11 Overview

This chapter discusses the risk factors in TCM in the context of regulatory options and presents an overview of the general regulatory environment applicable to TCM. It directly addresses the questions highlighted by the AHMAC criteria and puts forwards specific options for regulation.

11 Methodology

The Health Issues Centre (Victoria) was commissioned to prepare the analysis of the legal framework required for assessing and developing regulatory recommendations concerning the practice of TCM. Discussions were held with a wide range of government officers, professional representatives, and individual practitioners and educators in TCM. Government agencies included the Therapeutic Goods Administration, the Australian Quarantine Inspection Service, the Victorian Department of Human Services, the Western Australia Department of Health, the Australian Institute of Building Surveyors, the Victorian Department of Infrastructure, and the Australia New Zealand Food Authority. A number of written submissions were received, and are identified in the references at the end of the chapter.

11 The Problems

11.1 Inherent Risk

In New South Wales, Queensland and Victoria, an estimated total of 1500 practitioners offer TCM as their primary service and about 2,500 medical practitioners offer acupuncture as part of their practice. Together these groups make up at least 90% of the TCM workforce in Australia.

The TCM workforce survey in these States indicates a very significant level of adverse events, including a number of deaths, associated with TCM, underscoring the concerns highlighted in Chapter Four regarding the risks related to TCM. The survey data also confirms that the inherent risks of acupuncture are different to those of Chinese herbal medicine, although both involve intrusive techniques that can cause either predictable or unpredictable adverse effects, which may be serious or sometimes fatal.

A number of submissions to AHMAC and to this report agree that there is inherent risk in TCM but argue that to date this risk has been relatively well contained in Australia. One submission notes that a treatment practice which has the power to heal also often has the power to harm1.

Both the literature and the Workforce Survey confirm that whilst the risks from acupuncture and Chinese herbal medicine may be limited, they are significant. Chapter Four concludes that:

• the relative risk of adverse events from TCM is less than that from western medicine, although greater than some other forms of regulated health care practice in the community; and
• avoidance of predictable adverse reactions is likely to be minimised by appropriately trained individuals practising appropriate patient treatment and monitoring.

11.1.1 Risks from Acupuncture

The risks of acupuncture are associated with the insertion of needles into the body, which is a key aspect of the discipline. An NH&MRC Working Party has detailed four possible serious complications2:

• infection;
• puncture of vital organs;
• mental trauma; and
• failure to detect serious underlying disease resulting in delayed diagnosis and appropriate treatment (p.79-80).

All these risks are potentially catastrophic, and deaths have occurred in Australia associated with the use of acupuncture2. The risks of serious infection also affect the broader public through the spread of contagious disease.

11.1.2 Risks from Chinese Herbs

Chinese herbal medicine involves the prescription of combinations of herbs for topical application or ingestion. Potential risks include:

• inherent toxicity;
• contamination;
• substitution;
• adulteration with pharmaceutical drug; and
• poor or non-existent labelling of ingredients, when extemporaneously compounded by practitioners.

These issues are discussed in more detail below in Section 11.5 in the context of Commonwealth and State legislation.

11.2 Exacerbating Risk

The largest professional association argues that the potential risks associated with TCM is usually linked to poor training and unethical conduct5. Both the literature and the Workforce Survey suggest strongly that these risks could be minimised by appropriate TCM education.

One submission opposing occupational regulation argues that allergic reactions may occur to a wide range of substances such as foods, soaps and perfumes1. It seems likely, however, that potential harm from allergic reactions will be minimised if the patient's response to treatment is adequately monitored by an appropriately trained practitioner, who will make appropriate referrals when necessary.

The potential for harm was considered sufficient to establish an NH&MRC Working Party in 1989 to address concerns that the practice of acupuncture in Australia by non-medically trained acupuncturists and others was `proliferating'2. Concerns raised by the NH&MRC included the risk of failure to detect serious underlying pathology such as cancer, and that of aggravating existing conditions by inappropriate treatment3. These concerns are equally relevant to Chinese herbal medicine. They reinforce the need for appropriately trained practitioners who have sufficient knowledge of western medicine to know when to refer a patient to a medical practitioner.

11.3 Serious Complaints

One submission to the report argued that, regardless of the potential for injury, the low level of complaint associated with the practice of TCM in Australia suggests that self regulation and other regulatory measures provide adequate protection.

While data before the report does suggest a low rate of litigation and complaints to bodies such as the Health Services Commissioner, this may be partly explained by a lack of awareness that the statutory complaints units accept complaints regarding complementary medicine and its therapists. The responses by practitioners to the Workforce Survey indicate a substantial number of critical incidents.

