Simon Addison Smith, registration number 2024372, and Trishul Patel, registration number 2058183, have received a 12-month suspension and a warning respectively, after operating Cannabliss – the pharmacy where they worked – without “adequate governance and safeguards in place”, General Pharmaceutical Council (GPhC) hearing documents have said.
In joint remote hearings on February 25-28 and March 3, the fitness-to-practise (FtP) committee heard that the “operating model and record keeping” at Cannabliss were “non-compliant and unsafe”.
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The council heard that between February and May 2022 “the pharmacy was supplying cannabis based medicinal products (CBMP) against private prescriptions received from doctors who were on a specialist register”.
It heard that, among other things, the pair allowed the pharmacy to operate despite it “not [having] a risk assessment in place for the services it provided” and “did not maintain records to provide assurance that the CBMPs it supplied had been appropriately prescribed”.
And it “supplied high-risk medicines to people who may be vulnerable in circumstances where no safeguarding procedures or training had been put in place”, the document said.
Not an “isolated incident”
According to the hearing document, the committee found 17 of the 19 allegations against Smith proved and all allegations against Patel proved.
For Smith, the regulator accepted that he had “apologised for his misconduct...[and] had broadly accepted his failings”.
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And for Patel, the committee acknowledged that he had “accepted full responsibility and did not seek to blame others” and “engaged with the regulatory process from the outset”.
But in both cases, it stressed that “the conduct was not an isolated incident” and that “the nature of the business model [of] supplying CBMPs” was an aggravating factor.
“Several concerns”
“Several concerns were identified” when Cannabliss was visited by a GPhC inspector in May 2022 as part of a “routine” pharmacy inspection following its registration, the document said, including issues “in relation to the running of the pharmacy, the management of controlled drugs and the keeping of records”.
“At the time of the inspection, an untrained company director was working alone at the pharmacy and no responsible pharmacist was present,” the regulator heard, and after a copy of the responsible pharmacist log was obtained, “only nine entries between February and April 2022” were found.
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The committee also heard that “a number of dispensing labels were found” by the inspector that “had not been attached to a medicine but had already been signed by a dispenser and pharmacist”.
The council found that Cannabliss was “regularly open and operating on multiple [occasions] without a responsible pharmacist being present, or when [they] had not signed in”.
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According to the documents, the pair also “failed to ensure that controlled drugs were managed safely and/or in accordance with” the law and the inspector found that “CBPMs and Schedule 2 controlled drugs were not stored in a controlled drugs cabinet”.
Following these discoveries, “conditions were imposed on the pharmacy that it must not obtain or supply any controlled drugs”, the document said.
“Flagrant disregard”
The regulator accepted that Smith “had not sought to blame [Patel] or others” and that “no risks materialised and there was no evidence of harm to patients”.
But it stressed that his “conduct was not an isolated incident [and] took place over a period of 3-4 months”.
Smith was the “superintendent of the pharmacy and therefore in a position of clinical and regulatory leadership [but] he failed to work with colleagues effectively or set safe and compliant parameters within which others should work”, the committee found.
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“[He] did not engage with the regulatory process at all [and] his responses were flippant,” it said, adding that “his lack of engagement with his regulator demonstrated a flagrant disregard for the proper governance he knew was required”.
The regulator said that Smith “demonstrated a deep-seated attitudinal problem that he had not sought to remediate” and noted that he “continues to present a risk to the safety of patients and the wider public”.
And it concluded that “the proportionate period of suspension, bearing in mind the seriousness of the misconduct found proved, is 12 months”.
Read the determination in full here.
“Serious error of judgement”
In Patel’s case, the regulator accepted that “although repeated, his misconduct occurred over a relatively short time period”, adding that “he apologised and showed remorse for his misconduct”.
It acknowledged that “he had made strenuous offers to remediate through reflection and training” and “had demonstrated his understanding of the importance of proper governance systems”.
But it stressed that his “conduct was not an isolated incident [and] was repeated on 7-8 occasions”.
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Patel failed to “apply proper or sufficient professional curiosity when exercising his role and then failed to be proactive in ensuring that the pharmacy operated safely,” the committee said, adding that “he applied a casual approach to record keeping and reviewing patient prescription histories”.
But it “reminded itself...that [he] had acknowledged and recognised the risk that his poor management practices presented to patients” and concluded that a warning would be sufficient.
“A warning against [Patel’s] name on the register is a public acknowledgement that his conduct was unacceptable [and] was a serious error of judgement,” the regulator said.
Read the determination in full here.