The Big Debate

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The Big Debate #5: How can pharmacy supervision be modernised without compromising patient safety?

Started 13 days ago

Good evening everyone, welcome to our fifth Big Debate.

Pharmacy supervision has been at times defined as an emotive topic, and for good reasons. But no matter on which side of the argument pharmacy professionals stand it is agreed by all that patient safety should not be compromised.

A formal Community Pharmacy Supervision Practice Group – which includes members from the Association of Independent Multiple pharmacies (AIMp), the Company Chemists’ Association (CCA), the National Pharmacy Association (NPA), and the Pharmacists’ Defence Union (PDA) – first met on September 28 after sector bodies announced earlier this year that talks on pharmacy supervision had resumed.

Tonight, we’ll be holding a less formal debate – although please note that we expect our participants to abide by the C+D community principles – on the following question: how can pharmacy supervision be modernised without compromising patient safety?

Let us know your thoughts by commenting below. The “live” part of the debate will close at 8pm, but feel free to continue to exchange views for as long as you like.

C+D has introduced a streamlined functionality that allows users to mention each other in a comment. Simply use ‘@’ and type in the person’s name.

This debate will start at 7pm.

It’s 7pm, which means the debate is officially open! 

Hi All.

Back in 2017, David Reissner – who is a director at AIMp but will be joining us tonight in a personal capacity – wrote in a blog for C+D that medicines legislation does not define “supervision”. 

David is also chair of the Pharmacy Law & Ethics Association – better known by some as PLEA. So @David Reissner, why is there an issue with the word “supervision”? 

Hi @Paul Summerfield, thanks for joining us!

Why is there an issue?

The Pharmacy and Poisons Act 1933 made it unlawful to sell certain medicines unless the sale was supervised by a pharmacist. The word “supervision” was not defined in the Act. In cases decided in 1943 and 1953, the courts said a pharmacist who was upstairs could not have supervised a sale downstairs and that supervision required a pharmacist to know what was being sold and be in a position to intervene if a sale would be inappropriate.

There was no NHS when the Pharmacy and Poisons Act became law. That Act was replaced by the Medicines Act 1968; and the Medicines Act has been replaced by the Human Medicines Regulations 2012 which still requires supervision when Pharmacy medicines and Prescription Only Medicines are sold and supplied.

Although the words in today’s law are different to the wording in 1933, there is a common view that the old cases require a pharmacist to watch every supply of P medicines and POMs. This makes it difficult for pharmacists to involve themselves in providing other clinical services. DHSC The DHSC appears committed to changing the law as soon as possible “so that the clinical skills of pharmacists can be directed to helping patients”.

Good evening

Hi All

Changing the law will require the Human Medicines Regulations to be amended, and also the requirement in the NHS terms of service for prescribed medicines to be supplied under a pharmacist’s “direct supervision”.

Supervision has never been defined in legislation. Inserting a definition into the Human Medicines Regulations is likely to make the law too rigid in a world that is changing ever more rapidly, with new technologies. It would be better to adopt the approach used when the Responsible Pharmacist Regulations were introduced, allowing the responsible pharmacist to be absent so long as certain arrangements were in place. For example, the requirement for supervision might be deemed to have been satisfied if certain conditions are met.

The conditions to be met might include:

  • The responsible pharmacist is on the premises or contactable
  • SOPs that dictate what can be done by whom
  • What medicines can be supplied without the pharmacist having a line of vision to the person handing a medicine over (eg repeats or medicines previously dispensed under a pharmacist’s supervision)
  • What medicines cannot be handed out without the pharmacist watching
  • Skill mix, eg supplies that are within the competence of a pharmacy technician to make without a pharmacist watching.

Hello, @Gareth Jones!

Interesting points, David. So should the cross-sector group come up with a tentative definition for "pharmacy supervision"?

@David Reissner So what about the GPhC's interpretation of supervision which is taken from the case of Cosgrove in which supervision needs to be commensurate with the training and qualifications of those who you are supervising? This seems a more pragmatic approach to supervision

I agree that the use of the word "direct" in the regulations is less than helpful

I think the big difference when supervision was conceived and now is technology.I think it is possible to use the current 2-hour physical absence allowed per 24 hours to modify supervision.The key changes  being pharmacy medicines can be sold under the supervison of RP designated pharmacy staff and bagged medication which do NOT have "Speak To Pharmacist" tag attached can be given out.This should be trialled for a 12 month period and then reassessed before any expansion.

Hello everyone.

@David Reissner just out of curiosity, when was the last the a pharmacist was struck off or sued for not directly supervising sale of 32 pack of paracetamol?

Welcome, @Mark Koziol!

If we are not careful, we will allow the legal tail to wag the practice dog….

Whilst there appears to be a rush to change the legislation, we must first establish what kind of service do we want to provide to patients that will determine what we want practice to look like. From that flows the solution as to how pharmacists and their teams will work best and once that is established and only then, we will need to consider what, if any law changes will be required.

If the legislation is to be changed, and I am not advocating for this, then would the wording in Regulation 8 be better if the term "close" instead of "direct" was used? This would ensure that a pharmacist would have to be on hand and in the same premises, in my opinion

@Paul Summerfield The GPhC did give guidance on a case called Congreve that supervision entailed putting systems in place rather than standing over the person handing out medicines. However, that guidance disappeared from the GPhC's website a while back, probably when DHSC asked the rebalancing board to look at supervision.

Interesting points, there definitely seems to be some confusion around the wording in the legislation...

To go back to @David Reissner's point, saying that "SOPs could dictate what can be done by whom"... What do you make of that, @Gareth Jones? Are SOPs enough?

@Mark Koziol Very good point Mark. I do believe that supervision in some form is still needed and must still require a pharmacist to be on the pharmacy premises but what about technician led dispensing with a pharmacist supervising while providing other services?

@Mark Koziol I don't think the 87 years since the Pharmacy and Poisons Act was passed is a rush to legislation. Given DHSC's expressed intention to legislate, I think it is important for community pharmacy to influence the terms of a change in the law rather than hoping there won't be legislation.

@paulsummerfield How would you differentiate between "close" & "direct"?

If we're not careful any changes will be abused just like the two hour RP regs. I'm still waiting the sector leaders to show us how well they've been using those two hours. I understand its great foe investors as you can reduce the pharmacist presence for couple of hours while dispensing team work without any kind of supervision but that's neither safe nor good for the patients or the profession. 

We support the further development of the skills and role of the whole pharmacy team. At the same time, the accessibility of the pharmacist must be maintained and indeed enhanced. The effect of any changes should be to enable the pharmacist presence in the pharmacy to become more, not less, visible to patients. SOPs and systems only go so far; in most situations there is no substitute for the professional judgement of the pharmacist.

