Written answers

Wednesday, 19 June 2024

Department of Health

Medicinal Products

Photo of Cian O'CallaghanCian O'Callaghan (Dublin Bay North, Social Democrats)
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125. To ask the Minister for Health if the supply of a medication (details supplied) can be prioritised; and if he will make a statement on the matter. [26346/24]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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Novo Nordisk, the company responsible for supplying Ozempic, has advised of supply issues with its glucagon-like peptide-1 (GLP-1) receptor agonist products including Ozempic. Novo Nordisk has outlined that these supply issues are due to increased global demand for GLP-1 products coupled with manufacturing capacity constraints at manufacturing sites. The company anticipates that intermittent supply issues will continue in 2024.

Novo Nordisk has notified shortages of the following Ozempic products:

  • Ozempic 0.25mg solution for Injection in pre-filled pen: Novo Nordisk has notified a current shortage of this product due to a manufacturing delay. The shortage began in early June 2024 and the company has informed the Health Products Regulatory Authority (HPRA) that resupply is expected mid-July 2024.
  • Ozempic 0.5mg solution for Injection in pre-filled pen: Novo Nordisk has notified a shortage of this product due to a manufacturing delay. The shortage began in early June 2024 and the company informed the HPRA that resupply is expected on 18th June 2024. It is understood that it may take 24-48 hours for stock to be available to order at pharmacy level once resupply occurs.
Monthly allocations have been implemented at wholesale level to help ensure continuity of supply and equitable distribution of stock to patients. Pharmacies are advised to not order extra quantities of Ozempic over and above immediate patient need as doing so could exacerbate the supply constraints.

To assist in the management of this product shortage, prescribing and dispensing should be prioritised for the licensed indication and restricted to a one-month supply.

Healthcare professionals are requested to ensure that patients prescribed Ozempic are made aware of this issue and to consider the most suitable course of action for the individual including whether a patient can be safely prescribed a clinically appropriate alternative, if required.

The Health Products Regulatory Authority (HPRA) is engaging closely with the company and the wholesalers involved in the supply of this product to keep the health system and the public informed - www.hpra.ie/docs/default-source/Shortages-Docs/ozempic-availability-september---info-for-hcps-and-patients---1-sept-2023701f152697826eee9b55ff00008c97d0.pdf?sfvrsn=2

Novo Nordisk has issued letters to relevant stakeholders, including healthcare professionals to ensure they are aware of this supply issue and its management.

Further information and HSE guidance is also available relating to Ozempic supply interruption for healthcare professionals and patients - www.hpra.ie/docs/default-source/Shortages-Docs/glp1-ra-shortage-clinical-advice-ncpd-01112023.pdf?sfvrsn=2

I recognise that medicine shortages can be challenging for patients, carers, healthcare professionals and their teams. Based on shortages notified to the HPRA, this matter has been the subject of engagement across Health Service stakeholders. Where at all possible, all parties are focused on pre-empting and responding to any potential impacts on medicines supply. Where a shortage cannot be prevented, we will aim to provide useful information to healthcare professionals and patients.

The HPRA maintains a list of current and resolved shortages on www.hpra.ie/homepage/medicines/medicines-information/medicines-shortages, where the details, including the information above, are detailed. The webpage is updated daily as new information is received.

Patients who have any concerns about availability of their medication are encouraged to speak to their GP or pharmacist.

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