This was published when the organisation was the Royal Pharmaceutical Society.

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This page will be updated when needed, so make sure you refer to this every time you use the standards.

Remember, you’ll need to use your professional judgement for individual scenarios. 

What patient safety incidents to report and record

Recording and reporting patient safety incidents supports learning. The definition of the term ‘patient safety incidents’ used in this guide can be found in the patient safety standards.

We encourage you to record and report all patient safety incidents as good practice through recognised systems. However, use your professional judgement for individual scenarios. Find out more about using your professional judgment.

You should record patient safety incidents following internal procedures appropriate for the organisation, sector and setting. 

However, you may need to escalate certain patient safety incidents and report these as appropriate. This may involve duplication. Reporting requirements should be based on internal, local procedures or national requirements. If in doubt, report it.

The following should be determined internally through individual risk assessments and covered in your internal/organisational policies and standard operating procedures (SOPs) appropriate for the organisation and setting.

• What to record and report, and how
• When to escalate and report, and where, i.e., to regions/head office/other providers/Trusts/local NHS organisations/recognised national reporting routes
• Who is responsible for what, and who can report/record, e.g., superintendent/chief pharmacist are responsible for agreeing the organisational policy and process to ensure regulatory and professional standards are met, and for deciding roles and responsibilities within their teams.

How to deal with patient safety incidents identified by another organisation

Where errors are identified from other organisations, you should follow your own processes and attempt to inform the original organisation of the incident. 

Where to report patient safety incidents 

The table below shows where to report patient safety incidents across England, Scotland, Wales and Northern Ireland (where applicable).

Your internal and local policies should cover exactly who you need to report to for your setting.

You may need to escalate some incidents, i.e., to regions/head office/other providers/Trusts/ local NHS organisations/regulator/Medicines and Healthcare products Regulatory Agency (MHRA). This should be determined locally and individually through risk assessments and covered in your internal SOPs. SOPs could cover processes like how to complete company-mandated reporting systems and how to inform the people you work with (i.e., your immediate team, line manager, medication safety officer (MSO), superintendent/owner, clinical governance lead or local NHS organisation) where relevant.

Some incidents may need to be additionally reported to specific reporting schemes. For further information, see the section on additional reporting.

Who to report to

England

Registered pharmacy or GP practices	• Internal systems and processes* • NHS Learn from patient safety events (LFPSE) (via  local risk management systems (LRMS) or direct as appropriate) (NHS England website) • Care Quality Commission (CQC)** (CQC website).
NHS hospital or NHS healthcare organisation	• LRMS (NHS England website) and uploaded to LFPSE • CQC** (CQC website).
Independent sector hospital	• Internal systems and processes* • Private Healthcare Information Network (PHIN)*** (see our data section on the PHIN website) • CQC** (CQC website) • LFPSE (via LRMS or direct as appropriate) when providing NHS funded care.

Scotland

Local reporting systems with a focus on quality improvement and learning are promoted in Scotland. The Healthcare Improvement Scotland Adverse Events National Framework on the Healthcare Improvement Scotland website provides useful context.

Registered pharmacy or GP practices	• Internal systems and processes*  • National Services Scotland.
NHS hospital or NHS healthcare organisation	• Internal systems and processes* • National Services Scotland.****
Independent sector hospital	• Internal systems and processes* • Healthcare Improvement Scotland website.

Wales

Registered pharmacy or GP practices	• Internal systems and processes* • Once for Wales Concerns Management System (NHS Wales website).
NHS hospital or NHS healthcare organisation	• Internal systems and processes* • Once for Wales Concerns Management System (NHS Wales website) • Health Inspectorate Wales (HIW) (HIW website).
Independent sector hospital	• Internal systems and processes* • HIW (HIW website).

Northern Ireland

Registered pharmacy or GP practices	• Internal systems and processes* • Department of Health/Strategic Planning and Performance Group (SPPG) (Health and Social Care (HSC) website).
NHS hospital or NHS healthcare organisation	• Internal systems and processes* and local risk management systems • Northern Ireland Adverse Incident Centre (NIAIC) for incidents involving medical devices  • Incidents that meet the criteria of a Serious Adverse Incident (SAI) are currently reported to SPPG in line with regional SAI procedure*****
Independent sector hospital	• Internal systems and processes* • The Regulation and Quality Improvement Authority • NIAIC for incidents involving medical devices.

