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TGA opens consultation on the use of prescription opioids for pain

21 January 2018

Australia's medicines' regulator, the Therapeutic Goods Administration (TGA) has today issued a discussion paper on the use and misuse of prescription strong opioids such as oxycodone and whether there is a need for specific regulatory responses.

Levels of prescription opioid overdose, including accidental overdose are at record levels in Australia and internationally. One of the contributing factors has been significant "indication creep", such as their widespread use in chronic non-cancer pain, despite limited evidence of efficacy or safety for opioids in many of those patients.

Any potential regulatory changes by the TGA would need to be part of a broader process to address the problems with excessive or inappropriate use of opioids.

While practice change by prescribers and changes in community expectations about how consumers use prescription opioids for pain would have a major impact on appropriate opioid use, regulation has an important role to play.

The TGA has asked for feedback on the range of options through a public consultation process which begins today, 19 January, until 2 March 2018.

As part of the process the TGA will hold targeted consultation with industry peak bodies, clinical colleges, medical professional bodies, states and territories and consumer organisations on the possible options. The general public is also encouraged to contribute to the discussion.

Some of the options in the discussion paper, which is available at, include:

  • Consider the pack sizes for strong opioids (Schedule 8 controlled drugs)
  • Consider a review of the indications for strong opioids
  • Consider whether the highest dose products should remain on the market, or be restricted to specialist prescribing
  • Strengthening of the Risk Management Plans for opioid products
  • Review of label warnings and revision to the CMI (Consumer Medicines Information)
  • Consider incentives for expedited TGA review of improved products for pain relief and opioid antidotes
  • Potential changes to use of appendices in the Poisons Standard to provide additional regulatory controls for strong S8 opioids - this could potentially include controls of prescribing for particular populations or classes of medical practitioners, additional safety directions or label warning statements and specific dispensing labels.
  • Increase health care professional awareness of alternatives to opioids in the management of chronic pain.

The purpose of the consultation is to obtain broad stakeholder feedback on the desirability or otherwise of specific regulatory changes around strong opioids, and to seek input on alternative options.

All of the options proposed fall within TGA's existing administrative powers and if any changes are made they will not require new legislation.