Prevention of Future Deaths reports · 2024
Regulation 28 report to prevent future deaths, reference 2024-0635, written 18 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 | 18 Nov 2024 |
|---|---|
| Reference | 2024-0635 |
| Deceased | Yemisi Cielto-Opaleye |
| Coroner | Edwin Buckett |
| Coroner area | Inner North London |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths · Alcohol, drug and medication related deaths · Mental Health related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
Regulation 28: Prevention of Future Deaths report
Yemisi Cielto-Opaleye (died 13.12.2023)
THIS REPORT IS BEING SENT TO:
(1)
Chief Executive
North London Mental Health Partnership
Partnership Headquarters
4th Floor, East Wing
St Pancras Hospital
4 St Pancras Way
London
NW1 0PE
(2)
Chief Medical Officer
North London Mental Health Partnership
Partnership Headquarters
4th Floor, East Wing
St Pancras Hospital
London
NW1 0PE
1
CORONER
I am: Edwin Buckett
Assistant Coroner
Inner North London
St Pancras Coroner’s Court
Camley Street
London N1C 4PP
2
CORONER’S LEGAL POWERS
I make this report under the Coroners and Justice Act 2009,
paragraph 7, Schedule 5, and
The Coroners (Investigations) Regulations 2013,
regulations 28 and 29.
3
INVESTIGATION and INQUEST
1
On the 21st December 2023 Assistant Coroner Ian Potter began an
investigation into the death of Yemisi Cielto-Opaleye who died aged 47,
on the 13th December 2023 at St Pancras Hospital, London, N1.
The investigation concluded at the end of an inquest, with a jury which
took place over 5 days between 11th - 15th November 2024. This was
conducted by myself, Assistant Coroner Edwin Buckett.
The jury made a determination that the deceased died within 3 hours of
being administered an Olanzapine depot injection which caused
Olanzapine toxicity, whilst a psychiatric in-patient on Sapphire Ward, St
Pancras Hospital, London N1.
The jury returned a Narrative Conclusion which found that neglect
contributed to her cause of death.
4
CIRCUMSTANCES OF THE DEATH
The circumstances of the death are set out in the Narrative Conclusion
of the Jury which was as follows:
inpatient with
“On 5th April 2022 Yemisi was admitted to St Pancras Hospital as a
treatment-resistant
long
psychiatric
schizophrenia. On the 22nd June 2023 she was transferred to Sapphire
Ward. She was treated with a wide variety of psychiatric medication
administered both orally and by depot injection.
standing
Following admission to Sapphire Ward, a decision was made by the
consultant along with other hospital staff to introduce Olanzapine to
Yemisi’s treatment. Yemisi was administered Olanzapine orally for 3-4
days, falling below the recommended trial period advised before moving
to administering by depot injection and was therefore inadequate. As
Olanzapine is a non-formulary drug for the Trust, additional requirements
are in place to support prescribing decisions. The justification relied upon
by the consultant and lead pharmacist for prescribing the drug was
unsuitable as the drug does not meet the criteria outlined in Section 62
of the Mental Health Act of being a) life-saving, or b) reversible. In
addition, the requirement to seek a second opinion from an independent
doctor in certain circumstances when changing medications was not
fulfilled as the first depot injection was administered to Yemisi before
approval was received from the SOAD. Owing to Yemisi’s known and
documented history of refusing vital signs checks requiring participation,
the prescribing decision took into account the expected difficulties with
conducting these checks. However, there was no robust contingency
2
plan for ensuring these checks took place, the plan itself was insufficient
to accommodate Yemisi’s circumstances and went no further than what
is mandated in the Olanzapine policy.
Yemisi received a first Olanzapine depot injection on the 13th of
November, where she also did not comply with vital signs checks
requiring participation. There were no adverse effects noted and staff
indicated following this depot injection her mental state improved
somewhat. Yemisi’s non-compliance with vital signs checks requiring
participation led to the decision being made that both depot injections
would be administered relying solely on assessing Respiratory Rate and
Level of Consciousness, departing from the Trust’s Olanzapine depot
policy.
On the 13th of December 2023, the plan in place was for one of the
nurses on Sapphire Ward that day who had completed the Olanzapine
training to both prepare and administer the injection, and as per the
Olanzapine policy conduct the first set of vital signs checks, and be
available for the duration of the 3 hour observations unless this
responsibility is delegated to an appropriately qualified member of staff.
