Due to the significant development and involvement of pharmaceuticals in the delivery of healthcare since the 1940s, successive governments have sought to control access to certain medicines by members of the broader community. The manufacture and supply of pharmaceuticals is a multi-billion dollar industry which is heavily regulated in Australia. Legislation and policy exist at federal, state and territory spheres and serve to control and influence access, cost and use of medicines, and therefore the practice requirements of medical practitioners.

Several controls exist at the federal level of government designed to organise and manage the use of drugs and poisons in the community, including their use in the delivery of healthcare. An overview of the policy frameworks is necessary to understand the policy and legislative provisions in place in Australia.

The PBS is a significant federally funded scheme to enable patients to access low-priced medication, where the federal government subsidises the cost of numerous medicines. The scheme has been in existence for more than 60 years, when medicines were mass produced post World War II and governments embraced the notion that such substances should be available to all patients, not just those who had the ability to pay. Current provisions governing the operations of the PBS are embodied in Part VII of the National Health Act 1953 together with the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act. The scheme provides for approximately 80% of prescriptions dispensed in Australia. If a medication is not listed on the PBS, patients bear the total cost of the drug. As the type and variety of new medication has continued to expand, the cost of the PBS has been escalating in recent years. From 1 January 2010, patients pay up to $33.30 for most PBS medicines or $5.40 if they have a concession card. The PBS covered around 181 million prescriptions in the year to June 2009. This represents about eight prescriptions per person in Australia for the year. The cost of the PBS is currently around $7.7 billion per year. ⁴ The Pharmaceutical Benefits Advisory Committee advises the Federal Minister for Health and Ageing which medications should be subsidised by the PBS. This has generated debate regarding the ability and desire of the federal government to continue to fund the PBS in its current form.

The legislation in each of the Australian states and territories generally does not address the precise details of actually administering medications to patients. The common law cases provide the basis for many of the principles expected in clinical practice. For example, medical practitioners may be familiar with the term the ‘5 rights’ in relation to medication administration. In everyday clinical practice patients suffer harm from incorrectly administered medication. Hence, an action in negligence might arise and be considered a breach of a duty of care when any of the ‘5 rights’ has been contravened. This can occur when there is a failure to administer the right drug, in the right dose to the right patient at the right time via the right route.

The Australian Medical Association (AMA) acknowledges the increasing use of complimentary medicines and therapies by the Australian population. The term complimentary refers to a wide range of non-prescription products with health claims such as herbal medicines, homoeopathic medicines and nutritional substances. Well-known therapies include acupuncture, chiropractic, osteopathy, naturopathy and meditation. Other alternative therapies include reflexology, iridology, kinesiology and the Alexander technique. ¹¹ With the increase in CAMs there has also been growth in the education and training courses available for both medical and non-medical students. There has been an associated rise in the number of professional associations and bodies including peak bodies for medical practitioners associated with CAMS.

A study in 2004 revealed that nearly 40% of Australians are taking self-prescribed vitamins, more than 20% are taking herbal medicines, and 13.6% of people take mineral supplements. Interestingly, 11.2% of people use aromatherapy. A chiropractor was the CAM therapist most likely to be seen by an Australian (16.7% of Australians undertaking treatment), while naturopaths (5.7%) and acupuncturists (2.1%) were the next most likely to be visited. The study also shows that users of CAMs are mistakenly thinking that their alternative medicines and therapies are independently tested for safety by bodies such as the Therapeutic Goods Administration (TGA), when it is not the case. People are often using CAMs without their doctor’s knowledge. ¹²

The TGA has established an Office of Complimentary Medicine which provides regulation over the safety and quality of manufactured complimentary medicines. The TGA provides information regarding the safety, quality and efficacy of the products it tests. ¹³ However, the AMA highlights concerns about the absence of quality controls over the importation and use of raw herbs, which is a state and territory responsibility.

With the significant use of CAM in Australia, medical practitioners should be careful to acknowledge the requirements and any restrictions on the use of specific complementary medicines. The legal requirements are the same as for the provision of any care and treatment, where patients have the right to be informed, given options and be included in the decision-making process. This includes some knowledge of the benefits and risks, including potential interactions between scheduled medications and those utilised in CAMs. Even where a medical practitioner does not engage in the use of CAMs, for safe patient treatment and outcomes, patients should be encouraged to disclose and discuss any alternative therapy undertaken when also receiving conventional care. ¹⁴

The degree of knowledge a practitioner will be expected to have will be guided by the practitioner’s area of practice or specialty and the extent to which the practitioner uses CAM as part of usual practice. This is because of the frequency with which patients consume both prescription medication and CAMs, the lack of clear understanding of the possible effects this may have on treatment, the opaque distinctions made by patients between complimentary and conventional medicines, and the increasing research into the efficacy of CAM. ¹⁵ It is necessary to highlight that while the substance may not be subject to the various state and territory poisons legislation, medical practitioners should work within their employer policies or guidelines to avoid potential problems. The AMA highlight that the medical profession must be an integral part of a systematic approach to information about adverse events. There is an increasing trend to incorporate evidence-based CAMs. ¹⁶

The widespread use of medicines brings medical practitioners into close contact with members of the pharmaceutical industry. Kerridge, Lowe and McPhee¹⁷ argue that medical practitioners generally perceive that their practice is determined by knowledge and evidence, however the commercial influences on therapeutic decisions and the subtle and pervasive effects of pharmaceutical promotion can be overlooked. There is evidence that advertising does influence clinical decision-making. For example, one study found that contact with drug company representatives leads to the use and prescription of their drugs. ¹⁸

The AMA state that despite the Code of Ethics there are occasions where additional guidance in relation to practice is necessary. Hence, the position statement on Doctors’ Relationships with Industry — 2010. ¹⁹ Medical practitioners have a responsibility to ensure that their participation in any collaboration with the pharmaceutical industry is consistent with their duties towards patients and the broader community. The overwhelming advice is that professional interactions between medical practitioners and members of the pharmaceutical industry should be at arms length — a clear delineation should be kept at all times. Relationships between the two groups will be appropriate only insofar as they do not intrude into or distort the practitioner’s primary obligation; that is, patient welfare. Accepting evaluation packages or samples from pharmaceutical representatives should allow practitioners to evaluate the clinical performance of the medications and should not involve any form of material gain, either personally or for the practice.

In Medical Board of Queensland v Raddatz²⁰ a medical practitioner used products from a company called Mannatach. The products were considered by the tribunal to be ‘complimentary, alternative and unconventional in nature’. A complaint was made to the Queensland Medical Board that when treating a diabetic patient, Dr Raddatz had substituted insulin for a Mannatach product. Nevertheless, Dr Raddatz was a keen supporter and despite being investigated and counselled to desist from promoting and selling substances that were not scientifically validated, the practitioner continued. He denied any fault and indicated that he would continue to use the products and his wife would continue to sell them. Dr Raddatz had developed an association with the Mannatach Group through the use of a family trust. The tribunal found that the practitioner had a conflict of interest and his registration was cancelled for 2 years. Furthermore, the tribunal placed a condition on Dr Raddatz’s re-application for registration; he could only re-apply if he truly resolved to abide by all ethical standards, policies and practices provided by the Medical Board.