Pharmacist flouted suspension after patient's kidney damage

James Wootton (2021533) admitted all allegations against him, the GPhC heard
James Wootton (2021533) admitted all allegations against him, the GPhC heard

A pharmacist who dispensed “10 times” the prescribed dose of an antineoplastic medicine to a patient later hospitalised with kidney damage has been struck off for practising while suspended.

James Cradock Wootton – registration number 2021533 – also dispensed warfarin without checking the international normalised ratio (INR) level of a patient who later died “as a result of… the anticoagulants he was taking”, the General Pharmaceutical Council’s (GPhC) fitness-to-practise committee noted at a hearing on June 12.

The GPhC highlighted that Mr Wootton, who was not present at the hearing, had “admitted all the allegations against him in their entirety, in a series of emails to the council”.

But it stressed that Mr Wootton had not only caused “very serious harm to individual patients”, but had later “flouted” restrictions by falsifying pharmacy records in an attempt to “cover up” working as a pharmacist while suspended.

A series of dispensing safety breaches

Mr Wootton made a “series of serious breaches of safe dispensing requirements in relation to six different patients” in 2015 while he was working in the pharmacy he owns in Rhymney, Caerphilly in Wales, the regulator noted.

This included twice dispensing warfarin to a patient without a valid prescription, and without checking their INR level. The patient later “died as a result of a gastrointestinal haemorrhage and the anticoagulants he was taking”, the GPhC noted.

Mr Wootton issued another patient a prescription for Hydrea 500mg tablets, with a label instructing them to take – in the words of the GPhC – “nearly 10 times the proper dose”. “After taking the incorrect dose for two weeks, [the patient] was admitted to hospital with acute kidney damage,” the regulator summarised.

The GPhC also noted that at various times, Mr Wootton: dispensed furosemide and quinine sulphate to patients without a valid prescription; instructed a patient to take twice the prescribed daily dose of bisoprolol; and gave another patient a month’s supply of seven different drugs, when they only had a prescription for a seven day-supply of them.

Working while suspended

An investigation by the GPhC led to Mr Wootton being suspended from the register in 2016. However, a further dispensing error brought to light that he had breached this condition on his licence “by working as a responsible pharmacist, without direct workplace supervision, and without having his dispensing checked”, it said.

“He tried to cover up the fact that he had been working in breach of his suspension by twice falsifying pharmacy and dispensing records to suggest another person had been the responsible pharmacist,” the GPhC said.

This led to Mr Wootton being convicted at Cwmbran Magistrates’ Court in February 2017 for having “practised as a pharmacist while not being entered as such in part one or four of the register” on two occasions in July 2016.

Full admissions

The GPhC acknowledged that Mr Wootton – who said he has retired from working as a pharmacist – had “made full admissions in these proceedings, in the same way he pleaded guilty in court”.

However, “that is about all we can say in his favour”, the regulator said.

“Got things very badly wrong”

It concluded that Mr Wootton had “got things very badly wrong in his work” through a series of “repeated and protracted failings” that resulted in “very serious harm” to two patients.

“The registrant dug himself in deeper and deeper by attempting to mislead the council… by evading the controls which the council sought to impose on him, and then by trying to cover up that evasion when he was found out,” it continued.

It also claimed that he was “not wholly of good character”, as he had received a three-month prison sentence in 2009 for “having a knife in a public place” – a conviction which he failed to report to the GPhC.

The regulator stressed that there is “no evidence the registrant has done anything to remediate his obvious shortcomings as a dispensing pharmacist”, and ruled to strike him from the GPhC register.

Read the full determination here.

34 Comments
Question: 
What do you make of the GPhC's ruling?

Arvind Sami, Locum pharmacist

The problem I see it is that, even knowing an INR, in community, how would one ascertain what dose is actually needed? From my understanding the problem with warfarin, and please correct me if I am wrong, was that the dose to INR target relationship wasn't wholly predictable. The clinics were there to find an optimal dose. The benefit of the newer anticoagulatnts, apixiban or ticagrelor for example, was that no clinic was needed?

Does the patient know what dose they are "meant" to be taking? As others have mentioned, most of the doses are written as directed / acccording to INR clinic, or something to that effect trying to contact a doctor is near impossible!

