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Non-Departmental Publication (News and Communications)
Medicines and Healthcare products Regulatory Agency

Sep. 17 2024

Source Page: MHRA launches new Strategy for Improving Safety Communications on World Patient Safety Day: Improving information to patients and healthcare professionals
Document: MHRA launches new Strategy for Improving Safety Communications on World Patient Safety Day: Improving information to patients and healthcare professionals (webpage)

Found: MHRA launches new Strategy for Improving Safety Communications on World Patient Safety Day: Improving


Select Committee
The Patients Association
NHL0108 - NHS leadership, performance and patient safety

Written Evidence Apr. 24 2024

Inquiry: NHS leadership, performance and patient safety
Inquiry Status: Closed
Committee: Health and Social Care Committee (Department: Department of Health and Social Care)

Found: NHL0108 - NHS leadership, performance and patient safety The Patients Association Written Evidence


Written Question
Patients: Safety
Friday 8th March 2024

Asked by: Jim Shannon (Democratic Unionist Party - Strangford)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, how her Department records instances of near misses for (a) surgical fires and (b) other patient safety incidences.

Answered by Maria Caulfield

Any unexpected or unintended incident which could have or did lead to harm to one or more patients can be recorded on the Learn from Patient Safety Events (LFPSE) service, to support local and national learning. This can include surgical fires or burns. We are informed that NHS England does not define the severity of harm related to surgical fires or burns specifically. Grading the severity of harm related to a patient safety incident that is recorded on LFPSE, should be done using NHS England’s guidance on recording patient safety events and levels of harm, which asks that near miss events be graded as no harm. The guidance is available at the following link:

https://www.england.nhs.uk/long-read/policy-guidance-on-recording-patient-safety-events-and-levels-of-harm/

If a surgical fire or burn is assessed locally and constitutes a patient safety event, it would fall under the scope of the Care Quality Commission’s (CQC) Regulations 16 or 18, and must be reported to the CQC. This means that the most serious surgical fires or burns which result in serious harm or the death of a service user, are subject to mandatory reporting. NHS trusts can comply with this requirement by recording patient safety events using the LFPSE service, and NHS England shares all such data with the CQC, who are responsible for regulating compliance with CQC regulations. CQC Regulations 16 and 18 are available respectively, at the following links:

https://www.cqc.org.uk/guidance-providers/regulations/regulation-16-notification-death-service-user

https://www.cqc.org.uk/guidance-providers/regulations-enforcement/regulation-18-notification-other-incidents

Although the recording of wider patient safety events onto LFPSE is a voluntary process, providers are encouraged to record all patient safety incidents, irrespective of the level of harm, to support local and national learning.

The LFPSE service and its predecessor, the National Reporting and Learning System, do not have specific categories for surgical fires or burns. Determining how many patient safety events related to surgical fires or burns were recorded by National Health Service providers in each of the last five years would require a search of the free text of recorded patient safety events, using key words, and a subsequent expert clinical review of all potential records to determine relevance to the question. This could only be provided at disproportionate cost.


Non-Departmental Publication (Policy paper)
Medicines and Healthcare products Regulatory Agency

Sep. 17 2024

Source Page: MHRA Strategy for Improving Safety Communications
Document: (PDF)

Found: MHRA Strategy for Improving Safety Communications


Departmental Publication (Research and Statistics)
Department of Health and Social Care

Jul. 23 2024

Source Page: Patient Safety Commissioner annual report 2023 to 2024
Document: (PDF)

Found: Patient Safety Commissioner annual report 2023 to 2024


Arms Length Body Publication (Guidance)
NHS England

Sep. 26 2024

Source Page: Primary care patient safety strategy
Document: Primary care patient safety strategy (webpage)

Found: Primary care patient safety strategy


Non-Departmental Publication (News and Communications)
Medicines and Healthcare products Regulatory Agency

Nov. 28 2023

Source Page: National Patient Safety Alert: Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients (NatPSA/2023/013/MHRA)
Document: National Patient Safety Alert: Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients (NatPSA/2023/013/MHRA) (PDF)

Found: National Patient Safety Alert: Valproate: organisations to prepare for new regulatory measures for oversight


Non-Departmental Publication (News and Communications)
Medicines and Healthcare products Regulatory Agency

Aug. 22 2024

Source Page: Lecanemab licensed for adult patients in the early stages of Alzheimer’s disease
Document: Lecanemab licensed for adult patients in the early stages of Alzheimer’s disease (webpage)

Found: Lecanemab licensed for adult patients in the early stages of Alzheimer’s disease


Non-Departmental Publication (Transparency)
Medicines and Healthcare products Regulatory Agency

Jul. 16 2024

Source Page: Freedom of Information responses from the MHRA: 22 January 2024
Document: (PDF)

Found: Missing information 5: Use in elderly patients with LHON Risk-benefit impact : The safety of idebenon


Written Question
Compulsorily Detained Psychiatric Patients: Death
Friday 2nd August 2024

Asked by: Lord Bradley (Labour - Life peer)

Question to the Department of Health and Social Care:

To ask His Majesty's Government what plans they have to change the way that deaths of patients detained in secure settings under the Mental Health Act 1983 are investigated.

Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)

There are currently no such plans at this time to change the way that deaths of patients detained in secure settings under the Mental Health Act 1983 are investigated.

The Mental Health Bill will deliver our manifesto commitment to modernise the Mental Health Act 1983. It will give patients greater choice, autonomy, enhanced rights and support, and ensure everyone is treated with dignity and respect throughout treatment. The Bill will make the Act fit for the 21st century, redressing the balance of power from the system to the patient and ensuring people with the most severe mental health conditions get better, more personalised, care.

The Patient Safety Incident Response Framework sets out the NHS’s approach to developing and maintaining effective systems and processes for responding to patient safety incidents for the purpose of learning and improving patient safety. The Framework became a requirement in the NHS standard contract from April 2024. Under this framework a locally-led patient safety incident investigation is required for deaths of patients detained under the Mental Health Act (1983) or where the Mental Capacity Act (2005) applies, where there is reason to think that the death may be linked to problems in care (i.e., the incident meets the “learning from deaths” criteria, the investigation explores decisions or actions as they relate to the safety event).

In addition, all deaths among people detained under the Mental Health Act 1983 are reported to the Care Quality Commission and referred to the Coroners Office.