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The Dudley Group NHS Foundation Trust

P-001289 · Report · Decision date: 3 February 2022 · View The Dudley Group NHS Foundation Trust scorecard
Drugs / medication Treatment Medication Contamination/Misadministration
Complaint (AI summary)
Daughter complained her mother's chronic diarrhoea and SIBO were not appropriately treated, and medication for Parkinson's, pain, and anxiety was incorrectly administered.
Outcome (AI summary)
Complaint partly upheld. No failings in diarrhoea management. Failings in medication administration caused the daughter distress, but had no clinical impact on the patient.

Full decision details

The Complaint

4. Miss A complains about the care and treatment provided to Mrs E at the Dudley Group NHS Foundation Trust (the Trust). She says the Trust:

· Failed to appropriately treat her mother for chronic diarrhoea and a small intestine bacterial overgrowth (SIBO) for six months, between August 2017 and February 2018. She says the Trust failed to carry out appropriate testing during this period · Incorrectly administered Parkinson’s, pain relief, and anxiety medication to her mother during her admission between January 2018 and March 2018. She says it failed to give her mother’s Parkinson’s medication at the right time and did not manage her mother’s pain relief during this period. She says staff lied to her about administering the medication, when she knew this was not the case.

5. Miss A says the failure to appropriately treat her mother for the SIBO and prolonged diarrhoea caused malabsorption, uncontrollable weight loss, and anxiety for six months. She says this ultimately led to her mother’s death. She says the medication issues caused her mother’s Parkinson’s to worsen. She says the Trust left her mother without sufficient pain relief. She says having to witness her mother’s deterioration and subsequent death caused her significant distress and upset.

6. As an outcome, she is seeking service improvements and a financial remedy.

Background

7. Between August 2017 and October 2017, the Trust admitted Mrs E as an inpatient on three occasions, with bowel-related symptoms. Clinicians treated her for constipation, weight loss, lethargy, a decreased appetite, and worsening of her Parkinson’s.

8. Mrs E presented at the Emergency Department (ED) on 30 December 2017, however the Trust felt she did not require an inpatient admission.

9. During an admission on 11 January 2018, the Trust identified and treated Mrs E for diarrhoea. On 29 January, the Trust started her on rifaximin to treat a possible bacterial overgrowth. On 1 February the Trust discharged her home.

10. On 12 February, the Trust admitted Mrs E with pain and spasm in her left hand. Doctors prescribed a butrans patch and a fentanyl patch. Miss A phoned the Trust on 14 February to request the discharge of her mother.

11. On 25 February the Trust admitted Mrs E with a chest infection and doctors diagnosed her with bronchopneumonia. Due to the severity of the infection, doctors and Miss A agreed a ward based ceiling of care. This means that if the patient becomes more unwell during the admission, they will not transfer the patient to intensive care. The palliative care team arranged for a fast track discharge on 6 March 2018. Mrs E later sadly died.

Findings

15. Our gastroenterologist adviser told us that small intestinal bacterial overgrowth (SIBO) is associated with diarrhoea, which is often explosive due to gas production. A SIBO can be diagnosed from review of the blood tests. These show malabsorption, specifically of vitamin D, vitamin B12, and magnesium. A glucose breath test may be used for diagnosis, however, most clinicians would usually provide a trial of antibiotics as the breath test results can often provide false positives in the elderly. The BSG guidance outlines the initial investigations for patients with chronic diarrhoea including blood tests and a coeliac test. Clinicians should also request stool samples for patients with suspected cancer or inflammation.

16. Between August 2017 and February 2018, Mrs E was admitted to hospital as an inpatient on a total of six occasions, and she also presented at the ED on 30 December 2017. For ease of understanding we will consider each admission separately.

4 August - 8 August 2017

17. The original clerking admission shows that Mrs E suffered from ‘constipation but had loose stools a few days ago’. Doctors arranged blood tests, which our gastroenterology adviser explained showed no particular features that might lead to suspicion of SIBO. This is because her alkaline phosphatase was normal (this is usually increased with a vitamin D deficiency). Her haemoglobin was a little low and her red blood cells were at the upper limit of normal size. The stool chart completed during this admission reported a single type four (formed) stool on 8 August.

