Recurring concern

Incomplete clinical guidance for venous thromboembolism assessment and management

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First reported 18 Feb 2016•Latest report 12 Aug 2024

Definition

What this concern includes

Includes failures in clinical guidance, policies or decision criteria specifically governing VTE diagnosis, risk assessment, repeat assessment and management, including gaps in guidance for children and unclear guidance for when inpatient VTE risk assessments should be undertaken or repeated.

Not included

  • Excludes failures to provide thromboprophylaxis where the guidance and assessment process is adequate; those belong to the existing thromboprophylaxis concern.
  • Excludes generic clinical-guidance, training or policy deficiencies without an explicit venous-thromboembolism connection.
  • Excludes failures in treatment, monitoring or escalation after applicable VTE guidance has been reliably available and followed.
  • Excludes unrelated paediatric or adult clinical guidance concerns that do not materially concern VTE assessment or management.
Reports
8

Distinct published reports

Individual concerns
11

A report can raise multiple concerns

Date range
2016–2024

First to latest report issue date

Stated actions
10

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.

Department of Health and Social Care3
National Institute for Health and Care Excellence2
NHS England2
Barts Health NHS Trust1
East Lancashire Hospitals NHS Trust1
East London NHS Foundation Trust1
Pennine Care NHS Foundation Trust1
Royal College of Paediatrics and Child Health1
Royal Cornwall Hospital1

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. Inner North London

    AI-generated summary

    Nimo OSMAN · 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

    Nimo Osman was in state detention under a Hospital Order and receiving psychiatric inpatient care when she collapsed on the ward on 21 April 2022. She was unresponsive for over half an hour before an ambulance was called and died in hospital on 23 April 2022 from hypoxic ischaemic brain injury. The principal concerns were delays in recognising the emergency and calling an ambulance, whether learning had been embedded among staff, completion of venous thromboembolism assessments, and ambiguity in the Trust’s venous thromboembolism policy.

    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

    Ambiguity in the venous thromboembolism policy

    Wider context from the report

    “With regard to the East London NHS Foundation Trust’s policy in relation to Venous Thromboembolism, I noted during the course of the evidence that this appeared to possibly conflict with NICE guidelines in some respects. There also appeared to be aspects of the policy that were ambiguous and open to different interpretations. I was told the policy remains in force and unchanged. The concern here is that possible ambiguity may lead to a non-universal interpretation of the policy, thereby putting patients at risk. ”

    Source location

    Nimo OSMAN · 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

    Venous thromboembolism policy failing to align with NICE guidelines

    Wider context from the report

    “With regard to the East London NHS Foundation Trust’s policy in relation to Venous Thromboembolism, I noted during the course of the evidence that this appeared to possibly conflict with NICE guidelines in some respects. There also appeared to be aspects of the policy that were ambiguous and open to different interpretations. I was told the policy remains in force and unchanged. The concern here is that possible ambiguity may lead to a non-universal interpretation of the policy, thereby putting patients at risk. ”

    Source location

    Nimo OSMAN · 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

    Remove unclear VTE assessment information from the Physical Healthcare Policy and publish an update directing staff to the VTE policy.

    Verbatim wording from the response

    “the Physical Healthcare Policy is not clearly set out. Therefore, the VTE information has been removed from the aforementioned policy in a soon to be published update and it has been made clear that the VTE policy is the appropriate reference. The changes to the Physical Healthcare Policy are expected to be agreed through the Physical Health in Mental Health Committee in November 2024.”

    Source location

    Response from East London Foundation Trust
    Page 5 · response
    Published 13 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 separate VTE policy is unambiguous and aligned with NICE guidelines, although VTE information in the Physical Healthcare Policy is unclear.

    Verbatim wording from the response

    “13. It has come to my attention that the inquest only considered the VTE assessment information as provided in the Trust’s Physical Healthcare Policy v.14.1, February 2021. The Trust has a more recent and separate Venous Thromboembolism (VTE) Reducing Risk policy v. 3, March 2023. The information in the VTE policy is unambiguous and in-line with NICE guidelines. It is accepted that the VTE assessment information contained in”

    Source location

    Response from East London Foundation Trust
    Page 4 · response
    Published 13 August 2024

    Open published response
  2. West Yorkshire Eastern

    AI-generated summary

    LILLY GRACE PROCTOR · 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

    Lilly Proctor, aged 13, collapsed at home in the early hours of 3 April 2022 and died later that day in Pinderfields Hospital from massive pulmonary thromboembolism associated with deep vein thrombosis and hereditary Protein S deficiency. The report raises concerns that there was no child-specific UK screening tool or corresponding NICE guidance for venous thromboembolic disease in children, potentially disadvantaging clinicians diagnosing and treating the condition.

