Letters

TO THE EDITOR: Multisystem inflammatory syndrome in children (MIS‐C) or adults (MIS‐A) is a rare but severe systemic inflammatory syndrome,1 with an epidemiological peak occurring 4–6 weeks after severe acute respiratory syndrome coronavirus‐2 (SARS‐CoV‐2) outbreaks.2 Also known as paediatric inflammatory multisystem syndrome temporally associated with SARS‐CoV‐2, MIS‐C is the subject of active surveillance across paediatric centres.3 The peak age for the syndrome is 9 years,1 although cases have been reported in adults.4 We report, to our knowledge, the first Australian case of MIS‐A, diagnosed 2 months into the SARS‐CoV‐2 Delta outbreak in New South Wales, with 60 075 coronavirus disease 2019 (COVID‐19) notifications in the period 29 June to 4 October 2021.5 A 42‐year‐old woman presented with 7 days of subjective fevers, myalgia, light‐headedness, abdominal pain, nausea, palpitations and non‐pleuritic chest pain. Presentation occurred 27 days after acute COVID‐19 pneumonitis, confirmed by polymerase chain reaction and serology testing. The acute illness was mild, requiring neither oxygen nor hospitalisation, and the patient recovered fully 72 hours before onset of this new symptom complex. She was unimmunised against SARS‐CoV‐2. The patient was febrile (38.2°C), with tachycardia (114 beats per minute) and hypotension (79/56 mmHg) but no respiratory distress. She had bilateral conjunctival injection, a widespread blanching macular rash (Box), and oedema of the hands bilaterally. There was no lymphadenopathy or oral mucosal change. Investigations revealed significant inflammation, with a raised C‐reactive protein level (119 mg/L; reference interval [RI], ≤ 4 mg/L), lymphopenia (0.5 × 109/L; RI, 1.0–4.0 × 109/L), thrombocytopenia (74 × 109/L; RI, 150‐400 × 109/L), neutrophilia (12.2 × 109/L; RI, 2.0–8.0 × 109/L), deranged liver function tests (alanine transaminase, 160 U/L; RI, 10–35 U/L), and hypoalbuminemia (20 g/L; RI, 35–50 g/L). Her D‐dimer level was raised (2.34 mg/L; RI, < 0.5 mg/L), as was her brain natriuretic peptide level (1660 ng/L; RI, ≤ 125 ng/L); troponin and creatine kinase levels were normal. Blood and urine cultures were negative, and anti‐streptolysin O and anti‐DNase B titres were not raised. No echocardiographic evidence of myocarditis was seen, and there was no coronary artery dilatation. The patient responded to two doses of intravenous immunoglobulin (2 g/kg each) following 48 hours of inotropic support (metaraminol infusion then low dose noradrenaline). Aspirin (3 mg/kg daily) was administered, as well as intravenous antibiotics for 72 hours while cultures were pending. MIS‐A was diagnosed on the basis of current case definitions,6,7 although the patient also fulfilled criteria for probable toxic shock syndrome, as described in other case series.8 Adults and adolescents with MIS‐A typically present with multisystem involvement, often incorporating myocarditis, shock and gastrointestinal features,4,9 whereas younger children present more commonly with a Kawasaki disease‐like illness.9 Given the absence of specific diagnostic markers, the overlapping phenotype with toxic shock syndrome and the poor sensitivity of cultures and serological markers for these alternative diagnoses, such differentials must be carefully considered in the early phase of illness. Nonetheless, clinicians should be aware of MIS‐C or MIS‐A in patients presenting with shock, mucocutaneous changes and/or gastrointestinal symptoms, even without preceding symptomatic SARS‐CoV‐2 infection. Prompt treatment with intravenous immunoglobulin and/or steroids is essential to minimise long term morbidity from coronary artery dilatation.1 Although rare, further cases of MIS‐C and MIS‐A are anticipated following increasing COVID‐19 case notifications in NSW and Victoria. This letter was published as a peer‐reviewed Accepted Article (prior to structural editing and typesetting) on 14 October 2021. Box – Bilateral conjunctival injection (A) and diffuse blanching macular rash (B) in an adult with multisystem inflammatory syndrome

