Is the General Pharmaceutical Council making progress to improve its fitness-to-practise processes?

In June 2024, the General Pharmaceutical Council (GPhC) reported yet another “record high” in the number of fitness-to-practise (FtP) concerns it received within a three-month period.

The 1,423 concerns the regulator received between January and March 2024 brought the final total for 2023/2024 to 5,477 concerns. This was a 31% year-on-year increase from 2022/2023, when 4,178 concerns were submitted, and a 78% increase from 2021/2022, during which there were 3,080 concerns received.

The GPhC, which regulates pharmacies, pharmacists and pharmacy technicians across Great Britain, has attributed its growing inbox of concerns to increased pressures on front line pharmacies, coupled with limited resources, pharmacist shortages and medicine supply chain disruptions.

“Most healthcare regulators have noticed a significant increase in the volume of concerns received post COVID-19, and the GPhC was no exception,” a spokesperson for the regulator tells The Pharmaceutical Journal. “Since 2018/2019, we have seen a 105% increase in the volume of concerns received.”

The rapid growth in the online prescribing market has also been a significant contributor and “an unprecedented challenge”, the GPhC says, with FtP concerns associated with this sector more than doubling between 2020 and 2024. Obtaining data from these business owners can require court orders, adding to the time and complexity of these cases.  

A growing backlog 

These increases have left the GPhC struggling with a backlog of complaints, with some FtP investigations lasting for more than three years.

As a result, such delays to the FtP process “may present risks in terms of public protection, can have negative impacts on complainants and registrants, and affect public confidence in the regulatory system”, the Professional Standards Authority (PSA) warns.

The PSA — an independent regulator that sets standards for all UK health regulators, which are reviewed annually — has failed the GPhC on its standard for dealing with FtP cases in a “timely manner” for five years in a row.

The regulator was first failed by the PSA for its FtP processes in 2018/2019 and, in the years since, the backlog has only worsened.

The PSA’s most recent annual performance review of the GPhC, published in September 2023, included data on the number of open FtP cases that were more than 52 weeks old up to 2022/2023. In 2018/2019 — the first year the GPhC failed the timeliness standard — there were 155 cases that had been open for 52 weeks, while in 2022/2023 — the fifth year the regulator failed on timeliness — there were 430 cases that had been open for more than 52 weeks.

“Although the GPhC is taking steps to improve its performance, it is still taking too long to progress cases through the system, and the number of open older cases has increased,” the PSA said in the report.

At the time, the PSA wrote to then health secretary Steve Barclay to raise its concerns, describing the “serious and ongoing delays”, and said it would “monitor the GPhC’s work to improve its performance in this area”.

Since then, the PSA says it has “met regularly with Department of Health and Social Care officials to discuss our oversight of the regulator and backlog concerns”.

Improving efficiency

In dealing with the backlog, the GPhC says it has “worked hard to prioritise investigations presenting the highest risk to patients while working to increase resources and train new staff” within its financial constraints.

It is targeting three areas in particular: reducing or diverting the volume of concerns being received; improving efficiencies and driving out waste during the investigation; and ensuring that FtP hearings are effective the first time and conclude within their allocated time.

This broadly covers the four stages of the FtP process: initial assessment, investigation, investigating committee and FtP committee (see Box). At each stage, the regulator decides whether to close a case or refer it to the next stage. 

In the initial stages, the GPhC is considering options for how it can “divert concerns away from the GPhC” in the first place, noting that less than 10% of all concerns it receives meet the threshold for further investigation.  

A concern filed to the GPhC will be referred for further investigation when it is deemed necessary to ensure patient safety; is in the registrant’s own interests; or is in the public interest for some other reason.

As part of the GPhC’s five-year FtP strategy, published in July 2021, it introduced pharmacy and legal professionals into investigation teams, which it says ensure a more “focused approach to proportionate investigations and enable us to close concerns that cannot meet the regulatory threshold much sooner, releasing more capacity to consider the more serious concerns”. 

In 2022/2023, the GPhC also recruited additional case officers, used additional administrative support to allow case officers to focus on progressing cases, enlisted external law firms to manage cases and carried out audits on its FtP process and decision-making framework. 

Mixed success

At each of the four stages of the FtP process, the measures taken have provided some successes — but also some persistent issues.

For example, only 17% (255) of 1,467 concerns received during the fourth quarter of 2023/2024 were triaged within its five-day objective during the initial assessment stage. 

While the GPhC says this is “far below” its 59% target, its June 2024 council papers reported that the overall average time it takes to triage a concern decreased in quarter four of 2023/2024 to 12 days from 18 days in quarter three. 

Once a concern is investigated, a decision will be taken on whether it needs to go to the investigating committee for further review by its pool of decision-makers at the investigation stage (see Box). The GPhC has reported an increase in the number of cases closed or referred to the investigating committee, from a total of 244 in 2022/2023 to 392 in 2023/2024.

But, again, the regulator’s objective was missed in more cases than not in the last few months of 2023/2024. Only 35% (32) of 92 cases were closed within its ten-month objective before the investigating committee stage, down from 42% of cases during the previous quarter. 

More cases are reaching the end of the FtP process year-on-year, however, with the GPhC reporting that 69 substantive FtP hearings concluded in 2023/2024, compared with 39 hearings in 2022/2023. 

Closing cases at the investigating committee and FtP committee stages are challenging, owing to “the ‘legacy age profile’ of cases in this cohort”, the GPhC says. 

“This is likely to remain the position until at least quarter three 2024/2025 when we anticipate all cases to be through the investigating committee and the vast majority through the FtP committee, where appropriate.”

In an interview with The Pharmaceutical Journal, published in April 2024, Roz Gittins, chief pharmacy officer at the GPhC, said that 2025 “looks far more realistic” for the regulator to meet its timeliness standard.

Supporting pharmacists

An expedited FtP process cannot come quick enough. James Davies, director for England at the Royal Pharmaceutical Society (RPS), says the Society’s support team has seen a rise in contacts from members involved in FtP cases during the period that the GPhC failed to meet the PSA’s FtP timeliness standard.

“Between 2021 and 2024, the number of calls from members involved in FtP cases seeking advice has increased, including several members expressing frustration with the timescales for resolving these cases,” he says.

“We know from engaging with [RPS] members that lengthy FtP cases are a huge burden, negatively impacting their careers, reputations and wellbeing. 

“Whilst we recognise that the GPhC alone cannot support pharmacists’ mental health and wellbeing, it could do more,” he says.

Davies adds that the RPS would like to see better transparency in the handling of each case, more efforts to reduce delays and better communication with those undergoing the process. 

The GPhC says it offers an independent support service, which is provided by Victim Support, for pharmacists going through the FtP process and that it uses the services of advocacy charity PoWHER where required.

“We also work closely with the charity Pharmacist Support and refer to them where we consider they are best placed to help,” it adds.

Danielle Hunt, chief executive of Pharmacist Support, says the charity has not received an increase in enquiries relating to FtP in the past five years.

“We average at about five enquiries per month that are directly related to FtP,” she says.

Nevertheless, she says: “Anything the GPhC can to do improve timelines is more than welcome.” 

The GPhC says it is seeing “very positive signs” from the measures it has put in place. 

“The very nature of enforcement work, including the statutory timescales required to ensure a fair process is followed, means that it can take some months before the benefits of these changes are seen but we are confident that the tide has changed.”