Gloucestershire treatment algorithm is harmful and at odds with NICE

Gloucestershire is a beautiful county – but like the villages in Midsomer Murders, a potentially harmful place to live if you need B12 injections and your GP follows this Primary Care Management Treatment Algorithm. (4th section down).

How many B12 deficient patients are at risk of permanent damage in this area? How many struggle with poor mental health? How many are bed bound, confused, living in pain believing that their B12 deficiency is being ‘treated’ so wondering what on earth is causing their body and mind to feel like it’s shutting down?

There are threads on Twitter of doctors from Gloucestershire proudly sharing this treatment algorithm and feeling really smart because they were ahead of the COVID 19 curve in giving just about everybody oral B12 supplements.

It’s all in your mind…

I’ve heard of many patients being told that their debilitating symptoms can’t be due to B12 deficiency. That it’s more likely to be due to their age, their lifestyle, or the fact they have young children, or a stressful job, or – and this is the worst, that it’s all in their “imagination”.

So the long suffering patient is either sent to hospital to see every other Tom Dick or Harry in a network of ‘ologists’ often waiting months for appointments in order that it satisfies the urge of the GP to pin the symptoms on ‘something else’ because ‘it won’t be B12 deficiency causing the symptoms because your serum levels are really high at 200pg/ml.”

My own deficiency could have been ignored if I’d lived in this area. You’ll see they don’t appear to bother with people with serum level’s over 180pg/ml. I was diagnosed with a level of 216 (reference range of 220 -771). I wouldn’t even be worthy of the GP looking at the chart despite my many presenting symptoms. The problem of differing reference ranges of B12 levels has been well documented and the BMJ state that there is no ideal test and that the clinical picture is of utmost importance.

Terrifying isn’t it?

What’s really worrying about B12 deficiency and the way it is handled by those who have little knowledge of it, is that the patient very often starts off in the dark and then remains in the dark because they ‘trust’ that their GP is ‘all knowing’. They don’t consider that the information their GP has imparted is not complete, not properly informed, not helpful. They then deteriorate, but don’t question their treatment, don’t ask Dr Google, don’t seek more information because they have been either pushed down another path for a further red herring diagnosis or just simply ignored.

How to start treatment with B12 injections in Gloucestershire using this algorithm: 

  1. Your B12 has to be lower than 180pg/ml
  2. You must have neurological symptoms (on their list)
  3. You must have macrocytosis and anaemia
  4. You must be positive for anti intrinsic factor antibodies – (but after loading you will be put on oral tablets!)

But if you are not presenting with the list of ‘allowed neurological symptoms’ i.e. those recognised by your GP – and you have no anaemia (which by the way, is not always present and can be a very late stage symptom) then, even if your result falls between 150-180 – the GP is instructed to:

“Reassure the patient that this is unlikely to be of concern. Recheck serum B12 after 3 months, if still low, monitor B12 level every 6 months for 1 year and then annually for 2-5 years.” 

Now I’m no rocket scientist but even I know that this is pure bonkers. It still offers no treatment.

B12 deficiency comes in all shapes and sizes, with many causes and many symptoms

If I use my own case as an exercise of using this algorithm here: –
My level was 220, I had no anaemia, no IFA, no neurological symptoms that they list, but I was losing my memory, I had bowel and bladder problems, blurred vision, insomnia, anxiety, low back problems to name a just a few and yet I wouldn’t warrant treating. I dread to think how quickly I would have been confined to a care home with early onset dementia if I had been ‘cared for’ here.

Even if I had PA, if my GP had used this chart I would be placed onto oral tablets following the loading dose. This is complete madness. (Please see more on the low quality evidence on oral supplementation  here)

If my deficiency had been caused by malabsorption due to a drug such as metformin for diabetes I would have been advised to take calcium supplements or increase dietary calcium but would not be  given B12 injections in fact I would only be allowed B12 oral tablets. This is totally bizarre, misinformed guidance.

Where is the patient?

At no point does this algorithm suggest LISTENING to the patient or considering the clinical picture. The patient doesn’t exist here, just blood forms and it’s completely wrong.