Annaleise R Howard‐Jones · Sam R Orde · Zoe Jennings

To the Editor: We congratulate Donovan and colleagues1 on their snapshot bedside audit of 850 inpatients with diabetes across 27 Queensland hospitals. The results in their audit identified current strengths and deficits in inpatient diabetes management. These efforts will be invaluable to the planning of future improvement interventions in Australia. Inpatient diabetes management centres on improving glycaemia, as measured by reducing incident hypo‐ and hyperglycaemia, in order to reduce the consequences of dysglycaemia. While auditing bedside practice is important, it describes only part of the picture of inpatient diabetes. The complementary counterpart that augments the value of such auditing is the process of glucometric assessment, which is being enabled by the introduction of point‐of‐care networked blood glucose monitoring in Australian hospitals, with the first hospital‐wide system instituted in 2019.2 Glucometry involves collecting all blood glucose measures for inpatients throughout an admission and calculating mean and threshold indices of glucose management, which assists bedside care as well as enabling virtual glycaemic care programs.3 The potential synergy between glucometric assessment and bedside practice audits arises when these audits identify a change in practice within a hospital. Any resulting changes in that institution’s glucometric trends will provide quantitative information about the value of that practice change. This will enable the widespread dissemination and adoption of those practices found to have the greatest beneficial effects on glycaemia, and will provide an evidence base for generating national standards.4,5 Similarly, after adjusting for differences and variability in patient populations, glucometric benchmarking enables comparisons to be made between hospitals.6 When cross‐referenced with differences in practice, as identified by audits such as the Queensland Inpatient Diabetes Survey (QuIDS),1 the effects of these differences may be determined and their independent value thus broadly quantified. We applaud the increasing national adoption of both electronic medical records and networked blood glucose monitoring, enabling future glucometric benchmarking.7 In the face of the ever‐increasing prevalence of diabetes in hospitals,8 it is crucial for all those involved in inpatient diabetes care to champion the twin quality procedures of auditing bedside practice and glucometric benchmarking. It is only together that these processes can best help us achieve optimal outcomes in hospital for people with diabetes.

Rahul D Barmanray · Mervyn Kyi · Spiros Fourlanos

In reply

Peter Donovan · Benjamin P Sly · Gaurav Puri

To the Editor: I commend Wijeratne and Earl1 for drawing attention to the retirement issues faced by doctors. Psychological issues are compounded by the lack of legislative provision for doctors to progressively step down from the demands of full registration. Reducing workload is not a simple matter. The impediments to maintaining registration while reducing workload include recency of practice requirements and up to 73 hours per annum of continuing professional development (CPD) for physicians2 — far exceeding that of other health practitioners. Encore careers as described by the authors, while rewarding, could cause issues with the scope of practice requirements. Current guidelines around the definition of “practice of medicine”,3 unless changed, could find doctors practising medicine without a licence. Eighty‐eight per cent of doctors in a local medical association survey (131 respondents; response rate 27%) supported a step‐down approach, with 59% (of 113 respondents) supporting reduced CPD requirements.4 Many doctors see their profession as a calling and retain a strong desire to serve their communities both before and after retirement. Dignity and respect are key to effective transitions to retirement. Doctors often leave the profession on a sour note because their attempts to maintain registration in order to give back to their communities flounder under current regulations. There is despondency around the lack of recognition of their significant expertise and lack of regulator foresight in how to use the vast resource of senior doctors (eg, pandemics, fires, floods, community health needs). Australia appears to lag behind other countries in this regard. In the United States, states such as Pennsylvania offer retiring and retired doctors volunteer licences through their medical boards to volunteer their services for community health programs.5 The Australian Senior Active Doctors Association and the Australian Medical Association Queensland Senior Doctor Craft Group are working to achieve a step‐down approach.6 Other professions recognise and encourage the active participation of retired members; for example, retired lawyers in several states, including Queensland,7,8 can apply for free practising certificates to undertake pro bono work. In many cultures, “senior” is synonymous with wisdom, leadership and excellence. While retirement planning is important, so is addressing practices and regulations that undermine and limit the value that senior doctors can bring to their communities as they transition through the latter stages of their careers.

