Black Country Trust’s management of Mr U’s citalopram medication (July to October 2020).
30. Miss U says Black Country Trust’s decision to reduce this medication and its refusal to reverse its July 2020 changes resulted in Mr U’s mental health relapsing. She explained he suffered paranoia after this, neglecting his physical health resulting in admittance to hospital with an acute kidney infection.
31. Miss U explained her father caught COVID-19 whilst in hospital, leading to his death. She says had his medication stayed the same, he would not have relapsed and would not have needed admittance to hospital, therefore would not have contracted COVID-19.
32. In its complaint response, Black Country Trust does not refer to the initial medication change in July 2020. It explained Miss U contacted clinicians in October 2020, asking for a review of her father's medication. It says she asked it return citalopram to its original dose as her father’s mental health was relapsing.
33. Black Country Trust’s response explains clinicians refused her request, in view of Mr U’s co-morbidities and the risks of taking citalopram. It explained it decided to increase his other medication instead.
34. Black Country Trust explained it wrote to Mr U’s GP following a phone appointment with her and Mr U on 1 October 2020, following her concerns. The letter says Mr U spoke well and was engaged in the conversation. It goes on to say Mr U had said he was not distressed or hallucinating, with him having ‘insight into his mental health and capacity to make decisions regarding treatment’.
35. Before we decide if we should conduct 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.
36. We can see what should have happened by using relevant guidelines and standards. In this case there are national guidelines about the prescribing of mental health medication alongside physical health conditions.
37. Citalopram and escitalopram: QT interval prolongation - GOV.UK (www.gov.uk) states patients taking citalopram are more at risk of QT prolongation (when the heart muscle takes longer to contract and relax than normal putting the patient at risk of sudden cardiac arrest). It also recommends prescribing less than 20mg if the patient is over the age of 65.
38. Similarly, https://patient.info/medicine/citalopram-cipramil-paxoran explains patients with diabetes may need additional management if taking citalopram.
39. Guidance | Depression in adults: recognition and management | Guidance | NICE 1.9.1.1 says medication reviews should take place every six months where a patient takes medication to prevent mental health relapse.
40. The medical records, show Black Country Trust reviewed Mr U’s medication on 25 June 2020. The notes say it agreed a plan with him and Miss U to reduce the dose of citalopram from July 2020 by 10mg per month. It planned to review this in three months' time, earlier than required in the above NICE guidance.
41. In a letter to Mr U’s GP after this appointment, the consultant explained the risk of citalopram for a patient with cardiac issues and diabetes, Mr U’s co-morbidities. The letter says, ‘I told him that the dose of citalopram can be lowered to reduce the risk of side effects...I talked to his daughter too in this regard and she agreed to reduce the dose of citalopram gradually’.
42. The letter explains Black Country Trust’s intention to move Mr U to sertraline (another antidepressant) as it would not have the same impact on his heart condition or diabetes.
43. Miss U says her father started to relapse at the beginning of October. The medical records show she contacted Black Country Trust on 1 October and asked for an increase in citalopram from 20mg to 40mg, the original dose.
44. Black Country Trust arranged an emergency phone appointment the same day. We recognise it must have been very difficult for Miss U to witness her father’s mental health deteriorate.
45. On 8 October, the consultant wrote to Mr U’s GP to summarise the phone appointment. The consultant explained Mr and Miss U were ‘not keen to decrease the citalopram further…because they felt [Mr U] was doing really well in terms of his mental health and is back to his usual self’.
46. In the letter, the consultant explained the cardiac risks of continuing citalopram and recorded that Miss U and Mr U still wanted to continue this medication after considering the risks and benefits. The consultant wrote they would leave his citalopram dose at 20mg, with a plan to review this again in four months’ time.
47. We asked our adviser for their view on whether the consultant acted in line with guidance and standards in the management of Mr U’s citalopram.
48. Our adviser said the initial move to reduce the dose of citalopram, with the intention of moving to sertraline, was in line with MHPRA guidance. They said this was because of Mr U’s co-morbidities of cardiac issues and diabetes with patients taking citalopram being more at risk of QT prolongation.
