Prevention of Future Deaths reports · 2023
Regulation 28 report to prevent future deaths, reference 2023-0516, written 8 Dec 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 8 Dec 2023 |
|---|---|
| Reference | 2023-0516 |
| Deceased | Charlene Roberts |
| Coroner | Joanne Kearsley |
| Coroner area | Manchester North |
| Category | Alcohol, drug and medication related deaths · Mental Health related deaths |
| Organisation named | Pennine Care NHS Foundation Trust |
| Source | judiciary.uk record · original PDF |
| Responses published | 4 |
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. Chair of the Faculty for Eating Disorders Royal College of Psychiatrists 2. Medicines and Healthcare Products Regulatory Agency 3. , Greater Manchester Health and Social Care Partnership/ Integrated Care Board 4. Chief Excecutive Officer of NHS England CORONER I am Joanne Kearsley, Senior Coroner for 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 13th January 2023, I commenced an investigation into the death of Charlene Roberts, date of birth 12th March 1987 who died on the 12th January 2023 at Fairfield General Hospital. The medical cause of her death was confirmed as 1a) Cyclizine Toxicity 2) Aspiration Pneumonia, Anorexia and Factitious Disorder 4 CIRCUMSTANCES OF DEATH Charlene was an extremely complex patient who could be difficult to engage. She had a complex diagnosis of Anorexia (since early 2000s), Factitious disorder (2019) and cyclizine abuse (2019). All It is recognised at the outset of this report that this is a rare of these were linked to past trauma. presentation. Charlene was under the care of Greater Manchester Eating Disorder Service (Greater Manchester Mental Health Trust), the Community Mental Health Team for her Factitious Disorder (Pennine Care NHS Foundation Trust), a Dual diagnosis worker for her cyclizine abuse. Due to her eating disorder her weight and bloods were monitored by her GP in the community. However her physical health meant she was often admitted to the acute hospitals, in particular North Manchester General Hospital (Manchester Foundation Trust) and Royal Oldham Hospital (Northern Care Alliance.) . She had initially been prescribed cyclizine around 2014 when she was an inpatient. The prescribing of cyclizine had continued unquestioned for over 5 years and at one point for reasons that could not be ascertained she was prescribed it intravenously. . However she was consistently found interfering with cannulas and lines (PIC lines) when she was an inpatient and would inject cyclizine into them. It had been recognised by medical staff that she should not have lines inserted. If there was a clear medical reason for them to be placed when she was an inpatinet, she would require 1-1 observations. Her care had been escalated in 2022 to the Multi Risk Management process. It was accepted that Charlene was at a significant risk of death due to her eating disorder and her cyclizine abuse. Charlene had capacity to make decisions in relation to her use of cyclizine. She was not able to be detained under the Mental Health Act 1983. From mid 2022 until the time of her death all professionals accepted that they had run out of ideas and options as to how to make progress with Charlene. She was rejected from nearly 20 inpatient Specialist Eating Disorder Services predominantly due to the dual diagnosis of her substance abuse and eating disorder. There was no treatment for her addiction to cyclizine, only psychological therapy to work on her addiction. On the 10th January 2023 Charlene attended A&E at Fairfield General hospital to have her weekly bloods taken. This was a recent arrangement due to difficulties for the GP in finding somewhere for her to have bloods taken. Due to being compromised Charlene required ultrasound guidance to obtain bloods. She was physically unwell with a suspected infection and was admitted as an inpatient. On the 12th January 2023 Charlene's condition deteriorated and she went into cardiac arrest. She died at 10:34am. Following her death it was discovered she had left the ward on the 11 th January 2023 and taken an uber taxi to a local pharmacist where she had purchased cyclizine. Her cause of death following examination was found to be due to cyclizine toxicity. 5 CORONE~SCONCERNS During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion In the circumstances it is my there is a risk that future deaths will occur unless action is taken. statutory duty to report to you. The MATTERS OF CONCERN are as follows:- 1. Cyclizine During the course of the Inquest a number of issues pertaining to cyclizine were raised. In considering these it is important to note that cyclizine is not tested for in routine toxicology testing so the prevelance of cyclizine abuse is not well understood. Many professionals who gave evidence had not worked with a patient with such an addiction previously. It was clear throughout the hearing that the knowledge of cyclizine varied amongst many professionals as to how it was prescribed and obtained. Medicines and Healthcare Products Regulatory Authority The court heard evidence that intravenous cyclizne is by prescription only but oral cyclizine can be purchased over the counter at a pharmacy. In order to purchase oral cyclizine in a pharmacy a pharmacist should seek information as