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Application of PharmacoviApplication of Pharmacovigilance in post-marketing trgilance in post-marketing traditional Chinese medicineaditional Chinese medicine
Hua-Wen XinHua-Wen Xin
Wuhan General Hospital,Wuhan General Hospital,
Wuhan, ChinaWuhan, China
PharmacovigilancePharmacovigilance
The science and activities relating to the detection, assessment, understanding and prevention of
adverse effects or any other drug-related problems
Aims of PharmacovigilanceAims of Pharmacovigilance
To improve patient care and safety To improve public health and safety To contribute to the assessment of benefit,
harm, effectiveness and risk of medicines To promote education and clinical training To promote effective communication to the
public To promote rational and safe use of
medicines
Its concerns including:
herbals traditional and complementary medicine blood products biologicals medical devices vaccines
Traditional Chinese Medicine (TCM)Traditional Chinese Medicine (TCM)
>9000 kinds of TCM preparations have been approved to be sold.
58000 approval numbers have been granted.
Side effects and desired effects
Three groupsThree groups
raw herbal medicine(Zhong yao cai),
sliced herbal medicine(zhong yao yin p
ian),
patent medicine(zhong cheng yao)
Industrial output value of TCM during 2000-2007
uni t:100mi l l i on yuan
476 540775 796
9571186
1432
1772
0
500
1000
1500
2000
2000 2001 2002 2003 2004 2005 2006 2007
ADR caused by TCMADR caused by TCM
ADRs related to TCM were reported frequently in Chi
na
152,320 and 663 kinds of TCM were detected with AD
R in the year 2001,2002,2003.
The ADR due to TCM injections accounted for 77.2%
of all ADR caused by TCM.
The causes of ADRs by TCMThe causes of ADRs by TCM
Variability in active/toxic ingredients Use of inherent toxic herbs Overdose of herbs drug-herb interactions Coexisting diseases Idiosyncratic reactions
Manufacturing and quality problems: Adulteration Misidentification Substitution of one herb with another Variability in the amount of active
ingredients Improper processing and preparation contamination
The causes of ADRs by TCMThe causes of ADRs by TCM
546 kinds of Chinese patent medicine w
ere recorded in the Chinese Pharmacop
oeia issued in 2005.
But 235 kinds did not describe the item
s related to pharmacovigilance.
Number ADR Contraindications Precaution
Missing number
% Missing number
% Missing number
%
Capsule 25 21 84 17 68 12 45
tablet 24 19 79 18 75 4 17
Injection 24 11 46 8 33 6 25
Granules 8 7 88 7 88 2 25
Mixture 8 8 100 7 88 1 13
Powder 1 1 100 1 100 0 0
Pill 2 2 100 2 100 1 50
Missing items about pharmacovigilance in 92 label instruction of TCM
Efforts in PV about TCMEfforts in PV about TCM
SFDA has improved its regulations on herbal medicine to implement quality control systems
GAP GLP GMP
ADR monitoring in ChinaADR monitoring in China
Three Three stagesstages
Primal constructionPrimal construction
experimentation
developmentdevelopment
““Information bulletin for ADR Information bulletin for ADR monitoring”monitoring”
Hepatic lesion caused by Zhuanggu Guanjie pill
Renal damage by Longdan Xiegan pill Serious ADR (allergic reaction and so o
n) by Qingkailin injection,Shuanghuanglian injection,Shenmai injection, Yuxingcao injection, Lianbizhi injection
To ensure the safety and efficacy of TCM injection, in 2000, the state launched the “Improvement of Quality Standards of TCM Injections with the Production Permission and Work on Fingerprints Chromatogram” and issued the Technological Requirements of Fingerprint Chromatogram Research of TCM Injection.
Working hard to improve the safety and Working hard to improve the safety and quality controlquality control
Fix the production areas of crude drugs of TCM injection
Strictly control the quality of raw materials,intermediate production
Realize overall quality control for production and processing
Aristolochic acid causes serious renal damage
SFDA cancelled the pharmaceutical standards of some medicinal materials containing aristolochic acid.
All TCM preparations which contain Fructus Aristolochiae,…….would be managed strictly as prescribed drugs.
SFDA suspended accepting the application of these TCM preparations for variety protection, generic drug and new drug registration.
SFDA suspended using and approving Yuxingcao injection on 1 June 2006.
In May 2007,the national ADR monitorin
g centre informed timely some correlati
ve manufactures of the serious adverse
reactions caused by Xiangdan injection
and urged them to strengthen the resea
rch on the ADR.
The drug administration departments have revised the directions for puerarin, potassium de-hydroandrograpolide succinate( 穿琥宁 ) and andrographolide sodium bisulfite (穿心莲) injections.
Abolished the pharmaceutical standard for manchurian aristolochia stem.
Revoked the manufacturing permission for bimolane
In order to supervise the quality of TCM, the drug monitoring authority implements the market spot checks.
It is beneficial to punish the manufacturer and seller of quack and inferior drugs.
Cohort study is suggested to do in future so that a further relationship between TCM and ADR can be obtained.
ConclusionsConclusions
The establishment of risk assessment
Early-warning mechanism
The interaction of TCM and chemicals
The international exchange of safety
information
ReferencesReferences
Wang HN, et al. China Journal of Chinese Materia Medica,2008,33:612-614
Cheng F, et al. China Journal of Chinese Materia Medica,2009,34:1052-1054
Wang H, et al. Pharmacoepidemiology and drug safety,2009,18:357-361