The use of opioid medications
20. GMC guidance says doctors should: • prescribe drugs only when they have adequate knowledge of the patient’s health and are satisfied the drugs will meet their needs • take all possible steps to alleviate pain and distress whether or not a cure may be possible
21. The NMC guidance says nurses should: • accurately identify, observe and assess signs of normal or worsening physical and mental health in the person receiving care • make a timely referral to another practitioner when any action, care or treatment is required • act as an advocate for the vulnerable, challenging poor practice and discriminatory attitudes and behaviour relating to their care.
22. There is clear documentation in the notes and in the GP records that Mrs G had a known sensitivity to tramadol (which is a type of opioid). A sensitivity is where a patient may not be able to tolerate a medication and may experience side effects from it. The records show Mrs G’s sensitivity to tramadol had in the past caused her nausea and vomiting.
23. A sensitivity is different to an allergy to medication, which causes itching, rashes, or anaphylaxis (difficulty breathing) and can be life threatening.
24. During her admission doctors prescribed morphine and oxycodone (types of opioid pain relief) to Mrs G to ease her pain. The BNF lists nausea and vomiting as common or very common side effects of tramadol, morphine, and oxycodone.
25. Our adviser said having a sensitivity to one opioid does not mean a patient cannot be given a different one. With acute pain, the most important thing would be to ensure the pain was well controlled and to manage the side effects.
26. We know on admission, Mrs G was experiencing acute pain which required pain relief. Doctors were aware Mrs G had sensitivity to tramadol but there was nothing to indicate she had sensitivity to all opioids.
27. Our nursing adviser explained Mrs G’s kidney function was on the low end of the normal range and therefore some pain medications would not have been suitable for her. Oxycodone is less toxic to kidneys than normal morphine.
28. The Trust acted in line with GMC guidance at paragraph 20 when it prescribed morphine and oxycodone to Mrs G. However, we have also considered what happened when Mrs G was taking this medication.
29. The pain team prescribed oxycodone on 16 December and it was not until 19 December that Mrs G had some nausea. She was given anti sickness medication which was effective. Although there are entries in the records where Mrs G had nausea and vomiting during her admission, she was not consistently experiencing this. There are also entries in the records which say she was eating and drinking well.
30. The pain team reviewed Mrs G on 24 December. At this time Mrs G was concerned oxycodone was making her sick. As she had reduced kidney function and the oxycodone was helping with her pain, the pain team felt she should continue with this.
31. To alleviate the sickness she was experiencing, they prescribed anti-sickness tablets. They suggested she have this as a regular medication but she declined, choosing to ask for it when she needed it.
32. The Trust acted in line with GMC guidance to alleviate pain and distress when it continued to prescribe oxycodone to Mrs G and offered her anti-sickness tablets to alleviate any sickness from this.
33. There is no specific guidance to say when the pain team should review a patient about side effects. However, our adviser said ward staff should involve the pain team if they are experiencing significant side effects from the medication.
34. This is what would be required to meet the GMC guidance which says to consult colleagues where appropriate.
35. We can see that on 28 and 30 December, doctors were aware Mrs G had been experiencing some nausea and vomiting. They advised to continue the medication at that stage. However, Mrs G continued to experience gastrointestinal side effects in subsequent days.
36. On 1 January she vomited and had loose stools. Our nursing adviser said this is a symptom which should have been escalated to the medical team.
37. Doing so would have been in line with the NMC guidance to advocate for patients. If nursing staff had referred Mrs G’s ongoing and worsening symptoms to the medical team, they would have very likely requested further input from the pain team.
38. Our nursing adviser explained although Mrs G was prescribed an anti-sickness medication to take orally, there are alternatives which could have been explored and considered.
39. We can see the pain team did not review Mrs G until 4 January 2021. At that point they advised stopping the tablets and giving soluble paracetamol and oxycodone solution.
40. Shortly after, they considered this may not be the best option for discharge. They suggested started buprenorphine patches and lidocaine plaster (both of which are types of pain relief patches) instead.
41. Considering her nausea and vomiting, an earlier review by the pain team may have changed the treatment. It may have prompted them to move to patches sooner than they did or to consider alternative ways to manage the side effects of the opioid medications.
42. We know Mrs G declined to take anti-sickness medications as routine throughout her admission but we do not know the reasons for this. Therefore, we cannot say how agreeable Mrs G would have been to alternative options.
43. However, we can say this was a missed opportunity by the Trust to manage Mrs G’s unpleasant side effects. Knowing there was this missed opportunity to make their mother more comfortable has caused distress to her family.