Record the following via the MHRA Yellow Card Scheme (MHRA website) or via the Yellow Card app:

• Suspected adverse drug reactions****** from taking medicines and vaccines
• Adverse incidents involving medical devices
• Defective and counterfeit products
• Adverse incidents involving e-cigarettes and their refill containers (e-liquids). You can also report suspected side effects where harm occurs as a result of a medication error.

In England, suspected adverse drug reactions where harm occurs as a result of a medication error are reportable as a Yellow Card or to LFPSE (via LRMS). If reported to the LFPSE, these will be shared with the MHRA. If LFPSE is not available and harm occurs, report using a Yellow Card.

See the MHRA website for further information.

There are specific reporting arrangements for reporting medical device incidents in each of the four nations:

• In England and Wales, to the Yellow Card scheme or via the Yellow Card app
• In Scotland, to Health Facilities Scotland online incident reporting system and your local incident recording system
• In Northern Ireland, to NIAIC and your local incident recording system.

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*Internal systems and processes include following SOPs and event reporting policy within your own organisation.

**Registered providers carrying out regulated activities are to notify CQC when a medicines safety incident/error causes or is related to these statutory notifiable incidents or events; allegation of abuse, death of a person using the service, incident reported to/investigated by the police, serious injury to a person using the service. For further information, see the CQC website on notifications: guidance to providers. 

***Only Serious Incidents Never Events need to be reported to PHIN.

****Report adverse incidents and near-misses involving medical devices, in vitro diagnostic medical devices and personal protective equipment.

*****A programme to redesign the current SAI Procedure is progressing, which could result in changes to the current reporting process. 

******Report all suspected adverse drug reactions that are:

• Serious, medically significant or result in harm. Serious events are fatal, life-threatening, a congenital abnormality, disabling or incapacitating, or resulting in hospitalisation
• Associated with newer drugs and vaccines (▼); the most up-to-date list of black triangle medicines is available at: www.mhra.gov.uk/blacktriangle (see newer drugs and vaccines).

If in doubt whether to report a suspected adverse drug reaction, please complete a Yellow Card.

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Additional reporting

While all incidents should be reported through recognised national reporting routes (as above), some incidents should also be reported to specific reporting schemes below:

Controlled drugs (CDs)

If CDs are involved, you should also report this to your local CD accountable officer (CDAO) through the NHS controlled drug reporting site. You should also contact your local CDAO, CD local intelligence network (LIN) and CD liaison officer (CDLO) (where appropriate) below:

• Care Quality Commission Register of accountable officers in England
• Healthcare Improvement Scotland Register of Controlled Drugs Accountable Officers (Scotland)
• HIW Accountable Officers of Controlled Drugs (Wales)
• Department of Health (DoH) Accountable Officer (Northern Ireland).

If an incident such as CD theft, diversions, loss or fraud is a contributory factor that results in a patient safety incident, you should report it as a patient safety incident in addition to the following (where appropriate):

• Home Office Controlled drugs: thefts or losses form – form to submit to the Home Office after theft or loss of CDs
• Association of Police Controlled Drugs Liaison Officers (APCDLO) – specifically address offenses related to CDs and their safe management, e.g., fraud.

Aseptic preparation services 

The NHS Pharmaceutical Aseptic Services Group (PASG) operate a national scheme (open across the UK) to record errors occurring within aseptic preparation. Registered users can use an online error reporting portal. See the PASG website for further information.  

Unlicensed aseptic units can also refer to the RCPharm Quality Assurance of Aseptic Preparation Services standards.  

Radiopharmaceuticals 

Adverse reactions and defective radiopharmaceuticals should be reported to the UK Radiopharmacy Group. See the British Nuclear Medicine Society website for further information.

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Resources to help you understand the standards 

Here are some signposting links for further reading on patient safety topics. Please note: Access to RCPharm resources will require member log in.

