MHRA Double standards on vitamin B12 injections

So far, B12 injections can’t be bought from a pharmacy in the UK by the general public, but can be bought from a hair or beauty salon or any one of the 2500 technicians, clinics or outlets in the UK at a cost of between £25 – £100 each.

Isn’t this odd?- And some would say ridiculous or even immoral.

 

Following on from my previous blog regarding the B12 OTC Petition and the future Westminster Hall debate which my MP Jane Hunt will apply for – some of you kind people have asked your MP to join Jane and also make supporting speeches. Some MP’s have said, “I would need some compelling evidence to agree to do this.” – As if being restricted to just 4 lifesaving, cheap, injections a year isn’t compelling enough?

Well, the following information may help your MP to act – but if it doesn’t, then goodness knows what will and I suggest you get yourself a new one as soon as possible!

Find your MP here: FindYourMP and perhaps send this blog post to them?

Now here’s the funny bit

The MHRA in responding to our petition stated:

“……Vitamin B12 could not legally be classified as a medicine that can be made available for sale without prescription in pharmacies because it is an injection and because the condition it is licensed to treat, pernicious anaemia, needs a clinician  to diagnose it, and monitor its treatment (see point IV above). The same applies to insulin injections and to the diagnosis and monitoring of treatment of diabetes.
Vitamin B12 injection is currently licensed for use in maintenance therapy for pernicious anaemia every 2 – 3 months depending on the type of pernicious anaemia. Even if the product could be reclassified to make it available for sale in pharmacies, it could not be used more frequently than every 2 – 3 months, so reclassification to a Pharmacy medicine would not help those who require more frequent injections.”

and then they also state:

“Our current advice to private clinics administering vitamin B12 injections which are not licensed medicinal products intravenously for non-medicinal purposes is that we do not regard these to be medicines and that they fall outside of the remit of the MHRA. It must be absolutely clear in the advertising of such products that they do not have a medical purpose.”

So the same B12 (hydroxocobalamin in this case), from the very same manufacturers, is at the very same time;

A licensed medicinal product and also a non-medicinal product.

Mad, maddening and hilarious all at the same time isn’t it?

Slaps on the wrist

Some enterprising B12 injection providers have been telling the general public the truth, that B12 injections help boost immunity, that they combat fatigue and they may therefore help against COVID but the MHRA’s ludicrous rules around non-medicinal products which are also POM’s mean these statements do not comply and in fact telling the truth is a BIG FAT NO NO.

The MHRA have spent time during COVID alongside the ASA (Advertising Standards Agency) warning people who sell B12 injections direct to the public through beauty salons and the like – that they absolutely must not tell those they advertise to, what B12 injections will do or what they can help with.

12th June 2020

The MHRA allows clinics and individuals to market B12 injections by using the words ‘wellness’ or ‘boost’ or ‘supplement’ but not ‘deficiency’, they absolutely cannot be marketed with medical claims, and this is the bit that makes NO SENSE whatsoever, because we with B12 deficiency keep being told they are a ‘Prescription Only Medicine’!!!!!!

Please see below;

In May, the MHRA and the ASA published an Enforcement Notice which makes clear to businesses which offer vitamin shots the nature of the rulings and directs them to remove any COVID-19 related claims from their websites and social media pages. 

The following sets out and details these most recent regulatory developments:

  •  Prescription-only medicines (POMs) cannot be advertised to the public. 
  • Injectable vitamin D and injectable vitamin B12, specifically, are prescription-only medicines 
  • Advertisers must not, directly or indirectly, promote POMs to the public. Targeted enforcement, with the aid of monitoring technology, to find problem ads for removal and sanction came into effect on 12 June 2020. It also states this applies to ads for all “vitamin shot” products, not just vitamin D or vitamin B12. 
  • Action against direct and indirect claims that vitamin shots could help treat or prevent COVID-19

B12 Clinics

Like anything in this world there is good and not so good practice. Some clinics and individuals selling B12 injections direct to the public are stringently trained and follow their company’s guidance to the letter, keeping good records.

