Prevention of Future Deaths reports · 2018
Regulation 28 report to prevent future deaths, reference 2018-0352, written 13 Nov 2018. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 13 Nov 2018 |
|---|---|
| Reference | 2018-0352 |
| Deceased | Thomas Jackson |
| Coroner | Andrew Haigh |
| Coroner area | Staffordshire (South) |
| 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 | 2 |
Text recovered by OCR from a scanned PDF. OCR is imperfect: check anything you rely on against the source PDF. Reproduced verbatim, including the scan's own layout.
REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. Neil Carr OBE Chief Executive Midlands Partnership NHS Foundation Trust (MPFT) Trust Headquarters St. George's Hospital Corporation Street Stafford $T16 3SR CORONER | am Mr Andrew Haigh Senior Coroner for the Coroner Area of Staffordshire South CORONER’S LEGAL POWERS | 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. INVESTIGATION and INQUEST On 6" September 2016, | commenced an investigation into the death of Thomas Paul Arthur JACKSON, aged 24 years. The investigation concluded at the end of the inquest on 18 November 2018. The conclusion of the inquest was a detailed narrative one with the Cause of Death being: la) Clozapine Toxicity lb) Pneumonia ll) Treatment Resistant Schizophrenia. CIRCUMSTANCES OF THE DEATH Tom was subject to compulsory Mental Health Detention at a secure unit within St George’s Hospital, Stafford. In the early hours of 25"" August 2016 Tom was found in a poorly state in his room. He was certified dead at 02.25 hours. 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: (1) During the hearing it was noted that on a number of occasions record keeping was poor. This can make continuity of care difficult and it can lead to matters being missed. | wonder if the Trust can take any action to improve this. (2) It is apparent that patients do benefit from regular ‘ward rounds’ or ‘multi- disciplinary team meetings’ (there are a variety of titles) and, apart from the record of these meetings being very poor at times, there is a concern about the conduct of these meetings. In particular there appears to be on occasions inadequate consideration of the history in preparation for the meeting, failure of attendance of all appropriate personnel at such meetings and concern about the patient being able properly to participate. (3) It is clear that Clozapine is a beneficial drug for many patients and that a large number of patients in the care of the Trust do receive this drug. However it appears that many staff are not aware of the significance of this medication particularly when considering potential side-effects and warning signs of deterioration. (4) | would not wish for patients or their families to be overloaded with paperwork but | wonder if there could be a simple leaflet available to patients and family members covering standard information about treatment generally but including matters such as the dangers of patients smoking whilst they are receiving Clozapine. (5) | wonder if there needs to be a review of any lone-working policy or procedure with particular reference as to when to enter patients’ rooms. (6) It is well known that it is important for lessons to be learnt following serious incidents. The SIR procedure is a significant part of this. | understand there have been some changes since the time of Tom’s death but the SIR carried out in this matter contained a number of significant inaccuracies which can affect the validity of the process. Additionally although the records for patients who are in hospital for a long period of time can become voluminous there has also been some difficulty in disclosure of significant documents during the Inquest process. ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and | believe you and your organisation 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 by 8" January 2019. |, 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. COPIES and PUBLICATION | have sent a copy of my report to the Chief Coroner and to the following Interested ind: Day (solicitors representing Tom's mother and sister), [Tom's father), Capsticks Solicitors LLP (representing the Midland Partnership NHS Foundation Trust) and Hogan Lovells International LLP (solicitors representing Mylan Product Ltd). | 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. DATE: 13/11/2018 Theda A bree: Andrew A Haigh HM Senior Coroner for Staffordshire (South) Coroner’s Office No 1 Staffordshire Place Stafford ST16 2LP Tel No: 01785 276127 sscor@staffordshire.gov.uk
REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: The Rt. Hon. Matt Hancock MP - Secretary of State for Health & Social Care Department for Health and Social Care 39 Victoria Street London SW1H OEU CORONER | am Mr Andrew Haigh Senior Coroner for the Coroner Area of Staffordshire South CORONER’S LEGAL POWERS | 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. INVESTIGATION and INQUEST On 6'" September 2016, | commenced an investigation into the death of Thomas Paul Arthur JACKSON, aged 24 years. The investigation concluded at the end of the inquest on 1*' November 2018. The conclusion of the inquest was a detailed narrative one with the Cause of Death being: la) Clozapine Toxicity Ib) Pneumonia ll) Treatment Resistant Schizophrenia. CIRCUMSTANCES OF THE DEATH Tom was subject to compulsory Mental Health Detention at a secure unit within St George's Hospital, Stafford. In the early hours of 25" August 2016 Tom was found in a poorly state in his room. He was certified dead at 02.25 hours. 