Saving the baby: palliative care and the opioid debate

IT is 20 years since the endorsement of the first National Palliative Care Strategy by the Australian Health Ministers’ Advisory Council. It was a landmark document that acknowledged the importance of palliative care as an “integral part of a comprehensive health care system that supports people at all stages of life, helping people to die well in an atmosphere of care and support”.

The importance of embedding palliative care as an integral part of the health system was explicitly set out in the first objective, which called, inter alia, for “systemic recognition and awareness at the health policy and decision-making level”.

Twenty years later, people with life-limiting conditions are still being adversely affected, sometimes seriously, by health policy and regulation decisions that have failed to recognise the needs of people with life-limiting illness.

The most recent example has been a decision, implemented on 1 June 2020, to place restrictions on opioid prescribing, affecting multiple formulations listed on the Pharmaceutical Benefits Scheme (PBS) General Schedule, commonly used to relieve suffering for palliative care patients. The changes included new listings for half-pack sizes, increased restrictions for full-pack sizes, and new and amended clinical criteria, prescriber instructions and administrative advice.

The restrictions were made for legitimate reasons, reflecting global concerns about the harms caused by inappropriate use (and prescribing) of opioid prescription medicine, including overdose and addiction, with nearly 150 hospital admissions a day related to opioid use.

The measure came with safeguards, it was proclaimed at the time, to “ensure the safe and effective prescribing and use of opioids while maintaining access for patients who need them”. This guidance acknowledged that opioids could be an effective component of the management of short term and cancer-related pain.

Clarity of indication wording is important to deliver on this safeguard – without specific reference to palliative care and the consideration of specialist prescribers of opioids in the palliative care population, impacts on palliative care service delivery occurred rapidly.

The revised listings had wide-reaching unintended ramifications that caused distress for palliative care patients and their prescribers, including palliative medicine specialists, palliative care nurse practitioners, and GPs who manage patients with palliative care needs.

The decision was particularly disappointing given the proactive initiative in the formation of the Therapeutic Goods Administration’s Opioid Regulation Advisory Committee and the consensus advice given. Nor did it pay heed to Palliative Care Australia’s position statement, published in May 2019, Sustainable access to prescription opioids for use in palliative care, a statement endorsed by 12 other clinical and professional organisations including the Australian and New Zealand Society of Palliative Medicine, Palliative Care Nurses Australia, the Australian College of Nursing, Paediatric Palliative Care Australia and New Zealand, the Pharmacy Guild of Australia and the Royal Australasian College of Physicians.

That statement noted:

There is increasing focus at a government and regulatory level in Australia regarding opioid prescribing for chronic non-cancer pain. In an effort to reduce inappropriate prescribing that can lead to harm from misuse and abuse of opioids, palliative care patients are being placed at risk of unintended harm through reduced or ceased opioid prescribing.

Opioids are an essential part of the pharmacological options needed to help relieve the pain and/or breathlessness that may be experienced by someone living with a life-limiting illness. Evidence demonstrates that up to 25% of palliative care patients report severe pain in advanced disease, with up to 60% experiencing pain that causes them distress in the past 4 months of life. Chronic breathlessness was also a recognised distressing symptom in advanced disease, with reports of prevalence up to 70% in advanced cancer and 60–100% in non-malignant life-limiting illness.

The statement further noted that opioids were widely used to treat strong pain, particularly in malignant disease, supported at Step 3 of the World Health Organization analgesic ladder. It also noted consultation by the Therapeutic Goods Administration on this issue had recently highlighted that ‘’any regulatory response must not unduly restrict informed, rational prescribing of opioids”.

Eight recommendations were made to “future proof” sustainable opioid management in Australia, including that:

All prescribers are enabled to access appropriate opioids (oral and parenteral) consistently for pain and breathlessness management for people living with life-limiting illnesses, without the burden of unnecessary regulatory barriers.

The position statement also pointed a way to resolving potential unintended consequences by calling on the Australian Government to re-form the Palliative Care Medications Working Group to review the Palliative Care Schedule of the PBS. This is a much-needed exercise to ensure the Schedule reflects contemporary palliative prescribing practice and to reduce barriers to access appropriate medications for palliative patients.

