New opioid regulatory reforms commence January 2020

19 December 2019 | Avant media

New opioid regulatory measures have commenced to support safe and clinically appropriate opioid prescribing practices, without restricting doctors from accessing them for patients when needed.

The Therapeutic Goods Administration’s (TGA’s) new opioid measures include smaller pack sizes to be registered from January 2020 and available once medicine sponsors can bring them to market. Updated clinical indications for prescribing fentanyl patches and enhanced safety warnings and product information on all opioids will be phased in through the first half of 2020.

The regulatory changes come after the TGA conducted a public consultation in February 2018. Submissions were received on options for a regulatory response to the use and misuse of prescription opioids, to help reduce harm.

Smaller pack sizes

As a result of the regulatory changes, doctors will be able to prescribe smaller pack sizes of immediate-release prescription opioids. This will provide a more appropriate option for patients for short-term relief, e.g. after surgery or injury, and reduce the risk of harm from surplus opioids.

Patients who require long-term pain relief from opioids, such as those with cancer and in palliative care, will still be able to access the same opioid pack sizes currently available.

Injectable forms of opioids will continue to be accessed as they are now.

Updated indication for fentanyl patches

In recognition of the increased potential for inappropriate use of the powerful opioid fentanyl, tighter indications for prescribing fentanyl patches will come into effect in the first half of 2020. The updated indications will stipulate that fentanyl patches should only be used to treat pain in patients with cancer, patients in palliative care and patients with exceptional circumstances. They will also state that fentanyl should not be prescribed to opioid-naïve patients.

New warnings and tighter indications

Updated boxed warnings and class statements in the Product Information (PI) will be introduced across all classes of opioids regarding their potential for harmful and hazardous use. Tighter indications for certain immediate release and modified release products will also be introduced to restrict use to severe pain where other treatment options have been ineffective or cannot be used.

Safety information and warnings will also be prominently displayed in the Consumer Medicines Information to ensure consistency of language and information across all prescription opioids.

The TGA will be undertaking extensive communication and education activities for health professionals and consumers. The organisation is also working with various colleges and specialist bodies to ensure their prescribing guidelines are updated to reflect the changes.

One in 20 claims involve opioid prescribing

The new measures support insights from our new report, Opioid prescribing-related claims ­– insights to reduce risk, which found claims involving opioid prescribing are common.

Our report found one in 20 claims involved opioid prescribing practices in the financial years from 2016-19. Opioid prescribing claims reflect the complexity of prescribing in terms of legislative requirements, patient characteristics, efficacy of other medications and polypharmacy.

Clinically inappropriate prescribing was the most common issue, seen in 64% of these claims. Prescriptions were reportedly not clinically indicated, contraindicated, prescribed for too long, or at too high a dose.

Prescribing drugs of dependence without authority was also a notable issue, highlighting the need for doctors to know and comply with state, territory and federal legislation. Download the full report.

Avant submission

In our submission to the TGA’s consultation, we supported the key opioid regulatory changes and called for measures to change prescribing behaviour including:

  • national harmonisation of legislation and regulation
  • the implementation of a national real-time monitoring system
  • the development of clinical support tools for doctors
  • further education and guidelines about the medico-legal aspects of prescribing S8 drugs.

Useful resources

Doctors can access information on the upcoming changes and resources on the TGA website.  

View the RACGP’s guidelines on Prescribing drugs of dependence in general practice.

Our medico-legal experts have also developed a range of educational resources on prescribing principles and practices including our eLearning course that provides CPD points.

If you need medico-legal advice regarding opioid prescribing, please email us at nca@avant.org.au or call 1800 128 268, 24/7 in emergencies.

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