Withdrawal of medication
14. Miss A complains that staff at the Hospital stopped her mother’s steroids, which she had been taking in her inhalers for more than six years. She says they did not provide a replacement or check her cortisol levels (this is a steroid hormone produced in the adrenal glands that helps the body respond to stress, regulates blood sugar and fights infections).
15. The Trust’s view is the steroid content of Ms A’s beclometasone inhalers was negligible in terms of the impact this would have had on her adrenal glands. It said there was no strong reason to test Ms A’s cortisol levels, and this would not be routine medical practice.
16. The Endocrinology Adviser told us it is a recognised fact that long term steroid use can lead to adrenal suppression. This includes inhaled steroids because some of the steroid is absorbed from the lungs into the blood stream.
17. The NPSA Alert explained that some patients who take inhaled steroids may develop secondary adrenal insufficiency and be steroid dependent. Omission of steroids for patients with adrenal insufficiency can lead to adrenal crisis. This is a medical emergency which, if left untreated, can be fatal. The NPSA Alert says healthcare providers should ensure clinicians are prompted to check for the risk of adrenal crisis for patients being treated for acute physical illness or trauma. They should also establish whether the patient has a steroid emergency card.
18. The Endocrinology Statement said ‘there is a genuine risk of adrenal suppression in patients taking regular inhaled steroids and sudden withdrawal of the inhaled steroids can lead to adrenal crisis.’ The Endocrinology Adviser said this means the standard of care expected is for clinicians to consider the risk of adrenal crisis when stopping steroids.
19. The clinical records show Ms A had been using an inhaler for around six years. This contained a daily dose of 400mcg. The Endocrinology Adviser told us this is considered a low dose. On 29 March 2021 doctors admitted her to intensive care. Inhalers cannot be used by acutely unwell patients in intensive care and so they are usually stopped. At this point the appropriate standard of care would have been to recognise the risk of adrenal insufficiency and observe the patient for any signs of it.
20. Ms A carried a steroid emergency card. This would have explained that steroid treatment must not be stopped suddenly. The Endocrinology Adviser said this should have been a further prompt to consider adrenal insufficiency.
21. The Endocrinology Adviser said we do not know if Ms A was adrenally suppressed at the time of these events. The usual indicators for adrenal insufficiency are hyponatraemia (low levels of sodium in the blood), hypoglycaemia (low blood sugar levels) and low blood pressure. Ms A’s blood pressure remained low throughout her admission to the Hospital, despite treatment. But there is no evidence she had hyponatraemia or hypoglycaemia.
22. The clinical records show doctors were aware of Ms A’s abnormally low blood pressure. There is no evidence they considered whether adrenal deficiency was a possible cause of her low blood pressure. The Endocrinology Adviser said this should have led to doctors either carrying out a blood test to check cortisol levels or starting intravenous steroids (hydrocortisone) to treat for possible adrenal insufficiency. There is no evidence to suggest doctors weighed up the potential advantages and disadvantages of giving intravenous steroids.
23. In its complaint responses the Trust has emphasised the potentially negative effects of administering intravenous steroids. It is true that steroids can suppress the immune system and worsen an infection. The Trust did not mention that, in an adrenally suppressed patient, steroids can also be potentially lifesaving and may treat low blood pressure.
24. We find doctors did not follow the NPSA Alert when they stopped Ms A’s inhalers without considering the risk of adrenal crisis.
25. The Endocrinology Adviser told us it is difficult to determine how likely it was that Ms A developed adrenal insufficiency. Studies suggest an estimated 6.8 per cent of patients in her circumstances would have this problem. This means there was a relatively low probability that the withdrawal of steroids had a significant effect on Ms A. There is a more than 90 per cent chance she had normal or nearly normal adrenal function.
26. It is difficult to predict whether, if doctors had used steroid treatment during Ms A’s admission to the Hospital, this would have made any difference to her illness. She was very unwell: with a fast heart rate, low blood pressure and a significant infection. She also needed oxygen support. If Ms A did have adrenal suppression, steroid treatment may have helped reverse her low blood pressure, but the severity of her illness means it is likely her death was unavoidable.
27. We recognise Miss A considers the withdrawal of her mother’s steroid medication could have contributed to her death. This is not what we have seen. Because of Ms A’s other health problems during the admission, we cannot say the outcome would have been different if the failing had not happened. Clearly, it is distressing for Miss A to know doctors did not follow the relevant standards in this respect. This has left her with doubts about her mother’s care and treatment which continues to be a source of distress to her.
