Health practitioners – how to access medicines during a national shortage

When medicines are in short supply, it can sometimes make patient care more difficult for health practitioners. 

We aim to provide clear, timely information to help you access the medicines your patients need during a national medicine shortage. When appropriate, we also make other medicines available so patient care can continue.

A national medicine shortage occurs when there isn’t likely to be enough of a medicine to meet demand at any point in the next 6 months.

Shortages and supply disruptions are often unavoidable and have global impacts. They can be caused by manufacturing delays, supply chain issues, regulatory barriers, trade limitations, or sudden increases in demand. 

Under Australian law, suppliers must notify us about current or expected shortages of prescription medicines – and some over-the counter medicines – within 2 working days for critical shortages and 10 working days for other shortages.

Our medicine shortage reports database includes information on how long a shortage is expected to last and what is being done to manage it. This includes any steps taken by us or the supplier, which you can find in the ‘management action’ section of each report. We also publish information about any access pathways we are managing to help you get substitute medicines.

Check if alternative brands, strengths or doses are available

Each shortage listed in our medicine shortage reports database refers to a single product. In some cases, brands, strengths or dose forms may still be available. If they are, our database will include a note with this information. 

Where further consideration of treatment options is required, our database will include a note to advise patients to consult you as the prescriber. 

If the medicine isn’t available in any form, the database may list a suitable alternative. If so, it will include a note that says: a Serious Scarcity Substitution Instrument (SSSI) has been implemented. It will also include a link to more information on this substitute. 

An SSSI lets community pharmacists supply a specified substitute medicine without prior approval from you as the prescriber, provided all the conditions of the SSSI are met. This helps patients get a suitable medicine from a pharmacist without delay. Pharmacists must notify the prescriber of the substitution at the time of dispensing the substitutable medicine, or as soon as practical afterwards.

What if no alternative brands are available in Australia?

In certain circumstances, we may put temporary pathways in place to give prescribers access to unapproved or overseas-sourced medicines. It’s important to note that unapproved medicines haven’t been assessed by us for safety, quality or efficacy.

You should also be aware that unapproved or overseas-sourced medicines can cost your patients more. For example, medicines accessed through the SAS, and some overseas medicines approved under Section 19A, aren’t subsidised under Australia’s Pharmaceutical Benefits Scheme (PBS). 

Overseas-sourced medicines under Section 19A

In the shortages database, the report may include the following information: an overseas registered product has been approved for supply under Section 19A.

Under section 19A of the Therapeutic Goods Act 1989, we can approve supply of an alternative medicine that’s registered overseas. We only do this when the alternative product is manufactured to high standards and is already approved in a specified country, or if the product is currently being assessed in Australia. 

You can search our Section 19A approvals database to check if an alternative medicine is available to prescribe, supply or administer during the shortage. If it is, the listing will include information on how long the medicine is approved for and its indications.

Unapproved products may be available under the Special Access Scheme.

In the shortages database, a report may include the following information: alternative unapproved products may be available under the Special Access Scheme.

Under the Special Access Scheme (SAS), health practitioners may be able to access unapproved medicines in certain circumstances. These medicines have not been assessed by us for safety, quality or efficacy, and are not otherwise allowed to be used and supplied in Australia.

For more information, please see our information for health professionals on accessing an unapproved therapeutic good. 

You can find out more about medicine shortages on our medicine shortages hub. We also provide updates on many shortages through our social media channels.