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Politicians in Northern Ireland have been warned that the local pharmacy regulator is failing to meet key performance standards and has demonstrated “weaknesses in multiple regulatory functions”.

The Professional Standards Authority, a watchdog that oversees the UK’s 10 health and care regulators, wrote to health minister Mike Nesbitt and Stormont health committee chair Philip McGuigan in March to express its “considerable concern” that the Pharmaceutical Society of Northern Ireland failed to meet 7 out of 18 standards in 2023-24.

The PSA requested a meeting with Mr Nesbitt to discuss these failings, which include a lack of progress against plans to update its 2016 guidance for internet pharmacies – something it first planned to do in 2022-23 – “despite this being a known and growing risk to patient safety”. 

The PSNI also failed to progress fitness to practise investigations in a timely manner, according to the PSNI’s annual review which prompted it to reach out to Stormont legislators a year after it published a similarly damning performance review. 

The regulator “was taking too long to progress cases through the fitness to practise process and the number of open older cases had increased,” this report found. 

“We considered that due to the small caseload the PSNI should have been able to manage delays to cases more effectively,” said the PSA, also noting that the regulator was unable to explain these delays satisfactorily.

The time taken from receiving a concern to closing an FtP case has “continued to increase since 2019-20,” said the PSA, which found that there were 22 open cases more than a year old in the third quarter of 2024-25 compared to nine in 2019-20. 

The PSNI has taken steps to address this backlog, including the recruitment of a dedicated paralegal to work on historic cases and a consultant pharmacist “to provide expert advice,” as well as appointing an internal lawyer to deal with cases in-house “rather than through external legal providers”. 

The PSA commented: “We recognise that the PSNI’s small caseload means that median timeframes can be impacted by outliers, which may have delays caused by factors outside the PSNI’s control. 

“However, the data also shows an overall increase in the caseload, an increase in older cases and the number of cases awaiting hearing, which is higher than the number of hearings the PSNI usually holds each year.”

The PSA said it would monitor the regulator’s progress in meeting its goal to “clear the backlog” by June 30 this year. 

PSNI: Staff turnover posed 'unique challenge'

PSNI president Geraldine O’Hare commented: “We very much see PSA performance reviews and their findings as important indicators and drivers on our journey of continuous improvement, as we strive to become a modern fit for purpose regulator.

“Unfortunately, during much of 2024, the Society was considerably impacted by turnover of senior staff, which created a uniquely challenging situation.

“The departure of these members of staff caused an inevitable and significant impact on operational capacity, which included a forced realignment of senior management responsibilities. 

“Considerable effort was targeted towards stabilising the organisation and ultimately successfully managing the key public safety elements of core functions relating to registration, fitness to practise, education and training, and standards.”

PSNI chief executive Canice Ward noted the “not entirely surprising” findings of the PSA review and said he was “satisfied that things did start to turn around in the latter part of the year” and “determined” to make progress over the course of 2025.

The Department of Health told P3pharmacy: "The Department notes the performance review report from the PSA. The Department will engage with both the PSA and the Pharmaceutical Society of Northern Ireland to provide assurance that the significant issues identified within the report are being addressed."