Food and drink
28. Miss A complains that staff at the Hospital offered her mother drinks and snacks before they carried out an assessment to see whether it was safe for her to swallow.
29. The Stroke Guideline explains how clinicians should manage patients who have had a suspected acute stroke. It says appropriately trained health professionals should assess patients who have had a suspected stroke for their ability to swallow before providing any oral food, fluid or medication. If this indicates a swallowing issue, they should arrange a specialist swallowing assessment within 72 hours. When aspiration is suspected, or tube feeding is in place for three days, a professional should reassess the patient and refer them for dietary advice.
30. The clinical records contain no evidence that Ms A ate any food. There is evidence a nurse offered her snacks on 29 March 2021, but not that Ms A ate them. There is also evidence she had sips of water on the next day. There is no evidence she had any adverse reaction to this, and records suggest it was safe for her to drink. These incidents happened when Ms A was ‘nil by mouth.’
31. The records show a nurse assessed Ms A shortly after her admission to the Hospital. They noted she was too unwell at that stage to have a swallowing assessment. Her consciousness levels improved soon after her arrival and there are no records suggesting Ms A was seen to have swallowing difficulties. The first reference to any problem with swallowing was on 1 April 2021 when a pharmacist suggest medication should be put on hold because her swallowing was ‘not great.’
32. Clinicians inserted a feeding tube for Ms A on the morning of 31 March 2021. A dietician later reviewed her and produced a target for nutrition and fluids to be provided in the Hospital. Staff gave her this using the tube over the following days.
33. Doctors suspected Ms A had experienced a stroke, but this was not confirmed. The Nursing Adviser told us the Stroke Guideline would have applied to Ms A. This means she should have been offered a swallowing assessment within three days. There is no evidence that Ms A had a swallowing assessment. But we do not consider this fell below the required standard. This is because by the time she had been in the Hospital for three days a feeding tube was already in use.
34. Clearly, it was not ideal that a nurse offered Ms A food before a swallowing assessment had happened. But there is no evidence she consumed any food. We also understand sips of water are often allowed in these situations for comfort reasons. We cannot say what happened fell below the requirements set out in the Stroke Guideline.
Oral medication
35. Miss A says on 30 and 31 March 2021 nurses gave her mother oral medication when she was supposed to be ‘nil by mouth.’
36. Clinicians should have followed the Stroke Guideline, as explained above, before providing oral medication to Ms A. It says oral medication should be reviewed when a patient has a suspected stroke to ensure it is being given by the appropriate route.
37. The medication records are challenging to interpret. This means we cannot be certain about which medicines were given orally. They appear to show clinicians gave almost all of Ms A’s medication intravenously (by injection, drip or via feeding tube). But, on 30 March 2021 nurses gave her oral aspirin, digoxin and lansoprazole. There is no evidence clinicians reviewed the suitability of oral medication at that stage. They did not follow the Stroke Guideline.
38. The Second Medical Adviser told us there is no possibility the oral medication caused aspiration. Aspiration is generally caused by aspiration of stomach contents. In any case, we can see doctors diagnosed aspiration pneumonia when they first admitted Ms A to the Hospital. This may have happened during her seizure at home when stomach contents could have entered her lungs.
39. The Second Medical Adviser said there is no evidence the oral medication Ms A took on 30 March 2021 made her health worse. The main risk would have been that the medication was not properly absorbed and so was not as effective as it should have been. But Ms A was taking all of her more important medication intravenously, so this risk did not apply in her case. There was also a risk of her choking, but there is no evidence this happened.
40. We find clinicians fell below the standard set out in the Stroke Guideline when they administered oral medication without assessing if this was appropriate. But we do not consider this had any effect on Ms A’s health. We do recognise this would have been distressing for Miss A to witness. We consider this was an injustice to her.
Gentamicin
41. Miss A complains that clinicians gave her mother too much gentamicin on 30 March 2021. She says the first dose was at 9.25pm and the second at 11pm. She considers this was an overdose that affected her mother’s health.
42. The Trust confirmed Ms A had two doses of gentamicin within a six-hour window on 30 March 2021. Its view is this was unlikely to have made any difference to Ms A’s condition.
43. The SmPc contains detailed information about medicines licensed for use in the UK. It is approved by the national medicines regulatory agency. The SmPc says gentamicin can be administered either as a single daily dose or as three equal doses given approximately eight hours apart.
44. The SmPc suggests that the maximum safe concentration of gentamicin in the blood should be lower than 12mg/L. Before another dose is administered the level should have fallen below 2mg/L.
