Dear Coroner, Re: Regulation 28 Report to Prevent Future Deaths – Joel Phillip Colk who died on 2 October 2023

Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 13 November 2024 concerning the death of Joel Phillip Colk on 2 October 2023. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Joel’s family and loved ones. NHS England are keen to assure the family and the Coroner that the concerns raised about Joel’s care have been listened to and reflected upon. In your Report, you raised that the NHS Pathways system does not differentiate between types of, severity of or the drugs / chemicals reported as being the cause of an overdose. The system also does not take into account the amount reported as ingested, the timing of ingestion or the patient's weight. In the case of sodium nitrite ingestion, treatment is only effective if medications are administered before the patient suffers a cardiac arrest. The Coroner’s view is that the Pathways system does not reflect the time sensitive nature for an effective response. The NHS Pathways Clinical Decision Support System (CDSS) is a triage product that is used to support call handlers (health advisors) in urgent and emergency care (UEC) services. The product is owned by the Secretary of State for Health and Social Care and is manufactured and managed by the Transformation Directorate of NHS England. It is used in NHS 111 and over half of 999 ambulance services. NHS Pathways is an interlinked series of algorithms, or pathways, that link questions and care advice to lead to clinical endpoints known as “dispositions”. The system presents a series of questions in order that the most appropriate clinical response or disposition may be determined based on the presenting symptoms. A disposition will specify the skill set and time frame that a patient requires and, where required, appropriate care/worsening advice is provided.

NHS Pathways is built around a clinical hierarchy, meaning that life-threatening symptoms are assessed at the start of the call to trigger ambulance responses, progressing through to less urgent symptoms which require a less urgent response (or National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG

24 December 2024

disposition) in other settings. NHS Pathways is not diagnostic, but instead works on the basis of 'ruling out'.

Clinical Governance of the NHS Pathways Product

The safety of the clinical triage process endpoints resulting from a 111 or 999 assessment using NHS Pathways, is overseen by the National Clinical Assurance Group (NCAG), an independent intercollegiate group hosted by the Academy of Medical Royal Colleges (AoMRC). This group is made up of representatives from Medical Royal Colleges and other clinical professional bodies and groups. Senior clinicians from these organisations provide independent oversight and scrutiny of the NHS Pathways clinical content. The group considers all aspects of the triage process, including the impact on services, as well as the evidence base for changes to the clinical content. All changes to, and development of, the core telephone system and other platforms, are formally documented and presented for a critique in accordance with agreed processes endorsed by NCAG.

Alongside this independent oversight, NHS Pathways ensures its clinical content and assessment protocols are consistent with the latest advice from respected bodies that provide evidence and guidance for clinical practice in the UK.

Overview of the Management of Overdoses and Suicidal Callers

Ambulance Emergency Operation Centres (EOCs) use one of two approved triage tools to take 999 emergency calls – AMPDS or NHS Pathways. The outcome (disposition) reached at the conclusion of the initial assessment must be mapped to approved, contracted standards. There is a requirement to map these outcomes to the various categories (Categories 1 – 5) set out within the NHS Constitution and Ambulance Service 999 contracts. Category 5 (originally Category 4H) relates to calls that do not require an ambulance response; there is no standard for Category 5 calls. 

The grading of 999 calls are clinically based decisions and any changes are considered by the NHS England Emergency Call Prioritisation Advisory Group (ECPAG), based on receipt of a review of the evidence base with formal recommendations from the NHS England Clinical Coding Review Group (CCRG), with endorsement of the clinical rationale of proposed changes by the National Ambulance Service Medical Directors group (NASMeD). Any recommendations that are made and implemented will be formally reviewed with ongoing monitoring from ECPAG.

Overdoses, whether intentional or accidental, can be challenging cases to assess remotely; many different substances, medicines, doses and combinations are possible. This poses challenges to classify and appraise the relative lethality of the substances involved and balance this risk against the symptoms and circumstances at the time of the call. Where an overdose has occurred, and in the absence of signs or symptoms indicating an immediate life-threat (reduced consciousness level, breathlessness or shock, for example), the lowest disposition that can be reached is a Category 3 ambulance response. A higher response will be reached where there are symptoms indicating an immediate threat to life.

Ambulance EOCs follow specific principles on their respective triage tool to ensure clinical oversight for patients calling and presenting with overdose and suicidal ideations. These principles have been reviewed and strengthened through several national recommendations since 2019.

Firstly, on 2 April 2019, Professor
– the then National Clinical Director for Urgent and Emergency Care at NHS England – wrote to ambulance trusts and NHS 111 providers to mandate that robust clinical oversight was in place in control rooms and call centres to monitor self-harm and suicidal patients safely and effectively.

