Drug shortage crisis demands intervention, AMA warns, as patients struggle to secure medicines
There are more than 400 medicine shortages, and the country’s leading medical group blames it on ‘ad hoc’ governmental solutions.
The Albanese government must form a committee dedicated to preventing medicine shortages if it wishes to curtail a string of near-catastrophic droughts on essential treatments, the Australian Medical Association says.
The AMA directed its appeal to the Therapeutic Goods Administration, which is responsible for managing medicine supply.
It warned Australia was falling behind comparable countries in the post-Covid market while pushing for greater transparency, a dedicated forum for tracking access, and a scalable system to warn patients, clinicians and stakeholders when a crisis was on the horizon.
The TGA’s medicine shortage database currently lists 417 ongoing shortages of which 38 are critical, with 68 more shortages on the horizon. ADHD medications and drugs containing semaglutide like Wegovy or Ozempic are frequently affected, while antidepressants and HRT patches, used in menopause treatment, were recently hit.
Ozempic has faced shortages since April 15, 2022, and is expected to remain scarce until at least the end of this year.
“Medicine shortages and other disruptions have a profound effect on the community and inadequate communication can result in additional costs for patients, for whom there is often little transparency or forewarning,” AMA president Danielle McMullen said.
“I don’t think we’ve managed to work out exactly why, but it does seem we are seeing a bigger range of medicines in more shortage, more frequently and it does seem to be a combination of changes in demand and changes in logistics around the world.
“It can be a frustrating experience to have to go to different pharmacies to find your medicine or ring back your GP for an alternative prescription, but in the worst-case scenario when things really are in shortage and there is no alternative, the underlying health condition can get worse.
“Missing your medicines for a mental health condition can have really significant short-term side effects. People often have quite bad withdrawal symptoms but also we don’t want to be mucking around with people’s mental health and causing a deterioration just because the medicine was unavailable.”
The AMA is a regular recruit for the working parties established by the Health Department during access crises, but in its submission to the TGA consultation on medicine shortages and discontinuation it argued such ad hoc responses were too reactive and failed to get ahead of frequent shortages. It argued a committee with the sole purpose of tackling such shortages would be better equipped to spot coming crises, communicate them effectively and enlist the right experts to mitigate damage.
“The AMA would like to see ad hoc action groups formed in response to specific shortages replaced by a regular medicines shortage forum,” the submission, provided to The Australian, reads.
“This group should consist of representatives from key groups representing medicine, pharmacy, wholesalers and sponsors who could discuss current or upcoming shortages, solutions and, most importantly, communications to all stakeholders.”
In reviewing its practices, the TGA has floated the possibility of changing its regulatory framework to provide a year’s notice on when drugs are discontinued, rather than its current six month heads-up.
Dr McMullen feared such a measure was doomed to fail given drugs were often pulled from shelves at short notice.
“While the proposal to extend the discontinuation period from six to 12 months is practical for broader stakeholders, it may not be reasonably applied across all supplier,” the submission reads.
“It is not always possible to determine a year in advance whether minor market shifts or changes in the cost or efficiency of resources associated with a medicine could lead to a business decision to halt its production.
“For example, the Ozempic shortage demonstrated that providing an expected end date is not often useful, even counter-productive in some instances. If a regular medicines shortage forum was in place, it could be tasked with determining a better approach or test options in development.”
It argued a sliding scale or “traffic light” system could better gauge the urgency of access droughts at short notice.
The Pharmaceutical Benefits Scheme, which handles subsidies for medicines supplied by the TGA, has also faced recent criticism for limiting patient access. Its often sluggish implementation of new subsidy arrangements culminated in a mass deferral on new drug applications, requiring an intervention from federal Health Minister Mark Butler.
Services agencies are also under scrutiny, with new data supplied in Senate estimates indicating 77 per cent of all bulk-billing claims were completed past their official deadline from mid-2023 to mid-2024.
This article has been edited to clarify the TGA has no responsibility to procure medicines following their approval for use.
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