Topics
Ethics
The ethics approval process for multisite research studies in Australia: changes sought by the Australian Genomics initiative
Australian Genomics is calling for a change in research ethics and governance frameworks
on behalf of Australian Genomics
Responding to mandatory immigration detention: lessons for the health care community
What should the health care community do when faced with major human rights abuses?
Ryan Essex · David Isaacs
International travel by Australians for overseas transplantation
More systematic data collection could assist clinicians and patients when considering overseas travel for organ transplantation
Georgia Smith · Diba Gujari · Oscar Russell · Lyle Palmer · Maeghan Toews · Germaine Wong · Wai Lim · Stephen McDonald · Phillip Clayton · Dominique Martin · Patrick T Coates
Regulating voluntary assisted dying in Australia: some insights from the Netherlands
Over two decades of Dutch experience can inform deliberations about the nature of a regulatory framework in Australian jurisdictions
Bregje Onwuteaka‐Philipsen · Lindy Willmott · Ben P White
A perfect storm: fear of litigation for end of life care
Should doctors fear legal sanction for using opioids at the end of life?
Geoffrey K Mitchell · Lindy Willmott · Ben P White · Donella Piper · David C Currow · Patsy M Yates
Royal Commission into Aged Care Quality and Safety: the key clinical issues
Modern care of older people requires better gathering and use of data, more robust governance structures, and innovative models of care
Joseph E Ibrahim
Nursing home “no returns” policy, when residents are discharged to the emergency department at 4 am: what does the law say?
To the Editor: We note with interest the letter from Peisah and colleagues.1 A group of oft‐forgotten patients also affected by “no returns” policies is older people with mental illness. We have recent experience of a 72‐year‐old man with diagnoses of schizoaffective disorder and Alzheimer dementia who was admitted to an aged mental health inpatient unit with a relapse of his schizoaffective disorder. He was admitted from a nursing home where he had resided for 4 years, during which time his illness had been stable except for an admission some 12 months earlier. On admission, after minor changes to his pharmacological management, supportive psychotherapy and allied health input, his condition returned to baseline. When the medical team liaised with his nursing home to arrange his return, they were informed that he could not return because they did not have the facilities required for him. When the patient was informed of this, there was subsequent deterioration in his mental state. After his brother with enduring power of attorney threatened legal action, he was accepted back at the home. The community mental health team who are continuing his care in the community have indicated that he remains stable following discharge. There is a high proportion of nursing home residents with a mental illness other than dementia.2 United States and Canadian data suggest that older adults with mental illness experience stigma from nursing homes (mostly due to fear of aggression and other behaviour) and poor quality care.3 Such patients tend to be placed in the first instance in nursing homes with deficiencies in care and with a paucity of resources and specialised expertise to provide care for this group;4 this probably explains the recourse to the “no returns” policy experienced by our patient. Such situations cause harm to the patient and contribute to bed block in hospitals.5 The issues involving this particularly vulnerable population will hopefully be uncovered in the Royal Commission into Aged Care Quality and Safety. We encourage improved mental health literacy in Australian nursing homes.
Malcolm P Forbes · Angelo Ferraro
Qualified privilege legislation to support clinician quality assurance: balancing professional and public interests
Lipid abnormalities are causally related to atherosclerotic cardiovascular disease; selected lipid interventions have been shown to improve this risk
Susannah Ahern · Ingrid Hopper · Erwin Loh
Gathering data for decisions: best practice use of primary care electronic records for research
Despite most Australians having most of their health‐related interactions in the primary care sector, primary care‐based research is disproportionately low. Access to quality EMR data, lack of resources to remunerate GPs, and a lack of understanding among some GPs of the value and importance of secondary use of EMR data are barriers to data sharing. Data extraction tools that enable ethical, secure and privacy‐protected access to routinely collected datasets nationally have been developed. The task now is to build trustworthy primary care data repositories for research that will provide researchers with timely access to quality‐assured general practice data. Linkage with other datasets could enable significant scale‐up of primary care‐based research in Australia, contributing new knowledge in public health, health promotion, economics and evidence‐based clinical care. Technologies that allow consumers to have greater control over how their data are used can provide better options to policy makers, hence investment in this area is essential. Educating clinicians and the public about the need for, and existence of, research based on de‐identified patient medical records has the potential to generate greater social licence and acceptance of this emerging area of study. This has the potential to generate significant gains in terms of service delivery, economics and patient health. We can “do the right thing” now, but we must never become complacent.
