While a new pharmaceutical company has taken over manufacture and supply to Australia and alternatives are approved, access is still a major challenge.
Relentless challenges around the supply of critical pain relief medicines continue to cause distress and confusion for patients, their families and health professionals, says an Australian peak body.
According to Palliative Care Australia’s CEO Camilla Rowland, the shortage of oral liquid morphine products is one of the greatest concerns.
In July last year the Therapeutic Goods Administration announced that UK pharmaceutical company Mundipharma was removing oral liquid morphine (Ordine) from the Australian market.
The liquid opioid analgesic is used to manage severe pain and difficult or laboured breathing (dyspnoea) in many care settings, particularly oncology, palliative care and motor neurone disease.
At the time, a Mundipharma spokesperson told media their third-party manufacturer decided to stop producing the drug, and “sourcing another manufacturer would not be commercially viable”.
According to the TGA, the four strengths of Ordine (1, 2, 5 and 10mg/mL) were deleted from the market between December 2023 and March this year.
Following advocacy from the sector, which included a group of 18 organisations led by PCA, the TGA sourced and approved a range of alternative temporary medicines (Section 19A products) to fill the gap while a new manufacturer of Ordine (Arrotex Pharmaceuticals) established itself and supply.
Advice from the TGA suggests that a more reliable, consistent supply channel will come on line in August. While that is now only weeks away, doctors, nurses, pharmacists, and carers had to manage fluctuating supplies week by week, said Ms Rowland.
It will also take many months for all four strengths of the medication to return to supply.
“For many clinicians, the challenges around a lack of guaranteed supply of medicines has been ongoing for 18 months or more,” she said.
“This is an issue the palliative care sector has been managing for too long, and right now PCA and our members around Australia are hearing from increasingly frustrated and distressed clinicians.”
Ms Rowland said supplies of the temporary medicines (Section 19A products) had proven to be problematic and not provided the reassurance patients and the sector hoped for.
“We are in regular communication with the TGA on this issue and I want to thank them for their efforts to source alternative medicines as we all grapple with an ever more challenging global supply chain,” she said.
PCA chair Professor Meera Agar said having to swap between various products to fill the gap in the supply chain was an onerous workaround with significant impacts for people where time was precious.
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“Pain management requires an individualised approach. It’s work we do side by side with the patient and their carer, who is often the person administering this medication,” said Professor Agar, a practising palliative care physician in southwest Sydney.
“Use of a particular medicine is supported by experience, education, and evidence – but instead we find ourselves needing to ring around and find supplies, adding medical appointments, getting scripts, relearning a new medication regimen – and having to communicate that to people at a time where they are unwell.
“It’s easy to get confused about how to manage your medications when it keeps being swapped around depending on supply, not to mention the side-effects that can come from new and changing medicines.”
PCA deputy chair Dr Peter Allcroft, a palliative care specialist from Adelaide, said he was hopeful that a reliable supply of Ordine, when available, would ease the current pressure on clinicians.
“The ongoing difficulty with access to reliable medications has been a concern, particularly as these are medications that our clinicians feel comfortable with and have experience using,” he said.
“While it has been reassuring to have other pain relief options available for the families in our care, it’s important to note that access to pain relief is a basic human right.
“PCA and the sector more broadly would welcome the opportunity to work collaboratively with government to ensure that Australia has a stable supply of this critical medicine into the future.”
In an update published by the TGA last week, Arrotex Pharmaceuticals advised that the return-to-supply dates for Ordine oral liquid had been extended. While the medication is still branded as Ordine, the TGA has flagged that it may be rebranded.
“Normal supply of Ordine is now expected between late-August and late-November 2024, depending on the strength,” said the TGA.
The expected dates for a return to supply for the four strengths (as of 27 June) include:
- 2mg/mL: 23 August
- 1 and 5mg/mL: 27 September
- 10mg/mL: 29 November
A number of substitute overseas-registered oral liquid morphine products under section 19A of the Therapeutic Goods Act 1989 have been approved for supply in Australia while Ordine remains unavailable.
Not all are PBS-listed, however, and some are also in limited supply or unavailable. The TGA has a dedicated webpage to keep prescribers up to date on what is approved and the supply status for each.
