Newly implemented PBS restrictions designed to curb the misuse of opioids could lock some palliative care patients out of timely access to medications for treating pain and breathlessness, say peak palliative care organisations.

The tighter regulations, which came into effect on 1 June, were made following concerns about Australia’s increasing opioid-related hospitalisations and deaths.

Changes include smaller pack sizes, restrictions on repeats for acute pain, and the need for a second doctor to sign off authorisations on some opioid prescriptions.

According to the PBS, to be eligible for treatment with extended-release opioid formulations typically used in the chronic pain setting a patient’s condition must require daily long-term therapy with the treatment and the patient must have either pain attributable to cancer or one of three other criteria. Patients will need to be unresponsive or intolerant or have achieved inadequate relief of their chronic pain, to maximum tolerated doses of non-opioid treatments.

The changes apply to potent opioids fentanyl, morphine, oxycodone and hydromorphone, as well as tramadol, tapentadol, codeine and buprenorphine.

But Palliative Care Australia says an unintended consequence of the new rules is that they block access for palliative patients with non-cancer pain.

A new requirement for annual checks by a second medical practitioner to authorise opioid prescriptions for patients who have been using the medications for more than 12 months has lead to fears that palliative care patients, particularly non-cancer patients, may now face significant barriers to timely pain relief.

In a press release addressing it’s concerns Palliative Care Australia said that while it ‘recognised that safety regulations are required, put simply, the issues of addiction and misuse are not critical factors for palliative care patients.’

It’s calling on the PBAC to amend the PBS indication and authority criteria for non cancer palliative care patients arguing that the current restrictions could lead to unwarranted hospital admissions.

“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,” it said in a press release.

Non-cancer palliative care patients hit hardest

Speaking to the limbic Palliative Care Australia’s national clinical director, and palliative care nurse, Kate Reed said the changes took PCA by surprise.

“Palliative care Australia has been part of the discussion with the TGA around making some regulations around opioids that are misused within the community, however we were hopeful that palliative care patients were not going to be unintentionally caught up by those regulations.”

Ms Reed said while the changes don’t seem to impact palliative care patients with cancer diagnoses there is serious concern for non-malignant palliative care patients particularly the clinically deteriorating patient in residential aged care or community settings.

“We are concerned about patients in these settings – patients who might have heart failure for example and who have pain secondary to that who might need to have opioids to address their pain.”

Ms Reed points out that the PBS does allow for opioid prescribing for non malignant patients – a concern that surfaced when the restrictions were first rolled out because prescribing criteria for that group are not easily located on the revised PBS listing and palliative care is not explicitly mentioned.

The oversight has already caused problems for health professionals when requesting authorities through Services Australia, according to PCA.

“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 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.”

PCA said it is working with regulators and is ‘optimistic that these communication issues can be improved quite quickly’.

“It is absolutely possible for us to provide for non malignant palliative care patients,” adds Ms Reed.

“The criteria are there, it can be harder to find and Service Australia staff may not be aware of that.”

Meanwhile the requirement for a second medical practitioner to authorise prescriptions of certain opioids should exclude palliative care patients, Ms Reed argues.

“If a patient has been on opioids for a long time and they are heading towards dying then usually their requirements at that time go up. That means that we would need to quickly get approvals for increased dosages, maybe even different opioids, so that we can address their suffering as quickly as possible. We don’t have the time and we don’t want to burden a patient with having to get a second opinion,” she said.

Exclusion of nurse practitioners

Adding to that is the exclusion of palliative care nurse practitioners, who are able to prescribe opioid medications, from the list of health professionals approved to provide the second opinion.

“Nurse practitioners haven’t been recognised as the second check and that’s a worry because there are not that many palliative care specialists out there, it’s a small group, and it’s really important that people are able to access responses and help quickly for patients – it’s got to be timely.”

Ms Reed said PCA is working closely with the Department of Health to address the unintended consequences of what it acknowledges is a legitimate reform process.

“The changes to the PBS listing are very important and essential for opioid management within the wider community … but the point is that isn’t palliative care.”

PCA will be formally writing to the PBAC about PBS indications, quantities and authority requirements to alert them to the concerns for health care professional caring for palliative care patients.

As part of its advocacy PCA is urging health professionals to report cases where patients have been disadvantaged, or where palliative care health professionals have had delays and problems prescribing appropriate medications under the PBS restriction criteria.