Rachel Canaway · Douglas IR Boyle · Jo‐Anne E Manski‐Nankervis · Jessica Bell · Jane S Hocking · Ken Clarke · Malcolm Clark · Jane M Gunn · Jon D Emery
Victoria's voluntary assisted dying law: clinical implementation as the next challenge
Victoria's voluntary assisted dying law will soon come into effect; a remaining challenge is effective clinical implementation
Ben P White · Lindy Willmott · Eliana Close
Medical assistance in dying: a disruption of therapeutic relationships
To the Editor: The Perspectives article by William1 states that medical assistance in dying may disrupt therapeutic relationships and will challenge beliefs. Concern is expressed about countertransference of feelings and attitude between doctors and patients. However, such concern must surely exist with or without the availability of assisted dying laws. What guides our practice is not just codes of medical ethics, professionalism and law, important as those are. It is also a natural and nurtured feeling of compassion and oneness with our patients. Doing no intentional harm (non‐maleficence) does not rule out, or cast doubt on, the application of voluntary assisted dying. Cutting short intolerable pain, suffering and indignity, as specifically requested by the patient, is not maleficence. The suggestion that people requesting medical assistance in dying challenge our beliefs about the meaning and value of who we are and what we do is not something that applies to all of us. Some physicians would feel that assisting a patient's firmly held wish to hasten death is among the most compassionate of acts that can be undertaken, and would experience it as such, along with the patient and family members. Changing the law to something that is better than currently exists does not present a dilemma. It does not contravene medical ethics. It has nothing to do with non‐maleficence or justice (except to introduce an element of justice to those individuals seeking such change). As for education, skills and insights, these can all be honed to a new and better balance in the future. With regards to death anxiety, it may be true that much can be achieved through human engagement, but it is also true that providing the means of assisted dying can itself significantly reduce anxiety and allow any remaining time to be better enjoyed.2 Finally, the suggestion that medical assistance in dying will have a negative influence on the development of teamwork is overly pessimistic. It fails to recognise the positive and complementary potential of assisted dying laws. Alleviation of suffering is surely a noble aim, attainable in a high proportion of cases.
Peter G Beahan
Medical assistance in dying: a disruption of therapeutic relationships
To the Editor: We commend William1 for his perceptive review of the complex issues involved in euthanasia and assisted suicide (EAS).1 In contrast to the euphemisms in the popular media, he confronts us with some uncomfortable realities: EAS is the intentional taking of a person's life (E) or facilitating suicide (AS); doctors considering EAS may be (unconsciously) demonstrating “countertransference of their helplessness onto the patient;” and relief of all suffering is a fantasy beyond the ability of doctors, politicians and lawyers. Similar concerns are expressed by seven Canadian physicians in a critique entitled “Euthanasia in Canada: a cautionary tale”.2 Contrary to the rosy predictions of its proponents, within 2 years, the Canadian experiment with EAS has left physicians aghast. “The introduction of euthanasia in Canada has caused doubt, conflict and crisis.”2 The passing of the Voluntary Assisted Dying Bill 2017 by the Victorian Parliament marked a seismic shift in medical practice, overturning 2500 years of medical ethics: the Hippocratic prohibition on killing patients. We note the increasing pressures, internal and external, on medical associations to declare neutrality on this issue. We believe that such a stance is a mistake. Equally, it is a lost opportunity to educate the public. As stated in a 2018 review, “doctors are not agents of the state and organized medicine cannot afford to be ‘neutral’ on a topic that touches medicine at its very core”.3 Furthermore, the Australian and New Zealand Society for Palliative Medicine4 and the Australian and New Zealand Society for Geriatric Medicine all have position statements that oppose EAS.5 As the peak physician organisation in Australasia, we urge the Royal Australasian College of Physicians to make an unambiguous statement to the general public, the medical profession and politicians that: EAS is not part of health care; EAS should not require involvement of doctors; and EAS creates irreconcilable conflicts with our responsibilities to our patients. If a medical association declares neutrality on this important issue, it squanders the precious role such associations have in providing guidance to the public and political sphere. That squandering comes at precisely the time this debate would be immeasurably enhanced by the expertise and wisdom of those members of the community most involved in the care of patients with serious illnesses.
