Medical Product Allergen Labelling
Unclear labelling, inconsistent nomenclature, and insufficient research regarding allergens in medical products.
97 items
8 sources
1 inquiry
Source spread
Where this theme appears
Medical Product Allergen Labelling has been flagged across 8 independent accountability sources:
1 inquiry rec
68 PFD reports
15 committee recs
1 CQC action
4 IMB recs
1 patient safety alert
6 PHSO decisions
1 LGO/SPSO decision
When the same issue appears across inquiries, coroner reports, and regulators independently, it indicates a recurring issue across the public record.
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.
PFD Reports (68) — showing 50 strongest matches
William Andrews
Concerns: Surgical equipment design flaws, including the lack of a brightly coloured detachable cap on a bulb syringe, led to a retained tip. A national safety recommendation for such caps was ignored, and no cap counting procedure exists.
Response (Department of Health): The manufacturer of syringes has agreed to supply syringes without caps, has issued a safety notice to all UK customers, and will make syringes without caps available for stock exchange. …
Overdue
Leo Deady
Concerns: A significant proportion of breech presentations go undiagnosed nationally, yet there are no national guidelines for routine late-pregnancy scans to detect them, despite high risks.
Response (Department of Health): The Department of Health acknowledges the concerns regarding undiagnosed breech presentations but states that after consulting with the RCOG and taking account of existing research and guidance, it considers that …
Overdue
Jackie Scott
Concerns: Lack of clear allergen information meant the deceased unknowingly consumed peanuts in a take-away meal, resulting in a fatal anaphylactic shock.
Overdue
John James Jackson
Concerns: The coroner notes a lack of readily available information about the dangers of consuming large quantities of caffeine, particularly from 'Hero Energy Mints', which are advertised as an alternative to energy drinks.
Overdue
Victoria Meppen-Walter
Concerns: Concerns were raised regarding the easy online availability and regulation of chloroquine, along with the associated risks of its misuse.
Overdue
Dafydd Watts
Concerns: Drug literature and the British National Formulary fail to adequately inform physicians about rare but potential fatal occurrences associated with medication.
Overdue
Archie Hames
Concerns: The combined use of a specific tracheostomy tube and a particular Velcro strap attachment compromised the tube's integrity, likely causing detachment and posing risks with similar devices.
Response (Department of Health): Following concerns about tracheostomy tubes and velcro straps, MHRA issued a Medical Device Alert, and manufacturers Arcadia Medical and Smiths Medical clarified instructions for use to warn against using velcro …
Overdue
George Stone
Concerns: National guidelines for antidepressant warnings, specifically for Venlafaxine, fail to include the rare but severe risk of seizures, potentially leaving patients uninformed about a critical side effect.
Overdue
Tiya Chauhan
Concerns: Childcare settings and parents are unaware of the choking risks posed by raw jelly cubes, with packets lacking adequate warnings and supervision during play being insufficient.
Response (Department for Education): The Department for Education intends to issue additional guidance to the early years sector in 2015 under the EYFS banner, principally about what constitutes good paediatric first aid provision in …
Response (Ofsted): Ofsted will disseminate the inquest findings to Ofsted and contracted inspectors of EY provisions, ensuring they are aware of the risks of using raw jelly in activities during inspections of …
Response (Food Standards Agency): The Food Standards Agency will forward information about the risks of raw jelly cubes to local authority environmental health services and industry manufacturing/retail trade bodies. They will also forward the …
Overdue
Patricia Mellor
Concerns: Despite detailed recommendations from a hospital regarding Long QT Syndrome and drug-related cardiac arrest risks during anaesthesia, regulatory bodies (MHRA, NICE) have failed to update guidelines and product warnings.
Overdue
James Fyfe
Concerns: The cot side on a trolley could remain in an unlocked position due to design and maintenance issues, which were not clearly highlighted. The MHRA failed to escalate this known hazard to other hospital trusts.
Response (Medicines Healthcare Products Regulatory Agency): MHRA has discussed the QA3 instructions for use with the manufacturer, advising them to review them again to ensure that they are still accurate and appropriate. MHRA contacted four other …
Response (AneticAid): AneticAid defends the design and safety record of its QA3 trolley, arguing that no retrospective changes are needed. They suggest the issue is localised to Royal Berkshire Hospital and will …
Response (Royal Berkshire NHS Trust): Royal Berkshire NHS Trust has contracted with Anetic Aid (AA) to undertake periodic inspection and maintenance on all of its QA3 trolleys. The Trust has further updated its Clinical Engineering …
Responded
Annette Charlton
Concerns: Pharmaceutical manufacturers are producing medications in almost identical packaging, which significantly increases the risk of dispensing errors and poses a serious threat to patient safety.
