Closed Public Consultations

Here we provide an overview of the feedback received during previous consultations conducted by the PSI. These consultations are now closed. 

2024

The Regulated Professions Health and Social Care Amendment Act 2020 will introduce a new requirement for the PSI to ensure that pharmaceutical assistants undertake appropriate Continuing Professional Development (CPD). In response, we committed to the development of a CPD model for pharmaceutical assistants as part of our Corporate Strategy 2021-2024. The recommended CPD model is a bespoke CPD model that draws on elements from the CPD model for pharmacists and utilises the infrastructure (ePortfolio) already in place. The model was approved by Council at its meeting on 22 June 2023 and since then, we have commenced developing the model. 

The recommended CPD model includes the development of guidelines and standards or ‘themes’ that will provide direction and guidance for pharmaceutical assistants to conduct and manage their CPD learning activities within the new CPD model. We have developed these themes in consultation with the Pharmaceutical Assistants Association (PAA). 

A public consultation on the CPD themes took place from 20 June 2024 to 18 July 2024. We received   72 valid responses to the online survey. Additionally, four email responses were received separately. 

 

The first recommendation of the Expert Taskforce to support the expansion of the role of pharmacists in Ireland was published in November 2023.  It recommended that pharmacists should be enabled to extend and dispense certain prescriptions from six months up to a maximum of 12 months where appropriate.  The PSI committed to developing guidelines to support pharmacists to incorporate this change into their practice. It was decided to update Version 4 of the Guidelines on the Counselling and Medicines Therapy Review in the Supply of Prescribed Medicinal Products from a Retail Pharmacy Business and add new content to these guidelines to cover prescription extension. Other updates to the guidelines included adopting a principle- based framework to support and enable pharmacists to use their professional judgement as well as the removal of information that was not specifically relevant to the subject of the guidelines.  

The public consultation period opened from 24 April 2024 to 15 May 2024. We received a total of 170 responses to the online survey, of which 169 were usable.  Additionally, three separate email responses were received.  

2023

We consulted on statutory rule changes that provided for our revision of the qualification recognition process for pharmacist applicants who are awarded their pharmacy qualification in a non-EU/non-EEA country. The existing Third Country Qualification Recognition (TCQR) route for non-EU and non-EEA applicants is a multi-stage process in place since 2009. We are changing it with the intent of streamlining the process, both to benefit applicants, our administrative process, and the wider public. The proposed PSI Registration Rule changes will facilitate implementation of this new process. We hope the new process may be by place in late 2023.

2022

We published the first Core Competency Framework for Pharmacists in Ireland in 2013. To ensure that it remains relevant and fit-for-purpose, it is subject to regular review. This helps ensure that it continues to reflect the evolving role of pharmacists. A review of the current Core Competency Framework was undertaken and a revised Framework was developed. A public consultation was undertaken from 21 July to 18 August 2022.

2021

Following on from a detailed review and assessment of international (CPD) models in 2009, the PSI introduced a portfolio-based, self-reflective CPD model for pharmacists. The model allows pharmacists to employ a wide range of learning methods to meet their individual learning needs. In accordance with the legislation underpinning the model, pharmacists must maintain an online record of their CPD (ePortfolio) and demonstrate evidence of this to the Irish Institute of Pharmacy (IIOP) on request, once in every five years. Additionally, patient facing pharmacists may be requested to present for Practice Review. Having completed the first five year cycle of ePortfolio review, the PSI sought feedback from pharmacists on the CPD model.

2020

The PSI Council proposed a legislative amendment to continue to allow for the recognition of a six-month patient facing experiential learning placement, in exceptional circumstances, where a 5th year pharmacy student is unable to complete eight consecutive months of this training, arising from the COVID 19 pandemic. 

The proposed amendment relates to the patient facing experiential learning placement provided for under Rule 14(1)(b) of the Pharmaceutical Society of Ireland (Education and Training) (Integrated and Training) Rules 2014 (i.e. the eight-month placement in the 5th year of the MPharm programme).

As a public body, the PSI has an obligation to set out a clear strategy statement and our intended outcomes, and to provide an opportunity to all those who are interested in or affected by our work to have a say in our future direction.

Set against the background of the COVID-19 global pandemic and its impact in Ireland, we sought feedback on our next Corporate Strategy in August 2020.

The draft strategy builds on our achievements under the current strategy (2018-2020) and focuses on three key strategic objectives, while our strategic goal remains “to assure public trust in pharmacy through effective regulation”. 

