Petition update – Your help is needed for the next stage!

Petition response

We’ve had a response to our petition from the Department of Health and unfortunately they have reported what we already know about the regulations for a POM (Prescription only medicine).

They state that we can’t have injectable B12 made available from pharmacies in the UK because of the Human Medicines Regulation 62 section 3.

Westminster Hall Debate

This doesn’t mean we give up. This means we keep on going and thankfully My MP, Jane Hunt is committed to helping and will be making an application for a debate on our petition in Westminster Hall. The focus of this will be that the MHRA allow B12 injections to be given as a boost via hair salons and clinics. More on this in the next blog.

Your MP can help

We need your MP to speak for you, alongside Jane when this happens.

Please ask your MP to come on board, to make a speech on your behalf and get in touch with Jane so that they can work together on this.

Find your MP here: https://members.parliament.uk/FindYourMP

So if you feel strongly about being in control of your own health …

If you have had B12 injections stopped due to COVID…

If you are restricted to 3 monthly injections but need them more frequently…

If you feel you have no choice but to buy B12 from abroad because you can’t access what you need from your GP then please help to make this happen…

Here’s how you can help

I’ve added a draft email for you to use and adapt below so that you can easily send a message to ask your MP to help. It would be lovely to hear of their interest in this, so if possible please let me know by commenting on the blog.

Thank you so much for being part of this, I feel sure that if we keep working together we can make this important change happen.

Together I’m sure we can make this happen.

Kindness always

Tracey Witty

www.b12deficiency.info

Draft email 

Dear

Please can I ask for your support in making injectable vitamin B12 available OTC from pharmacies.

Following a reading of this petition at the House of Commons on the 23rd of September 2020 the Department of Health responded: They state that we can’t have injectable B12 made available from pharmacies in the UK because of the Human Medicines Regulation 62 section 3.

Jane Hunt MP is making an application for a Westminster Hall Debate on this petition and she needs your help.

This issue is really important to me because………………………….

Please contact Jane Hunt MP ( jane.hunt.mp@parliament.uk ) and get involved on my behalf.

Yours faithfully

If you can’t copy the above please find a copy of the text here

 

 

#ProtectTheNHS #SaveLives and #MakeB12OTC

Making injectable B12 available over the counter from pharmacies will help save lives and will help to save money and time for the NHS.

You may have been denied your B12 injections due to COVID 19.

You may have failed to achieve a diagnosis due to your GP’s lack of knowledge of the condition.

You may be struggling with your symptoms due to under treatment of your deficiency.

You may be buying supplies from another country due to lack of treatment from your GP.

You may however, be in the enviable position of being allowed to collect your prescribed ampoule from a chemist and have been taught by your GP Practice to self inject.

Whichever bracket you fall into, can you help?

Do you want to be able to buy B12 OTC from your pharmacy?

Do you want to be able to treat yourself when you need to, rather than when restrictive guidance allows?

NOW is the time to act, to take your future into your own hands and try with me to make B12 OTC.

Our Struggling NHS

The NHS was in trouble long before COVID 19 arrived, it’s been under funded and under threat for a long time. We can all help to make a difference!

As stated in my previous blog there are estimated to be 5.7 million people with B12 deficiency in the UK, which is greater than the population of Finland!

The cost of mental health

Obviously B12 deficiency affects all body systems but lets just focus on mental health as an example.

Each GP appointment costs on average £30 say NHS England with 40% of appointments now involving mental health.

According to the Children’s Society UK there are said to be 16 million people, that’s 1 in 4 of us who will experience a mental health issue at some point in our lives and “the estimated costs of mental health problems in the UK are over £100 billion each year.”

Given that depression and anxiety are common first presenting symptoms of B12 deficiency then it could be that a considerable proportion of this figure may have this very common, easily and inexpensively treated, but commonly misdiagnosed condition.

The NHS state that an under estimate of 49,988 people were detained under the Mental Health Act in the UK between 2018-2019. The cost of an overnight stay on a psychiatric ward is said to be around £400, that’s almost £20,000,000 per night! but clearly this is not the whole financial picture.

