Interview with Duncan Rudkin, GPhC

It is perhaps indicative of the general angst and uncertainty felt by many in the profession that the General Pharmaceutical Council’s decision to raise its fees – albeit by relatively small amounts – was met with howls of protest. Out of 5,409 responses to the GPhC’s fees consultation, 70 per cent disagreed with the £7 increase for pharmacists and 51 per cent with the £21 rise for registered pharmacy premises.

It would be easy for the regulator to brush away these concerns with a convenient excuse along the lines of “well, modern professional regulation is an expensive business”. However, chief executive Duncan Rudkin is sympathetic to registrants’ views, while pointing out that the fee increases were the first for several years.

“We absolutely recognise the challenging financial climate in which many of our registrants are practising. Individuals and businesses are under pressure. Our increase [in fees] is a small one, but you can see how things add up. I certainly empathise with people’s concerns.”

It may have been unpopular, but he is adamant that the increases were necessary. “Our income must ensure that we can continue to work effectively as regulator because this benefits not only patients and the public, but also registrants.”

The GPhC is looking into flexible fee options, but should it also be more vigorous in controlling its own costs? For instance, does it really need to be headquartered in Canary Wharf, among some of the most expensive real estate in the country? “We continue to challenge our cost base and will review our current accommodation as part of our annual plan for 2019-20. I doubt we will stay [in Canary Wharf] for ever because the organisation and its needs will change over time,” he says.

The GPhC’s budget for the current financial year includes a further £720,000 efficiency saving and “we will continue to improve our efficiency, effectiveness and service experience”.

Busy time

It is a busy period for pharmacy’s regulator. This year sees the second stage of the new revalidation system rolled out with pharmacists and pharmacy technicians for the first time engaging in peer discussions and reflective accounts centred on professional standards.

The GPhC has released a new evidence framework for pharmacist independent prescribing, is consulting on draft guidance for pharmacist prescribers and now has legal powers to use covert surveillance in investigations, as explained in a new enforcement policy for registered pharmacies. It also tightened public safeguards for online pharmacies, which attracted plenty of national media attention.

The GPhC also found itself drawn into the pharmacist apprenticeship debate, reminding the Institute for Apprenticeships and Technical Education that any proposed scheme must go through its accreditation process and calling for a longer, more detailed consultation than the rather perfunctory effort that raised pharmacists’ ire to such an extent.

A busy year for the GPhC… so far

Significant

However, perhaps the most significant piece of work has been the wide-ranging and radical proposals on overhauling the initial education and training standards for pharmacists – the consultation closed on April 3 – including a shift to a five-year degree course with an integrated 52-week placement replacing the current pre-registration year.

The landmark consultation bore more than a passing resemblance to the discussion paper put forward by Modernising Pharmacy Careers (MPC) in 2011, which ultimately got kicked into the long grass by a review of higher education funding, never to be heard about again.

The regulator’s proposals set out to ensure that future pharmacists are equipped with the right skills, knowledge and behaviours as their role develops in a changing NHS. However, reaction was decidedly mixed. Concerns were expressed by the likes of the Pharmacy Schools Council, chiefly over how this new, expensive model of education might be funded.

Questions were also asked about the impact on pharmacy course enrolment and workforce numbers in the future, and especially the financial burden students might face in funding their own placements and a longer course.

Why the change?

So why does pharmacy need an integrated five-year undergraduate and registration programme with a single set of standards? Essentially, it boils down to this: in the view of the regulator, future pharmacists must be ready and able to take on more responsibility as roles evolve and public expectations increase.

“We recognise the standards may be challenging to deliver but we need to make sure future pharmacists are prepared for future practice. We think now is the time to integrate academic study and workplace experience to equip pharmacists with the skills they require to respond to the changing needs of patients and the NHS,” says Rudkin.

“There needs to be a more coherent approach to the full period of initial education and training. There is currently too much variability of experience and learning in the pre-registration year and the time spent learning in practice needs better planning and management.”

The greater focus on clinical skills, patient communication and working flexibly with other healthcare professionals – while still retaining the core science component – requires a much stronger link between the separate elements of academic study in the MPharm course and workplace experience in the pre-registration year, he says.

“Student pharmacists need exposure to an appropriate breadth of patients and people in a range of environments – real and simulated – to enable them to develop the skills and the level of competence required.”

Clearly, a reconfiguration of the undergraduate degree course as radical as this will present many challenges to universities, employers and students. The Pharmacy Schools Council has expressed “serious concern” regarding funding and in the words of GPhC chair Nigel Clarke, this “may involve some difficult decisions”. What will be the nature of these challenges from the regulator’s perspective?

Rudkin says the GPhC is in the process of analysing the feedback received from the consultation and will present a report to its council that will contain more information about the issues raised. It will carefully consider any challenges in delivering the standards that are raised during the consultation.

“There will be different ways and models to deliver the standards and we will ensure that our approval methodology is flexible enough to accommodate diverse and innovative provision of pharmacy education.”

