Prevention of Future Deaths reports · 2021
Regulation 28 report to prevent future deaths, reference 2021-0218, written 24 Jun 2021. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 24 Jun 2021 |
|---|---|
| Reference | 2021-0218 |
| Deceased | Amy Ganner |
| Coroner | Simon Nelson |
| Coroner area | Manchester (West) |
| Category | Alcohol, drug and medication related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
Text recovered by OCR from a scanned PDF. OCR is imperfect: check anything you rely on against the source PDF. Reproduced verbatim, including the scan's own layout.
ANNEX A REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1) NOTE: This form is to be used after an inquest. REGULATION 28 REPORT TO PREVENT FUTURE DEATHS | THIS REPORT IS BEING SENT TO: 1. Rt Hon, Matt Hancock MP, Secretary of State, Department of Health CORONER | am Mr Simon Raymond Nelson, Assistant Coroner, for the coroner area of Manchester West 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. [HYPERLINKS] INVESTIGATION and INQUEST On 11 January 2021 | commenced an investigation into the death of Amy Anne June Ganner, aged 26 years. The investigation concluded at the end of the inquest on 22 June 2021. The conclusion of the inquest was Misadventure. The medical cause of death was 1a) Combined Drugs Toxicity. CIRCUMSTANCES OF THE DEATH Against a background of complex health conditions with chronic pain the deceased inadvertently ingested an excessive amount of prescribed medication prior to being discovered on 6" January 2021.. 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 could occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows. — The deceased had suffered with chronic pain from complex medical conditions for several years. Her medication included Tramadol capsules; Zomorph modified release capsules and morphine sulphate oral solution all of which were opioid drugs associated with central nervous and respiratory depressant effects. Their individual effects would be enhanced when taken in combination and these depressant effects would be exacerbated by her use of the other drugs appropriately prescribed for her. As for all opiate cases the toxicological significance of the morphine concentration will depend upon the degree of tolerance possessed by the deceased. In this case as the opiate based medication was prescribed for her and being used regularly she would be expected to have a degree of tolerance. However it is known and was asserted in evidence that tolerances can be quickly lost, in the event of a period of abstinence; that the diminution of tolerance varies from person to person and is extremely difficult to predict. Whilst the deceased was intelligent and had a clear understanding of the risks, benefits and role of her medication both her general practitioner who gave evidence and | | believe that it would be extremely helpful if the Department of Health was to support the production of a leaflet in both electronic and paper formats dealing with the concept of ‘tolerance’ and emphasising the serious risk of toxicity which would be available to all whom are prescribed opiate based medication. ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and | believe you and your organisation have the power to take such action. YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 20" August 2021. 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. COPIES and PUBLICATION | have sent a copy of my report to the Chief Coroner and to the following Interested Persons — mother father partner — General Practitioner ! am also under a duty to send a copy of your response to the Chief Coroner and all interested persons who in my opinion should receive it. | may also send a copy of your response to any other person who | believe may find it useful or of interest. The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send a copy of this report to any person who he believes may find it useful or 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. 24 June 2021 <J Ds N Cl, N
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.
• Department of Health & Social Care From the Lord Kamal/ Parliamentary Under Secretary of State for Innovation (Lords) 39 Victoria Street London SW1H0EU Simon Nelson HM Assistant Coroner, Manchester West HM Coroner's Court Paderbom House Howell Croft North Bolton BL11QY Dear Mr Nelson, 20 October 2021 Thank you for your letter of 24 June 2021 about the death of Amy Ganner. I am replying as Minister with responsibility for medicines, and I am grateful for the additional time allowed in order for me to do so. Firstly, I would like to say how saddened I was to read of Amy Ganner's death and I offer my sincere condolences to her family and loved ones. The circumstances your report describes are very concerning and I am grateful to you for bringing these matters to my attention. With regards to the concerns that you raise within your report, you may wish to note that the Medicines and Healthcare products Regulatory Agency (MHRA) undertook a review of opioid medicines and the risk of addiction and dependence in 2019, and sought advice from an Expert Working Group of the Commission on Human Medicines (CHM). In April and June 2019, the Expert Working Group made recommendations, which were endorsed by CHM, and subsequently took forward a number of actions to better support appropriate use of prescription opioids, and to increase awareness of their risks amongst both healthcare professionals and patients. As a result of