Recurring concern

Unreliable clinician management of medication side effects

First to latest report 12 Oct 2013 — 3 Jun 2026

Reports that mention this concern
11
Times this concern has been raised
15
Stated actions linked to this concern
10

What this concern includes

Includes failures in clinician-facing processes for identifying, enquiring about, recording, communicating, reviewing or escalating medication side effects, including unclear recording guidance and inadequate awareness of required escalation procedures.

What is not included
  • Excludes patient-facing medication counselling or warnings where the clinician-facing recognition, recording or escalation process is not deficient.
  • Excludes prescribing, dispensing, administration, monitoring or treatment failures that do not specifically concern recognising or responding to medication side effects.
  • Excludes generic clinical documentation, training or communication deficiencies unless they directly impair medication-side-effect management.
  • Excludes side effects from non-medication treatments unless the assertion explicitly concerns medication side effects.

Reports and published responses 11 reports

See individual reports that have raised this concern, and the actions taken in response

  1. Worcestershire

    AI-generated summary

    Jack Horace BURTON · 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

    Jack Horace BURTON, who had schizophrenia and was prescribed Clozapine, died of Clozapine toxicity after stopping smoking while on holiday in North Yorkshire. Concerns included inconsistent medical accounts about the relevance of reducing smoking and a lack of standardised guidance for asking and recording information about possible medication side effects.

    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.

    PFD Monitor interpretation

    Lack of standardised guidance for recording answers about possible medication side effects

    Wider context from the report

    “2. The evidence revealed that there is no guidance on any standardised practice available to practitioners relating to asking questions and recording answers given when discussing possible symptoms of side effects of the medication. Practitioners can therefore make no record if no information is provided, which does not indicate whether questions were asked. ”

    Source location

    Jack Horace BURTON · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

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

    PFD Monitor interpretation

    Lack of standardised guidance for asking questions about possible medication side effects

    Wider context from the report

    “2. The evidence revealed that there is no guidance on any standardised practice available to practitioners relating to asking questions and recording answers given when discussing possible symptoms of side effects of the medication. Practitioners can therefore make no record if no information is provided, which does not indicate whether questions were asked. ”

    Source location

    Jack Horace BURTON · Prevention of Future Deaths report
    Page 3 · concerns

    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

    Use the Clozapine Clinic standard operating procedure and GASS to monitor and record clozapine side effects in electronic patient records.

    Verbatim wording from the response

    “Herefordshire and Worcestershire Health and Care Trust have a standard operating procedure, Community Mental Health Team’s Clozapine Clinic Guidance and Promotion of Health & Wellbeing, this document is in date and available on the Trust intranet. Please find the document attached.”

    Source location

    Response from Herefordshire and Worcestershire NHS Trust
    Page 2 · response
    Published 28 July 2026

    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

    Re-issue the Clozapine Treatment Guidelines and clinic guidance to the mental health clinical workforce.

    Verbatim wording from the response

    “In further response to the concerns raised by the Coroner, the Trust has re-issued both documents to the mental health clinical workforce. Follow-up actions will be undertaken to ensure that both newly appointed and existing staff are aware of, and comply with, the guidelines.”

    Source location

    Response from Herefordshire and Worcestershire NHS Trust
    Page 2 · response
    Published 28 July 2026

    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

    Undertake follow-up to ensure newly appointed and existing staff are aware of and comply with both clozapine guidance documents.

    Verbatim wording from the response

    “In further response to the concerns raised by the Coroner, the Trust has re-issued both documents to the mental health clinical workforce. Follow-up actions will be undertaken to ensure that both newly appointed and existing staff are aware of, and comply with, the guidelines.”

    Source location

    Response from Herefordshire and Worcestershire NHS Trust
    Page 2 · response
    Published 28 July 2026

    Open published response

  2. Surrey

    AI-generated summary

    Venetia Clarissa Pierce · 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

    Venetia Clarissa Pierce, described as an elderly frail lady with recurrent urinary infections, was prescribed nitrofurantoin prophylactically in February 2024 and died in hospital on 30 December 2024. The inquest recorded nitrofurantoin-induced pneumonitis as the medical cause of death, with frailty contributing. Concerns included the absence of an MHRA safety alert on the surgery’s EMIS system and limited awareness among clinicians of the potential for pulmonary damage and respiratory failure from nitrofurantoin in elderly patients.

    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.