We are against the practice of remote supervision in almost any conceivable circumstances. Remote authorisation should only be permitted in an emergency, when it can be demonstrated that there is an overriding patient need, to allow acute prescriptions to be assembled, checked and handed out to patients/representatives. Such a situation would be exceptional and not the rule. Responsibility and accountability for safe supply should remain with the responsible pharmacist. The responsible pharmacist must be able to make decisions regarding the safe running of the pharmacy.

@David Reissner Thank you for correcting the case name. Having checked, Congreve is still good law and has not received negative treatment in the courts. So if supervision did go down this route, would this be beneficial for the patients whom we serve as health care professionals?

I am not speaking for "investors" or contractors here, but I haven't heard anything about reducing pharmacists' present; if anything, the opposite. I realise there is suspicion and mistrust on the part of some pharmacists and locums, but there are negative and positive reasons for them to look for a change in the law.

@Paul Baker You could look to the regulators to see how they have defined the various levels of supervision needed in fitness to practise sanctions. Direct Supervision is where the practitioner has the supervisor almost sitting on their shoulder, observing everything they do. Close Supervision is where the supervisor is in the same premises and can be called upon at any time to intervene or for advice.

For example @tohidul@yahoo.com , a negative reason is that remote supervision is already legally possible, even though it isn't something that's happening and all the contractor organisations have made it clear they don't want remote supervision. The law could be changed to ensure that remote supervision is no longer possible.

@David Reissner I am not hoping that there is no change in the law - I am stating that it is wrong to decide what legal changes are needed until we agree what we want to achieve in terms of patient service and how we want to achieve it through pharmacy practice. I would be keen to understand what you would want a change in the law to achieve - in terms of pharmacy practice?

Good evening everyone. As a practicing pharmacist, i do find it quite unsettling that depending on how the word 'supervision' is interpreted in a given circumstance, can put me on the right or wrong side of the law

Yes, it very much seems the case that any changes will see pharmacists "more present" and available to patients, according to what has been shared by those participating in the cross-sector discussions 
https://www.chemistanddruggist.co.uk/CD007153/Sector-bodies-resume-talks-to-refresh-parts-of-pharmacy-supervision 

ok, but when was the last time a pharmacist was struck off for not directly supervising sales or when HCA/dispenser/technician handed out a bag full of POMs while the pharmacist was working in the back?

Good thing that AIMp CEO Leyla Hannbeck has specified more than once that the current discussions on pharmacy supervision will not even cover remote supervision.

Hi Jonathan!
Are you available to build on this? Jonathan is the superintendent pharmacist at Mayberry Pharmacy in St Julian’s, Newport, joining us tonight on behalf of AIMp.

What we need to look at is a better use of skill mix. A pharmacist should always be present when any pharmacy activity is taking place,. To steal and amend a quote from another colleague - if you boarded a plane, you would expect to see a pilot; if you went to a dental surgery, you would expect to see a dentist. Why should a member of the public not expect the same from a pharmacy?

@PaulSummerfield  I'd always understood "direct" to mean "in a position to & able to intervene".  Seems similar to sitting on the shoulder

"Close" seems to be how hospitals work with Accredited Checking Techs working to SOPs.  I'm guessing that that wouldn't easily transfer to many community pharmacies.

@Paul Summerfield there is a requirement for supervision in other professions eg nursing, but the contexts are rather different. Supervision appears in medicines law in a few cases. Have a look at the new edition of Dale & Appelbe's Pharmacy and Medicines Law. Not only is there direct supervision in the NHS terms of service, there is "direct personal supervision" in the Misuse of Drugs (Safe Custody) Regulations. None of these different formulations is helpful. Then, there is also a requirement for supervision when medicines are assembled without a manufacturing licence in a pharmacy.

To be clear from the outset, we are not advocating remote supervision in any shape or form. The CEO of AIMp, Leyla Hannbeck, often says “a pharmacy without a pharmacist, is not a pharmacy”.

AIMp’s position is to make things simple. We should put the pharmacist at the centre of everything we do to ensure pharmacists can exploit their clinical skills for the benefit of their patients and that we are in tune with how the profession is progressing.

We need to ensure that the term supervision and its interpretation reflects what practically happens in the pharmacy.

For example, when handing out completed prescriptions, the pharmacist must be on site to intervene – for example, when patients ask for advice, or if the pharmacist wants to counsel a patient collecting their prescription.

But should every completed script be handed out under the ‘supervision’ of a pharmacist? If I am away in the consultation room for 30 minutes with a patient, am I supervising the scripts being handed out? Can I really intervene?   

Why does dispensing need to take place under the ‘supervision’ of a pharmacist? Once the clinical check has taken place, the presence of a pharmacist supervising the transaction adds no value. In reality, are they currently supervising the process in a normal pharmacy?

I am not sure any changes that require the Responsible Pharmacist to be ON the premises will have much support for providing clinical services AWAY from the pharmacy services.

@Jonathan Smith What wording do you think should be used and what changes would you like to see?

@Tohidul Islam I don't think it's good enough to say breaking the law on supervision is OK because no one gets prosecuted. Not all cases get publicity, but there was the Abdul-Razzak case - he was struck off in about 2016, but it wasn't a standard sort of case. The real question you should ask yourself is whether you think it is good enough for professionals to think it is OK to engage in a practice that they know is breaking the law, just because the regulator may not catch up with them. Or whether you think your professional practice should allow you to do things professionally without breaking the law.

We don't know yet whether legislative change is necessary or desirable - there is still further work for the new cross sector group to undertake considering scenarios and then determining what is needed to make them possible. There is a real concern about potential unintended consequences of legal changes and we would want to look very carefully at anything that is proposed. But I don't think we should hide from this debate either, we want to make community pharmacy a place where pharmacists, technicians and all other members of staff are able to operate at the top of their licence and there may be some changes we can make to facilitate that. 

@Jonathan Smith Unless pharmacists are exempt from liability if dispensers or technicians make dispensing or bagging errors during the dispensing process, even if pharmacists have correctly clinically checked the prescription, the blame will be passed onto the RP as the current law stands

@Paul Summerfield Congreve remains good law - for surveyors. It may be good law for pharmacists. I'd be prepared to argue that, but DHSC is not.

I like your comparison, @Paul Summerfield! I agree, as a patient, I would expect to find a pharmacist when visiting a pharmacy.

But I wonder if, as Jonathan said, pharmacists are "currently supervising"the process of handing out prescriptions at present?
Do we have some contractors in the audience who could tell us how they are making sure this happens at all times, and if they indeed think it should happen at all times?

