Medicines and Healthcare products Regulatory Agency

Noted (AI summary) NHS England acknowledges concerns around anaphylaxis and highlights discussions with stakeholders to improve data collection, understanding, and research. They reference the Immunology and Allergy Clinical Reference Group, specialised allergy service specifications, and initiatives by BSACI and the Royal College of Physicians. The Department of Health and Social Care acknowledges the concerns about national leadership on allergy services and capturing anaphylaxis cases. They mention that NHS England is responsible for clinical policy and strategy and highlight the establishment of an Expert Advisory Group for Allergy and the UK Fatal Anaphylaxis Registry.

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) The APA will write to the Indian High Commission to suggest a review of Indian herbal imports and will petition the Food Standards Agency to require herb labelling to display both botanical and common names. The MHRA explains its Yellow Card scheme for reporting adverse drug reactions, clarifies why a report couldn't be submitted in this case due to lack of product details, and notes other reporting routes; no changes to the scheme are proposed.

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. 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. 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. 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.

Noted (AI summary) The Department of Health and Social Care acknowledges concerns about online access to medicines and outlines existing regulations and initiatives to improve patient safety, including the Falsified Medicines Directive and Local Health and Care Record Exemplars.

Noted (AI summary) The Trust states that the care provided to Ms Davenport was appropriate. They have reviewed HDAT monitoring policy which includes ECG, Urea and electrolytes, Liver function, Prolactin, blood pressure and pulse, clinical signs of hydration, glucose regulation, review of side effects and PRN medication, but excludes monitoring blood levels.

Noted (AI summary) Cornwall Council has replaced all Nimbus mattress systems in the community with Elite systems. All Nimbus stock has been destroyed. The council states that the previous service records indicate that there is no evidence to suggest that alarm failure was an issue on the Nimbus system. The MHRA explains CE marking and post-market surveillance processes for medical devices like mattresses, noting that the incident was not reported to them. They state that without a serial number to identify the mattress, a report may be inconclusive and there is no further action that MHRA can take.

Noted (AI summary) 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 of TOE probe covers and take action if necessary.