PFD report

Deidre Harvey · Prevention of Future Deaths report

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Issued 8 Aug 2017•South Wales Central

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

View original report
Concerns
9

Raised in this report

Recipients
6

Named on the report

Responses found
5

Of 6 recipients

Stated actions
7

Described in responses

Recipients and published responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

Select any concern, action or position to view the source wording.

Concerns raised9

  1. Lack of effective tracking of items taken from and returned to patients
    Part of recurring concern: Unreliable controls for restricting dangerous items in inpatient care
  2. Lack of routine clinical monitoring of Hydroxychloroquine levels
    Part of recurring concern: Unreliable medication-specific blood-level monitoring
  3. Lack of active input from outside consultants into mental health unit patient care
    Part of recurring concern: Inadequate integrated care for people with co-occurring physical and mental health needsPart of recurring concern: Insufficient multi-disciplinary coordination in mental health carePart of recurring concern: Unreliable access to physical health specialist input for mental health inpatients
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.3

  1. Action

    Implement a safe system for recording items stored in and removed from patient PODS.

    Stated by Cwm Taf Morgannwg University Local Health BoardStated completedThe respondent said that this action was complete when they made their response on 20 July 2017.
  2. Action

    Disseminate risk management policies through ward meetings and obtain individual staff sign-off.

    Stated by Cwm Taf Morgannwg University Local Health BoardStated completedThe respondent said that this action was complete when they made their response on 20 July 2017.
  3. Action

    Seek expert pharmacovigilance advice on available evidence concerning hydroxychloroquine toxicity and the reported death.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 20 July 2017.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.5

  1. Position

    Mental health providers in England are responsible for assessing and managing environmental ligature risks under their policies and available guidance.

    Stated by Department of Health and Social CareRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Lack of effective tracking of items taken from and returned to patients

Wider context from the report

“Secretary of State for Health 1. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the ward or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 2. The inquest heard that an obvious ligature point was identified in September 2016 in the Mental Health Unit, and yet bureaucratic processes meant that approval for funding the rectification of this ligature point was held up for months, with staff having to “manage” the risk. The Coroner is concerned that there should be an expedited process for rectifying obvious ligature points on Mental Health Units Minister for Health, Welsh Assembly Government 1. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the unit or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 2. The inquest heard that an obvious ligature point was identified in September 2016 in the Mental Health Unit, and yet bureaucratic processes meant that approval for funding the rectification of this ligature point was held up for months, with staff having to “manage” the risk. The Coroner is concerned that there should be an expedited process for rectifying obvious ligature points on Mental Health Units Chief Executive – Cwm Taf University Health Board 1. The inquest heard of the Pod system on the Mental Health Unit in which items of danger to patients were deposited (and then possibly returned to the patient). There was no evidence of any effective system to identify who had what item, and when. The Coroner is concerned that there should be an effective system to check on what is taken from a patient and then later returned to a patient. 2. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the unit or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 3. The inquest heard that there was confusion between staff on the Mental Health Unit and the Community Psychiatric Nurse over management of risk for a patient admitted on the Mental Health Unit, with the result that responsibility for a risk assessment might not be recognised. The Coroner is concerned that there should be proper management and dissemination of risk management policies to frontline staff to avoid any confusion Editor British National Formulary Hydroxychloroquine 1. The expert evidence given was that Hydroxychloroquine (HCQ) is not contra-indicated in Appendix 1 of the BNF for anti-epileptic drugs. The manufacturer’s leaflet however does contain a caution against using HCQ alongside anti-epileptic drugs. It is acknowledged that the text of the BNF does indicate that HCQ should not be used in case of neurological disorders (including epilepsy) but this does not catch patients like Dee who was on an anti-epileptic drug (Lamotrigine) for her bipolar condition but was not epileptic. The coroner is concerned that the BNF might not fully describe the risk to patients taking Lamotrigine (or drugs of similar class or composition) alongside Hydroxychloroquine. Royal College of Psychiatrists Hydroxychloroquine 1. The evidence in the inquest showed that the psychiatrists treating Deidre were largely unaware of the potential side-effects of Hydroxychloroquine which Deidre was received for her Systemic Lupus Erythematosus. These include mental changes and psychosis. The Coroner is concerned that consultants treating other mental patients who are receiving this drug should be aware of these side-effects, and is concerned that there should be proper liaison with the consultant dermatologist over its toxic and potential mental health side-effects. In General the Coroner is concerned that the psychiatrists treating a patient in a Mental Health Unit should have the benefit of specialist advice from outside consultants who may be treating the patient for a physical condition British Association of Dermatologists Hydroxychloroquine 1. The expert evidence received in this inquest revealed that Hydroxychloroquine could build up to toxic levels even with normal dosage. ████████ of the Dept of Toxicology, Birmingham Heartlands Hospital reported that there is a clear cross-over between apparently toxic concentrations and apparently therapeutic concentrations. Deidre at the time of her death had a concentration of approximately 25 mg/L and fatalities at 7.5 mg/L. The Coroner is concerned that this drug should not be prescribed to a patient suffering from Lupus (which in itself is not life-threatening) without an awareness that toxic levels can build up even at the recommended dose. The Coroner is concerned that the dermatologist prescribing this drug should liaise with other consultants treating the patient for other conditions (in Deidre’s case for her mental health problems) so that specialist knowledge about the toxic effects of this drug can be shared. CEO Alerts NHS Hydroxychloroquine 1. The evidence in this inquest is that Deidre (who was a detained patient under Section 3 MHA) was being given a drug for a physical condition (Lupus) which can build up to toxic levels even at normal doses. The inquest heard that there is no routine checking of Hydroxychloroquine levels at clinical level, even though ████████ said he thought that clinical monitoring of this drug might be important. The Coroner is concerned that there may be other dependent persons suffering from lupus (or other conditions for which Hydroxychloroquine is prescribed in NHS hospitals in England and Wales) who may also have toxic levels of Hydroxychloroquine in their system unbeknown to their carers. ”

Is this part of a recurring concern?