    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

    Lack of child-applicable guidance for diagnosis and management of venous thromboembolic diseases

    Wider context from the report

    “(2) NICE Guidance NG158 “Venous thromboembolic diseases: diagnosis, management and thrombophilia testing” is specific to adults. There is no corresponding guidance applicable to children. Similarly, the NICE Clinical Knowledge Summary for pulmonary embolism dated September 2023 is specific to adults with no corresponding publication applicable to children. ”

    Source location

    LILLY GRACE PROCTOR · 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 validated child-specific screening tools for pulmonary thromboembolism

    Wider context from the report

    “(1) Whereas there are screening tools (such as “the Wells criteria”) to assist the detection of pulmonary thromboembolism in adults, no child-specific screening tool is available in the UK and no existing screening tool for use in the adult population has been validated for use in children in the UK. The inquest heard evidence of such child-specific screening tools being developed in other countries, of which Italy was an example. ”

    Source location

    LILLY GRACE PROCTOR · 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

    Ask the prioritisation board to consider whether guidance should be developed on venous thromboembolism in children.

    Verbatim wording from the response

    “Nevertheless, NICE will consider the issues raised in your report through our recently implemented organisation-wide approach to prioritisation and topic selection. This is overseen by a single prioritisation board that guides the selection and coordination of our guidance development. We will ask our prioritisation board to consider if guidance should be developed in this area. In line with our usual practice, decisions made by the prioritisation board will be published on the NICE website.”

    Source location

    Response from NICE
    Page 2 · response
    Published 9 May 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

    NICE should take the lead in developing paediatric pulmonary thromboembolism screening tools and specific national guidance.

    Verbatim wording from the response

    “Paediatricians and other clinicians who see unwell children and young people could benefit from an effective tool to assist the clinical detection of pulmonary thromboembolism in children and young people. Also a national guideline on this topic that is specific to children could be helpful. We would look to the National Institute for Healthcare Excellence to take a lead on this work to help develop a further evidence base or consensus guidance in this complex area of clinical practice. If this is to be taken forward, the College would be happy to assist and provide clinical expertise.”

    Source location

    Response from RCPCH
    Page 1 · response
    Published 9 May 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

    NICE cannot recommend a paediatric VTE screening tool because evaluated adult scores perform poorly and no suitable tool is known.

    Verbatim wording from the response

    “Regarding a screening tool, there is no specific screening tool that we are aware of. The Wells score and the Caprini score (scores used in adults) have both been evaluated in different paediatric populations, but their performance has not been good, and they cannot be recommended. There is, therefore, no screening tool that NICE could recommend. We note you have mentioned child specific screening tools being developed in other countries, but our clinical advisors are not aware of these and have not seen them used in practice.”

    Source location

    Response from NICE
    Page 1 · response
    Published 9 May 2024

    Open published response
  3. East London

    AI-generated summary

    Christine Goodfriday Nakaefeero · 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

    Christine Goodfriday Nakaefeero was found unresponsive at home on 21 June 2022 and died from a pulmonary embolism caused by a deep vein thrombosis. The report raises concerns that recommended hysterectomy surgery for her uterine fibroids was not arranged, and that the VTE assessment did not account for her large fibroids and use of tranexamic acid.

    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 of VTE risk assessment criteria to include relevant risk factors

    Wider context from the report

    “2. The clinicians treating Ms Nakaefeero assessed her VTE risk utilising an established algorithm based on national guidance. The assessment was undertaken appropriately but it failed to identify two risk factors which made the formation of a DVT more likely, namely, large uterine fibroids and the use of tranexamic acid. I have concerns that the omission of these factors in the assessment criteria limited the effectiveness of the risk assessment. ”

    Source location

    Christine Goodfriday Nakaefeero · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report

    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

    Insufficient evidence exists to justify changing the national VTE risk assessment tool for tranexamic acid use or pelvic fibroids.

    Verbatim wording from the response

    “The Trust has discussed this matter at the Venous Thromboembolism Prevention Committee and reviewed the available published evidence regarding the relative risk of these two factors and any other available guidance. Current evidence of relative risk is very limited and subject to debate nationally and there are no specific College or National guidelines available dealing with these specific topics.”

