Prevention of Future Deaths reports · 2024
Regulation 28 report to prevent future deaths, reference 2024-0650, written 22 Nov 2024. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 22 Nov 2024 |
|---|---|
| Reference | 2024-0650 |
| Deceased | Nicolette McCarthy |
| Coroner | Michael Spencer |
| Coroner area | East Sussex |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths · Mental Health related deaths · Suicide (from 2015) |
| Source | judiciary.uk record · original PDF |
| Responses published | 3 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
Regulation 28: REPORT TO PREVENT FUTURE DEATHS NOTE: This form is to be used after an inquest. REGULATION 28 REPORT TO PREVENT DEATHS THIS REPORT IS BEING SENT TO: (1) The Secretary of State for Health and Social Care. (2) NHS England. (3) National Institute for Health and Care Excellence (NICE). 1 CORONER I am MICHAEL SPENCER, HM Assistant Coroner for the coroner area of East Sussex. 2 CORONER’S LEGAL POWERS I 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 26 September 2023 I commenced an investigation into the death of Nicolette Elizabeth McCARTHY aged 46. The investigation concluded at the end of the inquest on 08 November 2024. The conclusion of the inquest was a narrative conclusion as follows: Nicolette Elizabeth McCarthy died as a result of suicide due to her acute mental ill health and a series of contributory factors. There were a series of failures in the systems and procedures which should have guaranteed her safety. 4 CIRCUMSTANCES OF THE DEATH The jury made the following findings of fact in Box 3 of the Record of Inquest: Nicolette Elizabeth McCarthy was detained to the Woodlands secure unit - under the Mental Health Act - Section 5(2) for concerns of her own safety following attempts to take her life. On the 18th and 19th September there remained a risk that she may attempt to end her own life. On 18th September 2023, Nicolette's family attended the ward round discussion, there is no evidence that confirmation of escorted or unescorted leave was delivered to them. Any ambiguity could have been avoided if Trust procedures had been followed, written confirmation of the S17 decision provided and acknowledged by the family. It was appropriate to grant in principle unescorted S17 leave but not implement it until written confirmation was provided to the family and the risk assessment updated. Nicolette should not have been required to leave unit grounds. Although the NHS/Sussex Trust have a policy that no smoking should take place within the grounds, there should have been provisions that within secure units secure smoking facilities or indeed an exemption should have been made. As per the Trust’s "Record of Patient leave" form, checks and consideration should have been given to the appropriateness of any items Nicolette had on her person for the leave being taken. As per the Trust’s concession, the Trust did not take immediate action, aligned to Nicolette’s individual clinical risk, when Nicolette did not return to the ward, following her Regulation 28 – After Inquest Document Template Updated 30/07/2021 15 minutes leave (starting at 14:37) on 19 September 2023. The failure to mark Nicolette as AWOL rather than on leave added to the confusion and highlighted gaps in the record keeping. Although staffing levels were low and incidents on 19th September 2023 further impacted staff availability, there was a failure to take steps as outlined in Trust policies following identification of Nicolette's absence. There were further factors in play: 1) insufficient adherence to recording patient login time in the procedure on the S17 leave sheet. 2) unacceptable delays in taking appropriate action on 19th September. 3) the Trust's adherence to robust note keeping/updating appears to have been lax and retrospective at times. It is possible that on 19th September 2023, had staff taken prompt action there would have been opportunities by which Nicolette's death could have been avoided 5 CORONER’S CONCERNS During the course of the investigation my inquiries 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: 1) During the course of the inquest, I heard evidence from clinicians and staff at the Trust to the effect that the NHS England smoke free policy is placing mental health in patients at an increased risk from self-harm and suicide. 2) Although smoking cessation advice and treatment (e.g. gum, vapes etc.) are routinely offered to patients, the evidence was that many struggle to give up smoking on their admission to the ward, in part because the anxiety associated with stopping exacerbates their mental health symptoms. Staff also felt that forcing patients to stop smoking against their will (e.g. by prohibiting them from smoking while on leave) would have a negative effect on their sense of autonomy and wellbeing, which are important for recovery. 