Yes — Unreliable controls for restricting dangerous items in inpatient care.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Lack of routine clinical monitoring of Hydroxychloroquine levels

Wider context from the report

“Secretary of State for Health 1. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the ward or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 2. The inquest heard that an obvious ligature point was identified in September 2016 in the Mental Health Unit, and yet bureaucratic processes meant that approval for funding the rectification of this ligature point was held up for months, with staff having to “manage” the risk. The Coroner is concerned that there should be an expedited process for rectifying obvious ligature points on Mental Health Units Minister for Health, Welsh Assembly Government 1. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the unit or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 2. The inquest heard that an obvious ligature point was identified in September 2016 in the Mental Health Unit, and yet bureaucratic processes meant that approval for funding the rectification of this ligature point was held up for months, with staff having to “manage” the risk. The Coroner is concerned that there should be an expedited process for rectifying obvious ligature points on Mental Health Units Chief Executive – Cwm Taf University Health Board 1. The inquest heard of the Pod system on the Mental Health Unit in which items of danger to patients were deposited (and then possibly returned to the patient). There was no evidence of any effective system to identify who had what item, and when. The Coroner is concerned that there should be an effective system to check on what is taken from a patient and then later returned to a patient. 2. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the unit or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 3. The inquest heard that there was confusion between staff on the Mental Health Unit and the Community Psychiatric Nurse over management of risk for a patient admitted on the Mental Health Unit, with the result that responsibility for a risk assessment might not be recognised. The Coroner is concerned that there should be proper management and dissemination of risk management policies to frontline staff to avoid any confusion Editor British National Formulary Hydroxychloroquine 1. The expert evidence given was that Hydroxychloroquine (HCQ) is not contra-indicated in Appendix 1 of the BNF for anti-epileptic drugs. The manufacturer’s leaflet however does contain a caution against using HCQ alongside anti-epileptic drugs. It is acknowledged that the text of the BNF does indicate that HCQ should not be used in case of neurological disorders (including epilepsy) but this does not catch patients like Dee who was on an anti-epileptic drug (Lamotrigine) for her bipolar condition but was not epileptic. The coroner is concerned that the BNF might not fully describe the risk to patients taking Lamotrigine (or drugs of similar class or composition) alongside Hydroxychloroquine. Royal College of Psychiatrists Hydroxychloroquine 1. The evidence in the inquest showed that the psychiatrists treating Deidre were largely unaware of the potential side-effects of Hydroxychloroquine which Deidre was received for her Systemic Lupus Erythematosus. These include mental changes and psychosis. The Coroner is concerned that consultants treating other mental patients who are receiving this drug should be aware of these side-effects, and is concerned that there should be proper liaison with the consultant dermatologist over its toxic and potential mental health side-effects. In General the Coroner is concerned that the psychiatrists treating a patient in a Mental Health Unit should have the benefit of specialist advice from outside consultants who may be treating the patient for a physical condition British Association of Dermatologists Hydroxychloroquine 1. The expert evidence received in this inquest revealed that Hydroxychloroquine could build up to toxic levels even with normal dosage. ████████ of the Dept of Toxicology, Birmingham Heartlands Hospital reported that there is a clear cross-over between apparently toxic concentrations and apparently therapeutic concentrations. Deidre at the time of her death had a concentration of approximately 25 mg/L and fatalities at 7.5 mg/L. The Coroner is concerned that this drug should not be prescribed to a patient suffering from Lupus (which in itself is not life-threatening) without an awareness that toxic levels can build up even at the recommended dose. The Coroner is concerned that the dermatologist prescribing this drug should liaise with other consultants treating the patient for other conditions (in Deidre’s case for her mental health problems) so that specialist knowledge about the toxic effects of this drug can be shared. CEO Alerts NHS Hydroxychloroquine 1. The evidence in this inquest is that Deidre (who was a detained patient under Section 3 MHA) was being given a drug for a physical condition (Lupus) which can build up to toxic levels even at normal doses. The inquest heard that there is no routine checking of Hydroxychloroquine levels at clinical level, even though ████████ said he thought that clinical monitoring of this drug might be important. The Coroner is concerned that there may be other dependent persons suffering from lupus (or other conditions for which Hydroxychloroquine is prescribed in NHS hospitals in England and Wales) who may also have toxic levels of Hydroxychloroquine in their system unbeknown to their carers. ”

Is this part of a recurring concern?

Yes — Unreliable medication-specific blood-level monitoring.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Lack of active input from outside consultants into mental health unit patient care