49. There is evidence in Black Country Trust medical records of Mr U having taken sertraline in 1998, at a low dose, with no adverse side effects. Our adviser explained this made sertraline a suitable and safe alternative as is does not have increased risks for patients with cardiac issues and diabetes.
50. Our adviser explained that there was no need for Black Country Trust to have tapered citalopram from July 2020, and that this could have been switched immediately to sertraline. However, we can see that clinicians gradually reduced the dose because of Mr U’s preference.
51. Our adviser also explained Mr U was still at high risk of the side effects of citalopram in October 2020. They explained there was a risk in moving back to a treatment that wasn’t licensed (thus potentially unsafe) for Mr U’s conditions.
52. They explained that in these circumstances, alternative treatments are often considered first and that Black Country Trust’s adjustments to his other medications were not unusual.
53. From reviewing the clinic letter from Mr U’s 1 October appointment. We cannot clearly see that he or Miss U requested an increase in citalopram. The letter states ‘they were not keen to decrease the citalopram further’ because Mr U was ‘doing really well in terms of his mental health and is back to his usual self’. After the consultant discussed the risks of continuing the medication, they noted that they ‘would like to continue on the citalopram at 20mg’.
54. Because of this can find no indication that Black Country Trust acted incorrectly by not increasing the dose of citalopram in October 2020.
55. The medical notes show the consultant followed guidelines for the management of medication for a patient with a heart condition and diabetes in suggesting a move to sertraline in June 2020. The consultant, Miss U and Mr U agreed a gradual reduction of citalopram and the dose had reduced from 40mg per day to 20mg by of October 2020.
56. We can see that when Miss U contacted Black Country Trust and raised concerns about her father relapsing, it made an emergency appointment to review him. A consultant assessed him and did not find he showed signs of a relapse but agreed to continue citalopram in line with their wishes. Considering the available evidence and advice received, we therefore cannot see clear indications the consultant did anything wrong at this point.
57. We acknowledge this will have been a very worrying time for Miss U and her family.
Black Country Trust’s management of antipsychotic medication, October 2020.
58. Miss U says that when she contacted the Trust in October 2020, she asked Black Country Trust to prescribe antipsychotic medication for her father. She says she felt he displayed symptoms of a mental health relapse.
59. In its response to the complaint, Black Country Trust explained it did not prescribe antipsychotic medication at this time as it looked to cause least harm to Mr U. It went on to say it increased his other medication instead, considering his cardiac problems.
60. There may be some cases where it is not practical for us to investigate a complaint further, as an investigation is unlikely to reach a satisfactory conclusion. This may include cases where there is not enough clear evidence to conclusively show us what happened.
61. In considering this issue we have considered GMC’s Good medical practice, section 15 which says ‘adequately assess the patient’s conditions, taking account of their history (including the symptoms…’).
62. It goes to say in section 16 doctors must ‘prescribe drugs or treatment…only when you have adequate knowledge of the patient’s health and are satisfied the drugs or treatment service the patient needs’ and to ‘check that the care and treatment you provide for each patient is compatible with any other treatments the patient is receiving’.
63. In the letter of 8 October 2020, written after the emergency appointment of 1 October, Mr U’s consultant recorded Mr U was doing ‘really well’ in terms of his mental health. The letter goes on to say Mr U denied ‘any paranoia of persecutory delusions’ and the consultant concluded that ‘there was no evidence of any other psychotic symptoms’.
64. There is no further documented information from either party in respect of Mr U’s condition until December 2020.
65. We have checked Mr U’s GP records to see whether there is any information to clearly show he was relapsing around October. There is no clear evidence of his mental state deteriorating up to that point.
66. In August and September, the Practice records detail his urinary symptoms, possible side-effects of his diabetes, and leg/foot pain. In October, the Practice records only refer to lower limb pain and blood pressure. There is no reference to him having a poor mental state or of Miss U raising concerns about this.
67. We recognise Miss U disagrees with this account of the 1 October appointment, and the information in the GP records, and recognise her account that he was relapsing at this point. She explained she frequently contacted the Practice to explain his deterioration.
68. We asked our adviser whether, based on the information we have available, the consultant should have considered prescribing antipsychotics during the telephone appointment of 1 October.
