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This one day masterclass is part of a series of masterclasses focusing on how to use Human Factors in your workplace. Leadership in the NHS is the responsibility of all staff. Understanding human factors will allow healthcare to enhance performance, culture and organisation. These masterclasses have been re-designed in line with the new Patient Safety Syllabus. It will look at why things go wrong and how to implement change to prevent it from happening again or mitigate the risks. This masterclass will focus on errors and designing system-based solutions to improve patient safety. Key learning objectives: Understand what Human Factors are Learning from incidents Designing system-based solutions Preventing human error Blame and psychological safety Just culture Register

Saturday 17 September 2022 marks the fourth annual World Patient Safety Day. This event was established by World Health Organization (WHO) as a day to call for global solidarity and concerted action to improve patient safety. It aims to bring together patients, families, carers, healthcare professionals and policymakers to show their commitment to patient safety. Avoidable harm in health and social care What is patient safety? Simply put, patient safety is concerned with avoiding unintended harm to people during their care and treatment. WHO describes it as follows: “Patient safety is a framework of organized activities that creates cultures, processes, procedures, behaviours, technologies and environments in health care that consistently and sustainably lower risks, reduce the occurrence of avoidable harm, make error less likely and reduce its impact when it does occur.”[1] Modern health and social care is incredibly complex and complicated, meaning that there are range of different ways in which unintended avoidable harm can occur. Each year, millions of patients suffer injuries or die because of this, with WHO stating that unsafe care is likely one of the top ten leading causes of death and disability worldwide.[2] In the UK, the NHS pre-Covid estimate was that there were around 11,000 avoidable deaths annually due to safety concerns, with thousands more patients seriously harmed.[3] This comes at a huge financial cost, with the Organisation for Economic Co-operation and Development (OECD) estimating that the direct cost of treating patients who have been harmed during their care in high-income countries approaches 13% of health spending.[4] Avoidable harm also has an untold physical and emotional impact on those affected, resulting in a loss of trust in the healthcare systems by patients, and frustration and a loss of morale among healthcare professionals at not being able to provide the best possible care. Need for transformation in our approach to patient safety The impact of avoidable harm and the need to make significant improvements to patient safety is well-established in health and social care. However, despite this knowledge, and the hard work of many people involved in the sector, avoidable harm continues to persist at an unacceptable rate. At Patient Safety Learning we believe that the persistence of avoidable harm is the result of our failure to address the complex systemic causes that underpin it. We argue that there needs to be a transformation in our approach to this problem. Key to this is ensuring patient safety is treated as core to the purpose of health and social care, not simply as one of several competing strategic priorities to be traded off against each other. In our report, A Blueprint for Action, underpinned by systemic analysis and evidence, we identify six foundations of safe care for patients and these practical actions to address them:[5] Shared Learning – organisations should set and deliver goals for learning, report on progress and share their insights widely for action. It is not enough to say, ‘we’ve learned from incidents of unsafe care’, we need to see action for improvement and impact. Leadership – we emphasise the importance of overarching leadership and governance for patient safety. This is not just about governance; it is about behaviours and commitment too. Professionalising patient safety – organisations need to set and deliver high standards for patient safety. These need to be used by regulators to inform their assessment of whether organisations are doing enough to prevent avoidable harm and assess whether they are safe. Patient Engagement – to ensure patients are valued and engaged in patient safety, at the point of care, if things go wrong and for redesigning health care for safety. Data and Insight – better measurement and reporting of patient safety performance, both quantitative as well as qualitative. Just Culture – all organisations should publish goals and deliver programmes to eliminate blame and fear, introduce or deepen a Just Culture, and measure and report progress. Medication safety When considering avoidable harm in health and social care, unsafe medication practices and medication-related harm are one of the leading causes of this, with WHO noting that: Medication harm accounts for 50% of the overall preventable harm in medical care.[6] $42 billion (US dollars) of global total health expenditure worldwide can be avoided if medication errors are prevented.[6] This year’s World Patient Safety Day focuses on the issue of medication safety and the need to build on the existing WHO Global Patient Safety Challenge: Medication Without Harm. The campaign emphasises the need to adopt a systems approach to this challenge, promote medication safety practices to prevent medication errors and reduce medication-related harm.[7] The Global Challenge was launched in 2017 with a goal “to gain worldwide commitment and action to reduce severe, avoidable medication-related harm by 50% in the next five years”.