Standard 1: Reflect

Knowledge and understanding – continuing professional development (CPD) and training

• e-learning for healthcare NHS Patient Safety Syllabus training programme – courses on patient safety
• GPhC Pharmacy team toolkit – learning from incidents – case studies and examples on how pharmacy teams have learned from incidents, to improve patient safety outcomes and minimise the risk of these happening again. All pharmacy teams are urged to use the toolkit to promote learning and reflection during pharmacy team meetings or other discussions
• Health Services Safety Investigations Body (HSSIB) Education – patient safety education programmes for those in health and social care settings (England)
• MHRA Drug Safety Update – helping you stay up to date with the latest emerging safety information on medicines 
• MHRA e-learning modules – Centre for Pharmacy Postgraduate Education (CPPE) e-learning modules helping pharmacists understand how to identify, report and prevent adverse drug reactions 
• NHS England National patient safety – syllabus training for all NHS employees to help ensure health and care services are as safe as possible for patients and service users
• NHS Professionals Patient Safety Courses – courses on Duty of Candour and Being Open Principles, Incident Response, Complex Systems and Systems Thinking, Human Factors, Just Culture, Patient Safety Incident Response 
• NHS Resolution Faculty of Learning – learning modules on responding to harm for staff, patients and their families
• RCPharm CPD – pharmacy guide on how to complete continuing professional development entries
• RCPharm reflective account – pharmacy guide on how to reflect 
• See national patient safety guidance – for information on patient safety.

Safety culture and systems – work system-based factors and approaches (or socio-technical systems) 

• NHS England systems engineering initiative for patient safety (SEIPS) quick reference guide and work system explorer – guide on work system-based factors and approaches, and socio-technical systems
• NHS England Safety culture: learning from best practice – themes and good practice ideas within the NHS patient safety strategy
• TURAS Learn Human Factors Hub – includes safety culture discussion cards
• See ways to encourage a patient safety culture in the workplace – find out ways to address issues and concerns.

Standard 2: Be open and honest

Duty of candour

• CQC Duty of candour: notifiable safety incidents – guidance and examples on what you must do when you discover a notifiable safety incident and Regulation 20
• GPhC Joint statement on the professional duty of candour – professional obligations of pharmacists and pharmacy technicians
• GPhC resources on the professional duty of candour – including keeping patients safe, being open and honest and the pharmacy team toolkit learning from incidents 
• GPhC Pharmacy team toolkit – learning from incidents – case studies and examples relating to duty of candour 
• NHS Professionals Patient Safety Courses – courses on duty of candour and being open principles 
• Welsh Government The NHS Duty of Candour – legal requirement for all NHS organisations in Wales.

Just culture and psychological safety

• NHS Education for Scotland (NES) Turas Learn Safety Culture Discussion Cards – helping teams to think and talk about our safety culture to understand what we do well and where we need to improve
• NHS England Being fair tool – encourages managers to treat staff involved in a patient safety incident in a consistent, constructive and fair way
• NHS England Patient safety culture – guides on improving patient safety culture, psychological safety and a just culture (being fair)
• NHS England Safety culture: learning from best practice – best practice examples
• NHS Faculty of Learning – resources on supporting a just and learning culture for staff and patients following incidents in the NHS
• NHS Professionals Patient Safety Courses – courses on just culture
• RCPharm MEP – see section 2.5.1 Getting the culture right and 2.5.2 Culture and patient safety incidents
• RCPharm professional judgement – pharmacy guide to break the process down into smaller steps
• See ways to encourage a patient safety culture in the workplace – find out ways to address issues and concerns.

Raising concerns 

• GPhC Reporting concerns – guidance on raising concerns about poor practice when patients and the public are at risk, concerns about pharmacies and individual pharmacists and pharmacy technicians relating to patient safety
• National Guardian’s Office ‘Freedom to Speak Up Guardians’ – supports workers to speak up when they feel that they are unable to 
• NHS Resolution – resolves concerns and disputes fairly, and shares learning for improvement 
• Pharmacist Support – an independent charity supporting pharmacists and their families, former pharmacists, trainee pharmacists and pharmacy students and that provides free and confidential support services
• RCPharm raising concerns and whistleblowing – pharmacy guide about raising concerns, including why it’s important, how to raise a concern and signposting to further information
• You could speak to your union or trade bodies for support
• See ways to encourage a patient safety culture in the workplace.

Communicating and supporting discussions with patients and the public

• NHS England Engaging and involving patients, families and staff following a patient safety incident – sets out expectations for how organisations should engage with all those affected by patient safety incidents, alongside PSIRF
• Patient Safety Commissioner – a patient group that promotes patients’ voices and patient safety in relation to medicines and medical devices 
• NHS Resolution Saying sorry leaflet – helps you say sorry meaningfully to those affected by an incident when things go wrong
• NHS Education for Scotland Turas Learn Safety Culture Discussion Cards – helps you to think and talk about safety culture to understand what is done well and where improvement is needed.

