Global Patient Safety Action Plan 2021-2030 PDF

GLOBAL PATIENT SAFETY ACTION PLAN 2021–2030 Towards eliminating avoidable harm in health care GLOBAL PATIENT SAFETY ACTION PLAN 2021–2030 Towards eliminating avoidable harm in health care Global patient safety action plan 2021–2030: towards eliminating avoidable harm in health care ISBN 978-92-4-003270-5 (electronic version) ISBN 978-92-4-003271-2 (print version) © World Health Organization 2021 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. 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Ltd., India Contents Executive summary....................................................................................................................................................................................................v Overview....................................................................................................................................................................................................................viii 1. Introduction......................................................................................................................................................................................................1 1.1 Background...........................................................................................................................................................................................1 1.1.1 Emergence of patient safety thinking.............................................................................................................................2 1.1.2 Global burden of unsafe care.............................................................................................................................................2 1.1.3 Evolution of the global patient safety movement......................................................................................................3 1.1.4 Coronavirus disease (COVID-19): a broader concept of avoidable harm...........................................................5 1.2 Mandate.................................................................................................................................................................................................5 1.3 Development process.......................................................................................................................................................................6 2. Vision, mission and goal...............................................................................................................................................................................8 3. Guiding principles..........................................................................................................................................................................................9 3.1 Engage patients and families as partners in safe care..........................................................................................................9 3.2 Achieve results through collaborative working......................................................................................................................9 3.3 Analyse and share data to generate learning..........................................................................................................................9 3.4 Translate evidence into actionable and measurable improvement............................................................................. 10 3.5 Base policies and action on the nature of the care setting.............................................................................................. 10 3.6 Use both scientific expertise and patient experience to improve safety.................................................................... 10 3.7 Instil a safety culture in the design and delivery of health care..................................................................................... 10 4. Partners in action......................................................................................................................................................................................... 11 4.1 Governments.................................................................................................................................................................................... 11 4.2 Health care facilities and services.............................................................................................................................................. 11 4.3 Stakeholders...................................................................................................................................................................................... 12 4.4 The WHO Secretariat...................................................................................................................................................................... 12 Contents | v 5. Framework for action................................................................................................................................................................................. 13 Strategic objective 1. Policies to eliminate avoidable harm in health care............................................................................. 16 Strategic objective 2. High-reliability systems.................................................................................................................................. 23 Strategic objective 3. Safety of clinical processes............................................................................................................................ 31 Strategic objective 4. Patient and family engagement.................................................................................................................. 40 Strategic objective 5. Health worker education, skills and safety.............................................................................................. 48 Strategic objective 6. Information, research and risk management.......................................................................................... 