The General Pharmaceutical Council has been accused of lacking regulatory focus on pharmacy employers, particularly the big corporate players. Allegations of staffing pressures at Boots did little to allay that concern. Neil Trainis reports…


It was back in December when we got a sense of how serious the General Pharmaceutical Council (GPhC) took the impact of working conditions in pharmacies on patient safety.

Among many well-known faces from the world of pharmacy and politics gathered at the House of Commons for the Pharmacists’ Defence Associations’ (PDA) launch of it’s A Safer Pharmacies Charter was Duncan Rudkin (left) and Nigel Clarke (centre), the chief executive and chairman of the GPhC respectively who watched on with interest.

There they stood as the charter was unveiled. It laid out a series of commitments; ensuring there is an independent second accuracy check of a medicine by a trained member of staff once it has been dispensed, that all staff are trained and competent to carry out pharmacy work and that patients have access to a pharmacist so they receive face-to-face expert advice on any medicines-related matter.

It also called for pharmacists to be able to take statutory and contractual rest breaks “and additional breaks as required to meet their professional obligations” and for pharmacists’ professional autonomy not to be hindered by organisational and other targets. That one was made no doubt with allegations that MURs had been commercially driven at Boots still fresh in the mind. And very raw.

Another commitment was for pharmacists to be able to raise concerns without any fear of reprisals and be physically safe while working in the pharmacy – “a zero-tolerance approach will be taken to violence or abuse of pharmacists and other pharmacy staff,” the PDA said.

The presence of Rudkin and Clarke at the launch raised some eyebrows. “It shows you just how serious the GPhC are taking this. They are both here,” one onlooker observed. The PDA had a point to make that day. It wanted pharmacy’s regulator to up its game when it came to work-based pressures. That meant improving its regulation of pharmacy employers.

PDA chairman Mark Koziol (right), who insisted his organisation was keen to work with the GPhC to realise the ambitions set out in the charter, did not mince his words. Why, he asked, should pharmacy tolerate working conditions that could force errors from pharmacists – the type of errors the GPhC would be quick to punish – and imperil patients’ safety?

“If your mother was going into an operating theatre and you were told that the anaesthetist was on holiday but no arrangements had been made to secure a replacement, you would be very angry,” he said.

“If you were also told that a third of the operating staff would be working in accident and emergency because it was busier there instead but nevertheless the operation was still going ahead, you would be very, very upset.

“You wouldn’t tolerate it, the respective regulator wouldn’t allow it, so why should we tolerate this or similar in pharmacy?

“Why should we tolerate key members of dispensary staff being redeployed to the checkout? Why should we expect the pharmacist to work eight or 10 hours, sometimes even more, with-out any rest breaks whatsoever?”

They were pertinent questions. And Koziol would go on to make some rather pertinent points. While the number of prescriptions was growing, resources were shrinking, he said. Staffing levels were being reduced and “targets to sell items or hit commercial imperatives often forcibly imposed.”

This environment could not cultivate good working practices and it could not improve patient safety. Quite the opposite. The consequences would be severe. Koziol went on.

“And as soon as that service starts to break down mistakes may not be picked up and patients may endure harm. Pharmacists joined their vocation because they wanted to help patients but increasingly they are working in a system which they know can be sub-optimal, forced to work in a way where they must start to make decisions about perhaps taking shortcuts in safety procedures.

“This potentially exposes the public to unnecessary risk and places an intolerable burden on the mental health of pharmacists because they know they can put patients in harm’s way. Surely it shouldn’t be like this.”

It was certainly not supposed to be like this. Koziol would go on to say: “As healthcare professionals we all know that it is far more important to focus on the causes than the symptoms of condition. And this is a principle we would like the GPhC to adopt. What’s the point in disciplining the pharmacist for a dispensing error if the reasons why this error occurred are not being addressed or acted upon?”

Following the launch Rudkin said the GPhC was keen to work with the PDA, although he pointed out that “the key points set out in the PDA’s charter reflect a number of the standards that we set for registered pharmacies and pharmacy professionals.”

