Source · Prevention of Future Deaths

Nadine Brookes-Walker

Ref: 2015-0463 Date: 16 Nov 2015 Coroner: Elaine Moloney Area: Manchester (North) Responses identified: 1 / 1 View PDF

Packaging for Fentanyl patches may not adequately convey the severe risks associated with using damaged patches, potentially leading to patient misuse.

Date 16 Nov 2015

56-day deadline 11 Jan 2016 est.

Responses identified 1 of 1

Product related deaths

Coroner's concerns

AI summary

Packaging for Fentanyl patches may not adequately convey the severe risks associated with using damaged patches, potentially leading to patient misuse.

View full coroner's concerns

Warning regarding the seriousness of the consequences of using damaged Fentanyl patches may not be apparent to the patient from the packaging

Responses

1 respondent

Nadine Brooks

PDF

Noted

Takeda believes the existing patient information leaflet adequately addresses the issue of damaged patches, and they have requested a review to determine if changes are needed; the MHRA also reviewed product information for fentanyl patches in April 2015. (AI summary)

View full response

Dear Ms Snook Re Nadine Alexandra Brookes-Walker (your Ref:
56281) Following the letter dated 17" November 2015 fton subsequent correspondence with yourself and vour and our response to the Regulation 28 report. Ithis letter constitutes Takeda' $ Matters_of concern: With regard to your specific comment 'warning damaged fentanyl patches may not be regarding the seriousness of the consequences of request for *action to be taken to apparent to the patient from the packaging' and your section 3 of the Matrifen prevent future deaths' we would like to to your attention patient information leaflet (PIL) where the is mentioned: the patch for any damage. Do not use patch if it has been divided, cut or looks damaged: Given the need to balance completeness with our current view is that the and understandability in the compilation of addresses the issue of damaged achent information presented in the Matrifen leaflet adequately patches_ Furthermore; a8 we are required to ensure that the PIL for brand leader product Durogesic, marketed Matrifen is consistent with that of the conduct a review to determine by Johnson & Johnson; We have requested that result of this incident: whether ahy changes are required to the product information understand that this is still under as & investigation In addition kindly be informed that the product Matrifen) have recently been extensively information for Fentanyl patches (which include Regulatory Agency (MHRA; to reviewed by the Medicines and Healthcare Products conducted in Aprii 2015. ensure the warnings are adequate. Last review WaS Lastly, we can confirm that this incident has been scheme. reported to the MHRA via the yellow card Takeda UK Ltd, Park; Park Avenue; Wooburn Green, Tel: +44(0} 1628 537900 +440) 1628 526615 Buckinghamshire HP1O ODF United Kingdom wwwtakeda co.uk Registered otfice: Building Park; Park Avenue; Green; Buckinghamshire, HPTO ODF, United Kingdom Registered Engiand and Wales JJrjor Our May 2096 May Way colleague using bring following Inspect the brevity PILs, they safety Building Glory Glory Fax: Clony Ciol Wcoburn

Takeda Should you require any additional information regarding this contad report; please do not hesitate to Deputy Safety Officer on

Report sections

Investigation and inquest

On the 5 th 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.

Circumstances of the 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 if this 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.

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Report details

Reference: 2015-0463
Date of report: 16 November 2015
Coroner: Elaine Moloney
Coroner area: Manchester (North)

Responses identified

Responses identified 1 of 1

All listed responses identified

Organisations named in PFD reports are normally expected to respond within 56 days. Deadline: 11 Jan 2016 (estimated).

Sent to

Teva UK Ltd

Source links

Judiciary.uk page → Report PDF →

Data: judiciary.uk under OGL.