PFD report

Rebekah Juliet Mills · Prevention of Future Deaths report

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Issued 15 May 2023•Manchester South

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
2

Raised in this report

Recipients
2

Named on the report

Responses found
1

Of 2 recipients

Stated actions
6

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

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Report evidence summary

Concerns raised2

  1. Lack of clinician recognition of the potentially fatal DVT risk in immobilised surgical patients
    Part of recurring concern: Unreliable DVT diagnosis and management
  2. Lack of clear guidance for clinicians on reducing DVT risk in immobilised surgical patients
    Part of recurring concern: Incomplete clinical guidance for venous thromboembolism assessment and management
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.5

  1. Action

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

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 17 May 2023.
  2. Action

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

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 17 May 2023.
  3. Action

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

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 17 May 2023.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.3

  1. Position

    DVT risk factors and their link to oral contraception are not new or under-recognised issues.

    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

Lack of clinician recognition of the potentially fatal 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. ”

Is this part of a recurring concern?

Yes — Unreliable DVT diagnosis and management.

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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

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. ”

Is this part of a recurring concern?

Yes — Incomplete clinical guidance for venous thromboembolism assessment and management.

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

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

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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

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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

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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

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 position was interpreted

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

PFD Monitor interpretation

DVT risk factors and their link to oral contraception are not new or under-recognised issues.

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

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

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.1

  1. 1

    Keep the safety of combined hormonal contraceptive products under close review.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 17 May 2023.

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

Keep the safety of combined hormonal contraceptive products under close review.

Verbatim wording from the response

“I hope this has provided clarification on the range of risk minimisation measures in place for combined hormonal contraceptives. We will continue to keep the safety of these products”

Source location

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

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