Concerns raised 2 Failure of prescribing software to trigger alerts for the interaction between amitriptyline, paroxetine and ivabradine View source Lack of prescriber understanding of the interaction between ivabradine, amitriptyline and paroxetine View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Chloe Elizabeth Burgess · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Chloe Elizabeth Burgess was found deceased at home on 8 September 2023. The report states that interactions between amitriptyline, paroxetine and ivabradine, together with an episode of sleep apnoea, contributed to severe cardiac arrhythmia and sudden cardiac death. The principal concerns were that the potential dangers of this medication combination were not widely appreciated and did not trigger alerts in prescribing software, and that prescribers of ivabradine should have a full understanding of the potential interaction.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to BNF Publications; that does not assign responsibility.
PFD Monitor interpretation Failure of prescribing software to trigger alerts for the interaction between amitriptyline, paroxetine and ivabradine
Wider context from the report “The inquest heard evidence that the potential dangers of the combination of amitriptyline, paroxetine and ivabradine is not widely appreciated and does not trigger an alert on the prescribing software used in primary care or by pharmacists . The potential dangers related to a failure to metabolise amitriptyline which can, incrementally, lead to toxicity.
I am also concerned that those prescribing ivabradine should have a full understanding of the potential interaction with amitriptyline and paroxetine.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to BNF Publications; that does not assign responsibility.
PFD Monitor interpretation Lack of prescriber understanding of the interaction between ivabradine, amitriptyline and paroxetine
Wider context from the report “The inquest heard evidence that the potential dangers of the combination of amitriptyline, paroxetine and ivabradine is not widely appreciated and does not trigger an alert on the prescribing software used in primary care or by pharmacists. The potential dangers related to a failure to metabolise amitriptyline which can, incrementally, lead to toxicity.
I am also concerned that those prescribing ivabradine should have a full understanding of the potential interaction with amitriptyline and paroxetine .
” Open source report
Concerns raised 2 Failure of clozapine packaging and leaflets to warn that combined use with alcohol may cause death View source Lack of guidance on the risk of death from combined clozapine and alcohol use View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Sean Benjamin CRAWFORD · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Sean Benjamin CRAWFORD died on 18 December 2020 in Darlington from the combined toxic effect of alcohol and clozapine, neither being individually at toxic levels. The principal concern was that available guidance and medication packaging warned about alcohol, sedation and potentially dangerous side effects but did not advise that death could result from this combination.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to BNF Publications; that does not assign responsibility.
PFD Monitor interpretation Failure of clozapine packaging and leaflets to warn that combined use with alcohol may cause death
Wider context from the report “The circumstances in which Sean came by his death, the combined effects of clozapine with alcohol, seems to be, statistically, very rare. None of the professionals who gave evidence in this case could cite a death with the same cause of death as that suffered by Sean. This said, clozapine is a well-established medication whose side effects are well known. It was originally developed in the 1960s. It is well-known that it requires careful management and monitoring. The side effects are recognised ones and widely known. None of the professional witnesses expressed any lack of familiarity with it or its side effects. One of these side effects is sedation. Likewise, obviously, alcohol is a recognised central nervous system depressant. This is a death from Central Nervous System Depression, consequent to a comparatively high level of clozapine and a comparatively high level of ethanol in the blood – neither individually fatal. It is evident that there is no guidance in any academic literature, British National Formulary, or NICE or MHRA advices on the dangers of death in this scenario. It is noticeable that the leaflet that comes with the Clozaril (clozapine) packages clearly states that it must not be taken with alcohol , and the evidence to me was that the medication comes with a further label, in a similar vein, on the packaging. Neither, however, advises of death being a possibility. All the literature advises that sedation is a potentially dangerous side effect of clozapine. Death from Central Nervous System Depression, over-sedation, is not uncommon. It is often associated with alcohol, and other substance, 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. The report was sent to BNF Publications; that does not assign responsibility.
