Prevention of Future Deaths reports · 2023
Regulation 28 report to prevent future deaths, reference 2023-0058, written 14 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 | 14 Feb 2023 |
|---|---|
| Reference | 2023-0058 |
| Deceased | John Abrahams |
| Coroner | Catherine McKenna |
| Coroner area | Manchester North |
| Category | 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 REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: CORONER 1. Secretary of State for Health and Social Care am Catherine Mckenna. Area Coroner for the Coroner area of Manchester North H 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 I INVESTIGATION and INQUEST On 31 August 2021 an investigation into the death of John Abrahams (Jack) was commenced. The investigation concluded at the end of the inquest on 10 February 2023. I recorded a conclusion of Suicide. 2 3 4 CIRCUMSTANCES OF DEATH Jack Abrahams was 20 years old when he took his own life by means of self-ligature. I heard evidence that when Jack was 17 years old, he had received a six month course of Isotretinoin (brand name Roaccutane) for treatment of acne. The available evidence did not meet the standard required to show a causative link between the course of treatment and Jack’s suicide. 5 CORONER’S CONCERNS During the course of the inquest the evidence revealed matters giving rise to concern. a risk that future deaths will occur unless action is taken. In my opinion there is In the circumstances it is my statutory duty to report ‘toyou. The MATTER OF CONCERN is as follows: The Commission for Human Medicine (CHM) established an Isotretinoin Expert Working Group (IEWG) in response to concerns about psychiatric events. The IEWG considered oral and written evidence over 2020 and 2021. The findings and recommendations of the IEWG were presented in a report to the CHM at the end of 2021 and include a recommendation which relates to prescribing for patients under the age of 18. I It is now over a year since the IEWG report was completed and the recommendations have still not been implemented. Medicines Healthcare products Regulatory Agency (MHRA) comprising of 81 psychiatric adverse events, one of which was an attempted suicide. The Court heard that a second working group is required to consider how to implement the IEWG recommendations and that this group has yet to meet. In that time there have been 45 adverse lsotretinion events reported to the • 6 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. 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely 12 April 2023, I, the Area Coroner, may extend the period. j 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 PIJBUCATION I have sent a copy of my report to the Chief Coroner and to the following Interested Persons namely:- The family of Jack Abrahams The MHRA • • • 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: 14 February 2023 Signed:
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.
From Rt Hon Steve Barclay MP Secretary of State for Health and Social Care 39 Victoria Street London SW1H 0EU 27 June 2023 Catherine McKenna HM Coroner's Court Floors 2 and 3 Newgate House Newgate Rochdale OL16 1AT Dear Ms McKenna, Thank you for your letter of 14th February 2023 about the death of John (Jack) Abrahams. Firstly, I would like to say how saddened I was to read of the circumstances of Jack’s death, and I offer my sincere condolences to Jack’s family and loved ones. The circumstances your report describes are very concerning and I am grateful to you for , the Chief bringing these matters to my attention. I am aware that Executive of the Medicines and Health Care products Regulatory Agency (MHRA), has responded in detail to the serious concerns you have raised. I do hope that, as an Executive Agency of the Department of Health and Social Care, response has addressed your concerns. I would also add that, since your original letter, the Isotretinoin Implementation Working Group mentioned in letter has met three times, with the third meeting occurring on 12 May 2023. I understand that the Group is now drafting a report for the Commission for Human Medicines, with the aim of presenting their advice in July this year. When the advice is finalised, it will be published and healthcare professionals will be made aware of changes soon after. I hope this response is helpful and further reassures you of the work being undertaken. Thank you for bringing these concerns to my attention. Yours sincerely, RT HON STEVE BARCLAY MP SECRETARY OF STATE FOR HEALTH AND SOCIAL CARE A7
10 South Colonnade
Canary Wharf
London
E14 4PU
United Kingdom
gov.uk/mhra
Catherine McKenna
HM Coroner for Coroner area of Manchester North
12th April 2023
Dear Ms McKenna,
Subject: Report to Prevent Future deaths
John Abrahams (Jack) (Deceased)
The Medicines and Healthcare products Regulatory Agency (MHRA) monitors the safety of
all medicines to ensure that up-to-date information on the benefits and risks of a medicine is
available for healthcare professionals and patients.