[8] As we reach the end of this period, Patient Safety Learning believes that it is important now that countries report publicly on their progress against this, enabling WHO evaluate both positive developments and where improvement is required. Medication safety covers a huge range of different issues and concerns and here we will highlight a few examples from Patient Safety Learning’s work and topical issues highlighted on our award-winning patient safety platform, the hub. Listening and responding to patient concerns A key barrier to improving patient safety around medication concerns the dismissal of concerns raised by patients when harmful side effects occur. A recent example of this in the UK was highlighted by the Independent Medicines and Medical Devices Safety (IMMDS) Review, which investigated a truly shocking degree of avoidable harm to patients over a period of decades relating to two medications, hormone pregnancy tests and sodium valproate, and pelvic mesh implants. The Review exposed a range of medication safety concerns, including a lack of informed consent, failures by incident reporting schemes to recognise safety concerns and a failure to support patients after unsafe care, stating: “As we have seen and heard, all too often patient reports of harm are either not listened to or are dismissed as subjective, unscientific and anecdotal.”[9] Key to highlighting these issues, and pushing for change, was the tenacious work of campaigning patients and families affected by this, as described in a recent interview on the hub with Marie Lyon, Chair of the Association for Children Damaged by Hormone Pregnancy Tests. In response to this Review there will soon be new Patient Safety Commissioner roles created in England and Scotland. While these roles can provide a new voice and hopefully influence for patients in relation to medication safety in the UK, this must also be accompanied by a shift in attitudes and approach towards patients’ involvement in care and their safety. Packaging and processes The WHO Medication Without Harm initiative recognises that one of the key challenges to the safe administration of medication often lies in complex and unclear processes which can result in mistakes that lead to patient harm. An example of this is when packaging and labelling of medications creates error traps, situations that could lead into avoidable harm in a busy, pressurised health and social care workplace, such as different medications being stored together in almost identical packaging. We have been collating different examples from healthcare professionals of look-alike medicines on our error traps gallery on the hub. We also need to look at how we can reduce the complexity around medication prescription and administration to reduce the risk of mistakes that lead to harm. Laurence Goldberg highlights examples of this such as regards to ready-to-administer injections and unit dose drug distribution in a new blog featured on the hub. Engaging with patients in the medication process Building on our previous comments around listening to patient concerns, actively involving them in their care is also a key issue in ensuring medication safety. In our recent analysis of investigation reports by the Healthcare Safety Investigation Branch (HSIB) in England we have seen numerous examples where family members of patients have played a key role in spotting and alerting healthcare professionals to safety concerns. Cases of this vary from appropriate insulin administration to safety concerns around the prescription of liquid morphine. WHO have developed a helpful tool to support patient involvement in this area, 5 Moments for Medication Safety. This helps to highlight how the risk of harm can be reduced by involving patients at different stages of the medication process. The implementation gap As with many other issues in patient safety, a key challenge in reducing medication-related harm remains overcoming the ’implementation gap‘, the difference between what we know improves patient safety and what is done in practice. In our report from earlier this year, Mind the implementation gap, we highlighted how too often we fail to translate patient safety insights and learning into practical improvements, due to a lack of systems for sharing learning, absence of oversight and unclear patient safety leadership. Returning to the IMMDS Review we can see a clear example of the implementation gap in relation to sodium valproate. Despite a clear body of evidence about the risks, birth defects or development delays associated with taking this medication during pregnancy, the safety actions identified by the review and ongoing campaigning by groups such as the Independent Fetal Anti-Convulsant Trust, pregnant women and birthing people in the UK continue to be prescribed this medication. In addition, they do not always receive the appropriate advice on the risks associated with this. There is much that still needs to be done in medication safety to improve our approach to not only sharing good practice but ensuring that this is implemented widely and consistently. Share your experience with us Do you have an experience to share around medication safety as a patient, carer or family member? Or perhaps you are a healthcare professional looking to share your frontline insights to help improve safety? Join the conversation by signing up to our patient safety platform the hub and sharing your views, or get in touch with us by emailing content@pslhub.org. Related reading You can find a wide range of medication safety related articles on issues such as medication administration, labelling, patient medication stories and medicine management on the medication section of our patient safety platform the hub. We’ve also published several articles on this subject specifically for World Patient Safety Day this year which you can find below: Patient Safety Spotlight interview with Angela Carrington, Lead Pharmacist for Medication Safety in Northern Ireland Reducing medication errors: a blog from Laurence Goldberg for World Patient Safety Day Top picks for World Patient Safety Day 2022: Medication safety in hospitals Top picks for World Patient Safety Day 2022: Patient engagement for medication safety Top picks for World Patient Safety Day 2022: Medication safety in social care References WHO, Patient safety – About us, Last Accessed 13 September 2022. WHO, 10 facts on patient safety, 26 August 2019. NHS England and NHS Improvement, The NHS Patient Safety Strategy: Safer culture, safer systems, safer patients, July 2019. OECD, Patient Safety, Last Accessed 20 October 2021. Patient Safety Learning, The Patient-Safe Future: A Blueprint For Action, 2019. WHO, World Patient Safety Day 2022, Last Accessed 14 September 2022. WHO, Medication Without Harm, Last Accessed 14 September 2022. WHO, Medication Without Harm: WHO Global Patient Safety Challenge, 2017. The IMMDS Review, First Do No Harm, 9 July 2020

