Paula Doreen

University Hospital Lewisham  
Lewisham High Street 
London 
SE13 6LH 

HM Assistant Coroner Lillian Field 
London Inner South Coroners Court 
1 Tennis Street 
Southwark 
London  
SE1 1 YD 

 5 December 2025 

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 

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 

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. 

Yours sincerely 

Chief Medical Officer 
Lewisham & Greenwich NHS Trust 

Enc: screenshots of SNAP protocol on iCare

10 South Colonnade 
Canary Wharf 
London 
E14 4PU 
United Kingdom 
gov.uk/mhra 

Liliane Field 
Assistant Coroner for London Inner south 

24 November 2025 

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. 

Yours sincerely, 

Chief Safety Officer 

 
 
 
 Medicines and Healthcare products Regulatory Agency

Liliane Field 
HM Assistant Coroner 
London Inner South District  
Southwark Coroners' Court, 
1 Tennis Street,  
Southwark,  
SE1 1YD 

National Medical Director  
NHS England  
Wellington House 
133-155 Waterloo Road  
London 
SE1 8UG 

5th December 2025 

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 

                                                                                                                       
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 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.  

Yours sincerely,  

National Medical Director  
NHS England

Oracle Corporation UK Limited

Oracle Parkway

Thames Valley Park
Reading
Berkshire

RG6 1RA

Telephone:

 0118 924 0000

Facsimile:
http://www.oracle.com

0118 924 8679

AND BY POST

Dr. Liliane Field,
Assistant Coroner for London Inner South
1 Tennis Street
London
SE1 1YD

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”).

 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

1

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.

 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).

11.2.

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.

Yours faithfully,

, Vice President, and General Manager

For and on behalf of Oracle Corporation UK Limited

Copy to:

(i)

(ii)

The   Chief   Coroner,   Room   C09,   Royal   Courts   of   Justice,   London,   WC2A   2LL
(chiefcoronersoffice@judiciary.uk).

,  Chief  Executive,  Lewisham  and  Greenwich  NHS  Trust,  University  Hospital

Lewisham, Lewisham High Street, London SE13 6LH.

 (iii)

(iv)

(v)

(vi)

, Chief Executive NHS England, Trust Office, 4th Floor Gassiot House, St

Thomas' Hospital, Westminster Bridge Road, London SE1 7EH.

,  Chief  Executive  Officer,  Royal  Pharmaceutical  Society  (RPS),  66-68  East

Smithfield, London E1W 1AW.

,  Chief  Executive  Medicines  and  Healthcare  Products  Regulatory  Agency

(MHRA), 10 South Colonnade, Canary Wharf, London E14 4PU.

, Chief Executive Officer, Royal College of Physicians, 11 St Andrews Place,

Regents Park, London NW1 4LE.

Ms Liliane Field 
Coroner for London Inner South 
Ref: Prevention of future deaths Report Reg 28 Paula Doreen Hughes 

1st December 2025 

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’.  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 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 ca se 
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, 
inconsistent 
implementation2,3.  

increased  prescriber  error  and 

issues  with  partial  or 

1. 

2. 

3. 

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] 
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] 
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.  

Yours sincerely,  

Patient Safety Manager  
Royal Pharmaceutical Society   

1. 

2. 

3. 

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] 
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] 
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]