Volume 214 Issue 9

Enrolment may strengthen the link between patients and their preferred primary care providers and needs to support flexible provision of high quality care

Michael Wright · Roald Versteeg

Community naloxone supply to prevent fatal overdose needs to consider patients using pharmaceutical opioids Pharmaceutical Benefits Scheme (PBS) opioid prescriptions in Australia have increased from 2.4 million in 1992 to 7 million in 2007 to 15 million prescriptions in 2016.1 The corresponding rate of opioid mortality over this time almost doubled from 3.8 deaths per 100 000 Australians in 2007 to 6.7 in 2017,2 with fatal opioid overdoses increasing from 482 in 2002 per 100 000 Australians to 900 in 2018.3 Most of these deaths involved prescription opioids, and contrary to what many assume, only one‐third of prescription opioid‐related deaths involved intravenous drug use.4 Among deaths associated with common prescription opioids (including fentanyl, morphine, oxycodone, tramadol and codeine), 49% involved people with chronic pain.4 Naloxone, a rapidly acting semi‐synthetic opioid antagonist, has an important role in reducing opioid overdoses by acting as an emergency reversal agent.5 It is currently available in Australia for intramuscular injection or nasal spray. The intranasal formulation was listed on the PBS in November 2019 as an unrestricted General Schedule medication. New South Wales, Western Australia and South Australia are trialling a program of take‐home naloxone available free to people using prescription or illicit opioids and at risk of opioid‐related death or those who may witness an overdose.5 Various aspects of patient history including current opioid medications (especially if the opioids are higher doses or slow release preparations) and comorbidities (such as complex diseases, mental illnesses or respiratory conditions) can help identify people who should be recommended to carry naloxone.5 Take‐home naloxone provided to laypeople to administer in the event of overdose was found to successfully reverse more than 96% of community overdoses in a systematic review.6 The evidence of naloxone’s therapeutic effect and life‐saving role has resulted in the drug being carried in most emergency medical kits and included on the World Health Organization Model Lists of Essential Medicines (https://www.who.int/groups/expert-committee-on-selection-and-use-of-essential-medicines/essential-medicines-lists). Community members, general practitioners and pharmacists frequently perceive naloxone as a medication for people who use illicit opioids, namely heroin.7 However, opioid‐related mortality in people taking pharmaceutical opioids for chronic pain is common. There is a clear evidence–practice gap demonstrating the need for increased discussion about opioid‐related risks and naloxone in this population. In the context of rising pharmaceutical opioid harm, the United States Centers for Disease Control and Prevention provided recommendations for co‐prescribing naloxone for at‐risk patients with chronic pain; such patients include those taking an oral daily morphine equivalent dose of 50 mg or more, taking concurrent benzodiazepines with opioids, having a history of substance use disorder, or having a history of overdose.8 Using these indications, an Australian study reported that 78% of patients on Schedule 8 opioids for chronic non‐cancer pain qualified for take‐home naloxone.8,9 Yet current national data show that less than 3% of all naloxone supplied is on individual PBS prescriptions, with most naloxone prescriptions accounted for by harm reduction programs.10 An additional negligible amount of naloxone is sold over the counter by pharmacists.10 Between 2014 and 2018, an estimated 10 642 units of naloxone were supplied in Australia. Even if a large proportion of this were dispensed to people taking pharmaceutical opioids for chronic pain, it would be vastly insufficient given the 300 000 Australians receiving long term opioids each year.10,11 The majority of Australian patients on pharmaceutical opioids who are at risk of overdose do not appear to be prescribed this emergency medication. Health care provider attitudes towards pharmaceutical opioid‐related risk may be contributing to low naloxone prescribing rates. In qualitative work, Australian GPs described hesitancy in prescribing opioids to younger and middle‐aged patients with chronic pain due to perceived risks of opioid‐related harm.12 In contrast, GPs were more comfortable prescribing opioids for older patients, as they believed there was a lower risk of serious opioid‐related harm in this population.12 These findings highlight doctors’ subjective judgements of overdose risk, which may be a barrier to recognising patients who would benefit from take‐home naloxone. Similar qualitative work highlighted that the biggest barriers to naloxone prescribing were low levels of awareness about naloxone, and unwillingness by doctors to prescribe it.7 This may be driven by incorrect beliefs that patients on pharmaceutical opioids are at low risk of overdose, lack of knowledge, and incorrect patient reporting of actual opioid use.7 GPs and pharmacists are