Liane Davenport
PFD Report
Partially Responded
Ref: 2020-0136
Coroner's Concerns (AI summary)
There is a need to consider and recommend routine blood level monitoring for patients on long-term, high-dose antipsychotics, especially for older and frailer individuals.
View full coroner's concerns
In the circumstances it is my statutory duty to report to vou: Falrfield, Station Roud, Cockermouth, Cumbria. CAI3 9PT emall bucoroncr@cuubrlu poruk Tcl 0300 303 3180 Fax 01900 706915 long
[BRIEF SUMMARY OF MATTERS OF CONCERN] (1) Should monitoring of blood levels of powerful antipsychotics be considered and recommended for patients on term high dose treatment; particularly as they become older & more frail? (2) (3) long
AcTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths ad / believe vour trust/agency has the power to take such action_
[BRIEF SUMMARY OF MATTERS OF CONCERN] (1) Should monitoring of blood levels of powerful antipsychotics be considered and recommended for patients on term high dose treatment; particularly as they become older & more frail? (2) (3) long
AcTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths ad / believe vour trust/agency has the power to take such action_
Responses
Noted
The Trust states that the care provided to Ms Davenport was appropriate. They have reviewed HDAT monitoring policy which includes ECG, Urea and electrolytes, Liver function, Prolactin, blood pressure and pulse, clinical signs of hydration, glucose regulation, review of side effects and PRN medication, but excludes monitoring blood levels. (AI summary)
The Trust states that the care provided to Ms Davenport was appropriate. They have reviewed HDAT monitoring policy which includes ECG, Urea and electrolytes, Liver function, Prolactin, blood pressure and pulse, clinical signs of hydration, glucose regulation, review of side effects and PRN medication, but excludes monitoring blood levels. (AI summary)
View full response
Dear Dr Shaw
RE: Inquest into the death of Liane Davenport
Regulation 28 Report to Prevent Future Deaths Response
We write in response to your Regulation 28 Report dated 10th October 2019 following your investigation into the death of Liane Davenport. This response has been prepared by Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust (“The Trust”) and addresses the concerns as set out by you.
As you are aware Mental Health Services at the time of Ms Davenport’s death were provided by Cumbria Partnership NHSFT. As of 1st October 2019, those services are now provided by the Trust.
Please note that we have only recently been made aware of this Regulation 28 Report as it was not addressed to the Trust (this was initially sent to Cumbria Partnership NHS Foundation Trust (‘CPFT’) and has recently been sent to the Trust) which is why there has been a significant delay in providing a response.
The issue you raised within your regulation 28 report is as follows:
Should monitoring of blood levels of powerful antipsychotics be considered and recommended for patients on long term high dose treatment, particularly as they become older and more frail.
As far as we are aware, there was no indication during the course of the inquest that you were considering a Regulation 28 report in relation to the above and the evidence given by confirmed that Ms Davenport was being monitored by the physical health team within the CMHART in response to the high doses of medications that she was taking.
Response
The Trust recognises the concerns that have been raised with regards to the monitoring of blood levels of patients on long term high dose treatment and in particular, powerful antipsychotic medication.
Executive Suite 1st Floor St Nicholas Hospital Jubilee Road Gosforth Newcastle upon Tyne NE3 3XT
An investigation was carried out by CPFT (prior to its merger with the Trust) which we understand was provided to HM Coroner in advance of the inquest hearing. This investigation evidenced that Ms Davenport’s physical health was monitored in accordance CPFT guidance at the time i.e. Ms Davenport attended CPFT for regular monitoring to identify any adverse physical health effects from the antipsychotic medication she was prescribed. This basic physical health monitoring included:
1. Monitoring and recording any side effects of treatment;
2. Monitoring weight;
3. Measuring weight circumference annually;
4. Taking pulse and blood pressure annually;
5. Fasting blood glucose levels, HbA1c and blood lipid levels annually;
6. ECG conducted annually;
7. Advice provided on healthy lifestyle intervention; and
8. Ms Davenport to attend annual physical health review with the CMHART Physical Health Clinic.
It is also noted in the investigation report that there was evidence of good communication with Ms Davenport’s GP between 2008 and December 2019 with regard to physical health monitoring and high dose antipsychotic treatment (‘HDAT’) and CPFT CMHART staff proactively chased up missed physical health clinic appointments by conducting home visits and escorting the patient to the appointments.
