Paula Doreen
PFD Report
All Responded
Ref: 2025-0511
Alcohol, drug and medication related deaths
Hospital Death (Clinical Procedures and medical management) related deaths
All 5 responses received
· Deadline: 13 Feb 2026
Coroner's Concerns (AI summary)
National risk of concurrent paracetamol prescriptions due to prescribing system deficiencies and inadequate assessment of patient confusion. Inconsistent management of therapeutic excess persists, and new systems risk losing safety nets.
View full coroner's concerns
In the circumstances it is my statutory duty to report you. 1. In respect of preventing concurrent prescriptions of paracetamol containing drugs and otherwise preventing prescribing errors resulting in therapeutic excess of paracetamol (NHSE, RPS, Cerner, MHRA, LGT) (1) NHSE, RPS, Cerner, MHRA I consider that the risk of concurrent prescriptions of paracetamol containing drugs is of wider national concern. The Cerner prescribing system offers a duplicate checking functionality that is not a standard feature. It is hard stop and can be overridden and was not adopted by the LGT when the system was introduced. All the healthcare professionals were aware that co-codamol contained paracetamol and should not be prescribed with paracetamol. However, the 2 prescribing doctors failed to recognise that Mrs Hughes was already prescribed a paracetamol containing drug. 2 nurses failed to recognise they were administering 2 paracetamol containing drugs. A pharmacist failed to identify the concurrent prescriptions during reconciliation.
(2) LGT LGT’s response to the incident was swift and commendable. A hard stop was introduced to the electronic prescribing system which eliminated concurrent prescriptions of paracetamol containing drugs. Further refinements of the system significantly reduced therapeutic excesses of paracetamol based on weight, which had been identified as an issue when investigating Mrs Hughes’ death. However, it is my understanding that consideration is being given to changing the electronic record and prescribing system. My concern is that during any move to a new system, the safety nets introduced by the Trust will be diluted or lost
2. Management of therapeutic excess if it has not been prevented (LGT) This issue has arisen from the finding that once the concurrent prescription had been identified, there had no attempt to consider whether there had been a therapeutic excess and whether Mrs Hughes had suffered harm. The Trust’s response to the incident focused on prevention. It did not consider the adequacy of the clinical response once the overdose had been identified. The Trust relies on information sharing of learning from incidents and thereafter places reliance on individual clinical practice. I received no evidence of a robust process for ensuring a consistent clinical response to the management of therapeutic excess and the potential for toxicity.
3. The assessment of the ACVPU score (LGT, RCP, NHSE) This concern has arisen out of the fact that Mrs Hughes was scored as alert when she was confused. Confusion would have added a score of 3 to her NEWS2 score and would have resulted in an earlier escalation of her condition. I heard that confusion is not always easy to identify and that the signs can be subtle.
(1) LGT The Trust provided training materials relating to detection and management of deteriorating patients. There was minimal guidance on how to accurately assess the ACVPU score and the confusion element in particular. There remains a tangible risk that the ACVPU score will continue to be assessed inconsistently, with new episodes of confusion continuing to be missed.
(2) NHSE, RCP I consider that consistent and accurate assessment of the ACVPU element of the NEWS2 score is likely to a matter of wider concern. This concern is being brought to the attention of NHSE and the RCP as I consider that they have the power to support healthcare professionals to ensure consistent and accurate scoring of confusion.
4. Mechanism for recording over the counter medications taken prior to attendance at the Emergency Department (LGT) This concern has arisen out of my finding that Mrs Hughes had taken an over the counter (OTC) drug containing paracetamol before her admission to hospital but that this had not been recorded as part of her medication history. The Trust’s Medicines Reconciliation Policy requires that patients should be asked about OTCs. The Trust relies on individual clinical practice. There is no mechanism to ensure that pre-admission OTCs are consistently recorded such that the risk of therapeutic excess of paracetamol (or other drugs available OTC) in those circumstances continues to exist.
5. Trust approach to mitigating against confirmation bias and encouraging professional curiosity (LGT) Confirmation bias and a lack of professional curiosity were significant features in Mrs Hughes’ being administered two paracetamol containing drugs at the same time and in not investigating whether she had received a therapeutic excess and suffered consequential harm. I have found that the Trust does not have robust mechanism for mitigating against confirmation bias and encouraging professional curiosity.
6. Trust policy on managing virtual patient reviews (LGT) This concern has arisen out of the fact that Mrs Hughes had been reviewed virtually rather than face to face a resident doctor on the morning before she became unwell. The Trust has no guidance or policy on virtual reviews. I was told that this is a matter of clinical judgment. The absence of any guidance to help a still relatively inexperienced resident doctor decide when they can dispense with a face-to-face review is a circumstance that creates a risk that future deaths may occur.
(2) LGT LGT’s response to the incident was swift and commendable. A hard stop was introduced to the electronic prescribing system which eliminated concurrent prescriptions of paracetamol containing drugs. Further refinements of the system significantly reduced therapeutic excesses of paracetamol based on weight, which had been identified as an issue when investigating Mrs Hughes’ death. However, it is my understanding that consideration is being given to changing the electronic record and prescribing system. My concern is that during any move to a new system, the safety nets introduced by the Trust will be diluted or lost
2. Management of therapeutic excess if it has not been prevented (LGT) This issue has arisen from the finding that once the concurrent prescription had been identified, there had no attempt to consider whether there had been a therapeutic excess and whether Mrs Hughes had suffered harm. The Trust’s response to the incident focused on prevention. It did not consider the adequacy of the clinical response once the overdose had been identified. The Trust relies on information sharing of learning from incidents and thereafter places reliance on individual clinical practice. I received no evidence of a robust process for ensuring a consistent clinical response to the management of therapeutic excess and the potential for toxicity.
3. The assessment of the ACVPU score (LGT, RCP, NHSE) This concern has arisen out of the fact that Mrs Hughes was scored as alert when she was confused. Confusion would have added a score of 3 to her NEWS2 score and would have resulted in an earlier escalation of her condition. I heard that confusion is not always easy to identify and that the signs can be subtle.
(1) LGT The Trust provided training materials relating to detection and management of deteriorating patients. There was minimal guidance on how to accurately assess the ACVPU score and the confusion element in particular. There remains a tangible risk that the ACVPU score will continue to be assessed inconsistently, with new episodes of confusion continuing to be missed.
(2) NHSE, RCP I consider that consistent and accurate assessment of the ACVPU element of the NEWS2 score is likely to a matter of wider concern. This concern is being brought to the attention of NHSE and the RCP as I consider that they have the power to support healthcare professionals to ensure consistent and accurate scoring of confusion.
4. Mechanism for recording over the counter medications taken prior to attendance at the Emergency Department (LGT) This concern has arisen out of my finding that Mrs Hughes had taken an over the counter (OTC) drug containing paracetamol before her admission to hospital but that this had not been recorded as part of her medication history. The Trust’s Medicines Reconciliation Policy requires that patients should be asked about OTCs. The Trust relies on individual clinical practice. There is no mechanism to ensure that pre-admission OTCs are consistently recorded such that the risk of therapeutic excess of paracetamol (or other drugs available OTC) in those circumstances continues to exist.
5. Trust approach to mitigating against confirmation bias and encouraging professional curiosity (LGT) Confirmation bias and a lack of professional curiosity were significant features in Mrs Hughes’ being administered two paracetamol containing drugs at the same time and in not investigating whether she had received a therapeutic excess and suffered consequential harm. I have found that the Trust does not have robust mechanism for mitigating against confirmation bias and encouraging professional curiosity.
6. Trust policy on managing virtual patient reviews (LGT) This concern has arisen out of the fact that Mrs Hughes had been reviewed virtually rather than face to face a resident doctor on the morning before she became unwell. The Trust has no guidance or policy on virtual reviews. I was told that this is a matter of clinical judgment. The absence of any guidance to help a still relatively inexperienced resident doctor decide when they can dispense with a face-to-face review is a circumstance that creates a risk that future deaths may occur.
Responses
Action Taken
The Trust provided additional training on ‘The Deteriorating Patient’ in 2022. Since September 2023, the Trust has introduced additional recommended courses and in June 2024, the ward received teaching sessions about NEWS2 and response. (AI summary)
The Trust provided additional training on ‘The Deteriorating Patient’ in 2022. Since September 2023, the Trust has introduced additional recommended courses and in June 2024, the ward received teaching sessions about NEWS2 and response. (AI summary)
View full response
Dear Coroner, Re: Regulation 28 Report to Prevent Future Deaths – Paula Doreen Hughes who died on 1st January 2022.
Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 12th October 2025 concerning the death of Paula Doreen Hughes on 1st January 2022. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Paula's family and loved ones. NHS England is keen to assure the family and yourself that the concerns raised about Paula’s care have been listened to and reflected upon.
Your Report raises concerns with prescribing errors, leading to concurrent prescriptions of paracetamol containing drugs being administered. You were concerned that the Cerner prescribing system offers a duplicate checking function but that this is not a standard feature. You also raised concerns with the assessment of Paula’s Alert, Confusion, Voice, Pain, and Unresponsive (ACVPU) score, in particular that she was scored as alert when she was confused. You noted that the consistent and accurate assessment of the ACVPU element of the National Early Warning Score (NEWS) 2 is likely to be a matter of wider concern.
The risk of concurrent prescriptions of paracetamol containing drugs
Currently, it is possible to have more than one paracetamol containing drug on a patient’s list of prescribable drugs and for both drugs to be issued concurrently. Electronic prescribing allows for the prescriber to be alerted if they attempt to prescribe two paracetamol containing drugs concurrently. In this case, although this safety feature was available in Cerner, it was not a ‘standard feature’ and it is assumed that it was not ‘switched on’. Had this feature been enabled, there is a reasonable likelihood that the error would have been prevented.
A significant proportion of NHS Trusts (92% of acute providers) have implemented Electronic Prescribing and Medicines Administration (EPMA) systems, though the functionality and configuration of clinical decision support (CDS) and alerts vary widely. While these alerts are an important safety feature, they are designed to National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG
5th December 2025
support, not replace clinical judgement and responsibility. In particular, there is a risk that frequent alerts can lead to “alert fatigue” and desensitisation, increasing the risk of overlooking critical warnings. This reinforces the need for careful consideration of which alerts remain active, even for common contraindications, as repeated exposure can normalise risk and condition users not to pay attention to alerts. Additionally, some NHS Trusts do not yet have EPMA systems, making vigilance through multidisciplinary review essential to mitigate these risks.
There are some cases where it may be intentional to have more than one paracetamol item prescribed concurrently, such as for prescribing both oral and intravenous paracetamol. In this scenario, multiple prescriptions would have to be written to give these options. There are some systems that provide decision support at the point of administration – for example, if the patient had received a dose of paracetamol in the last 4 hours or they had reached their limit for the day, then there would be an alert if the user attempts to give the patient more. However, this type of alert is not universal to all systems.
If an electronic prescribing system has safety-critical features, then a strong argument can be made that these should be a ‘standard feature’ rather than an optional feature (as appears to be the case with Cerner).
