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Medicinal Products

Dáil Éireann Debate, Tuesday - 22 February 2022

Tuesday, 22 February 2022

Questions (729, 793)

David Cullinane

Question:

729. Deputy David Cullinane asked the Minister for Health if his attention has been drawn to the shortage of hormone replacement therapy in the Republic of Ireland; the steps he has taken to address the shortages; if he has engaged with his counterpart in Northern Ireland in relation to same; and if he will make a statement on the matter. [9305/22]

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Mary Lou McDonald

Question:

793. Deputy Mary Lou McDonald asked the Minister for Health the reason for shortages in HRT medicines given that The Health Products Regulatory Authority has listed these as medicines shortages; the measures that are in place to minimise impact or disruption to patient care and the impact on healthcare professionals caused by these shortages; and if he will make a statement on the matter. [9602/22]

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Written answers

I propose to take Questions Nos. 729 and 793 together.

Medicine shortages have become increasingly prevalent worldwide over the past decade and are a feature of modern health systems around the world. There are many reasons for such shortages including shortages of raw materials, manufacturing difficulties, logistical/transport issues or product recalls due to potential quality defects. Medicines shortages can therefore originate at any point in the supply chain and can involve and impact on many different stakeholders. Accordingly, medicines shortages require a multi-faceted, multi-stakeholder response to ensure patient safety, continuity of care and protection of public health.

As a result of the increasing prevalence of medicines shortages globally, there has been significant interest at European level in this area, including a task force on medicines availability to identify and address issues linked to the disruption of supplies of medicines. Ireland, through my Department and the Health Products Regulatory Authority, continues to contribute to these efforts at a European level to consider initiatives to minimise the risk and disruption to patient safety and care, and the impact on healthcare professionals, caused by medicine shortages. As well, colleagues within the Department continue to engage with their counterparts in Northern Ireland in order to better address health concerns across the island.

At a national level, Ireland has a multi-stakeholder medicines shortages framework in place, coordinated by the Health Products Regulatory Authority (HPRA), to prevent, wherever possible, and manage medicine shortages when they occur. The HPRA have been notified of intermittent supply challenges involving HRT medicines that have been ongoing for some months. These supply difficulties are due to a significantly increased demand for theses products in Ireland in recent years. The HPRA continues to engage with the companies involved to mitigate the impact of the shortages.

In the case of medicines used most often in Ireland, there are typically multiple brands and/or generic medicines available from a range of sources. In the event that supply issues arise for individual medicines, different options, including alternative brands or generic medicines, should be made available to ensure continuity of treatment. If the patient has concerns, they should discuss their treatment and alternative options with their doctor, pharmacist or other healthcare professional.

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