54 Strategic objective 7. Synergy, partnership and solidarity........................................................................................................... 63 6. Implementation............................................................................................................................................................................................ 69 6.1 Policy options for implementation of the global action plan......................................................................................... 69 6.2 Key milestones in implementing the global action plan.................................................................................................. 69 7. Monitoring and reporting......................................................................................................................................................................... 73 7.1 Core Indicators.................................................................................................................................................................................. 73 7.2 Advanced indicators....................................................................................................................................................................... 77 8. Alignment of patient safety with the United Nations Sustainable Development Goals................................................... 79 9. Mapping World Health Assembly resolution WHA72.6 with the Global Patient Safety Action Plan 2021–2030...... 83 Acknowledgements................................................................................................................................................................................................ 88 Bibliography.................................................................................................................................................................................................... 90 Annexes Glossary.......................................................................................................................................................................................................... 91 References.................................................................................................................................................................................................... 95 vi | Global Patient Safety Action Plan 2021–2030 Executive summary Why do we need a Global consultation with Member States and all relevant stakeholders. Patient Safety Action Plan? The Seventy-fourth World Health Assembly (in 2021) Today, patient harm due to unsafe care is a large and approved the Decision WHA74(13) to adopt the Global growing global public health challenge and is one of the Patient Safety Action Plan 2021–2030 and to request leading causes of death and disability worldwide. Most the Director-General to report back on progress in the of this patient harm is avoidable. As countries strive to implementation of the Global Patient Safety Action Plan achieve universal health coverage and the Sustainable 2021–2030 to the Seventy-sixth World Health Assembly in Development Goals, the beneficial effects of improved 2023 and thereafter every two years until 2031. access to health services can be undermined by unsafe care. Patient safety incidents can cause death and disability, and suffering for victims and their families. The What is patient safety? financial and economic costs of safety lapses are high. Patient safety is: “A framework of organized activities There is often reduced public confidence and trust in that creates cultures, processes, procedures, behaviours, local health systems when such incidents are publicized. technologies and environments in health care that Health workers involved in serious incidents involving consistently and sustainably lower risks, reduce the death or serious harm to a patient can also suffer lasting occurrence of avoidable harm, make errors less likely and psychological harm and deep-seated feelings of guilt and reduce the impact of harm when it does occur.” self-criticism. The benefits of having a strategic and coordinated approach to patient safety, addressing the common How big is the problem of causes of harm and the approaches to preventing it, unsafe care? have been recognized by policy-makers and political and Every year, large numbers of patients are harmed or die health leaders worldwide. Global advocacy in recent years because of unsafe health care, creating a high burden of has culminated in the adoption by the Seventy-second death and disability worldwide, especially in low- and World Health Assembly (in 2019) of resolution WHA72.6 middle-income countries. On average, an estimated on “Global action on patient safety”. one in 10 patients is subject to an adverse event while The resolution urges Member States – and, where receiving hospital care in high-income countries. applicable, regional economic integration organizations – Available evidence suggests that 134 million adverse to recognize patient safety as a health priority in health events due to unsafe care occur in hospitals in low- and sector policies and programmes to achieve universal middle-income countries, contributing to around 2.6 health coverage. The World Health Assembly also million deaths every year. According to recent estimates, requested the World Health Organization (WHO) the social cost of patient harm can be valued at US$ 1 to formulate a global patient safety action plan in trillion to 2 trillion a year. Executive summary | vii What will success look like? Health care facilities and services. All health care facilities ranging from primary health centres to The Global Patient Safety Action Plan strives to eliminate large teaching hospitals, irrespective of ownership avoidable harm in health care with the vision of “a world and scope of services. in which no one is harmed in health care, and every Stakeholders. Nongovernmental organizations, patient receives safe and respectful care, every time, patients and patient organizations, professional everywhere”. bodies and scientific