Secondly, in 2020, the then Healthcare Safety Investigation Branch (HSIB), investigated the potentially under-recognised risk of harm from the use of propranolol. They made a safety recommendation for NHS England to evaluate current approaches to clinical oversight of overdose calls within ambulance control rooms, and to develop a national framework to describe requirements for appropriate clinical oversight of overdose calls. In April 2021, NHS England in conjunction with the Association of Ambulance Chief Executives (AACE) published a new operational procedure for all ambulance services in England entitled, “Category 3/ 999 Overdose and Suicidal Ideation Calls; Initial Assessment of Lethality/Toxicity Principles Document”). This document followed a detailed review that had been undertaken to consider agreed ambulance control room processes, to ensure suicidal patients receive the correct clinical response. This review had also been the catalyst for NHS England contacting all ambulance and NHS 111 services in early 2019 as described above. The guidance highlights the critical importance of clinical oversight and review (rather than, for example, a re- categorisation of calls to Category 1 on a case-by-case basis) and sets out that:
• where an overdose is declared, further clinical intervention should take place within 30 minutes, or the case must be automatically upgraded if this does not occur within 40 minutes.
• it is good practice for TOXBASE® (clinical toxicology database of the UK National Poisons Information Service) to be viewed for each overdose / accidental ingestion incident, despite the familiarity of the reviewing clinician with that particular toxicity profile, which includes sodium nitrite. It is noted that management practices often change in relation to specific toxins, therefore guidance around the use of TOXBASE® was issued instead. Utilising TOXBASE® similarly ensures that the relevant current guidance is accessed when managing emerging and novel substance ingestion enabling the clinician to assess risk on an individual case basis.
• the initial clinical review should also consider any ongoing suicidal ideation with a specific plan / means.

Most recently, the overdose guidance was updated in November 2023 to include callers who reach a Category 5 disposition (hear and treat). This followed a review by ECPAG, NHS England and NASMeD, part of the AACE, to ensure it remained clinically fit for purpose. For those cases which do not automatically result in a Category 1 or 2 emergency ambulance response, an urgent remote clinical assessment will take place, pending which the case will be dealt with as a Category 3 emergency ambulance response. The objective of further remote clinical assessment

is to determine the likely threat to the patient by gathering the clinical information about the substance(s) ingested and their quantities. Following this assessment, if the clinical view is that the case should be upgraded to a Category 1 or 2 emergency ambulance response, then this is done without delay.

In early 2019, NHS England also instructed ambulance and NHS 111 providers that any suicide-related cases reaching a Category 3 ambulance outcome should receive urgent clinical review. This would enable a clinician to consider the individual circumstances of each case, with a view to determining whether the case should be clinically upgraded to a Category 1 or 2 emergency ambulance response. In response to this request, and in order to assist organisations in easily identifying the cases that needed an urgent clinical review, NHS Pathways introduced a new disposition code ‘Dx0124 Emergency Ambulance Response for Risk of Suicide (Category 3)’. This disposition code raises the visibility of such cases, enabling such urgent clinical review. This review by clinicians could involve re-triage to higher levels of response if required. It has also facilitated clearer visibility of such cases within the ambulance dispatch queue. This is in addition to information which was already fed into the dispatch system by NHS Pathways by way of ‘symptom discriminator codes’. NHS Pathways has a code identifying suicidal means and a plan (SD4244- AMB suicidal means and a plan). The disposition code was deployed to all service users as part of Release 18 in October 2019. Should national guidance or standards be amended such that toxic substances, where identified, impact on ambulance categorisation or disposition, NHS England would align the NHS Pathways system accordingly.

Your second concern relates to the fact that it is not national protocol for ambulance services to carry antidote medication (Methylene Blue) for on-scene administration. You have raised that patients who have ingested often enter cardiac arrest before arriving at an acute hospital within an Emergency Department.

The carrying of particular medication by ambulance services is an operational issue and is up to individual ambulance trusts; NHS England does not mandate such issues. NHS England is aware of a small number of ambulance specialist units who carry Methylene Blue. This antidote is carried by specialist clinical teams for administration in cases of moderate/severe poisoning which can be measured through an exhaled breath monitor. Clinical feedback suggests it is likely Methylene Blue would not be used except for severe cases or where there is a long journey time to definitive care.

I would also like to provide further assurances on the national NHS England work taking place around the Reports to Prevent Future Deaths. All reports received are discussed by the Regulation 28 Working Group, comprising Regional Medical Directors, and other clinical and quality colleagues from across the regions. This ensures that key learnings and insights around events, such as the sad death of Joel, are shared across the NHS at both a national and regional level and helps us to pay close attention to any emerging trends that may require further review and action.

