Medical Product Allergen Labelling
Unclear labelling, inconsistent nomenclature, and insufficient research regarding allergens in medical products.
Source spread
Where this theme appears
This theme appears across 9 independent accountability sources, so the source mix matters as much as the headline total.
1 inquiry rec
69 PFD reports
15 committee recs
1 HSSIB rec
1 CQC action
4 IMB recs
1 patient safety alert
6 PHSO decisions
1 LGO/SPSO decision
Browse by source
Source-grouped records are useful for tracing where a concern came from. Large sections show the 50 strongest matches for that source; counts still show the full theme total.
Prevention of Future Deaths reports(69)— showing 50 strongest matches
William Andrews
Concerns: The coroner noted issues with medical equipment design, specifically syringe caps not being brightly coloured or visually distinct, and a lack of awareness among surgical teams that certain syringes now come with caps. Concerns also included the absence of a standard procedure for counting or checking these caps after operations.
Response (Department of Health): • The manufacturer, Rocialle, will now supply the syringe without the cap. • Rocialle has issued a safety notice to all UK customers. • Rocialle has agreed to make syringes … (AI summary)
Overdue
Leo Deady
Concerns: The coroner notes a significant rate of undiagnosed breech presentations and the absence of national guidelines for routine late-stage pregnancy scans to detect them, with no national consideration of the risks, benefits, and funding implications.
Response (Department of Health): • The Department of Health stated it considered there was no benefit to developing a national system of routine scanning in late pregnancy. • Officials consulted with the Royal College … (AI summary)
Overdue
Jackie Scott
Concerns: The coroner noted that a take-away meal consumed by Jackie Scott contained peanuts or peanut oil, of which he was unaware, leading to a fatal allergic reaction.
Overdue
John James Jackson
Concerns: The coroner noted insufficient information regarding the caffeine content and dangers of consuming large quantities of 'Hero Energy Mints.' The product's ambiguous classification between medication and sweets raised concerns about consumers potentially mistaking it for ordinary confectionery.
Overdue
Victoria Meppen-Walter
Concerns: The coroner raised concerns regarding the availability and regulation of chloroquine, noting the associated risk of misuse.
Overdue
Dafydd Watts
Concerns: The coroner noted that the possibility of a rare drug occurrence is not highlighted to physicians in drug literature or in the BNF entry.
Overdue
Archie Hames
Concerns: Independent expert testing found that the combined use of a specific tracheostomy tube and a particular Velcro strap compromised the tube's integrity, likely causing its detachment. The coroner also raised concerns about the broader implications for continued use of Velcro strap attachments with tracheostomy tubes.
Response (Department of Health): • The specific type of tracheostomy tube flange identified as being damaged by Velcro is no longer available on the market. • Manufacturers clarified instructions for use to warn against … (AI summary)
Overdue
George Stone
Concerns: National guidelines for warnings given to patients prescribed certain antidepressants do not currently include the risk of severe seizures, a known potential side effect of these medications.
Overdue
Tiya Chauhan
Concerns: The coroner raised concerns that the choking risks associated with raw jelly cubes are not sufficiently appreciated by childcare settings and parents. The report notes a lack of warnings on raw jelly packaging and insufficient supervision when used in play.
Response (Department for Education): • The Department for Education stated it would issue additional guidance to the early years sector in 2015 regarding paediatric first aid provision. • This guidance would include information on … (AI summary)
Response (Ofsted): • Ofsted stated it would include details of the inquest findings on raw jelly risks in its next newsletter to Directors of Children's Services. • Ofsted confirmed it would ensure … (AI summary)
Response (Food Standards Agency): • The Food Standards Agency (FSA) met with Ofsted officials to discuss the incident and consider appropriate action. • The FSA will forward information on the risks of raw jelly … (AI summary)
Overdue
Patricia Mellor
Concerns: The coroner raises concerns that the Medicines and Healthcare Products Regulatory Agency (MHRA) and NICE have not acted on recommendations to update product information warnings for anaesthetic agents and revise pre-operative assessment guidelines concerning Long QT Syndrome.
