About the Ozempic (semaglutide) shortage 2022 and 2023
About the Ozempic (semaglutide) shortage 2022 and 202.Key information from our series of medicine shortage alerts on Ozempic (semaglutide) is summarised here. As we get new information we will update this page.
Limited Ozempic (semaglutide) stock is starting to return to pharmacies
Novo Nordisk has informed the Therapeutic Goods Administration (TGA) that limited Ozempic (semaglutide) stock is starting to arrive in Australia. Although there will be small quantities of Ozempic available at some community pharmacies in the next few weeks, supply will remain quite limited for some time.About the Ozempic (semaglutide) shortage 2022 and 202
The TGA has been working with Novo Nordisk, pharmaceutical wholesalers and organisations representing health professionals and patient groups to manage the shortage. Currently we are asking wholesalers to distribute the limited initial supply of Ozempic as fairly as possible across Australia, including to remote and rural areas where access can be more difficult when national supply is limited.
Please keep in mind that the supply of Ozempic will be returning gradually over the next few months, and some pharmacies have many patients with scripts on waiting lists. This will be a busy time for pharmacists, so your patience and understanding are appreciated.About the Ozempic (semaglutide) shortage 2022 and 202
If you have a prescription for Ozempic
Please be aware that many people will be unable to fill their Ozempic prescriptions until supply improves over the next few months.
Only fill your script if your doctor agrees that Ozempic continues to be the most appropriate medicine for you.
If you have switched to other medicines because you couldn’t get Ozempic during the shortage, speak to your doctor about your ongoing treatment.
Do not take Ozempic in addition to your current diabetes medicines unless your doctor has told you to.
If you are restarting Ozempic treatment after a break due to the shortage, check with your doctor about the dose you should be taking.
Information for pharmacists
Where possible, pharmacists should allocate the initial limited supplies to patients who have been unable to switch to other medicines.
Patients who have switched to other glucose-lowering medicines during the shortage but still hold a valid prescription for Ozempic should be referred to their doctor for advice.
Information for doctors
Initial supplies of Ozempic will not meet the demand from all patients with type 2 diabetes and for those taking it off-label for other conditions.
Health professionals should allocate current limited supplies of Ozempic to people with type 2 diabetes who are currently using it, or who were using it before the shortage, and for whom other medicines are not suitable.
Doctors should avoid starting new patients on Ozempic until the supply stabilises.
Patients may need to restart treatment with a prescription for semaglutide 0.25/0.5 mg 1.34 mg/mL pre-filled pen to minimise risk of gastrointestinal side effects.
Doctors treating patients with obesity should continue to consider alternatives to semaglutide until supply stabilises.
Check the Royal Australian College of General Practitioners (RACGP) website for updated guidelines for prescribers with patients affected by the shortage of Ozempic.
Where appropriate, doctors can check with the community pharmacies in their area for updates on availability of Ozempic to help inform their prescribing decisions.
About the Ozempic (semaglutide) shortage 2022 and 202
As supply of Ozempic returns to normal, we will update this webpage with the information we receive from Novo Nordisk and the recommendations of the organisations who represent the interests of all patients.
The TGA will continue to work with Novo Nordisk and the pharmaceutical wholesalers to support fair and equal access to Ozempic across Australia.
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 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 re-establishing supply for a global shortage is taking some time.
Why the TGA can’t stop off-label prescribing
Off-label prescribing 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 liaising with Novo Nordisk and the relevant professional organisations
The TGA met with Novo Nordisk, pharmaceutical wholesalers and the following health professional groups and peak obesity organisations to manage the shortage and the return of supply now that shipments of Ozempic are arriving again:
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.
Past joint statements about the Ozempic shortage
In May 2022, the TGA published a joint statement with Novo Nordisk and relevant health professional organisations that asked doctors to prescribe Ozempic for patients with type 2 diabetes as a priority. These organisations included Diabetes Australia, the Australian Medical Association and the Pharmaceutical Society of Australia.
The TGA updated the statement in September 2022 after meeting with the health professional organisations again. Key obesity professional organisations also took part in the discussions, and the group recognised the challenges for people with type 2 diabetes affected by this shortage, while acknowledging that obesity is a highly prevalent, serious, complex and chronic disease that is challenging to manage. The group agreed that prescribers treating patients with either condition should be strongly advised to consider alternatives. Health professionals were also asked not to start new patients on Ozempic during the shortage.
Due to the ongoing and serious nature of the shortage, the TGA met with Novo Nordisk and the relevant organisations again in late October, and the Royal Australian College of General Practitioners (RACGP) published updated advice for health professionals– external site with patients affected by the shortage of Ozempic.
The RACGP will publish new advice in February 2023 for health professionals with patients whose Ozempic treatment was interrupted by the shortage, as well as other recommendations about starting new patients on Ozempic treatment.
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’s advice can be found on the PBS website– external site.
Pharmacists can get more information and order the overseas brand from the approval holders:
Medsurge Healthcare call 424 377 2912
Pro Pharmaceuticals Group call 424 377 2912
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
It may take several months for Ozempic supply to return to normal. If you are taking different diabetes medicine or another type of medicine that was prescribed for you during the shortage, you should continue taking that medicine until Ozempic is available at your regular pharmacy and you have spoken to your doctor about your ongoing treatment.
If you were able to access Ozempic during the shortage and have now run out, but still have a current prescription, contact your doctor for an alternative plan.
This medicine shortage has caused understandable frustration and anxiety throughout the community. Please keep in mind that health professionals at the medical practices and pharmacies you visit want the best possible health outcomes for everyone, but they do not control the availability of Ozempic. Please do not take your frustration or anger out on your pharmacist or doctor.
Please also be aware that 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.
As pharmaceutical companies are private entities, the TGA can’t force them to make or supply medicines in Australia. The TGA also can’t force them to list their products on the Pharmaceutical Benefits Scheme (PBS) or redirect stock from other markets.
The TGA does 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 advised that limited stock of Ozempic has started arriving in Australia. The supply will increase gradually over the next few months.
Following a shortage such as this, it will take time for pharmacies to build up their stock levels and to fill the scripts of customers on their waiting lists. To avoid disappointment and a recurring shortage, the TGA recommends that doctors wait until stock levels of Ozempic have returned to normal and waiting lists have been cleared before starting new patients on Ozempic.
The TGA is working closely with Novo Nordisk and relevant health professional and consumer organisations to manage the shortage, including the plan for new stock available in Australia.
We will update this webpage as soon as we have more information from Novo Nordisk and any new advice from the RACGP.
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 the TGA was 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.
The TGA is 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. However, the pharmaceutical company that makes Ozempic also makes Wegovy, a brand of semaglutide 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 have not yet confirmed when they will launch and supply this product in Australia.
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: [email protected] 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– external site.
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 +1 424 377 2912
Pro Pharmaceuticals Group call +1 424 377 2912
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.
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