Prevention of Future Deaths reports · 2016
Regulation 28 report to prevent future deaths, reference 2016-0014, written 19 Jan 2016. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 19 Jan 2016 |
|---|---|
| Reference | 2016-0014 |
| Deceased | Irene Pearson |
| Coroner | John Pollard |
| Coroner area | Manchester South |
| Category | Community health care and emergency services related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
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REGULATION 28: REPORT TO PREVENT FUTURE DEATHS REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT 10: EN Churchgate Surgery, 119, Manchester Road, Denton, Manchester, M34 3RA: MacMillan Cancer Care, 89, Albert Embankment, London, SE1 7UQ: Takeda U.K. Limited, Building 3, Glory Park, Glory park Avenue, Wooburn Green, Buckinghamshire HP10 ODF: 1 | CORONER | am John Pollard, senior coroner, for the coroner area of South Manchester 2 | CORONER’S LEGAL POWERS | make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013 3 | INVESTIGATION and INQUEST On 15" October 2015 | commenced an investigation into the death of Irene Anne Pearson dob 12" July 1941. The investigation concluded on the 18" January 2016 and the conclusion was one of Misadventure. The medical cause of death was 1a Opiate Toxicity .11 Carcinomatosis, Carcinoma Colon and Ischaemic Heart disease. 4 | 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 the precise effects of certain actions upon the delivery of such. On the 1g” 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. 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. — 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 4" 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) 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) 3. | 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 little or no liaison 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 they, as doctors, are limited to ten-minute appointments and they 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) 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. YOUR RESPONSE You are under a duty to respond to those issues attributed to you in paragraph 5 of this report within 56 days of the date of this report, namely by 15" March 2016. |, 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. COPIES and PUBLICATION | have sent a co to the Chief Coroner and to the following Interested Persons namel (Husband of the deceased). | have also sent it to CQC, Ss mceurcrcigncet Sa forensic toxicologist), Mrs M.J. Leeming (Senior Coroner Manchester West) and Mr S. Nelson (Senior Coroner Manchester North) who may find it useful or of interest. | am also under a duty to send the Chief Coroner a copy of your response. The Chief Coro ay publish either or both in a complete or redacted or summary i ay 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. John Pollard, HM Senior Coroner
2 responses 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.
Stockport NHS) NHS Foundation Trust Oak House Stepping Hill Hospital Poplar Grove Our ref. AB/CMiletter to coroner — Irene Pearson Stockpert Your ref. JSP/ Telephone: 0161 483 1010 Fax: 0161 487 3341 Direct line: 0161 419 5444 5 April 2016 E-mail: ann.bames@stockport.nhs.uk . M. Coroner SoS aM RECEIVED Greater Manchester South District Coroner's Court . Mount Tabor 7 BRU Mottram Street (a 6 KO Stockport SK1 3PA 171 (201g 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 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. 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. | 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. It is the practice of the Macmillan team when changing or prescribing medication to fax the relevant GP practice within 24 hours. In terms of prescribing for Mrs Pearson, the following information (in italics) indicates the liaison 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 50mgs/mi x10 ampoules Water for injection 01.04.15 BuTrans 10megs/hr x 4 patches. One patch every 7 days Oramorph 10mgs/5mis x100mis 2.5-5mis pm Cyclizine for injection 50mgs/ml x10 Cyclizine 50mgs TDS x100 12.05.15 Fentanyl 25megs/hr every 72hours x10 patches. Stop BuTrans patches 02.06.15 Benzydamine oral mucosal spray 30mls x2 increased Mirtazipine from 15mgs to 30mgs 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 SOmegs. Mr Pearson confirmed that she was much better and not experiencing any side effects. He was requesting more patches and this request was included in the letter faxed to the GP to prescribe if he felt it appropriate. 29.06.15 Request for Mirtazipine 15mgs x60. Take 2 at night 01.07.15 Following visit from Macmillan nurse, the Fentanyl patch was decreased from 50mcgs to 37megs and therefore a 12mcegs Fentany! patch was prescribed (x5). (ie. 25mcegs plus 12mcgs) 07.07.15 Mrs Pearson was visited due to an increase in pain; Irene and her family informed staff that they had increased the patch from 37megs back to 5Omcegs 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 Macmiflan team were all received by the practice and scanned onto the patient records. We cannot find a record of the letter sent on 08.06.2015 as above, however we did find that this change of medication from 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 yo) fave any further questions regarding this matter.
Our Reference: 015380 4th April 2016 Mr John Pollard Senior Coroner HM Coroner South Manchester Coroners Court 1 Mount Tabor Street Stockport SKI 3AG Dear Mr Pollard Re Irene Ann PEARSON (Deceased) (your Ref: JSP/ER/01780-2015) Following your officer’s phone call with Meera Pithia on 30 March 2016, this letter constitutes Takeda’s response to the Regulation 28 report. 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 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 exposing 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 they conduct a review to determine whether any changes are required to the product information as a result 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 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. 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. Takeda UK Ltd. Building 3, Glory Park, Glory Park Avenue, Wooburn Green, Buckinghamshire HP1C ODF United Kingdom Tel: +44(0)} 1628 537900 + Fax: +44(0) 1628 526615 + www.takeda.co uk Registered office: Building 3. Gory Park, Glory Park Avenue, Woobum Green, Buckinghamshire, HP10 ODF, United Xingdom. Registered in England and Wales No. 3362860 Furthermore, 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 report, please do not hesitate to a Deputy Drug Safety Officer iii Yours sincerely UK and Ireland Medical Director Takeda UK Ltd. ing 3, Glory Park Tel: +44(G) 1628 5 shire HP10 ODF United Kingdom n Green, Buckingt Bui a
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