Patient safety is increasingly at risk as most pharmacy premises will only be inspected once every 15-17 years, the Pharmacists’ Defence Association (PDA) has suggested.

In response, the GPhC told The Pharmacist that it was prioritising investigating patient safety concerns over routine scheduled inspections, adding that it was reviewing its inspection process and methodology.

In a report published last week, the PDA highlighted data from the General Pharmaceutical Council (GPhC) which showed that the number of routine pharmacy premises inspections conducted in 2023 was a quarter of what it was in 2019 – down to 878 from 2,667.

This represented approximately 6% of the total 13,805 pharmacy premises regulated by the GPhC in 2023, prompting the PDA to comment: 'At the current rate of inspections a pharmacy premises has a probability of having a "routine" inspection once every 15-17 years.'

According to the PDA, there were 3,667 routine pharmacy premises inspections in 2019, 2,892 in 2020, 276 in 2021 - although this was not representative due to Covid-19 lockdowns - 639 in 2022, and 878 in 2023.

Based on other data provided by the GPhC, the PDA estimated that 950 routine pharmacy premises inspections had taken place in 2024.

‘Pharmacy premises are becoming busier and providing ever more clinical services, so risks to patient safety will clearly increase,’ the association added.

The PDA report also highlighted a ‘significant increase’ in the number of concerns reported each year to the GPhC - climbing from 2,674 in 2019 to 4,178 in 2023.

This might be ‘related to the standards of the pharmacy premises and the actions of the pharmacy owner (for example by not providing adequate levels of support staff)’.

The PDA report also noted ‘generic’, inconsistent and ‘narrative style’ language used in GPhC inspection reports, such as: ‘The pharmacy has enough staff for the services provided.’

This meant ‘the criteria by which a GPhC inspector decides that a pharmacy has sufficient staffing is unclear’, the PDA suggested.

The PDA reiterated its ‘firm belief’ that instead of being regulated by the GPhC, pharmacy premises should be regulated by the Care Quality Commission (CQC) in England, the Care Inspectorate in Scotland and Health Inspectorate in Wales, as other health settings are.

When this was raised during the Health and Social Care Committee’s Pharmacy inquiry on 16 January 2024, GPhC chief executive Duncan Rudkin said that the regulation of pharmacy businesses 'needed to be looked at', saying that the pharmacy regulatory model was ‘designed in a different era’ and could need a creative rethink in order to be ‘right for the future’.

The PDA also raised concerns that when pharmacies repeatedly fail to meet standards ‘there seems to be no appetite to refer the persons responsible to the pharmacy through any fitness to practice process’.

And ‘pharmacy owners whose premises have repeatedly failed inspections are not prohibited from acquiring even more pharmacy premises’, the PDA suggested.

The PDA also said that some GPhC reports seem to indicate that standards were now reported as being met that had not been met previously, despite the issues seeming to be ongoing.

And it warned that in a ‘considerable number’ of GPhC premises inspection reports, near-misses and ‘dispensing incidents are not recorded, not acted upon and staff have limited access to record or learn from errors’.

It also said that inadequate staffing was suggested in the pharmacy premises inspection reports reviewed by the PDA, with staff ‘often quoted as being too busy at work to undertake necessary training and having to do it in their own time’.

This was ‘in itself is an indicator of inadequate staffing, yet all these premises met the staffing standard’, the PDA said.

And it shared comments from GPhC pharmacy premises inspection reviews that had met the staffing standard, including a pharmacy team reporting that due to ‘heightened pressure’ they ‘did not always follow the company’s operational guidance that supported its SOPs when completing tasks’; a pharmacy that was ‘around 10 days behind with the workload’; and one branch that had ‘a member of the store team’ working on the medicines counter who ‘had not received any pharmacy training but had read the SOPs.’

Responding to the PDA's report, Roz Gittins, chief pharmacy officer at the GPhC, said the regulator was 'currently carrying out an end-to-end review of the inspection process' and associated methodology, to ensure that it was 'having the most impact to drive improvement across the sector'.

'We will be using our findings to deploy a more risk-based methodology to ensure we target the areas that may impact patient safety the most. We are refocusing our efforts on inspections and stopping assurance calls which were a useful tool to support pharmacies during the Covid-19 pandemic and the aftermath,' she said.

'We will continue to respond to information which raises patient safety concerns and these inspections will remain our priority over and above any routine scheduled inspection activity to ensure patient safety.'