3) The Trust understand that they are bound by the Health Act 2006 and by NHS England policy not to permit or facilitate smoking on the ward or anywhere on the grounds of the hospital. This is taken seriously and is interpreted to mean that staff are prohibited from facilitating smoking, for example by granting leave for the purpose of smoking or by escorting patients to smoke outside on short periods of leave. Senior staff also believed that it would be contrary to NHS policy to permit smoking in a secure area, for example the enclosed ward garden. At the same time, it was acknowledged that patients would inevitably seek leave to smoke and that this could not be denied without a negative impact on their mental health. 4) The jury heard evidence that patients, like Mrs McCarthy, were routinely given 15- minute grounds leave for the purpose of smoking, a practice that is discouraged by the Trust. Clinical staff felt that the policy placed them in a difficult position, torn between the need to comply with the smoke free policy, while also supporting patient autonomy and keeping safe those patients who are at a higher risk of self- harm or suicide. 5) There is a further contradiction caused by the smoke free policy, in that patients are not permitted to smoke on the grounds, but are not supposed to leave the grounds during short periods of ‘grounds’ leave. The result is that patients would spend their 15-minute leave smoking by the side of the road on the edge of the ward grounds, which is a poorly supervised area, and staff would avoid asking them too closely where they were going and would avoid standing close to them, even Regulation 28 – After Inquest Document Template Updated 30/07/2021 when smoking themselves. This contributed to the circumstances that allowed Mrs McCarthy to slip away unnoticed and ultimately to take her own life. 6) 7) I also heard evidence from senior staff that the national policy guidance intended to address smoking and s17 leave (e.g. the NICE Guidance and CQC Guidance) does not adequately resolve these contradictions. I am concerned that the NHS smoke free policy, while clearly motivated by a genuine and pressing concern to protect life and promote health, may not be adequately tailored to reflect the safety requirements of mental health wards or the reality that some mental health patients will inevitably seek short periods of leave to smoke. Action may need to be taken at the national policy level to provide clearer guidance and/or review the law to reduce the risk of patients in mental health wards absconding while on unescorted grounds leave. 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe you (and/or your organisation) 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 by 17 January 2025. 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 8 I have sent a copy of my report to the Chief Coroner and to the following Interested Persons (1) Mrs McCarthy’s family. (2) Sussex Partnership NHS Foundation Trust. who may find it useful or of interest. I 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. I may also send a copy of your response to any person who I 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 by the Chief Coroner. 9 Dated: 22/11/2024 Michael SPENCER Regulation 28 – After Inquest Document Template Updated 30/07/2021 Assistant Coroner for East Sussex Regulation 28 – After Inquest Document Template Updated 30/07/2021
3 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.
Parliamentary Under-Secretary of State for
Patient Safety, Women’s Health and Mental Health
39 Victoria Street
London SW1H 0EU
28 February 2025
Our ref:
Michael Spencer
HM Assistant Coroner for East Sussex
Coroner’s Office (East Sussex)
Unit 56, Innovation Centre
Highfield Drive
St Leonards on Sea
East Sussex
TN38 9UH
By email:
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.
Yours sincerely,
PARLIAMENTARY UNDER-SECRETARY OF STATE FOR
PATIENT SAFETY, WOMEN’S HEALTH AND MENTAL HEALTH
Mr Michael Spencer
HM Assistant Coroner
Coroner’s Office (East Sussex)
Unit 56 Innovation Centre
Highfield Drive
St Leonards on Sea
East Sussex
TN38 9UH
National Medical Director for
Secondary Care and Quality
NHS England
Wellington House
133-155 Waterloo Road
London
SE1 8UG
17 February 2025
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
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
treating
dependence
dependence | Guidance | NICE.
| Tobacco: preventing uptake, promoting quitting and
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.
Yours sincerely,
National Clinical Director for Elective Care
National Medical Director for Secondary Care and Quality
3rd floor 3 Piccadilly Place Manchester M1 3BN United Kingdom +44 (0)300 323 0140 03 January 2025 Mr Michael Spencer HM Area Coroner Unit 56 Innovation Centre, Highfield Drive, St Leonards on Sea, East Sussex TN38 9UH Sent via email: Our reference: 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. nice.org.uk | nice@nice.org.uk 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. Yours sincerely, Chief Executive [Insert footer here] 2 of 2
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