Prevention of Future Deaths reports · 2022
Regulation 28 report to prevent future deaths, reference 2022-0316, written 13 Oct 2022. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 13 Oct 2022 |
|---|---|
| Reference | 2022-0316 |
| Deceased | Oli Hoque |
| Coroner | Nadia Persaud |
| Coroner area | East London |
| Category | Other related deaths · Hospital Death (Clinical Procedures and medical management) 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.
MISS N PERSAUD
HIS MAJESTY’S CORONER
EAST LONDON
Walthamstow Coroner's Court, Queens Road Walthamstow, E17 8QP
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1)
Ref: 13422724
REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO:
1. Rt Hon Therese Coffey, Secretary of State for Health & Social Care
1
CORONER
I am Nadia Persaud area coroner for the coroner area of East London
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.
http://www.legislation.gov.uk/ukpga/2009/25/schedule/5/paragraph/7
http://www.legislation.gov.uk/uksi/2013/1629/part/7/made
3
INVESTIGATION and INQUEST
On 23 June 2021 I commenced an investigation into the death of Oli Akram Hoque
(aged 26 years old). The investigation concluded at the end of the inquest on the 7
October 2022. The conclusion of the inquest was a narrative conclusion:
Oli Hoque died as a result of a very rare complication of a COVID-19 vaccination.
4
CIRCUMSTANCES OF THE DEATH
Oli Hoque received his first dose of the Astra Zeneca Covid-19 vaccination on the 19
March 2021. On or around the 1 April 2021 he began to suffer from headaches. These
became progressively worse and on the evening of the 4 April 2021 he attended A&E at
King Georges Hospital. Oli did not present with any symptoms at this time which would
have required assessment in the emergency department. In the late evening of the 5
1
April 2021, Oli was suffering from a severe headache. His sister took him to the Royal
London Hospital. A general practitioner assessed Oli and found no signs of raised
intracranial pressure. The general practitioner did not consider that Oli required further
assessment in the emergency department. At around 11am on the 6 April 2021 Oli's
condition declined significantly and an ambulance was called. Oli was suffering from
seizures at this time and was taken urgently to Queen's Hospital. In hospital,
radiological investigations revealed a cerebral venous sinus thrombosis. Oli received
care from a multi-disciplinary team and the agreed impression was that the cerebral
venous sinus thrombosis was vaccine induced. Sadly, despite all attempts to provide
treatment to Oli, he passed away at Queen's Hospital on the 15 April 2021.
On the 7 April 2021 the MHRA issued new advice to healthcare professionals on a
possible link between the Astra Zeneca COVID-19 vaccine and specific types of blood
clot.
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 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:
The Inquest heard evidence from a senior medical assessor from the Medicines and
Healthcare Regulatory Agency (MHRA). The Inquest heard that from the 25th February
2021 the MHRA investigated the potential signal of immune thrombocytopenia. This
identified three cases of cerebral venous sinus thrombosis which could possibly be
associated with the Astra Zeneca Covid 19 vaccine. The MHRA could not fully consider
these cases as they did not receive all of the necessary clinical information. The Inquest
heard that the MHRA do not have the power to compel relevant clinical information, to
assist them with safety investigations.
In light of the clear public interest in ensuring that the MHRA are able to carry out robust
safety investigations, it is a matter of concern that the MHRA are unable to compel the
timely production of relevant clinical data.
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 8th December 2022. 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.
8
COPIES and PUBLICATION
I have sent a copy of my report to the Chief Coroner and to the following Interested
Persons to the Inquest, family of Mr Hoque to the Care Quality Commission and to the
local Director of Public Health 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 other person who I believe may find it
2
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.
9
13/10/2022
Typographical error of date in section 5 amended 25 October 2022
3
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.
1!R IE CC lE lE ID 29 JU~ 2023 .. . . ,-.r. .ti!.. . -- From Maria Caulfield MP Parliamentary Under Secretary of State Department of Health & Social Care 39 Victoria Street London SW1H0EU 12 June 2023 •Department of Health & Social Care Ms Nadia Persuad Walthamstow Coroner's Court Queens Road Waltham stow E17 8QP Dear Ms Persaud, Thank you for your letter of 13 October 2022, to the then Secretary of State for Health and Social Care, Therese Coffey, about the death of Oli Hoque. I am replying as Minister with responsibility for Social Care, and thank you for the additional time allowed. Firstly, I would like to begin by saying how saddened I was to read of the circumstances of Mr Hoque's death and I offer my sincere condolences to his family and loved ones. It is of course vital that we take learnings where they are identified to improve NHS care, and I am grateful to you for bringing these matters to my attention. In preparing this response, Departmental officials have made enquiries with the Medicines and Healthcare products Regulatory Agency (MHRA). You may wish to know that whilst significant progress has been made in the scientific understanding of vaccine-induced thrombosis with thrombocytopenia, at the time of Mr Hoque's death in April 2021 , diagnostic criteria had only recently been established and communicated to healthcare professionals. It is therefore not surprising that cases reported were of variable detail and were reclassified over time as more evidence emerged. A Yellow Card report was voluntarily made for Mr Hoque the day after his admission to hospital. Furthermore, the hospital doctor provided the requested clinical information and test results within two days of the initial report being submitted. MHRA conducted daily, proactive follow up and utilised a Data Sharing Agreement (DSA) with Public Health England (now UK Health Security Agency, UKHSA) for additional case details where needed. MHRA sought the advice of its COVID-19 Expert Working Group and the Commission on Human Medicines on emerging evidence of thrombosis with thrombocytopenia and issued regular press releases as evidence continued to amass. MHRA do not have jurisdiction over healthcare professionals, and therefore did not comment on your consideration of whether issuance of this Regulation 28 report regarding legislative powers to access NHS case notes would assist the MHRA. There are professional guidelines in place for health care professionals to report safety issues, however, the Department is not aware of any jurisdiction globally that compels relevant clinical follow up information. MHRA recognises the importance of access to relevant clinical information for pharmacovigilance and ensured that relevant data flows were in place prior to commencement of vaccinations in December 2020 to support its four-stranded proactive vigilance strategy - 1) Enhanced passive surveillance - 'observed vs expected' analysis; 2) Rapid Cycle Analysis and Ecological analysis (analysing anonymised healthcare for pre-defined events as well as monitoring trends); 3) Targeted active monitoring; and 4) Formal epidemiological studies. It is the view of the MHRA that focus should be placed on encouraging reporting and working across the health family to streamline processes and reduce barriers to reporting. Steps taken to enable this include working with the NHS to enable interoperability and connectivity of reporting system such as the new Learning from Patient Safety Events System (LPSE) to allow automatic electronic upload into MHRA databases in a timely manner. The NHS Digital Clinical Safety Strategy1 covers integration of LPSE with the Yellow Card system; improvement of adverse events and incident reporting is a commitment made by NHSE and MHRA with a clear strategy and shared responsibilities. A recently published NHS standard contract (NHS England "2023/24 NHS Standard Contract) has a focus on interoperability which will help achieve those aims.2 Finally, MHRA continues to educate and promote the Yellow Card scheme with healthcare professionals through its five Yellow Card Centres and campaigns such as the MHRA's annual #MedSafetyWeek. I hope this response is helpful. Thank you for bringing these concerns to my attention. Yours sincerely, MARIA CAULFIELD 1 https://transform.england.nhs.uk/key-tools-and-info/digital-clinical-safety-strategy/ 2 https://www.england.nhs.uk/nhs-standard-contracl/23-24/
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