On 1 June 2020, the Pharmaceutical Benefits Scheme (PBS) listings for opioid medicines changed.

Governments across the world are making policy and regulation changes to address the high number of deaths and hospitalisations due to prescription opioids.  This has sometimes had inadvertent consequences for palliative care patients.  As palliative care advocates and health professionals know, appropriate use of opioids is essential for palliative care patients to manage the pain and breathlessness associated with their life-limiting illness, not just for people with cancer. While recognising that safety regulations are required, put simply, the issues of addiction and misuse are not critical factors for palliative care patients.

PCA and other organisations have identified serious concerns with the recent PBS changes, including how Services Australia is interpreting these changes at the pointy end of authorising prescriptions.  PCA is working actively with the relevant jurisdictions in the Department of Health involved in the area of medication regulation and subsidy, including the Therapeutic Goods Administration (TGA), Pharmaceutical Benefits Scheme, and Services Australia to address some of the unintended consequences of the changes and their interpretation.  PCA supports the broader issue of reform in opioids in line with the evidence while advocating that provisions need to be made to ensure palliative care patients have access to the medications they need – when and where they need them.

To date, PCA’s advocacy is centred on working with the government with a collegiate view that many of the changes had unintended consequences for which there is goodwill to have the problems addressed and amended.

Representatives from the palliative care sector have been members of the Opioid Regulatory Advisory Group (ORAG), formed to provide advice to TGA specifically around the ARTG and the specific needs of palliative care patients in the appropriate use of opioids, were important aspects of discussion in this forum in collaboration with pain medicine, primary care, consumer and drug and addiction expertise.

The TGA has maintained that ‘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’ as outlined on the TGA website.

Unfortunately, this intent has not clearly carried forward in the suite of changes in other areas of opioid regulation outside the ARTG, and there remains inconsistency with what has been communicated about changes to the PBS listing and the experiences of providers when requesting authorities through Services Australia.

PCA is working to ensure that the PBS changes relating to opioids do not exclude non-cancer palliative care patients.  As an example, where wording includes a criteria ‘Patient must have pain directly attributable to cancer’ (such as for Fentanyl patches), the palliative care indication is within the other criteria (for example The condition must be such that maximum tolerated doses of non-opioid and other opioid analgesics would provide inadequate management of pain relief).  This wording is not ideal as palliative care is not explicitly mentioned.

PCA is seeking amendments for the requirement for consultation by a second medical practitioner to authorise prescriptions of certain opioids.  A patient at the end of their life and in pain needs relief urgently and the requirement for a second authoriser will leave many patients, including those in residential aged care, in unbearable pain and suffering.  PCA is arguing that the logistics of this regulatory requirement for a dying patient is discriminatory and will lead to unwarranted hospital admissions.

PCA will be formally writing to the Pharmaceutical Benefits Advisory Committee (PBAC) about PBS indications, quantities and authority requirements to alert them to the concerns and suggest longer-term changes which will improve clarity for health care professional caring for palliative care patients.

PCA has advised the government that there may be concerns with health professionals interacting with Services Australia where Services Australia staff may not be aware of provisions for palliative care patients (including palliative care patients who do not have a cancer diagnosis).  PCA is optimistic that these communication issues can be improved quite quickly.

As a more significant reform issue, the palliative care schedule in the PBS is out of date and does not account for changes to the availability of new palliative care medications and updated evidence for dosing in other medications.  PCA will continue to work with PBAC to review and update the palliative care schedule.

PCA, together with other palliative care organisations, are working hard to address the concerns arising from the recent PBS changes.  If you are aware of examples where patients have been disadvantaged, or where palliative care health professionals have had unwarranted delays and problems in prescribing appropriate medications, PCA would like to hear of from you so they can be relayed as part of our advocacy.