Herbal medicines: Challenges in the modern world. Part 1. Australia and New Zealand

Expert Review of Clinical Pharmacology

Volumn 9, Issue 7, 2016, Pages 905-915

  Barnes, Joanne ^a   McLachlan, Andrew J ^b   Sherwin, Catherine M T ^c,d   Enioutina, Elena Y ^c  

^a UNIVERSITY OF AUCKLAND   (New Zealand)

^b UNIVERSITY OF SYDNEY   (Australia)

^c UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

^d UNIVERSITY OF UTAH   (United States)

Author keywords

Australia; Herbal medicines; Legislation; Natural health products; New Zealand; Regulations; Traditional medicines

Indexed keywords

AUSTRALIA AND NEW ZEALAND; CULTURAL ANTHROPOLOGY; DEVELOPED COUNTRY; HERBAL MEDICINE; HUMAN; LAW; PUBLIC HEALTH; ADVERSE EFFECTS; AUSTRALIA; CHEMISTRY; DRUG LEGISLATION; MEDICINAL PLANT; NEW ZEALAND; PHYTOTHERAPY; PROCEDURES; TRADITIONAL MEDICINE;

PLANT MEDICINAL PRODUCT;

AUSTRALIA; HUMANS; LEGISLATION, DRUG; MEDICINE, TRADITIONAL; NEW ZEALAND; PHYTOTHERAPY; PLANT PREPARATIONS; PLANTS, MEDICINAL;

EID: 84963620846     PISSN: 17512433     EISSN: 17512441     Source Type: Journal    
DOI: 10.1586/17512433.2016.1171712     Document Type: Review

References (68)

