Fitness to practise implications when a pharmacy is the subject of enforcement action

“Kings View now has unparalleled experience in the GPhC fitness to practise arena – particularly relating to online and remote prescribing and dispensing. We would encourage those seeking representation to research properly, as undoing bad decisions in such matters is very difficult.”  

What is the link between pharmacy enforcement and pharmacist fitness to practise

When a pharmacy fails to meet any of the GPhC’s pharmacy standards, the GPhC will, in most cases, agree an action plan, but in the most serious cases, the GPhC will issue an action plan. Action plans are used when standards are not met, but any ongoing patient risk is considered to be manageable.  Where there is evidence of ongoing patient risk which requires more urgent action, a GPhC inspector can either serve an improvement notice or the Registrar can impose conditions on the pharmacy.

However, the pharmacy enforcement process cannot deal with the conduct of individual pharmacy professionals who are implicated in the system failures.  Where the GPhC has started enforcement action against the pharmacy and pharmacy owner, it will, in most cases, also investigate the individual pharmacy professionals involved to look into their potential failings as pharmacy professionals with a role in overseeing pharmacy services.

The GPhC states in their guidance:

“It would not be in the public interest to allow the pharmacy professional who has potentially played a key role in the unsafe system to continue in their practice without any restrictions just because we have dealt with the unsafe system. This is particularly important if the system failings are attributable to the acts or omissions of pharmacy professionals because they could potentially continue working in other settings making the same decisions leading to system failings in other settings.”

Pharmacy professional roles which might play a part in system failings

The GPhC refers to a couple of specific pharmacy professional roles that may be implicated in systematic failures:

Superintendent pharmacists – have a statutory role in that “the retail pharmacy business, so far as concerns the keeping, preparing and dispensing of medicinal products other than medicinal products on a general sale list, is under the management of a superintendent.” Although the obligation for meeting the pharmacy standards falls on the owner, the SI can also be held to account for failings in the management of any of the pharmacy services. This will include:

• their involvement in putting in place a particular standard operating procedure (SOP), process or system
• their role in managing and overseeing the processes and system
• their involvement in the review of the safety and quality of the service or system being monitored
• their involvement in the development of risk assessments and actions to mitigate any identified risks
• the range and pattern of any failures in the processes and system
• the extent of their daily involvement in the management of the pharmacy
• their role and input in the clinical policies which should be in place to manage the prescribing and supplying decisions
• any omissions or failings in recognising and mitigating patient risks or safety concerns.

Responsible pharmacists have a statutory role in the operation of a pharmacy and this includes the obligation to “establish (if they are not already established), maintain and keep under review procedures designed to secure the safe effective running of the business.” This is a significant statutory obligation, and it requires more than the RP acting as the most senior dispensing pharmacist.

Where an inspection report identifies failings which put patients at risk, it will be appropriate to assess the role and conduct of the RP who has worked within the pharmacy. Important factors to consider will be how they are employed and how frequently they work as the RP and the extent of their actual control.

Kings View Chambers

Kings View now has unparalleled experience in the GPhC fitness to practise arena – particularly relating to online and remote prescribing and dispensing. We would encourage those seeking representation to research properly, as undoing bad decisions in such matters is very difficult.

“Because this was one of the first cases relating to remote and online pharmacy, the GPhC had yet to decide how it wished to regulate the arena. Online and remote GPhC cases are complex. We have since had findings of no impairment in three other substantive cases, with more being listed currently.”

Our case success

• Pharmacist’s fitness to practise found not impaired
• No impairment for online pharmacy owner

In upholding the appeal, Alan Bates, sitting as a Deputy Judge of the High Court, said:

1. Failure to assess witness credibility and reliability The panel did not sufficiently evaluate the general credibility and reliability of key witnesses, whose evidence was essential to the charges. It failed to consider factors such as contradictions between witnesses' accounts and whether their testimonies should be approached with caution. This omission undermined the panel's ability to justify its conclusions.
2. Lack of explanation for preferred evidence The panel failed to provide adequate reasons for preferring the complainants' evidence over the appellant nurse's and the paramedic's. Simply stating a preference for certain witnesses' accounts without detailed justification left the appellant without a clear understanding of why her evidence was rejected.
3. Errors in evidence evaluation The panel assessed each charge in isolation without considering broader patterns or contextual evidence. It failed to recognize that inaccuracies in one allegation (contradicted by CCTV) could cast doubt on the reliability of witnesses' accounts in other allegations, leading to flawed conclusions.
4. Improper handling of contextual evidence The panel neglected to evaluate the behaviour of the complainant nurses during the investigation, which was relevant to determining their credibility. Additionally, it overlooked the appellant nurse's claims that the allegations were fabricated to remove her from her managerial position.
5. Insufficient reasoning for findings The panel provided inadequate reasoning for its findings of misconduct. It did not fully explain how the evidence supported its conclusions, including why the NMC had met the burden of proof for each disputed allegation. This failure left the appellant with unsubstantiated conclusions, undermining the credibility of the process.

Lessons

This case highlights several critical considerations for fitness to practise tribunals. One key lesson is the importance of thoroughly evaluating the credibility and reliability of witnesses, particularly when their testimony is central to the charges. Without such assessments, the accuracy and fairness of the tribunal’s findings can be compromised. Witness accounts must be examined not only in isolation but also in a broader context, taking into account patterns and inconsistencies to achieve a holistic evaluation.

Additionally, tribunals must provide clear and rational reasoning for their decisions. Merely preferring one witness’s account over another without detailed explanations can lead to procedural unfairness. Ensuring transparency in decision-making fosters trust in the process and supports robust outcomes. Tribunals must also maintain procedural fairness by upholding the burden of proof on the prosecuting body. Accused parties should never feel pressured to disprove allegations, as fairness is crucial to preserving the system’s integrity.

Disclaimer: This article is for guidance purposes only. Kings View Chambers accepts no responsibility or liability whatsoever for any action taken, or not taken, in relation to this article. You should seek the appropriate legal advice having regard to your own particular circumstances.