Public consultation on PSI statutory rule changes to facilitate a delineated model of pharmacy operation

About this public consultation

This public consultation provides the opportunity for people to consider and provide feedback on amendments the PSI is proposing to the existing legal rules for pharmacy registration to support the introduction of a delineated operating model. This would allow for a pharmacy premises to remain open for a limited period without a pharmacist, provided that medicinal products are not available for sale or supply and are separated from the retail part of the pharmacy premises. This separation would permit pharmacists to take a break and/or leave the premises while allowing the retail part of the premises to stay open.

Creating the option for a delineated operating model is a step being taken by the PSI to address workforce sustainability and safety in pharmacy practice. The option to implement this model provides a change for the public and for those practising pharmacy in Ireland. 

Background information

In Ireland, pharmacists and pharmacies operate under strict laws and regulations to ensure safe and professional practice and responsible use of medicines, in the interest of public health and safety. The legal framework helps ensure that pharmacists, pharmacy owners and others with governance responsibilities in a pharmacy provide high-quality care, follow ethical standards, and manage medicines safely. The PSI’s role as regulator focuses on patient safety and public protection, and so we set registration requirements for pharmacists, pharmaceutical assistants and pharmacies, monitor compliance with pharmacy and medicines law and seek to promote good professional practice by setting standards and sharing information. 

The PSI Workforce Intelligence Report 2023 identified various challenges faced within pharmacy, with stated impacts on pharmacist retention and wellbeing. In particular, the report outlines that:  

• Pharmacies face challenges in securing sufficient pharmacist personnel to supervise all pharmacy opening hours, and to accommodate appropriate pharmacist breaks and rest periods.
• Taking appropriate rest periods and breaks during the working day is an important factor for maintaining a safe environment for patients and to help protect the health and wellbeing of workers. 54% of pharmacists working in the community reportedly never have, or rarely have, protected lunch breaks. One of the primary reasons for this is that the Pharmacy Act 2007 prohibits the sale or supply of medicines at a pharmacy in the absence of a pharmacist. 

The PSI recognises that pharmacy working conditions that fail to provide adequate rest breaks for pharmacists can impact a pharmacist’s performance and wellbeing, which can in turn have negative impacts on patient safety.  

Working with the Department of Health and other stakeholders, the PSI has sought amendments to existing legislation, the Regulation of Retail Pharmacy Business Regulations (2008) and the Pharmaceutical Society of Ireland (Retail Pharmacy Businesses) (Registration) Rules 2008 (SI 495 of 2008), to introduce the option for pharmacies to delineate the pharmacy service and medicines from the retail part of the premises.  

Overview of features of a Delineated Operating Model 

• The secure separation of the retail part of a pharmacy premises from the pharmacy and medicines service would permit pharmacists to take a break and/or leave the premises while allowing the retail part of the pharmacy to stay open for a maximum of up to two hours per day.
• To implement a delineated operating model, the pharmacy owner and those in governance roles must ensure that the arrangements and layout of the premises are such that the medicinal products are stored in a secured part of the premises to which non-registered pharmacist staff and the public do not have access.
• During delineated operation, patients and members of the public will not be able to:

     -  Obtain or purchase any medicines

     -  Have prescriptions dispensed,

     -  Collect dispensed medicines awaiting collection, or

     -  Retrieve prescriptions which are held on file at the pharmacy. 

A delineated operating model will not be necessary, relevant or applicable in every pharmacy. 

What are the main proposals to consider in this public consultation?  

To facilitate this model of operation within a pharmacy, the existing PSI (Retail Pharmacy Businesses) (Registration) Rules 2008 (SI 495 of 2008) need revision. We are consulting on the proposed changes to these rules. The changes include: 

• Application process for approval to operate a delineated operating model. A pharmacy can only implement a delineated operating model after making an application to PSI and receiving formal approval to do so. The particulars required for approval are set out in changes to the registration rules and include, for example, details of the security features. The application and approval process will not be time limited (i.e. once off approval to operate a delineated model) and will not be subject to annual renewal. An application to operate a delineated model can be made at any time to the PSI.
• Provisions for the PSI to examine pharmacy applications to operate a delineated operating model.   
• Provisions for the cessation of operation of a delineated operating model, including procedures for refusal to grant approval and withdraw approval. 
• Other technical amendments to the rules to align with the current continued registration processes. 

Where can I find more information about the registration rule changes to facilitate the delineated model of operation? 

Review the full text of the draft pharmacy registration rules proposing changes to the PSI (Retail Pharmacy Businesses) (Registration) Rules 2008 (SI 495 of 2008). 

The changes are colour coded with the red text indicating the new provisions and the black text the current provisions.  It is proposed that the current 2008 rules (SI 495), be revoked and replaced by the new Pharmaceutical Society of Ireland (Retail Pharmacy Businesses) (Registration) Rules 2025. This incorporates the current rules along with the new legislative provisions to support the delineated operating model.  

How can I provide feedback? 

We would like to hear from anyone interested in, or impacted by, the draft rules. Please review the information and rules provided and share your feedback with us. 

You can provide your feedback can to us by 5pm on Friday, 8 August in one of the following ways: 

1. Online Questionnaire 

The fastest way to provide your feedback is by completing this online consultation survey. 

2. Email 

You can also provide your feedback by email to consultation@psi.ie.  

What will we do with your feedback? 

After the closing date, the PSI will assess and collate all feedback. We will draft a consultation report that will be considered by the PSI Council and later published later on our website. Any further changes proposed to the legislation arising from the consultation feedback, will be reviewed and decided on by the PSI Council. 

Data Protection and Freedom of Information 

The information provided to PSI consultations will be stored in a secure and confidential manner by the PSI, it will only be used for the purposes outlined and it will be deleted in line with the PSI’s record retention policy. After each public consultation we publish a consultation report on this website that contains a summary of comments received, the PSI response to those, and a list of any organisations that have given their feedback, where provided. Please note that submissions made to the PSI as part of public consultations are subject to the provisions of the Freedom of Information Act 2014.