Geoffrey Hawson

In reply

Chanaka Wijeratne · Joanne Earl

To the Editor: As members of the Australian Rheumatology Association (ARA), we read with great interest the recent article by Russell and colleagues.1 The organisation has long been concerned that current training pathways and health care resourcing are resulting in a discordance between rheumatology health care supply in Australia and community needs. ARA believes the rheumatology workforce is in significant undersupply, ageing and largely focused in cities, and that our current training programs will not deal with these issues. A 2018 ARA survey of members found that 41% of respondents (of which 54.5% work at rural and remote clinics) plan to retire in the next 10 years.2 Our concerns are supported by Western Australian data3 reporting a critical shortfall of rheumatologists that trainee throughput will not address. However, accessing accurate national data has been difficult due to the issues outlined by Russell et al.1 For example, Australian Health Practitioner Regulation Agency (Ahpra) data suggest there are 441 practising rheumatologists in Australia, but the ARA is only able to identify 364 (including non‐members).4 In addition, understanding the community demand for care has been challenging, as this might be assessed through the surrogate of numbers of people on waiting lists, but there is heterogeneity of the referral acceptance guidelines and data collection processes. To this end, ARA has recently partnered with the Public Health Information Development Unit at Torrens University to define the rheumatology workforce in Australia, analyse interaction effects, and understand the relationships across public and private settings. This needs to be linked to disease prevalence data and geographic service area to understand supply and demand. We also need to understand the selection into the training process and pathways in order to drive policy addressing our suspected workforce problems. We strongly believe that any workforce planning research should engage and partner with specialty societies; for example, we believe that ARA is best placed to engage our members to aid understanding of their career choices and practice patterns. We encourage other specialty groups to follow suit and the Royal Australasian College of Physicians to consider their leadership role in this area.

Helen I Keen · Claire Barrett · Catherine Hill

To the Editor: In their study examining the suicide deaths of 3027 young Australians during 2006–2015, Hill and colleagues1 reported that nearly 60% of cases had experienced mental health problems during their lifetime, and around 75% of deaths were of young males. We would like to draw attention to another important statistic within these data. Specifically, 4.6% of males who died by suicide in Australia had a diagnosis of autism spectrum disorder (ASD). This is alarming, considering that the prevalence of males with ASD in Australia is estimated to be only 1.3%.2 For males in the study age range (ie, 10–24 years), the prevalence ranges from 1.2% to 3.3%, with the highest prevalence in the 10–14 year bracket. Nonetheless, the apparent high incidence of suicide by males with ASD is consistent with recent research indicating a three‐ to nine‐fold increased risk of suicide among people with ASD compared with the general population.3,4 The increased suicide risk in ASD may be explained by the high incidence of comorbid psychiatric disorders among this population.5 Indeed, in one national cohort study from Denmark, over 90% of people with ASD who attempted or died by suicide had another comorbid mental health condition.3 In addition, it is important to note the low rate of suicide reported among females with ASD (0.4%). This finding is inconsistent with large international studies that report significantly increased incidence of suicide among females with ASD compared with females in the general population, with rates similar to or exceeding that of males with and without ASD.3,4,5 Females with ASD may be underrepresented in the data presented by Hill and colleagues due to lower recognition of ASD among females or to diagnostic overshadowing, whereby ASD is overlooked in favour of other more apparent psychiatric diagnoses (eg, anxiety, borderline personality disorder, depression). Finally, we highlight the fact that there is no systematic procedure or requirement in Australia for asking about or reporting ASD diagnoses within the emergency department or hospital admission systems. Plausibly, ASD is inadequately captured in data concerning health and mental health profiles, health service system access, suicide attempts and deaths in Australia.

