
DO - 10.1111/j.1756-5391.2010.01072.x
M3 - Review article
C2 - 21349050
AN - SCOPUS:77954576934
SN - 1756-5383
VL - 3
SP - 88
EP - 94
JO - Journal of Evidence-Based Medicine
JF - Journal of Evidence-Based Medicine
IS - 2
ER -