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05 Sep 2019

The Therapeutic Goods Administration has announced upcoming changes to reduce harm in relation to prescription opioids.

In a statement, it says pharmaceutical opioids are now responsible for far more deaths and poisoning hospitalisations in Australia 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,” the statement says.

“These figures are too high, and the Australian Government has asked us (TGA) to play a role in tackling the problem. To help reduce the harm, the TGA conducted a public consultation on prescription opioids in 2018.

Several reviews and activities arose from the consultation. As a result:

  • Smaller pack sizes will be available for immediate-release prescription opioid products.
  • Sponsors will be required to include boxed warnings and class statements in the Product Information (PI) documentsfor all prescription opioids in relation to their potential for harmful and hazardous use.
  • The TGA will work with sponsors to ensure that safety information, including the relevant warnings, is prominently displayed in the Consumer Medicines Information.
  • The indications in the PI documents for prescription opioids will reinforce that opioids should only be used when other analgesics have proven not to be effective.
  • Fentanyl is one of the strongest opioids available in Australia. In recognition of the increased potential for harmful and hazardous use, the indication for fentanyl patches will be updated to state they should only be prescribed to treat pain in patients with cancer, patients in palliative care and those with exceptional circumstances.

The changes will be phased in from January 2020. All the changes and the full TGA statement can be found at:

Published: 05 Sep 2019