Wider context from the report

“Secretary of State for Health 1. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the ward or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 2. The inquest heard that an obvious ligature point was identified in September 2016 in the Mental Health Unit, and yet bureaucratic processes meant that approval for funding the rectification of this ligature point was held up for months, with staff having to “manage” the risk. The Coroner is concerned that there should be an expedited process for rectifying obvious ligature points on Mental Health Units Minister for Health, Welsh Assembly Government 1. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the unit or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 2. The inquest heard that an obvious ligature point was identified in September 2016 in the Mental Health Unit, and yet bureaucratic processes meant that approval for funding the rectification of this ligature point was held up for months, with staff having to “manage” the risk. The Coroner is concerned that there should be an expedited process for rectifying obvious ligature points on Mental Health Units Chief Executive – Cwm Taf University Health Board 1. The inquest heard of the Pod system on the Mental Health Unit in which items of danger to patients were deposited (and then possibly returned to the patient). There was no evidence of any effective system to identify who had what item, and when. The Coroner is concerned that there should be an effective system to check on what is taken from a patient and then later returned to a patient. 2. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the unit or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 3. The inquest heard that there was confusion between staff on the Mental Health Unit and the Community Psychiatric Nurse over management of risk for a patient admitted on the Mental Health Unit, with the result that responsibility for a risk assessment might not be recognised. The Coroner is concerned that there should be proper management and dissemination of risk management policies to frontline staff to avoid any confusion Editor British National Formulary Hydroxychloroquine 1. The expert evidence given was that Hydroxychloroquine (HCQ) is not contra-indicated in Appendix 1 of the BNF for anti-epileptic drugs. The manufacturer’s leaflet however does contain a caution against using HCQ alongside anti-epileptic drugs. It is acknowledged that the text of the BNF does indicate that HCQ should not be used in case of neurological disorders (including epilepsy) but this does not catch patients like Dee who was on an anti-epileptic drug (Lamotrigine) for her bipolar condition but was not epileptic. The coroner is concerned that the BNF might not fully describe the risk to patients taking Lamotrigine (or drugs of similar class or composition) alongside Hydroxychloroquine. Royal College of Psychiatrists Hydroxychloroquine 1. The evidence in the inquest showed that the psychiatrists treating Deidre were largely unaware of the potential side-effects of Hydroxychloroquine which Deidre was received for her Systemic Lupus Erythematosus. These include mental changes and psychosis. The Coroner is concerned that consultants treating other mental patients who are receiving this drug should be aware of these side-effects, and is concerned that there should be proper liaison with the consultant dermatologist over its toxic and potential mental health side-effects. In General the Coroner is concerned that the psychiatrists treating a patient in a Mental Health Unit should have the benefit of specialist advice from outside consultants who may be treating the patient for a physical condition British Association of Dermatologists Hydroxychloroquine 1. The expert evidence received in this inquest revealed that Hydroxychloroquine could build up to toxic levels even with normal dosage. ████████ of the Dept of Toxicology, Birmingham Heartlands Hospital reported that there is a clear cross-over between apparently toxic concentrations and apparently therapeutic concentrations. Deidre at the time of her death had a concentration of approximately 25 mg/L and fatalities at 7.5 mg/L. The Coroner is concerned that this drug should not be prescribed to a patient suffering from Lupus (which in itself is not life-threatening) without an awareness that toxic levels can build up even at the recommended dose. The Coroner is concerned that the dermatologist prescribing this drug should liaise with other consultants treating the patient for other conditions (in Deidre’s case for her mental health problems) so that specialist knowledge about the toxic effects of this drug can be shared. CEO Alerts NHS Hydroxychloroquine 1. The evidence in this inquest is that Deidre (who was a detained patient under Section 3 MHA) was being given a drug for a physical condition (Lupus) which can build up to toxic levels even at normal doses. The inquest heard that there is no routine checking of Hydroxychloroquine levels at clinical level, even though ████████ said he thought that clinical monitoring of this drug might be important. The Coroner is concerned that there may be other dependent persons suffering from lupus (or other conditions for which Hydroxychloroquine is prescribed in NHS hospitals in England and Wales) who may also have toxic levels of Hydroxychloroquine in their system unbeknown to their carers. ”

Is this part of a recurring concern?

Yes — Inadequate integrated care for people with co-occurring physical and mental health needs; Insufficient multi-disciplinary coordination in mental health care; Unreliable access to physical health specialist input for mental health inpatients.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure of liaison between dermatologists and other consultants about Hydroxychloroquine toxicity

Wider context from the report

“Secretary of State for Health 1. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the ward or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 2. The inquest heard that an obvious ligature point was identified in September 2016 in the Mental Health Unit, and yet bureaucratic processes meant that approval for funding the rectification of this ligature point was held up for months, with staff having to “manage” the risk. The Coroner is concerned that there should be an expedited process for rectifying obvious ligature points on Mental Health Units Minister for Health, Welsh Assembly Government 1. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the unit or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 2. The inquest heard that an obvious ligature point was identified in September 2016 in the Mental Health Unit, and yet bureaucratic processes meant that approval for funding the rectification of this ligature point was held up for months, with staff having to “manage” the risk. The Coroner is concerned that there should be an expedited process for rectifying obvious ligature points on Mental Health Units Chief Executive – Cwm Taf University Health Board 1. The inquest heard of the Pod system on the Mental Health Unit in which items of danger to patients were deposited (and then possibly returned to the patient). There was no evidence of any effective system to identify who had what item, and when. The Coroner is concerned that there should be an effective system to check on what is taken from a patient and then later returned to a patient. 2. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the unit or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 3. The inquest heard that there was confusion between staff on the Mental Health Unit and the Community Psychiatric Nurse over management of risk for a patient admitted on the Mental Health Unit, with the result that responsibility for a risk assessment might not be recognised. The Coroner is concerned that there should be proper management and dissemination of risk management policies to frontline staff to avoid any confusion Editor British National Formulary Hydroxychloroquine 1. The expert evidence given was that Hydroxychloroquine (HCQ) is not contra-indicated in Appendix 1 of the BNF for anti-epileptic drugs. The manufacturer’s leaflet however does contain a caution against using HCQ alongside anti-epileptic drugs. It is acknowledged that the text of the BNF does indicate that HCQ should not be used in case of neurological disorders (including epilepsy) but this does not catch patients like Dee who was on an anti-epileptic drug (Lamotrigine) for her bipolar condition but was not epileptic. The coroner is concerned that the BNF might not fully describe the risk to patients taking Lamotrigine (or drugs of similar class or composition) alongside Hydroxychloroquine. Royal College of Psychiatrists Hydroxychloroquine 1. The evidence in the inquest showed that the psychiatrists treating Deidre were largely unaware of the potential side-effects of Hydroxychloroquine which Deidre was received for her Systemic Lupus Erythematosus. These include mental changes and psychosis. The Coroner is concerned that consultants treating other mental patients who are receiving this drug should be aware of these side-effects, and is concerned that there should be proper liaison with the consultant dermatologist over its toxic and potential mental health side-effects. In General the Coroner is concerned that the psychiatrists treating a patient in a Mental Health Unit should have the benefit of specialist advice from outside consultants who may be treating the patient for a physical condition British Association of Dermatologists Hydroxychloroquine 1. The expert evidence received in this inquest revealed that Hydroxychloroquine could build up to toxic levels even with normal dosage. ████████ of the Dept of Toxicology, Birmingham Heartlands Hospital reported that there is a clear cross-over between apparently toxic concentrations and apparently therapeutic concentrations. Deidre at the time of her death had a concentration of approximately 25 mg/L and fatalities at 7.5 mg/L. The Coroner is concerned that this drug should not be prescribed to a patient suffering from Lupus (which in itself is not life-threatening) without an awareness that toxic levels can build up even at the recommended dose. The Coroner is concerned that the dermatologist prescribing this drug should liaise with other consultants treating the patient for other conditions (in Deidre’s case for her mental health problems) so that specialist knowledge about the toxic effects of this drug can be shared. CEO Alerts NHS Hydroxychloroquine 1. The evidence in this inquest is that Deidre (who was a detained patient under Section 3 MHA) was being given a drug for a physical condition (Lupus) which can build up to toxic levels even at normal doses. The inquest heard that there is no routine checking of Hydroxychloroquine levels at clinical level, even though ████████ said he thought that clinical monitoring of this drug might be important. The Coroner is concerned that there may be other dependent persons suffering from lupus (or other conditions for which Hydroxychloroquine is prescribed in NHS hospitals in England and Wales) who may also have toxic levels of Hydroxychloroquine in their system unbeknown to their carers. ”

