Recurring concern

Failure to ensure people with allergies have two adrenaline auto-injectors available

First to latest report 8 Oct 2018 — 10 May 2019

Reports that mention this concern
2
Times this concern has been raised
3
Stated actions linked to this concern
5

What this concern includes

Includes failures in arrangements for supplying, prescribing, dispensing, carrying or maintaining access to two adrenaline auto-injectors for people with allergies, including single-sale or single-injector arrangements that leave insufficient injectors available across relevant locations.

What is not included
  • Excludes general anaphylaxis education, allergy review and emergency-treatment deficiencies where the specific issue is not availability of two adrenaline auto-injectors.
  • Excludes failures involving injector storage, expiry, training or administration when two injectors were otherwise reliably available.
  • Excludes other medicines, emergency equipment or allergy treatments without a specific two-adrenaline-auto-injector availability concern.
  • Excludes general product-packaging or supply concerns that do not affect access to the required two injectors.

Reports and published responses 2 reports

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

  1. Inner North London

    AI-generated summary

    Karanbir Singh CHEEMA · 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

    Karanbir Singh CHEEMA, a pupil at William Perkin High School with multiple food allergies and asthma, went into anaphylactic shock after another pupil threw cheese at him on 28 June 2017 and died. Concerns included inadequate awareness of his allergies, insufficient checking and availability of EpiPens, an out-of-date EpiPen, failures in sharing and standardising allergy action plans, a cancelled follow-up appointment, and shortcomings in emergency response guidance and training.

    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 check or audit school allergy care plans and medication boxes

    Wider context from the report

    “2. Karanbir’s school care plan and medical box were not checked or audited to ensure, for example, that his care plan stipulated two EpiPens® (adrenaline auto-injectors), the box contained two EpiPens. ”

    Source location

    Karanbir Singh CHEEMA · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

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

    PFD Monitor interpretation

    Insufficient availability of two adrenaline auto-injectors at all times

    Wider context from the report

    “7. Karanbir had one EpiPen at home, one at school and one at his father’s home. There is clearly a need for medical teams to emphasise that two EpiPens must be available at all times. ”

    Source location

    Karanbir Singh CHEEMA · 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

    Provide two adrenaline auto-injectors for the child and two for the school, with GPs asked to prescribe four or, where applicable, three devices.

    Verbatim wording from the response

    “4. Availability of two adrenaline auto-injectors The Trust has made changes in that there will be two adrenaline auto-injectors to be kept with the child at all times and two to be kept at the school, so GPs will be asked to prescribe 4 adrenaline auto-injectors . The GP will be asked to prescribe 3 adrenaline auto-injectors if it is known that the school has a generic adrenaline auto-injector for use for any child.”

    Source location

    2019-0161-Response-by-London-North-West-University-Healthcare-NHS-Trust
    Page 2 · response
    Published 29 July 2019

    Open published response

  2. 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

    Use of adrenaline injector needles that fail to access muscle

    Wider context from the report

    “(3) In the Emergency treatment of anaphylactic reactions Guidelines for healthcare providers the preferred needle length is 25 mm for adrenaline injectors to access muscle in most people. I heard during expert evidence that Epipen needle length was 16mm - suitable according to the UK Resuscitation Council for “pre-term or very small infants”. The use of needles which access only subcutaneous tissue and not muscle is in my view inherently unsafe. An alternative autoinjector, Emerade has a 24 mm needle. ”

    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

    Implemented product-information changes covering two-injector use, repeat dosing, carer training, and exposed needle lengths for UK adrenaline auto-injectors.

    Verbatim wording from the response

    “- Improvements to the product information for prescriber and patient, including strengthening of the recommendation that patients should carry two auto-injectors to enable a second injection if there has been an insufficient response within the first 15 minutes; and reinforcement of the need for family members, carers and teachers to be properly trained in use of the patient’s auto-injector.”

    Source location

    2018-0279-Response-by-MHRA
    Page 3 · 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 25 mm needle recommendation applies to healthcare professionals’ manual injections, not adrenaline auto-injectors intended for self-administration.

    Verbatim wording from the response

    “For clarification, the preferred needle length of 25 mm that you refer to in your report is recommended by the UK Resuscitation Council in the context of anaphylaxis treatment by healthcare professionals, when adrenaline is recommended to be administered by manual intramuscular injection with a syringe”

    Source location

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

    Open published response

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

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Data last updated 7 September 2026