associations and societies, academic and research institutions and civil society The ultimate goal is to achieve the maximum possible organizations. reduction in avoidable harm due to unsafe health care globally. WHO Secretariat. WHO at all levels – country offices, regional offices and headquarters. The mission of the global action plan is to drive forward policies, strategies and actions, based on science, patient experience, system design and partnerships, to eliminate What is the framework for all sources of avoidable risk and harm to patients and health workers. action? The global action plan provides a framework for action through seven strategic objectives and is further What principles will guide elucidated through 35 strategies, five under each of the implementation? strategic objectives, to create a seven by five matrix. Seven guiding principles establish underpinning values Each strategy has been further operationalized into to shape the development and implementation of the suggested actions for four key groups or categories of action plan: partners: governments, health care facilities and services, stakeholders and the WHO Secretariat. engage patients and families as partners in safe care achieve results through collaborative working The seven strategic objectives (SOs) of the Global Patient Safety Action Plan 2021–2030 are as follows. analyse and share data to generate learning SO1: M ake zero avoidable harm to patients a state of translate evidence into actionable and measurable mind and a rule of engagement in the planning improvement and delivery of health care everywhere. base policies and action on the nature of the care SO2: Build high-reliability health systems and health setting organizations that protect patients daily from use both scientific expertise and patient experience harm. to improve safety SO3: Assure the safety of every clinical process. instil a safety culture in the design and delivery of SO4: Engage and empower patients and families to health care. help and support the journey to safer health care. Who are the key delivery SO5: Inspire, educate, skill and protect every health partners? worker to contribute to the design and delivery of safe care systems. Patient safety is everybody’s business and requires SO6: Ensure a constant flow of information and the active participation of many key partners ranging knowledge to drive mitigation of risk, a reduction from patients and their families to governmental, in levels of avoidable harm and improvements nongovernmental and professional organizations. They in the safety of care. include: SO7: Develop and sustain multisectoral and Governments. Ministries of health and their executive multinational synergy, partnership and agencies at both national and subnational levels, solidarity to improve patient safety and quality legislative institutions, other concerned ministries, of care. and regulatory bodies. viii | Global Patient Safety Action Plan 2021–2030 How will implementation How will overall progress be work at national and measured? subnational levels? A monitoring and reporting mechanism will assess The Global Patient Safety Action Plan 2021–2030 takes progress in implementing the global action plan. This into account that countries are at different stages in uses a set of 10 core indicators and global targets creating the capacity and capability to reduce preventable aligned with the strategic objectives. The WHO patient harm in health care and to strengthen their Secretariat will collect the necessary data in cooperation national health systems to meet this aim. Their health care with Member States and partners and then analyse the contexts also vary greatly. Member States are being asked progress made. An additional list of advanced indicators to assess and analyse their current situations to identify will assist countries in designing their own context- areas where progress can be made. specific measurements for patient safety. Progress on implementation of the Global Patient Safety Action The key implementation milestones at national and Plan 2021–2030 will be reported to the World Health subnational levels are: Assembly every two years. a landscape assessment of major safety risks and barriers to improvement in patient safety has been carried out; How will the plan support the strong commitment from political and organizational Sustainable Development leadership has been secured; Goals (SDGs)? a sustainable mechanism to implement patient safety Due to the interdisciplinary nature of patient safety, the policies, strategies and plans is in place (within the global action plan contributes to achieving not only SDG context of existing national health plans and safety 3 (good health and well-being) but also interlinks with and quality policies); other SDGs, including SDG 1 (no poverty), SDG 5 (gender national context and priorities, are well aligned equality), SDG 6 (cleaner water and sanitation), SDG 8 and consistent with the health care context of the (decent work and economic growth), SDG 10 (reduced country; inequalities) and SDG 12 (responsible consumption and production). a model of change for implementation has been agreed by all partners. Executive summary | ix Overview of the Global Patient Safety Action Plan 2021–2030 Vision A world in which no one is harmed in health care, and every patient receives safe and respectful care, every time, everywhere Governments Stakeholders Health care facilities and services World Health Organization Mission Drive forward policies, strategies and actions, based on science, patient experience, system design and partnerships, to eliminate all sources of avoidable risk and harm to patients and health workers Goal Achieve the maximum possible reduction in avoidable harm due to unsafe health care globally Patients and families as partners Evidence into improvement Results through collaboration Policies and action Data to generate learning Scientific expertise and Safety culture patient experience High-reliability Patient and family Information, research systems engagement and risk Health management Policies Safety worker Synergy, to eliminate of clinical avoidable