Is this part of a recurring concern?

Yes — Unreliable clinician management of medication side effects; Unreliable communication of patient-care information between clinical staff.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Lack of awareness of Hydroxychloroquine toxic accumulation at recommended doses

Wider context from the report

“Secretary of State for Health 1. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the ward or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 2. The inquest heard that an obvious ligature point was identified in September 2016 in the Mental Health Unit, and yet bureaucratic processes meant that approval for funding the rectification of this ligature point was held up for months, with staff having to “manage” the risk. The Coroner is concerned that there should be an expedited process for rectifying obvious ligature points on Mental Health Units Minister for Health, Welsh Assembly Government 1. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the unit or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 2. The inquest heard that an obvious ligature point was identified in September 2016 in the Mental Health Unit, and yet bureaucratic processes meant that approval for funding the rectification of this ligature point was held up for months, with staff having to “manage” the risk. The Coroner is concerned that there should be an expedited process for rectifying obvious ligature points on Mental Health Units Chief Executive – Cwm Taf University Health Board 1. The inquest heard of the Pod system on the Mental Health Unit in which items of danger to patients were deposited (and then possibly returned to the patient). There was no evidence of any effective system to identify who had what item, and when. The Coroner is concerned that there should be an effective system to check on what is taken from a patient and then later returned to a patient. 2. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the unit or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 3. The inquest heard that there was confusion between staff on the Mental Health Unit and the Community Psychiatric Nurse over management of risk for a patient admitted on the Mental Health Unit, with the result that responsibility for a risk assessment might not be recognised. The Coroner is concerned that there should be proper management and dissemination of risk management policies to frontline staff to avoid any confusion Editor British National Formulary Hydroxychloroquine 1. The expert evidence given was that Hydroxychloroquine (HCQ) is not contra-indicated in Appendix 1 of the BNF for anti-epileptic drugs. The manufacturer’s leaflet however does contain a caution against using HCQ alongside anti-epileptic drugs. It is acknowledged that the text of the BNF does indicate that HCQ should not be used in case of neurological disorders (including epilepsy) but this does not catch patients like Dee who was on an anti-epileptic drug (Lamotrigine) for her bipolar condition but was not epileptic. The coroner is concerned that the BNF might not fully describe the risk to patients taking Lamotrigine (or drugs of similar class or composition) alongside Hydroxychloroquine. Royal College of Psychiatrists Hydroxychloroquine 1. The evidence in the inquest showed that the psychiatrists treating Deidre were largely unaware of the potential side-effects of Hydroxychloroquine which Deidre was received for her Systemic Lupus Erythematosus. These include mental changes and psychosis. The Coroner is concerned that consultants treating other mental patients who are receiving this drug should be aware of these side-effects, and is concerned that there should be proper liaison with the consultant dermatologist over its toxic and potential mental health side-effects. In General the Coroner is concerned that the psychiatrists treating a patient in a Mental Health Unit should have the benefit of specialist advice from outside consultants who may be treating the patient for a physical condition British Association of Dermatologists Hydroxychloroquine 1. The expert evidence received in this inquest revealed that Hydroxychloroquine could build up to toxic levels even with normal dosage. ████████ of the Dept of Toxicology, Birmingham Heartlands Hospital reported that there is a clear cross-over between apparently toxic concentrations and apparently therapeutic concentrations. Deidre at the time of her death had a concentration of approximately 25 mg/L and fatalities at 7.5 mg/L. The Coroner is concerned that this drug should not be prescribed to a patient suffering from Lupus (which in itself is not life-threatening) without an awareness that toxic levels can build up even at the recommended dose. The Coroner is concerned that the dermatologist prescribing this drug should liaise with other consultants treating the patient for other conditions (in Deidre’s case for her mental health problems) so that specialist knowledge about the toxic effects of this drug can be shared. CEO Alerts NHS Hydroxychloroquine 1. The evidence in this inquest is that Deidre (who was a detained patient under Section 3 MHA) was being given a drug for a physical condition (Lupus) which can build up to toxic levels even at normal doses. The inquest heard that there is no routine checking of Hydroxychloroquine levels at clinical level, even though ████████ said he thought that clinical monitoring of this drug might be important. The Coroner is concerned that there may be other dependent persons suffering from lupus (or other conditions for which Hydroxychloroquine is prescribed in NHS hospitals in England and Wales) who may also have toxic levels of Hydroxychloroquine in their system unbeknown to their carers. ”

Is this part of a recurring concern?

