Alan Farrell (Dublin Fingal, Fine Gael)
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610. To ask the Minister for Health if his attention has been drawn the unavailability of certain prescription drugs (details supplied) and the effects this is having on patient care; and if he will make a statement on the matter. [3235/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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Mylan, the Marketing Authorisation Holder for Creon capsules, has not notified the Health Products Regulatory Authority (HPRA) of a current shortage of this product. There have been some global supply issues with Creon in 2022. The company placed an allocation on the product at the wholesale level to ensure equitable distribution of available stock to pharmacies and subsequently to patients. Should a pharmacist have difficulty obtaining the product from their supplier, the company has advised that increases in the pharmacy’s allocation can be discussed with Mylan.

Regarding the penicillin antibiotic supply, it is unclear which specific antibiotic is being referred to. Clinical treatment of patients is outside of the HPRA’s remit; however, based on some hospitals’ guidance on the website below, the query may relate to phenoxymethylpenicillin, amoxicillin or clarithromycin (noting that clarithromycin is not a penicillin, but can be used as an alternative): nchd.ie/asplenic.html

The HPRA is aware of shortages of phenoxymethylpenicillin, amoxicillin and clarithromycin antibiotics in recent weeks. The HSE also recommends these antibiotics to treat some respiratory conditions and Strep A infections. Due to a combination of factors, including the level of respiratory illnesses in the community, a significant increase in demand for medicines used to treat seasonal conditions such as colds and flu has been observed over recent weeks. In some cases, this demand has been 2-3 times the average level seen during the same period in previous years. From discussions with suppliers and regulators in other countries, the HPRA understands that similar trends have been observed in other European countries that have experienced significant demand increases.

The HPRA has engaged with all stakeholders, including suppliers, to ensure a coordinated response to this increased demand. The key focus at all times has been to ensure that suitable medicines remain available to treat patients. Suitable medicines continue to be available to treat respiratory illnesses and their symptoms in both adults and children.

Further to the HPRA’s regular and ongoing engagement with industry, they have been informed that in a number of instances suppliers have increased production and sourced additional stock to respond to this recent increase in demand. Although the HPRA has no role in procuring medicines, they continue to engage with the suppliers to obtain updates and remain open to expediting regulatory procedures to enable the supply of additional stock, where possible.

Regarding the current antibiotic supply, the marketing authorisation holders have advised that whilst the phenoxymethylpenicillin oral suspension is short, the oral solid dose products are available. While there have been shortages of some brands from individual suppliers, oral solid dose and oral suspensions of amoxicillin are available. Additionally, oral solutions of clarithromycin are available as well as some brands from individual suppliers of the oral solid dose forms.