Vitamin B12 OTC update and NICE Consultation

Jul 13, 2023 | Guidelines, Petition | 18 comments

NICE Draft Guidance
First of all I want to share with you the NICE Consultation document for over 16’s.

Here is the Summary of the consultation and guidance on comments and at this link you will find the comments form.

Please take the time to read through this if you are in the UK and want to get involved by making your voice heard. The draft Guidance is 41 pages long so grab a cuppa and take a look….The consultation closes at 5pm on Tuesday 22 August.

I am a Stakeholder for the Guidance, so if you would like to send me your comments on the Draft too I will send these in and they will be published. Your comments sent directly to NICE on the draft will be read and acknowledged but will not be published.

You can read a discussion on it in the media here too. (Thank you for sending it Suzie!)

We are over nine years in on this story and I want to bring you up to date with all the goings on over the past few weeks and months. There are always long gaps between the communication and I don’t want to keep giving you flimsy information piece meal so this post will help to bring you up to date.

What has happened since my last post on B12 OTC?
Lots of to-ing and fro-ing with my MP Jane Hunt in trying to arrange meetings. There have been many names involved in our trying to access B12 OTC and the job titles and positions held change so often is hard to keep up.

I regularly send Jane emails saying ‘have we heard anything?’  I also send her information on how it is for patients I’m either working with, or who are in the news detailing how B12 deficiency is affecting them. For example Charlotte who won a clinical negligence claim due to permanent damage caused by a late diagnosis and treatment. Giving information about real people all adds to our cause.

Subcutaneous injections
On the 10th of March 2023 I also sent Jane the following Query answer reportAlternatives to intramuscular administration of hydroxocobalamin from the West Midlands Medicines Information Service March 2020 –  (144230-vitamin-b12-west-midlands-ukmi-march-2020-1586185691).  It details that hydroxocobalamin injections are only licensed for IM (Intramuscular) in the UK and the bizarre notion that cyanocobalamin would be preferable to hydroxocobalamin ‘if subcutaneous administration is necessary’.

Subcutaneous administration of hydroxocobalamin

• There is very little information available regarding the subcutaneous administration of hydroxocobalamin, although it has been done. This should therefore be considered as an option only if other options are not available or not suitable.

Subcutaneous administration of cyanocobalamin

• The UK-licensed cyanocobalamin injection is only licensed for intramuscular administration. However, there is considerably more information available regarding the administration of cyanocobalamin via the subcutaneous route. If subcutaneous administration is necessary, it would be preferable to use cyanocobalamin rather than hydroxocobalamin. However, note that as cyanocobalamin is excreted more quickly, injections must be more frequent (monthly rather than every 3 months).

We no longer use cyanocobalamin injections on the NHS but as they are both preparations of B12 why on earth would there need to be a differentiation in the treatment route?

In the references from this same document we find this in Canadian paper Cobalamin (vitamin B12) and Folate Deficiency
Canada use cyancobalamin they state –  Injection (IM or subcut): 1000 mcg/mL

Where they state: …1 mg hydroxocobalamin administered subcutaneously once per week…

Many people have no choice but to buy safely and cheaply from online pharmacies in order to keep themselves well in the absence of any help from their GP. In the German manufacturers PIL (Patient information leaflets) for hydroxocobalamin they state that B12 can be given subcutaneously or intramuscularly, so why when other countries understand that B12 can be given by both routes did the UK only license it for intramuscular?

More MP’s in the game
Jane has now heard from more MP’s who have had communication from their constituents on this issue and they are: Peter Aldous, Alex Chalk and David Duguid.

We have been trying to meet with Ministers since the Westminster Hall debate. On the 24th of April Jane Hunt had a meeting with Minister Maria Caulfield who was Parliamentary Under-Secretary of State for Mental Health and Women’s Health Strategy regarding our request to make B12 OTC. Jane stated that the meeting was positive and that the Minister understood the case. They discussed the letter from the MHRA and the Minister felt it was was very encouraging. This is the letter that stated that we needed to wait until NICE published its new Guidance.

Now though, our OTC request case has been passed to Will Quince the Minister of State and he sent the following letter to Jane on the 26th of June 2023.

