The healthcare super-regulator has escalated concerns over the time it is taking the General Pharmaceutical Council (GPhC) to deal with fitness to practise cases (FtP) to the government.

While the Professional Standards Authority (PSA) recognised the GPhC had made some improvements around its handling of FtP cases, it said it had serious concerns over the timeliness of its investigations.

And this is now the fifth year in a row that the pharmacy regulator has failed to meet the PSA’s requirement for FtP timeliness – Standard 15.

Following the PSA’s review, which was published today, the GPhC assured that resolving FtP cases in a timely way was an ‘absolute priority’ and it committed to making improvements in this area.

The GPhC met all 17 of the PSA’s other standards, such as those relating to education, training and registration, including two which it had not passed the previous year.

‘Serious and ongoing’ delays to FtP cases

In today’s report, the PSA confirmed it has escalated concerns to the Department of Health and Social Care (DHSC) regarding ‘serious’ and ‘ongoing’ delays to the time taken by the GPhC to process FtP cases, and an increasing number of open older cases.

The PSA said that it has had concerns ‘in recent years’ about the time that the GPhC takes to deal with FtP cases, and that the position had not improved in the period from 1 July 2022 to 30 June 2023.

‘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’s most recent review stated.

And it said that due to ‘the serious and ongoing delays’, it had concluded that the pharmacy regulator had not met its standard related to the timeliness of processing FtP cases.

‘As this is the fifth year in a row that the GPhC has not met our Standard for timeliness in fitness to practise, we have taken action under our escalation policy,’ the PSA said.

It added that it had written to the secretary of state for health and social care and the Health and Social Care Committee to raise its concerns, and would monitor the GPhC’s work to improve its performance in this area.

According to the PSA’s report, in 2022/23 the GPhC had 77 FtP cases that had been open for at least 156 weeks; 103 that had been open for between 104 and 155 weeks; and 250 cases that had been open for between a year and 103 weeks.

This was significantly more than the previous year, and follows a steady increase since 2019.

The report also highlighted that this year, the number of FtP complaints received by the GPhC had increased by over a third, from 3,080 in 2021/22 to 4,178 in 2022/23.

It said that this was driven by ‘a sharp increase in concerns raised by members of the public’.

The GPhC said that was linked to increased pressures on frontline pharmacies, limited resources and pharmacist shortages, as well as instances of supply chain disruption.

The PSA had previously raised concerns relating to FtP cases, including timeliness, transparency and clarity of the initial assessment and investigation process, decision-making, ensuring parties were supported to participate in the process and the way risk assessments were documented.

But this year’s report found that the GPhC had made improvements to meet all of the PSA’s other standards.

GPhC ‘fully committed’ to regaining Standard 15

Duncan Rudkin, chief executive of the GPhC, Duncan Rudkin, acknowledged it still had work to do regarding FtP.

‘It is an absolute priority for everyone at the General Pharmaceutical Council to resolve our fitness to practise cases in a timely way, first and foremost to protect the public through responding to the concerns of the public and patients, to ensure fairness and transparency to registrants, and to meet the PSA’s Standards of Good Regulation,’ he said.

And he said that the GPhC remained confident in its ability to ‘take swift effective action where risk of harm is elevated’.

‘We are assured that the issues relating to timeliness do not represent a risk to patient and public safety,’ he added.

And he said that the GPhC had put in place and was implementing ‘a comprehensive action plan’ to deliver improvements in its FtP work.

‘As a result of this action plan, this year we have successfully regained two out of three previously unmet standards. This was a result of a sustained programme of work, with clear recognition from the PSA in the lead up to this outcome that embedding change takes time,’ Mr Rudkin said.

And he added that the GPhC remained ‘fully committed’ to regaining the timeliness standard.

‘We have a dedicated cross-organisational programme of work in place to achieve this outcome, and our Council is monitoring progress closely,’ Mr Rudkin said.