Online Pharmacies and Prescribing and Fitness to Practise Implications

There is significant attention and interest from the General Pharmaceutical Council (GPhC) in online pharmacies. Since 2019, the GPhC has taken enforcement action against numerous pharmacy owners and superintendent pharmacists for alleged failings of its standards for online pharmacies and prescribing.

Sanctions can be severe where a pharmacist’s fitness to practise is found impaired. It is important that pharmacists understand the GPhC’s standards to avoid sanctions.

GPhC & Online Pharmacies

The GPhC acknowledge that “increasingly people are choosing to access healthcare services online” that can hold “significant benefits” but “there are also significant risks that need to be managed to protect patient safety.”

In response, the GPhC has drawn up standards for registered pharmacies and guidance for registered pharmacies providing pharmacy services at a distance, including on the internet.

Pharmacy owners and superintendent pharmacists must follow the standards and guidance and ensure all staff have been trained on these requirements. We have provided an overview of the standards on Kings View Resolutions.

The common themes in these cases include:

medicines being prescribed to patients on the basis of an online questionnaire alone, with no direct interaction between the prescriber and either the patient or their GP
prescribing of high-risk medications or medications which require monitoring without adequate safeguards
prescribing of medicines outside the prescriber’s scope of practice
high volumes of prescriptions being issued by the prescriber in short periods of time.

Enforcement action against online pharmacies

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.”

GPhC enforcement action since April 2019[1]:

680 inspections of online pharmacies and only 72% met all standards
54 distinct online pharmacies to address patient safety risks; this includes 57 conditions notices and 12 improvement notices
there have been 1985 concerns related to online pharmacies raised to Fitness to Practise
currently 263 open online Fitness to Practise cases, which represents over 18% of its open caseload
10 registrants who are subject to an interim orders who were working in 5 different online pharmacies where concerns have been raised.

Interim orders allow for a pharmacist to be suspended or made subject to conditions at work, whilst the investigation is carried out. The interim order will be recorded on the register and will remain there for the duration of the order.

GPhC registered pharmacies, enforcement and 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).

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

[1] https://www.pharmacyregulation.org/news/bbc-news-investigation-safety-checks-online-pharmacies-carry-out-when-selling-prescription-only

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.