Substance‐related disorders

To the Editor: There is a new player in the treatment of opioid use disorder: extended‐release depot buprenorphine. This has been hailed “a game changer”1 and has proven to be of great benefit, particularly during the current coronavirus disease 2019 (COVID‐19) pandemic. Depot buprenorphine has an impact on presentations to hospital and health services, meaning that all clinicians must be familiar with the advantages and disadvantages (Box) as well as the formulations. Opioid use disorder is a complex, chronic, relapsing health condition that requires lengthy management and is over‐represented in incarcerated people. Opioid treatment successfully reduces illicit use, overdose deaths, and costs. In Australia, there are opioid treatment programs for incarcerated persons, improving individual and community wellbeing and social functioning following release. However, until recently, the treatment perpetuated a daily drug pattern and risks, such as diversion to others, injecting opioid treatments, overdose risks and violent behaviour.2 What changed the game and model of care in Australia is the development of extended‐release depot buprenorphine. The Australian game has two products: one is available as weekly and monthly injection options and the other as a monthly injection. Depot buprenorphine is a subcutaneous injection and must be administered by a health care professional, as inadvertent injection into other structures forms a depot gel that will not provide slow release of the medication and depot gels in a vein may cause serious, life‐threatening health problems.3 Weekly or monthly doses of depot buprenorphine are provided following stabilisation using sublingual buprenorphine, most often for 7 days, and may be started the day after the last daily sublingual buprenorphine. Dose conversion tables exist to match depot buprenorphine to the sublingual buprenorphine dose. Steady state equilibrium is achieved after three to four doses.3 Hospital and health service clinicians must be aware that all buprenorphine formulations complicate routine opioid analgesia for acute pain management, and consideration of other non‐opioid‐adjuvant analgesics is needed (Box).3 Uptake of depot buprenorphine has been welcomed by patients, the community and correctional programs, with many who have transitioned reporting positive outcomes, including reduction in cravings, anxiety, improved attitude, relationships, and general mood.4 The timing of this game changing depot buprenorphine has enabled remote health care and ongoing availability of opioid therapy in the context of the COVID‐19 pandemic.5 Box – Advantages and disadvantages of depot buprenorphine Advantages of depot buprenorphine: it provides greater convenience and does not require attendance for daily dosing it reduces the treatment cost for clients and service providers it has less risk of diversion and non-medical use of the medication it has greater medication adherence and enhanced treatment outcomes it opens opportunities for normal life and to consider employment, study and travel it removes risks related to takeaway opioid treatment doses it reduces stigma and discrimination and has a positive impact on the way that people with opioid use problems are perceived Disadvantages of depot buprenorphine: ul#arrow { position: relative; list-style: none; } ul#arrow li::before { content: '▶ '; position: relative; left: 0; } it complicates routine opioid analgesia in the management of severe acute pain: it may require the use of higher doses of traditional opioids such as morphine; and it may require the use of a mu opioid receptor super agonist such as fentanyl and/or the use of non-opioid analgesic approaches (eg, ketamine infusions or regional analgesia) it provides reduced patient health care, social interactions and support opportunities it results in a loss of control over how the patient manages their dose (especially takeaways)

