Dear Coroner,

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. National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG

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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 that people with eating disorders are able to access dedicated multidisciplinary support within their community. 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.

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.

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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.

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.

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4th Floor, Piccadilly Place, Manchester M1 3BN

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.

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.