Healthcare professionals delivering the medication safety agenda in their organisation require an understanding of national policy, frameworks and legislation

NHS Patient Safety Strategy

Medication Safety Officers (MSOs), those working in an equivalent role or individuals with a responsibility for delivering the medication safety agenda within an organisation, should be aware of the NHS Patient Safety Strategy which details what the NHS plans to do to achieve its vision of continuously improving patient safety.  An awareness of the strategy will help individuals understand where medication safety sits within the NHS plans for future work and initiatives.

National Patient Safety Improvement Programmes

National Patient Safety Improvement Programmes (SIPs) are a key part of the NHS Patient Safety Strategy. There are five programmes which includes the Medicines Safety Improvement Programme (MedSIP).  An awareness of the patient safety improvement programmes will help individuals understand how MedSIP aims to deliver safety and quality improvements related to national/regional medication safety agendas and local safety priorities.

Medicines Safety Improvement Programme (MedSIP)

The MedSIP programme aims to address the most important causes of severe harm associated with medicines which continue to challenge the health and care system in England.  Individuals would be expected to be aware of the programme, align relevant local/regional medication safety initiatives with the programme and contribute, where possible, to MedSIP consultations and discussions.  The lead for the MedSIP programme regularly consults with the MSO network and provides communication updates at the MSO network monthly webinar.

The MedSIP FutureNHS workspace offers resources to support understanding of the programme.

Patient Safety Incident Response Framework (PSIRF)

An MSO (or equivalent) is expected to work with other professionals within their organisation to regularly review and manage medication incidents, improve reporting and learning and take action to improve safety.  An understanding of the Patient Safety Incident Response Framework (PSIRF) will support this.

To support the NHS strategy the Patient Safety Incident Response Framework (PSIRF) outlines how providers should respond to patient safety incidents and how and when a patient safety investigation should be conducted.  This framework replaces the Serious Incident Framework (2015) and requires organisations to transition to the PSIRF framework.  This transition will be over a period of time as it requires work to design a new set of systems and processes within the organisation.  It is expected that all organisations will complete their transition to the PSIRF framework by Autumn 2023.

MSOs (or equivalent) will be expected to be aware of the status of PSIRF transition in their organisation and be prepared to work collaboratively with their organisation’s patient safety specialist, as required, to support the framework.

Further resources (including webinars, podcasts and additional tools) to support individuals in understanding their role in supporting their organisation’s work within PSIRF is available on the PSIRF FutureNHS workspace.

Never Events (NE) policy and framework

Never Events are serious incidents that are entirely preventable.  Guidance or safety recommendations providing strong systematic protective barriers are available at a national level and should have been implemented by all healthcare providers.

MSOs (or equivalent) and medication safety leads are expected to be aware of the Never Events policy and framework and to be able to recognise incidents that occur within their organisation which meet the criteria for classification as a Never Event.  An MSO (or equivalent) would be expected to be aware of escalation procedures within their local organisation for incidents identified as a confirmed or suspected Never Event.

Duty of Candour

An MSO (or equivalent) must understand their responsibility with respect to duty of candour and are responsible for sharing that information with their team(s) and other healthcare professionals working in their organisation who may be involved in handling medication related incidents.

The duty of candour regulation ensures that providers are open and transparent with the people who use their services. It sets out some specific requirements providers must follow when things go wrong with care and treatment, including informing people about the incident, giving reasonable support, providing truthful information and an apology when things go wrong.

A short animation from NHS Resolution provides guidance on the importance of being open and honest and is a useful resource to share with colleagues to help their understanding of the similarities and differences that exist between the professional and statutory duties of candour.

Care Quality Commission (CQC)

The CQC is the independent regulator of health and adult social care in England. The CQC monitor, inspect and regulate services.

The CQC publish reports on care in England using intelligence from inspections in additional to engagement with organisations and the public.  An MSO (or equivalent) or individuals with a responsibility for delivering the medication safety agenda within an organisation, should have an awareness of these publications which may be helpful in setting local medication safety priorities.

The CQC monitor and inspect using a set of fundamental standards of care.  An MSO (or equivalent) or individuals with a responsibility for setting and delivering the medication safety agenda within an organisation, should be aware of all standards relevant to the use of medicines to ensure alignment.  The proper and safe use of medicines is covered under regulation 12 – Safe care and treatment.

Key lines of enquiry (KLOEs) are used by the CQC as part of the inspection process.  These serve as prompts and sources of evidence to help the inspectors to answer the five key questions: is the service safe, effective, caring, responsive and well-led.  Awareness of these KLOEs assist an MSO (or equivalent) or individuals with a responsibility for setting and delivering the medication safety agenda to assess the medication safety culture within the organisation and identify of areas for safety improvement.

Preparing for a CQC inspection

MSOs (or equivalent) and individuals with a responsibility for delivering the medication safety agenda within an organisation may be asked to support managers in preparing for CQC visits and/or be invited to engagement meetings within the organisation. These individuals should be aware of CQC KLOE’s related to medication safety and be prepared to provide assurances that the organisation meets the CQC standards.