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).
In addition to this, there are legislative initiatives in development within the Department, via the Health (Miscellaneous Provisions) Act 2024, including Medicine Substitution Protocols, and reporting requirements for actors in the medicines supply chain. The Medicine Substitution protocols will act as an authorisation for registered pharmacists to supply an alternative medicinal product, for the medicinal product that is in short supply, without the need for a further prescription. The Department is liaising with relevant leads in the HSE to progress this, including an assessment of any potential patient safety risks.
In European law, pharmaceutical companies and wholesalers should ensure an appropriate and continuous supply of the medicines they market. Companies are required to notify the HPRA of medicines shortages or potential shortages impacting the Irish market.
The HSE has advised that medicines not on the formal Reimbursement List are considered on an individual patient basis. Community pharmacy contractors can contact PCRS Pharmacy Function Unit regarding reimbursement support. Individual applications can also be submitted by the dispensing pharmacy to: PCRS.IndividualRequest@hse.ie
Community pharmacy contractors can also submit queries relating to reimbursement of Exempt Medicinal Products (EMPs) to: PCRS.ExemptMed@hse.ie
