About the Antibiotics shortage 2022-2023

The Therapeutic Goods Administration (TGA) is aware of current shortages of some antibiotics in Australia, including amoxicillin, cefalexin and metronidazole. We recognise the importance of antibiotics in treating patients and are facilitating supply of alternative medicines as a priority.

Most of the shortages are caused by manufacturing issues or an unexpected increase in demand.

We publish up-to-date information on these shortages, including predicted return to supply dates, in our medicine shortage reports database. You can sort the database by clicking on 'Therapeutic class' and scrolling down to 'General anti-infectives for systemic use' to see the list of antibiotics currently in shortage.

What are the causes of these shortages?

• Most of the antibiotic shortages are caused by manufacturing issues or an unexpected increase in demand.
• Disruptions to the supply of Australian medicines can occur for many reasons, ranging from shortages of raw materials, batches of the medicine not meeting Australian specifications, or logistical delays including potential impacts of global events. 
• While pharmaceutical companies do their best to maintain supply through demand forecasting and stock control, situations can arise where a disruption to the supply of a medicine cannot be avoided. The TGA Medicine shortage reports database lists the reason for the shortage that the pharmaceutical company has provided to the TGA.

When can we expect to resolve the underlying issues that are causing the shortages?

• Whilst many of the shortages are expected to resolve in the next few months, we are aware of ongoing global constraints for some products which will see their shortages extend until the end of 2023.
• The TGA website https://apps.tga.gov.au/Prod/msi/search?shortagetype=All provides the most up to date information on medicine shortages. Sponsors can update the shortage end dates at any time and any changes will be published on the database.

How many antibiotics are currently unavailable in Australia?

• There are current shortages of 18 different antibiotic active ingredients, with 39 brands of antibiotics currently unavailable.

Is the TGA concerned about the shortages?

• We recognise the importance of antibiotics in treating patients and continue to facilitate the supply of alternative medicines as a priority.
• Importantly, many antibiotic medicines in shortage have alternatives available. If a consumer is unable to fill their antibiotic prescription, they should speak to their pharmacist or doctor as soon as possible about alternatives for their situation.
• We continue to work with sponsors and health professional groups to monitor and manage the shortage.

Is the shortage impacting treatment of the Strep A outbreak occurring in parts of Australia?

• There are multiple antibiotics which can be used in the treatment of milder streptococcal infections. There are oral antibiotics currently available which can be used as an alternative to penicillins for these mild streptococcal infections, including azithromycin. For those more serious streptococcal infections which require injectable antibiotics, most of the recommended antibiotic treatments are available.

What is being done to address the issue?

• To minimise the impact of the current antibiotic shortages, the TGA has implemented several management actions, including:
  • Published an Antibiotic Shortage webpage with advice for prescribers, including advising prescribers to consider alternative brands or strengths of an antibiotic which is in shortage, if available. Prescribers may also consider prescribing an alternative antibiotic with a similar spectrum of availability.
  • Approving multiple overseas-registered alternative antibiotics for temporary supply under section 19A of the Therapeutic Goods Act 1989, some of which are listed on the PBS.
  • Making a Serious Scarcity Substitution Instrument (SSSI) for oral amoxicillin and oral cephalexin medicines. The SSSIs will allow pharmacists to dispense another amoxicillin or cephalexin product to a patient when one is unavailable without prior approval from the prescriber so long as the conditions of the SSSI have been met.
  • Worked with wholesalers to facilitate equitable distribution and prevent stockpiling.
• The TGA continues to monitor medicine shortages and work with sponsors to ensure adequate supply for Australian patients.

Are the shortages particular to any regions of Australia?

• The TGA does not have any indication that there are localised shortages of antibiotics in particular Australian regions.
• Medicine sponsors must report shortages of prescription medicines and a small number of over-the-counter medicines to the TGA that occur or expected to occur at a national level.

Medicine shortages in general

How many medicines are in critically low supply?

• As of 10 January 2023, there are 393 current and 77 anticipated medicine shortages published on the TGA website.
• 44 of the current and 8 of the anticipated shortages are listed as critical, which means the shortage has the potential to have a life-threatening or serious impact on patients because suitable substitute medicines may not be readily available, or the medicine is listed on the Medicines Watch List.

How does the shortage list compare to previous years? Is this worse than previously experienced?

• Since the mandatory reporting of medicine shortages started in January 2019, the number of medicine shortages reported has been generally consistent.
• The average number of total shortages reported since 2019 is 450 per month, with a peak of 742 total notifications in April 2020.
• In absolute number terms, the current number of shortages is lower than in recent months or years.
• However, there are currently some very high profile shortages, including of several antibiotics and diabetes medicines. These are worldwide shortages and are not limited to Australia.

What is TGA doing to address the issue?

Actions the TGA may take to manage particular medicine shortages include:

• working with medicine sponsors and other stakeholders, including pharmacists and pharmaceutical wholesalers, to manage inventory and supply to enable fair distribution of stock in Australia
• working with clinical colleges to inform them of current and upcoming shortages so they can determine and communicate alternative treatments for patients
• facilitating the supply of overseas alternatives to medicines in shortage under section 19A of the Therapeutic Goods Act 1989
• directly working with sponsors to bring forward or increase future orders for products and coordinating planning on supply of critical medicines
• allowing pharmacists to dispense certain identified substitute medicines when a medicine is in shortage under a Serious Scarcity Substitution Instrument
• publishing information about shortages and management actions on the TGA website, email subscriber list and social media.

What is the Government doing more broadly?

• From 1 July 2023, as part of the PBS Medicines Supply Security Guarantee, minimum stockholding requirements will apply requiring manufacturers to hold a minimum of either 4 or 6 months’ stock in Australia for certain PBS listed medicines.
• While these measures will not prevent shortages they will help to ensure that Australian manufacturers are better placed to continue supply when supply disruptions occur.
• Having more resilient medicine supply chains are a priority for the Australian Government. The Government is closely monitoring and responding to supply chain issues and medicine shortages, particularly those associated with the COVID-19 pandemic.
• The Government is committed to increasing Australia’s sovereign manufacturing capacity in medical essentials through the establishment of the $15 billion National Reconstruction Fund.
• Medical technology is one of the National Reconstruction Fund priorities and the Government will work with the Future Made in Australia Office to develop a national investment plan to identify what needs to be made in Australia and how to make that happen.
• However, with the tens of thousands of medicines approved for use in Australia, it would not be practical or economic for most of them to be manufactured locally.