18. There is no evidence of Mrs E experiencing symptoms of diarrhoea during the admission between 4 and 8 August 2017. Doctors had discussed the possibility of a further period of rehabilitation for Mrs E, however she was discharged at her own request. We have seen no evidence of failings in this period of care.

30 August - 1 September 2017

19. The clinical records show Mrs E reported she had experienced diarrhoea three to four times a day at home for the past 10 days. Miss A explained the diarrhoea settled with the use of Imodium at home, and her GP had concerns about recent weight loss. From reviewing the stool charts, Mrs E had one type six (fluffy pieces with ragged edges) on 31 August, and again on 1 September in the morning but did not open her bowels again when nurses checked at 11am that day. Mrs E then made a request to self-discharge which the Trust agreed to. From reviewing the clinical records available, we can see no evidence Mrs E suffered from diarrhoea during this admission.

20. The clinical records show the doctors requested a computerised tomography (CT) scan, as well as a stool sample and coeliac test, as doctors provisionally suspected a diagnosis of an underlying malignancy (cancer) or coeliac disease. This is in line with the BSG guidance on treatment for chronic diarrhoea and suspected cancer or inflammation.

21. As Mrs E had requested to be discharged home, the Trust arranged for the CT scan to take place on an outpatient basis on 11 September 2017. Our gastroenterology adviser has confirmed the CT scan showed no features of concern. Prior to discharge, Mrs E’s blood test results were all noted to be unremarkable.

22. We have not seen any evidence Mrs E suffered from diarrhoea, or with a SIBO, during this admission, and we are satisfied the Trust treated her appropriately, and in line with the relevant guidelines.

18 October - 31 October 2017

23. During the clerking admission on 18 October, the records suggest Mrs E had worsening Parkinson’s symptoms and ‘longstanding diarrhoea’. The dietician saw Mrs E, along with Miss A who advised her mother had ‘not lost weight and was always the same weight’.

24. On 20 October there was a lengthy discussion with Miss A about her concerns for her mother, however there is nothing within the records from this discussion to suggest diarrhoea as a concern.

25. On 23 October, the records explain doctors had a further conversation with Miss A, where she reported her mother’s diarrhoea had improved after a dose of lorazepam, and there is no further mention of Mrs E’s bowels being a cause of concern during this admission.

26. Further to this, the stool chart shows Mrs E had either type four (long and smooth stools) or type five (soft blobs with clear cut edges) during this admission, averaging one a day. During this admission, there were three days in which Mrs E did not open her bowels at all. From reviewing the evidence available, there is nothing to suggest Mrs E was suffering from diarrhoea during this admission.

27. We know the Trust carried out blood testing on Mrs E throughout her admission, which our gastroenterology adviser confirmed showed no concerns or suggestions she was suffering from a bacterial overgrowth at this time.

28. The Trust arranged a flexible sigmoidoscopy (a test that looks at the rectum and lower part of the large intestine) but as she requested to be discharged, it was carried out on an outpatient basis on 4 November 2017.

29. The Trust’s information leaflet on flexible sigmoidoscopy explains this procedure may be beneficial for patients who are suffering from a change in bowel habits. It is a way of inspecting the bowel more closely. We can see on 4 November 2017, Mrs E had the flexible sigmoidoscopy to investigate her gastrointestinal symptoms further, however it was noted the bowel preparation before was poor and that there was solid stool present. Our gastroenterology adviser told us the results showed there were no features of concern within the bowel.

30. We have not seen any evidence Mrs E was suffering from diarrhoea during the admissions in 2017. Miss A says her mother was suffering from chronic diarrhoea during this period, but the records do not indicate she had any symptoms during her admissions.

31. We do not dispute Miss A’s recollection that her mother was suffering from diarrhoea, and the records support that this had been an issue pre-admission, but on the balance of probabilities, we are satisfied that this did not continue during the admissions.