    Source location

    Response from Barts Health NHS Trust
    Page 2 · response
    Published 28 July 2023

    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 established VTE risk assessment tool remains appropriate, with insufficient evidence to adapt or change it.

    Verbatim wording from the response

    “The Trust also explained to CQC that it was seeking expert advice from Professor Roopen Arya, Professor of Thrombosis and Haemostasis at King’s College Hospital and Director of the National VTE Exemplar Centres Network in England. Professor Arya advised the Trust that the use of the tool to assess VTE risk and determine intervention was appropriate and that at that time there was insufficient evidence to adapt or change this. I am aware that the Trust is also continuing to monitor the information it received from national bodies that informed how it implements best practice on prevention of VTE.”

    Source location

    Response from Department of Health and Social Care
    Page 2 · response
    Published 28 July 2023

    Open published response
  4. Manchester South

    AI-generated summary

    Corinne Haslam · 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

    Corinne Haslam died at Tameside General Hospital on 18 March 2022 following complications involving myocardial ischaemia, acute exacerbation of chronic obstructive pulmonary disease, left ventricular hypertrophy and treated pulmonary thromboemboli. Concerns included barriers to obtaining physical-health specialist input for mental-health ward patients, incompatible electronic records between Mental Health and Acute Trusts, and unclear guidance on venous thromboembolism risk assessments.

    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

    Lack of clear guidance for undertaking and repeating Venous Thromboembolism risk assessments

    Wider context from the report

    “3. It is a matter of concern that ward-based nursing staff do not appear to have been provided with clear and unambiguous guidance as to the circumstances when a risk assessment for Venous Thromboembolism (‘VTE’) should be undertaken following admission to a ward, and the circumstances in which such risk assessment should be repeated. ”

    Source location

    Corinne Haslam · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    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

    Issues concerning Pennine Care NHS Foundation Trust should be addressed in the Trust’s response.

    Verbatim wording from the response

    “I note that you have also addressed matters of concern to the Chief Executive of Pennine Care NHS Foundation Trust and I would expect the Trust’s response to address those issues.”

    Source location

    Response from Department of Health and Social Care
    Page 1 · response
    Published 28 July 2023

    Open published response
  5. Cornwall and Isles of Scilly

    AI-generated summary

    Julie Louise Hancock · 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

    Julie Louise Hancock underwent a right total knee replacement on 2 March 2022, was discharged on 5 March 2022, and died at home on 28 March 2022. Her post-mortem cause of death was pulmonary embolus due to deep vein thrombosis, with immobility following the knee replacement. The concerns included apparent prescription of low-risk thrombosis prophylaxis despite her being assessed as high risk, an unidentified doctor’s prescription of dalteparin that was stopped after one dose, and possible discrepancies between summary and full thrombosis-prevention guidance.

    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 ensure clinicians access accurate thrombosis prophylaxis guidance

    Wider context from the report

    “I enclose the bundle of evidence. At pp A32-A54, you will find what I am told is the Trust’s Guideline Summary for Thrombosis Prevention and Anticoagulation. At p42, following elective knee replacement, it is suggested clinicians may choose any one of Aspirin ████████ for 14 days LMWH for 14 days and anti-embolism stockings Rivaroxaban ████████ once daily for 14 days As matters of fact, I am told Mrs Hancock was prescribed 14 days of aspirin, an apparent error, one unidentified doctor also prescribed Dalteparin which was stopped after a single dose. It is of concern that the doctor cannot be identified and I have no record of the decision-making. At C32, you will find the Trust’s full guidance for drug prophylaxis following elective knee replacement which is taken from its Thrombosis Prevention and Anticoagulation Policy v9.0 dated Feb 2022. It provides: Low risk – Aspirin ████████ daily for 14 days High Risk – Rivaroxaban ████████ daily for 14 days or Dalteparin or Enoxaparin for 28 days plus stockings (until discharge.) ████████ had not seen the full guidance previously despite it having been published for over a year which, as a consultant orthopaedic surgeon, is of concern in itself. █ further said that Mrs Hancock was high risk yet she appears to have been given prophylaxis for a low risk patient because the summary guidelines appear not to reflect accurately the full guidance. ████████, as I understood ███, said that it had been █ practice to prescribe aspirin to all high-risk patients since (at least) February 2022. This raises the question of whether other patients have died from a PE or DVT because of wrongly prescribed prophylaxis that have not been reported to this Office. You will need to consider the position. I have only considered the situation as it came before me, namely, for an elective knee replacement. As I understand the anticoagulation policy will have a much wider reach than that there is an obvious need to consider the implications across all the Trust’s services. ”

    Source location

    Julie Louise Hancock · 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

    Scrutinise and ratify the Thrombosis Prevention and Anticoagulation Policy in its current form through the steering group.

