Prevention of Future Deaths reports · 2023
Regulation 28 report to prevent future deaths, reference 2023-0046, written 7 Feb 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 7 Feb 2023 |
|---|---|
| Reference | 2023-0046 |
| Deceased | Ania Sohail |
| Coroner | Catherine McKenna |
| Coroner area | Manchester North |
| Category | Suicide (from 2015) · Alcohol, drug and medication related deaths |
| Organisation named | Greater Manchester Mental Health NHS Foundation Trust |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
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. Secretary of State for Health and Social Care 2. Chief Executive of Greater Manchester Mental Health NHS Foundation Trust 1 CORONER I am Catherine McKenna, Area Coroner for the area of Greater 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 25 June 2021 an investigation into the death of Ania Sohail was commenced. The investigation concluded on 30 January 2023 at the end of the inquest that was held before a jury. The jury recorded the following conclusion; 'Suicide with intent. The death was contributed to by the ineffectiveness of all searches but in particular to the search on 18June 2021, inadequate post-leave assessment and the omission of Safety Plans which reflect the risks posed to Ania on 18 June 2021. In respect of the online pharmacies, there was a: a) Lack of integrated system or records which could be accessed by multiple pharmacies b) Lack of access to the GP Summary Care Records, other pharmacy supplies; and c) Lack of consent to the sharing of information.' 4 CIRCUMSTANCES OF DEATH On 19 June 2021, Ania Sohail collapsed in the lounge area of Griffin Ward, Junction 17 in Prestwich after ingesting • Propranolol tablets which she had secreted onto the ward following periods of home leave. She was taken to North Manchester Hospital and died later that day. A post-mortem examination established that the cause of death was Propranolol toxicity. Ania had been an inpatient on Griffin Ward since June 2020 and for the final 9 months of the admission was detained under section 3 of the Mental Health Act 1983. She had a diagnosis of Emotionally Unstable Personality Disorder and a history of self-harm and suicide attempts. During her admission to Griffin Ward, Ania had purchased Propranolol medication on seven separate occasions from four different on-line pharmacies. On each occasion, Ania had completed an on-line questionnaire in which she denied having a mental disorder and declined consent for the prescriber to share information with her GP. The prescribers were unaware that Ania was accessing Propranolol from multiple on-line pharmacies and that Ania was concealing the fact that she was an inpatient at a psychiatric unit by ordering the Propranolol to be delivered to her home address. The prescribers accepted the information provided by Ania at face value and had they been aware of the above information, it would have altered their prescribing decisions. Before the fatal overdose on 19 June 2021 and whilst an inpatient on Griffin Ward, Ania had taken overdoses of Propranolol on 10 March and 5 June 2021. Searches of her room had been undertaken following each overdose. Home leave had been suspended following the first overdose before beinq _________ gradually reintroduced. Following the second overdose, home leave was reinstated on the basis that pre and post leave assessments would be undertaken and Ania would be searched on return to Searches were conducted on a trauma informed basis and therefore were limited in the ward. nature. Ania’s first home leave following the second overdose was on 18 June 2021. When she returned from leave that evening, Ania was searched by a mental health support worker who confiscated two belts from her bag. Ania denied having any other contraband items on her person. There is no documented evidence of the two belts having been found on Ania that evening or that this was handed over to the nurse in charge of the shift. The nurse in charge of the shift has no recollection of being informed of the two belts or of undertaking a post-leave assessment. The entry within the Day notes does not evidence whether or not a post-leave assessment did in fact take place that evening. Ania collapsed in the lounge area of Griffin Ward at lunch-time the following day. She was on 1:5 observations. The evidence from the support worker with responsibility for undertaking the checks between lOam and 12noon was that for the majority of that time Ania was in her room with the door closed and that the checks were undertaken by knocking on her door every 5 minutes to check that she was alright. Following her collapse, Ania was conveyed to North Manchester General Hospital where attempts at resuscitation continued until deemed futile. Her death was verified at 15:36 hours that afternoon. CORONER’S CONCERNS