13 Aug Calls for national strategy as babies and cancer patients struggle with drug shortage

Source: TheAustralian

By: Tansy Harcourt

Pediatrician Antonia Milner has resorted to crushing up Azithromycin tablets for tiny babies who would normally receive liquid antibiotics.

Parents of children who take long-acting medication for ADHD are being told by their pharmacists to come back the following week in the hope another shipment of Vyvanse will have arrived to fill their scripts.

Anecdotally, Australia is facing a drug-shortage crisis of unprecedented levels.

The chief executive of Victorian drug company IDT, Paul McDonald, said the “situation is serious, we are seeing the drug-shortage list grow, 411 on the TGA drug-shortage list now and it’s not just regular meds it’s cancer patients”, and not enough is being done by the government to fix the problem.

“My fear is mostly around cancer patients that are undergoing a course of chemotherapy,” he said. “Some of these patients are children with leukaemia that have their courses disrupted by drug availability.”

If having a child with leukaemia isn’t difficult enough, current shortages of drugs such as Cisplatin and Carboplatin have been problematic long term. Oncologists are having to resort to alternatives that are available and potentially less effective drugs that sometimes require longer treatment cycles.

In many cases the drug shortage remains hidden from the public eye because doctors are resorting to “work around” treatments such as second-tier drugs or lower dosages to avoid creating panic among already under-pressure patients.

“When you get a shortage, oncologists and physicians start to use other drugs within the indication that may not be their primary choice,” said Mr McDonald. “So a lot of the issues with the drug shortage potentially aren’t visible because they just use the secondary and tertiary choices which may not be as beneficial as the primary choice”.

The Therapeutic Goods Administration currently lists 411 drugs on its shortage alert. Drug shortages are nothing new and the TGA said it was no worse than it had been since 2019 but Mr McDonald and doctors disagree.

And while diminished supplies of weight loss drugs such as Wegovy are overweight in the media spotlight, the shortage has included intravenous fluid required for surgeries, Vyvanse used for ADHD, Estradot for hormone replacement therapy, Midodrine for hypertension, Warfarin for blood thinning, Penicillin V, and a raft of cancer medications.

The IV fluid shortage has become so extreme some hospitals have been forced to cancel elective surgeries. NSW Health Minister Ryan Park described the state’s IV fluid supply as “patchy”.

“Until we’re through this difficult period, we are going to be fairly stringent about the use of IV and the way in which it’s controlled and managed,” he said. “Obviously it will always be done in a way that’s clinically appropriate and clinically safe, but it is a challenge.”

The drug shortages stem partly from the fact that Australia creates very few of its own drugs and 90 per cent of what is produced here is exported by its foreign-owned manufacturers.

Through a spokesman, federal Health Minister Mark Butler acknowledged the drug shortage was a problem and that “managing medicine supply is a priority” for the government.

“The Albanese government is committed to increasing Australia’s sovereign manufacturing capacity in medical essentials through the establishment of the $15bn National Reconstruction Fund (NRF),” the spokesman said. “The NRF will make medical technology one of its priorities and work with the Future Made in Australia Office to develop a national investment plan for health care essentials, which will identify what needs to be made in Australia and how to make that happen.”

The question is when?

Listed minnow IDT is the biggest producer of small-molecule active pharmaceutical ingredients (the active that goes into medicines) in Australia and recently announced a deal with the Victorian government to produce antibody drug conjugates, an advancing form of smart chemotherapy for treatments such as childhood leukaemia, but first-line cancer drugs such as Cisplatin and Carboplatin are now all produced overseas, imported and manufactured as medicines here in Australia.

About 95 per cent of chemotherapy drugs administered in Australia are made overseas. This means the nation is beholden to global drug supply issues, of which there are plenty. The current crisis kicked off during the Covid pandemic when China, a key producer of both “active” and finished drugs, shut down.

Many US drug contracts shifted finished-dose manufacturing to countries such as India and then hit problems with quality standards because of a lack of experienced workers. This was compounded by the fact that international regulators reduced the frequency of site visits during the peak of the pandemic. The end result was a slowdown of manufacturing and new regulatory approvals, creating a shortage in the US, which has flowed on to Australia.

IDT is the nation’s last remaining manufacturer of scale producing small molecule drugs; and global companies with facilities in Australia have preference for the active pharmaceutical ingredient from manufacturers overseas, which means demand for their locally made product has declined in preference for overseas manufactured materials.

A common strategy for pharmaceutical companies is to direct their supply of active pharmaceutical ingredients as a primary source from China and a secondary source from Europe, snubbing local manufacturers. When supply chain disruption occurs in China the companies turn to their alternate in Europe, which in turn struggles with the burden of larger expectation, and a drug shortage starts all the while local manufacturers are snubbed.

“No one can keep up, once disruption occurs, the problem is moved to another location” said Mr McDonald. “If a manufacturer focuses on a shortage of one particular drug, others are deprioritised and become the new shortage. We should be focusing on alternate supply chains that particularly focus on problematic products so that the natural supply chain can focus on what they do best, manufacture and supply critical medicines.”

Mr McDonald believes sovereign drug manufacturing needs to ramp up, and that because Australia has a reputation as a high-quality producer the country could become much bigger in the finished-dose part of the manufacturing cycle.

“The key thing is we’ve got facilities here that can manufacture these drugs,” he said.

The drug CEO said large global producers should be incentivised to manufacture in Australia.

“If we committed to large scale runs, the overheads from labour are absorbed over a much larger batch size. And then we’re competitive.

“If you’ve got Pfizer manufacturing a dozen of the highest volume chemotherapy agents right here in Melbourne, and exporting 90 per cent of that overseas, well back 20 years ago, IDT used to make a lot of the active pharmaceutical ingredients (API) for those private products, then it would travel five kilometres down the road from Boronia to Mulgrave to be formulated and fill finished. Now all that API comes from China or Europe.”