    Verbatim wording from the response

    “We can advise the Policy referenced at the part heard inquest of Mrs Hancock, Thrombosis Prevention & Anticoagulation Policy V9 dated February 2022 has ambiguity with regard how it presents local interpretation of NICE Guidelines on orthopaedic thromboprophylaxis. This policy had been refreshed in January 2022 by the VTE practitioner who has since retired. This policy did not go through the appropriate sub board groups for scrutiny, review and sign off. It has since been scrutinised by the Thrombosis Prevention and Anticoagulation Steering Group (TPAS; meeting 20th June 2023) who are satisfied that the acknowledged ambiguity in a single section of the document does not pose a greater risk to our patient population than removal of this guideline, which covers every inpatient specialty, would pose to many patients.”

    Source location

    Response from Royal Cornwall Hospitals NHS Trust
    Page 5 · response
    Published 19 May 2023

    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 the Thrombosis and Anticoagulation policy arrangements through a larger workstream to improve accessibility and remove ambiguity.

    Verbatim wording from the response

    “On this basis TPAS have ratified the document in its current form with the understanding that it will be reviewed as part of a larger workstream to make the RCHT Thrombosis and Anticoagulation policy offerings more accessible and without ambiguity.”

    Source location

    Response from Royal Cornwall Hospitals NHS Trust
    Page 5 · response
    Published 19 May 2023

    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

    Audit the ten most recently uploaded document-library policies within three months to verify that the correct approval process was followed.

    Verbatim wording from the response

    “It is anticipated that this policy will be separated into smaller, digestible policies (e.g. Management of Suspected/confirmed VTE; Prophylaxis for medical and/or surgical patients; Elective Orthopaedics) This updated policy/policies will then go through the appropriate channels and groups (TPAS, Medicines Practice Committee, full engagement with Care Group and Clinical Directors, Clinical Effectiveness Group, Policy Review Group and Quality Assurance Committee) before formal sign off and before it can be uploaded onto our documents library. We will be more than happy to share copies any updated policy/policies when they have been through scrutiny and sign off.”

    Source location

    Response from Royal Cornwall Hospitals NHS Trust
    Page 5 · response
    Published 19 May 2023

    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

    TPAS considered the policy’s acknowledged ambiguity insufficiently risky to warrant removal and ratified the current policy pending broader review.

    Verbatim wording from the response

    “We can advise the Policy referenced at the part heard inquest of Mrs Hancock, Thrombosis Prevention & Anticoagulation Policy V9 dated February 2022 has ambiguity with regard how it presents local interpretation of NICE Guidelines on orthopaedic thromboprophylaxis. This policy had been refreshed in January 2022 by the VTE practitioner who has since retired. This policy did not go through the appropriate sub board groups for scrutiny, review and sign off. It has since been scrutinised by the Thrombosis Prevention and Anticoagulation Steering Group (TPAS; meeting 20th June 2023) who are satisfied that the acknowledged ambiguity in a single section of the document does not pose a greater risk to our patient population than removal of this guideline, which covers every inpatient specialty, would pose to many patients.”

    Source location

    Response from Royal Cornwall Hospitals NHS Trust
    Page 5 · response
    Published 19 May 2023

    Open published response
  6. Manchester South

    AI-generated summary

    Rebekah Juliet Mills · 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

    Rebekah Juliet Mills suffered a knee injury in an accidental skiing fall, underwent surgery, collapsed at home several days later, and died from a pulmonary embolism. The inquest identified unclear clinical guidance about reducing the risk of DVT in young, immobile patients taking oral contraception who require surgery, with differing approaches and insufficient recognition of the potential fatal risk.

    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

    Lack of clear guidance for clinicians on reducing DVT risk in immobilised surgical patients

    Wider context from the report

    “During the course of the inquest evidence was given that the guidance for clinicians in relation to reducing the risk of DVT when dealing with patients such as Ms Mills who are young and on oral contraception but are immobile following an accident and require surgery is unclear. That lack of clarity can give rise to a differing approach and a lack of recognition of the potential fatal risk that patients such as Ms Mills can face in such a situation. The evidence was that greater clarity and greater understanding of the risks could prevent future deaths. ”

    Source location

    Rebekah Juliet Mills · 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

    Maintain warnings in combined hormonal contraceptive product information about venous thromboembolism risks, surgery and immobilisation.

