Aodhán Ó Ríordáin (Dublin Bay North, Labour)
Link to this: Individually | In context | Oireachtas source

794. To ask the Minister for Health if he will investigate and his views on whether there is a supply chain issue with the supply of the prescription medication concerta XL used for the treatment of ADHD; and if he will make a statement on the matter. [37071/22]

Joe O'Brien (Dublin Fingal, Green Party)
Link to this: Individually | In context | Oireachtas source

934. To ask the Minister for Health if his attention has been drawn to a shortage of concerta XL 36mg medication in pharmacies in north County Dublin; and if he will make a statement on the matter. [37612/22]

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

I propose to take Questions Nos. 794 and 934 together.

Unfortunately, medicine shortages are a feature of modern health systems worldwide. There are a multitude of reasons why a medicine may not be available including: shortages of raw materials; manufacturing difficulties; or product recalls due to potential quality issues.

Medicine shortages can therefore originate at any point in the supply chain and can involve and impact on many different stakeholders. Accordingly, medicine shortages require a multi-faceted, multi-stakeholder response to ensure patient safety, continuity of care and protection of public health. Ireland has a multi-stakeholder medicine shortage framework in place, coordinated by the Health Products Regulatory Authority (HPRA), to prevent, wherever possible, and manage medicine shortages when they occur.

Department officials engaged the HPRA who contacted the Marketing Authorisation Holder (MAG) of Concerta, along with the wholesalers, after receiving queries from a patient's carer regarding supply challenges as well as some direct representation from TDs. The MAH stated that although there are global constraints on Concerta products, there was no stock-out for the products in Ireland. However, some logistical and operational issues resulted in a delay in some wholesalers receiving their allocation for July. This has since been rectified and HPRA understands that the situation has been resolved. Additionally, the MAH has put in place measures to ensure that a situation like this does not reoccur, including an emergency mechanism where a pharmacist or wholesaler can request additional stock to meet patient needs.

In many instances a shortage of a particular medicine is effectively addressed to ensure continuity of care for a patient including through the substitution for a generic version (in the case of a branded medicine short supply) or a generic version from a different manufacturer (in the case of a generic medicine in short supply). Under the Health (Pricing and Supply of Medical Goods) Act 2013 medicines which are deemed to be interchangeable can be directly substituted for one another by a pharmacist.

Where an interchangeable product is not available in Ireland, a pharmacist, in consultation with the prescriber, can source a medicine containing the same active ingredient in order to ensure that continuity of patient care is maintained, wherever possible. Such medicines may be sourced in another European Member State, or by a specialist wholesaler in a third country, and are known as exempt medicinal products (EMPs). EMPs have not been granted a marketing authorisation in Ireland by the HPRA but are sourced in response to a bona fide unsolicited order in order to fulfil the special needs of a patient. These medicines will however have undergone an evaluation of their safety, quality, and efficacy for the granting of their marketing authorisation in another EU Member State or third country by the respective competent authority for medicines.

In other instances, where a medicine shortage occurs due to a more global issue affecting multiple countries, a patient may be directed to return to their clinician to consider prescribing an alternative medicine for the treatment of their condition.

Patients or their carers who have any concerns in relation to temporary alternative products provided because of medicine shortages are advised to speak with their pharmacist or other healthcare professional involved in their care.