Guild queries TGA opioid suggestions


In a submission to the TGA, the Guild has reiterated its support for a national real time monitoring system for opioids

The TGA’s probe into opioid misuse is investigating potential regulatory responses to the misuse of S8 opioids, in a bid to prevent Australia from following the US down the path to an opioid crisis.

In its submission the Guild also calls for an opioids roundtable to bring together all stakeholders to do whatever is in their respective powers to solve the problems of opioids in Australia.

Calling for real-time monitoring, the Guild said while there is an urgent need to address the opioid problem in Australia, the TGA’s suggestions are limited because it could only make recommendations within its powers contained in the Therapeutic Goods Act.

It said it did not believe the TGA’s suggestions would “effectively address the problems of the opioid crisis as they do not include a nationally consistent real time monitoring system which is the responsibility of the respective state and territory health departments.”

The TGA’s suggestions had included:

  • Option 1: Consider the pack sizes for strong (S8) opioids.
  • Option 2: Consider a review of the indications for strong (S8) opioids.
  • Option 3: Consider whether the highest dose products should remain on the market, or be restricted to specialist/ authority prescribing.
  • Option 4: Strengthening of the Risk Management Plans for opioid products.
  • Option 5: Review of label warnings and revision to Consumer Medicines Information.
  • Option 6: Consider incentives for expedited TGA review of improved products for pain relief and opioid antidotes.
  • Option 7: 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, specific dispensing labels).
  • Option 8: Increase health professional awareness of alternatives to opioids (both S4 and S8 opioids) in the management of chronic pain.

The Guild says it does not believe changing marketed pack sizes has an appreciable effect on prescribing habits, and that removing highest-dose products would not necessarily prevent the prescription of such medicines if prescribers simply ordered a larger quantity of a lower-dose opioid to match the dose of the de-registered product.

It says a review of the current risk management plans for opioids would be warranted, but questions how this would affect prescribing practices.

It also says adding warnings and revisions to CMIs could “have the potential to send mixed messages to the consumer and could cause unnecessary alarm or distress,” although consumers do not always read these and low health literacy means these messages might not reach the consumer anyway.

In its submission the Guild notes it has now been almost three years since the Department of Health held an opioids roundtable meeting.

“The purpose of the opioids roundtable was to obtain stakeholder views on the PBS listings and restrictions for opioids.

“Whilst the focus was on PBS listings, discussion was held in a broader context and covered a range of issues associated with opioid use,” the submission says.

“Roundtable participants included representatives from consumer groups, industry, government and health professionals.

“The Guild believes that there is an urgent need for this Opioids Roundtable to be re-convened as part of the TGA’s current project so that the issues raised at this meeting and the discussion paper can be re-examined with a view to finding solutions.”

The TGA’s consultation paper closed on March 2.

Since then, Tasmania has announced the commencement of earlier plans to use the DORA system to track drugs of concern including previously low-dose codeine, as well as the S8s it already tracks. This followed a February announcement that the ACT would use DORA to track S8s including opioids.

The Tasmanian announcement was welcomed by stakeholders including the state Guild president John Dowling, who told the AJP that “the Guild supports a national real time monitoring solution and not different things in different states”.

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