Years ago I explored the cost of Marketing Authorisation Holders (those who sell produce and supply B12 in the UK) applying for a new classification. This cost, in the grand scheme of things, is peanuts but there was always the legislation of injectables in the way. So, who would apply for something that wouldn’t be allowed? Absolutely no one. Lets hope this road block is about to change.

Jane heard yesterday that a meeting had been arranged with the MHRA and this take place in September.

When I first met with the MHRA in London years ago, they invited me down to an early morning meeting in London just to tell me “there is nothing we can do to help”  It was expensive, frustrating and depressing and there’s been many of those occasions over the years. In all that time my both MP and the CEO of the MHRA has changed. MP Jane Hunt has heard me ‘chinning on’ for 10 years about B12 because she was my former MP’s case worker and consequently she is very aware of just how devastating this deficiency can be.

Let’s hope that maybe now, all these years on, that we sit in a different and more helpful landscape?

Fingers, toes and everything else crossed!

Kindness always

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  1. Jimmy Norman

    The biggest obstacle as you say is the legislation. The MHRA can only operate within current legislation so we really need MP’s to amend it to make B12 an exception

    • Tracey Witty

      The MHRA are the ones who can change this Jimmy. Let’s hope they do.

      • Jimmy Norman

        I really hope so! We’ll just have to keep banging on their door until they do!

        • Tracey Witty

          Indeed we will!

  2. Kathy Erb

    Hi ladies,
    Lots of ppl take b12 injections every other day because of severe deficiency and feel so much better when taking more regular injections. Once a month is still not enough.
    Have Dr’s considered looking at the whole hormonal system including cortisol, Adrenal, testerone, etc. Dr Martin from northern Ontario Canada of Dr Martin Clinic has answers on this. He also talks extensively on sluggish thyroid and what to do about it.
    He puts out daily podcasts and weekly too.

    • Tracey Witty

      Thank you Kathy!

  3. Veronica de Sully

    Thank you very much for taking on this difficult task. It will be a relief when we can eventually buy over the counter in the UK and I don’t have to source from abroad

    • Tracey Witty

      Let’s hope so Veronica x

  4. Marjorie Ghisoni

    Thank you Tracey for trying so hard to make this happen for so many people who need it. There are many reasons this discussion is important but the main 3 are
    1. People need to be in control of their own health more and not be so dependent on the health service as this can lead to long delays in treatment with poor overall health outcomes for everyone.

    2. Waiting times to see a GP (the NHS Gatekeepers) are increasing at an alarming rate causing some people to not even bother trying to see their GP or seek treatment.

    3. Many people may not be aware that their local pharmacist can help them with everyday issues, freeing up time for the GP to see more people who need prescribed medication and treatment. Over the counter treatment can be provided by the (very experienced and knowledgeable) pharmacists, making B12 injections an ideal opportunity to improve health and reduce treatment waiting times. This to me is a win-win situation!

    • Tracey Witty

      Excellent comment, thank you Marjorie!

      The savings to the NHS and society as a whole would be phenomenal if we could just look after ourselves with a vitamin.

  5. Patricia Finnegan

    Keep going Tracey, we are counting on you.I’ve been watching from the beginning.

    • Tracey Witty

      Thank you Patricia 😊

  6. Louise Walton

    I purchase hydroxocobalamin from Germany and inject every 2 weeks. My GP will only prescribe 3 monthly despite my best efforts to get it at least monthly.
    If I don’t inject I get itching and burning feet and migraines.
    I inject SC, didn’t realise it was “a thing” it’s licensed for IV, IM, SC anyway
    Appreciate your efforts and fingers crossed

    • Tracey Witty

      I agree Louise, it shouldn’t be ‘a thing’! Thank you 😊


    I have needed B12 injections since my 1st bowel cancer op in 2000 and now again in 2022. I could only get this through a private doctor who has since been struck off for treating thyroid disease alternatively. I now have to trust my internet supply! Thank you for putting up such a prolonged fight on behalf of so many silent voices. I am not a practitioner, just a needy patient.

    • Tracey Witty

      Wendy, thank you for sharing. I am so shocked that those doctors who really help are punished, what a state the world is in!
      Very best wishes Tracey x

  8. CHRIS

    Is there anything we can do Tracey prior to September?

    • Tracey Witty

      Dear Chris, if we can keep our MP’s interested and ask them to help that would be great! Ask them to join forces with Jane Hunt – and I suppose HOPE! Thank you Tracey x


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