The numbers

If just 1% of the 5.7 million people suffer with poor mental health caused by B12 deficiency and are sectioned and detained for 30 days under the Mental Health Act then the cost to the NHS is at the very least £684 million.

Of those thought to be B12 deficient in the UK, consider that if just 0.001% which is 57 people, each had a 30 day section, this would cost at the very least £684,000.

By comparison, if each of those 57 people were able to have a weekly B12 injection, even at the current cost to the NHS which is £8.80 per box of 5 ampoules, (£1.76 each), then each person’s cost per year would be only £91.52. So the cost for 57 people just £5,216.64.

I personally know 4 people who have had extended stays in mental health units averaging 4 months. Each of these people are B12 deficient, two were sectioned prior to diagnosis and two were sectioned when on restricted 3 monthly B12 injections. Three of them now self treat by buying online at a cost of around 60p per ampoule and are now doing really well. But how long will we be able to buy from online pharmacies with Brexit looming?

The cost of just one of these people hospitalised for 4 months reaches at least £48,000. These figures are of course a gross under estimate of the actual cost of a section under the Mental Health Act. At the very least the cost of the initial assessment and the time of 2 doctors required for detainment would need to be added. And in some cases there might be the cost of an ambulance and its team, the police, a social worker, a Crisis Team, and sometimes even a locksmith.

This of course can never reflect the impact of the emotional cost to the person detained, to their family and friends, their personal financial losses, their inability to work, potential loss of career, continued need for mental health support and the wider cost to society as whole.

Get involved!

Will you help?

This interactive tool from the Go Compare Bill of Health explained by Net Doctor allows you to add up your own cost and contribution to the NHS.

Consider calculating your B12 deficiency related costs and emailing any of the following with your B12 story and why you think injectable B12 should be made available over the counter, as it is in many countries in Europe and around the world:

The MHRA – engagement@mhra.gov.uk 
Your MP – Find your MP’s email address
The health minister – matt.hancock.mp@parliament.uk
The chief medical Advisor – c.whitty@nhs.net

You could also email marie.turner@dhsc.gov.uk. Marie wrote to me from;

The Department of Health and Social Care which in their words “helps people to live more independent, healthier lives for longer. It leads, shapes and funds health and social care in England, making sure people have the support, care and treatment they need, with the compassion, respect and dignity they deserve.”

Marie wrote;

“Ms Witty has corresponded with the Department on this subject over a number of years, and it may help if I summarise the advice we have provided to her over this time…….

Ms Witty believes there are fundamental problems with the diagnosis and treatment of vitamin B12 deficiency and pernicious anaemia. When vitamin B12 deficiency has caused anaemia, its diagnosis is not generally difficult, and the Department is not aware of significant problems of under-recognition.”

Obviously the age old problem of incorrectly assuming anaemia is always present with B12 deficiency rears it’s ugly head in this letter, but it’s the bold text I’d like you to write to Marie about because she needs to know that as we are fully aware, B12 deficiency is absolutely under recognised, under treated and continually misdiagnosed to the detriment of the NHS and society as a whole.

If you need a little help with your email please find sample text here.

Your voice matters!

Best wishes,

Tracey
www.b12deficiency.info

Please consider signing and sharing the B12 OTC Petition.
PLEASE NOTE make sure you don’t pay to sign, the money goes to Change.org and not to the cause you are supporting.

 

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.

 

Go back to your GP if they used the previous BSH Guidance against you!

Many voices make a difference!

Well done everyone who wrote to the BSH (British Society for Haematology) regarding their previous misinformed COVID 19 Guidance for those with B12 deficiency.

They have thankfully now updated their website with much more sensible advice so if your GP followed their previous statement – Please get them to take a look at this new link in order to get your B12 injections reinstated. They have now helpfully made the clear distinction between non dietary and dietary lack.

Highlights include:

“The need for intramuscular (IM) hydroxocobalamin should be discussed with each patient individually.

…….Alternatives to attending the GP surgery such as local pharmacies or home administration by district nurses should be explored.

……. As an alternative, oral cyanocobalamin can be offered at a dose of 1 mg per day until regular IM hydroxocobalamin can be resumed, i.e. once GP surgeries are able to do so safely, aiming to have a shortest possible break from regular injections.

