Senator Steele-John unleashes the urgency of tackling medicine shortages

Pharma News: Almost 450 medicines are currently grappling with shortages nationwide, according to the Therapeutic Goods Administration (TGA). Even more alarming is the fact that 45 critical medicines are unavailable, with some shortages expected to persist until mid-2024 or later.

At yesterday’s Senate Estimates hearing, the Community Affairs Legislation Committee delved into the pressing issue of medicine shortages, shedding light on the urgency of the situation. The timing of this discussion coincides with the new TGA consultation, highlighting the importance of the matter at hand.

Australia finds itself susceptible to medicine shortages due to the decline in local manufacturing and the intricate nature of global supply chains, where over 90% of medicines are imported. The country’s limited control over just 2% of the global pharmaceutical market puts it at a disadvantage during disruptions in the global supply chain, favouring larger markets.

Green’s Senator Jordon Steele-John remarked, “I am deeply concerned about the continuing shortage of [Takeda’s] Vyvanse (lisdexamfetamine) in Australia. It’s a medication utilised by many people with ADHD. Has the Australian government made a direct appeal to the American government to increase the manufacturing amounts allowing more Vyvanse to be exported to Australia?”

Professor Tony Lola, Deputy Secretary of the Health Product Regulation Group, emphasised that the global shortage is primarily a result of manufacturing issues. He outlined the current shortage, with expected resolution dates ranging from March to April.

Acknowledging the challenges, Professor Lola stated, “The TGA does not have the authority under the Therapeutic Goods Act to compel or oblige sponsors to increase production. However, we do work closely with stakeholders to mitigate regional or geographical stockpiling and provide guidance to ensure priority for individuals already on these medications.”

Senator Steele-John drew a poignant parallel between his use of a wheelchair due to cerebral palsy and the urgency of resolving the Vyvanse shortage, stating, “Imagine if my wheelchair was the product of a pill I took multiple times a day, and that pill was not available due to a supply chain issue in the United States. And while I couldn’t get it, I had to crawl around on the floor.”

He added “That is literally the situation that so many people with ADHD are in. This medication is their form of assistive technology, and it is urgent that we resolve this supply chain shortage.”

The Medicine Shortages in Pharmacy survey, led by the Pharmaceutical Society of Australia (PSA), Pharmacy Guild, and Society of Hospital Pharmacists of Australia (SHPA) and published in August 2022, revealed intriguing statistics. Over 98% of pharmacists reported experiencing a medicine shortage in the preceding seven days, with pharmacies dedicating significant time to address these issues.

The survey indicated that 63% of hospital pharmacists switched patients to non-first line therapies due to medicine shortages, potentially impacting recovery and health outcomes. Furthermore, 43% noted a shift to more invasive administration methods such as an intravenous injection instead of an oral tablet, 39% had to switch patients to a medicine with higher risk of adverse effects, and 31% reported increased hospital admissions due to medicine shortages.

For the 7 million Australians in rural and remote areas, geographical isolation poses amplified challenges in accessing essential medicines, exacerbated by a maldistribution of the medical workforce.

To tackle critical shortages, the TGA implemented the Minimum Stockholding Requirements policy, requiring manufacturers to hold 4-6 months of stock in Australia starting July 1st, 2023. The TGA also mandated sponsors to provide up-to-date information on drug shortage periods to enhance transparency from September last year.

The extension of medicine supply from 30 to 60 days, aimed at saving $1.2 billion in dispensing fees, has sparked debates on its impact on medicine shortages, with controversial opinions from pharmacy stakeholders. The government dismissed these claims given overall medicine demand would remain unchanged. The Consumers Health Forum of Australia backed the policy because it benefits patients with minimal risk.

While medicine shortages are complex and often unavoidable, the current TGA consultation on Medicine shortages in Australia signifies a crucial step in developing effective strategies to reduce the risk of adverse events for patients and ensure uninterrupted therapy.

In reimagining healthcare across the entire patient journey, Health Industry Hub^TM is the only one-stop-hub uniting the diversity of the Pharma, MedTech, Diagnostics & Biotech sectors to inspire meaningful change.

The Health Industry Hub^TM content is copyright protected. Access is available under individual user licenses. Please click here to subscribe and visit T&Cs here.