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.
How Kings View Resolutions can help
Drawing on over 30 years’ combined experience, we can advise businesses and organisations on their rights and how to protect themselves from reputational and financial (compensation) damage and implications.
We can assist and advise businesses on matters, including:
• Whistleblowing policies
• Working ethos and culture
• Staff training and awareness
• Regulatory advice
• Advice on how to approach and deal with internal investigations and reviews
• Advice on how to deal and interact with whistleblowers
• Advice on interrelated and associated policies and procedures
• Representation in any legal and regulatory matters arising from staff whistleblowing
Our Services
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.
