Tuesday, 12 November 2019

Questions (384)

Pat Buckley

Question:

384. Deputy Pat Buckley asked the Minister for Health if his attention has been drawn to problems in procuring Epanutin 50 mg Infatabs for patients prescribed same (details supplied); his plans to rectify the situation in order to minimise harm to patients; and if he will make a statement on the matter. [46518/19]

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Written answers (Question to Health)

The Marketing Authorisation Holder for Epanutin 50mg Infatabs confirmed a shortage of Epanutin Infatabs 50mg, commencing 4th November 2019. This shortage is not confined to the Irish market. The company is changing its manufacturing site and this has resulted in the shortage. 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. This product contains the same active ingredient, phenytoin, and is owned by the same company.

On the 9th of October healthcare professionals were alerted in advance of the shortage, advising that pharmacy staff and patients should be made aware of the issue and that the replacement product that would be made available. Patients or their carers who have any concerns in relation to the temporary alternative product are advised to speak with their pharmacist or other healthcare professional involved in their epilepsy care.

Unfortunately, medicine shortages are a feature of modern health systems worldwide, but Ireland has a multi-stakeholder system in place to prevent and manage shortages when they occur.

The Health Products Regulatory Authority (HPRA) has worked with other stakeholders, including the pharmaceutical industry and the HSE, to develop an effective approach to the management of medicine shortages in Ireland. In 2018, the HPRA launched the “Medicine Shortages Framework”, which is built on a pragmatic and collaborative approach involving the wide range of stakeholders within the medicine supply chain. The HPRA coordinates all stakeholders to share information in order to prevent or mitigate the impact of medicine shortages when they occur.