ideally placed to provide and advocate for routine take‐home naloxone. GPs prescribe just over half of all opioids in Australia13 and are the main health care professional seen regularly by people taking opioids for chronic pain. Conversations about naloxone initiated by health care providers present an opportunity to highlight proactive steps to reduce opioid‐related risk, and also raise awareness of overdose management. Unfortunately, community knowledge about opioid‐related risk is low, and most people prescribed opioids for pain are unable to identify common signs of potentially fatal opioid toxicity.14 Improved naloxone prescribing alone is therefore unlikely to be effective without education and increased awareness of opioid overdose signs by patients, family members, friends and carers — who are the expected administrators of naloxone in the event of overdose. One commonly cited barrier to prescribing take‐home naloxone is fear that patients may be offended by the offer or recommendation.7,14 However, Australian research shows that when informed about naloxone, most people prescribed opioids for pain would want or in fact expect their doctor to prescribe it to them.14 Sensitivity around language is key to openly communicating with patients about this issue. Terms like “overdose” still carry considerable stigma and are poorly understood by laypeople. A more patient‐centred approach (and to avoid having important health messages dismissed as irrelevant by patients), might involve changing our language to use terms like “severe opioid‐related side effects” or “life‐threatening opioid toxicity” instead of “drug overdose” to explain the same concept. Discussing naloxone may also help patients recognise the level of harm associated with non‐indicated opioids. The therapeutic benefit of opioids for chronic pain is limited and guidelines strongly caution their use.13 Presenting naloxone as a necessary medication for people on long term opioids may help patients better understand the implications of taking these strong analgesics. This may intuitively encourage patients to request opioid deprescribing or dose reductions. Conversely, increased prescribing of naloxone may risk providers (and patients) justifying high dose opioid prescriptions by relying on naloxone as a safety net. These fears are common with opioid harm minimisation efforts but are not supported by evidence6 and should not detract from the expected number of lives that could be saved by naloxone. A novel approach may be to consider routine co‐prescription of naloxone for patients on strong long term opioids. Laxatives and antiemetics are commonly co‐prescribed with opioids by providers cognisant of common opioid side effects; however, this concept does not seem to extend to naloxone. Take‐home naloxone for people on opioids is analogous to intramuscular glucagon for patients with diabetes on insulin, or auto‐injectable adrenaline for anaphylaxis. Most people are unlikely to need these emergency medications, but in the case of profoundly dangerous adverse events, naloxone, like glucagon or adrenaline, has a life‐saving role. Changing the narrative around take‐home naloxone from “overdose treatment” to “routinely prescribed emergency medication” may help provider attitudes and encourage the normalisation of naloxone prescribing. Our conservative estimate suggests that about 200 000 naloxone scripts would be indicated annually using this approach, at a cost of $40–50 each on the PBS.8 This is comparable with the PBS cost of an adrenaline auto‐injector or glucagon, which are both listed at $40.15 The estimated volumes of naloxone required would also be similar to combined PBS prescription volumes of glucagon (about 44 000 prescriptions) and adrenaline auto‐injectors (about 110 000 adult prescriptions and 28 000 paediatric prescriptions) according to Medicare statistics of PBS prescriptions from July 2019 to June 2020, excluding doctor’s bag prescriptions.15 We present these comparisons between naloxone and other widely accepted emergency medications to show the severity of current naloxone under‐prescribing. From a health economics perspective, increased naloxone prescribing at the rates we suggest would cost the Australian a similar amount to glucagon and adrenaline combined through PBS reimbursement. Further, naloxone would still cost only a fraction of current PBS‐subsidised opioid prescriptions (oxycodone alone costing over $61 million in 2018–201915) and overdose‐related hospitalisation costs. Naloxone may assist with reducing opioid prescription rates and cost, and most importantly would save lives. GPs and pharmacists should consider discussing and co‐prescribing take‐home naloxone with opioids for patients with chronic pain. Australia’s increasing prescription opioid overdoses demands this conversation. However, normalising the role of naloxone as a routinely co‐prescribed emergency medication will require major changes in community and health care provider attitudes, improved awareness of the role of naloxone, and reduction of overdose‐associated stigma. Ongoing collaborative efforts are needed to embrace higher prescribing and dispensing of naloxone.

