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Ethics and Professional Responsibility

Presented at "Medicine in the New Millennium: Fringe or Frontier?"

Aotea Conference Centre, Auckland

March 2001

Nicola Sladden, Senior Legal Advisor

Office of the Health and Disability Commissioner

Medicine in the New Millennium

Medicine in the new millennium promises many exciting advances in our understanding of clinical and technological issues. The new millennium is also a time to focus on health consumers' rights and the corresponding responsibilities of health care providers.

I will briefly explain the Health and Disability Commissioner's complaints and investigation processes, before discussing some aspects of the Code of Health and Disability Services Consumers' Rights in more detail. I have chosen to focus on the rights that deal with standards of care and informed choices, as these are central to an understanding of ethical and professional responsibilities, particularly when dealing with new methods and alternative modalities of treatment. Anonymous case studies drawn from the files of the Health and Disability Commissioner will be used to illustrate key themes.

Ethical and Professional Responsibilities

Prior to 1996, the ethical and professional responsibilities of health care providers in New Zealand were scattered among a variety of sources, poorly defined and often unwritten. In July 1996 the Code of Health and Disability Services Consumers' Rights came into force. The Code does not create any new or revolutionary professional responsibilities, but rather "codifies" or "affirms" pre-existing consumer rights and corresponding provider responsibilities. The Code sets out these rights and responsibilities within a clear and accessible framework, supported by a spectrum of sanctions that can be imposed on those who breach the Code. One of the Code's strengths is that it allows the Commissioner to refer to external sources for guidance on appropriate standards within different professions, and for different modalities of treatment. This ensures that the Code remains dynamic and responsive to change within the health and disability sectors.

Purpose of the Health and Disability Commissioner Act 1994

The Code has legal status as a regulation made under the Health and Disability Commissioner Act. The Act was passed in 1994 in response to Judge Sylvia Cartwright's Report of the Cervical Cancer Inquiry. The purpose of the Act is to promote and protect the rights of consumers and to facilitate fair, simple, speedy and efficient resolution of complaints.

Code of Health and Disability Services Consumers' Rights

The Code sets out ten rights that are available to all health and disability services consumers, including those involved in teaching and research. In general terms, these rights cover basic principles (such as the right to respect), standards of practice, information disclosure, consent, and complaint procedures. Each right imposes a corresponding legal duty on health care providers. Under Clause 3 of the Code, a provider will not be in breach of the Code if he or she has taken "reasonable actions in the circumstances" to give effect to a consumer's rights. This takes into account factors such as a consumer's clinical circumstances and a provider's resource constraints. Proof of actual harm to a consumer is not necessary for the Commissioner to find a provider in breach of one of the rights.

Definition of Health Care Provider

"Health consumers" who enjoy the rights spelt out in the Code of Rights include "any person on ... whom any health care procedure is carried out". "Health care procedure" includes "any provision of health services to any person by any health care provider". "Health services" includes any "services to promote health". And a "health care provider" includes "any ... person who provides, or holds himself or herself out as providing, health services to the public or a section of the public, whether or not any charge is made for those services". This means that every iridologist, every primal therapist and every faith healer who holds himself or herself out as providing services to promote health is subject to providers' duties under the Code.

Complaints Process

Any person (not just the actual consumer) may make a complaint to the Health and Disability Commissioner if he or she believes that there has been a breach of the Code. Complaints are usually received from consumers or their families. All complaints made to statutory registration bodies, such as the Medical Council, must now be referred to the Commissioner. These bodies may not take any disciplinary action until the Commissioner's Office has dealt with the matter and decided to take no further action. (It is only disciplinary action that is suspended. For example, the Medical Council may still consider a member's fitness or competence to practise.) Where concerns have been brought to the Commissioner's attention but no complaint has been laid, an investigation may be commenced on the Commissioner's own initiative.

Investigation Process

The investigation process is impartial, independent and subject to the rules of natural justice. Adverse events are often the result of "systems errors". In the 1997 case of Nicholls,¹ the High Court affirmed that the Commissioner is empowered to investigate systems issues in addition to the actions of individuals.

In the past, the Health and Disability Commissioner's complaints process has been criticised as being slow and, at times, unfair. Ron Paterson, the current Commissioner, has made several changes in an effort to streamline investigations and improve procedural fairness. Early discussions with complainants to clarify the issues involved in the complaint now take place more frequently. The provider is notified of the scope of the investigation at an early stage, and almost always given a copy of the original complaint letter (with deletions made to protect the privacy of other providers if needed). Providers are entitled to submit a written response, within a reasonable period of time.