The Australian College of Acupuncturists 1994 submission to AHMAC also details a range of cases that demonstrate the serious nature of complaints that have arisen4. These, together with the cases in Chapter Four and the evidence to the NH&MRC Working Party underscore the serious nature of the risks associated with TCM. The material provided by the Australian College of Acupuncturists4 includes:

• a Coroner's call for accreditation of acupuncturists (1988);
• a series of serious incidents pre-1982, including acupuncture rendered to persons suffering hepatitis, and incidences of broken needles travelling for example, from the back into the peritoneal cavity;
• a case of an acupuncture needle deliberately broken by a registered medical practitioner which travelled from where its point of insertion in a woman's shoulder across her chest (1986);
• <$imoxibustion> injuries suffered at the hands of a practitioner who had previously failed the examinations required for membership of an Australian TCM professional association (1990); and
• inappropriate response by an acupuncturist whose patient became ill whilst undergoing treatment requiring subsequent hospital attention (1990).

Little evidence is available of recent complaints handling activity by relevant professional associations. The ATMS has advised that the level of complaints received is low, although a number of those complaints warranted serious disciplinary action by the Association1. In addition, whilst some associations may be effective in controlling their members, they have no capacity to control those who are not its members and particularly those whose training and qualifications are not adequate to become a member in the first place.

11.4 Changing Significance of Risk

The low rate of complaint to date may, in part, reflect the small numbers of primary TCM practitioners in Australia and they have been relatively cautious in their practice. There are approximately 1500 in total compared to over 10,000 medical practitioners.

Most submissions to this report suggest that the situation is changing and these changes have greatly increased the significance of the risks inherent in TCM. Traditionally, the consumers of TCM tended to be members of Australia's small ethnic Chinese population. It is possible that the potential for risk has also been restricted if these people tended not to combine herbal medicines with concurrent treatment with western pharmaceuticals.

The Draft Position Paper prepared by the Acupuncture Ethics and Standards Organisation Ltd and the Australian Acupuncture Association Ltd encapsulates the concerns5, suggesting that the risks are likely to be increased by:

the changing demographics of the profession, deregulation of the education sector, and progressive weakening of the existing self-regulatory mechanisms, (p.5).

In recent times, TCM has become considerably more popular both among consumers and practitioners:

• Australians are seeking TCM treatment more often and for a broader range of health needs, and are increasingly adopting complementary medicine practitioners as their primary health care providers, with more 35% of patients identified in Chapter Six as not having seen a medical practitioner for their condition before consulting their TCM practitioner. The burgeoning expenditure on complementary medicines confirms this increase (see Chapter Two).
• Western health care practitioners, such as medical practitioners, nurses and chiropractors, are increasingly offering services in complementary medicine, particularly acupuncture. In 1988, over 2800 medical practitioners were claiming Medicare rebates for acupuncture2, and in 1994-95 the Commonwealth Department of Human Services and Health paid well over $16 million in Medicare rebates for acupuncture treatment.

There has been an significant increase in overseas-trained practitioners, particularly since the Tiananmen Square incident in Beijing in 19895. There is no uniform, systematic evaluation of the adequacy of overseas courses or the validity of claimed qualifications. Particular concerns relate to whether overseas-trained practitioners have adequate training in western medicine. Submissions to this report also suggest that these practitioners have variable awareness of the statutory requirements in this country regarding skin penetration regulations or other infection control obligations. The Workforce Survey found that approximately 25% of primary TCM practitioners had TCM qualifications obtained overseas. Some submissions suggested that such practitioners tend not to meet the standards required for membership of the major professional associations, and in such cases the public lacks even the protection of these self-regulatory mechanisms. The Workforce Survey indicates, however that most TCM practitioners do belong to at least one professional association.

11.5 Registered Professions

Concern has been expressed by professional associations of primary TCM practitioners regarding the competence of health practitioners such as medical practitioners, dentists and chiropractors to practise TCM. While these concerns are applicable to TCM generally, they appear to have been explored more extensively in relation to acupuncture. The practitioners referred to are all subject to occupational regulation. The primary reservation is that practitioners registered to practice in other health care disciplines may not necessarily have adequate training or expertise in TCM. This concern is reinforced where acupuncture or Chinese herbal medicine has been learned in isolation from a sound education in the broader principles of TCM and may be practised on a part-time basis only.

In England, a 1995 Sheffield University national survey found that just under 40% of general practitioners either provide or support the use of complementary therapies6. Increasing acceptance of such therapies is also reflected in the British Medical Association's 1993 report, Complementary Medicine: New Approaches to Good Practice7. The BMA's policy is that medical practitioners who wish to offer therapies outside western medicine should first ensure they are fully trained in the relevant discipline.

