Written answers

Wednesday, 7 February 2024

Department of Health

Medicinal Products

Photo of Duncan SmithDuncan Smith (Dublin Fingal, Labour)
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480. To ask the Minister for Health if he is aware of the current shortage in the medicine victoza; what measures are being taken to address this shortage; what alternative medicine can be prescribed to people due to this shortage; and if he will make a statement on the matter. [4979/24]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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Currently, there are 2 shortages for Victoza® (liraglutide) by the Marketing Authorisation Holder (MAH), Novo Nordisk, Victoza 6 mg/ml Solution for injection in pre-filled pens (EU/1/09/529/002 and EU/1/09/529/003). The shortages affect the 2 pen and 3 pen pack sizes. Both are published on the Health Products Regulatory Authority (HPRA) website with a return date of 20th June 2024 and accompanied by a detailed update from the MAH and a link to HSE Clinical guidance (Shortages List (hpra.ie).

Novo Nordisk, the Marketing Authorisation Holder for Victoza® has indicated that increased overall demand for both Ozempic® and Victoza® injectable glucagon-like peptide-1 receptor agonists (GLP-1 RAs) coupled with capacity constraints at manufacturing sites have led to shortages, including out of stock situations. In addition, to facilitate increasing supply of Ozempic®, Novo Nordisk has decided to temporarily reduce the supply of Victoza®. As a result, shortages of Victoza® are expected at least until Q2 2024.

The MAH, Novo Nordisk, has, in a letter to Healthcare professionals, indicated that no new patients should be started on Victoza® until at least Q2 2024, when supply is expected to normalize, and available product should only be used to continue treatment of patients currently treated.

Unfortunately, medicine shortages are a feature of modern health systems worldwide which have been exacerbated by recent worldwide events. There are a multitude of reasons why a medicine may not be available including: shortages of raw materials; manufacturing difficulties; sudden unexpected increase in demand; or product recalls due to potential quality issues. Pharmaceutical companies and wholesalers in Europe are responsible for ensuring a consistent supply of the medicines they sell.

Ireland has a multi-stakeholder medicine shortage framework in place, coordinated by the Health Products Regulatory Authority (HPRA), to prevent, wherever possible, and to manage medicine shortages when they occur. The Department of Health maintains regular contact with the HPRA regarding medicines shortages.

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

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