Making regulatory changes for opioids in Australia is no quick fix when it comes to helping save more lives and better manage pain. Doctors Ben O’Mara and Megan Weier explain what changes work best.
Earlier this month, the Australian government made changes to rules of the Pharmaceutical Benefits Scheme (PBS), increasing restrictions on the use of codeine, morphine, oxycodone, fentanyl and other opioid-based prescription medications.
The restrictions include smaller opioid pack sizes, and doctors and other prescribers needing to complete more procedures in order to prescribe the drugs. Opioids that are generally only available with a prescription and used by many people for relief from severe pain are now harder to access.
The changes are, of course, understandable. Research finds that opioids are associated with increased rates of dependency, hospitalisations, overdose and, sadly, death, here in Australia, and across the world. More restrictions on opioids may help to save lives.
But restrictions on opioids are not the only regulatory change governments can make to reduce opioid-associated misuse and harms. Other changes are possible and need to be investigated to make accessing treatment for dependency on opioids easier, and improve how people manage pain.
How regulations for opioid painkillers work in Australia
In Australia, the government regulates and makes available opioid-based medications through a range of medical and legal systems, including those that manage pharmacy sales, doctor prescribing and drug scheduling.
The systems try to make sure that opioids can be used for their health benefits by patients across the country and that any risks of side effects or other problems are reduced.
The main ways of regulating how opioids can be accessed and used by Australian systems are:
- the Therapeutic Goods Administration (TGA), which approves medicines for use
- the PBS, which helps to make opioids more affordable and accessible by subsidising their cost
- recommended dosage (amount or frequency of a medicine taken each day)
- warning labels
- consumer medicine information
- scheduling (the category of a medicine according to what it contains and level of safety risk)
- advertising, and
- prescribing (including authority applications and real-time prescription monitoring).
A useful example of regulation in action is how patients access the medicine Fentanyl. Fentanyl is a powerful opioid that is often prescribed by a doctor as patches for managing very severe pain that doesn’t respond well to other treatments. The opioid is categorised by the Therapeutic Goods Administration as a Schedule 8: Controlled drug.
The “Scheduling” of a medicine refers to how its categorised according to its materials, level of safety risk, and how it can be accessed. Generally, the higher a medicine is scheduled, the more safety risks there are in its use. Scheduling determines whether a prescription from a doctor or other safeguards are required for a medicine.
Fentanyl has a high scheduling because evidence demonstrates there is a risk its use can lead to dependency (the experience of having physical and mental cravings to take more of the medicine), overdose (taking too much of a drug that is more than the body can handle) or the medicine being given or sold illicitly to family, friends and others in the community.
Regulations for opioids are enforced legally through legislation. There may be legal consequences for patients, doctors, pharmacies, pharmaceutical companies and others who do not use opioids according to legislative requirements.
Changes to regulations for opioids are often made to help reduce serious safety risks for patients, and address problems with use and misuse of the medicines. The aim of recent changes in Australia has been to help reduce the misuse of opioids, and experiences of dependency, by people using them for chronic health conditions, or for nonmedical purposes.
Why changes to opioid regulations in Canada and the UK matter for Australia
Like the government in Australia, Canadian and UK governments provide healthcare funding for their citizens.
In Canada, prescription medications are available through a mix of public and private insurance plans, such as the drug benefit program in the province of Ontario. The UK provides medications at affordable costs through the National Health Scheme. Subsidising the cost of opioids through government programmes makes a major difference to increasing their availability.
All three countries have health regulations for authorising the sale of opioids, their scheduling and how they are prescribed and monitored. Medical practitioner registration and national drug strategies also help support the implementation of regulations and the medicinal use of opioids while trying to reduce the risk of problems.
There are differences between the countries with regards to how opioids are accessed and used, and regulatory responses must be appropriate to their setting. However, the regulatory similarities between the countries, and studies that have looked at changes to some of those regulations and their associated outcomes, suggest insights that can inform future work here in Australia.
What kinds of regulatory changes are made in Canada and the UK, and are they effective?
Early evidence from Canada and the UK suggests there are limitations to regulatory changes for opioids.
In Canada, studies find that both restricting availability of opioids, and increasing access to opioid harm reduction treatments, have not been associated with major impacts for reducing overdoses, hospitalisations and other problems with opioids. However, one of the most promising regulatory changes has been the wide distribution of publicly funded naloxone, with some evidence suggesting the change helped reduce overdose deaths. Naloxone can reverse opioid overdoses.
