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Prescription opioids – understanding recent changes to Australian regulations

  • a lack of evidence of increased benefit for pain or cough relief over similar medicines not containing codeine
  • marked variability in its transformation to morphine in individuals, with the potential for severe toxicity in very rapid metabolisers
  • widespread inappropriate use to treat chronic pain
  • increasingly common extra-medical use in Australia and internationally
  • misuse of OTC codeine products resulting in deaths from hepatic injury, gastrointestinal perforations and respiratory depression.

The TGA’s rescheduling of codeine is part of a long-term trend of restricting the availability of opioids, which were once incorporated in a vast array of medicines and used with little or no supervision. Nevertheless, many other opioid drugs continue to be used legally and illegally worldwide. In this article, we take a look at the major opioid drugs and how they are used and regulated in Australia.


What are opioids?

Opioids are chemicals derived from opium poppies or that approximate the chemical structures of opiates. They mimic the body’s natural endorphins, such as those released by the pituitary gland after vigorous exercise, producing feelings of euphoria and physical wellbeing. Undesirable side effects include tolerance and dependence; depression of the central nervous system, which can lead to overdose; and constipation. Opioids are widely used in pain management.
  • opiates – drugs naturally derived from the opium poppy, such as codeine and heroin
  • semi-synthetic opiates – such as hydromorphone and oxycodone
  • synthetic opioids – such as fentanyl and methadone.

A brief history of opioid drugs

The first opioid was opium, a naturally occurring compound harvested from opium poppies that produces euphoria, pain relief and sedation in humans. The Sumerians were using opium for its euphoric effects nearly 5000 years ago in religious and mystic rituals. Egyptian records describe opium being used for ‘medical’ purposes such as to calm crying children and euthanasia.
By the early 18th century, opium smoking had become popular among wealthy Chinese, and subsequently among the general populace. Emperor Yung-cheng’s prohibition of the sale and smoking of opium, and then of opium importation and cultivation, had little effect. Western nations, primarily Great Britain, began cultivating opium (in India and elsewhere) and exporting it to China, against the wishes of the Chinese authorities, to offset large trade imbalances. Two subsequent Opium Wars (1839–42 and 1856–60) resulted in the legalisation of the trade and entrenchment of opium addiction throughout China, which continued to be a major health problem until the Communists seized power in 1949.
The appalling wounds and chronic pain experienced by combatants in the two world wars spurred the development of new opioid approaches to pain management. Methadone, a compound with pharmacological properties similar to those of morphine, was synthesised in 1946. Oxycodone became widely available in the 1950s, and in the 1990s was released with a new formulation (extended-release technology), permitting more controlled use. Morphine, fentanyl and hydromorphone were similarly reformulated, but diversion and illicit use of all these opioids continued.

Opioid production

Heroin continues to be the major illicit opioid in use worldwide. Heroin supply fluctuates with the fortunes of the Taliban in Afghanistan – the world’s single-largest producer of opium. The ‘Golden Triangle’, which spans remote parts of Myanmar, Thailand and Laos, remains a major illicit opium-producing region, and Mexico, Colombia and Pakistan are substantial contributors.
Australia (specifically, Tasmania), Spain, France, Turkey, Hungary and India (in descending order) are the world’s major producers of licit opiates for medical and scientific use. In 2017, Australia’s output of ‘opiate raw materials rich in morphine’ was expected to be the largest fraction (22 per cent) of licit global production.

Prescription opioids

As already noted, numerous opioid drugs are available in Australia and internationally on prescription, for multiple purposes. An estimated 2.9 million Australians were prescribed an opioid in 2014.

Pain relief

Opioids are highly effective in relieving acute pain and pain associated with cancer, and in palliative care. According to the Australian Commission on Safety and Quality in Health Care’s Australian Atlas of Healthcare Variation, in 2013–14 nearly 14 million opioid prescriptions were dispensed in Australia. However, current evidence does not support the long-term efficacy and safety of opioid therapy for chronic non-cancer pain.

Surgical uses

Research shows wide variation in the types and volumes of opioids prescribed to patients following common surgical procedures; in many cases excess pills are prescribed. These over-prescribed opioids are often diverted to the illicit market, where they fetch high prices. Alternatively, surgical patients continue to take opioids until well after the original need for pain relief has subsided, risking dependence, overdose and other health harms.

Opioid pharmacotherapy

Opioid pharmacotherapy treatment involves replacing an opioid drug of dependence with a legally obtained, long-lasting, orally administered opioid preparation. Oral administration has several advantages:
  • elimination of the risks of blood-borne virus transmission associated with injecting
  • reduction in the risk of opioid overdose through a quality controlled and precise dose
  • replacement of heroin, with a street value of $220 per gram in 2016 (about four times the price of gold).
In Australia, three medications are registered for long-term maintenance treatment for opioid-dependent people: methadone, buprenorphine and buprenorphine-naloxone. These pharmacotherapies reduce withdrawal symptoms, the desire to take opioids and the euphoric effect of taking opioids. Treatment with these drugs is administered according to the law of the relevant state or territory, and with medical, social and psychological support.