69. Our adviser explained they are unable to say whether Black Country Trust should have prescribed antipsychotics for Mr U at this time. They said the medical records show him to have taken antipsychotic medication previously and that the records say this had a good effect on his mental health. However, they were unable to give a view on whether they were indicated at this point due to the lack of clear information about his mental state.
70. We consider Miss U’s account of her father’s condition and symptoms in October 2020 differs significantly from that of Black Country Trust’s letter following the appointment of 1 October. Miss U says her father displayed symptoms of a mental health relapse. The consultant who spoke with Mr U on 1 October recorded there were no symptoms of psychosis.
71. Considering these differing accounts, we have decided it is unlikely further investigation would result in a satisfactory conclusion based on the information available. As we would be unable to reach a clear view on whether the consultant should have prescribed antipsychotics, we will not consider this point further.
72. We recognise this will be a frustrating decision for Miss U to hear.
Black Country Trust’s management of Mr U’s mental health medication (December 2020).
73. In her original complaint to Black Country Trust, Miss U said her father showed signs of paranoia in December 2020, and his medication should have been adjusted including prescribing antipsychotics at this point.
74. She said her father displayed physical symptoms and had been taken to the ED at Wolverhampton Trust on 19 December where no physical illness was found.
75. In its complaint response, Black Country Trust explained it had not prescribed antipsychotics when Miss U asked it to do so in December due to physical health concerns about Mr U. It said it could not be certain Mr U’s if symptoms were due to delirium rather than a relapse.
76. The letter said if delirium was the reason for Mr U’s mental health symptoms, then antipsychotic medication was more likely to make his condition worse. The response also said Mr U had not shown any symptoms in line with psychotic depression needing psychiatric medication at this time or in the months leading up to this.
77. Black Country Trust’s records show Miss U contacted it on 20 December. She felt her father’s condition had worsened and that her father was withdrawn and confused. She said he had developed physical symptoms and had needed to go to the ED at Wolverhampton Trust on 19 December. He was not found to have a physical illness and was discharged.
78. On 21 December, Miss U called Black Country Trust again. She expressed the same concerns about her father relapsing. She said she believed the reduction in citalopram had led to the decline and asked for an urgent review.
79. Black Country Trust agreed to discuss this in its multi-disciplinary team meeting (MDT) the following day. The MDT decided to bring forward Mr U’s next outpatient appointment. It appears it also agreed to increase his citalopram. This indicates to us the Trust took Miss U’s concerns seriously.
80. On 23 December, Miss U called Black Country Trust as she had concerns about managing her father’s symptoms over the Christmas period. She referred to the telephone appointment of 21 December where the consultant agreed to increase her father’s dose of citalopram from 20mg to 30mg.
81. During the call, the consultant spoke with Mr U who said he felt he was wet with urine constantly and this was keeping him awake. Despite his daughter saying he had become repetitive in speech and that he was hearing and seeing things, Mr U did not say this was the case. He explained he was not feeling distressed but that he felt he needed more sleep.
82. On 29 December, Miss U called to update Black Country Trust. Her father had undergone a health check to rule out a physical health issue contributing to his mental health and this had not identified any physical illness. She said Mr U continued to take 30mg of citalopram as per Black Country Trust’s consultant’s instructions on 21 December, but that her father’s symptoms had not changed.
83. In a second call that day, Miss U expressed concern about managing her father until a scheduled appointment the following week. Black Country Trust said it would try to bring this forward.
84. Miss U took Mr U to the ED at Wolverhampton Trust on 29 December as she had concerns about his physical symptoms. At this time, her father was not eating or drinking and Miss U said he was extremely anxious.
85. Following Wolverhampton Trust giving Mr U diazepam on 29 December, Black Country Trust agreed to see him on 31 January. After this, Black Country Trust’s plan was to reassess him. The medical records say he would be seen on 4 January ‘after he recovered from the sedation and drowsiness caused by the diazepam’.
