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Medicine shortages: Information for health professionals
We are changing the way we implement Serious Shortage Substitution Notices. See our web statement for further details.
An important function of the Therapeutic Goods Administration (TGA) is to monitor and respond to current and anticipated medicine shortages. A key element of the response to a medicine shortage is effective communication to health professionals.
A national medicine shortage occurs when the supply of a medicine is not likely to meet the normal or projected consumer demand within Australia at any point during the next six months. We publish information about national medicine shortages for reportable medicines.
At times, local-level supply disruptions can result in consumers not being able to obtain certain medicines from their pharmacy despite there being adequate supply of the product in Australia to meet demand. These are usually temporary disruptions that will be resolved quickly when additional stock moves through the Australian supply chain.
We appreciate that regardless of whether unavailability is due to a local-level supply disruption or a national shortage, supply disruptions can complicate treatment choices and cause distress to patients. Health professionals play a crucial role in mitigating the effects of medicine shortages on patients, by providing advice about alternative medicines or treatments, or helping to arrange supply of alternative products through one of the TGA’s access schemes.
Visit our medicine shortages landing page for links to other sources of information relating to shortages.
Options for accessing medicines in a shortage
Health professionals play an important role in assisting patients to access medicines when there is a shortage. There are a number of options that may be available to assist you:
Often when there is a national medicine shortage, or a local-level supply disruption, there is still stock available in Australia. When supplies are known to be low, sponsors, wholesalers and distributors may reserve stock to be accessed by patients in need. If you cannot access a medicine for a particular patient through your supplier, you can contact them to check if they are holding any stock. You can also try contacting an alternative supplier.
To check if a medicine is affected by a national shortage, you can search our medicine shortage reports database. You can search 'ALL medicine shortages', or just 'CRITICAL' shortages. Please note that 'CRITICAL' shortages are a subset of all medicine shortages and a medicine may not appear in those results, even if it is in our database.
Our database includes both current shortages and shortages anticipated within the next six months. Each shortage in our database represents only one product, i.e. one particular strength or pack size within a brand. There are often alternative brands available in the market.
By clicking on the medicine name in the database you can see information provided from the sponsor, including expected supply impact dates. You can also view the TGA management actions, such as the availability of alternative medicines under Section 19A or the Special Access Scheme (SAS).
If the out-of-stock medicine does not appear in the database, it may not be a 'reportable medicine' (most over-the-counter medicines are not reportable medicines) or it may be affected by a local-level supply disruption rather than a national shortage.
If you think a reportable medicine is in shortage, but does not appear on the medicine shortage reports database, please contact us with details.
You can subscribe to updates to the Medicine Shortages Reports Database.
When a registered medicine that is affected by a national shortage cannot be replaced by any other medicines included in the ARTG, the TGA may be able to approve supply of an alternative medicine under section 19A of the Therapeutic Goods Act 1989. This scheme also enables early access to products undergoing evaluation when no alternative registered goods exist.
We only approve products under section 19A that are of appropriate manufacturing quality and approved in another specified country or undergoing the approval process in Australia.
You can search our Section 19A approvals database to check if there is an alternative medicine available to prescribe, supply or administer for the duration of the shortage.
The Section 19A approval describes the:
- unavailable ARTG medicine and its approved alternative
- Australian sponsor of the alternative medicine and their contact details
- duration of the approval
- approved indications
- differences between the ARTG medicine in shortage and the alternative Section 19A approved product
- details of related medicine shortages.
Medicines can be used until they expire, even if the approval of the Section 19A has ended.
Information provided with the Section 19A medicine
A letter outlining the considerations you may need to apply for prescribing or dispensing usually accompanies the medicine. The following information is usually included, along with any other information specific to the medicine:
- When the medicine is supplied due to a medicines shortage or unavailability, details on:
- the registered medicine(s) that the medicine is intended to replace
- the reason for the short supply of the registered medicine(s)
- any differences between the registered medicine and the medicine(s) supplied
- any changes to practice you or your patients may need to make
- that the medicine has not been approved for general marketing in Australia and is being supplied under section 19A
- any contraindications for the medicine
- any potential safety risks
- how to report adverse events
- contact details of the Australian sponsor.