However this is not what transpired on the day.
responsibility
The
for preparing, administering, monitoring and
witnessing of these processes was unclear, and divided among multiple
members of staff which did not allow for effective continuity resulting in
inadequate levels of oversight. Yemisi did not consent to any of the staff
members on Sapphire Ward that day administering the injection, and so
a qualified member of staff from another ward was asked to come and
assist. They did not witness the preparing of the solution but were
satisfied that the dose and preparation were as described. This nurse
and the preparing nurse initially went to Yemisi’s room to conduct pre-
injection vital signs checks but those requiring participation were refused.
The absence of a full set of observations should have been escalated to
a doctor prior to administering the depot injection, but this was not done.
At this stage there was also a missed opportunity to reiterate potential
side effects of the drug or symptoms of post-injection syndrome to Yemisi
that she may have been able to flag as concerns. One nurse was then
asked to leave the room and therefore there was a failure to follow
protocol both by not having two members of staff present during the
administration of the depot injection, and also that it was administered
requiring
despite
participation not taking place.
requisite pre-injection vital signs checks
the
3
Following the injection, there was a total lack of clarity around
responsibility and delegation of Post-injection checks, where the Nurse
in Charge failed to allocate tasks consistent with safe implementation of
the plan. Communication was inadequate and no staff member on
Sapphire Ward was clear on their responsibility to conduct post-injection
checks that day.
Collectively there was sufficient understanding among staff on the ward
of the risks associated with Olanzapine depot injection, and the
requirements for post-injection checks (regardless of whether they had
completed the training). Despite an awareness of these risks, this failed
to translate to adequate safety planning, management and coordination
of staff responsibilities or action relating to Yemisi’s care.
to
Yemisi.
attention
for conducting
basic medical
As a result, none of the vital signs checks stipulated in the Trust’s
Olanzapine policy were carried out, representing a gross failure to
Relevant
provide
documentation/templates for record keeping do not provide clear
accountability
these checks. The Trust’s own
documentation/templates for Olanzapine monitoring do not allow for the
total number of checks stipulated (ie. at 90 minutes). The reasoning
given for not completing some of the post-injection checks included a
number of incidents on the ward that diverted staff resource – there was
a failure to escalate high acuity and get additional support. The only
check conducted was a General Observations check, not a post-
Olanzapine injection check, at 15:30, an hour after administration. This
check only involved visual observations from outside Yemisi’s door, and
could not have been sufficient to establish a patient’s level of
consciousness.
Yemisi was discovered lying face down on the floor in her room at around
17:20 by the nurse in charge who sounded the alarm and called for help
from other staff. Multiple staff began attempts to resuscitate her including
CPR/chest compressions and establishing whether the defibrillator could
be used. An ambulance was called, and paramedics arrived at Yemisi’s
room at 17:40. No pulse or ‘shockable rhythm’ was detected by staff or
defibrillators from the point she was discovered. London Ambulance
Service continued attempts to resuscitate her but pronounced life extinct
at 18:45.
4
Yemisi died on the 13th December 2023 as a result of the toxic effects of
the Olanzapine injection administered to her that day and neglect
contributed to her cause of death.”
5
CORONER’S CONCERNS
During the course of the inquest, the evidence revealed matters giving
rise to concern. In my opinion, there is a risk that future deaths will occur
unless action is taken. In the circumstances, it is my statutory duty to
report to you.
The MATTERS OF CONCERN are as follows.
Evidence was given that:
(1) Olanzapine Depot injections have a known risk of Post Injection
Syndrome which can lead to death. Although the risk is rare, the
Trust was aware of 2 other instances of Post Injection Syndrome
following the administration of some 10 Olanzapine injections in
the recent past, with both individuals surviving because of early
intervention by medical staff.
(2) The importance of timely observations is crucial to preventing
Post Injection Syndrome and preventing death in the event of an
adverse reaction to the drug.
(3) In order to administer an Olanzapine depot, a prescribing doctor
must seek approval from a Lead Pharmacist in the Trust because
the medication is a “non-formulary” medicine.
it
(4) The trial period for administering oral medication to a patient for
whom
is
is proposed should have a depot
approximately 2 weeks, whereas Yemisi only took Olanzapine
tablets for 3-4 days before having her first Olazapine depot
injection. Therefore, she took her oral medical for less than the
recommended period.
injection
(5) The requirement to obtain a second opinion from an independent
doctor (SOAD) when changing medication did not happen when
Yemisi was administered her first Olanzapine depot injection on
13th November 2023.