NHS England commissioned the ‘ePrescribing Risk and Safety Evaluation’ (ePRaSE) toolkit, which is an online self-assessment tool that NHS secondary care providers are able to register to use with annual releases. It is intended to test how effectively e- prescribing systems respond to high-risk prescribing scenarios. The 2025 release is now finalised and therapeutic duplication as a theme is included. This incident will be considered as part of the review of the scenarios for the next release in 2026 as a priority area.
NHS England also understands that Lewisham and Greenwich NHS Trust (LGT) are looking into available electronic prescribing systems that assist in preventing concurrent prescriptions of paracetamol containing drugs. They are currently liaising with neighbouring Trusts to consider the other barriers they can put in place to reduce the risk of this happening again. Assessment of the ACVPU (Alert, Confusion, Voice, Pain, Unresponsive) element of the National Early Warning Score (NEWS) 2
NEWS2 is a scoring system in which a score is allocated to various physiological measurements when a patient presents to, or is being monitored in, hospital. It asks clinicians to distinguish between a patient being 'alert' or otherwise experiencing 'confusion' and/or 'unresponsiveness'. The existence of ‘confusion’ is sometimes subtle and hard to recognise. The subtle signs of mental alteration might be better picked up by family or friends, and the work NHS England is undertaking on implementing Patient Wellness Questionnaires and patient safety initiatives such as Martha's Rule will support this. However, the Royal College of Physicians, to whom your Report is also addressed, would be best placed to address how to support training
of healthcare professionals to ensure consistent and accurate assessment of the ACVPU element from a national perspective.
From a local perspective, NHS England is aware that, in 2022, LGT provided additional training on ‘The Deteriorating Patient’ to the ward where Paula was cared for. Since September 2023, the Trust has introduced additional recommended courses including the ‘Simulation Study Day’, which focuses on the recognition and management of the deteriorating patient, the Airway, Breathing, Circulation, Disability, and Exposure (ABCDE) assessment, escalation and NEWS2. In June 2024, the ward Paula was on received a month-long series of informal teaching sessions about NEWS2 and response. I would also like to provide further assurances on the national NHS England work taking place around the Reports to Prevent Future Deaths. All reports received are discussed by the Regulation 28 Working Group, comprising Regional Medical Directors, and other clinical and quality colleagues from across the regions. This ensures that key learnings and insights around events, such as the sad death of Paula, are shared across the NHS at both a national and regional level and helps us to pay close attention to any emerging trends that may require further review and action.
Thank you for bringing these important patient safety issues to my attention and please do not hesitate to contact me should you need any further information.
Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 12th October 2025 concerning the death of Paula Doreen Hughes on 1st January 2022. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Paula's family and loved ones. NHS England is keen to assure the family and yourself that the concerns raised about Paula’s care have been listened to and reflected upon.
Your Report raises concerns with prescribing errors, leading to concurrent prescriptions of paracetamol containing drugs being administered. You were concerned that the Cerner prescribing system offers a duplicate checking function but that this is not a standard feature. You also raised concerns with the assessment of Paula’s Alert, Confusion, Voice, Pain, and Unresponsive (ACVPU) score, in particular that she was scored as alert when she was confused. You noted that the consistent and accurate assessment of the ACVPU element of the National Early Warning Score (NEWS) 2 is likely to be a matter of wider concern.
The risk of concurrent prescriptions of paracetamol containing drugs
Currently, it is possible to have more than one paracetamol containing drug on a patient’s list of prescribable drugs and for both drugs to be issued concurrently. Electronic prescribing allows for the prescriber to be alerted if they attempt to prescribe two paracetamol containing drugs concurrently. In this case, although this safety feature was available in Cerner, it was not a ‘standard feature’ and it is assumed that it was not ‘switched on’. Had this feature been enabled, there is a reasonable likelihood that the error would have been prevented.
A significant proportion of NHS Trusts (92% of acute providers) have implemented Electronic Prescribing and Medicines Administration (EPMA) systems, though the functionality and configuration of clinical decision support (CDS) and alerts vary widely. While these alerts are an important safety feature, they are designed to National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG
5th December 2025
support, not replace clinical judgement and responsibility. In particular, there is a risk that frequent alerts can lead to “alert fatigue” and desensitisation, increasing the risk of overlooking critical warnings. This reinforces the need for careful consideration of which alerts remain active, even for common contraindications, as repeated exposure can normalise risk and condition users not to pay attention to alerts. Additionally, some NHS Trusts do not yet have EPMA systems, making vigilance through multidisciplinary review essential to mitigate these risks.
There are some cases where it may be intentional to have more than one paracetamol item prescribed concurrently, such as for prescribing both oral and intravenous paracetamol. In this scenario, multiple prescriptions would have to be written to give these options. There are some systems that provide decision support at the point of administration – for example, if the patient had received a dose of paracetamol in the last 4 hours or they had reached their limit for the day, then there would be an alert if the user attempts to give the patient more. However, this type of alert is not universal to all systems.
If an electronic prescribing system has safety-critical features, then a strong argument can be made that these should be a ‘standard feature’ rather than an optional feature (as appears to be the case with Cerner).
NHS England commissioned the ‘ePrescribing Risk and Safety Evaluation’ (ePRaSE) toolkit, which is an online self-assessment tool that NHS secondary care providers are able to register to use with annual releases. It is intended to test how effectively e- prescribing systems respond to high-risk prescribing scenarios. The 2025 release is now finalised and therapeutic duplication as a theme is included. This incident will be considered as part of the review of the scenarios for the next release in 2026 as a priority area.
NHS England also understands that Lewisham and Greenwich NHS Trust (LGT) are looking into available electronic prescribing systems that assist in preventing concurrent prescriptions of paracetamol containing drugs. They are currently liaising with neighbouring Trusts to consider the other barriers they can put in place to reduce the risk of this happening again. Assessment of the ACVPU (Alert, Confusion, Voice, Pain, Unresponsive) element of the National Early Warning Score (NEWS) 2
NEWS2 is a scoring system in which a score is allocated to various physiological measurements when a patient presents to, or is being monitored in, hospital. It asks clinicians to distinguish between a patient being 'alert' or otherwise experiencing 'confusion' and/or 'unresponsiveness'. The existence of ‘confusion’ is sometimes subtle and hard to recognise. The subtle signs of mental alteration might be better picked up by family or friends, and the work NHS England is undertaking on implementing Patient Wellness Questionnaires and patient safety initiatives such as Martha's Rule will support this. However, the Royal College of Physicians, to whom your Report is also addressed, would be best placed to address how to support training
of healthcare professionals to ensure consistent and accurate assessment of the ACVPU element from a national perspective.
From a local perspective, NHS England is aware that, in 2022, LGT provided additional training on ‘The Deteriorating Patient’ to the ward where Paula was cared for. Since September 2023, the Trust has introduced additional recommended courses including the ‘Simulation Study Day’, which focuses on the recognition and management of the deteriorating patient, the Airway, Breathing, Circulation, Disability, and Exposure (ABCDE) assessment, escalation and NEWS2. In June 2024, the ward Paula was on received a month-long series of informal teaching sessions about NEWS2 and response. I would also like to provide further assurances on the national NHS England work taking place around the Reports to Prevent Future Deaths. All reports received are discussed by the Regulation 28 Working Group, comprising Regional Medical Directors, and other clinical and quality colleagues from across the regions. This ensures that key learnings and insights around events, such as the sad death of Paula, are shared across the NHS at both a national and regional level and helps us to pay close attention to any emerging trends that may require further review and action.
Thank you for bringing these important patient safety issues to my attention and please do not hesitate to contact me should you need any further information.
Noted
The MHRA outlines existing regulations and guidance concerning paracetamol labelling, prescribing information, and safety monitoring. They have liaised with NHSE regarding the ePRaSE tool. (AI summary)
The MHRA outlines existing regulations and guidance concerning paracetamol labelling, prescribing information, and safety monitoring. They have liaised with NHSE regarding the ePRaSE tool. (AI summary)
View full response
Dear Liliane Field,
CEC 236182 – Prevention of future deaths Reg 28 Paula Doreen Hughes.
We are very sorry to hear of the death of Paula Doreen Hughes and extend our sympathies to her family.
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social care with responsibility for ensuring medicines meet appropriate standards of quality, efficacy and safety. The Human Medicines Regulations 2012 lays out the conditions of the licencing and marketing of a medicine. In response to your concern, 1(1), the use of paracetamol and accidental overdose is a safety concern, especially in relation to the many trade names of non-prescription and prescription medicines containing paracetamol. Therefore the Human Medicines Regulations 2012, contain a number of conditions for the presentation of these medicines to highlight the presence of paracetamol in a medicine. Schedule 25, Part 4 of the Human Medicines Regulations, sets out statutory labelling requirements for paracetamol medicines to highlight the presence of paracetamol in that product. Paragraph 14 states that, except where the name of the product includes the word “paracetamol” and appears on the outer and immediate packaging, the words “contains paracetamol” should be displayed. Paragraph 15 states that, the labelling must highlight paracetamol on the front face of the carton or label and should also contain the warning: “Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor”, which must appear adjacent to either the directions for use or the recommended dosage. Further to this, if the product contains a leaflet, paragraph 16 states, if the product contains paracetamol, unless the product is wholly or mainly intended for children twelve years old or
younger, the words “Do not take anything else containing paracetamol while taking this medicine” and (a) and (b) highlights that the warning “Talk to a doctor at once if you take too much of this medicine, even if you feel well” and if the product does not contain a leaflet then the words “Talk to a doctor at once if you take too much of this medicine, even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage” should be displayed. Additional conditions are in place for children aged 12 years or younger, including the colour of the product, packaging presentations (blisters, child resistant enclosures), and adaptations of the above warnings for parents. For those medicines containing paracetamol which are prescribed to a patient, the statutory warnings should be added to the prescribing label which is applied to the box by the pharmacist. These are highlighted in the BNF (warning label 30, BNF Issue 90). The regulations (Schedule 8) also set out material which must accompany any application for the marketing of a medicine. The Summary of Product Characteristics (SmPC) as referenced in part 2, for healthcare professionals, provides a summary of the clinical particulars in the use of a medicine, including the recommended maximum daily dose. In addition, particulars in reference to overdose are provided. This includes the potential dose over which liver damage may occur and potential risk factors which may elevate the risk of overdose, including medical history, concomitant medicines or alcohol intake. A summary of the symptoms of overdose and management are also provided. The market authorisation holders are obligated under the Human Medicines Regulations to continually review the safety of their medicines and to inform the MHRA of any serious adverse reactions. The MHRA continues to monitor the safety of all medicines and if necessary, will take advice from our independent experts on recommended regulatory action. The MHRA provides a list of the SmPCs and patient leaflets for all medicines at the following: MHRA Products | Home. Additional resources on product information and the treatment of overdose are available from the BNF, the electronic medicines compendium (eMC), the National Poisons Information Service and NHS, Paracetamol for adults: painkiller for pain and high temperature - NHS. The Human Medicines Regulations and the BNF highlight the information that is required in general and electronic prescriptions. We have liaised with NHSE with regard to the ability of the prescribing system to dispense two concurrent medicines containing paracetamol and we understand they will incorporate learning from this incident into the commissioning of the ePRaSE tool.
