TGA flags changes to prescription opioid regulations following consultation
The TGA has given notice that changes will be made to the pack sizes, dosage and advice supplied with prescription opioids in an attempt to rein in harmful use.
A notification was posted on the TGA website earlier this week (4 February) announcing that it would be implementing a series of measures designed to “support and maintain the safe and clinically appropriate use of opioids without restricting prescribers from accessing them for their patients when needed”.
The raft of proposed measures were developed following a consultation process which began in 2018. A total of 98 stakeholder submissions were received, with feedback indicating strong and consistent support from all stakeholders for a regulatory response, the TGA said.
The flagged changes include:
- Smaller pack sizes will be available for immediate-release prescription opioid products.
- Sponsors will be required to 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 CMI to ensure consistency of language and information across all classes of prescription opioids.
- The indications in the PI documents for immediate release and modified release products will reinforce that opioids should only be used when other analgesics are not suitable or have proven not to be effective. In the case of modified release products, they should also only be used where the pain is opioid-responsive and the patient requires daily, continuous, long-term treatment. Modified release opioids are not indicated to treat chronic non-cancer pain (other than in exceptional circumstances), or to be used for ‘as-needed’ pain relief.
- 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. They should also only be used where other analgesics are not suitable or have proven not to be effective, and where the pain has been found to be opioid-responsive. The patches are not for use in patients who are opioid naïve (not already tolerant to opioids).
- 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. We have already begun to encourage 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”.
The TGA said the revisions are necessary as pharmaceutical opioids are now responsible for far more deaths and poisoning hospitalisations in Australia than illegal opioids such as heroin.
“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,” it said.
“These measures will align with broader Australian Government initiatives to improve appropriate pain management, particularly the National Strategic Action Plan for Pain Management.”
In its submission the Pharmacy Guild of Australia advocated again for a nationally co-ordinated real time monitoring system as an “essential element of the broad strategy to deal effectively with opioid abuse and misuse in Australia”.
“However we hope that this discussion paper and our suggestion of a follow-up Opioids Roundtable meeting will bring together all stakeholders so that they can do whatever is in their respective powers to solve the problems of opioids in Australia”.
PSA agreed that a “national real-time recording and reporting system is essential from a patient safety and public health perspective”.
“We stress that, in developing a regulatory response, it is fundamentally important that access
to evidence-based opioids continues to be supported,” it’s submission added.
The Australian Medical Association said it acknowledged that, “in the interests of patient safety, additional measures are sometimes required to control access to certain medicines that are prone to addition and misuse”.
“However, prescribing regulations and other measures should not pose a barrier to medical practitioners treating their patients or impose an administrative burden without evidence that they are effective and necessary”.