Mid Cheshire Hospitals NHS Foundation Trust
The Trust’s consideration of apixaban
16. Before we decide if we should investigate 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 we have not found any indications that something has gone wrong.
17. Mr Y complains that when he arrived at A&E on 30 June 2019, he recalls explaining to Doctor L that he was taking apixaban along with his other medications.
18. The Trust explained in its investigation report of 22 August 2019, that Doctor L first saw Mr Y at 15:00 on 30 June 2019, and that when they asked him which medications he was taking, he did not mention apixaban. The Trust noted apixaban was not recorded in the ambulance handover pro-forma.
19. Doctor L explained they and Doctor A became aware Mr Y was taking apixaban after he had a CT angiogram, following which he experienced significant pain. Doctors L and A said Mr Y told them he took apixaban once he started experiencing stomach pain.
20. There are no national standards which specifically deal with doctors recording a patient’s medications. GMC Good Medical Practice guidance says documents doctors make to formally record their work should be clear accurate and legible. It goes on to say that clinical records should include relevant clinical findings.
21. It is considered good practice for doctors to record a patient’s regular medication in the A&E records, particularly if further treatment is required. In the absence of a patient’s medications list, the information is usually obtained directly from the patient. In this case, the medical records show Mr Y explaining he was taking apixaban following initial treatment being started.
22. Mr Y presented to A&E with symptoms and ECG abnormalities suggestive of a myocardial infarction (a heart attack). Where a potentially life-threatening condition is suspected such as a heart attack, it is important that treatment is started as soon as possible. There is therefore a balance between starting treatment and identifying all relevant information. The medical records show Doctor L tried to understand what Mr Y’s regular medication was by asking him. We saw that only once initial emergency treatment was delivered, did Doctor L find in Mr Y’s previous admission notes that he was taking apixaban.
23. The medical records entry Doctor L made at 15:00 on 30 June 2019, notes Mr Y as taking atenolol, apixaban, pravastatin and ramipril. Next to the entry for apixaban, Doctor L wrote ‘not mentioned by the patient, found in previous admission notes and added’. The medical records also show Mr Y was given emergency treatment of aspirin, clopidogrel and fondaparinux.
24. We do not know what medical records systems Doctor L had available to them prior to initiating emergency treatment to Mr Y, or how long it would have taken to access the information about apixaban in his medical records. Given there was a clinical need for initial treatment in a potentially life-threatening situation, Doctor L asking Mr Y which medications he was taking was appropriate.
25. We are mindful we cannot be certain of whether Mr Y told Doctor L he was taking apixaban when asked. However, we see Doctor L did ask Mr Y which medications he was taking and recorded them in his medical records. We would have expected apixaban to be noted there, without the annotation explaining it had not been mentioned by the patient, if it was discussed prior to emergency treatment starting.
26. On the balance of the evidence available to us, we consider Doctor L followed GMC guidance by recording Mr Y as taking apixaban in his medical records once they became aware. As such, we do not consider this part of the complaint is an indication of failing.
Treatment
27. Mr Y told us when he attended A&E, Doctor L assessed him and treated him with clopidogrel and fondaparinux (blood thinning medications). Mr Y told us it was when he was on his way have a CT (computerised topography) scan that he experienced significant pain in his stomach and that he was given morphine for pain relief.
28. During our assessment call, Mr Y explained he thought the medication he was given in A&E had caused the stomach pain he experienced. He went on the explain that because the Doctor L did not note his taking apixaban, the medications provided to him could have potentially interacted with it causing his stomach pain.
29. The Trust explains in its investigation report that Mr Y appeared to have experienced symptoms from his condition (a heart attack) which was the likely cause for his stomach pain. The Trust explained it had reviewed the medications given to Mr Y and was of the view that neither aspirin, fondaparinux or clopidogrel would have caused the pain he experienced, nor would it have interacted with apixaban.
30. British National Formulary (BNF) guidance on apixaban notes both aspirin and clopidogrel as having the same method of action as apixaban, in that they cause bleeding. The guidance says although there is only theoretical evidence of aspirin and clopidogrel interacting with apixaban, using the medications together should be done with caution.