PFD Monitor interpretation Lack of guidance on the risk of death from combined clozapine and alcohol use
Wider context from the report “The circumstances in which Sean came by his death, the combined effects of clozapine with alcohol, seems to be, statistically, very rare. None of the professionals who gave evidence in this case could cite a death with the same cause of death as that suffered by Sean. This said, clozapine is a well-established medication whose side effects are well known. It was originally developed in the 1960s. It is well-known that it requires careful management and monitoring. The side effects are recognised ones and widely known. None of the professional witnesses expressed any lack of familiarity with it or its side effects. One of these side effects is sedation. Likewise, obviously, alcohol is a recognised central nervous system depressant. This is a death from Central Nervous System Depression, consequent to a comparatively high level of clozapine and a comparatively high level of ethanol in the blood – neither individually fatal. It is evident that there is no guidance in any academic literature, British National Formulary, or NICE or MHRA advices on the dangers of death in this scenario. It is noticeable that the leaflet that comes with the Clozaril (clozapine) packages clearly states that it must not be taken with alcohol, and the evidence to me was that the medication comes with a further label, in a similar vein, on the packaging. Neither, however, advises of death being a possibility. All the literature advises that sedation is a potentially dangerous side effect of clozapine. Death from Central Nervous System Depression, over-sedation, is not uncommon. It is often associated with alcohol, and other substance, use.
” 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 Add pharmacodynamic interaction tables to online BNF and BNFC versions.
Verbatim wording from the response “The BNF includes information on pharmacodynamic interactions, that is interactions between drugs which have similar or antagonistic pharmacological effects or side-effects. This information is present within interaction messages of relevant drug monographs in online versions of the BNF and the BNF app. The same information is presented in tables in print editions of the BNF, but at the time of this death, these tables were not present in online versions of the BNF or in the BNF + BNFC app.”
Source location Response from BNF Page 1 · response Published 22 February 2024
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 Review and revise pharmacodynamic interaction wording on sedative and CNS-depressant risks in BNF messages and tables.
Verbatim wording from the response “To address the concerns raised in your report, we plan to review the wording around the use of drugs that cause sedation (including clozapine and alcohol) and drugs with CNS depressant effects (including alcohol) within the pharmacodynamic interaction messages and in the tables. This will further highlight that concurrent use of two or more drugs that can cause sedation and / or CNS depression might increase the risk of CNS depressant effects, such as sedation, unconsciousness, coma, respiratory depression, and cardiovascular depression, and / or enhance the effects of drugs with CNS depressant effects. In addition, the pharmacodynamic interaction tables have now been added to the online versions of the BNF and BNFC ensuring this content is more accessible to users.”
Source location Response from BNF Page 1 · response Published 22 February 2024
Open published response
Concerns raised 1 Lack of guidance specifying when to test fluoxetine blood levels after palpitations View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Talia Evaniа Phillips · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Talia Evaniа Phillips died from catastrophic head and neck injuries sustained in a head-on road traffic collision, after likely losing control of her vehicle during a cardiac event associated with a significantly elevated blood level of Fluoxetine. The inquest raised concerns that guidance did not indicate routine Fluoxetine-level testing after palpitations and requested a review of when such blood testing should be advised.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to BNF Publications; that does not assign responsibility.
PFD Monitor interpretation Lack of guidance specifying when to test fluoxetine blood levels after palpitations
Wider context from the report “During the course of the inquest I heard that guidance around the prescribing of Fluoxetine did not indicate that fluoxetine levels would should be routinely tested in a patient prescribed Fluoxetine in the event of an episode of palpitations . Such a test may have identified chronically high levels of Fluoxetine.
It is requested that guidance in relation to the prescribing of Fluoxetine and management of patients on Fluoxetine should be reviewed to consider in what circumstances a blood test to establish the level of Fluoxetine in the patient's blood would be advisable .