Douglas T Bridge · Sinead M Donnelly · Frank P Brennan
A comprehensive review of significant issues in health law
Tensions and traumas in health law
Andrew Alston
The Australian Health Practitioner Regulation Agency does not require doctors to practise under the name that they are registered under
To the Editor: Within our clinical practice, we sought to establish the qualifications of a medical practitioner. In doing so, we discovered that medical practitioners are not required to practise under the name that they are listed under on the Australian Health Practitioner Regulation Agency (AHPRA) Register of Practitioners. A practitioner may register under one name, then practise under another. We see this as problematic for patients and inconsistent with the function of the register. AHPRA states that the register “has accurate, up to date information about the registration status of all registered health practitioners in Australia. It is an important way the National Registration and Accreditation Scheme helps keep the public safe”.1 The national register lists all practitioners registered with AHPRA and any conditions on their registration. Patients may access this information if they feel unable to make enquiries directly of a practitioner, or if they wish to view particulars before seeing the practitioner. AHPRA states that “if a practitioner's name does not appear on the register, they are not registered to practise in Australia”. The stated exemption to this statement is that “in a very small number of cases, the details of a registered health practitioner may not appear on the register because of personal safety issues”.1 It is under Part 10 of the Health Practitioner Regulation National Law Act 2009 that each national Board is empowered to maintain the register of all health practitioners currently registered by that Board.2 We note the current consultation paper by the COAG Health Council,3 in preparation for a second tranche of amendments to the National Law, which includes the proposal that the National Law be amended to “enable a practitioner to nominate one or more aliases or additional names to be recorded on the public register, with the register searchable using the alias”.3 We believe this relatively simple measure is consistent with the rights of the practitioner to use a favoured name and of the patient to confirm a practitioner's registration. We therefore support this change.
Katinka Morton · Grant Lester
The Australian Health Practitioner Regulation Agency does not require doctors to practise under the name that they are registered under
In reply: The national online register of practitioners is a vital part of Australia's system of regulating health practitioners to assure patient safety. It makes accessible to the public and employers the names of all health practitioners who are registered to practise. It also provides important information about limits or restrictions placed on the way a registered practitioner is allowed to practise. The national online register must remain an authoritative source of trusted information on health practitioners, so consumers can rely on it for accurate and up to date information to inform their health care decision making. Through our work, we have become aware that some health practitioners practise their profession using an alias rather than their legally recognised name published on the register. The Australian Health Practitioner Regulation Agency (AHPRA) has asked governments to consider an amendment to the Health Practitioner Regulation National Law Act 2009 to enable a practitioner to nominate one or more aliases to be recorded on the public register. We are pleased that this proposal is now the subject of public consultation. AHPRA believes that recording additional names or aliases on the register would help inform and protect the public, by making it easier to identify a practitioner who may not be practising under their legal name. There are some operational and practical issues to consider. A clear definition of an alias is required so health practitioners can readily understand their obligations to inform AHPRA and the national Boards of the use of these names. Consideration would need to be given to the requirements for practitioners to provide up to date information on the use of aliases in their practice, and whether any verification of this is necessary. The validity of the register could be compromised by information that is unverified or out of date. Finally, there may be risks from unintended consequences, including whether publishing aliases could be used for commercial gain or benefits not related to public information and protection, which is the focus of the National Law. AHPRA awaits the outcomes of the current public consultation process with interest.
Martin Fletcher
Challenges in community-based participatory research
Handbook of community-based participatory research
Fran Baum
Medicinal cannabis for chemotherapy-induced nausea and vomiting: prescribing with limited evidence
Although medicinal cannabis can now be prescribed for CINV, high quality clinical trial evidence is required to determine its efficacy and safety
Antony J Mersiades · Martin R Stockler · Ian N Olver · Peter Grimison
The first published randomised controlled trial of laser treatment for vaginal atrophy raises serious questions
We still await well conducted RCTs of CO<sub>2</sub> laser therapy for vaginal atrophy; in the meantime, topical vaginal oestrogen therapy remains the gold standard
Melissa J Buttini · Christopher Maher
Endemic unprofessional behaviour in health care: the mandate for a change in approach
Despite widespread calls for action, investment and interventions to change unprofessional behaviour in the health system have been ineffective
Johanna Westbrook · Neroli Sunderland · Victoria Atkinson · Catherine Jones · Jeffrey Braithwaite
Medical assistance in dying: a disruption of therapeutic relationships
Medical assistance in dying may disrupt therapeutic relationships and will challenge beliefs
Leeroy William
Voluntary assisted dying: time to consider the details
To the Editor:In less than 12 months, voluntary assisted dying (VAD) will become a reality in Victoria. The recent past has seen much passionate debate on both sides of this issue, covering aspects of its impact on society, public health, the law, medicine and an individual’s right to self-determination. Public health interventions have provided our society with significant benefits in many areas; however, for most physicians in clinical practice, our care is focused on each individual patient. To date, little attention has been placed on the implications of VAD for each doctor–patient encounter in which a request is made. For a clinician, the most challenging aspect of VAD now is how to support our patients. How do we balance the fundamentals of our professional and personal beliefs with our clinical and therapeutic responsibilities in practice? The legislation allows doctors the choice to participate in VAD or not; yet, we wonder how we may navigate this therapeutic space. While we believe that directly ending life is a boundary we cannot cross, we also know we cannot abandon our patient at what would clearly be a time of need. Can the doctor–patient relationship survive when electing not to participate? No amount of debate in Parliament will answer this question. We believe we need to derive collective wisdom to craft our compassionate response in this setting — in a considered and thoughtful manner. We believe we must recognise our own distress and anxiety and, nevertheless, remain focused on how we best care for patients. We need to remember our critical role as scientists to learn how to accurately assess, measure and report risks and benefits, to improve care for patients requesting VAD and to inform public health policy. In Victoria, VAD will soon be available. As doctors we must consider our response to our patients and assess the resulting impact on our relationship, here and now. This is a conundrum we had hoped we would never need to face. And it is what keeps us up at night.
