Australia faces drug shortage, TGA says more than 320 drugs are affected

Australia is facing growing drug shortages due to continued supply chain disruptions, sparking new calls to reduce the country’s near-total reliance on India and China for drugs vital.

Doctors and pharmacists have sounded the alarm that patients are at risk from a worsening crisis, with 321 drugs currently listed by the Therapeutic Goods Administration as facing shortages – of which nearly 50 are deemed critical – and 85 more are expected to join the list.

Drugs for diabetes, depression, anxiety, stroke, nausea, hormone replacement therapy and cancer treatment are among those currently or soon to be in short supply or completely unavailable.

Dr Cathryn Hester, Queensland vice-president of the Royal Australian College of General Practitioners (RACGP), said urgent action was needed.

“Scarcity of certain medicines is becoming a growing problem in Australia, and it has really been made worse by the Covid-19 pandemic which has affected international supply chains,” Dr Hester said.

“GPs are seeing more and more patients who tell them they cannot get the medicines they have been prescribed at their local pharmacy. GPs often have a good relationship with pharmacies in their area and will work with them to help get the medicines their patients need if they are having trouble finding them. We can also sometimes find a substitute for a certain drug, but drugs do not easily substitute for each other.

Dr Hester said Australia needed to “address this problem with a long-term solution because when people go without the medicines they need, it can harm their health and well-being”.

Pharmaceutical Society of Australia (PSA) national president Dr Fei Sim said drug shortages had been a “long” problem, but the pandemic had put additional pressure on supply chains.

“The shortages are affecting a range of drugs, from over-the-counter cold and flu medicines to prescription drugs like the diabetes drug Ozempic,” she said.

“Demand for common medicines like paracetamol is increasing as Australians struggle with a variety of illnesses.”

Under a new drug supply guarantee between the federal government and pharmaceutical companies, manufacturers will be subject to minimum storage requirements of four to six months for certain key brands enrolled in the Pharmaceutical Benefits Scheme.

But the new rules won’t come into effect until July 1, 2023.

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Dr Sim welcomed the guarantee, which will come with price increases for up to 900 different drugs, but said “more needs to be done to ensure a steady supply of PBS drugs”.

“Many people depend on these essential medicines for their health and well-being,” she said.

“PSA and the entire health sector are working with the Ministry of Health and the government to ensure a constant and continuous supply of lifesaving medicines. It is always best to work with your pharmacists and doctor, if a medication is not available, your healthcare team will work with you to ensure you have the best access to care available. Pharmacists will work with you in the event of a shortage of over-the-counter medications and suggest alternatives.

Acting Pharmacy Guild President Nick Panayiaris said The Guardian the shortages revealed “a whole sovereign risk problem here”.

“We used to be big drug makers in the country, and unfortunately more and more drugs have been lost, especially the generic drug industry, where a lot of it is now based in India and China, etc. “, did he declare.

“So the government needs to seriously look at this, because these are not just any products, these are essential medicines, which keep people alive.”

He added that pharmacies were “crushed” for ready-to-use products such as liquid paracetamol as the winter cold and flu season coincides with a further rise in Covid cases.

“We have an increased demand for the use of paracetamol, and unfortunately at the moment it’s a huge problem for us at the pharmacy level in terms of having an essential medicine that we really need when people are suffering the effects of Covid,” he said.

“There’s no certainty when we’ll get a reasonable stock position with these things at the moment – it’s just a bit of Russian roulette, to be honest with you.”

Amid the disruption caused by the Covid pandemic, former Treasurer Josh Frydenberg asked the Productivity Commission last year to assess the risks to Australian supply chains.

The final report, released last August, concluded while Australian supply chains had been disrupted by Covid and trade tensions, “most critical supply chains have proven to be resilient”.

“While people understandably have apprehensions about supply chains, only a few products in commerce are vulnerable,” the Productivity Commission’s Jonathan Coppel said in a statement.

“Companies can usually manage these risks through storage, contracts and diversification.”

Australia imported 5,950 different products in 2016-2017 worth $272 billion, around 16% of its gross national income.

Pharmaceuticals were the fifth largest import category at $10.6 billion, after vehicles, machinery, electrical equipment and mineral fuels.

“At the start of the Covid-19 pandemic, many expressed concerns about Australia’s reliance on imports of active pharmaceutical ingredients (APIs) and other pharmaceutical inputs,” the report said.

“Australia imports most of its pharmaceuticals from Europe and the United States, which increasingly rely on APIs made in India and China. In 2017, China produced 40% of APIs in the world and India provided 20% of global generic drug exports.

Disruptions to Indian and Chinese production during the pandemic raised fears of shortages in Australia, leading to panic buying and stockpiling and subsequent government-imposed purchase limits.

“Despite concerns, Australia’s pharmaceutical supply chain was ‘strong and weathered the challenges posed by the Covid-19 pandemic’ well,” the report said, citing a submission from Medicines Australia.

“Shortages of other medicines caused by the Covid-19 pandemic have also been reported, such as certain hormone replacement treatments and antidepressants. However, it doesn’t seem out of the ordinary. Medicines Australia noted that “drug shortage events, although perhaps more focused on products subject to hospital and public stocks due to [Covid-19]did not increase in Australia in 2020”.

The Productivity Commission pointed out that drug shortages were common even before the pandemic, affecting patients, doctors and pharmacists.

“The combination of intense price competition (particularly in the generics market) and a lack of transparency in supply chains hampers companies’ ability to accurately price (and therefore reward) the right quality management and supply chain resilience leading to shortages,” he said. said.

However, the Institute for Integrated Economic Research – Australia (IIER-A) has previously warned that Australia is dangerously dependent on imported medicines.

In early 2020, an IIER-A released a report highlighting that Australia imports over 90% of its medicines and is at the end of a very long global supply chain, making it vulnerable to disruption.

“Australia is particularly vulnerable to drug shortages resulting from factors beyond our control,” retired Air Vice-Marshals John Blackburn and Anne Borzycki of IIER-A wrote in an article at the time. of opinion.

“These factors may include manufacturing issues, political instability, pandemics, another global economic crisis and natural disasters. The just-in-time nature of Australian supply chains is of particular concern. While just-in-time makes business sense, it leaves Australians vulnerable to supply chain disruptions, whether unintentional or deliberate.

In an October 2021 report from IIER-A calling Australia a “complacent nation”, the group warned that the pursuit of profitability had “resulted in a significant erosion of our health systems and their resilience as our country was gradually losing manufacturing capacity to the point where we now import over 90% of our medicines and almost all of our personal protective equipment.”

“This happened without ensuring sufficient buffers in the event of a crisis through storage warrants,” the report said. “The fall in prices in normal times can have a very high cost in a crisis.”

Health Minister Mark Butler has been contacted for comment.

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