National Institute for Health and Care Excellence

PFD Addressee
Reports: 105 Earliest: Feb 2014 Latest: 13 Feb 2026

85% 2-year response rate (above 83% average). 19% of classified responses show concrete action taken.

Response Status (last 2 years, 26 reports)
Responded 22
AI Classification
Action Taken 19%
Action Planned 39%
Noted 39%
Disputed 2%
Based on 209 classified responses
PFD Reports Received by Quarter
PFD Reports
105 results
Muhammad Hassan
Historic (No Identified Response)
2022-0221 19 Jul 2022 Cambridgeshire and Peterborough
Child Death
Concerns summary (AI summary) A lack of national guidance on feeding expectations for low-risk, formula-fed babies in their first 72 hours risks premature discharge and insufficient information for families on signs of concern.
Thomas Hoskin
Historic (No Identified Response)
2022-0115 22 Apr 2022 West London
Child Death Hospital Death (Clinical Procedures and medical management) related deaths
Concerns summary (AI summary) There is a critical lack of specific guidelines for the optimal management of fatal fetal infection, leaving clinicians without assistance in situations like circulatory collapse at birth.
Jane Allison
All Responded
2022-0071 7 Mar 2022 County Durham and Darlington
Alcohol, drug and medication related deaths Community health care and emergency services related deaths
Concerns summary (AI summary) The BNF content for Nitrofurantoin was deficient in advising on monitoring for sudden pulmonary deterioration in elderly, active patients, even for short treatment courses.
Noted (AI summary) NICE acknowledges the correspondence but states that responsibility for the content of the BNF lies with the publishers, BMJ Group and Pharmaceutical Press, and therefore NICE cannot comment on the concerns raised. The Royal Pharmaceutical Society will add additional information regarding acute pulmonary reactions to the nitrofurantoin monograph in the BNF, specifically highlighting it in an additional section of the side-effects information, and will also add information on the importance of counselling patients on the possible symptoms of acute pulmonary reactions and the necessity of promptly reporting such symptoms. The medical group has emailed prescribing clinicians about nitrofurantoin side effects, will discuss the matter at a Significant Event Analysis Meeting, plans to provide written information to patients, and will contact the Local Medicine Management Team to suggest changes to local guidelines. The MHRA will request that Marketing Authorisation Holders strengthen the wording in the UK Summary of Product Information (SmPC) and Patient Information Leaflet (PIL) regarding pulmonary reactions to nitrofurantoin. The MHRA will also communicate any SmPC and PIL updates, to the BNF, and will communicate to UK healthcare professionals to inform them of these updates via the Drug Safety Update.
Coco Bradford
All Responded
2022-0012 18 Jan 2022 Cornwall and the Isles of Scilly
Child Death Hospital Death (Clinical Procedures and medical management) related deaths
Concerns summary (AI summary) Outdated IV fluid guidelines for children in shock posed a risk of fluid overload, and there was no clear guidance on balancing antibiotic use for sepsis against the risk of HUS in bacterial gastroenteritis.
Action Planned (AI summary) NICE acknowledges the guideline on gastroenteritis in under 5s [CG84] does not align with the UK Resuscitation Council’s 2021 guideline on paediatric advanced life support, and has forwarded the report to their guideline surveillance team who will review the UK Resuscitation Council’s 2021 guideline and consider if CG84 and other related NICE guidance need to be updated.
Mollie Dimmock
All Responded
2021-0379 9 Nov 2021 Buckinghamshire
Child Death Hospital Death (Clinical Procedures and medical management) related deaths
Concerns summary (AI summary) NICE Guidance NG121 lacks a clear definition for "large-for-gestational-age" babies, leading to inconsistent interpretation and application of delivery mode guidance. This creates uncertainty in crucial obstetric care decisions.
Noted (AI summary) NICE acknowledges the coroner's concerns regarding the lack of a standard definition for "large for gestational age" in its guideline on intrapartum care, but argues that providing a specific cut-off would convey inappropriate certainty.
Maureen Johnson
All Responded
2021-0298 7 Sep 2021 Manchester South
Community health care and emergency services related deaths
Concerns summary (AI summary) A lack of authoritative national guidance for assessing gastroenteritis, dehydration, and the need for face-to-face reviews in patients over 70 poses a risk.
Noted (AI summary) NICE states they have a Clinical Knowledge Summary on gastroenteritis, which they believe gives appropriate advice, and that no action is required of them.