32. We consider the Trust carried out appropriate testing and there was no evidence of Mrs E suffering a SIBO during the three 2017 admissions.

30 December 2017

33. Mrs E presented at the ED on 30 December with concerns of agitation, poor sleep, and diarrhoea.

34. For this ED presentation, our gastroenterology adviser told us the appropriate guidance is the GMC guidance. The guidance explains clinicians should adequately assess the patient’s conditions, taking account of their history and where necessary, examine the patient. Clinicians should provide or arrange suitable advice, investigations, or treatment where necessary.

35. We can see from reviewing the clinical records, the doctors took a full history, completed an examination, and took appropriate blood tests. Clinicians started Mrs E on medication to help with her agitation and arranged a follow-up appointment. Following this assessment, doctors felt Mrs E did not require an inpatient admission. There is nothing within the records to show Mrs E suffered with diarrhoea at any time during this presentation. We consider the ED assessment of Mrs E is in line with the GMC guidance on assessing and examining a patient’s condition. From reviewing the clinical records, we consider the decision not to admit Mrs E is reasonable and the Trust appropriately managed her during the ED attendance, and our clinical advice supports this view.

11 January 2018 – 2 February 2018

36. The Trust admitted Mrs E on 11 January 2018, with diarrhoea and hypokalaemia (an electrolyte abnormality). The clerking notes show Miss A explained her mother had been suffering from diarrhoea for two weeks.

37. The relevant guidance to follow in situations such as this is the BSG guidance. The BSG guidance explains very little data exists on the prevalence of SIBO in patients presenting with diarrhoea and/or malabsorption. Part of the difficulty in establishing a confident diagnosis is the lack of a standardised investigative tool. The sensitivity and specificity of breath tests to diagnose SIBO’s are poor. There are problems with a hydrogen breath test, which means it may have little benefit for clinicians when a SIBO is suspected. A positive test will reinforce the clinician’s view that the prior cause may be SIBO, but a negative test will not exclude a positive diagnosis as breath tests show a false negative in between 3-25% of patients.

38. The BSG guidance explains the most practical approach is to proceed straight to an empirical (based on observation or evidence) antibiotic trial.

39. The stool chart from this admission shows Mrs E was suffering from diarrhoea. She also had a yellow stool, which could indicate malabsorption. Doctors did not carry out a hydrogen breath test but did treat Mrs E empirically (through observation or experience) for several conditions including bacterial overgrowth with rifaximin, pancreatic insufficiency with Creon, and bile salt malabsorption with cholestyramine. This is in line with the BSG guidance, and a breath test was not necessary.

40. Our gastroenterology adviser told us it is unclear which of these helped resolve the diarrhoea but explained the evidence of Mrs E suffering low magnesium would suggest the rifaximin treatment, for the bacterial overgrowth, may have been involved in the successful treatment of the diarrhoea.

41. Doctors started Mrs E on rifaximin on 29 January 2018, which is 18 days from Mrs E’s admission. This is evidence of excellent clinical practice, as there would be many possible explanations and causes for diarrhoea, which needed ruling out with appropriate investigations.

42. We consider it likely Mrs E’s chronic diarrhoea resolved during this admission. The Trust was right not to arrange a breath test and provided the correct treatment of antibiotics, in line with the BSG guidance.

43. We have also looked at Mrs E’s concerns that various medication was not provided when it should have been.

Parkinson’s medication

44. Miss A says the Trust incorrectly administered her mother’s Parkinson’s medication at the wrong time. She says this caused Mrs E’s condition to worsen during the 12 to 14 February 2018 admission, and she witnessed her mother curled up in the foetal position.

45. Parkinson’s UK explains getting medications on time mean that symptoms are well controlled, and the patient is likely to experience fewer complications. The BNF Madopar guidance explains patients should take tablets within 30 minutes of meals, or within one hour after meals.

46. Mrs E’s regular medication charts show the instructions for the administration times of her medication (9am, 1pm, 5pm, and 9pm). The NMC guidance outlines that when administering medication, nurses should ensure they have checked the timing of medication where appropriate.

