Colm Burke (Cork North Central, Fine Gael)
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1322. To ask the Minister for Health if he will fully consider the allocation of sufficient funds to support future service delivery in the community pharmacy sector; and if he will make a statement on the matter. [12934/23]

Colm Burke (Cork North Central, Fine Gael)
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1324. To ask the Minister for Health if he will give due consideration to the additional workload placed on community pharmacists in managing medicine shortages when reviewing their dispensing fee (details supplied); and if he will make a statement on the matter. [12936/23]

Colm Burke (Cork North Central, Fine Gael)
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1325. To ask the Minister for Health the steps he will take to ensure that community pharmacists, as essential members of the primary care team, are totally integrated and embedded into community health networks; and if he will make a statement on the matter. [12938/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 1322, 1324 and 1325 together.

As Minister for Health, I recognise the significant role community pharmacists play in the delivery of patient care and acknowledge the potential for this role to be developed further in the context of health service reform. Their participation in the national COVID-19 vaccination rollout – the largest ever undertaken by the State – and in the recently launched free contraception scheme are examples of the importance of their role in the functioning of our health service.

The current fees payable to contracted community pharmacists under the community drug schemes are set out in Statutory Instrument no. 639 of 2019. These regulations were made under Section 42 of the Public Service Pay and Pensions Act 2017.

Subsection (14) therein requires that a review of the operation, effectiveness and impact of the fees set in that regulation be undertaken in 2023. This review must consider the appropriateness of the fees set, having regard to any change of circumstances and any alteration of the matters set out in subsection (10) therein, including the following:

- the nature of the services rendered by different classes of service providers and the general nature of expenses and commitments of the service providers providing those services.

- the obligation on the part of the State to have a prudent fiscal policy under the Stability and Growth Pact and the Fiscal Compact.

In conducting the review, the Department will be cognisant of proposals regarding extending the scope of practice offered by community pharmacists, ensuring that future healthcare expenditure under the community drug schemes is sustainable, and the role that community pharmacy should play in the reform of health service delivery as envisaged in Sláintecare. On this latter point, it is imperative that community pharmacists are recognised as an integral part of the delivery of both safe and efficient patient health care in the community.

Of course, any publicly funded pharmacy service expansion should address unmet public healthcare needs, improve access to existing public health services, and provide better value for money.

Colm Burke (Cork North Central, Fine Gael)
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1323. To ask the Minister for Health the steps he will take to expedite the registration process for pharmacists from outside the European Union; and if he will make a statement on the matter. [12935/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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Thank you for your question - the number of registered pharmacists on the Register of Pharmacists held and maintained by the Pharmaceutical Society of Ireland (PSI), the pharmacy regulator has continued to grow steadily over the past five years with 7083 pharmacists registered with the PSI on the 1 March 2023, under established processes based in Irish and EU law.

The Pharmacy Act 2007, as amended provides for three distinct routes to recognition with subsequent registration, of a pharmacist qualification; National, EU and Third Country.

The current Third Country Qualification Recognition (TCQR) process comprises several stages and has been in place since 2009. The PSI is currently undertaking a project to overhaul this route however and to reform it as much as possible, with the PSI Council agreeing a revised policy approach and plan for implementing changes.

A public consultation on revised statutory rules to amend the existing PSI (Registration) Rules has been open since the 24 February, to give effect to the revised TCQR approach. The intent is to streamline the process, both to benefit applicants, PSI administrative process, and the wider public and it is hoped that the new process may be in place in late 2023.

Notwithstanding any changes that may be implemented, the Department appreciates that the PSI must be able to verify that minimum standards are met by each qualification submitted for assessment, which facilitates an applicant to progress to registration. Pharmacists practise in a sector delivering irreversible patient care and treatment, and patient safety and wellbeing must always be assured through a robust and appropriate recognition process being in place.

Colm Burke (Cork North Central, Fine Gael)
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1326. To ask the Minister for Health the steps he will take to enable community pharmacists to be facilitated in managing therapeutic substitution more effectively, that is, without in all cases the necessity of reverting to a GP for a prescription; and if he will make a statement on the matter. [12939/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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In the case of medicines used most often in Ireland, there are typically multiple forms, strengths, brands, and generic medicines available from various sources. Where some individual medicines are in short supply, alternative options such as alternative strengths, brands, and generic medicines remain available to ensure continuity of treatment.

In other jurisdictions shortages protocols 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.

The Department of Health is scoping the introduction of a similar framework, a limited stock supply framework (LSS) in Ireland which will only be used in certain emergency situations such as shortages. This is the case in all other countries that have a protocol in place.

This framework proposal will need very careful consideration to ensure it is underpinned and supported by minimum criteria, which will support the safe and effective working of the process. Legislative amendments will also be required.

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 which will impact the timeframe for implementation.