Prevention of Future Deaths reports · 2020
Regulation 28 report to prevent future deaths, reference 2020-0276, written 9 Dec 2020. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 9 Dec 2020 |
|---|---|
| Reference | 2020-0276 |
| Deceased | Samuel Morgan |
| Coroner | Colin Phillips |
| Coroner area | Swansea and Neath Port Talbot |
| Category | Suicide (from 2015) |
| 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
THIS REPORT IS BEING SENT TO:
1. Minister of State for Mental Health, Suicide Prevention and Patient
Safety
Nadine Dorries MP
House of Commons
London
SW1A 0AA
Email:
2. Chief Executive, MHRA
10 S Colonnade, Canary Wharf, London E14 4PU
Email:
1
CORONER
I am Colin Phillips, acting senior coroner, for the coroner area of Swansea and Neath
Port Talbot
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.
[HYPERLINKS]
3
INVESTIGATION and INQUEST
On 29 January 2020 I commenced an investigation into the death of Samuel David
Morgan aged 25. The investigation concluded at the end of the inquest on 1 December
2020. The conclusion of the inquest was Suicide with Narrative.
4
CIRCUMSTANCES OF THE DEATH
The deceased was Samuel David Morgan (“Sam”) and he died on the 16th January 2020
at his home Westway Heol Y Barna Pontlliw Swansea as a consequence of self-
suspension. The risk of Sam taking his own life had not been identified. On the 9th
January 2020 he had been prescribed a 14 day course of 10 mg citalopram anti-
depressants. A review assessment was not set at the time of the medicine being
prescribed in contravention of NICE Guidance.
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. –
Sam’s mother saw a change in his mood the 7 days before his death which she
attributes to the effect of SSRIs. Whilst the precise effect of this medication (Citalopram)
on Sam is unknown, it is clear that Sam had never self-harmed previously and his
actions were completely out of character. He had started researching schizophrenia on
his phone just before his death. Every medicine pack includes a patient information
leaflet (PIL), which provides information on using the medicine safely and allows patients
to read at their leisure. However, it has been suggested that the “Black Box Warning” (as
developed by the Food and Drug Administration in the USA) would have a more
1
immediate impact and capture some patient’s attention highlighting any risks. The
simple and clear message in this specific case would be that there is an increased risk
of suicidal thinking in young adults. The benefits of such simple and direct messaging
extends to all prescribed medicines and associated major risks.
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 3 February 2020. 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
(Parents)
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
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
9.12.20
SIGNED BY CORONER
2
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 Nadine Dorries MP Minister of State for Patient Safety, Suicide Prevention and Mental Health 39 Victoria Street London SW1H 0EU Our Ref: Mr Colin Phillips Acting Senior Coroner, Swansea and Neath Port Talbot Coroner's Office Civic Centre Oystermouth Road Swansea SA1 3SN Dear Mr Phillips 2 February 2021 Thank you for your letter of 9 December 2020 about the death of Samuel Morgan. I was deeply saddened to read the circumstances of Sam’s death and wish to offer my most heartfelt sympathies and condolences to Sam’s family and loved ones at this difficult time. My officials have liaised with the Medicines and Healthcare products Regulatory Agency (MHRA) which I know has considered carefully your comments about the presentation of risks associated with citalopram and other selective serotonin reuptake inhibitor (SSRI) medicines on Patient Information Leaflets, and by extension the presentation of major risks associated with all prescribed medicines. I hope the MHRA’s response is helpful in explaining that the development of Patient Information Leaflets in the UK is supported by extensive user testing to shape the presentation of key safety messages and that the MHRA cannot identify any evidence that adopting a similar approach to the United States of ‘black box’ warnings is more effective in communicating risk. Nevertheless, should new data come to light, the MHRA will review if changes could be made to support risk communication in future. In addition, the MHRA has created a Yellow Card with the information you have provided in your report. As you will know, the MHRA’s Yellow Card report system enables it to monitor the safety of medicines. Every suicide is a preventable tragedy. While Health is a devolved matter, I can advise what action we are taking in England to reduce suicides, particularly amongst young men, who we know are at high risk. In England, suicide prevention is a priority for this Government and we continue to take action through the Suicide Prevention Strategy for England and its subsequent progress reports, as well as through the first cross-Government Suicide Prevention Workplan, which sets out an ambitious programme across national and local Government and the NHS to reduce suicides. We have issued guidance to local authorities that highlights the importance of working across all local services, including the voluntary sector, to target high risk groups such as men. Every local authority now has a suicide prevention plan in place and 97 per cent of these include action to reduce risk of suicide in men. From 2019/20, we are investing £57million in suicide prevention through the NHS Long Term Plan. This will see investment in all areas of the country by 2023/24 to support local suicide prevention plans and establish suicide bereavement support services. We have ensured that the suicide prevention funding for local areas is used to test different approaches to reaching and engaging men. Finally, I note your concern that a medical review was not scheduled to be held with Sam one week after the antidepressants were prescribed and that this is not in line with the recommendations of the National Institute for Health and Care Excellence (NICE) clinical guideline 901, which states: 1.5.2.7 A person with depression started on antidepressants who is considered to present an increased suicide risk or is younger than 30 years (because of the potential increased prevalence of suicidal thoughts in the early stages of antidepressant treatment