To read related alerts in date order visit our Ozempic (semaglutide) shortage collection.
The pharmaceutical company that supplies Ozempic, Novo Nordisk, has recently advised the TGA and the Ozempic Medicine Shortage Action Group that supply throughout the rest of 2023 and 2024 will be limited.
Novo Nordisk advised that demand had accelerated in recent months, particularly for the low-dose (0.25/0.5 mg) version. This additional demand is caused mainly by a rapid increase in prescribing for ‘off-label’ use (prescriptions to treat conditions other than those approved by the TGA).
The Therapeutic Goods Administration (TGA) consulted clinical and patient groups represented on the Medicine Shortage Action Group (MSAG). The advice of the action group to prescribers is:
- do not initiate new patients on Ozempic unless there are no suitable alternatives or there is a compelling clinical reason to do so
- for patients who are already prescribed Ozempic, consider if they can be changed to an alternative as continuous supply cannot be guaranteed
- supplies should be conserved for patients who are stabilised on Ozempic who have no other treatment options
- it is not known when the medicine will be available in sufficient quantities to meet the ongoing high demand. Novo Nordisk advised that very limited new supplies of Ozempic 0.25/0.5 mg would be available before the end of 2023 and there would be intermittent supply of all strengths of Ozempic throughout 2024.
We have been working with Novo Nordisk, pharmaceutical wholesalers and organisations representing health professionals and patient groups to manage the shortage of Ozempic since April 2022.
If you have a prescription for Ozempic to treat type 2 diabetes
Check that your regular pharmacy can supply the Ozempic you need ahead of your next dose.
- Currently we are asking health professionals not to prescribe Ozempic to new patients unless there are no suitable alternatives or there is a compelling clinical reason to do so to conserve supply for patients who are already stabilised on this medicine and who do not have suitable alternatives.
Information for pharmacists
- Pharmacists should continue to prioritise limited supplies of Ozempic to patients stabilised on treatment.
- Pharmacists should be aware that stock availability can change and sudden spikes in demand due to stockpiling or off-label use may affect continuity of care for patients stabilised on Ozempic.
Information for prescribers
After consultation with the Ozempic Medicine Shortage Action Group, we advise prescribers not to initiate new patients on Ozempic for the time being unless there are no suitable alternatives or there is a compelling clinical reason to do so.
Ozempic’s TGA-approved indication is for the management of type 2 diabetes not adequately managed by other medications, in conjunction with diet and exercise.
When deciding whether to continue treatment consult the appropriate prescribing guidelines. Prioritise patients for whom Ozempic will have the most clinical impact, including patients already stabilised on the medicine and without other treatment options.
Carefully consider which patients might be switched to alternatives.
We will continue to update this webpage with any new information we receive from Novo Nordisk and the recommendations of the organisations who represent the interests of all patients.
The TGA also updates supply information about Ozempic on the Medicine Shortage Reports Database.
Stay up to date
Since the worldwide shortage of diabetes medicine Ozempic started in April 2022, the TGA has received hundreds of messages with comments and questions from people who have been affected, many with similar concerns.
We recognise the importance of Ozempic for patients living with diabetes and the other chronic health conditions it is being used to treat, and we are taking this shortage very seriously.
This page includes answers to questions we have received about the Ozempic shortage.
The webpage is updated as soon as information changes. The TGA also updates supply information about Ozempic on the Medicine Shortage Reports Database.
Facts about Ozempic
Ozempic is a brand of the medicine called semaglutide. Ozempic:
- is supplied by pharmaceutical company Novo Nordisk
- is a weekly injection
- is an antidiabetic medicine that is a GLP-1 agonist, which is different to insulin
- is only approved by the TGA for lowering blood sugar in adults with type 2 diabetes
- is subsidised on the Pharmaceutical Benefits Scheme (PBS) for treatment of type 2 diabetes when certain conditions are met
- is being prescribed ‘off-label’ by medical practitioners to treat conditions other than those approved by the TGA.
You can read more about Ozempic in the Consumer Medicine Information.
Why the Ozempic shortage happened
The worldwide shortage of semaglutide started to affect Australia in early 2022 when Novo Nordisk couldn’t supply enough Ozempic to meet an unexpected increase in demand due to off-label prescribing for weight loss.
Making Ozempic involves a complex process to produce semaglutide using specialised equipment in a unique manufacturing setting. This means that increasing supply for a global shortage is taking some time.
Why the TGA can’t stop off-label prescribing
Off-label prescribing involves prescriptions to treat conditions other than those approved by the TGA. It is a regular occurrence in the Australian healthcare system, particularly for uncommon diseases and conditions or underrepresented patient groups.
