The General Pharmaceutical Council (GPhC) is consulting on its approach to pharmacy regulation including publishing inspection reports and conducting unannounced inspections of pharmacies. But not everyone is convinced as Neil Trainis discovers…

 

Although the independent regulator for pharmacists, pharmacy technicians and pharmacy premises in the UK has at times failed to get it right, there was something quite progressive about its latest stab at regulation.

For the first time ever, the public will be able to see if pharmacies in the UK are meeting standards after the GPhC was given the power – or to give it its real name, The Pharmacy (Premises Standards, Information Obligations, etc.) Order 2016 (Commencement) (England, Wales and Scotland) Order of Council 2018 – to publish its inspection reports.

Not a moment too soon, you may concur. NHS bosses seek to place the patient at the heart of their own healthcare, so what better than to put the pharmacy consumer at the centre of what goes on inside their trusty local community pharmacy on a daily basis.

The GPhC is consulting on this and five other key proposals which it believes will make it a more effective regulator. The consultation was due to end on August 9.

Other plans under consideration include introducing three types of inspection – routine, intelligence-led and themed inspections – changing inspection outcomes, requiring all standards to be met to receive an overall ‘standards met’ outcome and sharing examples of notable practice which would be published in an online “knowledge hub.”

Then there is the proposal to move to unannounced inspections which has fanned the flames of controversy more than all the other proposals. Yet it was the unprecedented publication of inspection reports that caught the imagination.

GPhC chief executive Duncan Rudkin said he hoped it would “provide greater assurance to patients and the public that registered pharmacies are meeting the standards for providing safe and effective pharmacy services.”

What do the pharmacy bodies think?
Paul Day at the Pharmacists’ Defence Association told Pharmacy Business: “We believe this has the potential to make the process more open and transparent to the public and profession.”

Day, however, said it was important the GPhC include details of public interest matters in its reports such as staffing levels, the ability of staff to raise concerns, the professional judgement of staff and the impact of corporate incentives or targets on health.

“The new approach may also allow for bench-marking which has not been possible in the past and will potentially be a useful source of information for owners and pharmacists wanting to improve their practice,” he said.

Numark’s director of marketing Mandeep Mudhar was similarly supportive of a move to publicise inspection reports, insisting: “It is positive as it gives patients reassurance that pharmacies are inspected to a rigorous standard, that they receive high levels of care through a professional setting.

“This has always been the case but now gives patients additional assurance no different to reports they see in other healthcare and public office professions.”

Leyla Hannbeck, chief pharmacist at the National Pharmacy Association, said: “There are many exceptional pharmacies that are not properly recognised under the current system. Positive inspection reports can help showcase the pharmacy profession to the NHS and commissioners.

“Under the current inspection regime however, this has become difficult so a more clear and consistent process is needed.”

What do patients think?
The Patients Association chief executive Rachel Power said publication of inspection reports would give the public “confidence and reassurance” that standards in pharmacies are being met.

“Patients turn to pharmacists for many essential aspects of their care, from dispensing medications to monitoring aspects of their health,” she said.

“Because pharmacists are often the first port of call for patients seeking medical information and advice, it is important that members of the public have full confidence in the level of care and services provided by these healthcare professionals.

“The news that inspection reports will be published will provide confidence and reassurance to patients that registered pharmacies in their local areas are meeting the standards for providing safe and effective services.”

What does the community pharmacist think?

Amish Patel, the owner of Hodgson Pharmacy in Kent, also approved of publication, saying: “Publishing of results would bring us in line with other healthcare organisations, namely those inspected by the Care Quality Commission. My main concern is the consistency and quality of inspections and the terminology used to describe inspection results.”

Patel, however, was not keen on unannounced inspections, suggesting they would disrupt the pharmacy. The GPhC on the other hand believes they are necessary to ensure its inspections capture what really goes on inside the pharmacy and not any pretence or temporary amelioration of the reality.

There is a strong sense that most people within pharmacy do not favour unannounced inspections nor do they agree with the GPhC’s rationale for them.

“Inspections are always a disruption to a busy pharmacy. Although we get a letter notifying us of an upcoming inspection, we never know exactly when an inspector is coming. Therefore, I feel this makes little difference,” Patel said.

Graham Phillips, the owner of Manor Pharmacy Group, said: “The whole thing is a bureaucratic nightmare and yet another distraction from patient care and has tied my team in knots! So much for the ‘red tape challenge.’”

Mudhar said: “This may present a challenge as it’s not only disruption to a busy pharmacy but also making sure the owner is in on the day and it’s not their day off otherwise the inspection is not a fair reflection.

“But our members also tell us that the inspection process is time consuming and requires their undivided attention in liaising with the inspector. Patient safety and patients seeking advice could then be compromised as the pharmacist’s attention is on the inspection process. Some advance notice would help in mitigating against this.”

And yet there was some support for unannounced inspections.

