chapter 19 Integrative medicine and the law*
INTRODUCTION
Integrative medicine involves the blending of conventional and complementary and alternative medicine (CAM) ‘with the aim of using the most appropriate of either or both modalities to care for the patient as a whole’.1 There have been many attempts at defining CAM and a frequently cited definition is:
a broad domain of healing resources that encompasses all health systems, modalities, and practices and their accompanying theories and beliefs, other than those intrinsic to the politically dominant health system of a particular society or culture in a given historical period.i
CAM includes a diverse group of healing practices such as traditional Chinese medicine, ayurvedic medicine, Western herbal medicine and naturopathy. Different taxonomies of CAM have been proposed and one frequently cited is that of the National Center for Complementary and Alternative Medicine.2 This taxonomy divides CAM into five categories:
The term ‘CAM’ has traditionally described the ‘relationship between unconventional healthcare disciplines and conventional care’ but is now more of ‘a collective label for the disciplines themselves’.3a CAM brings different approaches to diagnosis and treatment, and a central focus is prevention and wellness, which complements biomedicine.4
While historically CAM has been on the margins of healthcare, developments in the past decade that have accorded it greater legitimacy within mainstream healthcare include a massive investment in CAM research, particularly in the United States, increasing evidence of its safety and efficacy, acknowledgement of a role for evidence-based CAM in mainstream healthcare by professional medical bodies, and a number of high-level government and institutional inquiries around the world into the role of CAM.ii These inquiries have focused on the regulatory interventions necessary for a planned and systematic integration of CAM into mainstream healthcare. Although a wide-ranging inquiry has not been held in Australia, there have been three recent inquiries with a narrower focus on CMs, CPs and health services.iii The implementation of recommendations from these inquiries is assisting, or when implemented will assist, with the promotion of integration in Australia.
Significantly, it is the ad hoc integration occurring at the level of the consumer and the health practitioner, including the general practitioner (GP), that has been driving these developments at the state and national policy level. The most recent and comprehensive data show that nearly 70% of Australians use CAM.5 It means that Australians have one of the highest rates of CAM usage among Western nations.5 In the 12 months prior to the 2005 survey by Xue and colleagues, more than 44% had consulted a CP, resulting in an estimated 69.2 million visits to CPs.5 This figure approximates the number of visits to medical practitioners during the same period.5
There is evidence that consumers use CAM because of a desire for holistic and natural treatment, to fill gaps in medical care, such as the management of chronic illness, and the perceived effectiveness of CAM.6–8 It is also clear from prevalence studies that consumers use CAM as part of self-care, and in combination with biomedicine, to achieve their own type of integration. CAM users like to pragmatically pick and mix biomedical and CAM options to address their healthcare needs.5,9,10 One difficulty with this trend is that a high proportion of patients use CAM and biomedicine concurrently, and do not inform their doctor about the CAM use and, in addition, many doctors fail to ask patients about CAM use.5,10–16
Doctors, and particularly GPs, have been responding to consumer demand and integrating CAM treatments into treatment plans. In 2000, 20% of GPs in Victoria and 38% of GPs in Perth, Western Australia, had practised one or more CAM modalities. Eighty-two per cent of the Victorian GPs had referred patients for a complementary therapy, and nearly 68% of Perth GPs were in favour of referring patients to CPs as part of their medical care.17,18 A national survey of Australian GPs in 2000 (published in 2005) found that CAM, non-medicinal therapies, such as acupuncture, massage, meditation, yoga, hypnosis and chiropractic, ‘are widely accepted and can be considered mainstream in Australian general practice’.13a At the same time, the Victorian study showed that herbal medicine, naturopathy, vitamin and mineral therapy, osteopathy and homeopathy were ‘accepted by a sizable minority of doctors’.17a In a 2008 survey of Australian GPs, one-third reported practising integrative medicine and about 90% had recommended at least one CM in the past 12 months.16
Doctors may be motivated by a number of factors to integrate CAM, including the desire to address consumer preferences in healthcare, an interest in working with safer remedies, and the need to contain costs. It is also reasonable to assume that integrative doctors believe that CAM complements biomedical care, and can also be the primary treatment for patients suffering from chronic conditions who are unresponsive to conventional treatment.3,13,19
LEGAL OBLIGATIONS IN THE PRACTICE OF INTEGRATIVE MEDICINE
It is not possible to outline all the legal obligations that may be relevant to this context, or how those obligations impinge on integrative medical practice. The ethical and legal obligations relevant to medical practice are, of course, also relevant to the practice of integrative medicine, including professional codes of conduct, the criminal law, and obligations related to confidentiality and privacy. There are texts providing information about these obligations that are written specifically for medical practice.iv It is a matter of applying the relevant laws to the integrative context.
