Maurice Quinlivan (Limerick City, Sinn Fein)
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1331. To ask the Minister for Health if steps are being taken to secure a supply of the drugs rivotrol and zarontin for the treatment of epilepsy-related seizures, given the current international shortage of these pharmaceuticals; and if he will make a statement on the matter. [63853/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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Medicine shortages are increasingly prevalent worldwide over the past decade. The causes of such shortages are multi-factorial, including shortages of raw materials, manufacturing difficulties, increased demand, product recalls due to potential quality defects, and industry consolidations. Medicine shortages can originate at any point in the supply chain. They can involve and impact many stakeholders in different ways, as the supply models and clinical use of therapies can vary across national health systems.

The Department of Health, as advised by the Health Products Regulatory Authority (HPRA), is aware of a shortage of Rivotril 0.5mg tablets, which are supplied by Cheplapharm, due to manufacturing issues which have impacted supply to multiple countries. The company informed the HPRA that the shortage began on 17th October 2022, and supply is expected to resume in February 2023. Alternative products with the same active ingredient (clonazepam) are available. The HPRA has also expedited a controlled drug licence to assist the company in the accelerated import of Rivotril.

The only authorised presentation of Zarontin in Ireland is 250mg/5ml syrup. Essential Pharma, the company that markets the product, has confirmed that there are no shortages of this product and that there is stock in the wholesalers.

Management of medicines shortages necessitates a multi-faceted, multi-stakeholder response to ensure patient safety, continuity of care and protection of public health. To that end, at the request of the Department of Health, the Health Products Regulatory Authority (HPRA) has assumed a coordinating function in Ireland’s response to managing medicine shortages when they occur. The HPRA is generally informed of a medicine shortage by the relevant pharmaceutical company. Shortages can also be notified to the HPRA by other stakeholders across the health system. In each case, the HPRA will work with relevant stakeholders as necessary, including the HSE, to coordinate an effective approach to the management of a confirmed product shortage. The HPRA engages with stakeholders to coordinate actions and share information to prevent or mitigate the impact of medicine shortages when they occur.

The HPRA publishes a list of medicines currently in short supply on its website 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 has to hand, including removal from the list when a shortage has been resolved.

Patients or their carers who have any concerns in relation to temporary alternative products provided because of medicine shortages are advised to speak with their pharmacist or other healthcare professional involved in their care.