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Legal view: Pharmacists beware these CPCS pitfalls

“How many pharmacists feel confident that they would spot a red flag for cauda equina syndrome?”

The Community Pharmacist Consultation Service (CPCS) could land a pharmacist in legal trouble if red flag symptoms are missed, warns lawyer Noel Wardle

C+D recently reported that more than 90% of pharmacies in England have signed up to the new CPCS. Patients access the service through NHS 111 referrals for either the urgent provision of medicines or the treatment of minor illness. In the first two months of the service, more than 114,000 referrals were made, of which more than 50,000 were for patients with minor illnesses.

Where patients are referred for the treatment of a minor illness, they will usually visit the pharmacy for a face-to-face consultation during which the pharmacist is likely to consult the patient’s summary care record – with their consent, of course.

During the consultation, pharmacists must ensure that any red flags that may suggest a more serious underlying medical condition requiring onward referral are identified. This is a reference to red flag symptoms, contained within the clinical knowledge summaries produced by the National Institute for health and Care Excellence (Nice).

There are around 350 summaries listed on the Nice website, covering a wide range of conditions – from Achilles tendinopathy to whooping cough – so it may take pharmacists some time to familiarise themselves with this guidance.

While many pharmacists will feel confident advising patients, they should be aware of the risks of misdiagnosis or missing a red flag. For example, how many pharmacists feel confident that they would spot a red flag for cauda equina syndrome. And what would be the consequence of missing one?

Pharmacists carrying out the CPCS risk a claim for compensation if an error is made as part of a diagnosis that leads to patient harm. Any compensation claim should be covered by professional indemnity insurance, but premiums may rise if insurers believe the risk of claims is increasing. The General Pharmaceutical Council may also undertake a fitness-to-practise investigation if it believes that an individual is not practising with the requisite skill and care.

A healthcare practitioner who causes the death of a patient through gross negligence may face prosecution for manslaughter, but this is rare. In a review carried out following the Bawa-Garba case, the General Medical Council estimated that on average one doctor a year is investigated and prosecuted for gross negligence manslaughter.

While, to date, no pharmacist has been convicted of gross negligence manslaughter, the pharmacist’s role is becoming more clinical in nature and more autonomous, in the sense that pharmacists are moving away from “just” dispensing prescriptions written by others. With this, there is a greater risk of an error occurring that may be considered “truly and exceptionally bad” and so amounts to gross negligence.

Although pharmacists will no doubt welcome the service, and are being encouraged by leadership organisations to embrace a more clinical role, they do need to ensure that they and their teams have the appropriate knowledge and training to perform the service safely and effectively. For those who are not sure, there are training sessions and courses available.

It is expected that the CPCS referral pathway will be widened at the end of this year to allow GPs to make referrals. This is likely to increase the number of referrals significantly, given the pressure on GPs. Now would be a good time to make sure that the whole pharmacy team has the necessary skills, because it will be too late if a red flag is missed. And the consequences could be serious, for both the patient and the pharmacist.

Noel Wardle is a partner and head of healthcare regulation at Charles Russell Speechlys LLP

31 Comments

Community Pharmacist, Community pharmacist

We are often getting referrals for UTIs that can only be managed with antibiotics.

Also, patients are being referred outside of our opening hours.

As for sepsis identification equipment, most owners will not purchase it. Especially, if they own couple of pharmacies, cost quickly adds up. In terms of using the equipment, who has been signed off as competent?

If we are forced to provide a service, we should be given tools to do it properly by the NHS.

Leon The Apothecary, Student

It's a good point, Pharmacists providing these services would ideally benefit from having basic diagnosic training. Basic equipment is likely to set a Pharmacy back by...about a £100, it's the ECG that's the expensive part - they are about £500 each even for a basic model.

If the NHS wants Pharmacists to do more services like this, I personally think it would be great value for them to provide them with some equipment.

Leon The Apothecary, Student

I would respectfully what diagnostic tools and training docommunity Pharmacists have available to them to conduct reasonable observations?

Is Pharmacy a reasonable location to conduct a set of observations? Consultation rooms can be pretty varied in terms of quality in my experience.

Are Pharmacists a reasonable professional to be conducting observations for this, or is it out-of-scope?

Leon The Apothecary, Student

I believe it is a clear indication that Pharmacists to perform CPCS effectively would highly benefit from having proper diagnostic training and equipment similar to a paramedic such as their Lifepack 15 and primary bag.

As it stands at the moment there's a couple of risks. How are Pharmacists able to diagnose query sepsis with a news2 score when they don't have half the equipment to make the needed observations?

Uma Patel, Community pharmacist

I accept the basic point of missing ‘Red Flag’ symptoms and the consequences thereof.