31. Fondaparinux is not listed in the guidance as a contraindication to apixaban. This guidance indicates that, despite having the same method of action and presenting a potential contraindication for that reason, they are still able to be used at the same time if caution is applied.
32. NICE guidance on aspirin says aspirin can cause gastrointestinal discomfort. NICE guidance on clopidogrel says that active bleeding is a contraindication to the use of clopidogrel. The guidance also notes gastrointestinal discomfort as a common or very common side effect of clopidogrel. While both aspirin and clopidogrel can cause stomach discomfort, this is would only occur after repeated doses rather than a single dose.
33. NICE guidance on fondaparinux explains it is another blood thinning medication which acts to block a different element of the normal blood thinning process. It works in a similar way to apixaban and so if a patient is already taking apixaban, they do not need to be given fondaparinux. The guidance does not indicate that fondaparinux causes stomach pain in patients.
34. The patient.info website guidance on Acute Myocardial Infarction states it is common for patient’s experiencing the condition to have symptoms of epigastric chest pain (abdominal pain).
35. The medical records show Doctor L prescribed Mr Y with clopidogrel 600mg tablets, aspirin, and an injection of fondaparinux. In this case, Doctor L was unaware Mr Y was taking apixaban until after the initial course of medications was given and recorded that in the medical records.
36. We note that both aspirin and clopidogrel which Mr Y was given as emergency treatment, can cause stomach discomfort. However, this usually occurs after repeated doses which Mr Y did not have, rather he had a single dose of both medications and so we think it unlikely that these medications caused his stomach pain.
37. Based on the evidence available to us, we think Mr Y’s stomach pain was likely a symptom of the suspected heart attack he presented at A&E with, which is a common symptom of the condition. We think the medication the Trust provided Mr Y with as emergency treatment was appropriate as this was in line with BNF guidance on apixaban. As such, we do not consider this an indication of a failing.
North West Ambulance NHS Trust
Record keeping
38. Mr Y told us that on 30 June 2019, he experienced chest pain, called an ambulance and was taken to hospital with suspected heart problems. During our assessment call he told us he recalled telling the paramedics he was taking ramipril, atenolol, pravastatin and ‘apixa-something’.
39. He says he could not recall the exact name of apixaban but that the paramedic confirmed they understood which medication he was trying to describe. Mr Y complains the paramedics failed to record apixaban on the Patient Report Form (PRF).
40. The Ambulance Trust’s final response letter says apixaban was not one of the medications Mr Y told the paramedics about. The Ambulance Trust asked the two paramedics to provide their recollection on what happened on 30 June 2019, with respect to Mr Y’s claim about telling them he was taking apixaban. The Ambulance Trust said neither paramedic recalled Mr Y as mentioning he was taking apixaban and that they both knew what apixaban was.
41. NHS England’s Professional guidance on the structure and content of ambulance records (2014) says ambulance staff should record a patient’s significant medical history and its management including medications.
42. We reviewed the PRF form for 30 June 2019. It records Mr Y as taking ramipril, atenolol and pravastatin. We reviewed the Ambulance Trust’s investigation file which details the information gathered from the paramedics about Mr Y’s complaint. The Ambulance Trust spoke with Paramedic A and Paramedic B who took Mr Y to hospital on 30 June 2019.
43. Paramedic A said they do not remember Mr Y mentioning apixaban but knew it was a blood thinner. Paramedic B said they remember Mr Y and that he did not mention taking apixaban. Paramedic B said they knew what the medication was and would have recorded it given its importance.
44. We saw the paramedics asked Mr Y what medications he was taking, which Mr Y also agreed happened. The difference in view is whether apixaban was mentioned when Mr Y was asked and recorded in the PRF. While we cannot be certain whether Mr Y told the paramedics he was taking apixaban, on balance we think the paramedics would have recorded this in the PRF if it was communicated to them. The paramedics recorded the other medications Mr Y was taking which they understood by asking him.
45. Apixaban is an important medication for the management of symptomatic heart failure, diabetes and hypertension and we would have expected it to have been recorded in the PRF if Mr Y mentioned this.
46. We add weight to the fact the paramedics recognised apixaban as being a blood thinner and the importance of noting this. We think the paramedics recorded Mr Y’s medications in line with NHS England’s guidance and so do not consider this an indication of a failing.