Individual pharmacy professionals working in various roles and capacities such as SIs, RPs, or PIPs may have played a role in the system failings. The GPhC considers it not to be in the public interest to allow the pharmacy professional who has potentially played a key role in the unsafe systems to continue in their practice without any restrictions.
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.
Key sources of evidence
In assessing the roles of the SI and RP the GPhC will, usually, consider key sources of evidence. Key sources of evidence will include inspection reports, inspector witness testimony, job descriptions, witness testimony from other members of staff, reviews of SOPs and clinical policies by expert witnesses and audits of patient care.
How we can help you
Whether your pharmacy is facing an inspection by the General Pharmaceutical Council, working on a GPhC improvement plan, looking to proactively address regulatory issues or concerns and/or part of your businesses due diligence, mock inspections can hold important benefits.
Kings View Resolutions offer a range of legal and compliance services to pharmacists and pharmacies:
- Regulatory Compliance
- Internal Training
- Conducting Internal Investigations
- Preparing for Independent Investigations & Reviews
- Mock Inspections
- Whistleblowing Services
- Crisis Management
As leaders in our field, we are set up and able to deal with the most complex cases with sensitivity and in a timely manner, always open and transparent about our fees and charges. If your business is facing regulatory issues or you are not sure and require advice and support, speak to one of our legal consultants today.
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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.
