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Why is there a shortage of Ozempic pens?

Why the Ozempic shortage has 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.

tga.gov.au - About the Ozempic (semaglutide) shortage 2022 and 2023

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To read related alerts in date order visit our Ozempic (semaglutide) shortage collection.

The current Ozempic (semaglutide) supply situation

Therefore, we recommend that patients who are prescribed Ozempic should contact their doctor immediately to have their treatment reassessed. This is especially important around the holiday season and medical services will be limited for several weeks. The TGA is working with Novo Nordisk and the relevant health professional organisations to manage this serious shortage. The Royal Australian College of General Practitioners (RACGP) has published new advice for health professionals who have patients affected by the shortage of Ozempic. The TGA will publish updates about the supply of Ozempic from Novo Nordisk on the Medicine Shortage Reports Database.

Stay up to date

Since the worldwide shortage of diabetes medicine Ozempic started earlier this year, 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 page is updated as soon as information changes.

Soon you will be able to get an email alert whenever we change or add information about the Ozempic shortage on this webpage. Please sign up for this update service when it becomes available. We will explain how to sign up on this page.

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’ on a private prescription by medical practitioners to treat conditions other than those approved by the TGA. You can read more about Ozempic in the Consumer Medicine Information- external site.

Why the Ozempic shortage has 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 re-establishing supply for a global shortage will take 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

are communicating updates on this webpage and also the Medicine Shortage Reports Database- external site. You can read more about how the TGA manages medicine shortages in the information for consumers section of our website.

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 met with these organisations again and updated the statement in September 2022 to encourage the use of alternative treatments where possible, and reinforce the importance of doctors limiting prescriptions for Ozempic to patients with type 2 diabetes. Health professionals have also been 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 health professional organisations again in late October. The Royal Australian College of General Practitioners (RACGP) has published new advice for health professionals- external site who have patients affected by the shortage of Ozempic.

Overseas-registered semaglutide is available

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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 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 while you can’t get Ozempic

As Ozempic will be unavailable until the end of March 2023, we recommend that patients should make an appointment with their doctor as soon as possible to have their treatment plan reassessed. This is especially important as we approach the holiday season, as medical services will be limited for several weeks. We advise patients to see their doctor as soon as possible. There is a range of medicines available to effectively treat type 2 diabetes, and your doctor will be able to advise you about the most appropriate treatment options for you. Diabetes Australia- external site also has useful advice for people living with diabetes whose treatment is being changed. Patients who have been prescribed Ozempic for other health conditions should also see their doctor as soon as possible to have their treatment plan reassessed. This medicine shortage is causing 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 other semaglutide products offered online have not been checked by the TGA. All medicines supplied in Australia must be included in the Australian Register of Therapeutic Goods (ARTG), and all registered medicines are fully assessed by the TGA for safety, quality and effectiveness before they can be sold.

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. 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?

We don't know. At present, Novo Nordisk is unable to say when Ozempic supply will return to normal. Regular and adequate supply is not expected until the end of March 2023. We will update this webpage as soon as we have more information from Novo Nordisk. You can also check the Medicine Shortage Reports Database- external site for updates. Soon you will also be able to get an email alert whenever we change or add information about the Ozempic shortage on this webpage. Please check back frequently so that you can sign up for this updating service when it becomes available.

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.

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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. 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- 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. In the case of the Ozempic shortage, 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.

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. As pharmaceutical companies are private entities the TGA does not have the regulatory power to force them to manufacture their products in Australia.

tga.gov.au - About the Ozempic (semaglutide) shortage 2022 and 2023

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