Whilst Ms Davenport’s physical health was monitored as specified above, we note that she could have qualified for more regular monitoring of her physical health as she was on HDAT, in line with RCPsych guidance. We do, however, understand that the HDAT policy was not approved in CPFT until approximately 4 months after Ms Davenport’s death (1st March 2019) and as such, the relevant clinicians were acting in accordance with CPFT guidance at the time. In addition, we note that, in any event, neither basic nor HDAT monitoring would have involved the monitoring of plasma levels of the specific antipsychotic medication that Ms Davenport was on (Quetiapine and Amusulpiride) and this mode of investigation is not recommended in routine clinical practice by NICE, RCPsych or by the British Association of Psychopharmacology as the assessment of antipsychotic intolerance (or ‘toxicity’) is a clinical finding primarily associated with worsening side effects such as extrapyramidal effects, sedation, confusion and ECG changes.
In light of the above, the Trust considers that the care provided to Ms Davenport particularly in relation to her physical health monitoring was appropriate in the circumstances. However, to provide assurances to HM Coroner, the Trust has reviewed the measures which are in place to ensure that a patient’s physical health is sufficiently monitored when they are on HDAT for prolonged periods of time.
We have attached the Trust policy on HDAT monitoring (alongside the Trust Guidance to be read alongside this policy) for ease of reference which details the additional monitoring requirements for adult patients prescribed HDAT.
To summarise, the additional monitoring requirements/tests/measurements are as follows:
• ECG;
• Urea and electrolytes;
• Liver function;
• Prolactin;
• Blood pressure and pulse (sitting/lying/standing);
• Temperature;
• Clinical signs of hydration;
• Glucose regulation;
• Review of side effects including a specific review for movement disorder; and
• Review of PRN medication.
The Trust policy sets out the importance of each investigation/test and the frequency for conducting each investigation/test. You will note that the additional monitoring requirements do not include the monitoring of blood levels in accordance with the relevant national guidance as set out above.
We hope that the information provided offers you the necessary assurances that the Trust have invested time, effort and resource into investigating the issues you have highlighted with a view to improving patient care and safety and reducing the risk of any adverse incidents or outcome in the future.
Should you wish to discuss any of the above further, please contact
RE: Inquest into the death of Liane Davenport
Regulation 28 Report to Prevent Future Deaths Response
We write in response to your Regulation 28 Report dated 10th October 2019 following your investigation into the death of Liane Davenport. This response has been prepared by Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust (“The Trust”) and addresses the concerns as set out by you.
As you are aware Mental Health Services at the time of Ms Davenport’s death were provided by Cumbria Partnership NHSFT. As of 1st October 2019, those services are now provided by the Trust.
Please note that we have only recently been made aware of this Regulation 28 Report as it was not addressed to the Trust (this was initially sent to Cumbria Partnership NHS Foundation Trust (‘CPFT’) and has recently been sent to the Trust) which is why there has been a significant delay in providing a response.
The issue you raised within your regulation 28 report is as follows:
Should monitoring of blood levels of powerful antipsychotics be considered and recommended for patients on long term high dose treatment, particularly as they become older and more frail.
As far as we are aware, there was no indication during the course of the inquest that you were considering a Regulation 28 report in relation to the above and the evidence given by confirmed that Ms Davenport was being monitored by the physical health team within the CMHART in response to the high doses of medications that she was taking.
Response
The Trust recognises the concerns that have been raised with regards to the monitoring of blood levels of patients on long term high dose treatment and in particular, powerful antipsychotic medication.
Executive Suite 1st Floor St Nicholas Hospital Jubilee Road Gosforth Newcastle upon Tyne NE3 3XT
An investigation was carried out by CPFT (prior to its merger with the Trust) which we understand was provided to HM Coroner in advance of the inquest hearing. This investigation evidenced that Ms Davenport’s physical health was monitored in accordance CPFT guidance at the time i.e. Ms Davenport attended CPFT for regular monitoring to identify any adverse physical health effects from the antipsychotic medication she was prescribed. This basic physical health monitoring included:
1. Monitoring and recording any side effects of treatment;
2. Monitoring weight;
3. Measuring weight circumference annually;
4. Taking pulse and blood pressure annually;
5. Fasting blood glucose levels, HbA1c and blood lipid levels annually;
6. ECG conducted annually;
7. Advice provided on healthy lifestyle intervention; and
8. Ms Davenport to attend annual physical health review with the CMHART Physical Health Clinic.
It is also noted in the investigation report that there was evidence of good communication with Ms Davenport’s GP between 2008 and December 2019 with regard to physical health monitoring and high dose antipsychotic treatment (‘HDAT’) and CPFT CMHART staff proactively chased up missed physical health clinic appointments by conducting home visits and escorting the patient to the appointments.