…..Patients should be advised to monitor their symptoms and should contact their GP if they begin to experience neurological or neuropsychiatric symptoms such as pins and needles, numbness, problem with memory or concentration or irritability.”

Thank you to Rita – BSH Guidelines Programme Manager, for responding so swiftly.

My apologies I put this on social media a few days ago and forgot to blog!

_______________________________________________________________________________________________

More news:

The BBC have shown interest in our issue but as things with COVID 19 have escalated since our initial contact and finding an interviewee, we are currently on the back burner. I will keep you posted with any further developments.

Research

Those of us in need of B12 injections know that they are not a placebo despite what some clinicians believe.  In fact B12 is a known toxin scavenger and has long been identified as a poisons antidote.

So while some UK doctors are stopping B12 injections for those who need them to live well and function, medical researchers are looking at ways to combat COVID 19 and believe that B12 and nicotinamide (B3) can help.

University of Oxford’s Carmen Wheatley’s research;

SARS-Cov-2/Covid/19 ADULT RESPIRATORY DISTRESS SYNDROME /ARDS: HIGH DOSE IV METHYLCOBALAMIN IS A SAFE & COST EFFECTIVE RESCUE TREATMENT for ARDS

“A SAFE AND EFFICACIOUS PROPHYLACTIC /TREATMENT FOR COVID19, TO PREVENT AND TREAT ACUTE RESPIRATORY DISTRESS SYNDROME, ALREADY EXISTS: RESPECTIVELY using HIGH DOSE IM AND IV METHYLCOBALAMIN FORM OF VITAMIN B12. The hydroxocobalamin form of B12 has been used in ICUs in France, Italy and China for nearly 70 years, as the anti-CN antidote of choice. It is safe, licensed and available. Methylcobalamin would be preferable, for a number of research based reasons. But both could be life savers in the current health crisis.”

and:

Virtual screening and repurposing of FDA approved drugs against COVID-19 main protease

Key findings

COVID-19 Mpro formed a phylogenetic group with SARS CoV that was distant from MERS CoV. The identity% was 96.061 and 51.61 for COVID-19/SARS and COVID-19/MERS CoV sequence comparisons, respectively. The top 20 drugs in the virtual screening studies comprised a broad-spectrum antiviral (ribavirin), anti-hepatitis B virus (telbivudine), two vitamins (vitamin B12 and nicotinamide) and other miscellaneous systemically acting drugs. Of special interest, ribavirin had been used in treating cases of SARS CoV.

 _______________________________________________________________________

 

Best wishes and keep safe,

Tracey
www.b12deficiency.info

You can find all the blogs relating to COVID 19 on this new page

Now is the time to make B12 injections OTC, GET INVOLVED, email the MHRA with me!

What’s the kindest, simplest and cheapest way forward with B12 injections?

By removing barriers and making B12 injections available over the counter, that’s what. Simple.

Will you join me in emailing the MHRA (Medicines and Healthcare products Regulatory Agency – Gov.uk) so we can make this happen?

This one act would save lives, unburden the NHS, free up time in GP Practices and give a sense of peace and wellbeing to B12 deficient people across the UK.

After all dear regulators:
B12 is safe – B12 is inexpensive – B12 cannot be over dosed
We are adults, we can do this, we will be fine.

YOU CAN TRUST US!

Lets remove barriers and make B12 injections available OTC.

There are estimated to be 5.7 Million people in the UK with B12 deficiency, this is more than the entire population of Finland! Just imagine this many people being allowed to look after themselves, inject when needed and no longer feel a burden or irritant to the NHS. Just imagine the enormity of the potential financial savings, to the NHS and to society as a whole.

Our current situation
The COVID 19 pandemic has made a great many B12 patients feel that they don’t matter, that our health system doesn’t care. The recent letters received by many patients from their GP Practices show just how little so many health professionals understand about B12 deficiency. You can read more about the impact here along with bizarre changing advice for GP’s here and the patient comments at the foot of previous blogs.

The NHS 

Just about everybody in the UK knows of someone who works for the NHS and fully appreciates what they are up against. The very last thing anyone wants to do is make things worse but the situation some B12 deficient patients find themselves in currently is intolerable.

