Dáil Éireann Debate, Thursday - 13 July 2023
783. Deputy Colm Burke asked the Minister for Health what action is being taking to ensure that pharmacies and hospitals have access to sufficient supplies of insulin; and if he will make a statement on the matter. [35242/23]
View answerAt any given time, shortages of medicines can occur in any country. Increases in demand for medications and medicines shortages have been observed in the UK, throughout the EU and across the world in recent months.
In relation to insulin-containing medicines, there are currently 150 insulin-containing medicines authorised in Ireland. One product, Fiasp 100 units/ml solution for injection in a vial from Novo Nordisk, is the only one notified as in short supply currently to the HPRA.
Novo Nordisk, the company responsible for Fiasp 100 units/ml Solution for Injection in a vial, notified the HPRA of a shortage of the product due to manufacturing reasons, with resupply expected at the end of July. The company has provided a letter to healthcare professionals concerning this (attached), and the HPRA continues to engage with the company regarding the shortage.
Ireland has a multi-stakeholder medicine shortage framework in place, operated by the Health Products Regulatory Authority (HPRA) on behalf of the Department of Health. The multi-stakeholder framework includes representation from the pharmaceutical industry, healthcare professionals, the HSE, the Department of Health and patients.
In European law, pharmaceutical companies and wholesalers must ensure an appropriate and continuous supply of the medicines they market. When a potential shortage issue is identified, pharmaceutical companies should notify the HPRA as soon as possible. If the shortage cannot be prevented, then, where possible, the HPRA will work with other framework stakeholders to reduce the potential impact on patients. The Department of Health maintains regular contact with the HPRA regarding medicines shortages.
In Ireland, whilst individual brands or strengths of a medication may be temporarily unavailable, for the vast majority of medicines supplied in Ireland, there are alternatives, such as different strengths, brands or similar classes, to ensure continuity of care.
Unfortunately, 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.
The HPRA publishes a list of medicines currently in short supply on its website (Medicines Shortages (hpra.ie) with the reason for the shortage and expected dates for the return of supply. The information is available to assist healthcare professionals in managing medicine shortages when they arise and reduce their impact on patients. The information relating to shortages on the HPRA website is dynamic and changes depending on the current information to hand.
Any patient concerned of a medicine shortage are advised to discuss their treatment and alternative options with their doctor, pharmacist, or other healthcare professional.