86. Miss U called Black Country Trust several times on 2 January 2021, asking for an earlier review. The on-call consultant gave advice and reiterated Mr U would be reviewed on 4 January. It agreed a change of medication from citalopram to escitalopram (an antidepressant) 10mg and agreed to have Mr U’s consultant call them on 4 January 2021.
87. Our adviser felt escitalopram was a reasonable alternative to citalopram, bearing in mind Mr U’s co-morbidities. They explained it to have similar risks to cardiac patients, but the lower dose of 10mg made it of lower risk than citalopram. They said this gave clinicians more time to continue to manage Mr U’s mental health condition, particularly as there were concerns about his physical wellbeing.
88. Black Country Trust’s letter goes on to explain that after seeing Mr U in December 2020, whilst he was an inpatient at Wolverhampton Trust, Miss U again asked for antipsychotics for her father.
89. Black Country Trust medical records from December 2020 show it had concerns about Mr U’s physical health condition as it may be causing his symptoms. It said he had no sign of ‘clinical catatonia’ or ‘psychotic depression’ and did not need psychiatric medication including ‘antipsychotics or antidepressants’.
90. This management appears in line with Quality statement 3: Use of antipsychotic medication for people who are distressed | Delirium in adults | Quality standards | NICE (archive.org) December 2019, which says the use of antipsychotic medication is not advisable where other physical issues have not been resolved, ‘urinary retention’ being given as an example.
91. The above shows Black Country Trust acted in line with NICE guidance. It had spoken with Mr U on several occasions in December as well as seeing him whilst an inpatient at Wolverhampton Trust without finding him to be psychotic.
92. As giving medication unnecessarily can lead to other complications, particularly where the patient has cardiac issues or diabetes, our adviser says it was correct for Black Country Trust not to prescribe unnecessarily. They felt the antipsychotic medication was managed well, particularly as delirium may present with psychotic symptoms. This is also referred to in the Maudsley Practice Guidelines.
93. In addition, consultants checked Mr U on a three-monthly basis, more regularly than guidance requires. The medical records show the Trust addressed Miss U’s concerns quickly, bringing appointments forward and arranging appointments as emergencies.
94. In summary, considering the available evidence and advice received, there is nothing to indicate anything went wrong in the management of Mr U’s medication. Changes were in line with guidance and based on his wider health issues.
95. As such, we cannot see Black Country Trust did not manage his medication properly in December. It took other medications and co-morbidities into account when changing medication as well as reviewing this more regularly than required.
96. We acknowledge Miss U, and her family’s distress at seeing the deterioration of Mr U and his death after this episode will have increased this distress.
Wolverhampton Trust 's prescribing of diazepam
97. Miss U says Wolverhampton Trust prescribed her father diazepam on 29 December 2020, despite her saying he had suffered an allergic reaction to this medication previously. She explains he became catatonic (where the person becomes stiff and unresponsive) and needed intervention from Black Country Trust.
98. This has not been addressed by Wolverhampton Trust in its complaint response. However, it has provided a statement saying Mr U did not have any recorded allergies to any medication.
99. Good medical practice-english- Archived 30 January 2024 (gmc-uk.org) section 16 requires medical professionals to ‘provide effective treatments based on the best available evidence’ and to ‘check that the care or treatment you provide for each patient is compatible with any other treatments the patient is receiving’.
100. British National Formulary BNF 79 (vnras.com) page 353 says diazepam can be prescribed to treat anxiety.
101. In the medical records provided by Black Country Trust, there are notes of calls made to the hospital by Miss U on 30 December 2020.
102. During the call made at 11.15am, she says Wolverhampton Trust gave her father 5mg of diazepam, but it had not had any effect on him.
103. She called again at 4.34pm and described her father as being ‘like a zombie’ due to the diazepam with the ED having prescribed him 5mg each night. She says she gave him 2.5mg earlier in the day.
104. Black Country Trust records of the later call say Miss U referred to her father having 5mg in her call of 11.15am, then another 2.5mg in her call of 4.34pm. The notes say this may be why Mr U presented as Miss U describes. Black Country Trust made an appointment for the next day as an emergency.
105. Black Country Trust’s letter to Mr U’s GP after the appointment of 31 December explains he presented as ‘very much sedated’, and that it had instructed the family to stop giving him diazepam.