Overdue
James Fyfe
Concerns: The coroner identified a design and maintenance issue allowing a trolley's cot side to remain raised but unlocked, with uncertainty about its inclusion in maintenance schedules. It was also noted the MHRA did not escalate this known risk to other hospital trusts.
Response (Medicines Healthcare Products Regulatory Agency): • The Medicines Healthcare Products Regulatory Agency (MHRA) conducted a review of the incident in 2015, including visits to the Royal Berkshire Hospital and the manufacturer. • The MHRA advised … (AI summary)
Response (AneticAid): • AneticAid commenced a programme of QA3 end-user training with Royal Berkshire Hospital staff. • AneticAid stated it would actively continue to support the end-user training programme. (AI summary)
Response (Royal Berkshire NHS Trust): • The Trust contracted Anetic Aid Limited (AA) for periodic inspection and maintenance of its QA3 trolleys, and updated its Clinical Engineering Checklist to detail required inspection checks. • The … (AI summary)
Responded
Annette Charlton
Concerns: The coroner noted that manufacturers producing medications in almost identical packaging may contribute to dispensing errors and potentially to patient deaths.
Response (Crescent Pharma Limted): • Crescent Pharma Limited scheduled a meeting with the MHRA in January 2015 to discuss packaging redesign and the use of colour to differentiate products. • The company stated that … (AI summary)
Overdue
Brian Marks
Concerns: The coroner noted the similar appearance of PEJ and PEG tubes could lead to confusion, suggesting a simple colour coding system to aid differentiation when the tubes are in situ.
Response (Department of Health): • The Medicines and Healthcare Products Regulatory Agency (MHRA) will bring the issue of tube misidentification to the attention of relevant Standards Committees. • The MHRA will include the risk … (AI summary)
Responded
Stephen Myers
Concerns: The coroner identified that the labelling and packaging of isopropyl nitrite, sold as 'English Room Odoriser', were inadequate under current CLP regulations, lacking updated hazard warnings, pictograms, precautionary statements, and a tactile warning.
Response (Department for Business Innovation Skills): • The Department for Business, Innovation and Skills (BIS) forwarded the coroner's report and recommendations to the local Trading Standards Authority for investigation. • BIS clarified that it does not … (AI summary)
Overdue
Steven Curtis
Concerns: The coroner raises concerns about the safety of Maplin N19KJ telescopic ladders, noting approximately 43,000 units were sold before withdrawal due to safety issues. Further investigation is sought regarding the accident ladder's origin and a review by Maplin.
Overdue
Dilys Jenkins
Concerns: The coroner raises concerns that standard tracheostomy tube lengths may be inappropriate for the increasing size of the population, potentially contributing to complications like dislodgement. The Intensive Care Society is encouraged to influence the industry to address this issue.
Overdue
Nadine Brookes-Walker
Concerns: The packaging of Fentanyl patches may not sufficiently warn patients about the serious consequences of using damaged patches.
Response (Nadine Brooks): • The incident was reported to the MHRA via the yellow card scheme. • The Medicines and Healthcare Products Regulatory Agency (MHRA) extensively reviewed Fentanyl patch product information, including Matrifen, … (AI summary)
Responded
Irene Pearson
Concerns: The coroner raised concerns about the clarity of Matrifen leaflet warnings regarding hot baths and Macmillan Nurses' advice on patch removal. There were also identified gaps in liaison between Macmillan Nurses and the GP practice, alongside unclear GP patient notes.
Response (I Pearson): • Takeda reported the matter concerning heat exposure clarity to Johnson and Johnson. • Takeda requested Johnson and Johnson to review the product information for Durogesic. • Takeda confirmed the … (AI summary)
Response (I Pearson Response2): • The Macmillan team confirmed it would not advise patients to use baths to aid patch removal or submerge patches in water. • A 'Trust Alert' was issued to all … (AI summary)
Overdue
Patricia Thomas
Concerns: The coroner noted a potential drug interaction between Miconazole Gel and Warfarin, which can increase bleeding risk. There is a lack of awareness of this interaction among health professionals and difficulty in locating clear information.
Overdue
Rubana Pathan
Concerns: The coroner noted insufficient dissemination of information to healthcare providers and implant manufacturers regarding how a specific toxin, linked to breast implant sepsis, can suppress signs of local inflammation.
