Key guidance for communicating 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
Clear and accurate promotion of health products and services helps patients make more informed and better choices about their healthcare. It also enables health professionals to compete fairly.
However, false, misleading or deceptive advertising not only sets up unrealistic patient expectations but can also cause them to seek inappropriate or unnecessary health services, which can contribute to adverse outcomes. Add the knowledge imbalance in the doctor-patient relationship and the inherent vulnerability patients, and the risk magnifies.
ADVERTISING CONTENT: WHOSE RESPONSIBILITY IS IT?
In New Zealand, there are strict controls around the advertising of health products and services. As a practitioner, you are personally responsible for the content of such advertising, regardless of authorship.
If you are a sole practice or partnership, that legal responsibility cannot be delegated to an administrator, manager or the like.
Similarly, if you are responsible for the management or governance of a corporate health organisation, you may be held responsible for the content of the organisation’s advertising.
The penalties for getting it wrong can be severe.
Failing to take reasonable care to control advertising content can constitute unprofessional conduct and result in disciplinary action. Advertising that breaches the provisions of the Medicines Act or the Fair Trading Act can result in fines or even imprisonment.
Under the Fair Trading Act, fines can be as high as $200,000 for an individual and $600,000 for a corporation. Furthermore, advertising that breaches the Advertising Codes of the Advertising Standards Authority (ASA) may be the subject of complaint and potentially an order that it be taken down.
REGULATIONS IN HEALTH ADVERTISING
Health advertising is the subject of a plethora of complex and overlapping controls. These include:
- The Medicines Act 1981 and the Medicines Regulations 1984.
- The Fair Trading Act 1986.
- The NZMA Code of Ethics. (See also Coles Medical Practice in New Zealand).
- The Statement on Advertising issued by MCNZ, November 2016
- The Advertising Codes of Practice issued by the Advertising Standards Authority, including the Therapeutic and Health Advertising Code and the accompanying Guidance Notes.
A useful description of the broad principles underlying these and other controls are contained in the two key principles of the ASA’s Therapeutic and Health Advertising Code:
“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.
“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 implication, omission, ambiguity, exaggerated or unrealistic claim or hyperbole.”
More specific guidance is contained in the NZMA Code of Ethics:
“…Doctors should advertise professional services or make professional announcements only in circumstances where the primary purpose of any notification is factual presentation of information reasonably needed by any person wishing to make an informed decision about the appropriateness and availability of services that may meet his or her medical needs. Any such announcement or advertisement must be demonstrably true in all respects and contain no testimony or material or endorsement of clinical skills. Qualifications not recognised by appropriate New Zealand statutory bodies should not be quoted.”
Given the extent and complexity of the controls over health advertising, it is essential that you get professional advice before you start advertising. In the context of this fact sheet, it is possible only to touch upon some of the more salient features.
Substantiation of representations
In a recent amendment to the Fair Trading Act, it is now unlawful for anyone “in trade” to make an unsubstantiated representation. The Act provides:
“A representation is unsubstantiated if the person making the representation does not, when the representation is made, have reasonable grounds for the representation, irrespective of whether the representation is false or misleading.”
In essence, this means that if you make a claim about your goods or services, you must have reasonable grounds for doing so, and if challenged, you must be able to substantiate those grounds. Importantly, the substantiation must be available at the time the representation is made; it is not enough to simply produce the verifiable evidence later.
Anyone who makes an unsubstantiated claim about a health product or service risks breaching the Act, even if they did not manufacture or supply the product or service, or develop the promotional material.
For example, if a GPs clinic publishes an advertisement for a medical device manufacturer on its premises (or website), under the Fair Trading Act the clinic is responsible for substantiating the claims in the advertisement, even though the advertisement is not its own.
The burden of establishing appropriate substantiation lies with the advertiser. The nature of the goods or services, and the representation itself, has a bearing on the nature and extent of the substantiation required. Given the nature of representations often made about medical products, devices, or treatments, a very high level of substantiation is normally required, in the form of credible, independent and reliable scientific and medical evidence.
