Key guidance on communications with patients.
NZMII Case Study: Honesty is the best policy
Dr X was an orthopaedic registrar at a busy city hospital. Mr Y presented with lower back pain, altered sensation bilateral legs and leg weakness. He advised of a previous L5/S1 prolapse but symptoms had resolved. Pain had commenced whilst lifting a heavy object 3 weeks previously. Symptoms, including urinary difficulties, were worsening. A bladder scan demonstrated a raised post-void urine volume of 100ml. The level of urine remaining in the bladder was around the borderline level for cauda equina syndrome. Dr X discussed the findings with the consultant orthopaedic spine surgeon on duty. Thereafter, there was a miscommunication between Dr X and the surgeon as to the next steps. Dr X thought he had been instructed to determine whether Mr Y could pass any more urine. Upon doing so, Mr Y was discharged with medication and instructions to return to hospital if symptoms recurred. In fact, in order to rule out cauda equina syndrome, the surgeon had wanted a further post-void scan to be undertaken. At the end of the shift, the surgeon asked Dr X for details of the second scan – which had not been carried out. Rather than admit his error, and not appreciating the significance of the second scan, Dr X referred to the volume of urine he would have anticipated to have been in the bladder, based upon the results of the first scan. This false result was also noted in the clinical records. Unfortunately, the causa equina syndrome was not diagnosed until a later MRI scan, by which time emergency surgery was required.
The HDC complaint
The HDC investigated Dr X, including referral to an expert medical advisor. Legal advice and support was provided to Dr X, including advice around Dr X’s admission of a clear misjudgement in falsely stating that a further bladder scan had been undertaken. Dr X was under significant pressure in an already busy Emergency Department. His relationship with the surgeon was such that he felt unable to admit his error. Since the time of the consultation, the Emergency Department had increased staffing and the whole department has undergone training on recognising the red flags for causa equina syndrome. Dr X described the incident as a “wake up call” in his career. Dr X was not criticised for the initial discharge, on the basis that there had been a genuine misunderstanding of the surgeon’s instructions to him regarding a second scan. However, once it became clear to Dr X at the end of the shift that the surgeon’s instructions had been misunderstood, the HDC considered that the services provided by Dr X were in breach of the duty of reasonable skill and care under the Health and Disability Commissioner’s Code of Rights.
The HDC was particularly concerned with the fact that Dr X had a number of opportunities to admit his error, both on the day of the consultation and following Mr Y’s subsequent admission for emergency surgery. He failed to do so, and he knowingly falsified the clinical records. Dr X was ordered to apologies to Mr Y and report to the HDC on his reflections following further training. The HDC also referred the matter to the Medical Council of New Zealand.
Medical Council investigation
The Medical Council conducted its own investigation into Dr X’s actions. Dr X was again provided with full legal advice and support in his submissions to the Medical Council. The Council ultimately accepted that this was a one-off incident and recognised that Dr X had acknowledged his dishonesty and taken steps to ensure such an incident did not happen again, both in terms of his clinical training and interactions with colleagues. It was satisfied that an educational approach was appropriate to address the concerns, although noted that any further instances of dishonesty would be viewed very seriously.
With full legal support, Dr X was able to address the difficult issues that arose as a result of his error of judgement. It is interesting that the HDC considered there was no breach in standards for Dr X’s initial error, resulting from a misunderstanding of instructions. The real concern was the doctor’s failure to admit the error and maintaining that dishonesty. A more serious outcome for the doctor was avoided by his clear and unequivocal admission of his wrong-doing coupled with a commitment to further training and significant insights into the reasons for his behaviour.
Advertising of health products and services
Advertising of health products and services must be done in a responsible and ethical way, and the effect of any advertisement needs to be carefully considered. This factsheet provides an overview of the standards and laws that cover advertising, and key points about advertising that doctors need to be mindful of.
What is advertising?
Advertising has been defined broadly by MCNZ as:
“Any communication that is oral, in print, through electronic media or on the internet by or on behalf of a doctor to the public, to provide information about the doctor, the doctor’s services, or the clinic or group where the doctor practices or with which the doctor is associated”
The advertising of all therapeutic products (medicines and medical devices), natural health products, and dietary supplements is also regulated.
Excluded from the definition is explanatory material given to a patient during a consult about a health condition or a proposed procedure, treatment or medication, and material distributed for the purpose of public health or as part of a public health programme.
It is important to be mindful that while some advertisements can be obvious, such as a written communication on a clinic’s website, others may be less so, for example an oral endorsement of a therapeutic product made in a conversation with a patient could be considered to be an advertisement.