    Verbatim wording from the response

    “All oral hormonal contraceptives licensed in the UK have included warnings in the SmPC since the early 2000s on the risks of venous thromboembolism (VTE) which includes deep vein thrombosis (DVT) and pulmonary embolism. These warnings highlight the need to stop treatment at least 4 weeks prior to and for 2 weeks after elective operations and during immobilisation. The risks of VTE with combined hormonal contraceptives were further reviewed in 2013 by MHRA in conjunction with other regulators in the EU. The review confirmed the known relative risks of VTE for different groups of combined hormonal contraceptives (newer contraceptives compared to so-called second generation combined hormonal contraceptives containing levonorgestrel, norethisterone or norgestimate) but found some changes in the magnitude of the risks of VTE in all women (with and without hormonal contraceptive use).”

    Source location

    Response from Medicines & Healthcare products Regulatory Agency
    Page 2 · response
    Published 17 May 2023

    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 combined hormonal contraceptive venous thromboembolism risks and update product information with revised risk estimates and antithrombotic-treatment advice.

    Verbatim wording from the response

    “All oral hormonal contraceptives licensed in the UK have included warnings in the SmPC since the early 2000s on the risks of venous thromboembolism (VTE) which includes deep vein thrombosis (DVT) and pulmonary embolism. These warnings highlight the need to stop treatment at least 4 weeks prior to and for 2 weeks after elective operations and during immobilisation. The risks of VTE with combined hormonal contraceptives were further reviewed in 2013 by MHRA in conjunction with other regulators in the EU. The review confirmed the known relative risks of VTE for different groups of combined hormonal contraceptives (newer contraceptives compared to so-called second generation combined hormonal contraceptives containing levonorgestrel, norethisterone or norgestimate) but found some changes in the magnitude of the risks of VTE in all women (with and without hormonal contraceptive use).”

    Source location

    Response from Medicines & Healthcare products Regulatory Agency
    Page 2 · response
    Published 17 May 2023

    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

    Introduce user cards and prescriber checklists covering clot risks, warning symptoms, and alerts about planned or recent surgery or immobilisation.

    Verbatim wording from the response

    “The review also appreciated that it may not always be possible to suspend use of a contraceptive in advance of prolonged immobilisation, major surgery, surgery to the legs or pelvis, neurosurgery, or major trauma. Consequently, the changes to the product information incorporated clear advice that antithrombotic treatment should be considered if the contraceptive has not been discontinued in these circumstances. Additionally, a user card and a prescriber checklist were also introduced for contraceptive users and prescribers respectively on the risks of blood clots, when these are increased, and symptoms to watch out for. These documents included a reminder to alert healthcare professionals including surgeons if surgery or immobilisation is planned or has recently occurred.”

    Source location

    Response from Medicines & Healthcare products Regulatory Agency
    Page 2 · response
    Published 17 May 2023

    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

    Communicate revised venous thromboembolism risk estimates and risk-reduction measures to prescribers through Drug Safety Update.

    Verbatim wording from the response

    “We communicated the revised estimates of risk and on the new measures to reduce the risks to prescribers in 2014 through our newsletter Drug Safety Update¹.”

    Source location

    Response from Medicines & Healthcare products Regulatory Agency
    Page 2 · response
    Published 17 May 2023

    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

    Request updates to the product information for the small number of combined hormonal contraceptive products missing information from the venous thromboembolism review.

    Verbatim wording from the response

    “In response to your request, we have reviewed the product information for all combined hormonal contraceptives and identified that the information for a small number of combined hormonal contraceptive products was not updated to include the new information as expected following the VTE review. We will request these be addressed as soon as possible. We would note however that the information currently provided for these products is less complete than the updated information described above rather than contradictory to it.”

    Source location

    Response from Medicines & Healthcare products Regulatory Agency
    Page 2 · response
    Published 17 May 2023

    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 product warnings, risk estimates, antithrombotic advice, user materials and prescriber tools provide risk-minimisation measures for combined hormonal contraceptives.

