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'Why we're clarifying responsible and superintendent pharmacist roles'

"This is an area of complex law and we want to make sure we have got it right"

The man leading the push to amend the regulations for superintendent and responsible pharmacists explains to C+D why clarity is necessary

Pharmacy plays a vital role in the NHS, and it is important that pharmacy legislation and regulation is reviewed to ensure that safety for users of pharmacy services is improved, innovation and development of pharmacy practice is promoted, and unnecessary legislation is removed.

The independent Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board – which I chair – was formed to advise the government and devolved administrations on these issues.

Earlier this year, we saw a major legislative change by which new defences for inadvertent preparation and dispensing errors were made available to registered pharmacy professionals working at or from registered pharmacies. The introduction of these defences will alleviate concerns about the fear of prosecution, encourage the reporting of errors and improve the safety of services.

It is important that we continue to consider what more can be done. I am therefore delighted to launch the government’s public consultation on two further draft proposals.

Dispensing error proposal

These proposals will extend defences for inadvertent preparation and dispensing errors to registered pharmacy professionals working in hospitals and other relevant pharmacy services.

They will also clarify and strengthen the organisational governance requirements for registered pharmacies – especially around the roles and requirements of responsible pharmacists and superintendent pharmacists – in primary legislation.

The first of the proposals builds on the earlier dispensing error order. Errors are rare due to the diligence of pharmacy teams, and prosecutions rarer still. However, I know that there is still fear among some professionals, and I want to assure them that while the risk of prosecution has not been totally removed, these measures aim to significantly reduce this risk.

In setting out the new defences, parliament has made clear its intent that pharmacy professionals should not be prosecuted for inadvertent errors and that a culture of reporting and learning should be encouraged.

It is important to be clear that the defences cannot be relied upon where professionals have shown a deliberate disregard for patient safety or have not discharged their professional duty of candour to advise patients promptly when an error occurs. This is right and provides the necessary confidence for patients and the public.

All errors will also remain potentially the subject of sanctions from the pharmacy regulators, such as fitness-to-practise investigations, and general criminal law; for example, gross negligence manslaughter.

Responsible and superintendent pharmacists

The second proposal, on responsible pharmacists and superintendent pharmacists, is an important step in providing clarity about the respective roles and to ensure that accountability and responsibilities are clear within pharmacy teams and wider organisations.

In addition, the proposals include two technical changes to align the law in Northern Ireland with that of Great Britain, allowing for the appointment of a deputy registrar and requiring superintendent pharmacists to notify when they cease that role.

Have your say

This work has been developed over a long period of time by the rebalancing programme board, with input from numerous professionals, patient/public interests, representative bodies and organisations, and it is important to understand the impact of the changes being made. This is an area of complex law and we want to make sure we have got it right.

During the consultation period, the board will be hosting a partners’ forum event, at which we will ask for thoughts and comments on the proposals and clarify where there may be concerns. This follows on from the previous partners’ forum event, which was held in February of this year.

We will also link into a wide range of stakeholder networks to promote responses to the consultation and explain aspects of the proposals in greater detail. A Q&A has been published on the board’s website here.

After the consultation, the government will consider all responses, with the aim of laying the draft orders before parliament by the end of the year. The orders will require approval by parliament and the Privy Council before they come into force. I encourage everyone to take part in the consultation, which is running until September 11.

Ken Jarrold is chair of the Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board

The consultation document and draft orders can be found here, and the Q&A document here.


Stephen Walker, Community pharmacist

I remain puzzled why it is that whatever happens to us in Pharmacy in the UK seems dictated to us by non-pharmacists! When are we going to grab the bull by the horns and start to properly influence our own profession and future? I know we need legal and other input BUT we are not so stupid that we have to wait to be told what to do all the time, are we? I don't know Ken Jarrold, I am sure he is a well qualified person with good intentions. He is not on the GPhC register as far as I can see. All professions have different perspectives, it's about time we pushed ours to the top of the agenda. There are a few things I would like to clarify, like how do non-Pharmacists know what is best for us, and by default our patients and customers? How many hours a week do they spend with those whom we ultimately serve?

Mike Hewitson, Superintendent Pharmacist

The devil is in the detail with these things. 

We got an insight into the nefarious tactics which are sometimes employed to get controversial changes through with the Hub & Spoke consultation. The covering document said one thing, and the actual change said something completely different. 

Having sat through the last Partners Forum I was left with a sense that Mr Jarrold cherry picked the comments which fitted his agenda. I personally don't have much faith in the Rebalancing Board because of its composition. There is a real danger that the well meaning, but often weak individuals represented around the Board bring no legitimacy other than their own opinions when the two organisations that ought to be represented: NPA & PDA are excluded from these discussions. Mr Jarrold has been asked regularly and repeatedly to include these representative organisations, but has resisted at every occasion.

The Rebalancing Board still has not in my mind adequately defined the problem they are trying to solve. Until they can do this in a way which makes sense to ordinary pharmacists they will get no buy-in to their proposals, so again they will be fighting with the profession. 

Jonny Johal, Pharmacy Area manager/ Operations Manager

Why indeed Mr Jarrod, 1. Looking for something useful to do, 2. Give the superintendents more clout to blame the responsible pharmacists, 3. After secretly proposing technicians dispensing last time, you want to surprise our profession again, 4. You failed to notice that there are more important regulatory issues affecting pharmacy? I am so looking forward to your next earth shaking proposal. I am so looking forward to the board's next momentous proposal to transform the practice of pharmacy in the UK.

As a pharmacist and speaking personally, I am still waiting for this ''rebalancing board" to make a difference. "Complexity" as Mr Jarrod noticed, is an unnecessary invention by civil servants, health service managers included, because it gives them such job satisfaction . There is a "Yes, Minister" feel to this .

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