TGA enforces changes to prescription opioids in reducing risk of harm

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.

Following the initial consultation in 2018, the TGA established the Opioid Regulatory Advisory Group (ORAG), which includes representatives from health professional and consumer organisations, to provide independent, expert advice.

Prescription opioids such as fentanyl, codeine, hydromorphone, oxycodone, morphine, tramadol, tapentadol, buprenorphine and methadone are affected by the changes.

Review Outcomes

• Smaller pack sizes will be available for immediate-release prescription opioid products. For example, following a minor procedure a patient may currently be given a packet containing a week’s worth of opioids when the patient would usually only need to take them for two or three days. The unused opioids subsequently circulating in the community may be used in harmful or hazardous ways, either inadvertently or deliberately, or become targets for theft.
• The TGA will require that sponsors include boxed warnings and class statements in the Product Information (PI) documents for 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 (CMI) to ensure consistency of language and information across all classes of prescription opioids.
• 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 TGA will be communicating the changes to both prescribers and consumers using a range of channels to ensure health professionals follow best prescribing practice and consumers are fully informed how best to use opioids. The TGA has initiated communication to consumers to return unwanted opioids to pharmacies for destruction by distributing prescription covers with relevant messaging to every pharmacy in Australia as well as via various social media activities.

Timing

It is anticipated that the first of the smaller pack sizes will be registered from January 2020. The fentanyl indication changes will come into effect in the first half of 2020. Due to the large number of opioid products on the Australian market the other changes will be phased in.

These measures will align with broader Australian Government initiatives to improve appropriate pain management, particularly the National Strategic Action Plan for Pain Management.

The measures have been carefully considered to ensure that they support and maintain the safe and clinically appropriate use of opioids without restricting prescribers from accessing them for their patients when needed. These actions are also similar to activities that have been undertaken in other countries such as the United States and Canada.

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