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Responding to Patient Safety Incidents: Background

This page includes background information on the patient safety professional standards, such as why it was updated in 2024, what was updated, how it was updated, who was involved and who endorsed it.

Background

Professional standards provide a structure to support pharmacy professionals meet the regulatory standards and describe quality pharmacy services, or what ‘good’ looks like.

The RPS, Association of Pharmacy Technicians UK and Pharmacy Forum of Northern Ireland UK Professional standards for the reporting, learning, sharing, taking action and review of incidents (or error reporting professional standards) describe good practice for reporting, learning sharing, taking action and review of incidents as part of a patient safety culture. Its implementation improves patient safety and protects people who use pharmacy services. 

The standards are well used in practice; with over 1500 unique users viewing the standards on the RPS website annually. Therefore, it is essential to update these standards to include the latest legislative, regulatory, and national updates.

The revised standards ‘Patient safety professional standards – responding to patient safety incidents’ replace the 2016 version of the RPS ‘Professional standards for the reporting, learning, sharing, taking action and review of incidents’.

The original version of the standards were developed to describe good practice and systems of care for reporting, learning, sharing, taking action and review as part of a patient safety culture and to improve rates of incident reporting. They were published during a period of time when the profession was advocating for the 'decriminilisation' of dispensing errors and were part of the contribution of the RPS to enable rebalancing and a quality systems approach. Their publication followed a 2015 public consultation into pharmacy legislation on dispensing errors and standards. Legal defences to prosecution for dispensing errors were introduced in 2018. 

What are the patient safety professional standards and why are they important?

These standards:

  • Are generic and must be contextualised to reflect different areas of practice, levels of expertise and settings
  • Are not mandatory, but are developed and owned by the profession and describe quality pharmacy services or what ‘good’ looks like
  • Apply equally to anyone delivering pharmacy services (internally or outsourced in the NHS or independent sector), pharmacy professionals working in other healthcare settings and anyone working within the pharmacy in all sectors across the United Kingdom, regardless of their professional background or setting
  • Describe clear expectations and outcomes to help you demonstrate good professional practice, patient safety, systems of care and effective working practices
  • Help you to improve and develop services that are safe and put the needs of people first, including their safety and wellbeing.

Why were the standards updated?

The GPhC standards for pharmacy professional require pharmacy professionals to help people ‘maintain and improve their health, safety and wellbeing’. Their standards for the initial education and training of pharmacists states: “patient safety must come first”. Therefore, patient safety and wellbeing are an essential consideration when delivering pharmacy services. 

The refresh of the UK error reporting standards by the RPS, Association of Pharmacy Technicians UK and Pharmacy Forum of Northern Ireland was triggered automatically from the review date of the 2016 version.

The original version was mainly community-pharmacy focused, so we expanded the audience scope and setting. With an evolving pharmacy landscape and expanding roles, a review of these standards is required to ensure it is fit for purpose. 

The refresh needed to include the latest updates:

How can they be used?

Examples of good practice use can be found in the supporting resources page.

Further uses can be found in the purpose section of the standards.

Summary of changes

There have been improvements and amends to the 2024 standards including:

  • New title
  • New introduction 
  • New purpose section 
  • Updated scope section – generic scope and expanded audience, sector and setting
  • New or updated standards
  • New or updated descriptor outcomes
  • New supporting statements
  • New further information section - providing examples to support supporting statements 
  • New glossary section 
  • Updated references 
  • Updated terminology and incorporated key topics within relevant standards
  • Improved navigation with hyperlinking to glossary terms, further information sections and references 
  • Removed sections 3 and 4 and updated and integrated them into the purpose section 
  • Removed sections 5 and 6 and updated and integrated them into the supporting resources page
  • New web version of standards and PDF
  • New supporting resources page 
  • New background page.

See below for further details.