The TGA does not have the power to regulate the clinical decisions of health professionals and is unable to prevent doctors from using their clinical judgement to prescribe Ozempic for other health conditions.
What the TGA is doing about the Ozempic shortage
The TGA’s role in medicine shortages is to reduce the impact on patients where possible. In the Ozempic shortage, we:
- approved multiple overseas semaglutide medicines that can be used while the Ozempic that is registered in Australia is unavailable
- work with wholesalers to distribute stock fairly when it is available
- are meeting with the pharmaceutical company, medical colleges, health professional organisations and peak obesity groups to help to get the medicine that is available to the people who need it most, and to provide advice about alternatives
- are communicating updates on this webpage and also the Medicine Shortage Reports Database.
The TGA met with Novo Nordisk, pharmaceutical wholesalers and the following health professional groups and peak obesity organisations to manage the shortage:
- the Australian Medical Association (AMA)
- the Royal Australian College of General Practitioners (RACGP)
- the Australian Diabetes Society (ADS)
- Diabetes Australia (DA)
- the Pharmaceutical Society of Australia (PSA)
- the Pharmacy Guild of Australia
- the Society of Hospital Pharmacists of Australia (SHPA)
- the National Association of Clinical Obesity Services (NACOS)
- the Collective for Action on Obesity
- Australia and New Zealand Society for Paediatric Endocrinology and Diabetes (ANZSPED)
- the National Aboriginal Community Controlled Health Organisation (NACCHO).
You can read more about how the TGA manages medicine shortages in the information for consumers section of our website.
Overseas-registered Ozempic is available
The TGA has approved the supply of overseas-registered semaglutide products temporarily under section 19A of the Therapeutic Goods Act 1989.
Although these are the same medicine as the Australian-registered Ozempic, they come from suppliers in other countries and may be considerably more expensive.
While the Australian-registered Ozempic is subsidised on the Pharmaceutical Benefits Scheme (PBS), the overseas-registered products currently are not. The Pharmaceutical Benefits Advisory Committee (PBAC) considered whether the section 19A approved Ozempic product should be subsidised through the Pharmaceutical Benefits Scheme (PBS). A summary of the PBAC advice can be found on the PBS website.
Pharmacists can get more information and order the overseas brand from the approval holders:
- Medsurge Healthcare call 1300 788 261
- Pro Pharmaceuticals Group call 1300 077 674
Please be aware that other semaglutide products that may be offered online have not been checked for safety, quality or effectiveness by the TGA. Buying prescription medicines online without a valid prescription is not encouraged and is illegal.
What to do if you can’t get Ozempic
Pharmacists are encouraged to prioritise supply of Ozempic to patients stabilised on treatment. If your pharmacist cannot fill your script, talk to your doctor.
If you are taking different diabetes medicine or another type of medicine that has been prescribed for you during the Ozempic shortage, you should continue taking that medicine.
If you have previously been prescribed Ozempic ‘off-label’, please be aware that health professionals have been asked to direct current supplies of Ozempic to people who are currently stabilised on the medicine and cannot be adequately managed with other medication.
Please also be aware that Ozempic (semaglutide) products that may be offered online have not been checked for safety, quality or effectiveness by the TGA, and that buying prescription medicines online without a valid prescription is not encouraged and is illegal.
This webpage is updated as soon as information changes. The TGA also updates supply information about Ozempic on the Medicine Shortage Reports Database.
What the TGA can’t do during a medicine shortage
As pharmaceutical companies are private entities, the TGA can’t force them to make or supply medicines in Australia. We also can’t force them to list their products on the Pharmaceutical Benefits Scheme (PBS) or redirect stock from other markets.
We do not have the power to regulate the clinical decisions of health professionals, so we can suggest that doctors only prescribe Ozempic for type 2 diabetes during the shortage, but we can’t force them to stop prescribing it for other reasons.
When will the Ozempic shortage end?
Novo Nordisk, has recently advised the TGA and the Ozempic Medicine Shortage Action Group that supply throughout the rest of this year and 2024 will be limited.
We continue to work closely with Novo Nordisk and relevant health professional and consumer organisations to monitor this situation.
We will update this webpage as soon as we have more information from Novo Nordisk and any new advice from the RACGP.
You can also check the Medicine Shortage Reports Database for updates.
Social media’s effect on the shortage and TGA’s response
When videos about achieving rapid weight loss with Ozempic went viral on TikTok, the trend was also reported online and across other media. This triggered a huge demand for the product that the manufacturer was not prepared for, and it quickly developed into a worldwide shortage.
Many people who were then unable to get Ozempic to treat their type 2 diabetes in Australia wanted to know what we were doing about the medicine’s social media exposure.
