Complex policy problem: How to tackle Australia’s persistent medicine shortages

The debate over medicine shortages has erupted again, as the Australian Medical Association (AMA) and the Pharmacy Guild of Australia demand action, while the Therapeutic Goods Administration (TGA) reviews consultation feedback on the proposed changes to reporting for shortages and discontinuations.

At any given time, the TGA website lists over 400 medicines as out of stock, underscoring Australia’s dependence on imports for approximately 90% of its pharmaceutical supply. The AMA and the Pharmacy Guild are urging for the establishment of a dedicated forum to improve coordination and communication regarding disruptions to the supply of essential medicines.

AMA President, Dr Danielle McMullen, emphasised that such a forum could offer ongoing advice on anticipated shortages and potential solutions, significantly improving communication between doctors, patients, and other stakeholders.

“One issue that persists is the challenge of timely, accurate, and consistent communication regarding medicine shortages. These shortages affect so many people in our community, including doctors, pharmacists, and crucially, patients,” Dr McMullen explained.

Trent Twomey, National President of the Pharmacy Guild, highlighted that the current reactive approach to managing shortages is insufficient, leaving patients to bear the consequences.

“It doesn’t address the root cause of shortages, and patients continue to suffer. Information sharing and greater awareness of existing and forecasted supply disruptions is crucial to making sure Australian patients have the medicine they need,” said Twomey.

A dedicated forum, the AMA and the Guild propose, could replace the ad-hoc action groups that are typically formed in response to specific shortages. Comprising key representatives from medicine, pharmacy, wholesalers, and industry sponsors, such a forum would address the broader issue of ongoing supply disruptions.

“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,” Dr McMullen added. “We appreciate that medicine shortages are unpredictable, but this is about giving us the best possible chance to respond to supply disruptions, which remain prevalent in the post-COVID era.”

The Pharmacy Guild has also been calling for the reinstatement of the Medicine Shortage Working Party, which was disbanded in 2021. This forum, created during the COVID-19 pandemic, brought together representatives from all levels of the supply chain to share information and increase awareness of current and forecasted shortages.

The TGA’s Medicine Shortage Action Groups, formed in response to critical shortages, do not provide the same opportunity to discuss general policies or mitigation strategies for anticipated or localised shortages.

“The TGA’s reactive approach means that not all industry stakeholders are represented, leading to inconsistent information being shared across the supply chain. The Government can, and should, focus on the big picture – to reduce the impact being felt by vulnerable Australians who need these essential medicines,” remarked Twomey.

The AMA has expressed concerns over the TGA’s proposal to extend the notice period for discontinued drugs from six to 12 months, noting that it is not always feasible to predict market changes a year in advance. In its submission, the AMA suggested a “traffic light” system to communicate phased supply shortages. For example, a “yellow light” could indicate that practitioners should continue prescribing a particular product for existing patients, but avoid prescribing it for new patients.

In a recent interview with Health Industry Hub, Sylvain Vigneault, Country Manager at Viatris, spoke candidly about the untapped potential for greater investment in sovereign manufacturing.

“We all have to understand it’s a collective effort…to come together to address the need, [especially] in critical medicines where we should never be out of stock for life-threatening or very acute care,” Vigneault explained.

“Short-term consultations keep on adding short-term band-aids. The issue of medicine shortages will never evolve and transform until we address the source of the problem. So, let’s fix it once and for all,” he emphasised.

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