The ASA describes its approach to the assessment of an advertiser’s substantiation as follows:
“Substantiation provided to the ASA by the advertisers will be assessed by the Complaints Board or Appeal Board for the quality of the evidence and may include (but is not limited to) assessment of systematic reviews of randomised-controlled trials (RCTs), individual RCTs, systematic reviews of cohort studies, individual cohort studies and outcomes research. Results extrapolated from studies conducted in animals or patient/client testimonials are not an acceptable means for substantiating a therapeutic purpose claim. Advertisers should be confident that the studies they select to substantiate their claim are reflective of the body of available evidence. The Complaints Board or Appeal Board will also consider the likely level of risk to consumers associated with a claim made in the advertisement.”
The recognised ‘gold standard’ for substantiating therapeutic claims are Randomised Controlled Clinical Trials, conducted with humans and published in peer-reviewed journals.
Comparative advertising—advertising that compares products or services with competing products or services—is a common and accepted method of advertising, provided that the comparison is not false, misleading, or deceptive.
In its Statement on Advertising the Medical Council has advised:
“Although you should always discuss different treatment options with patients, you should not make direct comparisons between the quality of your services and the quality of services your colleagues provide.”
Subject to that direction, you may employ comparative advertising on points of comparison that can be readily substantiated to help patients make informed choices. In principle then, comparative advertising about fees, hours of service, experience/training/certification, particular services offered, specialist equipment available, might all be the subject of comparative advertising.
If you do make comparisons, it is essential that the comparison is with a “like-for-like” product or service in the same market. Otherwise, the comparison is likely to be misleading or deceptive.
Comparative advertising must be balanced and fair. It must be factual, fairly reflective of the body of available evidence, and be verifiable. It must not disparage the product or service being compared.
For a useful description of the matters that should be considered in any comparative advertising of health products or services, practitioners are referred to TAPS Guideline 8 Comparative Advertising for Healthcare Professionals issued by the Association of New Zealand Advertisers (ANZA).
Advertisements must not encourage inappropriate or excessive use of health resources. For example, arousing an ill-founded fear in customers for their future health. Nor may advertisements unduly glamorise products and services, or foster unrealistic expectations about their efficacy. Furthermore, advertisements must not encourage inappropriate or excessive purchase or use of medicines, or inappropriate or excessive requests for prescriptions.
Advertisements must not contain any claim or statement, express or by implication, that products, devices or services are:
- safe, or that their use cannot cause harm, or that they have no side-effects or risks
- effective in all cases
- infallible, unfailing, magical, miraculous, or certain or guaranteed to provide a cure
- likely to lead persons in the target audience to believe that they are suffering from a serious ailment, or that they may suffer harmful consequences if they do not use the product, device or service.
Use of scientific language
The use of scientific language in medical advertisements is acceptable. Indeed in many cases, it is essential. You should communicate scientific information accurately, but also appropriately to the target audience so that it can be readily understood.
Use of photographs
Particular care is required with the use of images in medical advertising, especially “before and after” photographs because of their potential to mislead or deceive. If “before and after” photographs are used, they must:
- Be used solely for the purpose of providing accurate and useful information to patients.
- Portray realistically the outcome that can reasonably and typically be expected.
- Not be altered or “air-brushed” in any way.
- Use the same lighting, contrast, background, framing, camera angle, exposure and other photographic techniques.
- Depict only patients who have undergone the advertised treatment while under the care of the advertiser.
As a doctor, you are not permitted to advertise your services by visiting, emailing or telephoning prospective patients, either in person or through an agent. (Note: the prohibition does not extend to contacting former patients for the purpose of re-enrolling them into a PHO).