these recommendations, the warnings on the risks of dependence, addiction, and tolerance in the product information for tramadol tablets, Zomorph modified release capsules and morphine sulphate oral solutions (amongst other opioid medicines) have been updated to contain consistent warnings on the risks of dependence, addiction, and tolerance. This information also encourages patients and healthcare professionals to discuss treatment regimens and plan for end of treatment. In addition, in May 2019 warnings that products 'Can cause addiction' and 'Contains opioid' were added to the packaging for opioid-containing medicines. The MHRA communicated this in its bulletin, Drug Safety Update (DSU)1 in September 2020, publicly available on the MHRA website and through the Yellow Card app. The DSU is also sent electronically to healthcare professionals, and direct subscribers. The individual representatives in the MHRA Patient Group Consultative Forum were also contacted by email to highlight the DSU article at the same time. The article also sets out how to report cases of dependence to the Yellow Card Scheme-which is a system for collecting and monitoring information on the safety of medicines The bulletin is also published online.2 Further, the update provides information for healthcare professionals and a link to a safety leaflet, either from a web page3 or in PDF form, for patients that can be printed from the MHRA website4 experience withdrawal effects if they stop taking their medicine suddenly, and if this happens to discuss it with their doctor. • This includes a warning that patients may develop tolerance and can In order to increase awareness a press release was issued at the same time5 as a notification that explained the strengthened warnings in relation to the risk of dependence and addiction. My officials have made the MHRA aware of your report and the circumstances of Ms Ganner's death and those details have been added to the MHRA's Yellow Card database The data held within the Yellow Card scheme is used to help monitor the safety of medicines and will help to build on the evidence base. The MHRA recognises the important safety concerns in your report and has taken action to try and ensure the risks associated with dependence, addiction and tolerance are minimised. The MHRA will ensure this issue remains under continuous monitoring to ensure these measures are effective. Furthermore, I will speak to the MHRA about how to improve access to their information leaflets, to ensure this information is as widely available as possible. 1https ://assets. publishing.service .qov .uk/government/u pload s/system/uploads/attachment data/file/920 770/ Sept-2020-DSU-PDF .pdf 2 https://www.gov.uk/ d rug-sa fety-u pd ate/ opioi ds-risk-of-dependence-a n d-addiction 3 https://www.gov.uk/guid ance/opioid-medicines-a nd-the-risk-of-add iction 4 https ://assets .publish ing.service.gov. uk/med ia/5f6a0 78ed3bf7f7238f231 00/0pioi d-patient-safety information-leafl et-v2-Auq2021 . pdf 5 https://www.gov.uk/government/news/uk-regulator-strengthens-opioid-warnings In relation to the wider context and the increasing concern internationally and here in the UK about the overuse and misuse of opioids leading to a growing problem of dependence and addiction, I would like to outline the range of action that has been taken to protect patients from harm. In 2017, the Government asked Public Health England (PHE) to conduct an evidence review to identify the scale, distribution and causes of prescription drug dependence, and what might be done to address it. PHE's report of the review was published in September 20196 , providing evidence for dependence on, and withdrawal from, prescribed medicines, with the aim of making sure that local healthcare systems build awareness and support to enhance clinician and patient decision making. In support of this, NHS England and NHS Improvement (NHSEI) is co-ordinating a programme to implement the recommendations of the review, working closely with relevant health system partners. The programme covers five classes of medicines including benzodiazepines; Z-drugs; gabapentinoids; opioids, for chronic non-cancer pain; and antidepressants. Finally, since October 2020, Primary Care Networks of GPs have been required to identify and prioritise patients, including patients using potentially addictive pain management medication, who would benefit from a structured medication review. You may also wish to note that further to the February 2020 update to the GP contract agreement 2020/21 to 2023/24, a Quality Improvement Module in the Quality and Outcomes Framework for general practice on preventing prescription drug dependency is in development. I hope this response is helpful. Yours, LORD KAMALL 6https://assets.publishing.service.gov.uk/governmenUuploads/system/uploads/attachment data/file/940255/ PHE PMR report Dec2020.pdf
See every Prevention of Future Deaths report matching Alcohol, drug and medication related deaths, and how often a new one appears.
What would an alert for this have sent me? Search the full text
Free to try — the preview shows the real matches and how many arrived in the last 12 months. Your first email alert is free.
These reports are published by the Chief Coroner's office at judiciary.uk and are © Crown copyright. The text here is reproduced from the published PDF so it can be searched. If something on this page is wrong, or you are a person named in it and want it reviewed, email drcjar@gmail.com and we will act promptly.