Recipient

Bausch & Lomb U.K. Limited

First report 27 Jan 2020•Latest report 27 Jan 2020

Recipient record

Reports, concerns and published responses

Private and voluntary organisations · Private limited company. This page brings together reports naming this recipient and response statements clearly connected to concerns raised in those reports.

Reports
1

Naming this recipient

Published responses
100%

Found for named reports

Concerns addressed
5

Across all linked responses

Stated actions
3

Described in responses

Reports over time

Reports over time

Reports naming this recipient by issue year.

Evidence profile

Report topics

Share of this recipient’s reports compared with all other recipients.

100%published responses found
3stated actions described

Topic comparisons are not available in the current evidence snapshot.

Concerns and recipient responses

Statements from Bausch & Lomb U.K. Limited linked to the concerns in each report. Select any concern, action or position to view the source wording.

  1. 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. The report was sent to Bausch & Lomb U.K. Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Provision of incorrect advice that an adrenaline auto injector switch is only a brand substitution

    Wider context from the report

    “7. The GPs relied upon the advice given by Enfield Clinical Commissioning Group (CCG) that the scriptswitch was simply the replacement of one branded product with another branded product of the same drug/device. This gave false reassurance. The CCG joint formulary committee introduced a new drug for GPs, but then gave the wrong advice to accompany this. ”
    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bausch & Lomb U.K. Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Failure to reconsider adrenaline auto injector dose after switching device

    Wider context from the report

    “5. When Shanté’s AAI was changed from an EpiPen to an Emerade, her GPs failed to reconsider the prescription and to increase her dose from 300mgs to 500mcgs. ”
    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bausch & Lomb U.K. Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Inadequate and incorrect national training content for 111 call handlers on adrenaline auto injectors

    Wider context from the report

    “17. In terms of national training for 111 call handlers, the NHS Digital distance learning pack contains advice that is in part inadequate and in part wrong. It does not give the crucial information that one dose of adrenaline, by whichever device it is administered, is very unlikely to be sufficient in the case of acute anaphylaxis. It contains a photograph to illustrate the use of an AAI, but in the photograph the device is held incorrectly. ”
    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bausch & Lomb U.K. Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Failure to identify patients at particularly high risk from allergies and asthma

    Wider context from the report

    “1. At the time of her death, Shanté was not receiving specialist care for her allergies. However, her general practitioners (GPs) failed to appreciate this. They assumed that she was being treated for her allergies at the transitional asthma clinic to which she had been referred following her paediatric discharge. This was an incorrect assumption. The GPs had not identified Shanté (who had a high BMI and was severely allergic) as being at particularly high risk from her allergies and asthma, and had no awareness that they were the sole providers of Shanté’s allergy care. ”
    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bausch & Lomb U.K. Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Lack of named accountability for allergy services and provision

    Wider context from the report

    “20. The issues within this prevention of future deaths report are predominantly national issues, but I heard at inquest that there is no person with named accountability for allergy services and allergy provision at NHS England or the Department of Health as a whole. ”
    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bausch & Lomb U.K. Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Failure to assess patients’ access to and understanding of adrenaline auto injector advice

    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. ”
    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bausch & Lomb U.K. Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Failure of the Adastra system to update location information across screens in real time

    Wider context from the report

    “14. When Shanté became ill following the ingestion of nuts, her mother rang NHS 111 and got through to the London Central & West (LCW) service. However, the call handler incorrectly recorded Shanté’s location: he failed to untick a box and so her grandmother’s address was recorded as her location, rather than her mother’s address where she was staying at the time. In an example of good practice, this error was recognised by the clinician who later took over the call. However, what nobody at LCW realised was that the Adastra computer system would not then update in real time for any screens save that of the particular clinician inputting the information. The staff at LCW have since been made aware of this and have been trained to walk over and look at the primary screen to check the address, but it is not clear to me that there is now a national understanding of that element of the system. ”
    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bausch & Lomb U.K. Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Failure to establish whether specialist allergy care was being provided

    Wider context from the report

    “1. At the time of her death, Shanté was not receiving specialist care for her allergies. However, her general practitioners (GPs) failed to appreciate this. They assumed that she was being treated for her allergies at the transitional asthma clinic to which she had been referred following her paediatric discharge. This was an incorrect assumption. The GPs had not identified Shanté (who had a high BMI and was severely allergic) as being at particularly high risk from her allergies and asthma, and had no awareness that they were the sole providers of Shanté’s allergy care. ”
    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bausch & Lomb U.K. Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Inconsistency in anaphylaxis ambulance categorisation between 999 and 111 services