Response (Homerton University Hospital NHS Trust): • The Trust requested a microbiologist to conduct a literature search on surgical site Staphylococcal Toxic Shock Syndrome. • The Trust shared detailed literature search findings and highlighted the need … (AI summary)
Overdue
Kathryn Bull
Concerns: The report describes a lack of understanding regarding the rare hyperammonaemia syndrome, an adverse consequence of gastric bypass surgery, and its symptoms.
Overdue
Christopher Holyoake
Concerns: The coroner notes a lack of awareness regarding the flammability of paraffin-based E45 cream among carers and the deceased, attributed to insufficient communication from the GP and an absence of fire hazard warnings on the product packaging and prescription.
Response (Reckitt Benckiser Group Plc): • Reckitt Benckiser Group Plc conducted an additional safety assessment of its E45 product portfolio regarding potential flammability risk. • The company will submit an application to the Medicines and … (AI summary)
Response (Chief Fire Officers Association and MHRA): • The Chief Fire Officers Association circulated the Regulation 28 report to fire and rescue services and will ensure its information is shared with appropriate staff. • The MHRA issued … (AI summary)
Response (NHS England): • NHS Improvement worked with the Medicines and Healthcare products Regulatory Agency (MHRA) to reduce the risk of future deaths. • NHS Improvement informed the British National Formulary (BNF) editors … (AI summary)
Responded
Jonathan Weatherley
Concerns: Previous product recall notices contained shortcomings, prompting the coroner to identify a need for a new, comprehensive recall. This recall should detail all known problems and affected products, and be widely disseminated collaboratively.
Overdue
Raymond Woodward
Concerns: The coroner noted that the risk of an adverse reaction to Buscopan in patients with coronary artery disease is not widely known. The current SPC for intravenous Buscopan lacks specific caution for those with ischaemic heart disease, suggesting a need for clearer guidance.
Response (Medicines and Healthcare Products Regulatory Agency2): • The Summary of Product Characteristics (SmPC) for Buscopan Ampoules was updated to communicate the risk of serious adverse reactions in patients with underlying cardiac disease. • Section 4.4 of … (AI summary)
Response (Medicines and Healthcare Products Regulatory Agency): • The Medicines and Healthcare Products Regulatory Agency (MHRA) analysed reported fatal cases in the UK suspected of being caused by Buscopan Ampoules. • The MHRA requested the licence holder … (AI summary)
Responded
Samantha Hopkins
Concerns: The coroner noted that PARAMEDIC 2 Trial exclusion criteria, including for pregnant women, were overlooked due to insufficient prominence on drug packets. There was also a lack of guidance from Warwick Medical School on how to highlight these exclusions to participants.
Response (South Central Ambulance Services NHS Trust): • The Trust collaborated with the University of Warwick to design a new label detailing exclusion categories for trial drug packs. • The new label design will be affixed to … (AI summary)
Response (Warwick Medical School): • The University stated it would include all four exclusion criteria on new labels for Investigational Medicinal Products (IMP) packaging. • The University confirmed that new labels would be distributed … (AI summary)
Responded
Dildar Shariff
Concerns: The coroner notes insufficient awareness among medical professionals and in NICE guidelines regarding the elevated haemorrhage risk for haemodialysis or uremic patients after a head injury. This gap in guidance could pose a risk to future patients.
Response (Response Dept of Health): • The Department of Health noted NICE's decision not to update its guidelines immediately in relation to the assessment and early management of head injury. • The Department of Health … (AI summary)
Response (N.I.C.E): • N.I.C.E. stated its existing head injury guideline does not require amendment. • The organisation logged the coroner's concerns with its guideline surveillance team for information during the next guidance … (AI summary)
Overdue
Zane Gbangbola
Concerns: The coroner notes that safety guidance documents for internal combustion engine equipment, particularly for use in confined areas, are inadequate and potentially misleading. The use of the HSE logo on these documents risks implying official endorsement, which could exacerbate harm.
Overdue
Grace Roseman
Concerns: The coroner identified concerns about the number of unmodified Bednest cribs still in circulation, where customers may be unaware of the mandatory safety modification or view it as optional, particularly those being passed on or sold secondhand.