In recent weeks, positive steps have been taken. Responding to a submission by Palliative Care Australia, the Pharmaceutical Benefits Advisory Committee (PBAC) announced a review of the Palliative Care Schedule to better reflect current evidence-based palliative care prescribing. The PBAC has also reconfirmed its commitment to its support of the quality use of opioids without impact to the appropriate supply of opioids to palliative patients.

In 2018, the Australian Government earned the ire of the Royal Australian College of General Practitioners (RACGP) when it wrote to 4800 GPs about their high opioid prescribing rates. GPs were reported in NewsGP as saying the move was “intimidating … not helpful, not supportive … just unpleasant”.

In a letter to the Department, the then RACGP President, Dr Bastian Seidel, said that the letter risked unfairly targeting doctors who had legitimate reasons to prescribe opioids, such as those working in palliative care.

The letter appeared to fall on listening ears when a year later, the then Chief Medical Officer, Professor Brendan Murphy, wrote to NewsGP to clarify the purpose of the letter and to reassure GPs who prescribe opioids for palliative care patients.

I want to reiterate that we strongly applaud and encourage the work of GPs who are working in palliative care, cancer management and in complex pain clinics. It would be most disappointing and undesirable if any such GPs feel their opioid prescribing practice is anything other than encouraged and supported.

Not surprisingly, it came as a shock not only to Palliative Care Australia but also to the College, the Australian Medical Association and the palliative care community as whole when, on 1 June 2020, restrictions were imposed on opioid prescribing without careful consideration of palliative care and the nature of its optimal delivery, in particular, in the community and residential care.

On 21 September, the PBS announced that, commencing 1 October 2020, the PBS listings for opioid medicines would change.

Following feedback received regarding recent changes to opioid analgesic medications listed on the PBS, the PBAC has recommended additional changes to ensure unimpeded access to opioid medication to palliative care patients. Further, in collaboration with Services Australia, the Department of Health have restructured the current listings in order to reduce the additional administrative burden.

We applaud the PBAC for quickly acting to address the unintended consequences of the otherwise commendable opioid decision for palliative care prescribers and patients. But the lesson is clear. While the baby has been retrieved, it should not have been thrown out with the opioid bathwater in the first place.

It would not have happened if the objectives of the first National Palliative Care Strategy had been embraced 20 years ago and palliative care had been embedded as an integral part of the health system. Progress has been made, and the current National Palliative Care strategy 2018 builds on this foundation. That being said, it’s clear that not all the needs of people with life-limiting conditions are being met, because palliative care remains something that is, far too often, left at the periphery of the health system.

The current National Palliative Care implementation strategy needs key actions and collaboration between key stakeholders in medicines regulation and subsidy to ensure optimal medicines are available to support evidence-based palliative care practice. A Palliative Care Medications Working Group to review the Palliative Care Schedule of the PBS would identify and implement these actions.

With a rapidly ageing and growing population, and more people living longer but with more complex and chronic conditions, palliative care needs are rapidly escalating. Palliative care needs to be core business not only in aged care, but for health systems generally. Palliative care is a universal human right. We must ensure equitable access to specialist and generalist palliative care services for those who need it, when and where they need it.

Governments must embrace this, not only to alleviate suffering and promote good health outcomes, but also to protect their bottom line. As the KPMG report – Investing to save – has demonstrated, investment in palliative care is not just cost effective for governments, it’s cost-saving. That alone should drive change, if not from the health department, then from Treasury.

Professor Meera Agar is Chair of Palliative Care Australia.

Dr Danielle McMullen is a GP and President of the AMA (NSW).

Associate Professor Leeroy William is President of the Australian and New Zealand Society of Palliative Medicine.

Rohan Greenland is CEO of Palliative Care Australia.

Associate Professor Melanie Lovell is a palliative care physician with HammondCare.

Dr Michell Gold is President of the Royal Australasian College of Physicians’ Chapter of Palliative Medicine.

Kate Reed is a palliative care nurse practitioner, and National Clinical Advisor for Palliative Care Australia.

The statements or opinions expressed in this article reflect the views of the authors and do not represent the official policy of the AMA, the MJA or InSight+ unless so stated.