to why it is required and should be present. Charlene's family gave evidence that following Charlene's death they had been able to obtain cyclizine in a pharmacy directly from a pharmacy assistant with no questions being asked of them. Chair of the Faculty of Eating Disorders Royal College of Psychiatrists The court was made aware of the research conducted in 2009 as published in the journal PNS, "Proceedings of the Nutrition Society", "Cyclizine dependence in patients with complex nutritional requirements" Thursby-Pelham, De Silva, Stroud and Fine, 23 July 2009. This identified cyclizine dependence in four female patients who all had complex nutritional problems. Whilst it is acknowledged that this is one study and as stated cyclizine addiction is rare, it was not something which had been considered before Charlene's addiction by the Eating Disorder Service. For the Manchester Eating Disorder Service there is now a greater awareness of cyclizine. This may be important nationally given its use as an anti-emetic. NHS England Cyclizine is not a controlled drug. At one stage consideration was given to using the Controlled Drugs local intelligence network as convened by NHS England (Controlled Drugs (Supervision and Management of Use) Regulations 2013) to put an alert out to local pharmacies to warn them about Charlene's purchasing of cyclizine. From the evidence there was a lack of clarity and understanding from professionals as to whether this local network could be used for drugs which are not controlled drugs. The fact that the legislation refers to controlled drugs may mean there is a lack of understanding about using this for system for non controlled drugs such as cyclizine. 2. Commissioned Pathway in Greater Manchester for the taking of bloods in community patients who are compromised. Greater Manchester Integrated Care Board During the course of the evidence the court heard evidence from the GP who was responsible for obtaining weekly bloods to monitor her eating disorder. There is no commissioned pathway in Rochdale for GPs to refer patients who require bloods but who are compromised and therefore hard to obtain blood from. As a result patients are attending A&E departments for these to be taken. w ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe each of you respectively have the power to 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 2 February 2024 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: The family of Charlene Roberts Greater Manchester Mental Health Trust Pennine Care NHS Foundation Trust NHS England 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 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 by the Chief Coroner. 9 Date 8th December 2023 Signed: /l - (/ ...
4 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.
E: Date: 7th February 2024 Ms Joanne Kearsley HM Senior Coroner Coroner’s Court Greater Manchester North Dear Ms Kearsley Re: Regulation 28 Prevention of Future Deaths Notice – Charlene Roberts Thank you for your Regulation 28 Report dated 8th December concerning the sad death of Charlene Roberts on 12th January 2023. On behalf of NHS Greater Manchester Integrated Care (NHS GM), We would like to begin by offering our sincere condolences to Charlene’s family for their loss. Thank you for highlighting your concerns during the inquest. On behalf of NHS GM, we apologise that you have had to bring these matters of concern to our attention. We recognise it is very important to ensure we make the necessary improvements to the quality and safety of future services. Following the inquest, you raised concerns in your Regulation 28 Report that there is a risk a future death will occur unless action is taken. We have worked with various departments within the ICB to review the concerns and ensure steps are taken to progress the concerns raised. I hope the response below demonstrates to you and Charlene’s family that NHS GM has taken the concerns you have raised seriously and will learn from this as a whole system. This letter addresses the issues that fall within the remit of NHS GM and how we can share the learning from this case. The medical cause of Charlene’s death was confirmed as 1a) Cyclizine toxicity 2) Aspiration pneumonia, anorexia and factitious disorder. During the course of the inquest the court heard evidence from the GP who was responsible for obtaining weekly bloods to monitor her eating disorder. There is no commissioned pathway in Rochdale for GPs to refer patients who require bloods but who are compromised and therefore hard to obtain blood from. As a result patients are attending A&E departments for these to be taken. There are ten localities across the Greater Manchester system, each of these have commissioned phlebotomy services based on the communities they serve, this means that there are variations in service across the system. As this incident occurred in Rochdale, we have sought a response directly from this locality. 