Medicines supplied under Section 19A may have information communicated in multiple languages on the packaging, however English translations are overstickered for key information such as the ingredients. The Australian sponsor details will also be included on the medicine pack
When there is a shortage of a medicine and there are no registered or s19A alternatives, we may publish a Serious Shortage Substitution Notice (SSSN) to help patients access suitable alternative medicines without revisiting their prescriber. Pharmacists can check if there is a SSSN on the TGA Regulatory Decisions and Notices web page. Once the Notice is also recognised by relevant State or Territory legislation pharmacists can dispense the substitute medicines according to the rules in the SSSN.
Only certain types of substitutions will be considered for a SSSN:
- Tablets/capsules of lower or higher strength (with the quantity dispensed made correspondingly higher or lower, so that the total amount of the prescribed drug—for example, in milligrams—is consistent). For example, if a higher strength is dispensed, it is expected that a lower number of tablets would be dispensed. Similarly, Notices can also apply to oral suspensions and syrups.
- Other dose forms containing the same active ingredient (for example, a capsule instead of a tablet, or a syrup or suspension).
- Where a fixed-dose combination may not be available but the two or three medicines that make up the combination are. These medicines can be dispensed individually.
- Dispensing of an immediate-release form in lieu of a modified-release version and vice versa.
Further information about the SSSNs, including a proposed Notice template describing what a SSSN will include, can be found on the Serious Shortage Substitution Notice page on the TGA website.
The Special Access Scheme (SAS) allows certain health practitioners to access therapeutic goods (such as medicines, medical devices or biologicals) that are not included in ARTG for a single patient. Therapeutic goods that are not included in the ARTG (and are not otherwise exempt from being in the ARTG) are described as 'unapproved'. Health professionals are encouraged to prescribe/dispense alternative ARTG products or Section 19A products prior to accessing medicines under SAS as these medicines are not assessed by the TGA for manufacturing quality.
More information is available on our SAS webpage to assist health professionals to access unapproved therapeutic goods for patients.
In particular, health professionals can use the SAS guidance tool for access to unapproved therapeutic goods and the SAS guidance for health practitioners and sponsors to determine the appropriate pathways to access therapeutic goods using the SAS.
Some medicines may be accessible by patients through the Personal Importation Scheme. This scheme allows individuals to import a 3-month supply of medicines for personal use. There are a number of restrictions on imported goods, for example, if the goods are medicines in Schedule 4 or 8 to the Poisons Standard a prescription from an Australian-registered medical practitioner will be required.
Imported therapeutic goods under the Personal Importation Scheme may not be approved for supply in Australia. This means there are no guarantees about their safety or quality.
Financial considerations for accessing alternative medicines in a shortage
While alternative access pathways are an important tool in helping to ensure continued supply of medicines when shortages occur, it is important to understand that this can involve increased costs for consumers. Medicines accessed through the SAS cannot be subsidised under the Pharmaceutical Benefits Scheme (PBS). Section 19A products may be subsidised through the PBS if the ARTG-registered product in shortage is already subsidised and the Section 19A sponsor makes an application to the Pharmaceutical Benefits Advisory Committee (PBAC). The TGA cannot compel the sponsor to make such an application.
Mandatory reporting of shortages
If supply of a 'reportable medicine' is likely to be affected by a shortage, reporting it is mandatory.
Medicines that must be reported
A ‘reportable medicine’ is one for which shortages must be reported to the TGA. Principally, these are medicines on the Australian Register of Therapeutic Goods (ARTG) that are:
- prescription medicines (schedule 4 and schedule 8)
- non-prescription medicines included in a legislative instrument called the Therapeutic Goods (Reportable Medicines) Determination (Reportable Medicines Determination)
Shortages of medicines in Schedules 2 and 3 to the Poisons Standard and unscheduled medicines are not required to be reported to the TGA unless they are included in the Reportable Medicines Determination.
Medicines are included in this legislative instrument if they are critical to the health of Australian patients or the reporting of any shortage or permanent discontinuation of them would be in the interests of public health (for example, salbutamol inhalers or adrenaline auto-injectors).
You can subscribe to the medicine shortages email alert service to receive email or RSS feed notifications of new and updated medicine shortages information.