During the course of the inquest the evidence revealed matters giving rise to concern. there is a risk that future deaths will occur unless action is taken. statutory duty to report to you. The MATTERS OF CONCERN in relation to on-line prescribing are as follows:- (1) Whilst each individual pharmacy had in-house safety checks to safeguard against over- In the circumstances it In my opinion is my prescribing by their own pharmacy, there is no integrated system in place which would alert a prescriber to prescriptions that have been dispensed by other on-line pharmacies. As a result, it is currently possible for a patient to obtain excessive quantities of medication by simply placing multiple orders with different on-line pharmacists. (2) There is no requirement for the on-line pharmacies to share information with the patients GP. This means that, in the absence of the patient’s consent to share information, the online prescriber is reliant on the accuracy and truthfulness of the history provided by the patient. (3) Lack of information sharing also creates a risk that a GP or Pharmacist Prescriber may unwittingly prescribe a medication that is contraindicated with a medication that has been dispensed through an on-line pharmacy. The MATTERS OF CONCERN in relation to the provision of mental health care on Griffin Ward are as follows:- (1) The Recovery & Discharge Plans contained inaccurate information regarding Ania’s consent to share information with her mother. The evidence was that this was an entry made in error in June 2020 and was not picked up by any of the nurses who updated the Recovery & Discharge Plan over the subsequent 11 months. (2) The Recovery & Discharge Plans did not address the risks associated with Ania’s procurement of Prbpranolol from on-line pharmacies. The evidence was that an update of the Recovery & Discharge Plan involved members of nursing staff simply adding a note that the overdoses had taken place. The Plan did not show that any meaningful thought had been given to addressing the particular risk associated with the procurement of on-line medication. (3) Mandatory refresher training on basic aspects of nursing care such as record keeping, searches, care-planning, undertaking pre- and post-leave assessments and confidentiality is not provided to staff. II L (4) There is no requirement for the outcome of negative personal searches to be documented in the records and consequently there is no ability to effectively audit whether searches are taking place and the treating team are unable to assess a patient’s level of compliance with rules around bringing contraband items onto the ward. (5) Searches undertaken of Ania’s room following the overdoses on 10 March and 5 June 2021 were ineffective and did not uncover the Propranolol that Ania had been stockpiling. (6) Documentation on which 1:5 observations are recorded does not evidence that a check has taken place every 5 minutes. per hour. There is therefore no mechanism by which observations can be effectively audited. Instead the current documentation, simply requires one signature (7) There is no requirement to make a separate entry evidencing that a post-leave assessment has been undertaking. The post-leave assessments are currently subsumed within Day Notes and do not clearly state whether an assessment was undertaken, what was discussed and the outcome of the assessment. 6 7 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. YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely 5 April 2023 I, the Area 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:- Mr and Mrs Sohail General Pharmaceutical Council General Medical Council ‘ Care Quality Commission MHRA UK Meds 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. Date: 7 February 2023 Signed:
2 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.
From Maria Caulfield MP
Parliamentary Under Secretary of State
Department of Health & Social Care
39 Victoria Street
London
SW1H 0EU
10 May 2024
Catherine McKenna
HM Coroner's Court
Floors 2 and 3
Newgate House
Newgate
Rochdale
OL16 1AT
Dear Catherine,
Thank you for your Regulation 28 report to prevent future deaths dated 7 February 2023
about the death of Ania Sohail. I am replying as the Minister with responsibility for mental
health and patient safety.
Firstly, I would like to say how saddened I was to read of the circumstances of Ania’s death
and I offer my sincere condolences to his family and loved ones. The circumstances your
report describes are concerning and I am grateful to you for bringing these matters to my
attention. Please accept my sincere apologies for the significant delay in responding to this
matter.
Your report raises concerns about online prescribing, information sharing and the provision
of care on Griffin Ward at Junction 17 (part of Greater Manchester Mental Health NHS
Foundation Trust).
