Vital medicine unites health organisations in a desperate plea

Pharma News: In a race against time to avert a looming crisis, key health organisations have united their efforts to address a distressing situation. They are bracing themselves for a critical shortage of a vital pain relief medication that is predicted to run out soon. The most vulnerable individuals, including those nearing the end of their lives and cancer patients, especially children with life-limiting illnesses, are at the greatest risk.

Taking the lead in this urgent campaign is Palliative Care Australia, supported by a coalition of 18 organisations*. The risks associated with this impending crisis are multifaceted, stemming from a combination of factors including disruptions in the global supply chain, regulatory changes, alterations in opioid prescribing patterns, and business decisions made by individual pharmaceutical companies. Adding to the distress, pharmaceutical company Mundipharma recently announced that it can no longer provide the Australian market with its oral liquid morphine product, Ordine.

Mundipharma attributed the withdrawal of Ordine from the Australian market to the closure of an overseas factory. According to the Therapeutic Goods Administration’s (TGA), existing supplies of Ordine are estimated to be depleted between December 2023 and March 2024.

“We are aware of the importance of these medicines in a range of clinical settings and are treating these discontinuations with high priority. 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,” said the TGA in a statement.

Oral liquid morphine holds a vital position on the World Health Organisation’s list of essential medicines. It is considered the gold standard for managing pain and shortness of breath. This medication is extensively utilised by both children and adults undergoing curative cancer treatment, particularly when significant pain is involved or the patient’s ability to swallow is compromised. Shockingly, there are currently no suitable alternatives available in Australia for these patients.

Josh Fear, National Policy Director of Palliative Care Australia, expressed concern, stating, “This is the fourth opioid to face supply challenges in Australia recently.”

He further explained the challenges in finding a suitable replacement, saying, “Due to Australia’s system for regulating medicines, it can take months to identify an alternative supplier, obtain TGA approval for the same medicine, and ultimately have it relisted on the Pharmaceutical Benefits Scheme (PBS), if a replacement is even found.”

The listing on the PBS is critical to ensure meaningful and equitable access to the medication. Without PBS subsidy, the prices for patients and their families can become prohibitively high. Fear emphasised the need for more agile systems in Australia to anticipate and respond to disruptions in the supply of essential medicines, as well as improved communication with clinicians and patients.

He added “These types of announcements will continue to cause anxiety and frustration for very vulnerable people and their treating clinicians until we address these issues.”

Recognising the severity of the situation, several health organisations have already written to Health Minister Mark Butler, urging him to take swift action. Fear expressed hope that a government focused on health reform and patient care would respond promptly, saying, “The larger issues at play here are not new, and we are optimistic that the government can reassure the public and prioritise the well-being of the affected individuals.”

Amidst the urgency, Mr Fear highlighted an opportunity for Australia to leverage its position as the second-largest producer of raw materials for morphine globally. He emphasised the potential to develop sovereign capability and manufacture essential medicines within the country. By doing so, Australia could enhance its resilience to supply disruptions and ensure a stable and reliable source of critical medications.

In the meantime, the coalition of health organisations expressed their commitment to working closely with the TGA. They hope to expedite the search for a suitable replacement for the essential pain relief medication. Every effort will be made to find a viable alternative as quickly as possible, ensuring that patients in need can access the necessary treatments without undue hardship.

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*Some of the prominent groups lending their support include Palliative Care Victoria, Palliative Care Queensland, Palliative Care South Australia, Palliative Care Tasmania, Palliative Care NSW, Palliative Care ACT, Palliative Care Western Australia, Australian and New Zealand Society of Palliative Medicine, Palliative Care Nurses Australia, Paediatric Palliative Care Australia and New Zealand, Quality of Care Collaborative Australia, Pain Australia, Australian Pain Society, Head and Neck Cancer Australia, Clinical Oncology Society of Australia, MND Australia, and the Society of Hospital Pharmacists of Australia.