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PDA concerned about ‘unsustainable record volumes of concerns’ received by the GPhC

The General Pharmaceutical Council (GPhC) will be meeting on Thursday 17 July 2025. One of the items that will be brought to the Council’s attention will be the record number of concerns it is receiving.

Wed 16th July 2025 The PDA

According to the published papers ahead of the meeting, Council will be informed that, “The volume of concerns received by the GPhC is unsustainable and wholly disproportionate to the number of pharmacists and pharmacy technicians that we register.”

The GPhC states that 93% of reported concerns are closed at the initial assessment stage with more than 60% of concerns originating from members of the public. This suggests that there is an issue around what is considered as being appropriate to report to a healthcare regulator.

The PDA recognises that there are many possible causes for this increase, including increased public awareness and willingness to report concerns and new and fast-growing models of pharmacy practice such as online prescribing. To address this issue, the PDA calls on the GPhC to take a pre-emptive approach, including through strengthening the quality and scope of pharmacy premises inspections.

The PDA has long called for there to be a greater balance between the regulation of individuals and that of the pharmacy premises, as systemic issues and inadequate working conditions could potentially increase the likelihood of a complaint being made about the responsible pharmacist. In its response to a Freedom of Information request made by the PDA in 2018, the GPhC said, “We do not draft allegations of a failure to comply with the Standards for Registered Pharmacies in fitness to practise cases against a registrant. It is not the failure to comply by itself which amounts to misconduct but the actual mischief of the registrant involved i.e. the act or omission. There will be cases which involve poor practice within the pharmacy but these are not captured as a failure to comply with the Standards for Registered Pharmacies. There is therefore no data to provide in response to this question.”

The PDA has regularly published information and articles to highlight its concerns around pharmacy premises inspections and the focus on individuals rather than on the systems and processes (including staffing levels) within which pharmacists practice.

Sir Liam Donaldson, in his seminal report following the Shipman Inquiry, ‘Good doctors, safer patients’ observed, “Indeed, the level of harm arising from error in unsafe systems versus unsafe doctors is several orders of magnitude higher”

This situation is not unique to doctors and whilst it is often easier to blame or find fault with individuals, the role of the system and those in charge of the system is often not considered or understood by those investigating concerns.

The number of pharmacy premises inspections has declined significantly in recent years. In the year to March 2018 the GPhC conducted over 4,000 pharmacy inspections. In the year to March 2025 this had reduced further to around 1,430 inspections.

It should be noted that included in this 1,430 are re-inspections, desktop inspections and what were previously known as ‘assurance visits’ and which are now termed Inspections (assurance visits were not counted as Inspections previously).

The PDA estimates that the likelihood of a pharmacy being inspected now stands at once every 12-15 years. Prior to 2018 a pharmacy would have been inspected at least once every five years. The PDA published comprehensive data about this issue in June 2024.

Similarly,  in July 2022, the PDA published its concerns about ‘light touch premises inspections’. An update article published in January 2023 showed that the quality of inspections was still a cause of significant concern.

The PDA believes that more emphasis is needed within the pharmacy premises standards and inspection process to address systemic risks that could affect individual pharmacist performance such as;

  • Workforce pressures and staffing
  • Organisational culture, and
  • Support systems for clinicians under stress.

At the July 2025 GPhC meeting, the Council will be informed that the GPhC is working to, “…develop a feasibility option and pilot for an independent complaint handling service as a means of diverting low level concerns about our registrants to a more appropriate service.”

The PDA urges the GPhC to investigate the root causes of the record number of concerns received and consider how the inspection regime could be improved to ensure that concerns are raised appropriately. This could include;

  1. Strengthening systemic inspections to identify and mitigate risks before they lead to complaints.
  2. Information for the public on what type of complaints the GPhC can address.
  3. Introducing a triage system that filters out legally motivated but clinically irrelevant concerns.
  4. Ensuring that premises standards include the requirement for robust and thorough complaints handling procedures to ensure that patient and public concerns are resolved or escalated appropriately.
  5. Collaborating with legal bodies to ensure that claims are grounded in genuine patient safety issues, not opportunistic litigation.

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