@ Jonathan Smith This separation of the professional activities 'the clinical checks and patient interaction' and the technical activities 'the assembly of the medicines' is an entirely sensible way forward to organise the work as far as future practice is concerned. It ensures that pharmacists work smart by focusing upon their unique skills around medicines. It enables them to start to develop an even greater clinical relationship with the patient and they can do this because the mechanics of the assembly - a technical role, could be undertaken by pharmacy technicians. 

I think the whole idea with the supervision practice group is to scope out all scenarios. To leave no stone unturned and debate all options that places the pharmacist at the centre of the pharmacy to add benefit to every patients journey, without potentially breaking the law.

We need a "like" button here!  @Mark Koziol nails it (and I got the quoting correct!!)

@David Reissner I completely understand what you mean. So, I take no one has yet been struck off or prosecuted for not directly supervising sales of 32 pack of paracetamol. Can you tell me what changes you are looking to make and what AIMp's vision of what community pharmacy looks like?

@BestLocum I don't think anyone is suggesting that the Responsible Pharmacist Regulations should be changed. I know many don't like these Regulations and I'm not expressing a view of my own on them - just saying that these Regulations already allow certain things to be done in a limited period away from the premises.

Surely legislation should be an enabler to maximise the use of the skills of our community pharmacy and pharmacy technician colleagues. This in turn would need to keep pace with new service models and ensure the safety of the patient is an the heart of everything that we do. 

@Tohidul Islam Mr Abdul-Razzak was struck off. He is the most recent I can think of. That was about 2016.

I agree, @Paul Baker, we do need a "like" button! Hopefully, we'll introduce that in time for your next big debate :)

@Tohidul Islam I'm not speaking on behalf of AIMp here. I'm here in a personal capacity.

If any changes are made to the supervision regulations or the law what guarantees will be in place to stop companies operating pharmacies without  a pharmacist as some are currently doing with the 2 hour RP regs and how can we stop the abuse that is currently happening?

Going back to the case that @David Reissner mentioned, the case of Abdul-Razzak in 2016. The High Court judge stated the following:

  1. A basic and essential duty of the Appellant, as a responsible pharmacist, was to adequately supervise the counter assistants so as not to permit or cause an unlawful supply of prescription-only medicines without a prescription. This was an essential and vital policing duty, but as explained by the Committee, [8] the Appellant failed to comply with this duty.

The word adequately is used here.

So even then, the Court formed the view of what supervision should look like. I would argue that this is the correct interpretation of how supervision should be viewed. Supervision is commensurate with the training and qualifications of those being supervised but some form of supervision must still take place.

@ Muhammed Siddiqur Rahman You make an important point, and one that needs to be addressed in the cross sector working group. If pharmacists are going to be freed up from parts of the dispensing process we have to deal with the current risk that they would face regulatory action for an error made by someone else.  

@Muhammad Siddiqur Rahman Is spot on, if we are looking at making some legal changes to support future practice, then lets make it legally clear that if the Pharmacist has made a proper clinical assessment and has handed on the prescription for assembly to the registered Pharmacy Technician in the dispensary; and that the Pharmacy Technician then makes a picking error then it is the pharmacy technician that bears the responsibility for that error in a professional, civil claims and criminal liability regard. In such a scenario, as long as the pharmacists job was done properly and that he/she can account for their proper clinical assessment and the overall safe operation of the pharmacy, then the pharmacist will not have erred and cannot face sanctions.

There seems to be some level of agreement that the pharmacist should always be present at the pharmacy.

In fact, in a video interview with C+D at the Pharmacy Show last month, the PDA chair @Mark Koziol argued that pharmacists should be more available to the patients and that perhaps pharmacies could adopt a model similar to GP practices that house several GPs, nurses and other healthcare professionals.

Would this model work for community pharmacies?

Please refer to Mr Koziol’s video interview for the PDA’s views on pharmacy supervision.

@Tohidul Islam Firstly, all the pharmacy organisations say they do not  want remote supervision. Frankly, I don't think it would be in their best interests. I think they would be concerned that if there were fewer pharmacists on pharmacy premises, DHSC would use it as an excuse to cut remuneration even further. But, as far as I know, DHSC doesn't want remote supervision. It wants pharmacists to be more free to use their clinical skills rather than watching a non-pharmacist handing out something that has previously been dispensed under supervision.. 

What do we want to achieve here?  Do we want a pharmacist on the premises at all times when pharmacy activity is taking place, but they are allowed (encouraged) to be doing clinical stuff whilst suitably qualified (how would that be defined) techs do the technical stuff?

What is the legal status of techs? 

What can actually happen in the 2 hour RP window if the pharmacist is off the premises?
 

How can it be shown without reasonable doubt that the talk to allow pre bagged medication to be handed out isn't just purely a a commercial one to increase profit margins? Many contractors/multiplea have shown behaviour alluding to this with the number of intentional closures over the last year. What would be the reason for trusting this pitch is actually to help patients? 

If this did become the case, what would stop pharmacists from only checking the medication when the patient actually turns up on the premises and removing the idea of "pre-bagged" medication all together? 

@David Reissner isn't that the case where the pharmacist was selling POMs such as diazepams? My question was more about direct supervision in everyday scenario.

@David Reissner I think there is a great deal of worry among employee and locum pharmacists that any drastic change to supervision laws will be manipulated by multiples for financial gain.We saw this in some instances with the 2 hour absence window.allowed

@Paul Summerfield We are past the point of debating what the law is. As I said earlier, I could make a case for saying the old cases don't apply. But that isn't good enough for DHSC. They have made it pretty clear that they intend to legislate amongst other things to make better use of pharmacists' clinical skills. I'm not saying the law needs to be changed: I'm saying it is going to be changed and the profession needs to get on board, rather than having unwanted changed imposed on it.

Our goal as profession is to put the patient at the heart of what we do and to put the pharmacist at the centre of the pharmacy. With something as critical as supervision, the term should not be open to interpretation and should be applied to the appropriate aspect of the job such that no pharmacist could be accidentally struck off for their interpretation of the word in a given scenario. 

@Paul Summerfield i do agree that supervision is commensurate with experience, the way in which i supervise my 5 year old when she uses a scissors is very different to how i would supervise an adult with a scissors.

But i would like to see exactly what needs to be supervised within the pharmacy form part of the discussions.

Just to be clear, the PDA has advocated having more than one pharmacist per pharmacy and ultimately for the creation of something that resembles more a high street health centre style pharmacy and less of a shop. Imagine the impact that this would have on service enhancements, patient benefits an the image of pharmacy, not to mention the impact upon the professional fulfilment and wellbeing of pharmacists and their staff. Surely, this is a vision worth fighting for. 

