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Application of Pharmacovigilance in post-marketing traditional Chinese medicine

Application of Pharmacovigilance in post-marketing traditional Chinese medicine. Hua-Wen Xin Wuhan General Hospital, Wuhan, China. Pharmacovigilance. The science and activities relating to the detection, assessment, understanding and prevention of

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Application of Pharmacovigilance in post-marketing traditional Chinese medicine

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  1. Application of Pharmacovigilance in post-marketing traditional Chinese medicine Hua-Wen Xin Wuhan General Hospital, Wuhan, China

  2. Pharmacovigilance The science and activities relating to • the detection, • assessment, • understanding and • prevention of adverse effects or any other drug-related problems

  3. Aims 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

  4. Its concerns including: • herbals • traditional and complementary medicine • blood products • biologicals • medical devices • vaccines

  5. 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

  6. Three groups • raw herbal medicine(Zhong yao cai), • sliced herbal medicine(zhong yao yin pian), • patent medicine(zhong cheng yao)

  7. Industrial output value of TCM during 2000-2007

  8. ADR caused by TCM • ADRs related to TCM were reported frequently in China • 152,320 and 663 kinds of TCM were detected with ADR in the year 2001,2002,2003. • The ADR due to TCM injections accounted for 77.2% of all ADR caused by TCM.

  9. The 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

  10. The causes of ADRs by TCM Manufacturing and quality problems: • Adulteration • Misidentification • Substitution of one herb with another • Variability in the amount of active ingredients • Improper processing and preparation • contamination

  11. 546 kinds of Chinese patent medicine were recorded in the Chinese Pharmacopoeia issued in 2005. • But 235 kinds did not describe the items related to pharmacovigilance.

  12. Missing items about pharmacovigilance in 92 label instruction of TCM

  13. Efforts in PV about TCM • SFDA has improved its regulations on herbal medicine to implement quality control systems • GAP • GLP • GMP

  14. ADR monitoring in China Primal construction Three stages experimentation development

  15. “Information bulletin for ADR monitoring” • Hepatic lesion caused by Zhuanggu Guanjie pill • Renal damage by Longdan Xiegan pill • Serious ADR (allergic reaction and so on) by Qingkailin injection,Shuanghuanglian injection,Shenmai injection, Yuxingcao injection, Lianbizhi injection

  16. 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.

  17. Working hard to improve the safety and quality 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

  18. 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.

  19. SFDA suspended using and approving Yuxingcao injection on 1 June 2006.

  20. In May 2007,the national ADR monitoring centre informed timely some correlative manufactures of the serious adverse reactions caused by Xiangdan injection and urged them to strengthen the research on the ADR.

  21. 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

  22. 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.

  23. Conclusions • The establishment of risk assessment • Early-warning mechanism • The interaction of TCM and chemicals • The international exchange of safety information

  24. References • Wang HN, etal. 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, etal. Pharmacoepidemiology and drug safety,2009,18:357-361

  25. Thank you for your attention!

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