PFD report

Irene Anne Pearson · Prevention of Future Deaths report

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Issued 19 Jan 2016•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.

View original report
Concerns
7

Raised in this report

Recipients
3

Named on the report

Responses found
2

Of 3 recipients

Stated actions
2

Described in responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

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

Report evidence summary

Concerns raised7

  1. Failure to define the terms “prolonged” and “hot” in the hot-bath warning
  2. Failure to reconcile prescribed opiate patches with the patient’s actual possession
  3. Failure to maintain clear and sufficiently detailed electronic clinical notes
    Part of recurring concern: Incomplete, inaccurate or unavailable clinical and care records
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.2

  1. Action

    Report the incident to the Medicines and Healthcare Products Regulatory Agency.

    Stated by TakedaStated completedThe respondent said that this action was complete when they made their response on 19 January 2016.
  2. Action

    Disseminate a Trust Alert to hospital and community staff reminding them not to submerge fentanyl patches or advise bathing for removal.

    Stated by Stockport NHS Foundation TrustStated completedThe respondent said that this action was complete when they made their response on 19 January 2016.

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

  1. Position

    Exact definitions of prolonged heat exposure and hot temperatures cannot be provided because evidence is insufficient and absorption varies between individuals.

    Stated by TakedaUnable to actThe respondent said that a constraint prevented them from taking the relevant action.

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 define the terms “prolonged” and “hot” in the hot-bath warning

Wider context from the report

“2. Even when the said warning phrase is reached in the leaflet, it then refers to “a prolonged hot bath” without in any way defining the words “prolonged” or “hot”. These terms are easily open to subjective interpretation, which may lead to an unsafe usage environment. (Takeda UK) ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

Open source report

Source evidence

How this individual concern was interpreted

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

PFD Monitor interpretation

Failure to reconcile prescribed opiate patches with the patient’s actual possession

Wider context from the report

“5. The GP Practice’s electronic notes of the attendances upon the patient were unclear and there appeared to be discrepancies between what was noted as prescribed by way of opiate patches, and what the patient actually had in her possession. The notes were on occasions ‘scanty’ in detail and the doctor giving evidence accepted this and told me that this was because they, as doctors, are limited to ten-minute appointments and they do not always have time properly to record their notes. (Churchgate Surgery) ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

Open source report

Source evidence

How this individual concern was interpreted

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

PFD Monitor interpretation

Failure to maintain clear and sufficiently detailed electronic clinical notes

Wider context from the report

“5. The GP Practice’s electronic notes of the attendances upon the patient were unclear and there appeared to be discrepancies between what was noted as prescribed by way of opiate patches, and what the patient actually had in her possession. The notes were on occasions ‘scanty’ in detail and the doctor giving evidence accepted this and told me that this was because they, as doctors, are limited to ten-minute appointments and they do not always have time properly to record their notes. (Churchgate Surgery) ”

Is this part of a recurring concern?

Yes — Incomplete, inaccurate or unavailable clinical and care records.

Open source report

Source evidence

How this individual concern was interpreted

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

PFD Monitor interpretation

Failure to provide a full report of the patient’s care

Wider context from the report

“6. When HM Coroner asks for a full report of the care of the patient from the General Practitioner, it is insufficient (as in this case), for the practice simply to photocopy part of the patient’s records. (Churchgate Surgery) ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

Open source report

Source evidence

How this individual concern was interpreted

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

PFD Monitor interpretation

Provision of potentially dangerous bath-removal advice for exhausted Matrifen patches

Wider context from the report

“3. I heard evidence that the Macmillan Nurses had advised the deceased to take a bath when preparing to remove the ‘exhausted’ patch so as to aid removal. The toxicologist point out that even when due for changing the patch contains (and therefore can release) a very considerable level of the drug. The advice to use this method of removal would therefore be inherently potentially dangerous.(Macmillan Cancer Care) ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

Open source report

Source evidence

How this individual concern was interpreted

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

PFD Monitor interpretation

Failure to prominently communicate the danger of taking a hot bath whilst wearing the patch

Wider context from the report

“1. The package leaflet of advice on the use of Matrifen is very extensive running to several pages of closely printed words. It is not until half way down the eighth page (and then contained in the middle of a 4th bullet point) that there is reference to the danger of taking a hot bath whilst wearing the patch. The Forensic Consultant Toxicologist gave evidence to me that heating of the body will cause an onrush of the delivery of the drug. (Takeda UK) ”

Is this part of a recurring concern?

Yes — Inadequate product safety warnings about serious hazards.

Open source report

Source evidence

How this individual concern was interpreted

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

PFD Monitor interpretation

Lack of liaison with the GP Practice over regulation of additional opiate pain-control

Wider context from the report

“4. I was told that the Macmillan Nurses will prescribe additional opiate pain-control, but there seemed little or no liaison with the GP Practice as to the regulation of this.(Macmillan Cancer Care) ”

Is this part of a recurring concern?

Yes — Failure to provide sufficient GP involvement in patient care.

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

Report the incident to the Medicines and Healthcare Products Regulatory Agency.

Verbatim wording from the response

“We can confirm that this incident has been reported to the Medicines and Healthcare Products Regulatory Agency (MHRA). For your information, we can additionally confirm that the product information for Fentanyl patches (which include Matrifen) has recently been extensively reviewed by the MHRA to ensure the safety warnings are adequate.”

Source location

I-Pearson-Response_Redacted
Page 1 · response
Published 19 January 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 a Trust Alert to hospital and community staff reminding them not to submerge fentanyl patches or advise bathing for removal.

Verbatim wording from the response

“The Macmillan team have provided assurance that they would not advise anyone to take a bath to aid removal of an exhausted patch or indeed to submerge the patch in water. In response to the information you have shared we have sent a ‘Trust Alert’ out to all hospital and community staff to ensure they are reminded of this risk.”

Source location

I-Pearson-Response2
Page 1 · response
Published 19 January 2016

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

Exact definitions of prolonged heat exposure and hot temperatures cannot be provided because evidence is insufficient and absorption varies between individuals.

Verbatim wording from the response

“Item 2: With regard to your request for us to define ‘prolonged’ and ‘hot’, I am afraid we are not able to do this as we do not have sufficient data on heat exposure and fentanyl absorption to determine what an appropriate duration or temperature would be.”

Source location

I-Pearson-Response_Redacted
Page 1 · response
Published 19 January 2016

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 current Matrifen leaflet adequately addresses the risk of exposing patches to heat sources.

Verbatim wording from the response

“Item 1: With regard to your specific comment concerning the lack of clarity over heat exposure, we would like to bring your attention the fact that the first page of the Matrifen patient information leaflet displays a list of ‘Important things you need to know about Matrifen transdermal patches’. This comprises 7 bullet points highlighted in bold text, including ‘do not expose the patches to a heat source (such as a hot water bottle)’. Given the need to balance completeness with brevity and understanding in the compilation of patient information leaflets, our current view is that the information presented in the Matrifen leaflet adequately addresses the issue of exposing patches to heat sources.”

Source location

I-Pearson-Response_Redacted
Page 1 · response
Published 19 January 2016

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 faxing practice within 24 hours and GP record scanning are considered sufficient liaison for medication changes.

Verbatim wording from the response

“I was told that the Macmillan Nurses will prescribe additional opiate pain control, but there seemed little or no liaison with the GP Practice as to the regulation of this.”

Source location

I-Pearson-Response2
Page 1 · response
Published 19 January 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

Official responses located
2/3

Data last updated 7 September 2026