CEC 236182 – Prevention of future deaths Reg 28 Paula Doreen Hughes.
We are very sorry to hear of the death of Paula Doreen Hughes and extend our sympathies to her family.
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social care with responsibility for ensuring medicines meet appropriate standards of quality, efficacy and safety. The Human Medicines Regulations 2012 lays out the conditions of the licencing and marketing of a medicine. In response to your concern, 1(1), the use of paracetamol and accidental overdose is a safety concern, especially in relation to the many trade names of non-prescription and prescription medicines containing paracetamol. Therefore the Human Medicines Regulations 2012, contain a number of conditions for the presentation of these medicines to highlight the presence of paracetamol in a medicine. Schedule 25, Part 4 of the Human Medicines Regulations, sets out statutory labelling requirements for paracetamol medicines to highlight the presence of paracetamol in that product. Paragraph 14 states that, except where the name of the product includes the word “paracetamol” and appears on the outer and immediate packaging, the words “contains paracetamol” should be displayed. Paragraph 15 states that, the labelling must highlight paracetamol on the front face of the carton or label and should also contain the warning: “Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor”, which must appear adjacent to either the directions for use or the recommended dosage. Further to this, if the product contains a leaflet, paragraph 16 states, if the product contains paracetamol, unless the product is wholly or mainly intended for children twelve years old or
younger, the words “Do not take anything else containing paracetamol while taking this medicine” and (a) and (b) highlights that the warning “Talk to a doctor at once if you take too much of this medicine, even if you feel well” and if the product does not contain a leaflet then the words “Talk to a doctor at once if you take too much of this medicine, even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage” should be displayed. Additional conditions are in place for children aged 12 years or younger, including the colour of the product, packaging presentations (blisters, child resistant enclosures), and adaptations of the above warnings for parents. For those medicines containing paracetamol which are prescribed to a patient, the statutory warnings should be added to the prescribing label which is applied to the box by the pharmacist. These are highlighted in the BNF (warning label 30, BNF Issue 90). The regulations (Schedule 8) also set out material which must accompany any application for the marketing of a medicine. The Summary of Product Characteristics (SmPC) as referenced in part 2, for healthcare professionals, provides a summary of the clinical particulars in the use of a medicine, including the recommended maximum daily dose. In addition, particulars in reference to overdose are provided. This includes the potential dose over which liver damage may occur and potential risk factors which may elevate the risk of overdose, including medical history, concomitant medicines or alcohol intake. A summary of the symptoms of overdose and management are also provided. The market authorisation holders are obligated under the Human Medicines Regulations to continually review the safety of their medicines and to inform the MHRA of any serious adverse reactions. The MHRA continues to monitor the safety of all medicines and if necessary, will take advice from our independent experts on recommended regulatory action. The MHRA provides a list of the SmPCs and patient leaflets for all medicines at the following: MHRA Products | Home. Additional resources on product information and the treatment of overdose are available from the BNF, the electronic medicines compendium (eMC), the National Poisons Information Service and NHS, Paracetamol for adults: painkiller for pain and high temperature - NHS. The Human Medicines Regulations and the BNF highlight the information that is required in general and electronic prescriptions. We have liaised with NHSE with regard to the ability of the prescribing system to dispense two concurrent medicines containing paracetamol and we understand they will incorporate learning from this incident into the commissioning of the ePRaSE tool.
Action Planned
The Royal Pharmaceutical Society will consider how to raise awareness of issues around duplication of medicines in electronic prescribing systems through future communications and engagement with the pharmacy sector. (AI summary)
The Royal Pharmaceutical Society will consider how to raise awareness of issues around duplication of medicines in electronic prescribing systems through future communications and engagement with the pharmacy sector. (AI summary)
View full response
Dear Ms Liliane Field,
RE: Regulation 28 Prevention of Future Deaths Report for Ms Paula Doreen Hughes, deceased.
We are writing to you regarding the report into the death of Ms Paula Doreen Hughes dated 1st January 2022. We would like to express our sincere condolences to the family of Ms Paula Hughes.
The Royal Pharmaceutical Society (RPS) is the professional leadership body for pharmacists and pharmacy in Great Britain, representing all sectors of pharmacy. Our role is to lead and support development of the pharmacy profession including the advancement of science, practice, education and knowledge in pharmacy. We transferred our regulatory role to the General Pharmaceutical Council (‘GPhC’) in 2010, and they now regulate pharmacy and pharmacy professionals in Great Britain.
We acknowledge the conclusion from the inquest on 22nd July 2025 that the medical cause of death of Paula Doreen Hughes was recorded as acute (fulminant) hepatic failure; paracetamol overdose; and ischaemic heart disease, urinary tract infection, diabetes mellitus and excess alcohol consumption.
We also acknowledge your conclusion narrative that it was ‘a medication error resulting in an unintended therapeutic excess of paracetamol contributed to by failure to recognise it and administer timely treatment to mitigate the risk of liver toxicity’.
1. Kit Lo, M., Bourne, K., Besharat, I., 2025. Designing an electronic prescribing and medicines administration system in a paediatric setting. The Pharmaceutical Journal [Online]. Available from: https://pharmaceutical-journal.com/article/ld/designing-an-electronic- prescribing-and-medicines-administration-system-in-a-paediatric-setting [Accessed 17 November 2025]
2. Lorenc, T., Khouja, C., Sowden, A., 2022. Electronic prescribing and Clinical Decision Support Underpinning theories and future directions [Online]. Available from: https://eppi.ioe.ac.uk/cms/Default.aspx?tabid=3966 [Accessed 17 November 2025]
3. HSIB, 2019. Investigation report: Electronic prescribing and medicines administration systems and safe discharge [Online]. Available from: https://www.hssib.org.uk/patient-safety-investigations/electronic-prescribing-and-medicines-administration-systems-and-safe- discharge/investigation-report/ [Accessed 17 November 2025] We note the matters of concern in the report with respect to the Royal Pharmaceutical Society (RPS):
1. In respect of preventing concurrent prescriptions of paracetamol containing drugs and otherwise preventing prescribing errors resulting in therapeutic excess of paracetamol (NHSE, RPS, Cerner, MHRA, LGT)
(1) NHSE, RPS, Cerner, MHRA
I consider that the risk of concurrent prescriptions of paracetamol containing drugs is of wider national concern. The Cerner prescribing system offers a duplicate checking functionality that is not a standard feature. It is hard stop and can be overridden and was not adopted by the LGT when the system was introduced. All the healthcare professionals were aware that co-codamol contained paracetamol and should not be prescribed with paracetamol. However, the 2 prescribing doctors failed to recognise that Mrs Hughes was already prescribed a paracetamol containing drug. 2 nurses failed to recognise they were administering 2 paracetamol containing drugs. A pharmacist failed to identify the concurrent prescriptions during reconciliation. ‘
In considering our response we have sought input from our Expert Advisory Groups (RPS Hospital and Digital Expert Advisory Groups) and colleagues in the NHS England Patient Safety Team. We have also informally discussed and shared the learning from this case with relevant stakeholders at our meetings as appropriate to raise awareness.
In our response, we have focused on what we believe to be the two key system learning areas: (1) the people issues and (2) the technology issues.
In relation to the people issues, there were opportunities for healthcare professionals (without the need for any digital intervention) to identify the medication error. Electronic prescribing and medicines administration systems (EPMA) and clinical decision support (CDS) tools have been widely adopted in healthcare settings to support clinicians in making prescribing decisions and reduce the number of prescribing errors.1 They, however, do not replace the personal responsibility and accountability for prescribing and clinical decision making for healthcare professionals. The coroner accurately highlights in the report the importance of professional curiosity in delivering person-centred care. The PFD report does also highlight the need to remind clinicians of the risks around the prescribing of paracetamol containing products and the issue of duplication. Professional leadership bodies can highlight this particular safety concern and raise awareness of national resources such as the BNF which have a particular reference to safe paracetamol prescribing.
In relation to the technology issues, detecting and managing safety risks with electronic prescribing can be difficult due to the complex nature of potential errors relating to not only the system itself, but also the behaviours of users and characteristics specific to organisations. The systems may face a range of problems in practice, including alert fatigue, increased prescriber error and issues with partial or inconsistent implementation2,3.
1. Kit Lo, M., Bourne, K., Besharat, I., 2025. Designing an electronic prescribing and medicines administration system in a paediatric setting. The Pharmaceutical Journal [Online]. Available from: https://pharmaceutical-journal.com/article/ld/designing-an-electronic- prescribing-and-medicines-administration-system-in-a-paediatric-setting [Accessed 17 November 2025]
2. Lorenc, T., Khouja, C., Sowden, A., 2022. Electronic prescribing and Clinical Decision Support Underpinning theories and future directions [Online]. Available from: https://eppi.ioe.ac.uk/cms/Default.aspx?tabid=3966 [Accessed 17 November 2025]
3. HSIB, 2019. Investigation report: Electronic prescribing and medicines administration systems and safe discharge [Online]. Available from: https://www.hssib.org.uk/patient-safety-investigations/electronic-prescribing-and-medicines-administration-systems-and-safe- discharge/investigation-report/ [Accessed 17 November 2025]
We understand from RPS Digital and Hospital Expert Advisors that most EPMA software in acute trusts have some form of decision support system as part of their package. Most would have a therapeutic duplication alert or a ‘pop up’ enabled that would alert the prescriber when they are prescribing paracetamol and another medicine that contains a paracetamol containing medicine. The system functionality can be set not to alert when prescribing, as there may be legitimate circumstances when a prescriber may want to prescribe the same or a similar medicine. For example, the acceptable duplication of insulin dosing where a patient may need a long-acting insulin prescribed as part of their regime in conjunction with a short acting insulin, or where regular morphine and PRN/as required morphine is co- prescribed for breakthrough pain.
We believe that steps could be taken to try and build alerts and warnings for the unacceptable duplication of medicines into these electronic prescribing systems to make them safer. This would require national oversight to coordinate work with secondary care system suppliers.
We understand that NHS England commission the ‘Electronic Prescribing & Safety Evaluation’ (ePRaSE) project, an online NHS-sponsored self-assessment tool developed to help trusts learn about how well their electronic prescribing systems have been configured and maintained to mitigate against known prescribing risks to keep patients safe.
Thank you for highlighting your concerns in this prevention of future death report. We will consider how we can raise awareness of these important issues through our future communications and engagement with the wider pharmacy sector.
RE: Regulation 28 Prevention of Future Deaths Report for Ms Paula Doreen Hughes, deceased.
We are writing to you regarding the report into the death of Ms Paula Doreen Hughes dated 1st January 2022. We would like to express our sincere condolences to the family of Ms Paula Hughes.
The Royal Pharmaceutical Society (RPS) is the professional leadership body for pharmacists and pharmacy in Great Britain, representing all sectors of pharmacy. Our role is to lead and support development of the pharmacy profession including the advancement of science, practice, education and knowledge in pharmacy. We transferred our regulatory role to the General Pharmaceutical Council (‘GPhC’) in 2010, and they now regulate pharmacy and pharmacy professionals in Great Britain.