THE DOCTOR’S DUTY OF CARE TO THE PATIENT
Through the law of negligence, the law imposes on a doctor an obligation to exercise reasonable care and skill in examination, diagnosis, treatment, and provision of information and advice, that duty being a ‘single comprehensive duty’.v The relevant law has been affected by reforms arising from the Review of the Law of Negligence (Ipp Review) initiated by the Australian Government in 2002 in response to an insurance crisis.20 Although it was originally intended that a model statute be developed to implement the reforms recommended by the Ipp Review in all Australian states and territories, this did not eventuate. As a result, there are a number of differences in the legislative provisions enacted in the states and territories.
There is currently little guidance from the courts on the meaning of the new statutory provisions and how they affect the common law, which applied across Australia prior to the Ipp Review reforms. What follows therefore is a discussion of elements of the law that doctors need to bear in mind in their daily practice. It is, of necessity, a broad brush approach, as it is not possible to provide specific guidance in relation to each state or territory.
Although CAM therapies are not without their risks, generally speaking CAM as a whole does have a lower risk profile than biomedicine. Adverse events do occur in CAM but are much less common than in biomedicine.vii And there are fewer complaints and claims against CPs. A US study found that claims against complementary practitioners ‘occurred less frequently and typically involved less severe injury than did those against conventional practitioners in the same period’.21a
Reasonable responses to these risks would generally include:
These matters are all considered further below.
THE SCOPE OF THE DOCTOR’S DUTY
At this time the scope of a doctor’s duty of care extends to the provision of biomedicine only. However, according to the Australian Medical Association’s (AMA) position statement on CM, a doctor appears to have an ethical obligation to at least ask a patient about CAM use in medical consultations.22 Although the ethical obligation to engage with patients about CAM is unlikely to be enforced by the AMA, it may increasingly be recognised and enforced in other forums, such as professional disciplinary hearings and in medical litigation, because of the risks stemming from patients combining CAM and biomedicine. A doctor may also have a legal obligation to provide information and advice to some patients about evidence-based CAM treatment options, and this is discussed below (see ‘Informed decision-making in integrative practice’).
At present, a doctor has no positive duty, ethically or legally, to integrate CAM therapies into medical practice. At the same time, it is ethical and lawful for a doctor to provide evidence-based CAM treatments to a patient, or to refer a patient to receive such healthcare.viii However, once a doctor chooses to integrate CAM into conventional medical practice, the scope of the doctor’s duty of care expands to include integrative practice.
MEETING THE REQUIRED STANDARD OF CARE
The standard of reasonable care and skill required of a medical practitioner under the common law is ‘that of the ordinary skilled person exercising and professing to have that special skill’.ix In the case of a GP, the standard of reasonable care and skill is that of a doctor who specialises in general practice.
The peer professional opinion test appears to create a type of defence in medical litigation.x This means that if a doctor is able to provide probative evidence that his or her conduct or opinion is widely accepted as competent professional practice in the circumstances, he or she will not be negligent (provided the court considers that the opinion is reasonable).
The peer professional opinion test is similar in other states, although the widely accepted practices and opinions are not limited to Australian ones, in Queensland and Western Australia.xi In those states a doctor could draw on widely accepted practices in integrative medicine outside Australia, to establish that he or she had acted within the standard of care.
There have been no decisions where the courts have determined that peer professional opinion is irrational or unreasonable, and it is likely that this will occur only in very exceptional circumstances.20
PROFESSIONAL STANDARDS AND THE PEER DEFENCE
Medical boards are the primary regulator of doctors and have ultimate responsibility for those who are integrating CAM into conventional practice.22 Guidance on professional standards is found in the codes and guidelines published by the medical boards.xii Although the codes and guidelines are recommendations of the medical boards and are not legally binding, they are authoritative and an important guide to professional standards and what is expected of medical practice and performance. They are potentially enforceable through disciplinary processes in relation to allegations of unprofessional conduct and unsatisfactory professional performance. The codes and guidelines need to be applied to the integrative context. They are not comprehensive and do not cover every possibility, and it is expected that doctors will apply general principles to different circumstances as they arise.
Most medical boards have a specific policy statement on CAM and doctors should be familiar with the relevant policy and its application to practice.xiii However, there are a number of differences in the policies, raising questions about what the appropriate professional standards are in this area. The establishment of the National Registration and Accreditation Scheme for the health professions, including medical practitioners, in 2010 will provide the opportunity for the development of a national integrative medicine policy.xiv
A number of jurisdictions in the United States have passed legislation intended to protect doctors from being inappropriately targeted and disciplined for the practice of CAM.24 Inappropriate targeting would involve findings related to the use of CAM as substandard, on the basis that a CAM treatment is different from a biomedical treatment.25 The Medical Council of New Zealand has made provision for a similar protective clause within its policy statement on CAM.26
There are no similar legislative or policy provisions within Australia, but the process for dealing with CAM-related complaints by medical boards may have a similar effect. The Western Australia Medical Board, for example, makes it clear that any investigation into a complaint will involve an assessment of the overall competence of the practitioner, some assurance that integrating CAM will not in itself result in a finding of unprofessional conduct.27 However, where CAM use forms a part of the complaint, there will be specific inquiries into matters such as the risk/benefit ratio of the treatment and whether it is greater or less than that of other treatments.27 It is likely that this will be the approach across all Australian jurisdictions. Doctors should therefore be prepared to produce evidence of the reasoning process that led to the decision-making, as well as the informed decision-making of the patient.
