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Medicinal Products

Dáil Éireann Debate, Wednesday - 16 October 2024

Wednesday, 16 October 2024

Questions (264)

Brendan Smith

Question:

264. Deputy Brendan Smith asked 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]

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Written answers

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.

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