Pallavi Prathivadi · Suzanne Nielsen

Putting the patient at the core of personalised cancer care delivery remains the elusive final frontier Over 20 years ago, the Australian House of Representatives Inquiry into the management of breast cancer recommended that cancer care should be delivered using a multidisciplinary approach.1 Ten years later, an article published in this Journal articulated how to put multidisciplinary care into practice,2 paving the way for the concept to be embedded into clinical cancer practice and policy of today.3 One of the key recommendations made in the article, and since adopted as national policy, was for the patient to be included “as a member of the multidisciplinary team”. But as of today, multidisciplinary care does not routinely include input from patients themselves. Patients do not attend multidisciplinary meetings. Rather, their circumstances are discussed and treatment recommendations are made. They may subsequently make a shared decision with the clinician, but their input tends to occur after the multidisciplinary discussion and it is uncommon for the patients’ perspectives to systematically inform these discussions. Putting the patient at the core of personalised cancer care delivery thus remains the elusive final frontier. The potential benefits of such an approach are well established and include a greater alignment of care with individual patient goals, better understanding of needs, and better patient outcomes and satisfaction.4 Health care providers are poor surrogates for assessment of patients’ symptoms, needs and experiences and patient‐reported outcomes (PROs) collection is a way to systematically integrate patients’ perspectives into assessment, treatment planning, and ongoing monitoring.5 PROs report on patients’ subjective perception of health, functional status, unmet needs, and quality of life and are collected directly from patients either online, via a smartphone, or through paper‐based means. While there are many sets of questions that are relevant to any patient with cancer, specific questions can be tailored to particular cancer types, populations, or different phases of cancer trajectory.6 PROs as a concept are not new and not unique to cancer. However, while they have been used extensively in research, including clinical trials, their adoption in routine clinical care has received much less attention, with only one article on the topic published in this Journal over 10 years ago.7 This article summarises the current evidence supporting the use of PROs in cancer as an example of their potential of relevance to broader health care delivery, and argues for their routine adoption into practice. The evidence for the utility of PROs in cancer care is compelling. A single‐institution randomised controlled study of 766 patients included participants with multiple metastatic cancers and assigned them to a usual care group or a group that reported on their symptoms using an electronic portal.8 The study found that patients reporting PROs had longer survival, with a median prolongation of 5.2 months; comparable in effect size to many effective, novel cancer therapies.8 In Ontario, where PROs have been routinely collected since 2007, administrative data analysis has shown survival improvement irrespective of the phase of cancer treatment, as well as reduced hospitalisation and emergency department presentations.9 Two systematic reviews concluded there was strong evidence that implementation of PROs improves patient–provider communication and patient satisfaction.10,11 PROs are recommended by the Australian Commission on Safety and Quality in Health Care, have been advocated for by the Clinical Oncology Society of Australia, and have been included as a critical element of care in the Australian Digital Health in Cancer Care Roadmap.12 But to date, their adoption into routine clinical practice has been limited. Like multidisciplinary care 20 years ago, a significant barrier to their integration has been the ability of the health system to operationalise routine collection and response to PROs data. In 2020, we finally have technology for efficient, real‐time collection, reporting of, and response to PROs through customisable portals and dashboards and integration with the electronic medical records. But technology alone is not sufficient and its roll‐out, especially with regards to electronic medical records, has been slow and fragmented. Similar to the approach to multidisciplinary care,2 it is time to articulate the principles and outcomes necessary to integrate PROs into the routine clinical workflow (Box 1). Where multidisciplinary care called for a core team of experts, the PROs collection requires a core dataset. While a dataset using a generic PROs measure, such as the Edmonton Symptom Assessment System Revised (ESAS‐r) used in Canada, may be most appropriate for screening for unmet needs in any clinical setting, more specific measures may be required for assessment of different cancer types, different phases of disease (ie, at diagnosis v end of life) or for different populations, such as Indigenous patients.13 There is a need for a clear communication framework involving relevant heath care providers in a timely fashion, with feedback communicated to the patient. The process must be accessible to patients irrespective of technology, rurality, remoteness or language barriers. Lastly, the collection of PROs needs to be underpinned by agreed standards that clearly articulate and support the role of the patient in this process. While the barriers to adoption of PROs in clinical practice are significant,14 they are not insurmountable. System redesign may be required to integrate PROs collection and feedback into the routine workflow, with clear pathways to inform a standardised approach. PROs collection should not become an additional task but rather be considered part of a realignment of workload and services to meet patients’ needs, reduce care variation, and optimise resource utilisation. A systematic approach to identification of needs is critical to supporting self‐management, an essential component of patient care, as it assists the patient in knowing what symptoms are unexpected, what to report, and how to seek support when needed.15 Data from existing PROs systems show that rapid, real‐time feedback to health care providers facilitates timely response, reducing the likelihood of issues escalating or remaining unaddressed. In many cases, this response may only require reassurance and/or advice on self‐management, with only the more severe issues necessitating referral and/or hospital admission. With advances in technology, patients and health care providers can obtain visual summaries of trends over time that may assist further in decision making, while aggregated data derived from individual cases can be used to drive health system improvement and plan services to meet demand. Are we ready for this final frontier? PROs can become an important part of value‐based care delivery with support through relevant drivers, such as reimbursement and accreditation. But we need to build capacity through training and a community of practice to share learnings, resources and tools. Many tools already exist (Box 2), with technology fully capable to support rapid processing of data and linkage to electronic health records; although it is important to note that PROs collection can be achieved using paper‐based surveys or simple reporting such as text messaging. As we reflect on the 20 years of multidisciplinary cancer care in Australia, it is worth remembering that multidisciplinary care is not just about multidisciplinary meetings. Similarly, PROs are not just about PROs collection tools. Together, these two complementary approaches put into practice the principle of personalised care. It is the focus on the patient that enables us to realise the full potential of the multidisciplinary care through framing multidisciplinary recommendations in the context of what the patient identifies as their main issues, needs or concerns. It is time to reach this final frontier and make personalisation of cancer care through PROs an achievable standard in Australia. Box 1 – Principles of clinical use of patient‐reported outcomes (PROs) in cancer care Principle Outcome Core data Agreed core dataset appropriate for patient, population or setting Communication framework Relevant information is communicated to relevant team members in a timely fashion through agreed channels Access Systems established to ensure access for all users irrespective of distance, technology, language, literacy level, or completion method Standards of care Patients and clinicians are aware of PROs and support their use at key points in clinical care pathway through: best practice protocols; stratified alert systems; reporting framework; professional development opportunities; adequate resourcing to allow collection, scoring, review, response and feedback and re‐screening; and feedback and co‐design opportunities Patient involvement Information and education Self‐management support Feedback and co‐design opportunities Box 2 – Examples of clinical practice resources for patient‐reported outcomes (PROs) use in routine care Australian Commission on Safety and Quality in Health Care (https://www.safetyandquality.gov.au/our-work/indicators-measurement-and-reporting/patient-reported-outcome-measures) General information on PROs, including list of validated measures and guides for implementation International Consortium for Health Outcomes Management (https://www.ichom.org/) Multiple resources and standard datasets for multiple conditions including cancer Cancer Care Ontario, Patient Reported Outcomes and Symptom Management Program (https://www.cancercareontario.ca/en/cancer-care-ontario/programs/clinical-services/patient-reported-outcomes-symptom-management) A system of PROs screening for patients with cancer, including clinical pathways and guides for patients and health care providers Clinical Oncology Society of Australia, PROs Think Tank report (https://www.cosa.org.au/media/332504/cosa_pros_think_tank_report_final.pdf) An overview of evidence, current practice and recommendations for PROs uptake into cancer care in Australia

Clinical Oncology Society of Australia (COSA) Patient Reported Outcomes Working Group

