A medical practice on the Isle of Wight

3. Mrs T complains about the service, care, and access to treatment between March 2020 and March 2021, at the Practice. She complains about:

• the unacceptable delays in the Practice restarting her vitamin B-12 injections after COVID-19 pandemic measures ended. She says the delays were against clinical guidance

• the Practice communicating different decisions to her and NHS England more than once, and failing to give her the opportunity to go to and comment in a meeting about her care.

4. She experienced concentration and fatigue problems, which she believes was because of low B-12 levels. She also felt stress and anxiety because the Practice refused to restart the injections.

5. Mrs T would like the Practice to restart the injections, review the relevant guidance and apologise for what it got wrong. She would also like £950 compensation for stress and inconvenience.

6. Mrs T has B-12 injections to help with symptom management and malabsorption (when the small intestine cannot absorb enough of certain nutrients and fluids). She has a history of Crohn’s disease (a condition where parts of the digestive system become inflamed), inflammatory bowel disease and ulcerative colitis (where the colon and rectum become inflamed).

7. At the beginning of March 2020, the Practice advised Mrs T to take 1000mcg of vitamin B-12 in an oral supplement, as they could not give her injections during the pandemic.

8. Mrs T had a telephone consultation with a gastroenterologist, who wrote to the Practice in September 2020 recommending she have B-12 injections every eight weeks. The Practice wrote back to check the advice, as Mrs T’s B-12 levels were within normal range.

9. The gastroenterologist replied to the Practice in October 2020, saying Mrs T had not told them she was taking oral B-12, and decided it was reasonable to continue with the oral supplements, as long as the Practice made sure the levels did not fall.

10. Mrs T says she asked the Practice in October and November 2020 to restart her B-12 injections but it said she did not need them.

11. On 19 November 2020, Mrs T asked a different GP. She complained to NHS England on 25 November, while the Practice gave her a new GP. On 2 December 2020 the new GP told Mrs T her B-12 levels were good.

12. The Practice wrote to Mrs T on 12 January 2021, to say it had taken haematological advice, and oral supplements were still appropriate. However, NHS England advised in a complaint response on 21 January 2021, it felt Mrs T should have B-12 injections. NHS England stated the Practice had failed to follow National Institute for Healthcare Excellence (NICE) and British Society for Haematology (BSH) guidelines.

13. Mrs T’s new GP told her in an appointment on 22 January 2021 they had not seen the complaint response from NHS England. The Practice refused to restart the B-12 injections as Mrs T’s B-12 levels were very good. Mrs T contacted NHS England the same day.

14. On 3 February 2021 the Practice told Mrs T her B-12 level had almost doubled. It recommended staying on oral supplements, with a routine annual check.

15. NHS England asked its professional standards team to review Mrs T’s case on 9 February 2021. It responded on 15 February 2021, saying a peer review had shown a difference of clinical opinion. NHS England said it was not uncommon for medical professionals to disagree about how best to treat a patient, and it would not override the Practice’s decision to treat her with oral B-12 supplements.

Access to B-12 injections

19. Mrs T had her last vitamin B-12 injection on 8 January 2020. She got a letter from the Practice on 23 November 2021, saying it would restart her injections. She was without B-12 injections for one year and ten months.

20. In its complaint responses, the Practice said it had acted within NICE and BSH guidance, to give her good care. After speaking with a gastroenterologist and haematologist, the Practice had a partner meeting and still felt oral B-12 supplements were appropriate, instead of B-12 injections.

21. Mrs T was originally put on B-12 injections for malabsorption, due to ulcerative colitis. We got expert clinical advice from a medical professional who has experience in B-12 deficiency, to explain the right standards for care and what the guidance was during the pandemic. Our adviser said the NICE standard for B-12 and folate deficiency shows Mrs Ts’ B-12 deficiency is not diet related. This means Mrs T should be given B-12 injections every three months for life.