Katerina Lagios

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

Hester Wilson

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

To the Editor: Fetene and colleagues1 describe refusal to prescribe or dispense prescriptions to some of their study cohort of people who inject drugs (PWIDs) and concern that their mental health treatment needs may not be met due to SafeScript, Victoria’s real time prescription monitoring system. SafeScript is a live electronic database providing information about the prescribing and dispensing of monitored medicines to each patient, instantly available in real time on a prescriber’s or pharmacist’s desktop (https://www2.health.vic.gov.au/safescript). SafeScript alerts prescribers and pharmacists to the risk of uncoordinated treatment by multiple providers or to the overdose risk of drug–drug interactions. Prescribers and pharmacists may have responded appropriately by offering more effective treatments instead of providing a continued supply of the medication. For instance, benzodiazepines are not recommended for first line or prolonged treatment of anxiety. Many people who misuse drugs have comorbid mental health disorders and need medical support. SafeScript is helping to identify this group of at‐risk patients so they can receive the appropriate medical treatment they require. SafeScript provides a clinical decision support system for prescribers and pharmacists, enabling more informed decisions for safer prescribing or dispensing of high risk monitored medicines. By providing proactive alerts, strong real time prescription monitoring systems, such as SafeScript, reduce overdose deaths from prescription opioids2 and decrease the number of opioid prescriptions, diversion, and opioid‐related morbidity and substance use disorder outcomes.3 Since the rollout of SafeScript, the number of multiple provider episodes and the average morphine equivalent dose have both been trending gradually but consistently downwards. SafeScript was designed with the lessons learnt from the United States. The implementation of this system included several measures to encourage and support a professional response for high risk patients, such as podcasts and face to face and online training, in which more than 4500 prescribers and pharmacists have participated. Furthermore, the SafeScript implementation included upgrading the Drug and Alcohol Clinical Advisory Service, providing trained general practitioner clinical advisors to offer peer support, a consumer pharmaceutical helpline, and increased funding to support professionals and consumers manage benzodiazepine problems. In addition, $273.1 million were invested in drug treatment, support and harm reduction services in 2019–2020,4 representing a 65% increase in investment through the last five Victorian state budgets. This new initiative helps prescribers and pharmacists provide the appropriate clinical care and professional response needed by high risk patients.

Malcolm Dobbin

Posts can provide valuable feedback during public consultation for health guidelines

Benjamin C Riordan · Daniel T Winter · Paul S Haber · Carolyn A Day · Kirsten C Morley