Francis Andrews, Non Pharmacist Branch Manager

Rather than have 'digs' at each other's spelling and punctuation, we should all take this as an oppurtunity to reflect on our practices? Would it be advisable to add a note to a patient's PMR confirming whether or not INR has been checked recently or in conjunction with dispensing thier Warfarin?

Gerry Diamond, Primary care pharmacist

Shocking and negligent

Tom Kennedy, Pharmacy Area manager/ Operations Manager

A pharmacist does jail time for carrying a knife around and all anyone talks about is him not asking to see an INR book.  Lol pharmacists are weirdos.

 

 

Nat Mitchell, Community pharmacist

Ha! The thing is that most of us can understand taking a knife into work, but we just don't get the INR thing!!

David Moore, Locum pharmacist

No one here seems to have commented on the fact that this pharmacist was still practicing despite being suspended.

peter kelly, Community pharmacist

The Warfarin case is interesting. My software gives me the option of recording a patients INR. It doesn't give an option of recording that the person handing in the prescription was asked for an INR reading but did not have it to hand. This option would be helpful.  

Kevin Western, Community pharmacist

ps I think the key phrase here is "without a valid prescription" and presumably without going through the emergency supply procedure - how many of us "loan" meds... 

Kevin Western, Community pharmacist

We ask for INRs and most patients know them, another clue is to ask how often they have them checked.. if its every 6 weeks they are generally well controlled, if its weekly then things arent going well and I will look into it further may even (Whisper) do an MUR... i would also ask what dose they are taking and how they make it up.. 4 browns or a blue and brown etc.

there are some we never see and cant help but thats life im afraid. I wouldnt refuse to dispense without a good reason, never seen INR on SCR so that doesnt help either.

Valentine Trodd, Community pharmacist

From a practical point of view... impossible to consistently check INR levels in community pharmacy. Deliveries are 75% of my work in current job - never see most of them - and wouldn't have the foggiest of their INR. In fact I don't recall seeing a single yellow book in the last 5 years. This guidance is written by people in ivory towers with no clue of what's going on in the real world.

community pharmacist,

Fair enough for deliveries it is hard but where I work we ask them and nine times out of ten they either have their yellow book or know the INR. In some cases they will come back to show us or ring up and let us know so I still think it is worth checking. 

Stephen Eggleston, Community pharmacist

All you can do is request to see the yellow book and if none is available, try to check if the patient knows what dose and INR result is the target - and then record the details on the PMR. Refusal to dispense seems both impractical and potentially dangerous. As already mentioned, start asking for the yellow book and patients will soon get used to the idea and volunteer it

Nat Mitchell, Community pharmacist

I'm still asking for exemption certificates each time!

Thomas Bisset, Community pharmacist

The salient warfarin issue is "supply without a prescription or checking INR", so no one was in a position to check. You can "encourage" patients to bring in their books next, or only supplying a week's worth till you see the book. Just accepting that they don't have it, not asking and not trying is something I've been guilty of in the past. The lesson here is if it goes wrong, willfully ignoring guidance is not a defence. 

Anne Cole, Hospital pharmacist

NPSA alert Mar 2007: http://www.nrls.npsa.nhs.uk/resources/?EntryId45=59814
Actions that can make anticoagulant therapy safer: Alert and other information

Healthcare organisations in England and Wales should:
- Ensure that patients prescribed anticoagulants receive appropriate information.
- Promote safe practice for prescribers and pharmacists to check that patients’ blood clotting (International Normalised Ratio, INR) is monitored regularly and that the INR level is safe before issuing or dispensing repeat prescriptions for oral anticoagulants.

Ben Merriman, Community pharmacist

[Devil's Advocate mode] If a Rx was presented to you on a Saturday afternoon and the patient had no yellow book/INRStar print off, would you refuse to dispense?  what about on a Saturday afternoon when the surgery was closed and the patient had none left?

Nat Mitchell, Community pharmacist

I was aware of this guidance but I must admit that I don't follow it.  I just don't think that it would work.  Deliveries, family collecting, patients not knowing their INR, surgery not knowing their INR.  All real world issues I'm afraid and guidance is often not written with the real world in mind.