Brian Jackson
Partially Responded
2021-0246 16 Jul 2021 Liverpool and Wirral
Hospital Death (Clinical Procedures and medical management) related deaths
Concerns summary (AI summary) Delirium symptoms were missed due to reliance on a flawed CAM-ICU assessment tool, especially for certain presentations, risking suboptimal diagnosis and treatment for patients nationwide.
Action Planned (AI summary) NICE acknowledges concerns and will consider them during an update to its guideline on delirium, focusing on risk assessment and diagnosis, including in ICU settings.
Anne Bradley
Partially Responded
2021-0214 20 Jun 2021 West Sussex
Hospital Death (Clinical Procedures and medical management) related deaths
Concerns summary (AI summary) Lack of scope guides during colonoscopies reduced tumour localisation accuracy, and the absence of a formal feedback system prevented endoscopists from learning about tattooing issues or incorrect tumour identification.
Disputed (AI summary) The British Society of Gastroenterology does not support a generalised recommendation on the use of MEIs based on this particular case and states the surgeon is ultimately responsible for identifying the correct section of bowel. The Royal College of Physicians, following consultation with JAG, disputes that the lack of a magnetic imaging device was the primary factor in the patient's death, citing multiple contributing factors and questioning the appropriateness of mandating such equipment. NICE states that it has guidelines covering cancer recognition/referral and colorectal cancer management, but not colonoscopy or specific equipment; they consider that no action is required by NICE. St Richard's Hospital reports that scope guides are already in place on the site and confirms that a system to ensure information in relation to tattooing is documented, monitored, and fed back to endoscopists has been instigated.
Geoffrey Hill
All Responded
2021-0262 2 Jun 2021 Black Country
Hospital Death (Clinical Procedures and medical management) related deaths
Concerns summary (AI summary) An elderly, confused patient in A&E spent over 7 hours without a falls risk assessment or trolley rail assessment, highlighting a lack of national guidelines for falls prevention in emergency departments.
Action Planned (AI summary) NICE will consider the issues raised in the report when they update their guideline on falls in older people (CG161).
Dyllon Milburn
All Responded
2021-0167 21 May 2021 Manchester City
Community health care and emergency services related deaths Mental Health related deaths Suicide
Concerns summary (AI summary) The current repeat prescription system lacks automated alerts to remind patients to request and collect medication, contributing to non-compliance for those with mental illness.
Noted (AI summary) NICE acknowledges the concerns but states it cannot influence changes to the EMIS system. They highlight existing guidelines on medicines adherence (CG76) and depression management (CG90) that contain relevant recommendations. The RCGP will open a dialogue with the Royal Pharmaceutical Society to consider in more detail the issue of patients not collecting prescriptions, and recommends that much greater integration of pharmacy and GP IT systems will likely be needed. EMIS confirmed that their software was working as designed and complies with NHS Digital requirements and are presently considering a number of potential digital tools to aid further patient compliance; they welcome a discussion with stakeholders to create best practice for managing this risk. The practice uses EMIS Web software and outlines the three methods by which patients can request repeat prescriptions, also noting that there is no system to alert them if a patient is not requesting their repeat medications on a month-by-month basis and expressing concerns about the resources needed to respond to such alerts.
Ella Kissi-Debrah
All Responded
2021-0113 20 Apr 2021 Inner South London
Child Death Community health care and emergency services related deaths Other related deaths
Concerns summary (AI summary) National air pollution limits exceed WHO guidelines, and there is low public awareness of pollution levels. Medical professionals also fail to adequately communicate the adverse health effects of air pollution.