Standards and laws
The responsibility for ensuring compliance with relevant standards and laws lies with the doctor who is advertising. This is so even when a third party is engaged to draft an advertisement on a doctor’s behalf. It is a responsibility that cannot be delegated.
Relevant standards include:
- “Advertising” by MCNZ;
- The Advertising Codes of Practice issued by the Advertising Standards Authority (ASA), in particular the “Therapeutic and Health Advertising Code”; and
- Any relevant industry codes of practice, such as the Medicines New Zealand Code of Practice, the Medical Technology Association of New Zealand Code of Practice or the New Zealand Self Medication Industry Association Code of Practice.
There are also statutes that play a role in regulating advertising, including the Fair Trading Act 1986, the Medicines Act 1981, the Medicines Regulations 1984 and the Misuse of Drugs Regulations 1977.
- Tip: MedSafe has published a document called Guideline on the Regulation of Therapeutic Products in New Zealand – Part 7: Advertising of therapeutic products, to assist with the interpretation of this legislation.
It should be noted that from 1 September 2026 the Medicines Act 1981 will be replaced by the Therapeutic Products Act 2023, updating the regulations relating to advertising. While the Therapeutic Products Act 2023 is not currently in force, doctors should be mindful of the Act in anticipation of this change. In terms of advertising, the key sections to be familiar with include sections 196 (‘Advertisement, communication and distribute’) and 197 (‘Advertising’), as well as the sections that relate to offences, defences, and orders (including ss 205, 221, 222, 257, 319, and 334).
The laws and standards around advertising are complex and extensive. It is useful then to have an understanding of the principles that underly the governance of advertising. ASA’s Therapeutic and Health Advertising Code sets out two key principles:
- Principle 1: Social responsibility Therapeutic and health advertisements shall observe a high standard of social responsibility particularly as consumers often rely on such products, devices and services for their health and wellbeing; and
- Principle 2: Truthful representation Advertisements shall be truthful, balanced and not misleading. Advertisements shall not mislead or be likely to mislead, deceive or confuse consumers, abuse their trust, exploit their lack of knowledge or without justifiable reason, play on fear. This includes by implications, omission, ambiguity, exaggerated or unrealistic claim or hyperbole.
Key points to be aware of
Advertising can be beneficial or harmful. It can be utilised in a beneficial way to provide information about a doctor’s skills, expertise and services, and enable patients to make informed decisions about their care or treatment. However should the advertisement contain false, misleading or deceptive information, it could have a harmful effect. For example, it might foster unrealistic expectations, cause a patient to seek treatment that is not clinically indicated, or create unfounded fear about a person’s health (all of which is prohibited).
Claims made or information provided in an advertisement must be truthful and balanced and products or services must not be glamourised. Care must also be taken not to allow advertising to reinforce stereotypes of a particular person or group of people.
The MCNZ statement provides that truthful and balanced content means content that is:
- valid, evidence-based and substantiated;
- clear and easy to understand;
- from a reputable and verifiable source; and
- identifies clearly the relevant researchers, any funding received, and the publication that the results/information are sourced from.
This ties in with section 12A of the Fair Trading Act which makes it unlawful for anyone “in trade” to make an unsubstantiated representation, that is a representation made without reasonable grounds. Because of how this section is phrased, anyone who makes an unsubstantiated claim may breach the provision even when that person did not manufacture or supply the product or service, or develop the promotional material. For example, if a GP clinic publishes an advertisement for a medical device on its website, the clinic (and possibly also the manufacturer or supplier of that medical device) is making claims about the device by advertising it. Under the Fair Trading Act the clinic has a responsibility to substantiate the claims in the advertisement, even though the advertisement may not be its own. The level of substantiation required to support the claim will vary depending on what is being advertised. The Commerce Commission has provided the example of a claim that asserts a particular product can cure disease, saying it would expect this to be supported by a high level of substantiation in the form of credible and reliable scientific evidence. Comparatively, a general claim about the performance or effectiveness of a familiar product such as “calcium is good for healthy bones and teeth” would require a lower level of substantiation.
Under the Fair Trading Act, false or misleading advertisements, or unsubstantiated representations, may result in a fine of up to $200,000 for an individual, and $600,000 for a body corporate. Doctors can also face disciplinary action for conduct that does not comply with the relevant standards. It is essential then that doctors ensure that the information provided by them, or by someone on their behalf, complies with all standards.