47. The clinical records do not detail the times the Trust administered Madopar, so we cannot say the Trust administered it at the correct times, in line with the NMC guidance and clerking instructions. This is a failing.

48. The Trust explained in its response dated 27 November 2019, that following the complaint, it has taken action to improve procedures around timing of the Parkinson’s medication to ensure consistency for patients.

49. We have sought clinical advice regarding the potential impact this failure to administer medication at the right time had on Mrs E.

50. Miss A explained her mother’s condition worsened because of the lack of continuity administering Madopar. The clinical records show Mrs E’s condition was worsening throughout her admissions and doctors considered this was due to her disease progression.

51. The patient information leaflet for Madopar, states that one of the side effects of the medication is that patients experience on-off effects. This is where patients can switch quite suddenly between being 'on' and able to move, and being 'off' and immobile. The BNF guidance on Madopar explains the frequency of the side effects of depression, hallucinations, and movement disorders are common. But the side effects of aggression, confusion, delusion, and drowsiness are not known.

52. We sought clinical advice to see whether Mrs E’s deterioration throughout her admission was due to the lack of continuity in administering her medication, or whether this was due to her disease progression. Our nursing adviser told us Mrs E’s condition would never be cured, and the progression of her Parkinson’s would not be related to the lack of medication continuity. They explained it is possible her worsening symptom control is related to medication continuity, but it could equally be related to disease progression.

53. It is likely we will never know whether Miss A’s mother’s deterioration was due to the lack of medication continuity. We cannot say therefore, even on the balance of probabilities, there was a link between the lack of continuity of administration times and her worsening condition, which was more likely as a result of her Parkinson’s progressing.

54. Miss A will never know the answer to this which must be distressing.

55. We can see the Trust has acknowledged its failings in relation to the lack of continuity. It explained it now has a procedure in place where the nurse looking after a patient with Parkinson’s sets a timer to inform them when the next dose is due, and they add stickers to time sensitive drugs.

56. We have considered whether the actions taken by the Trust are in line with the Ombudsman’s Principles for Remedy. The Principles explain where we have identified a failing that leads to an injustice, there are several appropriate remedies for an organisation to take in respect of this. This includes remedial action to prevent the same thing from happening again.

57. We can see that largely, the actions taken by the Trust are appropriate. However, we can see Parkinson’s UK recommends that patients taking antiparkinsonian drugs should be offered the opportunity to self-medicate during their admission, where appropriate. Our nursing adviser told us that a Parkinson’s specialist nurse can also ensure that, on review of their patients, the medication is being taken on time.

58. Our decision is the action taken by the Trust does not go far enough to remedy the complaint. We have made a recommendation about this and will discuss this later in our report.

Pain relief

59. Miss A says the Trust incorrectly administered her mother’s pain relief medication during her admissions between January 2018 and March 2018. She says the Trust left Mrs E without sufficient pain relief during this period.

60. The relevant guidance here is the NMC guidance and the BNF guidance. The NMC guidance explains nurses are expected to administer medications in line with the prescriber’s discretion. If there is any reason why the prescription cannot be followed, this should be clearly documented. For example, a delay in administering medication because the medication is not available. In such circumstances the reason for the non-administration of the medication, or a delay in administering the medication, should be clear. The prescription chart should be signed on all occasions after a missed dose to indicate an awareness of the previously missed dose. Also, the BNF guidance on codeine explains it can be prescribed for pain relief and to treat diarrhoea.

61. We have reviewed the medication administration charts during the three admissions.

62. We can see during the first admission from 11 January to 2 February 2018, the Trust prescribed the codeine linctus four times a day. During this time, the Trust administered the codeine appropriately. On 11 January, the nursing staff reported code seven on the medication administration charts, which indicates the patient self-medicated. We can see that on 15 January, 20 January, 23 January, 27 January, 28 January, and 31 January 2019, code four was used, which indicates the medication was not available.