I understand that the Trust wrote to you on 4 April 2023 with the Trust’s comprehensive
response to the matters of concern that you raised in your report.
In preparing this response, Departmental officials have made enquiries with the Care
Quality Commission (CQC) and NHS England.
The CQC was formally notified of Ania’s death through a statutory notification from the
Trust on 21 June 2021. CQC has subsequently carried out a series of inspections of the
acute and psychiatric intensive care wards for working age adults (including Griffin Ward) in
September 2021 to consider the safety of the wards and the care and treatment being
provided to patients. These contributed to the Trust being placed into Segment 4 of the
NHS Oversight Framework which meant it entered the national Recovery Support
Programme and is now in receipt of mandated intensive support. An NHS England System
Improvement Board was set up to support the delivery of the programme, chaired by the
Regional Director for Strategy and Transformation for NHS North West, with
representatives from the Trust, Greater Manchester Integrated Care Partnership, Care
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Quality Commission, Health Education England, Bury Local Authority (as safeguarding
lead), General Medical Council and the Nursing and Midwifery Council.
The Trust has subsequently been the subject of an NHS England-commissioned
independent investigation into the failings within the Trust’s services reported at the
Edenfield Centre and the failure within the organisation to appropriately manage concerns
and mitigate against patient harm. The investigation’s final report was published in January
2024 and notes that Griffin Ward has now been closed. The Trust has developed an
improvement plan, which was updated to reflect the findings of the independent
review. The report is available at: Independent Review of Greater Manchester Mental
Health NHS Foundation Trust
From a national perspective, with regard to online prescribing, NHS England has advised
that the NHS does everything in its capacity to take into account the plurality of healthcare
provision that is available to the public in England. NHS England is supportive of a patient’s
rights to choose the providers they wish to use. For vulnerable patients, the right course of
action is to advise them on the risks of using services outside of the NHS and the benefits
of remaining within the NHS.
NHS England has no jurisdiction over private provision. Private providers would need a very
good reason to breach a patient’s refusal to share their information as they are legally
obliged to safeguard sensitive information under the General Data Protection
Regulation. The General Pharmaceutical Council has provided information to online
pharmacies on Providing medicines online, which is available at: Online Pharmacy Services
(rpharms.com)
The Summary Care Record (SCR) was originally designed and communicated as a means
to support patients when they receive emergency care. Over time, the significant value of
access to SCR to wider healthcare services has been recognised and, as a result, NHS
England has worked with an Expert Advisory Committee to extend its use into multiple
other care settings through a governance framework into which patients and professionals
contribute.
NHS England has also done significant work with a number of private sector organisations,
including a range of private hospitals and privately funded healthcare services as part
of Proof of Concepts (PoCs), into settings where SCRs have previously been unavailable.
eg private GP Services. This work will continue throughout 2024. Whilst it is difficult to
define precisely what is included within “private hospitals and privately funded healthcare
services”, all “private hospitals and independent healthcare services” that have approached
NHS England to date seeking access to SCR have either been onboarded into the existing
proof of concepts or there have been discussions with the requesters regarding initial setup
and their use for access to SCR. Learnings from these PoCs will be reported back to the
Expert Advisory Committee to better understand any benefits realised but also any potential
unintended consequences. NHS England will work with the Expert Advisory Committee to
seek full rollout approval in this sector and consider the scope of this approval and any
specific exclusions, constraints, or caveats.
You may be interested to note that the General Pharmaceutical Council (GPhC) issued a
statement in January 2024 following concerns about the potential risks for patients using
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online services to get medicines and treatment in a case that was similar to Ania’s. In it the
GPhC makes clear that it will take enforcement and regulatory action where appropriate
against owners of registered pharmacies, as well as individual pharmacy professionals
involved in both the prescribing and supply of medicines where their conduct may have
fallen short of professional standards. The GPhC’s statement is available at: BBC News:
investigation into safety checks online pharmacies carry out when selling prescription-only
medicines | General Pharmaceutical Council (pharmacyregulation.org)
I hope this response is helpful. Thank you for bringing these concerns to my attention.