Brian H Le · Jennifer Philip
Potential solutions to improve the governance of multicentre health services research
To the Editor: As Clay-Williams and colleagues,1 we have also experienced frustration at the time-consuming, expensive2 and protracted processes required as a prerequisite before undertaking research involving identified patient data across Australia. Ironically, in the case of clinical quality registries, we collect data designed to measure quality of care so that patients may benefit from improved clinical processes. Yet, the system conspires to delay and undermine these efforts. There are lessons we have learned in developing clinical quality registries that deal with some governance issues identified by Clay-Williams and colleagues. They describe developing a legal agreement, which 21% of hospitals refused to accept. The Southern Eastern Border States (SEBS) Committee was developed with representatives of health departments from Victoria, New South Wales, Queensland and South Australia to streamline and prevent duplication of legal agreements.3 We worked with a SEBS Committee representative to develop special clauses and conditions to include in the Medicines Australia Clinical Trials Research Agreement schedule, subsequently endorsed by the SEBS Committee. Participating sites, both public and private, recognise and routinely accept this agreement. This same committee, or one with a similar construct, could determine nationally whether research is low risk to address the confused and contradictory advice given by ethics committees. We agree that standardisation of forms and processes is required — participating sites should not be permitted to introduce their own forms, causing confusion to researchers and introducing additional delays. A national information portal and repository for protocol amendments which governance officers can access to review or approve changes would be welcomed. However, while Clay-Williams and colleagues recommend that there should be no requirement for principal investigators to be employees of the participating site, we believe that for clinical quality registries, having a local principal investigator provides a vital link between researchers and local staff. As previously suggested,4 limits should apply on an acceptable time period to provide a definitive determination on study conduct within an institution, as occurs in Europe with clinical trials.5 It is unacceptable that this process lasts more than 60 days. As researchers usually have no capacity to have an impact on institutional authorisation processes, greater accountability should vest with governance offices. The current costly and dysfunctional system is stifling research in Australia.
Sue M Evans · John R Zalcberg · Ri Scarborough
Potential solutions to improve the governance of multicentre health services research
In reply
Jeffrey Braithwaite · Robyn Clay-Williams · Natalie Taylor
The efficacy of medical student selection tools in Australia and New Zealand
To the Editor: In their recent article, Shulruf and colleagues1 concluded that prior academic achievement constituted the most effective means of predicting timely graduation. This outcome measure overlooks a more important graduate attribute: professionalism — the values and skills that the profession and society expects of doctors. This attribute is identifiable at admission, and it is possible to test for and select for this.2 When considering the desired outcome of satisfactory performance at junior medical officer level, the authors state that the “outcome of subsequent workplace performance, while important, is moderated by influences beyond the undergraduate environment”.1 This statement contradicts extensive literature suggesting otherwise. An erosion of vicarious empathy during medical education programs is well documented and is evident across other health care professions.3 Medical school education fails to consistently foster the development of advanced moral reasoning in medical students, with particular problems developing during the period of clinical immersion, when the influence of the “hidden curriculum” becomes evident to students.3 The above have been linked to the experience of burnout in students, which can manifest as professionalism lapses in both pre-clinical and clinical rotations.4 Papadakis and colleagues5 suggested that disciplinary action by a medical board was strongly associated with prior unprofessional behaviour in medical school. Most complaints against doctors are due to conduct, not competence. Many organisations have developed guidelines to ensure medical students adhere to professional standards. Academic and intellectual qualities alone cannot predict the ideal candidate for admission to medical school, and facets of professionalism such as moral orientation, resilience and self-control are acknowledged to contribute to one’s efficacy as a doctor. Furthermore, prioritising timely completion may promote students not seeking help, perpetuating poor performance in an effort to ensure timely completion. This perpetuates a workplace culture where people do not feel able to seek help, with significant repercussions as seen in the recent suicides of young doctors. Timely completion may indeed be predicted by prior academic success; however, attitudinal and behavioural factors are highly relevant at selection and throughout subsequent careers. An overemphasis on prior academic achievements may de-emphasise student characteristics associated with the development of professionalism.
Mark H Arnold · Jennifer Smith-Merry · Andrew S Lane
Glycaemic control apps for diabetes: lifting the lid
We need to establish guidelines and a framework to ensure the development of effective, safe and relevant health apps, with appropriate regulatory oversight
Rahul Barmanray · Esther Briganti