PSI Roadshow Events - October 2023

Yes. We are committed to continually learning from and reviewing the processes that we have in place within the PSI, with the aim of improving our effectiveness as a regulator. However, the Fitness to Practise process is a statutory one, the steps of which are strictly set out in the Pharmacy Act 2007 and as a legislative process, we are bound to follow it and do not have any discretion to deviation from it. Where we can, we try and make the process as efficient and clear as possible for all participants and review all complaints guidance and Committee procedure documents on an annual basis at least to ensure they remain fit for purpose. Whilst we have over time, identified areas which we feel could improve the process and experience both for complainants, registrants and the regulator since the Pharmacy Act was first enacted in 2007, and have secured some legislative change in the meantime which has brought about improvement, many changes we would like to see, still require further legislative change. This call for legislative change applies right across the PSI in other areas such as registration, inspections, and recognition of qualifications, and to this end, in 2023, we published a position paper on the need for legislative reform of the Pharmacy Act 2007 in order to allow us to regulate more effectively in the public interest.

In 2024 and under our next Corporate Strategy, we will be engaging with the Department of Health to progress this work and will also include a consultation stage with the pharmacy profession. In the meantime, we continue to regularly review our written procedures and template documents and in June 2022, following a root and branch review, we substantially amended the written procedures of the Committees of Inquiry, so as to bring in greater efficiencies in the scheduling of inquiries, managing adjournments, handling remote hearings, and document management.

Pharmacy and medicines legislation, to include that including the management of retail pharmacy businesses is significant in terms of volume and complexity and is constantly evolving. As a result, we do not provide a summary of the current applicable legislation on our website, but we do have links to most of the relevant applicable legislation relating to the sale and supply of medicinal products by pharmacists and pharmacies as well as a link to the Pharmacy Act 2007 on the PSI website. We also issue guidelines and guidance documents to provide clarity on the practical application and expectation of certain legislative requirements relating to the practise of pharmacy. It is important that all pharmacists are aware of the legislation relating to their practice and the services they offer and keeping that knowledge up to date through CPD and other professional competence schemes is extremely important.

There is no statutory timeframe within which a complaint must be made or processed. However, the PSI has a statutory obligation to process complaints as expeditiously as possible, and we endeavour to progress and conclude the complaints as quickly as possible, while always ensuring that fair procedures and the statutory process is followed, protecting the legal rights of both complainant and pharmacist and/or pharmacy owner.

This will depend on the circumstances of each case. In line with established case law in professional regulation and fitness to practise complaints, the conduct in question must meet a threshold of “seriousness”. Some reports of the Committees of Inquiry appear on the PSI website (if directed by the Council of the PSI or the High Court), which detail the conduct giving rise to complaint, and any findings arising therefrom. This will give pharmacists an indication of the type of conduct which can end up before a Committee of Inquiry and which might result in findings. We also publish anonymised Learnings from complaints and inquiries on our website, which again, give an indication of the type of conduct which may end up before a Committee of Inquiry. Learnings can be accessed at the following link.

The PSI does not set a minimum number of weekly hours for a supervising pharmacist to be present in the pharmacy. All pharmacies are different, they have different opening times and offer various services. Therefore, it is the view of the PSI that when nominating a supervising pharmacist that there should be a risk-based decision made by the pharmacy owner and the superintendent pharmacist, in consultation with the proposed supervising pharmacist, as to what consistent and continuous basis means in the context of each individual pharmacy, to ensure the delivery of safe and effective care.

There is a statutory requirement within the Pharmacy Act that every pharmacy has a nominated supervising and superintendent pharmacist. Where a vacancy in one of these governance roles arises, it is expected that every reasonable effort is made to recruit a suitable replacement in a timely manner. However, the PSI is aware that there has been increasing difficulty in recruitment of pharmacists, particularly within the role of supervising pharmacist. The primary concern must always be the provision of safe and high-quality pharmacy services to patients and the public. 

