Micheál Carrigy (Longford-Westmeath, Fine Gael)
Link to this: Individually | In context | Oireachtas source

1848. To ask the Minister for Health if she will address the ongoing shortage of salbutamol nebuliser solution in community pharmacies; the actions being taken by the HSE, the Medicines Management Programme and the HPRA to stabilise supply; the expected timeframe for restoration of normal availability; the clinical guidance being issued to prescribers and pharmacists regarding safe alternatives or substitution protocols; and if she will ensure that vulnerable patients such as (details supplied) who rely on nebulised salbutamol for COPD or asthma relief are prioritised for access where clinically indicated; and if she will make a statement on the matter. [58812/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context | Oireachtas source

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 multi-stakeholder 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.

Teva B.V, the company responsible for supplying Ipramol, has notified the HPRA of the shortages of Ipramol Steri-Neb 0.5 mg / 2.5 mg per 2.5 ml nebuliser solution, Salamol Steri-Neb 2.5 mg / 2.5 ml nebuliser solution and Salamol Steri-Neb 5 mg / 2.5 ml Nebuliser Solution. These shortages were notified on the 22nd July 2024, 3rd April 2025 and 11th July 2025, respectively, and is due to an unexpected increase in demand, globally and manufacturing delays.

Teva B.V are presently unable to advise of an exact date for resolution of the shortages.

In case of shortages with a significant public health impact, the HSE can issue clinical guidance to healthcare professionals, where appropriate, to mitigate the impact of a shortage. There have been several such shortages where the HSE has issued clinical guidance as a mitigation measure, including in this therapeutic area.

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.