Concerns raised 1
Potential for over-sedation and death from combined sedative medications View source
This report raised 1 other concern. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised. 3
Action
Remind secure-environment prescribers to discuss medication purposes, risks, interactions, follow-up, and document contemporaneous consultation advice.
Stated by Northamptonshire Healthcare NHS Foundation TrustStated completedThe respondent said that this action was complete when they made their response on 5 January 2026. View source
Action
Remind prescribing clinicians to assess and manage cumulative sedative burden, recognise oversedation, repeat unexpected observations, document findings and escalation decisions, and escalate concerns proactively.
Stated by Northamptonshire Healthcare NHS Foundation TrustStated completedThe respondent said that this action was complete when they made their response on 5 January 2026. View source
Action
Introduce and routinely provide patients with a harm-minimisation leaflet covering polypharmacy, illicit substances, substance use alone, reduced tolerance, and medication initiation or titration risks.
Stated by Northamptonshire Healthcare NHS Foundation TrustStated completedThe respondent said that this action was complete when they made their response on 5 January 2026. View source
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AI-generated summary
Fallon Leanne ADAMS · 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
Fallon Leanne Adams was found unresponsive and cold in her cell at HMP Peterborough on 9 February 2023 and was declared deceased after CPR and a negative heart trace. The inquest concluded that she died from intoxication by mixed drugs, with illicitly obtained medication having a high probability of causing her death. Concerns included the combined sedative effects of prescribed and non-prescribed medication, a lack of specific warnings about over-sedation and death, and inadequate welfare checks and observations.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Potential for over-sedation and death from combined sedative medications
Wider context from the report “• Whilst an inmate at HMP Peterborough Fallon ADAMS was prescribed methadone (for opiate withdrawal) and chlordiazepoxide (for alcohol withdrawal). She also took non-prescribed ████████ apparently obtained from an illicit source within the prison. All of these medications have a sedative effect which in combination have the potential to cause over sedation and death.
• The evidence seemed to show that at no stage was Ms ADAMS given a specific warning or advice stating that taking additional non-prescribed medication ████████ could result in over sedation and death.
• I also heard evidence in relation to Regulation 28 issues. Whilst it is clear that a number of relevant changes were being made it was not clear that a specific warning in relation to the risks of over sedation was being implemented.
” Source location Fallon Leanne ADAMS · Prevention of Future Deaths report
Open source report
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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 Remind secure-environment prescribers to discuss medication purposes, risks, interactions, follow-up, and document contemporaneous consultation advice.
Verbatim wording from the response “We agree it is important that a patient is informed about the risk(s) of any medication(s) our clinicians prescribe, including those that may arise from interactions with other medications they may be taking, whatever the source.” Source location Response from Northamptonshire Healthcare Foundation Trust
Open published response
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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 Remind prescribing clinicians to assess and manage cumulative sedative burden, recognise oversedation, repeat unexpected observations, document findings and escalation decisions, and escalate concerns proactively.
Verbatim wording from the response “In response to your Report, we have reminded our prescribing clinicians of our expectations concerning the assessment and management of cumulative sedative burden, recognition of over-sedation, and the need for proactive escalation where concerns are identified.” Source location Response from Northamptonshire Healthcare Foundation Trust
Open published response
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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 Introduce and routinely provide patients with a harm-minimisation leaflet covering polypharmacy, illicit substances, substance use alone, reduced tolerance, and medication initiation or titration risks.
Verbatim wording from the response “We have also introduced a new harm minimisation advice leaflet, which is now routinely provided to patients. This leaflet clearly outlines key risks, including polypharmacy, the use of illicit drugs alongside prescribed medication, the dangers of using substances alone in cells (particularly overnight), reduced tolerance following periods of abstinence, and the increased risk associated with medication initiation and titration periods.” Source location Response from Northamptonshire Healthcare Foundation Trust
Open published response
4 Apr 2025 Jacqueline GREEN · Prevention of Future Deaths report Bedfordshire and Luton
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Concerns raised 1
Failure to address or adopt safeguards against unintentional paracetamol overdose in low-bodyweight adult inpatients View source
This report raised 4 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Jacqueline GREEN · 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
Jacqueline GREEN was admitted to Bedford Hospital after a fall and was found to be very weak, frail, cachectic and dehydrated. She received paracetamol at a dose intended for patients weighing over 50 kg despite weighing 33.6 kg, subsequently developed paracetamol-induced liver injury and died from liver failure. The concerns included inadequate safeguards for prescribing paracetamol to low-weight adults, unexplained variation in the administration of doses, and incomplete implementation of relevant safety measures.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to address or adopt safeguards against unintentional paracetamol overdose in low-bodyweight adult inpatients
Wider context from the report “1. Despite the fact that the HSSIB made Safety Observations to mitigate the risks of unintentional paracetamol overdose in adult inpatients with low bodyweight in their National Report dated 24.02.2022 (https://www.hssib.org.uk/patient-safety-investigations/unintentional-overdose-of-paracetamol-in-adults-with-low-bodyweight/) none of these had been addressed/adopted at Bedford Hospital by the time of the Deceased’s admission on 29 August 2023 which meant that, despite weighing only 33.6kg, the deceased was prescribed a daily dose of 1,000 mg x 4 which was only suitable for a patient weighing in excess of 50kg.