4th Floor, Piccadilly Place, Manchester M1 3BN www.gmintegratedcare.org.uk A10 There are a very small group of people who may be more difficult to take blood than others due to clinical presentation. Rochdale GPs do have the ability to arrange, on a case-by-case basis, where a compromised patient needs to have bloods taken with support from ultrasound. We acknowledge that in this case the GP may have not been aware of this process and as such the process was reiterated to all GP practices via GP communications in January 2024. In addition to the locality-specific actions as set out above, a GM level review of phlebotomy provision has been undertaken recently which has identified the variation in provision and sets out the intention to improve the consistency of offer to patients across Greater Manchester. This is also a priority deliverable of the Greater Manchester Primary Care Blueprint. Actions taken or being taken to share learning across Greater Manchester: 1. The regulation 28 and our response to be presented/shared with the Greater Manchester System Quality Group on 21st March 2024. This meeting is attended by commissioners, including commissioners of specialist services, localities, regulators, Healthwatch and NICE. Through sharing in this forum, we expect members to review and ensure learning is incorporated into their commissioned services. 2. The process to support bloods being taken from patients who are compromised reiterated to all GP practices via GP communications. This was completed in January 2024. In conclusion, key learning points and recommendations will be monitored to ensure they are embedded within practice. We hope this response demonstrates to you and Charlene’s family that we have taken the concerns you have raised seriously and are committed to working together as a system including our service users, carers and families to improve the care provided. Thank you for bringing these important patient safety issues to our attention and please do not hesitate to contact me should you need any further information. Yours sincerely Interim Deputy Chief Executive And Chief Nursing Officer GM Integrated Care Place Based Lead GM Integrated Care – Rochdale 4th Floor, Piccadilly Place, Manchester M1 3BN www.gmintegratedcare.org.uk A11
10 South Colonnade Canary Wharf London E14 4PU United Kingdom gov.uk/mhra Ms Joanne Kearsley HM Senior Coroner 2 February 2024 Dear Ms Kearsley, Regulation 28 Report – Charlene Roberts I would like to thank you for your email dated 11 December 2024 regarding the Regulation 28 Report for the death of Charlene Roberts. I would like to express our condolences to the Roberts family and hope that the information provided below may help at this difficult time. Following receipt of the Regulation 28 Report we have considered the point addressed to the MHRA regarding the information sought by pharmacists when patients request over the counter cyclizine. Firstly, it may be helpful if to provide background information relating to the MHRA and the work we carry out. The MHRA is the executive Agency of the Department of Health and Social Care that acts on behalf of the Ministers to protect and promote public health and patient safety by ensuring that medicines and healthcare products are used safely and meet appropriate standards of safety, quality, performance, and effectiveness. The MHRA assesses the balance of risks and benefits of medicines throughout their use in clinical practice in a process known as pharmacovigilance. This involves the collection of information and assessment of any potential risks, followed, when necessary, with communications and regulatory action to minimise those risks. Cyclizine is available both as a prescription only product for intravenous formulations and as a pharmacy only product for oral formulations. Pharmacy only products can only be purchased from a pharmacy in the presence of a pharmacist. These medicines are not usually displayed on open shelves and pharmacy staff may discuss with the purchaser how the medicine is to be used, ask questions to make sure that the chosen medicine is appropriate, and check if the person needs to see another health professional such as a doctor, this helps prevent inappropriate use. A8 Within the Risk Management Plan (RMP) for cyclizine, “drug abuse and misuse” is an important identified risk and is therefore detailed within section 4.4 of the Summary of Product Characteristics (SPC), which states that “there have been reports of abuse with cyclizine, either oral or intravenous, for its euphoric or hallucinatory effects”. As an important identified risk for this product, this risk is routinely reviewed by the Market Authorisation Holder (MAH) in Periodic Safety Update Reports to identify any new evidence of this risk and evaluate the whether the risk minimisation measures remain effective. To date the MHRA have received a total 27 UK, spontaneous suspected adverse drug reaction (ADR) reports of cyclizine within the following Higher Level Terms (HLTs); Intentional product misuses; Intentional product use issues and; Substance related and addictive disorders. This reporting is in the context of over one million prescriptions of cyclizine in 2022 alone. It is also important to note that the fact that an ADR has been reported does not necessarily mean that the drug has been proven to cause it and reporters are only required to have a suspicion of an association to report an ADR. Many factors have to be taken into account in assessing causal relationships including the time between taking the suspect drug and experiencing the adverse effect, contribution of other medication, and any underlying disease. Additionally, reporting