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Prescription opioids: What changes are being made and why
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.
These figures are too high, and the Australian Government has asked the Therapeutic Goods Administration (TGA) to play a role in tackling the problem. To help reduce the harm, we conducted a public consultation on prescription opioids in 2018. A summary of the submissions received and consultation outcomes has been published at Prescription strong (Schedule 8) opioid use and misuse in Australia - options for a regulatory response. A total of 98 submissions were received with feedback indicating strong and consistent support from all stakeholders for a regulatory response.
Following the initial consultation, the TGA established the Opioid Regulatory Advisory Group (ORAG), which includes representatives from a range of health professional and consumer organisations, to provide independent, expert advice. ORAG has strongly supported the proposed options and provided advice on how best to implement them.
Throughout the process, it has been recognised that opioids play an important role in providing pain relief for many people and there has been a focus on ensuring appropriate and safe access is maintained.
Several reviews and activities arose from the consultation. As a result:
- Smaller pack sizes will be available for immediate-release prescription opioid products. For example, following a minor procedure you may currently be given a packet containing a week's worth of opioids when you 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.
- We 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. These documents provide information for health professionals about medicines and their appropriate use.
- We 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. These documents provide important information for consumers about medicines.
- The indications, which outline (the appropriate circumstances for use of a medicine), in the PI documents for immediate release (only for short-term management of severe pain) 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. Hydromorphone and fentanyl modified release products should also not be used in opioid naïve patients (patients who do not already use opioid medicines regularly).
- 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. 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 pain should be severe enough to require daily, continuous, long-term opioid treatment. The patches are not for use in patients who are opioid naïve (not already tolerant to opioids).
- We 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.
These measures will align with broader Australian Government initiatives to improve appropriate pain management, particularly the National Strategic Action Plan for Pain Management. This strategic plan will address issues of pain management holistically and will ensure the appropriate support is available for areas of need. The need to maintain appropriate access to opioids, particularly in regional and remote areas, has been a consideration at all times in the TGA's regulatory response.
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, for example the United States and Canada.
When will these changes come into effect?
It is anticipated that the first of the smaller pack sizes will be registered from January 2020. The fentanyl indication changes came 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.
What should I do with prescription opioids that I don't use anymore?
You should return unused opioids to your local pharmacy. The TGA website has more information about Safe disposal of unwanted medicines.
Who was involved in TGA's reviews?
The TGA's team of doctors, pharmacists and other medicines specialists received advice from the Opioid Regulatory Advisory Group (ORAG).
Organisations represented on ORAG included: Australian and New Zealand Society of Palliative Medicine, PainAustralia, the Australian and New Zealand College of Anaesthetists Faculty of Pain Medicine, Royal Melbourne Hospital, the Australian Medical Association, Palliative Care Australia, University of Western Australia, the Royal Australasian College of Physicians, Australian Commission on Safety and Quality in Health Care, Tasmanian Health Services, Society of Hospital Pharmacists of Australia, Pharmaceutical Society of Australia, and the Royal Australian College of General Practitioners.
|||[Product] is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.|
[Product] is indicated for the management of severe pain where:
[Product] is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.
[Product] is not indicated as an as-needed (PRN) analgesia.
Not for use in opioid naïve patients. (Hydromorphone and fentanyl patches only)
The new fentanyl patch indication will be:
"For the management of pain associated with cancer, palliative care, and other conditions where:
Not for use in opioid-naïve patients."