Great points, @Paul Baker. What training would pharmacy technicians need to be able to advise on the medicines they are handing out to patients - if that ever becomes something they do without being supervised by a pharmacist?

What is the likely scenario the DHSC would like to see regarding the changes to laws of pharmacy supervision that ARE going to happen?

@David Reissner who decided the law WILL BE CHANGED? 

@BestLocum I get where you are coming from. As I said earlier, I understand there is suspicion and mistrust out there. But, as I also said in another earlier post, the multiples could have a lot to lose if remote supervision were clearly possible. This is an opportunity to put remote supervision out of reach. Also, I said earlier that there is a negative reason for a change in the law (putting remote supervision out of reach). There is a possible reason. I'd like to hear more from pharmacists who feel that being required to watch someone handing out medicines is not the best use of their clinical skills which they could put to better use for the benefit of patients.

@Peter Noori The welsh government has recently given out grants for automation within pharmacy and that automation was focussed on prescription collection vending machines to allow patients to collect their medication 24/7 rather than under the supervision of the pharmacist.

The aim of this has been to improve social distancing within the pharmacy in light of COVID but also to free up time for the pharmacy staff and pharmacist to provide a more clinical role. 

This is a tendency to look at this from a legal perspective - but it is helpful to think about what we know patients want. They want to be able to walk into a community pharmacy and speak to a pharmacist, something that is even more important now with greater problems accessing other primary care services. Research shows that they also want to be able to access a wider range of clinical services from their community pharmacist. Reviewing supervision to ensure that the RP is able to delegate certain tasks is part of what we need - more NHS commissioning of clinical services from community pharmacies is another part of the picture.  

@Peter Noori Are you saying it's right to have a legal requirement for a pharmacist to be watching when a medicine previously dispensed under supervision is handed out? Surely pharmacists have better things to do unless there is a particular reason related to the patient or the nature of the medication?

Regarding @Mark Koziol 's point, the model mentioned is possible with the number of IPs around now. Pharmacies could run clinics as a further stepping stone before needing the GP whether it is minor infections which need ABx or asthma progression for step 1/2 (just examples). It should be NHS funded with full access to read and make notes on SCR which will help out the GP workload. Up until the last few weeks I haven't heard Pharmacy being mentioned in the news so it is a great opportunity for the profession to show what is possible. But it needs to be united.

Some consultation rooms/buildings will need to be expanded though.

@Valeria Fiore I can only speak from a hospital perspective (and then only form the perspective of the hospital that I worked at, but have no reason to believe that other hospitals were massively different).

Pharmacists "clinically checked" prescriptions (often on the ward) these would be sent to the pharmacy & dispensed (often by a pharmacy assistant (NVQ)) and checked by a tech with an ACT (Accredited checking tech) qualification.  All controlled by SOPs, together with error reporting.  ACT qualifications had to be revalidated every x years.

There was an RP in the dispensary at all times and the clinical checking pharmacist would also be available by phone.

Not really sure how this would easily translate to a small community pharmacy....

@Mark Koziol Sorry, having trouble getting round to your earlier question about what pharmacy practice should look like. Not easy to give a short answer but I outlined some ideas in my second post this evening. Your question is the very subject of the talks going on at the moment between all the stakeholders including the PDA and you will obviously have a say in what you think practice should look like. As I have said more than once, the negative reason for a change in the law is to rule out remote supervision which is currently legally possible. The positive reason is to enable pharmacists to spend their time better, using their clinical skills to benefit patients. And the neutral reason for supporting change is that it is going to happen anyway and this is everyone's chance to influence what the change will be.

I agree with @Mark Koziol that having more than one pharmacist in a bricks and mortar pharmacy would be beneficial to all parties with one pharmacist being the RP and maintaining the safe and effective running of the pharmacy whilst the other pharmacist would conduct important and much needed face to face clinical services as the healthcare demands and accessibility from patients are greater than before

@Tohidul Islam You will see DHSC's intention to change the law in the five year funding agreement for community pharmacy. Also in the announcement on year 3 of that agreement which they published in, I think, August. If you want more details, email me offline.

Can the multiples be trusted? Even when there was emergency guidance put out by the GPhC at the start of Covid, in case a pharmacist was not available, the multiples made SOPs that worked in their financial favour and didn't actually follow what the GPhC guidance.  Won't the same happen to this?

@Gareth Jones makes a vitally important point about patients wanting to walk in to a pharmacy and expect to speak to a pharmacist because it is in a pharmacy where they can best access primary care. This is the reason why we believe not only that the current approach to supervision must change to facilitate that, but that also it is increasingly likely that there will emerge a contract for supply and a contract for services in the future. Additionally, we like David Reissners point about putting remote supervision out of reach in this exercise ; this is vital because doing so will serve the long term strategic interests of patients, the NHS and pharmacists.

@Muhammad Siddiqur Rahman For what it's worth, I haven't heard anyone say there shouldn't be more than one pharmacist on premises. I don't think the law could impose it without a lot more pharmacists being available. I think the availability of pharmacists is not something we can debate tonight though. 

@Amit Tanna as @David Reissner has said, this is an opportunity to put remote supervision out of reach

We need to be realistic about supervision. We can't be protectionist or be Luddites. We need to embrace technology to the benefit of patients and therefore for the benefit of our profession 

There is plenty of common ground here. When I am a patient, I sometimes want to go into a pharmacy (or phone) and speak to a pharmacist and I have spent many years encouraging my family to do the same. It has been one of the great successes of pharmacy during the pandemic that pharmacists and other pharmacy employees have been available. No one wants to lose that. As I see it, it is about making the best use of pharmacists' time and skills. 

Very interesting, @Paul Baker. I wasn't familiar with the processes of hospital pharmacies. Something for the cross-sector group to consider?

It seems there are a few elements that the newly formed group will need to analyse during their upcoming talks. But I think it would help if a consensus was reached on the meaning of pharmacy supervision.

And with that, I'm closing the "live" element of this debate but feel free to continue to share your views. Thank you all for attending! 

@BestLocum You ask what the likely changes would be. You should have a look at the DHSC announcement in August on pharmacy funding. There are a lot of clues about the kind of things they want.

Thanks @David Reissner will study that DHSC August 2021 announcement!

@Paul Mayberry Automation is definitely part of DHSC's plans and they see the old case law as getting in the way of using technology. As you say, there is no point in being Luddites. We mustn't allow pharmacists to go the way of the hand-loom weavers in the 19th century.

I have not heard any luddites this evening - but clearly we have some previous large scale behaviors and conduct round the RP 2 hour absence provisions that are now coming home to roost. The lesson that this teaches us is that this time, when we are drafting the new supervision arrangements - we will be forewarned and forearmed about the possibilities of the unintended but likely consequences.  