Action Planned (AI summary) DEFRA, DFT, and DHSC will continue to work to improve public awareness of air pollution, including a pilot project with GPs providing air quality advice and information to a range of vulnerable groups. They will also make expertise available to relevant professional organisations. The Mayor of London has implemented measures such as the Ultra Low Emission Zone (ULEZ) and is expanding the monitoring network. They are also supporting health and care system support for vital structural changes. NICE amended its asthma guideline (NG80) in March 2021 to clarify the link between air pollution and asthma and added links to NICE guidelines on air pollution: outdoor air quality and health and indoor air quality at home. The RCGP is in the process of producing a planetary health element of the curriculum that all new GPs will be assessed against and are also planning a high-profile webinar incorporating elements regarding pollution. The RCP will work with specialist societies to raise the profile of air pollution's impacts, review the internal medicine curriculum, increase knowledge among physicians, produce resources for professionals to discuss air pollution with patients, improve incentives for conversations, and urge government to tighten regulations. The NMC will consider the concerns in their evaluation of pre-registration standards, focusing on communication with families, and identify further activity to ensure professionals understand their obligations to communicate clearly with patients about evidence related to managing and preventing ill-health. The BTS intends to build upon work undertaken to date by raising awareness of the effects of poor air quality, producing an updated Position Statement on air quality and lung health, and adding the health care profession voice to the debate on climate change and air pollution through membership of the UK Health Alliance on Climate Change and involvement in the Taskforce for Lung Health. The RCPCH curriculum includes a domain on health promotion, and they are working with NHS England/Improvement and Health Education England to develop asthma competencies for child health professionals and carers. They also declared a climate emergency and published a report on tackling climate change. HEE will write to the relevant medical Royal Colleges, GMC and NMC to highlight that improving awareness of the impact of air pollution on health should be considered when developing curricula. The GMC will review standards for medical education to consider how environmental issues are covered, encourage medical schools to address air pollution in curricula, and promote inclusion of environmental impacts in postgraduate training curricula. HEE will add the theme of environmental impacts to the list of potentially important areas to consider as they progress the credentialing agenda. UKHACC delivered a pilot project with Global Action Plan, funded by Defra and the Clean Air Fund, to educate paediatricians and respiratory health professionals on air pollution advice for patients. The London Borough of Lewisham has expanded monitoring capacity, taken part in the Breathe London project, and refreshed the Joint Strategic Needs Assessment for Air Quality. They also promote air quality monitoring tools via social media and local advertising, and ensure information is positioned on relevant websites and newsletters.
Zoe Knight
All Responded
2020-0168 4 Sep 2020 South Manchester
Hospital Death (Clinical Procedures and medical management) related deaths
Concerns summary (AI summary) Acute aortic dissection is difficult to diagnose due to symptom overlap. A critical recommendation to add "aortic pain" to the Manchester Triage System to improve awareness and earlier diagnosis has not been implemented.
Noted (AI summary) NICE acknowledges the concerns and notes that existing guidance (CG95) flags points where healthcare professionals should consider aortic dissection. They note that topic experts decided against including more detailed guidance, but that they will engage with professional bodies to improve use of their guidelines.
Viktor Scott-Brown
All Responded
2020-0163 18 Aug 2020 County Durham and Darlington
Community health care and emergency services related deaths Suicide
Concerns summary (AI summary) A psychiatrist failed to inform a patient about Lamotrigine's self-harm/suicide side effect due to a lack of awareness, exacerbated by inconsistent or absent warnings in reputable pharmacological guidelines, posing patient safety risks.
Noted (AI summary) Oxleas NHS Foundation Trust states they no longer have any involvement in the authorship or editing of the Maudsley Prescribing Guidelines since April 2015. Tees Esk & Wear Valley NHS Foundation Trust is developing a Medication Safety Series document regarding prescribing resources and sources of patient information, aiming to have a draft ready for approval on 24th September 2020 and complete dissemination by 2nd October 2020. NICE has passed the concerns regarding lamotrigine to the BNF publishers and will consider moving a footnote about the risk of suicidal thoughts and behaviour into the recommendation of their guideline on epilepsies, currently being updated. BNF Publications will add suicidal ideation as a side effect to the lamotrigine monograph and the important safety section of the lamotrigine monograph in the BNF.
Beryl Holland
All Responded
2020-0037 25 Feb 2020 Greater Manchester South
Emergency services related deaths Hospital Death (Clinical Procedures and medical management) related deaths
Concerns summary (AI summary) Inconsistent hospital policies and a lack of national guidance for managing pressure ulcer risks in Emergency Departments led to prolonged waits and inadequate care for vulnerable patients.
Noted (AI summary) NICE notes that its guideline CG179 provides relevant guidance on pressure sore prevention in emergency departments and no further action is required, but mentions a multi-year programme to improve how NICE produces and presents guidance and advice. The Department for Health and Social Care notes the existence of NICE guidelines on pressure sore prevention and that Stockport NHS Foundation Trust has adopted a Patient Safety Checklist and improved access to dynamic mattresses.
Jon James
All Responded
2020-0042 20 Feb 2020 South Wales Central
Alcohol, drug and medication related deaths Police related deaths Wales prevention of future deaths reports
Concerns summary (AI summary) There is no national NICE guidance on Acute Behavioural Disturbance, which is vital for emergency services and police, contributing to a rising number of related deaths.