Some GP’s are helping patients to self inject,(as instructed by the BMA) but others are point blank refusing to engage at all with their anxious, depressed and desperate patients. Some feel they have no choice but to buy injectable B12 from abroad to keep themselves safe. This can’t be right can it?

After all ‘B12 clinics’ hairdressers and beauty therapists can get away with selling B12 injections at vastly inflated prices as a “health boost” or “health benefit’ when the real price of the ampoule is around 60 pence. Isn’t this odd when those of us who need it as a ‘medicine’ can’t buy it safely from pharmacy in the UK when many other nations can?

The MHRA are the organisation who hold all the cards, who can help us to make this happen, they are the people we are petitioning to make B12 available OTC.

The solution?  MAKE B12 injections available OTC. SIMPLE.

What we need is an urgent reclassification of B12 injections from Prescription-only medicine (POM) to pharmacy (P) medicine  this could and really should be easy, especially now when it seems these days, hard fast rules can change with a blink of an eye.

Years ago I wrote to all the Marketing Authorisation holders of hydroxocobalamin in the UK. I know that to reclassify our B12 injections from a POM to a P would usually require some form filling an exchange of funds and removal of the over riding one small, but obstructive statement in the current legislation, detailed below.

I was told; “Before a medicine can be reclassified from POM to P, Ministers must be satisfied that it would be safe to allow it to be supplied without a prescription. This means that it is a medicine which no longer meets any of the following criteria (Human Medicines Regulations 2012, regulation 62(3)).

This below is one of the criteria which applies in our case and what so far has stopped us from buying B12 injections OTC and self treating.

3 (d)is normally prescribed by a doctor or dentist for parenteral administration.

During the present crisis, wouldn’t now be a sensible time to cut through the red tape for the good of all and future-proof our access to this essential medicine?

You can find the Reclassification criteria here

and  HOW TO CHANGE THE LEGAL CLASSIFICATION OF A MEDICINE IN THE UK 

The underlying principle for classifying medicines is to maximise timely access to effective medicines while minimising the risk of harm from inappropriate use.

Making medicines available over-the-counter: the trade-offs (see page 4)

You see, our B12 injections are perfect for this!

 

More from the MHRA, they say:

Public and professional input
We are committed to widening access to medicines for the benefit of public health when it is safe to do so, and we are seeking input from patients and health professionals into the reclassification process. In addition to safety considerations, a key factor in the reclassification process is focusing on issues that matter to patients and health professionals. In order to understand those issues we run stakeholder groups and public consultations.

So here’s your call to action!

On this page the MHRA ask patients to get involved, inviting us to email them, they state:

Get involved!
“We would like to hear from patients with an interest in medicines and self-care, and community pharmacists, GPs, nurses and healthcare professionals who are currently working in a patient-facing role and who are willing to reflect on professional issues and attend a short meeting if required. If you are interested in taking part, please email engagement@mhra.gov.uk We will keep your details and contact you when a specific product is under discussion.”

So PLEASE do this! Ask them to help us to access what we need and to remove the barriers to our well being.

Please email them, engagement@mhra.gov.uk telling them why you want Hydroxocobalamin B12 injections reclassified.

You can cut and paste the sample text below by using this link:

Please urgently reclassify Hydroxocobalamin B12 injections from a POM to a P.

COVID 19 has meant cancelled or restricted injections for B12 deficient patients even though Hydroxocobalamin is listed as an essential medicine by WHO

Please see; https://www.b12deficiency.info/blog/2020/04/18/covid-19-is-leaving-b12-deficient-patients-unprotected-traumatised/

Please see this petition for all the many reasons why they should be made OTC:

https://www.change.org/p/dr-june-raine-please-make-our-life-saving-injectable-vitamin-b12-hydroxocobalamin-available-over-the-counter?

Please remove the barriers to me being well. B12 is safe, I cannot overdose. I am an adult. Trust me as others in the world are trusted to self inject.

Yours sincerely ………………

 

Please get involved and make your voice count! Just think of the relief for all concerned if we could be in charge of our own healing.

Best wishes
Tracey

www.b12deficiency.info

If you haven’t signed yet please join the 90,567 people who have.