Joint statement: Prioritisation of semaglutide (Ozempic) supply for people with type 2 diabetes during shortage

4 August 2022

Novo Nordisk Pharmaceuticals Pty Ltd, the sponsor of semaglutide (Ozempic) solution for injection pre-filled pen, notified the Therapeutic Goods Administration (TGA) of a shortage of both strengths of semaglutide (Ozempic) products due to an unexpected increase in consumer demand. The increased demand is due to extensive prescribing for obesity management, for which Ozempic is not indicated. The shortage is significantly affecting people using Ozempic for its approved use for type 2 diabetes.

This statement has been developed by the TGA and:

• The Australian Medical Association (AMA)
• The Royal Australian College of General Practitioners (RACGP)
• The Australian Diabetes Society (ADS)
• Diabetes Australia (DA)
• Pharmaceutical Society of Australia (PSA)
• The Pharmacy Guild of Australia
• The Society of Hospital Pharmacists of Australia (SHPA)
• National Pharmaceutical Services Association (NPSA)
• Novo Nordisk Pharmaceuticals Pty Ltd.

To prioritise essential continuity of care for people with type 2 diabetes during the shortage, health professionals should limit prescribing and dispensing of semaglutide to its approved use:

Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:

• as monotherapy when metformin is not tolerated or contraindicated
• in addition to other medicinal products for the treatment of type 2 diabetes.

Novo Nordisk Pharmaceuticals Pty Ltd has advised that supplies of semaglutide (Ozempic) in Australia are sufficient for this approved use, and is working with the TGA, professional associations and consumer groups to limit the effects caused by the recent significant prescribing outside of Ozempic's approved use.

Information for consumers

If you have been prescribed semaglutide (Ozempic) for type 2 diabetes, the TGA appreciates the importance of this medicine to you. To ensure you have access to the supplies that are arriving in Australia contact your usual pharmacy as early as possible to have your prescription filled. This will give them time to arrange for the medicine to be available when you need it. Do not wait until you run out (or are close to running out) of your medicine.

During a medicine shortage, it is best to leave your prescription with your regular pharmacy or a preferred pharmacy if you can. This will allow your pharmacist to order for you and help you to get the medicines you need.

If you do not have type 2 diabetes and have been prescribed semaglutide (Ozempic) for another condition, your pharmacist may not be able to fill your prescription because of the current shortage. If you have any questions or concerns about this issue, talk to your health professional about alternatives that may be available to you.

Information for prescribers

Limiting prescribing of semaglutide to people with type 2 diabetes is essential.

Health professionals should inform people with type 2 diabetes about the semaglutide shortage and advise them to contact their pharmacy as soon as possible with their prescription to ensure supply.

Health professionals can also contact local pharmacies for the status of semaglutide stock availability.

People requesting a semaglutide prescription for obesity management should be advised of alternative treatment options as people using Ozempic for the registered indication of type 2 diabetes are being prioritised.

Information for pharmacists

Prioritising semaglutide supply to people with type 2 diabetes is essential to ensure continuity of care during the shortage.

Talk to your customers about contacting the pharmacy as soon as possible with their prescription, so that timely supply can be organised. Encourage your customers to leave their prescription with their regular or preferred pharmacy.

Order stock through your usual wholesalers.

To help reduce the impact of this shortage, the TGA has authorised the supply of overseas-registered semaglutide products under section 19A of the Therapeutic Goods Act 1989. However, due to global supply constraints, supply of the section 19A products may be limited. More information on these products, including the approval holders and their contact details are available from the Database of section 19A approvals.