Action Planned (AI summary) NICE acknowledges concerns about the need for guidance on acute behavioral disturbance (ABD) and will consider this in a future update to its guideline on violence and aggression (NG10).
Shanté Turay-Thomas
All Responded
2020-0124 27 Jan 2020 Inner North London
Community health care and emergency services related deaths Emergency services related deaths Other related deaths
Concerns summary (AI summary) GPs failed to ensure specialist allergy care, provided inadequate advice on carrying two adrenaline pens, and did not offer training for new auto-injector devices, compounded by deficient CCG guidance on dosage.
Noted (AI summary) NHS England will continue to work with HEE, the professional Royal Colleges, and other organizations to stay updated on new guidance and resources for managing severe allergies, and will explore using communication routes or commissioning levers to support their adoption. They also describe their assurance role for CCGs and commissioning of healthcare services. Advanced states they will work with NHS Digital to develop a standard for electronic updating of ambulance systems to inform them when an ambulance has been recalled. They also suggest an independent review of clinical triage systems. NICE notes that the British National Formulary (BNF) and BNF for Children (BNFc) already contain detailed advice on adrenaline auto-injectors, including MHRA/CHM advice from 2017 and 2019. It will consider how best to make clear in CG134 the advice that 2 adrenaline auto-injectors should be prescribed, which patients should carry at all times. Bausch & Lomb distributes trainer pens to allergy clinics and is currently reviewing the design of its trainer pens to incorporate a needle cover shield extension when activated, to more closely replicate the patient experience with the actual pen. NHS Digital details changes made to NHS Pathways following the incident, including improving the Anaphylaxis algorithm, developing an audit framework, and conducting a user satisfaction survey to improve call-handling and call prioritisation. The Winchmore Hill Practice undertook an audit of patients prescribed Emerade to ensure dosage was in accordance with the BNF, reviewed AAI pen doses, and contacted patients with up-to-date advice from the MHRA. The practice has shared learning with the CCG medicine management team and amended the message on scriptswitch; any proposed changes to be made by CCG Pharmacist, will need to be approved by a Senior doctor at the practice. LAS clarifies the division of responsibilities for triage systems, stating that ECPAG and NHS Digital are responsible for setting categories and addressing inconsistencies between systems. LAS will discuss the PFD report at relevant user groups. The Department of Health and Social Care notes several actions, including the FSA working to get emerging trend information and alert local authorities, and working to identify means of access to relevant datasets so they can be included for analysis of food-related cases of anaphylaxis. The Healthcare Safety Investigation Branch (HSIB) will consider the matters of concern in the report and whether these meet its criteria for national investigation when the situation allows. Enfield CCG distributed a Medicines Safety Bulletin on Adrenaline Auto Injectors (AAIs) to GPs and other primary care healthcare professionals on 30th January 2020 and has contacted all GP practices. They are implementing a post-incident review and a report will be completed to ensure all actions identified are implemented to prevent a recurrence, including a review of governance processes and decision-making points.
James Wheeler
All Responded
2020-0001 3 Jan 2020 Manchester (South)
Care Home Health related deaths Community health care and emergency services related deaths
Concerns summary (AI summary) There is a critical lack of national guidance for monitoring refractory epilepsy, particularly for assistive technology. Additionally, a local authority failed to consistently conduct legally required annual Care Act reviews due to resource constraints.
Noted (AI summary) NICE's guideline on epilepsies (CG137) is being updated, with a draft consultation expected in November 2020 and publication planned for June 2021. The update will consider the effectiveness of new technologies for detecting seizures and interventions for reducing seizure-related mortality. The Department of Health and Social Care acknowledges concerns regarding annual reviews and highlights the Social Care Act 2014. They note that a LeDeR review is being conducted and that the CQC has inspected Cheddle Lodge, finding it compliant with regulations in October 2019. Stockport Council is creating a dedicated review team of six social workers and a team manager to address the backlog of annual reviews in the Learning Disabilities Service, with an option to increase staff numbers as required.
Maureen Waterfall
Historic (No Identified Response)
2019-0455 30 Dec 2019 Manchester (South)
Alcohol, drug and medication related deaths Hospital Death (Clinical Procedures and medical management) related deaths Mental Health related deaths
Concerns summary (AI summary) There is no licensed antidote for Edoxaban anticoagulant, increasing risks for head injury patients. Concerns were raised about the lack of national guidance on antidote administration targets and storage, especially for non-tertiary hospitals.