As well as regulating medicines, the TGA also regulates the advertising of therapeutic goods to the public in Australia. Prescription-only medicines such as Ozempic can’t be advertised to the public in Australia. The reason these laws are in place is to support consumers making informed health care decisions in consultation with their health practitioner and not based on, for example, social media advertising.
We are actively investigating alleged unlawful advertising of Ozempic and is meeting with social media platforms including TikTok to reinforce Australian therapeutic goods advertising laws. The TGA is also investigating how the offending posts can be removed and how to stop similar videos from being posted in the future.
In addition, the TGA has written to media broadcasters about their obligations concerning the promotion of the use or supply of therapeutic goods when publishing news stories.
We encourage people to report any concerns about material such as the TikTok videos to the TGA.
How the Ozempic shortage affected Trulicity (dulaglutide) supply
Some patients who had been prescribed Ozempic for its registered use to treat type 2 diabetes were then prescribed alternate medicines, including Trulicity (dulaglutide). Unfortunately, this in turn has resulted in a shortage of Trulicity. You can go to the page about the Trulicity shortage for more information.
About Wegovy - the new brand of semaglutide
Many people have written to the TGA suggesting we should approve another brand of semaglutide for weight loss, and that we should make it available on the PBS.
As pharmaceutical companies are private entities, the TGA can’t force them to make or supply medicines in Australia. The pharmaceutical company that makes Ozempic also makes Wegovy, a brand of semaglutide indicated specifically for ‘chronic weight management, as an adjunct to a reduced-energy diet and increased physical activity when specific criteria are met’. Wegovy has been registered on the Australian Register of Therapeutic Goods (ARTG), however, Novo Nordisk has not advised when this product will be launched in Australia.
While Ozempic and Wegovy contain the same active ingredient, semaglutide, they have different approved indications and uses, as well as different dosages and devices. As such, Ozempic and Wegovy are not interchangeable.
You can email Novo Nordisk at: aunrccc@novonordisk.com with any questions about the Wegovy launch.
Why doctors can't prescribe semaglutide on the PBS for weight loss
For a medicine to get a Pharmaceutical Benefits Scheme (PBS) listing for a particular use - known as an ‘indication’ - such as for managing obesity, the pharmaceutical company that produces it must first apply to have the indication added to the medicine’s Product Information.
The company then must apply for a PBS listing for that indication. The Government relies on the advice of the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert advisory body, to assess the application. By law, the Government:
- cannot list a medicine on the PBS unless the PBAC recommends it
- requires advice from the PBAC before a change can be made to an existing PBS listing, such as the medical conditions and patients that can be treated.
When assessing a medicine for a proposed PBS listing, the PBAC must consider the safety as well as the clinical and cost effectiveness of the medicine, including comparing it to alternative treatments. PBAC outcomes (including the outcome for Wegovy) are listed on the PBS website.
As pharmaceutical companies are private entities that make their own decisions on the availability of their medicines, we can’t make them apply to add a particular indication or for a PBS subsidy.
Patients who need semaglutide for other chronic medical conditions
The TGA acknowledges the importance of treating obesity and preventing the comorbidities and complications associated with it.
When the Ozempic shortage started, the TGA worked with health professional groups who assessed which patients were most at risk if they did not have access to Ozempic when it was available. It was decided that generally the risk to patients with diabetes is higher and it was recommended that patients who needed Ozempic for weight loss should use other forms of treatment until the shortage was over.
The TGA has approved the temporary supply of overseas-registered semaglutide products, which your pharmacist can order from the following companies:
- Medsurge Healthcare call 1300 788 261
- Pro Pharmaceuticals Group call 1300 077 674.
Although Novo Nordisk has advised that stock of Ozempic continues to arrive in Australia, there are concerns that the current stock levels will not support prescriptions for uses other than the TGA-approved indication of type 2 diabetes. Therefore, the shortage has been extended to 31 December 2023 and prescribers are being asked to consider these concerns when prescribing Ozempic ‘off-label’ for managing obesity and related chronic health conditions.
Wegovy, which is a new brand of semaglutide indicated for the management of obesity, has not been launched, and is not currently available in Australia.
Why this medicine isn’t produced locally
Many people want to know why Ozempic and other medicines aren’t being manufactured in Australia. Unfortunately, it would not be practical or achievable economically for most of the many thousands of medicines approved for use here to be manufactured locally.
In the case of Ozempic, for example, making semaglutide involves a complex process using specialised equipment in a unique manufacturing setting.
Having more resilient medicine supply chains is a priority for the Australian Government, and the TGA closely monitors and responds to supply chain issues and medicine shortages when they happen.
Also, as pharmaceutical companies are private entities, the TGA does not have the regulatory power to force them to manufacture their products in Australia.