Response (Crescent Pharma Limted): Crescent Pharma has scheduled a meeting with the MHRA to discuss packaging redesign and the use of colour to differentiate products and strengths, after their request to do so in …
Overdue
Brian Marks
Concerns: PEJ and PEG tubes are easily confused due to their similar appearance, highlighting the lack of a simple colour-coding system for differentiation.
Response (Department of Health): The MHRA will bring the issue of tube misidentification to the attention of the Standards Committees and intends to include the risk of misidentification of similar devices in the next …
Responded
Stephen Myers
Concerns: A product containing isopropyl nitrite, misused by inhalation, has inadequate labelling that fails to comply with current safety regulations (CLP) regarding hazards and warnings.
Response (Department for Business Innovation Skills): The Department for Business, Innovation and Skills clarifies that responsibility for labelling of "poppers" rests with the Health and Safety Executive and enforcement with local Trading Standards. It states that …
Overdue
Steven Curtis
Concerns: There are safety concerns regarding Maplin N19KJ telescopic ladders, with 43,000 sold, warranting investigation into a potential catastrophic failure and the origin of the accident ladder.
Overdue
Dilys Jenkins
Concerns: Tracheostomy tube manufacturers may not be keeping pace with population changes, leading to tubes of potentially inappropriate length which could increase dislodgement risk.
Overdue
Nadine Brookes-Walker
Concerns: Packaging for Fentanyl patches may not adequately convey the severe risks associated with using damaged patches, potentially leading to patient misuse.
Response (Nadine Brooks): Takeda believes the existing patient information leaflet adequately addresses the issue of damaged patches, and they have requested a review to determine if changes are needed; the MHRA also reviewed …
Responded
Irene Pearson
Concerns: Matrifen patch warnings about hot baths are obscure and vague, and dangerous advice was given to use baths for patch removal. Poor liaison on opiate prescribing and unclear, scanty GP electronic notes contributed to unsafe care.
Response (I Pearson): Takeda has reported the coroner's concerns about heat exposure and fentanyl patches to Johnson and Johnson and requested they conduct a review to determine if changes to product information are …
Response (I Pearson Response2): Following the inquest, the Macmillan team sent a 'Trust Alert' out to all hospital and community staff reminding them not to advise patients to take a bath to aid removal …
Overdue
Patricia Thomas
Concerns: A significant lack of awareness among health professionals regarding the dangerous interaction between Miconazole Gel and Warfarin, combined with unclear information resources, risks uncontrolled bleeding.
Overdue
Rubana Pathan
Concerns: Medical professionals and implant manufacturers lack awareness that a rare toxin causing sepsis can suppress typical inflammation signs, potentially delaying diagnosis and treatment for patients with breast implants.
Response (Homerton University Hospital NHS Trust): The hospital disseminated information about Staphylococcal Toxic Shock Syndrome to clinicians, including an evidence and literature search. The case will be discussed at a Hospital Grand Round, and the Trust …
Overdue
Kathryn Bull
Concerns: Death was caused by hyperammonaemia syndrome, a rare and poorly understood adverse consequence of gastric bypass surgery, with symptoms that are not well known.
Overdue
Christopher Holyoake
Concerns: E45 cream, a highly flammable paraffin-based product, lacked fire hazard warnings on its packaging and prescription, leading to a dangerous lack of awareness among carers and the deceased.
Response (Reckitt Benckiser Group Plc): The company will be submitting an application to the MHRA to update the labelling of several E45 products to include guidance on potential flammability. The warning to be added to …
Response (Chief Fire Officers Association and MHRA): CFOA has circulated the report to Chief Fire Officers/Chief Executives and other practitioners in the fire and rescue services and Chief Fire Officers/Chief Executives will ensure that the information and …
Response (NHS England): NHS Improvement have informed the editors of the BNF that the risk also applies to less concentrated aqueous based paraffin containing products, and the BNF will in future include a …
Responded
Jonathan Weatherley
Concerns: Recall notices for the products were inadequate, failing to highlight all known problems and affected items, necessitating a comprehensive, widely distributed new recall.