” Source location Jacqueline GREEN · Prevention of Future Deaths report
Open source report
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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 EPMA prescribing prompts requiring accurate weight recording and appropriate paracetamol dosing, including liver-toxicity warnings below 50 kilograms.
Verbatim wording from the response “There is now a prompt when prescribing paracetamol (all routes) on EPMA that reminds prescribers of the need to ensure there is an accurate weight recorded and that the dose is appropriate.” Source location Response from Bedford Hospitals NHS Foundation Trust
Open published response
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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 and launch a Nervecentre paracetamol prescribing guide.
Verbatim wording from the response “A Nervecentre paracetamol prescribing guide has been produced and been launched in to support safe prescribing of paracetamol.” Source location Response from Bedford Hospitals NHS Foundation Trust
Open published response
Concerns raised 1
Risk of administration of toxic and fatal quantities of medications to those in the care of staff View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Shahida KHAN · 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
Shahida KHAN died on 17 December 2022 at Cloverdale Care Home after being given substantial quantities of prescribed medication, causing toxicity and respiratory depression. She had epilepsy and suffered three seizures immediately before her death. It could not be ascertained how she came to be given toxic and fatal quantities of medication, raising a concern about the risk of recurrence for other people in the care home.
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× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Risk of administration of toxic and fatal quantities of medications to those in the care of staff
Wider context from the report “2. The deceased was administered with toxic and fatal quantities of ████████,
████████ and ████████. It cannot be ascertained how this happened.
3. In the absence of an explanation there is a risk of a further recurrence where those in
the care of the staff are administered toxic and fatal quantities of medications.
” Source location Shahida KHAN · Prevention of Future Deaths report
Open source report
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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 Conduct a further investigation into medication storage, auditing and administration competencies at the care home.
Verbatim wording from the response “In order to address your specific concerns and those matters which came to light at the inquest on 23 April 2024, specifically regarding medication levels found on postmortem, Voyage conducted a further investigation specifically focused on medication storage, medication audit and medication administering competencies at the care home where Ms Khan resided. This investigated confirmed:” Source location Response from Voyage Care
Open published response
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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 all residents’ care and care plans, including relevant rescue-medication administration protocols.
Verbatim wording from the response “As previously stated, we have found no evidence of misadministration by our staff, having completed rigorous medication counts as part of our investigation. We have, however, taken a number of further steps to reduce the risk, insofar as is possible, of a Person We Support being administered toxic and fatal quantities of medications. These include:” Source location Response from Voyage Care
Open published response
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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 Renew medication training for all staff at the care home.
Verbatim wording from the response “▪ We have reviewed the medication training in the home and are in the process of renewing medication training for all staff at the home.” Source location Response from Voyage Care
Open published response
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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 Commission an independent pharmacist to review medication policies, procedures, training content and audits.
Verbatim wording from the response “▪ We have commissioned an independent pharmacist to review our policies, procedures, training content and audits. Whilst not as a direct result of this sad circumstance, it is relevant to our response as a reflective and responsible provider.” Source location Response from Voyage Care
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Implement an electronic Medication Administration System across the organisation.
Verbatim wording from the response “▪ A further related action is the planned implementation of an electronic Medication Administration System across the organisation. This is part of a larger programme of work designed to provide more comprehensive oversight of the delivery of care to residents, including the administration of medication.” Source location Response from Voyage Care
Open published response
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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 Existing medication storage, auditing, competency policies, procedures and staff training were considered robust and subject to audit.
