Brendan Smith (Cavan-Monaghan, Fianna Fail)
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264. To ask the Minister for Health if he is aware of widespread concerns in relation to the inadequate and limited supply of HRT patches (details supplied); the measures that will be undertaken to ensure that women will have no delay in accessing such products; and if he will make a statement on the matter. [41995/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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Thank you for your query on the important issue of medicine shortages.

Sandoz Pharmaceuticals d.d., the company responsible for supplying Estradot, has notified Ireland’s medicines regulator, the Health Products Regulatory Authority (HPRA), of a shortage of Estradot transdermal patches (50 microgram/24 hour transdermal patch, 75 microgram/24 hour transdermal patch, 100 microgram/24 hour transdermal patch). These shortages were notified on 10th July, 26th June and 30th July 2024, respectively, and are due to a manufacturing delay which is impacting multiple countries. The HPRA have been notified by Sandoz Pharmaceuticals d.d of an expected return date, reported as the 31st of October 2024 (for all three presentations).

Theramex Ireland Limited, the company responsible for supplying Evorel transdermal patches, has notified the HPRA of a shortage of Evorel 50 micrograms per 24 hours transdermal patch due to an unexpected increase in demand. This shortage was notified on 5th September 2024 and an expected return date is indicated as November 2024.

In the event that patients or their carers are unable to source a medicinal product, my Department and I would advise that they discuss possible alternatives with their healthcare professional pending the resumption of normal supply.

I am aware of the stress that shortages of medicines can cause for patients and healthcare professionals alike, thusly managing and mitigating medicine shortages is the subject of several workstreams across the Department and wider health service.

The HPRA operate a multistakeholder medicine shortage framework on behalf of the Department of Health, which 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 across the health service as they arise.

Brendan Smith (Cavan-Monaghan, Fianna Fail)
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265. To ask the Minister for Health if he is aware of widespread concerns in relation to the shortage in supply of fortisip compact protein drinks (details supplied); the measures that will be undertaken to ensure that supply of these necessary drugs are made available to patients; and if he will make a statement on the matter. [41996/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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To inform the response to your question, my Officials have consulted with Ireland’s medicines regulator, the Health Products Regulatory Authority (HPRA)

Creon current supply position:

Viatris, the company that places Creon on the market in Ireland has notified the HPRA of a global supply constraint of Creon (pancreatin) medicines. Viatris has informed the HPRA that this constrained supply is due to high global demand for this medicine coupled with manufacturing capacity constraints and a shortage of the active pharmaceutical ingredient required to manufacture this medicine. The company has informed the HPRA that it has put measures in place at wholesale level (monthly stock allocations) that are intended to ensure equitable distribution of the available stock to all patients who need this medicine.

The current availability of Creon medicines is as follows:

Creon 10000 Gastro Resistant Capsules: Viatris has notified a current shortage of Creon 10000 Gastro Resistant Capsules due an increase in demand for the product, impacting multiple markets globally. The company anticipates resupply in Ireland at the start of November 2024. It is expected that Creon 10000 Gastro Resistant Capsules will remain on allocation with release to pharmacies on a periodic basis after resupply in November.

Viatris has not notified the HPRA of a current shortage of Creon 5000 Gastro Resistant Granules or Creon 25000 Gastro Resistant Capsules.

Warfarin Teva current supply position:

Teva, the company responsible for supplying Warfarin Teva tablets, has notified the HPRA of a shortage of Warfarin Teva 3mg tablets due to a quality issue. This shortage was notified as beginning in July 2024 with anticipated resupply at the on the 15th of November.

Teva has also notified the HPRA of a shortage of Warfarin Teva 5mg tablets due to a quality issue. This shortage was notified as beginning in May 2024 with anticipated resupply at the on the 15th of November.

Teva has recently confirmed resupply of Warfarin Teva 1mg tablets.