We acknowledge the conclusion from the inquest on 22nd July 2025 that the medical cause of death of Paula Doreen Hughes was recorded as acute (fulminant) hepatic failure; paracetamol overdose; and ischaemic heart disease, urinary tract infection, diabetes mellitus and excess alcohol consumption.
We also acknowledge your conclusion narrative that it was ‘a medication error resulting in an unintended therapeutic excess of paracetamol contributed to by failure to recognise it and administer timely treatment to mitigate the risk of liver toxicity’.
1. Kit Lo, M., Bourne, K., Besharat, I., 2025. Designing an electronic prescribing and medicines administration system in a paediatric setting. The Pharmaceutical Journal [Online]. Available from: https://pharmaceutical-journal.com/article/ld/designing-an-electronic- prescribing-and-medicines-administration-system-in-a-paediatric-setting [Accessed 17 November 2025]
2. Lorenc, T., Khouja, C., Sowden, A., 2022. Electronic prescribing and Clinical Decision Support Underpinning theories and future directions [Online]. Available from: https://eppi.ioe.ac.uk/cms/Default.aspx?tabid=3966 [Accessed 17 November 2025]
3. HSIB, 2019. Investigation report: Electronic prescribing and medicines administration systems and safe discharge [Online]. Available from: https://www.hssib.org.uk/patient-safety-investigations/electronic-prescribing-and-medicines-administration-systems-and-safe- discharge/investigation-report/ [Accessed 17 November 2025] We note the matters of concern in the report with respect to the Royal Pharmaceutical Society (RPS):
1. In respect of preventing concurrent prescriptions of paracetamol containing drugs and otherwise preventing prescribing errors resulting in therapeutic excess of paracetamol (NHSE, RPS, Cerner, MHRA, LGT)
(1) NHSE, RPS, Cerner, MHRA
I consider that the risk of concurrent prescriptions of paracetamol containing drugs is of wider national concern. The Cerner prescribing system offers a duplicate checking functionality that is not a standard feature. It is hard stop and can be overridden and was not adopted by the LGT when the system was introduced. All the healthcare professionals were aware that co-codamol contained paracetamol and should not be prescribed with paracetamol. However, the 2 prescribing doctors failed to recognise that Mrs Hughes was already prescribed a paracetamol containing drug. 2 nurses failed to recognise they were administering 2 paracetamol containing drugs. A pharmacist failed to identify the concurrent prescriptions during reconciliation. ‘
In considering our response we have sought input from our Expert Advisory Groups (RPS Hospital and Digital Expert Advisory Groups) and colleagues in the NHS England Patient Safety Team. We have also informally discussed and shared the learning from this case with relevant stakeholders at our meetings as appropriate to raise awareness.
In our response, we have focused on what we believe to be the two key system learning areas: (1) the people issues and (2) the technology issues.
In relation to the people issues, there were opportunities for healthcare professionals (without the need for any digital intervention) to identify the medication error. Electronic prescribing and medicines administration systems (EPMA) and clinical decision support (CDS) tools have been widely adopted in healthcare settings to support clinicians in making prescribing decisions and reduce the number of prescribing errors.1 They, however, do not replace the personal responsibility and accountability for prescribing and clinical decision making for healthcare professionals. The coroner accurately highlights in the report the importance of professional curiosity in delivering person-centred care. The PFD report does also highlight the need to remind clinicians of the risks around the prescribing of paracetamol containing products and the issue of duplication. Professional leadership bodies can highlight this particular safety concern and raise awareness of national resources such as the BNF which have a particular reference to safe paracetamol prescribing.
In relation to the technology issues, detecting and managing safety risks with electronic prescribing can be difficult due to the complex nature of potential errors relating to not only the system itself, but also the behaviours of users and characteristics specific to organisations. The systems may face a range of problems in practice, including alert fatigue, increased prescriber error and issues with partial or inconsistent implementation2,3.
1. Kit Lo, M., Bourne, K., Besharat, I., 2025. Designing an electronic prescribing and medicines administration system in a paediatric setting. The Pharmaceutical Journal [Online]. Available from: https://pharmaceutical-journal.com/article/ld/designing-an-electronic- prescribing-and-medicines-administration-system-in-a-paediatric-setting [Accessed 17 November 2025]
2. Lorenc, T., Khouja, C., Sowden, A., 2022. Electronic prescribing and Clinical Decision Support Underpinning theories and future directions [Online]. Available from: https://eppi.ioe.ac.uk/cms/Default.aspx?tabid=3966 [Accessed 17 November 2025]
3. HSIB, 2019. Investigation report: Electronic prescribing and medicines administration systems and safe discharge [Online]. Available from: https://www.hssib.org.uk/patient-safety-investigations/electronic-prescribing-and-medicines-administration-systems-and-safe- discharge/investigation-report/ [Accessed 17 November 2025]
We understand from RPS Digital and Hospital Expert Advisors that most EPMA software in acute trusts have some form of decision support system as part of their package. Most would have a therapeutic duplication alert or a ‘pop up’ enabled that would alert the prescriber when they are prescribing paracetamol and another medicine that contains a paracetamol containing medicine. The system functionality can be set not to alert when prescribing, as there may be legitimate circumstances when a prescriber may want to prescribe the same or a similar medicine. For example, the acceptable duplication of insulin dosing where a patient may need a long-acting insulin prescribed as part of their regime in conjunction with a short acting insulin, or where regular morphine and PRN/as required morphine is co- prescribed for breakthrough pain.
We believe that steps could be taken to try and build alerts and warnings for the unacceptable duplication of medicines into these electronic prescribing systems to make them safer. This would require national oversight to coordinate work with secondary care system suppliers.
We understand that NHS England commission the ‘Electronic Prescribing & Safety Evaluation’ (ePRaSE) project, an online NHS-sponsored self-assessment tool developed to help trusts learn about how well their electronic prescribing systems have been configured and maintained to mitigate against known prescribing risks to keep patients safe.
Thank you for highlighting your concerns in this prevention of future death report. We will consider how we can raise awareness of these important issues through our future communications and engagement with the wider pharmacy sector.
Action Taken
Lewisham and Greenwich NHS Trust describes safety features in its iCare electronic prescribing system, including 'hard stops' and 'soft stops' for paracetamol prescriptions. The Trust have reviewed their IPS very recently and are participating in a leadership exercise on this topic. (AI summary)
Lewisham and Greenwich NHS Trust describes safety features in its iCare electronic prescribing system, including 'hard stops' and 'soft stops' for paracetamol prescriptions. The Trust have reviewed their IPS very recently and are participating in a leadership exercise on this topic. (AI summary)
View full response
Dear HM Assistant Coroner Dr Lillian Field RESPONSE TO PREVENTION OF FUTURE DEATH REPORT Paula Doreen Hughes
We are writing in response to your prevention of future death report dated 10th October 2025, concerning the care provided to Ms Paula Doreen Hughes. The Trust continue to extend our condolences to the family of Ms Hughes.
Your report highlighted in total six matters of concern that the Trust will endeavour to address, and we provide further information as to these concerns below.
1. Preventing concurrent prescriptions of paracetamol containing drugs and otherwise preventing prescribing errors resulting in therapeutic excess of paracetamol There are several safety elements incorporated into the Lewisham and Greenwich NHS Trust (LGT) electronic prescribing and medicines administration (EPMA) system, iCare. This includes a ‘hard stop’ on prescribing concomitant paracetamol containing products and a number of ‘soft stops’ as listed below: (i) For prescribers: Hard stop alert if the patient is already prescribed a paracetamol containing product, or if multiple paracetamol-containing products are prescribed concurrently (except for a single stat IV dose prescribed with regular oral paracetamol, which is often done post- surgery as part of Enhanced Recovery After Surgery (ERAS))
Dose range checking for IV paracetamol exceeding 15 mg/kg or oral doses exceeding 1 g (the oral paracetamol dose range checking will soon be updated to also oral doses exceeding 15 mg/kg for patients weighing less than 50 kg following updated guidelines)
(ii) For nurses: Soft stop alert for nurses at point of administration if giving 5 doses given in 22 hours or 6 doses given in 24 hours - the alert itself makes it clear how many doses and when the doses were given Soft stop alert for nurses at point of administration if intravenous dose is greater than 15 mg/kg (i.e., it is possible for the prescriber to prescribe paracetamol with only an estimated weight, if an actual weight is recorded and the dose is found to be too high it will alert the nurse) - currently only for IV doses but will include oral doses following updated guidelines "Dose too close" alert for when paracetamol is being given within 4 hours of a previous dose
In May 2027, the Trust will be joining Epic, an electronic records and prescribing system shared by our neighbouring Trusts, Guy’s and St Thomas’ NHS Foundation Trust (GSTT) and King’s College Hospital NHS Foundation Trust (KCH).
There is not currently a hard stop in place for duplicate paracetamol prescriptions within the instance of Epic. However, this functionality is available, and the working understanding is that all safety features on iCare that are not present on Epic will be implemented. This will require agreement from all three Trusts (LGT, GSTT and KCH) and we will seek assurance of this as part implementation.
2. Management of therapeutic excess if it has not been prevented The iCare system has an approved protocol available for paracetamol overdose (screenshots attached). This is the Scottish and Newcastle Anti-emetic Pre-treatment (SNAP) protocol. We recognise that a clinical guideline would help clinicians to identify whether this is required or not, and this is not something that currently exists at LGT. We will develop a clinical guideline for the management of paracetamol overdose in due course, that will be available to all Trust staff, to include a robust clinical response to the management of therapeutic excess and the potential for toxicity.
3. The assessment of the ACVPU score The Trust acknowledges the concerns raised by the Coroner regarding the inaccurate assessment of ACVPU in this case, the associated impact on NEWS scoring, and the risk this poses to timely escalation of a deteriorating patient. We recognise that assessment of confusion can be subtle and subjective, and that training and policy must clearly support staff to identify even early or mild indicators of altered cognition. In direct response to the Coroner’s concerns, the following actions have been agreed by the Senior Nursing leadership team:
(i) Strengthening of Deteriorating Patient Training The Lead Practice Development Nurse will review and update the Trust’s Deteriorating Patient Training Programme to incorporate clearer guidance, case-based scenarios, and explicit teaching on the assessment of ACVPU, including recognition of subtle confusion.
(ii) Refresher Training for Ward Staff All clinical staff on the ward where the patient was admitted will complete refresher training on recognising and escalating the deteriorating patient, with a specific focus on accurate ACVPU assessment. This will help ensure consistent and reliable NEWS scoring across the team.
(iii) Improvement in Training Compliance Trust-wide The Trust will increase the number of staff completing deteriorating patient training across all relevant clinical areas during 2026/27, compared with the 2025 baseline. This will support a broader uplift in staff knowledge and skills relating to the identification of patient deterioration, including cognitive change.
(iv) Review of the Adult Deteriorating Patient Policy The Lead Practice Development Nurse, the Trust Resuscitation Lead and Consultant Lead for Deteriorating Patients will review and revise the Trust’s Adult Deteriorating Patient Policy to ensure the inclusion of relevant Royal College of Physicians guidance and clear instructions for assessing ACVPU, including how to identify subtle confusion.
