TGA launches medicine shortage investigation

It is an escalating problem putting patients at risk and GPs on edge – medication shortages continue to disrupt the health of Australia.
 
In a bid to combat this, the Therapeutic Goods Administration (TGA) has launched a new inquiry to examine how to reduce the impact of shortages and discontinuations, and how to better communicate them with healthcare professionals.
 
The Medicine shortages in Australia – Challenges and opportunities review is calling on medical professionals to take part in a survey to offer insights into the current problem, as well as solutions for the future.
 
‘Medicine supply chains are complex global systems involving many parties,’ the TGA said.
 
‘There are numerous points in the supply chain where problems can cause a national medicine shortage, each requiring a different response.
 
‘We need the cooperation of all stakeholders in the medicine supply chain to develop solutions to better prevent, manage and communicate shortages.’
 
The TGA survey will include questions on a range of topics, including how to better plan for, respond to, and communicate shortages, their impacts, and improvement opportunities.
 
RACGP Expert Committee – Quality Care Chair Professor Mark Morgan said changes must be made, with current shortages already impacting patients’ health.
 
‘There are indirect harms when prescribers must choose a less effective or less safe alternative medicine,’ he told newsGP.
 
‘It would be beneficial if Australia had the capacity to manufacture, quality assure and approve the use of alternatives.
 
‘Australia should manage national stockpiles of medicines to ride out temporary manufacturing or transport problems, but it is unclear how effectively this is governed at the moment.’
 
When a shortage occurs currently, the TGA has the power to enact a range of management actions, including distributing stock, issuing guidance on prioritising prescribing, and approving the supply of alternative products.
 
However, there are several actions it is not allowed to take, such as obligating pharmaceutical companies to manufacture medicines in Australia, managing how medicines are distributed, or redistributing medicines to specific locations or patients.
 
It is also unable to decide how much a medicine costs or obligate health practitioners to prescribe medicines in a certain way.
 
But Professor Morgan said most medication use in Australia is predictable thanks to data on population size, medicine-use history, and trends or seasonal variations.
 
‘I do question how the recurring problem of shortages can be fixed and whether there is a clear national strategy,’ he said.
 
‘Our supermarkets do a fairly good job of sourcing thousands of product lines with substitutions when necessary and nobody dies from lack of an avocado!’
 
Professor Morgan said shortages can be common in specific instances, including the outbreak of a new disease, such as COVID-19, or when there is a rapid change in clinical practice or patient demand.
 
That patient demand is most apparent with the current shortage of semaglutide (sold as Ozempic), thanks to its social media popularity.
 
Its shortage has become so severe that the TGA has pleaded with prescribers not to initiate new patients on semaglutide and consider alternatives for those already using it.
 
Currently, 448 medications are in short supply in Australia, with 46 products listed as in ‘critical shortage’.
 
New shortage updates have become an almost weekly occurrence for the TGA.
 
Most recently, it issued a warning about fluoxetine 20 mg dispersible tablets (sold as Zactin Tabs), while the week before it also notified prescribers that there was a shortage of lisdexamfetamine dimesilate capsules (sold as Vyvanse).
 
Professor Morgan said the TGA has increased its communications with the RACGP about medicine shortages, but there is still more to be done.
 
‘It is important for GPs not to prescribe second-rate medicines just because of hearing in the media of a medication shortage,’ he said.
 
‘It is helpful to warn patients there might be a supply problem and to offer to collaborate with the patient’s pharmacist to ensure medical needs are met.’
 
The TGA’s survey is now live and will remain open until 12 March.
 
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