Current calls for primary care‐based screening and brief interventions for alcohol use should be reviewed Alcohol continues to contribute to significant morbidity and mortality in the Australian community. It is responsible for 4.5% of total disease burden,1 and 4186 deaths in 20172 and over 144 000 hospitalisations per year.3 While levels of alcohol consumption are slowly declining, alcohol continues to be a major preventable contributor to disease and death among Australians. Currently, over 25% of Australians report consuming alcohol at moderate or high risk levels.4 Over the past 20 years, there has been considerable research into the value of alcohol screening, brief intervention and referral for treatment (SBIRT) in primary health care as a public health measure to reduce alcohol consumption and related harms. The Alcohol Use Disorder Identification Test (AUDIT)5 was developed to assist with widespread standardised implementation of screening, and brief intervention for alcohol use disorder and has been extensively researched. More recently, the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)6 was developed to address a broad range of substances. There is good evidence based on numerous randomised controlled trials that brief interventions for alcohol use result in reductions in drinking which are at least sustained for 12 months.7 However, the actual size of the reduction in drinking has been revised down from 2007 when it was estimated that SBIRT would result in a reduction of alcohol intake by 57 g (nearly six standard drinks) per week,8 to 20 g (two standard drinks) per week.7 This reduction in effect size will inevitably affect estimates in cost‐effectiveness models. While overall average consumption has reduced, at least based on self‐report, SBIRT has been found to have little effect on frequency of binge drinking, numbers of drinking days per week, and intensity of drinking.7 It is therefore likely to have little effect on adverse events from intoxication, the major cause of harm for younger people. Despite strong evidence that SBIRT will result in self‐reported reduced drinking (albeit less reduction than previously thought), there have been problems with real‐world translation into practice, both on a large scale multi‐practice level9,10 and a national basis as demonstrated in Scotland.11 In terms of demonstrated effects on alcohol consumption at a population level, the most extensive program implemented so far has been Scotland’s Alcohol Strategy.11 This program aimed to deliver SBIRT across the entire primary care, emergency department and antenatal populations and was part of a suite of measures to address alcohol‐related harms in Scotland. Other measures included prohibition of multi‐buy discounting (eg, “buy five, get one free”), minimum unit pricing (unsuccessfully challenged by the Scottish Whisky Association in the Scottish Supreme Court and now being implemented), tightening of liquor licencing processes, and a tripling of investment in treatment and support services. Subsequent measures of alcohol consumption across Scotland, Wales and England have not demonstrated any significant differences in the trajectories of alcohol consumption between these countries. Consumption has decreased in all three countries.11 Although 43% of hazardous and harmful drinkers were screened in Scotland and received brief interventions, data on exactly who was screened were difficult to collect, and screening among women attending antenatal care was only partially implemented.11 Young people were difficult to access, probably due to lower health service attendance rates. Furthermore, a 2018 Cochrane review7 found that research into the effects of SBIRT on alcohol‐related harms, the end point of most importance, has been very limited, and was unable to reach a conclusion regarding the effect of SBIRT on alcohol‐related harms. The studies that have looked at this important issue found that there was no effect.7 In addition, recent research has cast doubt on the effectiveness of referral to treatment among the higher risk (mostly dependent) drinkers. Frost and colleagues12 reviewed the effects of brief interventions on rates of referral. They found that patients at high risk who had received a brief intervention actually had less contact with specialist addiction services in the year following the brief intervention compared with those who had not received the brief intervention. Despite these concerns regarding effectiveness in real‐world settings, SBIRT has been recommended over the past decade in Australia by the 2009 National Preventative Health Strategy,13 and by the National Alcohol Strategy in 2019.14 Significant investment in structurally supporting SBIRT in primary care or other settings has not been forthcoming from Commonwealth or state governments. Currently in Australia, we have a situation where the Australian National Alcohol Strategy advocates for the adoption of SBIRT. This is despite a lack of evidence that it is effective in reducing harms even in research settings, as well as a lack of evidence for its effect on reducing population levels of drinking, and evidence that it does not result in increased engagement in specialist treatment even in well resourced health systems which have identified this as a target area. However, despite the current evidence that population‐based screening does not seem to have an effect on overall alcohol consumption, there is no denying the clinical value of addressing unhealthy alcohol consumption when identified in primary care. The AUDIT and the ASSIST both explore relevant key areas such as frequency of use, harms and dependence, which are important for the clinician and the patient to understand and address. They enable the clinician and patient to determine the risks associated with the patient’s current drinking patterns, and to start a conversation which then enables an agreed response. They should still be promoted as tools to use when a patient has been identified as drinking excessively through normal clinical processes. Despite current levels of alcohol‐related morbidity, the general practice environment does not support general practitioners responding to the problem. Longer consultations are insufficiently remunerated, skills development has been suboptimal, and secondary and tertiary services are not readily available when and where required. SBIRT alone will not address the current levels of alcohol use in Australia and associated harms. There should be increased emphasis on development of the skills base of the medical workforce at student, general practice and other specialty training levels so that clinicians can respond to hazardous and harmful alcohol and substance use effectively. Tools such as the AUDIT and the ASSIST may well have a role here. Use of current GP Medicare items such as mental health care plans, chronic disease management plans and team care arrangements should be encouraged and facilitated to better support complex care for patients with problems relating to alcohol and substance use. In addition, addiction services should work with general practice to streamline access to advice and referrals and improve communication channels. At the same time, policy changes to reduce alcohol‐related harms should continue to be pursued. Medical bodies including the Australian Medical Association and the Australian colleges representing physicians, GPs, surgeons, psychiatrists and emergency physicians have advocated strongly for such changes regarding alcohol, but despite this advocacy, most of the Australian community has not felt the need for major change. In general, policy change will only occur in response to community concern. The 2019 National Drug Strategy Household Survey indicated that the Australian community continues to identify methamphetamine as the drug of most concern, above alcohol. In addition, support continues to decline for reducing trading hours for pubs and clubs and increasing the minimum drinking age, as well as for all other evidence‐based measures aimed at reducing the harms nominated in the survey.4 It appears that the Australian community currently least supports the harm reduction strategies with the strongest evidence, but on the other hand supports the strategies with the least evidence. If there were more community support, other policy changes could include reviews of pricing of alcohol and packaged liquor outlet density, further regulation of advertising of alcohol, and further changes to drink driving laws. These might include requiring a zero blood alcohol level for broader groups of drivers such as all younger drivers (ie, under 25 years of age) and drivers with previous drink driving convictions. There should be a renewed emphasis on alcohol as a significant driver of morbidity and mortality at three levels: on the clinical level, renewed emphasis on education and training for medical practitioners to enable clinicians to better respond to people drinking harmfully; on the health care structural level, changing remuneration arrangements to better support primary care treatment for people with alcohol‐related problems should be advocated for; and in parallel with these changes, increased advocacy for changes to policies that reduce drinking and related harms on a population level, with particular emphasis on high risk populations. Health professionals are generally not trained as advocates. Bringing about change, even when supported by sound evidence, is difficult and takes time. Vested interests have sophisticated advocacy skills and are well resourced. Opportunities for the development of advocacy skills at medical student and postgraduate levels should be developed and promoted. Australia remains a world leader in tobacco control. The health professions should join forces, building on the lessons from tobacco control, to change the way the Australian community views alcohol, and then lead changes in clinical practice and policy which will reduce alcohol‐related harms.

