Recurring concern

Failure to recognise and respond to anaphylaxis

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First reported 25 Apr 2016•Latest report 25 Nov 2025

Definition

What this concern includes

Includes failures of controls specifically dedicated to recognising, assessing, communicating or responding to suspected anaphylaxis, including symptom recognition, distinction from mild reactions, appropriate testing, escalation, treatment and patient or family safety information.

Not included

  • Excludes generic clinical recognition or escalation failures where anaphylaxis is not the identified hazard.
  • Excludes management of other allergic, respiratory or infectious conditions unless the assertion explicitly concerns suspected anaphylaxis.
  • Excludes failures limited to treatment after anaphylaxis was reliably recognised and escalated, unless the treatment control itself is part of the anaphylaxis response.
  • Excludes generic staff training, communication or documentation deficiencies that are not directly tied to anaphylaxis recognition or response.
Reports
5

Distinct published reports

Individual concerns
8

A report can raise multiple concerns

Date range
2016–2025

First to latest report issue date

Stated actions
28

Described in published responses

Reports over time

Reports over time

Reports about this concern issued each year.

* 2026 is projected from reports observed to 7 Sep 2026.

Most frequent recipients

Most frequent recipients

Reports about this concern sent to each recipient.

Medicines and Healthcare products Regulatory Agency2
NHS England2
Advanced Health And Care Limited1
Association of Ambulance Chief Executives1
Bausch & Lomb U.K. Limited1
Cambridgeshire Constabulary1
Department for Environment, Food & Rural Affairs1
Department of Health and Social Care1
General Dental Council1
General Pharmaceutical Council1
London Ambulance Service NHS Trust1
London Central & West Unscheduled Care Collaborative Limited1
Manchester University NHS Foundation Trust1
National Institute for Health and Care Excellence1
NHS Enfield Clinical Commissioning Group1

Concerns and responses across reports

Only concerns grouped under this recurring concern are included. Select any concern, action or position to view the source wording.

  1. Cambridgeshire and Peterborough

    AI-generated summary

    Benedict BLYTHE · 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

    Benedict died at Peterborough City Hospital on 1 December 2021, aged 5, from fatal anaphylaxis following accidental exposure to cow’s milk protein. The report identifies concerns about the retention and testing of samples, including blood and stomach contents, and the police seizure and retention of relevant evidence such as vomitus during investigations of unexplained deaths.

    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 collect blood samples for mast cell tryptase and specific IgE serology in suspected anaphylaxis

    Wider context from the report

    “1) In relation to Pathology That Kennedy samples collected during a post-mortem examination, should be revised to include the following in cases of suspected anaphylaxis: a. blood samples for mast cell tryptase and sp IgE serology 2 suspected allergens b. stomach contents to be immediately stored (and/or frozen) by the pathologist for the analysis of the presence of the triggering allergen c. blood samples if taken at hospital should not be destroyed but retained for testing d. that an early blood sample is taken after death and stored for later analysis e. that the possibility that the death is due to anaphylaxis is raised with the senior coroner for the area where the death occurred at the earliest opportunity f. tissue samples are taken and retained. g. Consideration given to the development of a standard protocol to ensure appropriate samples are taken at the correct time to assist later investigation. 2.) The police investigation: In the circumstances where there is an unexplained death of a child or the person and where that data samples and evidence available at the scene including by way of example vomitus, that the police should include as part of their investigation, the seizure and retention of any such material for the purposes of later investigation either by the Police Pathologist or the Coroner. ”

    Source location

    Benedict BLYTHE · 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

    Publish autopsy guidelines for suspected acute anaphylaxis, including blood and stomach-content sampling guidance.

    Verbatim wording from the response

    “The Kennedy Protocol has not been formally updated since 2016; it is not known when or if the protocol is to be revised. Since then Autopsy guidelines have been published on sudden unexpected death in infancy and childhood in 2023 under the remit of the Death Investigation Committee at the Royal College of Pathologists and these have superseded the 2016 publication. Neither the 2016 or 2023 guidelines included samples in cases of suspected anaphylaxis. However, the RCPath published autopsy guidelines on autopsies for suspected acute anaphylaxis (includes anaphylactic shock and anaphylactic asthma) in 2018. This document does include very specific guidance of sampling blood and stomach contents in such cases together with caveats for interpreting mast cell tryptase levels.”

    Source location

    Response from Royal College of Pathologists
    Page 1 · response
    Published 2 December 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

    Query the relevant guideline authors about adding IgE testing to an updated autopsy guideline.

