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Medicinal Products

Dáil Éireann Debate, Tuesday - 9 June 2020

Tuesday, 9 June 2020

Questions (437)

Louise O'Reilly


437. Deputy Louise O'Reilly asked the Minister for Health if his attention has been drawn to problems in procuring epanutin 50mg infatabs for patients prescribed same; if his attention has further been drawn to conflicting information regarding the shortage from industry and the Health Products Regulatory Authority; his plans to rectify the situation in order to minimise harm to patients; and if he will make a statement on the matter. [10455/20]

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Written answers (Question to Health)

The Marketing Authorisation Holder (MAH) for the anti-epileptic medicine Epanutin confirmed a shortage of its Epanutin Infatabs 50mg Chewable Tablets presentation. which contains the active ingredient phenytoin, commencing November 2019. The shortage is due to a manufacturing site change and other changes to the manufacturing process of this particular product and the resulting shortage is not confined to the Irish market. The company is taking all possible steps to ensure that normal supply resumes as soon as possible.

However, in order to mitigate any impact of the shortage to patients, the company is supplying the product it places on the Australian market under a different brand name, Dilantin Infatabs 50mg Chewable Tablets, to meet the needs of Irish patients. This product contains the same active ingredient, phenytoin, and is owned by the same company.

On the 9th of October 2019, healthcare professionals were alerted in advance of the shortage, advising that pharmacy staff and patients should be made aware of the issue and of the replacement product that would be made available. A copy of this letter is available on the Health Products Regulatory Authority (HPRA) website. Ireland has a multi-stakeholder medicine shortage framework in place, coordinated by the HPRA, in order to prevent, wherever possible, and manage medicine shortages when they occur. The HPRA remains in regular contact with the MAH regarding the interruption in supply of Epanutin 50mg Infatabs.

Patients or their carers who have any questions or concerns in relation to the temporary alternative presentation of phenytoin are advised to speak with their pharmacist or other healthcare professional responsible for their epilepsy care.