Chris B Holmwood

To the Editor: The coronavirus disease 2019 (COVID‐19) pandemic has raised multiple health challenges for Australian society. In addition to the direct impacts of infection, there will be broader health impacts caused by physical and social distancing and the collapse in economic activity leading to the loss of employment and income. Interventions by the federal government, including JobKeeper, increased JobSeeker payments, the introduction of telehealth, and increased mental health spending, have made an important initial contribution to addressing the health impacts for individuals, families, and communities.1,2 A by‐product of these interventions, however, has been a rapid increase in government debt.3 We are now seeing increased calls to enact austerity policies. Such policies prioritise rapid reductions in government debt usually through cuts to health and social services. These calls should cause concern. Economic crises can damage mental health, increase the misuse of alcohol and other drugs, and increase suicidal behaviour.4 Austerity policies are likely to worsen these effects.4 Such concerns are illustrated by the effects of austerity policies in Europe and the United Kingdom made in response to the global financial crisis, which had serious health‐related consequences.5 For example, a study on the impact of austerity measures on health reported that austerity policies were implicated in worsening mental health, increased suicide rates, heightened mortality in older age groups, and greater unmet health care needs.6 Indeed, despite relatively progressive government interventions during the global financial crisis in Australia, we still had a rise in suicide rates among employed and unemployed Australians.7 If enacted in Australia, austerity policies have the potential to lead to health‐damaging effects. It is important not to compound the health impacts of the pandemic with austerity programs focused on short term reductions in government debt. Health and social services are critical buffers against economic shocks,8 and austerity is likely to undermine these buffers. Policies that prioritise economic and social supports as well as increasing access to care are likely to reduce the health impacts of economic crises.4 In particular, European countries that invested most in social protections during the global financial crisis suffered the least harms to their populations’ wellbeing.5,6 It is also crucial to recognise that austerity policies are a choice. There are alternatives for managing high levels of government debt to cutting public spending on services,6 and austerity policies are not widely endorsed by economists.9 Government spending on health, education, and social supports has the potential to increase economic growth.10 Taking a longer term view and avoiding austerity measures will better serve the health of Australia’s population, and indeed the health of the nation.