As part of the investigation process, the Commissioner often seeks comment on the facts of the case from an expert advisor, particularly where issues of professional standards are involved. For example, if a complaint involved the provision of chelation therapy, the Commissioner might ask a member of the New Zealand Chelation Therapy Society to provide an opinion on whether professional standards had been met. In the past, the identity of expert advisors was kept anonymous. In order to provide greater transparency and accountability, the Commissioner is moving to a model where professional bodies nominate names of suitable advisors, those names are published within the profession, and individual advisors are identified in particular reports. Another change that has already been implemented is the reproduction of expert advice in full in the body of the report.

At any stage during the investigation, the Commissioner may refer the matter to an advocate (who acts on behalf of the Commissioner) to seek to facilitate a resolution of the complaint, or to an independent mediator in an attempt to reach a settlement.

Following an investigation, the Commissioner forms an opinion on whether the provider has breached the Code, and recommends further action as appropriate. At this stage, the provider is sent a copy of the provisional opinion, and given an opportunity to respond to any adverse comments. Where there has been a finding of no breach, or a decision to take no further action, the complainant is sent a copy of the provisional opinion, and given the opportunity to respond. After consideration of these responses, a final report is issued.

Typically, investigations take six to nine months to close, but a complex investigation involving a large number of providers in a hospital setting may take one to two years. One of the core commitments of the current Commissioner has been to ensure the "fair, simple, speedy and efficient resolution of complaints" as required by the Act.

 

Right 4 - Right to Services of an Appropriate Standard

Right 4 is the umbrella provision that underpins the right of every consumer of health care to receive good quality care. Right 4(1) is the right to have services provided with reasonable skill and care. Right 4(2) is the right to services that comply with legal, professional, ethical and other relevant standards.

The Code is not, and should not be, the primary mechanism for the establishment of standards. Right 4 of the Code is intended to provide a means by which standards set by other bodies can be enforced. Ultimately, the responsibility for establishing and maintaining quality standards should lie with the relevant profession. As mentioned earlier, when an issue of standards is involved, the Commissioner usually seeks expert advice from a practitioner from within that field of practice. The Commissioner may also make reference to relevant written standards and guidelines where these are available.

Guidelines on Complementary, Alternative or Unconventional Medicine

For medical practitioners making use of different modalities of treatment, guidance can be found in the Medical Council of New Zealand Guidelines on Complementary, Alternative or Unconventional Medicine (1999). These guidelines inform medical practitioners of the standards of practice expected of them should they choose to practise complementary or alternative medicine. The Medical Council doubts the feasibility or even desirability of pursuing the goal of 100% evidence-based practice. Nevertheless, it states that in general "the standards of Medical Practice acceptable to the Medical Council are those that are consonant with the standards of what has come to be called evidence-based medicine".

The Medical Council states that an unproved or experimental treatment may only be offered if the treatment has broad professional support, and the patient has provided fully informed consent. If the treatment involves any risk to patient safety, the formal approval of an ethics committee is also required. In providing treatments in areas of uncertainty, where no treatment has proven efficacy, the medical practitioner must ensure that the patient is "told the degree to which tests, treatments or remedies have been evaluated, and the degree of certainty and predictability that exists about their efficacy and safety".

In assessing complaints related to the practice of any doctor who has adopted or advocated investigations or treatments of complementary, alternative or unconventional medicine, the Medical Council will consider a number of factors. These factors include whether there was a reasonable expectation that the treatment offered would result in a favourable patient outcome, and how the risk/benefit ratio for the treatment compared with that for other treatments for the same condition.

In assessing a complaint involving the use of alternative, complementary or unconventional medicine, the Commissioner may refer to these Medical Council guidelines in forming an opinion on whether there has been a failure to comply with professional standards.

Case Study - Breach of Right 4(2) (98HDC15904)

The following case study illustrates the application of Right 4(2) to a situation where a doctor held himself out as being competent to provide modalities of treatment in which he had little or no formal training.

A woman suffering from muscle pains consulted a doctor who held himself out to the public as being both a conventional medicine practitioner and a provider of alternative therapies. The doctor carried out a form of "muscle testing" and made a diagnosis of intracellular brucellosis. He conducted "spiritual healing" and sold the patient several hundred dollars' worth of "homeopathic remedies" before proclaiming her "cured". The woman's symptoms were no better, so she saw another doctor, who diagnosed fibromylagia. (A blood test for brucellosis was negative.) The Commissioner sought expert advice from a GP, a homeopath and a practitioner of alternative medicine. All three experts were clear that the treatment was at variance with accepted principles of homeopathy, alternative medicine and standard medical practice. The homeopath advisor stated that the remedies prescribed were inappropriate and potentially harmful. The Commissioner found that the doctor had breached rights 4(1) and 4(2) of the Code by failing to comply with the relevant standards of his profession.

 

Right 4(5) - Right to Co-operation among Providers

Right 4(5) states that "every consumer has the right to co-operation among providers to ensure quality and continuity of services". The phrase "building safe bridges between health services providers" has been used at this conference, and I think this reflects the essence of right 4(5).