“We believe this is the right approach,” Day said. “Announced visits have potentially allowed some owners time to make temporary changes and display a non-typical view of their premises during inspection visits.

“We know some multiples provide pharmacists with scripted answers to inspection questions. While there is value in helping colleagues respond to inspections, it’s important that answers also reflect the day-to-day situation on the ground and not just a pre-determined view of how things should be designed in head office.

“One of the large multiples recently conducted an exercise in which the answers pharmacists would give to sample GPhC inspection questions were checked and validated by senior managers. The company logged the ‘approved’ answers using a form on its intranet.”

Unannounced inspections are nothing new of course. They have been on the agenda for quite some time. In an interview with this magazine four years ago, GPhC chairman Nigel Clarke got hot under the collar when it was suggested the regulator was trying to catch pharmacists out with surprise inspections as part of its prototype inspection model.

“Is that accurate? It doesn’t sound right to me,” he said in 2014. “We usually write to people and say ‘we’ll be inspecting some time in the next six weeks.’ So that’s not a surprise therefore, so let’s get accuracy.”

He would go on to suggest with a palpable sense of irritation that not many pharmacists re-garded unannounced inspections as surprise inspections. Instead he insisted the response the GPhC had garnered was “largely that they find it very positive…it’s actually a very useful experience.”

On one level this seemed to illustrate how out of touch the GPhC was with pharmacy practice at ground level. Contrary to Clarke’s view, a busy, stressed community pharmacist rushed off their feet attending to the needs of their patients may very well be taken by surprise by an unannounced inspection, especially if the regulator had vaguely told them the visit would occur “some time in the next six weeks.” That would not be enough to eliminate the element of surprise.

What must be said is at least the GPhC is consulting to get a flavour of the attitudes towards unannounced inspections. What will be interesting is its reaction if the response is largely dismissive.

Let us not forget that the GPhC is also garnering views on three new types of inspection – routine, intelligence-led and themed inspections. Rudkin believes this is part of a wider set of proposals that will allow it “to be more flexible as a regulator and respond to the changing needs of patients and the public and to changes in pharmacy.”

“This will depend on whether the GPhC acts on the intelligence provided in a fair and timely fashion,” Day said.

“It currently inspects pharmacies on average once every 4.5 years so we’d like to see some improvement on that in terms of routine inspections, with additional intelligence-led and themed inspections where required.

“We should learn from other sectors and ensure that even the ‘excellent’ pharmacies are re-inspected regularly.”

When asked if the three new types of inspection would make the GPhC more responsive to information and issues within pharmacy, Mudhar said: “It should do as it can address specific themes or issues rather than a one size fits all approach. It also allows pharmacies that require more support or advice to be given this support in a better way and it allows for key themes that may affect large numbers of community pharmacies to be addressed in more specific detail.”

Patel said: “This again brings pharmacy more aligned to how other organisations are inspected. One would hope that this model makes the GPhC more responsive.”

So even before they had been able to respond to the consultation, we were brash enough to ask Day, Mudhar and Patel if they broadly agreed with the GPhC’s new approach to regulation.

“We support this move in the right direction but believe that the GPhC needs to go much further. We believe the public would expect the GPhC to have a much more rigorous approach already,” Day said.

“Since its inception in 2010, the GPhC has never issued a single sanction against a pharmacy owner for a breach of premises standards, despite identifying over 1,900 such breaches since November 2013.

“It appears that it will generally accept assurances from the pharmacy owner or superintendent that the identified issues have been resolved without revisiting the pharmacy and we think this needs to change.

“In addition, the GPhC has not proposed any changes to the standards themselves or how its inspectors go about identifying breaches at individual standard level (for example, how it identifies the adequacy of staffing levels – standard 2.1).”

Mudhar said: “Hard to tell until the new process starts. Hence this consultation is important for everyone to respond to with a view to ensuring the process is fair, supportive, puts patient safety at the forefront and is not deliberately penal or unfair to contractors.”

Patel said: “I am currently impartial. I do not feel the current approach has been perfected, so moving to a new approach seems premature. I just want to see an appropriate inspection model that actually works and is fair and consistent.”


Six key proposals on the table

A new model that includes three types of inspection: routine inspections, intelligence-led inspections and themed inspections.
Unannounced inspections to ensure they reflect whether pharmacies are meeting the standards on a daily basis.
Changing to two inspection outcomes – ‘standards met’ or ‘standards not all met’ and four possible findings at principle level – ‘standards not all met,’ ‘standards met,’ ‘good practice’ and ‘excellent practice.’
Requiring all standards to be met to receive an overall ‘standards met’ outcome – if any standard was not met, it would result in a ‘standards not all met’ outcome overall.
Publication of inspection reports and improvement action plans when relevant on a new website.
Sharing examples of notable practice and publishing examples in a ‘knowledge hub’ on the new website.

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