    Wider context from the report

    “16. The individuals making these errors were working within the context of NHS Digital’s categorisation of anaphylaxis as needing a category 2 ambulance rather than a category 1 ambulance, on the Adastra computer system that supports the LCW 111 service. This was the wrong categorisation and not the categorisation that the call would have received if 999 had been called and the London Ambulance Service contacted in the first instance. Acute anaphylaxis is immediately life threatening and must be treated as a category 1. I heard at inquest that NHS Digital has since changed its categorisation. However, I also heard that for those areas (I think approximately half the country, though this is not completely clear to me), where the 999 service and the 111 service are supported by different computer systems rather than the same system being common to both services, there could remain inconsistencies of categorisation between 999 and 111. Even where there are inconsistencies in categorisation, the 999 service will not re-categorise following a 111 clinician’s categorisation, unless a 999 clinician has spoken to the patient, so inappropriate 111 categorisation will not be safety netted by the 999 service. This must be recognised and factored in. ”
    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bausch & Lomb U.K. Limited; that does not assign responsibility.

    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. ”
    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bausch & Lomb U.K. Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Failure of 111 call audits to identify all significant call-handling failings

    Wider context from the report

    “15. During the course of the 111 call, a number of errors were made. These were the errors of LCW individuals. When LCW audited the call in the first instance, the audit identified the problem with the address, but failed to recognise how badly the call had gone in other ways. Without effective audit and recognition of failings, it is difficult to see how there can be effective improvement. ”
    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bausch & Lomb U.K. Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Rare provision of practical placebo-device adrenaline auto injector training

    Wider context from the report

    “13. I heard that the gold standard of training for use of any AAI is to give the patient the relevant pen (whichever that patient is prescribed) containing a placebo rather than adrenaline and, following appropriate instruction, ask the patient actually to administer a dose. I heard at inquest that the incidence of this standard of training (in any setting) is rare. That may be for good reasons, but it seems that revisiting best practice training at a national level would be helpful. ”
    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bausch & Lomb U.K. Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Failure to provide healthcare-professional training after an adrenaline auto injector switch

    Wider context from the report

    “6. Following the scriptswitch, the GPs failed to ask Shanté to come in to the surgery for training in use of the Emerade. This would also have presented an ideal opportunity to explore Shanté’s understanding of the use of her pens and to ensure that she understood she needed to carry two at all times. ”
    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bausch & Lomb U.K. Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Failure to communicate device-specific training requirements for adrenaline auto injectors

    Wider context from the report

    “9. The CCG failed to inform prescribers that the Emerade pen requires different training to the EpiPen because different AAIs do not operate in the same way. In fact, the CCG gave the opposite advice. ”
    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bausch & Lomb U.K. Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Failure of NHS Digital to retain and act on previously identified call-handling safety issues

    Wider context from the report

    “19. One of the errors made by the first 111 call handler was a failure to ask to speak direct to the patient. This was the error of an individual. However, this is not the first time that the issue has been brought to the attention of NHS Digital. At inquest, I asked the witness who appeared on behalf of NHS Digital, and indeed had been chosen by NHS Digital as the person best able to assist the court, if this had been an issue in the past. He said no. However, on 18 December 2018, Peter Harrowing, HM Assistant Coroner for Avon, sent a prevention of future deaths report to NHS Digital following the inquest touching the death of David Longden. It was only when I asked the witness appearing on behalf of NHS Digital specifically about Coroner Harrowing’s report in respect of Mr Longden, pointing out that Coroner Harrowing had raised the need for NHS Digital to place greater emphasis on the call handler speaking to the patient, that the witness remembered that he had indeed seen that report. I choose to characterise this as a memory lapse rather than as an intention wilfully to mislead the court. (A witness who lies whilst giving evidence on oath at inquest may be found in contempt of court and may even be prosecuted for the crime of perjury.) Nevertheless, if NHS Digital does not have a grasp of this sort of detail, specifically brought to its attention by a coroner in a prevention of future deaths report, it is difficult to see how there can be effective improvement. ”
    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bausch & Lomb U.K. Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Failure of AAI leaflets to specify the need for device-specific healthcare-professional training

    Wider context from the report

    “12. The Emerade AAI (and I assume the EpiPen and JEXT) leaflet does not specifically advise that training from a healthcare professional is needed in how to use this particular AAI as opposed to any other. ”
    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bausch & Lomb U.K. Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Failure of the 999 service to safety-net inappropriate 111 categorisation

