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

 

 

 

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.

B12 cancelled. See you in six months…… if you make it

Some might say this title is dramatic, but those who are currently denied access to B12 injections, who are panicked to within an inch of their lives with coronavirus and who now have no essential vitamin B12 treatment, would probably feel it’s a completely reasonable statement.

Being expected to cope for months on end without your safe, cheap, effective and life saving injections would be like making someone climb up Mount Everest without any shoes or coat whilst carrying a donkey on their back.

I know of no other vital, life saving medicine that has been stopped during this crisis and I can’t imagine that any other group of people in the UK are being denied such an easy, quick treatment at this time.

 

 

A bleak 6 months ahead

This letter below, sent to a whole county might make the untrained eye think that it’s perfectly reasonable to stop B12 injections and give B12 tablets for six months….

Letters, emails, phone calls and texts like these are being received all over the UK, I have seen them from Lancashire, Herefordshire, Gloucestershire, Hertfordshire, Cheshire, Leicestershire, Northumberland, Tyne & Wear, Flintshire, Cardiff, Essex, Wolverhampton, Cornwall, North Yorks,  west Lothian, Midlothian, Aberdeenshire.

Here’s the text from the first paragraph;

We are writing to you on behalf of your GP in regards to your B12 injections. As from Monday, the 30th of March we will no longer be giving B12 injections to patients therefore all our future appointments have been cancelled. This is as a result of coronavirus and our aim is to protect you as well as our staff. We will restart the injections once the current measures are suspended.

Do you see the sneaky stuff in there?

What is ridiculous to B12 deficient patients is this totally incorrect and bizarre idea that we can access stores of B12. We can’t and that’s why we’re B12 deficient and why we need regular replacement, this simple fact needs to be understood.

The last bullet point is the real kicker. The uneducated clinicians will say, “you don’t have Intrinsic factor antibodies (IFA) so you don’t have pernicious anaemia (PA) and so you will stay on tablets because we decided you can now miraculously absorb B12 from food!” This ludicrous concept crops up frequently (I have blogged about it before here.) It needs repeating so often – PA is just one of many causes and they are all serious and need correct treatment.

It seems they’re going to try and say you don’t need injections by testing your serum levels after they’ve given B12 oral tablets that simply can’t replace the benefit of B12 injections. They’ll do this by saying “your serum B12 levels are high now so you must be well” whilst ignoring the fact that you’re a depressed, exhausted, broken heap on the floor.

Most of us are in a state of panic at the moment, but imagine having anxiety levels through the roof and then being told you can’t have your life-saving medication for six months because someone ignorant of your condition has decided that YOU don’t matter. Not for six months anyway.

Some people were already on their knees when their injection was cancelled because the last one they had was in December, how exactly are they supposed to function? Some of these people are key workers expected to ‘soldier on’ until they collapse, some are parents thrust into 24/7 child care whilst trying to hold onto a job or their businesses by a thread.

Bay Medical Group (For Happier Healthier people!) have added this clumsy and unhelpful Q&A to their website entitled B12 Switch to oral medication.

Tidal wave of future problems

It’s impossible to expect there to be no mental or physical health casualties among those with B12 deficiency if the only provision for them is a tablet that won’t work to heal nerves or reduce symptoms but will raise serum levels.

Many of us feel like we’re currently living inside the most bizarre film set of all time, but it is also feels a bit like a ridiculous black comedy for some with B12 deficiency.

Many of our GP’s are unaware of the mental health aspect of B12 deficiency despite depression being one of the most common symptoms.

Without B12 injections we can’t function, we can’t remember, can’t walk, can’t feel happy, can’t think, can’t hear, can’t speak properly, can’t live fully.

How are the people with returning psychosis supposed to cope? How are their loved ones expected to manage this severe symptom which is an every day reality in untreated B12 deficiency in either their child, sibling, mother or father?

We’re all told to look after our mental health during this period but these incomprehensible restrictions are making things so much worse than they need to be.

Even people without previous mental health problems are having them surface during this period of isolation. The mental health charity Sane are warning that the Coronavirus could lead to a mental health epidemic.

Cutting essential, cheap, effective treatment for thousands of people through a lack of understanding of a common condition is beyond foolish. In fact it’s a time bomb and there will be guaranteed casualties amongst B12 deficient patients who only take oral tablets during this period.

The WHO

The World Health Organisation states the following in their document Mental health and psychosocial considerations during the COVID-19 outbreak 

The following directives are appropriate for those with B12 deficiency; –

Messages for team leaders or managers in health facilities:-

16. Manage urgent mental health and neurological complaints (e.g. delirium, psychosis, severe anxiety or depression) within emergency or general healthcare facilities. Appropriate trained and qualified staff may need to be deployed to these locations when time permits, and the capacity of general healthcare staff capacity to provide mental health and psychosocial support should be increased (see the mhGAP Humanitarian Intervention Guide).

17. Ensure availability of essential, generic psychotropic medications at all levels of health care. People living with long-term mental health conditions or epileptic seizures will need uninterrupted access to their medication, and sudden discontinuation should be avoided.

Messages for older adults, people with underlying health conditions and their carers

22. Older adults, especially in isolation and those with cognitive decline/dementia, may become more anxious, angry, stressed, agitated and withdrawn during the outbreak or while in quarantine. Provide practical and emotional support through informal networks (families) and health professionals.

24. If you have an underlying health condition, make sure to have access to any medications that you are currently using. Activate your social contacts to provide you with assistance, if needed.