Yes — Toxicity risks from excessive or combined medication use; Unreliable clinician management of medication side effects; Unsafe medication prescribing.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Delays in rectifying obvious ligature points on mental health units

Wider context from the report

“Secretary of State for Health 1. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the ward or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 2. The inquest heard that an obvious ligature point was identified in September 2016 in the Mental Health Unit, and yet bureaucratic processes meant that approval for funding the rectification of this ligature point was held up for months, with staff having to “manage” the risk. The Coroner is concerned that there should be an expedited process for rectifying obvious ligature points on Mental Health Units Minister for Health, Welsh Assembly Government 1. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the unit or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 2. The inquest heard that an obvious ligature point was identified in September 2016 in the Mental Health Unit, and yet bureaucratic processes meant that approval for funding the rectification of this ligature point was held up for months, with staff having to “manage” the risk. The Coroner is concerned that there should be an expedited process for rectifying obvious ligature points on Mental Health Units Chief Executive – Cwm Taf University Health Board 1. The inquest heard of the Pod system on the Mental Health Unit in which items of danger to patients were deposited (and then possibly returned to the patient). There was no evidence of any effective system to identify who had what item, and when. The Coroner is concerned that there should be an effective system to check on what is taken from a patient and then later returned to a patient. 2. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the unit or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 3. The inquest heard that there was confusion between staff on the Mental Health Unit and the Community Psychiatric Nurse over management of risk for a patient admitted on the Mental Health Unit, with the result that responsibility for a risk assessment might not be recognised. The Coroner is concerned that there should be proper management and dissemination of risk management policies to frontline staff to avoid any confusion Editor British National Formulary Hydroxychloroquine 1. The expert evidence given was that Hydroxychloroquine (HCQ) is not contra-indicated in Appendix 1 of the BNF for anti-epileptic drugs. The manufacturer’s leaflet however does contain a caution against using HCQ alongside anti-epileptic drugs. It is acknowledged that the text of the BNF does indicate that HCQ should not be used in case of neurological disorders (including epilepsy) but this does not catch patients like Dee who was on an anti-epileptic drug (Lamotrigine) for her bipolar condition but was not epileptic. The coroner is concerned that the BNF might not fully describe the risk to patients taking Lamotrigine (or drugs of similar class or composition) alongside Hydroxychloroquine. Royal College of Psychiatrists Hydroxychloroquine 1. The evidence in the inquest showed that the psychiatrists treating Deidre were largely unaware of the potential side-effects of Hydroxychloroquine which Deidre was received for her Systemic Lupus Erythematosus. These include mental changes and psychosis. The Coroner is concerned that consultants treating other mental patients who are receiving this drug should be aware of these side-effects, and is concerned that there should be proper liaison with the consultant dermatologist over its toxic and potential mental health side-effects. In General the Coroner is concerned that the psychiatrists treating a patient in a Mental Health Unit should have the benefit of specialist advice from outside consultants who may be treating the patient for a physical condition British Association of Dermatologists Hydroxychloroquine 1. The expert evidence received in this inquest revealed that Hydroxychloroquine could build up to toxic levels even with normal dosage. ████████ of the Dept of Toxicology, Birmingham Heartlands Hospital reported that there is a clear cross-over between apparently toxic concentrations and apparently therapeutic concentrations. Deidre at the time of her death had a concentration of approximately 25 mg/L and fatalities at 7.5 mg/L. The Coroner is concerned that this drug should not be prescribed to a patient suffering from Lupus (which in itself is not life-threatening) without an awareness that toxic levels can build up even at the recommended dose. The Coroner is concerned that the dermatologist prescribing this drug should liaise with other consultants treating the patient for other conditions (in Deidre’s case for her mental health problems) so that specialist knowledge about the toxic effects of this drug can be shared. CEO Alerts NHS Hydroxychloroquine 1. The evidence in this inquest is that Deidre (who was a detained patient under Section 3 MHA) was being given a drug for a physical condition (Lupus) which can build up to toxic levels even at normal doses. The inquest heard that there is no routine checking of Hydroxychloroquine levels at clinical level, even though ████████ said he thought that clinical monitoring of this drug might be important. The Coroner is concerned that there may be other dependent persons suffering from lupus (or other conditions for which Hydroxychloroquine is prescribed in NHS hospitals in England and Wales) who may also have toxic levels of Hydroxychloroquine in their system unbeknown to their carers. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Incomplete description of the risk of combining Lamotrigine or similar drugs with Hydroxychloroquine