Discharge
44. The DOH discharge guidance sets out that patients should be reviewed twice daily to determine if they need to remain in hospital. If a patient does not meet certain criteria then staff should consider discharge to a less acute setting.
45. GMC guidance says doctors must adequately assess the patient’s conditions, taking account of their history, and where necessary examine the patient. They should promptly provide or arrange suitable advice, investigations or treatment where necessary.
46. Our physician adviser said a patient can be discharged when they are clinically optimised, meaning when care and assessment can be safely continued in the community.
47. On 30 December, Mrs G’s pain levels had resolved and she was able to mobilise. Doctors considered she was fit to be discharged. We have considered the criteria referred to in paragraph 43 and can see at that stage, she did not meet any of the criteria to remain in hospital. It was therefore in line with the guidance to consider discharging her.
48. Unfortunately, there was no rehabilitation place available for Mrs G at this time so she remained in hospital. The records show on 30 December, Mrs G developed low blood pressure and so doctors discontinued her blood pressure medication.
49. Although Mrs G’s blood pressure improved on 31 December, it dropped again shortly afterwards. Staff had to assist Mrs G back to bed and it prevented her from having therapy. The next day she still had low blood pressure, and an episode of diarrhoea.
50. Mrs G’s blood pressure remained low on 4 and 5 January. It had dropped to 93/64 which our adviser said is very low. The records show a doctor reviewed Mrs G during a ward round, noting her low blood pressure and advised her to drink plenty to improve this.
51. Our physician adviser said this advice to increase oral fluids was appropriate but Mrs G was no longer medically fit to be discharged. This is because doctors had not identified the cause of or treated her low blood pressure. They did not consider whether Mrs G’s diarrhoea and vomiting had settled or do an assessment for signs of dehydration.
52. The low blood pressure could suggest the onset of a hospital acquired infection. She was also at increased risk of falls. We consider doctors should not have discharged her without seeing an improvement in her blood pressure.
53. The Trust’s actions here were not in line with GMC guidance to adequately assess the patient, taking account of their history. This is a failing.
Impact of this failing
54. As set out in paragraph 51, there were signs Mrs G may have been developing an infection before she was discharged. The inadequate assessment and premature discharge led to Mrs G being readmitted three days later. Not investigating the cause of and treating her symptoms (the low blood pressure) led to her developing an acute kidney injury.
55. Miss G is understandably concerned these events led to her mother’s prolonged admission in hospital during which she caught COVID-19.
56. Our physician adviser said it is possible that if, on 5 January, staff had given Mrs G fluids and treated her dehydration, she would have been discharged within a few days when her blood pressure improved. However, it is not possible to say it is more likely than not she would have been discharged.
57. They said she may still have been in hospital on 17 January, which is when she developed shingles. Shingles resides in the nerves and remains latent after childhood chickenpox. The virus then reactivates sometime later. In Mrs G’s case, it was probably related to the use of methotrexate and her illness affecting her immune system. It is not a hospital acquired virus.
58. People with shingles do not routinely require admission to hospital. However, it can be a very painful condition and it increases in severity with age. Our physician adviser said it is not possible to predict if Mrs G had been at the rehabilitation centre when she developed shingles, whether she would have required hospital admission for pain relief.
59. If she had required admission for shingles, then she would still have been at risk of catching COVID-19 on 27 January. This means we cannot say if the Trust had adequately assessed Mrs G on 5 January, her admission would have been any shorter or she would not have caught COVID-19.
60. We recognise the failure to adequately assess Mrs G has caused uncertainty to the family about whether things might have been different for their mother. This uncertainty, along with Mrs G’s discharge and readmission to hospital with acute kidney injury three days after is distressing for them. We have made recommendations later in the report for the Trust to put this right.
COVID-19
61. HSIB’s investigation found there were several factors to affect the risk of COVID-19 transmission in hospital. From our own consideration of such complaints, it can be difficult to say, even on the balance of probabilities, how a patient has caught COVID-19.
62. The PHE guidance explains the incubation period (the time from infection to developing symptoms) is between one and 14 days. At the time Mrs G tested positive for COVID-19, she had been back in hospital for 19 days. This means Mrs G caught COVID-19 whilst in hospital.
63. This does not automatically mean there was a failure by the Trust in its infection control procedures. Infection control procedures and processes reduce the risk of the spread of infectious diseases. Unfortunately, it cannot entirely remove the risk, even when hospitals do everything they should.