    Verbatim wording from the response

    “There are guidelines published by the RCPath for anaphylaxis (referenced below) of note; IgE is not specifically referenced in any of the documents and this will be queried with the authors of the relevant guideline to be included in an updated version. The reference below was published after the guideline was written.”

    Source location

    Response from Royal College of Pathologists
    Page 1 · response
    Published 2 December 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

    Published anaphylaxis autopsy guidance and expected use of relevant guidance are considered sufficient despite paediatric guidelines lacking specific anaphylaxis details.

    Verbatim wording from the response

    “The Kennedy Protocol has not been formally updated since 2016; it is not known when or if the protocol is to be revised. Since then Autopsy guidelines have been published on sudden unexpected death in infancy and childhood in 2023 under the remit of the Death Investigation Committee at the Royal College of Pathologists and these have superseded the 2016 publication. Neither the 2016 or 2023 guidelines included samples in cases of suspected anaphylaxis. However, the RCPath published autopsy guidelines on autopsies for suspected acute anaphylaxis (includes anaphylactic shock and anaphylactic asthma) in 2018. This document does include very specific guidance of sampling blood and stomach contents in such cases together with caveats for interpreting mast cell tryptase levels.”

    Source location

    Response from Royal College of Pathologists
    Page 1 · response
    Published 2 December 2025

    Open published response
  2. East London

    AI-generated summary

    Hannah Enola Ayamo Jacobs · 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

    Hannah Enola Ayamo Jacobs, aged 13, developed anaphylactic symptoms after being served a dairy hot chocolate despite her reported dairy allergy and later died following cardiac arrest. The concerns included dental staff not recognising excessive salivation as inability to swallow and a sign of anaphylaxis, possible misunderstanding of symptoms by her mother, and the availability and use of adrenaline auto-injectors during shortages.

    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

    Allergy plans failing to distinguish lip swelling as a potential anaphylaxis symptom

    Wider context from the report

    “• The other symptom Hannah demonstrated was swelling of her lips which is listed on allergy plans as a mild to moderate symptom and thus provided a false sense of reassurance to her mother that cetirizine was what she needed. ”

    Source location

    Hannah Enola Ayamo Jacobs · 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

    Failure to recognise inability to swallow as a sign of anaphylaxis in dental settings

    Wider context from the report

    “• The evidence at the inquest referred to allergy action plans discussed in the healthcare settings and given to parents and patients. Hannah displayed what appeared to be excessive salivation at the dentist which her paediatric consultant (who gave evidence) said, with the benefit of hindsight was actually a manifestation of her inability to swallow. This is a sign of anaphylaxis This was not recognised by dental staff as an inability to swallow and thus of anaphylaxis. ”

    Source location

    Hannah Enola Ayamo Jacobs · 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 sufficiently clear distinction between anaphylactic and mild reactions

    Wider context from the report

    “• The risk of future deaths in the context of anaphylaxis remains in the absence of further consideration of what constitutes an anaphylactic reaction as opposed to a mild reaction, and the education of parents and patients of the safety of using AAIs (adrenaline auto injectors) IF IN DOUBT. ”

    Source location

    Hannah Enola Ayamo Jacobs · 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

    Develop and maintain allergy action plans distinguishing mild or moderate reactions from anaphylaxis and advising adrenaline if in doubt.

    Verbatim wording from the response

    “The BSACI Allergy Action Plans have two boxes that clearly list the symptoms and signs of firstly a mild or moderate reaction and secondly anaphylaxis. These were developed with a wide range of healthcare professionals and patient groups. Additionally, plans state “if in doubt, give adrenaline”.”

    Source location

    Response from BSACI
    Page 2 · response
    Published 30 August 2024

    Open published response

    Source evidence

    How this respondent action was interpreted

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

    PFD Monitor interpretation

    Work with professional bodies to agree and support allergy standards of care and education.

    Verbatim wording from the response

    “The RCP will work with Royal College of Paediatrics and Child Health, Royal College of Pathologists, British Society for Immunology – Clinical Immunology Professional Network, British Society for Allergy and Clinical Immunology, dental and pharmacy professional groups, to agree and support standards of care and education related to allergy. This will include updating standards for allergy accreditation, including the adoption of the BSACI adult allergy action plan where many of the aspects related to this case are addressed including carrying adrenaline autoinjectors, and difficulty in swallowing is an indication for the use of adrenaline.”

