Source · Prevention of Future Deaths

Irene Pearson

Ref: 2016-0014 Date: 19 Jan 2016 Coroner: John Pollard Area: Manchester (South) Responses identified: 2 / 3 View PDF

Matrifen patch warnings about hot baths are obscure and vague, and dangerous advice was given to use baths for patch removal. Poor liaison on opiate prescribing and unclear, scanty GP electronic notes contributed to unsafe care.

Date 19 Jan 2016

56-day deadline 15 Mar 2016 est.

Responses identified 2 of 3

Community health care and emergency services related deaths

Coroner's concerns

AI summary

View full coroner's concerns

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: Forensic Consultant Toxicologist gave evidence to me that heating of the body will cause an onrush of delivery of the drug: (Takeda UK)
2. Even when the said warning phrase is reached in the leaflet; it then refers to prolonged hot bath without in any way defining_the_ words 'prolonged" or "hot" Glory Glory the The the "2

These terms are easily open to subjective interpretation, which may lead to an unsafe usage environment: (Takeda UK) 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 pointed out that even when due for change, the patch contains (and therefore can release) a very considerable level of the drug: The advice to use this method of removal would therefore seem to be inherently potentially dangerous (Macmillan Cancer Care)
4. was told that the Macmillan Nurses will prescribe additional opiate pain-control, but there seemed Iittle or no Iiaison with the GP Practice as to the regulation of this-(Macmillan Cancer Care)
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 as doctors, are limited to ten-minute appointments and do not always have time properly to record their notes. (Churchgate Surgery)
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)

Responses

2 respondents

I Pearson

4 Apr 2016 PDF

Action Planned

Takeda has reported the coroner's concerns about heat exposure and fentanyl patches to Johnson and Johnson and requested they conduct a review to determine if changes to product information are required. (AI summary)

View full response

Dear Mr Pollard Re Irene Ann PEARSON (Deceased) (your Ref: JSPIERJ01780-2015) Following your officer' $ phone call with Meera Pithia on 30th March 2016, this letter constitutes Takeda'$ response to the Regulation 28 report. Item @ 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 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 bot water bottle) . Given the need to balance completeness with brevity and understandability in the compilation of patient information leaflets, our current view is that the information presented in the Matrifen leaflet adequately addresses the issue of expoging patches to heat sources However; we have reported this matter to Johnson and Johnson; who own the brand leader product Durogesic, and have requested that conduct & review to determine whether any changes are required to the product information a8 a Tesult of this incident: We are obliged to ensure that the product information leaflet for Matrifen is consistent with that for Durogesic. We can confirm that this incident has becn 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) hag recently extensively reviewed by the MHRA to ensure the wamings are adequate. Item 2; With regard to your request for us to define 'prolonged' and *hot' Iam afraid we are not able to do this a8 we do not have sufficient data on heat exposure and fentanyl absorption t0 determine what an appropriate duration or temperature would be. Takeda UK Ltd. Building 3, Glory Park; Glory Park Avenue, Wooburn Green, Bucknghamshire HPIQ ODF United Kingdom Tel: +44(0} 1628 537900 * Fax: +44(0] 1628 526615 wvwwtakeda co uk Regittered ollice; Buldg dory Park, Clory Park Avenue. wonhum Grcen; Buckinghamstiire; HPIO ODr, United Xingdom Registcrcd h Englard Jnd Walc; No 3362860 things tbey been safety

Takeda Futthermore; since rate of absorption will vary by person, depending on dosage, age and body weight for example, giving advice in terms of exact duration and temperature would be inappropriate. Should you require any additional information regarding this rcport_please do not hesitate to contaci Deputy Safety Officer on

I Pearson Response2

5 Apr 2016 PDF

Action Taken

Following the inquest, the Macmillan team sent a 'Trust Alert' out to all hospital and community staff reminding them not to advise patients to take a bath to aid removal of fentanyl patches. (AI summary)