Verbatim wording from the response “Your concerns touch upon medication storage, medication audit and medication administering competencies. I can confirm that Voyage has established policies and procedures in place to deal with medication storage, medication audit and medication administering competencies, and these were in place at the time of Ms. Khan’s death. Extracts of these have already been provided to you. The policies and procedures are robust and are subject to audit. Staff are trained in all of the areas referred to both on induction and annually.” Source location Response from Voyage Care
Open published response
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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 No evidence was found that Voyage staff misadministered medication, following rigorous medication stock counts and investigation.
Verbatim wording from the response “As previously stated, we have found no evidence of misadministration by our staff, having completed rigorous medication counts as part of our investigation. We have, however, taken a number of further steps to reduce the risk, insofar as is possible, of a Person We Support being administered toxic and fatal quantities of medications. These include:” Source location Response from Voyage Care
Open published response
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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 Further comment and decisions on steps addressing the concerns were constrained pending completion of the Police investigation.
Verbatim wording from the response “is usually given to the People we Support by staff, the investigation by the Police will no doubt have to consider the possible involvement of third parties, for example other visitors to the service. We have confirmed to your office that the matter has been referred to the Police and, in those circumstances, I would respectfully request that this response should not be published until the Police have completed their investigation, to avoid any risk of compromising this. Until the Police complete their investigation it is difficult to comment further, and we will be advised by them as regards next steps including any steps which should be taken to address matters of concern at paragraph 5 of the PFD Report. In liaison with them, we will also take the steps necessary and appropriate, to manage staff, which may include suspension pending the conclusion of investigations.” Source location Response from Voyage Care
Open published response
17 Feb 2020 Joseph James Gingell · Prevention of Future Deaths report Essex
View report summary
Concerns raised 1
Toxic effects from excessive amounts of drugs taken with other medication View source
This report raised 2 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Joseph James Gingell · 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
Joseph James Gingell, who had a long history of mental illness and opioid and benzodiazepine dependence, was found deceased in a hotel near the Dartford Crossing. His cause of death was mixed drug toxicity with alcohol, and he had obtained drugs online without a prescription. Concerns included the toxic effects of combining drugs, self-certification without checks, and allowing patients not to inform their GP, which could remove a safeguard for people with addiction problems.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Toxic effects from excessive amounts of drugs taken with other medication
Wider context from the report “(1) The drugs found in Mr Gingell’s system are known to have toxic effects when taken in excessive amounts in conjunction with other medication.
” Source location Joseph James Gingell · Prevention of Future Deaths report
Open source report
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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 Coordinate a programme implementing Prescribed medicines review recommendations with relevant arm’s-length bodies to improve cross-system safety.
Verbatim wording from the response “In the wider context of this issue, Public Health England published in 2019 a Prescribed medicines review⁷. This reported on the evidence for dependence on, and withdrawal from, prescribed medicines with the aim of making sure that local healthcare systems build awareness and support to enhance clinician and patient decision making. In support of this NHSE&I are co-ordinating a programme to implement the review recommendations, working closely with relevant Arm’s Length Bodies (ALBs) to ensure cross system improvements. The programme covers five classes of medicines including:” Source location Response from NHS England
Open published response
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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 Continue working nationally, regionally and locally with key partners to improve controlled-drug and online-prescribing safety.
Verbatim wording from the response “NHSE&I remains committed to improving the safety of controlled drugs and online prescribing. We will continue to work across the system with key partners nationally, regionally and locally to ensure patient safety. We would also suggest that contact is made directly with the CQC and MRHA who would be better placed should you wish to understand their work in this area further.” Source location Response from NHS England
Open published response
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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 NHSE&I lacks powers to stop illegal supply of dependence-forming controlled drugs outside the legislative framework.
Verbatim wording from the response “The sale or supply of controlled drugs outside of the legislative framework is the responsibility of the Home Office, and NHSE&I does not have powers to stop illegal supply of dependence forming drugs with toxic potential. However, we can and do take this into account in the provision of NHS services. NHSE&I expects all NHS providers to follow the NICE guidance on Coexisting severe mental illness (psychosis) and substance misuse: assessment and management in healthcare settings² which directs people to consider the use of drugs, prescribed or otherwise when providing clinical care.” Source location Response from NHS England
Open published response
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Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation The Home Office is responsible for controlling the sale or supply of controlled drugs outside the legislative framework.
