Can GPhC enforcement action lead to fitness to practise sanctions?

The General Pharmaceutical Council (GPhC) is taking enforcement action against online pharmacies and pharmacists for not adhering to its standards for registered pharmacies.  According to the GPhC (since April 2019[1]:

• it has undertaken 680 inspections of online pharmacies and only 72% met all standards;
• Taken enforcement action against 54 distinct online pharmacies to address patient safety risks; this includes 57 conditions notices and 12 improvement notices; and
• Since 2019 there have been 1985 concerns related to online pharmacies raised to Fitness to Practise.

The GPhC have statutory powers to act “to protect the public and to uphold public confidence in pharmacy” if it receives concerns about a registered pharmacy.  These powers include enforcement options and enforcement powers:

• Improvement action plans – Generally the first enforcement option and where there is no immediate risk to the public or patients. Improvement action plans require pharmacy owners to develop an improvement plan, setting out what they will do, within a set time, to put right the issues and meet the standards.
• Conditions on registration – Registered pharmacies can have conditions attached to their registration when this is necessary for the purpose of “securing the safe and effective practice of pharmacy at those premises”. Unless there is deemed to be an immediate public safety risk, pharmacy owners will have “reasonable notice” in writing of the condition(s) to be imposed and failure to comply with conditions can lead to an improvement notice.
• Improvement notices – Where the GPhC have reasonable grounds for believing there is a failure to meet standards for registered pharmacies, or a failure to meet conditions relating to the standards, they can serve an improvement notice. Pharmacy owners are responsible for making sure that the improvement work is carried out within the timeframe set out in the improvement notice (at least 28 days).

Certain GPhC enforcement actions are appealable.  Pharmacy owners can appeal the following actions:

• Improvement notices to the Magistrates’ court, or in Scotland to the sheriff. An appeal must be brought within 28 days beginning with the date on which the improvement notice was served. The Court may suspend an improvement notice pending the determination or abandonment of the appeal. On appeal against an improvement notice, the court may either cancel the notice or confirm it, with or without change.
• Disqualification, removal directions & interim suspensions to the High Court (or the Court of Session in Scotland) within three months beginning with the date on which the direction is given.

Can GPhC enforcement action lead to fitness to practise sanctions?

Yes.  The GPhC has made clear that it has taken fitness to practise action against pharmacists who dispensed medicines when appropriate safeguards were not in place to make sure that the prescriptions were clinically appropriate for patients.  The fitness to practise action follows on from enforcement action taken by the GPhC.

The GPhC reported that over 30% of its open fitness to practise cases relating to online pharmacy, which “is disproportionate to the sector of the market that online services occupy.” 

A common issue, specifically in relation to fitness to practise investigations stemming from enforcement action, is a failure by prescribing pharmacists prescribing high-risk medicines to patients not having the information they needed about the patient to provide appropriate care or to enable them to use their judgement to make clinical and professional decisions.

This links directly back to the GPhC’s standards for pharmacists, and in particular:

• Standard 4: Pharmacy professionals must maintain, develop and use their professional knowledge and skills; and
• Standard 5: Pharmacy professionals must use their professional judgement

Where there is evidence that registered pharmacists have not adhered to the GPhC’s standards, the regulator will open a case and could take action against pharmacists.

Kings View Barristers

With over 30 years combined experience, Kings View Chambers have established itself as one of the best when it comes to fitness to practise defence.  We fully understand that fitness to practise defence is not merely about processes and procedures.  We also understand that we are working with people who are anxious and worried about what investigations might mean for them, their professions and the reputations.

We are proud to be rated ‘excellent’ by our clients.  Our commitment to client care is genuine in both seeking the very best outcomes for our clients, but also ensuring we do what we can to support them through the process.

Contact us today for a no obligation and free telephone consultation about your case in the knowledge that you are speaking to one of the best in the business.

Is legal representation the answer?

It is widely accepted and proven that legal representation makes a real difference to the outcome of investigations and results in lesser sanctions for doctors.

What is also unquestionably clear is that GMC investigations and MPTS hearings are complex, daunting, prolonged and legalistic leaving doctors stressed and anxious.  Where legal advice and representation can have the biggest impact on this, is helping doctors understand the process, what to expect and how to engage with the GMC during an investigation and hearing.

Research has shown that registrant’s engagement and legal representation can impact on decisions about seriousness, and that the lack of legal representation has been identified as being associated with more severe sanctions outcomes in fitness to practise cases, stating:

“Legal representation was seen as important by participants because legal advice could support and guide registrants through the FtP process, which is complex and legalistic. Legal advice was seen as important in aiding registrants to understand regulators’ expectations, especially in terms of the need for registrants to demonstrate insight and perhaps to show evidence of remediation activities. Lack of legal representation was, therefore, seen to potentially have an impact in terms of the seriousness of the outcome for registrants who are perhaps unaware of how to present their case to best effect.”

 A compassionate approach to legal representation

The right legal advice and representation is not just about the legalities and technicalities of a case.  Our barristers fully understand the stress and anxiety that doctors experience during prolonged GMC investigations.

We also understand that we are working with people who are anxious and worried about what investigations might mean for them, their professions and the reputations.

We never lose sight of the human aspects of FtP investigations and hearings.  We will always give an open and honest assessment of cases, but we will marry that with an approach that also supports health and care professionals through the duration of a case.

“I was not optimistic about the case, I felt that it is a lost case that we couldn’t do much about and especially just before the start of the trial I lost my confidence and was very nervous. Mr McCaffrey was there to prove me wrong. He turned everything around in a victorious , panegyric manner. I was stunned.” – CL

Catherine is professional, empathic and very knowledgeable. She provided all the necessary assistance throughout the long thorough investigation. – AR

A colleague recommended me to Catherine. She was very experienced , professional, empathetic , non-judgemental and listened to me. – Mel

I found myself consumed with dark thoughts, isolated and afraid. Stephen worked with me and slowly but surely formulated a plan not to just to fight my case and win, but to build me back up bit by bit so as to prepare me to face external scrutiny and present with confidence to panels where this was necessary. – FJ

What you can Expect when Instructing Kings View

All clients are entitled to an initial, no obligation and free telephone consultation about their case.  During this consultation, we will outline the stages and next steps, including indicative timeframes and fixed price quotations for preparation and representation and confirmed in writing at each and every stage.

We understand that timescales are entirely dependent on the stage you are at in proceedings, what work needs to be done and dictated by internal investigations or hearing dates.  We always meet those timescales however should more time be needed, then we will apply for such on your behalf and with your permission.

Contact us today for a no obligation and free telephone consultation about your case in the knowledge that you are speaking to one of the best in the business.

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.