Wider context from the report

“Secretary of State for Health 1. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the ward or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 2. The inquest heard that an obvious ligature point was identified in September 2016 in the Mental Health Unit, and yet bureaucratic processes meant that approval for funding the rectification of this ligature point was held up for months, with staff having to “manage” the risk. The Coroner is concerned that there should be an expedited process for rectifying obvious ligature points on Mental Health Units Minister for Health, Welsh Assembly Government 1. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the unit or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 2. The inquest heard that an obvious ligature point was identified in September 2016 in the Mental Health Unit, and yet bureaucratic processes meant that approval for funding the rectification of this ligature point was held up for months, with staff having to “manage” the risk. The Coroner is concerned that there should be an expedited process for rectifying obvious ligature points on Mental Health Units Chief Executive – Cwm Taf University Health Board 1. The inquest heard of the Pod system on the Mental Health Unit in which items of danger to patients were deposited (and then possibly returned to the patient). There was no evidence of any effective system to identify who had what item, and when. The Coroner is concerned that there should be an effective system to check on what is taken from a patient and then later returned to a patient. 2. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the unit or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 3. The inquest heard that there was confusion between staff on the Mental Health Unit and the Community Psychiatric Nurse over management of risk for a patient admitted on the Mental Health Unit, with the result that responsibility for a risk assessment might not be recognised. The Coroner is concerned that there should be proper management and dissemination of risk management policies to frontline staff to avoid any confusion Editor British National Formulary Hydroxychloroquine 1. The expert evidence given was that Hydroxychloroquine (HCQ) is not contra-indicated in Appendix 1 of the BNF for anti-epileptic drugs. The manufacturer’s leaflet however does contain a caution against using HCQ alongside anti-epileptic drugs. It is acknowledged that the text of the BNF does indicate that HCQ should not be used in case of neurological disorders (including epilepsy) but this does not catch patients like Dee who was on an anti-epileptic drug (Lamotrigine) for her bipolar condition but was not epileptic. The coroner is concerned that the BNF might not fully describe the risk to patients taking Lamotrigine (or drugs of similar class or composition) alongside Hydroxychloroquine. Royal College of Psychiatrists Hydroxychloroquine 1. The evidence in the inquest showed that the psychiatrists treating Deidre were largely unaware of the potential side-effects of Hydroxychloroquine which Deidre was received for her Systemic Lupus Erythematosus. These include mental changes and psychosis. The Coroner is concerned that consultants treating other mental patients who are receiving this drug should be aware of these side-effects, and is concerned that there should be proper liaison with the consultant dermatologist over its toxic and potential mental health side-effects. In General the Coroner is concerned that the psychiatrists treating a patient in a Mental Health Unit should have the benefit of specialist advice from outside consultants who may be treating the patient for a physical condition British Association of Dermatologists Hydroxychloroquine 1. The expert evidence received in this inquest revealed that Hydroxychloroquine could build up to toxic levels even with normal dosage. ████████ of the Dept of Toxicology, Birmingham Heartlands Hospital reported that there is a clear cross-over between apparently toxic concentrations and apparently therapeutic concentrations. Deidre at the time of her death had a concentration of approximately 25 mg/L and fatalities at 7.5 mg/L. The Coroner is concerned that this drug should not be prescribed to a patient suffering from Lupus (which in itself is not life-threatening) without an awareness that toxic levels can build up even at the recommended dose. The Coroner is concerned that the dermatologist prescribing this drug should liaise with other consultants treating the patient for other conditions (in Deidre’s case for her mental health problems) so that specialist knowledge about the toxic effects of this drug can be shared. CEO Alerts NHS Hydroxychloroquine 1. The evidence in this inquest is that Deidre (who was a detained patient under Section 3 MHA) was being given a drug for a physical condition (Lupus) which can build up to toxic levels even at normal doses. The inquest heard that there is no routine checking of Hydroxychloroquine levels at clinical level, even though ████████ said he thought that clinical monitoring of this drug might be important. The Coroner is concerned that there may be other dependent persons suffering from lupus (or other conditions for which Hydroxychloroquine is prescribed in NHS hospitals in England and Wales) who may also have toxic levels of Hydroxychloroquine in their system unbeknown to their carers. ”

Is this part of a recurring concern?

Yes — Toxicity risks from excessive or combined medication use.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Lack of awareness among psychiatrists of Hydroxychloroquine mental and toxic side-effects

Wider context from the report

“Secretary of State for Health 1. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the ward or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 2. The inquest heard that an obvious ligature point was identified in September 2016 in the Mental Health Unit, and yet bureaucratic processes meant that approval for funding the rectification of this ligature point was held up for months, with staff having to “manage” the risk. The Coroner is concerned that there should be an expedited process for rectifying obvious ligature points on Mental Health Units Minister for Health, Welsh Assembly Government 1. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the unit or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 2. The inquest heard that an obvious ligature point was identified in September 2016 in the Mental Health Unit, and yet bureaucratic processes meant that approval for funding the rectification of this ligature point was held up for months, with staff having to “manage” the risk. The Coroner is concerned that there should be an expedited process for rectifying obvious ligature points on Mental Health Units Chief Executive – Cwm Taf University Health Board 1. The inquest heard of the Pod system on the Mental Health Unit in which items of danger to patients were deposited (and then possibly returned to the patient). There was no evidence of any effective system to identify who had what item, and when. The Coroner is concerned that there should be an effective system to check on what is taken from a patient and then later returned to a patient. 2. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the unit or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 3. The inquest heard that there was confusion between staff on the Mental Health Unit and the Community Psychiatric Nurse over management of risk for a patient admitted on the Mental Health Unit, with the result that responsibility for a risk assessment might not be recognised. The Coroner is concerned that there should be proper management and dissemination of risk management policies to frontline staff to avoid any confusion Editor British National Formulary Hydroxychloroquine 1. The expert evidence given was that Hydroxychloroquine (HCQ) is not contra-indicated in Appendix 1 of the BNF for anti-epileptic drugs. The manufacturer’s leaflet however does contain a caution against using HCQ alongside anti-epileptic drugs. It is acknowledged that the text of the BNF does indicate that HCQ should not be used in case of neurological disorders (including epilepsy) but this does not catch patients like Dee who was on an anti-epileptic drug (Lamotrigine) for her bipolar condition but was not epileptic. The coroner is concerned that the BNF might not fully describe the risk to patients taking Lamotrigine (or drugs of similar class or composition) alongside Hydroxychloroquine. Royal College of Psychiatrists Hydroxychloroquine 1. The evidence in the inquest showed that the psychiatrists treating Deidre were largely unaware of the potential side-effects of Hydroxychloroquine which Deidre was received for her Systemic Lupus Erythematosus. These include mental changes and psychosis. The Coroner is concerned that consultants treating other mental patients who are receiving this drug should be aware of these side-effects, and is concerned that there should be proper liaison with the consultant dermatologist over its toxic and potential mental health side-effects. In General the Coroner is concerned that the psychiatrists treating a patient in a Mental Health Unit should have the benefit of specialist advice from outside consultants who may be treating the patient for a physical condition British Association of Dermatologists Hydroxychloroquine 1. The expert evidence received in this inquest revealed that Hydroxychloroquine could build up to toxic levels even with normal dosage. ████████ of the Dept of Toxicology, Birmingham Heartlands Hospital reported that there is a clear cross-over between apparently toxic concentrations and apparently therapeutic concentrations. Deidre at the time of her death had a concentration of approximately 25 mg/L and fatalities at 7.5 mg/L. The Coroner is concerned that this drug should not be prescribed to a patient suffering from Lupus (which in itself is not life-threatening) without an awareness that toxic levels can build up even at the recommended dose. The Coroner is concerned that the dermatologist prescribing this drug should liaise with other consultants treating the patient for other conditions (in Deidre’s case for her mental health problems) so that specialist knowledge about the toxic effects of this drug can be shared. CEO Alerts NHS Hydroxychloroquine 1. The evidence in this inquest is that Deidre (who was a detained patient under Section 3 MHA) was being given a drug for a physical condition (Lupus) which can build up to toxic levels even at normal doses. The inquest heard that there is no routine checking of Hydroxychloroquine levels at clinical level, even though ████████ said he thought that clinical monitoring of this drug might be important. The Coroner is concerned that there may be other dependent persons suffering from lupus (or other conditions for which Hydroxychloroquine is prescribed in NHS hospitals in England and Wales) who may also have toxic levels of Hydroxychloroquine in their system unbeknown to their carers. ”