Shane A Kavanagh · Anthony D LaMontagne · Sharon Brennan‐Olsen

To the Editor: Australia's social distancing policies to contain the spread of coronavirus disease 2019 (COVID‐19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2), have had social consequences. Social distancing and school disruptions have increased parental responsibilities. There has also been an increased opportunity for parents to use alcohol to cope with increased stress.1 Parents, especially mothers, have taken to social media to share “memes” about needing a drink to survive staying at home (Box). These posts are mostly shared with the aim of creating an online environment for peer support and stress relief, but they risk normalising the use of alcohol as a coping strategy and promoting the false belief that alcohol is good for mental health.2 Alcohol is a central nervous system depressant that may relieve stress in the short term, but regular drinking increases psychological distress and the risk of alcohol‐related harm.3 A review of recent advertising complaints indicated that some alcohol advertisers have been quick to capitalise on COVID‐19.4 An investigation of a social media account found an average of one alcohol advertisement every 35 seconds, with themes of easy access without leaving home (58%), buy more (35%), drink during COVID‐19 (24%), and drink to cope (16%).5 Australia has a regulation system for alcohol advertising, which most people mistakenly believe is government‐funded.6 It is in fact an industry‐funded quasi‐regulatory system that is activated by consumer complaints and lacks systematic independent monitoring.7 Further, regulations do not prevent certain social media platforms from being used by alcohol brands to post advertisements and engage with consumers.8 In light of the alcohol industry's opportunistic advertising through social media, it is questionable how well Australia's regulatory system protects parents and other targeted populations at risk from exposure to constant encouragements to drink during these challenging times. Box – Examples of parental drinking‐related memes during the coronavirus disease 2019 (COVID‐19) lockdown

Janni Leung · Jason Connor · Leanne Hides · Wayne D Hall

To the Editor: Harms related to the inappropriate use of prescription drugs include fatal and non‐fatal overdose and are a significant public health concern in Australia.1 In response, Victoria recently introduced SafeScript (https://www2.health.vic.gov.au/safescript) — a system similar to the widely implemented real time prescription monitoring (RTPM) systems in the United States.2 The Victorian RTPM system is designed to help health professionals make safer decisions when supplying high risk medicines.3 RTPM systems have been associated with unintended consequences, such as a transition from pharmaceutical opioid use to illicit opioid use, which has been associated with an increased risk of overdose and spread of blood‐borne viruses.2,4 Indeed, a 2019 American study suggests that lowering prescription opioid supply through initiatives such as RTPM use will only have a modest effect on opioid‐related deaths, unless supported with a multipronged approach including increased access to pharmacotherapy and harm‐reduction services.5 In Victoria, the implementation of an RTPM system may be of more benefit than seen in the US since these services are widely available. We have begun to explore effects of the introduction of SafeScript through analysis of data collected through the Burnet Institute's SuperMIX study — a prospective cohort study of about 1300 people who inject drugs (https://www.burnet.edu.au/projects/89_supermix_the_melbourne_injecting_drug_user_cohort_study). We introduced questions related to RTPM use in March 2019, with a total of 387 interviews conducted since the implementation of SafeScript in Victoria. We found that 20% of participants (48/242) who used a medicine monitored by SafeScript reported being refused a prescription by a general practitioner. One‐third (16/44) of those who have been refused were requesting the prescriptions for the treatment of anxiety and 45% were refused two or more times by doctors. Three per cent of participants (8/245) reported having a prescription they had already been receiving withdrawn. In addition, six out of 241 participants were refused dispensing of a prescribed medicine by a pharmacist. One‐third of participants (15/47) who had been refused a prescription were told this was due to a risky combination of medicines or having multiple providers. A third of participants (14/45) who had been refused a prescription reported an intention to not seek medication from their doctors in the future. Most had moderate to severe anxiety (33/41) and depression (36/41) disorders measured through a self‐administered Patient Health Questionnaire (PHQ). In the case of refused prescriptions requested for the treatment of anxiety, ten out of 13 patients had moderate to severe anxiety disorder and 11/13 patients had severe depression disorder, suggesting unmet treatment needs in patients denied prescriptions. RTPM systems such as SafeScript may help prevent the inappropriate use of prescription medications. Our initial analysis provides early insights on the impacts of SafeScript on this cohort, indicating careful implementation is required, particularly for people who inject drugs living with concurrent mental illnesses. The use of RTPM systems may reduce medicine‐related harm if integrated mental health and drug treatment services are adequate. It is not clear whether this is the case in Victoria. It is important to understand what happens when people are refused prescriptions — what care they receive and whether this care is appropriate for their needs. Increased mortality following restrictions to prescribed medicines is reported elsewhere.2 Rigorous research should evaluate the impact of RTPM use in Australia to understand if similar outcomes are observed.

