Complementary medicine.

Continuing education and the APD program

This quiz is an ideal activity for APD members to include in your CPD log, where it relates to personal learning goals. Record the time taken, to the nearest hour, to complete the quiz and any associated research.

Introduction

In the March 2005 edition of the Journal of the Dietitians Association of Australia we introduced the first part of our continuing education quiz on complementary medicine (CM). In this edition we continue the CM theme (part 2), which will focus on the legislation covering CM.

This continuing education quiz provides dietitians with basic information designed to maximise the appropriateness and safety of CM use, and how CM may be used to optimise the nutrition management of your patients. Those dietitians working in private practice as well as the hospital sector will find the information valuable in helping to answer patient questions and provide additional references for further reading.

1. In Australia, CM must be manufactured under the same standards as pharmaceutical medicines, in accordance with which code?

a. Food Standards Australia and New Zealand (FSANZ).

b. Good Manufacturing Practice (GMP).

c. Therapeutic Goods Administration (TGA).

d. Food and Drug Administration (FDA).

2. Which statement about regulatory control of a therapeutic good (e.g. CM) is not true?

a. CM are generally classified as 'listed medicines' and are assessed by the TGA for quality and safety only and not efficacy.

b. Listed medicines present a lower risk than registered medicines.

c. All listed medicines in Australia must carry an AUST-L number on their label.

d. Only pharmaceutical medicines can be classified 'registered medicines' and are assessed by the TGA for quality, safety and efficacy.

3. Regulation of the CM practitioner industry in Australia has been the focus of much discussion. Which statement below is not true?

a. Complementary therapies are a mixture of registered and unregistered professions.

b. The regulation of complementary health care practitioners is an Australian Federal Government responsibility.

c. Naturopaths, herbalists and homoeopaths are not registered practitioners in Australia, however, are self-regulated within their representative associations.

d. Chiropractors and osteopaths and traditional Chinese medicine practitioners (in Victoria only) are registered professions within Australia.

4. The TGA acknowledges that evidence from a 'traditional use' framework is valid in supporting claims for CM. What statement does not illustrate the 'traditional use' framework?

a. If a substance has been used with good effect and apparent safety for generations it may be considered safer than a newly created substance that has never existed in nature.

b. Three or more generations of recorded use of a substance for a specific health-related or medicinal purpose.

c. Evidence obtained from at least one properly designed randomised controlled trial.

d. Three independent written histories of use in the classical or traditional medical literature.

5. Which CM preparation has been shown to help lower total cholesterol, increase HDL cholesterol, reduce LDL cholesterol, reduce oxidation of LDL cholesterol and reduce platelet aggregation?

a. Glucosamine (glucosamine sulphate)

b. Saw Palmetto (serenoa)

c. Coenzyme Q10 (ubiquinone)

d. Policosanol (sugar cane wax alcohol)

6. Pick which product is regulated as a CM?

a. Fortified food

b. Sports drink

c. Nutritional supplements

d. Functional food

e. All of the above

Answers

1. b.

In Australia, CM must be manufactured under the same standards as pharmaceutical medicines, according to the Code of GMP. Manufacturers (including those involved in processing, packaging, labelling or storing of any component of the product) must hold a GMP licence. The GMP licence is a way of ensuring that the manufacture of therapeutic goods takes place under conditions that will ensure the safety and quality of the goods. (1-3)

Manufacturing standards are monitored by periodic TGA audits of the manufacturing process. The frequency of audit is determined according to whether the premises has been previously rated as 'low', 'medium' or 'high' risk. On average, the audit frequency is between six months and two years. (1)

The manufacture of CM in Australia is more tightly controlled than many other countries. For example, manufacturers in the USA do not have to adhere to a code of GMP. Consequently, the American marketplace contains a wide range of CM products of various quality. It is important to be aware of these differing standards when deciding what to recommend.

2. d.

Complementary as well as pharmaceutical medicines can be classified as 'registered medicines' and are assessed by the TGA for quality and safety, as well as efficacy.