(6) In a busy psychiatric in-patient ward, staff can become distracted
by having to tend to other patients, urgently, when events occur
such as unexpected new patient admissions and disturbances.
5
(7) Yemisi had a long history of refusing to take medication and
refusing vital signs checks as a psychiatric in-patient.
I am concerned that:
(a) The risk of death from the use of Olanzapine depot injection needs
to be made clear to patients who are going to be given that
injection. Although it is very small risk, the fact that the risk can be
largely eradicated by vital signs checks at intervals within the 3-
hour period with early medical intervention, the risk needs to be
stated to, and understood by, patients or those who represent
their interests, before such a depot injection is given;
(b) In a psychiatric in-patient setting, there are many demands on
staff who can become distracted from their expected duties.
Unless there is a suitably qualified medical member of staff whose
sole duty it is to remain in the company of a patient, who has had
an Olanzapine depot injection at all times during the 3 hour post-
injection observation period, there is a risk that vital signs checks
will be missed and that Post Injection Syndrome will not be
detected early enough if it occurs;
(c) There is a risk that approval from a Lead Pharmacist to initiate a
non-formulary medicine such as an Olanzapine depot can occur
without the Pharmacist knowing whether a SOAD has been
obtained in relation to that medication and that patient;
(d) In cases where psychiatric in-patients are known to have a history
of refusing vital signs checks, careful consideration and scrutiny
should be given as to whether an Olanzapine depot injection is a
suitable medication for such patients, especially in view of the
crucial post-injection monitoring requirements.
6
ACTION SHOULD BE TAKEN
In my opinion, action should be taken to prevent future deaths and I
believe that 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 17th January 2025. I, the coroner, may extend
the period.
6
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 following.
• HHJ Alexia Curran, the Chief Coroner of England & Wales
•
, the sister of Yemisi Cielto-Opaleye.
I am 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 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
DATE 18.11.2024
SIGNED BY ASSISTANT CORONER
Edwin Buckett
7
1 response 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.
Trust Headquarters 4th Floor, East Wing St Pancras Hospital 4 St Pancras Way London NW1 0PE Email: . Private and Confidential Assistant Coroner Edwin Buckett Inner North London St Pancras Coroner’s Court Camley St London N1C 4PP 17th January 2025 Dear Coroner Buckett Re Inquest touching the death of Yemisi Cielto Opaleye I am writing following the inquest for Yemisi Cielto Opaleye which concluded on 15th November 2024 and following which you issued a Prevention of Future Deaths report to the Trust. Ms Cielto Opaleye died following administration of Olanzapine depot injection on one of the Trust’s inpatient wards. The matters of concern raised in your report were as follows: (a) The risk of death from the use of Olanzapine depot injection needs to be made clear to patients who are going to be given that injection. Although it is very small risk, the fact that the risk can be largely eradicated by vital signs checks at intervals within the 3- hour period with early medical intervention, the risk needs to be stated to, and understood by, patients or those who represent their interests, before such a depot injection is given; (b) In a psychiatric in-patient setting, there are many demands on staff who can become distracted from their expected duties. Unless there is a suitably qualified medical member of staff whose sole duty it is to remain in the company of a patient, who has had an Olanzapine depot injection at all times during the 3 hour postinjection observation period, there is a risk that vital signs checks will be missed and that Post Injection Syndrome will not be detected early enough if it occurs; (c) There is a risk that approval from a Lead Pharmacist to initiate a non-formulary medicine such as an Olanzapine depot can occur without the Pharmacist knowing whether a SOAD has been obtained in relation to that medication and that patient; (d) In cases where psychiatric in-patients are known to have a history of refusing vital signs checks, careful consideration and scrutiny should be given as to whether an Olanzapine depot injection is a suitable medication for such patients, especially in view of the crucial post-injection monitoring requirements. Better Mental Health. Better Lives. Better Communities. Chair: Chief Executive: Firstly we wish to express our sincere condolences to the family and friends of Ms Cielto- Opaleye. As stated in our letter to you of 17th October 2024, we accept, as you outline in your report, that the failure to carry out the observations of Ms Cielto-Opaleye’s vital signs, which should have been carried out in accordance with the Trust’s Olanzapine Depot Guidelines dated February 2021, at 14.48 hours (20 mins); 15:08 hours (40 mins); 15:28 hours (60 mins); 15:58 hours (90) mins and 16:28 hours (120 mins) represents a failure on the part of the Trust’s staff who were responsible for carrying out those observations. The Trust