    PFD Monitor interpretation

    Limited clinician awareness of nitrofurantoin pulmonary damage and respiratory failure in elderly patients

    Wider context from the report

    “b. Although a “recognised” complication, understanding of the potential for pulmonary damage and respiratory failure from use of nitrofurantoin in the elderly may remain low. The court heard evidence from a respiratory consultant that awareness amongst GPs, hospital clinicians including urologists was limited and that even if Mrs Pierce had been referred to hospital earlier the condition might not have been diagnosed. ”

    Source location

    Venetia Clarissa Pierce · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report

  3. London South

    AI-generated summary

    Mr Luke Alexander Worrell · 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

    Mr Luke Alexander Worrell, who had treatment-resistant schizophrenia and was taking Clozapine, developed persistent vomiting, dehydration and an ileus before suffering a ruptured oesophagus and dying in hospital on 2 January 2021. The report identified concerns about clinical staff failing to recognise the potentially fatal gastrointestinal side effects of Clozapine and about the inappropriate use of a community treatment order instead of continued detention under a mental health section. The inquest narrative also described failures to recognise the need for face-to-face psychiatric assessment after his deterioration following discharge.

    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.

    PFD Monitor interpretation

    Lack of clinical staff awareness of Clozapine's potential fatal side effects

    Wider context from the report

    “1. The lack of awareness by a series of clinical staff of the potential fatal side effects of Clozapine ”

    Source location

    Mr Luke Alexander Worrell · Prevention of Future Deaths report
    Page 3 · concerns

    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

    Raised clinician awareness of clozapine side effects by communicating associated risks to mental health chief pharmacists and health communities.

    Verbatim wording from the response

    “NHS England has undertaken considerable work to highlight to clinicians and colleagues the importance of keeping people safe from the side effects of Clozapine, which are well-recognised.”

    Source location

    Response from NHS England
    Page 1 · response
    Published 7 March 2025

    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 clozapine product information and consider whether warnings for healthcare professionals, patients and carers can be clarified.

    Verbatim wording from the response

    “We continuously review the safety of medicines on the UK market and take appropriate regulatory action as required. Currently, we are reviewing the product information for clozapine. As part of this review, we will be giving careful consideration to the information which is provided to healthcare professionals, patients and their families and carers, and whether this can be improved to provide greater clarity. We intend to engage with relevant stakeholders during this process to ensure the regulatory documents meet the needs of patients and prescribers. It is anticipated that this review of clozapine will be completed this year, and we will inform you of the outcome.”

    Source location

    Response from MHRA
    Page 2 · response
    Published 7 March 2025

    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

    Engage relevant stakeholders during the clozapine product-information review to ensure regulatory documents meet patients’ and prescribers’ needs.

    Verbatim wording from the response

    “We continuously review the safety of medicines on the UK market and take appropriate regulatory action as required. Currently, we are reviewing the product information for clozapine. As part of this review, we will be giving careful consideration to the information which is provided to healthcare professionals, patients and their families and carers, and whether this can be improved to provide greater clarity. We intend to engage with relevant stakeholders during this process to ensure the regulatory documents meet the needs of patients and prescribers. It is anticipated that this review of clozapine will be completed this year, and we will inform you of the outcome.”

    Source location

    Response from MHRA
    Page 2 · response
    Published 7 March 2025

    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

    Commenting on clinical decisions in specific cases, including those concerning clozapine, is outside the respondent’s remit.

    Verbatim wording from the response

    “We have considered the evidence provided and the circumstances leading to Mr Worrell’s death and acknowledge that your concerns relate to lack of awareness of clinical staff of the potentially fatal side effects of clozapine, and clinical decisions. Unfortunately, we cannot directly address these points, as it is not within our remit to comment on the clinical decisions in specific cases.”

    Source location

    Response from MHRA
    Page 2 · response
    Published 7 March 2025

    Open published response

  4. Suffolk

    AI-generated summary

    Gemima CHRISTODOULOU-PEACE · 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

    Gemima Christodoulou-Peace was found suspended by her neck from a ligature and died from suspension hanging, with the inquest noting insufficient evidence that she intended her death at all material times. The report raises concerns about the absence of a single reference point for identifying medications associated with increased suicidal behaviour, limited recording and accessibility of mental-health telephone calls, and delays in access to prescribing mental-health support. Gemima had requested a medication review, but had not seen a prescribing mental-health practitioner before her death.

    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.