Standard 3: Review

Investigation and improvement methodologies

• CPPE patient safety training – supports the investigation process and improvement methodologies
• Patient safety learning the hub – supports the investigation process and improvement methodologies
• RCPharm clinical audit guide – includes how to complete audits
• RCPharm errors and near misses guide – includes near-miss error logs
• RCPharm peer discussion guide – includes how to do a peer discussion.

Human factors and work system-based factors (or socio-technical systems) 

• Health Education England Patient Safety
• NHS England Introduction to SEIPS NHS England Patient Safety Learning Response Toolkit – includes SEIPS framework
• NHS England SEIPS quick reference guide and work system explorer – guide on work system-based factors and approaches, and socio-technical systems
• NHS Professionals Patient Safety Courses – courses on complex systems and systems thinking, human factors and patient safety incident responses 
• The Chartered Institute of Ergonomics and Human Factors (CIEHF) – includes nine principles that organisations can apply to capture the human contribution to adverse events
• TURAS Learn Human Factors Hub – includes human factor tools
• RCPharm webinar: Exploring Human Factors: Truths, Myths and Practical Insights
• RCPharm webinar: Exploring Human Factors 2: Connecting safer work practices across care boundaries – benefits of a systems approach
• RCPharm webinar: Exploring Human Factors 3: Designing systems to enhance medication safety
• RCPharm webinar: Exploring Human Factors 4: Learning from patient safety investigations – greater improvement using human factors.

Safety-I and safety-II

• Hollnagel E., et al (2015). From Safety-I to Safety-II: A White Paper. Available on the NHS website
• Q blog post by the Health Foundation: Turning Safety-II thinking into action 
• NHS England The NHS Patient Safety Strategy – includes a video on the concept of Safety II and the importance of also looking at why things routinely go right in healthcare.

Thematic review

• NHS England Thinking thematically: top tips for completing a thematic review – guide on thematic review
• Specialist Pharmacy Service (SPS) Thematic analysis – thematic review templates and examples.  

Standard 4: Record and report

Reporting and recording

• RCPharm clinical documentation – pharmacy guide on what you could document
• RCPharm errors and near misses – pharmacy guide that includes near-miss error logs
• See where to report patient safety incidents – for what to report and where to report
• See sharing best practice – for case studies on sharing, learning and the benefits 
• See ways to encourage a patient safety culture in the workplace – how to create a learning culture 
• See national patient safety guidance for information on reporting.

Standard 5: Act

• NHS England SEIPS quick reference guide and work system explorer – guide on work system-based factors and approaches, socio-technical systems

Standard 6: Share learning

Case studies and examples

• GPhC knowledge hub website – for notable practice for inspection examples
• GPhC Pharmacy team toolkit – learning from incidents – case studies and examples on how pharmacy teams have learned from incidents, improved patient safety outcomes and minimised the risk of these happening again. All pharmacy teams are urged to use the toolkit to prompt learning and reflection during pharmacy team meetings or other discussions
• MHRA interactive Drug Analysis Profiles (iDAPs) – information on what’s been reported to the Yellow Card scheme 
• NHS England Patient safety review and response case studies by clinical speciality – case studies highlighting the importance of recording patient safety events
• RCPharm errors and near misses guide – pharmacy guide includes near-miss logs 
• See sharing best practice – for your examples of sharing learning.

Networks and contacts – for support and sharing your learning

• Community Pharmacy Patient Safety Group – forum for community pharmacy organisations to share and learn from each other when things go wrong
• HSSIB (England) – carry out independent patient safety investigations across the NHS in England and in independent healthcare settings where safety learning could help to improve NHS care
• Integrated care system (ICS) (England) – including integrated care partnerships (ICPs), integrated care boards (ICBs) and local authorities
• Medical device safety officer (MDSO) (England) – see National Association of Medical Device Educators and Trainers website 
• MSO (England) – see SPS website or email [email protected]
• NHS Education for Scotland The Knowledge Network – share learning nationally from adverse events
• NHS Resolution – resolving concerns and disputes fairly and sharing learning for improvement 
• Patient Safety Learning The Hub – online learning platform that encourages and facilitates knowledge sharing, collaboration and conversation about patient safety across the whole of health and social care
• Patient safety specialists (England) – see NHS England website or email [email protected]
• Private Healthcare Information Network – independent, government-mandated organisation about private hospitals
• Public Health Agency Health and Social Care (HSC) safety forum (Northern Ireland) – support HSC organisations as they strive to provide safe, high-quality care
• Northern Ireland Adverse Incident Centre (NIAIC) (Northern Ireland) – regional centre for the voluntary reporting and investigation of adverse incidents involving medical devices, non-medical equipment, and providing relevant safety guidance
• Health and Social Care Quality Improvement (HSCQI) Alliance – network that provides a supporting infrastructure for quality, improvement and innovation across the NI HSC system.