    Source location

    Response from Royal College of Physicians
    Page 2 · response
    Published 30 August 2024

    Open published response

    Source evidence

    How this respondent action was interpreted

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

    PFD Monitor interpretation

    Update allergy accreditation standards, including adoption of the BSACI adult allergy action plan.

    Verbatim wording from the response

    “The RCP will work with Royal College of Paediatrics and Child Health, Royal College of Pathologists, British Society for Immunology – Clinical Immunology Professional Network, British Society for Allergy and Clinical Immunology, dental and pharmacy professional groups, to agree and support standards of care and education related to allergy. This will include updating standards for allergy accreditation, including the adoption of the BSACI adult allergy action plan where many of the aspects related to this case are addressed including carrying adrenaline autoinjectors, and difficulty in swallowing is an indication for the use of adrenaline.”

    Source location

    Response from Royal College of Physicians
    Page 2 · response
    Published 30 August 2024

    Open published response

    Source evidence

    How this respondent action was interpreted

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

    PFD Monitor interpretation

    Continue widely promoting Paediatric Allergy Training study days across the child health workforce.

    Verbatim wording from the response

    “As the Royal College of Paediatrics and Child Health, we are primarily responsible for the education and training of paediatricians across the UK. We are not involved in the training of dentists and dental staff and have no role in the supply of epi-pens to pharmacies. As part of our training, we run CPD courses on child health topics that are of interest and relevance to the wider child health workforce. This includes Paediatric Allergy Training study days that focus on the practical clinical management of allergy in children and young people. These courses are suitable for all professionals seeing children with allergic disease. You can read more about these courses on our RCPCH Learning platform. We will ensure these continue to be widely promoted across the child health workforce.”

    Source location

    2024-0464 Response from Royal College of Paediatrics
    Page 1 · response
    Published 30 August 2024

    Open published response

    Source evidence

    How this respondent action was interpreted

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

    PFD Monitor interpretation

    Develop an online allergy education platform covering anaphylaxis recognition, symptoms and management for healthcare and non-healthcare professionals.

    Verbatim wording from the response

    “The BSACI Allergy Action Plans do state that difficulty swallowing is a manifestation of anaphylaxis. These plans were developed with allergy healthcare professionals and patient representatives. The BSACI is developing an online allergy education platform for all healthcare professionals and non-healthcare professionals which will include anaphylaxis. This will include the signs and symptoms and management approach for mild, moderate and severe allergic reactions. This will be rolled out extensively to a wide range of stakeholders. We would welcome the involvement of healthcare professionals across tertiary, secondary and primary care (e.g. Royal College of General Practitioners, Royal College of Nursing) in this activity, and healthcare leadership (e.g. NHS England, devolved nations heath boards, Integrated Care Boards).”

    Source location

    Response from BSACI
    Page 1 · response
    Published 30 August 2024

    Open published response

    Source evidence

    How this respondent action was interpreted

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

    PFD Monitor interpretation

    Roll out the online allergy education platform extensively to healthcare professionals, non-healthcare professionals and other relevant stakeholders.

    Verbatim wording from the response

    “The BSACI Allergy Action Plans do state that difficulty swallowing is a manifestation of anaphylaxis. These plans were developed with allergy healthcare professionals and patient representatives. The BSACI is developing an online allergy education platform for all healthcare professionals and non-healthcare professionals which will include anaphylaxis. This will include the signs and symptoms and management approach for mild, moderate and severe allergic reactions. This will be rolled out extensively to a wide range of stakeholders. We would welcome the involvement of healthcare professionals across tertiary, secondary and primary care (e.g. Royal College of General Practitioners, Royal College of Nursing) in this activity, and healthcare leadership (e.g. NHS England, devolved nations heath boards, Integrated Care Boards).”

    Source location

    Response from BSACI
    Page 1 · response
    Published 30 August 2024

    Open published response

    Source evidence

    How this respondent action was interpreted

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

    PFD Monitor interpretation

    Write to NICE requesting review of anaphylaxis symptoms and related guidance for dental professionals.

    Verbatim wording from the response

    “Whilst I note your concern that dental professionals did not recognise the early symptoms of anaphylaxis, I also note that the symptom of excessive salivation is not listed as a potential symptom in the NICE guidance. We will write to NICE to highlight this, and to ask them to consider reviewing the listed symptoms of anaphylaxis and their guidance to dental professionals more broadly.”

    Source location

    Response from General Dental Council
    Page 3 · response
    Published 30 August 2024

    Open published response

    Source evidence

    How this respondent action was interpreted

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

    PFD Monitor interpretation

    Review CPD requirements and consider proposing changes to medical-emergency recommendations.

