Volume 215 Issue 9

The fourth annual assessment of Australia’s exposure, vulnerability and response to climate change finds us continuing to lag behind the rest of the world

Paul J Beggs · Ying Zhang · Alice McGushin · Stefan Trueck · Martina K Linnenluecke · Hilary Bambrick · Helen L Berry · Ollie Jay · Lucie Rychetnik · Ivan C Hanigan · Geoffrey G Morgan · Yuming Guo · Arunima Malik · Mark Stevenson · Donna Green · Fay H Johnston · Celia McMichael · Ian Hamilton · Anthony G Capon

Recent climate-related heat events in the Northern Hemisphere are part of a global trend with immediate and long term implications for Australia’s health system

Tarun S Weeramanthri · Simon Quilty · Sharon L Campbell

In a critical year for climate action, two cases provide new pathways for climate litigation based on intergenerational impacts

Katherine Owens

A 34-year-old Australian man, with no relevant past medical history, presented with 4 weeks of progressive, nodular skin lesions on his non-dominant hand and arm

David WJ Griffin · Jenny SJ Wong · Orla Morrissey · Cristina Mateevici

A 67-year-old man presented to his rural GP with left facial pain

Timothy R Holmes · Jenny L Hepschke · Ian Jacobson · Anthony Maloof

A 6-month-old female infant with atopic dermatitis presented with multiple erythematous papules and vesicles with crusts on the perioral area, trunk and extremities

Hsing‐Jou Su · Chun‐Bing Chen

An 11-year-old girl presented with a solitary, non-tender, erythematous, indurated plaque resembling keloid slowly growing on her left upper chest for 5 years

Yi‐Teng Hung · Jennifer Wu · Chun‐Yu Cheng

A 77-year-old woman presented with a 5-month history of an asymptomatic rash affecting her lower abdomen and proximal thighs

Emily K Kozera · Deshan F Sebaratnam

A 73-year-old woman presented with a 7-month history of a non- healing ulcer on her left hallux

Michelle KY Chen · Deshan Frank Sebaratnam

A Commonwealth law poses legal risks for practitioners acting under state and territory voluntary assisted dying laws

Eliana Close · Katrine Del Villar · Lindy Willmott · Ben P White

The threat of climate change is immediate and grave, and now is the time to act

Hugh Montgomery · Fintan Hughes

Documenting patient diversity would support more tailored, culturally responsive care and better outcomes

Margaret P Kay

Focusing on people at particular risk of self-harm and assault with firearms could reduce injury and death rates

Joel Negin · Jane Bell · Lorraine Ivancic · Philip Alpers · Natasha Nassar

Low intensity practice facilitation improves aspects of primary care for people from refugee backgrounds

Grant M Russell · Katrina Long · Virginia Lewis · Joanne C Enticott · Nilakshi Gunatillaka · I‐Hao Cheng · Geraldine Marsh · Shiva Vasi · Jenny Advocat · Shoko Saito · Hyun Song · Sue Casey · Mitchell Smith · Mark F Harris

Herd protection is unlikely unless vaccination is extended to younger children or combined with other mitigation measures

Emma S McBryde · Michael T Meehan · Jamie M Caldwell · Adeshina I Adekunle · Samson T Ogunlade · MD Abdul Kuddus · Romain Ragonnet · Pavithra Jayasundara · James M Trauer · Robert C Cope

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: We read with interest the perspective by Sonido and colleagues.1 We wish to highlight that Australian and New Zealand guidelines on screening for hydroxychloroquine retinopathy have been published by the Royal Australian and New Zealand College of Ophthalmologists (RANZCO),2 written by a panel of retinal specialists in consultation with relevant medical disciplines. Key recommendations in the RANZCO guidelines include: baseline examination within the first year of hydroxychloroquine use; annual screening after 5 years of use for patients with no risk factors; and consideration of earlier review for patients at increased risk, such as those who receive hydroxychloroquine doses > 5 mg/kg/day; have renal impairment; use concurrent tamoxifen; have concomitant retinal or macular disease; or receive chloroquine.2 The guidelines recommend baseline examination within 1 year of beginning treatment to exclude concomitant retinal and macular disease, which may confound findings or add to the effects of hydroxychloroquine maculopathy.2 This contrasts with the recently updated United Kingdom guidelines, which do not recommend any form of screening in the first 5 years of treatment.3 The RANZCO minimum requirements for screening include dilated fundus examination, automated visual field testing, and spectral domain optical coherence tomography of the macula. Although automated macular visual field testing is appropriate in Caucasian patients, additional wider field testing is recommended in Asian patients to detect pericentral changes. Fundus autofluorescence and multifocal electroretinography are additional useful investigations and require interpretation by ophthalmologists trained in their interpretation. Patients who are found to have signs of retinopathy at screening or who have equivocal findings should be promptly referred for specialist ophthalmologist retinal assessment. Using the 2016 American Academy of Ophthalmology guidelines (comparable to the RANZCO guidelines), the cost‐utility of screening for hydroxychloroquine retinopathy was found to range from US$33 155 to $344 172 per quality‐adjusted life year.4 By reducing unnecessary screening in the first 5 years of dosing, we anticipate costs in the lower range per quality‐adjusted life year for screening using the RANZCO guidelines. Education of prescribers is necessary. United States studies show that 27% of patients are prescribed dosages exceeding current retinal guidelines,5 with significant non‐adherence to screening recommendations by both prescribers and patients. We encourage all prescribers of hydroxychloroquine to educate patients regarding screening, monitor for all complications, and report to the Therapeutic Goods Administration to obtain a comprehensive Australian dataset of all complications.

Adrian T Fung · Vicky Lu · Heather G Mack

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