Co-operation between providers using different modalities is a two-way street, and may entail a level of co-ordination of care. My GP should not discourage me from talking to my dentist about the possible effect of mercury fillings on my health. Similarly, my nutritionist should not discourage me from seeing my GP to obtain a prescription medicine, and may even be able to work with my GP to best address my health problems in a holistic way.

Case Study - Physician in breach of Right 4(5) (98HDC21016)

A report by the Commissioner into the care provided at a leading tertiary hospital illustrates some of the pitfalls that arise when multiple health care providers are involved with the care of one consumer.

A 21-year-old woman was admitted to hospital with a history of fever, weight loss, fatigue and rash. During her admission, the medical team responsible for her care had great difficulty in establishing a diagnosis. Consultants from several other specialities including infectious diseases, dermatology, radiology, haematology and intensive care were involved with her care. The patient's condition continued to deteriorate, and she died seven weeks later. The post-mortem diagnosis was of a rare, incurable cancer, and the Commissioner accepted expert advice that the death could not have been avoided. However, the Commissioner found that the patient and her family had been subject to unnecessary discomfort and delays. In particular, there had been a lack of clear communication between the various specialities, and recommendations by some of the specialists had not been followed up. The medical consultant was found in breach of right 4(5) of the Code for failing to adequately co-ordinate the young woman's care.

Elements of Informed Consent

The Code is based upon the central right of health care consumers to be fully informed in order to make informed choices. As the Code makes clear, the requirements for informed consent are more complex than a one-off action to authorise a medical intervention; informed consent is more than just a signature at the bottom of a form. Rather, it involves a process that is embodied in three essential elements under the Code, namely, effective communication (right 5), provision of all necessary information (right 6), and the consumer's freely given and competent consent (right 7).

Right 5 - Right to Effective Communication

Right 5 provides that every consumer has the right to effective communication in a form, language, and manner that enables the consumer to understand the information provided. This may involve the provision of an interpreter where appropriate. In addition, right 5 states that every consumer has the right to an environment that enables both consumer and provider to communicate openly, honestly and effectively.

Effective communication is part of the process that optimises informed decision-making, and lies at the heart of a genuine understanding of the available options. In giving a consumer information, the provider should not see himself or herself as simply meeting legal requirements or institutional standards, or providing value-neutral data. Rather, the provider should be participating in a shared dialogue that is responsive to the needs, capacities and concerns of the particular consumer as an individual with unique circumstances.

 

Case Study - Surgeon in Breach of Right 5

As the following example demonstrates, the whole clinical environment and not just the immediate consumer-provider relationship can impact on communication.

During a consultation with an orthopaedic surgeon a consumer witnessed the surgeon's "rude behaviour" and "violent outbursts" towards his nurse and office staff. The surgeon informed the Commissioner that the cause of the problem was that his staff had not set up the consulting room the way he liked it, and he was experiencing back pain from having to use the wrong type of examination couch. The Commissioner found that the surgeon's manner resulted in an environment where the consumer was upset, fearful and unable to communicate freely. The Commissioner found the surgeon in breach of right 5(2) and recommended that he attend a professional course in communication.

Right 6 - Right to be Fully Informed

The test in right 6 is whether the consumer has received the information that a reasonable person in the consumer's circumstances would expect to receive or need to receive. The information that should be given includes an explanation of the consumer's condition, and the options available, including an assessment of the expected risks, side effects, benefits, and costs of each option.

The extent to which the availability of unconventional modalities of treatment should be voluntarily disclosed to the consumer has not yet arisen as a specific issue in any investigation by the Commissioner. The relevant test is whether a reasonable person in the consumer's circumstances would expect such information. The Medical Council Guidelines suggest that patients should be advised on "the evidence-based and conventional treatment options". However, if a patient demonstrates an interest in other modalities of treatment, it may be wise for a provider to indicate the limits of his or her knowledge in that area and suggest that further information could be obtained from other practitioners. The Medical Council Guidelines state that "when appropriate and where there is no reason to believe that such a referral would expose the patient to harm there is no barrier to making a referral to an unconventional practitioner".

In situations where a practitioner wishes to offer a treatment he or she believes to be effective, even though its efficacy is not yet proven, the issue of information provision is crucial. The consumer should be informed that the proposed course of treatment has not been proven effective (for example, in a randomised, controlled trial) but that the provider recommends it for specified reasons. Many consumers assume that conventional treatments have been proven effective when that is not the case. Health professionals do have a duty to disclose a lack of scientific evidence for a proposed procedure.

Case Study - GP in Breach of Right 6 

The following case study demonstrates the importance of providing appropriate information before seeking consent for any proposed treatment.

