Published 4 August 2023
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Novo Nordisk Pharmaceuticals has notified the Therapeutic Goods Administration (TGA) about a critical shortage of the emergency glucagon product GlucaGen HypoKit. The shortage, which is due to manufacturing delays, is expected to last until 30 September 2023.
The GlucaGen HypoKit is primarily used to treat people with type 1 diabetes who are unconscious due to severe hypoglycaemia (extremely low blood sugar levels or a ‘hypo’). It may also be used in certain other situations as directed by a specialist. The kit includes a vial with glucagon in powder form and a syringe containing saline to mix with the powder, plus a needle to give the injection.
People living with type 1 diabetes and their carers need to keep this medicine on hand for emergency use. The TGA is urgently working with Novo Nordisk, as well as wholesalers and health professionals, to manage the impact of the shortage on people who have recently been diagnosed with type 1 diabetes, or who may need to replace a used or expired kit.
To assist with this, the TGA has approved the supply of several overseas-registered glucagon products under section 19A of the Therapeutic Goods Act 1989 (see Information for clinicians and pharmacists).
The TGA has also formed a medicine shortages action group (MSAG) to discuss the implications and management of this shortage, including representatives from the Australian Diabetes Society, Diabetes Australia, the Australia and New Zealand Society for Paediatric Endocrinology and Diabetes, and the Endocrine Society of Australia. The MSAG has developed the following advice for patients, carers, clinicians and pharmacists.
We understand the importance of the GlucaGen HypoKit to people living with type 1 diabetes and their carers. We appreciate your concern if a kit you have is nearing expiry, or you require a kit for the first time. Please follow the advice below:
It is especially important for people who live in remote areas where emergency care is not immediately available to have a kit, and to have one that is not due to expire.
Pharmacists will be prioritising where possible any emergency stock for people with type 1 diabetes who need a kit for the first time or people whose GlucaGen HypoKit is due to expire before 30 September 2023, to prevent stockpiling.
Speak with your doctor or pharmacist if you are concerned about this situation.
The TGA has approved the supply of several overseas-registered glucagon products under section 19A of the Therapeutic Goods Act 1989. Information for pharmacists about ordering these products, including each approval holder’s contact details, is available from our section 19A database.
Please be aware that some overseas-registered glucagon products require different storage conditions to the Australian registered product to prolong their shelf life. Please refer to the supplied package leaflet of your overseas product for details about its storage conditions, and ensure patients are aware of these differences.
Clinicians who require a GlucaGen HypoKit for their doctor’s bag are asked to keep any kits they have that are nearing expiry date until the shortage has ended and they are able to replace them with a new kit.
Hospitals are asked to use alternatives for treatments involving the use of GlucaGen HypoKit where possible and only use GlucaGen HypoKit for treating hypoglycaemia.
The following people should be prioritised to receive glucagon supplies:
Advise patients that:
Please note that while the current shortage is expected to end by 30 September 2023, this date may change and we encourage you to check the medicine shortage reports database- external site for updates about the supply of GlucaGen HypoKit.
Please also keep in mind that the TGA can work with pharmaceutical companies to communicate information about a medicine shortage to health professionals and patients, but we cannot compel companies to increase supply or apply to have their products subsidised on the Pharmaceutical Benefits Scheme (PBS).
The TGA will continue to monitor the supply of GlucaGen HypoKit and work with the MSAG and suppliers to update this advice if needed.
Source : https://www.tga.gov.au/safety/shortages/medicine-shortage-alerts/shortage-glucagen-hypokit-glucagon
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