63. During the second admission, from 12 to 14 February 2018, the Trust prescribed paracetamol to be administered four times a day. The Trust also prescribed a butrans patch to be changed every three days. The medication administration charts show these were given as prescribed throughout this admission.

64. During the third admission from 25 February to 3 March 2018, the Trust prescribed Matrifen (fentanyl) patches to be changed every three days. The medication charts show these were administered as prescribed throughout this admission.

65. Overall, we can see the Trust failed to give the codeine on a total of six occasions throughout Mrs E’s admissions between January and March 2018. The six missed doses represent one missed dose on one single day, rather than consecutively missed doses. On each occasion clinicians used a code four, which means the codeine was not available.

66. We have looked at whether the Trust took appropriate action when it identified the medication was not available. We can see from the evidence available it appears the medication stock for Mrs E was running out during her admissions. There is not sufficient evidence to show the nurses were proactive enough in ensuring a continued supply of this medication was available on the ward. Nurses should have ordered a further supply when the bottle in use was nearing the end. Nurses would do this either as part of a ward stock or against a patient’s name. We consider this is a failing and the nursing staff should have taken further action when staff identified the medication was not available, and our clinical advice supports this view.

67. Having identified evidence of a failing, we have reviewed whether the codeine not being available on these six occasions had any impact on Mrs E. We have reviewed the daily rounding charts from Mrs E’s admissions. These document if nurses asked about her pain during the admissions.

68. Her pain scores are recorded throughout the admissions on the nursing charts, with a pain score of 0 recorded on each of the six occasions when the medication was not provided, which indicates Mrs E answered she was experiencing no pain at the time. The clinical examinations also do not suggest Mrs E reported any pain at this time.

69. Miss A says her mother was in horrendous pain during her admission, and we have no doubt how distressing this would have been for her. As we have outlined above, there is nothing contained within the clinical records to indicate Mrs E suffered any pain during the admission. The records also show Miss A was present at times when staff completed the observations. We do not know why Mrs E reported being in no pain to the nurses when Miss A says she was in horrendous pain throughout the admission. We have no reason to dispute what Miss A says, but on balance, we can see several entries where Mrs E reported no pain to clinicians. On this basis, it seems more likely than not that Mrs E did not suffer as a result of missing these doses of codeine.

70. We have also considered whether clinicians should have given the pain relief when Mrs E reported she was not in pain. The prescription charts from this period outline the clinicians should give codeine to treat Mrs E’s diarrhoea, and the stool charts confirm she was suffering from diarrhoea at the time. As such, the decision to administer codeine when she was experiencing no pain was appropriate and in line with the BNF guidance.

71. We recognise it must have been very stressful for Miss A to witness her mother going without medication during her admission, at a time when she was already unwell. We hope our findings reassure her that these omissions did not cause her mother to suffer.

72. We can see the Trust has apologised to Miss A for the drug errors and confirmed the issue has been raised at the junior doctors meeting. However, we do not think this goes far enough to address the drug errors identified throughout Mrs E’s admissions. We make a recommendation in relation to this later in our report.

Anxiety medication

73. Miss A says the Trust failed to administer her mother’s anxiety medication during her admissions between January and March 2018. She says this caused her mother additional anxiety.

74. As outlined above, the NMC guidance outlines when a medication is not available, the reason for the non-administration of the medication, or a delay in administering medication, should be clear.

75. We have reviewed Mrs E’s anxiety medication during the admission from 11 January to 2 February 2018. On review of the clinical records, we can see the list of Mrs E’s regular medications and can see she was taking sertraline prior to her admission on 11 January. Doctors also prescribed Mrs E lorazepam from 26 January 2018 until discharge.

76. We have reviewed the medication administration from 11 January to 2 February 2019. The only occasion we can see the Trust did not give Mrs E’s sertraline was on 13 January. On this date, the staff recorded code four on the medication administration charts, which shows the drug was not available. From reviewing the medication charts, we can see on 29 January, nursing staff failed to give Mrs E’s dose of lorazepam. There was no code entered on her medication charts and no rationale provided for omitting the medication. Nursing staff appropriately administered the medication throughout the rest of her admission.

