Dáil Éireann Debate, Thursday - 23 November 2023
299. Deputy Mark Ward asked the Minister for Health the medication that is prescribed for ADHD; what measures are being taken to address shortages of these medications; and if he will make a statement on the matter. [51614/23]
View answerTakeda 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.
Accord Healthcare Ireland Ltd has advised of shortages of some strengths of Atomoxetine (10mg, 18mg, 25mg, 40mg and 80mg) due to an unexpected increase in demand. These shortages are affecting multiple EU countries, not just Ireland. The company anticipates resupply of the 18mg and 80mg strengths on 1st December 2023 and the 10mg, 25mg and 40mg strengths on 31st December 2023.
InfectoPharm Arzneimittel and Consilium GmbH has advised of shortages of all strengths of Ritalin LA prolonged release capsules (20mg, 30mg and 40mg) due to an unexpected increase in demand. The company anticipates resupply of the 30mg strength on 11th December 2023 and the 20mg and 40mg strengths on 15th December 2023.
Janssen, the company that places the Concerta XL products on the market, has also advised that it is encountering global supply chain issues related to component availability and increased demand in multiple markets. The company has stated that there are allocations in place to ensure equitable distribution to mitigate the impact on patients in Ireland and that it is working closely with pharmacies to ensure patients receive their medication.
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.
The Department of Health is progressing several workstreams for management of shortages, including primary legislative amendments to make regulations for management of shortages via the Health (Miscellaneous Provisions) Bill 2023.
Ireland is heavily involved in work by the European commission and the European Medicines Agency to address European wide issues relating to medicines shortages. This includes work to ensure adequate supplies of medicines, for the coming Winter period. On the 24th October, the EU Commission published a communication, entitled Addressing medicine shortages in the EU. It reinforced the Commission’s plan to introduce a suite of short-, mid- and long-term actions to be undertaken to strengthen security of medicines supply in Europe.
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.