If they find a potential client is severely B12 deficient but has not been diagnosed and needs to be referred to a GP, they will explain this without skewing chances of diagnosis by not giving a B12 injection. Others won’t, they simply may not know that diagnosing B12 deficiency for the person is key to being able to access B12 from their GP as there is usually a lifelong need and having regular B12 injections from a private clinic would may not be financially sustainable.

A lifeline

These clinics and technicians provide an essential lifeline for so many who are dragging themselves around trying to survive on one injection every three months whilst trying to function, keep their mental health on track, look after a family, hold down a job and who may have had to home school on top of everything else during this years lockdowns.

They also provide a lifeline to the many patients who are B12 deficient but remain untreated due to a within range result on a serum B12 test. Too many GP’s do not understand the limitations of the test and that the clinical picture of B12 deficiency is of utmost importance. Some are unwilling to budge and allow treatment even when faced with a tearful patient on their knees begging for treatment.

Although my remit with my website is to keep people under the care of their GP when possible, I have referred people to the services of B12 clinics and technicians. This has occured when people are desperately ill and haven’t the strength or the inclination to battle with their GP for correct treatment. This has meant that these trusted sources can give the first injection and also teach the patient to self inject prior to purchasing their own supplies from pharmacies in other countries for around 60p per ampoule.

BREXIT

The awful truth is that the opportunity to buy from abroad has narrowed with BREXIT so now the situation is even more URGENT. We need B12 injections to be made available OTC from pharmacies in the UK so that when there is no help from the GP and where costly private injections are not an option, that people can access vital treatment.

Let’s not forget that the BSH sent out harmful Guidance stopping essential B12 injections which they then had to amend. Some GP’s Practices proudly report they are moving more and more patients onto tiny and useless 50mcg cyanocobalamin tablets unless they have a diagnosis of pernicious anaemia. This ludicrously harmful practice needs to be reversed. It needs to be shouted from the roof tops that PA is JUST ONE OF MANY CAUSES of B12 deficiency. It is NOT more serious than any other cause and apart from a deficiency caused by a proven dietary lack, treatment by injection is required for the swiftest recovery.

MHRA Threat to clinics

In communication with the MHRA, they also stated:

“However, we do have concerns about the level of clinical oversight present in IV vitamin therapy and injection services in general and the appropriacy of such services is currently under review.”

This ‘review’, if deciding on stopping treatment of B12 injections by clinics who do comply with the ridiculous rules of the MHRA, would not only negatively impact the companies and individuals who give B12 injections, but also to the people who rely on them to keep functioning both physically and mentally.

Don’t want to self inject?

There will always be people who do not wish to give themselves B12 injections and I for one hope that pharmacies would offer a service to people afraid of self administration.
Since embarking on the petition to make B12 OTC, some have commented that they fear that GP’s might stop giving B12 altogether if successful. I feel this fear is unfounded, doctors in countries who do allow OTC still prescribe and administer B12 injections to patients who need them. It would remain the responsibility of Primary Care to diagnose and treat B12 deficient patients but they would have to choose to.

Why do we need B12 to be made OTC?

Because so many people are restricted to just one lifesaving B12 injection once every three months. Some people say they can cope on this regime but many of us can’t, myself included. Each of us is differently affected and require a different frequency of B12 injections.

Whilst many GP’s will not treat patients according to individual need (or feel their hands are tied), then it is essential to allow patients the ability to look after themselves.

Please, if you feel strongly on this issue, ask your MP to get involved.

When rules are harmful, discriminating and ridiculous they need to be changed. Surely the MHRA can make vital lifesaving B12 injections available over the counter if they want to?

Wishing you the very best for 2021.

I hope that together we can reach this joint goal, along with freedom, togetherness and peace.

Tracey x
www.b12deficiency.info

 

 

 

B12 Awareness Day 2020 In the House of Commons

I am delighted to announce that MP Jane Hunt will present a petition to the House of Commons today, Wednesday the 23rd of September 2020, which asks for injectable vitamin B12 to be made available over the counter from pharmacies.

Please note this is my New Government Petition and NOT the Change.org petition.

If your MP also has an interest in this issue, please ask them to come on board and help us to get this passed.