These actions have already been shared with the relevant clinical leadership teams to ensure full alignment and implementation across nursing and medical services. The Trust is committed to improving the accuracy of ACVPU assessment and the reliability of NEWS scoring to support early identification of deterioration, in line with the Coroner’s concerns.
4. Mechanism for recording over the counter medications taken prior to attendance at the Emergency Department The London Care Record (a secure digital system which provides access for healthcare staff to review health and care information such as GP records), information obtained from patients and their carers, and information brought in London Ambulance Service (LAS) are regularly used sources of information. The Emergency Department can be a challenging environment in which to initiate the medicines reconciliation process.
Handover documentation from LAS includes a section for Medication History, but does not prompt specifically for over-the-counter (OTC) medication. In Mrs Hughes’ case however, this information had been included in the ‘Event History’ section. The LAS handover document is uploaded to iCare as a PDF. Depending upon the screen size of the device being used, the PDF may need to be magnified to clearly read information included.
Some actions identified through discussion with senior pharmacy staff to address some of the challenges of completing a medicines reconciliation in the Emergency Department (ED) are as follows: Explore options for amending ED clerking proforma to include prompt ‘Any medications – including over the counter – taken in the last 96 hours’ Explore options for LAS handover proforma to include OTC medicines as a separate prompt Review the Medicines Reconciliation Policy Add a specific section for OTC products Review checklist to improve clarity around discussing OTC products Add a specific reference to looking at the LAS handover document as a source of information Review checklist for different staff groups/settings A Medicines Reconciliation Quick Reference Guide for ED staff highlighting sources of information and including prompt for OTC products There are some options for reviewing pharmacy specific processes on iCare in relation to documenting the use of OTC products that the Trust will explore. The feasibility of these options and an appraisal of these would be required, including: o Introduce a question: ‘The patient has been asked about OTC products’ and a yes/no button as part of Pharmacy Medication History. This would act as a prompt for those completing medication histories to specifically ask about OTC products o Include the field, ‘OTC medication – yes/no/NA’ as part of ‘Document Medication by History’ form. This would allow the documentation of regularly used OTC items to be included as part of the medication history.
Implementation will require collaboration with wider clinical teams and this will be achieved through taking the plans through clinical governance forums.
5. Trust approach to mitigating against confirmation bias and encouraging professional curiosity
Regarding the care of Ms Hughes, it is evident that members of staff did not demonstrate the necessary rigour, attention to detail and professional curiosity which may have contributed to her deterioration.
The initial duplicate paracetamol prescription was a simple error, but the ongoing continued behaviours of the individuals involved in facilitating excess paracetamol being given could be attributed due to confirmation bias and lack of professional curiosity.
Doctors are taught from the earliest stages in their education and training to think independently, use safety systems to prevent error and to raise their concerns where appropriate. Staff, including nurses, are taught to raise concerns and challenge unsafe practise. Staff are taught to follow standards as set out in the trust medicines policy however this is part of a wider framework of professional behaviour and standard setting, relating to both GMC and NMC training and guidelines. There are multiple ways any health care professional could raise concerns about a prescription, both formally and informally at LGT and challenge is welcomed. Nurses are taught to be able to flag concerns at multiple levels – with resident doctors, consultants, pharmacy and with their nursing counterparts. In this scenario, it is more likely that a lack of attention to detail was the problem vs an unwillingness to challenge. None of the staff interviewed expressed concerns about communication. Additionally, there is also a ‘Speak up Guardian’ who’s contact details can be found on the Trust’s intranet.
Learning from patient safety incidents is embedded at LGT at a local (weekly incident teaching) and at an organisational level. The October 2025 Patient Safety Group has presented this case for discussion and learning specifically regarding whether confirmation bias played a role in Ms Hughes’ care. This case will also be shared in Grand Round and with medical students in 2025/26.
6. Trust policy on managing virtual patient reviews The Trust is developing guidance on virtual reviews using the NHS guidance (https://www.england.nhs.uk/long-read/remote-consulting/) [updated by NHSE in March 2025]. This guidance relates to full patient reviews as part of clinic appointments/virtual wards, however the guidance can also be transposed to telephone referrals/reviews.
Additionally, most reviews are expected to be done face to face, however, it is also accepted that a colleague may ask for advice without face-to-face review and there are professional standards around this. There are multiple situations where a virtual review is acceptable, and it would be unsustainable and impossible for every review to be done face to face. This would be the same process between all health care professionals.
Staff are encouraged to escalate if there is disagreement on the need for a face-to-face review. The organisation is currently reviewing escalation processes around advice giving, recognising that it is key for staff to be able to escalate if they feel a patient requires more senior input or a face-to-face assessment for example.
Internal professional standards (IPS) are a key part of the review process. The Trust have reviewed their IPS very recently and are participating in a leadership exercise on this topic with dissemination to all staff on any learning/changes required. This is being done in conjunction with Getting It Right First Time (GIRFT) as part of a wider exercise on efficiency and safety and led by the medical directorate. There are now many systems within the NHS (as part of the wider NHS desire for streamlined pathways and community interface) that support virtual review (e.g. virtual ward) and whilst they are not directly relevant to this case, it is accepted that we do not need to always review face to face as long as adequate information is shared and there is an escalation process. This will no doubt become more important and there is ongoing work with an intention to edit the IPS locally, and work with the Virtual Ward providers to maximise safety around virtual review.
The Trust will disseminate the above by way of patient safety bulletins, the need for vigilance around virtual review and advise staff of the dangers of it and the clear routes for escalation if they are not satisfied with the response.
Ensuring compliance and the effectiveness of new processes will be overseen and monitored by the Trust via its governance structures for quality. We would like to assure you that Lewisham and Greenwich NHS Trust have taken the concerns raised seriously and learning from this incident will be shared and overseen by the Quality and Patient Safety Committee.
Should you have any further questions regarding any of the information provided in this letter or require any further information please do not hesitate to contact us.
We are writing in response to your prevention of future death report dated 10th October 2025, concerning the care provided to Ms Paula Doreen Hughes. The Trust continue to extend our condolences to the family of Ms Hughes.
Your report highlighted in total six matters of concern that the Trust will endeavour to address, and we provide further information as to these concerns below.
1. Preventing concurrent prescriptions of paracetamol containing drugs and otherwise preventing prescribing errors resulting in therapeutic excess of paracetamol There are several safety elements incorporated into the Lewisham and Greenwich NHS Trust (LGT) electronic prescribing and medicines administration (EPMA) system, iCare. This includes a ‘hard stop’ on prescribing concomitant paracetamol containing products and a number of ‘soft stops’ as listed below: (i) For prescribers: Hard stop alert if the patient is already prescribed a paracetamol containing product, or if multiple paracetamol-containing products are prescribed concurrently (except for a single stat IV dose prescribed with regular oral paracetamol, which is often done post- surgery as part of Enhanced Recovery After Surgery (ERAS))
Dose range checking for IV paracetamol exceeding 15 mg/kg or oral doses exceeding 1 g (the oral paracetamol dose range checking will soon be updated to also oral doses exceeding 15 mg/kg for patients weighing less than 50 kg following updated guidelines)
(ii) For nurses: Soft stop alert for nurses at point of administration if giving 5 doses given in 22 hours or 6 doses given in 24 hours - the alert itself makes it clear how many doses and when the doses were given Soft stop alert for nurses at point of administration if intravenous dose is greater than 15 mg/kg (i.e., it is possible for the prescriber to prescribe paracetamol with only an estimated weight, if an actual weight is recorded and the dose is found to be too high it will alert the nurse) - currently only for IV doses but will include oral doses following updated guidelines "Dose too close" alert for when paracetamol is being given within 4 hours of a previous dose
In May 2027, the Trust will be joining Epic, an electronic records and prescribing system shared by our neighbouring Trusts, Guy’s and St Thomas’ NHS Foundation Trust (GSTT) and King’s College Hospital NHS Foundation Trust (KCH).
There is not currently a hard stop in place for duplicate paracetamol prescriptions within the instance of Epic. However, this functionality is available, and the working understanding is that all safety features on iCare that are not present on Epic will be implemented. This will require agreement from all three Trusts (LGT, GSTT and KCH) and we will seek assurance of this as part implementation.
2. Management of therapeutic excess if it has not been prevented The iCare system has an approved protocol available for paracetamol overdose (screenshots attached). This is the Scottish and Newcastle Anti-emetic Pre-treatment (SNAP) protocol. We recognise that a clinical guideline would help clinicians to identify whether this is required or not, and this is not something that currently exists at LGT. We will develop a clinical guideline for the management of paracetamol overdose in due course, that will be available to all Trust staff, to include a robust clinical response to the management of therapeutic excess and the potential for toxicity.
3. The assessment of the ACVPU score The Trust acknowledges the concerns raised by the Coroner regarding the inaccurate assessment of ACVPU in this case, the associated impact on NEWS scoring, and the risk this poses to timely escalation of a deteriorating patient. We recognise that assessment of confusion can be subtle and subjective, and that training and policy must clearly support staff to identify even early or mild indicators of altered cognition. In direct response to the Coroner’s concerns, the following actions have been agreed by the Senior Nursing leadership team:
(i) Strengthening of Deteriorating Patient Training The Lead Practice Development Nurse will review and update the Trust’s Deteriorating Patient Training Programme to incorporate clearer guidance, case-based scenarios, and explicit teaching on the assessment of ACVPU, including recognition of subtle confusion.
(ii) Refresher Training for Ward Staff All clinical staff on the ward where the patient was admitted will complete refresher training on recognising and escalating the deteriorating patient, with a specific focus on accurate ACVPU assessment. This will help ensure consistent and reliable NEWS scoring across the team.
(iii) Improvement in Training Compliance Trust-wide The Trust will increase the number of staff completing deteriorating patient training across all relevant clinical areas during 2026/27, compared with the 2025 baseline. This will support a broader uplift in staff knowledge and skills relating to the identification of patient deterioration, including cognitive change.
(iv) Review of the Adult Deteriorating Patient Policy The Lead Practice Development Nurse, the Trust Resuscitation Lead and Consultant Lead for Deteriorating Patients will review and revise the Trust’s Adult Deteriorating Patient Policy to ensure the inclusion of relevant Royal College of Physicians guidance and clear instructions for assessing ACVPU, including how to identify subtle confusion.
These actions have already been shared with the relevant clinical leadership teams to ensure full alignment and implementation across nursing and medical services. The Trust is committed to improving the accuracy of ACVPU assessment and the reliability of NEWS scoring to support early identification of deterioration, in line with the Coroner’s concerns.
4. Mechanism for recording over the counter medications taken prior to attendance at the Emergency Department The London Care Record (a secure digital system which provides access for healthcare staff to review health and care information such as GP records), information obtained from patients and their carers, and information brought in London Ambulance Service (LAS) are regularly used sources of information. The Emergency Department can be a challenging environment in which to initiate the medicines reconciliation process.