would like to repeat its apology as stated in that letter and apologise unreservedly to the family of Ms Cielto-Opaleye for these failures and accept that in all likelihood they contributed to Ms Cielto-Opaleye’s death on Sapphire ward on the 13th of December 2023. In relation to your report and addressing each of your concerns: Matter of concern 1: The risk of death from the use of Olanzapine depot injection needs to be made clear to patients who are going to be given that injection. Although it is very small risk, the fact that the risk can be largely eradicated by vital signs checks at intervals within the 3- hour period with early medical intervention, the risk needs to be stated to, and understood by, patients or those who represent their interests, before such a depot injection is given. Trust Response: As discussed in court, our olanzapine depot prescribing policy was reviewed and re written in March 2024. Section 9.2.1 of that policy states: If olanzapine depot is considered, the team must provide medication counselling for olanzapine depot to patient. The information must include advice about the three- hour post administration observations. The patient must be given a copy of the olanzapine depot alert card in appendix 1. The key messages to discuss with the patient before administration are: • • Olanzapine depot carries a small risk of post-injection syndrome. Most symptoms appear within one hour following injection and resolve within 24- 72 hours. A patient information leaflet can be obtained from the Choice and Medication link on the Trust intranet (» Printable leaflets (choiceandmedication.org)) • • The patient must be advised not to leave prior to completion of the three hour observation period. If the patient indicates he/she will leave prior to end of the three- hour period, the depot must not be administered and the medical team advised as soon as possible. We acknowledge that the small risk of death from post injection syndrome is not explicitly highlighted within this literature and this will be reviewed within the policy. Matter of concern 2: In a psychiatric in-patient setting, there are many demands on staff who can become distracted from their expected duties. Unless there is a suitably qualified medical member of staff whose sole duty it is to remain in the company of a patient, who has had an Olanzapine depot injection at all times during the 3 hour post injection observation Better Mental Health. Better Lives. Better Communities. Chair: Chief Executive: period, there is a risk that vital signs checks will be missed and that Post Injection Syndrome will not be detected early enough if it occurs. Trust Response: The olanzapine depot policy dated March 2024 section 10.1.2 states that ‘the nurse must be available for the duration of the three-hour post-administration observation.’ Section 10.1.7 states that ‘An appropriately trained and /or professional member of staff, other than a nurse, can take the subsequent clinical observations if delegated by the administering nurse’. We agree that this policy will be reviewed and in instances of olanzapine depot administration in an inpatient setting an extra qualified member of staff will be booked on shift with the sole responsibility of preparing, administering and delivering post administration observations of the patient for the three hour period. Matter of concern 3: There is a risk that approval from a Lead Pharmacist to initiate a non- formulary medicine such as an Olanzapine depot can occur without the Pharmacist knowing whether a SOAD has been obtained in relation to that medication and that patient. Trust Response: The role of the pharmacist is not referenced within the Mental Health Act 1983. In the case of Yemisi Cielto-Opaleye, a valid T3 form and SOAD approval was in place for the administration of the depot on the 13th December 2023. On the date of the first olanzapine depot administration on the 13th November 2023 a S62 ‘Urgent Treatment Form’ was in place dated 10th November 2023 and treatment was administered legally under clause b, that is, ‘(not being irreversible) immediately necessary to prevent a serious deterioration in their condition’. In terms of the irreversibility, the White Paper that preceded the 1983 Act defined it as “treatments which necessitate the removal or destruction of brain tissue or are designed to effect irreversible change in cerebral or bodily function” and at the 1982 special standing committee on the bill the under-secretary of state gave the removal of a brain tumour or a diseased thyroid as examples. Matter of concern 4: In cases where psychiatric in-patients are known to have a history of refusing vital signs checks, careful consideration and scrutiny should be given as to whether an Olanzapine depot injection is a suitable medication for such patients, especially in view of the crucial post-injection monitoring requirements. Trust Response: We accept that this is reasonable and in the case of patients known to refuse vital signs that alternatives to olanzapine depot should be thoroughly explored. I hope that this response provides the necessary assurance. Please contact me if you have any queries. Yours sincerely Chief Medical Officer Better Mental Health. Better Lives. Better Communities. Chair: Chief Executive:
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