The only tiny mention ‘people’ get here is the suggestion that buying oral supplements over the counter may be cheaper than the NHS Prescription charge. WOW.

This algorithm is at odds with NICE guidance and is a ridiculous home-made protocol which won’t work for the vast majority. It’s time for Gloucestershire to start following good practice for patients.

What NICE state:

  • Not thought to be diet related — administer hydroxocobalamin 1 mg intramuscularly every 2–3 months for life.
  • Thought to be diet related — advise people either to take oral cyanocobalamin tablets 50–150 micrograms daily

So what can be done?

If you are in Gloucestershire – (or anywhere else this is happening), why not take action to make change? Your voice counts and you absolutely matter.

Why not contact;
The Expert Patient Programme – (The EPP is an NHS initiative to improve the lives of those living with long-term conditions such as diabetes, Parkinson’s, lupus, epilepsy, ME, arthritis, fibromyalgia or heart disease). NHS Gloucestershire offers the Expert Patient Programme (EPP) which you can access by telephone on 0300 421 1623

B12 deficiency is a long term condition, you have a lot to offer, make sure you are represented! Get you voice heard here and ask for their help.

Healthwatch
You could also call Healthwatch Gloucestershire on 0800 652 5193 tell them your story, ask for their help in accessing correct treatment.

Write to your CCG, why not email your MP and maybe send them this blog? Why not ask your friends and family to do the same?

The BSH have recently bowed under public pressure let’s help Gloucestershire to do the same here, make your voice count!

Don’t let your GP take you down Folly Lane, there is no time for foolishness or delay in treating B12 deficiency, time is of the essence and you deserve every chance possible of repairing your nerves.

Very best wishes

Tracey
www.b12deficiency.info

If you think you might be B12 deficient please click here, and please try not to supplement before testing.

Please add your signature here if you would like to support making B12 OTC in the UK – Please DO NOT pay to sign! Any money given does not go toward the cause you are supporting.

 

COVID 19 is leaving B12 deficient patients unprotected & traumatised….

Gradually, everything that was remotely protective for B12 deficient patients appears to be being deleted, eroded and changed to suit those who seem intent on switching us permanently to tablets which won’t help to repair nerves.

B12 supports the immune system, it is vital for life, injections are required to keep those of us who cannot absorb B12 from food well and functioning. The WHO list hydroxocobalamin as an essential medicine. Humans simply cannot live without it and should not be forced to, but that’s what’s happening now.

Those having injections regularly cannot absorb B12 from food, it is not dietary lack that brought them to their knees it was one of the other many causes of B12 deficiency.

Many are terrified to challenge their GP’s, many who have asked to be allowed to self inject have been ignored. Nurses are calling patients for their agreement to permanently switch their future treatment to tablets only. This must be resisted at all costs, see why below. Patients are already traumatised by COVID, separated from their loved ones and then have to deal without vital treatment because of a distinct lack of understanding of this very common and commonly misdiagnosed condition.

Things are changing day by day and there is no one sensible source of information for our GP’s. Some patients have had letters stating the GP’s are following advice from Public Health England, NHS England, CCG’s, etc and some even say ‘advice from Europe’.

 

The situation is an absolute disaster and needs sorting fast.

Patients need vital injections

Patients can be taught to give injections, we can be trusted, we are adults

Patients can then function, can do their Key work, can look after their families, can maintain mobility, can reduce pain levels and keep mental health problems at bay.

The BMA (British Medical Association) March

In March the BMA produced a traffic light workload prioritisation table for the RCGP.

Stating:
………Past experience has shown that patients will die from non-COVID-19 related illnesses in addition to COVID-19 itself as we divert all of our health care resources towards it (1). General Practice has a huge role to play in maintaining the underlying health of our population in an attempt to prevent this. It is vital that we continue to provide care to all patients if we have the capacity, with workloads stratified to ensure that those at greatest need are prioritised.”

It uses the following headings:

GREEN – CONTINUE      AMBER – IF POSSIBLE       RED – STOP

B12 injections are under Amber as follows;

“Vitamin B12 injections – consider teaching appropriate patients to self-administer and ensure frequency is not more than 12 weekly”

(Not more than 12 weekly eh? That’s not what NICE say – see below!).