    Verbatim wording from the response

    “We are currently in the process of reviewing our CPD requirements, and we will consider whether we should propose changes to the recommendations regarding medical emergencies as part of the review. The review is expected to conclude in 2025, but some potential changes would require legislative changes, the timing of which is not under our control.”

    Source location

    Response from General Dental Council
    Page 3 · response
    Published 30 August 2024

    Open published response

    Source evidence

    How this respondent action was interpreted

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

    PFD Monitor interpretation

    Develop anaphylaxis guidelines and patient information leaflets with patient organisations, including an accessible leaflet explaining anaphylaxis signs and symptoms.

    Verbatim wording from the response

    “BSACI has collaborated with patient organisations to develop guidelines and information leaflets. This includes an Anaphylaxis patient information leaflet which can be viewed here. This clearly states the signs and symptoms of anaphylaxis and is accessible to all patients.”

    Source location

    Response from BSACI
    Page 2 · response
    Published 30 August 2024

    Open published response

    Source evidence

    How this respondent position was interpreted

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

    PFD Monitor interpretation

    The current standards and guidance provide clear obligations, so additional or different standards are not currently considered necessary.

    Verbatim wording from the response

    “The current framework of standards and guidance sets out clear obligations for dental professionals to have appropriate training and keep medication on their premises to use in the event of a medical emergency. I think that it is appropriate to continue to require adherence to the RCG as set out at Standard 1.5 and other appropriate guidance, including the NICE guidance as set out in Standard 7.1.”

    Source location

    Response from General Dental Council
    Page 3 · response
    Published 30 August 2024

    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

    Potential CPD changes requiring legislation may be delayed because the timing of legislative changes is outside the respondent’s control.

    Verbatim wording from the response

    “We are currently in the process of reviewing our CPD requirements, and we will consider whether we should propose changes to the recommendations regarding medical emergencies as part of the review. The review is expected to conclude in 2025, but some potential changes would require legislative changes, the timing of which is not under our control.”

    Source location

    Response from General Dental Council
    Page 3 · response
    Published 30 August 2024

    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

    Excess salivation is not listed as anaphylaxis in national guidance, so dental staff reasonably did not interpret it as early anaphylaxis.

    Verbatim wording from the response

    “1. The evidence at the inquest referred to allergy action plans discussed in the healthcare settings and given to parents and patients. Hannah displayed what appeared to be excessive salivation at the dentist which her paediatric consultant (who gave evidence) said, with the benefit of hindsight was a manifestation of her inability to swallow. This is a sign of anaphylaxis. This was not recognised by dental staff as an inability to swallow and thus of anaphylaxis.”

    Source location

    Response from NHS England
    Page 1 · response
    Published 30 August 2024

    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

    Training dentists and dental staff, and supplying adrenaline auto-injectors to pharmacies, fall outside the organisation’s role.

    Verbatim wording from the response

    “As the Royal College of Paediatrics and Child Health, we are primarily responsible for the education and training of paediatricians across the UK. We are not involved in the training of dentists and dental staff and have no role in the supply of epi-pens to pharmacies. As part of our training, we run CPD courses on child health topics that are of interest and relevance to the wider child health workforce. This includes Paediatric Allergy Training study days that focus on the practical clinical management of allergy in children and young people. These courses are suitable for all professionals seeing children with allergic disease. You can read more about these courses on our RCPCH Learning platform. We will ensure these continue to be widely promoted across the child health workforce.”

    Source location

    2024-0464 Response from Royal College of Paediatrics
    Page 1 · response
    Published 30 August 2024

    Open published response
  3. Inner North London

    AI-generated summary

    Shanté Andrée Marie TURAY-THOMAS · 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

    Shanté Andrée Marie Turay-Thomas ate hazelnuts on 18 September 2018 and died soon afterwards from acute anaphylaxis. The report identifies concerns about inadequate allergy care, advice and training concerning adrenaline auto-injectors, prescribing and clinical communication, and errors in the NHS 111 response and ambulance categorisation.