Recent trends in general practice structure may have an impact on future patient care in Australia The organisational structure of general practice in Australia has changed considerably since the late 1990s.1 Prompted by health care system changes, practice cost increases and incentives, originally small‐scaled general practices have merged into larger entities.1 At present, 2% of Australian general practitioners work in solo private practices, while 20% of full‐time GPs and 33% of part‐time GPs are employed in large practices with six or more GPs.1 Practice ownership levels have changed as well. In 2020, 25% of Australian GPs were practice owners, a decline from 35% in 2008.2 Factors such as management responsibilities, financial burdens and a lack of work–life balance seem to discourage practice ownership.3 Concurrently, commercial ownership models emerged, ranging from ownership by other health professionals to corporate groups of publicly listed companies, with shareholders having little or no involvement in patient care or practice management.3 In 2000, there were six corporate groups; by 2020, three remained, which operate over 400 medical centres. Survey data from 2020 indicate that approximately 16% of GPs work in corporate‐owned practices.1 Co‐located services increased as well. In 2016, 81% of practices had pathology services on location versus 49% in 2010; for imaging, these figures are 30% versus 15% and for physiotherapy 50% versus 29% respectively.3,4 Trends towards increasing general practice size and corporatisation have also been reported in other advanced economies. In the United States, about 16% of primary health physicians are employed in corporate‐owned practices.5 Sweden has encouraged for‐profit facilities to increase provider choice and competition, resulting in 40% of general practices being privately owned.6 Corporatisation of general practice in New Zealand is rising as new generation GPs prefer a lower administrative burden.7 While national policies in the United Kingdom have encouraged partnerships and the integration of general practices to improve service quality and facilitate access, most practice groups have remained independent businesses (< 5% corporate‐owned).4 Corporate business models may have clear advantages for GPs, including financial security and a better work–life balance, and they might benefit patients as they offer a range of on‐site medical services and extended opening hours.3 However, concerns have been raised about the consequences of growing practice sizes and corporate‐owned general practices, in particular regarding corporate obligation to deliver revenue to their shareholders who do not participate in any aspect of patient care, putting profits before patient care.8 Moreover, some corporations currently active in Australian general practice operate across international borders and their cultures may be inimical to patient‐focused health care. The aim of this narrative is to synthesise the available information about the impact of changes to size and ownership on the delivery of patient care and the health care system. The review is based on articles and reports found through an extensive search of the (grey) literature, the reference lists of key articles and related articles, and via the “cited by” feature in Google Scholar. Only publications in English, published after 2000 and applicable to the developments in Australia were considered for inclusion. After screening, 14 publications were included (Supporting Information, table 1). Impact of general practice size and ownership model Independent of size and ownership, general practices should deliver high quality services, with commitments to access, continuity and quality of care and optimal use of health expenditure (Box 1). Impact on access to care Initially, most corporate practice models offered bulk‐billing; however, the introduction of the Medicare rebate freeze in 2013 resulted in a change to mixed‐ or private‐billing models.9 The expansion of GP practice consolidation and corporatisation is associated with less closely located competition, which may lead to further reductions in bulk‐billing and an increase in service fees and out‐of‐pocket expenses.10 While there is no direct evidence that larger practices and corporatisation lead to financial barriers to accessing care, access may be affected when multiple smaller practices conglomerate into larger, more centrally located practices, especially for people residing in regional and remote areas where there are already fewer GPs per person.1 The reported long waiting times in corporate medical centres and the shortage of viable transport options to more distant general practices may further impede access to medical care when required.11 Impact on continuity of care Continuity of care enhances patient satisfaction and trust, which improves the understanding and management of illnesses, adherence to treatment and may ultimately lower mortality rates.12 Results from an Australian online survey13 showed that while most participants (n = 2477 ) do have a usual GP (80%) or general practice (90%), 28% had sought care from multiple practices in the preceding year. Reasons for multiple practice visits were not provided.13 In larger practices, the “usual GP” was often replaced by “usual practice”, resulting in patients consulting GPs they had never met before.13 Similarly, higher levels of continuity of care were experienced in small practices (50%) compared with practices with seven or more GPs (31%), according to a study from the UK.14 A large UK study4 (n = 903 357) found that corporatised practices provided significantly worse overall