Prevention of Future Deaths reports · 2015
Regulation 28 report to prevent future deaths, reference 2015-0463, written 16 Nov 2015. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 16 Nov 2015 |
|---|---|
| Reference | 2015-0463 |
| Deceased | Nadine Brookes-Walker |
| Coroner | Elaine Moloney |
| Coroner area | Manchester North |
| Category | Product related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1) REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: (1’A- 1. Teva Pharmaceutical Industrics Ltd 2. 3. CORONER I am Elaine Moloney, Assistant Coronerfor the Coroner area of Manchester North 2 CORONER’S LEGAL POWERS I make this report under paragraph 7, Schedule 5, of the Coroner’s and Justice Act 2009 and Regulations 28 and 29 of the Coroners (Investigations) Regulations 2013 3 INVESTIGATION and INQUEST On the 5th May 2015 I commenced an investigation into the death of Nadine Brookes-Walker (age 32 years), for whom the cause of death was given as being that of la) Fentanyl Toxicity and at an Inquest held at Rochdale Coroners Court Heywood on 5 November 2015 the conclusion of “Accidental overdose of prescribed medication” was given. 4 CIRCUMSTANCES OF DEATH Mrs Brookes-Walker had an extensive medical history dating back to her birth and for the last 4 years was using Fentanyl patches prescribed by her GP for relief of pain, which was severe. She was using one patch every 72 hours. Her uncle, , who lived with her, gave evidence at the Inquest that he had applied a new patch to her shoulder the night before she died. He stated that he had difficulty removing it from its package and there had been previous like occasions when the patches would stick to the inside of the packaging, requiring force to remove them. The toxicologist giving evidence to the hearing, , gave evidence that ifthis caused the patch to become damaged it was likely that an excessive amount of fentanyl was released into Ms Brookes-Walker’s body. I concluded from the whole of the evidence that it was more likely than not that the patch had become inadvertently damaged whilst being removed from its packaging and this had led to a fatal amount of fentanyl being administered to Mrs Brookes-Walker. stated in evidence that he was not aware of any danger arising from use of damaged patches and that he could not recall any warnings on the packaging regarding this. Furthermore, there had been occasions when all 5 patches contained within a single box were difficult to remove from their package, suggesting there may be a manufacturing fault in some batches. 5 CORONER’S CONCERNS During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths will occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows: Warning regarding the seriousness of the consequences of using damaged Fentanyl patches may not be apparent to the patientfrom the packaging 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe each of you respectively have the powerto take such action. 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely I, the . Coroner, may extend the period. Your response must contain details of action taken or proposed to be taken, setting out the timetable for action. Otherwise you must explain why no action is proposed. 8 COPIES and PUBLICATION I have sent a copy of my report to the Chief Coroner and to the following Interested Persons namely: , Nc+r CC. I am also under a duty to send the Chief Coroner a copy of your response. The Chief Coroner may publish either or both in a complete or redacted or summary from. He may send a copy of this report to any person who he believes may find it usefulor of interest. You may make representations to me the coroner at the time of your response, about the release or the publication of your response by the Chief Coroner. Date: 16 November2015 Signed: p
1 response published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.
Our Reference: 014953
9" May 2016
Rebecca Snook
Coroners Deputy First Officer
H M Coroners Court wk
The Phoenix Centre 4 Ww
L/Cpl Stephen Shaw MC Way :
Heywood
OL101LR
Dear Ms Snook
Re Nadine Alexandra Brookes-Walker (your Ref: 56281)
Following the letter dated 17" November 2015 from _ cee ae... our
subsequent correspondence with yourself and this letter constitutes Takeda’s
response to the Regulation 28 report.
Matters of concern:
aiatters of concern:
. Inspect the patch for any damage.
Do not use the patch if it has been divided, cut or looks damaged.
Given the need to balance completeness with brevity and understandability in the compilation of
PILs, our current view is that the current information presented in the Matrifen leaflet adequately
addresses the issue of damaged patches.
Furthermore, as we are required to ensure that the PIL for Matrifen is Consistent with that of the
brand leader product Durogesic, marketed by Johnson & Johnson, we have requested that they
conduct a review to determine whether any changes are required to the product information as a
resuit of this incident. I understand that this is still under investigation,
In addition kindly be informed that the product information for Fentanyl patches (which include
Matrifen) have recently been extensively reviewed by the Medicines and Healthcare Products
Regulatory Agency (MHRA) to ensure the safety warnings are adequate. Last review was
conducted in April 2015,
Lastly, we can confirm that this incident has been reported to the MHRA via the yellow card
scheme.
Takeda UK Ltd. ue
liding 3, Glory Park, Glory Park Avenue, Wooburn Green, Buckinghamshire HP 19 GDF Onn
Tet +44(0) 1628 537900 « Fax: *44{0) 1628 526615 « wwwtakeda couk eee
ry Park Aver
Should you require any additional inform
ation regarding this report, please do not hesitate to
—_ = =—Ses Deputy Drug Safety Officer on fF
Yours sincerely
UK and Ireland Medical Director
|
Takeda UK Ltd.
Building 3, Glory Park, Glory Park Avenue, Wooburn Green, Buckinghamshire HP ig 00 United i
Tel: +4.4(0) 1628 537900 « Fax: +44 (0) 1628 526615 » wwwitakedaica.uk Ss
Regist
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