Source: Australian Therapeutic Goods Administration
Understand the impact of the regulatory changes, and how to implement best practice opioid prescribing for people living with pain while ensuring adequate pain management.
Reducing opioid harm through regulatory changes
The Australian Government, through the Therapeutic Goods Administration (TGA) within the Department of Health, is implementing a number of regulatory changes in order to minimise the harms caused by opioid prescription medicines to Australians each year. The changes will ensure the safe and effective prescribing and use of opioids while maintaining access for patients who need them.
Why the changes are being made
Over the past decade, Australians have experienced a significant increase in the level of harm and deaths arising from the use of pharmaceutical opioids. Every day in Australia, nearly 150 hospitalisations and 14 emergency department admissions involve issues relating to opioid use, and three people die from the harm that results.
Opioids can be an effective component of the management of acute and cancer-related pain. However, the evidence shows that for most people with chronic non-cancer pain, opioids do not provide clinically important improvement in pain or function compared with placebo. In contrast, they carry significant risk of harm, even when used as prescribed. These risks can range from nausea, constipation and hyperalgesia through to addiction, respiratory depression, coma and death.
The regulatory changes aim to reduce the harms from opioids by reducing the number of people who start opioid treatment for short-term pain, for example following injury or surgery, but then continue to use the medicine long-term where the risk of harm outweighs benefit. The changes will also allow prescribers (such as doctors and nurse practitioners) to implement best-practice opioid prescribing for people living with pain while ensuring adequate pain management.
For people who are gaining little benefit from opioids or who are experiencing harm, prescribers will be encouraged to work in partnership with patients to safely taper the opioid treatment over time to either stop the opioid medicine or ensure the lowest effective dose is used to effectively treat their pain while minimising the risk of side effects.
Many people who taper to the lowest effective dose find that their lives improve. They can think more clearly and are more alert. Some people find their mobility is better and they are steadier on their feet. Less reliance on medication reduces trips to the pharmacy and may save money.
Non-pharmacological treatments should be trialled first and, where pain programs are accessible, these can be a good way of accessing tailored treatment that considers the individual as a whole person.
What changes are being made
The regulatory changes will require opioid ‘sponsors’ (pharmaceutical companies) to:
- register smaller pack sizes for immediate-release opioids that will provide a more appropriate option for short-term pain relief, for example after injury or surgery, and reduce the risk of harm from unused opioids (the existing larger pack sizes will still be available for those who need them)
- add additional warning statements to the approved Product Information for all opioids to remind prescribers of the appropriate circumstances for opioid prescribing and potential adverse effects
- improve the information available to prescribers and consumers to encourage best-practice prescribing and to be better informed about the potential risks with opioid use and how to minimise them
- update prescribing ‘indications’ for opioids to ensure patients are prescribed an opioid only where the benefits outweigh the risks.
Products affected by the regulatory changes
Prescription opioid products that are affected by the regulatory changes include:
PBS changes align with TGA regulations
There will be various changes to the Pharmaceutical Benefits Scheme (PBS) to support the regulatory changes, for example funding for smaller quantities, changes to the ‘indications’ that will be funded, and changes to the authority process required for opioids to be subsidised. See Revised opioids PBS listings from 1 June 2020 for full details of the revised listings.
Prescribers will need to ensure that patients with chronic non-cancer pain are unresponsive or intolerant, or have not achieved adequate pain relief from lower strength opioids, before prescribing high-strength opioids such as morphine and fentanyl under the PBS.
This PBS changes came into effect from 1 June 2020.
Following the 1 June changes, additional changes have been made to the PBS to ensure continued and unimpeded access for palliative care patients receiving opioid analgesic medications. These came into effect from 1 October 2020. Further information for prescribers and patients on the PBS opioid changes has also been published to this page.
When the changes take effect
The regulatory changes have already commenced, with some Product Information documents already updated, and will be further phased in during 2020. The latest versions should be available through your prescribing software as they are updated.
Health professional bodies (including the Royal Australian College of GPs (RACGP) and the Australian and New Zealand College of Anaesthetists Faculty of Pain Medicine (FPM)) have been working to update their opioid prescribing guidelines and these should be introduced in 2020.
Clinical need takes priority
The regulatory changes will not lead to a ban on prescribing opioids to any category of patient, if ongoing use is considered to be clinically appropriate. The changes will prompt prescribers to reflect on their opioid prescribing practice, to ensure that, when either initiating or continuing to prescribe an opioid, they have a discussion with their patient and consider whether they will benefit from opioid treatment and how the risks and harms are managed. Medication is only one potential component of a multi-modal plan of pain management, which also takes a person’s social and psychological background into consideration.
Opioids can be used as part of the management of chronic non-cancer pain in circumstances where other pharmacological and non-pharmacological treatment strategies have not been effective, and the impact of poorly controlled pain has been considered. However, there is a known risk of adverse effects and potential for harm and a lack of evidence on the effectiveness of long-term use of opioids for managing many chronic non-cancer pain conditions. Opioids may not offer any additional pain relief compared with non-opioid medications such as paracetamol or NSAIDs (such as ibuprofen), and the risk of harm is higher. The changes to opioid indications align with the latest scientific evidence regarding opioid prescribing and aim to reduce the risk associated with their use while ensuring adequate pain management.
Whether opioids are appropriate for a patient with non-cancer pain will continue to be a clinical decision for the individual prescriber. Prescribers are bound by professional standards and are accountable to an independent regulator. Information for clinicians on opioid analgesic tapering has been developed to assist prescribers in their clinical decision making process. These resources were developed in partnership with pain specialists and healthcare professional stakeholders with input from members of the Opioid Regulatory Communication Committee (ORCC). As opioids are no longer indicated for Chronic Non-Cancer Pain (CNCP) unless in exceptional circumstances, these resources should serve as a guide for cases where the prescriber and patient believe they can collaborate to achieve a reduction in opioid dose.
The Australian Government does not oversee individual clinical decisions made by prescribers and they will ultimately make their own decisions on how to incorporate this guidance into practice.
What resources are available?
There will be a range of activities to support the implementation of these changes and to equip doctors and other health professionals with the tools and resources to apply these in practice. Similarly, there will be a range of resources for consumers to empower them to make informed choices about their treatment.
Our opioid resources page has links to more information for consumers, patients and carers from organisations, such as Painaustralia and NPS MedicineWise.