    Wider context from the report

    “16. The individuals making these errors were working within the context of NHS Digital’s categorisation of anaphylaxis as needing a category 2 ambulance rather than a category 1 ambulance, on the Adastra computer system that supports the LCW 111 service. This was the wrong categorisation and not the categorisation that the call would have received if 999 had been called and the London Ambulance Service contacted in the first instance. Acute anaphylaxis is immediately life threatening and must be treated as a category 1. I heard at inquest that NHS Digital has since changed its categorisation. However, I also heard that for those areas (I think approximately half the country, though this is not completely clear to me), where the 999 service and the 111 service are supported by different computer systems rather than the same system being common to both services, there could remain inconsistencies of categorisation between 999 and 111. Even where there are inconsistencies in categorisation, the 999 service will not re-categorise following a 111 clinician’s categorisation, unless a 999 clinician has spoken to the patient, so inappropriate 111 categorisation will not be safety netted by the 999 service. This must be recognised and factored in. ”
    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bausch & Lomb U.K. Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Single-sale availability of Emerade adrenaline auto injectors

    Wider context from the report

    “4. The Emerade AAI is sold singly. It could be sold in boxes of two as the norm and only singly in the alternative. ”
    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bausch & Lomb U.K. Limited; that does not assign responsibility.

    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. ”
    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bausch & Lomb U.K. Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Failure to advise prescribers to reconsider adrenaline auto injector dose after a device switch

    Wider context from the report

    “8. The CCG failed to draw prescribers’ attention to the need, following scriptswitch from EpiPen to Emerade, to reconsider the dose and to prescribe the higher dose of 500mcgs for patients at higher risk (which would have included Shanté). ”
    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Bausch & Lomb U.K. Limited; that does not assign responsibility.

    PFD Monitor interpretation

    Failure to display the advice to carry two adrenaline auto injectors on the outside of the box

    Wider context from the report

    “3. The Emerade AAI accompanying leaflet does include the advice that two pens should be carried at all times, but the advice is not re-iterated on the outside of the box. Consideration will need to be given to whether this is the appropriate advice in all cases, but it seems worthwhile to review the issue as a whole. ”
    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

    Review the design of Emerade trainer pens.

    Verbatim wording from the response

    “Bausch distributes trainer pens to allergy clinics and further supplies may be accessed through the Emerade website by all patients for practice purposes. These trainer pens do not include a placebo as this would limit use of the trainer pen to single use and, by administering an apparent “dose”, would present a risk of confusion, with implications for patient safety.”

    Source location

    2020-0124-Response-from-Bausch-Lomb_Redacted.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

    Incorporate an activated needle-cover shield extension into redesigned trainer pens while retaining repeated practice use.

    Verbatim wording from the response

    “Bausch is currently reviewing the design of its trainer pens and plans to incorporate a needle cover shield extension when activated, to more closely replicate the patient experience with the actual pen, albeit still capable of being used on multiple occasions for practice purposes.”

    Source location

    2020-0124-Response-from-Bausch-Lomb_Redacted.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

    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 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

    Emerade leaflets already advise patients to obtain instruction from a doctor or pharmacist and healthcare professionals to provide thorough training.

    Verbatim wording from the response

    “However, the wording of the Patient Information Leaflet for Emerade includes the following information, specifically advising patients that training from a doctor or pharmacist is required:”

    Source location

    2020-0124-Response-from-Bausch-Lomb_Redacted.pdf
    Page 3 · 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

    Changes to medicinal-product labelling require approval from the competent regulatory authority under the Human Medicines Regulations 2012.

    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 position was interpreted

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

    PFD Monitor interpretation

    Placebo trainer pens are not used because single-use restriction and apparent dosing could create confusion and patient-safety risks.

    Verbatim wording from the response

    “Bausch distributes trainer pens to allergy clinics and further supplies may be accessed through the Emerade website by all patients for practice purposes. These trainer pens do not include a placebo as this would limit use of the trainer pen to single use and, by administering an apparent “dose”, would present a risk of confusion, with implications for patient safety.”

    Source location

    2020-0124-Response-from-Bausch-Lomb_Redacted.pdf
    Page 4 · response
    Published 13 August 2020

    Open published response
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Published response patterns

Compared with other recipients in reports included in PFD Monitor

Describes published response evidence, not performance.

Published responses found

100%
100%All other recipients 58%
0%100%

How actions were described at the time

This respondent
33%67%
All other recipients
47%25%27%<1%<1%
  • Completed
  • In progress
  • Planned
  • Unclear
  • Partially completed

Statuses reflect what recipients said at the time. PFD Monitor does not verify whether actions happened.

Types of action described in responses

Percentages use all actions described by each group. An action may have more than one type, so percentages do not total 100%.

Information checked against published PFD reports and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Data last updated 7 September 2026