We have put in place an internal escalation process where we regularly monitor the number of supervising pharmacist vacancies. Where vacancies arise and no replacement has been nominated, we actively engage with pharmacy owners and superintendent pharmacists of these pharmacies to seek assurances that steps are being taken to ensure the safe operation of the pharmacy is being maintained, and appropriate efforts are being made to recruit a new supervising pharmacist.

Should any quality or safety issues arise within the pharmacy, you should feel comfortable in escalating these matters to the superintendent pharmacist and/or pharmacy owner. We would recommend that you document any such actions that you have taken regarding any issues you have raised. Likewise, superintendent pharmacists and pharmacy owners are expected to have open and clear lines of communication with supervising pharmacists, which also means being receptive to and responding to any issues brought to their attention by a supervising pharmacist. The Pharmacy Assessment System is a useful quality improvement tool to assess compliance and identify areas for improvement within your pharmacy. 

The outputs of these assessments can then be used to support and build an evidence base for engagement between supervising pharmacists, superintendent pharmacists and pharmacy owners. If you have raised concerns or issues with your superintendent pharmacist and pharmacy owner, and do not feel like you have received a satisfactory response, you can contact the PSI on info@psi.ie.

Pharmacy technicians are one of the key support roles within pharmacy. In Ireland, pharmacy technicians are not regulated or registered with a regulatory body, nor is the qualification standardised. In some countries, pharmacy technicians are regulated, and other countries are looking to introduce it in the future. While there are no immediate plans to progress this in Ireland, the following recommended action is contained within the Workforce Intelligence Report published by the PSI:

“Develop a national strategy for the future role of pharmacy technicians within the health system, examining topics such as scope of practice, the need for regulation of the role, standardisation of the qualification and workforce planning.”

This action is owned by the Department of Health, and a decision to progress regulation of pharmacy technicians would be made government level.

The Higher Education Authority (HEA) published a report on building capacity in the higher education system in June 2023. We were pleased to participate in this process in the context of our regulatory role in setting standards for pharmacy education and training at undergraduate and postgraduate levels. If the recommendations are implemented, there is the potential to create an additional 190 undergraduate places for pharmacy students annually which will make an important contribution to a sustainable supply of pharmacists and lessen the pressure on students aspiring to secure an undergraduate place. These increases could come from both existing schools of pharmacy, and new schools of pharmacy. We are awaiting further updates on the progression of the HEA recommendation.

Progressing the recommendation and actions contained in the Workforce Report will be achieved through collaboration of the multiple agencies and organisations identified as owners of the various recommendations and actions. A multi-agency group will update and monitor on progress on what has been committed to, in order to ensure actions are followed through. The Workforce Survey that was conducted as part of the project will be repeated so that we can measure against the baseline and track trends in workforce data and pharmacist and pharmacy student sentiment over time.

We expect that all staff working in a pharmacy take appropriate rest breaks to ensure the safe delivery of pharmacy services to the public. As committed to in the Workforce Intelligence Report, we will publish guidance on the expectations of pharmacy owners, superintendent pharmacists and supervising pharmacists in ensuring safe staffing levels, adequate staffing mix, and appropriate rest periods. We also plan to introduce a delineated model for community pharmacy which will enable segregation within the pharmacy, restricting access to medicines and pharmacy records thereby enabling the retail component of the pharmacy to operate in the absence of a pharmacist.

The PSI is committed to seeking opportunities to reduce the administrative and regulatory burden in pharmacy. The following action is included in the Workforce Intelligence Report:

“Develop and implement solutions, including digital solutions, aimed at reducing the regulatory burden associated with manual paper-based processes”.

One of the ways we will look to achieve this is through digitising processes such as the Pharmacist Duty Register and Controlled Drug Register. This will require legislative amendments and the validation of dispensary software systems, and we will look to work with the Department of Health and other stakeholders to progress these changes.