Medicines and Healthcare products Regulatory Agency

Noted (AI summary) The ABPI, as a trade association without regulatory authority, has made the originator company, Bristol Myers Squibb (BMS), aware of the coroner's report and concerns regarding apixaban patient safety information and labelling. MedicinesUK states its member companies will comply with any future changes to product information regarding anticoagulants and head trauma warnings, should such changes be required by the MHRA. The MHRA has completed a preliminary assessment and initiated a full review across all Direct Oral Anticoagulants (DOACs) and warfarin regarding patient information leaflet warnings for head trauma, with plans to seek expert advice on potential updates.

Noted (AI summary) The MHRA explains that there is no standardised test for contrast medium allergy, that lidocaine is a prescription-only medicine but not a controlled drug (and thus local hospital policies determine controls), and states that any additional procedures for handling medicines would be outside their remit unless there is a safety concern. The RCR has established a working party to develop new iodinated contrast medium (ICM) and gadolinium guidelines, anticipated for publication in early 2026. They also provide general observations on allergy testing and anaphylaxis management but do not commit to specific actions. The Trust states there is no reliable or standardised test to predict contrast reactions in patients without prior symptoms and that life-threatening reactions are rare. They confirm no national alerts for lidocaine contamination and cannot determine the source of lidocaine found in the patient. The Department for Health and Social Care acknowledges the concerns but defers direct response to other agencies, providing existing information from NHS England on the safe and secure handling of medicines and storage requirements for lidocaine.

Noted (AI summary) The Trust provided additional training on ‘The Deteriorating Patient’ in 2022. Since September 2023, the Trust has introduced additional recommended courses and in June 2024, the ward received teaching sessions about NEWS2 and response. The MHRA outlines existing regulations and guidance concerning paracetamol labelling, prescribing information, and safety monitoring. They have liaised with NHSE regarding the ePRaSE tool. The Royal Pharmaceutical Society will consider how to raise awareness of issues around duplication of medicines in electronic prescribing systems through future communications and engagement with the pharmacy sector. Lewisham and Greenwich NHS Trust describes safety features in its iCare electronic prescribing system, including 'hard stops' and 'soft stops' for paracetamol prescriptions. The Trust have reviewed their IPS very recently and are participating in a leadership exercise on this topic. Oracle Health (formerly Cerner) states its Millennium prescribing system features are appropriate and functioning as designed, and will continue to review and monitor awareness of this functionality among its Trust clients. The decision on whether to take a particular code or configuration enhancement remains with the client.

Noted (AI summary) MHRA acknowledges the concerns about support belts lacking warnings and guidance, provides background on its regulatory role, and explains existing device regulations and post-market surveillance activities, including Yellow Card scheme and collaborations. It highlights manufacturer responsibilities for safety and labeling. The response includes details on the product and its instructions for use. The DHSC acknowledges the concerns regarding the lack of warnings and information on lap belt products, states that the responsibility for these concerns sits within another organisation, and will be writing to the Office of Product Safety and Standards. OPSS has written to major online marketplaces (Amazon, eBay, Temu, Shein and Alibaba) to make them aware that certain products may not be provided with suitable instructions or warnings to assure safe use by likely users, and alerted online marketplaces to its Product Safety Report published for the ORTONES belt to make clear this product should not be supplied.

Noted (AI summary) NICE is working collaboratively with the MHRA on the issues raised and will provide a further response once that work has concluded; the outcome will inform any action NICE may need to take in respect of its recommendations. The MHRA outlined existing warnings and guidelines related to SSRIs and suicidal behavior, referencing NICE guidance, and added the adverse reaction report to the Yellow Card database. The Royal College of GPs provides general comments on GP curriculum, shared decision making, NICE guidance and its Mental Health toolkit, but notes no specific changes it will make.

Noted (AI summary) The Trust will not allow removal or deferral of cancer patients on a Patient Tracker List without consultant approval. A restructure of cancer administration pathways is underway and an external review of controlled medication practices is planned. The Trust has changed the process of Controlled Medication Keys and is trialing a digital key system and exploring installing CCTV. The MHRA acknowledges the concerns but states they cannot comment on medical advice or care quality. They explain the MHRA's role in assessing medical devices and note they received a previous NRLS report regarding a gastrostomy balloon device, but the investigation was closed in August 2023 due to the implementation of ENFit standards. The DHSC acknowledges the concerns regarding the care provided by the Trust and its processes. It outlines the roles of NHS England, CQC and MHRA and refers to NICE guidance and NIHR funded studies on sepsis.

