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Submissions received and next steps: Prescription strong (Schedule 8) opioid use and misuse in Australia - options for a regulatory response

12 September 2018

This page was updated on 12 September 2018 to include a summary of the consultation outcomes and the next steps that will be taken by the TGA.

Submissions received

The TGA thanks respondents who provided submissions in response to the February 2018 public consultation paper Prescription strong (Schedule 8) opioid use and misuse in Australia - options for a regulatory response.

A total of 98 submissions were received, which comprised:

  • 19 submissions from government bodies
  • 6 submissions from industry suppliers/sponsors/manufacturers
  • 1 submission from an industry organisation
  • 52 submissions from health professionals, medical institutions or medical professional bodies
  • 15 submissions from consumers or consumer organisations
  • 5 submissions from other individuals or organisations

All submissions that gave permission to be published on the TGA website are available below in PDF format.

Further consultation on prescription opioid use and misuse in Australia was conducted at a targeted stakeholder workshop on 1 June 2018. Senior staff members from the TGA also have taken part in recent workshops in Brisbane, Melbourne and Canberra that were organised by peak clinical and pharmacy groups in June and July 2018 on options to manage prescription opioid use and misuse. The feedback from these workshops, along with the submissions received during the public consultation, has been considered by TGA and the Government to determine the next steps for this work.

Consultation outcomes summary

There was strong and consistent support for four of the proposed options in the consultation paper. The various stakeholder workshops also supported these options. The supported options are:

  • reviewing available product pack sizes for opioids commonly used to treat acute pain
  • reviewing the indications for the opioid products used to treat pain
  • reviewing the label warnings and content of Consumer Medicines Information (CMI) documents for opioids
  • working with stakeholders to raise health professional and consumer awareness about pain management guidelines, including the use of non-opioid alternatives for the management of chronic pain; and safe disposal of opioid products.

The consultation response and stakeholder workshop also raised a number of broader initiatives to address issues associated with opioid abuse and misuse. These initiatives do not fall within the regulatory remit of the TGA.

Some respondents expressed concern that any regulatory actions should not impair clinically-appropriate access to opioid medications for the treatment of chronic pain, including cancer-related pain. It is recognised that opioids are essential medicines that play a critical role in pain management. In implementing the above options, Australian patients will be able to continue to access opioids appropriately and safely.

Next steps

A brief overview of the planned actions for each of the supported options is provided below. The focus of initial activities will be on the stronger (Schedule 8) opioids, which include fentanyl, morphine and oxycodone, as well as tramadol which is a schedule 4 opioid commonly used to treat pain. The TGA will also consider actions taken by international regulators in implementing these options. For example, in the United States the Food and Drug Administration (FDA) is, amongst a range of activities, looking at strategies to decrease patient exposure to opioids and decrease the risk of addiction. Similarly, Health Canada is looking to reduce unnecessary opioid use, better inform patients and also support better prescribing practices.

Review of pack sizes

TGA has commenced a review of opioids commonly used to treat acute pain in the home setting. These products are generally intended for short term use and may be prescribed at the point of hospital discharge following an injury or surgical procedure, or following dental procedures. The review will consider whether registered pack sizes align with the requirements for their intended short-term use, and if these products are available in Australia. If suitable pack sizes are not available then we will work with sponsors to support them in registering smaller pack sizes of these products.

Importantly, this review is not considering restriction of larger pack sizes for products that are registered to treat chronic pain, including cancer pain.

Review of indications

We have commenced a review of the product information (PI) for opioid products indicated for use in treating pain with a focus on the currently approved indications. The review will also consider whether appropriate warnings are included in the PI. The review will take into consideration current clinical guidelines, responses to the public consultation and the indications and warnings provided in comparable overseas medicines information documents. The review will initially focus on the appropriateness of the indications for very potent opioids such as Fentanyl, which has been identified as an opioid of particular concern for abuse and misuse both in Australia and overseas.

Review of label warnings and Consumer Medicines Information

A review of how the risks of opioids are communicated to consumers through the Consumer Medicines Information (CMI) document has commenced. The focus will be on how clearly the risks of addiction and overdose are conveyed to consumers, as well as determining whether information on safe disposal is adequate. The review will also consider whether product labelling could be used as a means to provide safety information to consumers.

Education for health professionals and consumers

The TGA will build on existing relationships with external stakeholders who provide education to health professionals and consumers. Together with these stakeholders we will develop a plan to raise awareness and educate health professionals about pain management guidelines, including the use of opioid alternatives. We will also explore opportunities for partnership with other groups to provide consumers with information about the safe use and appropriate disposal of opioid products.



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