Standard 7: Evaluate

Evaluation

• NHS England Patient Safety Incident Response Framework (PSIRF) – includes the learning response toolkit
• RCPharm research and evaluation guides – includes how to evaluate and improve existing services’ quality.

Risk management 

• The International Organization for Standardization (ISO) 31000:2018 Risk management Guidelines – global standards on identifying, analysing, evaluating, treating, monitoring and communicating risks across an organisation
• ISO 31073:2022 Risk management vocabulary – definitions of terms used in ISO related to risk management, such as risk appetite and risk tolerance.

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Ways to encourage a patient safety culture in the workplace, including a just, open, reporting and learning culture

Getting the culture right is a ‘just culture’. It is based upon the principles of fairness, quality, transparency, reporting, learning and safety. It is achieved when just culture principles are embedded into attitudes, behaviours and practices, and the design of legislation, regulation, standards, policies and systems. 

A just culture promotes an open culture (transparency and discussion), a reporting culture (raising concerns) and a learning culture (learning from incidents). It also creates a just and open working environment that is rewarding to work in, fosters professional empowerment, and enhances the quality of service to patients and the patient experience. These cultures support each other to create a safety culture – balancing accountability, learning and leading to improved patient safety. 

A just culture means removing fears, increasing sharing and reporting of concerns, being able to learn from incidents, being able to share lessons learnt (throughout the profession where appropriate) and using this shared learning to reduce the likelihood of similar incidents happening again, contributing to better patient safety. Individuals will only report concerns if they feel they will not be victimised and that it is ‘safe’ to report these concerns. 

To provide assurance and confidence, everybody needs to know where they stand. We all have responsibilities for living the culture and embedding the habit. Individuals and organisations can do this through strong leadership and educating people about a just and safe culture. It is a continuous and evolving movement, and may take years to achieve. Further information on culture and patient safety incidents can be found in section 2.5.2 in the MEP.

The information below summarises some ways to encourage a just and safety culture in the workplace. However, some suggestions cannot be implemented by those delivering pharmacy services alone and may need help from government, regulators, commissioners of pharmacy services, pharmacy leadership teams, pharmacy employers, NHS organisations, pharmacy and healthcare organisations or patient safety networks. 

Ensure sufficient resources by:

• Acknowledging human factors principles by employing organisations 
• Designing and improving reporting, learning and sharing systems to make them as easy as possible for pharmacy teams to use
• Making use of existing and new technology to improve systems
• Providing a safe and supportive working environment 
• Providing adequate staff levels to balance workload and conflicting priorities
• Providing guidance, training and skills to respond to patient safety incidents, and protected time for this  
• Providing time for individuals and teams to respond to patient safety incidents  
• Employing organisations to reduce the risk of incidents occurring by proactively reviewing, identifying and improving system issues and processes.

Ensure sufficient knowledge of anyone delivering pharmacy services or employed within the pharmacy by:

• Defining roles and responsibilities for responding to patient safety incidents and knowing when and how to escalate – see standards for outcomes and internal SOPs
• Encouraging and allocating resources for individual reflection and continuous professional development – an incident can be an indication of a learning need
• Knowing how to use existing improvement methodology, incident investigation tools and templates to analyse incidents
• Knowing what should be reported – see what patient safety incidents to record and report
• Knowing what support is available for employees – see networks
• Knowing what support is available for patients and/or their carers – see networks
• Knowing where to report incidents – see where to report patient safety incidents.
• Regularly learning from incidents. 

Sharing the benefits/impact of taking part in all stages of responding to incidents by:

• Communicating effectively with colleagues by highlighting key messages through personalised communications (e.g. emails, social media, face-to-face)
• Encouraging incident reporting behaviour (e.g. local praise for reporting, recording, sharing, learning and taking action as positive for patient safety)
• Providing feedback to anyone delivering pharmacy services or employed within the pharmacy to reinforce reporting habits – internal, local and national reporting systems need to be able to provide this
• Sharing case studies where reporting, sharing, learning and acting have made a positive difference
• Sharing learning from incidents with local and national MSO networks for dissemination.