BMA April

B12 injections have since been downgraded by the BMA and the headings have been changed, only a few are now considered “Medium Priority” as of April the 10th 2020.

Amber – Medium Priority

“Vitamin B12 injections for post bariatric surgery patients – consider teaching appropriate patients to self-administer and ensure frequency is not more than 12 weekly. Review whether oral supplementation would be appropriate”.

Red – Lower Priority

“Vitamin B12 injections – consider teaching appropriate patients to self-administer and ensure frequency is not more than 12 weekly. Review whether oral supplementation would be appropriate if asymptomatic with a dietary deficiency ” BMJ 2019 https://www.bmj.com/content/365/bmj.l1865

The question is, why during this crisis, isn’t our immunity boosting, life saving vitamin injection for people who can’t absorb B12 from food in the Green band? It simply doesn’t make any sense.

This is what NICE CKS states, that if B12 deficiency is;

Not thought to be diet related — administer hydroxocobalamin 1 mg intramuscularly every 2–3 months for life.
Thought to be diet related — advise people either to take oral cyanocobalamin tablets 50–150 micrograms daily between meals, or have a twice-yearly hydroxocobalamin 1 mg injection.

British Society for Haematology (BSH) is moving goal posts; 

BSH advice during the COVID19 pandemic now decide that those of us who rely on B12 injections can now access our non existent liver stores, here’s an excerpt below;

Liver stores last for a year and hence levels of B12 will not be affected if one to two 3 monthly injection is omitted in patients on maintenance parenteral  B12 supplements.  BSH supports omitting B12 injections even in this group during COVID19 outbreak at least until the surge has passed.

For patients who report symptoms in the weeks  preceding B12 injection, oral B12 50-150 micrograms per day can be offered as an alternative because there will still be sufficient absorption.  If still very symptomatic then B12 injection can be given with clear understanding that the interaction with healthcare increases transmission risk of COVID19. We suggest taking the opportunity to measure B12.

FAO/WHO 2001. Human Vitamin and Mineral Requirements. Chapter 5.
“…..Interruption of this so-called enterohepatic circulation of vitamin B12 causes the body to go into a significant negative balance for the vitamin. Although the body typically has sufficient vitamin B12 stores to last 3-5 years, once PA has been established the lack of absorption of new vitamin B12 is compounded by the loss of the vitamin because of negative balance. When the stores have been depleted, the final stages of deficiency are often quite rapid, resulting in death in a period of months if left untreated.” 

 

Oral B12 research 

Patients during the crisis are now regularly told that they can in fact absorb B12 from cyanocobalamin tablets and yet:

A review from Cochrane; (Wang et al., 2018) details this: …… 

No study reported on clinical signs and symptoms of vitamin B12 deficiency (e.g. fatigue, depression, neurological complications), health-related quality of life, or acceptability of the treatment scheme.”

Authors’ conclusions:  “Low quality evidence shows oral and IM vitamin B12 having similar effects in terms of normalising serum vitamin B12 levels, but oral treatment costs less.  We found very low-quality evidence that oral vitamin B12 appears as safe as IM vitamin B12.  Further trials should conduct better randomisation and blinding procedures, recruit more participants, and provide adequate reporting.  Future trials should also measure important outcomes such as the clinical signs and symptoms of vitamin B12 deficiency, health related-quality of life, socioeconomic effects, and report adverse events adequately, preferably in a primary care setting.

The Difficulties With Vitamin B12

https://pubmed.ncbi.nlm.nih.gov/27009308/?i=5&from=b12

A 22-year-old woman presented with progressive sensory ataxia and optic neuropathy. Previous investigation by her general practitioner had found a low serum vitamin B12, which had been corrected with oral supplementation. Neurological investigations showed raised plasma homocysteine and methylmalonic acid towards the upper limit of normal with a low serum vitamin B12 MRI showed an extensive cord lesion in keeping with subacute combined degeneration of the spinal cord. We treated her with high dose parenteral vitamin B12 and she has made a partial recovery. We discuss the management of patients who present with neurological manifestations of vitamin B12 deficiency; highlighting the fact that parenteral replacement is needed in such cases, even if the serum vitamin B12 level appears to be normal. We also discuss ancillary investigations that should be performed in patients with suspected vitamin B12 deficiency.