rates are influenced by a number of factors and for this reason the number of reports should not be used as a basis for determining incidence. The MHRA keeps the safe and effective use of medicines, including cyclizine, under continual review. We will consider the case raised in this report as well as wider evidence regarding the misuse of cyclizine and determine whether the current risk minimisation measures are sufficient. If further action is required, we will communicate this to healthcare professionals and patients. While we work closely with healthcare system partners, clinical practice is not within the remit of the MHRA. We would consider that concerns regarding the information provided by the pharmacy when patients request to purchase cyclizine without a prescription, and any consultation patients should receive, would be relevant to raise with the General Pharmaceutical Council, or GPhC, who are responsible for the regulation of the pharmacy profession, or the Care Quality Commission, or CQC, who regulate health and social care in the UK. I hope the information provided is useful, please do not hesitate to contact me if I can be of further assistance. Yours sincerely, Chief Safety Officer Medicines and Healthcare products Regulatory Agency A9
Joanne Kearsley Manchester North Coroner’s Office 2nd and 3rd Floors Newgate House Rochdale OL16 1AT Dear Coroner, National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG 2nd February 2024 Re: Regulation 28 Report to Prevent Future Deaths – Charlene Roberts who died on 12 January 2023. Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 8 December 2023 concerning the death of Charlene Roberts on 12 January 2023. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Charlene’s family and loved ones. NHS England are keen to assure the family and the coroner that the concerns raised about Charlene’s care have been listened to and reflected upon. In your Report you addressed to NHS England a concern that there was a lack of clarity and understanding from healthcare professionals as to whether the Controlled Drugs Local Intelligence Network could be used for non-controlled drugs, such as Cyclizine. As part of our consideration of this case, I have also asked my colleagues in the national Mental Health Team to provide some input on provision of eating disorder services and the impact of substance comorbidities on access to these services. Non-Controlled Drugs The provisions of the Controlled Drugs (Supervision of Management and Use) Regulations 2013 (the “2013 Regulations”) relate to controlled drugs only. They provide the legal framework under which information should be shared about an individual working in health and/or social care, a “relevant person” (see Regulation 5). The Local Intelligence Network supports the sharing of this information and members have a duty to co-operate and share information concerning the safe use and management of controlled drugs. The Regulations do not, however, provide a framework to share information about patients. On occasion, members of the Local Intelligence Network may share information about individual patients with relevant partners to support the safe management and clinical use of controlled drugs. Circumstances where this may occur include where there is a credible concern that someone may be accessing controlled drugs inappropriately from several clinical services. On these occasions, information provided about individual patients is in line with the Caldicott principles, and the individual’s freedom to choose how they access healthcare is balanced with the need for patient safety and public protection. A5 As cyclizine, in isolation, is not a controlled drug and Charlene was not a “relevant person”, the 2013 Regulations would not support the sharing of information in this instance using the Local Intelligence Network. However, all healthcare providers and healthcare professionals, have a duty to safeguard their patients. We would anticipate that relevant information would be shared with other clinical teams that may be involved in the provision of care to an individual patient, including community pharmacy contractors, in line with the Caldicott principles linked to above. Eating Disorder Care Provision The NHS Long Term Plan (LTP), a 10 year plan for the NHS, published in January 2019, sets out an ambition to increase care provision for adults with severe mental illness, including eating disorders, providing them with greater choice and control over their care and supporting them to live well in their communities. This includes creating integrated pathways of care across primary care, mental health services, voluntary and community sector organisations and social care for people with severe mental illness, delivering just under £1 billion of additional funding per year for transforming community mental health services by the end of 2023/24. Adult eating disorder services are expected to transform in alignment with the Adult Eating Disorders published guidance for commissioners and providers, which includes ensuring to access dedicated multidisciplinary support within their community. that people with eating disorders are able To deliver on this ambition, all Integrated Care Systems have received fair-share funding to transform their adult community