Limited Ozempic supplies to commence distribution in Australia

TGA

Limited supplies of Ozempic (semaglutide) have now commenced distribution in Australia. From late next week there will be limited quantities of Ozempic, which is indicated for certain patients with type 2 diabetes mellitus available at some (but not all) community pharmacies.

Supply is expected to improve over the next few weeks, although will remain quite limited for some time. The arrival time of stock at individual pharmacies will vary as stock is urgently dispatched from Novo Nordisk to pharmaceutical wholesalers around Australia.

The Department of Health and Aged Care has asked wholesalers supplying pharmacies to apply purchasing limits on pharmacies to help ensure a more even distribution of the stock. We have also asked wholesalers to prioritise filling pharmacy orders in rural and remote areas during the first few weeks to assist supply in those areas, noting patients in these areas have fewer choices of pharmacy at which to fill their prescriptions.

Initial supplies of Ozempic will not be enough to meet demand from all patients with current valid prescriptions for type 2 diabetes nor for those taking it off-label for other conditions.

In the current situation, it is strongly recommended that health professionals should allocate supplies to patients using Ozempic for registered indications, particularly those who have not been switched by their doctor to other glucose-lowering medicines. We will continue to monitor supply and will work with stakeholders to update this advice when the situation changes.

The TGA recognises Ozempic has also been used off-label to treat other health conditions such as obesity, which is a serious chronic disease that is challenging to manage. Prescribers treating patients with obesity should continue to consider alternatives to semaglutide because supply will remain unstable for some time.

The TGA, health professionals, pharmaceutical wholesalers, patient groups and Novo Nordisk are all working together to manage the shortage and help patients as much as possible.

If you have a prescription for Ozempic, please be mindful that there will likely be some difficulty in sourcing Ozempic and many people will be unable to fill their Ozempic prescriptions until supply improves over the coming months. Only fill your script if your prescriber agrees that Ozempic continues to be the most appropriate medicine for you. If you have switched to another medicine because you have been unable to obtain Ozempic, you should speak to your doctor about your ongoing treatment. You may need to re-start on the introductory dose of Ozempic to minimise gastrointestinal side effects. Do not take Ozempic in addition to your current diabetes medicines unless your doctor has told you to.

Pharmacists should, where possible, 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.

Prescribers should avoid initiating new patients until supply stabilises and should continue to prioritise supply of Ozempic for people with type 2 diabetes who are current or previous users and for whom other medicines are not suitable. The Royal Australian College of General Practitioners has published a statement with updated guidelines for prescribers with patients affected by the shortage. 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. Where feasible, prescribers are encouraged to liaise with community pharmacies to obtain updates on stock availability to help inform their prescribing decisions.

Ozempic has been included in the Australian Register of Therapeutic Goods for treatment of type 2 diabetes. A worldwide shortage of semaglutide began to affect Australia in early 2022 when Novo Nordisk couldn't supply enough Ozempic to meet an unexpected increase in demand due to both high use in type 2 diabetes and off-label prescribing for weight loss.

The TGA is working closely with Novo Nordisk, pharmaceutical wholesalers and relevant health professional and consumer organisations to manage the shortage, including the plan for new stock available in Australia. The partners have emphasised the importance of equitable and sustainable access for patients, including for people in rural and remote areas for whom supply can be more difficult when national supply is limited.

For more information visit the Ozempic shortage webpage.

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