Caution note from the B12 institute about oral supplements .

____________________________________

Everyone making the rules is watching the smoke but not one is seeing the fire…..

People in crisis sometimes make bad decisions and stopping B12 injections is one of them, it’s short sighted and harmful and there will be a price to pay if things don’t change soon.

A simple solution would be to allow us to buy injectable B12 OTC as is allowed in many other countries, which leads me to my next blog.

Best wishes and keep safe
Tracey

www.b12deficiency.info

(Thank you Dr Katie Brooks for finding WHO ref)

Incontinence in women, men & children

One of my symptoms of B12 deficiency was bladder incontinence, I had to keep going to the loo and there was no let up during the small hours either.

Thankfully this was one of my symptoms which corrected within the first weeks of regular B12 injections. Had I not realised I was B12 deficient, I may have believed it was due to my age or my shoe size or my eye colour and perhaps even ‘perfectly normal’. Some of us have difficulty seeking help for incontinence and see it as something to ‘put up with’ rather than something that could and should be treated.

Each time I see TV adverts for companies selling incontinence pads (or those weird ‘pretty??!’ crepe britches) showing young women stating that incontinence is ‘perfectly normal’ I’ll ask the telly, “what if it’s caused by B12 deficiency?”

Apparently 1 in 3 women experience bladder leaks, this is a massive number, some of whom might potentially be in need of B12 but may be unaware of low B12 being a cause.

This report from the BBC shows that the Royal College of Nursing (RCN) has issues with these adverts. They criticised TENA for not highlighting to mothers that treatment for the condition is available.

The RCN said: “Incontinence is known to be under reported due to the embarrassment experienced by women living with the condition.

Female incontinence
As you’ll see from the information on the NHS link below, there are a few causes for bladder incontinence related to the pelvic floor muscles, and although they do list ‘neurological conditions that affect the brain and spinal cord such as Parkinson’s disease or multiple sclerosis’  –  just think how helpful it would be if they could alert people by adding B12 deficiency to this list?

  • damage during childbirth – particularly if your baby was born vaginally, rather than by caesarean section
  • increased pressure on your tummy – for example, because you are pregnant or obese
  • damage to the bladder or nearby area during surgery – such as the removal of the womb (hysterectomy), or removal of the prostate gland
  • neurological conditions that affect the brain and spinal cord, such as Parkinson’s disease or multiple sclerosis
  • certain connective tissue disorders such as Ehlers-Danlos syndrome
  • certain medicines

Male Incontinence
Men also experience incontinence and it’s no surprise that they are even worse than women for talking about it or seeking help. Naturally there are some different causes listed for males (please see below), but would it be on the radar of the GP to test for B12 deficiency even if the subject of incontinence arose at an appointment?

  • chronic cough
  • constipation
  • obesity
  • bladder or urinary tract infections
  • an obstruction in the urinary tract
  • weak pelvic floor or bladder muscles
  • loss of sphincter strength
  • nerve damage
  • enlarged prostate
  • prostate cancer
  • neurological disorders, which can interfere with bladder control signals

Other lifestyle factors that may lead to UI include:

  • smoking
  • drinking
  • not being physically active

Are your vital B12 injections being stopped? FREE help options here….

If your treatment is being restricted or stopped altogether, hopefully there will be some help options for you here.

The Letters….
There are letters being sent out to patients, some of whom have received B12 treatment for donkey’s years, which announce that they will no longer receive their vital injections.

The incidence of this behaviour is increasing …..


This appears to be due to a cost saving exercise and largely happens without any prior consultation with individual patients to discuss their needs. (The cost of B12 is pennies but the time for nurses to give the injection appears to be the ‘saving’ here.)

