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Medicinal Products

Dáil Éireann Debate, Tuesday - 18 April 2023

Tuesday, 18 April 2023

Ceisteanna (1671)

Peter Fitzpatrick

Ceist:

1671. Deputy Peter Fitzpatrick asked the Minister for Health if he will provide information on the supply of two medications, amitriptyline and dalmane (details supplied); and if he will make a statement on the matter. [17678/23]

Amharc ar fhreagra

Freagraí scríofa

Mylan, the company responsible for supplying Dalmane to the Irish market, notified the Health Products Regulatory Authority (HPRA) of a shortage of the product, citing the unavailability of the active ingredient as the reason. Multiple countries are impacted. The company expects resupply of the product to occur in October 2023. There are alternative treatments available with the same indication as Dalmane. Patients should discuss alternative treatments with their prescriber.

Regarding Amitriptyline, the HPRA has not received notification for shortages of amitriptyline-containing medicines from the different companies that supply the medicines in Ireland.

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 Health Products Regulatory Authority (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.

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