Handover documentation from LAS includes a section for Medication History, but does not prompt specifically for over-the-counter (OTC) medication. In Mrs Hughes’ case however, this information had been included in the ‘Event History’ section. The LAS handover document is uploaded to iCare as a PDF. Depending upon the screen size of the device being used, the PDF may need to be magnified to clearly read information included.
Some actions identified through discussion with senior pharmacy staff to address some of the challenges of completing a medicines reconciliation in the Emergency Department (ED) are as follows: Explore options for amending ED clerking proforma to include prompt ‘Any medications – including over the counter – taken in the last 96 hours’ Explore options for LAS handover proforma to include OTC medicines as a separate prompt Review the Medicines Reconciliation Policy Add a specific section for OTC products Review checklist to improve clarity around discussing OTC products Add a specific reference to looking at the LAS handover document as a source of information Review checklist for different staff groups/settings A Medicines Reconciliation Quick Reference Guide for ED staff highlighting sources of information and including prompt for OTC products There are some options for reviewing pharmacy specific processes on iCare in relation to documenting the use of OTC products that the Trust will explore. The feasibility of these options and an appraisal of these would be required, including: o Introduce a question: ‘The patient has been asked about OTC products’ and a yes/no button as part of Pharmacy Medication History. This would act as a prompt for those completing medication histories to specifically ask about OTC products o Include the field, ‘OTC medication – yes/no/NA’ as part of ‘Document Medication by History’ form. This would allow the documentation of regularly used OTC items to be included as part of the medication history.
Implementation will require collaboration with wider clinical teams and this will be achieved through taking the plans through clinical governance forums.
5. Trust approach to mitigating against confirmation bias and encouraging professional curiosity
Regarding the care of Ms Hughes, it is evident that members of staff did not demonstrate the necessary rigour, attention to detail and professional curiosity which may have contributed to her deterioration.
The initial duplicate paracetamol prescription was a simple error, but the ongoing continued behaviours of the individuals involved in facilitating excess paracetamol being given could be attributed due to confirmation bias and lack of professional curiosity.
Doctors are taught from the earliest stages in their education and training to think independently, use safety systems to prevent error and to raise their concerns where appropriate. Staff, including nurses, are taught to raise concerns and challenge unsafe practise. Staff are taught to follow standards as set out in the trust medicines policy however this is part of a wider framework of professional behaviour and standard setting, relating to both GMC and NMC training and guidelines. There are multiple ways any health care professional could raise concerns about a prescription, both formally and informally at LGT and challenge is welcomed. Nurses are taught to be able to flag concerns at multiple levels – with resident doctors, consultants, pharmacy and with their nursing counterparts. In this scenario, it is more likely that a lack of attention to detail was the problem vs an unwillingness to challenge. None of the staff interviewed expressed concerns about communication. Additionally, there is also a ‘Speak up Guardian’ who’s contact details can be found on the Trust’s intranet.
Learning from patient safety incidents is embedded at LGT at a local (weekly incident teaching) and at an organisational level. The October 2025 Patient Safety Group has presented this case for discussion and learning specifically regarding whether confirmation bias played a role in Ms Hughes’ care. This case will also be shared in Grand Round and with medical students in 2025/26.
6. Trust policy on managing virtual patient reviews The Trust is developing guidance on virtual reviews using the NHS guidance (https://www.england.nhs.uk/long-read/remote-consulting/) [updated by NHSE in March 2025]. This guidance relates to full patient reviews as part of clinic appointments/virtual wards, however the guidance can also be transposed to telephone referrals/reviews.
Additionally, most reviews are expected to be done face to face, however, it is also accepted that a colleague may ask for advice without face-to-face review and there are professional standards around this. There are multiple situations where a virtual review is acceptable, and it would be unsustainable and impossible for every review to be done face to face. This would be the same process between all health care professionals.
Staff are encouraged to escalate if there is disagreement on the need for a face-to-face review. The organisation is currently reviewing escalation processes around advice giving, recognising that it is key for staff to be able to escalate if they feel a patient requires more senior input or a face-to-face assessment for example.
Internal professional standards (IPS) are a key part of the review process. The Trust have reviewed their IPS very recently and are participating in a leadership exercise on this topic with dissemination to all staff on any learning/changes required. This is being done in conjunction with Getting It Right First Time (GIRFT) as part of a wider exercise on efficiency and safety and led by the medical directorate. There are now many systems within the NHS (as part of the wider NHS desire for streamlined pathways and community interface) that support virtual review (e.g. virtual ward) and whilst they are not directly relevant to this case, it is accepted that we do not need to always review face to face as long as adequate information is shared and there is an escalation process. This will no doubt become more important and there is ongoing work with an intention to edit the IPS locally, and work with the Virtual Ward providers to maximise safety around virtual review.
The Trust will disseminate the above by way of patient safety bulletins, the need for vigilance around virtual review and advise staff of the dangers of it and the clear routes for escalation if they are not satisfied with the response.
Ensuring compliance and the effectiveness of new processes will be overseen and monitored by the Trust via its governance structures for quality. We would like to assure you that Lewisham and Greenwich NHS Trust have taken the concerns raised seriously and learning from this incident will be shared and overseen by the Quality and Patient Safety Committee.
Should you have any further questions regarding any of the information provided in this letter or require any further information please do not hesitate to contact us.
Noted
Oracle Health (formerly Cerner) states its Millennium prescribing system features are appropriate and functioning as designed, and will continue to review and monitor awareness of this functionality among its Trust clients. The decision on whether to take a particular code or configuration enhancement remains with the client. (AI summary)
Oracle Health (formerly Cerner) states its Millennium prescribing system features are appropriate and functioning as designed, and will continue to review and monitor awareness of this functionality among its Trust clients. The decision on whether to take a particular code or configuration enhancement remains with the client. (AI summary)
View full response
Dear Madam,
9 December 2025 Re: Response to Regulation 28 Report to Prevent Future Deaths dated 14 October 2025
1. This is Oracle Corporation UK Limited’s (formerly Cerner Limited) (“Oracle Health”) response (the “Response”) to the Regulation 28 Report to Prevent Future Deaths dated 14 October 2025 (the “Report”). The Report was issued by Assistant Coroner Dr. Liliane Filed (the “Assistant Coroner”) following an Inquest opened on 20 January 2022 into the death of Paula Doreen Hughes (the “Deceased”) on 1 January 2022 (the “Inquest”). Oracle Health was not invited to participate in the Inquest or given an opportunity to make representations and was not aware of it, or the findings of the Assistant Coroner, until receiving the Report. A. EXECUTIVE SUMMARY
2. Oracle Health was saddened to learn of, and deeply regrets, the various medical omissions at the Queen Elizabeth Hospital (“QE Hospital”) and extends its condolences to the family of the Deceased and others bereaved. Oracle Health assures the Deceased’s family that the contents of the Report are taken extremely seriously. While there is no suggestion that Oracle Health’s Millennium software deployed at the QE Hospital was in any way at fault or contributed to the Deceased’s death, Oracle Health has conducted a detailed review of that software in response to the Report and concludes as follows (key findings are highlighted in bold throughout):
2.1.
2.2. Oracle Health was invited to comment on one specific issue in the Report, out of a number of identified issues, which issue related to concurrent prescriptions of paracetamol and duplicate checking functionality. Further to its review, Oracle Health has not identified any evidence of any defect or deficiency in its software. Millennium’s United Kingdom (“UK”) default configuration has had the functionality to display alert notifications to protect against paracetamol overdosing at the stage it: (i) is ordered or prescribed, since before go-live at Lewisham and Greenwich NHS Trust (“LGT”); and (ii) is administered to patients, since August 2022, although this functionality had been used in United States of America (“USA”) deployments previously. Company Reg. No. 1782505 Registered in England and Wales Registered Office: as above
2.3.
2.4.
2.5. Whether NHS Trust (“Trust”) clients choose to enable these features, or develop their own solutions independently, involves consideration of how alert notifications integrate with Trust clinical workflows. There is also a general need to guard against ‘alert fatigue’. Oracle Health has no record of LGT raising any relevant service or test issues as part of the deployment testing process or subsequent to the systems going live. Approaches to safeguard against paracetamol dosing incidents were discussed with a number of Trust clients, including LGT, at a regular quarterly meeting in June 2024. Oracle Health does not consider that any further code development of alert notifications is required, but it continues to augment the content and function of all alert notifications and Millennium in general. Oracle Health will continue to work closely with its Trust clients to inform and educate them on the available functionality. B. ORACLE HEALTH AND MILLENNIUM
3.
4.
5. Oracle Health’s Millennium software has been successfully deployed globally, first in the USA in 1984 and, since 1986, internationally. Oracle Health has licensed its solution at 28,000 facilities around the world, and has adapted Millennium to various types of facilities, including 3,000 hospitals, 3,500 physician practices, 200 home health facilities and 200 employer sites. Oracle Health’s clients include over 40 NHS Trusts. Oracle Health designed Millennium as an electronic patient record (“EPR”) solution. The solution creates an electronic medical record through which physicians can access near real time data. By organising the data around the patient, rather than the patient encounter, Millennium eliminates duplication and places data only once in a central repository. Millennium enables information from disparate clinical domains and multiple facilities to be seamlessly integrated. The Millennium solution currently comprises nine solution and service sets with sub-modules. The relevant sub-modules for the purposes of this Response are PowerChart and Discern Expert.As explained in more detail below, these sub-modules manage patient information, streamline workflows, and improve clinical decision-making. Common uses include the creation of workflows and rules for documenting patient encounters, ordering medications and tests, reviewing lab results, and supporting clinical documentation. C. CONFIGURATION AND DEPLOYMENT AT LGT
6.
7.
8. On 21 March 2013, LGT signed an agreement to implement Oracle Health’s Millennium solution. Millennium went live at LGT, including the QE Hospital in around 2018. There are no specific Government or NHS regulations, or guidance, governing duplicate checking functionality for prescriptions in electronic healthcare systems. However, as an experienced industry leader in electronic healthcare, Oracle Health has developed content, workflows, and decision support to help meet the potential needs of its client base. The initial steps in the deployment of the Millennium solution involves an assessment of a client’s existing systems, an evaluation of their objectives and a demonstration of the relevant solutions in default configuration. Following the initial consultation process, Oracle Health typically hosts a series of design and configuration workshops (“D&C Workshops”), covering key aspects of the Millennium software.
8.1.
8.2. These D&C Workshops are generally attended by subject matter experts empowered to make design decisions on behalf of the particular client and afford an opportunity to tailor certain aspects of the system’s functionality to the specific needs and workflows of the particular client. It is critical to the success of deployments that appropriate decision-makers attend these sessions and they are required to have a solid understanding of the workflow processes within their areas of expertise. The D&C Workshops cover, and provide an opportunity to customise, specific sub-modules such as Discern Expert, which contains configurable rules through which certain alert notifications within Millennium can be enabled and the circumstances defined in which they are triggered (“Rules”). They also cover other sub-modules, such as PowerChart, which contains other types of alert notifications that can be customised and generated, based on clinical information provided to Oracle Health, relating to, e.g. Drug-Allergy, Drug-Drug Interaction, and Duplicate checking.