@Paul Baker You ask about the legal status of pharmacy technicians. The short answer is that they have no status when it comes to supervision. 

Most people, when they make an appointment at their GP surgery expect to see a GP. But they will probably 

1) not see anyone

2) be triaged - maybe by someone who has been trained to do so

3) Then see a nurse or a pharmacist

4) If they are generally very ill go to A&E

5) Bump into a GP in the supermarket complaining how busy they are !

@Mark Koziol If, instead of the current law, a pharmacist was required to make a clinical assessment, I wouldn't disagree with that - except I don't know that it would fit all circumstances. Would it be necessary when making a supply on all repeat prescriptions, for example. At the other end of the scale, something more than a clinical assessment may be required for some medicines. That's why I don't think a definition of supervision would be helpful. It would be  a straightjacket. It would be preferable to have a set of circumstances that are recognised as satisfying the law.

Hi @David Reissner, unfortunately, I was unable to make it to @ChemistDruggist “Big Debate” yesterday. A few questions if I may.

Q1. You said: “Although the words in today’s law are different to the wording in 1933, there is a common view that the old cases require a pharmacist to watch every supply of P medicines and POMs. This makes it difficult for pharmacists to involve themselves in providing other clinical services.”

Do you agree that pharmacists are not currently watching every supply of P and POM medicines? Are you aware of any pharmacies ceasing handout whilst the pharmacist conducts services in the consultation room? If they do not already do so at the independent multiple pharmacies your association (AIMp) represents, will this be changing now, given that this legal requirement is being highlighted?

Q2.

@David Reissner  you mentioned that:

“all the contractor organisations have made it clear they don't want remote supervision.”

and

“Firstly, all the pharmacy organisations say they do not  want remote supervision.”

This would include AIMp, of which you are a Director.

 

However, you also said:

“… It would be better to adopt the approach used when the Responsible Pharmacist Regulations were introduced, allowing the responsible pharmacist to be absent so long as certain arrangements were in place. For example, the requirement for supervision might be deemed to have been satisfied if certain conditions are met.

The conditions to be met might include:

The responsible pharmacist is on the premises or contactable

SOPs that dictate what can be done by whom

What medicines can be supplied without the pharmacist having a line of vision to the person handing a medicine over (eg repeats or medicines previously dispensed under a pharmacist’s supervision)

What medicines cannot be handed out without the pharmacist watching

Skill mix, eg supplies that are within the competence of a pharmacy technician to make without a pharmacist watching.”

 

In your example:

  1. The pharmacist is absent from the pharmacy (remote to it), and
  2. The requirement for supervision still exists (which as you explained involves pharmacist supervision – you’ve not said otherwise in the example), and
  3. That requirement might be met, for example, where the pharmacist is merely contactable (but off the premises), or there are some SOPs.

 

That appears to be a clear example of remote supervision. If you say it’s not, please could you explain?

Q3. @David Reissner you said:

“Are you saying it's right to have a legal requirement for a pharmacist to be watching when a medicine previously dispensed under supervision is handed out?”

Leaving aside for one moment that handout is one of the key opportunities for clinical counselling points to be made, one of the most common forms of dispensing error is handout errors. Who would be liable for such an error, at criminal law?

In our context, as I understand it, there's no requirement for a manufacturer's licence when the preparation or dispensing of a medicinal product is done by or under the supervision of a pharmacist, in a registered pharmacy. This comes from section 10 of the Medicines Act 1968. 

For those advocating that pharmacy technicians take over the assembly process:

  1. Would you see the statutory requirement changing such that assembly had to be, or could be, supervised by a pharmacy technician instead of a pharmacist, to avoid the need for a manufacturer's licence?

  2. If so, would you also see the statutory requirement for supervision of sale/supply (handout) being done by a pharmacy technician, instead of a pharmacist as is required at present?

    a) If your answer to Q2. is “yes”, would you agree that this would remove two of the key statutory requirements which mean a pharmacist is required to be present in a pharmacy? Would you propose anything in place of this?

    b) If your answer to Q2. is “no”, how would you see regulatory/civil/criminal liability being apportioned fairly between the pharmacist and pharmacy technician - if the pharmacy technician has supervised assembly but the pharmacist has supervised handout?

Hi @Gregory Lawton. Thanks for the questions.

First of all, may I clear up a misunderstanding on your part? In this debate, I am not speaking on behalf of AIMp. While I am a director, AIMp had its own representative in the debate. I was offering personal views drawing on my background of a legal career in which I advised many individual pharmacists, locums and employees, as well as pharmacy owners of all sizes from the smallest to the largest. My clients included members of the NPA and PDA.

A1. If, as you say, pharmacists are not watching every supply of P and POM medicines, DHSC does not rule out this being a criminal offence on each occasion. I am not saying I agree: I am saying that it is DHSC’s view that matters. Pharmacists and pharmacy owners (whether they belong to AIMp or any other organisation or no organisation) should not be left in the position where DHSC considers that what you describe as current practice may be unlawful. I would add that whether you or I like it or not, DHSC intends to change the law.

@Gregory Lawton 

A2. In the post you quote from, I was describing the current law which, in my view, allows remote supervision. This is the case even without the Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008 which allow the RP to be absent for up to two hours a day. It is these Regulations that require the RP to be contactable if the RP is not on the premises. I then went on to set out possible options for legal change. These were simply ideas of how to make a change but it will not be up to me: it will be up to DHSC and its lawyers to decide how to do it. I am certainly not arguing that although remote supervision is permissible now, it should be permissible after the law is changed.

@Gregory Lawton Your Q3 is really at least three questions rolled into one:

A3. You need to read the sentence you quoted in the context of all my comments in the debate. Of course handing out a medicine is a key counselling opportunity. I am not saying that on every occasion a medicine that has been dispensed under supervision, it should be handed out when a pharmacist is not watching. I am saying that there will be occasions when it is not necessary for the pharmacist to be watching when a medicine previously dispensed under supervision is handed out. It should depend on the clinical judgement of the pharmacist who supervised the dispensing. As I said in another post, what supervision involves should depend on a range of things such as the nature of the medication, whether it is a repeat and the needs of the patient. These are things for the pharmacist to assess.

Secondly, I don’t think “handout errors” are a common form of dispensing error unless you mean that dispensed items are handed out to the wrong patient. I don’t see why the risk of that happening is greater if the pharmacist is not watching. I expect pharmacies to have SOPs to minimise this risk.