” Open source report
8 Aug 2017 Deidre Harvey · Prevention of Future Deaths report South Wales Central
View report summary
Concerns raised 9 Lack of effective tracking of items taken from and returned to patients View source Lack of routine clinical monitoring of Hydroxychloroquine levels View source Lack of active input from outside consultants into mental health unit patient care View source Failure of liaison between dermatologists and other consultants about Hydroxychloroquine toxicity View source Lack of awareness of Hydroxychloroquine toxic accumulation at recommended doses View source Delays in rectifying obvious ligature points on mental health units View source Incomplete description of the risk of combining Lamotrigine or similar drugs with Hydroxychloroquine View source Lack of awareness among psychiatrists of Hydroxychloroquine mental and toxic side-effects View source Failure to disseminate risk management policies clearly to frontline staff View source See 6 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Deidre Harvey · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Deidre Harvey died on 19 April 2017 after attaching a dressing gown cord to her neck in a mental health unit bathroom; the cause of death was recorded as hanging. The report raised concerns about coordination between mental-health and outside consultants, management of ligature risks and dangerous items, risk-assessment communication, and the potential toxicity and monitoring of hydroxychloroquine.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to BNF Publications; that does 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.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to BNF Publications; that does 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.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to BNF Publications; that does 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.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to BNF Publications; that does 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.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to BNF Publications; that does 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.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to BNF Publications; that does 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.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to BNF Publications; that does 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.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to BNF Publications; that does 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.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to BNF Publications; that does 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.
” Open source report
29 Apr 2014 Dafydd Rhys WATTS · Prevention of Future Deaths report Avon
View report summary
Concerns raised 1 Failure to draw physicians’ attention to the possibility of such an occurrence in drug literature or BNF entries View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Dafydd Rhys WATTS · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Dafydd Rhys WATTS died of eosinophilic pericarditis and DRESS syndrome following treatment with levetiracetam for epilepsy. The report raised concern that the possibility of this exceptionally rare reaction and death was not drawn to physicians’ attention in the drug literature or BNF entry.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to BNF Publications; that does not assign responsibility.
PFD Monitor interpretation Failure to draw physicians’ attention to the possibility of such an occurrence in drug literature or BNF entries
Wider context from the report “Although the evidence suggests that this is only the fourth such death documented it appears that the possibility (albeit remote) of such an occurrence is not drawn to physicians attention in the drug literature or in the BNF entry .
” Open source report
14 Jan 2014 Craig Adam White · Prevention of Future Deaths report South Lincolnshire
View report summary
Concerns raised 4 Failure to provide continuing patient education about Infliximab treatment risks View source Delays in initiating treatment when tuberculous meningitis is suspected View source Lack of protocols for pre-Infliximab tuberculosis screening View source Lack of healthcare professional awareness of the increased tuberculosis risk inherent in Infliximab treatment View source See 1 more concern
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Craig Adam White · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Craig Adam White was a 21-year-old student who developed disseminated tuberculosis, including tuberculosis leptomeningitis, while receiving immunosuppressive treatment for Crohn’s disease. He had recurrent chest infections and later deteriorated with neurological illness before tuberculosis was confirmed. The principal concerns were tuberculosis screening before Infliximab treatment, healthcare professionals’ awareness of the associated risk, continuing patient education, and prompt treatment when tuberculous meningitis is suspected.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to BNF Publications; that does not assign responsibility.
PFD Monitor interpretation Failure to provide continuing patient education about Infliximab treatment risks
Wider context from the report “3 The need for continuing patient education about the risks of Infliximab treatment
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to BNF Publications; that does not assign responsibility.
PFD Monitor interpretation Delays in initiating treatment when tuberculous meningitis is suspected
Wider context from the report “4 The need for prompt treatment to be initiated when tuberculous meningitis is suspected
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to BNF Publications; that does not assign responsibility.
PFD Monitor interpretation Lack of protocols for pre-Infliximab tuberculosis screening
Wider context from the report “1 Protocols for pre-Infliximab treatment screening for tuberculosis
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to BNF Publications; that does not assign responsibility.
PFD Monitor interpretation Lack of healthcare professional awareness of the increased tuberculosis risk inherent in Infliximab treatment
Wider context from the report “2 Awareness of Health Care Professionals, in particular prescribers of the increased risk of TB inherent Infliximab treatment
” Open source report