The NICE B12 guideline – has anything changed?

In this month’s blog post our CEO, Katrina Burchell, looks at how NICE Guidelines should improve things for patients with a review of how NICE is supposed to work and a summary of what the Pernicious Anaemia Society and others have been doing since the publication of the Guideline on B12 deficiency in over 16s in March 2024. Many of our members are still reporting that their primary care providers notably GPs and nurses remain unaware of what the guidelines say or are misinterpreting them due to a lack of knowledge and awareness about B12 deficiency and pernicious anaemia. With a chronic autoimmune condition like pernicious anaemia many of us have found that we have to advocate for ourselves so understanding the guideline is important for the patient as well as the doctor and our mission is to ensure we improve communication and ultimately improve the guideline as we build on research in the future.

In March 2025 it will be a year since the Nice Guideline on B12 Deficiency in over 16s was published. It seems timely to think again about why this was needed, what it says and when and how it applies. We should also look at what is being done to raise awareness and ensure better diagnosis and treatment for people with Pernicious Anaemia and B12 deficiency from other causes.

NICE stands for the National Institute for Health and Care Excellence. It’s an independent organization in the UK that provides national guidance and advice to improve health and social care in England.  

Here’s what NICE does:

• Develops guidelines: They create evidence-based guidelines on a wide range of health and social care topics, such as treatments for diseases, diagnostic tests, and care pathways.
• Evaluates new medical technologies: NICE assesses the clinical and cost-effectiveness of new medical technologies, such as drugs and medical devices, to determine whether they should be made available on the NHS.  
• Promotes quality improvement: They work to improve the quality of health and social care services by providing advice and tools to healthcare professionals and organizations.
• Informs the public: NICE provides information to the public about health and social care issues, helping people to make informed decisions about their own health and care.

 

By providing evidence-based guidance, NICE helps to ensure that people in England receive high-quality, effective, and cost-effective healthcare. NICE Guidelines are widely respected and used as a reference point across the UK and even internationally.  

The application of NICE guidelines outside of England varies:

• Scotland, Wales, and Northern Ireland: These parts of the UK have their own guideline development bodies (SIGN, TGCS, and BSG, respectively). They may choose to adopt or adapt NICE guidelines based on their specific needs and resources.
• Internationally: NICE guidelines are often used as a reference point by healthcare professionals and policymakers in other countries. However, they may need to be adapted to suit the specific context of each country’s healthcare system and resources.

It’s important to note that while NICE guidelines are influential, they are not legally binding. Doctors in the UK are expected to practice in line with evidence-based guidelines, but they must consider individual patient circumstances, local resources, and the specific guidance from their respective health systems.

In the case of Pernicious Anaemia and B12 deficiency diagnosis and treatment, other guidance exists. The British National Formulary (BNF), the British Society of Haematology Guidelines, NHS Clinical Knowledge guides, Integrated Care Board guidance notes such as this one from NHS Cambridgeshire and Peterborough, Vitamin B12 full guidance. On top of these guidelines individual GP surgeries have policies and procedures which, as many of our members encounter, often seem to trump common sense!
 
NICE guidelines are intended to help ensure that people have equal access to treatment, regardless of where they live. NICE guidelines cover topics such as: Prescribing medicines, Recommending treatments, Safeguarding, Public health, and Social Care.
 
Scotland has its own system for producing clinical guidelines called the Scottish Intercollegiate Guidelines Network (SIGN). For example, the Scottish Good Practice Statement (SGPS) is the official guidance on the diagnosis and management of ME/CFS in Scotland. NICE and other organizations have collaborated on projects in Scotland, such as the Guideline on managing the long-term effects of COVID-19. In Wales the All Wales Medicines Strategy Group (AWMSG) and in Northern Ireland -the Department of Health, Social Services and Public Safety (DHSSPS) decide how they will be implemented locally.

NICE guidelines are evidence-based recommendations for health and care in England and Wales. They help health and social care professionals to prevent ill health, promote good health and improve the quality of care and services. Our members will recall that the Pernicious Anaemia Society was the organisation which called for a specific B12 guideline to improve the diagnosis and treatment of Pernicious Anaemia. We were involved in the stakeholder process and issued our statement on the good and bad parts of the Guideline published in March 2024.

NICE guidelines should be influential and widely respected as a reference point across the UK because the process they have gone through before publication is extensive in terms of research and interested party feedback. However, as you can see in my statement about the content of the B12 deficiency guideline there is still much wrong with this specific one in so far as concerns Pernicious Anaemia and our members.

As I mentioned, the NICE guidelines are not legally binding but ignoring or failing to adhere to NICE guidelines when making decisions about patient treatment could lead to legal consequences. This is because a doctor must show a duty of care to a patient and failure to do so may lead to claims of negligence. Doctors in the UK are expected to practice in line with evidence-based guidelines. While NICE guidelines are considered a high-quality source of evidence, they are not the sole determinant of treatment decisions. Doctors must consider individual patient circumstances, local resources, and the specific guidance from their respective health systems. There are some circumstances where deviating from NICE guidelines may be acceptable. The guidelines are intended to support a clinician’s knowledge and skills. Clinicians are still responsible for making decisions appropriate for each patient. A clinician may be able to justify a decision to deviate from the NICE guideline if it was reasonable and made in good faith. It is important here to remember the tenets of joint patient and doctor decision making and informed consent – key words in the NHS. This is why we often recommend to our members that they ask their doctor to put in writing their reasons for deviating from the guidelines. It is certainly not sufficient for a GP practice just to say that it is their “policy” or “internal procedure”. They must be able to explain why they are treating you as the patient differently from what the guideline says.