Dagnachew M Fetene · Peter Higgs · Suzanne Nielsen · Filip Djordjevic · Paul Dietze

The negative impact of cannabis use by pregnant women is independent of tobacco use

Luke E Grzeskowiak · Jessica A Grieger · Prabha Andraweera · Emma J Knight · Shalem Leemaqz · Lucilla Poston · Lesley McCowan · Louise Kenny · Jenny Myers · James J Walker · Gustaaf A Dekker · Claire T Roberts

To the Editor: Rising obesity rates in high income countries have resulted in a growing demand for weight‐loss products.1 Unfortunately, drugs that increase energy expenditure often have severe adverse effects. 2,4‐Dinitrophenol (DNP) uncouples oxidative phosphorylation, inducing a hyper‐metabolic state. It was first used for weight loss in the 1930s but was banned due to deaths.2 It has recently had a resurgence in popularity in the body building/body sculpting arena as a “fat burner” and “pre‐event shredder”, and is available online and as an undeclared ingredient in supplements.1 DNP was up‐scheduled in Australia in 2017 to Schedule 10 (“substances of such danger to health as to warrant prohibition of sale, supply and use”).3 We used data from the New South Wales Poisons Information Centre (NSWPIC) and the National Coronial Information System (NCIS) to evaluate effects of up‐scheduling. Ethics approval was granted from the Sydney Children's Hospitals Network (LNR/16/SCHN/44) and from the Victorian Department of Justice (CF/15/18367) human research ethics committees. There were 24 DNP exposures reported to NSWPIC between 2004 and 2018, with an increasing trend (Box). Most patients (71%, n = 17) were male, 83% (n = 20) were adults aged 20–74 years, and 92% (n = 22) were in hospital or were referred to hospital by NSWPIC. The NSWPIC database showed one death — an adult man who had a cardiac arrest after taking four DNP capsules — and NCIS recorded three more deaths from DNP. All deaths occurred since 2015, with two occurring since the 2017 rescheduling. Despite up‐scheduling, we have identified rapidly increasing harms from DNP, which suggest a resurgence of DNP use. Increasing use and deaths have also been reported in the United Kingdom4 and the United States.5 This highlights the need for urgent action by state and federal law enforcement agencies and awareness campaigns targeting high risk groups. It is important to note that the Therapeutic Goods Administration makes scheduling changes but does not enforce non‐medicinal product restrictions, which is the role of police and Fair Trading. It is likely that DNP is frequently obtained online and often disguised for shipping (eg, labelled as turmeric), thus complicating detection.1 Increased incoming mail screening and awareness and education at gyms may be an option to restrain the use of DNP. Medical practitioners should warn patients of the dangers of illicit weight‐loss supplements. Box – Time trends in 2,4‐dinitrophenol exposures reported to the New South Wales Poisons Information Centre (NSWPIC) in 2004–2018. Up‐scheduling to Schedule 10 was announced in September 2016 and implemented in February 2017. The timing of deaths is censored due to low numbers; however, all deaths occurred since 2015, including two since the 2017 scheduling

Rose Cairns · Jacques Raubenheimer · Jared A Brown · Kylie McArdle · Nicholas A Buckley