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 MATTER OF CONCERN is as follows: It is well known that Clozapine is a potentially dangerous drug which needs to be carefully monitored. Monitoring is for both whole blood to look at infection markers and for blood plasma to cheek on Clozapine levels. Since this death the Trust involved has established a policy for the regular checking of blood plasma levels for patients in receipt of Clozapine. However it appears that this is a local policy and that there is no national policy for these checks to be carried out. | wonder if there should be a direction for all trusts to carryout blood plasma tests on patients receiving Clozapine on a regular basis perhaps at least six monthly or yearly. — ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and | believe you and your organisation 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 by 8'" January 2019. |, 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. COPIES and PUBLICATION | have sent a copy of my report to the Chief Coroner and to the following Interested weecigh Day (solicitors representing Tom’s mother and sister), iii. father), Capsticks Solicitors LLP (representing the Midland Partnership NHS Foundation Trust) and Hogan Lovells International LLP (solicitors representing Myian Product Ltd). | 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. 13/11/2018 ae Andrew A Haigh HM Senior Coroner for Staffordshire (South) Coroner's Office No 1 Staffordshire Place Stafford ST16 2LP Tel No: 01785 276127 sscor@staffordshire.gov.uk
REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: James Bailey Commissioner for Highways and the Built County Highways Department Staffordshire County Council 1Staffordshire Place Stafford ST16 2LP CORONER | am Mr Andrew Haigh senior coroner for the coroner area of Staffordshire South CORONER’S LEGAL POWERS | 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. INVESTIGATION and INQUEST On 30 May 2018 | commenced an investigation into the death of Kendall James Chadwick aged 45 years. The investigation concluded at the end of the inquest on 8 November 2018. The conclusion of the inquest was accidental death with the medical cause of death being fracture of the base of skull. CIRCUMSTANCES OF THE DEATH Mr Chadwick died at the scene of a road traffic collision on the A518 at Lower Loxley on 24th May 2018. He had been riding a motorcycle and made an unsafe overtaking manoeuvre near a bend. He lost control of the bike and crashed off the road sustaining a fatal head injury. 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 MATTER OF CONCERN is as follows. —The location is the bend close to the Leese Hill. | am aware of at least one other fatality at the site. There is a sign for the bend, a slow sign in the road for the bend and chevrons and marker posts at the bend. The police have not expressed any particular concerns about the safety of the bend. | should however be grateful if you could have look at the bend to see if any additional steps would be advisable -such as an illuminated sign or rumble strips. At the time of the collision the chevron boards were in a dirty condition and there may be issues about maintenance here as well. 6 | ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and | believe you 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 10.1.2018. |, 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 | have sent a copy of my report to the Chief Coroner and to Mr Chadwick’s family. | have also sent it to Staffordshire Police who may find it useful or of interest. | 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 15" November 2018 Andrew A Haigh HM Senior Coroner for Staffordshire (South) Coroner's Office No 1 Staffordshire Place Stafford ST16 2LP Tel No: 01785 276127 sscor@staffordshire.gov.uk
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.
Staffordshire County Council Mr Andrew A Haigh HM Senior Coroner for Staffordshire South Coroner’s Office No 1 Staffordshire Place Stafford ST16 2LP Communities and Road Safety Staffordshire County Council 2 Staffordshire Place Tipping Street Stafford ST16 2DH Telephone: 01785 278160 18th December 2018 Our ref: MA/RR/A518LLoxley Your ref: AAH/EAS 1042/16 |€ Dear Mr Haigh, Re: Kendall James CHADWICK (Deceased) | refer to your Regulation 28 Report regarding the Inquest into the death of Kendall James Chadwick and your comments concerning the bend close to Leese Hill on the A518 at Lower Loxley. This letter is in response to your matters of concern recorded in section 5 of your report. Following receipt of your letter, a thorough investigation has taken place at the location in question. These investigations incorporated a site visit and included assessment of the current road layout and the existing signage and road marking arrangement. A similar investigation was undertaken following a fatal road traffic collision that you refer to in your report that took place on the 9" February 2011. Following that investigation, anti-skid surfacing was installed in August 2012. The 2018 SCRIM deficiency survey to determine skid resistance, has highlighted that this section of the A518 where the anti-skid surfacing was installed, is performing positively and is above the investigatory level. In addition to the measures that you document such as the enhanced signage and the use of marker posts, on both approaches to the bend there is a Vehicle Activated Sign to warn motorists of the bend ahead. Examining the accident history for this location, apart from the collision involving Mr Chadwick in May this year, Staffordshire County Council has not been made aware of any personal injury collisions on this section of carriageway since 2014. xy ss 7 NS A ese” Staffordshire County Council The conclusions of the investigation identified two general maintenance tasks to be undertaken. These tasks include the replacement of the damaged chevron signs and reinstalling the missing marker posts. These works will be completed at the earliest opportunity. | hope the information provided within this letter is useful. Please let me know if you require anything further. Yours sincerely, /) (C (ow Road Safety Manager BSN WF
