PFD report

Samantha Ann Hopkins · Prevention of Future Deaths report

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Issued 6 Sep 2016•Portsmouth and South East Hampshire

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
1

Raised in this report

Recipients
2

Named on the report

Responses found
2

Of 2 recipients

Stated actions
8

Described in responses

Recipients and published 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.

Concerns raised1

  1. Failure to prominently highlight trial exclusions on the outside of the trial drug packet
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

    Include compliance with the updated IMP labelling requirements in annual WCTU quality assurance visits at each participating site.

    Stated by University of WarwickStated plannedThe respondent said that this action was planned when they made their response on 6 September 2016.
  2. Action

    Introduce labels displaying all four exclusion criteria on IMP bags or external packaging and distribute them to participating ambulance services for application.

    Stated by University of WarwickStated plannedThe respondent said that this action was planned when they made their response on 6 September 2016.
  3. Action

    Remind staff during training and through an internal memo to check trial-drug packaging and exclusion criteria before use.

    Stated by South Central Ambulance Service NHS Foundation TrustStated plannedThe respondent said that this action was planned when they made their response on 6 September 2016.

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 prominently highlight trial exclusions on the outside of the trial drug packet

Wider context from the report

“Although the SCAS staff participating in the PARAMEDIC 2 Trial had been instructed as to the classes of patients to be excluded in the trial and information was provided inside the trial drug packet about the exclusions, they overlooked that pregnant women were expressly excluded and the exclusion warning inside the packet was also overlooked. If the exclusions had been prominently listed on the outside of the packet, this oversight might have been avoided. I was also told in evidence that Warwick Medical School (which is responsible for the PARAMEDIC 2 trial) had given the participating ambulance services no guidance on how the exclusions were to be highlighted to trial participants and that this had been left to the ambulance services themselves. I am concerned that exclusions should be prominently highlighted on the outside of the trial drug packet. As there are only four categories of exclusion, this should be easily achievable. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

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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

Include compliance with the updated IMP labelling requirements in annual WCTU quality assurance visits at each participating site.

Verbatim wording from the response

“The University manages the Paramedic 2 trial via our UK-CRC accredited trials unit, the Warwick Clinical Trials Unit (WCTU), which has a comprehensive Quality Management System (QMS) for the delivery and oversight of clinical trials. As part of this QMS, annual Quality Assurance visits are deliver[y] by the WCTU at each site, and compliance with the new trial labelling requirements shall be included in these visits going forward.”

Source location

2016-0316-Response-by-Warwick-Medical-School
Page 2 · response
Published 6 September 2016

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 labels displaying all four exclusion criteria on IMP bags or external packaging and distribute them to participating ambulance services for application.

Verbatim wording from the response

“As a result of the Coroner’s opinion on the matter of labelling, the University shall now include all four exclusion criteria on new labels that shall sit on the IMP bag or its external packaging. I have attached for your attention a copy of the labels that have been ordered, and which shall be distributed to all five Ambulance Services, with a direction that these must be applied to all IMP packaging, such that by January 2017, all IMP that is in circulation shall comply with this updated guidance.”

Source location

2016-0316-Response-by-Warwick-Medical-School
Page 2 · response
Published 6 September 2016

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

Remind staff during training and through an internal memo to check trial-drug packaging and exclusion criteria before use.

Verbatim wording from the response

“Having reviewed the final label design internally, SCAS have decided to purchase bespoke plastic bags with the label agreed by University of Warwick and the Paramedic 2 team, printed on to the bag. This will ensure that the exclusion criteria are clearly visible to our staff when first selecting the trial drug pack. Staff will also be reminded during training and by an internal memo of the importance of ensuring that they are aware of the exclusion criteria and the importance of checking the packaging to remind themselves immediately before the trial drugs are used. Whilst we have assured ourselves that appropriate training on the trial is already in place, the Trust considers that this additional warning will be a vital reminder to our staff when they are presented with the time critical pressures of a cardiac arrest.”