Response (Bednest): • The company modified the Bednest crib design in November 2015 to remove the half-down side functionality. • A self-fit modification kit was designed and distributed to customers, supported by … (AI summary)
Response (Department for Business Energy and Industrial Strategy): • The standard EN 1130 is being amended to include a proposed section and warnings addressing hazards related to bedside sleepers and drop-side mechanisms. • Officials at BEIS will review … (AI summary)
Responded
Marjorie Bassendine
Concerns: The coroner noted concerns about the potential for multiple psychotropic medications to prolong the QT interval, highlighting the importance of pre-treatment and regular ECGs to monitor for long QT syndrome.
Response (RCPSYCH): • The Royal College of Psychiatrists stated it would liaise with its Special Committee for Psychopharmacology and Faculty of Old-Age Psychiatry to publicise and raise the identified issues. • The … (AI summary)
Response (Medicines and Healthcare Products Regulatory Agency): • The report details were added to the Adverse Drug Reaction database. • The product information for olanzapine, mirtazapine, and indapamide was reviewed. • The issue will be kept under … (AI summary)
Overdue
Pauline Taylor
Concerns: The coroner raised concerns about the fire hazard of emollient creams with low paraffin content, citing inadequate warnings on packaging and insufficient awareness of these risks. Locala also did not update risk assessments after significant patient changes.
Response (Medicines and Healthcare Products Regulatory Agency): • The MHRA is undertaking an in-depth review of instructions for use and reported adverse incidents, aiming to complete it by the end of 2017 and consider publishing additional safety … (AI summary)
Response (PAGB): • PAGB is developing new warning statements for product packaging and patient information leaflets, which will undergo user-testing to ensure clarity. • PAGB will work with the MHRA and other … (AI summary)
Response (Locala): • Locala disseminated updated guidance on paraffin-containing skin products and their fire risk to all business units and staff. • Training was updated, and risk assessment processes were revised to … (AI summary)
Response (NHS England): • The NHS Patient Safety Team undertook work with the Medicines and Healthcare Regulatory Agency and other organisations regarding the concerns. • Actions taken were detailed in the Patient safety … (AI summary)
Response (United Kingdom Home Care Association): • The United Kingdom Homecare Association published a fact sheet, 'UKHCA Guidance; Emollient Products Guidance for homecare providers,' in January 2018. • The United Kingdom Homecare Association published an article, … (AI summary)
Overdue
Christina Fletcher
Concerns: The coroner noted the absence of specific guidance from the GPhC for pharmacies on 'red flag' systems for patients with similar identifying details. Concerns were also raised about the lack of clear guidance on the chain of custody for Controlled Drugs, leading to inconsistent local practices.
Overdue
Margaret Clark
Concerns: The coroner raised concerns that Ecolab Ultracover sheaths, used for Transoesophageal Echocardiograms (TOEs), may be linked to multiple fatal oesophageal tears. A review of these sheaths is recommended, considering their replacement with Probetection sheaths across all hospitals and Trusts.
Response (Medicines and Healthcare Products Regulatory Agency): • The MHRA requested and received complaint details from the manufacturer of Ecolab sheaths. • The MHRA reviewed its adverse incident database for reports concerning Ecolab sheaths. • The MHRA … (AI summary)
Responded
Michael Spencer
Concerns: The coroner raised concerns regarding the non-availability of Andexanet alfa, a reversal agent for Factor Xa inhibitor anticoagulants, in the UK, given the increasing clinical use of these drugs.
Overdue
Venkata Kagga
Concerns: The coroner noted insufficient safety features for button batteries in household devices and a lack of understanding of their risks. Concerns were also raised about non-compliance with policies for young children in emergency services, inadequate medical assessments, and poor information sharing across NHS services.
Response (HSIB): • HSIB reviewed the content of the Regulation 28 letter. • HSIB sought advice from a subject matter expert and NHS Improvement. • HSIB launched a scoping exercise to determine … (AI summary)
Overdue
Natasha Ednan-Laperouse
Concerns: The coroner identified inadequate allergen labelling and a lack of coordinated monitoring for allergic reactions at Pret-a-Manger, alongside concerns about Epipen auto-injectors having insufficient needle length and a lower adrenaline dose than recommended.