Noted (AI summary) NHS Frimley ICB organised a cross-system meeting across the South-East region to discuss the issues raised in the report and will be writing to NHS England about this case. The response is also being shared within relevant system and regional groups. NHS Frimley ICB organised a cross-system meeting across the South-East region to discuss the issues raised in the report and will be writing to NHS England about this case. The response is also being shared within relevant system and regional groups. The National Pharmacy Association will review their existing guidance and consider how to refine it, and raise awareness of the issue with Member pharmacies, and raise the matter with the sector-wide Patient Safety Group. The General Pharmaceutical Council acknowledges the concerns and refers to existing guidance on person-centered care, reasonable adjustments for patients with cognitive impairment, and the use of MCAs. They will consider how to further raise awareness of these issues. Community Pharmacy Thames Valley expresses sympathy and notes that dispensing medication falls under a national contract, and has escalated the concerns to Frimley ICB and Community Pharmacy England and requested an anonymised case study to raise awareness. The Specialist Pharmacy Service (SPS) outlines currently available information on the management of adherence and use of medicines compliance aids and suggests changes that may help prevent future deaths, while highlighting existing resources. Community Pharmacy England will raise the concern about clearly identifying MCAs in multi-person households with the RPS and CPPSG and ask them to consider additional guidance. They will also make community pharmacy owners aware of the specific risk and actions will be taken in the autumn of this year. The MHRA believes the concerns relate to the dispensing process and are better addressed by the General Pharmaceutical Council. Slough Pharmacy has amended their processes to include removing each tray from packaging and double-checking with the patient and provides a different brand of trays with totally different packaging to any households that involve more than one person with trays.

Noted (AI summary) The NPA will raise concerns with the DHSC about Zuclopenthixol dihydrochloride (clopixol) packs and special container status at upcoming meetings, suggesting the DHSC is a more appropriate body for the report. Lundbeck states it does not classify Zuclopenthixol as requiring special container status, but has queried the NHS Business Authority and provided supportive stability data. The General Pharmaceutical Council acknowledges the concern and will consider whether to issue communications to pharmacy professionals to raise awareness about exceptions to the rules around quantity to supply for special containers. The MHRA confirms that the GPhC led on the response to the report, shared on 7 May 2024, and that the response is supported.

Noted (AI summary) BNF plans to review wording on sedation risks in drug interaction information, to highlight risks of concurrent use of sedating drugs. They have also added pharmacodynamic interaction tables to online versions of the BNF and BNFC. The MHRA will conduct a further assessment of the information provided within the clozapine product information regarding drug-drug interactions, including information for healthcare professionals, patients, families, and carers, as part of a wider review of clozapine to be completed this year. They will engage with relevant stakeholders and monitor the safety of clozapine. The DHSC acknowledges the concerns and notes that the MHRA will conduct a further assessment of the information provided within the clozapine product information. They have shared the report with NICE for consideration.

Noted (AI summary) The Home Office, after consulting with the Department for Health and Social Care, believes that appropriate measures are already in place to reduce the risk of accidents involving liquid morphine and has no plans to introduce additional controls. NICE believes its existing guideline [NG46] on controlled drugs: safe use and management is sufficient, including recommendations for healthcare professionals to advise patients on safe storage and appropriate use. The MHRA will work with marketing authorisation holders to update product information for Oramorph, highlighting the need for secure storage and supervision after dilution.

Noted (AI summary) NHS England notes that the concerns raised relate to the design of medical devices and fall under the remit of the MHRA, but they have worked with the British Thoracic Society and continue to work with the Faculty for Intensive Care Medicine to develop guidance on alarm systems and breathing circuits. The MHRA states that the audible alarm system in the Philips Trilogy 202 device is based on an internationally recognised standard and that there is currently no evidence to indicate a wider safety concern. They are engaging with professional organizations to explore alarm prioritisation and have requested information from a patient safety incident database.

Noted (AI summary) 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 beyond noting existing guidance and MHRA's monitoring. 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, but does not commit to specific changes.

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.