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Insight

Lannon v Council of the Pharmaceutical Society of Ireland

Locations

Ireland

High Court provides clarification on the Imposition of Sanction and Assessment of Insight

The High Court has recently provided a very instructive judgment in respect of its consideration of the proportionality and appropriateness of a sanction imposed upon a pharmacist by the PSI. The judgment contains very useful guidance for both regulators and registrants on the principles pertaining to the imposition of sanction and in particular, the assessment of insight.

The High Court upheld a decision to impose a two-month suspension on a pharmacist who had been found by a Committee of Inquiry to be responsible for the dispensing of "prescription only" high-tech medication for two minor patients over a prolonged period, in the absence of a valid prescription.

Background

Mr Lannon ("the Pharmacist") had been a registered pharmacist for over fourteen years and was also a supervising pharmacist in the Pharmacy he was employed in.

In 2018, a complaint was made about Mr Lannon by the Head of Pharmacy Function of the HSE, in respect of the dispensing of Kalydeco, a "high-tech" drug used as a treatment for cystic fibrosis, to two minor patients. All patients prescribed Kalydeco are required to attend for three monthly reviews with their treating specialist medical practitioner, in order for their prescription to be renewed. Kalydeco can only be dispensed by A pharmacist on foot of a valid prescription issued by a specialist medical practitioner.

The two patients' prescriptions for Kalydeco were duly renewed over time with the last prescription being valid up to July 2017. Notwithstanding the absence of valid prescriptions, the pharmacy continued to dispense Kalydeco to the two patients during a period of eight months between August 2017 and February 2018.

Fitness to Practice Inquiry

The complaint was the subject of a fitness to practice Inquiry conducted by the Professional Conduct Committee ("the PCC") of the PSI. The PCC considered an allegation that the Pharmacist had supplied or permitted the supply of Kalydeco to the patients in the absence of a valid prescription on eight occasions and had failed to ensure that there was adequate compliance with the standard operating procedures of the pharmacy for the management of high-tech medicines. It was alleged that this amounted to poor professional performance.

The PCC ultimately found the allegations proven and found the Pharmacist guilty of poor professional performance. The Committee recommended the suspension of the Pharmacist's registration for a period of two months, in addition to the attachment of a number of conditions to his registration, to take effect after the suspension had ended.

In recommending this sanction, the PCC indicated that its paramount consideration was the protection of the public and noted that it was not persuaded that the Pharmacist had insight into his conduct. The PCC expressed concern with the approach he had taken during the Inquiry. In this regard, the PCC referred to the Pharmacists reliance upon the fact that he did not personally dispense the medications on each of the 8 occasions; his erroneous argument that a valid prescription had been in place when it had not been; his contention that refusal to dispense the medication presented a case of ethical dilemma and his attacks on HSE personnel.

The ultimate decision in respect of the imposition of sanction by the PSI rests with its Council, which met to consider the report of the PCC and to determine the appropriate sanction. The Pharmacist appeared before the Council at the sanction meeting and addressed the Council, in addition to having legal submissions made on his behalf. Before the Council, the Pharmacist accepted responsibility for his actions and submitted a report from an expert pharmacist engaged by him, to the effect that his professional prescribing practice in general was of a high standard, aside from the issues the subject of the allegations.

 The Council decided to impose the sanctions recommended by the PCC, and in doing so adopted the reasons given by the PCC. The Council, in addition, noted that it had considered the submissions made by the Pharmacist to Council, the principles of sanctioning and noted that it considered suspension would act in the public interest as a deterrent to inappropriate behaviour and as a signal to the Pharmacist, the profession and the public as to what is regarded as inappropriate behaviour by a supervising pharmacist.

High Court Proceedings

The Pharmacist appealed the severity of the sanction to the High Court. Whilst the conditions were accepted and were not challenged, it was argued that the sanction of suspension was disproportionate and ought be removed. It was submitted that the suspension would have a serious reputational and financial impact on the Pharmacist.
 
A number of specific grounds of challenge were pursued by the Pharmacist, in respect of the decision of Council. The Pharmacist also gave evidence to the High Court, during which he accepted that, on reflection, he should have approached the Inquiry differently. He accepted that he had taken an overly benign view of his actions and had not fully appreciated his responsibilities as a supervising pharmacist. The judgment notes that the Pharmacist accepted that it was reasonable for the PCC to have formed a view that he lacked insight into his actions.

Ms Justice Egan delivered judgment on 14 February 2022.

The judgment contains an analysis of the approach the High Court should take in assessing a challenge to the appropriateness of a sanction. The Court said that while it must take an independent view of the appropriate level of sanction, it remained incumbent on the Pharmacist to identify an error by the Council or a specific reason for altering a sanction, as regard must be had to the specialist knowledge of the regulatory board and considerable respect must be afforded to the regulators decision (the concept of curial deference).

We outline below the Courts findings in respect of the five primary points upon which the appeal was grounded.
 
  1. Mischaracterisation of the seriousness of the conduct

Both the PCC and the Council had graded the Pharmacist's poor professional performance to be "at or very close to, the most serious end of the spectrum."

