Nigel Clarke: ‘Pharmacy isn’t just handing over a bag of medicine’

The chair of the General Pharmaceutical Council (GPhC), Nigel Clarke, is gesturing at the impressive view from the regulator’s London headquarters in Canary Wharf. From the 26th floor, he points out another regulator — the now defunct offices of the European Medicines Agency, whose staff have decamped to Amsterdam.

As we sit down to start the interview, Clarke — resplendent in some dazzling pink spotted braces — is full of anecdotes about the history of pharmacy. As well he might — after all, Clarke had a major hand in setting up the Royal Pharmaceutical Society after he chaired the independent inquiry into a professional body in 2007.

And he is, once again, in the midst of changing times. The GPhC, like most other regulators, is struggling to get a grip on the new online pharmacy boom. A consultation on how to regulate the online sector closed in August 2018 and its results are not expected until summer 2019 at the earliest. The regulator is also coping with the fallout from the 2018 inquiry into the deaths at Gosport War Memorial Hospital.

The GPhC is now proposing a radical revision of standards for pharmacy education, merging degree and preregistration years and giving pharmacists much more clinical experience. But there are questions over the regulator itself. The government is considering proposals to merge healthcare regulators and there have been concerns raised that the GPhC has been too slow to put its house in order over its treatment of black, Asian and minority ethnic pharmacists.

The Pharmacy Schools Council said it was concerned about the lack of detail in your consultation on training standards and how it was going to be funded. Could you respond to that criticism?

This is the most important piece of work we’ve done in a long time. It is trying to work out how pharmacists get trained for the future, when the profession is changing quite quickly now. I have some sympathy for the council’s first response. We have to be mindful of the economic reality of how universities and schools operate. If you take as a basic premise, that there is not enough training in pharmacy at the moment, and not enough alongside other healthcare professions, that has to be fed in.

Is your plan to merge the MPharm and preregistration training?

Before I started at the GPhC, I was asked to chair a review of what a five-year MPharm would look like and much of that was about asking: “Should we take the preregistration year and integrate it more into the whole of the five years so that there is a greater degree of ‘on-the-job’ training?” But it does raise issues of who’s paying and there are complex matters around — for example, the position of overseas students who represent a significant income stream for schools. As I keep saying to everybody, the whole point of a consultation is they should be able to hear what people have to say.

Are you concerned that Health Education England’s planned cuts to NHS preregistration training may hinder this process?

I would be concerned at anything that will make it more difficult to deliver the best outcome. I haven’t spoken to Health Education England since it took the decision, so it would be rather pre-emptive of me to have a view. But if you take money out of the system anywhere then either you provide less, you find it from somewhere else or you’ve got to do it cheaper. If we’re setting out standards that imply a degree of provision of education, to which a price tag is attached, then we have to be mindful that if there’s fewer people available to pay, then we end up with ‘the best being the enemy of the good’.

If the government has a direction it wants the profession to go in then we all need to recognise that someone’s going to have to pay for it. Pharmacy has a significant role to play in improving medicines use in the UK, but that means very good education.

Are you doing any work to improve the persistent lower performance of black candidates in the preregistration exam?

When we reviewed this it became clear that people in this cohort were at a different stage in their lives compared with a lot of other students. They were often people with children who were older and had jobs. There were also some issues around the quality of their preregistration experience. We are reviewing how people are managed through preregistration and that the work experience element is supported. Are they are given the best opportunity to pass the registration exam with flying colours? As part of that, we will review the registration assessment itself. We’ve still got a long way to go.

It’s an ongoing piece of work?

Very much so. You’re not going to solve deep-seated problems overnight, or just as a single organisation, when some of these things clearly have a much broader cause and effect.

Have you got any targets for that?

Not in timing terms — but in absolute numbers, yes. You don’t want to be in a position where you get a pass rate of 55% for one group of people. It’s deeply unsatisfactory for them and for the profession.

Data obtained by The Pharmaceutical Journal show a differential between white and non-white pharmacists in terms of concerns raised, and suspensions and deletions from the register following fitness-to-practise procedures. Is there a problem at the GPhC?

It’s extremely difficult to tell. Concerns — the numbers are quite large, and growing. This is true for all regulators in healthcare and no one knows why. There is clearly a change in public expectation of service providers and issues around communication which are unsatisfactory. But by the end of the fitness-to-practise (FTP) process, the numbers are much smaller. It is more difficult to draw conclusions safely, but the numbers are worrying enough to cause us concern.