Brenda McWilliams
Historic (No Identified Response)
2019-0406 29 Nov 2019 Manchester (North)
Hospital Death (Clinical Procedures and medical management) related deaths
Concerns summary (AI summary) Medical practitioners failed to consistently prescribe VTE medication post-discharge, and an interpretation of NICE guidance may leave high-risk community patients unassessed and untreated, despite recognized serious risks.
Thomas Wedrychowski
Historic (No Identified Response)
2019-0403 28 Nov 2019 Wiltshire and Swindon
Hospital Death (Clinical Procedures and medical management) related deaths Mental Health related deaths
Concerns summary (AI summary) Annual monitoring for diabetes in patients on antipsychotics may be insufficient for high-risk individuals, and there is a critical lack of physical healthcare information sharing between primary and secondary care providers.
Maureen Milton
All Responded
2019-0396 22 Nov 2019 Staffordshire (South)
Other related deaths
Concerns summary (AI summary) There is insufficient awareness among healthcare professionals and carers about the severe fire risk posed by petrol-based emollient creams, which impregnate clothing and accelerate burns.
Noted (AI summary) The MHRA has convened a stakeholder group to design educational resources for healthcare professionals and the public, aiming to launch a toolkit in 2020 with a press release and stakeholder propagation of key messages. NICE acknowledges the concerns but states that overseeing medicine safety, product warnings, and running safety awareness campaigns do not fall within its remit; they refer to existing BNF guidance for prescribers. Public Health England reviewed the report but defers to the Medical and Healthcare products Regulatory Agency (MHRA) as the concerns relate to medicines.
Stuart Clarke
Partially Responded
2019-0366 6 Nov 2019 Manchester City
Hospital Death (Clinical Procedures and medical management) related deaths
Concerns summary (AI summary) The lack of national guidelines for timely referral of patients with valve disease between primary, secondary, and tertiary care leads to significant patient deterioration before intervention.
Noted (AI summary) The Greater Manchester Cardiac Network will review how they can support and extend work at MFT to improve the heart care pathway for quicker diagnosis and treatment of patients requiring TAVI. The Department of Health and Social Care acknowledges the concerns and notes that NICE is developing a clinical guideline on heart valve disease in adults, while the Manchester University NHS Foundation Trust and the Greater Manchester Cardiac Network are working on improving diagnosis and treatment processes. NICE references existing guidelines on chronic heart failure and notes the development of a clinical guideline on heart valve disease presenting in adults, which will consider referral indications, and the concerns raised have been highlighted to the guideline developers. BCIS will contact its members to review local referral pathways for TAVI procedures to expedite treatment and prevent delays, and supports moves to ensure adequate capacity for TAVI candidates.
Graham Saffery
All Responded
2019-0301 18 Sep 2019 Bedfordshire & Luton
Alcohol, drug and medication related deaths Community health care and emergency services related deaths
Concerns summary (AI summary) The BNF, a key GP resource, lacks warnings for co-prescribing amitriptyline and oxycodone, despite other guidance recommending caution and monitoring for this interaction.
Action Taken (AI summary) The CCG has shared learning from the incident with other practices and the East of England NHS England, developed a SystmOne search to identify at-risk patients, briefed prescribing leads, and will continue to monitor a national dashboard for patients on specific medication combinations. They have also discussed the learning with chief pharmacists at local hospitals and ELFT.
Xander Curran-Pass
Historic (No Identified Response)
2019-0249 24 Jul 2019 Manchester (South)
Child Death Hospital Death (Clinical Procedures and medical management) related deaths
Concerns summary (AI summary) Lack of national sharing for improved Induction of Labour processes, insufficient guidance on prolonged reduced fetal movement, and failure to advise a mother to return for further monitoring for ongoing concerns were identified.
James Francis
All Responded
2019-0202 19 Jun 2019 West Sussex
Hospital Death (Clinical Procedures and medical management) related deaths
Concerns summary (AI summary) Critical patient information, including a recent fall and observation requirements, was not effectively communicated during shift handovers. There were also significant delays in seeking medical attention for deteriorating health and insufficient information provided to paramedics.
Action Planned (AI summary) NICE is undertaking a surveillance review of its head injury guideline (CG176) and the review is likely to conclude that an update is required to clarify that the guideline applies to indirect head injury. Shaw Healthcare has revised shift handover meetings, monitoring and management checks, GP/111 call procedures, information given to paramedics, and staff training, and has created a Falls Management Policy. They have increased training and awareness, and expect 90% of staff to have completed mandatory training at any one time.