Overdue
Raymond Woodward
Concerns: The risk of adverse cardiovascular reactions to Buscopan, especially in patients with ischaemic heart disease, is not widely known, and the Summary of Product Characteristics (SPC) for intravenous Buscopan could be more specific regarding this risk.
Response (Medicines and Healthcare Products Regulatory Agency2): The Summary of Product Characteristics (SmPC) for Buscopan Ampoules has been updated to more clearly communicate and minimise the risk of serious adverse reactions in patients with underlying cardiac disease. …
Responded
Samantha Hopkins
Concerns: Critical trial exclusions, such as for pregnant women, were overlooked due to insufficient prominence on drug packet warnings and lack of guidance for highlighting these exclusions.
Response (South Central Ambulance Services NHS Trust): New labels detailing exclusion categories will be placed on further issues of the trial drug packs. SCAS has committed that by January 2017 that all trial drugs in circulation will …
Response (Warwick Medical School): The University has instructed participating Ambulance Services to issue a reminder to all participating staff, to reiterate the inclusion and exclusion criteria for the trial. Compliance with this instruction shall …
Responded
Dildar Shariff
Concerns: There is a critical lack of national awareness and NICE guideline inclusion regarding the increased haemorrhage risk in haemodialysis or uremia patients, potentially leading to future deaths.
Response (Response Dept of Health): The Department of Health acknowledges the coroner's report and notes NICE's decision not to update its guidelines at this time, but that the information will be looked at when the …
Response (N.I.C.E): NICE acknowledges the coroner's concerns about awareness of haemorrhage risk in renal failure patients with head injuries. While they believe their existing guideline covers this adequately, they have logged the …
Overdue
Zane Gbangbola
Concerns: Inadequate and misleading safety guidance for internal combustion engine equipment used in confined spaces, coupled with the misleading use of the HSE logo, increases the risk of harm.
Overdue
Grace Roseman
Concerns: Crib manufacturer failed to fully address the risk of death from an un-modified crib design, leaving a large number of potentially unsafe products in circulation with unaware customers.
Response (Department for Business Energy and Industrial Strategy): The Department for Business Energy and Industrial Strategy will discuss with BSI how to ensure paediatric advice is fed into the revision of the standard for cribs and cradles and …
Response (Bednest): Bednest has modified its cribs, sent modification kits to known purchasers, added additional labeling, ceased sales through retailers like NCT, and maintains information about the modification kit on their website. …
Responded
Marjorie Bassendine
Concerns: Failure to recognise the cardiac risks of multiple psychotropic medications led to a lack of pre-treatment and regular ECGs to monitor for potential QT interval prolongation.
Response (RCPSYCH): The Royal College of Psychiatrists will publicize the coroner's concerns to its members, review continuing medical education initiatives, and inform the Presidents of the Royal Colleges of Physicians and General …
Response (Medicines and Healthcare Products Regulatory Agency): The MHRA reviewed product information for olanzapine, mirtazapine, and indapamide and considers the existing warnings regarding QT prolongation to be appropriate. They are not proposing any regulatory action to change …
Overdue
Pauline Taylor
Concerns: Emollient creams with paraffin pose an unrecognised fire hazard due to inadequate warnings and lack of awareness, alongside insufficient patient risk assessments.
Response (Medicines and Healthcare Products Regulatory Agency): MHRA has liaised with ArjoHuntleigh to confirm risk mitigation factors are appropriate and are working to communicate important healthcare information to healthcare professionals and the public through established alert systems. …
Response (PAGB): PAGB will provide a written submission to the MHRA by September 30th, 2017 regarding paraffin-containing products and will work with the MHRA, fire brigades, and other stakeholders to ensure clear …
Response (Locala): Locala has shared learning from the case internally, raised awareness about paraffin-containing products in their monthly medicines management report, and is developing a flowchart, documentation, and training for staff to …
Response (NHS England): NHS Improvement notified of the death in 2015 and included actions taken in response to the death in the Patient safety review and response report published in June 2017.
Response (United Kingdom Home Care Association): The UK Homecare Association has provided information to homecare providers including a fact sheet prepared by the London Fire Brigade, an article in their magazine, and an email briefing regarding …
Overdue
Christina Fletcher
Concerns: A lack of clear regulatory guidance on 'red flag' systems for pharmacies to identify patients with similar details and inconsistent chain of custody protocols for controlled drugs pose risks.