45. All drugs have what is called a half-life. This is the time taken for half of the drug to be broken down or eliminated by the body. The SmPc says the half-life for gentamicin is two to three hours.
46. The clinical records show clinicians gave Ms A gentamicin for the first time at 7.20pm on 29 March 2021. This was 240mg intravenously. They checked her level of gentamicin in her blood at 1.13pm the next day. This showed a blood level of 0.9mg/L.
47. Ms A had her next intravenous dose of gentamicin at 9.25pm on 30 March 2021. Clinicians administered 360mg. They mistakenly gave a second intravenous dose of the same amount at 11pm. Clinicians documented they recognised this error in the clinical records. The level of gentamicin in her blood was 2.8mg/L at 5.46am on 31 March 2021. Clearly, when Ms A received the second dose the levels of gentamicin in her blood would have been higher than 2mg/L.
48. We find clinicians did not follow the SmPc when they gave Ms A two doses in error on 30 March 2021. The Trust has already accepted this was an error. We asked for clinical advice about whether this had a significant effect on Ms A’s health.
49. The First Medical Adviser told us the peak level of gentamicin in the blood is thirty minutes after the infusion has finished. The infusion usually takes between ten and fifteen minutes to complete. So, the peak level of gentamicin in Ms A’s blood would have been around 11.45pm on 30 March 2021.
50. The First Medical Adviser said the SmPc referred to gentamicin having a half-life of between two and three hours. They said for a patient aged 60 this would be closer to three hours. From the measurement of 2.8mg/L at 5.46 am it is possible to calculate the level of gentamicin in Ms A’s blood at the peak time of 11.45pm as being approximately 11.2mg/L. So, this is below the maximum safe level of 12mg/L.
51. The First Medical Adviser said the medication error would not have had any clinical significance for Ms A. We can see how this has been a source of distress for Miss A since she first learnt about the error. We hope she is reassured this would not have had any effect on her mother’s health.
Blood transfusions
52. Miss A complains that her mother had blood transfusions that were unnecessary. She says she has never been given a clear explanation about why her mother needed the transfusions. She questions whether the reason for this was to dilute the concentration of gentamicin in her mother’s blood following the ‘overdose.’
53. Good Medical Practice says doctors must provide a good standard of practice and care. It says they must promptly provide or arrange suitable advice, investigations or treatment where necessary. It says doctors must prescribe drugs or treatment only when they have adequate knowledge of the patient’s health and are satisfied the drugs or treatment serve the patient’s needs.
54. The clinical records show Ms A did not receive a blood transfusion during her admission to the Hospital. Doctors prescribed human albumin solution (HAS) which is derived from human blood donations but is not a blood transfusion. Albumin is a protein in the blood which helps regulate the distribution of fluids throughout the body. The records show Ms A received four 100ml doses of 20% HAS between 30 March and 1 April 2021. Clinicians administered 20% HAS. The Trust has explained doctors gave HAS to Ms A for fluid resuscitation.
55. On 29 March 2021 Ms A’s albumin level was 26g/l and on 30 March it was 23g/l. The normal range is between 35 and 50g/l. So, Ms A’s albumin level was low.
56. The First Medical Adviser told us there are no formal guidelines about the use of 20% HAS in the UK but it has been used and trialled widely. 20% HAS is a hyperoncotic solution. This means when added to the circulation it draws in fluid from other tissues in the body. This means patients can be given less fluid than they would otherwise need. It helps resuscitate people with low blood pressure who are at risk of fluid overload. This includes people with heart failure.
57. The First Medical Adviser said there is limited evidence that 20% HAS is better than giving conventional intravenous fluids such as a saline solution. Some studies have shown that it can help to increase blood pressure and lower the amount of fluid retained in the body. They have shown no significant difference in survival rates. Crucially, the studies have shown 20% HAS is not known to be harmful.
58. The decision to use 20% HAS was based on the opinion of the clinician. There is nothing to suggest this decision fell below any relevant standards or that it was unsuitable for Ms A. There is no evidence it exposed her to harm or that it was used to mask any issues relating to other treatment. As we have already explained, there is nothing to suggest Miss A had harmful levels of gentamicin in her body.
59. We find doctors provided a suitable treatment to Ms A when they gave her 20% HAS. The records show they did so based on an analysis of her observations and her history. The choice of treatment was based on a clinical opinion. The evidence suggests doctors followed Good Medical Practice in this respect. We hope Miss A is reassured we have seen nothing to suggest there were any failings relating to the use of HAS in her mother’s treatment.