Darren Hedley · Mark A Stokes · Julian N Trollor

In reply

Nicole TM Hill · Patrick D McGorry · Jo Robinson

To the Editor: The incisive editorial by Dudley and Lin1 should serve as a clarion call for the development of “more robust strategies with targeted, customised approaches … evidence‐based interventions and peer‐reviewed evaluations”. Their sobering editorial highlights the immense challenges that need to be overcome to affect the growing suicide rates underscored by Hill and colleagues.2 They point out that transgenerational trauma and socio‐economic disadvantages increase suicide in Indigenous populations and call upon collaborative governmental support to address the problem. Intriguingly, although prevalence is higher in moderate to severely disadvantaged youth, the statistics among the least disadvantaged youth are not lagging far behind.2 This suggests that there are likely additional commonalities, such as mental illness, which features in at least half of all such suicide (> 55%).2 It is in light of this confronting reality that we raise the additional need for in‐depth knowledge and mechanism‐informed targeted treatment to avert suicide. It is concerning that one‐third of parents and carers are inadequately informed of mental health services available for mentally ill youth, impeding access to appropriate services,1 which clearly needs to be addressed. But simultaneously, it is important to identify more specific interventions and discern when and how to apply them effectively. This requires a reconceptualisation of suicide as a process, which involves both broad factors within the social environment and specific changes within cognitive and emotional processing networks within the brain.3 Mental illnesses, such as depression, have an impact on the latter by creating a cognitive drive that can be modelled as sequential steps that emerge from a faulty appraisal system to engender feelings of defeat and entrapment that increase hopelessness.3 It is because of these poorly understood antecedents4 and lack of rescuing factors that suicidal ideation ensues3 and is intensified to ideation or intent by additional motivational factors before being converted volitionally to planning and attempting suicide.3 The latter alters neural network connectivity, and further increases the likelihood of future suicide.5 Such deeper insights are needed to provide a framework for targeted preventive interventions. Therefore, we strongly resonate with the authors’ demand for targeted evidence‐based interventions and urge that in addition to these much‐needed initiatives, our energies should also be invested in mechanism‐based research.

Gin S Malhi · Erica Bell · Zola Mannie

In reply

Ping‐I Lin · Michael J Dudley

In reply

Chris B Holmwood

To the Editor: Burrell and colleagues captured data from 77 hospitals containing 91% (n = 204) of coronavirus disease 2019 (COVID‐19) intensive care unit (ICU) cases during the first four months of the pandemic.1 Overall mortality (n = 30, 15%) for mechanically ventilated and non‐ventilated patients in this study was lower than other published data. In contrast, overseas reports have indicated mortality rates for patients with COVID‐19 admitted to ICUs of 40%, 44%, 60% and 70% in the United Kingdom, China, Italy and the United States, respectively.2 Evidence indicates that within developed countries, mortality rates associated with COVID‐19 vary according to physiological parameters but also markedly according to location.3 Low ICU bed occupancy and the distribution of cases across a large number of institutions1 has positively influenced Australian COVID‐19 mortality rates. Less obvious is the role and effect of critical care nurses. ICU nurse to patient ratios in Australian units were 1:1 and 2:1 for 77.8% and 7.5% of ICU days, respectively.1 Mortality is affected by local practice3 and in countries where ratios of 1:6 or more are common,2 mortality rates in ventilated patients can exceed 80%.4 Globally, point‐of‐care pandemic practice in ICUs has involved fewer critical care nurses, variously supported by redeployed nurses without critical care qualifications or experience. Critical care nurse expertise augments pre‐emptive rather than reactive strategies for ICU patient management. In the study by Burrell and colleagues, invasive ventilation was instituted for 119 (58%) patients: 79 (66%) of these on day 1, increasing to 94/113 (83%) by the end of week 1.1 Eighty‐five (42%) patients were able to be supported with either non‐invasive ventilation, high flow oxygen therapy or supplemental oxygen, monitored and managed by critical care nurses. Within an ICU model of care, critical care nurse staffing levels, skills mix, advanced practice functions and level of education ensure the high quality and safety of care delivery. Australian critical care nurses are expert clinicians with advanced education, training and experience who directly influence patient outcomes at the micro (patient and family), meso (unit or organisation) and macro (policy) level.5 Clearly elucidating workforce issues and composition is critically important for documenting models of care and associated outcomes in critical care.