Overdue
Margaret Clark
Concerns: A change to new TOE probe sheaths (Ecolab) was linked to multiple fatal oesophageal tears, and these potentially unsafe sheaths may still be in use in other hospitals despite safer alternatives existing.
Response (Medicines and Healthcare Products Regulatory Agency): The MHRA reviewed complaints and adverse incident databases regarding Ecolab sheaths and found few reports. They are unable to compare "softness" of sheaths and will continue to monitor the safety …
Responded
Michael Spencer
Concerns: A specific drug (Andexanet alfa) to reverse potentially fatal bleeding caused by Factor Xa inhibitor anticoagulants is not available in the UK, even for compassionate use.
Overdue
Venkata Kagga
Concerns: Critical safety features for button batteries in household devices are lacking, and national safety alerts are not effectively sustained. Hospital policies for paediatric assessment and compliance were not followed, exacerbated by poor information sharing across services.
Response (HSIB): HSIB has launched a scoping exercise, including collecting further details about the incident and conducting a short literature review, to examine whether the case meets their criteria for investigation.
Overdue
Natasha Ednan-Laperouse
Concerns: Allergens were not adequately labelled on Pret-a-Manger packaging, and there was no coordinated system for monitoring customer allergic reactions. Additionally, the needle length and adrenaline dose of Epipens may be inadequate for treating anaphylactic reactions.
Response (Medicines and Healthcare Products Regulatory Agency): The MHRA has already undertaken a review of adrenaline auto-injectors, progressed this within Europe, resulting in improved training, additional risk minimisation measures and factual disclosures within the product information. They …
Response (Department for Environment Food Rural Affairs): The Department is undertaking an urgent review of allergen information provision for food which is pre-packed for direct sale, with a consultation on policy options planned for early in the …
Overdue
Stephen Whitehead
Concerns: The absence of a national registry for biliary stents creates a risk of "forgotten stents," while national guidelines lack a clear definition of "short-term" use.
Response (Department of Health and Social Care): The Department acknowledges the coroner's concerns but refers to the BSG's opinion that a national stent registry is not required and NICE's view that existing guidance remains appropriate. It also …
Response (BSG): The BSG is in discussion with JAG about adding a stent planning/recall database to key performance indicators and incorporating it into the ISREE programme, with a formal discussion planned for …
Responded
Ronald Clark
Concerns: Stents supplied in identical packaging with only small labels pose a risk of using incorrect sizes during medical procedures.
Response (NHS England): The National Patient Safety Team is reviewing the National Safety Standards for Invasive Procedures (NatSIPPs) and the NatSIPP on prosthesis verification is being updated to reflect developments in implant selection …
Overdue
Victor Hall
Concerns: Ambiguous medication packaging contributed to an error, which the MHRA failed to address. There's a need for enhanced guidance and training for nursing and pharmacy staff on thorough medication checks and documentation at all stages.
Response (Northern Care Alliance NHs Trust): The Trust will undertake a full review of the dispensary environment at Salford Royal Hospital, looking at workspace design and dispensing processes, with implementation by the Learning and Development team …
Overdue
Owen Carey
Concerns: The restaurant's allergen training was inadequate, notices on menus lacked prominence to trigger discussions, and menus failed to clearly state key allergen information, creating false reassurance for customers.
Response (Byron): Byron has rectified the lack of records kept of on-job training immediately and each employee will now have records kept, and are investing in a market leading training system called …
Response (BSACI): BSACI will write to the chair of the FSA to advocate for funding for the UK Fatal Anaphylaxis Registry (UKFAR), which they are exploring closer working with to ensure its …
Response (National Trading Standards): National Trading Standards states that food safety and allergen regulation is outside their remit, which focuses on regional or national issues like complex consumer fraud. They note the Food Standards …
Response (FSA DEFRA and DHSC): The FSA plans to develop an online reporting system and improve data sharing for allergic reactions, including those not resulting in death, to enable timely identification of trends and action …
Responded
Katherine Stamp
Concerns: The serious side effects of clozapine, particularly regarding smoking and pneumonia, are under-appreciated by prescribers and not sufficiently detailed in national guidance.
Overdue
Maureen Waterfall
Concerns: 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.
