Dáil Éireann Debate, Thursday - 23 November 2023
338. Deputy Claire Kerrane asked the Minister for Health if he will provide an update on the availability of tyvense medication, in particular in the case of a person (details supplied); and if he will make a statement on the matter. [51719/23]
Amharc ar fhreagraI will address the question regarding the shortage of the medication Tyvense. However, as Minister for Health, I have no role in the clinical decision-making process of a medical practitioner. I will ask the HSE to respond directly on this.
Takeda Pharmaceuticals International AG Ireland Branch has advised of shortages of some strengths of Tyvense (20mg, 40mg and 70mg) due to an unexpected increase in demand and manufacturing challenges. These shortages are affecting multiple EU countries, not just Ireland. The company has informed the Health Products Regulatory Authority (HPRA) that resupply of all strengths is expected on 4th December 2023. The company has provided a letter to healthcare professionals detailing this information. To date, there have not been any notifications of shortages of the 30mg, 50mg or 60mg Tyvense capsules.
Unfortunately, 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. Medicine shortages are, unfortunately, a feature of modern health systems worldwide and a global health problem. Shortages of medicines are not unique to Ireland and there is no evidence that shortages disproportionately impact patients in Ireland compared to other countries.
Ireland has a medicines shortage framework in place which is operated by the HPRA on behalf of the Department of Health. The Medicines Shortages Framework’s aim is to help avert potential shortages from occurring and to reduce the impact of shortages on patients by co-ordinating the management of potential or actual shortages as they arise. The multi-stakeholder framework includes representation from the pharmaceutical industry, healthcare professionals, the HSE, the Department of Health and patients.
The HPRA publishes a list of medicines currently in short supply on its website (Shortages List (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 webpage is updated daily as the HPRA receives new information.
Alternative medicines are authorised for the treatment of ADHD. If patients or their carers cannot source their usual medicine at present, they are encouraged to discuss alternatives with their healthcare provider pending the resumption of normal supply.
The Department and HPRA maintains regular contact regarding medicines shortages.
