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.