patient experience compared with traditional GP practices and particularly in regards to consulting a preferred GP. In the qualitative aspect of an Australian study,11 participants visiting corporate practices reported a lack of continuity of care and that doctors were often not aware of their medical history. Furthermore, participants indicated that appointments were short, unsatisfactory and lacked follow‐up. Lower follow‐up rates were also found in for‐profit Swedish primary care centres for patients with chronic diseases compared with centres owned by not‐for‐profit organisations (71% v 75%).15 Impact on quality of care While the efficiency of management processes, co‐location of health services and extension of opening hours of corporate‐owned general practices undoubtedly accommodate the need of patients, research suggests that the quality of corporatised GP services may be worse compared with care delivered by traditional providers.11,16,17 In a UK cross‐sectional study16 (n = 971 232), out‐of‐hours services delivered by corporate organisations scored significantly lower for the timeliness of provided care and for physician and overall patient experience. In 2013, a survey11 of 617 Australian Capital Territory residents did not find a relationship between practice size and patient satisfaction. However, there was a difference between patient satisfaction and care delivered in non‐corporate practices (91%) and corporate practices (79%).11 A UK study17 (n = 8300) found that non‐traditional providers performed consistently worse (P < 0.01) on 15 out of 17 performance measures related to patient experience, cost and efficiency, access and clinical effectiveness. There are few Australian studies that investigate whether size or ownership affects patient outcomes. One of these,18 which focused on diabetes care in nearly 150 practices across three states between 2011 and 2014, found that neither practice size nor ownership type related to good glycaemic control and completion of annual cycles of diabetes care. Impact on health expenditure In 2018–19, about $8.0 billion (6%) of the total government health expenditure related to benefit paid for non‐referred medical services, which include GP services, an increase of 75% in the past decade Box 2).19 The concurrent 48% government expenditure increase per capita on received GP services has been linked to the rise in chronic diseases, resulting in a multitude of services delivered to single patients.1,19 It has been argued that the observed increase might be associated with the practice of overservicing to meet income targets, or with GPs over‐referring to commercially related and co‐located services.22 An analysis of 8 years of general practice activity data, found that practice size was positively associated with pathology ordering: practices with five to ten full‐time equivalent (FTE) GPs had a nearly eight times higher rate of ordering than those with fewer than two FTE GPs.23 An investigation of the impact of pathology co‐location with similar data found no direct association between co‐location and increased test ordering, although the clinical appropriateness of tests was not investigated.24 In addition, some corporate GPs reported feeling pressured by their employers to increase services billed and the occasional use of provider numbers for clinically unnecessary services or added consultation items without the physician’s consent.8 There is also evidence of potential underuse of GP services. Up to 40% of emergency department presentations could have been managed in a general practice setting, and a clear relationship was found with lower levels of continuity of care provided.4,25 Large and corporate‐owned practices seem to be associated with overservicing and lower levels of continuity of care and may therefore negatively affect health costs. A considerable amount of secondary care expenditures might thus be saved each year through effective primary health care delivery. Conclusion There is a growing trend of general practice consolidation with co‐located pathology, imaging and allied health services. This trend is expected to continue as 50% of current practice owners plan to retire within 10 years and nearly 60% of non‐owning GPs are “not at all interested” in becoming practice owners in the future.1 While there is little Australian evidence that worse clinical care is delivered in privately or corporate‐owned general practices, there is also no evidence that care is better. Hence, if general practice in Australia is to navigate the future changes in practice size, ownership and increasingly co‐located service organisation, more Australian research and potentially regulation are needed to track and control what this means for patient care in terms not only of patient experience but also for health outcomes in general practice. Box 1 – Key elements of general practice service provision Box 2 – Government health expenditures and Medicare benefits paid per capita in the financial years 2008–09 and 2018–1919 2008–09 2018–19 Increase (%) Estimated resident population Australia 21 249 199 24 992 747 17.6% All government health expenditure ($)1,3 78.6* 133.6* 70.0%† Benefit paid all services ($) 14.3* 24.1* 68.9%† Benefit paid out‐of‐hospital non‐referred services (GP services) 4.6* 8.0* 74.6%† Benefit paid per capita for total Medicare 671 963 43.5% Benefit paid per capita for GP services 218 322 47.7% Average of GP services per capita 5.3 6.3 18.9% GP = general practice. * Billion. † The increase in percentage is calculated before rounding the expenditures to one decimal point in billions. Source: Australian Institute of Health and Welfare.20,21