Verbatim wording from the response “The sale or supply of controlled drugs outside of the legislative framework is the responsibility of the Home Office, and NHSE&I does not have powers to stop illegal supply of dependence forming drugs with toxic potential. However, we can and do take this into account in the provision of NHS services. NHSE&I expects all NHS providers to follow the NICE guidance on Coexisting severe mental illness (psychosis) and substance misuse: assessment and management in healthcare settings² which directs people to consider the use of drugs, prescribed or otherwise when providing clinical care.” Source location Response from NHS England
Open published response
16 Aug 2019 George Benjamin Rimmer · Prevention of Future Deaths report West Sussex
View report summary
Concerns raised 1
Lack of bottle warnings about unmeasured or excessive dosing View source
This report raised 3 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
George Benjamin Rimmer · 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
George Benjamin Rimmer was found deceased at home on 25 October 2018 after being prescribed Oramorph for pain following decompression surgery. The concerns included taking the medicine directly from the bottle rather than measuring doses, possible lack of counselling about exceeding the prescribed dose, and insufficient warnings about excess or cumulative dosing.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Lack of bottle warnings about unmeasured or excessive dosing
Wider context from the report “(1) Mr Rimmer was known to swig out of the bottle rather than take a measured dose as many patient do;
(2) Mr Rimmer self medicated as required;
(3) Mr Rimmer’s GP did not recall advising him of the possible consequences of exceeding the prescribed dose.
(4) There was no evidence to show that anyone had counselled Mr Rimmer with regards to the use of this drug.
(5) The leaflet that comes with the bottle does not provide a sufficient warning of the dangers of taking an excess dose.
(6) There is no mention of the dangers of drinking from the bottle and not measuring the dose.
(7) There is no warning on the bottle to act as a reminder of the dangers of taking an excess dose or of the cumulative effect of taking more than the prescribed amount.
” Source location George Benjamin Rimmer · Prevention of Future Deaths report
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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 Request MHRA approval to strengthen and embolden the prescriber-direction warning on the Oramorph bottle label.
Verbatim wording from the response “However, we propose to strengthen and emphasise the wording on both the bottle label and carton label:” Source location 2019-0269-Response-by-Boehringer-Ingelheim
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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 Existing dosing instructions and approved labelling were considered sufficiently clear despite lacking an explicit warning against drinking directly from the bottle.
Verbatim wording from the response “Whilst there is no explicit warning in the PIL not to drink directly from the bottle, the wording of the ‘HOW TO TAKE ORAMORPH ORAL SOLUTION’ is also consistent with other oral morphine solutions (ref 9,10) available in the UK. These also provide specific instructions about measuring the correct dose but, like Oramorph®, they do not have an explicit warning not to drink directly from the bottle.” Source location 2019-0269-Response-by-Boehringer-Ingelheim
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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 Existing bottle and carton wording was considered sufficiently clear and compliant with statutory requirements, despite a proposal to strengthen and emphasise it.
Verbatim wording from the response “Please be aware the space to include additional information on the bottle label is limited and guidance to the patient is covered in detail in the PIL (see response to matter of concern 4 confirming that the warning symptoms/signs and risks of an excess dose, including death, are clearly stated).” Source location 2019-0269-Response-by-Boehringer-Ingelheim
Open published response
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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 Proposed changes to the leaflet, bottle label, and carton require review and approval by the MHRA and HPRA.
Verbatim wording from the response “Please be advised that any proposed additions and amendments to the PIL, bottle and outer carton labelling will need to be reviewed and approved by both the MHRA (UK) and the Healthcare and Products Regulatory Agency (HPRA) in Ireland, since we maintain a joint pack for both countries.” Source location 2019-0269-Response-by-Boehringer-Ingelheim
Open published response
24 Aug 2018 Karl James Willis · Prevention of Future Deaths report Exeter and Greater Devon
View report summary
Concerns raised 1
Toxicity of amitriptyline when taken in excessive amounts or with other medication View source
This report raised 2 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No respondent-stated action or position is linked to these concerns in the published data.