Use of discount coupons or gift certificates
If you offer discount coupons or gift certificates, take care to ensure that they do not undermine your relationship with a patient or with the informed consent process. If a discount coupon or gift certificate is used, it should record clearly that:
- The presentation of the certificate or coupon does not equate to granting informed consent.
- Prior to treatment you will discuss treatment options with the patient.
- The patient has the right to opt out of treatment at any time.
- You will not provide the treatment if the patient is assessed and found to be an unsuitable candidate.
The Medical Council considers it inappropriate to offer medical treatments as prizes or gifts to promote a commercial service or for financial gain.
Endorsements by practitioners
The Medicines Act prohibits healthcare professionals from endorsing or promoting any medicine or medical device in advertisements to consumers. The rationale is that the endorsement of professionals tends to give “undue authority” to the particular product or device.
However, practitioner testimonials are permitted in advertisements circulated solely or principally to healthcare professionals. They are also permitted for natural health products and dietary supplements, provided that the advertisement does not make, expressly or impliedly, any therapeutic claim about the product.
To the extent that practitioner testimonials are permitted, they are subject to the NZMA Code of Ethics:
“Doctors should not allow their standing as medical practitioners to be used inappropriately in the endorsement of commercial products. When doctors are acting as agents for, or have a financial or other interest in, commercial organisations or products, their interests should be declared. If endorsing a product, doctors should use only the proper chemical name for drugs, vaccines and specific ingredients, rather than the trade or commercial name. Any endorsement should be based on specific independent scientific evidence, and that evidence should be clearly outlined.”
In essence, a testimonial is an anecdotal recommendation or positive statement about a doctor’s care, skill, expertise or treatment, either of an individual or of a class of persons. A testimonial might take the form of a character reference, or a statement of the benefits of a particular treatment. Testimonials are not limited to comments from patients and may include feedback or endorsements from other healthcare professionals.
In its Statement on Advertising the Medical Council has directed:
“Testimonials can create unrealistic expectation of outcomes in patients and must not be used or quoted in your advertising or on any websites, social media forums or any other platforms you control that advertise your services.”
The Medical Council considers that responsibility for the content of any website or other form of media over which a practitioner has control, rests with the practitioner. Thus in its Statement on Advertising Council advises:
“You must not encourage patients to leave testimonials on websites or other platforms you control that advertise your or your practice’s services, nor should you encourage patients to submit testimonials about you or your practice’s services to third party websites. It is your responsibility to monitor regularly the contents of such websites or platforms and to remove any testimonials that are posted there. However, you are not responsible for any unsolicited testimonials or comments that are published on a website, in social media or other forms of media over which you do not have control.”
The Medical Council’s Statement also prohibits advertisements from claiming or implying endorsement of any health product, device or service by any government agency, professional body or independent agency unless:
- the agency or the body is named,
- the agency or the body has given its prior consent,
- the endorsement is current, and
- the endorsement is verifiable.
THE THERAPEUTIC ADVERTISING PRE-VETTING SYSTEM
The Therapeutic Advertising Pre-vetting System (TAPS) is operated by ANZA to pre-vet compliance with the ASA’s Advertising Codes of Practice, and, in particular, with the Therapeutic and Health Advertising Code. The system provides a robust mechanism to pre-vet all therapeutic advertising for regulatory compliance before placement in the media. Advertisements are vetted by an Adjudicator appointed by ANZA for the purpose. Normally, the Adjudicator will have experience in pharmaceutical marketing. A TAPS review entails an assessment of the accuracy, balance, fairness, and verifiability of the content of the advertisement, and the form of the advertisement such as its legibility or audibility.
While the TAPS system is considered to be robust and reliable, a TAPS certification does not provide the advertiser with a defence to a complaint made to the ASA*. Above all, a TAPS certification does not relieve you from the ultimate responsibility for the content of the advertisement, and for compliance with relevant regulatory controls.
*Depending on the circumstances, it might provide a defence to a complaint of professional misconduct made to the Medical Council.