    Verbatim wording from the response

    “All oral hormonal contraceptives licensed in the UK have included warnings in the SmPC since the early 2000s on the risks of venous thromboembolism (VTE) which includes deep vein thrombosis (DVT) and pulmonary embolism. These warnings highlight the need to stop treatment at least 4 weeks prior to and for 2 weeks after elective operations and during immobilisation. The risks of VTE with combined hormonal contraceptives were further reviewed in 2013 by MHRA in conjunction with other regulators in the EU. The review confirmed the known relative risks of VTE for different groups of combined hormonal contraceptives (newer contraceptives compared to so-called second generation combined hormonal contraceptives containing levonorgestrel, norethisterone or norgestimate) but found some changes in the magnitude of the risks of VTE in all women (with and without hormonal contraceptive use).”

    Source location

    Response from Medicines & Healthcare products Regulatory Agency
    Page 2 · response
    Published 17 May 2023

    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

    Clinical guidance addresses DVT prevention, diagnosis and management, including VTE risk assessment and antithrombotic prevention for surgery and trauma.

    Verbatim wording from the response

    “Also, as highlighted in the response provided to you from NHS England, the risk factors for DVT and the link to oral contraception are not new or under-recognised issues. The prevention, diagnosis and management of DVT fall under the remit of clinical guidance. Risk factors, diagnosis and management of VTE are clearly set out in the NICE Pulmonary Embolism Clinical Knowledge Summary². Guidance on risk assessment for VTE and on the use of antithrombotic preventative measures for patients undergoing surgery or who have experienced a trauma are addressed in NICE guideline (NG89)³: Venous thromboembolism in over 16s: reducing the risk of hospital-acquired deep vein thrombosis or pulmonary embolism. We welcome however the additional briefing that the Greater Manchester Integrated Care board have requested to focus on the learnings for clinicians from Rebekah’s death.”

    Source location

    Response from Medicines & Healthcare products Regulatory Agency
    Page 2 · response
    Published 17 May 2023

    Open published response
  7. Leicester City and South Leicestershire

    AI-generated summary

    Cherry Rosemary Dunn · 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

    Cherry Rosemary Dunn died after an acute episode at Kirby Ward on 5 November 2018, with the inquest recording pulmonary embolism, deep vein thrombosis and immobility as causes of death. Concerns included bilateral leg swelling not prompting sufficient consideration of deep vein thrombosis, ambiguity in VTE risk assessments, and confusing hospital discharge letters that affected decisions about prophylactic anticoagulation.

    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 of VTE risk assessments to provide comprehensive and clear assessment criteria

    Wider context from the report

    “• VTE risk assessment form The VTE risk assessment used at the time of Mrs Dunn’s death was not as comprehensive as it could have been. Leicestershire Partnership NHS Trust have made improvements to their original form (previous and current ones attached to this report). However, a concern remains that it is still not as clear as it could be, and different conclusions could be arrived at depending on the doctor completing the form. This would then impact on whether prophylactic anticoagulation is prescribed. Therefore, there is a concern that this is a problem nationally and different hospitals use different VTE risk assessments that can be confusing. ”

    Source location

    Cherry Rosemary Dunn · 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 national guidance on bilateral leg swelling in DVT diagnostic profiling

    Wider context from the report

    “• Clinical indications of VTE Bilateral leg swelling overshadowed the consideration for a DVT and without guidance to all doctors nationally, bilateral leg swelling will remain a problem for the diagnostic profiling of a DVT. ”

    Source location

    Cherry Rosemary Dunn · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report
  8. Blackburn, Hyndburn and Ribble Valley

    AI-generated summary

    Euphemia Lumsden Aldred · 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

    Euphemia Aldred fell at home, sustained fractures to her left leg and ankle, and was treated in hospital with a plaster cast. After discharge, she was no longer prescribed low molecular weight heparin, developed a deep vein thrombosis and pulmonary embolism, and died; the report identified that the relevant Trust policy did not comply with NICE guidance on venous thrombo-embolism prevention.

    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 of the obstetric VTE prophylaxis and management policy to comply with NICE guidance

    Wider context from the report

    “The East Lancashire Hospitals Trust Policy Document: Venous Thrombo-Embolism (VTE) (on Obstetric) Part 1 Prophylaxis, Part II Management of VTE V1.4 October 2015 did not comply with the NICE Guidance on Venous Thrombo-embolism in Adults: Reducing the Risk in Hospital: CG92 January 2010. ”

    Source location

    Euphemia Lumsden Aldred · Prevention of Future Deaths report
    Page 1 · concerns

    Open source report
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Data last updated 7 September 2026