education, skills partnership processes and safety and solidarity harm x | Global Patient Safety Action Plan 2021–2030 1. Introduction O ver the next 10 years, the World Health Organization (WHO), its global partners and its Member States will be working tirelessly to help all people of the world to Through its year-by-year milestones, this flagship initiative will be the driver for the successful implementation of the global action plan. have access to health services. The global action plan, set out in this document, will Universal health coverage is an inspiring goal whereby provide a strategic direction for concrete actions to be all individuals and communities receive safe and quality taken by countries, partner organizations, health care health services without suffering financial hardship. This facilities and WHO to implement World Health Assembly is the target to be achieved if the world is to stay on track resolution WHA72.6. As a result, it will strengthen health to achieve the United Nations Sustainable Development systems globally to diagnose, treat, cure, and care, whilst Goals (SDGs) and the “triple billion” goals in the WHO striving to “first, do no harm” the celebrated maxim of the Thirteenth General Programme of Work. However, the Greek physician, Hippocrates (460–375 BC). sustainable development agenda will not be met without ensuring that health services are safe. In the absence of such assurance, the benefits of increased coverage cannot 1.1 Background be fully realized, and people may experience reduced trust Every point in the process of care can contain an inherent in health services and reduced willingness to seek health risk. The nature and scale of risks vary greatly, based on care – even when they most need it. the context of health care provision and its availability, That is why the Seventy-second World Health Assembly infrastructure and resourcing within and across countries. in May 2019 adopted resolution WHA72.6 on “Global The challenge for all health systems and all organizations action on patient safety” to give priority to patient safety providing health care is to maintain a heightened as an essential foundational step in building, designing, awareness to detect safety risks, as well as to address all sources of potential harm. operating and evaluating the performance of all health care systems. The adoption of this resolution was a Patient safety is a framework of organized activities remarkable milestone in global efforts to take concerted that creates cultures, processes, procedures, behaviours, action on patient safety and reduce the burden of patient technologies and environments in health care that harm due to unsafe health care. consistently and sustainably lower risks, reduce the The resolution requested the Director-General of occurrence of avoidable harm, make errors less likely and WHO to formulate a global patient safety action plan reduce impact of harm when it does occur. in consultation with Member States and a wide range The practice of patient safety involves coordinated action of partners and other organizations. To respond to to prevent harm to patients, caused by the processes of resolution WHA72.6 and move forward from global health care themselves. commitment to tangible action, WHO launched a flagship initiative "A Decade of Patient Safety Patient safety is a strategic priority for modern health 2021–2030". This important step defines WHO’s care and is central to countries’ efforts in working towards contribution to the global patient safety movement. universal health coverage. Introduction | 1 As a theme of scholarship and research, patient safety The paradigm shift in thinking about safety in health draws on the concepts and methods of many disciplines, care came with the realization that it was not completely including health services research, applied psychology, different from other high-risk industries, and when behavioural science, ergonomics, communication science, things went wrong it was seldom due to an error by a accident theory and systems research. single individual. Rather, the true cause of an accident in aviation or an adverse event in health care was often 1.1.1 Emergence of patient safety human error embedded in a complex amalgam of actions and interactions, processes, team relationships, thinking communications, human behaviour, technology, In the period immediately after the Second World War, organizational culture, rules and policies, as well as the when many countries were developing their health care nature of the operating environment. With this realization systems, the idea of safety was limited to traditional came a deeper understanding that the poor design and hazards such as fire, equipment failure, patient falls operation of systems could provoke human error or and the risk of infection. There was also a belief that worsen its impact when it occurred (1). health workers, such as well-trained staff (that is, In this systems thinking view of the risks of health doctors and nurses), would always behave carefully and care, the term “medical error” became something of conscientiously and seek to avoid or minimize what were a misnomer, since error in itself was not the primary seen as inevitable “complications” of care. At that time, problem. Indeed, harm to patients cannot be corrected postoperative bleeding, fetal distress during childbirth solely by urging health workers to be more careful. The and wound infections were – and still remain – consistent use of the term “patient safety”, a more holistic concept, to harms or complications associated with care. There are describe the safety risks in health care and the measures many more. to address these risks and patient harm came into being Similarly, there have long been events in health care at the beginning of the 21st century (2). It recognized considered as unexpected complications – for example, the scale of the problem of inadvertent harm in the transfusion of the wrong blood group, administration delivery of health care, the common causes that allowed of too high a dose of medication for a child, carrying similar kinds of adverse events