    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 explain the need for sequential administration of two adrenaline auto injectors in acute anaphylaxis

    Wider context from the report

    “2. Shanté’s GPs knew that she should carry two adrenaline auto injector (AAI) pens at all times, and they may have mentioned this to her, but they failed to record this and they did not emphasise it to her. They failed to emphasise to Shanté and her family that the reason for carrying two pens is primarily because in the event of severe acute anaphylaxis, the very strong likelihood is that both pens will need to be administered, one five minutes after the other, to keep the patient alive until the arrival of an emergency ambulance. The GPs did not explore with Shanté the reason for her erratic requests for a pen. They did not explore with her where she kept her pens. They did not test her understanding of medical advice. ”

    Source location

    Shanté Andrée Marie TURAY-THOMAS · Prevention of Future Deaths report
    Page 4 · 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

    Failure to record and emphasise the need to carry two adrenaline auto injector pens

    Wider context from the report

    “2. Shanté’s GPs knew that she should carry two adrenaline auto injector (AAI) pens at all times, and they may have mentioned this to her, but they failed to record this and they did not emphasise it to her. They failed to emphasise to Shanté and her family that the reason for carrying two pens is primarily because in the event of severe acute anaphylaxis, the very strong likelihood is that both pens will need to be administered, one five minutes after the other, to keep the patient alive until the arrival of an emergency ambulance. The GPs did not explore with Shanté the reason for her erratic requests for a pen. They did not explore with her where she kept her pens. They did not test her understanding of medical advice. ”

    Source location

    Shanté Andrée Marie TURAY-THOMAS · Prevention of Future Deaths report
    Page 4 · 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

    Amend and release the Distance Learning Pack with stronger anaphylaxis guidance, second-dose adrenaline advice and accurate images of adrenaline autoinjectors.

    Verbatim wording from the response

    “NHS Digital welcomed the evidence given by the expert witness, Professor Fox, at the inquest and immediately recognised that the distance learning pack could be improved, assuring the Coroner (in evidence and in the supplementary second witness statement dated 20th December 2019) that a review would be undertaken, in consultation with Professor Fox, to address the points raised during his evidence.”

    Source location

    2020-0124-Response-from-NHS-Digital_Redacted-1.pdf
    Page 4 · response
    Published 13 August 2020

    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

    Amend NHS Pathways guidance so a second adrenaline autoinjector is advised after five minutes without improvement, through Release 20.

    Verbatim wording from the response

    “NHS Pathways has always prompted call handlers to give instructions in respect of a second administration of AAI if there is no improvement, as NHS Digital stated in the PFD submissions, dated 17 January 2020. This is NHS Pathways content and is not affected by the system into which NHS Pathways is embedded (e.g. Adastra in this case).”

    Source location

    2020-0124-Response-from-NHS-Digital_Redacted-1.pdf
    Page 5 · response
    Published 13 August 2020

    Open published response

    Source evidence

    How this respondent action was interpreted

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

    PFD Monitor interpretation

    Disseminate prescribing, dosing, device-change and training guidance for adrenaline auto-injectors through safety bulletins, newsletters, intranet updates, scriptswitch messages and practice events.

    Verbatim wording from the response

    “1. The narrative verdict was discussed at the NCL Medication Safety Officer (MSO) Local Network on 17th January 2020. The network agreed that a Medicines Safety Bulletin on Adrenaline Auto Injectors (AAIs) would be distributed to GPs and other primary care healthcare professionals. The NCL Medicines Safety Bulletin on Adrenaline Auto Injectors (AAI) dated 24th January 2020 is attached as appendix 1. The bulletin was approved virtually by one NCL Medication Safety Officer (MSO) Local Network following the meeting on 17th January 2020 and distributed to Enfield GP practices on 30th January 2020.”

    Source location

    2020-0124-Response-from-Enfield-CCG.pdf
    Page 1 · response
    Published 13 August 2020

    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

    Follow up practices through meetings and training, and collate records confirming patient device training and dosage reviews.

    Verbatim wording from the response

    “CCG pharmacists to check what action they have taken regarding the NCL Medicines Safety Bulletin on Adrenaline Auto Injectors (AAI) have contacted all GP practices. This is being followed up with individual practice meetings, training meetings for GPs, training sessions for Primary Care Network pharmacists, and by CCG pharmacists working in practices. A record is in the process of being collated to capture actions by individual practices to ensure all patients regularly receive appropriate training in the use of their device and dosages have been reviewed. This process is due to complete by 30th April 2020.”

    Source location

    2020-0124-Response-from-Enfield-CCG.pdf
    Page 4 · response
    Published 13 August 2020

    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

    Process AAI prescriptions as acute prescriptions and provide device-specific safety instructions covering appropriate dosing, carrying two pens and emergency action.

