PFD report

Natasha Charlotte Rose Ednan-Laperouse · Prevention of Future Deaths report

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Issued 8 Oct 2018•London (West)

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

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Concerns
4

Raised in this report

Recipients
4

Named on the report

Responses found
2

Of 4 recipients

Stated actions
8

Described in responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

Select any concern, action or position to view the source wording.

Report evidence summary

Concerns raised4

  1. Inadequate or unclear allergen labelling on packaging
    Part of recurring concern: Inadequate food-allergen information and warnings for allergic consumers
  2. Failure to maintain a coherent and coordinated system for monitoring customer allergic reactions
  3. Inadequate adrenaline dose for anaphylaxis
    Part of recurring concern: Failure to recognise and respond to anaphylaxis
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 recipient says it has done, is doing, or plans to do in response to a concern raised.6

  1. Action

    Conduct an urgent review of allergen information requirements for food pre-packed for direct sale, including stakeholder engagement and development of policy options.

    Stated by Department for Environment, Food & Rural AffairsStated in progressThe respondent said that this action was in progress when they made their response on 9 October 2018.
  2. Action

    Encourage businesses to implement best-practice approaches to allergen information provision.

    Stated by Department for Environment, Food & Rural AffairsStated in progressThe respondent said that this action was in progress when they made their response on 9 October 2018.
  3. Action

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

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 9 October 2018.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.2

  1. Position

    The 25 mm needle recommendation applies to healthcare professionals’ manual injections, not adrenaline auto-injectors intended for self-administration.

    Stated by Medicines and Healthcare products Regulatory AgencyDisputes the concernThe respondent disagreed with part of the concern or the basis for it.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Inadequate or unclear allergen labelling on packaging

Wider context from the report

“(1) That allergens were not labelled adequately or clearly on Pret-a-Manger packaging when prepared in their kitchens “pre-packed for direct sale” utilising regulation 5 of the Food Information Regulations. Regulation 5 allows for food outlets to avoid full food labelling requirements whether they prepare a small number of items in local shops or in the case of Pret, over 200 million items for sale by preparing these items in “local kitchens”. These items prepared in “local kitchens” are in fact “assembled” in large parts from items made in factory style outlets to Pret specifications. I was left with the impression that the “local kitchens” were in fact a device to evade the spirit of the regulation. ”

Is this part of a recurring concern?

Yes — Inadequate food-allergen information and warnings for allergic consumers.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure to maintain a coherent and coordinated system for monitoring customer allergic reactions

Wider context from the report

“(2) In the case of Pret-a-manger there was no coherent or co-ordinated system for monitoring customer allergic reactions despite sales of more than 200 million items. In some cases concerns were notified to Customer Services and in some they were noted to the safety department. The two did not know what the other was responding to. It was clear that there was no overarching monitoring system in place. In response to questioning on this I was told that the manager responsible for safety now received all notifications and would monitor them. In my view this remains highly inadequate. In my view sales of 200 million items some with expressly commissioned but hidden allergens require a robust safety auditing system. The previous system was unsafe and the system proposed equally so in my view. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

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. ”

Is this part of a recurring concern?

Yes — Failure to recognise and respond to anaphylaxis.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

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. ”

Is this part of a recurring concern?

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

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

Conduct an urgent review of allergen information requirements for food pre-packed for direct sale, including stakeholder engagement and development of policy options.

Verbatim wording from the response

“Taking into account matter of concern (1) raised in your Regulation 28 report, an urgent review of allergen information provision for food which is pre-packed for direct sale is under way with a view to strengthening the framework.”

Source location

2018-0279-Response-by-Department-for-Environment-Food-Rural-Affairs
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

Encourage businesses to implement best-practice approaches to allergen information provision.

Verbatim wording from the response

“Our central concern is about improving consumer safety, and therefore, alongside the review, we are encouraging businesses to implement a best practice approach to allergen information provision. The FSA have also been working in collaboration with patient groups to run awareness campaigns such as #EasytoASK which works to promote best practice behaviour by consumers with allergies.”

Source location

2018-0279-Response-by-Department-for-Environment-Food-Rural-Affairs
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

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

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

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 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 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

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

Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.2

  1. 1

    Implemented improved training and educational materials for patients, carers and healthcare professionals using adrenaline auto-injectors.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 9 October 2018.
  2. 2

    Published updated advice for patients and carers on using adrenaline auto-injectors.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 9 October 2018.

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 improved training and educational materials for patients, carers and healthcare professionals using adrenaline auto-injectors.

Verbatim wording from the response

“- Recommendations for improved training and educational materials for patients, carers and healthcare professionals in the use of adrenaline auto-injectors.”

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

Published updated advice for patients and carers on using adrenaline auto-injectors.

Verbatim wording from the response

“The MHRA has in the meantime published updated advice on the use of adrenaline auto-injectors to patients and their carers:”

Source location

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

Open published response
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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Official responses located
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Data last updated 7 September 2026