Thank you for bringing these important patient safety issues to my attention and please do not hesitate to contact me should you need any further information.

Dear Madam

Joel Phillip Colk deceased

I write in response to the Regulation 28 Prevention of Future Deaths report issued on 13 November 2024 to the South East Coast Ambulance Service NHS Foundation Trust (SECAmb) following the inquest into the sad death of Mr Colk.

I was very sorry to learn of the death of Mr Colk and I would like to convey my heartfelt condolences to his family and friends.

I note the other relevant organisations named in this PFD report:

• NHS England & NHS Improvement

With regard your first matter of concern:

“The Court heard that when a call is made to 999 that the call is categorised using NHS Pathways and that all overdoses would be in the same classification resulting in the same disposition and response category. The system does not differentiate between types of, severity of or the drugs/chemicals reported as being the cause of the overdose. The system also does not differentiate call classification taking into account the amount reported as ingested, the timing of ingestion or the patient's weight. The Court heard that all of these factors can impact on the time in which care needs to be rendered to prevent death. The example given to the Court was that someone who had taken a relatively small paracetamol that would be unlikely to cause harm would, using Pathways, have the same resultant disposition as someone who had ingested a significant amount of a known lethal chemical.

The Court heard that in the case of ingestion that treatment is only effective if medications are administered before the patient suffers a cardiac arrest. This likely will occur incredibly rapidly and is a known effect of the chemical. The Pathways system does not reflect the time sensitive nature for an effective response when it is known that sodium nitrite has been ingested and would not create a higher disposition requiring more urgent attendance than category 3.”

The NHS Pathways Clinical Decision Support System (CDSS) is a triage product that is used to support call handlers (known as Emergency Medical Advisors within SECAmb). The product is owned by the Secretary of State for Health and Social Care and is manufactured and managed by the Transformation Directorate of NHS England.

NHS Pathways as a product has independent oversight by the National Clinical Assurance Group (NCAG), which in turn is hosted by the Academy of Medical Royal Colleges (AoMRC). Robust processes exist nationally to provide scrutiny of the NHS Pathways clinical content, which is built around a clinical hierarchy, meaning that life- threatening symptoms are assessed at the start of the call to trigger ambulance responses.

It is widely acknowledged that overdoses, both intentional or accidental, are challenging to assess remotely, with a vast array of different substances being presented to urgent and emergency care services resulting in a significant variance of potential toxidromes.

This is further challenged in the absence of signs and symptoms which would be indicative of an immediate threat to life; symptoms indicating a compromise of airway, breathing or circulation do receive Category 1 or Category 2 ambulance dispositions within overdose presentations.

When an absence of immediately life-threatening symptoms such as the above is being presented in intentional overdose, the lowest ambulance disposition that can be reached is a Category 3 emergency ambulance outcome. However this Category 3 outcome is supported by additional measures specific to overdose that have been in place within SECAmb since July 2019 and further amendments to local procedures following the publication of a operational guidance by NHS England and the Association of Ambulance Chief Executives (AACE) entitled, “Category 3 – 999 Overdose and Suicidal Ideation Calls; Initial Assessment of Lethality / Toxicity Principles Document” in April 2021, subsequently being further updated in November
2023.

SECAmb has procedures and processes in place to fully follow the principles as set out, which include:

• Where an overdose is declared, further clinical intervention should take place within 30 minutes, or the case must be automatically upgraded if this does not occur within 40 minutes.

• It is good practice for TOXBASE® (clinical toxicology database of the UK National Poisons Information Service) to be viewed for each overdose / accidental ingestion incident, despite the familiarity of the reviewing clinician with that particular toxicity profile, which includes . It is noted that management practices often change in relation to specific toxins, therefore guidance around the use of TOXBASE® was issued instead. Utilising TOXBASE® similarly ensures that the relevant current guidance is accessed when managing emerging and novel substance ingestion enabling the clinician to assess risk on an individual case basis.

• The initial clinical review should also consider any ongoing suicidal ideation with a specific plan / means.

999 Overdose and suicidal ideation calls – initial assessment of lethality / toxicity principles document, (NHS England, 2023)

Although SECAmb followed the 999 Overdose and suicidal ideation calls – initial assessment of lethality / toxicity principles with the call being automatically upgraded to a Category 2 response as a clinical review did not take place within 40 minutes, we do recognise that in this case Mr Colk volunteered the information to the 999 call handler that he had taken . Recent reports cited within a PFD response provided by the National Ambulance Resilience Unit (NARU) indicate 1 case of being ingested for every 0.5 million 999 calls in UK ambulance services, so whilst the incidence of poisoning is increasing, it is still a very rare occurrence (Courts and Tribunals Judiciary - Response from NARU, 2024).