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AI-generated summary
Karl James Willis · 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
Karl James Willis was found deceased at home, with toxicology showing amitriptyline at a concentration within the reported fatal range and morphine sufficient to increase its toxicity. The inquest recorded the medical cause of death as aspiration pneumonitis and amitriptyline and morphine toxicity, with a conclusion of misadventure. Concerns included online access to amitriptyline without adequate checks, the ability to provide inaccurate information, and the option not to inform the patient’s GP.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Toxicity of amitriptyline when taken in excessive amounts or with other medication
Wider context from the report “(1) Amitriptyline is well recognised to have toxic effects when taken in excessive amounts or in conjunction with other medication
” Source location Karl James Willis · Prevention of Future Deaths report
Open source report
8 Aug 2018 Ian Paul Wolstenholme · Prevention of Future Deaths report Manchester North
View report summary
Concerns raised 1
Potential for serious harm or death from combined drug toxicity associated with polypharmacy View source
This report raised 1 other concern. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No respondent-stated action or position is linked to these concerns in the published data.
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AI-generated summary
Ian Paul Wolstenholme · 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
Ian Paul Wolstenholme was found collapsed at home on 17 December 2017 and died later that day. The medical cause of death was combined drug toxicity, with liver cirrhosis and diabetes mellitus also contributing. The report raised concern about the lack of guidance for prescribing highly addictive and potentially harmful drugs together, particularly in cases of polypharmacy.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Potential for serious harm or death from combined drug toxicity associated with polypharmacy
Wider context from the report “1. During the course of the evidence, it became apparent that there is no guidance – national or otherwise - available to Clinicians such as GPs, Hospital doctors etc. on the how best to approach the prescribing of highly addictive and potentially very harmful drugs alongside one another. In this case, the deceased had been legitimately prescribed three different types of neuropathic analgesia (including Pregabalin), alongside other opiate based medications. Whilst such drugs are almost always prescribed for very good clinical reason/s, this type of polypharmacy gives rise to the potential risk of serious harm/death . I believe that guidance would help to prevent future deaths from combined drug toxicity .
” Source location Ian Paul Wolstenholme · Prevention of Future Deaths report
Open source report
Concerns raised 1
Failure to account for the totality and synergistic effects of prescribed central nervous system and respiratory-depressant medication 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 respondent-stated action or position is linked to these concerns in the published data.
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AI-generated summary
Stuart Andrew WALLS · 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
Stuart Andrew WALLS was found dead in his room on 12 March 2017 after being last seen alive the previous morning. The inquest concluded that he died from drug poisoning caused by the combined effects of prescribed medication, with concern that multiple central-nervous-system medicines could have a synergistic effect on respiration even when taken at prescribed doses.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to account for the totality and synergistic effects of prescribed central nervous system and respiratory-depressant medication
Wider context from the report “Stuart died as a result of drug poisoning. However, there was no evidence of illicit drug use (other than cannabis which the Consultant Histopathologist confirmed had not played a part in the death). All prescribed drugs in his blood were within the therapeutic range.
The Consultant Histopathologist explained that the prescribed drugs had combined in a synergistic effect, acting together to poison Stuart.
My concern is that in the prescription of medication, particularly those that act on the central nervous system and affect respiration control, full account should be taken of the totality of drugs prescribed and their potential synergistic effect.
The reasons for my concern are:
Four prescription drugs namely Diazepam, Pregabalin, Amitriptyline and Promethazine were all found at a level consistent with therapeutic use. Each of these alone was at a level not expected to kill however each can exacerbate the effect of the other. I understood from the evidence that each of the drugs have a direct effect on the central nervous system. In particular a depressive effect on respiration. The Consultant Histopathologist confirmed this to be the case.
In addition to those prescribed drugs, methadone was also prescribed at 60 mg daily. That is well within normal prescription range. It was found at a level of 507ng/mL in blood. Methadone also has an effect on the central nervous system and is another respiratory depressor. The toxicology report said:
“...the deceased was prescribed 60mg of methadone daily. It has been reported that in 20 long-term opiate addicts who were administered a mean oral dose of 60mg methadone (range 10-225mg), the peak blood methadone concentrations ranged between 124-1255 ng/mL. It has been reported that in a study of 18 patients maintained on methadone 7.5 to 130 mg daily for at least 2 months, peak plasma concentrations of 69-698 ng/mL (pre-dose concentrations: 44-614 ng/mL) were achieved in 3 hours. The blood methadone level in the deceased was 507 ng/mL which may, therefore, reflect therapeutic use”.
It is of course, not known how much methadone Stuart had taken or when. However, properly taking the prescribed dose could still achieve the recorded level.