Whilst Ms Davenport’s physical health was monitored as specified above, we note that she could have qualified for more regular monitoring of her physical health as she was on HDAT, in line with RCPsych guidance. We do, however, understand that the HDAT policy was not approved in CPFT until approximately 4 months after Ms Davenport’s death (1st March 2019) and as such, the relevant clinicians were acting in accordance with CPFT guidance at the time. In addition, we note that, in any event, neither basic nor HDAT monitoring would have involved the monitoring of plasma levels of the specific antipsychotic medication that Ms Davenport was on (Quetiapine and Amusulpiride) and this mode of investigation is not recommended in routine clinical practice by NICE, RCPsych or by the British Association of Psychopharmacology as the assessment of antipsychotic intolerance (or ‘toxicity’) is a clinical finding primarily associated with worsening side effects such as extrapyramidal effects, sedation, confusion and ECG changes.
In light of the above, the Trust considers that the care provided to Ms Davenport particularly in relation to her physical health monitoring was appropriate in the circumstances. However, to provide assurances to HM Coroner, the Trust has reviewed the measures which are in place to ensure that a patient’s physical health is sufficiently monitored when they are on HDAT for prolonged periods of time.
We have attached the Trust policy on HDAT monitoring (alongside the Trust Guidance to be read alongside this policy) for ease of reference which details the additional monitoring requirements for adult patients prescribed HDAT.
To summarise, the additional monitoring requirements/tests/measurements are as follows:
• ECG;
• Urea and electrolytes;
• Liver function;
• Prolactin;
• Blood pressure and pulse (sitting/lying/standing);
• Temperature;
• Clinical signs of hydration;
• Glucose regulation;
• Review of side effects including a specific review for movement disorder; and
• Review of PRN medication.
The Trust policy sets out the importance of each investigation/test and the frequency for conducting each investigation/test. You will note that the additional monitoring requirements do not include the monitoring of blood levels in accordance with the relevant national guidance as set out above.
We hope that the information provided offers you the necessary assurances that the Trust have invested time, effort and resource into investigating the issues you have highlighted with a view to improving patient care and safety and reducing the risk of any adverse incidents or outcome in the future.
Should you wish to discuss any of the above further, please contact
Sent To
- Medicines and Healthcare Products Regulation Agency
- North Cumbria University Hospitals NHS Trust
Response Status
Linked responses
1 of 2
56-Day Deadline
16 Nov 2020
About PFD responses
Organisations named in PFD reports must respond within 56 days explaining what actions they are taking.
Source: Courts and Tribunals Judiciary
Report Sections
Investigation and Inquest
On 19/02/2019 commenced an investigation into the death of Liane Davenport: The investigation concluded at the end of the inquest 4th October 2019. The conclusion of the inquest was Liane Davenport was on high doses of two anti-psychotic medications to control symptoms of chronic schizophrenia, she also had significant coronary artery disease and left ventricular dysfunction: It is most likely that her death at home; Cumbria on December 4th 2019 was due to a combination of her heart disease and the high blood Ievel of Amisulpride needed to control her schizophrenia: 1a Coronary Artery Atherosclerosis 2 Amisulpride toxicity CIRCUMSTANCES Of The DEATH Liane had a 45 year history of Schizophrenia, and a 10 year history of Lupus with associated arthritic problems. Over the last year of her life she had had hospital admissions for sepsis associated with pneumonia and endocarditis, for which she had prolonged but successful treatment: She had however become physically frail and lost up to 10Kg weight over her final year. She had been on term antipsychotic treatment requiring high doses of Quetiapine and Amisulpride -8OOmg daily of each drug-to control her mental state: It was acknowledged at inquest that the Amisulpride dose was significantly higher than the 30Omg suggested by BNF but at review shortly before her death her consultant felt it was safe to continue as there had been no physical problems and her blood chemistry and ECG were within normal limits. There was no evidence to suggest she had taken more than her prescribed doses: At post mortem toxicology her plain blood Quetiapine level was 433ng/ml -within the quoted therapeutic range but her Amisulpride level was 10698ng/ml -against a suggested therapeutic upper range of 4OOng/ml: at Leicester comments on the the large volume of distribution for Amisulpride which may raise the level somewhat: He tells me he could not find any quoted toxic or Iethal ranges but points to a reported case where a level of 9600 was survived with treatment whereas 2 fatal cases involved levels of over 40,000.
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Data sourced from Courts and Tribunals Judiciary under the Open Government Licence.