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Medicinal Products

Dáil Éireann Debate, Tuesday - 27 June 2023

Tuesday, 27 June 2023

Questions (690)

Duncan Smith

Question:

690. Deputy Duncan Smith asked the Minister for Health the measure he and his Department are taking to ensure supply of HRT medicines following shortages of utrogestran and oestrogen patches; and if he will make a statement on the matter. [30912/23]

View answer

Written answers

Laboratoires Besins International has advised of a shortage of Imvaggis 0.03 mg Pessary, impacting multiple markets. The company stated the reason is manufacturing delays and supply is expected towards the end of July.

Alternatives are available. Many Hormone Replacement Therapies (HRT) are authorised for use in Ireland in various formulations (e.g., oral tablets, transdermal patches, gels, and sprays) and strengths. For the vast majority of HRT products authorised, including transdermal patches and gels, the Health Products Regulatory Authority (HPRA) has not received any notifications of current shortages. This includes all but two of the above mentioned authorised products outlined in the HSE’s clinical guidance for HRT (hyperlink below).

MMP guidance for prescribers on HRT shortages – September 2022 (hse.ie)

Unfortunately, medicine shortages are a feature of modern health systems worldwide which have been exacerbated by recent worldwide events. There are a multitude of reasons why a medicine may not be available including: shortages of raw materials; manufacturing difficulties; sudden unexpected increase in demand; or product recalls due to potential quality issues. Ireland has a multi-stakeholder medicine shortage framework in place, coordinated by the HPRA, to prevent, wherever possible, and to manage medicine shortages when they occur. The Department of Health maintains regular contact with the HPRA regarding medicines shortages.

The HPRA publishes a list of medicines currently in short supply on its website (Medicines Shortages (hpra.ie) with the reason for the shortage and expected dates for the return of supply. The information is available to assist healthcare professionals in managing medicine shortages when they arise and reduce their impact on patients. The information relating to shortages on the HPRA website is dynamic and changes depending on the current information.

The HPRA will continue to liaise with suppliers of HRT medicines over the coming weeks with a view to securing updates and commitments regarding the restoration of normal supplies for patients as soon as possible.

The supply Utrogestan Vaginal 200mg Vaginal Capsule which had been in short supply resumed on 20 June.

Patients are advised to discuss their treatment and alternative options with their doctor, pharmacist or other healthcare professional.

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