Duncan Smith (Dublin Fingal, Labour)
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261. To ask the Minister for Health if he is concerned about a paracetamol shortage in Ireland; the plans that his Department is putting in place to address the matter; and if he will make a statement on the matter. [62443/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Department of Health has been notified by the Health Products Regulatory Authority (HPRA) of recent shortages impacting some prescription paracetamol products, which are not only restricted to Ireland. For two suppliers of prescription paracetamol-only products, the companies have stated that resupply is expected in January 2023. There are other prescription paracetamol suppliers with stock available.

In the case of medicines used most often in Ireland, including paracetamol, there are typically multiple forms, strengths, brands, and generic medicines available from various sources. In the event that there are some supply issues for individual medicines, alternative options such as alternative strengths, brands, and generic medicines will usually be available to ensure continuity of treatment. In some cases where the medicine initially prescribed for the patient is unavailable, patients may be switched to a suitable therapeutic alternative following appropriate consultation with a healthcare professional.

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.

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.