106. British National Formulary BNF 79 page 353 says diazepam can treat anxiety, which Mr U had presented with. Prescribing this is also in line with the GMC requirements of providing effective treatment that is compatible with a patient’s other treatments.
107. As mentioned above, Wolverhampton Trust say there is no record of Mr U being allergic to diazepam. We contacted his GP to ask about known allergies. It provided a printout from his medical records which has a section for allergies. This does not have an allergy to diazepam listed.
108. As such, we find no indication of anything having gone wrong in the Trust prescribing diazepam. Mr U’s medical records do not show him having an allergy to this and, due to his heightened anxiety, this medication is known to help.
109. We realise this will have been a distressing situation and caused upset both to Mr U and his family.
Wolverhampton Trust’s placing Mr U on a COVID-19 ward.
110. Miss U says when Wolverhampton Trust admitted her father on 3 January 2021, it placed him on a COVID-19 ward. She says he contracted the virus as a result, testing positive after discharge, and this caused his death.
111. Wolverhampton Trust say this is not the case as Mr U was placed on a ‘green ward’ where all patients had tested negative for COVID-19. It confirmed during Mr U’s stay in hospital a patient, who had tested negative upon admittance, did develop COVID-19, testing positive after a routine ward test. It explained it had placed Mr U in a side room to avoid contact. He also tested negative on 8 January 2021, when he was discharged.
112. Wolverhampton Trust says in its final response letter that Mr U tested positive for COVID-19 on 22 January 2021. The Trust had discharged him 14 days earlier and he was not an inpatient at this time.
113. We have considered the following guidance when making our decision about this part of the complaint.
114. UK Chief Medical Officers' statement on the self-isolation period: 11 December 2020 - GOV.UK (www.gov.uk) explained it had reduced the self-isolation period to 10 days from the earlier period of 14 days.
115. COVID-19: epidemiology, virology and clinical features - GOV.UK (www.gov.uk) explains the incubation period for the differing variants of COVID-19. The averages differ between variants, with these ranging from three to five days and five to six days.
116. As referenced above, COVID-19: epidemiology, virology and clinical features - GOV.UK (www.gov.uk) gives information on the incubation period of the different variants of COVID-19, the incubation period for the SARS2 variant has been confirmed to be between five and six days. This was the variant affecting most people in January 2021.
117. Additionally, the Government reduced the period of isolation after testing positive from 14 days to ten days in December 2020, UK Chief Medical Officers' statement on the self-isolation period: 11 December 2020 - GOV.UK (www.gov.uk). This shows the incubation period being less than originally thought as those with the virus were not seen as a risk to others after ten days.
118. Wolverhampton Trust explains Mr U was on a ‘green’ ward during his stay in hospital, not a COVID-19 ward. The medical records do not refer to the ward as ‘green’, only referencing it as ‘C16W’ in its records.
119. The medical records state family members stayed with Mr U whilst in hospital, referring to them looking after his personal hygiene needs. We consider this shows the ward was ‘green’. This is because COVID-19 guidelines at this time prevented visitors to patients on a COVID-19 ward.
120. Mr U left Wolverhampton Trust on 8 January 2021 after a negative test result that day. He tested positive for COVID-19 on 22 January 2021, 14 days later.
121. Following our consideration, there is no indication of the Trust having done anything wrong.
122. Family members were able to visit and stay with Mr U when he was in hospital on ward C16W. This indicates he was not on a COVID-19 ward because Government lockdown restrictions did not allow visitors to a COVID-19 ward.
123. Also, Mr U did not test positive for COVID-19 until 14 days after discharge from the hospital.
124. In December 2020, Government guidelines had changed in respect of isolation periods. This had reduced from a fourteen-day to a ten-day period.
125. Studies into the different COVID-19 variants (undertaken after the pandemic) say the incubation period for the variants prevalent at the time of Mr U being in hospital had a five-to-six-day incubation period.
126. For these reasons, we would be unable to say Mr U contracted the virus whilst in hospital.
127. We acknowledge our decision does not give the answers looked for by Miss U and her family and that the death of Mr U has had a massive impact on his family.