Some practices are enclosing diet sheets for patients to learn how to make sure they are eating foods containing B12. Quite bizarre when these patients wouldn’t be deficient in the first place if they could absorb B12 from food.

The same old line about ‘too much B12 being harmful’ (which is complete rubbish) is often used in these letters and if the patient is unaware of the truth about B12 they might quietly comply with the harmful removal of their vital treatment.

Some letters state that the reason B12 injections are being stopped is “many patients are being over treated with this vitamin”. If this is the case in your letter, please ask them to provide you with this evidence.

Our clinicians need reminding that Pernicious anaemia (PA) is the very tip of a huge iceberg.

Some GP’s may incorrectly believe that only patients with a definite diagnosis of PA, those with a positive intrinsic factor antibody test, require treatment for life so seem to be using this as their treatment exclusion criteria.

The trouble is that the IFA test is not entirely reliable, it has a very low sensitivity and misses many that do have PA.

Obviously this ignores all those who require life long treatment due to other causes of B12 deficiency (of which there are many), thereby potentially causing great harm to the vast majority of their B12 deficient patients.

Cost saving?

These letters appear to be indiscriminate cost saving initiatives and are being sent out as individual practice directives and not that of the CCG (Clinical Commissioning Group).

You may know that each GP Practice is governed by a CCG and each CCG has a Medicines Optimisation Department – the role of this department is to “make sure that the right patients get the right choice of medicine at the right time”.

If you have received a letter stopping your vital lifelong treatment then why not find your CCG and talk to the Medicines Optimisation department about what is happening?

There are 211 CCG’s, find yours here.

You may find the  NHS Constitution of great help when discussing your lack of treatment.

This valuable document is for everyone and should be used in situations when your GP or your surgery is not making any sense regarding your treatment. I have added some parts of the text below but want to highlight the following sentence for you to bear in mind; 

“The Secretary of State for Health, all NHS bodies, private and voluntary sector providers supplying NHS services, and local authorities in the exercise of their public health functions are required by law to take account of this Constitution in their decisions and actions.” 

_______________________________________________________________________

The NHS Constitution sets out your rights as a patient, and explains the commitments the NHS has made to providing you with a high quality service. Organisations providing NHS care must take account of the NHS Constitution when treating you, so you may find it helpful to refer to it if you are thinking about making a complaint.

This Constitution establishes the principles and values of the NHS in England. It sets out rights to which patients, public and staff are entitled, and pledges which the NHS is committed to achieve, together with responsibilities, which the public, patients and staff owe to one another to ensure that the NHS operates fairly and effectively. The Secretary of State for Health, all NHS bodies, private and voluntary sector providers supplying NHS services, and local authorities in the exercise of their public health functions are required by law to take account of this Constitution in their decisions and actions. References in this document to the NHS and NHS services include local authority public health services, but references to NHS bodies do not include local authorities. Where there are differences of detail these are explained in the Handbook to the Constitution.

1. The NHS provides a comprehensive service, available to all irrespective of gender, race, disability, age, sexual orientation, religion, belief, gender reassignment, pregnancy and maternity or marital or civil partnership status. The service is designed to improve, prevent, diagnose and treat both physical and mental health problems with equal regard. It has a duty to each and every individual that it serves and must respect their human rights.
At the same time, it has a wider social duty to promote equality through the services it provides and to pay particular attention to groups or sections of society where improvements in health and life expectancy are not keeping pace with the rest of the population.

4. The patient will be at the heart of everything the NHS does. It should support individuals to promote and manage their own health. NHS services must reflect, and should be coordinated around and tailored to, the needs and preferences of patients, their families and their carers. As part of this, the NHS will ensure that in line with the Armed Forces Covenant, those in the armed forces, reservists, their families and veterans are not disadvantaged

Improving lives. We strive to improve health and wellbeing and people’s experiences of the NHS. We cherish excellence and professionalism wherever we find it – in the everyday things that make people’s lives better as much as in clinical practice, service improvements and innovation. We recognise that all have a part to play in making ourselves, patients and our communities healthier.

Everyone counts. We maximise our resources for the benefit of the whole community, and make sure nobody is excluded, discriminated against or left behind. We accept that some people need more help, that difficult decisions have to be taken – and that when we waste resources we waste opportunities for others.