9. As described below, Oracle Health continuously engages in ongoing dialogue with its clients regarding potential software code and configuration enhancements to its Millennium solutions. Post go-live, it is also common for Trust clients, including LGT, to develop enhancements or adjust configurations in conjunction with internal I.T. teams. Oracle Health does not always have visibility over these ‘in house’ developments and cannot therefore comment on them. D. DOSAGE ALERT NOTIFICATIONS IN DEFAULT CONFIGURATION
10. Oracle Health understands that the Assistant Coroner was provided with screenshots and an oral description of certain aspects of Millennium as configured at LGT. However, the Assistant Coroner may not have had the benefit of a description of the relevant functionality that exists within Millenium in UK default configuration, without any pre or post deployment overlay by LGT.
11. In UK default configuration, Millennium is capable of displaying two main types of alert notifications to protect against overdosing:
11.1. Prescription Duplicate Alert Notification:
11.1.1.
11.1.2.
11.1.3. The duplicate checking functionality, if enabled, can generate an alert notification at the stage medicines are ordered, or prescribed, by a user such as a clinician. This functionality was available before LGT went live in 2018. Medication, including paracetamol, is generally prescribed by clinicians using the ‘order’ tab within a patient’s EPR. After selecting the relevant medicine, prescribers are directed to complete order entry details before signing the order to complete the prescription. The system has the ability, or functionality, to display an alert notification during the ordering process, warning the user that the medicine sought to be prescribed is a duplicate of a prescribed medicine that already appears within the patient’s record (“Prescription Duplicate Alert Notification”).
1
11.1.4.
11.1.5.
11.1.6. Screenshot 1: Prescription Duplicate Alert Notification As noted above, this functionality was available at the time Millennium went live at LGT, but historically Trust clients have chosen not to enable it at deployment. Trust clients can make this decision for various reasons. This includes, for example, a desire to avoid ‘alert fatigue’1 where there may be good clinical reasons for exceeding certain standard prescription parameters, including the needs and characteristics of a particular patient. Excessive alerting can render alert notifications ineffective and also interfere with clinical workflows. The number, type and frequency of alerting is typically something that is discussed extensively during the design and configuration workshops. However, Trust clients may also choose to wait until after go-live to determine what type of alert notifications would best support their particular needs. Millennium’s alert notification functionality has been enhanced over the years so that it is now possible, for example, for Trust clients to specify the circumstances in which the alert notification will be displayed. For example, a Trust client can adjust the settings so that the alert notification only fires during specific stages of a patient’s journey in hospital, to avoid the alert being over-inclusive and capturing prescriptions that are not relevant at that particular stage of treatment. However, even with the enhancements, clients still need to consider the risks of 'alert fatigue' and this is one reason why many clients are yet to utilise this functionality. The Report states that “The Cerner prescribing system offers a duplicate checking functionality that is not a standard feature. It is hard stop and can be overridden and was not adopted by the LGT when the system was introduced”. By way of clarification: (a) the Prescription Duplicate Alert Notification is a standard feature within Millennium’s UK default configuration, but it is not always enabled by Trust clients including for the reasons identified at paragraph
11.1.4 above; and (b) in this context, “hard stop” has a specific meaning and refers to alert notifications that cannot be dismissed and which require specific action or Broadly defined as a high volume of alert notifications causing users, including clinicians, to become desensitised and ignoring, or failing to respond appropriately to such, alert notifications.
11.2. confirmation by a user there and then: they cannot be “overridden”. This is one of the configuration options available within Millennium’s prescribing system but is not mandated, and other configuration options do exist, which allow alerts to be overridden (often with the need to document an override reason which gives visibility of the clinical reasoning behind the decision to override). Administration Alert Notification:
11.2.1. Second, since August 2022, the Rules in the UK have been capable of generating an alert notification at the stage paracetamol is actually administered to patients. The implementation of this functionality in the UK followed the introduction of a similar alert notification for equivalent medication in the USA several years previously.
11.2.2. To administer medicine, the recommended workflow is that users, such as nurses: (i) access a patient’s ‘Medication Administration Record’ within PowerChart to conduct a holistic review of that patient’s drug chart; (ii) proceed to the ‘Medication Administration Wizard’ and scan a patient’s wristband to verify identity; and (iii) use the Medication Administration Wizard to administer the medication. It is recommended that the user also scans the individual medications within the Medications Administration Wizard to ensure a match to the prescription held on the system before administering the medicine. Users are also able to perform these same checks by manually selecting the medication to be administered and performing a visual check of the medication.
11.2.3. Whether using the scanner or manually, the Rules can generate an alert to warn a user that the proposed administration of paracetamol would result in a dose exceeding the maximum recommended daily limit for that particular patient within a 24-hour window (“Administration Alert Notification”): Screenshot 2: Administration Alert Notification
11.2.4. Similar to the Prescription Duplicate Alert Notification functionality, the Administration Alert Notification functionality has also been enhanced and updated subsequent to its original implementation. Oracle Health has not been asked by LGT to assist with the implementation of the Administration Alert Notification, and it is not known whether it has introduced the alert notification itself. Oracle Health notes that the reference in the Report to “refinements of the system significantly reduced therapeutic excesses of paracetamol based on weight” tends
to suggest that LGT has introduced the Administration Alert Notification, or a similar variant, in some form. E. TESTING, TRAINING AND ONGOING MONITORING
12.
13. Oracle Health has no record of LGT raising any relevant service or test issues as part of the deployment testing process or subsequent to the systems going live. Oracle Health holds Special Interest Group (“SIG”) meetings approximately every quarter, which enable Oracle to share enhancements, upgrades, and best practices with regard to Millennium functionality. They also enable clients to come together and present on any issues encountered within particular fields. At a SIG meeting in September 2022, Oracle Health introduced the Administration Alert Notification in the UK, including details about its form, how the alert is triggered, and how Trusts could seek to implement it. Trust clients in attendance also provided feedback on how the alert notification might be refined in the future. At a SIG meeting in June 2024, LGT raised in general terms paracetamol dosing incidents as a topic for discussion among other Trust clients, including whether any additional alert notifications may have been implemented by those Trusts internally. At the same meeting, Oracle Heath presented updates to the Administration Alert Notification, including functionality that would take into account the patient’s weight in calculating the maximum dose before triggering the alert notification. F. POTENTIAL ENHANCEMENTS
14.
15. As noted above, Oracle Health continuously engages in ongoing dialogue with its clients regarding software code and configuration enhancements to its Millennium solutions. Such enhancements can arise at the global, or national, level in response to the knowledge and experience gained by Oracle Health from working with its extensive client base. They can also arise in response to specific issues at the level of local deployments. In each case, Oracle Health will discuss with its client the appropriateness of taking a potential upgrade and its impact on existing workflows and the user interface. Ultimately, the decision on whether to take a particular code or configuration enhancement remains with the client and can involve clinical and commercial considerations. Oracle Health considers that the Millennium prescribing system features are appropriate and functioning as designed in respect of the risk of duplicate paracetamol doses, including the Prescription Duplicate Alert Notification and the Administration Alert Notifications. Oracle Health will continue to review and monitor awareness of this functionality among its Trust clients.
9 December 2025 Re: Response to Regulation 28 Report to Prevent Future Deaths dated 14 October 2025
1. This is Oracle Corporation UK Limited’s (formerly Cerner Limited) (“Oracle Health”) response (the “Response”) to the Regulation 28 Report to Prevent Future Deaths dated 14 October 2025 (the “Report”). The Report was issued by Assistant Coroner Dr. Liliane Filed (the “Assistant Coroner”) following an Inquest opened on 20 January 2022 into the death of Paula Doreen Hughes (the “Deceased”) on 1 January 2022 (the “Inquest”). Oracle Health was not invited to participate in the Inquest or given an opportunity to make representations and was not aware of it, or the findings of the Assistant Coroner, until receiving the Report. A. EXECUTIVE SUMMARY
2. Oracle Health was saddened to learn of, and deeply regrets, the various medical omissions at the Queen Elizabeth Hospital (“QE Hospital”) and extends its condolences to the family of the Deceased and others bereaved. Oracle Health assures the Deceased’s family that the contents of the Report are taken extremely seriously. While there is no suggestion that Oracle Health’s Millennium software deployed at the QE Hospital was in any way at fault or contributed to the Deceased’s death, Oracle Health has conducted a detailed review of that software in response to the Report and concludes as follows (key findings are highlighted in bold throughout):
2.1.
2.2. Oracle Health was invited to comment on one specific issue in the Report, out of a number of identified issues, which issue related to concurrent prescriptions of paracetamol and duplicate checking functionality. Further to its review, Oracle Health has not identified any evidence of any defect or deficiency in its software. Millennium’s United Kingdom (“UK”) default configuration has had the functionality to display alert notifications to protect against paracetamol overdosing at the stage it: (i) is ordered or prescribed, since before go-live at Lewisham and Greenwich NHS Trust (“LGT”); and (ii) is administered to patients, since August 2022, although this functionality had been used in United States of America (“USA”) deployments previously. Company Reg. No. 1782505 Registered in England and Wales Registered Office: as above
2.3.
2.4.
2.5. Whether NHS Trust (“Trust”) clients choose to enable these features, or develop their own solutions independently, involves consideration of how alert notifications integrate with Trust clinical workflows. There is also a general need to guard against ‘alert fatigue’. Oracle Health has no record of LGT raising any relevant service or test issues as part of the deployment testing process or subsequent to the systems going live. Approaches to safeguard against paracetamol dosing incidents were discussed with a number of Trust clients, including LGT, at a regular quarterly meeting in June 2024. Oracle Health does not consider that any further code development of alert notifications is required, but it continues to augment the content and function of all alert notifications and Millennium in general. Oracle Health will continue to work closely with its Trust clients to inform and educate them on the available functionality. B. ORACLE HEALTH AND MILLENNIUM
3.
4.
5. Oracle Health’s Millennium software has been successfully deployed globally, first in the USA in 1984 and, since 1986, internationally. Oracle Health has licensed its solution at 28,000 facilities around the world, and has adapted Millennium to various types of facilities, including 3,000 hospitals, 3,500 physician practices, 200 home health facilities and 200 employer sites. Oracle Health’s clients include over 40 NHS Trusts. Oracle Health designed Millennium as an electronic patient record (“EPR”) solution. The solution creates an electronic medical record through which physicians can access near real time data. By organising the data around the patient, rather than the patient encounter, Millennium eliminates duplication and places data only once in a central repository. Millennium enables information from disparate clinical domains and multiple facilities to be seamlessly integrated. The Millennium solution currently comprises nine solution and service sets with sub-modules. The relevant sub-modules for the purposes of this Response are PowerChart and Discern Expert.As explained in more detail below, these sub-modules manage patient information, streamline workflows, and improve clinical decision-making. Common uses include the creation of workflows and rules for documenting patient encounters, ordering medications and tests, reviewing lab results, and supporting clinical documentation. C. CONFIGURATION AND DEPLOYMENT AT LGT
6.
7.