The PSI proposed changes to the existing statutory rules which set out the fees payable by retail pharmacy businesses for continued registration. This was done as a part of ongoing initiatives to meet challenges arising in the context of the COVID-19 emergency, recognising the measures undertaken by pharmacies to meet the challenges of the pandemic in protecting patients and staff, which have included impact on finances. The proposed amendment to the fee rules would permit granting of a deferral of continued registration fees which are due to be paid by registered pharmacies, for a specified period of time, during the ongoing Covid-19 public health emergency. If the amendment proceeds, pharmacies may apply for a deferment of fees up to 31 July 2020. Any such deferred fees will not fall due until 30 September 2020. 

The PSI proposed changes to the existing statutory rules which set out requirements for first time recognition and registration for applicants who first qualified in a Third Country. This was done as part of initiatives to meet potential and real challenges arising in the context of the COVID-19 emergency and will be linked for the duration of the emergency. A short consultation was open between 28 April and 4 May 2020.

The PSI proposed changes to the existing statutory rules which set out the education and training requirements for the five-year integrated Masters degree in pharmacy (MPharm). This was done as part of initiatives to meet potential and real challenges arising in the context of the COVID-19 emergency for individual students. A short consultation was open between 26 and 31 March 2020. The PSI Council agreed to the draft Rules, with minor amendments, on 6 April 2020. The proposed statutory Rules do not come into force until they are signed into law by the Minister for Health.

2019

Anyone wishing to practice as a pharmacist in Ireland must register with the PSI as the pharmacy regulator. One of the principal functions of the PSI is to maintain a register of all pharmacists and pharmaceutical assistants practicing in Ireland, and ensuring all those wishing to register with us hold an appropriate qualification before they can practice. There are three routes of recognition/registration for pharmacists, dependant on where a person has obtained their pharmacy qualification; National Route, European Union/European Economic Area Route and the Third-Country Qualification Recognition Route. 

Applicants with a UK qualification applying for first time recognition/registration post Brexit will be processed as a third country qualification irrespective of the date on which the qualification was first obtained.

In September and October 2019, the PSI invited feedback on proposed amendments to the PSI (Registration) Rules 2008. The purpose of the consultation was to propose rules which would amend the current Third Country Route process, and in the context of an evidence base for equivalence, the timelines and administrative process in handling an application from an individual holding a UK qualification will be as timely as possible, and in line with current EU Route timelines.

One of the principal functions of the PSI- the pharmacy regulator is to promote and ensure a high standard of education and training for those seeking to become pharmacists. This role includes setting the accreditation standards for the educational programmes that are offered by the higher education institutions in Ireland.

In continuing to promote and ensure a high standard of education and training for pharmacy, we have an obligation to review accreditation standards on a regular basis. 

The PSI Council approved the new accreditation standards at their meeting in September 2019. The revised standards are not immediately effective but will be used by the providers in preparation for implementation. 

Following feedback received at the regional superintendent seminars in 2018, we are progressing the development of a standards-based approach for pharmacy. The development of standards takes a different approach to the guidelines issued to date, in that standards provide concise, outcome-focussed statements. To inform the development of the standards, we invited input during a scoping consultation.

The initial standards being developed aim to facilitate compliance with Regulation 5 (Management and Supervision) of the Regulation of Retail Pharmacy Businesses Regulations 2008.

  • Read the report on the scoping consultation for Governance and Accountability Standards for Retail Pharmacy Businesses
2018

Under the Pharmacy Act 2007 it is an offence to operate a retail pharmacy business other than in accordance with particular conditions, one of which is that the sale and supply of medicinal products must be carried out by or under the personal supervision of a registered pharmacist at all times (Section 26). However, the Act also provides that no offence is committed where a registered pharmaceutical assistant acts on behalf of a registered pharmacist during the temporary absence of the registered pharmacist (Section 30).

This same section of the Pharmacy Act provides the PSI Council with the ability to define what is the temporary absence of a pharmacist, and what may or may not be done by a pharmaceutical assistant when acting on behalf of a pharmacist during that period of temporary absence. The Council can do this by making statutory rules, subject to ministerial approval.

The Council of the PSI previously consulted on draft Pharmaceutical Society of Ireland (Temporary Absence of a Pharmacist from a Pharmacy) Rules 2018 in July and August 2018. Following this consultation, Rule 8 was amended. The PSI Council considered the amended set of draft rules at its meeting on 6 December 2018 and proposed them for public consultation in December 2018 and January 2019. This public consultation closed on 11 January 2019. At the meeting of the Council on 14 February, the Council considered the feedback received during the public consultation process. The Council agreed that the proposed Rules, with amendments, be submitted to the Minister for Health for his consent so that they might be made into law. The proposed statutory Rules do not come into force until they are considered and signed into law by the Minister.

