Dáil Éireann Debate, Thursday - 22 June 2023
306. Deputy Cormac Devlin asked the Minister for Health to provide an update on efforts by officials to restore the supply of basic medications as listed by the HPRA; if he will consider reviewing regulations to allow Irish pharmacists to substitute prescribed items and-or Irish residents to access the online services of UK or EU-based pharmacies; and if he will make a statement on the matter. [30310/23]
View answerThank you for your question which to my mind contains three distinct elements which I will address separately as follows;
Firstly, medicine shortages are a feature of modern health systems worldwide and a global health problem, not unique to Ireland, with increases in demand for medications, and medicines shortages observed in the UK, throughout the EU and across the world in recent months.
Ireland experienced some shortages of antibiotics earlier this year – as did most other European countries following a surge in winter illnesses. Shortages have not disappeared, but there are factors, such as the winter surge, that can put additional pressure on a health system and on medicine supply. It takes time for supply chains to stabilise following this period of excess demand.
Whilst individual brands or strengths of a medication may be temporarily unavailable, for the vast majority of medicines supplied in Ireland, there are alternatives, such as different strengths, brands, or similar classes, to ensure continuity of care.
Medicines shortages are managed through the Medicines Shortages Framework and immediate actions are taken by relevant stakeholders to mitigate the impact on patients. Ireland has a multi-stakeholder medicine shortage framework in place, coordinated by the HPRA, to prevent, wherever possible, and to manage medicine shortages when they occur. Based on an analysis of data reported by the pharmaceutical industry over several years, the reasons for shortages vary and are primarily due to manufacturing issues The Department of Health maintains regular contact with the HPRA regarding medicines shortages.
The HPRA publishes a list of medicines currently in short supply on its website (Medicines Shortages (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.
Secondly, I am aware of actions taken in other jurisdictions where Serious Shortages Protocols (SSP) are used to facilitate community pharmacists to supply either an alternative quantity, strength, pharmaceutical form, or medicine. Legislation in Ireland already allows for generic substitution (alterative strengths, quantity and forms) but does not allow for therapeutic substitution. Shortages protocols are product specific and are only used in very limited situations. For example, in the UK every draft SSP is reviewed by NHS England’s National Medical Director and Chief Pharmaceutical Officer, who can suggest amendments and raise any potential safety concerns, and Ministerial authorisation is necessary to give effect to the protocol. Each SSP is time limited.
Consideration is being given as to what legislative amendments are required to institution a similar framework to allow pharmacists to supply prescription controlled medicines in accordance with the specific protocol in the event of a serious shortage, rather than supply in accordance with a prescription, for the purposes of mitigating current and future challenges arising nationally in the availability and supply of medicines. This would negate the need for patients to be referred back to their prescriber to amend the original prescription, thus saving time and reducing inconvenience to patients, GPs and Pharmacists.
Improving the availability of authorised medicines is a key priority in ensuring optimal patient care. It is anticipated that a Medicines Substitution Protocol (MSP) could be a useful tool to alleviate the pressure the medicines shortages cause to Pharmacists, GP’s, hospital emergency departments and patients by allowing pharmacists to make certain changes to prescribed medicines that are the subject of a serious shortage.
Consideration on how to institute MSPs involving relevant stakeholders is in progress. There are risks associated for both the pharmacist and patient with substituting prescriptions and the Department will need to be satisfied that these risks are addressed. Work is ongoing to anticipate the governance, legal, training and patient safety aspects of this proposal which will be required. The Department will engage with key stakeholders as this policy is developed.
Finally, the issue of Irish patients accessing the online services of UK or EU-based pharmacies which is known as “mail order supply” is prohibited under the current relevant medicines legislation. The use of the appropriate medication at the right time in the right way by the right patient is one of the most effective health care interventions available and empowers patients to live healthier lives. The use of medicines is complex, and medicines are not ordinary items of commerce but are subject to a rigorous assessment and regulatory safety regime prior to them being made available to any patient. Furthermore, the supply of any prescription medicine is subject to a legislative safety framework whereby a registered pharmacist is required to review any prescription dispensed, to assess the pharmaceutical and therapeutic appropriateness of the product for the patient, and offer to counsel the patient. This system of face-to-face interaction between pharmacists and their patients is in place to promote and conserve patient safety and well being where a patient obtains a regulated medicine from a regulated supplier underpinned by a clinical care regime. There are currently no plans to review this system of medicines supply.
