Nicolette McCarthy

Dear Coroner, Re: Regulation 28 Report to Prevent Future Deaths – Nicolette Elizabeth McCarthy who died on 19 September 2023.

Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 22 November 2024 concerning the death of Nicolette Elizabeth McCarthy on 19 September 2023. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Nicolette’s family and loved ones. NHS England are keen to assure the family and the Coroner that the concerns raised about Nicolette’s care have been listened to and reflected upon.

I am grateful for the further time granted to respond to your Report, and I apologise for any anguish this delay may have caused Nicolette’s family or friends. I realise that responses to Coroners’ Reports can form part of the important process of family and friends coming to terms with what has happened to their loved ones, and I appreciate this will have been an incredibly difficult time for them.

Your Report raises concerns about the application of NHS smoke free estate policy and whether it adequately reflects the safety requirements of mental health wards and mental health patients who seek leave to smoke. My response to the Coroner addresses the concerns raised in relation to national guidance and policy, which are within the remit of NHS England.

Smoking remains the biggest modifiable risk factor in mortality and morbidity in England and the leading modifiable cause of health inequalities. Whilst diseases relating to smoking are treatable and preventable, smoking continues to lead to an estimated 64,000 to 74,000 deaths per year. In 2022/2023, 4% of all hospital admissions were attributable to smoking, and 16% of hospital admissions were for conditions that can be caused by smoking.1 NHS smoke free estate policy aims to support wider efforts for smoking cessation.

Increased risk of self-harm and suicide

1 https://digital.nhs.uk/data-and-information/publications/statistical/statistics-on-public- health/2023/part-1-hospital-admissions#smoking-related-ill-health National Medical Director for Secondary Care and Quality NHS England Wellington House 133-155 Waterloo Road London SE1 8UG

17 February 2025

Your report states that NHS England’s smoke free policy places mental health inpatients at an increased risk of self-harm and suicide. Currently, there is no known published evidence that smoke free policies place patients at an increased risk of self- harm or suicide.2

Published evidence demonstrates that people with mental health conditions wish to stop smoking as much as people without mental health conditions, and that once withdrawal has passed, smoking cessation can improve the symptoms of depression and anxiety equivalent to taking antidepressants. Some people may have increased anxiety about the potential impact of withdrawal on their mental health symptoms based on an assumption that smoking has a positive effective on their mood and anxiety levels. However, it is likely that these withdrawal symptoms manifest when blood nicotine levels drop and the nicotine from the next cigarette will therefore only temporarily relieve them. Smoking is not a healthy solution for managing mental illness and it is well-known that nicotine can increase anxiety.

We do, however, acknowledge that not all patients who are detained under the Mental Health Act feel willing or able to stop smoking, and that supporting patients to make changes toward healthier behaviour, particularly if they are experiencing mental health challenges or crisis, is difficult. A comprehensive offer of support should therefore be available to all patients, which is positively reinforced at all opportunities to support the patient in stopping smoking. If appropriate advice is provided alongside effective management of withdrawal symptoms using smoking cessation aids, and other tools/resources, patients are more likely to stop smoking and experience a positive impact on their mental wellbeing.

NHS Long Term Plan Commitments

The NHS Long Term Plan commits to providing NHS funded tobacco dependency treatment to all inpatients who smoke. Sussex Partnership NHS Foundation Trust began delivering its services from April 2022, having an offer in place for all inpatients from October 2022. There is an expectation that providers will already have awareness of the relevant NICE guidance (NG209) and that they will make a range of smoking cessation aids available and support patients with personalised treatment plans.

Delivery of tobacco dependence treatment allows patients to address tobacco dependence, supports delivery of smoke free estates and allows staff to focus on caring for patients and their underlying mental health conditions. The implementation and commissioning of tobacco dependence treatment should be driven by Integrated Care Boards and complement wider work to improve the quality of care and support inpatients receive, and safety planning should be considered on an individual basis for each patient. Patients should be seen as individuals, and their personal choices, circumstances and preferences should remain at the heart of all care provided to them.