Is this part of a recurring concern?

Yes — Unreliable clinician management of medication side effects.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure to disseminate risk management policies clearly to frontline staff

Wider context from the report

“Secretary of State for Health 1. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the ward or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 2. The inquest heard that an obvious ligature point was identified in September 2016 in the Mental Health Unit, and yet bureaucratic processes meant that approval for funding the rectification of this ligature point was held up for months, with staff having to “manage” the risk. The Coroner is concerned that there should be an expedited process for rectifying obvious ligature points on Mental Health Units Minister for Health, Welsh Assembly Government 1. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the unit or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 2. The inquest heard that an obvious ligature point was identified in September 2016 in the Mental Health Unit, and yet bureaucratic processes meant that approval for funding the rectification of this ligature point was held up for months, with staff having to “manage” the risk. The Coroner is concerned that there should be an expedited process for rectifying obvious ligature points on Mental Health Units Chief Executive – Cwm Taf University Health Board 1. The inquest heard of the Pod system on the Mental Health Unit in which items of danger to patients were deposited (and then possibly returned to the patient). There was no evidence of any effective system to identify who had what item, and when. The Coroner is concerned that there should be an effective system to check on what is taken from a patient and then later returned to a patient. 2. The inquest heard that patients on Mental Health Units often have significant physical problems which are treated by outside consultants, who may have little input into their care on the unit or may not even know they are there. In this inquest the consultant psychiatrist treating Deidre was not aware of the potentially toxic effects of the drug for her lupus. The Coroner is concerned that outside consultants should have a more active input into the care of the mental health patient on a Mental Health Unit, in order that their expertise and knowledge is available to the treating consultant psychiatrist. 3. The inquest heard that there was confusion between staff on the Mental Health Unit and the Community Psychiatric Nurse over management of risk for a patient admitted on the Mental Health Unit, with the result that responsibility for a risk assessment might not be recognised. The Coroner is concerned that there should be proper management and dissemination of risk management policies to frontline staff to avoid any confusion Editor British National Formulary Hydroxychloroquine 1. The expert evidence given was that Hydroxychloroquine (HCQ) is not contra-indicated in Appendix 1 of the BNF for anti-epileptic drugs. The manufacturer’s leaflet however does contain a caution against using HCQ alongside anti-epileptic drugs. It is acknowledged that the text of the BNF does indicate that HCQ should not be used in case of neurological disorders (including epilepsy) but this does not catch patients like Dee who was on an anti-epileptic drug (Lamotrigine) for her bipolar condition but was not epileptic. The coroner is concerned that the BNF might not fully describe the risk to patients taking Lamotrigine (or drugs of similar class or composition) alongside Hydroxychloroquine. Royal College of Psychiatrists Hydroxychloroquine 1. The evidence in the inquest showed that the psychiatrists treating Deidre were largely unaware of the potential side-effects of Hydroxychloroquine which Deidre was received for her Systemic Lupus Erythematosus. These include mental changes and psychosis. The Coroner is concerned that consultants treating other mental patients who are receiving this drug should be aware of these side-effects, and is concerned that there should be proper liaison with the consultant dermatologist over its toxic and potential mental health side-effects. In General the Coroner is concerned that the psychiatrists treating a patient in a Mental Health Unit should have the benefit of specialist advice from outside consultants who may be treating the patient for a physical condition British Association of Dermatologists Hydroxychloroquine 1. The expert evidence received in this inquest revealed that Hydroxychloroquine could build up to toxic levels even with normal dosage. ████████ of the Dept of Toxicology, Birmingham Heartlands Hospital reported that there is a clear cross-over between apparently toxic concentrations and apparently therapeutic concentrations. Deidre at the time of her death had a concentration of approximately 25 mg/L and fatalities at 7.5 mg/L. The Coroner is concerned that this drug should not be prescribed to a patient suffering from Lupus (which in itself is not life-threatening) without an awareness that toxic levels can build up even at the recommended dose. The Coroner is concerned that the dermatologist prescribing this drug should liaise with other consultants treating the patient for other conditions (in Deidre’s case for her mental health problems) so that specialist knowledge about the toxic effects of this drug can be shared. CEO Alerts NHS Hydroxychloroquine 1. The evidence in this inquest is that Deidre (who was a detained patient under Section 3 MHA) was being given a drug for a physical condition (Lupus) which can build up to toxic levels even at normal doses. The inquest heard that there is no routine checking of Hydroxychloroquine levels at clinical level, even though ████████ said he thought that clinical monitoring of this drug might be important. The Coroner is concerned that there may be other dependent persons suffering from lupus (or other conditions for which Hydroxychloroquine is prescribed in NHS hospitals in England and Wales) who may also have toxic levels of Hydroxychloroquine in their system unbeknown to their carers. ”

Is this part of a recurring concern?

Yes — Unreliable guidance and communication for safety risk assessments.

Open source report

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Implement a safe system for recording items stored in and removed from patient PODS.

Verbatim wording from the response

“A safe system of work has been implemented to ensure that staff are recording items stored in and taken from patient PODS.”

