Dáil Éireann Debate, Thursday - 15 June 2023
294. Deputy Louise O'Reilly asked the Minister for Health if his attention has been drawn to the shortage of the pain medication (details supplied); if he is aware that this means that the smaller boxes are being purchased and paid for in full by persons on the drug payment scheme because they cannot purchase the prescribed amount; if there is any way for people to claim back this money; and if he will make a statement on the matter. [29005/23]
View answerThe Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines under the Community Drug Schemes, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013.
Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA).
In line with the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.
The HSE advise that Solpadeine capsules in packs of 32 and Solpadeine Soluble tablets in packs of 60 are currently on the reimbursement list.
Chefaro Ireland DAC, the company responsible for supplying Solpadeine, has notified the following shortages of Solpadeine products which are impacting multiple countries, not just Ireland:
• A shortage in Solpadeine Capsules (12 pack) has been notified with an expected return date of Mid-August 2023.
• A shortage of Solpadeine Capsules (24 pack) has been notified with an expected return date of September 2023.
• A shortage of Solpadeine Capsules (32 pack) has been notified with an expected return date of Mid-July 2023.
• A shortage of Solpadeine Soluble (60 pack) has been notified with an expected return date of October 2023.
There is currently no reported shortage of Solpadeine Soluble (24 pack).
Under the Drugs Payment Scheme (DPS), no individual or family pays more than €80 a month towards the cost of approved prescribed medicines. The DPS is not means tested and is available to anyone ordinarily resident in Ireland. The DPS significantly reduces the cost burden for families and individuals with ongoing expenditure on medicines.
DPS card holders should be able to access Solpadeine capsules in packs of 32 and Solpadeine Soluble tablets in packs of 60 as soon as they become available, provided that these have been prescribed by a clinician. To access other Solpadeine products which are in stock but not on the reimbursement list, they would have to pay.
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 Health Products Regulatory Authority (HPRA), to prevent, wherever possible, and to manage medicine shortages when they occur. 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 with the reason for the shortage and expected dates for the return of supply.
See www.hpra.ie/homepage/medicines/medicines-information/medicines-shortages.
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.
