Record number of fitness-to-practise cases creates ‘increased risk’ of missing patient safety threats, regulator warns

The pharmacy regulator has raised concerns over an increased risk that it will fail to act on information “indicating an immediate threat to patient safety” because of a backlog in fitness-to-practise (FtP) concerns.

Council papers for the 9 November 2023 meeting of the General Pharmaceutical Council (GPhC) show that there were 1,373 FtP concerns raised with the regulator between July and September 2023.

The regulator had previously reported its highest quarterly number of FtP concerns between July and September 2022, at 1,118 concerns.

The papers describe the current level of concerns as “historically unprecedented” and say that this has resulted in only 13% of new FtP cases being triaged within a five-day key performance indicator.

“Whilst more cases were triaged this quarter, record levels of concerns were received (at 1,373),” the papers say, adding that “at the end of quarter 2 there were 980 concerns open at initial assessment”.

“Council should also be aware that with a backlog at triage there is an increased corporate risk that we fail to act on information indicating an immediate threat to patient safety quickly.”

According to the papers, the GPhC is undertaking “periodic reviews” of FtP cases waiting for allocation “to see if there are any obvious high-risk cases and, additionally, new concerns are given a quick review when received”.

“Where any potentially serious issues are identified, these are prioritised, rather than being dealt with in date order,” the papers say.

In September 2023, the Professional Standards Authority (PSA), which regulates the GPhC, wrote to both Steve Barclay, the health secretary, and Steve Brine, chair of the House of Commons Health and Social Care Committee, after the GPhC failed to meet a PSA standard on FtP timeliness for the fifth year in a row.

In a statement published alongside its annual review of the GPhC’s performance in September 2023, the PSA said that the GPhC had taken steps to improve its FtP performance, but warned: “However, we still have concerns about the time it takes the GPhC to deal with FtP cases.”

The November GPhC council papers say that there have been “some important and continued improvements in productivity at all stages of the fitness to practise process”.

“This is important as it means the caseload is starting to be moved along in greater volumes,” they add.

The GPhC has set itself a target of making at least 201 “decisions”, which includes referring cases to the next stage of the FtP process, as well as closing cases, each quarter.

The council papers say that the regulator has made a “step change” towards achieving this in the second quarter of 2023/2024, with 149 decisions made between July and September 2023, compared with 114 decisions the previous quarter.