for this group) should normally be seen after 1 week and frequently thereafter as appropriate until the risk is no longer considered clinically important. Clinicians are expected to take account of NICE guidelines, product information and advice in the BNF when discussing treatment options with a patient, ensuring that patients are aware of known risks associated with medicines so that properly informed decisions are taken. The risk of suicidal behaviour associated with SSRIs, particularly in young people aged up to 25 years, has been highlighted to healthcare professionals via MHRA Drug Safety Updates, as well as in published guidance by the MHRA2. The GP handbook, the British National Formulary (BNF) also highlights these risks and the importance of monitoring particularly at the start of treatment. I hope this response is helpful. Thank you for bringing these concerns to my attention. Yours sincerely, NADINE DORRIES MINISTER OF STATE FOR PATIENT SAFETY, SUICIDE PREVENTION AND MENTAL HEALTH 1 https://www.nice.org.uk/guidance/cg90/chapter/Recommendations 2 https://www.gov.uk/government/publications/ssris-and-snris-use-and-safety/selective-serotonin-reuptake- inhibitors-ssris-and-serotonin-and-noradrenaline-reuptake-inhibitors-snris-use-and-safety
Colin Phillips Acting Senior Coroner Swansea and Neath Port Talbot Coroner’s Office Civic Centre Oystermouth Road Swansea SA1 3SN By Email: Your Ref: 20 January 2021 Dear Mr Phillips, Medicines & Healthcare products Regulatory Agency 10 South Colonnade Canary Wharf London E14 4PU United Kingdom +44 (0) 20 3080 6000 gov.uk/mhra Inquest into the death of Samuel David Morgan Thank you for your email dated 9 December enclosing the Regulation 28 report to prevent future deaths relating to the tragic death of Mr Samuel David Morgan, aged 25 years, by self-suspension 7 days after citalopram. I extend my sincere condolences to Mr and Mrs Morgan and the family being prescribed and friends of the deceased. Citalopram is an antidepressant that belongs to the selective serotonin reuptake inhibitor (SSRI) class of medicines. The current warnings about the known risk of suicide with use of SSRI antidepressants were implemented following UK and European reviews of the evidence. The text agreed for the patient information leaflet (PIL) was developed with patients’ input and was subject to user testing. The risk of suicide is highlighted in bold and bullet pointed in the first section of the SSRI medicines’ PIL entitled “Eight important things you need to know about ….. (the SSRI medicine).” Specifically, this headline section of the PIL states: • “Some people who are depressed or anxious think of harming or killing themselves. If you start to feel worse, or think of harming or killing yourself, see your doctor or go to a hospital straight away”. Section 2 of the PIL provides more details on thoughts of suicide and worsening depression or anxiety in bold and key messages are bullet pointed: “Thoughts of suicide and worsening of your depression or anxiety disorder: If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer. You may be more likely to think like this: • • If you have previously had thoughts about killing or harming yourself. If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant. If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.” We have taken note of your suggestion that the “black box” warnings in the US product information of suicide warnings for patients ‘would have a more immediate impact’, however we are unable to find evidence that this is more effective in communicating risk than the current practice in the UK of headlines and emboldened text supported by extensive user testing to shape the presentation of key safety messages. Should new data come to light we will review this and see what changes could be made to support risk communication in the future. To supplement the patient information, the MHRA has informed healthcare professionals in the UK about the risk of suicidal behaviour associated with SSRIs via articles in the MHRA’s bulletin Drug Safety Update in April 2008 and December 2014 available at https://www.gov.uk/drug-safety-update/antidepressants- suicidal-thoughts-and-behaviour. We also published guidance for prescribers on the MHRA webpage in December 2014 to summarise key safety messages (https://www.gov.uk/government/publications/ssris-and-snris-use-and-safety/selective- serotonin-reuptake-inhibitors-ssris-and-serotonin-and-noradrenaline-reuptake-inhibitors-snris-use-and- safety). The GP handbook, the British National Formulary (BNF) states, “the use of antidepressants has been linked with suicidal thoughts and behaviour; children, young adults, and patients with a history of suicidal behaviour are particularly at risk. Where necessary patients should be monitored for suicidal behaviour, self-harm, or hostility, particularly at the beginning of treatment or if the dose is changed.” The information in the product information and the BNF should form the basis of a discussion between the doctor and patient when deciding on the most appropriate medicine for them. In addition, clinical guidance issued by the National Institute for Health and Care Excellence (NICE) (Clinical Guideline 90, CG90) on depression in adults recommends that if a person with depression is started on antidepressants and is considered to be an increased suicide risk or is younger than 30 years (because of the potential increased prevalence of suicidal thoughts in the early stages of antidepressant treatment for this group) they should normally be seen after 1 week and frequently thereafter as appropriate until the risk is no longer considered clinically important. I am unable to comment on the issue of the prescription for Mr Morgan to be in contravention of NICE guidance you refer to in the report. Should you wish to follow this up please do contact NICE directly or raise with the General Medical Council. We are grateful you for notifying us of this tragic case. We have used this information to generate a Yellow Card report with the reference number . Yellow Card reports help us to continuously monitor the safety of medicines. if you or the family wish to submit further information, please use this reference number to ensure it is added to the appropriate case. Yours sincerely Interim Chief Executive Medicines and Healthcare products Regulatory Agency
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