77. During the admission from 12 to 14 February 2018, nursing staff gave the sertraline on 12 and 13 February, but the records show nursing staff did not give her dose of sertraline on 14 February. Nursing staff recorded code four on the medication charts.

78. During the admission from 25 February to 3 March 2018, the only occasion during this admission when the Trust did not give the sertraline was on 28 February. Nursing staff entered no code and provided no rationale within the records for omitting the medication. On 2 and 3 March 2018, nurses did not give the sertraline however code nine was used, which indicates the medication was given by Miss A.

79. In summary, we can see there were two occasions, on 28 January and 29 February when nursing staff did not administer Mrs E’s sertraline medication and did not document any rationale. This is contrary to the NMC guidance.

80. There are also two occasions, on 13 January and 14 February, when the sertraline medication was not available, and there is no evidence to show what action the nurses took when it was clear the stock was unavailable. This is contrary to NMC guidelines.

81. We will now consider whether there is any link between the failing and Miss A’s claimed injustice that the medication errors caused her mother’s anxiety to worsen.

82. The NHS page for sertraline outlines that if a patient misses a dose of the medication, to not worry and continue to take the medication the following day, at the regular administration time. The medication leaflet for sertraline outlines the half-life (time for the medication to leave the body) is approximately 26 hours.

83. From reviewing Mrs E’s clinical records, we can see Mrs E was anxious throughout her admissions, even when the nursing staff administered the anxiety medication correctly. The records state Miss A gave anxiety medication to Mrs E at times throughout the admissions. This makes it difficult to determine whether Mrs E’s anxiety worsened due to the missing doses.

84. We can see the NHS page for sertraline outlines that if patient misses a dose, there is ‘no need to worry and to continue to take the regular dose the next day’. The half-life of the medication, and the times of administration, suggests when the Trust missed a dose, Mrs E would still have the medication in her system. The prescription charts show that after each missed dose of sertraline, nursing staff administered the medication correctly the following day. Our clinical advisers did not identify the missed doses had any substantial impact on Mrs E. Based on the evidence available, we consider the failure to administer her anxiety medication is unlikely to have had a negative impact on Mrs E.

85. Overall, we consider there were clear failings in the Trust’s administration of Parkinson’s, anxiety, and pain relief medication. We cannot say they had a negative impact on Mrs E clinically, but it would have been worrying to have witnessed so many omissions. This would understandably have cast doubt on the Trust’s standard of care, which will have compounded Miss A’s distress at an already worrying time. There were multiple occasions where the stock of medicine ran low, which suggests Trust did not do enough to ensure there was sufficient stock on the ward. We recommend the Trust to create an action plan to show what it intends to do to ensure these failings do not occur again in the future.

Our Decision

Our decision

1. We have not identified any failings in the Trust’s management of Miss A’s mother’s (Mrs E’s) chronic diarrhoea. We therefore do not uphold this element of the complaint.

2. We have seen some failings in the administration of the Parkinson’s, pain relief, and anxiety medication. While we consider it is unlikely to have had any clinical impact on Mrs E, it is likely to have caused Miss A distress at an already worrying time. We therefore partly uphold this element of the complaint and recommend that the Trust takes action to learn from its failings.

3. It is clear that Miss A has been through a lot, and we hope our findings are of some comfort to her.

Recommendations

86. In considering our recommendations, we have referred to our ‘Principles for Remedy’. These state that where poor service or maladministration has led to injustice or hardship, the organisation responsible should take steps to put things right.

87. In considering our recommendations, we have referred to our ‘Principles for Remedy’. These state that where poor service or maladministration has led to injustice or hardship, the organisation responsible should take steps to put things right.

88. Our principles say that public organisations should look for continuous improvement and should use the lessons learned from complaints to make sure they do not repeat maladministration or poor service. In line with this, we recommend the Trust create an action plan to show how it has learned from the failings we have identified with the administration of the Parkinson’s, pain relief and anxiety medication.

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