Effective today, 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.
This move has been made in light of the fact that nearly 150 hospitalisations, 14 emergency department admissions and three deaths occur each day in Australia due to the use of pharmaceutical opiods, with the changes intended to ensure the safe and effective prescribing and use of opioids while maintaining access for patients who need them.
What are the changes?
The regulatory changes will require opioid pharmaceutical companies or “sponsors” as they are known 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:
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, dentists and nurse practitioners) to implement best-practice opioid prescribing for people living with pain while ensuring adequate pain management.
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 this webpage 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 come into effect from 1 June 2020.
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.
A wide range of clinical guidelines and other resources (including the FPM and RACGP guidelines) can be found on the TGA’s Prescription Opioids webpage.
ADA medicines info and the PharmaAdvice service can be accessed by visiting ada.org.au