To the Editor: We welcome the recent article by Secombe and colleagues1 highlighting the impact of alcohol policy reforms in the Northern Territory, namely the influence of the minimum floor price on critical care admissions.1 We agree that the social costs and harms of alcohol in the NT are too high,2 and are reassured by the improved health outcomes associated with the implementation of emerging alcohol policies.3,4 There have been, however, other notable alcohol and social policy investments in the NT, including the introduction of Police Auxiliary Liquor Inspectors (PALIs). PALIs are uniformed inspectors, stationed at takeaway alcohol outlets, who seek to prevent the consumption of alcohol in restricted areas. These areas include all land defined as Aboriginal land as per the Aboriginal Land Rights (NT) Act 1976,5 within 2 km of a licensed venue, and in certain regulated public and private areas. PALIs ascertain where individuals purchasing alcohol will be consuming their purchase by requesting a form of identification, alongside questions regarding intended drinking location. If a valid (non‐restricted) address cannot be provided, purchase is not permitted. The first squad of PALIs graduated on 20 August 2018. As noted by Secombe and colleagues, the minimum floor price was introduced on 1 October 2018. Considering the time of implementation of both policies, it is imperative that we better understand the intersection between PALIs, the minimum floor price and other alcohol policy initiatives, such as the Banned Drinker Register.6 The recent analysis by Secombe et al provides a partial snapshot of the impacts of a highly complex public health issue. Given that a suite of alcohol policies has been introduced by the NT Government to combat alcohol‐related harms,6 a more sophisticated evaluation approach is required to understand these relationships. This means a broader range of data sources need to be used to evaluate the impacts of alcohol policies in the NT. This should include health, police, corrections, domestic violence, child protection, and education data. Furthermore, to advance comprehensive understandings of these alcohol reforms, it is also imperative to include qualitative approaches that explain how and why different alcohol policies work.

Sarah C Clifford · Kalinda E Griffiths · James A Smith

Upscheduling has not led to substitution with higher strength analgesics, and has reduced the misuse of codeine- containing preparations

Malcolm D Dobbin

An effective approach can only be achieved by a national strategy for averting opioid-related deaths

Nicholas Lintzeris

Objective: To investigate changes in sales to pharmacies of over‐the‐counter (OTC) and prescription analgesics, cold and flu products, and cough suppressants after the rescheduling of codeine as a prescription only medicine in February 2018. Design: Interrupted time series analysis of sales to pharmacies. Setting: Pharmaceutical sales to community pharmacies in Australia, March 2015 – March 2019. The period January 2017 (month after rescheduling was announced) to January 2018 (month before rescheduling was implemented) was excluded from the time series analysis. Main outcome measures: Monthly pack and tablet sales per 10 000 population of OTC and prescription analgesics, cold and flu products, and cough suppressants. Results: During 2016, 7586 packs and 248 127 tablets of OTC codeine per 10 000 population were sold to pharmacies; in the 14 months after rescheduling, a small level increase in monthly prescription codeine sales was evident (2247 tablets/capsules per 10 000 population; 95% CI, 1231–3264 per 10 000 population). Monthly OTC analgesic sales increased by 258 (95% CI, 151–365) packs per 10 000 population and 37 856 (95% CI, 26 143–49 569) tablet/capsules per 10 000 population. Monthly sales of single ingredient paracetamol (41 415 [95% CI, 31 374–51 456] tablets/capsules per 10 000 population), ibuprofen (1392 [95% CI 916–1868] tablets/capsules per 10 000 population), paracetamol/ibuprofen (1618 tablets [95% CI, 1567–1669] tablets/capsules per 10 000 population), and other paracetamol combinations (233 [95% CI, 112–353] tablets/capsules per 10 000 population) all increased, but not those of prescription analgesic products not containing codeine. Rises for OTC cold/flu products containing the opioid derivative dextromethorphan were small; sales of OTC cough suppressants containing opioid derivatives (dextromethorphan, pholcodine, dihydrocodeine) did not change. Conclusions: The rescheduling of codeine was followed by increased sales to pharmacies of paracetamol, ibuprofen, and paracetamol combination products. While these products carry no risk of dependence, their inappropriate use is also associated with harms that warrant adverse event monitoring.