Overdue
Mary Nelson
Concerns: Dangerous fluoxetine accumulation suggests a need to revise dosage guidance, especially for the elderly, and consider in-life drug testing. This death was also not reported to the Yellow Card system.
Overdue
Alana Cutland
Concerns: The drug information leaflet for doxycycline failed to highlight the possibility of a psychotic reaction, which the deceased experienced, hindering early intervention by her family.
Response (the Medicines Healthcare Products Regulatory Agency): The MHRA reviewed evidence on doxycycline and psychotic reactions. Based on expert advice, they will request that the lead marketing authorisation holder submit a proposal by 30 November 2020 to …
Responded
Samuel Morgan
Concerns: Patient information leaflets for SSRIs lack immediate, high-impact warnings, such as a "Black Box Warning," to clearly highlight the increased risk of suicidal thinking in young adults.
Response (Dept. of Health and Social Care): The Department of Health and Social Care acknowledges concerns about the presentation of risks associated with citalopram and lack of a follow-up appointment, but does not commit to specific changes …
Response (Medicines and Healthcare Products Regulatory Agency): The MHRA acknowledges the concerns, highlights existing warnings about suicide risk with SSRIs, and states that the information has been used to generate a Yellow Card report for continuous monitoring, …
Responded
Samantha Singh
Concerns: A patient's RAST test results were wrongly categorised as normal, leading to delayed action. Subsequently, only one EpiPen was prescribed against NICE guidance, and no allergy clinic referral or follow-up was offered.
Overdue
Andrew Cook
Concerns: Concerns involve potential under-reporting of PEG allergy, insufficient research into its effects, and the lack of clear labelling on medical products regarding PEG's presence, dose, and various synonyms.
Response (Medicines and Healthcare Products Regulatory Agency): The MHRA will discuss labelling requirements with other regulators internationally, collect and review information from a range of data sources on PEG exposure, and raise the profile of PEG/macrogol working …
Responded
Jane Allison
Concerns: The BNF content for Nitrofurantoin was deficient in advising on monitoring for sudden pulmonary deterioration in elderly, active patients, even for short treatment courses.
Response (National Institute for Health and Care Excellence): 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 …
Response (Royal Pharmaceutical Society): 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, …
Response (Claypath and University Medical Group): 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 …
Response (Medicines and Healthcare Products Regulatory Agency): 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 …
Responded
Susan Skillen
Concerns: Patient information for methotrexate lacks crucial warnings about the rare but serious side effect of phototoxicity, requiring a review of literature and adverse event reporting.
Overdue
Celia Marsh
Concerns: The investigation of suspected anaphylaxis deaths is hampered by outdated pathology guidance, poor sample retention, delayed reporting, and insufficient education for medical staff and high-risk patients. There's also a lack of robust systems to capture anaphylaxis cases.
Response (Response UK Health Security Agency): The UK Health Security Agency states that responsibility for establishing systems related to food policy and anaphylaxis sits outside of their remit, and instead lies with the Food Standards Agency …
Response (UK Hospitality): UKHospitality commits to carrying out a consultation with members on managing the risk of vegan dishes for people with hypersensitivity, and reflecting any recommendations in future updates to the Industry …
Response (Food Standards Agency): The Food Standards Agency will focus on a smaller subset of priorities including Precautionary Allergen Labelling (PAL), improving information in the non-prepacked sector, and enabling a step-change in the knowledge, …
Response (Food and Drink Federation): The Food and Drink Federation highlights existing guidance on allergen labelling, particularly regarding the differences between 'free-from' and vegan claims and will continue to support the work of the FSA.
Response (British Retail Consortium): The British Retail Consortium supports members with label decisions but emphasizes company responsibility, noting challenges with 'free-from' and vegan definitions and the potential for unintended consequences with specific dietary statements.
Response (British Society for Allergy and Clinical Immunology): The British Society for Allergy and Clinical Immunology will consider holding an educational event on food avoidance in relation to adults with eczema and will address the need for improved …
Response (Department of Health and Social Care): The Department of Health and Social Care acknowledges the recommendation to establish a robust system of capturing and recording cases of food-related anaphylaxis and notes that data regarding all anaphylaxis-related …
Response (Royal College of Pathologists): The Royal College of Pathologists is updating its autopsy practice guidelines for suspected acute anaphylaxis to include contact details for the UKFAR and direct pathologists to report fatal anaphylaxis cases.
