Pharmaceutical Regulator’s Fitness to Practise Concerns

06 October 2022

For the third year running the General Pharmaceutical Council (GPhC) – charged with the responsibility of regulating pharmacists and pharmacies – has failed to meet three of the Standards of Good Regulation laid down by the Professional Standards Authority (PSA).

Concerns about the GPhC’s fitness to practise function were raised in 2018/19 and since then the Authority has been monitoring how the regulator is working to address them. This year it completed its action plan and launched a new fitness to practise strategy.

Last year the PSA’s escalation process was triggered because the GPhC had not met the same standards for three consecutive years.

For the period 1 March 2021 to 30 June 2022 it met only 2 out of 5 of the important fitness to practise standards. It failed to meet standards 15, 16 and 18.[1]

The PSA reports that the GPhC is still taking too long to progress its fitness to practise investigations: there were 183 cases still unresolved for between 1 and 2 years, 66 still unresolved for between 2 and 3 years, and 49 still unresolved after 3 years. The number of older cases had increased this  year despite an initial improvement in the first quarter of the financial year.

Recognising that it needs to improve the timeliness of case progression, the GPhC introduced several initiatives aimed at doing so including:

• Recruiting additional case officers and using additional administrative support to enable case officers to focus on progressing cases;
• Using external law firms to provide direction on complex cases;
• Completing an analysis to aid more accurate forecasting.

The PSA welcomed the GPhC’s commitment to further work planned to improve timeliness. But it has been concerned about the GPhC’s documenting of risk assessments for a number of years, although the regulator accepts its risk assessments need improvement and is taking steps to do so. Among them it has delivered training to its investigation teams on risk assessments and on giving good reasons.

The GPhC also continues to improve the support it provides to those involved in the fitness to practise process since the last report in 2018/2019. It has implemented a range of changes to improve customer service, including the launch of its new fitness to practise strategy. Whilst some improvements were observed last year, some of the PSA’s concerns remain.

Following so closely on a PSA report which declared that the Nursing and Midwifery Council had failed to meet its standard for timeliness in fitness to practise cases for the third year in a row, the pressure is growing on some healthcare regulators to improve their performance in the interests of both public protection and the welfare of their own registrants who have to suffer the mental anguish of lengthy unresolved investigations.

[1] Standard 15: The regulator’s process for examining and investigating cases is fair, proportionate, deals with cases as quickly as is consistent with fair resolution of the case and ensures that appropriate evidence is available to support decision-makers to reach a fair decision that protects the public at each stage of the process.  Standard 16: The regulator ensures that all decisions are made in accordance with its processes, are proportionate, consistent and fair, take account of the statutory objectives, the regulator’s standards and the relevant case law and prioritise patient and service user safety. Standard 18: All parties to a complaint are supported to participate effectively in the process.