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

Apr 19, 2020 | COVID, Petition | 12 comments

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.b12info.com/blog/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

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12 Comments

  1. drkatiebrooks

    It may also be worth pointing out that there is a precedent for people self-administering intramuscular injections; for example, during fertility treatment.

    Reply
  2. Sarah

    Just wanted to say thank you for all your hard work. It’s a comfort to know someone is fighting for all who are B12 deficient.

    Reply
  3. Deborah Hawkes

    I have Pernicious Anaemia and suffer serious health problems from my B12 deficiency. I strongly believe we should have over the counter access to injectable B12. I could not cut and paste the above information to email mhra requesting that they reclassify it, but i have taken a screen shot of it, signed it, and sent that instead.

    Reply
  4. Stella Adams-Schofield

    Hi Tracey, Sorry, I have tried every method to copy your text and right click and select copy and paste are disabled in both the post and the comments to protect the rights of the author.

    Reply
  5. Sarah Mackay

    Tracey, you are an Angel. We’ll be sending the email. I think what it would do is #ProtectTheNHS and#SaveLives.

    Reply
    • Tracey Witty

      Thank you Sarah, I agree it would definitely save lives and protect the NHS! Best wishes Tracey

      Reply
    • Tracey Witty

      Sarah, thank you for lovely comment. Thank you for getting involved! Indeed it would protect the NHS and Save lives. We just need the power that be to understand this! x

      Reply
  6. Mrs Sheila Leach

    What about people who do not want to inject themselves? Will we now be forced into paying for b12 and injecting it ourselves? A nurse told me she would not want to inject herself so why should I?

    Reply

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