1. World Health Organization. WHO traditional medicine strategy: 2014-2023; [cited 2016 Feb 18]. Available from: http://apps.who.int/iris/bitstream/10665/92455/1/9789241506090_eng.pdf
2. World Health Organization. Traditional medicine: definitions; [cited 2016 Feb 18]. Available from: http://www.who.int/medicines/areas/traditional/definitions/en/
3. D.M.Eisenberg, R.B.Davis, S.L.Ettner, et al. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. Jama. 1998;280(18):1569–1575.
4. D.M.Eisenberg, R.C.Kessler, C.Foster, et al. Delbanco TL. Unconventional medicine in the United States. Prevalence, costs, and patterns of use. N Engl J Med. 1993;328(4):246–252.
5. A.H.MacLennan, S.P.Myers, A.W.Taylor The continuing use of complementary and alternative medicine in South Australia: costs and beliefs in 2004. Med J Aust. 2006;184(1):27–31.•• Manuscript describes prevalence of CMs and health conditions for which CMs are used in Australia.
6. A.L.Zhang, D.F.Story, V.Lin, et al. A population survey on the use of 24 common medicinal herbs in Australia. Pharmacoepidemiol Drug Saf. 2008;17(10):1006–1013.
7. E.Kavanagh-Hall. Use of natural remedies is on the rise; [cited 2016 Feb 8]. Available from: http://www.nzherald.co.nz/wairarapa-times-age/news/article.cfm?c_id=1503414&objectid=11399310• Newspaper article highlights increased interest in CMs in New Zealand.
8. T.K.Morgan, M.Williamson, M.Pirotta, et al. A national census of medicines use: a 24-hour snapshot of Australians aged 50 years and older. Med J Aust. 2012;196(1):50–53.
9. P.D.Coxeter, A.J.McLachlan, C.C.Duke, et al. Herb-drug interactions: an evidence based approach. Curr Med Chem. 1513-1525;11(11):2004.
10. C.C.Xue, A.L.Zhang, V.Lin, et al. Complementary and alternative medicine use in Australia: a national population-based survey. J Altern Complement Med. 2007;13(6):643–650.• Manuscript highlights popularity and increase use of CMs in Australia.
11. X.Zhu, A.-L.Carlton, A.Bensoussan. Development in and challenge for traditional Chinese medicine in Australia. J Altern Complement Med. 2009;15(6):685–688.
12. M.Siahpush. Why do people favour alternative medicine? Aust N Z J Public Health. 1999;23(3):266–271.
13. G.Moses. Complementary and alternative medicine use in the elderly. J Pharm Prac Res. 2005;35:63–68.
14. B.Oh, P.Butow, B.Mullan, et al. The use and perceived benefits resulting from the use of complementary and alternative medicine by cancer patients in Australia. Asia Pac J Clin Oncol. 2010;6(4):342–349.
15. M.J.Verhoef, L.G.Balneaves, H.S.Boon, et al. Reasons for and characteristics associated with complementary and alternative medicine use among adult cancer patients: a systematic review. Integr Cancer Ther. 2005;4(4):274–286.
16. A.C.Tan, I.Konczak, D.M.Sze, et al. Towards the discovery of novel phytochemicals for disease prevention from native Australian plants: an ethnobotanical approach. Asia Pac J Clin Nutr. 2010;19(3):330–334.
17. B.S.Simpson, D.J.Claudie, N.M.Smith, et al. Learning from both sides: Experiences and opportunities in the investigation of Australian aboriginal medicinal plants. J Pharm Pharm Sci. 2013;16(2):259–271.
18. J.Tucci, S.Wilkens. A brief review of the application and pharmacology of ethnomedicines of indigenous Australians. Aust J Rural Health. 2015. doi:10.1111/ajr.12256. [Epub ahead of print]
19. E.A.Palombo, S.J.Semple. Antibacterial activity of traditional Australian medicinal plants. J Ethnopharmacol. 2001;77(2–3):151–157.
20. R.W.Li, S.P.Myers, D.N.Leach, et al. A cross-cultural study: anti-inflammatory activity of Australian and Chinese plants. J Ethnopharmacol. 2003;85(1):25–32.
21. R.N.Westhorpe, C.Ball. Pituri and other aboriginal medicines for pain relief. Anaesth Intensive Care. 2011;39(1):3.
22. N.J.Sadgrove, G.L.Jones. A possible role of partially pyrolysed essential oils in Australian Aboriginal traditional ceremonial and medicinal smoking applications of Eremophila longifolia (R. Br.) F. Muell (Scrophulariaceae). J Ethnopharmacol. 2013;147(3):638–644.
23. Australian Government, Department of Health. National medicines policy; [cited, 2016 Feb 18]. Available from: http://www.health.gov.au/nationalmedicinespolicy
24. Australian Government, Department of Health. An overview of the regulation of complementary medicines in Australia, Therapeutic Goods Administration; [cited 2016 Feb 18]. Available from: https://www.tga.gov.au/overview-regulation-complementary-medicines-australia
25. Expert Committee on Complementary Medicines in the Health System. Complementary medicines in the health system, report to the parliamentary secretary to the Minister for Health and Ageing, Commonwealth of Australia (Sept 2003); [cited 2016 Feb 10]. Available from: http://www.tga.gov.au/sites/default/files/committees-eccmhs-report-031031.pdf•• The expert committee concluded that as CMs are “medicines.” The existing framework of the quality use of medicines, under Australia’s National Medicines Policy should equally apply to their use in the community.