Specific section changes

Title (new)

Feedback from the consultation and steering group included providing clarity on what these standards are for and what incidents it relates to. They should be patient safety standards. In response we updated the following:

  • New title: ‘Patient safety professional standards – responding to patient safety incidents’. This was changed to:

    • Support a collection of potential further patient safety professional standards 

    • Expand the term ‘incidents’ to ‘patient safety incidents’, which includes errors

Introduction (new)

  • Covered the background of the standards, what these standards are for, how they fit with other legislation, regulatory standards, other standards, policies and procedures, and what patient safety incidents they cover

  • Described the relationship between a GPhC regulatory standard and an RPS professional standard.

  • New figure 1 – illustrates where RPS professional standards fit in relation to legislation, regulatory standards, other standards, policies and procedures. 

Purpose (new)

Feedback from the consultation and steering group included providing information on why we need the standards, why it’s important to follow them and how they can support you to protect people who use pharmacy services. In response we updated the purpose section with the following:

  • Provided clarity on why we need the standards, the importance of implementing them, patient expectations, how they can be used to protect people who use pharmacy services and how everyone is equally responsible in supporting patient safety

    • Updated and integrated section 3: ‘how patients who use pharmacy services are protected’ into the purpose

    • Updated and integrated section 4: ‘how reporting, learning, sharing, taking action and review are fundamental to patient safety’ into the purpose

    • Key themes include person-centred care, health equality and equity, patient safety culture, empowerment, service design, professionalism, leadership, skill mix, capacity, capability.

Scope

Feedback from the consultation and steering group included explaining what to record and how to use the standards. The audience needs to be defined clearly as well as roles and responsibilities of all individuals in the team.  The scope needs expanding to include changing workforce models as its currently very community focussed.  In response we updated the scope section with the following:

  • Updated and expanded scope for clarity

  • Expanded audience – who they apply to and who else they may be of interest to and how, focus on pharmacy as these are pharmacy standards

  • Expanded setting and sector – include all pharmacy services, not just community pharmacy. Applies to anyone delivering pharmacy services, pharmacy professionals working in other healthcare settings and anyone working within the pharmacy, regardless of professional background or setting

  • Expanded geographics – now focuses on all pharmacy sectors and settings across UK and Northern Ireland, not just community pharmacy

  • Added general scope of standards – they are generic standards that need to be contextualised

  • Added how to use the standards. 

The standards

  • There are now seven standards (previously six) setting the outcome and expectation for clarity and consistency of terminology

  • New – ‘reflect’ and ‘evaluate’

  • Updated – ‘be open and honest’ and ‘record and report’

  • Merged – ‘share’ and ‘learn’.

  • Seven new and updated descriptor outcomes – to provide more details and support attainment of the standard by describing what should be actively and routinely demonstrated and why

  • 37 new supporting statements – explaining how a standard and descriptor could be demonstrated 

  • These have been added in response to feedback from the consultation and steering group to provide clarity 

  • 33 new further information sections - information and examples that provide clarity and meaning to the supporting statements and to keep the supporting statements unique and in scope

  • New figure 2 – structure of the standards and an explanation on how to use them

  • New figure 3 diagram of Professional standards for responding to patient safety incidents (adapted from Community Pharmacy Patient Safety Group). We created a new diagram to incorporate the needs mentioned in the consultation.

Glossary (new)

Added new terms: ‘patient safety incident’ and ‘harm’.

References

  • Deleted previous references 1–43

  • Added new references 1–13. 

Website

  • New web and PDF version of the standards

  • New supporting resources page – includes case studies and information on what to report, who to report to and signposting to resources

  • New background page – changes made, background, why and how they were updated, development process and timeline, acknowledgements and endorsements.

Further details of changes to the standards

Reflect (new)

Feedback from the consultation and steering group included reflection as an important activity to include. In response, we updated the section with the following to provide clarity: 

Added:

  • New standard

  • New descriptor outcome 

  • New supporting statements and further information for: 1.1, 1.2, 1.3, 1.4, 1.5 and 1.6.

