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Complementary Medicines 1 PCOL2605/NURS2005 Brooke Storey-Lewis Discipline of Pharmacology Adapted from lectures written and presented by Prof. Peter Carroll (2017) COMMONWEALTH OF AUSTRALIA Copyright Regulation WARNING This material has been reproduced and communicated to you by or on behalf of the University of Sydney pursuant to Part VB of the Copyright Act 1968 (the Act). The material in this communication may be subject to copyright under the Act. Any further reproduction or communication of this material by you may be the subject of copyright protection under the Act. Do not remove this notice

Learning Outcomes 1.

Define ‘complementary medicine’

2.

Identify and describe the different types of complementary medicines including herbal, traditional medicine, homeopathic, vitamins & minerals, nutritional and essential oils

3.

Understand how listed complementary medicines are regulated by the TGA

4.

Appreciate why people use complementary medicines

5.

Understand the risks associated with the use of complementary medicines

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Complementary Medicines – Regulated as medicines under the Therapeutic Goods Act and the Therapeutic Goods Regulations – Australian Regulatory Guidelines for Complementary Medicines (ARGCM) v. 8.0 – Information for manufacturers, sponsors, healthcare professionals and the general public on regulation of CMs

https://www.tga.gov.au/sites/default/files/australian-regulatory-guidelines-complementary-medicines-argcm-v8.0.pdf The University of Sydney

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What defines a Complementary Medicine? (ARGCM v. 8.0, 2018) Therapeutic Goods Regulations (1990):

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What is a Complementary Medicine? (ARGCM v. 8.0, 2018)

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Types of Complementary Medicines (ARGCM v. 8.0, 2018) Herbal medicines – Herbal substances as the major active ingredients – Preparations of plants and other organisms that are treated as plants in the International Code of Botanical Nomenclature e.g. fungi/algae/yeast – St John’s wort, valerian, Echinacea, ginseng etc Echinacea The University of Sydney

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Types of Complementary Medicines (ARGCM v. 8.0, 2018) Traditional medicines – Health practices, approaches, knowledge and beliefs incorporating medicines of plant, animal and/or mineral origin – E.g. Traditional Chinese, Ayurvedic, Aboriginal and TSI medicine – Ethnopharmacology The University of Sydney

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Types of Complementary Medicines (ARGCM v. 8.0, 2018) Homeopathic medicines – Capable of producing in a healthy person symptoms similar to those which it is administered to alleviate – “Let like cure like” – E.g. Onion used to treat hayfever

– Prepared via serial dilution of a mother tincture (extract) in water, ethanol, aqueous ethanol or glycerol or serial trituration in lactose The University of Sydney

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Types of Complementary Medicines (ARGCM v. 8.0, 2018) Homeopathic medicines – Homeopathic medicines derived mainly from plants, may be toxic – Highly diluted  rendered non-toxic and therefore safe for use

– Manufactured to different strengths or “potencies” – E.g. 1X = 1:10 dilution, 2X = 1:100 dilution, 3X = 1:1000 dilution – >1:1000 dilution  ARTG exemption

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Types of Complementary Medicines (ARGCM v. 8.0, 2018) Vitamins and Minerals – Some listed on the Poisons Standard (Vit A/D/K) – Must not imply that vitamins and minerals are a good substitute for a balanced diet/good nutrition – Appropriate in cases of documented deficiency e.g. Vitamin D – Some preparations contain doses far in excess of RDI The University of Sydney

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Types of Complementary Medicines (ARGCM v. 8.0, 2018) Nutritional substances – Some regulated as foods, others as therapeutic g – Fish oil & krill oil, shark cartilage

Essential Oils – Cosmetic claim = regulation by National Industrial Chemicals Notification and Assessment Scheme – Therapeutic claim = regulation by TGA, e.g. eucalyptus oil The University of Sydney

Regulation of Complementary Medicines

Any product which makes a therapeutic claim must be registered or listed on the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia

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Regulation of Complementary Medicines – Registered medicines are considered to be of higher risk and are evaluated for safety, quality and efficacy – AUST R number

– Listed medicines are lower risk and are evaluated for safety and quality only, not efficacy – AUST L number – Sponsors choose from a list of permitted indications The University of Sydney

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Regulation of Complementary Medicines Assessed Listed Medicines – New pathway – Sits between listed and registered – Allows sponsors to access “higher level indications” – Efficacy is assessed by the TGA – Label AUST L(A), can include ‘TGA assessed’ claim The University of Sydney

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https://www.tga.gov.au/three-tiered-risk-based-framework-complementary-medicines

Regulation of Complementary Medicines – The majority of complementary medicines are listed on the ARTG – Some are registered – Considered to be higher risk based on ingredients or indications – Fully evaluated for quality, safety and efficacy – List: https://www.tga.gov.au/list-evaluated-registered-complementary-medicines

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Listed Medicines – Considered to be of lower risk compared to registered medicines – Assessed by the TGA for quality and safety, NOT efficacy – https://www.tga.gov.au/listed-complementary-medicines

The TGA has not directly evaluated any Listed* medicine to see if it works. Unless its an Assessed Listed medicine* The University of Sydney

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Listed Medicines – Assessing Quality (ARGCM v. 8.0, 2018) – Product manufactured in TGA approved facilities? – Licensed manufacturer – Imported = international manufacturer clearance

– Product manufactured according to Good Manufacturing Practice? – https://www.tga.gov.au/publication/manufacturing-principles-medicinal-products