Caroline Moel-Mandel · Vijaya Sundararajan

Temporomandibular disorders are a major cause of orofacial pain resulting in significant morbidity and reduction in an individual’s perceived quality of life

Samuel V Thambar · Sachin Kulkarni · Joshua Tesar · Scott Armstrong

We can learn from all clinical trials, whatever their outcomes

Mark R Nelson

The safety and value of reducing opioid use are recognised, but difficult conversations and less accessible alternatives are barriers

Hester Wilson

The predominantly age-based structure of the British vaccination program has enabled a rapid delivery with high vaccine uptake

Anthony Harnden · Andrew Earnshaw

Objectives: To determine whether a multifaceted primary health care intervention better controlled cardiovascular disease (CVD) risk factors in patients with high risk of CVD than usual care. Design, setting: Parallel arm, cluster randomised trial in 71 Australian general practices, 5 December 2016 – 13 September 2019. Participants: General practices that predominantly used an electronic medical record system compatible with the HealthTracker electronic decision support tool, and willing to implement all components of the INTEGRATE intervention. Intervention: Electronic point‐of‐care decision support for general practices; combination cardiovascular medications (polypills); and a pharmacy‐based medication adherence program. Main outcome measures: Proportion of patients with high CVD risk not on an optimal preventive medication regimen at baseline who had achieved both blood pressure and low‐density lipoprotein (LDL) cholesterol goals at study end. Results: After a median 15 months’ follow‐up, primary outcome data were available for 4477 of 7165 patients in the primary outcome cohort (62%). The proportion of patients who achieved both treatment targets was similar in the intervention (423 of 2156; 19.6%) and control groups (466 of 2321; 20.1%; relative risk, 1.06; 95% CI, 0.85–1.32). Further, no statistically significant differences were found for a number of secondary outcomes, including risk factor screening, preventive medication prescribing, and risk factor levels. Use of intervention components was low; it was highest for HealthTracker, used at least once for 347 of 3236 undertreated patients with high CVD risk (10.7%). Conclusions: Despite evidence for the efficacy of its individual components, the INTEGRATE intervention was not broadly implemented and did not improve CVD risk management in participating Australian general practices. Trial registration: Australian New Zealand Clinical Trials Registry, ACTRN12616000233426 (prospective).

Ruth Webster · Tim Usherwood · Rohina Joshi · Bandana Saini · Carol Armour · Sue Critchley · Gian Luca Di Tanna · Shane Galgey · Charlotte M Hespe · Stephen Jan · Ajay Karia · Baldeep Kaur · Ines Krass · Tracey‐Lea Laba · Qiang Li · Serigne Lo · David P Peiris · Christopher Reid · Anthony Rodgers · Louise Shiel · Jessica Strathdee · Nuria Zamora · Anushka Patel

Coronavirus disease 2019 (COVID‐19) and subsequent containment measures affected consumer behaviour in Australia, including the stockpiling of essential items. Increased demand for prescription medications caused concern about potential medication shortages, and a range of policies were implemented in March 2020 to protect supplies.1 We used interrupted time series modelling to quantify the impact of the COVID‐19 pandemic on medication dispensing. The Pharmaceutical Benefits Scheme (PBS) subsidises public medication costs in Australia. We analysed Section 85 date of supply data2 to model dispensing during January 2016 – December 2019, by month, separately for all PBS prescriptions, the ten medications most frequently dispensed during the 2018–19 financial year, hydroxychloroquine, and dexamethasone. These models, which accounted for long term trends and seasonal changes, were used to predict expected dispensing during January – June 2020 (with 95% confidence intervals [CIs]), which we compared with actual dispensing rates during this period (online Supporting Information). Ethics approval was not required for our analysis of publicly available data. The number of prescriptions dispensed during March 2020 was significantly higher than predicted (4.80 million more prescriptions, +18.5%; 95% CI, +14.0% to +23.3%), but significantly lower in April (2.28 million fewer prescriptions, –9.2%; 95% CI, –5.3% to –12.8%) and May (2.08 million fewer prescriptions; –8.1%; 95% CI, –4.3% to –11.5%); there was no significant difference in June 2020 (988 778 fewer prescriptions, –3.8%; 95% CI, –7.5% to +0.1%) (Box). A similar pattern applied to the ten most dispensed medications; the increase in the number of hydroxychloroquine prescriptions dispensed in March was particularly large (24 286 more prescriptions, +95.5%; 95% CI, +89.1 to +102%) (Supporting Information). Increased dispensing of prescription medications in March 2020 was consistent with the general panic buying reported early in the COVID‐19 pandemic.3 Pharmacies also received increased requests for prescription and over‐the‐counter medications at this time, in some cases causing local shortfalls1 and concern that continued high dispensing might interrupt medication supply at the national level. This applied in particular to drugs considered early in the pandemic as potential treatments for COVID‐19, such as hydroxychloroquine. In response to increased dispensing in March, the Australian government rapidly implemented a range of policies for protecting medication supplies. Dispensing limits of one month’s supply were applied to medications if shortages would have serious health consequences.1 These policies reduced the total number of medications dispensed in April and May 2020, followed by the return to normal levels of prescription dispensing in June. Other factors likely to have been important were stockpiles amassed by people during March, public adjustment to the pandemic, and the early suppression of COVID‐19 in Australia. Restrictions on prescription dispensing were balanced by services to assist susceptible patients to isolate themselves; for example, the COVID‐19 home medicines service funded home delivery of prescription medications by community pharmacies and Australia Post,4 and funding for telehealth was increased to facilitate remote prescribing.5 Our findings indicate that medication supply can be safeguarded from panic dispensing by a range of regulatory policies combined with medication services for vulnerable people. This may be particularly important for ensuring equitable access to medications for treating COVID‐19. The risk of further COVID‐19 outbreaks underscores the importance of maintaining these policies and services. Box – Total number of prescriptions dispensed in Australia, January 2016 – June 2020, and numbers of COVID‐19 diagnoses in Australia, January 2020 – June 2020 CI = confidence interval. * Source: Australian Department of Health.2