New key themes:

Being proactive, regular reflection, safety culture, systems, existing practice, identify gaps and learning needs, improving the delivery of safe and effective person-centred care, understanding your own and others’ roles and responsibilities, continuous professional development, work-system based factors, socio-technical systems, system-based approaches, addressing issues and concerns, developing processes and policies collaboratively, causes of errors, barriers to reporting, using existing national, local and regulatory guidelines, training, access to IT tools and systems and having resources in place, e.g., staff and time, SEIPS, risk tolerance, risk management and thematic review.

Be open and honest

Feedback from the consultation and steering group included making the outcome clearer by providing more detail, e.g., rationale, importance, what actions demonstrate that you have been open and honest, when to be honest, who needs to be honest, who you need to be honest with or how you can be honest. In response, we updated the section with the following to provide clarity:

Added:

  • Updated to include ‘open and honest’ 

  • New descriptor outcome – what should be actively and routinely demonstrated and why

  • New supporting statements and further information for: 2.1, 2.2, 2.3, 2.4, 2.5 and 2.6 – to explain how the standard and descriptor could be demonstrated and examples.

New key themes:

Be responsive, accountability, just culture, psychological safety, promoting psychological safety, duty of candour, transparency, whistleblowing, empowerment, accountability, challenging poor practice without fear, who to be open with and who to keep informed and involved, wellbeing, safety, communication needs, involving affected individuals, actively listening, providing information and support and MHRA Yellow Card self-reporting.

Review

Feedback from the consultation and steering group included making the outcome clearer by providing more detail, e.g., rationale, importance, frequency of review, reviewing impact of changes to practice/actions, review effectiveness, how to measure and monitor changes to practice, monitoring and measuring impact, analysing data, timeframes, review of procedure and service evaluation, what to review (intervention, IT systems, risk management procedures), use of tools, safety I and safety II thinking, reviewing what’s going well. In response, investigation elements were moved here and we updated the section with the following to provide clarity:

Added:

  • New descriptor outcome

  • New supporting statements and further information for: 3.1, 3.2, 3.3, 3.4, 3.5, 3.6 and 3.7.

New key themes:

Investigate in a timely manner, contributing factors, determine an appropriate response or action, gather and analyse data, systems-based, investigate, thematic reviews, system-based interventions, risks, themes, trends, patterns, behaviours, frequency, documentation, enquires, corrective or preventative measures, recommendations, audits, complaints, compliments, peer discussions, near miss logs, environment, technology, people, work systems, socio-technical systems, human factors, complex factors, incident analysis, risk identification, identify root cause, support safety interventions and learning, incident investigation tools, improvement methodologies and mechanisms, SEIPS, systems-based learning, involve others and safety I and II approach.

Report and record (new)

Feedback from the consultation and steering group included making the outcome clearer by providing more detail, e.g., rationale, importance, what what to report, when to report, how to deal with errors identified by a different organisation, who to report to, inclusion of SOPs, GDPR, collaboration, what to record. In response, we updated the section with the following to provide clarity:

Added:

  • New standard ‘report and record’ to replace ‘report’ – focuses on recording, reporting and sharing info with the right people/organisations. 

  • New descriptor outcome – what should be reported and why 

  • New supporting statements and further information for: 4.1, 4.2 and 4.3 – to explain how the standard and descriptor could be demonstrated and examples.

Added:

  • New descriptor outcome

  • New supporting statements and further information for: 4.1, 4.2 and 4.3.

New key themes:

Timely, internal, local and national reporting mechanisms, escalation, facilitate learning, record, report, information, reporting systems, secure, data protection, discussion, advice, collaboration, learning, what to report and record, good practice, culture, service quality, who you involved, generate new ideas, motivation to report and how to deal with errors identified by a different organisation.

Act

Feedback from the consultation and steering group included making the outcome clearer by providing more detail, e.g., rationale, importance, who should action, what to action, assessing reactive and proactive response, reviewing systems, strengthening systems, sustainable changes and follow up. In response, we updated the section with the following to provide clarity:

Added:

  • New descriptor outcome – what action to take and why

  • New supporting statements and further information for: 5.1, 5.2, 5.3, 5.4, 5.5, 5.6 and 5.7.

