Prevention of Future Deaths reports · 2014

Craig White

Regulation 28 report to prevent future deaths, reference 2014-0017, written 14 Jan 2014. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report14 Jan 2014
Reference2014-0017
DeceasedCraig White
CoronerARW Forrest
Coroner areaSouth Lincolnshire
CategoryHospital Death (Clinical Procedures and medical management) related deaths
Organisation namedUnited Lincolnshire Teaching Hospitals NHS Trust
Sourcejudiciary.uk record · original PDF
Responses publishednone published

The report

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.

AR W Forrest ium, rrcp, FRoPath
GMC Number: 1333523

Her Majesty's Senior Coroner for South Lincolnshire

REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1)

NOTE: This form is to be used after an inquest.

[| REGULATION 28 REPORT TO PREVENT FUTURE DEATHS

THIS REPORT IS BEING SENT TO:

1. a chi, Standard Safety Quality Committee, Intensive

Care Society

2. Senior Secretary, British Society of Gastroenterology

3. PY Senior Medical Advisor, British National Formulary

Publications

4, BE Director, Vigilance and Risk Management of Medicines

MHRA

5. Clinical Director, TPP
6. Medical Director, Lincolnshire Community Health

Services

rh re << Director, United Lincolnshire Hospitals NHS
Trust

sea rons a

| 1 | CORONER

| 1am ARW Forrest, Senior Coroner for the Coroner's area of South Lincolnshire.

2 | 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.

3 | INVESTIGATION and INQUEST

On 21* December 2012 | commenced an investigation into the death of Craig Adam

Unit 1, Gilbert Drive, Endeavour Park, Boston PE21 7TQ
Tel: 01522 553374 Fax: 01522 516717
Email: HMCoroner_Southlincolnshire@lincolnshire.gov.uk

A RW Forrest ium, rrcp, FrePath
GMC Number: 1333523
Her Majesty's Senior Coroner for South Lincolnshire
[| WHITE, age 21. The investigation concluded at the end of the inquest on 10” January

2014. The conclusion of the inquest was MISADVENTURE due to disseminated

tuberculosis.

4 | CIRCUMSTANCES OF THE DEATH
Craig Adam White was a 21 year old student, in his final year at Lincoln University. He

was born and brought up in Lincolnshire, an area with a low incidence of tuberculosis.

He received BCG immunisation as a child. He developed Crohn's disease at the age of
16. Eventually good control of the disease was achieved with a regimen that included
treatment with Azothioprine and infusions of Infliximab every 8 weeks. Infliximab was
administered in hospital by a nurse on a gastro-intestinal ward. A letter was not sent to
Craig's general practitioner after each infusion. Infliximab is a monoclonal antibody which
inhibits the activity of the Cytokine Tumour Necrosis Factor Alpha. This blocks part of the
pathological mechanism of Crohn's disease, but also inhibits the body's response to
infection and, in particular Tuberculosis. Because the drug was prescribed and
administered entirely by secondary care practitioners, it did not appear on the System
One Home screen that would be consulted when Craig consulted his primary health care
providers. Before starting treatment with Infliximab he had been screened for latent
tuberculosis by Chest X-ray, history and his BCG immunisation scar being noted. His
Crohn's disease was biopsy proven and review of the biopsies after his death confirmed
the diagnosis and excluded his gastro-intestinal illness being an atypical presentation of

_| tuberculosis.

From September 2012 onward Craig presented to the University Health service at Lincoln
with recurrent chest infections. He did not see a registered medical practitioner there.

The experienced nurse practitioner / independent nurse provider who saw him on several
occasions gave evidence that she knew Craig was on Infliximab, that she knew it was an
immunosuppressant but did not know of the increase risk it posed of tuberculosis. At the

| cares she took roughly 7 minutes to find the relevant section (10.1.3) of the British

Unit 1, Gilbert Drive, Endeavour Park, Boston PE21 7TQ
Tel: 01522 553374 Fax: 01522 516717
Email: HMCoroner_Southlincolnshire@lincolnshire.gov.uk

A R W Forrest ium, rrcp, rrcpath
GMC Number: 1333523

Her Majesty's Senior Coroner for South Lincoinshire

National Formulary that draws attention to the increased risk of tuberculosis.

