My Department is aware of the stress that shortages of medicines can cause for patients and healthcare professionals alike, therefore mitigating medicine shortages and strengthening security of supply is the subject of several workstreams in my Department, the wider health service and across Europe. 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.
Ireland has a multi-stakeholder Medicines Shortages Framework in place operated by the Health Products Regulatory Authority (HPRA) on behalf of the Department of Health. This framework aims to help prevent potential shortages from occurring and to reduce the impact of shortages. Stakeholders include the HPRA, the Department, the HSE, healthcare professionals, manufacturers, wholesalers, patient representative groups and marketing authorisation holders. Details of this framework can be found at Medicines shortages on the HPRA website (www.hpra.ie/regulation/human-medicine/patients-and-healthcare-professionals/medicines-shortages). The HPRA maintains a list of current and resolved shortages on its website. The webpage is updated daily as the HPRA receives new information.
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.
Where there is a shortage of a product from the Reimbursement List, the dispensing pharmacy can contact the Primary Care Reimbursement Service to query reimbursement of alternate products on the Community Drug Schemes. Exempt Medicinal Products may be supported for the period of the shortage under Discretionary Hardship Arrangements for individuals with a medical card and under Drugs Payment Scheme (DPS) for those with established DPS eligibility.
The Nursing Homes Support Scheme (Fair Deal) provides financial support towards the cost of long-term residential care. The NHSS covers the cost of the standard components of long-term residential care which are:
Nursing and personal care appropriate to the level of care needs of the person;
Bed and board;
Basic aids and appliances necessary to assist a person with the activities of daily living; and
Laundry service.
The scheme is designed to support nursing home care costs and does not determine the reimbursement arrangements that apply to individual medicines or medicinal products.
Matters relating to the availability of medicines, the use of unlicensed medicines and the reimbursement of such products are governed through the separate medicines and community drugs arrangements. A person's eligibility for other schemes, such as the medical card scheme or the drugs payment scheme, is unaffected by participation in the NHSS or residence in a nursing home.