John Francis Kelly, registration number 2611, has received a warning from the Pharmaceutical Society of Northern Ireland (PSNI) after he was found to be responsible for a series of failures around “suboptimal governance procedures”.
In a hearing on August 28, the PSNI’s fitness-to-practise (FtP) committee heard that Kelly made a number of governance failures at Earlswood Pharmacy in Belfast “on various dates” between September 2018 and July 2021.
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According to the hearing documents, Kelly’s “responsibility lay as superintendent pharmacist in charge of the business” and it was his duty to “ensure that adequate and appropriate processes and mechanisms were in place”.
The regulator recognised that there was “no evidence of actual patient harm” and that Kelly “made early admissions as to his wrongdoing”, adding that he made a “prudent decision” to “promptly” close the pharmacy.
However, it noted that the events took place over an almost three-year period “from September 2018 to July 2021”.
Poor record-keeping
At the time of the misconduct, Kelly was superintendent pharmacist and sole director of Chemcare (NI) Limited, which operated two pharmacies in Belfast including Earlswood Pharmacy.
The committee heard that Kelly “failed to ensure” that Earlswood Pharmacy’s records were “properly maintained”, that the pharmacy “had appropriate and sufficient standard operating procedures (SOPs) in place” and that “these were readily accessible and available”.
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It was also that he “failed to ensure” the pharmacy “had any verifiable audit trail for deliveries of medicinal products” or that “controlled drug (CD) registers were kept and maintained as required”.
Kelly also failed to periodically undertake “an appropriate stock audit of CDs” and “ensure that an adequate system was in place to record all near misses/errors”, the committee heard.
Finally, the PSNI said Kelly failed to maintain appropriate records “with respect to extemporaneously prepared and dispensed unlicensed medicines”.
“Prudent decision”
The committee heard that Kelly had “a long and unblemished career in the profession” prior to the misconduct and that there was “no evidence of any issues with his professional practice” since the events more than four years ago.
He had “made an immense contribution in the development of community pharmacy services across Northern Ireland”, it said.
It added that he “demonstrated insight into his actions” including taking “prompt steps to rectify the breaches”, accepted “responsibility” and “expressed remorse and was apologetic in respect of the concerns”.
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And it highlighted that Kelly “took a prudent decision to close the Earlswood Pharmacy” in October 2021, reporting that he “found it difficult to engage registered pharmacists” to run it.
It said this was “a significant step to try to remediate the issues that had arisen in that pharmacy” and “a relevant factor” regarding the risk of recurrence.
“Potential for harm”
But the PSNI found that while no actual patient harm was evidenced, the “failures gave rise to a potential for harm due to the suboptimal governance procedures in place at the time”.
“The bottom line is that it fell to [Kelly] as the superintendent pharmacist to ensure that the Earlswood Pharmacy operated in accordance with legal requirements, in accordance with relevant guidance, and provisions of the code, to ensure that this pharmacy operated safely and effectively for the public,” it said.
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It decided that the failures amounted to misconduct and found that his fitness to practise was impaired “on the wider public interest grounds”.
It concluded that a warning “would demonstrate to [Kelly] and more widely to the profession and the public” that his conduct “fell below acceptable standards”.
The warning “will remain on the PSNI’s website and the online register for a period up to two years,” the regulator said.
Read the determination in full here.