New key themes:

Timely, manage risk, quality of practice, systems of care, e-Systems, sustainability, addressing contributory factors, system weaknesses, latent hazards, systems-based approach, risk-management approach, understand why the incident occurred, develop, reactive, proactive, corrective measures, preventative measures, measure impact, monitor effectiveness, interventions, data collection tools, improvement methodologies, behaviours, implement learning, feedback, acknowledge good practice, support, design, collaborate to identify needs, test, roles and responsibilities, required response, strengthen, improve, system changes, follow up and minimising risk.

Share learning (new)

Feedback from the consultation and steering group included making the outcome for ‘learn’ and ‘share’ clearer by providing more detail, e.g., rationale, importance, aligning with new patient safety incident response framework recommendations, include what to learn from, who to learn from and why, creating an inclusive learning culture and allocating time for learning. Include how to share, what to share, timeframes of sharing, who to share with and creating a sharing culture and its benefits. Investigate should be a separate and should include involving the patient and what to investigate (e.g. contributory factors/causes, patterns and themes). In response, investigation elements were moved to standard ‘Review’ which focuses on what to investigate and analyse. We updated the section with the following to provide clarity: 

Added:

  • New standard ‘Share learning’ to replace ‘share’ and ‘learn’ – merged ‘share’ and ‘learn’ due to overlap

  • New descriptor outcome – what learning should be shared, with who and why

  • New supporting statements and further information for: 6.1, 6.2, 6.3 and 6.4 – to explain how the standard and descriptor could be demonstrated and examples.

New key themes:

Share appropriate learning, who to share with, how to share, why share, learning culture and environment, sharing mechanisms, cascade internally, locally and nationally, benefit and impact of recording, reporting, learning, sharing or acting, learn together, professional, clinical and legal responsibilities, learning from incidents, learning from others, learning to inform improvement, learning from near misses, prevention better, networks, communications, what to share, what went well and what went wrong, inclusive of other professionals and cascade. 

Evaluate (new)

Feedback from the consultation and steering group included separating activities of evaluation and review. In response, we updated the section with the following to provide clarity: 

Added:

  • New standard

  • New descriptor outcome

  • New supporting statements and further information for: 7.1, 7.2, 7.3, 7.4 and 7.5.

Added:

  • New descriptor outcome

  • New supporting statements and further information for: 7.1, 7.2, 7.3, 7.4 and 7.5

New key themes:

Regularly evaluate systems, interventions and changes made, assess outcomes, follow up, appropriate timeframe, appropriate intervals, interpret data, assess impact and effectiveness, risk management approach, have outcomes been met, new interventions identified, assess current systems, IT systems, update, risk management procedures, safety management, what is going well and what could be improved, prescribing and management systems.

How patients who use pharmacy services are protected 

Feedback from the consultation indicated this section was useful and relevant. However, it doesn’t describe an outcome and is not clear how it relates to incidents specifically. 

In response to the feedback, this section was removed, updated and included in the ‘introduction and purpose’ section. 

How reporting, learning, sharing, taking action and review are fundamental to patient safety

Feedback from the consultation indicated clarity was needed on the purpose of this section, it was missing elements, e.g., reflection, timeframes, a focus on patient safety, patient-centred care and joint working with the MDT. 

In response to the feedback, the section was removed, updated and included in the ‘purpose’ section. The Report, Learn, Share, Act, Review (RLSAR) wheel was removed as it was out of date and mainly community pharmacy focused. We created new standards and a new diagram incorporate the needs mentioned in the consultation.

What to report and who to report to

Feedback from the consultation suggested moving this level of detail out of the standards and to include addition organisations to report to including Learn from Patient Safety Events, medication safety officer networks, CD local intelligence network, CD accountable officers (via CD Reporting). Inclusion of following employers’/organisations procedures and policies for reporting, sharing errors identified from elsewhere, and where pharmacy teams within general practice/primary care should report. 

In response to the feedback, the section was removed, updated and moved to a supporting resource page as it wasn’t within the scope of the standards and more about supporting implementation of the standards. 

