Prevention of Future Deaths reports · 2025
Regulation 28 report to prevent future deaths, reference 2025-0427, written 19 Aug 2025. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 19 Aug 2025 |
|---|---|
| Reference | 2025-0427 |
| Deceased | Venetia Pierce |
| Coroner | Susan Ridge |
| Coroner area | Surrey |
| Category | Alcohol, drug and medication 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.
IN THE SURREY CORONER’S COURT IN THE MATTER OF: __________________________________________________________ The Inquest Touching the Death of Venetia Clarissa Pierce A Regulation 28 Report – Action to Prevent Future Deaths __________________________________________________________ 1 THIS REPORT IS BEING SENT TO: Chief Executive Medicines and Healthcare Products Regulatory Agency (MHRA) Chief Executive EMIS Health 2 CORONER Ms Susan Ridge, H.M. Assistant Coroner for Surrey 3 CORONER’S LEGAL POWERS I make this report under paragraph 7(1) of Schedule 5 to The Coroners and Justice Act 2009. 4 INQUEST An inquest into Mrs Pierces death was opened on 16 January 2025. The inquest was resumed and concluded on 6 August 2025. The medical cause of Mrs Pierces’ death was: 1a. Nitrofurantoin induced pneumonitis 2. Frailty With respect to where, when and how Mrs Pierce came by her death it was recorded at Box 3 of the Record of Inquest as follows: Venetia Clarissa Pierce died at the Royal Surrey County Hospital, Guildford on 30 December 2024 from nitrofurantoin induced pneumonitis a recognised complication of taking that antibiotic. Her underlying frailty contributed to the cause of death as it undermined her ability to recover. Mrs Pierce had been prescribed nitrofurantoin in February 2024 as prophylactic treatment to prevent recurrent urinary infections. The inquest concluded with a narrative conclusion: Recognised complications of nitrofurantoin medication. 5 CIRCUMSTANCES OF THE DEATH During the course of the inquest the court heard that Mrs Pierce, an elderly frail lady suffered with recurrent urinary infections. In February 2024 she was prescribed nitrofuratoin by her surgery as a prophylactic treatment to prevent those infections. As this helped Mrs Pierce, the prescription was placed on repeat and she continued to take the antibiotic as a prophylactic. Over 2024, Mrs Pierce reported a number of lower respiratory tract infections and periods of coughing. On 22 December 2024 she was taken to hospital and admitted with symptoms of a chest infection. Although her infection appeared to have reduced and she was actively treated with antibiotics and steroids, Mrs Pierce continued to decline. Further testing and examination of her history revealed that it was more likely than not that she had developed nitrofurantoin induced pneumonitis which led to her death on 30 December 2024. 6 CORONER’S CONCERNS The MATTERS OF CONCERN are: a. The MHRA issued a drug safety alert regarding the risks of pulmonary and hepatic adverse drug reactions in relation to nitrofurantoin in April 2023. However, no MHRA safety alert appeared on the surgery EMIS system when the drug was prescribed to Mrs Pierce. The court heard that the safety alert only arises when patients have a pre-existing pulmonary disease which Mrs Pierce did not have. b. Although a “recognised” complication, understanding of the potential for pulmonary damage and respiratory failure from use of nitrofurantoin in the elderly may remain low. The court heard evidence from a respiratory consultant that awareness amongst GPs, hospital clinicians including urologists was limited and that even if Mrs Pierce had been referred to hospital earlier the condition might not have been diagnosed. 7 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe that the people listed in paragraph one above have the power to take such action. 8 YOUR RESPONSE You are under a duty to respond to this report within 56 days of its date; I may extend that period on request. Your response must contain details of action taken or proposed to be taken, setting out the timetable for such action. Otherwise, you must explain why no action is proposed. 9 COPIES I have sent a copy of this report to the following: 1. Chief Coroner 2. Mrs Pierces’ family 3. Surrey Heartlands Integrated Care System 4. Springfield Surgery 5. Royal Surrey County Hospital 10 Signed: Susan Ridge H.M Assistant Coroner for Surrey Dated 19 August 2025
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.
Fulford Grange Micklefield Lane Leeds, LS19 6BA optum.com October 14, 2025 FAO Susan Ridge HM Assistant Coroner for Surrey Dear Ms Ridge, We write in response to the Regulation 28 Report dated 19th August 2025 (the “Report”). We were sorry to read about the passing of Mrs Pierce, and we would like to take this opportunity to offer our condolences to her family following their loss. We have undertaken an internal review of EMIS Web (the “System”), focusing on the issue raised as a concern in the Report that was relevant to Optum as a healthcare IT supplier. We understand your view is that more needs to be done in terms of MHRA Drug Alerts, specifically in this case, regarding the risks of pulmonary and hepatic adverse drug reactions in relation to Nitrofurantoin. This review was undertaken by our internal team, including two Medical Directors, a Clinical Safety Officer, the Head of Clinical Safety and a Clinical Informatician. Investigation Findings EMIS Web provides a number of alerts and warnings, when relevant, specifically to a patient’s current medication, diagnoses or applicable laboratory results. Alerts are embedded at natural decision points in the user flow and are tiered in terms of severity. This is designed to reduce alert fatigue and ensure critical alerts are prominent and presented early to the user. It should be noted however that alerts and warnings do not replace a clinician’s clinical reasoning but are there to assist in the decision-making process. Following consent being granted by Springfield Surgery, we investigated her medical record, and it was established that Mrs Pierce received Nitrofurantoin on 5 occasions, across 2 prescribed courses. When first prescribed on the 19th February 2024; and upon the commencement of the second course on the 17th May 2024, the system displayed several warnings (please see Fig 1). The warnings are displayed in order of severity (as per the description above) and are driven by coded information within the clinical record, alerting the user to a high- risk situation for Mrs Pierce. In order to progress with the prescription of Nitrofurantoin, the user had to override the warnings. • An allergy warning based upon a coded adverse drug reaction to Nitrofurantoin placed upon the record on the 4th March 2013. This was evident from the Audit function within the System. • High Severity warnings regarding cautionary use in patients with reduced kidney function (eGFR). • A Medium Severity warning relating to age; with advice to monitor lung and liver function on long-term therapy. (Fig 1) These warnings remained accessible to any user of the System at all other times, either via the Safety Check function or by accessing the British National Formulary (BNF) via the System – which includes all MHRA Safety Alerts. Conclusion As a provider of Clinical Decision Support tools, Optum always looks for opportunity to enhance its products to enable clinicians to be best supported when taking ultimate responsibility for any clinical decisions and / or care that is provided. In this instance, based on the information provided in the Report, and our subsequent review, we do not believe there are any software developments beyond the existing functionality in the System that are required to mitigate the specific risk raised in the Report. We trust that the details outlined above are helpful. If you have any further queries then please contact our Senior Clinical Director, , in the first instance. Kind regards, Chief Medical and Strategy Officer
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