Response (Medicines and Healthcare Products Regulatory Agency): • The Medicines and Healthcare Products Regulatory Agency (MHRA) required manufacturers to disclose exposed needle length for adrenaline auto-injectors in product information. • The MHRA implemented additional warnings and disclosed … (AI summary)
Response (Department for Environment Food Rural Affairs): • An urgent review of allergen information provision for food pre-packed for direct sale is underway to strengthen the framework. • The Department aims to launch a consultation on allergen … (AI summary)
Overdue
Stephen Whitehead
Concerns: The coroner identified the absence of a national registry for biliary stents, posing a risk of forgotten stents. Additionally, national guidelines lack an operational definition of 'short-term' use for these stents, creating ambiguity about safe timeframes.
Response (Department of Health and Social Care): • Pennine Acute Hospitals NHS Trust established an ERCP biliary stent oversight meeting and reviewed its system for patient follow-up. • The British Society of Gastroenterology (BSG) and its Joint … (AI summary)
Response (BSG): • The BSG will communicate to endoscopy units and members the importance of clear written information for patients, GPs, and surgical teams regarding stent insertion, removal, and timeframe. • The … (AI summary)
Responded
Ronald Clark
Concerns: Stents of varying sizes are supplied in identical packaging, which increases the risk of the wrong size being used during medical procedures due to difficult identification. The coroner recommends purchasing agencies ensure manufacturers use distinct coloured packaging for different stent sizes.
Response (NHS England): • The National Patient Safety Team is reviewing the National Safety Standards for Invasive Procedures (NatSIPPs). • The NatSIPP on prosthesis verification is being updated to reflect developments in implant … (AI summary)
Overdue
Victor Hall
Concerns: The coroner noted concerns regarding a medication error partly attributed to the Phosphate Polyfusor product design and staff not checking medication packaging against prescriptions. Insufficient guidance, documentation, and training were also identified for healthcare professionals on medication administration and transfer procedures.
Response (Northern Care Alliance NHs Trust): • The Trust conducted a thorough review into the concerns raised and commenced monitoring of medicines safety training compliance and incidents on Ward H2. • A full review of the … (AI summary)
Overdue
Owen Carey
Concerns: Concerns were raised regarding the adequacy and effectiveness of allergen training for restaurant staff, particularly with high turnover, and the insufficient prominence of allergen notices on menus. Additionally, menus lacked explicit key allergen information, potentially leading to false reassurance for customers.
Response (BSACI): • The British Society for Allergy and Clinical Immunology (BSACI), in partnership with Imperial College, responded to a Food Standards Agency tender for a UK register for anaphylaxis and received … (AI summary)
Response (National Trading Standards): • National Trading Standards stated that activities relating to the regulation of food safety and allergens do not fall within its remit. • The organisation indicated that local authorities are … (AI summary)
Response (FSA DEFRA and DHSC): • The Food Standards Agency (FSA) stated it is updating guidance for businesses to ensure clarity on requirements for readily discernible allergen notices. • The FSA is planning a business … (AI summary)
Responded
Katherine Stamp
Concerns: The coroner noted that clozapine's side effects, especially relating to smoking and pneumonia, are under-appreciated, and the BNF does not provide sufficient clarity to prescribers regarding these effects.
Overdue
Maureen Waterfall
Concerns: The coroner noted the absence of a licensed antidote for Edoxaban and insufficient sharing of associated bleeding risks with non-tertiary centres. Concerns also included a lack of national guidance for antidote administration target times and storage.
Overdue
Mary Nelson
Concerns: The coroner raised concerns about Fluoxetine accumulating to dangerous levels that could trigger cardiac rhythm disturbance, questioning if dosage guidance needs revision or in-life drug level testing. Additionally, the death was not reported via the Yellow Card system.
Overdue
Alana Cutland
Concerns: The drug information leaflet for doxycycline did not mention the possibility of a psychotic reaction, which the coroner suggests could have allowed earlier intervention.
