Naloxone shortage goes national in wave of opioid overdose

Access to lifesaving overdose medicine has become ‘critically’ precarious, foregrounding the shortcomings of a federal program in a crisis of stigma, stimulants and supply issues.

Unharm founder Will Tregoning has urged the Albanese government to seek out alternate Naloxone producers amid a national shortage placing casual drug users in the jaws of increasingly common opioid-laced drugs. Picture: John Appleyard

Public trust in a federal access program for the overdose drug Naloxone has been shaken after more than a year of shortages were announced, potentially placing lives at risk.

The Therapeutic Goods Administration advised Naloxone would be in limited supply from December 10, and then updated its advice in late January to warn it would remain scarce until at least the beginning of next year.

The notice cites an “unexpected increase in consumer demand” and classifies it as a critical shortage which comes after both NSW and Victorian health authorities advised they had seen massive uptakes in the nationwide Take Home Naloxone program.

“The TGA is in consultation with the sponsor to monitor supply and develop a management strategy,” the notice reads.

Australia’s supply of Naloxone is produced overseas by the pharmaceutical giant Mundipharma. There is no alternative brand approved or available.

Naloxone is a nasal spray used to reverse opioid overdose; it has seen a worldwide access drive and swathes of subsidies follow from population-wide studies beginning in Victoria through the 2010s.

National Drug Research Institute professor Paul Dietze conducted the very first of these studies and has since worked with the World Health Organisation’s opioid overdose management working group while assisting in providing national access to Naloxone.

“The drug company hasn’t forecast exactly the demand, and there are obviously competing demands across the world,” Professor Dietze said.

“What it does provide, though, is an opportunity for other competitors to enter the marketplace.

“There’s potential for special access schemes to be implemented to try and bring in alternatives if the supply shortage remains. It’s just a reflection of the extraordinary success of the Naloxone program.”

Because Naloxone expires, efforts to prevent further shortages would need to account for ­replenishment, Professor Dietze advised.

Naloxone nasal spray, sold under the brand name Nyxoid, is an overdose reversal drug at the centre of a federal access program. Picture: Alan Barber

Nitazenes, an extremely potent opioid, are increasingly commonly cut into stimulants such as cocaine and methamphetamine. Picture: Australian Border Force

“It’s hopefully just a blip; (hopefully) they’ll have a better sense of the size of the market, because the amount of Naloxone that’s going out has increased dramatically,” he said.

“Anticipating that change would have been quite difficult, so hopefully they’ll be able to ­accommodate that in future.”

Both NSW and Victorian health authorities have reported steep uptakes in Naloxone after releasing health warnings on the presence of opioid-laced cocaine, MDMA and methamphetamine in the illegal drug market.

A Victorian government spokesperson said Naloxone demand was “currently being met”, while NSW Health Minister Ryan Park said demand had risen 290 per cent since 2019 from 13,000 doses supplied in a year to 37,860.

“I am advised that NSW Health is not aware of any current impact on access to Naloxone in NSW,” Mr Park said.

“I understand that the National Naloxone Reference Group met last week and the supply of Nyxoid in Australia was discussed among attendees.”

In June, four people were found dead in Melbourne after taking cocaine laced with a synthetic opioid. In NSW last September, two were killed and two hospitalised by heroin-laced cocaine.

Synthetic opioids known as nitazenes are increasingly common in Australia and can be many orders of magnitude more potent than fentanyl.

While Naloxone has been available for decades in Australia, it was not commonly accessible until a pilot access program under the Morrison government that was expanded by Labor.

In Australia, it is sold under the brand name Nyxoid and in the US as Narcan.

Unharm founder Will Tregoning, whose charity focuses on drug harm minimisation, said the shortage drew attention to shortcomings of the Take Home Naloxone program.

“It’s not fit for purpose … at a time when the risk is greater than ever,” Mr Tregoning said.

“It puts government in this difficult position where, on the one hand, they should be out there increasing awareness of the need to have Naloxone, but there’s no benefit increasing awareness if they don’t have the supply to actually meet the demand that they create.

“The irony is that stigma is probably artificially keeping demand lower. So even as we see efforts to unwind stigma, it is now just going to bump up against this new problem around lack of supply.”

Forecasting no reprieve from the rising rate of opioid spiking, based on similar trends in Europe and the UK, Mr Tregoning argued Australia should seek out possible alternate Naloxone providers.

“(Relying solely on Mundipharma) is a huge weakness of the program. I know there are other forms of non-nasal spray Naloxone that are authorised for distribution in Australia, but it is much less likely to be taken up,” he said.

“I’d be really concerned about any kind of approach that involves discouraging people from accessing Naloxone at this point … this is an unprecedented potential crisis that we’re dealing with.”

Federal Health Minister Mark Butler was contacted for comment.

The TGA said it was “currently assessing applications for overseas-registered alternatives” and pointed to the availability of Naloxone injections and ampoules.

A Mundipharma spokesperson said: “From our perspective, the increase is driven by growing consumer demand. Medicine manufacturing cannot be rapidly scaled up due to stringent requirements.”