Government inaction leaves essential medicine shortages unresolved

Pharma News: Over the past 12 months, at least six essential medications and products have been withdrawn from the Australian market, creating significant challenges for patients and healthcare providers.

“Patients who are reaching the end of their life are suffering additional distress and uncertainty due to the ongoing shortage of morphine-based pain-relieving medicines in Australia,” stated Dr Michelle Gold, President of the Australia New Zealand Society of Palliative Medicine and Director of Palliative Medicine at the Alfred Hospital in Melbourne.

The shortage has forced doctors to switch to alternative medications that may be less effective and pose risks to patient care due to potential confusion among nurses, doctors, and community carers, including family members. Despite the government’s awareness of the issue since last year, there has been little evidence of action from the Federal Government to address the situation.

“We have been alerting the TGA and the Minister of this looming crisis for close to a year now. We have written directly to the Minister and the TGA, and we have had meetings with department officials. While the TGA are doing what they can to inform the professions and the public, they are not responsible for ensuring the supply of these much-needed medicines,” emphasised Dr Gold.

“The regulations and government policy surrounding the supply of essential medicines are complex, but it is extremely frustrating that essential morphine-based medicines, which we prescribe daily in Palliative Medicine, are in such short supply or not available at all. We are being forced to use medicines or products that result in less effective pain relief and may lead to unwanted side effects,” Dr Gold added.

The situation is particularly dire in private and rural settings, where local pharmacists face more complex processes and prohibitive costs to access medicines from the shortage list, known as the S19A list.

“If a medicine is listed under s19A as being a substitute for the PBS listed medicine, this alternative may very well not have PBS listing, making it very expensive. For example, morphine liquid can be up to ten times more expensive.

“Even worse is Hydromorphone SR (slow release). Previously, a pack of 100 x 32mg tablets of the Australian product would be $182. This has been removed from the market, and the overseas alternative is $4209 for 100 tablets, which is 23 times more expensive. I am sure anyone can see the problem here,” explained Dr Gold.

This disparity means patients in the public system might receive these medicines at a subsidised cost, while those in private care or the community could face hundreds of dollars in expenses for the same medicine, or it may be inaccessible altogether.

ANZSPM is advocating for PBS listing for all substitute medicines where the original had such a listing, highlighting the inequity in end-of-life treatment across public, private, and community sectors, and urging the government to address this issue.

Dr Gold noted that the government is currently seeking advice for an upcoming medicines shortage reform process.

“ANZSPM is involved in providing our advice and concerns to the TGA and contributing to the reform. Some changes lie outside the TGA’s powers and relate to existing shortcomings in legislation and government policy.

“We shall be advocating for these changes and hoping that steps are taken to secure our nation’s supply of essential pain-relieving medicines in the future. Patients receiving end-of-life care deserve better than what we can offer today,” she said.

The current situation has doctors being advised almost weekly on which medicines they can access, forcing them to adapt quickly to continue providing the standard of care they strive for.

“Imagine being a patient near the end of their life, whose pain is under control, being told, sorry, that medicine or product is no longer available. We are all trying to find the best alternatives for our patients, but selection is limited and changes weekly,” Dr Gold concluded.

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