Like pharmaceutical medicines, CMs are regulated by the Therapeutic Goods Act 1989 and the Standard for the Uniform Scheduling of Drugs and Poisons. These two pieces of legislation provide a basis on which the government manages the availability, quality, safety and efficacy of CM in the Australian marketplace. (1)

The TGA maintains the Australian Register of Therapeutic Goods (ARTG)--a database of information about therapeutic goods approved for use in or export from Australia. The ARTG is divided into two main parts--'listed' and 'registered' products--on the basis of a risk assessment of the product. The assessment is based on the toxicity and the strength of the product, the potential for side effects, the potential for harm with prolonged use and the seriousness of the medical condition for which the product is intended. (1)

* 'Listed' products are those assessed as representing a lower level of risk, and are:

** Identified by an AUST-L number

** Evaluated for quality and safety, but not for efficacy

** Mostly CM, plus over-the-counter medicines, low-risk prescription medicines and medical devices

** Advertised as managing or maintaining health.

* 'Registered' products are those assessed as being of higher risk, and are:

** Identified by a AUST-R number

** Assessed for quality, safety and efficacy

** All prescription medicines, a few CM, some nonprescription medicines and medical devices

** Permitted to be advertised with specific therapeutic claims (in these cases, high-level evidence of their efficacy must be provided). (1)

The consultation paper (December 2004) of the new Joint Australia New Zealand Therapeutic Products Agency (the Joint Agency) has recommended a risk-based approach to the regulation of all medicines. The Joint Agency has recommended that medicines be classified as either Class I (presently 'Listed' products) or Class II medicines (presently 'Registered' products). (4) This consultation paper is presently in review.

3. b.

In Australia, the regulation of Complementary Health Care Practitioners is a state and territory government responsibility and the role of the Australian Federal Government is limited to providing support where necessary. (3)

In Australia, naturopaths, herbalists and homoeopaths are considered unregistered professionals with their current model of self-regulation being administered by the large number of professional associations that represent their three professions. The professional associations each possess codes of ethics and codes of conduct that require CM practitioners to complete accredited courses and mandate continuing practitioner education and professional indemnity insurance. However, the lack of uniform professional standards can be confusing. Some of the representative associations include the Australian Traditional Medicine Society, National Herbalists Association of Australia, Australian Natural Therapists Association and Australian Complementary Medicine Association.

Chiropractors and osteopaths and more recently, traditional Chinese medicine practitioners (in Victoria), have become registered. These practitioners must demonstrate a minimum standard of education before being legally allowed to practise and have their titles protected by law.

Medical practitioners are increasingly using complementary therapies (registered and unregistered therapies) in their practice with an estimated 30-40% of Australian GPs practising a complementary therapy and over 75% formally referring their patients for such therapies. (5,6) This interest is supported by the formation of links between the Australasian Integrative Medicine Association (AIMA), the Royal Australian College of General Practitioners and the Australian Medical Association.

For conventional medicine practitioners who desire further training in various complementary therapies, this interest can be supported through AIMA who can recommend a number of postgraduate courses in various complementary therapy areas (refer to Continuing Education Quiz 1, Nutr Diet 2005; 62: 49-52 for more details).

4. c.

Randomised controlled trials are not required by the TGA as evidence to substantiate 'traditional use'. 'Traditional use' is defined as documentary evidence that a substance has been used over three or more generations for a specific health-related or medicinal purpose. When traditions of use have been recorded as an oral rather than a written history, then evidence of such should be obtained from the appropriated practitioner or indigenous group(s) who maintain such a history. (7)

The levels of evidence designated by the TGA are slightly different from those designated by the National Health and Medical Research Council (8) in that the TGA acknowledges evidence from traditional use, accepting that if a substance has been used with good effect and apparent safety for generations it may be considered safer than a newly created substance that has never existed in nature. (7)

In 1997, the Complementary Medicine Evaluation Committee (CMEC) was established. CMEC's role includes consideration of the level and quality of evidence provided to support health claims made in advertising by sponsors. Inclusion of CM into the ARTG is guided by the recommendations of CMEC.

5. d.

Policosanol is isolated from the waxes of plants such as sugar cane. Numerous randomised, double-blind clinical trials have confirmed the cholesterol-lowering effects of oral policosanol. Results show that a daily dose of 5 mg can help reduce LDL cholesterol by 11-18%, reduce total cholesterol by 8-15% and increase HDL cholesterol by 8-15%, whereas a higher dose of 20 mg daily can reduce LDL cholesterol by 31%, reduce total cholesterol by 23% and increase HDL cholesterol by 27%. (9-11) Comparative studies with statin drugs have produced positive results; (12-14) however, overall it does not appear to significantly reduce triglyceride levels.

6. c.

In Australia, nutritional supplements are regulated as CM by the Australian TGA whereas sports drinks, fortified food, functional foods are all regulated by the FSANZ food standards code.

