Failure to discuss side effects
14. Before we decide if we should do a detailed investigation of a complaint, we look at whether there are signs the organisation has got something wrong. We do this by comparing what should have happened with what did happen. We have done this and have not seen any signs that something has gone wrong.
15. The Practice explained it did not discuss with Mr A the potential side effect of the facial sores and scarring as it is not a common side effect.
16. We asked our adviser whether a skin reaction is a side effect that would normally be discussed. They said the GMC guidance says the doctor should reach an agreement with the patient on the proposed treatment, including a discussion about the serious and common side effects.
17. They referred us to the NICE guidance on hydroxocobalamin, which is the B12 injection the Practice prescribed to Mr A. Skin reactions are listed here as a general side effect, but how often this happens is not noted. They said skin reactions are a rare side effect that are not very likely and because of this, it would not usually be discussed with a patient. They did not think it was wrong for the Practice to not discuss this side effect with Mr A.
18. In the Trust’s complaint response it says skin reactions are an uncommon symptom it has not seen before.
19. Section 40 of the GMC guidance says doctors must discuss side effects of a treatment with a patient, including serious and common side effects. Because the reaction Mr A sadly experienced is not a common side effect, we would not expect it to be discussed with patients, so we cannot say the Practice did anything wrong.
20. We are sorry to hear how painful the skin reaction was for Mr A and we understand how it affected his overall self-confidence.
21. The Trust apologised for not discussing this side effect and says it will use this experience when discussing potential side effects of the B12 injection in future.
Prescribed treatment
22. Mr A complains he did not need B12 injections at all and the Practice should not have prescribed them. He thinks B12 oral medication would have been more appropriate for him.
23. We asked our adviser whether B12 injections were an appropriate treatment for Mr A. They explained there are no clinical guidelines on when to prescribe B12 injections instead of another treatment. He said clinicians will make different decisions on this.
24. The NICE guidance on anaemia, B12 and folate deficiency says doctors should interpret the results from clinical symptoms. The lab commented on Mr A’s blood test results from 30 June 2022.
25. A vitamin B12 deficiency was noted. Our adviser said the result noted in the absence of macrocytosis (the enlargement of red blood cells), suggests rechecking in three months’ time. We were not given the blood level results, but our adviser said if there was no macrocytosis, the Practice could have suggested to wait three months and check again.
26. There are no NICE guidelines to say whether B12 should be given by injection or orally, and our adviser says treatment will vary across practices. But, our adviser confirmed B12 injections can be an appropriate course of treatment.
27. Mr A told us he got a different opinion from a different practice, who said B12 injections were not the appropriate treatment plan. We understand why Mr A would be concerned and upset after hearing this. It is clear the treatment plan can vary from practice to practice because of there being no set guidance for this situation.
28. We cannot see any sign of a failing in the Practice choosing B12 injections for this reason.
Failure to discuss the different options available
29. The Practice could have discussed the different options available to help Mr A to make a decision. His options included waiting three months and B12 injections or oral tablets. We understand Mr A may have chosen a different treatment plan if this had been offered to him. We thought about whether this would have prevented Mr A from getting the side effects he experienced.
30. As discussed earlier, Mr A’s skin reaction is not a common side effect or one that would be routinely discussed before deciding on treatment. Because of this we cannot say Mr A would have known about the possibility of a skin reaction if he had been offered different treatment plans.
31. Our adviser said that NICE guidance on cyanocobalamin, the oral medication Mr A would have preferred, does not list any side effects. This means the side effect Mr A experienced would not have been discussed with him if the Practice offered this treatment.
32. So, Mr A would not have decided on treatment based on what side effect he was told about. He may have chosen B12 in oral tablets and still experienced the same side effect. We cannot say either way.
33. We are sorry that Mr A was not given the different treatment options available. But we cannot link Mr A experiencing this side effect to the Practice’s failure to discuss the different treatment options with him.