Rochelle Wynne · Caleb Ferguson · Patricia M Davidson

In reply

Aidan JC Burrell · Tessa Broadley · Andrew A Udy

To the Editor: We read with interest the study by Black and colleagues1 on the effectiveness of a pro‐active risk factor management strategy based on absolute cardiovascular disease risk score compared with usual care, in a rapid access chest pain clinic setting. The study suggested that such a strategy significantly improved 5‐year cardiovascular risk scores; however, we would consider some caution before reaching such a conclusion. Although the authors point out several potential sources for bias in their study, there is an additional one that has not been highlighted. In the results, the authors state that “the increase in use of guideline‐based therapies was similar in the two groups,” yet do not go on to explain the differential effect as to why the blood pressure and lipid profiles decreased in the interventional group only. We suggest that the reason for this lies in a fundamental difference between the groups selected. The interventional group at baseline was receiving proportionately greater amounts of lipid‐lowering and anti‐hypertensive therapy: 56% and 30% higher, respectively, than in the control arm. These higher treatment rates may explain the lower blood pressure, the lipid profiles observed and, consequently, the improved final risk scores in the interventional arm. Also, as the authors pointed out, almost a third of eligible patients approached declined to participate and is therefore an important source of potential selection bias. We also note that the offer of referral to a public smoking cessation service was limited to those in the intervention group. National guidelines recommend this strategy as part of standard care,2 and hence we question whether this intervention should truly be considered to deviate from best practice or usual care.

Penni L Blazak · Kim Greaves

In reply

James A Black · James E Sharman · Thomas H Marwick

To the Editor: “Patients often suggest a ‘social meeting’ after you have treated them. It’s a slippery slope” — quote from an Australian medical student.1 A review published in The Medical Journal of Australia of what constitutes misconduct in health professional–former patient sexual relationships highlights the variation between different health professional codes and the repercussions.2 The article notes the lack of national guidance or codes of conduct for health professional students regarding this or similar professional boundary issues.2 The lack of knowledge on this and other professionalism dilemmas faced by students led to the Professionalism Opinions of Medical Students (PoMS) study.1 We obtained ethics approval from the University of Western Australia (Ref. RA/4/1/9278) to conduct the PoMs study using a mixed methods approach with a validated online survey1 to triangulate how the Australian public (n = 503), qualified doctors (n = 809), and medical students (n = 2602) viewed a range of professionalism dilemmas that medical students may encounter. Participation was voluntary and anonymous. Medical students were informed about the study through their medical school. Doctors and the public were informed about the study using media and social media resources. The surveys were closed when recruitment had plateaued. One of the scenarios asked for respondents’ opinions on how acceptable it would be for a medical student to embark on a romantic relationship with a former patient, and if student participants had encountered a similar situation. To determine whether unconscious bias influenced participants’ opinions, there were two randomly administered versions with female or male protagonists (no same‐sex version was included). The scenario is described below: A male/female medical student bumps into a 25‐year‐old woman/man at an evening concert. The student had taken her/his history and performed an abdominal examination in the emergency department a fortnight ago when she/he had attended with abdominal pain. The pair get chatting and the woman/man invites the student back to her/his flat for “somewhere quieter for a drink”. The male/female student accepts the invitation. How acceptable is this student’s behaviour? Almost 4% of medical student respondents (n = 84) reported encountering a situation similar to the one described. Using the χ2 test to compare the responses, there were significant differences in how the three demographic groups viewed this scenario. Notably, more than 50% of the public (n = 237), compared with more than 37% of the students (n = 896) and 29% of the doctors (n = 215) who completed this section of the survey considered this behaviour as acceptable (P < 0.001), regardless of the gender of the protagonist. Doctor participants were the only group to have no gender bias for the acceptability of the protagonist’s behaviour. Medical students’ opinions were intermediate, but were significantly influenced by their stage in the course. Survey participants in the early years of the medical course expressed opinions that aligned more with the public’s responses (478/1099, 43%), but the responses of students in the later years of the course were closer to the views expressed by qualified doctors as to how acceptable they considered the behaviour to be (412/1195, 34%; P < 0.01), supporting the concept of professional identity formation. The PoMS results demonstrate that medical students encounter patient sexual relationship dilemmas and are often unsure about how to manage this — a situation compounded by a lack of national guidance or codes of conduct. We endorse the suggestion that governing bodies provide clearer guidance to health professionals,2 but also advocate that health professional students are provided with explicit guidance on this and on how to apply the other behavioural expectations of good medical practice3 as a student.

