June 2020 TGA changes to prescription opioids
As of the 1st June 2020, the Pharmaceutical Benefits Scheme (PBS) will be revising the listing of prescription opioids. This comes on the back of a public consultation which occurred in 2018, looking at prescription opioid use and misuse. In response to this consultation, the Opioid Regulatory Advisory Group (ORAG) was formed to look at implementing changes to regulation to reduce the harm caused by opioid prescription medications in Australia each year.
The reason behind these regulatory changes is that:
- Opioid related deaths and hospitalisation secondary to poisoning are more frequent than illegal opioids such as heroin.
- Every day in Australia, nearly 150 hospitalisations and 14 emergency department admissions involve opioid harm, and three people die from drug-induced deaths involving opioid use.
- Evidence shows that most people with chronic non-cancer pain do not receive a clinically important improvement in pain or function when compared with those who received a placebo.
The aim of these regulatory changes is to:
- Reduce harm caused by opioids by reducing the number of people who start opioid treatment for short-term pain.
- Encourage prescribers to taper opioid medication in those who are receiving minimal benefit or experiencing harm.
- Encourage best practice prescribing of opioid medications for non-cancer pain management.
- Encourage non-pharmacological treatments such as pain programs to ensure biopsychosocial management of pain.
The changes being implemented include:
- Smaller pack sizes for immediate-release opioids that will provide a more appropriate option for short-term pain relief.
- 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.
- To ensure appropriate use of opioid medicines for the management of pain, patients must be referred to a pain specialist or alternative prescriber for clinical review if opioid use exceeds or is expected to exceed 12 months. The date of the review and name of the medical practitioner consulted must be provided for every authority application.
Prescription opioid products that are affected by the regulatory changes include:
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.
The TGA opioid resources page has links to more information for consumers, patients and carers from organisations, such as Painaustralia and NPS MedicineWise.
- Starting Opioid Medication – making an informed decision
- Stopping Opioids
- The Australian Government, Department of Health: Prescription opioids: Information for health professionals (link)
- The Australian Government, Department of Health: Prescription opioids: What changes are being made and why (link)
- TGA Fact Sheet: Revised opioids PBS listings for the management of severe disabling pain (link)
- The Australian Government, Department of Health: Prescription opioids: Information for consumers, patients and carers (link)
- Pain Australia Fact Sheet: Changes to availability of pain medication on June 1: How will you be affected? (link)
- PBS News: Revised opioids PBS listings from 1 June 2020 (link)