The national supply of a ‘gold standard’ pain drug is to cease in Australia from the end of the year, the TGA has announced.
Australian peak health organisations have joined forces in a public outcry over the TGA’s announcement of the looming end to national supply of a critical pain medication.
They say people nearing the end of their life or undergoing cancer treatment, including children with life-limiting illness are most at risk.
The TGA announced last month it had been notified of pharmaceutical company Mundipharma’s intention to discontinue supply of all Ordine (morphine) oral liquid medicines in Australia.
Ordine oral liquid is an opioid analgesic medicine used to manage severe pain and difficult or laboured breathing (dyspnoea) in many care settings, including oncology and palliative care.
There are four strengths of this product marketed in Australia and all strengths will be discontinued from supply between December this year and March 2024, the TGA said in a statement. The drug will be completely unavailable from 31 March.
“We are aware of the importance of these medicines in a range of clinical settings and are treating these discontinuations with high priority,” the TGA said.
“We are working with the sponsor of these products, Mundipharma, to monitor remaining supplies of these medicines, as well as a range of other stakeholders, including relevant medical and pharmacy groups, to support treatment continuity for patients.”
The TGA said pharmacists could continue to order stock as usual for now, but urged them not to stockpile to “facilitate equitable distribution of stock”.
“If you or someone you care for takes Ordine (morphine) oral liquid and you have concerns about ongoing treatment with this medicine, we would recommend talking to your prescriber,” the TGA said.
“There are other oral liquid analgesics available in Australia and we are closely monitoring the supply of those products for any flow-on impacts. We are also investigating the potential for future approvals for importation and supply of overseas-registered morphine oral liquids under section 19A of the Therapeutic Goods Act 1989.”
A Mundipharma spokesperson told media their third-party manufacturer decided to stop producing the drug, and “sourcing another manufacturer would not be commercially viable”.
“We urge affected patients to discuss alternative options with their healthcare professional,” the statement said.
A group of 18 palliative care organisations, led by Palliative Care Australia, have joined forces to amplify their concerns about the move. They say oral liquid morphine is a gold-standard treatment for management of pain and shortness of breath. It is also widely used for children and adults undergoing curative cancer treatment, particularly when treatment is associated with significant pain or the patient’s ability to swallow is compromised.
There are no appropriate alternatives currently available in Australia for these patients and without it, people may not be able to tolerate the treatments they need, said Josh Fear, Palliative Care Australia’s national policy director.
“This is the fourth opioid to have supply challenges in Australia in recent times,” he said.
“Due to Australia’s system for regulating medicines, it can take months for an alternative supplier to be found, then for the same medicine to be re-approved by the TGA, and then finally for it to be re-listed on the Pharmaceutical Benefits Scheme (PBS) – if a replacement is found at all.
“PBS listing is critical for meaningful and equitable access. Without PBS subsidy, prices can be very cost-prohibitive for patients and their families.
“As global supply chains become more complex, Australia needs more nimble systems for anticipating and responding to disruptions in the supply of essential medicines. We also need a better way of communicating with clinicians and patients.
“Until then, these kinds of announcements will continue to cause anxiety and frustration for very vulnerable people and their treating clinicians.”
It is understood a number of health organisations have already written to Health Minister, Mark Butler, highlighting the issue.
“The bigger issues at play here are not new, and we are hopeful that a government focused on health reform and patient care can respond and put people at ease,” Mr Fear said.
“Globally, Australia is the second-largest producer of the raw materials for morphine, yet we are still regularly experiencing supply problems. There is an opportunity here to develop our sovereign capability and manufacture essential medicines right here in Australia.
“In the meantime, we look forward to working with the TGA as it works to find a replacement for this essential medicine as quickly as possible.”