We do put a great deal of work into equality, diversity and inclusion, not only in the way in which the teams in the FTP division of the GPhC work, but also how our panels function. We might exclude 20 people from the register in a year; when you’ve got around 260 concerns being raised every month that is relatively small, but if it is disproportionate then we need to understand what’s going on.

The GPhC is behind other healthcare regulators on this — is that fair criticism?

We put our hands up to that. It has taken us longer, partly because our numbers are so much smaller. The General Medical Council registers four times as many people as we do — discrepancies will be very visible. We need to be more mindful and get a proper grip on it, but it’s not as if we don’t know. We’ve done quite a lot of work, at least structurally; there’s a lot more training all through the organisation than there was around equality, diversity and inclusion awareness. In the end, every case is individual so it’s difficult to do things like blind cases where you eliminate names. We need more independent work on whether there’s any common threads. I’m not clear we’re going to find that, but the point you raise is an important one. We are mindful of the fact that this is an issue we must get a proper understanding of.

In July 2018, the GPhC said it would produce a ‘careful and comprehensive review’ of the Gosport Inquiry. What stage is that at?

That is about to be published. It is quite historic — pharmacy has made a lot of big steps since then and I think people reading the document will probably think we’re already doing quite a lot of this already. A lot of it is about whistleblowing, openness and the ability to work with other healthcare professionals, patients, families, carers and so forth.

So, no changes to your standards?

That’s right. We are building on progress that pharmacy has made in the intervening time. This is about doctors and pharmacists being able to talk to each other properly. In a very well-run hospital, that’s exactly what happens.

Is it true you will be pragmatic about the implementation of the Falsified Medicines Directive in pharmacy inspections?

Yes. All we need to know really, is that the pharmacy has a plan for introducing it over a certain period of time and that they’re aware of their obligations.

I’m sure there’ll be a sigh of relief from community pharmacy hearing that.

That doesn’t mean that they can ignore it completely!

Are you worried about Brexit and its effect on the pharmacy profession?

Yes. For us there are two issues. The first is our concern about the safety of the patients if they are not getting the medicines that they ought to be getting. Damaging confidence in pharmacy would be bad for patient care. The other is around mutual recognition of qualifications: it would not affect anybody who’s already on the register, so they should not be concerned, this is more about how the regulations will work after Brexit and I’m afraid we don’t know. We have seen a reduction in applications from the EU over the past two years, but it’s not a big number compared with the size of the register and the number of new registrants every year.

Have you carried out any covert inspections since the GPhC was given the power to do that in 2018?

We haven’t done anything like that yet and at the moment, I’m unclear as to exactly how we would. Some of this is just acquiring evidence in relation to cases where complaints have already been made and we know things are happening. 

You had a consultation on the regulation of online pharmacies in 2018 — when should we expect the results?

In 2019. We should not be standing in the way of innovation as a basic principle, because there is so much that can be done to improve healthcare by the use of new technologies. Regulators can be rather sluggish about this sort of thing. Having said that, I am acutely aware that the supply of medicines is a clinically skilled exercise in which a close relationship between the healthcare professionals involved and the patients and their carers is important. It isn’t just a case of handing over a bag of medicines and thinking that’s the whole transaction.

I’m concerned we make sure that the crucial patient safety elements of the dispensing process, and the advisory bits that sit around it, are properly maintained in different supply structures. We have to be clear about what is in the best interest of patients.

You’re putting your fees up this year…

For less than a pint in London.

True. But we’re in quite a swanky office in Canary Wharf — do you think that you could make savings by moving somewhere else?

The deal we negotiated was a really good one. We were rent-free for a long time and got an office where people could actually talk to each other. You may think this looks swanky, but this is what modern offices look like. That doesn’t mean that we wouldn’t keep that under review.

How is the Professional Standards Authority’s review of healthcare regulators going?

I think it is looking at a more nimble way of dealing with healthcare regulation. Some of the regulators have very much greater concerns than we do — the Nursing and Midwifery Council, for example, really needs to change certain aspects of its FTP operation. It can do that through secondary legislation, which wouldn’t involve the rest of us. The big picture reform is probably not on the agenda.