Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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877. To ask the Minister for Health the steps being taken to address the ongoing shortage of a medication (details supplied), which has now been out of stock for approximately eight months; if she is aware of the impact this shortage is having on long-term patients who have relied on this medication for decades; and if she will confirm when supply is expected to resume. [55143/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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My Department is aware of the stress that shortages of medicines can cause for patients and healthcare professionals alike, therefore mitigating medicine shortages and strengthening security of supply is the subject of several workstreams in my Department, the wider health service and across Europe.

Medicine shortages are a feature of modern health systems worldwide which have been exacerbated by recent worldwide events. It is a global health problem, not unique to Ireland, and increases in demand for medications and medicines shortages have been observed in the UK, throughout the EU and across the world in recent months, and there is no evidence that shortages disproportionately impact patients in Ireland compared to other countries.

Ireland has a multistakeholder Medicines Shortages Framework in place, operated by our medicines regulator, the Health Products Regulatory Authority (HPRA) on behalf of the Department of Health. The framework aims to help prevent potential shortages from occurring and to reduce the impact of shortages on patients by coordinating the management of potential or actual shortages as they arise. Stakeholders in this framework include the HPRA, the Department, the HSE, healthcare professionals, manufacturers, wholesalers, patient representative groups and marketing authorisation holders.

The HPRA maintains a list of current and resolved shortages on its website. The webpage is updated daily as the HPRA receives new information.

Teva B.V., the company responsible for supplying Ipramol Steri-Neb 0.5 mg/2.5 mg per 2.5 ml nebuliser solution, has notified the HPRA of a shortage of Ipramol Steri-Neb 0.5 mg/2.5 mg per 2.5 ml nebuliser solution due to an unexpected increase in demand impacting globally. Teva B.V. are presently unable to advise of an exact date for resolution of the shortages of Ipramol Steri-Neb 0.5 mg/2.5 mg per 2.5 ml nebuliser solution.

To note, the recent shortage of Ipramol Salamol Steri-Neb 2.5mg/2.5 ml Nebuliser Solution has been resolved.

In the event that patients are unable to source a medicinal product due to supply constraints, they are advised to discuss possible alternatives with their healthcare professional pending the resumption of normal supply.

Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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878. To ask the Minister for Health if contingency arrangements are in place to support patients who have been prescribed alternative medications such as (details supplied), both of which are now also reported to be in short supply, leaving patients without appropriate inhalation therapy; and if she will ensure that the HSE and HPRA work with community pharmacists and wholesalers to secure temporary alternative treatments or imported supplies for patients with chronic respiratory conditions, such as those dependent on nebulised therapy three times daily. [55144/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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My Department is aware of the stress that shortages of medicines can cause for patients and healthcare professionals alike, therefore mitigating medicine shortages and strengthening security of supply is the subject of several workstreams in my Department, the wider health service and across Europe.

Unfortunately, medicine shortages are a feature of modern health systems worldwide. There are a multitude of reasons why a medicine may not be available including: shortages of raw materials; manufacturing difficulties; or product recalls due to potential quality issues.

Ireland has a multistakeholder Medicines Shortages Framework in place operated by the Health Products Regulatory Authority (HPRA) on behalf of the Department of Health. This framework aims to help prevent potential shortages from occurring and to reduce the impact of shortages. Stakeholders include the HPRA, the Department, the HSE, healthcare professionals, manufacturers, wholesalers, patient representative groups and marketing authorisation holders.

In European law, pharmaceutical companies and wholesalers should ensure an appropriate and continuous supply of the medicines they market. Companies are required to notify the HPRA of medicines shortages or potential shortages impacting the Irish market. The HPRA maintains a list of current and resolved shortages on its website, such as:

Teva B.V., the company responsible for supplying Ipramol Steri-Neb 0.5 mg/2.5 mg per 2.5 ml nebuliser solution, has notified the HPRA of a shortage of Ipramol Steri-Neb 0.5 mg/2.5 mg per 2.5 ml nebuliser solution due to an unexpected increase in demand impacting globally. Teva B.V. are presently unable to advise of an exact date for resolution of the shortages of Ipramol Steri-Neb 0.5 mg/2.5 mg per 2.5 ml nebuliser solution.

To note, the recent shortage of Ipramol Salamol Steri-Neb 2.5mg/2.5 ml Nebuliser Solution has been resolved.