A good example of this is understanding why a GP practice is asking to retest your blood for intrinsic factor antibodies (after a diagnosis of PA) or retest your B12 levels while you are on injections because the guideline is clear that this is not necessary. What is their reason for these requests to draw blood via an invasive procedure when there is no medical advantage in knowing the B12 blood serum result? What is it they are looking for additionally, if your symptoms have improved while on B12 injection treatment? Why are they using their and your time to carry out procedures which are not recommended? Why are they still offering only 8-12 weekly injections to symptomatic patients when the NICE guideline says that more frequent injections may be trialled to see if symptoms resolve? Why are they moving patients to oral tablets when guidelines say that further research is needed in that area?

Healthcare providers in the NHS cannot restrict access to NICE approved treatments without exceptional justification. It says this specifically in the NHS constitution. People often quote “first, do no harm” as being part of the doctor’s oath but you might be surprised to learn that the oath doesn’t actually say that. As often is the way with quotes and sayings they get changed along the way of history. Hippocrates apparently wrote in Greek ὠφελέειν ή μὴ βλάπτειν (roughly translated into Latin as primum non nocere) in his passage from the treatise on Epidemics (First book, second part, paragraph 5); “In illnesses one should keep two things in mind, to be useful rather than cause no harm”

So eight months on, what has been done?

What have we, the Pernicious Anaemia Society, done?

• Our comments as a key stakeholder were taken on board and many improvements were made before publication. We worked closely with other interested parties and were instrumental in putting together the B12-Allliance collaboration of charities to increase awareness and education for patients and health care professionals of B12 deficiency whatever the cause.
• We issued our statement on the guideline and our CEO, who is also the Chair of the B12-Alliance, was instrumental in the text and publication of the statement of CluB-12.
• We invited guest bloggers to comment on the guidelines including two very popular blogs by Bruce Wolffenbuttel: Only One Chance and Alfie Thain: Pernicious Anaemia: A Misnomer? Exploring the Pros and Cons of a Name Change for an Overlooked Lifelong Condition
• We ran a seminar about the process and the guidelines with one of the people involved in the process: Making a Difference – The NICE Guideline on B12 deficiency
• We drafted a national pathway suggestion to lobby for national adherence to NICE through updating ICBs and through GIRFT (Getting it Right First Time).
• We are working on educational material for Healthcare Professionals (watch this space early in 2025) and patients: How Vitamin B12 Works in your Body
• We lobbied the Royal College of GPs about training and awareness about B12 deficiency and Pernicious Anaemia and they have now agreed to write an EKU module for doctors on this topic.
• We introduced a series of seminars for patients and healthcare professionals raising awareness about diagnosis and treatment of PA including important topics like iron deficiency
• We updated our website and information sheets
• We explored and continue to work on research projects for those issues identified in the NICE recommendations on B12 deficiency and in the James Lind Alliance Priority Setting Partnership.

What has NICE done?

• It is tempting to just say not very much; they did not reply to our attempts to work with them on getting the information out to primary and secondary care. They don’t seem to have a remit specifically to push the guidelines to the audience that needs to see them, namely GP’s and nurses in GP surgeries.
• NICE did update the CKS (Clinical Knowledge Summary) in March 2024 Scenario: Management – Anaemia – B12 and folate deficiency
• They made a page specifically for patients and actively connected with the Pernicious Anaemia Society as a source of expertise for patients to contact Information for the public: Vitamin B12 deficiency in over 16s: diagnosis and management

What are others doing?

• Articles in the newsletter Pulse aimed at practising GP’s have been largely positive, but the comments underneath sadly often reflect the dinosaur-type attitudes to B12 deficiency that some of our members experience in interactions with their GP.
• The British Medical Journal published a What You Need to Know article about the Guideline in June 2024: Vitamin B12 deficiency: NICE guideline summary and some positive social media posts.
• Consultant haematologist Dr Priya Sriskandarajah published an article in Pulse Today including a link to a 2-hour CPD training course on key questions on vitamin B12 deficiency: CPD: Key questions on vitamin B12 deficiency. This course is available only to those with a GMC membership number, so we have not as yet been able to review the content. This is something we are working on so that we can support or comment as appropriate. 
• The BNF updated their website but the information about frequency remains the same Hydroxocobalamin. Hydroxocobalamin licensed in the UK for intramuscular injection every 3 months, or 2 months with neurological involvement. No mention of course that beauty salons can administer exactly the same “drug” (aka vitamin) for aesthetic reasons and charge people inflated amounts for an essential treatment for those with Pernicious Anaemia.
• The British Society of Haematology website still shows their guidelines as last reviewed in 2014 (yes not a typo, 10 years ago!). With a bit of searching you can also find their corrected statement on B12 injections during Covid.

Looking Ahead

Continued efforts are needed to raise awareness of the NICE Guidelines among healthcare professionals. Patient education initiatives are crucial to empower individuals to advocate for proper B12 deficiency diagnosis and treatment. It is fundamental that the cause of the deficiency is investigated, and that people are treated accordingly. Research advancements can address remaining questions about B12 deficiency but if people are continually under-diagnosed and under-treated, they will continue to resort to self-help which limits the opportunities for thorough research for all.
At the Pernicious Anaemia Society we will continue addressing these challenges, to work towards ensuring better diagnosis, treatment, and overall, care for people with Pernicious Anaemia.