The PSI conducted a review of the Code of Conduct for pharmacists, which included a consultation process on the existing Code in 2017. Following this consultation, and engagement with relevant experts, the Code was revised and updated, and a public consultation was carried out in August 2018.

Under the Pharmacy Act 2007 it is an offence to operate a retail pharmacy business other than in accordance with particular conditions, one of which is that the sale and supply of medicinal products must be carried out by or under the personal supervision of a registered pharmacist at all times (Section 26). However, the Act also provides that no offence is committed where a registered pharmaceutical assistant acts on behalf of a registered pharmacist during the temporary absence of the registered pharmacist (Section 30).

The PSI Council considered the matter of temporary absence and a proposed draft set of rules under section 30 of the Act at its meeting in March 2017. The Council decided to reject the proposal presented at that time, and requested further examination of the issue of temporary absence, and what would be covered within the scope of the rules.

A Working Group was then established to examine and produce a report, which was submitted to Council on the 17 May 2018. The considerations of the group were informed by an independent NARIC report on the Pharmaceutical Assistant qualification, and centred on patient safety, public protection and risk in proposing how long a pharmacist may be absent from a pharmacy. At their meeting on 17 May 2018, the Council considered the matter and accepted the Working Group report and its recommendations. It was agreed to proceed with developing draft rules under section 30 of the Act, based on this proposed policy. Draft rules were considered and approved for consultation by the Council at the 21 June 2018 Council meeting, and a public consultation was carried out in July and August 2018.

At the meeting of the Council on 20 September 2018, the Council considered the feedback received during the public consultation process, and the context and parameters of the matter for decision. The Council agreed that the proposed PSI (Temporary Absence of a Pharmacist from a pharmacy) Rules 2018, without change, be submitted to the Minister for Health for his consent so that they might be made into law.

Update 25 October 2018: A delay arose in the submission of the approved Rules to the Minister for his consent. This has arisen in the context of an element of the drafting framework used in the rules, and it is now required that the tasks that may be undertaken during a pharmacist’s period of temporary absence are incorporated within the Rules, rather than as envisaged under Rule 8 considered by the Council. A risk matrix was drawn up as part of the Working Group report on temporary absence, for the Council’s consideration earlier this summer. This matrix of tasks will inform the basis for a schedule to the Rules, which will address the activities that may be carried out by a pharmaceutical assistant when acting on behalf of a pharmacist, in their temporary absence.

Update 13 December 2018: The PSI Council considered a redraft of the Rules at its meeting on 6 December, and these were approved for further public consultation. That public consultation was opened for feedback on the revisions, on 13 December. The proposed statutory Rules do not come into force until they are considered and signed into law by the Minister.

In July and August 2018, the PSI invited feedback on the proposed changes to the PSI (Registration) Rules (S.I. No. 494 of 2008) (as amended). The proposed changes relate to:

  • The introduction of a new legal mechanism, whereby the PSI would be enabled to ‘propose to refuse’ the application for continued registration of a pharmacist in circumstances where the pharmacist has not engaged with continuing professional development (CPD) requirements (i.e. those pharmacists who refuse/decline/fail to submit evidence of their ePortfolio for ePortfolio Review, when requested. It is not intended to use this mechanism for those pharmacists who are working towards meeting the standards for ePortfolio Review).
  • The manner by which a pharmacist, whose professional qualification in pharmacy was awarded after training completed outside the State, satisfies language competence when applying for registration as a pharmacist in Ireland.
  • Read the public consultation report on the proposed amendments to the Pharmaceutical Society of Ireland (Registration) Rules

 

The PSI conducted a review of the Pharmacy Assessment System to evaluate its implementation to date. The Pharmacy Assessment System was developed as a practical tool to facilitate the supervising pharmacist, superintendent pharmacist and the pharmacy owner, along with their pharmacy team, to critically review and reflect on their pharmacy’s practice and identify areas where improvements may be required. This plays an important role in demonstrating a pharmacy team’s commitment to continuous quality improvement directed towards ensuring patient safety and quality care. A summary of the feedback will be made available in due course, as well as information about any proposals or changes that will arise following this review.

We consulted on draft Accreditation Standards for CPD Programmes and Courses for Pharmacists. The aim of the standards is to quality assure CPD training programmes and courses that are provided to pharmacists. These standards will be used by the Irish Institute of Pharmacy when carrying out accreditation exercises for those courses requiring accreditation. These standards are intended to replace the Generic Interim Accreditation Standards for Formal Programmes of Learning for Pharmacy in Ireland that are in place since 2012.

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