    Verbatim wording from the response

    “2. All prescriptions for AAIs are now dealt with as acute prescriptions, as opposed to repeat prescriptions. This ensures that each prescription is scrutinised in detail to ensure that the type of pen and dose of adrenaline is appropriate for the patient. On the face of any AAI prescription, it is expressly stated for the avoidance of any doubt that a patient should carry two AAI pens on their person at all times and ensure that they are familiar with the use of the pen. There is also some safety netting advice in the event of an emergency. We have enclosed a sample prescription to illustrate this change. In addition, each prescription is accompanied by an AAI brand specific letter to the patient providing the most important details about the AAI pens to enable a patient to use it safely and effectively. We have also enclosed a copy of a standard letter in this regard.”

    Source location

    2020-0124-Response-from-Radcliffes-Le-Brasseur_Redacted.pdf
    Page 1 · response
    Published 13 August 2020

    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

    Train clinical staff on the three common AAI devices and maintain sample pens for patient demonstrations and training.

    Verbatim wording from the response

    “3. The Practice has taken significant steps to ensure that it is up to date with anaphylaxis management and the use of AAI pens. It arranged in-house training for all clinical staff on 9 December 2019, which was delivered by a Nurse, ████████. This training included demonstrations as to how to use the three most common AAI pens, namely Emerade, JEXT and EpiPen, advice as to the different dosages available, instructions and demonstrations as to the different methods of administration for each brand. This was all based on the respective brands’ advice/instruction on their own explanatory posters and the demonstrations were done by Nurse ████████. She has since confirmed that she has also seen a few patients who have attended the Practice to obtain some training on the use of their AAI.”

    Source location

    2020-0124-Response-from-Radcliffes-Le-Brasseur_Redacted.pdf
    Page 2 · response
    Published 13 August 2020

    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

    Deliver enhanced anaphylaxis content within mandatory basic life-support training, including symptom recognition, carrying two pens and device-specific administration.

    Verbatim wording from the response

    “4. In addition to the in-house training, mandatory basic life support training was held at the Practice on 27 February 2020. This was delivered by an external provider, Mr ████████ of ████████ and Associates Healthcare Training and Education. The basic life support training always includes a segment on anaphylaxis management. However, the Practice contacted the training provider prior to the course in order to emphasise that a more extensive section was required on anaphylaxis management. We enclose a copy of the e-mail in this regard. The basic life support training lasted two and a half hours in duration. It included a 40 minute section on anaphylaxis management which encompassed recognising symptoms, the imperative of carrying two pens at all times and the different administration of the three types of pens available.”

    Source location

    2020-0124-Response-from-Radcliffes-Le-Brasseur_Redacted.pdf
    Page 2 · response
    Published 13 August 2020

    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

    Recruit an in-house pharmacist to provide current AAI guidance and patient training during prescribing and dispensing.

    Verbatim wording from the response

    “8. The Practice recruited an in-house pharmacist who commenced work in December 2020. This appointment will prove conducive in ensuring that both patients and clinicians have up to date information in relation to AAI awareness. The pharmacist is also on hand to provide training to any patients in relation to the correct use of an AAI. There is accordingly now two layers of protection in that guidance is offered to a patient when prescribing the AAI as well as when dispensing it.”

    Source location

    2020-0124-Response-from-Radcliffes-Le-Brasseur_Redacted.pdf
    Page 3 · response
    Published 13 August 2020

    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

    Appoint a Practice Anaphylaxis Champion to oversee staff awareness, training, prescribing surveillance, protocol adherence and patient reviews.

    Verbatim wording from the response

    “9. The Practice has undertaken a rigorous review of all patients that have been prescribed AAI pens so as to ensure that the correct dose and pen is being prescribed. The Practice has nominated one of the Pharmacists to act as the ‘Practice Anaphylaxis Champion.’ This role will include ensuring staff awareness, training and regular surveillance of appropriate prescribing practices and adherence to practice protocols. The Pharmacist will also contact all patients prescribed AAIs to undertake regular reviews of their condition, treatment and training.”

    Source location

    2020-0124-Response-from-Radcliffes-Le-Brasseur_Redacted.pdf
    Page 3 · response
    Published 13 August 2020

    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

    Amend the ScriptSwitch message with AAI availability, prescribing, dose-checking, counselling, training and allergy-action-plan requirements.

    Verbatim wording from the response

    “11. The Practice has shared learning with the CCG medicine management team and the message on scriptswitch has been amended as follows:”

    Source location

    2020-0124-Response-from-Radcliffes-Le-Brasseur_Redacted.pdf
    Page 3 · response
    Published 13 August 2020

    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

    Have commissioning teams liaise with relevant organisations to facilitate uptake of new guidance and resources supporting management of severe allergies.