A medication error is defined as "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer,” according to the National Coordinating Council for Medication Error Reporting and Prevention. An estimated 237 million medication errors occur in the NHS in England every year.[1] This number represents the sum of medication errors over all stages of the medication use process. Most errors occur during drug administration (54%), followed by prescribing (21%) and dispensing (16%). The majority of medication errors (72%) have little/no potential for harm, and only 2% have potential to cause severe harm. One of the recommendations to reduce medication errors and harm is to use the “five rights”: the right patient, the right drug, the right dose, the right route, and the right time. According to the NHS Patient Safety Strategy, “Medication errors are any Patient Safety Incidents (PSI) where there has been an error in the process of prescribing, preparing, dispensing, administering and monitoring or providing advice on medicines". The NHS Medicines Safety Improvement Programme has been established to address the most important causes of severe harm associated with medicines and aims to reduce severe avoidable medication-related harm by 50% by March 2024. Prescribing errors can be reduced by incorporating decision support software into the electronic prescribing protocol, although many of the warnings generated by this type of software are of no clinical significance and are often regarded as an intrusion or an inconvenience and are usually ignored. A pharmacist’s signing off a prescription before it is dispensed will also capture potential prescribing errors. Dispensing errors are usually identified before the prescription is issued by a second check but with the introduction of dispensing/distribution robots in most hospital pharmacies, dispensing errors have almost been eliminated. The focus today is to reduce drug administration errors. In surveys, the most common errors were late or early administration of drugs or drug omission. Distractions and interruptions are a regular part of nurses’ working lives. If these occur when nurses are preparing and administering medicines, they can lead to drug errors that compromise patient safety. Poor numeracy and the need for complex calculations have also been highlighted as contributory factors to medication errors in both hospitals and in the community. However, many of these errors can be eliminated by the provision of medicines in a ‘ready-to-administer’ format where no manipulation is required before administration to the patient. Individual doses should have machine readable codes on the label to ensure correct drug identification. Ready-to-administer injections (RTA) Injectable drugs should be made available in a ready-to-administer (RTA) format. The World Health Organization (WHO) defines RTA as “an injectable medicine that requires no further dilution or reconstitution and is presented in the final container or device, ready for administration or connection to a needle or administration set”. The preparation of IV medications at the bedside requires multiple steps and reducing these complex steps and manipulations can reduce the number of errors. Additionally, the use of prefilled RTA syringes can help reduce unnecessary wastage of medications by optimising pharmaceutical product size. Healthcare professionals responsible for administering injectable drugs should demand RTA preparations. In the first instance, hospital pharmacies should prepare high-risk injectable medicines in their aseptic compounding units or purchase them from third party contractors. Looking to the future, the pharmaceutical industry should offer licensed injectable medicines in a RTA format. Manufacturer-prepared RTA prefilled syringes can play an important role in simplifying these processes and reducing errors and potential patient harm. When contracts for injectable drugs are awarded, priority should be given to those products that are presented in a RTA format. Purchasing for safety must be implemented and not just discussed. Unit dose drug distribution (UDD) Unit dose drug distribution is a system that provides the prescribed dose of a specific drug for a certain patient at a specific time. It differs from other systems in that each dose of a prescribed drug is packaged individually, in a ready-to-administer form. Each dose is labelled so that it retains its identity right up to the time it is administered to the patient. The package, labelled with the drug name, strength, batch number, and expiry date, virtually eliminates contamination resulting from transfer and handling of the drug. Unused medications can safely be reissued. In addition, the system sharply reduces the potential for medication errors. For blister-packed tablets and capsules, separation of individual blisters and over-wrapping them in individual sachets has the advantage that the integrity and stability of the original pack is not compromised. Using a ‘closed-loop’ process where the patient, the drug and the healthcare worker are identified, a safer system for drug administration can be established using unit doses with the added advantages of reduced drug wastage, reduction in nursing time and reduced inventory on the ward. Medication errors, particularly drug administration errors can be reduced considerably by redesigning packaging, eliminating the preparation of doses in clinical areas and simplifying the medicine rounds. This can all be brought about at no overall additional cost to the healthcare provider by utilising the efficiencies generated by the new practices. Reference 1. Elliott RA, Camacho E, Jankovic D, et al. Economic analysis of the prevalence and clinical and economic burden of medication error in England. BMJ Qual Saf 2020:1-10. doi:10.1136/ bmjqs-2019-010206.