The PDA had set out its expectations. Everything seemed clear. Then last month a BBC documentary on alleged staffing pressures at Boots highlighted the GPhC’s apparent inability to bring the big pharmacy players into line.

The PDA, which had been critical of the regulator’s tendency to focus on individual pharmacists rather than pharmacy employers and large multiple pharmacy operators, swept back into action, accusing the GPhC of failing to effectively regulate corporate pharmacy employers.

A Freedom of Information request by the PDA revealed the GPhC had not disqualified, removed, or sought to disqualify or remove, any corporate pharmacy owners from the register. Despite Boots’ insistence that it had the resources and staff to operate effectively and safely, there appeared to be good reason for the GPhC to take action. But it chose not to.

Not even a 55-page witness statement that was presented to the GPhC by Greg Lawton, a former manager at Boots who resigned over fears staffing levels at the UK’s largest pharmacy chain could jeopardise patients’ safety, could persuade pharmacy’s regulator to take action.

The GPhC said it carried out “a thorough investigation” into Lawton’s claims before concluding “there was not sufficient evidence overall to suggest a risk to patient safety across the organisation.” Three people died as a result of dispensing errors by Boots between May 2012 and November 2013.

Rudkin said: “We take the clear view that setting the right staffing levels is best done by the people responsible for managing a pharmacy on the ground, rather than by the regulator at a distance. It’s our role to provide assurance to the public that standards are met. If they are not, we take steps to ensure the necessary improvements are made.”

Koziol disagreed. As he saw it, the GPhC’s approach to staffing gave the big corporates the scope to put commercial interests before patient interests. In other words, the GPhC was part of the problem rather than the solution.

“The GPhC has stated that setting the right staffing levels is best done by the people responsible for managing a pharmacy on the ground, rather than by the regulator at a distance,” he said.

“We fundamentally disagree with this approach because patient safety must always come before commercial profits and this approach from the GPhC gives carte blanche to the corporates to do as they see fit.

“It patently introduces unacceptable conflicts of interests for pharmacy employers. The GPhC must not be allowed to side-step on this matter and distance itself from the one factor that makes the biggest difference to patients; the appropriateness of the staffing resources in the pharmacy. There are many ways in which it can become properly involved in this matter.”

The PDA charged the GPhC with “a lack of regulatory focus” on pharmacy employers, in particular those from the big pharmacy companies.

“Employers, especially the corporates, may assume that they are unlikely to get challenged by the regulator and so have little incentive to change their culture or behaviours,” the PDA said.

“In such a scenario, unacceptable workplace pressures will continue, with consequences for patients and pharmacists alike, with the national media just waiting to shine a spotlight on our profession yet again.”

The BBC documentary also called the GPhC’s powers to regulate big corporate pharmacy into question. Joy Wingfield, a pharmacy law and ethics expert, suggested: “I’d like to see the powers (the GPhC) have against corporate employers re-examined.”

The Royal Pharmaceutical Society waded into the debate. “The GPhC is accused by some of being too passive in the enforcement of regulatory standards and of becoming too dependent on organisations defining their own approach to quality improvement,” it said.

“The GPhC needs to demonstrate how they will improve the support they give pharmacists in raising public interest concerns and change the perception that nothing will change if concerns around staffing levels or other issues are raised with them. The Society is eager to work with the GPhC on behalf of the profession in any way it can to bring this change about swiftly.”

Yet despite declarations that were designed not to expose and scathe the GPhC but help it become a better regulator, there remained the sense that it was powerless to rein in pharmacy employers. The coming 12 months, it said, would bring “important new powers” allowing it to take action where justified.

“In 2018 we are expecting legislation to come into effect that will give us important new powers to publish reports from our inspections of pharmacies and to take proportionate enforcement action against pharmacies when necessary,” a GPhC spokesperson told Pharmacy Business.

“Further powers for the regulator are a matter for the government and the government is currently consulting on reforming health professional regulation. We are proactively engaged in the discussions with government and others about how regulation can best work to protect patients and support improvements in the care they receive.”

If Rudkin, Clarke at el at the GPhC are serious about improving the environment pharmacy teams work in tirelessly for the benefit of their patients, the next 12 months are significant.


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