People who can only keep their psychosis and depression caused by B12 deficiency at bay with B12 injections should surely be considered here?

B12 (hydroxocobalamin is listed as an essential medicine by WHO (see page 19 here) but it seems this is not understood by many GP’s.

Injection discrimination 

There are often comparisons made between insulin and B12 injections and whilst everybody understands that insulin is essential and required by each patient in different amounts some health professionals mistakenly think that B12 is a placebo, a frivolous want for lazy people with hypochondria and Munchausen’s Syndrome. They also think that we all need the same measly amount regardless of our symptoms and level of damage. B12 is as important to patients as insulin is to diabetics.

Our friends and family outside of the B12 world see our predicament as bizarre, they ask us the following questions about B12 injections: –

Are they life-saving YES

Is it expensive NO

Can you overdose NO

We can ask the same of questions about insulin: –

Is it life-saving YES 

Is it expensive YES

Can you overdose YES

Can you imagine the outrage if insulin were stopped for six months?

Methotrexate, heparin and insulin are all automatically given to patients to self inject at home, but all these are medications which need strict control, in contrast B12 injections (hydroxocobalamin) cannot be overdosed.

Immediate Solutions  

B12 is essential, if you are prescribed B12 injections then it means you cannot absorb B12 from food so oral tablets won’t work.

The British Journal of Haematology state:

“The use of high dose oral cyanocobalamin is licenced for use in several countries….however the efficacy and cost-effectiveness…is yet to be established.”

And I am stating:

Vital treatment should not be restricted or stopped.
We are not in a war.
There is no shortage of B12.

We of course appreciate that GP Practices are under huge pressure at the moment and that many are experiencing staff shortages but there is always a way around these problems.

Practices need to reinstate B12 injections for anyone who is well and can get to the surgery or prescribe B12 ampoules and sub cutaneous needles for people to collect from a pharmacy so that they, or someone close to them can give them their vital injection. (Sub cutaneous injections would be most sensible for patients to use and are the route most who self inject choose, myself included.)

We need our doctors to get behind this movement so that they and the Practice nurses can be freed up from giving injections to those who can inject themselves.

For the sake of the GP’s and nurses who are too busy to teach you to self inject, here are some helpful NHS guides below;

Self injection with sub cut;

https://www.qegateshead.nhs.uk/sites/default/files/users/user53/gynaeoncology/IL426%20Subcutaneous%20Self%20injection%20for%20anti-coagulation%20treatment.pdf

Link for how to break an ampoule and load syringe;

http://www.bristol.ac.uk/media-library/sites/vetscience/documents/clinical-skills/How%20to%20Open%20a%20Glass%20Vial.pdf

We need to be concerned about those people who are unable to function due to lack of B12 but who daren’t insist on treatment, those who quietly accept that their essential injection has been stopped. Our GP’s must be vigilant here and check on those at risk because they don’t want to, or feel they shouldn’t make a fuss.

Petition – Doctors, help us to get off your backs!

I’ve had numerous emails and comments detailing particular struggles with the denied access to B12 from all ages and the one solution which could make this situation better now and in the future is to make injectable B12 available over the counter from pharmacies. This would remove an enormous financial and time burden from the NHS, and GP Practices and would allow the panic to, at least partially, subside in hundreds of thousands of people in the UK.

If your doctor is on our side (I know that some are) please ask them to support this petition and share it with their colleagues.

Please consider joining the 89,000 + kind people who have already signed and shared our Petition.
(Please note: Every time you sign a change.org petition you will be asked to ‘Chip in’ money, but be warned, this money goes directly to the very wealthy change.org company and not a penny goes to the cause you might support.)

If we can get The MHRA and other NHS agencies to help us at a time where barriers are being removed then the tidal wave which is already gathering speed could be slowed.

Removing barriers

On Twitter, there’s evidence that some doctors are celebrating the fact that during this crisis, barriers that made their patient’s and their lives difficult have been removed in minutes, funding hasn’t been blocked and they can do parts of their job more easily…..

Martin Marshall (@MartinRCGP) Tweeted:

“2 emails from friends overnight saying the same thing, one a GP and local NHS leader and the other a clinical academic. They say they’ve achieve more progress in their work in the last 6 days than in the previous 6 months. People are making things happen and barriers are removed.”

Well isn’t now the time for B12 patients to get a piece of the action and have their huge barrier to good health removed?

We are living in unprecedented times but whilst all of us are in this mess together and whilst our backs are against the wall we need to see the great opportunity for change before us. Perhaps now there’s a real chance that we can get our B12 injections made available over the counter and bring us into line with other countries around the world so that we in the UK aren’t left behind.

Good Practice

It’s important for me to acknowledge that there are brilliant Practices in the UK that know their patients need their B12 injections and are either still administering them or are prescribing ampoules and equipment to make it possible for patients to self treat. (My Practice is one of these and I am so grateful, thank you Doctor B!) Anyone under the care of these good Practices will be eternally grateful for their understanding and care at this time. Many would give up their first born to be treated by you!

Take care and stay safe,

Tracey x
www.b12deficiency.info

 

B12-life-logo

Please make our life saving injectable vitamin B12 (hydroxocobalamin) available over the counter.

Please sign and share this petition as far and wide as possible wherever you are from, you will be helping to save lives.

http://www.change.org/en-GB/petitions/ian-hudson-please-make-our-life-saving-injectable-vitamin-b12-hydroxocobalamin-available-over-the-counter

 

Thank you, Tracey