Jane is scheduled to present the petition titled “Removing classification of prescription only medicine from injectable vitamin B12,” at the end of the day just before the adjournment debate, usually around 7pm. There is no precise time yet but you will be able to watch it live on Parliament TV or on BBC Parliament.

The full petition text will be also posted on House of Commons Hansard and the Government will need to respond to it. Too many people are restricted to just four vitamin B12 injections per year which is not enough to heal damaged nerves.

All we can do now is sit and wait for a positive outcome which would bring us into line with many other countries who do allow injectable B12 to be purchased over the counter. This has the potential to make treatment of vitamin B12 deficiency free from stress and anxiety for millions of UK citizens, affording us the same level of dignity and control over our own health as a diabetic injecting insulin.

Huge thanks to everyone who has supported this movement and to MP Jane Hunt and her team for making this possible and for for caring about people with B12 deficiency.

I have everything crossed and I’m you sure you do too.

Kindness always

Tracey x
www.b12deficiency.info

Thank YOU for your kindness in sharing this post. You can buy your “B12 for life” campaign pin here.

 

Make your comment count if your B12 injections are being stopped!

First of all THANK YOU so much for your signatures and sharing of our petition which asks if we can access our B12 injections OTC from a pharmacy.

Petition update: Last year Nicky Morgan my MP met with Dame Sally Davies about the petition and the lack of education our GP’s receive on B12 deficiency.
Dame Sally Davies then wrote to the then Chair of The RCGP (Royal College of General Practitioners) about the outcome of their meeting. In the midst of all this Brexit got in the way.

Dame Sally Davies then stepped down and so did the Chair of the RCGP.  So the communication chain here was broken.

Then we had a general election.

This meant that over 7 and a half years of work between myself and my MP had to start again. They were not allowed to keep past records from constituents so all that work and communication on their side was deleted.

You’ll appreciate how depressing this all was.

The work of getting the petition in front of those who can help us to change things did start again a few weeks ago when I met with my new MP Jane Hunt.

Jane has been involved from the very beginning as she was Nicky Morgan’s case worker. She has had to put up with 7 and a half years of me making a nuisance of myself regarding B12, so is fully primed and backs us all the way.

Please consider commenting or writing to your MP too.

This update is asking if you could take the time to comment on the blog posts below to state if you are being denied B12 injections due to #Covid19 or for any other reason. The reason for this is so that my MP can direct those she is working with directly to patient experience.

The problem with only commenting on FaceBook is that this moves quickly and gets lost. Your comments on the blogs give us a clear picture of what is happening to you and it gives us a permanent place to show those who can make change.

If we could buy B12 ampoules from UK pharmacies and self inject this would save millions for the NHS, take pressure off GP Practices and people with B12 deficiency could be in charge of their own healing.

Obviously in the midst of Coronavirus NHS and GP services are under huge strain.
Many are being told their essential injection appointment is cancelled, if all our MP’s and health agencies can work together then maybe we can make change in the not too distant future by making injectable B12 available over the counter.

So please comment here;

If you are being denied treatment due to Coronavirus please comment here;
https://www.b12deficiency.info/blog/2020/03/17/the-new-c-word/

If you are being given tablets instead of B12 injections due to GP’s lack of knowledge:
https://www.b12deficiency.info/blog/2019/07/26/wherever-we-are-in-the-world-we-are-all-in-the-same-boat/

If you are being told you no longer need B12 injections because your levels are normal:
https://www.b12deficiency.info/blog/2019/06/20/a-bizzarre-and-wasteful-practice-is-your-doctor-following-this-crowd/

The World Health Organisation has hydroxocobalamin listed as an essential medicine, we need B12 to live so let’s work together.

Finally, many of you have been asked to “chip in” financially by Change.org to get this petition in front of more people. That “Chip in” money goes to the very wealthy Change.org owners. It does not go directly to the cause you might be supporting. We can do the sharing ourselves without a cost to anyone.

Obviously any spare cash you have at the moment would be welcomed by food banks and the most vulnerable.

If in the future you want to support www.b12deficiency.info this can be done via the donation button at the foot of my website.

Thank you and take care
Tracey x