Regulatory notice on Hub and Spoke model of dispensing

Published: 19 June 2025

This notice is issued to inform all registered pharmacists and pharmacy owners of the PSI’s position on the implementation of a hub and spoke pharmacy model. It aims to ensure that all pharmacists and pharmacy owners understand their professional and legal responsibilities and maintain compliance with the Pharmacy Act 2007 and associated regulations.

Background

A hub and spoke pharmacy model refers to a system in which elements of the dispensing process are divided between two or more separate registered pharmacy premises, within the same pharmacy group or between pharmacies under different beneficial ownership. This may include, for example, the preparation of monitored dosage systems (MDS) . While this model may appear to offer operational efficiencies, it raises significant regulatory and professional concerns under current Irish legislation.

Regulatory framework

Pharmacy practice in Ireland is governed by a robust regulatory framework designed to ensure the safe and effective supply of medicines and the protection of public health. This framework includes, but is not limited to :

1. The Pharmacy Act 2007, which establishes the statutory functions of the PSI.
2. The Regulation of Retail Pharmacy Businesses Regulations 2008 (as amended) (‘the Regulations’), which set out the operational and professional standards required of all registered pharmacies.

Under this framework, the operation of a hub and spoke model is considered inconsistent with regulatory obligations for the following reasons:

a) Division of Core Activities: The separation of key functions—such as the storage, preparation, compounding, dispensing, sale, or supply of MDS or other medicinal products—between two distinct registered pharmacies contravenes Regulation 4(1)(a), which requires that each pharmacy independently supports these activities within its own premises.

b) Inter-Pharmacy Transfer of Medicines: The routine transfer of medicines between pharmacies, outside of an immediate patient need, falls outside the scope of permitted inter-pharmacy exchange and raises concerns regarding traceability and control.

c) Accountability and Professional Liability: Dividing professional responsibilities between different pharmacies and pharmacists introduces ambiguity in the chain of accountability. This complicates the determination of liability in the event of a dispensing error or patient harm, undermining the integrity of professional oversight.

PSI Position

The PSI considers the hub and spoke model to be incompatible with the current legislative framework governing pharmacy practice in Ireland. Accordingly, it is not deemed appropriate to implement or operate this model within registered pharmacies for the preparation and supply of medicines to patients, including, but not limited to, monitored dosage systems (MDS). The PSI expects those in governance roles to exercise their duties with due diligence and to refrain from adopting models of practice that are not currently supported by the legislative framework.