26. L.D.W.Sansom, J.Horvath. Expert review of medicines and medical devices regulation – stage two, report on the regulatory frameworks for complementary medicines and advertising of therapeutic goods; [cited 2016 Feb 18]. Available from: http://www.health.gov.au/internet/main/publishing.nsf/Content/Expert-Review-of-Medicines-and-Medical-Devices-Regulation
27. Australian Government, Department of Health, Therapeutic Goods Administration. Therapeutic goods advertising code; [updated 2015 Nov; cited 2016 Feb10]. Available from: https://www.tga.gov.au/publication/therapeutic-goods-advertising-code
28. Australian Government, Department of Health. Therapeutic Goods Administration. Advertising of complementary medicines, Australian regulatory guidelines for complementary medicines (ARGCM), Version 5.3 July 2015; [cited 2016 Feb 18]. Available from: https://www.tga.gov.au/book/complementary-medicines-exemptexcluded-certain-regulatory-requirements
29. Listed medicines: the role of Australia’s medicines regulator, Therapeutic Good Administration; [cited 2016 Feb 18]. Available from: https://www.tga.gov.au/community-qa/listed-medicines-role-australias-medicines-regulator•• Government act outlining regulatory restrictions for herbal products.
30. Registered Medicines, Therapeutic Good Administration. [cited 2016 Feb 18]. Available from:https://www.tga.gov.au/registered-medicines•• Government act outlining regulatory restrictions for herbal products.
31. Australian Government, Department of Health, Therapeutic Goods Administration. Exempt medicines, Australian regulatory guidelines for complementary medicines (ARGCM), Version 5.3; [cited 2016 Feb 10]. Available from: https://www.tga.gov.au/book/complementary-medicines-exemptexcluded-certain-regulatory-requirements
32. A.K.Drew, S.P.Myers. Safety issues in herbal medicine: implications for the health professions. Med J Aust. 1997;166(10):538–541.
33. Australian Government, Department of Health, Therapeutic Goods Administration. Safety review of Andrographis paniculata and anaphylactic/allergic reactions; [cited 2016 Feb 10]. Available from: https://www.tga.gov.au/alert/safety-review-andrographis-paniculata-and-anaphylacticallergic-reactions
34. P.W.Whiting, A.Clouston, P.Kerlin. Black cohosh and other herbal remedies associated with acute hepatitis. Med J Aust. 2002;177(8):440–443.
35. W.Chau, R.Ross, J.Y.Li, et al. Nephropathy associated with use of a Chinese herbal product containing aristolochic acid. Med J Aust. 2011;194(7):367–368.
36. A.M.Goudie, J.M.Kaye. Contaminated medication precipitating hypoglycaemia. Med J Aust. 2001;175(5):256–257.
37. P.A.Tait, A.Vora, S.James, et al. Severe congenital lead poisoning in a preterm infant due to a herbal remedy. Med J Aust. 2002;177(4):193–195.
38. Australian Government, Department of Health. Quality use of medicines; [updated 2011 Sep 15; cited 2016 Feb10]. Available from: http://www.health.gov.au/internet/main/publishing.nsf/content/nmp-quality.htm
39. NPS Medicinewise. Using complementary medicines; [cited 2016 Feb 10]. Available from: http://www.nps.org.au/topics/how-to-be-medicinewise/using-complementary-medicines
40. Australian Government, Department of Health, Therapeutic Goods Administration. Pan Pharmaceuticals Limited: regulatory action & product recall information; [cited 2016 Feb 10]. Available from: https://www.tga.gov.au/product-recall/pan-pharmaceuticals-limited-regulatory-action-product-recall-information
41. E.Shirlow, T.Faunce. Recent legal developments and the authority of the Australian Therapeutic Goods Administration. J Law Med. 2009;16(5):764–769.
42. World Health Organization- Regional Office for the Western Pacific. Essential medicines and health products information portal. Guidelines for the appropriate use of herbal medicines; 1998; [cited 2016 Feb10]. Available from: http://apps.who.int/medicinedocs/en/d/Jh2945e/
43. R.Jones Rongoā – medicinal use of plants - understanding rongoā. Te Ara - the Encyclopedia of New Zealand; [updated 2012 Sep 22; cited 2016 Feb10]. Available from: http://www.TeAra.govt.nz/en/rongoa-medicinal-use-of-plants/
44. S.G.Brooker, R.C.Cambie, R.C.Cooper. New Zealand medicinal plants. Auckland, New Zealand: Heinemann Publishers; 1987.
45. Billion dollar natural health industry awards its leaders. Press Release; 2012 Mar 22. Natural products New Zealand; [cited 2016 Feb]. Available at: http://www.naturalproductsnz.org/cms/wp-content/uploads/2012/03/Natural-Products-industry-recognises-top-performers-22-3-12.pdf
46. Ministry of Health. A portrait of health: key results of the 2006/07 New Zealand health survey. Wellington: Ministry of Health; [updated 2014 Apr 29; cited 2016 Feb10]. Available from: http://www.health.govt.nz/publication/portrait-health-key-results-2006-07-new-zealand-health-survey
47. M.Koning, R.Ailabouni, R.B.Gearry, et al. Use and predictors of oral complementary and alternative medicine by patients with inflammatory bowel disease: a population-based, case-control study. Inflamm Bowel Dis. 2013;19(4):767–778.
48. A.Evans, B.Duncan, P.McHugh, et al. Inpatients’ use, understanding, and attitudes towards traditional, complementary and alternative therapies at a provincial New Zealand hospital. N Z Med J. 2008;121(1278):21–34.