    PFD Monitor interpretation

    Lack of a single reference point for identifying medications that increase suicidal behaviour

    Wider context from the report

    “1. Currently a treating clinician would need to undertake independent review on every prescription medication a patient is taking, to identify if any of those medications have a reported side-effect of increasing suicidal behaviour. For some medications this side-effect is very rare, so it is highly unlikely that a treating clinician could know all the medications identified as having a risk of increasing suicidal behaviour. At present there is no single reference point which a treating clinician can access, to readily and quickly identify if a patient is on a prescribed medication which is known to increase suicidal behaviour. ”

    Source location

    Gemima CHRISTODOULOU-PEACE · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    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

    Prescribers are responsible for using the Summary of Product Characteristics to prescribe medicines safely.

    Verbatim wording from the response

    “Information including the reported frequency of adverse drug reactions can be found in the Patient Information Leaflet and Summary of Product Characteristics which accompanies every licensed medicine marketed in the UK, including montelukast. The Summary of Product Characteristics forms the legal basis for the correct use of a medicinal product. It provides all the necessary information for prescribers to use a product safely and should be used to inform any discussions with a patient about the risks as well as the benefits of their treatment. The Patient Information Leaflet supplied with a patient’s medicine also supports those discussions and can be a useful reference to ensure patients are informed about their treatment. It is the prescriber’s responsibility to prescribe a drug based on the information contained within the Summary of Product Characteristics.”

    Source location

    Response from DHSC
    Page 2 · response
    Published 31 July 2024

    Open published response

  5. West Yorkshire (Western)

    AI-generated summary

    Robert Newton Stevenson · 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

    Robert Newton Stevenson, a 63-year-old retired consultant cardiologist and general physician, left home on 30 May 2022 and was later found hanging; resuscitation attempts were unsuccessful. The report raised concern about a possible rare link between ciprofloxacin and suicidal behaviour, including whether prescribing doctors were sufficiently aware of and communicating this potential side effect.

    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.

    PFD Monitor interpretation

    Lack of prescribing doctors’ awareness of the potential rare side effect

    Wider context from the report

    “During the inquest I was referred by Mr Stevenson’s treating urologist to published literature relating to Ciprofloxacin and Quinolone antibiotics and a potential rare link to suicide behaviour in patients, although I found on the balance of probabilities that it remained unclear that he was suffering from this side effect, it remained possible for this to be the case. • I heard evidence to suggest that the prescribing doctor did not reference this side effect at the time of issuing the prescription to Mr Stevenson, since it was not in accord with current advice. • I also heard evidence to suggest that prescribing doctors may not be fully aware of this rare side effect, and that patient’s suffering from depression may be more vulnerable to it. • I am therefore concerned that this potential risk has not been given sufficient emphasis and I would ask you to consider the appropriateness of reviewing the current guidelines as to the dispensation of the drug to patients by clinicians and increasing the awareness of the side effect in order to monitor and mitigate the risks. ”

    Source location

    Robert Newton Stevenson · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

  6. West Sussex

    AI-generated summary

    Katharine Eva Stamp · 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

    Katharine Eva Stamp died while detained under the Mental Health Act from sudden cardiac arrhythmia due to hypoxia, with the hypoxia described as involving aspiration pneumonia, probable sleep apnoea, obesity, smoking and clozapine effects. The report raised concerns that clozapine side effects, particularly in relation to smoking and pneumonia, were under-appreciated and that the BNF did not provide sufficient clarity to prescribers; it also stated that the lack of an effective national weight-gain monitoring programme for mental health inpatients was causally linked to her obesity and probable sleep apnoea.

    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.

    PFD Monitor interpretation

    Under-appreciation of clozapine side effects relating to smoking and pneumonia

    Wider context from the report

    “The side effects of clozapine, with specific reference to smoking and pneumonia, are under-appreciated Professor ████████ gave expert evidence to the Court These side effects may be rare, but they are still important The BNF does not provide sufficient clarity to prescribers about these side-effects ”

    Source location

    Katharine Eva Stamp · Prevention of Future Deaths report
    Page 1 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

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

    PFD Monitor interpretation

    Insufficient BNF clarity about clozapine side effects

    Wider context from the report

    “The side effects of clozapine, with specific reference to smoking and pneumonia, are under-appreciated Professor ████████ gave expert evidence to the Court These side effects may be rare, but they are still important The BNF does not provide sufficient clarity to prescribers about these side-effects ”

    Source location

    Katharine Eva Stamp · Prevention of Future Deaths report
    Page 1 · concerns

    Open source report

  7. Manchester South

    AI-generated summary

    Graham Earl · 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

    Graham Earl had pulmonary fibrosis diagnosed while receiving Amiodarone therapy and was not referred back to the cardiologist. He later developed influenza, deteriorated, and died at Stepping Hill Hospital on 16 February 2019. The principal concerns were that the link between Amiodarone and pulmonary fibrosis was not recognised promptly, the medication was amended without reference to secondary care, and there was insufficient awareness of escalation procedures for side effects.

