Many have written about the dramatic increase in US opioid-related mortality, which increased 345% in 15 years 1, with 47 600 opioid-related deaths reported in 2017 alone 2. These deaths are one of the drivers of reduced life expectancy in the USA 3, a trend rarely seen outside wartime 4. Similar trends in opioid-related mortality have also occurred in Canada 1. While North America has been the region most seriously affected by this crisis, Australia has experienced a near doubling of its rate of opioid overdose deaths in the past 10 years (an increase from 3.8 to 6.6 deaths per 100 000), with 1045 people dying in 2016 5, 6. Rates such as these have not been seen since the record levels observed during the 'heroin glut' of the late 1990s 7. As most deaths are now related to prescribed opioids 5, 6, Australia has begun implementing many strategies to increase the regulation of prescribed opioids, several of which have been implemented in North America—for example, national implementation of prescription drug monitoring programs (PDMP) and requiring a prescription for the low-potency opioid codeine. Furthermore, proposed changes to pack sizes and limiting the indications for which opioids can be prescribed are other measures being considered by the Therapeutic Goods Administration 8. Some of these changes mirror strategies implemented in the USA, such as the rescheduling of hydrocodone 9, and the national implementation of PDMPs 10, although arguably, Australia has introduced these measures earlier into the increase in prescription opioid-related deaths. Such strategies may reduce prescription opioid use and harms, although despite similar restrictions on prescribed opioids, overall opioid-related mortality rates continued to escalate in the USA. Green et al. warn that too much focus on prescribed opioids and their regulation may distract from the crucial task of expanding other evidence-based strategies to address rising mortality 11. It is timely then to consider the role of regulation and the focus on prescribed opioids carefully in light of international experiences 12. Recent US trends in opioid-related mortality have been characterised as reflecting three interrelated opioid crises or 'waves'—an initial increase in prescribed-opioid related mortality followed by increased heroin-related mortality and then an increase in fentanyl-related mortality 13. The initial increase in prescription opioid-related deaths has been attributed to a range of factors. These include concurrent sedative use, the use of long-acting formulations and the use of higher opioid doses 14, combined with changes in clinical practices that may increase opioid prescribing (e.g. pain being considered the '5th vital sign', driving frequent pain assessment and consequent opioid prescribing), increased opioid prescribing for chronic non-cancer pain and, finally, the inappropriate marketing of some opioids as 'safe' or 'non-addictive' by pharmaceutical companies 15. One criticism of the US response was that the initial focus was on young people and their use of diverted pharmaceuticals and did not aim to address medical use as a key contributor 16. Next, a dramatic (five-fold) escalation in heroin-related deaths was observed, from 3036 deaths in 2010 to 15 469 deaths in 2016 17, 18. Some studies suggest a shift from prescribed to illicit opioids was due to heroin being 'cheap', easy to access and being easier to inject compared with pharmaceutical pills 19, coinciding with the introduction of tamper-proof pharmaceutical opioid formulations. However, analyses have not been able to prove causality 20, with complex relationships between illicit and prescribed opioid use identified 12. Furthermore, some reported increases in heroin use and harms occurred prior to many of the regulatory interventions coming into effect 20. Most recently, illicitly manufactured fentanyl and related analogues resulted in more than 28 000 deaths in 2017 alone 2, 19. Fentanyl and analogues are commonly found as contaminants in heroin 21, 22. Consequently, many use fentanyl and analogues unknowingly, and opioids are of unpredictable strength. Importantly, these drugs are highly potent and have a rapid onset of action, creating new challenges for overdose response and harm reduction. The responses to the opioid crisis have varied in the United States and Canada, but the initial responses in both countries have focused on regulating the prescribed opioid supply. PDMPs have been a key response. However, outcomes from PDMPs are mixed. A recent systematic review was unable to determine if PDMPs are associated with increased or decreased harms, with several studies showing increased heroin-related deaths following PDMP implementation 10. In Australia, most states have some level of monitoring, with more comprehensive programs already active in states such as Tasmania, the ACT and Victoria. Current programs do not require mandatory checking at the point of prescription, a feature associated with greater effectiveness 10, although in Victoria, mandatory use by those who prescribe and dispense medicines is intended to begin