Having open and honest conversations by:

• Supporting colleagues and understanding their behaviours and limitations by actively listening to them 
• Actively promoting and supporting whistleblowing, reporting, sharing and taking action by employing organisations
• Creating a supportive culture and encouraging a safety culture and just culture within the organisation/workplace 
• Discussing new ways of working, and co-designing and producing them with people impacted by the work
• Discussing proactive actions to manage risk to avoid the same situation in other scenarios or with other medicines
• Educating the public and general media that encouraging incident reporting improves patient safety, that healthy levels of reporting are positive and show that a pharmacy team is committed to patient safety, that campaigns to encourage reporting will lead to a ‘good’ increase in incidents of reporting and that increases in incidents of reporting should be described fairly and within context
• Enhancing and managing psychological safety in the workplace when incidents occur to minimise psychological harm
• Having discussions with teams and providing training at the right time, e.g., during inductions, and refreshing regularly to set expectations
• Informing teams that a defence to a criminal sanction for inadvertent dispensing errors is implemented, incentivising an increase in the reporting of dispensing errors – see legislation
• Informing teams that human factors principles are considered by employers and regulators. 

Sharing best practice 

Lead by example. Here are some of your case studies and examples of meeting the standards, good practice and lessons learned.

The General Pharmaceutical Council (GPhC) notable practice for inspection examples:

• Example of effectively using near miss records and regular reviews to reduce the risk of mistakes being made – effectively using near miss records and regular reviews to reduce the risk of mistakes being made
• Example of using regular newsletters to share learning within an open and honest culture – Using regular newsletters to share learning, promote feedback and engage team members in identifying LASA medicines and other risks related to patient safety
• Example demonstrating the use of ‘reflective statements’ to improve dispensing accuracy following near misses – Use of ‘reflective statements’ to improve dispensing following near misses. 

See GPhC knowledge hub website for further examples.

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Controlled drugs diversion on the ward – Shalini Gujral, chief pharmacist, private sector

While undertaking the weekly pharmacy top-up on the ward, the pharmacy assistant noticed an empty box of dihydrocodeine 30mg tablets and an empty box of diazepam 2mg tablets in the medicine stock cabinet. Both boxes were pristine with no evidence that they had been dispensed from. The drugs could not be located in the medicines cabinet or clinical room. She notified the ward pharmacist, who confirmed no patients had been on these drugs for the last month. The chief pharmacist and hospital director (who is also the CDAO) were notified immediately. The clinical notes of patients attending in the last two weeks were checked, and no diazepam or dihydrocodeine had been prescribed. The incident was recorded on Datix and treated as a diversion. The following external bodies were notified about the diversion: the CD LIN, the CDLO and the Home Office. As part of the investigation, staff with access to the clinical room and drug cupboards were interviewed. These interviews highlighted that drug security in the clinical room on the ward could not be assured at all times, as the drug cabinets were sometimes unlocked. The missing drugs could not be accounted for, but changes were made following this incident, including medicines management and security training for staff and increased security measures for schedule 4 and 5 CDs. Policies were updated and disseminated after this change, so all staff were aware of the new CD requirements. This incident highlighted the importance of reviewing processes following an incident and acting accordingly. A copy of the investigation was provided to the external bodies notified about the incident. 

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Prescribing methotrexate 10mg tablets incident – GP practice

Methotrexate (MTX) was prescribed as 10mg tablets, take two tablets twice weekly (supply of eight tablets). The patient took all eight tablets (80mg) as one dose, as they thought they were 2.5mg tablets (what is usually prescribed), despite two pharmacies apparently informing him of the different strength, and the pharmacy dispensing the prescriptions reiterating this and informing him of the dose change, i.e., two tablets a week. The 10mg tablets should not have been prescribed, but the prescription was for the correct dose and direction was issued. 

On realising the problem, the pharmacy was informed. The pharmacy contacted the patient and confirmed they had taken the above dose, and they advised the person to go straight to hospital. The bloods taken in hospital were monitored by the surgery. The patient was contacted to arrange for repeat bloods. The surgery informed the patient’s consultant of the events, who confirmed to withhold MTX for two weeks (the patient was going on holiday, so the consultant advised the medication be withheld until their return, as they were going to a sunny location (risk of photosensitivity)). 

What could have been done better?