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Dear Mr Pollard Re: Irene Anne Pearson (Deceased) am writing in response to your regulation 28 report forwarded to the Trust by Macmillan Cancer Care following the inquest into the death of the above named person: am grateful to you for highlighting your concerns and for providing me with an opportunity to respond: shall address each of your concerns in the order in which you raised them: heard evidence that the Macmillan Nurses had advised the deceased to take a bath when preparing to remove the 'exhausted' patch s0 as to aid removal: The toxicologist pointed out that even when due for change, the patch contains (and therefore can release) very considerable level of the The advice to use this method of removal would therefore seem to be inherently potentially dangerous: The Macmillan team have provided assurance that would not advise anyone to take a bath to aid removal of an exhausted 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 are reminded of this risk was told that the Macmillan Nurses will prescribe additional opiate pain control, but there seemed little or no Iiaison with the GP Practice as to the regulation of this: It is the practice of the Macmillan team when changing or prescribing medication to the relevant GP practice within 24 hours_ In terms of prescribing for Mrs Pearson, the following information (in italics) indicates the Iiaison which occurred from the Macmillan team to the GP practice: understand that on receipt; these faxes are scanned and attached to the GP records_
24.03.15 Dexamethasone 4mgs daily x28 tablets Cyclizine SOmgslml x10 ampoules Water for injection drug: they patch they fax

01.04.15 BuTrans 1Omcgs/hr x patches: One patch every 7 days Oramorph 1Omgs/smls x1OOmls 2.5-Smls pm Cyclizine for injection SOmgs/ml x10 Cyclizine S0mgs TDS x1o0
12.05.15 Fentanyl 25mcgs/hr 72hours x10 patches: Stop BuTrans patches
02.06.15 Benzydamine oral mucosal spray 3Omls x2 Increased Mirtazipine from 15mgs to 3Omgs
08.06.15 A letter was faxed to GP after Mrs Pearson's husband phoned the Macmillan team following a review by an Out of Hours GP who had increased the Fentanyl patch from 25mcgs to 5Omcgs: Mr Pearson confirmed that she was much better and not experiencing any side effects He was requesting more patches ad this request was included in the letter faxed to the GP to prescribe if he felt it appropriate
29.06.15 Request for Mirtazipine 1 x6O. Take 2 at night
01.07.15 Following visit from Macmillan nurse, the Fentanyl patch Was decreased from SOmcgs to 37mcgs and therefore 12mcgs Fentanyl patch was prescribed (x5). (i.e. 25mcgs plus 12mcgs)
07.07.15 Mrs Pearson was visited due to an increase in pain; Irene and her family informed staff that had increased the patch 37mcgs back to sOmcgs on the 06.07.2015 without seeking advice: We have clarified with the GP practice and the notifications of the above prescriptions completed by the Macmillan team were all received by the practice and scanned onto the patient records. We cannot find a record of the letter sent on 08.08.2015 as above; however we did find that this change of medication the Out of Hours GP was communicated to the practice_ hope that this response answers your concerns and provides you with the assurance that the Trust is committed to improving the quality of care we give to all our patients. Please do not hesitate to contact me if yourave any further questions regarding this matter:

Report sections

Investigation and inquest

On 15th October 2015 | commenced an investigation into the death of Irene Anne Pearson dob 12th July 1941. The investigation concluded on the 18th January 2016 and the conclusion was one of Misadventure The medical cause of death was Ia Opiate Toxicity 11 Carcinomatosis, Carcinoma Colon and Ischaemic Heart disease

Circumstances of the death

The deceased was diagnosed with terminal cancer of the colon which had then spread to various other organs (carcinomatosis): As part of her palliative care, she was prescribed Matrifen patches. She was ill-advised as to the level of medication which she needed and as to precise effects of certain actions upon the delivery of such: On the 19 July 2015,at her home, she had a hot bath and was found dead in the bath; with the hot tap running: It is believed she was wearing the patch when she got into the bath.

Action should be taken

In my opinion action should be taken to prevent future deaths and believe you have the power to take such action:

Similar PFD reports

Shared signals

Related inquiry recommendations

Report details

Reference: 2016-0014
Date of report: 19 January 2016
Coroner: John Pollard
Coroner area: Manchester (South)

Responses identified

Responses identified 2 of 3

1 response not yet linked

Organisations named in PFD reports are normally expected to respond within 56 days. Deadline: 15 Mar 2016 (estimated).

Sent to

Churchgate Surgery

Macmillan Cancer Support

Takeda UK Ltd

Source links

Judiciary.uk page → Report PDF →

Data: judiciary.uk under OGL.