However Mr Wardle has selected a rare example effecting 1 in 70000. I would like to make the following points:

Average GP has a list of about 2000 and a pharmacy serves about 6000 patients

In over 40 years as community pharmacist I have never heard of cauda equina syndrome. I doubt if many colleagues have either

NICE Clinical Knowledge Summaries (CKS) does not mention this condition

CKS is for ‘primary care practitioners’. It is not meant for over the phone or personal minor ailment consultation

Competence is judged by peer comparison

I think such articles cause unnecessary anxiety and deter pharmacist from accepting roles within their competencies

Gabriela Peterlin, Locum pharmacist

So very true. Pharmacists are not doctors-as much as many would like to believe they are-and are not equipped for making diagnosis. Sincerely, how many doctors, trained for it, do?? This service is ridiculous for pharmacists to do, as many of my colleagues think. Time to abolish it completely. 

Brian Plainer, Locum pharmacist

Cauda equina is rare. Best advice here is if there's bilateral sciatica then patient is promptly referred to their GP for checking as an MRI is most likely needed to ascertain the cause. At FIRST SIGN lack of control of urination/defaecation and/or pain/numbness in the rectal/urinary region - they need to call 999 for an emergency ambulance.

I also only discovered this as I'm currently struggling with bilateral sciatica yet am unable to obtain a routine MRI due to Covid situation.

GP's may see a handful only of such cases throughout their careers, but missing it as a diagnosis can be extremely costly as the consequences to affected patients can be life-changingly dire.

David Richards, Primary care pharmacist

Just incase you need it.....

https://cks.nice.org.uk/sciatica-lumbar-radiculopathy#!diagnosisSub:1

Although I wonder how any litigation defense would hold up in court when they ask to prove competence, considering we aren't taught diagnostic skills unless you undertake extra clinical training. If someone ever presented with something you feel you can't deal with just refer them and document it.

Angela Channing, Community pharmacist

Exactly what I thought. Scare-mongering. Never heard of it either and all it does is make newly qualifieds and those lacking clinical confidence to say "go to your GP/Casualty".

Then we end up with people with opinions like the guy on ThisMorning. If there is ever an article about consulting your pharmacist on ...... in say, the DailyMail/Wail! then straight to the hundreds of comments and there will be dozens saying the same thing:-

" I went to the chemist (sic) like they tell you and the young chap/girl there thought for a minute and said, ... I think you should go and see your GP,  so if the chemist won't give you anything, what's the point? "

And this comes up time and time again. Why do pharmacists not have the confidence anymore to deal with simple minor ailments. Why are they scared to consult or sell OTC or recommend some vitamins or something, anything?

Statistically the person probably isn't going to die if they have no red flag symptoms and you tell them to try an OTC remedy for a few days.

As any old retired GP will tell you, in most acute minor things...."time heals".  I'm thinking over zealous Law and Ethics lecturers are filling the kiddies heads with everything that could go wrong rather than the stats as stated above  1 in 70,000. And I can guarantee this article has already made some less confident community pharmacists think.... "I'm just going to refer nearly everything on this new CPCS thing". 

Gabriela Peterlin, Locum pharmacist

You are so very right! 

Leon The Apothecary, Student

If it looks like a horse, smells like a horse, and sounds like a horse, then it's most likely a horse...but beware zebras

I would argue anyone who has to diagnose has to beware the risks of a misdiagnosis; which means it's important to ensure we show our clinical diligence when we do refer. We can't confirm something, but we also can't exclude it either!

Angela Channing, Community pharmacist

From the tv show ER, " if you hear hooves, think horses not zebras!".  

The guy who wrote this article obviously thinks we are on an African safari, rather than spending most days at the local stables/riding centre. 

PS.  Leon, we aren't trained in diagnosis. 

Leon The Apothecary, Student

It's a very good point Angela, I feel Pharmacists need to have training in taking basic observations and interpreting them, at least to fully realise the goal of CPCS.

Caroline Jones, Community pharmacist

With all these extra skills and risks.....where is the extra pay to compensate? Some Pharmacists are being paid £15/16ph........

Gabriela Peterlin, Locum pharmacist

They want you to study for free, spend extra time for free, be a doctor, and on top of it, do not even provide space and facilities within pharmacies, and peace of mind. But I think all this is the sector’s fault, as it forgot what true pharmacy is. It is not a doctor’s surgery. There is a division of work. Doctors diagnose, chemists ‘mix’ medicines. I am lucky enough to have started in proper pharmacy,  long ago, not this strange construct what is has become. Milking public for funds that we do not even see. 

Benie I, Locum pharmacist

And yet CPCS was hastily thrust on pharmacists with little or no training. If in doubt send the patient to A&E seems to be the safest option for.all parties. 
And for this extra responsibilty the pharmacist has the privilege of doing it all for free.

 

 

 

Snake Plissken, Student

Recently contacted A&E for chap. Came in wanting a replacement for his blue inhaler. Could barely complete a full sentence sat down. The person responding over the phone was expecting me to have completed a full clinical assessment after asking if he was conscious. Wanted oxygen sats, temp etc. When I told her a didn’t have the kit to give her that info she put the phone down. Luckily the operator was still connected and put me through to someone else a little more understanding.

