Medicine shortages impacting patient care while minimum stockholding requirements still a year away

Pharma News: Global medicine shortages are interrupting supply of medicines that are the mainstay of treatment for some of the most prevalent health conditions in the Australian community. 

According to the Therapeutic Goods Administration (TGA), there are currently more than 330 medicines in short supply and almost 80 more anticipated shortages.

RACGP Victoria Chair Dr Anita Muñoz said “Unfortunately, there’s an expectation from Government at the moment that GPs and pharmacists come up with solutions to the shortages, including medication substitution or withholding medications for use only in certain subsets of patients.

“Although we can sometimes substitute a medication for others temporarily, there are many instances where we have very limited options to do so. Patients genuinely go without or receive sub-optimal care for a period of time while they’re waiting for the supplier to resume. And that really isn’t a sustainable way to solve this issue.”

Medicines Australia and the GBMA (Generic and Biosimilars Medicines Association) were granted authorisation by the ACCC* during the pandemic to enable a coordinated strategy in relation to the supply of essential medicines and related devices in response to the COVID-19 pandemic.

From 1 July 2023, Minimum Stockholding Requirements will apply where manufacturers will be required to hold a minimum of either 4 or 6 months’ of stock in Australia for certain PBS listed medicines, referred to as ‘Designated Brands’. While these measures will not prevent shortages that are outside of the control of Australian companies, they will help to ensure that manufacturers are better placed to continue supply when global disruptions occur.

The investment by the medicines industry in managing supply chain risk through the minimum stockholding requirements is supported by the Government through one-off price increases on 1 October 2022 and floor price protections for low-cost medicines. 

CEO of Medicines Australia, Elizabeth de Somer, said the ongoing issues of medicine shortages formed a significant part of the recent Strategic Agreements with the Commonwealth Government.

Marnie Peterson, CEO of the GBMA, said members of the medicines sector were increasing their medicine stockholdings and aim to introduce additional security in supply of medicines.

However, these arrangements seem a long way off for GPs and their patients.

Dr Muñoz said “There are many months of pulling rabbits out of hats to come up with solutions for patients and to work with pharmacists to choose alternatives,” she said.

“We are far enough into this pandemic that we have had sufficient time to come up with upstream solutions for these kinds of issues, rather than plugging the system with downstream temporary measures. Chopping and changing and making last-minute changes can confuse patients, and only increase the chances that medication misadventure will happen,” she added.

A 2021 report by the Institute for Integrated Economic Research – Australia (IIER-A) depicted Australia as “a complacent nation”. The IIER-A warned that the pursuit of cost efficiencies had “resulted in significant erosion of our healthcare systems and their resilience as our nation gradually lost manufacturing capacity to the point where we now import more than 90% of our medicines and virtually all our personal protective equipment”.

“This occurred without ensuring sufficient buffers in a crisis through stockholding mandates,” the report noted. “Lower prices in normal times can come at a very high cost in a crisis.”

*The ACCC authorisation for Medicines Australia and GBMA is due to expire on 30 September 2022 and both organisations are considering the potential need for the authorisation to continue.