National guidance and Section 17 Leave

Your Report also states that national guidance on smoking and Section 17 leave does not resolve the contradictions in smoke free policy. Section 17 leave is designed to

2 Hughes, 2007; Taylor, 2014; Taylor et al., 2021; Wu et al., 2023.

allow patients to leave hospital as part of their care package in order to support patients to transition to care outside of the hospital. Guidance from the Care Quality Commission (CQC) is clear that Section 17 leave should not be used to facilitate smoking breaks. There is an expectation that a robust, individualised risk assessment should be completed before granting any Section 17 leave, including considering the risks of harm from not granting leave and the potential of self-harm and suicide. It is unclear to NHS England from the information provided whether an individualised risk assessment was completed for Nicolette.

Having a wider smoke free NHS estate is not a legal requirement in England, but has been recommended by both the National Institute for Health and Care Excellence (NICE) since 2013 (see NICE NG209) and HM Government (Tobacco Control Plan,
2017). The NICE Guidance does state that healthcare providers should ensure that there are policies, procedures and resources in place to ‘work with people who use services to overcome any problems that may result from smoking restrictions’ [1.21.3] and ensure that ‘management of smoking’ is included in the care plan for people in closed institutions who smoke [1.21.6]. The NICE Guidance also provides advice on stopping smoking for those patients using mental health services: Treating tobacco dependence | Tobacco: preventing uptake, promoting quitting and treating dependence | Guidance | NICE.

I note that you have also addressed your concerns to NICE and the DHSC, and it would be appropriate for these organisations to respond to the Coroner, as the responsible policy holders for the issues raised. Individual NHS Trusts are responsible for the local implementation of these policies and not the wider NHS England Estates Team.

NHS England’s South East regional colleagues are also in the process of seeking assurances from the relevant system regarding local arrangements and processes with regard to the concerns raised by the Coroner.

I would also like to provide further assurances on the 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 events, such as the sad death of Nicolette, are shared across the NHS at both a national and regional level and helps us to 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 Mr Spencer

Re: Regulation 28 Prevention of Future Deaths Report (Nicolette Elizabeth McCarthy)

I write in response to your regulation 28 report dated 22 November 2024 regarding the very sad death of Nicolette Elizabeth McCarthy. I would like to express my sincere condolences to Nicolette’s family.

The patient safety leads at NICE have carefully considered the content of your report and understand that your request relates to highlighting the difficulty of implementation of national guidance on smoking cessation in the context of inpatient care for acute mental illness.

Given that the matters of concern relate to contradictions in national policy, these are not areas that are within NICE’s remit. We believe that the issues raised are best addressed by NHS England, and I note that your report has also been sent to them. The Care Quality Commission (CQC) may also be able to provide useful feedback to the points raised.

Although not directly mentioned in your report, it may be helpful for us to highlight our guideline Tobacco: preventing uptake, promoting quitting and treating dependence (NG209). Section 1.14 deals with support for people in secondary health services including mental inpatient care. The guideline is not restrictive in its recommendations; rather it focuses on expectations that people should have for support in managing their addiction, in an environment in which smoking is not allowed.

We would expect local policy to note the existence and recommendations of NG209 and other guidance, along with the needs of the person with regards to smoking and avoiding stress, and to take account of these in developing a reasonable local policy. This might emphasise support for people who do not want, or are not ready, to stop smoking in one go, to reduce their harm from smoking (recommendations 1.15.1 – 1.15.14, along with appropriate local opt-outs from the policies recommended in section 1.21 of the guideline.

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See also recommendation 1.14.19, and note that the committee made a research recommendation on ‘How can people with mental health conditions be supported effectively to stop smoking (at individual and system level)? What are the challenges and opportunities and how can they be addressed?’

Our research recommendations are all unanswered research questions that emerge during the development of NICE guidance. These are uncertainties that the guideline developers have identified during the development of the guidance or where robust evidence is lacking.

Research recommendations can cover questions about any aspect of the guidance. These are not topics for NICE to specifically investigate further but have been highlighted on our website for external research organisations or individuals to take forward.

The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals and practitioners are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or the people using their service. It is not mandatory for the NHS to apply the recommendations, and the guideline does not override the responsibility to make decisions appropriate to the circumstances of the individual, in consultation with them and their families and carers or guardian.

We are also aware that the government has recently introduced the Tobacco and Vapes Bill which may be of relevance to any actions required as a result of the issues that you have raised. I note that you have also sent your report to the Secretary of State for Health and Social Care, who will be able to provide the relevant detail on the Bill.

I hope that the information above is helpful and would like to reiterate my sincere condolences to Nicolette’s family.