Paul M McGurgan · Katrina L Calvert · Christine M Jorm

To the Editor: The Standing Committee on Social Policy and Legal Affairs recently completed its inquiry and final report into family, domestic and sexual violence in Australia.1 This comprehensive report made 88 recommendations to inform Australia’s next National Plan to Reduce Violence Against Women and their Children (National Plan). The report explores violence victimisation in diverse communities (eg, Indigenous people, people with a disability). However, consideration of women involved in the criminal justice system is conspicuously absent. Many women involved in the criminal justice system are victim‐survivors of family, domestic and sexual violence. Estimates suggest that between 70% and 90% of women in prison in Australia have been victims of violence.2 In addition, our previous research found that women released from prison are 16 times more likely to die from violence compared with women of the same age in the Australian population.3 However, the only mention of women involved in the criminal justice system as victim‐survivors in the report is in the subsection discussing Indigenous people which acknowledges that Indigenous women experience disproportionate levels of violence victimisation and incarceration. While Indigenous women should be a priority group for violence prevention, and are over‐represented in prisons in Australia, this was a critical missed opportunity to address the over‐representation of victim‐survivors in the criminal justice system. For many Indigenous and non‐Indigenous women, their offending is connected to previous experiences of violence victimisation.2 Victim‐survivors are also being funnelled into the criminal justice system due to inappropriate criminal justice responses to family and domestic violence.4 As noted in the report, the current National Plan (2010–2022)5 has not been successful in reducing violence against women, and as such, this type of violence remains a prominent and all too common issue in Australia. Women involved in the criminal justice system should be among the priority groups for national violence prevention strategies. The next National Plan should address the health and social needs of these women, which are often drivers of both criminal justice involvement and violence victimisation (eg, mental health, housing, financial independence). Trauma‐informed criminal justice responses that recognise the impact of traumatic experiences on health and behaviour, such as pre‐arrest diversion to mental health or family violence services,6 are also needed. Without this, women who are victim‐survivors of violence will continue to be criminalised due to a misunderstanding of the impacts of family, domestic and sexual violence on their health, lives and behaviour.