You have the right to receive care and treatment that is appropriate to you, meets your needs and reflects your preferences.

  • Quality of care and environment:
    You have the right to be treated with a professional standard of care, by appropriately qualified and experienced staff, in a properly approved or registered organisation that meets required levels of safety and quality.

_________________________________________________________________________

Patients with B12 deficiency are regularly discriminated against.

You can see that this powerful and useful document can be employed to protect both you and your treatment.

If your particular GP is unhelpful, could there be another in the practice who you could see instead?

It is important to understand that many of our clinicians receive NO TRAINING whatsoever in B12 deficiency. Some receive a little, but what they may be taught is not necessarily up to date – or their training focused solely on PA (pernicious anaemia) – and the frankly ridiculous notion that anyone without a definite diagnosis of this or the presence of anaemia does not require treatment.

It is not the fault of the trainee doctor or nurse that this vital education is missing – but countless patients have provided a valuable opportunity for CPD by providing information for those in qualified to be in charge of their care. Many times this is ignored.

When doctor’s don’t know best….

I know how difficult it is for patients to challenge their doctor regarding treatment, but if you, or someone you love is being desperately under treated for this vitamin deficiency then it is essential that you, or someone close to you, takes the bull by the horns and speaks up as firmly as possible.

I hope the NHS Constitution will help you to do this.

1. You have to ignore the idea that you are upsetting the doctor, or that you are insulting them by questioning poor decisions about your health and wellbeing.

2. You have to believe doctors are no different from you, they have just learnt different things, read different books and passed different exams and that is all.

3. You have all the expertise on you, how you feel and how your deficiency effects you. You have to not be shy about sharing this in the face of such ignorance.

Ask yourself how you would challenge a joiner who mistakenly removes joists that make your roof safe?

Or a plumber who’s poor workmanship means that carbon monoxide is leaking into your bedroom?

You have to rid yourselves of the idea that the ‘doctor knows best’ when you know that their actions are doing harm.

You are not a lesser being than your doctor. You absolutely matter.

 

If you need help with complaining for FREE you can contact your local council or local Healthwatch  team to find out about independent NHS complaints advocacy services in your area. Complaints Advocates may help you to write a letter, attend a meeting with you or explain the options available to you.

If you have already complained to the GP, the Practice Manager, the CCG, NHS England, and are still unhappy then; 

You can contact the Parliamentary and Health Service Ombudsman (PHSO) which makes final decisions on unresolved complaints about the NHS in England. It is an independent service which is FREE for everyone to use.

To take your complaint to the Ombudsman, visit the Parliamentary and Health Service Ombudsman website or call 0345 015 4033.

You can of course complain to you MP and ask for help, some will oblige, others will direct you to NICE or NHS England.

Why not print this blog post out and help your GP or advocate to understand the situation better?

The home page of the site helps to show the issues facing patients; www.b12deficiency.info

If you need personalised support, please see my Contact page.

Very best wishes

Tracey

A very bright light at the end of a very long tunnel – Letter 7

The letters page http://www.b12deficiency.info/letters/ is full of examples of poor understanding of B12 deficiency…. but letter 7 is very different!!

If you are struggling to gain access to correct treatment and you have similar problems to this patient, maybe your GP or haematologist could benefit from reading this, frankly, amazingly supportive letter?

‘…….a treated case of pernicious anaemia and subacute combined degeneration of the cord. She requires high doses of hydroxocobalamin to maintain her general well being, i.e. 1mg intramuscularly daily.… I will leave it to yourself to make enquiries and discuss whether her hydroxocobalamin can be fully funded by the NHS.’

 

Many of us have problems with accessing correct treatment. Many of us try desperately to raise awareness of B12 deficiency.

If you want to learn more and know of others who do too, please share the conference information with them – http://www.b12deficiency.info/conference-2016/

Letter 7 Haem-letter-1200

Please note; This letter came to me fully redacted so I have no idea who wrote this letter or which NHS Trust they work for.

Best wishes

Tracey