Mustafa Mian · Subhashaan Sreedharan · Sarah Giles

Practitioners who prescribe opioid medications for people with chronic non‐cancer pain must navigate increasingly stringent policy requirements,1 research findings questioning the benefit of opioids for such patients,2 and patients who fear uncontrolled pain if opioids are withdrawn.3 In Australia and New Zealand, people with chronic non‐cancer pain may be referred to specialist pain management services, most of which participate in the electronic Persistent Pain Outcomes Collaboration (ePPOC; https://www.uow.edu.au/ahsri/eppoc), an initiative for collecting standardised information about their patients, the services they provide, and the outcomes of treatment. This information is used at point of care, and for reporting, benchmarking, and research. To explore the impact of changes in opioid use on outcomes for patients, we analysed ePPOC data collected at 67 pain services (online Supporting Information) during January 2015 – June 2020. We extracted data for all patients with completed episodes of care and who had answered questions about opioid use at referral and episode end. We summarised their characteristics and outcomes as means with standard deviations (SDs). All analyses were conducted in SAS 9.4. Our study was approved by the University of Wollongong and Illawarra and Shoalhaven Local Health District health and medical human research ethics committee; reference, 2019/ETH03804). The mean age of the 10 302 patients who provided information at both referral and at the end of their treatment episodes was 49.5 years (SD, 14.4 years); 5807 were women (56.4%), and 3490 had experienced their pain for more than five years (33.9%). The most frequent site of their main pain was the back (3936 patients; 38.2%). A total of 6340 patients (61.5%) were using opioid medications at referral (Box 1); their mean oral morphine equivalent daily dose4 was 56.3 mg (SD, 75.3 mg), the median daily dose was 31.0 mg (interquartile range [IQR], 15–75 mg). They reported higher mean pain scores than patients not using opioids at referral (6.2 [SD, 1.6] v 5.8 [SD, 1.7]) and greater interference in daily activities (7.2 [SD, 1.8] v 6.5 [SD, 2.0]; each measured with the Brief Pain Inventory5). Mean values for depression, anxiety, stress, pain catastrophising, and pain self‐efficacy were also worse for people using opioid medications (data not shown). The most frequent service events were individual appointments with medical and allied health staff (35 678 of 55 012 events, 65%) and group pain programs (18 841 events, 34%); there were 493 procedural interventions (1%). The median episode length was 175 days (IQR, 99–322 days). Opioid prescribing varies between pain services, including direct prescribing by the pain specialist and recommendations to patients’ general practitioners. However, a major focus of multidisciplinary care is supporting patients to reduce their opioid use, which typically involves collaboration between the patient, their GP, and the pain service. By the end of their treatment episodes, 1724 patients who reported using opioids at referral (27.2%) had stopped doing so, 1234 patients (19.5%) had reduced their dose by at least 50% and 3382 patients (53.3%) had either not changed, increased, or reduced opioid use by less than 50%. For each group, scores had improved in each clinical domain, and the changes were greatest for patients who had ceased opioid use, as were the proportions experiencing clinically significant improvement. Scores for measures specifically related to pain experience (pain severity, interference, catastrophising and self‐efficacy) at the end of treatment were similar to or better than those of patients who had not been using opioids at referral, despite greater initial pain severity. Conversely, the smallest mean improvements were for the patients who had not reduced opioid use by at least 50% (Box 2). Although our study was limited by its retrospective nature, the lack of follow‐up of patients who did not complete treatment, and its restriction to specialist pain practices, our findings are encouraging. We found that significant clinical improvements are possible for people with chronic non‐cancer pain attending multidisciplinary pain management services in Australia and New Zealand, even as they discontinue opioid medications. The challenge is to extend these services and supported self‐management skills to primary and community care. Box 1 – Opioid use by patients at referral and at the end of treatment in specialist pain clinics * Opioid therapy was initiated for 536 of patients who had not being using opioid medications at referral (13.5%). † Opioid use had been reduced by less than 50% for 1025 patients (30.3%), not changed for 878 patients (26.0%), and increased for 1479 patients (43.7%). Box 2 – Mean pain and psychometric scores, and changes in scores between referral and end of treatment (with standard deviations), by opioid use at the two time points table#t2 tbody td:nth-child(n+2) P. Pleft { text-align: center; } Clinical domain Patients not using opioids at referral Patients who were using opioids at referral Ceased taking opioids Reduced opioid use by at least 50% Other* Total number of patients 3962 1724 1234 3382 Pain severity (BPI5) 3787 1646 1174 3215 Referral 5.8 (1.7) 6.1 (1.7) 6.3 (1.6) 6.3 (1.6) Episode end 4.9 (2.0) 4.9 (2.0) 5.5 (1.8) 5.8 (1.7) Change in score –0.9 (1.7) –1.2 (1.8) –0.8 (1.6) –0.5 (1.5) Clinically significant improvement† 817/2997 (27%) 459/1410 (33%) 231/1035 (22%) 436/2827 (15%) Pain interference (BPI5) 3905 1702 1219 3316 Referral 6.5 (2.0) 7.1 (1.8) 7.3 (1.7) 7.2 (1.9) Episode end 4.9 (2.4) 5.0 (2.4) 5.7 (2.3) 6.2 (2.2) Change in score –1.6 (2.2) –2.1 (2.3) –1.6 (2.1) –1.0 (2.0) Clinically significant improvement† 2050/3279 (63%) 1062/1546 (69%) 679/1133 (60%) 1481/3003 (49%) Depression (DASS‐216) 3827 1673 1201 3240 Referral 17.8 (12.1) 20.2 (12.4) 20.9 (12.6) 20.7 (12.4) Episode end 12.8 (11.1) 13.8 (11.6) 15.6 (12.0) 16.6 (11.9) Change in score –5.0 (10.1) –6.4 (11.0) –5.3 (10.7) –4.0 (10.2) Clinically significant improvement† 1308/2231 (59%) 662/1100 (60%) 434/810 (54%) 1042/2190 (48%) Anxiety (DASS‐216) 3821 1676 1191 3233 Referral 12.1 (10.2) 13.3 (10.4) 14.1 (10.4) 13.7 (10.3) Episode end 10.1 (9.5) 10.9 (9.7) 11.9 (9.7) 12.5 (10.1) Change in score –2.0 (8.2) –2.4 (8.7) –2.2 (8.4) –1.2 (8.0) Clinically significant improvement† 858/1972 (44%) 438/962 (46%) 288/716 (40%) 662/1904 (35%) Stress (DASS‐216) 3818 1660 1191 3226 Referral 19.8 (11.0) 21.1 (10.8) 21.9 (10.9) 21.2 (11.1) Episode end 15.6 (10.6) 16.6 (10.7) 17.9 (10.5) 18.6 (10.8) Change in score –4.1 (9.6) –4.5 (10.2) –4.0 (9.3) –2.6 (9.2) Clinically significant improvement† 1154/1936 (60%) 553/905 (61%) 387/710 (55%) 898/1828 (49%) Pain catastrophising (PCS7) 3796 1649 1174 3204 Referral 26.3 (13.3) 28.1 (13.4) 28.5 (13.4) 28.3 (13.3) Episode end 18.3 (13.3) 17.9 (13.5) 20.9 (13.6) 22.1 (13.6) Change in score –8.0 (11.6) –10.2 (12.2) –7.6 (11.1) –6.2 (11.2) Clinically significant improvement† 1425/2513 (57%) 714/1164 (61%) 435/841 (52%) 1056/2308 (46%) Pain self‐efficacy (PSEQ8) 3860 1685 1210 3262 Referral 24.0 (12.6) 20.6 (12.0) 18.6 (11.0) 18.9 (11.9) Episode end 32.1 (14.4) 32.0 (14.4) 26.9 (13.1) 24.0 (13.1) Change in score +8.1 (12.7) +11.5 (14.0) +8.3 (12.7) +5.1 (12.1) Clinically significant improvement† 1433/2796 (51%) 827/1382 (60%) 504/1058 (48%) 1015/2773 (37%) BPI = Brief Pain Inventory (range, 0–10); DASS‐21 = Depression Anxiety and Stress Scale (range, 0–42); PCS = Pain Catastrophising Scale (range, 0–52); PSEQ = Pain Self‐Efficacy Questionnaire (range, 0–60; higher scores indicate greater self‐efficacy). * Opioid use by patients had been reduced by less than 50%, not changed, or increased. † For patients who reported at least moderate symptom severity at referral (see Supporting Information for definitions of clinically significant improvement).