    Verbatim wording from the response

    “• I will ensure your report is sent to HEE and the Royal College of General Practitioners. Our commissioning teams will liaise directly with all relevant organisations to facilitate uptake of any new guidance and resource that would support better management of people with severe allergies.”

    Source location

    2020-0124-Response-from-NHS-England_Redacted.pdf
    Page 2 · response
    Published 13 August 2020

    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

    Consider whether communication routes or commissioning levers can support uptake and embedding of new allergy guidance and resources.

    Verbatim wording from the response

    “We are deeply saddened by Shante’s death. We are grateful to have had the opportunity to respond to your concerns relevant to NHSEI. We will continue to work with HEE, the professional Royal Colleges and the other organisations addressed in your report to keep abreast of any new guidance or resources that they produce that would support better management of people with severe allergies. We will consider whether any of our communication routes or commissioning levers can help with their uptake and embedding.”

    Source location

    2020-0124-Response-from-NHS-England_Redacted.pdf
    Page 3 · response
    Published 13 August 2020

    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

    Initiate discussions with MHRA about adding advice to outer packaging that patients should carry two adrenaline auto-injectors.

    Verbatim wording from the response

    “With respect to information on the labelling of medicinal products, this is controlled by the Human Medicines Regulations 2012 and the addition of any text must be approved by the competent regulatory authority before it can be implemented. When considering the addition of information not specified in the regulations, it is necessary to take into account whether this can be included on the packaging in legible form without adversely impacting the essential information already required to be present.”

    Source location

    2020-0124-Response-from-Bausch-Lomb_Redacted.pdf
    Page 2 · response
    Published 13 August 2020

    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

    Consider how best to clarify in CG134 that two adrenaline auto-injectors should be prescribed and carried at all times.

    Verbatim wording from the response

    “We do not consider it appropriate for us to duplicate the BNF advice referred to above. However, we will consider how best to make clear in CG134 the advice that 2 adrenaline auto-injectors should be prescribed, which patients should carry at all times.”

    Source location

    2020-0124-Response-from-NICE_Redacted.pdf
    Page 2 · response
    Published 13 August 2020

    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

    Matters of concern 1–14 and 20 do not concern NHS Pathways and fall outside its remit.

    Verbatim wording from the response

    “HM Coroner raised matters of concern numbered 1 - 20 in the PFD report. Matters of concern 1 – 14 and 20 are not applicable to NHS Pathways. We set out below our response to matters of concern 15 to 19.”

    Source location

    2020-0124-Response-from-NHS-Digital_Redacted-1.pdf
    Page 1 · response
    Published 13 August 2020

    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

    Routine twin-pack supply cannot replace single-pen dispensing or patient education about carrying two auto-injectors.

    Verbatim wording from the response

    “Emerade, like other adrenaline auto-injectors is authorised for supply as twin-packs as well as single auto-injectors.”

    Source location

    2020-0124-Response-from-Bausch-Lomb_Redacted.pdf
    Page 2 · response
    Published 13 August 2020

    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

    Existing BNF and BNFc advice sufficiently covers adrenaline auto-injector doses, quantities and training, so NICE will not duplicate that advice.

    Verbatim wording from the response

    “Having reviewed your concerns, we consider that the British National Formulary (BNF) and the BNF for Children (BNFc) already contain detailed advice on these aspects of care, including the following pieces of MHRA/CHM advice from 2017 and 2019, in the section on Adrenaline/Epinephrine (https://bnf.nice.org.uk/drug/adrenalineepinephrine.html):”

    Source location

    2020-0124-Response-from-NICE_Redacted.pdf
    Page 1 · response
    Published 13 August 2020

    Open published response
  4. London (West)

    AI-generated summary

    Natasha Charlotte Rose Ednan-Laperouse · 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

    Natasha Charlotte Rose Ednan-Laperouse, who was allergic to sesame, ate a baguette purchased from Pret-a-Manger that contained unlabelled sesame. She developed an anaphylactic reaction on a flight to Nice and died in hospital shortly after landing on 17 July 2016. The report raised concerns about inadequate allergen labelling, inadequate monitoring of customer allergic reactions, and the needle length and adrenaline dose of some autoinjectors used in emergency treatment.