Response (the Medicines Healthcare Products Regulatory Agency): • The Medicines Healthcare Products Regulatory Agency (MHRA) conducted a review of available evidence and sought expert advice concerning doxycycline and psychotic reactions. • The MHRA will request the lead … (AI summary)
Responded
Samuel Morgan
Concerns: The coroner noted a potential link between SSRIs and suicidal thinking in young adults. They suggested a 'Black Box Warning' on medication packaging could more effectively highlight this increased risk to patients.
Response (Dept. of Health and Social Care): • The Medicines and Healthcare products Regulatory Agency (MHRA) created a Yellow Card report based on the information provided in the coroner's report. • The government continues to implement the … (AI summary)
Response (Medicines and Healthcare Products Regulatory Agency): • The Medicines and Healthcare Products Regulatory Agency (MHRA) stated that patient information leaflets for SSRIs include bold and bullet-pointed warnings about the risk of suicide, developed with patient input … (AI summary)
Responded
Samantha Singh
Concerns: Concerns were raised regarding the surgery's incorrect categorisation of a RAST test, the prescription of a single EpiPen contrary to NICE guidance, and the lack of a referral to an allergy clinic or follow-up.
Overdue
Andrew Cook
Concerns: The coroner noted potential under-reporting of PEG allergy and a need for more research into its effects. Concerns were raised about the lack of clear information on medical product labelling regarding PEG's presence, dose, and molecular weight, compounded by inconsistent nomenclature.
Response (Medicines and Healthcare Products Regulatory Agency): • The MHRA plans to launch a Devices Safety Information webpage and issue a Drug Safety Update to raise awareness of PEG/macrogol in medical devices and medicines, including nomenclature variations. … (AI summary)
Responded
Jane Allison
Concerns: The coroner noted concerns that the British National Formulary (BNF) guidance was deficient in providing advice for monitoring and identifying sudden pulmonary deterioration in elderly, active patients prescribed Nitrofurantoin for short durations.
Response (National Institute for Health and Care Excellence): • NICE stated it could not comment on the concerns raised regarding the British National Formulary (BNF) content, as responsibility for the content remained with the publishers. • NICE suggested … (AI summary)
Response (Royal Pharmaceutical Society): • The nitrofurantoin monograph in the British National Formulary (BNF) will be updated with additional information on acute pulmonary reactions. • Acute pulmonary reactions will be highlighted in a specific … (AI summary)
Response (Claypath and University Medical Group): • The practice sent an email to all prescribing clinicians alerting them to the side effects of nitrofurantoin and will discuss the matter at a Significant Event Analysis Meeting. • … (AI summary)
Response (Medicines and Healthcare Products Regulatory Agency): • The MHRA conducted a review of available evidence and sought expert advice regarding nitrofurantoin and pulmonary adverse drug reactions. • The MHRA will request Marketing Authorisation Holders to strengthen … (AI summary)
Responded
Susan Skillen
Concerns: The coroner noted that patient literature for methotrexate did not include phototoxicity as a rare side effect, and it was unclear whether this literature would be reviewed after a Yellow Card report.
Overdue
Celia Marsh
Concerns: The coroner identified outdated pathology guidance and inadequate sample retention in suspected anaphylaxis death investigations. Concerns also include gaps in education for doctors and patients regarding severe food allergies and a need for improved food labelling practices.
