Shutterstock.com
The General Pharmaceutical Council (GPhC) has said it will prioritise first inspections of online pharmacies within six months of registration, while extending this target to within 12 months for bricks-and-mortar pharmacies from January 2025.
In papers discussed at a GPhC council meeting on 12 December 2024, the regulator said: “We are… proposing that first inspections be prioritised within 12 months of registration based on a pharmacy’s risk profile or within six months for online pharmacies.”
This is owing to an “observed difference in compliance rates”, it added.
Following the meeting, the GPhC said in a statement on 13 December 2024 that the changes would be implemented in January 2025.
According to GPhC data, fewer pharmacies with online services have met all standards at their first inspection — 66% of online pharmacies compared with 90% of traditional pharmacies.
“Although the numbers are small, pharmacies with online services have an even steeper drop off in performance the larger the gap between initial registration and first inspection,” the papers said.
Under the current system, a full on-site first inspection of a new pharmacy — which includes when a pharmacy changes premises, even if it was previously registered — must be conducted at six months.
The papers added that the process “takes significant time and resource, and in many cases the only material differences from the previous registration are the premises themselves, which the inspector will have already visited as part of the registration process”.
Extending this to 12 months for non-online pharmacies “increases our capacity to conduct first inspections of riskier services and gives increased flexibility to respond to risk and information of concern”, the GPhC said.
For a non-online pharmacy, an inspector will determine during the registration inspection whether the first inspection should be conducted before 12 months, based on known information about the pharmacy and the type of services being provided.
One further recommendation was that inspectors could defer first inspection for up to two years or conduct a visual inspection remotely when a new registration consists of a change of address only.
The GPhC said inspectors would retain the ability to conduct an on-site inspection “where this was felt necessary, for example if the pharmacy has a poor regulatory history or any issues of concern were identified during the registration process, for example planned future changes to services or the layout of the premises”.
In June 2024, there were 175 premises on the register that had never had a routine inspection, a figure which has since fallen to 99 premises “owing to targeted efforts to prioritise these inspections”, the GPhC said.
Commenting on the changes, Roz Gittins, chief pharmacy officer at the GPhC, said: “Updating the inspections process means we can be more targeted, focusing on areas of higher risk, and the key standards for patient safety.”
This will allow the regulator to carry out more inspections “as efficiently as possible”, she added.
In 2022, The Pharmaceutical Journal reported that online pharmacies were eight times more likely than bricks-and-mortar pharmacies to fail on GPhC regulatory standards.
In February 2024, the GPhC said it was considering using ‘mystery shoppers’ to monitor online pharmacies.
Analysis of GPhC inspection reports revealed that 28 (21.7%) of the 129 ‘distance-selling’ pharmacies that had been inspected between April 2019 and March 2022 failed to meet at least one of the five regulatory standards following their most recent inspection.
This figure was in comparison to 75 (2.6%) of the 2,808 high street pharmacies that were inspected over the same period.
Also at its December 2024 meeting, the GPhC approved plans to introduce an annual survey of pharmacy students and foundation trainees, asking for their views on the quality of their education and training.
In a statement published on 13 December 2024, the regulator said the survey was part of proposed enhancements to the quality assurance of education and training, which followed a consultation, held between April and June 2024 — the proposed enhancements originally included plans for annual monitoring of pharmacy education and training providers.
In its December 2024 council papers, the GPhC said that “after careful consideration, we have moved closer towards the need for flexibility and away from blanket yearly monitoring”.
Commenting on the announcement, Gareth Nickless, programme leader for the postgraduate diploma in clinical pharmacy for secondary and tertiary care at Liverpool John Moores University, said the annual survey “would allow the GPhC to compare performance of different [higher education institutions] in perceived teaching quality and help evaluate variation in training delivered by organisations providing trainee pharmacist placements”.
“I would encourage the GPhC to triangulate the results of these surveys with performance in the registration examination to identify the extent to which teaching and training quality affects this,” he added.