mental health services, to include eating disorder services, since April 2021. The adult eating disorder guidance outlines the requirement for NHS commissioned Community Eating Disorder (CED) services to provide high quality care and to support early intervention. This includes noting the importance of medical monitoring and states that, "The ability to comprehensively monitor and manage the physical health of all people with an eating disorder (across all diagnoses and presentations) is an essential function of a CED service (pg. 15)". To support services to plan and implement improved pathways in alignment with the guidance, NHS England has undertaken, or is undertaking, the following: • Development of an internal resource, the Adult Community Mental Health Roadmap, intended to set out the different elements which will make up the delivery of LTP commitments on community mental health transformation (including eating disorders). Adult eating disorder services must ensure they are working with primary care services to provide clear medical monitoring arrangements. • Routinely monitors performance returns from services (via Integrated Care Systems) to track local progress. A6 • Strengthening the governance supporting service transformation by creating an all-age eating disorder Clinical Reference Group (CRG), with membership that includes people with lived experience, practitioners, regional NHS leads, eating disorder clinicians and academics. The aim of the CRG is to lead the transformation of eating disorder services, supporting collaboration across the full pathway (community and inpatient settings). The CRG will support collaboration across the different parts of the organisation helping us to align our work to better serve those with eating disorders. Drug and alcohol addiction/misuse are not automatic exclusion criteria for accessing NHS mental health services. NHS England are developing a joint action plan with the Department of Health and Social Care to improve the provision of mental health treatment for people with drug dependence. This will be published and implemented later in 2024. I would also like to provide further assurances on national NHS England work taking place around the Reports to Prevent Future Deaths. All reports received are discussed by the Regulation 28 Working Group, comprising Regional Medical Directors, and other clinical and quality colleagues from across the regions. This ensures that key learnings and insights around preventable deaths are shared across the NHS at both a national and regional level and helps us pay close attention to any emerging trends that may require further review and action. Thank you for bringing these important patient safety issues to my attention and please do not hesitate to contact me should you need any further information. Yours sincerely, National Medical Director A7
Date: 17 September 2024 Dear Ms Kearsley, Re: Charlene Roberts (Regulation 28: Report to Prevent Future Deaths). Thank you for sending this Regulation 28 Report to the Royal College of Psychiatrists, which we received via the Chair of our Eating Disorder Faculty, . On behalf of the Royal College of Psychiatrists, I am most grateful for the opportunity to comment upon this report. I would like to extend my deepest sympathies to Charlene Roberts’ family and loved ones. The Royal College of Psychiatrists (RCPsych) is the professional medical body responsible for supporting psychiatrists. The College sets standards and promotes excellence in psychiatry; leads, represents and supports psychiatrists; improves the scientific understanding of mental illness; works with and advocates for patients, carers and their organisations. The College does not work on the care of individuals, and I am not able to comment on the specific circumstances surrounding the case of the death of Charlene Roberts. However, I have considered your findings, and have the following comments to make in relation to the issue that you raise. As you acknowledge in your Report the relevance of cyclizine addiction is not well known and that includes in relation to people with co-existing eating disorders. The study from 2009 that you helpfully reference does point to there being need to explore this possible link, we haven’t been able to locate anything which indicates further research has been specifically undertaken in this area. A12 However small the potential risk, in response to your Report we are always looking at ways that we can improve the quality, standards and the safety of care within mental health services. Therefore, will be using mechanisms to communicate this potential risk to our members, such as through our College Newsletters, Faculty specific communications and any other opportunity where we can make this issue more widely known. We will also, where possible, raise it with mental health organisations themselves as well as those who have responsibility and oversight for the mental health system and who will have routes by which this information can be disseminated. Please do not hesitate to contact me if I can be of any further assistance and many thanks again for bringing this issue to our attention. Yours sincerely, Senior Policy and Standards Manager Royal College of Psychiatrists A13
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