in 2020. Australia's PDMPs may differ in important ways from the programs initially implemented in the USA, such as through their focus on health rather than law enforcement, yet one key aim is the same, reduced diversion and non-medical use of prescribed opioids. Careful evaluation of the introduction of PDMPs in Australia, alongside any other regulatory strategies, will be critical to understand both intended and unintended outcomes. There are important differences in the opioid landscape between North America and Australia. These include the prevalence of high-potency opioids and the reach of opioid treatment. So far, few signals of illicitly manufactured fentanyl have been identified in Australia 23. Most fentanyl-related deaths in Australia are from diverted pharmaceutical fentanyl 24. Heroin-related deaths in Australia have been relatively stable between 2001 and 2012 5, although most recent data indicate that heroin-related mortality may be on the rise 6. Both of these indicators should be closely monitored in light of the trends observed internationally. Although Australia's treatment reach is greater than that of the USA and Canada 25, supervised dosing requirements with buprenorphine-naloxone treatment in Australia are more restrictive, and current treatment fails to attract many who could benefit. Furthermore, it is estimated that treatment capacity in Australia must double to meet demand 26. Despite changes in recent years that allow greater prescribing of opioid agonists in primary care, primary care providers are reluctant to take on this role 27, meaning that other models of care are needed. Cost and access issues affect all people who seek opioid treatment, and there are clear inequities compared to medications for other chronic conditions. Much evidence clearly demonstrates that opioid agonist treatment is an effective strategy to reduce opioid-related mortality 28, and this supports evidence that expanding treatment availability is critical. Opioid treatment paradigms (in both mode of delivery and funding) remain largely unaltered since the 1980s and fail to meet the needs of the changing populations of people who use opioids. The nature of opioid use and treatment options has changed dramatically in these past decades. The treatment system needs to change with it. It would be prudent to amplify other known and effective evidence-based interventions, including take-home naloxone and supervised injection facilities. Injectable heroin or hydromorphone is available in many parts of the world now, although cost and infrastructure requirements make these programs challenging to bring to scale 29. Low-threshold distribution programs of regulated opioids offer a novel strategy to deliver a safer opioid supply 30. There are proposals for piloting a program of this type in Vancouver (e.g. supply of low-cost pharmaceutical opioids through vending machines), and similar approaches could be considered elsewhere should toxic (i.e. fentanyl-contaminated) opioid supplies emerge 29. In conclusion, not unlike the USA 10 years ago, Australia has a large and growing population of people taking pharmaceutical opioids for medical and non-medical reasons 30, 31. Increased regulation and other strategies to improve evidence-based opioid prescribing are critical to prevent new cases of prescription opioid dependence, but implemented alone, these approaches may have unintended harms and would not be expected to address overdose mortality with other opioids, including heroin. Reduced access to pharmaceutical opioids may lead to greater demand for illicit opioids, and this could inadvertently contribute to an illicit market ripe for higher-potency opioids, the introduction of which has been catastrophic in North America. Much focus has appropriately been placed on the potential impact of regulatory change on people with pain, yet relatively less focus has been placed on how changes may affect other groups of people who use these drugs. We must invest in nationally scaled-up treatment, proactive overdose education and naloxone supply through multiple distribution channels, with continued monitoring for high-potency opioids such as fentanyl in the Australian heroin supply, to enable timely public health responses. Safer opioids should be delivered in ways that are accessible and acceptable to those who may benefit from them. This includes delivering opioid agonist treatment in settings that respond to the legacy population of people dependent on prescribed opioids and considering new paradigms for safer opioid supply for those not attracted to existing treatment options. Mortality from prescription opioids, heroin and illicitly manufactured fentanyl are each important and preventable, and we need a range of responses for each that reflects the complexity of current situation. Now is the time to consider such innovations if Australia wants to position itself to avoid a replication of the North American opioid crisis.
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Nielsen et al. (2019) studied this question.
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