Source location

2016-0316-Response-by-South-Central-Ambulance-Services-NHS-Trust
Page 2 · response
Published 6 September 2016

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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

Design an exclusion-category label for trial drug packaging.

Verbatim wording from the response

“The matter was first discussed fully at the Paramedic-2 Trial Management Group (TMG) on 8th September 2016 where all five participating sites were represented. At this meeting an action plan was made to design an appropriate label detailing all of the exclusion categories’ which would be placed on further issues of the trial drug packs. Following the meeting, a label was designed for this purpose and I am pleased to enclose a copy of the final design for your information.”

Source location

2016-0316-Response-by-South-Central-Ambulance-Services-NHS-Trust
Page 1 · response
Published 6 September 2016

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

Produce bespoke trial-drug bags bearing the agreed exclusion-category label and affix labels to all circulating trial-drug bags.

Verbatim wording from the response

“Having reviewed the final label design internally, SCAS have decided to purchase bespoke plastic bags with the label agreed by University of Warwick and the Paramedic 2 team, printed on to the bag. This will ensure that the exclusion criteria are clearly visible to our staff when first selecting the trial drug pack. Staff will also be reminded during training and by an internal memo of the importance of ensuring that they are aware of the exclusion criteria and the importance of checking the packaging to remind themselves immediately before the trial drugs are used. Whilst we have assured ourselves that appropriate training on the trial is already in place, the Trust considers that this additional warning will be a vital reminder to our staff when they are presented with the time critical pressures of a cardiac arrest.”

Source location

2016-0316-Response-by-South-Central-Ambulance-Services-NHS-Trust
Page 2 · response
Published 6 September 2016

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.3

  1. 1

    Specifically audit compliance with the instruction to reiterate the trial inclusion and exclusion criteria during annual WCTU quality assurance site visits.

    Stated by University of WarwickStated plannedThe respondent said that this action was planned when they made their response on 6 September 2016.
  2. 2

    Issue a reminder to all participating staff reiterating the Paramedic 2 trial inclusion and exclusion criteria.

    Stated by University of WarwickStated plannedThe respondent said that this action was planned when they made their response on 6 September 2016.
  3. 3

    Disseminate learning from the concerns to the rest of the Trust’s staff.

    Stated by South Central Ambulance Service NHS Foundation TrustStated plannedThe respondent said that this action was planned when they made their response on 6 September 2016.

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

Specifically audit compliance with the instruction to reiterate the trial inclusion and exclusion criteria during annual WCTU quality assurance site visits.

Verbatim wording from the response

“However, as a result of the Coroner’s observations on this matter, the University has instructed the participating Ambulance Services that a reminder should be issued to all participating staff, to reiterate the inclusion and exclusion criteria. In order to provide additional assurance, compliance with this instruction shall be specifically audited by the WCTU during the annual Quality Assurance Site visits.”

Source location

2016-0316-Response-by-Warwick-Medical-School
Page 3 · response
Published 6 September 2016

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

Issue a reminder to all participating staff reiterating the Paramedic 2 trial inclusion and exclusion criteria.

Verbatim wording from the response

“However, as a result of the Coroner’s observations on this matter, the University has instructed the participating Ambulance Services that a reminder should be issued to all participating staff, to reiterate the inclusion and exclusion criteria. In order to provide additional assurance, compliance with this instruction shall be specifically audited by the WCTU during the annual Quality Assurance Site visits.”

Source location

2016-0316-Response-by-Warwick-Medical-School
Page 3 · response
Published 6 September 2016

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

Disseminate learning from the concerns to the rest of the Trust’s staff.

Verbatim wording from the response

“We take all complaints and concerns seriously and I thank you for bringing your concerns to our attention. We can only improve our service by receiving this feedback and in this instance learning will have taken place and will also be disseminated to the rest of our staff.”

Source location

2016-0316-Response-by-South-Central-Ambulance-Services-NHS-Trust
Page 2 · response
Published 6 September 2016

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

Data last updated 7 September 2026