Transcript Survive , Thrive -- the road of BTRT in Australia

Issues on
Chinese Herbal Medicines
Chinese Medicine Industry Council of Australia Ltd
Max Ma
16 Feb 2010
Major Issues on Chinese Herbal
Medicines
 Abuse/Misuse issues
 Regulatory issues
 Listable substances issues
 Solutions
Abuse / Misuse Issues – Restrictions
CHM substances used outside TCM eg. Mahuang – weight loss
Overdosed
Prolonged period of usage
Single herbs rather than compound formula
Unprepared /unprocessed herbs
Not fits in the right conditions
- all these are not the fault of CHM, but matters of
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Practitioner expertise
Inappropriate self-administration usage
Poor management of adverse events
Lack of knowledge of CHM by manufacturing industry
Regulatory Issues
 Efficacy is not a primary concern for listed products
 Tends to use modern medicine’s concept/tools /criteria
to assess TCM/CHM
 CHM standard: BP can not cover CHM
eg. Disintegration for honey pills / raw herb identification
 “Evidence” relevance, quality and perception
1.
Single concentrated Hong Hua (Carthamus flower) extract to be injected
to pregnant rats does not necessarily apply to human, esp. via oral
administration or compound formula.
2.
Must consider the right of male and non pregnant women to use it as
blood stasis removal herbs
3.
A range of herbs to be avoided in use for pregnant women have already
been in practice by qualified practitioners for ages.
Listable Substances Issues
Some substances (Important to TCM) restricted in listed medicines
 Ma Huang (Ephedra spp): ephedrine less than 0.001% for listing –
approx. 1/100th of the therapeutic dose; SUSDP
 Xing Ren/Tao Ren/Wu Mei /Yu Li Ren (Prunus spp.) – Amygdalin
(Hydrocyanic acid) for therapeutic use (appendix C, SUSDP)
HCA- less than 0.0000001%
 Fu Zi /Wu Tou (Aconitum Spp): aconitine to aconine if well
prepared and 1/2000 less toxic. SUSDP
 Ban Bian Lian (Lobelia chinensis) : Lobelia inflata S2,SUSDP
 Bing Lang (Areca catechu): Arecoline 10mg/kg SUSDP
Listable Substances Issues
 Kuan Dong Hua (Tussilago farfara): D1, S4
 Huo Ma Ren (Cannabis sativa seeds): Cannabis D1, S4
 Tian Nan Xing/Dan Nan Xing (Arisaema spp.) D1,S4
 Shi Chang Pu (Acorus tatarinowii): A. calamus D1,S4
 Ku Lian Pi (Melia azedarach): Appendix C, SUSDP
V.S Chuan Lian Zi (Melia toosendan Seeds)
 Luo Bu Ma Ye (Apocynum spp) - SUSDP
Solutions on restricted substances
Objective & Principle
To ensure the safety while efficacy should be balanced
 Joint review /amendment via TCM/CHM sub-committees
 Listable/Supply for TCM Practitioners use only with No Indications allowed or
indications in TCM terminology only
 Dose control: must develop an appropriate dose for ARTG listing
eg. Prepared Fuzi 3-15g/day (CP) - 3g Max. (AUS)
Arisaema (Tian Nan Xing prepared): 3-9g(CP) – 3g max (AUS)
prunus amenniaca (xing ren): 4.5-9g/day(CP) – 5g max.(AUS)
rather than equiv.1mg dry herb (D2,S4) or HCA 0.001ppm (ELF 2.6)
 Must be prepared / processed where needed
 Mandatory warning on label
Thank You
Happy Chinese New Year!