From the Baroness Blackwood Parliamentary Under Secretary of State for Innovation 39 Victoria Street London SW1H 0EU 020 7210 4850 15 March 2019 Your Ref: AAH/CLW 564-16 Our Ref: PFD-1156914 Mr Andrew Haigh HM Senior Coroner, Staffordshire (South) Coroner's Office 1 Staffordshire Place Stafford ST16 2LP Dear Mr Haigh, Thank you for your correspondence of 13 November to Matt Hancock about the death of Mr Thomas Jackson. I am replying as Minister with portfolio responsibility for medicines and I am grateful for the additional time in which to do so. Firstly, I would like to say how sorry I was to read of the circumstances of Mr Jackson’s death. I appreciate his loss, at such a young age, must be extremely distressing for his family and loved ones and I offer my sincerest condolences. It is essential that we look to make improvements where we can to ensure the safety of healthcare and prevent future deaths and I am grateful to you for bringing these matters to my attention. My officials have made enquiries with a number of bodies on the matter of concern in your report that there should be routine therapeutic blood monitoring (testing of blood plasma levels) in patients who are prescribed clozapine. I am advised that there is no national guidance that requires NHS trusts to undertake routine (six monthly or annual) monitoring of clozapine plasma levels. There is NICE guidance, ‘Psychosis and schizophrenia in adults: prevention and management’ (CG178)1, which supports the routine monitoring of the physical health of people prescribed antipsychotic medication (including clozapine). 1 https://www.nice.org.uk/guidance/cg178 I am informed that clinical guideline CG178 is to undergo a surveillance review to check whether it needs to be updated and given the concerns you raise, the issue of monitoring blood plasma levels in people taking clozapine (or other antipsychotics) has been logged for the consideration of the guideline surveillance team undertaking the review process. As you may be aware, the Medicines and Healthcare products Regulatory Agency (MHRA), is responsible for the safety of medicines and medical devices. The MHRA seeks independent advice from the Commission on Human Medicines (CHM) which advises on whether the overall balance of benefits and risks of medicines is favourable at the time of licensing and remains so thereafter. One of the ways in which the MHRA monitors the safety of licensed medications is through the Yellow Card scheme which receives information from both healthcare professionals and patients on side effects suspected to be associated with medicines. The concerns you have raised have been added to the MHRA’s adverse drug reaction database under Yellow Card reference number ADR 24386668-001. Detailed guidance on the monitoring requirements for clozapine is provided in the authorised product information which consists of the Summary of Product Characteristics (SmPC) for prescribers and the Patient Information Leaflet which is supplied with each pack of medicine. The SmPC and PIL for clozapine can be found at mhra.gov.uk/spc-pil. Currently, patient monitoring requirements for clozapine include the measurement of clinical parameters such as regular full blood counts; blood pressure; electrocardiograms; hepatic enzymes; blood sugar; lipids and weight. Therapeutic drug monitoring of blood plasma levels is not currently required under the terms of the clozapine marketing authorisation. Individual NHS trusts might monitor clozapine drug levels based on clinical signs and symptoms to check compliance with treatment or as part of investigations into suspected toxicity but they are not required to routinely monitor therapeutic drug levels. In light of the concerns you have raised, the MHRA has undertaken further investigation of the utility of drug monitoring in supporting safe use of clozapine and in doing so, has sought advice from the Pharmacovigilance Expert Advisory Group, which advises the Commission on Human Medicines. I am advised that further analysis of the available data is underway and further expert advice is being sought. The MHRA is happy to keep you informed on the progress of its assessment and I have asked that they do so with you directly. Finally, I am informed that the national Medicine Safety Programme (MSP) is also aware of the issues concerning clozapine toxicity. The MSP is due to announce its initial priority areas in April 2019, and is currently in discussions as to whether to prioritise clozapine toxicity as a core component of the programme’s initial work to improve the safety of medication use across England. I hope this reply is helpful. NICOLA BLACKWOOD
See every Prevention of Future Deaths report matching Hospital Death (Clinical Procedures and medical management) related deaths, 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.