Hilarie Tardif · Christopher Hayes · Samuel F Allingham

The Royal Commission into Aged Care Quality and Safety has highlighted the high rates of polypharmacy and potential medication‐related harm in residential aged care facilities (RACFs) in Australia.1 Residential medication management review (RMMR) is a government‐funded service for facilitating quality use of medicines in RACFs.2 Previous studies have found that RMMRs by accredited pharmacists and general practitioners identify a mean of 2.7–3.9 medication‐related problems per resident, and 45–84% of pharmacists’ recommendations were accepted by GPs.3 Guidelines recommend that residents should generally receive an RMMR on entering an RACF and when their clinical circumstances change,4 but annual claims data5,6 and recent research indicate that not all residents receive RMMRs.7 We examined time to first RMMR after RACF entry by analysing data for the national historical cohort of the Registry of Senior Australians (ROSA).7 In ROSA, de‐identified data collected during aged care eligibility assessments are linked to information about government‐subsidised aged care services, general practice and allied health services subsidised under the Medicare Benefits Schedule (MBS), medicines subsidised under the Pharmaceutical Benefits Scheme (PBS), and the Australian Institute of Health and Welfare National Death Index.8 Non‐Indigenous people aged 65 years or more who first entered permanent residential care during 1 January 2012 – 31 December 2015, had received an entry‐into‐care assessment within 100 days, and had received at least one PBS‐subsidised medication during the preceding year were included. Recipients of Department of Veterans’ Affairs‐funded services and people who had previously undergone RMMRs (eg, during transition care) were excluded. The cumulative incidence function was used to determine time to first MBS claim lodged by GPs for RMMRs (item code 903) or Home Medicines Reviews (HMRs) (item code 900) after entry to permanent residential care, adjusted for competing events (death, or permanent departure from the first RACF for another reason) using the Fine–Gray method,9 with follow‐up to 31 December 2016. Statistical analyses were undertaken in SAS 9.4. The University of South Australia (reference, 200489) and Australian Institute of Health and Welfare (reference, E02018/1/418) Human Research Ethics Committees provided ethics approval for the study. A total of 176 390 residents in 2799 RACFs were followed for a median 479 days (interquartile range [IQR], 149–858 days). Median age at entry was 84 years (IQR, 79–88 years), 108 908 were women (61.7%), and 84 864 were living with dementia (48.1%). In the year preceding entry, residents received a median of 11 unique prescription medications (IQR, 8–16 medications); 109 765 (62.2%) had received at least one high risk medication (as defined by the United States Institute for Safe Medication Practices10), and 7912 (4.5%) had received HMRs in the 12 months prior to RACF entry. By three months after RACF entry, 19.1% of residents (Wald 95% confidence interval [CI], 18.9–19.3%) had received RMMRs, 11.8% (95% CI, 11.6–11.9%) had died without RMMRs, and 5.7% (95% CI, 5.6–5.8%) had left their RACF for other reasons without RMMRs. At 12 months, 43.1% (95% CI, 42.8–43.3%) had received RMMRs, 20.6% (95% CI, 20.5–20.8%) had died without RMMRs, and 9.0% (95% CI, 8.8–9.1%) had left without receiving RMMRs. By 24 months, 49.7% (95% CI, 49.5–50.0%) had received RMMRs, 25.8% (95% CI, 25.6–26.0%) had died without RMMRs, and 10.2% (95% CI, 10.1–10.4%) had left their first RACF for other reasons without receiving RMMRs (Box). The high burden of medication use at the time of RACF entry suggests that most residents could have benefited from RMMRs, but MBS claims for RMMRs were lodged for fewer than one in five residents within three months of RACF entry, and fewer than one in two within two years. Our findings are generalisable to all older Australians entering RACFs, as ROSA captures data for all people aged 65 years or more who access government‐subsidised permanent residential aged care in Australia. We could not determine why residents were not referred for RMMRs, nor the impact of recent program changes2 on RMMR uptake and resident outcomes. In 2014–15, fewer GP medication review claims were reimbursed under the MBS (54 803 RMMRs, 63 872 HMRs) than pharmacist claims (93 517 RMMRs, 72 607 HMRs).5,6 Analysing GP claims may underestimate the number of RMMR reports prepared by pharmacists because GP claims are submitted after the medication management plan is discussed with the resident or family, while pharmacist claims are submitted after the report is sent to the GP.7 MBS claims may not be lodged if the full RMMR process cannot be completed (eg, because the resident died, their clinical circumstances had changed, or the RMMR report was not received or followed up), or claiming may be overlooked. Linkage with pharmacist claims data at the individual resident level could facilitate investigation of these limitations. Despite RMMRs being a key means for minimising medication‐related harm, MBS claims for RMMRs are lodged for only a fraction of residents who enter RACFs. The potential underuse of the program may be a missed opportunity for identifying and resolving medication‐related problems in Australian RACFs. Box – Stacked cumulative incidence function for time to first residential medication management review (RMMR), for first two years of permanent residential care* RACF = residential aged care facility. * For 176 390 residents (in 2799 residential aged facilities) included in the Registry of Senior Australians.8

Janet K Sluggett · J Simon Bell · Catherine Lang · Megan Corlis · Craig Whitehead · Steven L Wesselingh · Maria C Inacio

The use of coronary artery calcium scoring can assist in defining risk in the primary prevention of cardiovascular disease in Australia.

Garry LR Jennings · Ralph Audehm · Warrick Bishop · Clara K Chow · Siaw-Teng Liaw · Danny Liew · Sara M Linton

To the Editor: Improving our understanding of the place of computed tomography (CT) coronary calcium scoring in the assessment of cardiovascular disease risk is critical. However, we disagree with the conclusions in the article by Venkataraman and colleagues1 that the results of their study support the use of CT coronary calcium scoring in individuals with intermediate risk using the Australian cardiovascular disease risk (ACVDR) calculator. Unfortunately, the study has significant flaws in its outcome measures — CT coronary artery calcium scoring and Multi‐Ethnic Study of Atherosclerosis (MESA) — which result in misleading conclusions. The authors examined the predictive power of the ACVDR to detect individuals having a calcium score greater than zero or greater than 100. However, since CT coronary calcium scoring is not a reference standard for cardiovascular disease, this is an invalid outcome for estimating the comparative accuracy of the various cardiovascular disease risk scores. This study also used the MESA risk score as an outcome measure, although this is a risk calculator that has not been validated in the Australian population. As the MESA score was developed to include CT coronary calcium scoring, any risk calculator that also includes this score is likely to appear to perform better than risk calculators that do not. The authors state that their “findings suggest that Australian patients are undertreated by international standards”. The threshold recommended by the current guidelines for cholesterol‐lowering medication in the United States — used by the authors as the international standard — would more than triple the proportion of the Australian population recommended to take medication.2 Primary prevention of cardiovascular disease involves individuals who have not yet had a cardiovascular event, making it particularly incumbent on medical professionals that recommendations consider benefits and harms. The information gained from CT coronary calcium scoring needs to demonstrate that benefits outweigh risks, such as radiation exposure, costs, and incidental findings. Trials to date have shown no improvements in health outcomes. Overall, patients are more likely to be reclassified in a higher risk category, some correctly, but higher absolute numbers may be incorrectly reclassified as high risk.3 Individuals with a calcium score of zero are still at risk of cardiovascular disease, about 0.5% per year. The notion that images seen on CT coronary calcium scoring demonstrate the presence or absence of disease is appealing, but it is a gross simplification.4 While CT coronary calcium scoring may have a place in risk assessment, the findings from this study do not support its use.

Andrew Hayen · Paul P Glasziou · Jenny A Doust

In reply

Prasanna Venkataraman · Thomas H Marwick