_| Craig did not respond to first line antibiotic treatment for his chest infection. Treatment
with two second/third line antibiotics, Clarithromycin and Ciprofloxacin, which have some
limited activity against tuberculosis, produced temporary improvement in his condition.
On 31st October 2012, Craig consulted a general practitioner with 10 years experience in
Boston (Lincolnshire) with a history of recurrent chesty cough. Only a subset of Craig's
clinical record was available on the System One E-records available to the GP. Craig
told the GP that he was being treated with Infliximab and Azothioprine for his Crohn's
disease. The GP gave evidence that he was aware of the association of treatment with
Infliximab and tuberculosis. He was aware from his own practice of the very low incidence
of TB in those born and brought up in Lincolnshire. He arranged for blood tests
including full blood count, urea and electrolytes and a C- reactive protein and a Chest X-
Ray. These showed a raised C reactive protein, a low white blood cell count, a
marginally reduced plasma sodium and a small right sided pleural effusion. The doctor
decided to prescribe a 3" line antibiotic (Ciprofloxacin) and to wait and see if the clinical

picture improved.

On 30t November Craig became acutely ill, he was confused, he fitted in the Accident
and Emergency department at Pilgrim Hospital and was taken to the Intensive Therapy
Unit. After a CT scan, done primarily to establish it was safe to perform a lumbar
puncture, a lumbar puncture was done. This only showed a small elevation in protein
concentration. Craig was sedated and treated with antibiotics and the anti-viral drug
Acyclovir. The following day he was extrubated and transferred to a general medical
ward. Whilst there, he had a fluctuating level of consciousness. An MRI done on 5th
November 2012 showed changes suggestive of Leptomeningitis. He was prescribed
further antibiotics, including Co-trimoxazole. A further CT scan was done on 9th
December 2012. Again this was primarily to assess the safety of a lumbar puncture. On
this occasion the tests requested on the CSF included a Polymerase Chain Reaction -

Unit 1, Gilbert Drive, Endeavour Park, Boston PE21 7TQ
Tel: 01522 553374 Fax: 01522 516717 :
Email: HMCoroner_Southlincolnshire@lincolnshire.gov.uk

AR W Forrest uum, rrcp, FrcPath
GMC Number: 1333523

Her Majesty's Senior Coroner for South Lincolnshire

‘(PCR) test for tuberculosis. Specific treatment for tuberculosis meningitis was not
initiated at that point. Craig was readmitted to the ITU on 9% December 2012. Review
by Intensivists, Gastroenterologists and a Neurologist on 9 and 10% December 2012
produced a differential diagnosis of Multi-Focal Leukeoencephalopathy, Listeria
Meningitis, Crytococcal Meningitis, TB Meningitis and Aseptic Meningitis. Amphotericin
was-added to his treatment. Specific treatment for tuberculosis was not administered.
Evidence was given that at that point "Gold Standard" treatment for tuberculosis
meningitis would have had a less than 80% chance of resulting in Craig's survival.
Craig's condition deteriorated and at 17.30 hours on 12 December 2012, just before the
first set of tests to confirm a diagnosis of Brain Stem Death were to be carried out, the
consultant Intensivist received a call from the Microbiology Laboratory informing him that
a positive result for tuberculosis had been found on PCR testing of the cerebro-spinal fluid

sample obtained on 9* December 2012.

At Post Mortem Craig was found to have widely disseminated tuberculosis in his chest
and abdomen as well as Tuberculosis Leptomeningitis, early Cerebritis and abscess
formation in his brain with an acute thrombosis in the sigmoid sinus.

An epidemiological investigation by Public Health England has not revealed how Craig

came to be infected with tuberculosis.
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 Protocols for pre-Infliximab treatment screening for tuberculosis
2 Awareness of Health Care Professionals, in particular prescribers of the
increased risk of TB inherent Infliximab treatment

Unit 1, Gilbert Drive, Endeavour Park, Boston PE21 7TQ
Tel: 01522 553374 Fax: 01522 516717
Email: HMCoroner_Southlincoinshire@lincolnshire.gov.uk

AR W Forrest ium, erep, rrcpath
GMC Number: 1333523
Her Majesty's Senior Coroner for South Lincolnshire

3 The need for continuing patient education about the risks of Infliximab treatment
4 The need for prompt treatment to be initiated when tuberculous meningitis is

suspected

ACTION SHOULD BE TAKEN
In my opinion action should be taken to prevent future deaths and | believe you and/or

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 13" March 2014. |, 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

‘| Persons

| have also sent it to Prescribing Advisor, Great East Midlands
Commissioning Support Group, and cS Public Health Physician, who
may find it useful or of interest.

lam 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.

14" January 2014
ARW cout ae svevsscsstesDieesnd fie a sk Gabedeousesawediuyevesdsce

H M Senior Coroner for South Lincolnshire

Unit 1, Gilbert Drive, Endeavour Park, Boston PE21 7TQ
Tel: 01522 553374 Fax: 01522 516717
Email: HMCoroner_Southlincolnshire@lincolnshire.gov.uk

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