    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.

    PFD Monitor interpretation

    Lack of GP awareness of escalation procedures for medication side effects

    Wider context from the report

    “3. The indication was that GPs involved were not aware of what they should do if there were side effects from the medication in terms of escalation; ”

    Source location

    Graham Earl · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

  8. South Wales Central

    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.

    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. ”

    Source location

    Deidre Harvey · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

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

    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. ”

    Source location

    Deidre Harvey · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

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

    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. ”

    Source location

    Deidre Harvey · Prevention of Future Deaths report
    Page 2 · concerns

    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

    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

  9. East London

    AI-generated summary

    Mr Devindar Lal Seth · 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

    Mr Devindar Lal Seth, aged 94, suffered a fall, fractured his hip and underwent surgery before developing opiate toxicity after postoperative pain treatment. The opiate toxicity was not identified by ward staff until family members raised concerns, and there was also a delay in ventilation after he suffered aspiration. The report identified a lack of clear guidance for ward staff about the risks and side effects of opiate medication in older orthopaedic patients.

    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.

    PFD Monitor interpretation

    Lack of clear, accessible guidance for ward staff on opioid risks and side effects in orthogeriatric patients

    Wider context from the report

    “During the course of the evidence, it was confirmed that there is no clear guidance available to ward staff on the risk of opiate medications in orthogeriatric patients and side effects to look out for. I have been provided with the WHO Analgesic Ladder and the Guidelines for Acute Pain Management in Adults. The guidelines provide substantial amounts of information in relation to the contra-indications of NSAIDs. The only information relating to opioids in the Guidelines is that regular opioids can cause constipation. It is clear that none of the ward staff in this case recognised the effect that the opiate medication was having upon Mr Seth and I consider that it would be helpful for easily accessible guidance to be available for both nursing and medical staff. ”

    Source location

    Mr Devindar Lal Seth · Prevention of Future Deaths report
    Page 2 · concerns

    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

    Produce staff guidance on opioid medication risks, side effects and signs of opioid toxicity.

    Verbatim wording from the response

    “2. The Pharmacy department is producing guidance for staff relating to the risk of opiate medications, their side-effects and the signs of opiate toxicity.”

    Source location

    Davindar-Lal-Seth-Response
    Page 2 · response
    Published 26 February 2016

    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

    Cascade opioid-toxicity guidance to ward and medical staff and publish it in the hospital newsletter.

    Verbatim wording from the response

    “3. This guidance will be cascaded to all members of the ward and to medical staff and the communication manager will include the guidance as an article in the Newham University Hospital site newsletter.”

    Source location

    Davindar-Lal-Seth-Response
    Page 2 · response
    Published 26 February 2016

    Open published response

  10. Inner South London

    AI-generated summary

    Michael Samuel Ian Anthony · 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

    Michael Samuel Ian Anthony was found dead in his flat on 8 May 2013 and died from diabetic ketoacidotic coma. He had a very high Gabapentin level, and concern was raised about whether Gabapentin was contraindicated for someone with severe Type 1 diabetes and whether prescribing doctors knew of its rare potential to precipitate diabetic coma.

    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.

    PFD Monitor interpretation

    Lack of prescriber awareness of Gabapentin's rare side effect of precipitating diabetic coma

    Wider context from the report

    “(1) It was not known whether Gabapentin was contraindicated to be prescribed in the deceased, who suffered severe Type 1 diabetes, or whether the prescribing doctors were aware of the rare side effect of Gabapentin in precipitating diabetic coma. If they were not there would be a potentially avoidable risk to other patients. ”

    Source location

    Michael Samuel Ian Anthony · Prevention of Future Deaths report
    Page 1 · concerns

    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

    Build the drug-safety review into day-to-day clinical practice.

    Verbatim wording from the response

    “Many thanks for your letter of 10th April last sent to both myself and ████████████████████████ in relation to the above deceased. We note and acknowledge receipt of the Regulation 28 report to prevent future deaths on the above addressed to myself and ████████████████████████. I have asked for full disclosure by email to the coroner’s office of the toxicologist report. In the meantime, we have asked for a review from the regional drug information service at Guy's. This is attached below and forms part of our reflection, learning and response.”

    Source location

    2014-0161-Response-by-Guys-St-Thomas-NHS-Trust
    Page 1 · response
    Published 9 April 2014

    Open published response

Actions and positions describe what organisations say in published responses. Implementation is not independently verified.

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Data last updated 7 September 2026