As a Trust, we would like to use this case alongside others to support a workstream in early development that we are undertaking, regarding the potential for the use of new and emerging technologies, such as Artificial Intelligence to ‘ambiently listen’ to 999 calls. The aim is to enhance patient safety and reduce human cognitive burden, potentially highlighting certain calls to clinicians that have rare or unique risks earlier. We are in the early stages of understanding this technology and undertaking this work alongside four other NHS Ambulance Trusts as part of the Southern Ambulance Collaborative, and although we envisage if successful this having wider benefits to a range of presentations that 999 ambulance calls present, we have included

overdose as an example within the proposed case for change.

With regard your second matter of concern:

“The Court was also told that clinicians do not carry on any Ambulances within South East Coast Ambulance Service NHS Foundation Trust Methylene Blue which is the antidote to ingestion as this is not within national guidance. I heard that in some areas there are ongoing trials for some areas that this is on board vehicles within the HART (Hazardous Area Response Team). Therefore in this area the treatment is only available when a patient reaches an acute hospital with an A&E department and the evidence was that often patients enter cardiac arrest before this occurs.”

Governance and Decision-Making

SECAmb employs a rigorous and comprehensive governance framework to determine which medications are carried by its clinicians. Our Medicines Governance Group (MGG)—chaired by the Chief Pharmacist and comprising senior clinicians, operational managers, academic representatives, public members, and subject matter experts—oversees all medication-related decisions. Any proposal to add or amend a medicine within our formulary requires a robust New Drug Application (NDA) and consideration of clinical evidence, operational feasibility, financial sustainability, and alignment with national best practice.

Challenges in Pre-Hospital Diagnosis and Treatment

poisoning causes methaemoglobinaemia, which can only be reliably diagnosed using specialised diagnostic equipment (e.g., Masimo Rainbow SET sensors). In a pre-hospital context, the accurate identification of sodium nitrite ingestion is complicated by non-specific presentations and the unlikelihood of having immediate access to this specialist equipment on every frontline vehicle. Consequently, the administration of methylene blue in the pre-hospital setting poses significant diagnostic and logistical challenges, especially given the low incidence of confirmed sodium nitrite poisonings.

Availability and Cost Implications

Methylene blue is supplied in 50 mg vials in the UK, with treatment for methaemoglobinaemia potentially requiring several vials per patient, depending on body weight. Equipping the entire SECAmb fleet of over 300 clinical vehicles with sufficient stock—much of which may expire before use—would place significant demands on the service in terms of finance, logistics and workforce training. Additional resource investment would also be necessary for specialised diagnostic equipment, further complicating routine operations.

Specialist Resource Considerations

Although certain regions are trialling the use of Hazardous Area Response Teams (HART) to carry methylene blue, these teams are designed for high-risk environments. SECAmb’s HART operates from two bases (Ashford and Crawley), but their geographic reach and the unpredictable nature of poisonings do not guarantee they would always be the initial or timely responders to these cases. In many instances, rapid transfer to hospital—where comprehensive evaluation and definitive treatment (such as intubation, ventilation, inotropic support, or exchange transfusion) can be provided—remains the most pragmatic approach.

Cardiac Arrest Considerations

Critically, for those patients who have already sustained a cardiac arrest by the time ambulance clinicians arrive, the likelihood of restoring spontaneous circulation using methylene blue is indicated to be low. Advanced cardiac life support measures— including prompt hospital transfer for definitive care—are therefore prioritised, as per current clinical best practice.

Ongoing National Discussions

SECAmb is aware that discussions are ongoing nationally regarding the role of methylene blue for sodium nitrite poisoning. We remain actively engaged with NHS ambulance services and will carefully review any future recommendations that emerge, particularly if published via JRCALC or other authoritative bodies.

In conclusion, SECAmb remains committed to delivering the highest standard of pre- hospital care within the framework of evidence-based clinical practice. We continuously review our medication formulary in line with emerging guidance and new evidence. At present, and in accordance with current national recommendations, equipping all front-line ambulances with methylene blue and specialist diagnostic tools is neither clinically feasible nor cost-effective. Nevertheless, we will continue to monitor evolving guidance and, where appropriate, modify our protocols to maintain patient safety and optimise outcomes.

I hope this response clearly sets out our commitment to meet the needs of all patients requiring an emergency care response from us and from the wider system. If I can be of any further assistance, please do not hesitate to contact me.