8. On 21 March 2013, LGT signed an agreement to implement Oracle Health’s Millennium solution. Millennium went live at LGT, including the QE Hospital in around 2018. There are no specific Government or NHS regulations, or guidance, governing duplicate checking functionality for prescriptions in electronic healthcare systems. However, as an experienced industry leader in electronic healthcare, Oracle Health has developed content, workflows, and decision support to help meet the potential needs of its client base. The initial steps in the deployment of the Millennium solution involves an assessment of a client’s existing systems, an evaluation of their objectives and a demonstration of the relevant solutions in default configuration. Following the initial consultation process, Oracle Health typically hosts a series of design and configuration workshops (“D&C Workshops”), covering key aspects of the Millennium software.
8.1.
8.2. These D&C Workshops are generally attended by subject matter experts empowered to make design decisions on behalf of the particular client and afford an opportunity to tailor certain aspects of the system’s functionality to the specific needs and workflows of the particular client. It is critical to the success of deployments that appropriate decision-makers attend these sessions and they are required to have a solid understanding of the workflow processes within their areas of expertise. The D&C Workshops cover, and provide an opportunity to customise, specific sub-modules such as Discern Expert, which contains configurable rules through which certain alert notifications within Millennium can be enabled and the circumstances defined in which they are triggered (“Rules”). They also cover other sub-modules, such as PowerChart, which contains other types of alert notifications that can be customised and generated, based on clinical information provided to Oracle Health, relating to, e.g. Drug-Allergy, Drug-Drug Interaction, and Duplicate checking.
9. As described below, Oracle Health continuously engages in ongoing dialogue with its clients regarding potential software code and configuration enhancements to its Millennium solutions. Post go-live, it is also common for Trust clients, including LGT, to develop enhancements or adjust configurations in conjunction with internal I.T. teams. Oracle Health does not always have visibility over these ‘in house’ developments and cannot therefore comment on them. D. DOSAGE ALERT NOTIFICATIONS IN DEFAULT CONFIGURATION
10. Oracle Health understands that the Assistant Coroner was provided with screenshots and an oral description of certain aspects of Millennium as configured at LGT. However, the Assistant Coroner may not have had the benefit of a description of the relevant functionality that exists within Millenium in UK default configuration, without any pre or post deployment overlay by LGT.
11. In UK default configuration, Millennium is capable of displaying two main types of alert notifications to protect against overdosing:
11.1. Prescription Duplicate Alert Notification:
11.1.1.
11.1.2.
11.1.3. The duplicate checking functionality, if enabled, can generate an alert notification at the stage medicines are ordered, or prescribed, by a user such as a clinician. This functionality was available before LGT went live in 2018. Medication, including paracetamol, is generally prescribed by clinicians using the ‘order’ tab within a patient’s EPR. After selecting the relevant medicine, prescribers are directed to complete order entry details before signing the order to complete the prescription. The system has the ability, or functionality, to display an alert notification during the ordering process, warning the user that the medicine sought to be prescribed is a duplicate of a prescribed medicine that already appears within the patient’s record (“Prescription Duplicate Alert Notification”).
1
11.1.4.
11.1.5.
11.1.6. Screenshot 1: Prescription Duplicate Alert Notification As noted above, this functionality was available at the time Millennium went live at LGT, but historically Trust clients have chosen not to enable it at deployment. Trust clients can make this decision for various reasons. This includes, for example, a desire to avoid ‘alert fatigue’1 where there may be good clinical reasons for exceeding certain standard prescription parameters, including the needs and characteristics of a particular patient. Excessive alerting can render alert notifications ineffective and also interfere with clinical workflows. The number, type and frequency of alerting is typically something that is discussed extensively during the design and configuration workshops. However, Trust clients may also choose to wait until after go-live to determine what type of alert notifications would best support their particular needs. Millennium’s alert notification functionality has been enhanced over the years so that it is now possible, for example, for Trust clients to specify the circumstances in which the alert notification will be displayed. For example, a Trust client can adjust the settings so that the alert notification only fires during specific stages of a patient’s journey in hospital, to avoid the alert being over-inclusive and capturing prescriptions that are not relevant at that particular stage of treatment. However, even with the enhancements, clients still need to consider the risks of 'alert fatigue' and this is one reason why many clients are yet to utilise this functionality. The Report states that “The Cerner prescribing system offers a duplicate checking functionality that is not a standard feature. It is hard stop and can be overridden and was not adopted by the LGT when the system was introduced”. By way of clarification: (a) the Prescription Duplicate Alert Notification is a standard feature within Millennium’s UK default configuration, but it is not always enabled by Trust clients including for the reasons identified at paragraph
11.1.4 above; and (b) in this context, “hard stop” has a specific meaning and refers to alert notifications that cannot be dismissed and which require specific action or Broadly defined as a high volume of alert notifications causing users, including clinicians, to become desensitised and ignoring, or failing to respond appropriately to such, alert notifications.
11.2. confirmation by a user there and then: they cannot be “overridden”. This is one of the configuration options available within Millennium’s prescribing system but is not mandated, and other configuration options do exist, which allow alerts to be overridden (often with the need to document an override reason which gives visibility of the clinical reasoning behind the decision to override). Administration Alert Notification:
11.2.1. Second, since August 2022, the Rules in the UK have been capable of generating an alert notification at the stage paracetamol is actually administered to patients. The implementation of this functionality in the UK followed the introduction of a similar alert notification for equivalent medication in the USA several years previously.
11.2.2. To administer medicine, the recommended workflow is that users, such as nurses: (i) access a patient’s ‘Medication Administration Record’ within PowerChart to conduct a holistic review of that patient’s drug chart; (ii) proceed to the ‘Medication Administration Wizard’ and scan a patient’s wristband to verify identity; and (iii) use the Medication Administration Wizard to administer the medication. It is recommended that the user also scans the individual medications within the Medications Administration Wizard to ensure a match to the prescription held on the system before administering the medicine. Users are also able to perform these same checks by manually selecting the medication to be administered and performing a visual check of the medication.
11.2.3. Whether using the scanner or manually, the Rules can generate an alert to warn a user that the proposed administration of paracetamol would result in a dose exceeding the maximum recommended daily limit for that particular patient within a 24-hour window (“Administration Alert Notification”): Screenshot 2: Administration Alert Notification
11.2.4. Similar to the Prescription Duplicate Alert Notification functionality, the Administration Alert Notification functionality has also been enhanced and updated subsequent to its original implementation. Oracle Health has not been asked by LGT to assist with the implementation of the Administration Alert Notification, and it is not known whether it has introduced the alert notification itself. Oracle Health notes that the reference in the Report to “refinements of the system significantly reduced therapeutic excesses of paracetamol based on weight” tends
to suggest that LGT has introduced the Administration Alert Notification, or a similar variant, in some form. E. TESTING, TRAINING AND ONGOING MONITORING
12.
13. Oracle Health has no record of LGT raising any relevant service or test issues as part of the deployment testing process or subsequent to the systems going live. Oracle Health holds Special Interest Group (“SIG”) meetings approximately every quarter, which enable Oracle to share enhancements, upgrades, and best practices with regard to Millennium functionality. They also enable clients to come together and present on any issues encountered within particular fields. At a SIG meeting in September 2022, Oracle Health introduced the Administration Alert Notification in the UK, including details about its form, how the alert is triggered, and how Trusts could seek to implement it. Trust clients in attendance also provided feedback on how the alert notification might be refined in the future. At a SIG meeting in June 2024, LGT raised in general terms paracetamol dosing incidents as a topic for discussion among other Trust clients, including whether any additional alert notifications may have been implemented by those Trusts internally. At the same meeting, Oracle Heath presented updates to the Administration Alert Notification, including functionality that would take into account the patient’s weight in calculating the maximum dose before triggering the alert notification. F. POTENTIAL ENHANCEMENTS
14.
15. As noted above, Oracle Health continuously engages in ongoing dialogue with its clients regarding software code and configuration enhancements to its Millennium solutions. Such enhancements can arise at the global, or national, level in response to the knowledge and experience gained by Oracle Health from working with its extensive client base. They can also arise in response to specific issues at the level of local deployments. In each case, Oracle Health will discuss with its client the appropriateness of taking a potential upgrade and its impact on existing workflows and the user interface. Ultimately, the decision on whether to take a particular code or configuration enhancement remains with the client and can involve clinical and commercial considerations. Oracle Health considers that the Millennium prescribing system features are appropriate and functioning as designed in respect of the risk of duplicate paracetamol doses, including the Prescription Duplicate Alert Notification and the Administration Alert Notifications. Oracle Health will continue to review and monitor awareness of this functionality among its Trust clients.
Sent To
- Royal Pharmaceutical Society (RPS)
- Lewisham and Greenwich NHS Trust
- Medicine and Healthcare Product Regulatory Agency
- NHS England
- Royal College of Physicians
Response Status
Linked responses
5 of 6
56-Day Deadline
13 Feb 2026
All responses received
About PFD responses
Organisations named in PFD reports must respond within 56 days explaining what actions they are taking.
Source: Courts and Tribunals Judiciary
Report Sections
Investigation and Inquest
On 20 January 2022 I commenced an investigation into the death of Paula Doreen Hughes, aged 55 years. The investigation concluded at the end of the inquest on 22 July 2025. The conclusion of the inquest was Paula Doreen Hughes died on 1 January 2022 at Queen Elizabeth Hospital, Woolwich, London. The medical cause of death was recorded as CORONER FOR INNER SOUTH DISTRICT GREATER LONDON Southwark Coroners' Court, 1 Tennis Street, Southwark, SE1 1YD 1a Acute (fulminant) hepatic failure 1b Paracetamol Overdose 2 Ischaemic heart disease, urinary tract infection, diabetes mellitus and excess alcohol consumption I concluded that the death with the following narrative: A medication error resulting in an unintended therapeutic excess of paracetamol contributed to by failure to recognise it and administer timely treatment to mitigate the risk of liver toxicity
Circumstances of the Death
Paula Hughes had been admitted to Queen Elizabeth Hospital on 6 January 2022 having suffered a fractured humerus following a fall the previous evening. Between 6 and 8 January 2022 she received paracetamol in excess of the recommended dose largely as a consequence of paracetamol being inadvertently prescribed addition to co-codamol, a paracetamol containing drug, on 7 January. Pharmacy review failed to pick up the concurrent prescription and both drugs were administered together on 3 or 4 occasions until the duplicate prescription was deleted at around 14.30 on 8 January. Despite a deterioration in her condition from around midday on 8 January, it was not recognised that Mrs Hughes had received an overdose of paracetamol until the morning of 9 January, by which time she had been admitted to intensive care in fulminating acute liver failure. As a consequence, she did not receive timely treatment with n-acetyl cysteine which would have mitigated the toxic effects of paracetamol on her liver.
Action Should Be Taken
In my opinion action should be taken to prevent future deaths and I believe you, Lewisham and Greenwich NHS Trust, NHS England, The Royal Pharmaceutical Society. Cerner, The Medicines and Healthcare products Regulatory Agency and The Royal College of Physicians have the power to take such action.
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Data sourced from Courts and Tribunals Judiciary under the Open Government Licence.