    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

    Inadequate adrenaline dose for anaphylaxis

    Wider context from the report

    “(4) The dose of adrenaline in Epipen is 300mcg. The UK Resuscitation Council recommends a standard emergency dose of 500mcg. Emerade contains a dose including 500mcg. The combination of what my expert told me was an inadequate dose of adrenaline for anaphylaxis and an inadequate length needle raises serious safety concerns. ”

    Source location

    Natasha Charlotte Rose Ednan-Laperouse · 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

    Conducted and progressed a European safety review of adrenaline auto-injectors, including assessment of needle length and clinical effectiveness evidence.

    Verbatim wording from the response

    “You question whether the exposed needle length of Epipen (16 mm) is adequate to reach muscle in most patients. The adequacy of adrenaline auto-injector needle length was addressed by the MHRA as one aspect of a review in 2014. The available evidence was found to be lacking in some key aspects and the MHRA therefore took this forward as part of a wider European safety review that reported on 25 June 2015. As one of the legally binding conditions following the European safety review, manufacturers were required to disclose the exposed needle length of their adrenaline auto-injector devices in the product information to inform the healthcare professional and patient so they can take this in to account in deciding which device is appropriate for an individual patient.”

    Source location

    2018-0279-Response-by-MHRA
    Page 1 · response
    Published 9 October 2018

    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

    Evaluating clinical study data for each adrenaline auto-injector brand as submissions become available.

    Verbatim wording from the response

    “The review of clinical study results for Epipen undertaken by the MHRA and other competent authorities throughout Europe commenced on 15th September 2018. The MHRA raised questions which the company is currently addressing and will result in further information being submitted for evaluation. Regulatory action will be taken as necessary on completion of the review.”

    Source location

    2018-0279-Response-by-MHRA
    Page 2 · response
    Published 9 October 2018

    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

    Conducting an overarching evaluation of all adrenaline auto-injector study data to determine whether further safety measures are needed.

    Verbatim wording from the response

    “It is foreseen that the evaluation of results for all adrenaline auto-injectors marketed in the UK (Epipen, Jext and Emerade) will be completed during 2019. The availability of data on exposed needle length for all devices, together with the results of clinical studies, will allow an informed decision to be taken on prescribing and advice given to patients. When all study data are available, an over-arching evaluation is intended, to inform whether further measures may be required, that may include a recommendation for longer needle lengths.”

    Source location

    2018-0279-Response-by-MHRA
    Page 3 · response
    Published 9 October 2018

    Open published response

    Source evidence

    How this respondent position was interpreted

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

    PFD Monitor interpretation

    The 500 microgram adrenaline recommendation applies to healthcare professionals’ manual injections, not auto-injector self-administration.

    Verbatim wording from the response

    “A discrete, efficacious dose of adrenaline for the emergency treatment of anaphylaxis is not defined. The Resuscitation Council guidance for a 500 mcg dose refers to the dose administered by a healthcare professional (by manual intramuscular injection with a syringe and needle) and is not their recommended dose for adrenaline auto-injector self-administration. In a healthcare setting, a second dose of 500 mcg adrenaline is recommended to be administered after 5 minutes if the patient is not responding. An experienced specialist could also treat anaphylaxis with repeated bolus doses of 50mcg of intravenous adrenaline or may initiate intravenous infusion of adrenaline according to the response. In the healthcare”

    Source location

    2018-0279-Response-by-MHRA
    Page 3 · response
    Published 9 October 2018

    Open published response
  5. Manchester City

    AI-generated summary

    Norma Edwina Holden · 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

    Norma Edwina Holden presented to the Accident and Emergency Department with abdominal pain, facial and mouth swelling, a swollen tongue and muffled speech, and was later found to have died from septic shock. Concerns included incomplete history-taking and communication to treating doctors, failure to recognise and act on apparent symptoms such as possible anaphylactic shock, lack of appropriate tests, and failure to obtain basic blood tests for infection or sepsis.

    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 recognise and act on symptoms of possible anaphylactic shock

    Wider context from the report

    “During the inquest evidence was heard to the fact that Mrs Holden presented to the Accident and Emergency Department with a history of abdominal pain. Triage history stated swelling to face and mouth. It appears that Mrs Holden had a swollen tongue and her speech was muffled. ████████ was unaware of the symptoms of swollen tongue and facial swelling. I am concerned that the history taking is incomplete and not reported to treating doctors appropriately and that obvious symptoms appear to have not been noticed and actioned, such as possible anaphylactic shock, and appropriate tests conducted. In addition, basic blood tests were not obtained for analysis of any infection/sepsis, to enable appropriate targeting of antibiotics. ”

    Source location

    Norma Edwina Holden · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report
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Data last updated 7 September 2026