Opioid use and harm

Illicit opioids

In 2013, it was estimated that about 460 000 Australians aged over 14 years (2.4 per cent of the population) had ever used opioids including heroin, methadone or buprenorphine, morphine and oxycodone for non-medical reasons over their lifetime. An estimated 230 000 (1.2 per cent) had used heroin. According to the National Drug Strategy Household Survey 2016, 0.2 per cent of Australians aged over 14 years (approximately 40 000 people) had used heroin in the preceding 12 months. Using other methods, researchers estimated that 68 000 to 118 000 Australians aged 15–64 years had injected drugs in 2014, at least half of whom were heroin injectors.

Pharmaceutical opioids

Research released in 2017 showed that pharmaceutical drugs are now implicated in more than two-thirds of all accidental deaths associated with opioids. The rate of such deaths has more than doubled among Australians aged 35 to 44 years since 2007. In 2013, some 597 Australians aged between 15 and 54 years died from accidental opioid overdose. Initial data for 2014 and 2015 indicate that the numbers of accidental opioid deaths are continuing to rise.
Amanda Roxburgh, a senior researcher at the University of New South Wales, reported in 2017 that ‘the opioid-related deaths we are seeing today are showing very different patterns to what we saw at the peak of the heroin epidemic in the late 1990s and early 2000s. The vast majority of deaths involve prescription opioids rather than heroin, including strong painkillers such as oxycodone and fentanyl, and are among older Australians in their 30s, 40s and 50s. By contrast, the rate of death among very young Australians aged 15–24 are low and among those aged 24–35 they are declining.’
In the past, opioids were used to treat cancer patients in hospitals for pain relief, but in recent decades their use has become mainstream. A patient might leave hospital with a few weeks’ supply of twice-daily tablets, but ongoing pain and increasing tolerance can prompt people to escalate their intake and demand subsequent prescriptions. ‘There’s good research showing there’s been a four-fold increase in the prescribing of these drugs between 1990 and 2014, particularly for Oxycontin, Tramadol and fentanyl’, said Ms Roxburgh.
In July 2017, in response to concerns about misuse of prescription opioids and other medicines, the Australian government announced that it would invest $16 million to monitor the prescription of opioids nationally. Once established, the system – known as Safescript – will alert pharmacists and doctors if patients receive multiple supplies of prescription-only medicines.

Opioid management in western Victoria

The Australian Commission on Safety and Quality in Health Care recently revealed that general practitioners (GPs) in parts of rural Victoria were found to be prescribing opioids in quantities three times greater than their metropolitan counterparts.
In an interview on ABC Radio, Dr Malcolm Hogg, head of Pain Services at the Royal Melbourne Hospital, said ‘It would appear on the data alone that there is a higher number of prescriptions and there is a higher dose per head of population in the rural areas. Isolated GPs may not have access to interventions or physiotherapists or psychologists, and so they have a greater reliance on medications to manage pain.’
When asked about the likely response to OTC codeine preparations becoming prescription-only, Dr Hogg said there was a risk regional GPs would simply transfer patients onto prescription codeine rather than performing comprehensive assessments. ‘We need to recognise that pain and persistent pain has a significant impact on psychological and social functioning,’ he said. ‘There would be great benefits to society if we better manage that.’
Hamilton GP Dale Ford has been grappling with how to best help patients with chronic pain. ‘We were commonly seeing people who had rather complex pain issues where they’d probably seen one or two specialists, a diagnosis had been made but [there was] no particular plan on how their pain and their life generally was going to be managed. I found myself in a position where it looked as though opioid prescribing was the only answer.’
Interviewed for the Geelong Advertiser in early January 2018, Dr Michael Vagg, a director at Pain Matrix in Geelong, said ‘there is an awful lot of codeine use in the country … we are hearing reports about people who are very worried about (the change) and who have begun stockpiling codeine.’ Geelong pharmacist and Pharmacy Guild of Australia representative Nader Mitri confirmed this concern, adding that people who use codeine should visit their GP and pharmacist to discuss treatment for their pain.

Conclusions

On 21 January 2018, the TGA issued a discussion paper on the use and misuse of strong opioids such as oxycodone and whether specific regulatory responses were needed. This, and the data presented above, suggests that making codeine prescription-only is unlikely to be the last action the TGA takes to restrict opioid drug availability. The Safescript monitoring system will provide further evidence about patterns and trends in prescription opioid use to guide the TGA’s decision-making.
  • About the author: Campbell Aitken
  • Dr Campbell Aitken is a freelance editor and a senior research fellow at the Burnet Institute.

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