County Durham and Darlington

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 IOPC expresses condolences and explains its role in the police complaints system. It details the recommendations made to Durham Constabulary, their response, and the IOPC's follow-up actions to seek further clarity on the acceptance of recommendations. DWP expresses condolences and states that existing guidance and support are adequate for vulnerable customers. They describe the call-back procedure followed and note that the ESA agent did not stop Ms Holmes’ benefit pending receipt of a PW1 form, indicating recognition of her vulnerabilities. TEWV acknowledges concerns and details actions taken including confirming assessment methods, developing an interim policy to address disputes between police and mental health services, and preparing a patient safety briefing on actions to take when disputes arise with partner agencies. The Police and Crime Commissioner acknowledges receipt of the report and expresses condolences. They state they have discussed the concerns with the Chief Constable, who has implemented an interim escalation policy with TEWV pending the roll-out of the national ‘Right Care Right Person’ approach. The constabulary has worked with TEWV to develop a strong partnership plan, implemented an interim escalation policy, and will train frontline officers with a national training package and local guidance.

Noted (AI summary) Durham County Council refers to its written submission to the inquest and reaffirms its commitment to suicide prevention, but provides no new information.

Noted (AI summary) The Department for Transport explains that there is no legal requirement to hold a driving licence to register a vehicle, or to become the keeper of an already registered vehicle, and outlines circumstances where this might occur.

Noted (AI summary) Humankind has implemented a standard operating procedure for prescription deliveries, including mandatory witnessed delivery and recording in the service user's notes. They have also established a contact procedure and contingency plan for failed deliveries, and record failed deliveries as incidents in their management system. Boots UK acknowledges the concerns raised and states the gravitas is duly noted.

Noted (AI summary) NICE acknowledges the correspondence but states that responsibility for the content of the BNF lies with the publishers, BMJ Group and Pharmaceutical Press, and therefore NICE cannot comment on the concerns raised. The Royal Pharmaceutical Society will add additional information regarding acute pulmonary reactions to the nitrofurantoin monograph in the BNF, specifically highlighting it in an additional section of the side-effects information, and will also add information on the importance of counselling patients on the possible symptoms of acute pulmonary reactions and the necessity of promptly reporting such symptoms. The medical group has emailed prescribing clinicians about nitrofurantoin side effects, will discuss the matter at a Significant Event Analysis Meeting, plans to provide written information to patients, and will contact the Local Medicine Management Team to suggest changes to local guidelines. The MHRA will request that Marketing Authorisation Holders strengthen the wording in the UK Summary of Product Information (SmPC) and Patient Information Leaflet (PIL) regarding pulmonary reactions to nitrofurantoin. The MHRA will also communicate any SmPC and PIL updates, to the BNF, and will communicate to UK healthcare professionals to inform them of these updates via the Drug Safety Update.