Yours sincerely,
MARIA CAULFIELD
A7
Trust Management Offices
First Floor, The Curve
Bury New Road
Prestwich
Manchester
M25 3BL
Web: www.gmmh.nhs.uk
PRIVATE AND CONFIDENTIAL
Ms Catherine McKenna
HM Area Coroner
Manchester North Coroner’s Office
Floors 2 and 3 Newgate House
Rochdale
OL16 1AT
4th April 2023
Dear Ms McKenna
Re: Ania Sohail (deceased) Regulation 28 Preventing Future Deaths Response
On behalf of Greater Manchester Mental Health NHS Trust (GMMH) I would like to offer
Ania’s family our sincere condolences at this difficult time.
Ms McKenna, thank you for highlighting your concerns during Ania’s Inquest which
concluded on 30 January 2023. On behalf of the Trust can I apologise that you have had to
bring these matters of concern to the Trust’s attention.
Please see the Trust’s response in relation to the concerns you have raised, and the actions
taken by the Trust:
(1) The Recovery and Discharge plans contained inaccurate information regarding
Ania’s consent to share information with her mother. The evidence was that this
was an entry made in error in June 2020 and was not picked up by any of the
Nurses who updated the Recovery and Discharge Plan over the subsequent
eleven months.
The Recovery and Discharge Plan that was in place prior to the incident Ania’s death is no
longer used by GMMH and has been replaced by the care plan document that is used in all
other inpatient areas of the Trust. This document is called the ATAC (Acute Triage and
Assessment Care Plan). A local audit of care plans will be undertaken by the ward manager
by the end of May to ensure learning is embedded and consent is evidenced in the care plans.
Greater Manchester Mental Health NHS Foundation Trust, Trust Headquarters,
Bury New Road, Prestwich, Manchester M25 3BL.
Page 1 of 4
A8
The Service has developed training that has been delivered through ‘Lunch and Learn’ events
in respect of capacity, consent and the Trust’s ATAC document.
There has been a Trust wide learning event how to assess and record decisions around testing
a patient’s capacity and formally record the decision made. This was recorded and is available
to all Trust employees.
(2) The Recovery and Discharge Plans did not address the risks associated with
Ania’s procurement of Propranolol from online Pharmacies. The evidence was
that an update of the Recovery and Action Plan involved members of Nursing
staff simply adding a note that the overdoses had taken place. The plan did not
show that any meaningful thought had been given to addressing the particular
risk associated with the procurement of online medication.
During the Trust review, following Ania’s death, it was unclear whether all staff were aware
that Ania was buying medications from online Pharmacies or that this was an easily accessible
way to obtain medication. In response, GMMH have created a Safety Briefing regarding the
use of online pharmacies and Propranolol, aimed at communicating to staff the risks
associated with the procurement of medication via online Pharmacies and the General Medical
Councils ‘ten principles’ around online purchasing. This briefing, and the circumstances
leading to its development featured in the Trust patient safety Newsletter in February 2023.
This Newsletter is developed monthly and is shared with all staff across the Trust. A copy of
the Safety Briefing is attached to this response.
(3) Mandatory refresher training on basic aspects of Nursing care, such as good
record-keeping, searches, care-planning, undertaking pre and post-leave
assessments and confidentiality is not provided to staff.
The Trust has developed an inpatient ‘Care Bundle – Leave from inpatient units’. The care
bundle provides guidance to staff when supporting service users who are inpatients to access
leave into the community and return to the ward safely. The care bundle prompts staff to
complete pre and post-leave assessments and where to document these. This care bundle
has been shared with all inpatient staff through established communication systems and was
featured in the Patient safety Newsletter in January 2023.
An audit of pre and post leave assessments and related documentation will be carried out by
the ward manager by the end of May 2023.