Doctors should also be conscious of the inherent power and knowledge imbalance in a doctor-patient relationship. This imbalance means that patients tend to trust what their doctor says to them (especially when the patient is particularly vulnerable). Advertisements therefore need to be managed in a responsible and ethical way, and the trust a patient places in his or her doctor must not be exploited. As a related point, doctors must not pressure people to use their services or advertise services by approaching prospective patients directly.
Helpfully, some key ‘advertising scenarios’ have been considered by MCNZ:
- Testimonials: “testimonial” is defined by MCNZ as “a recommendation or positive statement that a person makes about another person…” (Examples of testimonial statements are provided in the MCNZ factsheet). Because of the unrealistic expectations testimonials can create, they are not permitted to be used or quoted to advertise a doctor’s services to consumers.
- Endorsing medical products or methods of treatment: doctors must not use their position as a doctor to endorse medical products or methods of treatment in an advertisement to consumers, and any interest (financial or otherwise) or role in relation to a medical product or method of treatment needs to be declared (without endorsement). The reasoning is that the endorsement of a medical professional tends to give ‘undue authority’ or support for the particular product or service. Doctors must also be conscious of any conflict that might arise between their interest in a product or treatment, and the care they provide to a patient. If that conflict compromises the patient’s care, MCNZ requires the patient to be informed and provided with access to alternative sources of care.
- The testimonial and endorsement restrictions apply where an advertisement is made to consumers. Section 60 of the Medicines Act exempts advertisements that are circulated solely or principally to healthcare professionals. See the ASA “Therapeutic and Health Advertising Code” for further information.
- The advertising of titles, qualifications and memberships: done improperly, this might cause a patient to think a doctor is more skilled and qualified than they actually are, which can be confusing or misleading. MCNZ has placed restrictions on what qualifications may be advertised (being those that appear on MCNZ’s register or conferred or awarded by a doctor’s college or other properly accredited training organisation), and provided guidance on how to use acronyms to avoid misinterpretation.
- Discussing treatment options with patients and making comparisons: when discussing treatment options, doctors need to avoid making direct comparisons between the quality of their own and their colleagues’ services or suggest they have superiority over them. (Outside of this, comparative advertising is permitted provided that the advertisement compares “like with like’ and is “factual, fair and able to be substantiated, referenced to the source and reflective of the body of available evidence” – refer ASA “Therapeutic and Health Advertising Code”).
- Using images: care needs to be taken when using images in advertising – what impression or expectation does the image create? Will it encourage the unnecessary use of services? MCNZ highlights the example of “before and after” images, warning of the impression such advertising might give or expectation it might create. The MCNZ factsheet provides detailed guidance for using “before and after” images.
- Offering inducements: inducements include discount coupons, gift certificates, online deals and vouchers. These should not be offered to a patient if it would undermine the doctor’s relationship with the patient as well as the informed consent process. There is certain information that must be made clear to a patient when offering inducements, which are set out in MCNZ’s factsheet. Furthermore medical care or treatment may not be offered as a prize or gift, in order to increase a practice’s profile or for financial gain.
The ASA “Therapeutic and Health Advertising Code” also provides information relating to the above scenarios, and doctors should review that Code alongside MCNZ’s factsheet (and the relevant legislation).
The ASA Code addresses other important points for advertisements that the MCNZ factsheet does not, for example that advertisements must contain such information as the name and address of the advertiser and other information prescribed by various legislation, and must not claim, state or imply that the advertised product or service is safe or cannot cause harm or is a “sure cure” (amongst other things).
The ASA Code also provides examples not covered by the MCNZ factsheet, for example weight loss or weight management advertisements that include a medicine or medical device. The Code reflects the wider social and health issues that stem from obesity, as well as the individual vulnerabilities of those who find weight loss (or maintaining weight loss) difficult to achieve. In particular, the Code highlights the potential for patients to be misled, or for unrealistic expectations to be fostered, by promises of “quick” or “easy” weight loss. Such statements should therefore be avoided, and advertisements should include an acknowledgment of nutrition and exercise as important elements in individual weight management (amongst other things).
The Medicines Act provides further restrictions and requirements, for example that medical advertisements must not contain any statement that contradicts the information required by regulations to be marked on or attached to a medical product or its container or package, or fail to include statements that are required by regulation to be in an advertisement. (As noted above, the MedSafe Guideline on the Regulation of Therapeutic Products in New Zealand – Part 7: Advertising of therapeutic products is a useful starting point to understand the further legislative restrictions and requirements. It also provides helpful information about advertisements for medicines, medical devices and related products).