Thirdly, you are right that any dispensing error involves a criminal offence (section 64 of the Medicines Act 1968). Currently, that offence is committed by the person who makes the supply, namely the pharmacy owner and the person who physically hands over the medicine. In addition, the pharmacist who supervises has been treated as guilty (for example in the Elizabeth Lee case). As you know, there are now defences to prosecutions under section 64 of the Medicines Act, but if the law was changed to allow a previously dispensed medicine to be handed out without a pharmacist watching, and if there were no applicable defences in the Medicines Act, I expect that the pharmacy owner and the person who handed out the medicine would still be guilty of a criminal offence. Arguably, the pharmacist who was not required to be watching would no longer be guilty. This is, of course, all hypothetical and depends on the wording of any future law.

@Gregory Lawton 

We didn’t discuss last night assembling medicines in a pharmacy under supervision. As I understand it, DHSC/MHRA already accept that the requirement for supervision in section 10 of the Medicines Act can be met without a pharmacist watching the assembly of every item.

This debate is about how pharmacists supervise when medicines are supplied, not about supervision by pharmacy technicians. However, pharmacy technicians have an important role to play. This is clear from DHSC’s references to “skill mix” when setting out its intentions, for example in the 5-year funding plan for community pharmacy. I referred to DHSC's intentions a few times last night and I mentioned links. This is the link to the funding plan https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/819601/cpcf-2019-to-2024.pdf Have a look at paragraphs 31 and 32 in particular.

@David Reissner When I asked about techs and legal responsibility, I wasn't really referring to supervision, I was I guess alluding to the questions raised earlier regarding responsibility for errors made by techs whilst working under SOPs.

@Paul Baker I'm not quite sure what you are asking. I did explain in answer to one question that if the wrong medication is given out, then the person who hands it out commits an offence under section 64 of the Medicines Act (though they may now have a defence if certain conditions are met). Have a look at  this C&D report https://www.chemistanddruggist.co.uk/CD011844/Dispenser-loses-appeal-against-error-conviction Does that answer your question?

Hi @David Reissner, thank you for the replies.

I understand your point that you did not attend the debate as a Director of AIMp, but rather, as a person, who is a Director of AIMp.

In relation to Q1, I did not consider that you answered the question, though others can judge that for themselves. It is worth noting though that you said it was a "common view that the old cases require a pharmacist to watch every supply of P medicines and POMs", and not merely the view of the DHSC.


In relation to Q2, your proposal described future law, and the other bits I quoted were your explanations that, in effect, the pharmacy bodies have said that they do not want remote supervision. I would be interested in how you would reconcile your view that the current law allows remote supervision with the "common view that the old cases require a pharmacist to watch every supply of P medicines and POMs". I would also be interested to understand by what mechanism you believe the current law allows remote supervision.

Whilst you say that your proposals are merely examples parliament could adopt, it is striking that each time I've heard it said that remote supervision is not being discussed/talked about, or that it is not wanted, I've subsequently heard the same person - who in each case has been a senior figure at AIMp - cite an example which does appear to amount to remote supervision, and without saying what it is, precisely, that AIMp is proposing the change should be. To avoid further ambiguity, perhaps you, or a representative of AIMp could make clear - on behalf of the AIMp - precisely what it is that you are proposing, beyond saying that the law needs to change.


In relation to Q3, if it is for the pharmacist to assess whether the medication needs counselling points to be given, does the current law not already allow this? Further, you said that you expect pharmacies to have SOPs to minimise the risk of handout errors; if we're relying on the robustness of those SOPs, are you aware of any SOPs in the last decade, which have stated that handout must cease if the pharmacist is providing clinical services (because the pharmacist will not be watching over the supply)?

The last unnumbered question wasn't specifically meant for you. However, you may have missed the references to assembling medicines, which appeared in the live debate. Do you have a source showing that the "DHSC/MHRA already accept that the requirement for supervision in section 10 of the Medicines Act can be met without a pharmacist watching the assembly of every item"? I'd be interested to read how they interpreted supervision in this context, and on what basis they interpreted it in a different way to the courts in relation to handout.


You also said “Although the words in today’s law are different to the wording in 1933, there is a common view that the old cases require a pharmacist to watch every supply of P medicines and POMs. This makes it difficult for pharmacists to involve themselves in providing other clinical services.” 

What have pharmacists been doing to date? Have clinical services been on hold?

@Gregory Lawton Firstly, as you say, I am a person and that is how I am contributing to this debate. You could also say I am contributing as a lawyer and a patient, but not as a director of AIMp. Please don't read anything sinister into it. I am entitled to my own views and the views I express in this debate are my own. 

In relation to Q1, it is indeed a common view that the old cases (Roberts v Littlewoods Mail Order Stores and Pharmaceutical Society of Great Britain v Boots Cash Chemists (Southern) Ltd) require a pharmacist to watch every supply of P medicines and POMs. This is what generations of pharmacy students have been taught - see chapter 6 of the 11th edition of Dale & Appelbe’s Pharmacy and Medicines Law (2017), especially at pages 90-92. I am not saying I personally agree with this view and the new 12th edition is more nuanced (see pages 206-213 and 222-224). However, DHSC is not willing to risk the possibility that the old cases remain good law.

You ask what the mechanism is by which remote supervision is currently lawful. Let’s assume that supervision requires a pharmacist to be aware of what is being sold/supplied and in a position to intervene if a sale or supply would be inappropriate. If the pharmacist isn’t on the premises, all the pharmacy staff have to do is make a video call to a pharmacist anywhere. They can even use a handheld device or computer screen to put the patient/customer in front of the remote pharmacist.

You ask what I am proposing the change should be. I have spelt out ideas in posts above. I don’t want to spell out my own ideas in further detail here because it is something the pharmacy organisations, including those representing pharmacists, are currently discussing. It is something they need to work out.

In relation to your Q3, I haven’t said that current law doesn’t allow counselling. Counselling is allowed and, indeed, encouraged – but it is a professional matter rather than a legal requirement (except to the extent that the NHS terms of service deal with it).

When I was in legal practice, I saw many SOPs from a range of businesses. However, every pharmacy has its own and I don’t have access to them, so I can only answer your question in general terms. I am sure I have seen SOPs that deal with what should happen if the pharmacist is not present, and in earlier years I dealt with many Statutory Committee cases arising from supplies in the absence of a pharmacist, when it was made abundantly clear that instructions should be given to staff not to make any supplies in the absence of a pharmacist.

I cannot give you a direct reference to DHSC/MHRA’s position on supervision in section 10 of the Medicines Act 1968.  My understanding is that they have interpreted the law differently because they saw a need for flexibility and felt they did not have to follow the old cases because those old cases specifically relate to the sale of certain medicines under section 18 of the Pharmacy and Poisons Act 1933; it is, a requirement that can be traced through to regulation 220 of the Human Medicines Regulations 2012 which is in force today (though worded differently to the 1933 Act).  The requirement for supervision in section 10 of the Medicines Act 1968 has a different history and although I believe the word supervision should have the same meaning in section 10 and regulation 220, I am not aware of any case law on section 10. The absence of any case law has provided an opportunity to interpret section 10 in a way that reflects current practice and perceived needs when medicines are assembled.