The proposed new regulatory definitions for CM by the Joint Australia New Zealand Therapeutic Products Agency, of which nutritional supplements fall into, define complementary medicine substances as originating from plant or plant material, vitamins or provitamins, minerals or amino acids. (4)

Food Standards Australia and New Zealand code regulates sports drinks using standard 2.9.4 'Formulated Supplementary Sports Foods'. Fortified foods are currently regulated using standard 1.3.2 (Vitamins and Minerals) of the code, which sets out those vitamins or minerals that may be added to specified foods (subject to certain conditions being met). However, this standard is presently under review. (15)

'Functional foods' can be defined as foods that support human health and wellbeing, providing health benefits beyond basic nutrition. (16) The FSANZ proposal for nutrition, health and related claims (P293), when completed, will provide an appropriate process for the substantiation of claims of enhanced health outcome through the consumption of functional foods. Currently, health claims are prohibited in Australia and New Zealand with the exception being the link between folate and a reduced risk of foetal neural tube defects. (15,16)

References

1. Therapeutic Goods Administration, Department of Health and Ageing. Regulation of Complementary Medicine. (Cited 29 Mar 2005.) Available from URL: http://www.tga.gov.au/cm/cm.htm

2. Braun L, Cohen M. Herbs and Natural Supplements--An Evidence Based Guide. Marrickville, Sydney: Elsevier Mosby publishers, 2005.

3. Australian Government, Department of Health and Aged Care. Government Response to the Recommendations of the Expert Committee on Complementary Medicines in the Health System, March 2005. (Cited 29 Mar 2005.) Available from URL: http://www.tga.gov.au/cm/cmresponse.pdf

4. Proposed regulatory definitions for Complementary Medicines and Homoeopathic Medicines in Joint Australia New Zealand Therapeutic Products Agency consultation paper, December 2004. Trans-Tasman Therapeutic Products Agency Project. (Cited 29 Mar 2005.) Available form URL: http://www.jtaproject.com/

5. Hall K, Giles-Corti B. Complementary therapies and the general practitioner: a survey of Perth GPs. Aust Fam Physician 2000; 29: 602-6.

6. Pirotta M, Cohen M, Kitsirilis V, Farish S. Complementary therapies: have they become accepted in general practice? Med J Aust 2000; 172: 105-9.

7. Therapeutic Goods Administration, October 2001. Guidelines for Levels and Kinds of Evidence to Support Indications and Claims. (Cited 29 Mar 2005.) Available from URL: http://www.health.gov.au/tga/docs/htm/tga/ccevi.htm

8. National Health and Medical Research Council. How to Use the Evidence: Assessment and Application of Scientific Evidence. Canberra: NHMRC, 2000.

9. Castano G, Mas R, Fernandez J, Illnait J, Fernandez L, Alvarez E. Effects of policosanol in older patients with type II hypercholesterolemia and high coronary risk. J Gerontol A Biol Sci Med Sci 2001; 56: M186-92.

10. Mas R, Castano G, Illnait J et al. Effects of policosanol in patients with type II hypercholesterolemia and additional coronary risk factors. Clin Pharmacol Ther 1999; 65: 439-77.

11. Menendez R, Mas R, Amor A et al. Effects of policosanol treatment on the susceptibility of LDL isolated from healthy volunteers to oxidative modification in vitro. Br J Clin Pharm 2000; 50: 255-62.

12. Alcocer L, Fernandez L, Campos E, Mas R. A comparative study of policosanol versus acipimix in patients with type II hypercholesterolemia. Int J Tissue React 1999; 21 (3): 85-92.

13. Castano G, Mas R, Arruzazabala M et al. Effects of policosanol and pravastatin on lipid profile platelet aggregation and endothelemia in older hypercholesterolemic patients. Int J Clin Pharmacol Res 1999; 19 (4): 105-16.

14. Crespo N, Illnait J, Mas R, Fernandez L, Fernandez J, Castano G. Comparative study of the efficacy and tolerability of policosanol and lovastatin in patients with hypercholesterolemia and non-insulin dependent diabetes mellitus. Int J Clin Pharmacol Res 1999; 19 (4): 117-27.

15. Food Standards Australia and New Zealand. Australia and New Zealand Food Standards Code. (Cited 4 Apr 2005.) Available from URL: http://www.foodstandards.gov.au/foodstandardscode/

16. National Centre of Excellence in Functional Food. Health Claims Regulations. (Cited 4 Apr 2005.) Available from URL: http://www.nceff.com.au/regulatory/reg-aus.htm

Sandra Murray and members of a group of dietitians interested in complementary medicine have prepared this quiz. Correspondence should be directed to Sandra Murray at [e-mail] or Rocco Di Vincenzo at [e-mail]