I don’t quite think the rest of the nhs quite understand our position/clinical competence in community pharmacy. 

Pear Tree, Community pharmacist

I don't understand how one is supposed to undertake a clinical assessment without a thermometer, pulse oximeter, BP monitor, and stethoscope, ophthalmoscope,a torch, and a tongue depressor, and then confidently re-assure someone to go back home and take some pain relief tablets. What if they had pneumonia/meningitis and your false re-assurance results in septic shock? ITU admission and ventilatory support? Or DEATH? My point   is how are you going to answer when the coroner asks: have you listened for crackles? percussed for dullness? checked sat levels? Resp rate? In my opinion, the way the service is written/specified, which seem to place clinical errors/ommissions purely as the pharmacist's responsibilities, should be changed to reflect the limited observation and the examination equipment and room available to pharmacists. 

Angela Channing, Community pharmacist

I was of the understanding CPCS was a combo deal of minor ailments and emergency supply. If any of those exams are needed then you just have to refer. I am hoping 111 have their algorithms set up to only send us 'minor ailments' that can be treated with an OTC med.  Hopefully as well, their system also flags up all CD 2 and 3s that we cannot give out as E.S.  e.g. tramadol !  " the man on the phone said you could give me some trammies?!?!"  "Errr, sorry no"    "******** expletives"  ......door slams.

Please get that sorted please 111 people! 

Benie I, Locum pharmacist

No consistency with nhs 111.

Leon The Apothecary, Student

Hoping their merge will see some changes.

Reeyah H, Community pharmacist

All that sepsis training and we don't keep oximeters. For a full check, we would need at least half an hour giving time to complete obvs and add score up. Now we are being threatened that if don't make a success out of this, it's somehow our fault and no more services will be given to us. WHERE IS THE TRAINING?!!! Apart from one day courses by CPPE, which were advertised AFTER CPCS went live? 

Angela Channing, Community pharmacist

Just as with MURs, I think we are set up from the beginning to fail. Everyone on here seems to be rambling on as though the consulting room is now to become a set from 'ER' or 'Casualty' ?!

The way I understand it (and I will await the CPPE course in the Spring with bated breath!) to paraphrase The Rt Hon Mrs. Theresa May (on her 2017 manifesto!)  "Nothing has changed!! "  It's emergency supply and minor ailments schemes.

What is all this talk of paramedic bags and oxi-whatsits?!?! I rather feel, some people are getting a little carried away.  ( I was talking to a friend of mine who told me, a customer who is a solicitor is taking a Practice Pharmacist to court for a missed diagnosis).

To those old enough to remember Hill Street Blues tv show.... "Hey...., lets be careful out there!" 

Leon The Apothecary, Student

I keep a set of equipment, including a steth, sphyg, and oximeter on my person for that very reason. I feel there's a risk I can negate by having the needed tools available.

Benie I, Locum pharmacist

And who paid fort those items ?

Leon The Apothecary, Student

Tax-deducible items for a locum, my friend. Wasn't expensive, and money well spent, in my opinion! Although, I think it would be very reasonable to buy a set of basic equipment for anyone who is seriously considering CPCS as a minor ailment scheme in the future.

Leon, is your indemnity provider aware you are potentially performing diagnostic readings and referring/not referring based on these readings? 

C A, Community pharmacist

And providing your "own tools" is one of the things the HMRC look at to determine if you are truely self employed...

Angela Channing, Community pharmacist

Can pharmacy students do all that now then?! Only joking, I'm assuming you have qualifed now? and are an IP and/or have done the advanced clinical practitioner course or whatever it is known as. 

But I'm sorry Leon, and I'm sure most would agree with me, especially us 'oldies' we have not been trained in diagnosis and I don't want to be a 'pretend' Dr. with that equipment! I wouldn't know how to use it anyway. (beyond my competence level I think the GPhC would phrase it).

Have you actually been officially trained to use these things? And, how many times a week do you use them? It was bad enough lugging a big certificate around, let alone half the set of ER ! 

I carry a vitamin and herbal medicines book, a pack of 20 pens!  (where do they all go?!) and a few local CCG charts and paperwork for services and a water bottle. As far as I'm concerned it's emergency supply and minor ailments and if it isn't one of those or needs such 'equipment' then they will be referred.  Above my pay grade, I'm afraid! I mean, what next? Whipping out an appendix on the consulting room table?!?! 

Leon The Apothecary, Student

Oh, been working within the pharmacy setting for about 12 years or so Angela, I'm no spring chicken myself!

Different kind of student these days, but I have had formal training and certification in completing most observations.

It's interesting because I wonder what is the perception of Pharmacists is when CPCS was conceptualised, and how it could be evolved with some additional training.

Also, the pens are always gone.

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