Melissa Willoughby · Stuart A Kinner

To the Editor: The average woman giving birth in Australia has ten to 12 antenatal visits and a 2–4 days inpatient stay, representing 8 months of intense engagement with health services. In 2020, women in Melbourne endured a prolonged lockdown period due to the coronavirus disease 2019 (COVID‐19) pandemic.1 During this time, the maternity sector had to move quickly to address three urgent priorities. Firstly, all 12 public maternity hospitals in Melbourne joined forces to create the Collaborative Maternity and Newborn Dashboard for the COVID‐19 pandemic (CoMaND) to meet the need for timely perinatal data collection.2 By harnessing hospital maternity data collection systems under a research protocol, they could centrally monitor perinatal outcomes to assess indirect impacts of the sector’s pandemic response (Box). The second of the priorities was to institute a system to record outcomes for women who were infected with severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) during pregnancy. To this end, the Coronavirus Health Outcomes in Pregnancy and Newborns (CHOPAN) registry was established. It has collected information from 100 women with confirmed SARS‐CoV‐2 infection during pregnancy and has since expanded nationally (https://www.psanz.com.au/covid-19/). The third priority was to address the exclusion of pregnant women from COVID‐19 treatment trials, which occurred despite the fact that many of the investigational drugs had established pregnancy safety profiles.4 The Australasian COVID‐19 Trial (ASCOT) is an international multicentre randomised adaptive platform clinical trial of COVID‐19 therapies (https://www.ascot‐trial.edu.au). After representations from the maternity sector, a pregnancy ASCOT working group tasked with facilitating the safe inclusion of pregnant women was appointed, which established a welcome precedent for inclusion of pregnant women in future clinical research.5 The CoMaND and CHOPAN collaborations are exemplars of clinician‐led initiatives for data‐informed emergency responses in maternity care. It is anticipated that these resources will be of ongoing value into the COVID‐19 vaccination era. Successful advocacy for the inclusion of pregnant women in clinical trials may be another positive legacy of the COVID‐19 pandemic. Their safe inclusion in clinical trials takes us a step closer to an equitable health service, ensuring we generate a robust evidence base to direct clinical care for pregnant women and their children. Box – An example of outcome reporting from the fifth CoMaND report2 Denominator: number of singleton babies at ≥ 20 weeks’ gestation. Numerator: number of babies who meet the denominator criteria with birth weight ≥ 90th percentile adjusted for fetal sex and gestational age. Pre‐pandemic median: 8.75%. Significant shifts (≥ 6 weeks above the pre‐pandemic median) indicated with red arrows. Percentile source: Dobbins et al.3

Lisa Hui · Clare Whitehead · Susan P Walker

To the Editor: The SAME study affirmed the safety and efficacy of switching between originator and biosimilars and the potential for cost savings.1 Yet the global uptake of biosimilars has been relatively slow2 due to a number of factors, including marketing suggesting that such drugs are less safe or efficacious than the originator.3 Implicated in such marketing is confusion arising from the use of the word “interchangeable”, which is a defined term under United States legislation. The word “substitution” is used in Australia, which raises the likelihood of further confusion. Pfizer, which sponsors both biologics and biosimilars, petitioned the US Food and Drug Administration to avoid false and misleading statements about biosimilars.3 Key to Pfizer’s arguments is the definition of “interchangeability” in the Biologics Price Competition and Innovation Act of 2009 (US). To establish interchangeability, further clinical data are needed to show that switching a patient back and forth between the reference product and biosimilar “can be expected to produce the same clinical result as the reference product in any given patient [and] … the risk in terms of safety or diminished efficacy of alternating or switching … is not greater than the risk of using the reference product without such alternation or switch” (§ 262(k)(4)). This represents a higher threshold than biosimilarity, and there are currently no approved interchangeable biosimilars in the US, although a Bill (HR 8190) is currently being considered by the US Congress on insulin products. In Australia, case law has accepted the Therapeutic Goods Administration definition of a biosimilar as “a version of an already registered biological medicine” having “similar characteristics” to the biologic, with no explicit statement as to what “similar” means.4 If the sponsor of the originator were to claim that a competitor biosimilar is not interchangeable, although this would be correct in a legal sense, such claims could be misunderstood by Australian audiences as meaning that it is less safe or not therapeutically equivalent, even when it is “a‐flagged” and approved for pharmacist substitution.5 Therefore, it is important to distinguish the use of “interchangeability” and “substitution”, as these terms may be understood differently by doctors, pharmacists, other health professionals, and patients. Describing a biosimilar as (only) “similar” obscures the reality that approved biosimilars are as safe and efficacious as the originator. In such circumstances, a switch is appropriate, especially if it will save the patient and Pharmaceutical Benefits Scheme considerable money.

David Lim · Rhiannon Bandiera · Elizabeth Handsley

In reply

Ashish Srinivasan · Craig Haifer · Lena Thin