What stops pharmacy teams from reporting, learning, sharing and taking action 

Feedback from the consultation indicated this section was helpful, useful and important as it clearly explains hesitation to report. There are good examples of issues around non-reporting and excellent descriptions of what needs to be in place to counter these. Improvements included emphasising the benefits of reporting errors and adopting language that is supportive and enabling rather than negative/defensive/blaming. 

In response to the feedback, the section was updated and moved to a supporting resource page as it wasn’t within the scope of the standards and more about supporting implementation of the standards. It was retitled ‘Ways to encourage a patient safety culture in the workplace – including a just, open, reporting and learning culture’ to make it more supportive and promote a safety culture.

How the standards were updated

Multi-disciplinary engagement – steering group

An expert steering group was recruited to provide strategic oversight in the update. 25 patient safety experts from different sectors and settings were invited to join from across the UK. A 6-week public consultation also informed the update. We also asked expert patients and patient groups to provide feedback. The group used a consensus process to review and update the standards.

The group, chaired by Jan Yogini, included representatives from professional regulators, professional organisations, lay people and other relevant and interested stakeholder groups.

The review consisted of four virtual discussions over 12 months aligned to key milestones (see timeline below). Meetings kept members of the group informed about progress and stimulated discussion about improvements to the standards, any supporting resources needed and how the standards might be promoted once published. 

The group discussed the proposed changes by RPS and provided strategic oversight in the update of the standards to ensure the standards are still current, in scope and fit for purpose.

The group used a consensus process to review and update the standards in the open consultation.

The multidisciplinary nature of the group ensured the generic nature of the standards was maintained. The group ensured that changes were in line with current practice and were understandable to users.

For further information on the members of the steering group, please see the acknowledgments.

Consultation

A six week public consultation ran from 21 April 2023 until 2 June 2023 to inform the update of the UK Error Reporting Standards, in collaboration with the expert steering group. 

The steering group designed the questions, and it was disseminated through the RPS website and networks. There were 17 questions on how the standards can be more current, within scope and fit for purpose.. Feedback was provided on what was missing and what needed updating or deleting. There were 48 responses to the consultation (11 from organisations and 37 from individuals). Results were analysed and comments from the consultation were reviewed by the steering group. Those that were in scope and relevant were incorporated into the standards. Those that were not in scope but supported the implementation of the standards were used to create a supporting resources page that can be updated as required. Results were analysed using text and descriptive analysis. The group used a consensus process to agree all final amendments to the standards.

In general, there was positive feedback that the standards were clear, concise and easy to read. They also relate back to GPhC pharmacy standards. Feedback indicated use of the standards depends on individual roles. They are mainly used by organisations to support learning, training, encouraging reporting and providing feedback. They are used to align local reporting and medication safety policies. This demonstrates the continued need for patient safety and error reporting standards to support practice and patient safety. However, they need to be improved with supporting resources and clarity on what is expected and of whom e.g. roles and responsibilities. Clarity was requested around expectations and outcomes that demonstrate good professional practice, patient safety, systems of care and effective working practices. Case studies and examples of good practice of what could to be done to achieve each standard, i.e., what ‘good’ looks like was also requested. Separating guidance from standards was requested. Current terminology and key themes were identified for inclusion and mentioned under the summary of changes. There were many resources recommended to support use of the standards which can be found under supporting resources.

For further information on the updates and changes made, please see the summary of changes.

Development process and timeline

February 2023 – the steering group was assembled.

March 2023 – steering group meeting 1. A scoping session to review scope and purpose, discuss the open consultation, horizon scan key developments and topics to include. Group agreed on the update approach.

May – June 2023 – the open consultation (six weeks) launched to explore views, usage, experience and appropriateness of standards.

July – August 2023 – the consultation was analysed, and comments incorporated into first draft.

August – September 2023 – drafting and reviewing standards and supporting resources page.

October 2023 – meeting 2 and 3. Discussed consultation outcome and reviewed and discussed the draft standards section by section, as well as supporting resources.

November 2023 – final testing and shared draft with expert patients and patient groups for comment.