• Staff involved in the process should take more diligence and check before overriding computer system warnings, and question if messages don’t appear correct 
• The GP could have noticed before signing the script
• Pharmacy A could have returned or highlighted that 10mg were prescribed and queried this to the practice, and not given the script to the patient to take to another pharmacy
• Pharmacy B could have returned or highlighted that 10mg were prescribed and queried this to the practice and not dispensed the prescription.

Reflections on the event

The person who amended the strength from 2.5mg to 10mg after receiving a hospital letter to increase the dose was an administrative member of staff. They had undertaken some external learning on DMARD drugs, and at no point in the training resource was any issue of prescribing 10mg tablets raised. Review of resources highlighted original National Patient Safety Agency (NPSA) documents on this now on the archived gov.org website. BNF states “do not prescribe 10mg tablets,” but underneath it, reflects the wording of a current NPSA alert where prescribers are advised to “consider the patient’s overall polypharmacy burden when deciding which formulation to prescribe, especially in those with a high pill burden”. On discussing with the person who altered the repeat, they stated that they were thinking to reduce the number of tablets but were not aware of the BNF guidance. 

Changes made

The person involved undertook additional training and has themselves done a personal reflective account on this. If printing prescriptions for MTX or any DMARDS, recent blood test results must be printed and attached to the prescription to give the prescriber added awareness of a high-risk drug and to check thoroughly before signing.

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Pauline Lockey, patient safety clinical lead (medication safety) NHS England

As a patient safety clinical lead in NHS England’s National Patient Safety Team, a core part of my work is to identify patient safety risks that occur in the delivery of healthcare. Where a risk has been identified, I work with colleagues to develop advice and guidance to support the NHS to take action to address those risks and keep patients safe. I’m part of a wider team that reviews patient safety events recorded by staff and patients on our national systems to identify new or under-recognised patient safety issues. In some cases, an identified new or under-recognised risk will meet the criteria for a National Patient Safety Alert, but where this doesn’t happen, we look to work with partner organisations which may be better placed to take action to address the issue. 

As an example, we identified a report that outlined that a baby required hospital treatment for seizures, following administration of doses of phosphate that were 16 times higher than intended; effervescent phosphate tablets were used to administer the doses of phosphate. Our analysis of reported patient safety events data, identified a number of concerns relating to the use of portions of phosphate or calcium effervescent tablets in children. There were indications that errors occurred at each stage of the medicine journey – prescribing, dispensing, preparation and administration.

There are no licensed oral liquid calcium or phosphate products available in the UK. Administration of a portion of a licensed effervescent calcium or phosphate tablet is common, and such off-label practice is challenging and prone to error. Collaborative working with several partner organisations led to the publication of the following resources and the delivery of a webinar to the national medication safety officer network: 

• Neonatal and Paediatric Pharmacy Group (NPPG) Position Statement: Enteral Calcium and Phosphate Supplementation in Neonates and Children (The Royal College of Paediatrics and Child Health (RCPCH) / NPPG Medicines Committee)
• Managing the risks of using effervescent tablets in children (Specialist Pharmacy Service)
• How to give phosphate or calcium from effervescent tablets  (Medicines for Children)
• Revision of the British National Formulary for Children (BNFC) monographs for calcium carbonate and phosphate. 

Further case studies can be found on the NHS England Patient Safety Review and response case studies by clinical speciality. These highlight the importance of recording patient safety events and the direct action the National Patient Safety Team takes in response to patient safety events recorded by organisations, staff and the public, and how their actions support the NHS to protect patients from harm. 

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Leanne Gurney, medicines safety pharmacy technician in England

As a medicines safety pharmacy technician working in an Acute Hospital Trust, I work alongside the MSO. Together, we promote the safer use of medicines, managing medication incidents in the organisation, and improving the reporting and learning from these. We do this by working with multi-disciplinary teams and healthcare professionals. Shared learning across our Trust is promoted in a variety of ways, such as our Medicines Event Review Group, Learning from Events Forum, and during quality reviews.

When reviewing our pharmacy incidents, we ensure we take a just culture approach and look at the incident both in detail and systemically. It’s important to understand the psychological impact an error can have on an individual and how it can lower confidence in practice, while valuing professional accountability. We have reflective conversations with our colleagues, ensuring that we handle the conversation constructively and give the individual an opportunity to be open and honest in a safe space, while we in the medicines safety team remain professional and empathetic towards them. There are a multitude of factors that contribute towards errors, and those that are highlighted tend to funnel into the environmental factors, such as physical or external influences like tiredness or distractions.