Throughout the consultation the GPhC sought to engage with as many interested groups and individuals as possible, “so that we can get these standards right. We intend to keep the conversations going to make sure that we can collectively bring about the required developments.”

How does Rudkin respond to claims from the British Pharmaceutical Students’ Association that the proposals do not appear to have been written with the interests of students’ development in mind, but rather are a result of financial constraints? “Our key focus was to make sure the draft standards enable students to develop the skills, knowledge and behaviours they need to confidently and successfully take on their future roles,” he responds.

The increased financial burden on students could prove a major sticking point, as the BPSA and others point out. Depending on how the course is structured, there might be the unwelcome possibility of both creating an additional year of student loans to cover a fifth year of tuition fees and maintenance support, and losing a year’s salaried employment.

The MPC paper in 2011 suggested this could be mitigated by including pharmacists in the NHS bursary scheme and tuition fee waiver programme. The paper also argued that pharmacy should receive a clinical supplement for at least 12 months of the five-year programme. Pharmacy is currently funded as a science programme, unlike medicine and dentistry.

Rudkin points out that the BPSA’s draft response noted that many students would welcome the proposals if they were paid for the 52 weeks of learning in practice. Views were also largely based on whether students would have to pay tuition fees in their final (fifth) year.

“How these proposals are funded will continue to be part of our discussions with stakeholders,” Rudkin says.

Safety incidents on the rise

Patient safety incidents in pharmacy are on the rise, up by almost a third for the first quarter of 2019 compared with the final quarter of 2018, according to the latest NPA Medication Safety Officer’s report. The NPA has previously noted that ‘work and environment’ factors are a major contributor to safety incidents, linked to “workload, distractions and time pressures due to staff shortages”.

Fitness-to-practise concerns raised with the GPhC are also at record levels. Is there a link with staff shortages? Research by Pharmacy Magazine earlier this year revealed that 13 per cent of contractors had made staff members redundant due to the funding cuts. Surely this must add to workplace pressures and risk compromising patient safety? Is it a concern to the GPhC?

Rudkin says data from inspection visits, for example, does not indicate there is a causal or obvious link between staff numbers and safety incidents. Indeed, the number of pharmacies – 26 – failing to meet Standard 2.1 (“there are enough staff, suitably skilled and qualified, for the safe and effective provision of the pharmacy services provided”) actually fell in the last quarter of 2018 compared to the previous four quarters.

However, it is a complicated area to analyse and he is wary of putting two numbers together and “drawing a hasty conclusion”, especially when the absolute numbers of pharmacies concerned are still quite small and many other factors are at play.

One of the reasons behind the GPhC’s rising fitness-to-practise caseload may lie in the increasing complexity of modern practice and more patients and members of the public using pharmacy services, he says.

“We are constantly trying to understand what the data is telling us and are investing to improve our capacity in dealing with fitness-to-practise issues but also to analyse the data and ultimately draw insight from it. But it is very complicated,” he admits.

The regulator has written to pharmacy bodies to ask how they are implementing its 2018 guidance on ensuring safe and effective pharmacy teams and to describe the challenges relating to staffing levels. It will continue to monitor the situation closely and in February held a meeting with key stakeholders to identify further actions that can be taken to help ensure safe working in pharmacies.

Focus on individuals?

The GPhC has been criticised in the past for focusing on individual registrants in fitness-to-practise cases and rarely on employers and the external circumstances contributing to errors, for example.

A freedom of information request by the Pharmacists’ Defence Association in 2017 found that the regulator had issued over 3,500 sanctions since 2010 against individual registrants but had never brought a fitness-to-practise case for failing to comply with the standards for registered pharmacies.

To what extent does the GPhC consider human, environmental factors and context (e.g. staffing levels and employment practices) when considering errors in fitness-to-practise cases?

“We look at all the circumstances surrounding an error including all mitigating and aggravating factors,” says Rudkin. “For instance, was the individual open and honest when something went wrong and took steps to put it right or did they conceal the error?”

Through robust investigation processes, we arrive at a fair and proportionate outcome based on the facts of the case, he adds, while the investigation can also take account of the context in which the issue arose.

“We encourage a just culture through our professional standards. Our standards for pharmacy professionals make it clear that people must speak up when they have concerns or when things go wrong. Under principle 2 of our standards for registered pharmacies, owners are required to ensure that there is a culture of openness, honesty and learning.”

Perhaps with the notorious Bawa-Garba case in mind, where a junior doctor was convicted of manslaughter for the death of a six-year-old boy and struck off the medical register – there were concerns at the time that the doctor’s reflections in her learning portfolio were used against her in court – Rudkin recognises that the possibility of disciplinary action can deter people from reporting errors. (The Bawa-Garba striking off was later overturned by the Court of Appeal.)

“It is important to emphasise that single dispensing errors would not in our view constitute a fitness-to-practise concern, unless there were aggravating factors.”

He says pharmacists may wish to look at the GPhC’s suite of good decision-making guidance. These help to provide transparency about the processes it uses and “gives people confidence that decisions we take are consistent, fair and proportionate”.