Response (Response UK Health Security Agency): • UKHSA stated that responsibility for establishing the systems referred to by the Coroner sits outside its remit. • UKHSA indicated that the Food Standards Agency (FSA) and the Health … (AI summary)
Response (UK Hospitality): • UKHospitality released an updated Industry Catering Guide in November 2022, developed in partnership with the Food Standards Agency and Food Standards Scotland. • The updated Industry Guide includes a … (AI summary)
Response (Food Standards Agency): • The Food Standards Agency (FSA) strengthened the Food Law Code of Practice in March 2021 to require more detailed notification of allergy-linked incidents, including serious anaphylaxis or death. • … (AI summary)
Response (Food and Drink Federation): • The Food and Drink Federation (FDF) developed and published technical guidance for food manufacturers on appropriate allergen labelling, including the use of 'free-from' and vegan claims. • The FDF … (AI summary)
Response (British Retail Consortium): • The British Retail Consortium (BRC), jointly with the Food and Drink Federation (FDF), developed a guidance document on how to manufacture and label 'free-from' products, which is publicly available … (AI summary)
Response (British Society for Allergy and Clinical Immunology): • The British Society for Allergy and Clinical Immunology (BSACI) has provided governance for the UK Fatal Anaphylaxis Register (UKFAR) and used a grant to update its backlog of cases. … (AI summary)
Response (Department of Health and Social Care): • The Department of Health and Social Care noted the recommendation and concurred with the importance of learning from such tragedies. • The Department of Health and Social Care stated … (AI summary)
Response (Royal College of Pathologists): • The Royal College of Pathologists is updating its autopsy practice guidelines for suspected acute anaphylaxis. • The updated guidelines will include contact details for the UKFAR. • The updated … (AI summary)
Responded
Angela Kearn
Concerns: The coroner noted limited medical awareness of Immersion Pulmonary Oedema and the absence of specific standards for full face snorkel masks during their development. There were also concerns about insufficient communication of safety warnings to existing mask owners regarding use by individuals with cardio-respiratory conditions.
Response (National Trading Standards): • National Trading Standards stated it was unable to act on the issues raised in the report. • It explained that product safety does not fall within its scope of … (AI summary)
Response (GMC): • The GMC stated that doctors in the UK are equipped with professional behaviours, knowledge, and skills to assess complex and uncertain acute and emergency situations. • The GMC stated … (AI summary)
Overdue
Select committee recommendations(15)
#24 —
Recommendation: Witnesses from organisations representing staff working in health and social care told us that providers received unusable PPE from central government. The Royal College of Nursing told us of instances where it had received masks on which the elastic was …
Response attribution not verified
#16 —
Recommendation: The Department accepted that the urgent need for PPE meant it accepted greater risks when buying PPE than it usually would. The Department maintained, however, that it did not ask the Health and Safety Executive to lower standards. It told …
Response attribution not verified
#14 —
Recommendation: Not all of the PPE the Department bought can be used. The Department told us that only 0.5% of the 18 billion items of PPE it had received and checked so far had failed to meet clinical safety standards and …
Response attribution not verified
#18 — Call for Home Office to require warnings and expedite spiking testing review
Recommendation: The Home Office should require commercially available drug-testing products to carry warnings about their limitations; expedite its planned scientific review of the relative merits of the various spiking testing pilots being run by the police, universities and hospitals and report …
Gov response: The Government recognises the use of spiking test kits in various parts of the country, but we remain clear that there is no single test kit that reports to cover the number of drugs that …
Position Not Stated
#7 — Introduce generic substitution following consultation to ensure patient safety and supply chain stability.
Recommendation: We believe that allowing generic substitution would be an important way of reducing the need for patients to return to their GP for out-of-stock medication. We further recommend the introduction of generic substitution, which should follow a government consultation focusing …
Response attribution not verified
#6 — Update regulations to allow pharmacists to make dose and formulation substitutions for out-of-stock medicines.
Recommendation: We recommend that regulations are updated within three months to allow pharmacists in community settings to make dose and formulation substitutions for out-of-stock items, subject to the safeguards set out in the Royal Pharmaceutical Society’s Medicines Shortage Policy.
Response attribution not verified
#5 —
Recommendation: We recommend that the Government commits to removing dual prescription charges for oestrogen and progesterone, replacing it with a single charge for all women. We also recommend that the Government works with the NHS and the ‘HRT tsar’ to develop …
Response attribution not verified
#17 — Concerns about false assurances from existing spiking testing kits for victims
Recommendation: We are pleased that the Home Office is planning a scientific review of testing kits but are concerned that in the meantime victims could get false assurances from such kits.
Response attribution not verified
#4 —
Recommendation: We are extremely disappointed that despite a clear Government commitment on a single-cost, annual pre-payment certificate for HRT, almost nine months later that commitment has not been realised. Progress has been further derailed by supply issues. We welcome the Health …
Response attribution not verified
#68 — Support randomised control trials into effectiveness of CBPMs for chronic pain treatment.