Andrea L Schaffer · Rose Cairns · Jared A Brown · Natasa Gisev · Nicholas A Buckley · Sallie‐Anne Pearson

Objectives: To characterise the community pharmacy supply of naloxone by supply type — individual prescription, prescriber bag, and non‐dispensed (supplied over the counter or expired) — during 2014–2018; to examine whether the 2016 rescheduling of naloxone as an over‐the‐counter drug influenced non‐dispensed naloxone supply volume. Design, setting: Analysis of monthly naloxone prescriptions (Pharmaceutical Benefits Scheme) and sales data (IQVIA), 2014–2018, for Australia and by state and territory; time series analysis of non‐dispensed naloxone supply to assess effect of rescheduling on naloxone supply. Major outcomes: Total naloxone supply to community pharmacies; prescribed and non‐dispensed naloxone supply. Results: During 2014–2018, 372 351 400 μg units of naloxone were sold to community pharmacies: non‐dispensed naloxone accounted for 205 866.5 units (55.3%), prescriber bags for 155 841 units (41.8%), and individual prescriptions for 10 643.5 units (2.9%). Population‐adjusted national naloxone sales to community pharmacies increased between 2014 and 2018 (per year: incidence rate ratio [IRR], 1.15; 95% CI, 1.09–2.22). This increase was primarily attributable to increased volumes of prescriber bag naloxone (IRR, 1.63; 95% CI, 1.50–1.78) and, to a lesser extent, increased individual prescription supply (IRR, 2.04; 95% CI, 1.85–2.26). Non‐dispensed naloxone supply volume was unchanged at the national level (IRR, 0.93; 95% CI, 0.85–1.01); changes in non‐dispensed supply immediately following rescheduling and subsequently were not statistically significant in time series analyses for most jurisdictions. Conclusions: Total naloxone supply to community pharmacies in Australia increased between 2014 and 2018, but rescheduling that enabled over‐the‐counter access did not significantly influence the volume of non‐dispensed naloxone.

Wai Chung Tse · Paul Sanfilippo · Tina Lam · Paul Dietze · Suzanne Nielsen

The evidence from real world implementation is compelling

Mike Daube · Julia Stafford

To the Editor: In their Perspective article, Mitchell and colleagues1 discuss the problems for patients resulting from overcautious attitudes in prescribing opioids within the constraints of the doctrine of double effect. In doing so, they also highlight how problems may be compounded by the inappropriate use of language in respect to voluntary assisted dying. Victoria has passed and is now implementing the Voluntary Assisted Dying Act 2017, not “assisted suicide” legislation. Like so much of the language we use, there are underlying, negative connotations to certain words. The use of the term “suicide” in the context of a person living with a terminal or serious and incurable condition that can only be relieved through death conflates two very different realities. One is the understandable or rational desire to avoid the trajectory of escalating suffering at the end of life, while the other is the tragedy of suicide resulting from social, financial or mental health conditions that culminate in feelings of abjection and of hopelessness towards the future. The focus of the authors of this article is both positive and welcome; assuring practitioners that they can adopt a proactive and patient‐centred approach towards pain relief. However, the use of language in this instance is unfortunate, as it has often been employed cynically to undermine the iterations of voluntary assisted dying Bills across Australia. Other common documented examples are referring to voluntary assisted dying as killing, murder, or state‐sanctioned murder — actions involving violence and malicious intent. Voluntary assisted dying is a managed and documented pathway embarked on by a person with decision making capacity to achieve a peaceful death on their own terms. Suicide, on the contrary, is a tragedy, usually undertaken alone as a violent and desperate act, including by people who have no legal recourse to voluntary assisted dying. It leaves a legacy of complicated grief for loved ones. Language is important. Without careful reflection, it can easily be used to subvert good intentions, including legal reforms. It can thereby thwart the will of the people — a perfect storm indeed.

Julia M Anaf

Introducing the floor price was followed by a significant reduction in ICU admissions associated with acute alcohol misuse

Paul J Secombe · Penny Stewart · Alex Brown · Michael J Bailey · David Pilcher

The decline in codeine-related presentations was not associated with a rise in alternative opioid-related presentations

Keith Harris · Andrew Jiang · Robert Knoeckel · Katherine Z Isoardi

Should doctors fear legal sanction for using opioids at the end of life?

Geoffrey K Mitchell · Lindy Willmott · Ben P White · Donella Piper · David C Currow · Patsy M Yates