To put the amount of methadone into context, the toxicology evidence indicated a therapeutic range of 75 – 1100 ng/ml in blood; a toxic range of 200 – 2000 ng/ml and a fatal range of 400 – 2000 ng/mL. A level of tolerance builds with regular use.
Methadone is a potent opioid narcotic analgesic and would also have a synergistic effect together with the other four drugs mentioned above.
Therefore, even taking the properly prescribed medication as prescribed could have led to the situation that resulted in the death of Stuart WALLS. That is, drugs properly prescribed and properly taken could achieve a level, acting synergistically, that caused drug toxicity sufficient to cause death.
” Source location Stuart Andrew WALLS · Prevention of Future Deaths report
Open source report
8 Aug 2017 Deidre Harvey · Prevention of Future Deaths report South Wales Central
View report summary
Concerns raised 2
Lack of awareness of Hydroxychloroquine toxic accumulation at recommended doses View source Incomplete description of the risk of combining Lamotrigine or similar drugs with Hydroxychloroquine View source
This report raised 7 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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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.
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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
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 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.
” Source location Deidre Harvey · Prevention of Future Deaths report
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
Open published response
26 Oct 2015 Wayne Patrick O'NEILL · Prevention of Future Deaths report Worcestershire
View report summary
Concerns raised 1
Failure to prevent reintroduction of psychotropic medications contraindicated in combination View source
This report raised 3 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Wayne Patrick O'NEILL · 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
Wayne Patrick O'NEILL was a serving prisoner at HMP Long Lartin who collapsed in his cell and died on 2 January 2013. The inquest recorded respiratory failure, bronchospasm following ingestion of propranolol, and asthma as the medical cause of death. Concerns included the prescribing of propranolol despite asthma, the combination of psychotropic medicines with potential cardiac effects, and the failure to undertake an ECG before his 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 Failure to prevent reintroduction of psychotropic medications contraindicated in combination
Wider context from the report “(1) the evidence revealed that Mr O'Neill had died from one of two causes; either, as the jury found, he had taken propranolol illicitly which induced the broncho spasm that caused his respiratory failure. It is worth noting that Mr O'Neill had previously been prescribed propranolol and evidence was given at the inquest by a forensic psychiatrist that the fact it was contra indicated (given Mr O'Neill's asthma) appeared "to have been lost" to the prescribing clinicians at the time.
The alternative cause of death was that Mr O'Neill died from acute cardiac failure induced by the combination of psychotropic medication prescribed to him including citalopram, Olanzapine and amitriptyline.
An alert had previously been raised by the Medicines Healthcare Regulatory Authority warning against the prescribing of these drugs in combination.
An attempt had been made to take Mr O'Neill off these drugs but subsequent clinician had re-introduced them .
It was not clear from the evidence that when Mr O'Neill was screened in reception following his transfer from HMP Birmingham to HMP Long Lartin the significance of these combinations of medication was recognised.
Expert evidence was heard during the cause of the inquest notably from ████████ a Cardiologist. He said there was a strong case for ECG traces to be performed on all prisoners in receipt of this medication. This would reveal whether there was any prolongation of the QT interval.
The evidence revealed that an ECG trace had not been undertaken during the years that Mr O'Neill was an inmate at HMP Birmingham. A trace was arranged at HMP Long Lartin but had not taken place by the time of Mr O'Neill's death having only been requested as a matter of routine. The evidence suggested that the reason why the ECG was requested was due to an elevated pulse rate detected at the reception screen rather than recognition of the potentially toxic effects of the prescribed medication.
Evidence was given that obtaining an ECG trace is a simply, cheap and straight forward matter. It would seem sensible, accordingly for all the prisoners in receipt of this combination of medication to undergo ECG traces as part of the reception screening process.
” Source location Wayne Patrick O'NEILL · Prevention of Future Deaths report
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 Share the medicines-regulatory alert on prescribing medication combinations with all HMP Long Lartin prescribers.
Verbatim wording from the response “Whilst the combination of psychotropic medication had originally been prescribed at HMP Birmingham, the Medicines Healthcare Regulatory Authority alert relating to the prescribing of certain medications, has been shared with all of our prescribers at HMP Long Lartin to reinforce awareness of prescribing combinations of such medication.” Source location 2015-0444-Response
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Includes assertions directly identifying toxic effects or a continuing toxicity risk from excessive medication amounts or medication taken with other medication.