Ilove Pharmacy, Non Pharmacist Branch Manager

Save yourself the aggravation and send them to A&E unless you're not too bothered about being struck off(zero guarantee that an employer will defend you)  Patients at some point will have to take responsibility for their own health.

A Hussain, Senior Management

If you don't know the dose then the INR isn't much use to you and patient's aren't armed with their yellow book at all times.  GP's know their INR so I'm afraid that this is their job.  Just state the number of mg required until the next INR and the problem is solved.

Anne Cole, Hospital pharmacist

The INR is an essential measure of efficacy and safety. It is the role of pharmacists to check safety at the point of dispensing. If your patients don't bring their yellow books why not start asking them to bring them? Over time they will become used to bringing them in and be reassured that another professional is checking their warfarin is safe. It is the role of the patient's whole healthcare team to check their medicines are as safe as possible for them #teamwork

A Hussain, Senior Management

Not going to work in community.  Hospital is different.  I don't know a patients cholesterol, blood glucose etc etc and I still dispense the corresponding meds.  Guidance is just that.  I would ask about monitoring if doing an emergency supply but not if it's on a prescription.  I repeat.  The GP has the relevant information to hand.  To write a vague script and leave it upto the patient and pharmacist to work out is the issue.  I don't know what the relevant dose is for a given INR.  Why is that?  It's because it's not really my job.  I have plenty to do without this daft 'guidance'.

Gerry Diamond, Primary care pharmacist

There is merit in all arguments. Practice pharmacist have access to INRs and check latest results and patient attended clinics before issuing anticoagulants meds. But if a rx is delivered by a community pharmacy who knows if the pharmacist does a second check when most repeat meds may not have an interaction with the patient. I guess at least on week days you can check with the GP surgery and the patient. Failing that the patient or their rep should attend chemist to show yellow book. As an OOH pharmacist I would probably ask the patient to attend the treatment centre with their yellow book before issuing a warafrin rx at weekend. Otherwise I'd pass it on to GP and not touch it with a barge pole. Sorry to hear that chap got struck off but it's changed days,,,,

A Hussain, Senior Management

Rather not dispense/prescribe a life saving medication than risk a theoretical problem!  That's probably against guidance too.  What if the patient refuses to show you their yellow book?  Also, when were you last the pharmacist trying to get hold of the GP for an urgent problem, let alone one that you have created out of nothing?

Gerry Diamond, Primary care pharmacist

Mr Hussain I assume you are not a clinician and there are protocols for prescribing safely in OOH services. As an advance practitioner every effort is made to meet patient needs and where there is a paucity of clinical information then the matter is past to a GP on duty in order to work within a clinical governance framework,

 

Thank you

G Diamond BSc MSc MBA DipClinPharm Dip.Diabetic. Dip Resp.Care NMP RPEBC MRPharMS

Anonymous Anonymous, Information Technology

Who actually writes all of their qualifications after their name?!? Next you'll be telling us you won first prize in year three for spelling!

A Hussain, Senior Management

Gerry I'm not going to get into the argument over whether I am 'clinical' or not.  Congratulations on all of your post-nominals by the way.  I've seen surgeons with fewer letters after their names you clever boy.  No diplomas in English I see. If there were then you would know the difference between passed and past.  Maybe you could prescribe some flamazine for that burn!!

Gerry Diamond, Primary care pharmacist

Clearly neither clinical or managerial lolx

A Hussain, Senior Management

Gerry, remember this. It's nor after neither. Or comes after either. English isn't even my first language!!

As an owner/part owner of four pharmacies, I am aware that this doesn't exactly make me Bill Gates. But I employ over 30 people so I bet that I could show you a thing or two about management. 

Ilove Pharmacy, Non Pharmacist Branch Manager

Be glad you're not Bill Gates who is busy forcing GM foods on Africa and pretending to try and cure malaria

 

Chemical Mistry, Editorial

Always ask the patient for the INR and their the range they should be in, usually are very knowlegable and now changed over to the newer drugs like apixaban etc.

Usually stated in the SOP'S so better to be clued up in good practice similar for Lithium levels Blue book.

Not having a go at anyone just pointing it out since assume this pharmacist was over 40 and you can't be to careful nowadays i hear.

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