We also have our colleagues involved in errors fill out reflective accounts in their own time. Sometimes, individuals prefer doing this as it gives them more time to think about the situation and any personal circumstances that contributed towards the error that they may not want to divulge during the conversation. 

As pharmacy technicians within the pharmacy team, we can really make an impact on our patient care by being open and honest when errors have occurred. And understanding, through the investigation, the reasons why they happened gives us the opportunity to make our Trust a safer place to work.

A medicines safety alert was issued regarding potassium permanganate soak tablets, which are used to treat skin conditions that blister or weep. They are to be diluted in water, and the affected area of skin is soaked in the solution. However, when patients have ingested it orally, it has caused death or severe harm even in a hospital setting. The medication safety team liaised with stakeholders for a multidisciplinary approach to review the entire treatment pathway with necessary risk assessments in place. When reviewing systems and processes for safety, it is important to consider removing barriers as well as adding additional steps – a complex process has potential for mistakes or non-adherence.

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Further supporting links and resources

Presentation

We have made a PowerPoint presentation (click the link to download) to help you and your teams use and understand the standards.

This presentation is designed to be used and adapted as required for teaching and learning. It is not intended to be used for commercial use.

Webinar

Learn how to use the standards from the lead author, Regina Ahmed, and the expert panel members.

National patient safety guidance 

England 

• Community Pharmacy England patient safety incident reporting
• NHS England patient safety alert: Improving medication error incident reporting and learning – recommends changes to review medication error incidents and improve medication safety locally
• NHS England patient safety learning response toolkit – includes the PSIRF and SEIPS framework
• NHS England patient safety – includes national patient safety strategy, national patient safety alerts, patient safety culture, patient safety systems, patient safety resources on FutureNHS, a framework for involving patients in patient safety, LFPSE service, serious incident framework, data on patient safety events, never events policy and framework and national patient safety improvement programmes.

Wales 

• Welsh government NHS quality and safety framework – describes what quality looks like. It explains what needs to be in place for high-quality health and care services.

Scotland 

• Healthcare Improvement Scotland patient safety – patient safety initiatives, including the Scottish patient safety programme
• Healthcare Improvement Scotland learning from adverse events through reporting and review – provides an overarching approach developed from best practice to support care providers to effectively manage adverse events.

Northern Ireland

• The Department of Health, Social Services and Public Safety Northern Ireland The Quality Standards for Health and Social Care – March 2006
• Health and Social Care Board Procedure for the reporting and follow-up of Serious Adverse Incidents – October 2013 
• NHS England patient safety alert: Improving medication error incident reporting and learning – also applies to NI and recommends changes to review medication error incidents and improve medication safety locally.

Regulatory – standards and professional standards

• Association of Pharmacy Technicians (APTUK)
• Pharmaceutical Society of Northern Ireland – code of ethics and standards
• GPhC standards – regulatory standards for pharmacy professionals, registered pharmacies, and guidance to support the standards
• RCPharm professional standards and frameworks – professional standards and frameworks for hospital, homecare, prescribing, secure environments, end of life care and more
• RCPharm and GPhC joint statement on the position of professional standards – describes the relationship between a GPhC regulatory standard with an RCPharm professional standard
• CQC incident notification – information on the changes, events and incidents that affect service or the people who use it, that need to be reported to CQC by registered providers.

Legislation

• The Pharmacy (Preparation and Dispensing Errors – Hospital and Other Pharmacy Services) Order 2022 – this legislation removes the threat of criminal sanctions for inadvertent dispensing errors by registered pharmacy professionals working in hospitals and other pharmacy services (e.g. in prisons and care homes)
• The Pharmacy (Preparation and Dispensing Errors – Registered Pharmacies) Order 2018 – this legislation removes the threat of criminal sanctions for inadvertent preparation or dispensing errors by registered pharmacy professionals in registered pharmacies
• NHS England NHS England Approved particulars – Information Governance Programme July 2023 – requirements for community pharmacy to fulfil paragraph 28 (2) (f) of Schedule 4, part 4 to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (as amended).

Reports and publications

• The Patients Association Patient Safety Commissioner 100 Days Report – report on what needs to change to improve the safety of medicines and medical devices
• Health Foundation webpage – search for improvement tools and publications
• NHS England The NHS Patient Safety Strategy – describes how the NHS will continuously improve patient safety, building on the foundations of a safer culture and safer systems.