Dear Mr Spencer,

Thank you for the Regulation 28 report of 22 November 2024 sent to the Secretary of State about the death of Nicolette Elizabeth McCarthy. I am replying as the Minister with responsibility for patient safety and mental health.

Firstly, I would like to express how saddened I was to read of the circumstances of Ms McCarthy’s death, and I offer my sincere condolences to her family and loved ones. The circumstances your report describes are deeply concerning and I am grateful to you for bringing these matters to my attention. Thank you also for the additional time provided to the Department to provide a response to the concerns raised in the report.

Your report raises concerns over the impact and implementation of the smoke-free policy in the NHS on mental health inpatients who smoke and on staff working practices within mental health inpatient units.

In preparing this response, my officials have made enquiries with NHS England to ensure we adequately address your concerns.

Under the 2006 Health Act, the inside areas of hospital premises are required to be smokefree. Whilst this does not cover outdoor areas, the National Institute for Health and Care Excellence (NICE) has set out in its quality statement Smoking: reducing and preventing tobacco use (QS82)1, that healthcare services have a duty of care to protect the health of people who use or work in their services. Therefore, NICE recommends that healthcare setting should not allow smoking anywhere in their grounds and should seek to remove any areas previously designated for smoking. This should be reflected in the policies set up by individual NHS trusts. Although NICE guidance is not mandatory, we expect NHS organisations to take NICE’s guidance into account in the delivery of their services.

1 Overview | Smoking: reducing and preventing tobacco use | Quality standards | NICE

You may also be aware that the Department is currently taking action to tackle the harms of second-hand smoking through the Tobacco and Vapes Bill which is currently making its way through Parliament. Part of the Bill provides ministers with powers to expand the current smoke-free places provisions in the Health Act 2006 to more public places and workplaces, including outdoor spaces. In England, we have announced our intention to make outside hospital grounds smoke-free. This will be subject to a full consultation and as part of this we will consider whether designated areas for smoking are appropriate. Research shows that people suffering from schizophrenia are 10 times more likely to die from respiratory disease than smokers without mental health problems, and people with serious mental illness die on average 15 to 25 years earlier than the rest of the population. Smoking is a major cause of that, and it is therefore important that hospitals do take action to promote and preserve the health of patients and staff and provide the necessary support to help people stop smoking, whether temporarily or permanently. As NICE has highlighted in its response to your report, their Guidance Tobacco: preventing uptake, promoting quitting and treating dependence (NG209)23 advises that there should be a discussion about any stop-smoking aids that the person has used before, and advice given on using nicotine-containing products including nicotine replacement therapy and nicotine containing e-cigarettes, and medication licensed for smoking cessation. Turning to your concerns regarding a lack of clarity around using Section 17 of the Mental Health Act 1983 to allow inpatients a short leave of absence in order to take a smoking break. Under Section 17 of the Act, a leave of absence can only be authorised by the patient’s responsible clinician and would require a risk assessment to be undertaken. The Care Quality Commission’s guidance: Smokefree policies in mental health inpatient services3 makes it clear that Section 17 should not be used to facilitate smoking breaks. I understand the concerns raised in your report about whether a smoke-free policy covering hospital grounds may place mental health inpatients at an increased risk from self-harm and suicide. However, research carried out on smoking bans in psychiatric inpatient settings4 indicates that smoking cessation does not exacerbate mental health symptoms. I am also aware of a number of mental health trusts that have implemented smoke-free policies successfully, resulting in high rates of compliance and few unintended consequences. We recognise that there is a difficult balance to be had between protecting patients and members of the public by enforcing a smoke-free environment in hospitals and allowing those patients who smoke to do so. We also recognise that this can be particularly difficult for mental health patients. We believe that in this case, the balance lies in protecting the public, but we do expect NHS organisations to support such patients that smoke, either through smoking cessation measures or through safe leave arrangements. I understand that, in its response to your report, NHS England will address your concerns around national guidance and policy and is also engaging with the Sussex Partnership NHS Foundation Trust to provide information about the local issues you have raised.

2 Overview | Tobacco: preventing uptake, promoting quitting and treating dependence | Guidance | NICE 3 _Brief_Guide_Smoke_Free_Policy_MH_inpatient_services.odt 4 Smoking bans in psychiatric inpatient settings? A review of the research - PubMed

I hope this response is helpful. Thank you for bringing these concerns to my attention.