The Care Bundle is attached to this response.
In respect of searches, a Trust Risk & Safety Advisor has facilitated training sessions
regarding how to conduct both room and personal searches effectively. All ward staff have
completed this training and the ward manager keeps a record of staff compliance.
Confidentiality and when to breach this is included in the Trust Clinical Risk Assessment
policy and the training. This was also included in the learning event held in respect of
Capacity and Consent, that is available to all staff via the Trust Intranet. All staff on Griffin
ward will have access to this training event by the end of April 2023.
Greater Manchester Mental Health NHS Foundation Trust, Trust Headquarters,
Bury New Road, Prestwich, Manchester M25 3BL.
Page 2 of 4
A9
(4) There is no requirement for the outcome of negative personal searches to be
documented in the records and consequently there is no ability to effectively
audit whether searches are taking place and the treating team are unable to
assess a patient's level of compliance with rules around bringing contraband
items onto the ward.
As part of the Inpatient Leave Care Bundle, outlined in point 3, pre and post leave
assessments should be recorded in the clinical record, including any reason to search a
person following leave. The Trust Search Policy includes clear guidance on what should be
recorded when a search is undertaken and whether anything was found or not.
(5) Searches undertaken of Ania's room following the overdoses on 10 March and 5
June 2021 were ineffective and did not uncover the Propranolol that Ania had
been stockpiling.
GMMH Trust did carry out room searches on the above dates and did not find any medication.
Staff did not conduct intimate searches of her person as there was no indication that this was
required at the time. As outlined in point 3 the staff on the ward have received training on how
to search a person’s room and carry out a personal search.
The Trust policy HS13 Search of service users, visitors and belonging policy was reviewed
and updated to include the learning from Ania’s death. This included a review of contraband
items and reinforcement of search procedures.
(6) Documentation on which 1 :5 observations are recorded does not evidence that
a check has taken place every 5 minutes. Instead, the current documentation,
simply requires one signature per hour. There is therefore no mechanism by
which observations can be effectively audited.
The current Trust observation policy does have a 1:5 minute recording sheet that requires a
signature every 5 minutes. This has now been adopted by the service and its completion is
audited by the ward manager as a minimum weekly.
The Trust is currently undertaking a review of our Observation policy and practices through a
task and finish working group which to date has reviewed best practice standards and
guidance on the management and practice of therapeutic observations & engagement
including the review of any digital innovations to support practice.
Senior members of this group have attended workshops facilitated by the CQC who
acknowledge that carrying out and recording observations is a National issue. A training needs
analysis of the requirements for staff training and education is being undertaken and a training
package and competency assessment framework is being developed.
(7) There is no requirement to make a separate entry evidencing that a post-leave
assessment has been undertaking. The post-leave assessments are currently
subsumed within Day Notes and do not clearly state whether an assessment
was undertaken, what was discussed and the outcome of the assessment.
As outlined in point 3 pre and post leave assessments should be undertaken and recorded in
the patient’s clinical record. The care bundle that has been developed sets out clear
expectations of what assessments staff should be doing and what they should be recording.
Greater Manchester Mental Health NHS Foundation Trust, Trust Headquarters,
Bury New Road, Prestwich, Manchester M25 3BL.
Page 3 of 4
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In addition to the audit being caried out in this service, an audit tool will be developed by the
Head of Nursing on the back of this to be rolled out across the Trust.
Ms McKenna, on behalf of the Trust can I thank you again for bringing these matters of concern
to the Trust’s attention. I hope this response demonstrates to you and Ania’s family that GMMH
have taken the concerns you have raised seriously. If you have any further questions in
relation to the Trust’s response, please do let me know.
Yours Sincerely,
Chief Clinical Information Officer
Associate Medical Director
Consultant Psychiatrist on behalf of
Medical Director
Greater Manchester Mental Health NHS Foundation Trust, Trust Headquarters,
Bury New Road, Prestwich, Manchester M25 3BL.
Page 4 of 4
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