With the General Pharmaceutical Council due to start unannounced premises inspections later this year, Rachel Carter asks the sector for its opinion on the change

 

Premises inspections are hardly a relaxed affair at the best of times. But now the General Pharmaceutical Council (GPhC) has confirmed a new model, due to be rolled out in April, that will see pharmacy inspections brought in line with the inspection processes for other health professionals, such as GPs and dentists.

Duncan Rudkin, chief executive of the GPhC, has said the changes are designed to give ‘greater assurance to the public that pharmacy services are safe and effective’. But with surprise inspections from the regulator now on the horizon, how is the sector responding?

 

Unannounced visits

 

One of the key changes will be the introduction of unannounced inspections, which the regulator has said will ensure standards are being met every day, and not just when an inspector is due. Under the current model, contractors are usually sent a letter warning that they will be inspected at some point in a six-week period, without specifying a date or time.

The National Pharmacy Association (NPA), while welcoming the key principles underpinning the GPhC’s new approach, warns that unannounced visits could cause disruption and may not have the ‘desired effect’, especially if only one pharmacist is on duty at the time.

NPA policy manager Helga Mangion says the pharmacist on duty ‘might have to leave patients waiting in order to answer the inspector’s questions’, which could mean the visit ‘may become a distraction and even undermine patient safety in certain circumstances’. ‘Giving notice, as is the case currently, helps the pharmacy maintain a high level of customer service on the day, while also giving time to the inspector,’ she adds.

Nick Hunter, chief officer at Nottinghamshire local pharmaceutical committee (LPC), says that ‘from a professional perspective and thinking about patients’, he supports the change. ‘If you take schools and Ofsted, for example, a lot of work gets done in preparation for the visit. But is that measuring something artificial?’ he asks. ‘It should be a more realistic measure, so we ensure that the sector is delivering the best patient care and operating safely. I’m not suggesting we aren’t, but it’s about demonstrating that. That alone is probably enough to say it’s the right thing to do.’

But Mr Hunter adds some of his members are concerned about the changes ‘at a time when they are under massive pressure’ – a view he shares. ‘Workload is at an unprecedented high and I can imagine a GPhC inspection is the last thing on pharmacists’ minds, so they could fall foul of something minor just because they haven’t prepared,’ he says. ‘But if they’d been sent a letter, they would have stayed until 11 at night to get it sorted.’

 

Three types of inspection

 

As well as the ‘routine’ unannounced inspections of pharmacy premises, the regulator’s new approach will also include two other types of inspection – intelligence led and themed. The intelligence-led inspections will also ‘generally be unannounced’, the GPhC has said, and will be conducted in response to specific information received from other regulators or health professionals, for example, or from the public and the media.

Numark’s head of patient services, Rajshri Owen, says the organisation is in favour of this type of inspection because it will enable the GPhC to respond more quickly where ‘concerns have been raised about the operation of a pharmacy’. ‘It makes you feel that feedback, from the public for example, is acted upon – and we hope that will help further intelligence to be fed back more regularly as well,’ she says.

The themed inspections will be announced and will involve two or more inspectors, sometimes with other experts, visiting a selection of pharmacies to focus on specific issues. Two examples of inspection themes are services provided to care homes and the risk management of supplying medicines online – but the regulator has also said that some themed inspections may be undertaken in response to specific issues found in routine inspections.

Ms Owen says Numark is hopeful these inspections will help the GPhC to keep ‘a finger on the pulse’ and stay up to date with new processes, as well as ensuring safety and effectiveness.

 

Standards not met

 

The new approach will also see the existing inspections ratings system overhauled. Under the current model, pharmacies are assessed against 26 standards, grouped into five principles. They receive one of four ratings following inspection: poor; satisfactory; good or excellent.

The standards will remain the same but there will now be two overall outcomes of ‘standards met’ and ‘standards not all met’. A pharmacy must meet every standard to get the former.

Ms Owen says Numark believes the new ratings will ‘provide clarity and are less open to individual interpretation’ than the previous system. Mr Hunter agrees that the two outcomes will make it clearer for someone looking at the final report – but says the scoring is ‘worrying’ because it appears pharmacies ‘only need to fail on something relatively minor’ to receive a report stamped ‘standards not all met’. ‘How big a thing has got to be wrong to constitute an overall rating of “not all met”?’ he adds.

 

Publicly available reports

 

More detail will have to follow from the GPhC. The regulator has put together a reference group of pharmacists, superintendents and representatives from pharmacy bodies across the sector, which under the changes will be used to test and refine the operational measures. One of the topics this group has already considered, the GPhC says, is the inclusion of sensitive commercial and personal information in inspection reports – which will, for the first time, be made publicly available on a new website.

Numark’s Ms Owen says this should give the inspection process and outcomes ‘more transparency’, but adds that the organisation shares the concern it’s heard from contractors about whether they will be allowed sight of a report before it’s published.

‘This is an important concern and the GPhC needs to ensure contractors can challenge a report if they feel it doesn’t accurately reflect the inspection,’ she says. ‘Where the report is challenged and the inspection is reviewed, it’s also important that the owner can view the reviewed report before publication as well.’

Mr Hunter says he’s picked up ‘huge concerns’ about the publication of reports. But he feels comments left by patients on social media and Google ‘pose a bigger risk’ to a pharmacy’s credibility. ‘If a patient’s experience of a pharmacy is good, they’re not going to look at the GPhC report. If it’s bad they might, but I think it’s more likely that they’ll post online about it,’ he says.

‘I think there’s more worry about the changes than the reality will actually bring. We’re seeing a lot more stress in the sector and I hope pharmacists seek support and don’t let it get on top of them.’

Rachel Carter is a freelance journalist