64. We appreciate Mrs G had been isolated in a side ward from admission and at that time patients were not allowed visitors. However, COVID-19 can be transmitted through a carrier who has no outward signs of the virus, through a carrier who has a false negative test, through water vapour in the air or through surfaces or clothing.
65. The NHS England letter which was sent to all Trusts said organisations should do a root cause analysis (RCA) for every likely healthcare associated COVID-19 inpatient infection, which it defines as patients diagnosed more than seven days after admission.
66. An RCA is a process of establishing how and why an adverse event happened. It considers how systems, process, and human factors may have contributed to an incident taking place. Its purpose is not to apportion blame but to understand why the events happened and what can be done to minimise the risk of it happening again.
67. The Trust’s RCA is what we would consider initially when considering a complaint about a hospital acquired infection. Unfortunately, the Trust has not been able to provide us with an RCA for Mrs G’s infection.
68. The Trust’s infection control lead told us RCAs were done and they generally found the same things as contributing factors each time, such as patients were in six bed bays, limited toilets and issues with ventilation.
69. However, we know Mrs G was in a side room throughout her admission and therefore the root causes of her infection may not have been the same as in others.
70. The absence of the RCA means we do not know the circumstances of Mrs G catching COVID-19. For example, whether this was part of an outbreak at the hospital or whether staff on the ward had tested positive. We do not know whether she was known to have had contact with anyone who tested positive. We do not know if there were any issues in relation to staff testing or regarding cleaning processes and checks.
71. Unfortunately, the lack of an RCA and documentary evidence means we do not have the evidence to consider whether the Trust’s infection control was robust.
72. The Trust’s response to Miss G’s complaint about her mother catching COVID-19 supports our view the Trust did not consider the possible causes of Mrs G’s infection. It provided little detail to her, other than it was following the national guidance.
73. The Trust did not produce an RCA in line with the guidance set out at paragraph 64. We consider this is a failing.
74. We would like to be clear that in reaching this view, we do not doubt the Trust’s infection control team were under incredible pressure during the COVID-19 pandemic. Nor do we doubt all Trust staff were working in very difficult circumstances.
Impact of this failing
75. We know the aim of infection control is to reduce the risk of patient’s catching infections such as COVID-19. Unfortunately, it is not possible to entirely remove the risk. We cannot say any action taken by the Trust would have entirely removed the risk to Mrs G.
76. However, the lack of an RCA and documentary evidence means we do not know if Mrs G was protected as much as possible from catching COVID-19. This means Miss G is left with uncertainty about whether more could have been done to prevent her mother’s infection from which she sadly died.
77. This uncertainty is an injustice to Mrs G and we have set out later in the report what the Trust should do to put this right.
Communication
78. Miss G is concerned about the Trust’s communication with her during her mother’s first admission. She says because of this she was unable to share her concerns about her mother’s side effects from opioid medication.
79. GMC guidance says doctors must be considerate to those close to the patient and be sensitive and responsive in giving them information and support. The NMC Code says nurses should share with people and their families the information they want or need to know about the health, care and ongoing treatment.
80. Our physician adviser said doctors should update relatives when there is something of clinical significance to share, or when they are specifically asked for an update.
81. In normal circumstances, when visiting is permitted, relatives would have opportunity to ask questions of staff when they are on the ward. However, it was more difficult during the COVID-19 pandemic as visiting was restricted and updates were therefore given by telephone
82. During Mrs G’s first admission, she was experiencing mobility difficulties but doctors had not found a specific cause for this. We can see throughout this admission, there were no events or changes which were of clinical significance to prompt staff to update the family.
83. Although Mrs G was experiencing nausea or vomiting as side effects of a medication, in our view, this is not something which would require an update to relatives, unless they specifically asked.
84. Although it is not documented in the records, we accept the family called the hospital regularly. They told us that on the occasions the calls were answered, they expressed their concerns about the medications causing nausea and vomiting. These would not have prompted an update from doctors as they were not events or changes of clinical significance. They were aware of the side effects and the likely cause.
85. The records show there were two conversations with Mrs G’s family on 29 December 2020 in relation to discharge arrangements and on 2 January 2021 with concerns around Mrs G’s mental health. These would have been opportunities for the family to discuss their concerns about Mrs G receiving opioid medication and any side effects she was experiencing from this.
86. The Trust communication with the family was in line with the guidance set out in paragraph 78.
87. We recognise the restrictions on visiting during the COVID-19 pandemic made communication with relatives challenging. We appreciate Miss G may not have received as much information about her mother’s condition as she would have liked.