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Listed Medicines – Assessing Safety (ARGCM v. 8.0, 2018) – The TGA does not perform direct toxicity testing – Lack of reported or documented toxicity – Published literature/original study data – ‘History of use’ – traditional medicines

– Dossier of safety data evaluated The University of Sydney

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Listed Medicines – Efficacy? (ARGCM v. 8.0, 2018) – Sponsors must hold evidence to support indications – Evidence from scientific literature and/or based on history of traditional use (≥ 75 years) – Provide evidence to TGA if requested – Proportion of complementary medicines reviewed for compliance – Evidence Guidelines https://www.tga.gov.au/sites/default/files/cm-evidence-listedmedicines-140724.pdf The University of Sydney

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Advertising of Complementary Medicines – Advertising should promote quality and safe use of the product – Regulation of advertising involves input from: – TGA – Therapeutic Goods Advertising Code Council (TGACC) – Australian Self-Medication Industry – Complementary Medicines Australia

– Advertisements require prior approval by the Dept. of Health The University of Sydney

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Post-Marketing Surveillance of Complementary Medicines – Community adverse event reporting – Sponsor adverse event reporting – Inspection of manufacturers – Sampling & laboratory testing – Compliance reviews –  Cancellation – https://www.tga.gov.au/complementary-medicines-cancellations-artg The University of Sydney

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Who uses Complementary Medicines?

Australia’s Complementary Medicines Industry Snapshot 2018. http://www.cmaustralia.org.au/resources/Documents/Australian%20Complementary%20Medicines%20Industry%20snapshot%202018_English.pdf The University of Sydney

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Who uses Complementary Medicines? 2019 data

Australia’s Complementary Medicines Industry Audit 2019. http://www.cmaustralia.org.au/resources/Documents/CMA-INDUSTRY_AUDIT-V4.pdf The University of Sydney

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Australia’s Complementary Medicines Industry Audit 2019. The University of Sydney

http://www.cmaustralia.org.au/resources/Documents/CMA-INDUSTRY_AUDIT-V4.pdf

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Australia’s Complementary Medicines Industry Audit 2019. The University of Sydney

http://www.cmaustralia.org.au/resources/Documents/CMA-INDUSTRY_AUDIT-V4.pdf

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Who uses Complementary Medicines? – Female > Male – Caucasians – Rural > Urban – Middle aged, higher education level, higher annual income

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Where are people purchasing Complementary Medicines?

Australia’s Complementary Medicines Industry Snapshot 2018. http://www.cmaustralia.org.au/resources/Documents/Australian%20Complementary% 20Medicines%20Industry%20snapshot%202018_English.pdf

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https://www.chemistwarehouse.com.au/shoponline/81/vitamins

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Where are people purchasing Complementary Medicines? – 2019 data – Online sales increasing

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Why do people use Complementary Medicines? – Dissatisfied with conventional therapy – Reduce symptoms/side effects from conventional therapy – Attraction to a holistic method of health care – Preventative therapy or an adjunct to conventional therapy – Personal beliefs and hope – Perception that complementary medicines are safe – Sense of control over treatment The University of Sydney

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What are the benefits and risks? Three outcomes to taking a complementary medicine: 1. Beneficial effect 2. Neutral effect 3. Harmful effect Do people that take complementary medicines consider harm to be a potential effect? The University of Sydney

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What are the benefits and risks? – Patients often will not inform their doctor that they are taking CMs – Fear of negative response/judgement – Do not consider complementary medicines to be “medicines”

– Healthcare professionals should always ask if patients are using CMs – Many patients take conventional and complementary medicines together

– Complementary medicines may produce significant drug interactions with both prescribed and over-the-counter drugs The University of Sydney

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A national census of medicines use: a 24-hour snapshot of Australians aged 50 years and older. Morgan et al (2012). MJA, 196, 50-53. – 46.3% used CMs – 87.3% of these used both – Mean CM used 1.2 – F>M – Use decreased with age – Used for – – –

General health (29.3%) Arthritis (20.2%) Bone health & disease prevention (4.7%)

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The following may interact with warfarin: Gingko biloba St John’s wort Ginger Co-enzyme Q10 Glucosamine Celery Horse chestnut Ginseng

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Feverfew Garlic Alfalfa Aniseed Fenugreek Red clover Green tea

Myers SP (2002). Aust. Prescriber, 25 (3), 54-56

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Is high dose vitamin use safe? Carroll (2012). The Australian Journal of Pharmacy, 93, 32-33

– Vitamin E products claim to have antioxidant activity and assist in maintaining CV health – Reported RDI of vitamin E for adults is 22.4 IU per day – Many vitamin E products on the market have a recommended daily dose >400 IU (18X RDI) – Some 1000 IU (45X RDI!) The University of Sydney

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Is high dose vitamin use safe? Carroll (2012). The Australian Journal of Pharmacy, 93, 32-33

Long term use of high dose vitamin E (>400 IU/day) reported to: – Increase the incidence of heart failure – Increase the incidence of hemorrhagic stroke – Increase the incidence of lung cancer, particularly in smokers – Increase the risk of prostate cancer – Increase overall mortality

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Image Sources https://ostelin.com.au/products/vitamin-d-specialist-range-1-a-week-7000iu/ https://www.bosistos.com.au/product/bosistos-tea-tree-oil-3 http://www.ferrogradc.com.au/ https://www.amcal.com.au/calci-tab-600-mg---120-tablets-p-8902411112520

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