The Pharmacist argued that the Council had mischaracterised the seriousness of the conduct in question due to a failure to consider a number of factors, including:
  • a failure to consider the Pharmacists otherwise unblemished record;
  • that he had only personally dispensed the medication once;
  • that the dispensing was for a single medication;
  • that the two patients would suffer adverse consequences in the absence of the dispensing;
  • that no harm was caused to the patients;
  • that the dispensing occurred in an established pharmacist-customer relationship; and
  • that neither the Pharmacist not the Pharmacy gained financially from the dispensing.
The Court held that the fact of an otherwise unblemished record does not result in the conduct at issue being less serious. It highlighted the obligation that the Pharmacist had as a supervising pharmacist to ensure that medication was not dispensed from the Pharmacy without a valid prescription. Despite the Pharmacist contending that because the 8 supplies related to the same patients and same drug it amounted to a single incident, the Court held it could not properly be classed as an isolated or single incident, given that it persisted over a lengthy period of time.

In useful guidance, the Court held that it is not the presence or absence of actual harm which is the key consideration for the regulator, rather it is the risk of harm. The Court concluded that the seriousness of the poor professional performance had not been mischaracterised and in doing so, Judge Egan gave deference to the Council in its ability to assess the severity of conduct, referring to its familiarity with and expertise in these matters and noted it was well placed to assess where on the spectrum of severity the proposed sanction should fall.
 
  1. Disparity in the sanction vis a vis comparators

The Pharmacist had sought to rely on newspaper and website reports of other sanctions that had been imposed by PSI in the past and submitted that these should be considered as comparators, suggesting that the sanction in this case was more severe than those imposed in, what were suggested to be, comparator cases. The Pharmacist contended that there was no evidence the Council had engaged with the comparators.

In useful guidance on the relevance of comparator cases, the Court held that while consistency of sanctioning is important, precedent decisions and sanction guidance documents are not restrictive and the Court is not "boxed in" by sanctioning precedent.
Importantly, the Court held that while a failure to follow published sanctioning guidelines could amount to a legal error, it was difficult to see how a failure to follow a previous sanction decision could ever amount to a legal error.

The Court did note that it would have been helpful if the Council had included in its decision an explanation of why the more pertinent comparators did not alter its conclusion that the sanction recommended was appropriate.  However, the Court was satisfied that it was evident from the transcript that the Council understood the limited value of the comparators and the relevance of consistency.
 
  1. Failure of the Council to engage with evidence of insight

While the Pharmacist accepted that he may not have displayed insight at the Inquiry, he argued that he had displayed insight at the Council meeting, and also before the High Court, and that this insight had not been given sufficient weight.

Although the Court found that the Pharmacist had acquitted himself well before the Council and the Court, it held that it could not accept the submission that this demonstration of insight long after the event must be an over-riding consideration when assessing the proportionality of the sanction.

Judge Egan was satisfied that the continued denial of poor professional performance and the lack of insight displayed at all times up to the sanction hearing remained relevant. Acknowledging the entitlement of the pharmacist to defend the proceedings, the Court noted that failure to accept allegations cannot be an aggravating factor but found that it could reduce the level of mitigation that may be available at a later stage.

The Court noted that although any practitioner is entitled to maintain innocence, in doing so, it is inevitable that he cannot argue at a later hearing that he had insight at the relevant time. The Court remarked that" insight gained several years post event is insight of a different quality to insight which is displayed at an earlier stage".

The sanction was found not to be disproportionate having regard to the seriousness of the conduct and the duration of it and the length of time it took to develop insight. The Court indicated a different approach may have been taken by it,  if the suspension imposed had been longer,.
 
  1. Failure to engage with Expert Evidence adduced by the Pharmacist

The Pharmacist claimed that the Council failed to engage with the evidence of a pharmacist who had been called to give expert evidence as to the pharmacist's otherwise good practice.

Having heard evidence from that expert, and having reviewed the documentation, the Court was clear that it was fully satisfied that the Pharmacist now practices in accordance with good dispensing practices and that the poor professional performance the subject of the findings occurred in an otherwise unblemished career. However, it held that the fact that the pharmacist has otherwise acted in accordance with good practice and continues to do so, does not detract from the seriousness of the conduct at issue and does not render the action disproportionate.
 
  1. Failure to afford leniency

The Pharmacist submitted that the Council had failed to afford as much leniency as possible to him and failed to give appropriate weight to mitigating factors. This argument was rejected, on the basis that the PCC's recommendation on sanction, which was adopted by the Council, referred specifically to the PSI's guidance on sanction which sets out the obligation to assist practitioners with as much leniency as possible. In addition, the PCC had set out each of the mitigatory factors raised in its report, and explained their relevance in the context of the recommended sanction.

The Court expressed sympathy for the Pharmacist, who demonstrated remorse and insight throughout the appeal, but declined to cancel the sanction imposed. It held that the sanction was reasonable and the Council had conducted a correct calibration of the conduct, the purpose of sanction and the mitigating factors.


Guidance Emanating for Registrants and Regulators

Some key principles can be drawn from the judgment of Ms Justice Egan, including:
  • It is not the presence or absence of actual harm which is the key consideration for the regulator, rather it is the risk of harm.
  • While consistency of sanctioning is important, precedent decisions and sanction guidance documents are not restrictive and the Court is not boxed in by sanctioning precedent. Application of consistent principles seems more important than the following of precedent decisions.
  • Insight gained several years post event is insight of a different quality to insight which is displayed at an earlier stage.
  • Evidence that a registrant has otherwise acted in accordance with good practice does not detract from the seriousness of the conduct at issue in an Inquiry.

In conclusion, this judgment of the High Court provides a very helpful restatement and summary of the principles to be applied by a regulator when imposing sanction 9and the High Court when considering an appeal), and in particular contains a useful elucidation in terms of how insight should be assessed.  
 
Written by Zoe Richardson and Matthew McGarry. 

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