AIMA, established in 1992, is the peak body for integrative medicine in Australia. The members of AIMA are doctors who are interested or involved in integrating natural and holistic approaches into conventional care. AIMA provides a vehicle for peer support for integrative doctors, provides educational programs and resources (including a journal) and acts as an advocate of integrative medicine with government and professional bodies.28
The RACGP sets standards for general practice in Australia. The RACGP seeks to ensure that the general practice training curriculum reflects ‘both the fundamental nature of Australian general practice and the evolution of … [the] discipline in response to community needs and advances in science and technology’.29a The RACGP has a major role to play in standard setting in integrative medicine, as most doctors integrating CAM are GPs. Hence the college collaborates with AIMA through a joint working party to provide guidance to practitioners on good medical practice in the evolving field of integrative medicine.
The RACGP/AIMA Joint Working Party (JWP) was established in 2005 and the terms of reference include establishing how complementary medicine can be incorporated into high-quality clinical practice.xv A Joint Position Statement on Complementary Medicine was released in 2005 and the primary position of the JWP is that ‘evidence based aspects of complementary medicine are part of the repertoire of patient care in mainstream medical practice’.30a
More recently the RACGP has established a Chapter of Integrative Medicine within the college and there are plans to introduce a Fellowship of Integrative Medicine and standards for integrative practice.xvi An integrative medicine curriculum was published in 2007.xvii This incorporates the skills and knowledge needed by GPs in integrative medicine across five domains of general practice. The curriculum, Chapter and proposed Fellowship are key developments, as they direct, or will direct, doctors to the skills that they need to acquire to achieve competent practice in this area. It is clear that the RACGP is committed to addressing the integrative medicine educational needs of GPs and providing guidance in relation to the standard of care expected. When fully implemented these developments will play a highly significant role in carving out what amounts to widely accepted, competent professional practice for integrative medicine in Australia, particularly in general practice.
EXAMINATION, DIAGNOSIS AND TREATMENT IN INTEGRATIVE PRACTICE
For doctors, integrative medicine involves integrating CAM into conventional medical practice. This is clear from the entire legal context. It is also apparent from guidelines, such as the Western Australia policy statement on complementary, alternative and unconventional medicine, which refers to the doctor’s obligation to undertake a proper assessment, arrive at a diagnosis according to biomedical principles, devise a treatment plan, and provide information in relation to any conventional treatment, and its risks and benefits.28
As is illustrated in a number of chapters in this integrative medicine text, the doctor will need to make a differential biomedical diagnosis according to the usual methods of history taking, examination and diagnostic testing. And, as is standard practice within general practice, it will be necessary to exclude particular diseases, such as cancer, as a cause of symptoms (see, for example, Ch 51, Breast disease). CAM diagnostic testing may be appropriate if it will provide further information to assist in the care of the patient (see, for example, alternative testing methods in Ch 21, Allergies).
In the treatment phase, it is a matter of ascertaining treatments for the patient’s condition, including any appropriate CAM options, and working with the patient to devise a treatment plan. An integrative approach may be appropriate for some conditions but not others (see, for example, Ch 42, Skin).
It is clear from existing professional guidelines that evidence-based CAM is relevant to the practice of integrative medicine.22,30 The RACGP-AIMA position statement on complementary medicine states that:
The RACGP-AIMA statement adopts the Sackett et al definition of evidence-based medicine as:
the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. By individual clinical expertise we mean the proficiency and judgment that individual clinicians acquire through clinical experience and clinical practice.30c,31
The RACGP policy on evidence-based medicine is also relevant to decision-making about CAM treatments. This policy refers to the evidence-based approach incorporating three components: the best evidence available, the biopsychosocial circumstances of the patient, and the clinical skills and judgment of the doctor.32 Evidence-based medicine therefore involves more than the highest levels of scientific validation. It is an assessment that considers all treatments, conventional and complementary, across a multidimensional spectrum that takes into account safety and efficacy, and ‘practicality, availability, utility and cost effectiveness as well as other dimensions’.33a And adopting an evidence-based approach to CAM is not so much about having specific knowledge as it is about acquiring evidence-based medicine problem-solving skills, and having access to texts, databases, peer networks and CAM prescribing software.34a
Cohen and Eisenberg have devised a decision-making grid based on an analysis of the evidence available for safety and efficacy.36 The grid is a useful risk management tool and provides guidelines on when CAM could be recommended, when it should be avoided, and when it could be implemented with close monitoring.
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