January 2024 – standards finalised, endorsements requested and draft sent to designers.

February 2024 – updated website and launch and promotion planned.

April 2024 – standards published on the RPS website.

Supporting resources 

In response to the consultation feedback and to support the uptake of the standards, we have produced a supporting resources page with the following:

  • What patient safety incidents to record and report
  • How to deal with patient safety incidents identified by another organisation
  • Resources to help you understand the standards
  • Where to report patient safety incidents 
  • Ways to encourage a patient safety culture in the workplace — including a just, open, reporting and learning culture
  • Sharing best practice – case studies and examples 
  • Further supporting links and resources. This page is open access.

For further information on the supporting resources please see the devoted page.

Who updated the standards? – Acknowledgments 

Steering group 

Name

Role

Organisation

Yogini Jani

Director 

Chair of steering group

Centre for Medicines Optimisation Research and Education, UCLH NHS Foundation Trust

Anna Bischler

Associate Director

Specialist Pharmacy Service

Paul Bowie

Programme Director (Safety & Improvement)

NHS Education for Scotland

Angela Carrington

Lead Pharmacist for Medication Safety, Northern Ireland

Health and Social Care, Northern Ireland

David Clark

Deputy Regional Manager

General Pharmaceutical Council

Stuart Evans

Lead Cancer Pharmacist

Swansea Bay University Health Board

Julie Greenfield

Pharmacy Forum Manager

Pharmacy Forum NI

Susan Gibert

Director of Customer Experience

Sciensus Pharma

Shalini Gujral

Chief Pharmacist

One Healthcare

Karen Harrowing

Pharmacist/Independent Advisor

Self- employed/Independent Sector

Scott Hill

National Clinical Lead – Area Drug and Therapeutics Committee Collaborative

Healthcare Improvement Scotland

Mitul Jadeja

Specialist, Safety & Surveillance

Medicines and Healthcare products Regulatory Agency (MHRA)

Lynette James

All Wales Consultant Pharmacist – Acute Care and Medication Safety

NHS Wales

Emma Kirk

Medication Safety Officer Network Lead, Specialist Pharmacist: Lead Medication Safety

NHS Specialist Pharmacy Service

Graeme Kirkpatrick

Head of Patient Safety (Advice & Guidance)

NHS England

Alun Kurmaully

Practice Pharmacist

Ty Elli Practice Group, Llanelli

Pauline Lockey

Patient Safety Clinical Lead (Medication Safety)

NHS England

Amanda McLean

Specialist Quality Governance and Risk Pharmacist

NHS Lothian

Ngozi Onyele

CQC Pharmacist Specialist

Care Quality Commission

Janice Perkins

Chair x2

RPS Community Pharmacy Expert Advisory Group

ommunity Pharmacy Greater Manchester

Matthew Prior

Deputy Director of Pharmacy    

University Hospitals Coventry and Warwickshire

Sue Renn

Principal Pharmacist – Technical Services

Hull University Teaching Hospitals NHS Trust also representing NHS Pharmaceutical Aseptic Services Group

Steve Simmonds

Contractor Services Development Executive

Community Pharmacy Wales

Nicola Stockmann

Vice President

Association of Pharmacy Technicians UK (APTUK)

Katrina Worthington

Regulations Officer

Community Pharmacy England

 

We would also like to thank the following for their contribution:

RPS staff:

  • Sharon Brennan
    Director of Policy and External Affairs, National Voices
  • Mr Andrew Payne
    Lay representative
  • Consultation respondents – The individuals and organisations who provided feedback during the open consultation
  • Scottish Pharmacy Quality Assurance Group.
  • Regina Ahmed (Lead Author)
    Guidance Manager and Pharmacist Prescriber
  • Wing Tang
    Head of Professional Support and Guidance
  • Caitlin O'Sullivan
    Content editor
  • Nick Hard
    Planning Unit.

Who endorsed the standards?

The standards have been endorsed by the following: 

RPS-500APTUKPharmacy-forum

We will continue to publish and maintain the standards in collaboration with these and other organisations.