to occur in all countries out a surgical procedure on the wrong side of the body, worldwide, the need to see human error as something and many more, sometimes resulting in the death of to be mitigated and prevented rather than eliminated patients. entirely, and the strong parallels with the experience of other high-risk industries, thus creating opportunities For most of the 20th century, whilst such occurrences for transfer learning. An alternative emerging approach would occasionally hit the headlines, cause momentary in patient safety (Patient Safety II) focuses on proactively public concern, and be a preoccupation of medical making health care safer through an emphasis on the litigation lawyers, they aroused little interest amongst conditions under which people succeed rather than fail. doctors and health care leaders. Why? Essentially, they This perspective views patient safety in terms of intended were seen as the inevitable cost of doing business in the and acceptable outcomes to the extent possible. pressurized, fast-moving environment of modern health care that was saving lives and successfully treating many more diseases. Mistakes happen, it was argued. They were 1.1.2 Global burden of unsafe care also viewed mainly as local events best dealt with through The magnitude of the problem of unsafe care attracted internal investigation. greater public attention with the release of the landmark Studies in the 1990s began to view the safety of care report To err is human: building a safer health system, through a different lens. They showed that the frequency published by the United States Institute of Medicine in of adverse outcomes amongst hospital patients was 1999 (3). The report extrapolated a death rate from the substantial and had hitherto been little recognized. incidence of adverse events in United States hospitals They introduced the term “medical error” to describe this from two earlier studies and estimated that at least phenomenon, and it became widely adopted by policy- 44 000 and perhaps as many as 98 000 people died in makers, researchers, clinicians, patient groups and the hospitals each year as a result of medical errors. In 2000, media. Other terms also came into common usage to the United Kingdom Department of Health published An describe safety failures in health care, such as incident, organisation with a memory (4). Both reports scoped the adverse event, serious untoward incident, never event, subject of safety and harm in health care, drew parallels near miss and close call. with other high-risk industries, and provided the first 2 | Global Patient Safety Action Plan 2021–2030 estimates of the burden of patient harm for what was to According to recent estimates, the social cost of patient become a new health priority and a new field of research harm can be valued at US$ 1 trillion to 2 trillion a year. in health services. A human capital approach suggests that eliminating harm could boost global economic growth by over 0.7% In more recent years, the focus has also been on economic annually (13). losses and access problems due to unsafe care that have the potential to become major barriers to achieving universal health coverage (5). Research studies have 1.1.3 Evolution of the global patient shown that an average of one in 10 patients is subject to safety movement an adverse event while receiving hospital care in high- income countries (6). The estimate for low- and middle- In May 2002, the Fifty-fifth World Health Assembly income countries suggests that up to one in four patients adopted resolution WHA55.18. This urged Member States is harmed, with 134 million adverse events occurring to pay the closest possible attention to the problem of annually due to unsafe care in hospitals, contributing to patient safety and to establish and strengthen evidence- around 2.6 million deaths (7). Overall, 60% of deaths in low- based systems necessary for improving patient safety and and middle-income countries from conditions amenable the quality of health care. to health care are due to unsafe and poor-quality care (8). People mostly link patient safety with hospital-based World Alliance for Patient Safety care; however, unsafe care is a systemwide problem. Half (2004–2014) of the global disease burden arising from patient harm originates in primary and ambulatory care (9). Subsequently, in May 2004, the Fifty-seventh World Health Assembly supported the creation of an The economic cost of unsafe care can be understood in international alliance to facilitate the development two ways: the direct cost due to resource wastage and the of patient safety policy and practice in all Member indirect costs in loss of productivity in the population. In States and to act as a major force for improvement high-income countries, up to 15% of hospital expenditure globally. In October 2004, the World Alliance for can be attributed to wastage due to safety failures. For Patient Safety was launched as a working partnership example, the National Health Service in England paid between WHO and external experts, health care leaders £1.63 billion in litigation costs because of safety lapses in and professional bodies. The creation of the World 2017–2018 (10). Alliance for Patient Safety was a hugely significant step in the struggle to improve the safety of health Unsafe medication practices and errors – such as care in all Member States. Working in partnership incorrect dosages or infusions, unclear instructions, use of with WHO, the World Alliance for Patient Safety took abbreviations and inappropriate or illegible prescriptions – on this mantle and a programme of work was rapidly are a leading cause of avoidable harm in health care initiated, backed by a substantial allocation of worldwide. Globally, the cost associated with medication foundation funding from the United Kingdom errors has been estimated at US$ 42 billion annually (11), Government (14). not counting lost wages and productivity or increased health care costs. This represents almost 1% of global The World Alliance for Patient Safety created a unique expenditure on health. Unsafe and poor-quality care leads environment in