Prevention of Future Deaths reports · 2021
Regulation 28 report to prevent future deaths, reference 2021-0075, written 15 Mar 2021. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 15 Mar 2021 |
|---|---|
| Reference | 2021-0075 |
| Deceased | Jamie Poole |
| Coroner | Emma Serrano |
| Coroner area | Stoke-on-Trent & North Staffordshire Coroner’s Court |
| Category | 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.
REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. - Chief Executive NHS England PO Box 16738 Redditch B97 9PT 1 CORONER I am Emma Serrano Area Coroner for Stoke-on-Trent & North Staffordshire Coroner's Court 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 17/07/2017 I commenced an investigation into the death of Jamie Lee Poole, aged 27. The investigation concluded at the end of the inquest on 9th March 2021. The conclusion of the inquest was a narrative conclusion of: ‘A recognised complication of immunosuppressant treatment for a lifesaving kidney transplant’. The cause of death recorded at inquest was:- 1a) Cerebral oedema. 1b) Electrolyte disarray with calcium and magnesium deficiencies. II) Renal failure due to Henoch-Schoenlein purpura. 4 CIRCUMSTANCES OF THE DEATH Jamie Lee Poole was diagnosed with IgA nephropathy, which causes kidney failure, which required the lifesaving surgery of a kidney transplant in 2011. After the transplant she was placed on a dose of immunosuppressant (tacrolimus) to prevent rejection of the transplanted kidney. One of the known side effects of the use of the medication is that it can cause low levels of magnesium within the body. Her kidney function again started to deteriorate in October 2016. She was managed for this within the community. Omeprazole was introduced in Jamie Lee Pools prescription medication, as part of the management of the reoccurrence of her kidney failure. A known side effect of this medication is that it can cause low levels of magnesium within the body. She was admitted to the Royal Stoke University Hospital on 27 June 2017 with low levels of magnesium and low calcium and was treated for correction of electrolyte disturbance. On the 28 June 2017 between 6:20 and 6:30 in the morning she was found on the floor having collapsed. It was discovered that she had significant swelling on her brain. This was caused by a lack of oxygen to the brain, which was either caused by a heart problem or a seizure, which on balance would have been caused by the low levels of magnesium. She was transferred to the intensive care unit at the Royal Stoke University, Stoke-on-Trent where she passed away on the 2 July 2017. She passed away due to acute cerebral oedema and acidosis. This was caused by low levels of magnesium and calcium. 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 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) Transplant patients are put on strong immunosuppressive medication to prevent rejection of the transplanted organ. The medication, tacrolimus in Jamie Lee Pools case, has a common known side effect of reducing magnesium levels within the body. This can be life threatening. Despite this, it is not standard practice to regularly test transplant patients magnesium levels. I heard evidence at inquest that, whilst the Trust providing care for Jamie Lee Poole, has now remedied this, and routinely test post- transplant patients’ for magnesium levels, this is not the case in other areas. The evidence that I heard that was that, whether these levels were tested routinely and regularly, was very much dependant on trust area. In one area, patients may be tested routinely for this in others they would not. ACTION SHOULD BE TAKEN 6 In my opinion action should be taken to prevent future deaths and I believe you NHS England 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 11 May 2021. 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: 1. , parents of the deceased. 2. Royal Stoke University Hospital, Stoke-on-Trent I am also under a duty to send the Chief Coroner a copy of your response 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 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 15/03/2021 Signature: Emma Serrano Area Coroner Stoke-on-Trent & North Staffordshire Coroner's Court
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.
Ms Emma Serrano, Area Coroner Stoke-on-Trent & North Staffordshire Coroner's Court, Coroner’s Chambers, 547 Hartshill Road, Hartshill, Stoke-on-Trent ST4 6HF National Medical Director NHS England & NHS Improvement Skipton House 80 London Road London SE1 6LH 26th April 2021 Dear Ms Serrano, Re: Regulation 28 Report to Prevent Future Deaths – Jamie Lee Poole (2nd July 2017) Thank you for your Regulation 28 Report dated 15/03/2021 concerning the death of Jamie Lee Poole on 2nd July 2017. Firstly, we would like to express our condolences to Jamie Lee Poole’s family. The regulation 28 report concludes Jamie Lee Poole’s death was a result of Acute Cerebral Oedema and acidosis secondary to low Magnesium and Calcium levels. Following the inquest, you raised concerns in your Regulation 28 Report to NHS England regarding routine testing of post-transplant patients for magnesium levels. We are deeply saddened to hear about the tragic loss of Jamie Lee Poole, aged 27. The cause of death has been attributed to acute cerebral oedema and acidosis secondary to low calcium and severe which had been diagnosed on blood testing during a clinic review. Hypomagnesemia is a recognised electrolyte disturbance associated with both Tacrolimus and Proton Pump Inhibitors (PPI), both of which she was taking at the time. Symptomatic severe hypomagnesemia leading to fatality in established kidney transplant patients on isolated Tacrolimus or other Calcineurin inhibitor (CNI) therapy is rarely reported in literature. However, several factors such as elevated drug levels and drug interactions with PPI and others can exacerbate the risk through altered magnesium handling by the body. We wish to convey our sincere condolences to the family and have taken the matter extremely seriously to prevent future occurrence. We will be instituting the following remedial actions: NHS England and NHS Improvement - A National Patient safety alert (Level 2) on the risk of severe hypomagnesemia in the context of Tacrolimus and Proton pump inhibitor use in transplant recipients and other conditions - The advice for monitoring Mg levels periodically is already in place for PPI’s Proton pump inhibitors (PPIs) | Prescribing information | Dyspepsia - unidentified cause | CKS | NICE) & MHRA (2012) Proton pump inhibitors in long term use: reports of hypomagnesaemia. Drug Safety Update 5(9). Although this guidance is in place, it may not be practiced reliably. A Reminder Alert will be sent out on Magnesium monitoring in patients on PPI and at risk of hypomagnesemia as recommended by NICE. - An Expert Clinical review to make recommendations on magnesium monitoring in patients on Immunosuppression, and a review of prescribing PPI and H2 antagonists in patients on CNI. This would be undertaken jointly by the professional societies of UK Renal Pharmacy Group and British Transplant Society/Renal Association. Dissemination of updated guidance will be to all clinical teams involved in the care of kidney transplant recipients through the Renal Networks. Thank you for bringing this important patient safety issues to our attention and please do not hesitate to contact us should you need any further information. Yours sincerely, National Medical Director
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