I am going to answer your last question with a question. I am repeatedly told, and you have said again that pharmacists are already providing clinical services and using consultation rooms, and asked why a change in the law is needed. The point is: if their practice does not comply with the law (and DHSC will not concede that current practice is legally compliant when a pharmacist is not watching every supply), then the law has to be brought into line. Why don’t some pharmacists want this?

Hi @David Reissner 

Thank you for your reply, and apologies for the delay in mine.

I can understand why you wanted to be able to express your own views without them necessarily being attributed to AIMp; I imagine policy decisions at AIMp will be made through collective decision-making, not on the hoof by one person, mid-debate. At the same time, others were there seemingly acting in a representative capacity (but not themselves expressly saying that they were doing so); your view will be influential at AIMp; and I’m not aware of anyone at AIMp setting out exactly how it wants the law to change. Whilst I am interested in your views too, I asked what AIMp is proposing. Could you – acting on behalf of AIMp – or someone else acting as its representative -  state what its desired outcome is? It would be fanciful to think that AIMp doesn’t have a policy objective, when a group has been formed to address this specific question, and it is so actively involved in the discussions. What is it – as an organisation - proposing the law should change to?

 

To pick up on one of the points, you said: “I am sure I have seen SOPs that deal with what should happen if the pharmacist is not present, and in earlier years I dealt with many Statutory Committee cases arising from supplies in the absence of a pharmacist. I believe this was in response to my question, "are you aware of any SOPs in the last decade, which have stated that handout must cease if the pharmacist is providing clinical services (because the pharmacist will not be watching over the supply)?" The point I was asking about is what happens when the pharmacist is present in the pharmacy, but in the consultation room, for example, or speaking to another patient. Does handout cease – and do the SOPs require that to happen? The SOPs you have seen – do those refer to the pharmacist not being present at all on the premises, as opposed to when they are on the premises but not in a position to be aware of (and therefore supervise) the handout?

 

It may also be helpful to address the last paragraph of your post.

“I am going to answer your last question with a question. I am repeatedly told, and you have said again that pharmacists are already providing clinical services and using consultation rooms, and asked why a change in the law is needed. The point is: if their practice does not comply with the law (and DHSC will not concede that current practice is legally compliant when a pharmacist is not watching every supply), then the law has to be brought into line. Why don’t some pharmacists want this?”

I am left wondering who has been trying to get the DHSC to concede that practice is legally compliant when a pharmacist is not watching every supply, and for which providers that practice is "current", but this is not the main concern.

 

There are two issues with this last paragraph.

The first is that it does not logically follow that if practice does not comply with the law, the law has to be brought in to line. Pharmacists may well prefer to bring practice in to line with the law instead. If there is concern that practice does not comply with the law, then solutions could include a second pharmacist - as @Mark Koziol suggested on behalf of the PDA - and giving the pharmacist enough staff to allow him/her to supervise properly, so that he/she is not pulled in too many different directions and unable to focus on that particular task. Simply because the DHSC may want the law to change in a particular way does not mean that the profession should acquiesce and be silent on any objections it has.

Secondly, my reading of the law is that it is not pharmacists’ practice that does not comply with supervision law, if something is handed out without their supervision. Regulation 220 of the Human Medicines Regulations 2012 does not expressly state that a pharmacist must supervise the sale or supply. It is phrased instead as a requirement that if a person wants to sell or supply a medicine, then it must be supervised by a pharmacist. The pharmacy owner – acting through the person handing it out - must ensure that a pharmacist is supervising.

It appears that the law places the onus on the pharmacy owner to ensure there is a pharmacist supervising, and not on the pharmacist to supervise. In turn, it appears that it is the pharmacy owner who would be liable under Regulation 220 of the Human Medicines Regulations 2012. This provides:

220.—(1) Unless paragraph (2) applies, a person (“P”) may not sell or supply, or offer for sale or supply, a medicinal product that is not subject to general sale.

(2) This paragraph applies if—

(a)P is a person lawfully conducting a retail pharmacy business;

(b)the product is sold, supplied, or offered for sale or supply, on premises that are a registered pharmacy; and

(c)P or, if the transaction is carried out on P’s behalf by another person, that other person is, or acts under the supervision of, a pharmacist.

(3) This regulation is subject to Chapter 3.

 

In Regulation 220, “P” is the person selling or supplying the medicine, and in accordance with subparagraph (2)(a), he/she is also the pharmacy owner (this is what is meant by “a person lawfully conducting a retail pharmacy business”; that interpretation would be consistent with Sections 69 and 74BB, 74D, 74E, 74H, 74I and 78 of the Medicines Act 1968, and the fact that “P” is distinguished from “pharmacist” in Regulation 220). Ergo, it is the pharmacy owner who is selling or supplying the medicine under Regulation 220. In accordance with subparagraphs (1) and (2)(c), read together, if a person sells or supplies the medicine on behalf of P but this is not under the supervision of a pharmacist, P (the pharmacy owner) has acted unlawfully. Regulation 255(1)(c) sets out the associated criminal offence.

There’s a separate conversation to be had about who would ever face criminal charges in such a case, where there’s more than one shareholder. Who is the pharmacy owner in such a case?

Further, it seems that the pharmacist may also have some liability here, but this may be by virtue of section 72A of the Medicines Act 1968, rather than Regulation 220. Section 72A provides:

“1)

It is the duty of the responsible pharmacist mentioned in sections 70, 71 and 72 of this Act to secure the safe and effective running of the pharmacy business at the premises in question so far as concerns—

(a) the retail sale at those premises of medicinal products (whether they are on a general sale list or not), and

(b) the supply at those premises of such products in circumstances corresponding to retail sale.”

 

If, by the pharmacy owner failing to secure supervision of the sale or supply in accordance with Regulation 220, the pharmacist had also failed to secure the safe and effective running of the pharmacy business, then the pharmacist too could be liable. However, section 84 of the Medicines Act 1968 – which sets out the offences for Part IV of the act, including section 72A - does not set out any associated criminal offence for a breach of this provision.

I can understand that pharmacy owners may want legal certainty, even if they – if they are uncertain - have thus far been happy to carry on without it.