The Association of New Zealand Advertisers (ANZA) administers a service called the Therapeutic Advertising Pre-vetting Service (TAPS). TAPS “pre-vets” advertisements for medicines, medical devices and related products for compliance with the relevant codes and regulations (for a fee). It is a helpful mechanism when navigating the requirements and regulations around advertising. However, while the TAPS system is considered to be robust and reliable, it does not guarantee compliance. Nor does it remove the liability of the advertiser for the content of its advertisements. Ultimately that responsibility lies with the doctor who is advertising.
The laws and regulations around the advertising of health products and services can be tricky to navigate, especially given the range of sources from which they stem. This factsheet provides an overview only of some of the restrictions and requirements. For more detailed guidance, doctors should seek professional advice.
Current as at September 2023
Mark Kelly : Listening and Empathy
Ending a doctor-patient relationship
For a number of reasons, a doctor-patient relationship may need to be brought to an end ‘prematurely’ (that is, before its natural or expected end). Examples include:
- If the doctor wants to downsize, relocate or close their practice.
- If the patient is abusive, violent or poses a significant safety risk to the doctor or their colleagues.
- If the doctor-patient relationship breaks down.
The focus of MCNZ’s guidance on ending a doctor-patient relationship is on the wellbeing and future care of patients. It requires doctors to “put the patient first” and emphasises the importance of being fair and professional with the patient when ending a therapeutic relationship.
Whatever the circumstance then, if a doctor is considering bringing a therapeutic relationship to an end it is important that they do so carefully by following a proper process which includes communicating their concerns to the patient, considering the impact on the patient, and then if appropriate ending the relationship.
Considerations before ending a doctor-patient relationship
Doctors are expected to consider whether the decision to end the therapeutic relationship will impact negatively on the patient and their whānau, such as limiting the patient’s options for, or access to, medical care. This may be particularly relevant in rural communities. Doctors should also pay particular attention to the impact on the patient where treatment may be incomplete, acute, or ongoing, and whether the treatment can be effectively transferred to another health professional.
Critically, doctors must ensure that the patient does not require urgent medical help. If the patient does require urgent care, then cessation of care should not proceed.
It is important too that the decision to bring the doctor-patient relationship to an end is not done abruptly. It is recommended that doctors consider first discussing their decision with a peer, colleague, or practice manager (while ensuring that the patient’s dignity and privacy are protected). It is recommended too that you contact your medical indemnifier for guidance. It is a good idea to keep a written record of all such discussions.
An explanation should also be given to the patient of the doctor’s concerns and the reasons they are considering ending the therapeutic relationship. It is important for doctors to first try and find a solution with the patient, taking into account their needs and circumstances, and any issues of safety whether to the patient, the doctor, or to the doctor’s colleagues. Only when reasonable attempts to find an acceptable solution are unsuccessful should the doctor-patient relationship be brought to an end.
One situation which requires particular care is where there is or may be the risk of professional boundaries in the therapeutic relationship being blurred or crossed. In such circumstances it is likely that the therapeutic relationship should be brought to an end. Of course the termination of the therapeutic relationship does not itself signal a “green light” to the commencement or continuation of a personal relationship with the patient. Typically, such situations are so fraught that the doctor should seek independent advice at the first opportunity.
If the decision is made to end the therapeutic relationship, doctors need to think about the most appropriate and culturally safe way to do this. MCNZ’s guidance provides a six-step process for discontinuation of care.
Process for discontinuation of care
- Inform the patient (in person or in writing) that the doctor-patient relationship has ended and the reasons for this.
- End the relationship in a respectful and professional manner so that it does not damage the patient’s future engagement with other doctors or the health system.
- Note the end of the doctor-patient relationship and the reasons for its termination, in the patient’s records.
- Give the patient sufficient notice to find another doctor, or help them find one (if needed). If you are a specialist in secondary care, refer the patient back to their GP or another secondary care specialist.
- Transfer the patient’s records to another doctor (although make sure that you have the patient’s authority to do so, ideally in writing). This is important to facilitate continuity of care. Also ask the patient if they would like a copy of their records.
- Unless there are extenuating circumstances, maintain a copy of the patient’s records.
Until this process is complete the patient may require acute or ongoing care. If doctors are unable to provide that care, they will need to advise the patient of alternatives.
Ending a doctor-patient relationship can be stressful and not always straightforward. Where a doctor-patient relationship has broken down it can be particularly difficult not to rush the process in bringing the relationship to an end. It is important however that proper steps are taken, with each therapeutic relationship and patient being assessed carefully in light of the particular circumstances.
Should further guidance be required, check the MCNZ statement Ending a doctor-patient relationship:
You may also care to seek advice from your indemnifier.
Current as at November 18, 2022