PSI – The Pharmacy Regulator publishes 2021 Annual Report | Fieldfisher
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PSI – The Pharmacy Regulator publishes 2021 Annual Report



The Pharmaceutical Society of Ireland ("PSI") is the statutory body entrusted with responsibility for regulating pharmacists and retail pharmacies in Ireland. There were approximately 6,845 pharmacists on the Register of Pharmacists maintained by PSI at the end of 2021, up 78 from 2020, and 1,981 pharmacies on the Register of Retail Pharmacy Businesses, up 13 from 2020.
The PSI recently published its Annual Report for 2021 ("the 2021 Report"), the purpose of the annual report being for the PSI to demonstrate how it has exercised all aspects of its statutory responsibilities during 2021. We focus in this blog on the key aspects of the report related to fitness to practise.
The PSI is tasked with receiving and managing complaints against pharmacists and pharmacies. The 2021 Report provides an outline of the work conducted in this area during 2021 and some key statistics, for example:
  • Complaints Received: In 2021, PSI received 80 complaints, significantly higher than the 46 received in 2020 and 61 received in 2019. This represents a 74% increase from 2020. The Report highlights that the activity levels in 2020 were not necessarily reflective of a typical year due to COVID-19.
  • Source of Complaints: 79% of the complaints received were made by members of the public, with 19% made by the Registrar of the PSI.
  • Types of Complaints: The majority (21) of the complaints related to pharmacy practice issues, with a further 22 made up equally of failure to supply issues and dispensing errors. 4 complaints related to health impairments. 5% of complaints received in 2021 related to Covid related issues, such as failure to wear facemasks and operational standards in pharmacy practice.
  • Preliminary Screening: Of the 59 complaints considered by the preliminary screening committee of the PSI, 25 were referred for further action either by way of mediation (5 complaints) or to fitness to practise Inquiry (20 complaints)
  • Remote Hearings: Statutory disciplinary committee meetings, including fitness to practise inquiries, and meetings of the PSI Council continued to be held fully remotely in 2021. While the Report acknowledges that remote hearings take longer to conclude than in-person hearings, the Report notes that this facilitated complaints to be progressed as expeditiously as possible.
  • Inquires Held: The PSI completed 12 Inquiries relating to 19 respondents in 2021, as follows:
    • The Professional Conduct Committee ("PCC") heard 10 Inquires; and
    • The Health Committee ("HC") heard 2 Inquiries.
  • Sanctions Imposed: In 2021, the PSI Council imposed sanctions on a number of pharmacists/pharmacies, as follows:
    • 1 pharmacists registration was cancelled;
    • Conditions were attached to registration in 2 cases;
    • A number of pharmacists were admonished or censured
  • Ongoing Monitoring of Conditions: During 2021, PSI was involved in monitoring compliance with conditions attached to the registration of 8 registrants, including pharmacists and pharmacies.
Other Key Updates
  • The PSI launched its Corporate Strategy 2021 – 2023. The strategy sets out three key objectives that PSI hopes to achieve by 2023, as follows:
    • Objective 1 – Advancing the Role of Pharmacy and pharmacists in the Future Integrated Healthcare System
    • Objective 2 – Evolving a More Effective Regulatory Model for Community Pharmacies
    • Objective 3 – Building their Capability and Performance as a Regulatory Organisation
  • On 13 February 2021, most of the substantial sections of the Regulated Professions (Health and Social Care) (Amendment) Act 2020 were commenced. There were over 40 distinct amendments and new provisions, which impacted the process of considering complaints and disciplinary proceedings against pharmacists and pharmacies. The PSI engaged in a significant body of work to incorporate the new amendments into template documentation, procedures and processes and to train Council and Committee members.
  • The main amendments introduced that affect PSI include:
    • New grounds for complaints;
    • Enhanced powers of communication with regulators outside of the jurisdiction regarding complaints and their outcome;
    • Enhanced powers and rights in relation to appeals to the High Court following decisions by the Council, for example there is now an entitlement to appeal sanctions of admonishment and censure; and
    • New express power to publish Committee reports and transcripts of Inquiry proceedings, where the Council considers it is in the public interest to do so.
  • New Council Procedures for Considering Committee Reports: On 7 October 2021, the Council of the PSI launched a new procedure applicable to its consideration of reports from Committees of Inquiry, where sanction is required to be imposed. The Report describes the aim of the procedures as being to streamline and make most effective the process and to allow for fairness to the parties in terms of the time taken to present oral submissions before the Council.
This blog aims to highlight the key aspects of the report of relevance to fitness to practise but the full report is available at the following link Annual_Report_and_Financial_Statements_2021.sflb.ashx (

Written by: Zoe Richardson and Adenike Akintonde


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