Responded
Angela Kearn
Concerns: Medical profession lacks awareness of Immersion Pulmonary Oedema. Full face snorkel masks have inadequate safety standards and insufficient public warnings regarding risks for users with cardiovascular/respiratory conditions.
Response (National Trading Standards): National Trading Standards states that they are unable to act on the issues raised, as product safety does not fall within their remit. They recommend the report be sent to …
Response (GMC): The GMC asserts that medical training in the UK equips doctors with the necessary skills to assess complex acute situations, and no further specific training intervention is required for Immersion …
Overdue
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 …
Gov response: 7: PAC conclusion: The Department has wasted hundreds of millions of pounds on PPE which is of poor quality and cannot be used for the intended purpose. 7a: PAC recommendation: The Department should write to …
Not Addressed
#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 …
Not Addressed
#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 …
Gov response: 7: PAC conclusion: The Department has wasted hundreds of millions of pounds on PPE which is of poor quality and cannot be used for the intended purpose. 7a: PAC recommendation: The Department should write to …
Not Addressed
#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 …
Not Addressed
#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 …
Gov response: Pharmacies play a vital role in our healthcare system. As set out in the Government’s manifesto, we are committed to expanding the role of pharmacies and to better utilising the skills of pharmacists and pharmacy …
Accepted
#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.
Gov response: The Committee raises an interesting point. Medicine supply chains are highly regulated, complex and global. Supply disruption affects many countries around the world and is not specific to the UK. Issues with the medicines supply …
Partially Accepted
#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 …
Gov response: 47. The government accepts this recommendation in part. 48. As set out in the response to recommendation 4, we are committed to reducing prescription charges for HRT. The implementation of the bespoke HRT PPC will …
Partially Accepted
#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.
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 …
Under Consideration
#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 …
Gov response: 43. The government accepts this recommendation in part. 44. The government is committed to reducing the cost of HRT prescriptions and work is underway with the NHS Business Services Authority to develop a bespoke pre-payment …
Partially Accepted
#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. …
Partially 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 …
Not Accepted
#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.
Gov response: The government recognises that there are significant physical and psychological risks that cosmetic fillers (commonly known as ‘dermal fillers’) present to members of the public. Filler products can be used for medical treatment or for …
Not Accepted
#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 …
Gov response: The Human Medicines Regulations 2012 (HMRs 2012) require pharmacists to dispense “in accordance with a prescription”. This has been interpreted to mean supply of medicines must be the exact product and quantity prescribed with some …
Partially Accepted
#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.
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. …
Under Consideration
#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 …
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 …
Not Accepted
IMB Recommendations (4)
Derwentside (2024)
To ensure that the processes of identifying and catering for food allergies are completely failsafe.
Governor / Director
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
National Patient Safety Alerts (1)
PHSO Casework Decisions (6)
P-002285 — A pharmacy in the Greater London area
Ms A complains the Pharmacy did not tell her when it was giving her different brands of thyroxine (medication to treat an underactive thyroid gland) between February and November 2022. Ms A says she had a reaction to ingredients in some of the brands and experienced side effects like hives, …
NHS in England
Nov 2023
P-003990 — Medicines and Healthcare products Regulatory Agency (MHRA)
Mrs C says Medicines and Healthcare products Regulatory Agency (MHRA) did not act in line with its applicable policies/standards when it made its decision to change the policy on sodium valproate.
UK Government
Sep 2025
P-002023 — London North West University Healthcare NHS Trust
Ms T complains the Trust did not do surgery correctly to remove abnormal cells in her cervix as it led to heavy vaginal bleeding. She also complains it prescribed her with clindamycin (an antibiotic) to which she was allergic.
NHS in England
Jun 2023
P-002585 — A practice in the Kirklees area
Mrs T complains a GP at the Practice used a contaminated swab when they did a vaginal swab test on her in December 2022.
NHS in England
Upheld
Feb 2024
P-002814 — A dental practice in the City of Brighton …
Ms A complains the Practice failed to investigate her complaints of sensitive teeth and inappropriately gave her antibiotics.
NHS in England
Partly Upheld
Jul 2024
P-001560 — Moorfields Eye Hospital NHS Foundation Trust
Miss O complains that the Trust incorrectly diagnosed a condition in her left eye and therefore gave her the wrong medication.
NHS in England
Sep 2022