Pharmacovigilance in Traditional Chinese Medicine safety surveillance

Pharmacoepidemiology and Drug Safety

Volumn 18, Issue 5, 2009, Pages 357-361

  Wang, Hainan ^a,b   Ye, Xiaofei ^a   Gao, Qingbin ^a   Wu, Cheng ^a   Qian, Yifeng ^a   Luo, Baozhang ^a   Sun, Yalin ^a   He, Jia ^a  

^a SECOND MILITARY MEDICAL UNIVERSITY   (China)

^b CENTER FOR DRUG EVALUATION   (China)

Author keywords

Pharmacovigilance; Safety surveillance; Traditional Chinese Medicine

Indexed keywords

ARISTOLOCHIC ACID; CHINESE DRUG;

ANEMIA; ARTERIAL PRESSURE; CHINESE MEDICINE; DRUG EFFICACY; DRUG LABELING; DRUG QUALITY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; GOOD LABORATORY PRACTICE; GOOD MANUFACTURING PRACTICE; HERBAL MEDICINE; HUMAN; KIDNEY DISEASE; KIDNEY FAILURE; KIDNEY FIBROSIS; PRIORITY JOURNAL; PROTEINURIA; REVIEW; SIDE EFFECT; CHINA; SAFETY; TIME;

CHINA; HUMANS; MEDICINE, CHINESE TRADITIONAL; SAFETY; TIME FACTORS;

EID: 67649405159     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.1725     Document Type: Review

References (16)

1. Manfred Hauben, Xiaofeng Zhou. Quantitative methods in pharmacovigilance focous on signal detection. Drug saf 2003; 26(3): 159-186.
2. WHO. The importance of pharmacovigilance. Safety monitoring of medicinal products, 2002.
3. White Paper on China's Drug Supervision published. http://news.-xinhuanet.com/english/2008_07/18/content_8567067_4.htm
4. FDA Warning Letters About Products, 2000. http://www.casewatch.-org/ fdawarning/prod/2000/index.shtml
5. Xu J, Yang Y. Traditional Chinese medicine in the Chinese health care system. Health Policy doi: 10.1016/j.healthpol.2008.09.003 (in press).
6. Chen ruquan. Adverse drug reaction and post-marketing evaluation of traditional Chinese medicine. J Hubei Coll TCM 2003; 5(1): 5-8 (in Chinese).
7. Cosyns JP. Aristolochic acid and 'Chinese herbs nephropathy': a review of the evidence to date. Drug Saf 2003; 26(1): 33-48.
8. Nortier JL, Vanherweghem JL. Renal interstitial fibrosis and urothelial carcinoma associated with the use of a Chinese herb (Aristolochia fangchi). Toxicology 2002; 27: 181-182.
9. Debelle FD, Vanherweghem JL, Nortier JL. Aristolochic acid nephropathy: a worldwide problem. Kidney Int 2008; 74(2): 158-169.
10. Tang J-L, Liu B-Y, Ma K-W. Traditional Chinese medicine. Lancet 2008; 372(9654): 1938-1940 (in Chinese).
11. Qin Z, Li Y, Zhong X, Qiu J, Wang Z, Lu Z. Adverse reaction of Chinese traditional patent medicine and its risk early warning managemen. Chin Prim Health Care 2008; 22(5): 72-75 (in Chinese).
12. Lu QL, Fang JJ. A survey of twenty year's ADR caused by traditional Chinese medicine. Adverse drug react J 2001; (1): 18-21 (in Chinese).
13. Yang J, Ma P. A survey report of 92 label instruction of traditional Chinese patent medicine and 61 ADR reports. Chin Hosp Pharm J 2008; 28(2): 148-149 (in Chinese).
14. Wu Z. Speech at the Directors' Workshop of ADR Monitoring Centers in China. Chin J Pharmacovigilance 2007; 4(4): 194-199 (in Chinese).
15. Li C, Xia J, Deng J, Jiang J. A comparison of measures of disproportionality for signal detection on adverse drug reaction spontaneous reporting database of Guangdong province in China. Pharmacoepidemiol Drug Saf 2008; 17(6): 593-600.
16. Ye X, Fu Z,Wang H, et al. A computerized system for signal detection in spontaneous reporting system of Shanghai China. Pharmacoepidemiol Drug Saf 2009; 18(2): 154-158.