The PBS has amended opioid restrictions it introduced back in June following intense lobbying from medical groups who said palliative care patients, particularly non-cancer patients, would face significant barriers to accessing timely pain relief under the new listing.
The tighter prescribing regulations that came into effect on 1 June 2020 were designed to curb misuse of the pain relieving medications following widely acknowledged concerns about Australia’s increasing opioid-related hospitalisations and deaths.
But the changes caused significant confusion and concern from doctors treating patients in palliative care.
In particular the requirement for an annual review by a second medical practitioner to authorise prescriptions for patients using opioids for more than 12 months was met with fierce opposition by Palliative Care Australia along with the Royal Australian College of Physicians (RACP), the Australian and New Zealand Society of Palliative Medicine (ANZSPM) and the AMA. The groups said many palliative care patients would be left in unbearable pain and suffering while waiting for the review, which could take days.
Speaking to the limbic in May, 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.’
“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.”
Secondary review
Responding to the backlash the Pharmaceutical Benefits Advisory Committee (PBAC) has now recommended a number of changes to opioid analgesic medications listed on the PBS.
From 1 October, patients treated in the palliative care setting will be able to undergo the annual secondary review with a palliative care nurse practitioner. Meanwhile for those who are unable to attend a consultation, a patient may be exempt from requiring an annual secondary review if their condition doesn’t allow them to.
In a press release AMA president Dr Omar Khorshid said the update is an ‘important change for palliative care patients who may be too unwell for this to occur’.
“Opioids are clinically necessary in many circumstances to relieve suffering from pain and breathlessness experienced by palliative care patients,” he said, adding that current clinical guidelines do not recommend opioids for the long-term treatment of chronic non-cancer pain.
The PBS listings have also been restructured to include treatment phases and reflect the length of time a patient has been treated with both PBS-subsidised and non-PBS subsidised opioids.
From 1 October, the date of the review and name of the medical practitioner consulted will also no longer be required to be provided for every authority application but prescribers will need to ensure this information is kept for compliance purposes.
The prescribing authority says this will simplify the process for requesting authority approval from Services Australia, and ensure that prescribers will not be required to repeat the same information for each authority application.
Palliative Care Australia said while the changes are an important step in the right direction it wants further reform to the palliative care schedule, which it says is currently 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.
All new and amended restrictions will be updated on the PBS website from 1 October 2020