The consumer visited a general practitioner (out of her home town) to have a mole on her neck checked. On examining the mole, the general practitioner noticed the consumer had a neck problem. He advised her that he was trained in neck and back manipulation techniques and could treat her problem. The general practitioner advised the consumer that if he treated her she would no longer suffer from pain in her neck, back and groin and commented to the effect that he "could not make it any worse". After some discussion with the consumer, the general practitioner carried out the manipulation. The consumer felt dizzy at the time of the treatment and later developed pain in her neck, lower back and hips and shooting pains from her groin to knee in both legs. As a consequence, she required drug treatment for severe muscle spasms, and was still experiencing pain and discomfort eighteen months later. The Commissioner found that the general practitioner had breached right 6(1)(b) of the Code as he did not provide the consumer with an explanation of the expected risks and side effects of the proposed manipulation, nor did he explain her possible treatment options. This matter was referred by the Commissioner to the Director of Proceedings, who laid a charge against the medical practitioner with the Medical Practitioners Disciplinary Tribunal. The Tribunal found the practitioner guilty of conduct unbecoming a medical practitioner.

 

Right 7 - Right to Make an Informed Choice and Give Informed Consent

Under right 7, consumers have the right to make an informed choice and give informed consent. This right is subject to other legal standards, such as the common law doctrine of necessity. Careful attention to the process of informed consent is particularly important when the proposed treatment is in any way innovative or unconventional.

Right 7(6) states that informed consent to a health care procedure must be in writing where the procedure is experimental. As mentioned earlier, a signed consent form is not sufficient to establish that informed consent has been obtained. It is advisable to document in the clinical record all interactions that go towards informed consent.

Case Study - Anaesthetist in Breach of Right 7

The Commissioner's Gisborne Hospital 1999-2000 report makes it clear that a practitioner's sincere belief that the treatment would be in the patient's best interests is no excuse for treating a patient without informed consent. The following case study is based on one of the incidents discussed in the report.

A patient booked for surgery at Gisborne Hospital advised her anaesthetist that she had experienced a serious adverse reaction to the anaesthetic drug fentanyl in 1981. She specifically requested that she not be administered fentanyl again. The consultant believed that her previous reaction to fentanyl had been due to an overdose, and not a true allergic reaction. He decided to re-expose her to fentanyl in a closely controlled environment in order to establish whether she was in fact truly allergic to it because "he believed that it was not in the patient's best interests to spend the rest of her life not having fentanyl available to her". The anaesthetist administered fentanyl and the patient did not show any signs of allergy. The Commissioner found that by proceeding to administer fentanyl to a patient in the face of her specific refusal to consent to such administration, the anaesthetist breached right 7 of the Code.

Spectrum of Sanctions

Once an investigation has revealed a breach of the Code, a hierarchy of sanctions is available to the Commissioner. It is appropriate, and consistent with the statutory framework, for complaints to be resolved at the lowest appropriate level. The current Commissioner also recognises the need to balance the availability of effective sanctions against the risk of making health providers feel that they are "under siege".

The most common outcome of a finding of a breach of the Code is a series of recommendations. At the lower level, recommendations vary from written apologies, to a suggested review of an area of practice, to the involvement of a professional College.

The second level of sanction involves forwarding the final report to appropriate persons, so that they may take any further action they deem appropriate. Breach reports in more serious cases are commonly sent to the Director-General or Minister of Health. Reports may also be sent to the funder or a professional body (such as a College) and are invariably sent to the relevant statutory registration body.

The third level of sanction involves the Commissioner making a specific recommendation to a professional body (such as a College) or to the relevant statutory registration body. For example, the Commissioner may recommend that the Medical Council review the competence of a medical practitioner to practise medicine.

If a matter is deemed to be sufficiently serious, it will be referred to the Director of Proceedings. The Director of Proceedings may decide to institute disciplinary proceedings before the Complaints Review Tribunal or a Professional Disciplinary Body.

The Commissioner is also empowered to name the parties in a public statement about a case. It is not the current Commissioner's practice to do so, particularly in the case of registered health professionals where disciplinary proceedings may be brought. However, in the case of unregistered or institutional health providers, it might be necessary for him to "blow the whistle" and publicise concerns to adequately protect vulnerable consumers.

Complaints involving GPs give a helpful sense of the sorts of numbers involved at each of these levels. In the year 2000, out of thousands of GP consultations, 293 complaints were made to the Commissioner's Office, 46 GPs were found to have breached the Code, and 8 were subject to professional disciplinary proceedings.

The Bottom Line

The bottom line is that health care providers in the new millennium practise in a consumer focused environment. The Code of Health and Disability Services Consumers' rights sets out legally enforceable rights of consumers and corresponding responsibilities of providers. While each of the ten rights in the Code is important, practitioners making use of new methods and alternative modalities of treatment should pay particular attention to the need to maintain appropriate standards, and to ensure that consumers are empowered to make fully informed choices.