Recommendation: We recommend that the Government supports researchers to conduct randomised control trials into the effectiveness of CBPMs to treat chronic pain. If the evidence base supports this, and it is deemed to be cost-effective, we recommend that the Government enables …
Gov response: The Government accepts this recommendation. Any researcher wanting to conduct Randomised Control Trials on the effectiveness of medicinal cannabis on chronic pain can ask the medicines regulator and the NIHR for scientific and research advice. …
Accepted
#66 — Widen NHS accessibility of unlicensed cannabis-based medicinal products before Parliament ends.
Recommendation: Pending the outcome of the ACMD’s review, we recommend that the Government widens the accessibility of unlicensed CBPMs on the NHS before the end of this Parliament.
Gov response: The Government does not accept this recommendation. Whether to prescribe medicinal cannabis, or any other drug, is a clinical decision and not a matter for Government policy. Licensed cannabis-based medicines are routinely available and funded …
Rejected
#23 — Review dermal filler licensing to make them prescription-only substances, like Botox.
Recommendation: We recommend that the Department review the licencing of dermal fillers to be prescription-only substances, in line with Botox, in order to provide more protection for people undertaking procedures involving dermal fillers.
Response attribution not verified
#3 — Medicine shortages undermine community pharmacy potential and erode public confidence.
Recommendation: Tackling medicine shortages is another vital component in securing the ability of pharmacy to meet its future potential. Medicine shortages cannot be ignored and left to become the norm. The wider implications of medicine shortages for the long- term potential …
Response attribution not verified
#67 — Potential therapeutic value of cannabis-based medicinal products for chronic pain.
Recommendation: There is evidence of the potential therapeutic value of CBPMs to treat chronic pain.
Response attribution not verified
#65 — Lack of NHS access to cannabis-based medicinal products for patients.
Recommendation: We support cannabis-based products for medicinal use (CBPMs) where there is an evidence base that it can be an effective form of treatment for managing conditions or symptoms. We welcome the ACMD conducting a further assessment of CBPMs following on …
Response attribution not verified
IMB individual recommendations(4)
Derwentside (2024)
To ensure that the processes of identifying and catering for food allergies are completely failsafe.
Governor / Director
Implemented
Heathrow Immigration Removal Centre (2021)
C&C should be more nimble regarding food selection to accommodate the varying detainee population, and better anticipate changing legislation on food safety (eg: Natasha’s Law). To help detainees with limited command of the English language, menus should always be provided with explanatory photos, reflecting the choice available each week.
Governor / Director
Derwentside IRC (2023)
To ensure that the processes for identifying and catering for food allergies are completely failsafe.
Governor / Director
Sudbury (2025)
It is to be hoped that the proposed changes to the kits being used to test for substance misuse do not lead to a loss of effectiveness of, and confidence in, the testing regime.
HMPPS
Noted
National patient safety alerts(1)
PHSO casework decisions(6)
P-002285 — A pharmacy in the Greater London area
A pharmacy failed to inform Ms A about changes in thyroxine medication brands, leading to ten months of severe allergic reactions and symptoms.
NHS in England
Nov 2023
P-003990 — Medicines and Healthcare products Regulatory Agency (MHRA)
Mrs C complained the Medicines and Healthcare products Regulatory Agency (MHRA) did not follow standards when changing its policy on valproate medicines, risking her life.
UK Government
Sep 2025
P-002023 — London North West University Healthcare NHS Trust
Ms T complained the Trust performed cervix surgery incorrectly, causing heavy bleeding, and prescribed an antibiotic (clindamycin) to which she was allergic.
NHS in England
Jun 2023
P-002585 — A practice in the Kirklees area
Mrs T complained a GP used a contaminated swab during a high vaginal test, causing severe emotional distress and fear of infection, negatively impacting her relationship.
NHS in England
Upheld
Feb 2024
P-002814 — A dental practice in the City of Brighton …
Ms A complained the dental practice failed to investigate her sensitive teeth at multiple examinations and inappropriately prescribed antibiotics, causing pain, abscesses, and tooth loss.
NHS in England
Partly Upheld
Jul 2024
P-001560 — Moorfields Eye Hospital NHS Foundation Trust
Miss O complained of incorrect diagnosis and medication for her left eye condition, leading to constant pain, depression, and inability to continue normal activities.
NHS in England
Sep 2022