In the UK, there is evidence to suggests that changes to legislation, regulation and policy for making it easier to access naloxone for helping deal with opioid related overdoses has led to reductions in opioid-related deaths.
More research is needed to establish what regulatory changes work best in Canada and the UK. What is clear, however, is that there are generally two kinds of regulatory changes used for reducing opioid-related harms and supporting their medicinal use:
- Increasing access to treatment for dependency, the risk of overdose and other problems associated with opioids
- Restricting access to opioid drugs through prescribing practices and drug scheduling.
Importantly, an evidence base on regulatory changes, a better understanding of how opioids are used and practical support for people experiencing issues with opioids all seem to be growing in Canada, and to a lesser degree in the UK.
Promising options for future opioid regulatory changes and related work
Australian studies have come to similar conclusions as those from Canada and the UK. Evidence suggests that dependency, overdose and other harms associated with opioids remain a concern. There has been a marked increase in opioid prescribing and lower-dose codeine use, despite attempts at regulating low-dose codeine sales. The most promising regulatory changes are those that have increased access to naloxone and have helped prevent overdoses, and saved lives.
Recent research into the outcomes from shifting all codeine containing medicines to prescription-only in 2018, suggests reductions in their sales, and less intentional opioid overdoses. There has also been an increase in prescription use of paracetamol with codeine with Australian veterans – however this was not accompanied by an increase stronger opioid dosage prescribing. The studies are encouraging for how restrictions may reduce the risk of opioid issues, but again show limited impacts, and the need for more research.
Despite the gap in knowledge, there is learning from Canada, the UK and Australia that can make a real and positive difference to work on policy, legislation and regulation for opioids. The insights provide useful areas of focus for future work.
So far, the value of making changes that both restrict access to opioids, and increase access to treatment for issues with opioids, is still not well understood. If the aim is to reduce opioid-related harm and ensure appropriate management of pain continues, then an important next step is for researchers to gather not just more evidence of whether regulatory changes have led to major reductions in dependency, overdoses and deaths, but also whether people who currently or previously used opioids are receiving appropriate pain management and care.
Researchers have argued that there is a need to find ways of improving access to effective pain management in Australia. Any possible unintended consequences, such as patients not having easy access to opioids for appropriate medicinal use or ‘gold standard’ multi-disciplinary pain clinics, must also be explored.
Similarly, much greater attention needs to be given to the potential for policy changes that are not just based on restricting access to opioids.
The implementation of more government funded programmes for both opioid dependence treatment and pain management as part of national drug and pain policy initiatives could play a pivotal role in balancing regulatory approaches for opioids. Likewise, evaluating the impact of naloxone availability at a national level across Australia, and recent impacts from restrictions on opioids, may help to begin addressing the gap in evidence.
There is also an opportunity to support the recent regulatory changes through more sharing of targeted education and awareness campaigns about pain management advice, while also talking about the potential side effects and problems with opioids. Australian health agencies have developed useful videos about managing chronic pain and information for understanding the stigma associated opioids that may be able to support more people in better managing how opioids are used.
To help reduce stigma, attention should also be given to how opioids are talked about, both by regulating bodies and the media, in talking only about opioids as a problem that is centred on dependence and harm. For example, it is common for media reporting on regulation changes to include an interview with someone who has become mistakenly dependent on opioids after an accident or operation. Such an approach further stigmatises people who use opioids, while failing to recognise the ways that people can use opioids that are both safe and unsafe, or for medical or recreational reasons (or, in some cases, both).
Making regulatory changes for opioids in Australia is no quick fix when it comes to helping save more lives and better manage pain. Fortunately, it is possible to expand understanding of what changes work best, and to keep trying to find ways of improving Australian medical and legal systems so that more people can find the best medical support available, when they need it.
Acknowledgement: This article is based on the findings of a systematic review conducted by Dr O’Mara currently under consideration for publication in the refereed journal Evidence Base, and which was funded by the Australian and New Zealand School of Government.
Dr Ben O’Mara is an Adjunct Research Fellow at the Department of Media and Communication, Faculty of Health, Arts and Design, Swinburne University. Dr Megan Weier is a Research Fellow at the Centre for Social Impact, University of New South Wales.
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