In June 2020, the federal government made several changes to regulations that govern the prescription and supply of opioids, significantly impacting people living with chronic pain.
The new regulations certainly have merit, given there’s been a sharp increase in deaths and hospitalisations from prescription opioid misuse in Australia over recent years.
However, changes to medication regulations alone are a one-dimensional strategy to reduce opioid use. Other strategies are needed to support patients, including better patient education and providing patients with other pain management options.
Our research, published last year, shows a “one-size-fits-all” approach to reducing opioid use isn’t favoured by prescribers or patients. Instead, patients should have access to individualised and coordinated care.
The new regulations
Australia’s drug regulator, the Therapeutic Goods Administration (TGA), says opioids should only be used for the short-term management of severe pain (for example, after surgery) and only when other pain medicines are not suitable or effective, for example in cases where patients can’t tolerate non-steroidal anti-inflammatories such as ibuprofen.
The new regulations say opioids should no longer be prescribed for chronic non-cancer pain, except in “exceptional circumstances”.
Other changes include reduced opioid pack sizes and fewer repeat prescriptions, meaning patients may need to see their doctor more often for ongoing supplies.
For patients using opioids for a period of 12 months or longer, a second prescriber must assess and approve ongoing opioid supply.
Strong opioids such as morphine and fentanyl can only be used in patients with cancer, in palliative care, or after a trial of lower-strength opioids.
States across Australia are currently in the process of introducing national real-time prescription monitoring. Health-care professionals who are prescribing or dispensing medicines will be able see a patient’s prescription history.
Why were the changes made?
Opioid-related deaths increased by 62% between 2007 and 2016. Prescription opioids are responsible for more deaths than illicit opioids such as heroin.
Evidence suggests long-term opioid use (greater than three months) for chronic non-cancer pain offers limited benefit. Instead, research suggests pain and physical functioning often improve when opioids are tapered or deprescribed, particularly combined with other treatments such as cognitive and physical therapy. Tapering refers to slowly reducing the amount of the drug taken over time, with the aim of eventually stopping it altogether.
The TGA said regulatory changes were made to reduce the harms of prescription opioids and “ensure the safe and effective prescribing and use of opioids while maintaining access for patients who need them”.
Many patients may be left without options
The full impact of these regulatory changes isn’t known yet. In clinical practice, it’s hard for both health-care professionals and patients to accept and respond to these changes.
Although the new rules may reduce harms from prescription opioids, they may make it harder for chronic pain patients to access medicines.
Opioids are often prescribed when patients are unable to use other medicines, or when they’re not effective.
Other strategies to manage pain, such as seeing a physiotherapist or psychologist, are often expensive and there can be long wait times to see pain specialists.
Reduced access to opioids may mean patients are left without pain management options.
Prescribers can still give opioids to patients with chronic non-cancer pain, if they think the benefits of continuing the medication will outweigh the risks. However, there were initial concerns from doctors on how to implement these changes.
Many researchers have longstanding concerns opioids may be stopped without gaining consent from patients.
In the United States, abrupt and forced opioid tapering has caused significant issues. These include increased or uncontrolled pain, acute opioid withdrawal, use of illicit opioids, depression and suicide.
If opioids are to be discontinued for certain patients, it must be done safely.
We shouldn’t use a ‘one-size-fits-all’ approach
Health-care professionals must consider ways in which patients can access appropriate and affordable pain management.
Access to non-opioid pain management can be limited for many people, particularly non-drug treatments such as physiotherapy, psychology or multidisciplinary pain management. Challenges include high out-of-pocket costs, lack of availability particularly in rural and remote locations, and long waiting lists.
With the new regulations, each prescriber will need to make a decision about the harms and benefits of ongoing opioid use for individual patients.
There are resources available for both health-care professionals and patients to assist with opioid tapering. Australian clinical practice guidelines on opioid deprescribing are under development and are due to be published in 2022.
Aili Langford, Bpharm (Hons), PhD Candidate School of Pharmacy, Faculty of Medicine and Health, University of Sydney; Carl Schneider, Senior Lecturer, Sydney Pharmacy School, Faculty of Medicine and Health, University of Sydney; Christine Lin, Professor, University of Sydney, and Danijela Gnjidic, Associate Professor and NHMRC Dementia Leadership Fellow, School of Pharmacy, Faculty of Medicine and Health, University of Sydney, University of Sydney