49. T.Nicholson. Complementary and alternative medicines (including traditional Maori treatments) used by presenters to an emergency department in New Zealand: a survey of prevalence and toxicity. N Z Med J. 2006;119(1233):U1954.
50. K.Wilson, C.Dowson, D.Mangin. Prevalence of complementary and alternative medicine use in Christchurch, New Zealand: children attending general practice versus paediatric outpatients. N Z Med J. 2007;120(1251):U2464.
51. Medicines Act 1981 as at 1 July 2014; [cited 2016 Feb 10]. Available from: http://www.legislation.govt.nz/act/public/1981/0118/latest/whole.html
52. Dietary supplement regulations 1985 (SR 1985/208). Reprint 2010 Mar 31; [cited 2016 Feb10]. Available from: http://www.legislation.govt.nz/regulation/public/1985/0208/latest/DLM102109.html
53. Food Act 1981. Reprint 2014 Jun 24; [cited 2016 Feb10]. Available from: http://www.legislation.govt.nz/act/public/1981/0045/latest/DLM48687.html
54. Dietary supplements amendment regulations 2010; [cited 2016 Feb 10]. Available from: http://www.legislation.govt.nz/regulation/public/2010/0005/latest/whole.html
55. Australia New Zealand Therapeutic Products Authority (ANZTPA) postponed. 2007; [updated 2015 Nov 6; [cited 2016 Feb10]. Available from: https://www.tga.gov.au/media-release/australia-new-zealand-therapeutic-products-authority-anztpa-postponed
56. Australia New Zealand Therapeutic Products Agency (ANZTPA). Trans Tasman Ministerial Council agrees foundations for joint therapeutic products regulator; [cited 2016 Feb 10]. Available from: http://www.medsafe.govt.nz/hot/anztpa.asp
57. Ministry of Health, The Development of a Natural Health Products Bill. Agency disclosure statement. Regulatory impact statement; [cited 2016 Feb 18]. Available from: https://www.health.govt.nz/system/files/documents/pages/natural-health-products-bill-ris_0.pdf
58. Joint statement by Hon Peter Dutton MP, Minister for Health for Australia, and Hon Dr Jonathan Coleman, Minister of Health for New Zealand, regarding ANZTPA. 2014 Nov 20; [updated 2015 Aug 11; cited 2016 Feb10]. Available from: https://www.tga.gov.au/media-release/joint-statement-hon-peter-dutton-mp-minister-health-australia-and-hon-dr-jonathan-coleman-minister-health-new-zealand-regarding-anztpa
59. Ministry of Health. The regulation of natural health products: consultation document. Wellington: Ministry of Health; 2015; [cited 2016 Feb10]. Available from: http://www.health.govt.nz/publication/regulation-natural-health-products-consultation•• This consultation document provides a summary overview of the draft proposals for the new regulatory framework for NHPs that is to be introduced by the Natural Health and Supplementary Products Bill that is intended to come into force in New Zealand by July 2016. At the time of writing, the NZ Government is seeking public feedback on all aspects of the draft proposals; there are also some specific issues on which the Government is seeking responses as part of the consultation.
60. Ministry of Health. Draft permitted substance search; [cited 2016 Feb 10]. Available from: http://www.health.govt.nz/publication/regulation-natural-health-products-consultation•• This search tool allows individuals to search the draft list of permitted substances for ingredients of natural health products under the new regulatory framework for NHPs that will be introduced by the Natural Health and Supplementary Products Bill that is intended to come into force in New Zealand by July 2016. The draft list of permitted substances is undergoing public consultation at the time of writing.
61. Ministry of Health. Proposed list of conditions about which claims can be made [Internet]. Wellington: Ministry of Health, 2015; [cited 2016 Feb 10]. Available from: http://www.health.govt.nz/publication/regulation-natural-health-products-consultation
62. World Health Organization. International statistical classification of diseases and related health problems; [cited 2016 Feb 10]. Available from: http://apps.who.int/classifications/icd10/browse/2016/en
63. Ministry of Health. Draft guidelines for natural health products evidence requirements. Wellington: Ministry of Health; 2015; [Last accessed2016 Feb18]. Available from: http://www.health.govt.nz/publication/regulation-natural-health-products-consultation
64. Ministry of Health. Draft Code of Manufacturing Practice [Internet]. Wellington: Ministry of Health, 2015; [cited 2016 Feb 10]. Available from: http://www.health.govt.nz/publication/regulation-natural-health-products-consultation
65. Ministry of Health. Draft Code of Manufacturing Practice Guidelines [Internet]. Wellington: Ministry of Health, 2015; [cited 2016 Feb 10]. Available from: http://www.health.govt.nz/publication/regulation-natural-health-products-consultation
66. S.G.Newmaster, M.Grguric, D.Shanmughanandhan, et al. DNA barcoding detects contamination and substitution in North American herbal products. BMC Med. 2013;11:222.
67. J.J.Gagnier, D.Moher, H.Boon, et al. Randomized controlled trials of herbal interventions underreport important details of the intervention. J Clin Epidemiol. 2011;64(7):760–769.
68. S.Skalli, R.Soulaymani Bencheikh. Safety monitoring of herb-drug interactions: a component of pharmacovigilance. Drug Saf. 2012;35(10):785–791.