Gino Kenny (Dublin Mid West, People Before Profit Alliance)
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270. To ask the Minister for Health if he is aware of the unavailability of medication for persons who suffer with diverticulosis, given that patients who are normally prescribed colofac and spasmonal cannot avail of this medication, and neither pharmacists nor GPs can confirm when these medications will be available from suppliers; the reason for the lack of supply of these medications; and if he will confirm when they will be available again. [22218/23]

Mark Ward (Dublin Mid West, Sinn Fein)
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274. To ask the Minister for Health if he is aware of a shortage of the medicines colofac and spasmonal within Ireland; the options available to those that are prescribed the medicines; the steps being taken to address the shortages; and if he will make a statement on the matter. [22281/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 270 and 274 together.

The Department of Health is aware of the current shortage of Spasmonal 60 mg tablets, Spasmonal Forte 120 mg hard tables and Colofac 135 mg tablets in Ireland.

Mylan IRE Healthcare Limited, the company responsible for placing Colofac 135 mg tablets on the Irish market has notified a shortage of the product due to manufacturing delays. The company anticipates that resupply is expected during August 2023. Multiple countries are impacted. An alternative authorised product containing the same active substance (mebeverine) is available.

Mylan IRE Healthcare Limited, responsible for placing Spasmonal products on the Irish market, has also notified of a shortage due to active ingredient unavailability. It impacts multiple countries also. The company estimates that a resupply of Spasmonal Forte 120mg Hard Capsules is expected at the end of May 2023. The company is investigating the resupply date for Spasmonal 60mg Capsules.

Unfortunately, medicine shortages are a feature of modern health systems worldwide which have been exacerbated by recent worldwide events. There are a multitude of reasons why a medicine may not be available including: shortages of raw materials; manufacturing difficulties; sudden unexpected increase in demand; or product recalls due to potential quality issues. Ireland has a multi-stakeholder medicine shortage framework in place, coordinated by the HPRA. The Medicines Shortages Framework, operated by the HPRA on behalf of the Department of Health, aims to prevent, where possible, and mitigate the impact of medicines shortages. The framework allows for shortages to be carefully managed by the HPRA in close collaboration with the Department, the HSE, industry and healthcare professionals. The HPRA maintains regular contact with the Department of Health regarding medicines shortages.

The HPRA publishes a list of medicines currently in short supply on its website (Medicines Shortages (hpra.ie) 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.

If a member of the public has any concerns regarding their treatment with these or any other medications, they should discuss this directly with their doctor or pharmacist.