The General Pharmaceutical Council has said online pharmacies are to receive their first routine inspections within six months of opening while inspectors will take a ‘risk-based’ approach to deciding when a new bricks-and-mortar pharmacy must be visited.

In an update on its inspection methodology published ahead of a council meeting this Thursday (December 12), the GPhC said 66 per cent of online pharmacies are meeting all standards at their first routine inspection, compared to 90 per cent of patient-facing premises.

“We are therefore 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,” said the regulator as it announced a move away from the current system whereby it aims to visit all new pharmacies within six months.

The GPhC said: “Under the current system, a full on-site first inspection must be conducted at six months. This 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.

“We are therefore proposing that where a new registration consists of a change of address only, the inspector will risk assess the new registration and may choose to defer the first inspection for up to two years (based on time since last inspection) or conduct a visual inspection of the premises remotely, for example by video call.

“The inspector would still 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.”

The GPhC said data from random sampling between June 2022 and September this year showed that there was little difference in the performance of 535 pharmacies that had been inspected in the last five years and 931 that had not received a non-routine inspection for over five years, with these groups respectively passing 92 per cent and 90 per cent of the time.

However, just 68 per cent of 19 pharmacies from the random sample had passed their first routine inspection. The poor performance of online pharmacies appears to have had an outsize impact on this figure.

As a result, the GPhC also plans to drop its “fixed frequency” approach to routine inspections and instead work to ensure that “a fixed proportion of the oldest last inspected pharmacies are included in every sample”.

The regulator said that “in terms of the impact of our regulatory interventions, the first inspection has a greater positive impact in ensuring safety and driving improvement”.

“There is a clear trend that as time between registration and first routine inspection increases, the percentage of pharmacies meeting all standards reduces,” it added.

The GPhC said there are currently 99 registered pharmacies that have never had a routine inspection, down from 175 in June.