The MHRA obtains independent advice from the Commission on Human Medicines (CHM).
The Isotretinoin Expert Working Group (IEWG) was convened by the CHM to evaluate the
latest data on risk of psychiatric adverse reactions and sexual dysfunction suspected to be
associated with the use of isotretinoin and to consider whether regulatory action is required
to minimise risks or raise awareness of the risks.
The IEWG considered oral and written evidence over 2020 and 2021. The review included a
public call for information which resulted in 659 responses with views from patients, families,
and other stakeholders and more than 7 hours of direct presentations, all of which were
considered carefully by the IEWG in making their recommendations. The findings and
recommendations of the IEWG were presented in a report to the CHM at the end of 2021.
Patients and other stakeholders were invited to attend part of this meeting of the CHM to
hear the presentation and discussion of the data.
The CHM further advised in August 2022 that, in order to ensure the safe and effective
introduction of the recommendations, an Implementation Working Group should be
established with representation from the wider healthcare system in addition to relevant
A3
healthcare professionals. This was due to concerns raised around the logistical
implementation of the recommendations which they felt may delay treatment for those that
need it.
The Implementation Working Group has had two meetings in March 2023 and is making
good progress with a further meeting planned in mid May 2023.
The report of this review will be published shortly. We will advise you of the publication date
when it is confirmed.
Yours sincerely,
Chief Executive
Medicines and Healthcare products Regulatory Agency
A4
10 South Colonnade Canary Wharf London E14 4PU United Kingdom gov.uk/mhra Ms Catherine McKenna HM Coroner for Coroner area of Manchester North 03 May 2023 Dear Ms McKenna, Report to Prevent Future deaths - John Abrahams Thank you for your report dated 14 February 2023, received on 15 February 2023. I would like to offer my sincere condolences to Mr Abraham’s family on their tragic loss. The Medicines and Healthcare products Regulatory Agency (MHRA) monitors the safety of all medicines to ensure that up-to-date information on the benefits and risks of a medicine is available for healthcare professionals and patients. The MHRA obtains independent advice from the Commission on Human Medicines (CHM). The Isotretinoin Expert Working Group (IEWG) was convened by the CHM to evaluate the latest data on risk of psychiatric adverse reactions and sexual dysfunction suspected to be associated with the use of isotretinoin and to consider whether regulatory action is required to minimise risks or raise awareness of the risks. The IEWG considered oral and written evidence over 2020 and 2021. The review included a public call for information which resulted in 659 responses with views from patients, families, and other stakeholders and more than 7 hours of direct presentations, all of which were considered carefully by the IEWG in making their recommendations. The findings and recommendations of the IEWG were presented in a report to the CHM at the end of 2021. Patients and other stakeholders were invited to attend part of this meeting of the CHM to hear the presentation and discussion of the data. A5 The report of this review was published 26 April 2023. A link to the published report is here: Isotretinoin: an expert review of suspected psychiatric and sexual side effects - GOV.UK (www.gov.uk). It was accompanied by a Drug Safety Update Bulletin, sent to healthcare professionals: Isotretinoin (Roaccutane▼): new safety measures to be introduced in the coming months, including additional oversight on initiation of treatment for patients under 18 years - GOV.UK (www.gov.uk). The CHM further advised that, in order to ensure the safe and effective introduction of the recommendations, an Implementation Working Group should be established with representation from the wider healthcare system in addition to relevant healthcare professionals. This was due to concerns raised around the logistical implementation of the recommendations which they felt may delay treatment for those that need it. The Implementation Working Group has had two meetings in March 2023 and is making good progress with a further meeting planned in mid-May 2023. The output of the Group’s work will be made public in due course. Should you have any further questions, I should be pleased to assist. Yours sincerely, Chief Executive Medicines and Healthcare products Regulatory Agency A6
See every Prevention of Future Deaths report matching Suicide (from 2015), and how often a new one appears.
What would an alert for this have sent me? Search the full text
Free to try — the preview shows the real matches and how many arrived in the last 12 months. Your first email alert is free.
These reports are published by the Chief Coroner's office at judiciary.uk and are © Crown copyright. The text here is reproduced from the published PDF so it can be searched. If something on this page is wrong, or you are a person named in it and want it reviewed, email drcjar@gmail.com and we will act promptly.