Source location

2018-0266-Response-by-University-Health-Board
Page 1 · response
Published 20 July 2017

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Disseminate risk management policies through ward meetings and obtain individual staff sign-off.

Verbatim wording from the response

“Dissemination of risk management policies to frontline staff are now shared by team leaders through ward meetings and staff sign off individually to demonstrate sharing.”

Source location

2018-0266-Response-by-University-Health-Board
Page 1 · response
Published 20 July 2017

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Seek expert pharmacovigilance advice on available evidence concerning hydroxychloroquine toxicity and the reported death.

Verbatim wording from the response

“On 21st November 2018, we sought the advice of the Commission on Human Medicines’ Pharmacovigilance Expert Advisory Group (PEAG) on the available data including the information outlined in the report of Mrs Harvey’s death. The PEAG advised that in order to ensure that any actions are evidence based, further details on the report would be helpful.”

Source location

2018-0266-Response-by-MHRA
Page 1 · response
Published 20 July 2017

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Mental health providers in England are responsible for assessing and managing environmental ligature risks under their policies and available guidance.

Verbatim wording from the response

“Turning to your second matter of concern, on the removal of ligature points in mental health settings, it is for mental health providers in England to ensure they have policies in place to effectively assess and manage environmental risk in line with available guidance⁴⁵.”

Source location

2018-0266-Response-by-Department-of-Health-Social-Care
Page 3 · response
Published 20 July 2017

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Responsibility for NHS matters in Wales is devolved and falls outside the scope of this England policy response.

Verbatim wording from the response

“Your report directs two matters of concern to the Secretary of State for Health which I will address in turn giving the policy position in England. You will appreciate that responsibility for the NHS in Wales is a devolved matter.”

Source location

2018-0266-Response-by-Department-of-Health-Social-Care
Page 1 · response
Published 20 July 2017

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

MHRA and NHS Improvement are responding separately to concerns about monitoring patients prescribed hydroxychloroquine.

Verbatim wording from the response

“Finally, I am aware that the MHRA and NHS Improvement are responding separately to your matter of concern on the monitoring of patients who are prescribed Hydroxychloroquine. I hope that response is helpful.”

Source location

2018-0266-Response-by-Department-of-Health-Social-Care
Page 3 · response
Published 20 July 2017

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The MHRA has primary responsibility for monitoring Hydroxychloroquine toxicity and will provide the substantive response on this issue.

Verbatim wording from the response

“The issue of monitoring for toxicity that you raised is primarily in the remit of the MHRA, and they will provide the substantive reply to you on this issue. We have supported their work through undertaking a search of the National Reporting and Learning System. This did not identify any additional cases where systematic toxicity from Hydroxychloroquine had been identified, but did reinforce the importance of annual eye screening for patients on long-term Hydroxychloroquine, as set out in current guidance from the British Society for Rheumatology and British health Professionals in Rheumatology ‘Guideline for the prescription and monitoring of non-biologic disease-modifying anti rheumatic drugs (see https://cks.nice.org.uk/dmards#!scenario:8)”

Source location

2018-0266-Response-by-NHS-Improvement
Page 2 · response
Published 20 July 2017

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

NHS organisations, professionals and health boards are responsible for assessing ligature risks and implementing mitigation where risks cannot be immediately addressed.

Verbatim wording from the response

“NHS organisations are expected to ensure that units / wards are safe for the patients being cared within them. Fixtures and fittings should therefore be assessed to ensure they are anti-ligature. Where ligature risk points are identified but cannot be immediately addressed, it is the responsibility of the professionals caring for people on such a unit and the health board generally to put robust measures in place to mitigate the risks.”

Source location

2018-0266-Response-by-Welsh-Government
Page 1 · response
Published 20 July 2017

Open published response

Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.4

  1. 1

    Develop and update a corrective action plan to plan and monitor improvements.

    Stated by Cwm Taf Morgannwg University Local Health BoardStated completedThe respondent said that this action was complete when they made their response on 20 July 2017.
  2. 2

    Develop a standard list of documents for disclosure at inquest.

    Stated by Cwm Taf Morgannwg University Local Health BoardStated in progressThe respondent said that this action was in progress when they made their response on 20 July 2017.
  3. 3

    Discuss the incident through the all-Wales Serious Incidents Group to support learning and develop and disseminate further guidance.

    Stated by Welsh GovernmentStated plannedThe respondent said that this action was planned when they made their response on 20 July 2017.
  4. 4

    Keep the case and resulting learning under ongoing review.

    Stated by Welsh GovernmentStated in progressThe respondent said that this action was in progress when they made their response on 20 July 2017.

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Develop and update a corrective action plan to plan and monitor improvements.

Verbatim wording from the response

“1. Action taken to plan and monitor improvements A corrective Action Plan for Improvement was developed following Mrs Harvey’s death. This has been updated to reflect the concerns identified within the Regulation 28 Report.”

Source location

2018-0266-Response-by-University-Health-Board
Page 1 · response
Published 20 July 2017

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Develop a standard list of documents for disclosure at inquest.

Verbatim wording from the response

“A standard list of documents for disclosure at inquest is being developed.”

Source location

2018-0266-Response-by-University-Health-Board
Page 1 · response
Published 20 July 2017

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Discuss the incident through the all-Wales Serious Incidents Group to support learning and develop and disseminate further guidance.

Verbatim wording from the response

“In the shorter term, Welsh Government officials will be taking this tragic incident for discussion at the all Wales Serious Incidents Group in October. Led by the NHS Delivery Unit, it will contribute to improve learning and the development and dissemination of further guidance to be shared across the differing professional groups.”

Source location

2018-0266-Response-by-Welsh-Government
Page 1 · response
Published 20 July 2017

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Keep the case and resulting learning under ongoing review.

Verbatim wording from the response

“I do assure you that Welsh Government will keep this case and the learning that arises under ongoing review.”

Source location

2018-0266-Response-by-Welsh-Government
Page 2 · response
Published 20 July 2017

Open published response
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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Data last updated 7 September 2026