Regulation Impact Statement Updates

Official website for publishing regulatory impact analysis information for regulatory decisions announced by the Australian Government, COAG and COAG Councils.

Addressing prescription opioid use and misuse in Australia

Aust Gov
14th January 2020

Independent Review – Therapeutic Goods Administration

On 12 December 2019, the Therapeutic Goods Administration introduced changes to the regulatory framework for prescription opioids to address prescription opioid use and misuse in Australia.

Changes will include:

  • Registration of smaller pack sizes for oral immediate-release prescription opioids.
  • Requiring boxed warnings and class statements in the Product Information (PI) documents for all prescription opioids in relation to their potential for harmful and hazardous use.
  • Ensuring the safety information, including the relevant warnings, is prominently displayed in the Consumer Medicine Information to provide consistency of information across all classes of prescription opioids.
  • Restricting the indication for fentanyl patches to state they should only be prescribed to treat pain in patients with cancer, patients in palliative care, and those with exceptional circumstances.

Consistent with the Government’s Regulation Impact Statement (RIS) requirements, the Therapeutic Goods Administration certified its review Addressing prescription opioid use and misuse in Australia undertook a similar process and analysis to that required for a RIS. The Office of Best Practice Regulation (OBPR) does not assess the quality of independent reviews and RIS-like documents used in place of a RIS.

The Therapeutic Goods Administration has self-assessed regulatory costs of less than $2 million per annum. The Therapeutic Goods Administration estimates the average annual regulatory costs will be $108, 000 per year.

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