So, to what extent is certainty provided by the case law? I have been able to access the 11th edition of Dale and Appelbe to check the sections you cited. I have also examined Roberts v Littlewoods Mail Order Stores [1943] and Pharmaceutical Society of Great Britain v Boots Cash Chemists (Southern) Ltd [1953], and Summers v Congreve Horner [1992]. The cases relate to different law, but may be persuasive to different extents.

 

Roberts v Littlewoods

Held that supervision meant that the pharmacist must be aware of each individual sale and “bodily present” i.e. not upstairs or otherwise in a position in which he/she would not be aware of the sale.

 

Pharmaceutical Society v Boots

The pharmacist was present in person and he/she was in a position to intervene and prevent the sale / supply if necessary. Supervision could only occur at the time the contract was completed (i.e. the point of sale/supply).

 

The following is an interesting excerpt from the case, from the judgement of Lord Justice Somervell (though this section is not available in some of the law reports – the judgement varies by law report):

 

“The customer when he comes in is invited to take a receptacle and goes round and can choose the articles which he wants. He then goes to one of two desks at the end of the room, and there, admittedly, there is a registered pharmacist, able to carry out, subject to the point which I will mention in a moment, such duties as are involved in his position.

It is not disputed that in a chemist's shop where this system does not prevail a man may go in and ask a young lady, who will not herself be a registered pharmacist, for one of these articles on the List and the transaction may be completed and the article paid for, although the registered pharmacist, who will no doubt be on the premises, will not know anything himself of the transaction unless the assistant serving the customer, or the customer, requires to put a question to him.”

 

— IF the underlined section, “where this system does not prevail” is taken to mean pharmacies where the P meds are not available for self-selection for a customer to place into a basket, then the paragraph as a whole gives the impression that “it is not disputed” that routinely, the pharmacist will be on the premises but not involved in the transaction (this can be gleaned from “will not know anything of the transaction”) unless the assistant/customers specifically chose to involve them, or ask a question.

So, it seems the pharmacy point from that case (aside from the wider implications exploring the contractual elements and the point at which the transaction is complete) is that IF the P meds are available for self-selection, the pharmacist must supervise in the way described above in the first paragraph of this section, but if the layout is such that the medicines are not available to self-select and require the customer to request them, then that same level of supervision is not required. However, I appreciate that Somervell LJ’s comments are obiter, so may carry less weight than the ratio of the decision in the case.

 

Summers v Congreve Horner

This case relates to the activities of a residential surveyor of 3.5 years experience. Supervision, in the context of the contract considered in that case, was held by Staughton LJ to mean “keeping an eye on somebody, watching over them” but not “watching them every moment of the day”. Its meaning was also held to be dependent on the circumstances, and that it is enough if the unqualified person receives that degree of supervision which good practice requires in the profession. On the contrary, Parker LJ, dissenting, held that “supervision” in the context of the case meant attendance and observation in person (this point is not mentioned in Dale and Appelbe edition 11, at least on pages 90-92).

The applicability of the case to pharmacy may be limited; clearly, conducting a survey on a house is different to handing out medicines, and in pharmacy, “supervision” appears in statute, not in the context of a specific contract. If the case does apply to pharmacy, then an activity may only be held to be “supervision” if it is good practice in the profession. Consequently, if the video call you mentioned was not “good practice” in pharmacy, then it may not amount to supervision. “Good practice” may mean that a pharmacist is physically present; and there is no reason that a pharmacist could not be present. This would be in line with the view of Parker LJ (again if the case was applicable to pharmacy). As such, if my interpretation is correct, any pharmacy owner allowing remote supervision to happen could be liable at criminal law and commit an offence under Section 255 of the Human Medicines Regulations 2012.

 

Conclusion

It seems likely that Roberts v Littlewoods and Pharmaceutical Society v Boots would be more persuasive than Summers v Congreve Horner, particularly considering the genesis of the statute, including when taking into account the hierarchy of the courts involved in the respective decisions. As such, in my view the DHSC’s interpretation (though I have not seen it myself) is likely to be correct, which would mean remote supervision was prohibited. Please let me know though if you think there’s something I’ve missed, here.

 

Options for change

If change is needed, options include codifying Roberts v Littlewoods into statute, or codifying into statute that a pharmacist must be physically present in the pharmacy throughout its operating hours, but does not need to be aware of each and every sale and supply - provided that he/she is in a position to intervene if necessary and is satisfied that staff members authorised to conduct sales and supplies have been appropriately trained, and that they have been told of the circumstances in which they should ask the pharmacist to become involved in the sale/supply. That would seemingly meet the objective of providing legal certainty in statute and satisfying the DHSC objective of freeing pharmacists up to conduct clinical services – though the existing law does not seem to have troubled anyone in that regard between 1933 and now (other than Roberts, perhaps!).

 

Decriminalisation

In the same way as pharmacy owners might want legal certainty around supervision (arguably they have it), I’m sure whoever was supervising the sale or supply would want the certainty that inadvertent dispensing errors would not lead to criminal prosecution – be that the pharmacist, pharmacy owner or another member of staff. If the issue is one of legal certainty, I don’t see the supervision group calling for it in respect of criminal prosecution for inadvertent dispensing errors. It is not just sections 63 and 64 of the Medicines Act which need consideration in that regard; a person could, in my understanding, be found guilty under section 214 of the Human Medicines Regulations 2012 if they supply a medicine otherwise than in accordance with a prescription. Arguably the offence here may only be committed by pharmacy owners, but this has not been tested – and pharmacy owners shouldn’t have to face this uncertainty either. It seems to me though that if a pharmacist was no longer required to supervise the sale or supply of a medicine, in any circumstances, it would be equally unfair to the member of staff handing it out without supervision to be subject to the prospect of criminal prosecution. The outcome of any change to supervision law must also – if it is to be fair – address this issue.

 

Medicines assembly

I still do not understand why the DHSC believes a different interpretation of "supervision" can be given to dispensing & preparation than to handout (though again, I have not seen anything from the DHSC showing that this is its interpretation). "Supervision" in the context of dispensing & preparation can be found in Section 10 of the Medicines Act 1968 – which creates an exemption to Regulation 17 of the Human Medicines Regulations 2012. However, Regulations 31 to 35, which set out the offences for Part 3 – which in turn includes Regulation 17 – do not set out any statutory criminal offences for a breach. A breach of Regulation 17 would involve manufacture/assembly without a licence; what would be the consequences/sanction? Little, if any?

 

As such, I can see that removing the requirement for a pharmacist to supervise the handout has the potential to remove one of the fundamental pieces of legislation requiring a pharmacist to be physically present in a pharmacy. If it were to be removed in the case of dispensed, bagged up medicines, for example – ignoring for a moment the importance of the clinical check in such circumstances - what requirement would remain in statute to have a pharmacist present?