22. During the pandemic, the guidance says patients who self-administer B-12 injections at home should continue to do this. However, it is not recommended to switch a patient to self-administration during the pandemic, as instruction would be difficult for the patient to follow. Mrs T had her injections administered by a medical professional. The guidance says in cases like Mrs T’s, replacement oral supplements are appropriate, aiming for the shortest possible break, between injections.

23. We can see NHS England decided the Practice acted against guidance, and referred the complaint on for a confidential investigation. NHS England decided there was a difference of clinical opinion, and it could not insist on a specific course of treatment.

24. In line with the guidance, Mrs T’s B-12 injections should have restarted several months before they did, as the Practice should have been aiming for the shortest possible break.

25. We asked our clinical adviser to compare Mrs T’s historical B-12 levels given by injection, with her levels after she switched to oral supplements, to find out the impact this failing had on her health.

26. Mrs T’s B-12 levels were well within normal limits when she was asked to switch to oral supplements. They remained within normal limits while on the oral replacement and increased between September 2020 and January 2021. Mrs T did not experience reduced B-12 levels after her injections were replaced with oral supplements.

27. We can see the Practice did not act within the relevant guidelines by not restarting Mrs T’s B-12 injections. NHS England identified this as a failing and did a separate investigation into the Practice.

28. As Mrs T’s B-12 levels did not cause any concerns despite this failing, there is no clinical impact.

29. Mrs T would like the Practice to review its procedures and restart her injections. She would like an apology and to be paid compensation of £950 for the stress and worry it caused.

30. We can see some of these outcomes have already been addressed. The Practice wrote to Mrs T in November 2021 saying her B-12 injections would be restarted. It confirmed by letter in February 2022 that as she preferred injections, it would give these. The Practice has apologised to Mrs T via NHS England, and offered a face-to-face discussion, should she wish to take up the offer.

31. We understand it must have been very stressful for Mrs T to move to oral B-12 supplements and it is natural she would feel uncertain about this. The evidence shows if the Practice had restarted her injections sooner, it would have reduced her stress.

32. However, we cannot link the Practice’s failing to follow guidance to a clinical impact, as her health was not negatively affected by having oral supplements instead of injections.

33. We are pleased to hear Mrs T is having B-12 injections regularly again and we hope this has brought an end to her uncertainty.

34. Considering the above, we cannot link the events complained about with the negative impact Mrs T has claimed. Therefore, we will not be taking any further action.

Communication of decisions

35. After Mrs T was not happy with the Practice’s response, she complained to NHS England about the Practice. As we have seen, it made a decision and after reviewing it, decided there was a difference of clinical opinion.

36. The GMC Good Medical Practice guidance says medical professionals should work together, and changes in medicine should only be done with good knowledge of a patient. This shows it would not have been good medical practice for NHS England to resolve matters by simply changing the Practice’s clinical decision. This is because the Practice’s knowledge of Mrs T’s clinical history is more complete and up to date than NHS England’s, who do not treat her regularly.

37. About the care meeting Mrs T was not invited to, the Practice explained it was a GP partners meeting. Mrs T would not be invited to this internal routine meeting, as she would likely overhear discussions involving other patients, breaching confidentiality. There is no guidance that gives any situation where Mrs T would have been allowed to attend.

38. Reviewing all the available evidence, we cannot see where the Practice has communicated different decisions to any party. There is a time when a GP said they had not seen a complaint response from NHS England, but as this is not saved to a patient’s clinical records, we can see why the GP was not aware of it.

39. The records show many challenges to clinical opinion from both the Practice and NHS England throughout September and October 2020. These letters give a clear timeline of events for the Practice’s decision making.

1. We have carefully considered Mrs T’s complaint about a medical practice on the Isle of Wight (the Practice). We have decided while there are signs the Practice acted against clinical guidance, in withholding Mrs T’s vitamin B-12 injections. Although the Practice failed to follow guidance, we cannot say this had a negative effect on her health as her B-12 level did not drop too low. We understand how Mrs T may have felt frustrated and uncertain during this time.

2. We can see no signs the Practice acted outside good medical practice, when communicating Mrs T’s care with NHS England and hospital staff. It did not go against guidance by discussing her care in a meeting, without her being there.