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
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.
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.
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.