Some Australian registration bodies have taken similar initiatives. For example, the Nurses Board of Victoria has issued Guidelines for Use of Complementary Therapies in Nursing Practice. It defines complementary therapies or interventions, specifically including acupuncture, as "treatments that are aimed at a more holistic approach to healing"8. The guidelines caution that nurses are responsible for ensuring that they practice only within the limits of their skills and refer on where necessary and provide advice regarding the selection of appropriate courses, suggesting that nurses look for courses that are accredited or approved by `the professional organisation'. Unfortunately no advice is provided as to how to identify this organisation(s).

Concern has been expressed that the availability of a Medicare rebate for acupuncture services rendered by medical practitioners may lead consumers to believe that all acupuncturists are registered practitioners and therefore subject to the usual disciplinary and other controls exercised by a registration board5. It seems more likely, however, that the availability of a Medicare rebate might suggest that the medical practitioner has adequate training to undertake acupuncture, whereas this may be incorrect.

The demonstrated danger inherent in acupuncture carried out by an incompetent practitioner, whether trained in western medicine or according to the philosophies of TCM, raises the question of whether acupuncture itself requires special licensing. This occurs in Victoria for radiography, with a separate radiography licensing committee in the health department dealing with applications from other individual registered health practitioners who wish to undertake radiography as part of their broader practice.

The conclusions of the NH&MRC Working Party were in contrast to the views noted above of some TCM associations. It should be noted that the NH&MRC review was a response to concerns about the proliferation of non-medically trained acupuncturists "in light of the contemporary orthodox western medical knowledge base", and that this was reflected in the limited composition of the working party2. It found that most reports of complications implicated acupuncturists whose training was not at least equivalent to that of medical practitioners in areas such as anatomy, bacteriology and clinical diagnosis, and concluded that non-medical acupuncturists required a stronger grounding in western health care but medical practitioners required little additional training to acquire acupuncture skills2. Even so, it found many of the courses undertaken by medical practitioners to be inadequate. It suggested that the Australian Medical Acupuncture Society was the appropriate body to identify suitable courses for registered doctors and, more importantly, the fact that it conducted its own examinations provided greater confidence in the ability of its members to practise safely2.

A variety of different approaches are taken to this issue:

• In New York, licensed physicians, osteopaths and dentists may be separately certified as having appropriate training to practise acupuncture.
• In other places, acupuncture is considered within the scope of medical practice without any additional certification, and some countries allow the practice of acupuncture only by medical practitioners.
• In New Mexico, both styles of practice are registered, and membership of the licensing body for acupuncturists comprises both TCM practitioners and doctors certified to practise acupuncture, as well as several members of the general public.

Models of occupational regulation for TCM overseas were discussed in Chapter Ten on the regulation of Traditional Chinese Medicine.

The Workforce Survey suggests that in Australia, the rate of adverse events associated with TCM is higher for registered than unregistered health practitioners. This disparity may be related to a combination of factors including:

• Shorter education courses in TCM were correlated with higher adverse event rates (Chapter Four), and registered health practitioners were identified as undertaking substantially shorter training programs in TCM (Chapter Five).
• Severity of conditions treated and the frequency of practice in TCM may also influence the rate of adverse events.
• Willingness to report adverse events in a self-administered questionnaire may be greater amongst registered practitioners, although there is no evidence to support this.

11.6 Consumer Choice and Integrated Care

Medical and other practitioners seeking to make referrals that accommodate consumer preference for a wider range of health care options, are unable to easily identify appropriately trained practitioners given the current plethora of TCM professional associations. In a multicultural Australia it may be considered especially appropriate for people to be able to access health care consistent with their cultural traditions and philosophies rather than western medicine alone3.

Commonwealth, State and Territory governments are currently attempting to reorient the health system towards a greater consumer focus by trialing various models of co-ordinated care to incorporate consumer treatment preferences. This requires the involvement of all providers used by consumers in the health care team, a need reinforced by the potential dangers of toxic interactions occurring when western and herbal medicines are used together.

In the United Kingdom, the National Health Service contracts with general practitioners to co-ordinate most of the health care required by patients enrolled with them, within a given budget. Some of these GP's have expressed concern that they may be assuming a legal responsibility for the competence of practitioners to whom they refer. This is problematic where the scope of practice of practitioners to whom the referral might be made carries with it significant risks of harm, but no statutory register exists of appropriate qualifications or of practitioners identified as meeting standards of basic competence6,9.

TCM providers argue that consumer choice is further constrained because prescription of certain herbs traditionally used by TCM practitioners is restricted by the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP). The SUSDP complements the operation of the Therapeutic Goods Administration and is administered by the AHMAC Drugs and Poisons Scheduling Standing Committee. Herbs listed in schedules 1 to 4 of the SUSDP may only be prescribed by registered medical practitioners, dentists or veterinarians and dispensed by registered pharmacists. This issue is discussed further in the next section.