Venetia Pierce
PFD Report
Partially Responded
Ref: 2025-0427
164 days overdue · 1 response outstanding
Response Status
Responses
1 of 2
56-Day Deadline
14 Oct 2025
164 days past deadline — 1 response outstanding
About PFD responses
Organisations named in PFD reports must respond within 56 days explaining what actions they are taking.
Source: Courts and Tribunals Judiciary
Coroner’s Concerns
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.
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.
Responses
EMIS conducted an internal review and concluded that their EMIS Web system already provides relevant warnings, including an allergy warning, high severity warnings for reduced kidney function, and a medium severity warning for age, which were displayed and had to be overridden. EMIS states no further software developments are required to mitigate the raised risk.
AI summary
View full response
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
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
Report Sections
Investigation and 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.
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.
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.
Copies Sent To
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
Inquest Conclusion
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.
The inquest concluded with a narrative conclusion: Recognised complications of nitrofurantoin medication.
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Data sourced from Courts and Tribunals Judiciary under the Open Government Licence.