which major new initiatives arose that to US$ 1.4 trillion to 1.6 trillion worth of lost productivity individual partners were not able or willing to undertake each year in low- and middle-income countries (7). alone. It became a vehicle for sharing knowledge and resources aimed at improving the safety of health care. It Available evidence estimates the direct costs of harm, was envisaged that patient safety solutions, identified and such as additional tests, treatments and health care, in the evaluated by one or two health systems or major hospital primary and ambulatory setting to be around 2.5% of total groups, would be adapted for global or multi-country health expenditure, though this probably underestimates implementation. It was also foreseen that additional the true figure (12). Harm in primary and ambulatory care coordination and facilitation of international expertise often results in hospitalizations. Each year, these may and learning would reduce duplication of efforts and account for over 6% of hospital bed-days and more than minimize the wastage of valuable resources. 7 million admissions among member countries of the Organisation for Economic Co-operation and Development A fundamental aim of the World Alliance for Patient Safety (OECD). This is in addition to the 15% of acute care activity was to facilitate the development of patient safety policy caused by harm occurring in hospitals alone (6). and practices in Member States. It was planned that Overview of the Global Patient Safety Action Plan 2021–2030 | 3 this would be accomplished through the fulfilment of a Patient Safety Solutions programme to identify, number of core functions and other short-term initiatives develop and promote worldwide interventions to as set out by the World Alliance for Patient Safety in an improve patient safety; annual work programme. Reporting and Learning best practice guidelines to aid in the design and development of existing and Global Patient Safety Challenges new incident reporting systems; The first programme of work produced by the World Patient Safety Curriculum guides (in two editions: Alliance for Patient Safety introduced the concept of the the first for medical schools, followed by a multi- Global Patient Safety Challenge. This initiative identifies professional edition) to assist in patient safety a patient safety burden that poses a significant risk to education in universities, schools and professional health, then develops front-line interventions and institutions in the fields of dentistry, medicine, partnerships with countries to disseminate and midwifery, nursing and pharmacy; implement the interventions. Each Challenge focuses African Partnerships for Patient Safety, for building on a topic that poses a major and significant risk for sustainable hospital-to-hospital patient safety patient health and safety. partnerships. The topic chosen for the first Global Patient Safety Challenge in 2005 was health care-associated infections WHO Patient Safety Initiatives Clean Care is Safer Care (15). This topic became a key (2015–2020) element of WHO’s early work was followed a few years later by Safe Surgery Saves Lives, the second Global In 2016, a WHO Global Consultation on Setting Patient Safety Challenge (16). Both Global Challenges Priorities for Global Patient Safety provided a platform aimed to gain worldwide commitment and spark action to recognize that the scale of avoidable harm in health to reduce health care-associated infections and the risks care systems around the world was unacceptably high, associated with surgery, respectively. with few signs of improvement (17). Building on WHO’s earlier work carried out jointly with the World Alliance The scale and speed of implementation of these for Patient Safety, this led to consolidation and further Challenges were unprecedented. They secured strong development of the second phase of WHO’s global and rapid commitment from ministers of health, patient safety programme. professional bodies, regulators, health system leaders, civil society organizations and health care practitioners. WHO established major global patient safety initiatives, engaged with a large number of stakeholders and partners, and held large-scale and high-level Other initiatives of the World Alliance for consultations, including: Patient Safety The third WHO Global Patient Safety Challenge: In addition to designing and implementing the two Medication Without Harm, launched as a multi- Global Patient Safety Challenges, the World Alliance year initiative with the goal of reducing the severe, for Patient Safety established the following range of avoidable medication-related harm globally by 50% landmark initiatives in its initial work programme, which over a period of five years; continued during the Alliance’s lifetime: Global Patient Safety Network, a highly interactive Patients for Patient Safety programme, led by network established in collaboration with Member individuals who had suffered harm from health care States, health care leaders, international experts and or by their family members; professional bodies; Taxonomy for Patient Safety initiative, ensuring Global Ministerial Summits on Patient Safety consistency in the norms and terminology used initiated by the Governments of the United Kingdom in patient safety work, as well as a classification of Great Britain and Northern Ireland Ireland and framework – the International Classification for Germany in collaboration with WHO since 2016, as a Patient Safety; series of annual summits; Patient Safety Research initiative to identify World Health Assembly resolution WHA72.6 on priorities for patient safety-related research in high-, “Global action on patient safety”, adopted in May middle- and low-income countries, as well as projects 2019, and outlined a comprehensive and multifaceted and capacity-building; patient safety strategy; 4 | Global Patient Safety Action Plan 2021–2030 Global Patient Safety Collaborative, launched in together with the capacity and financial stability of collaboration with the Government of the United health care delivery systems. Situational factors, such as Kingdom to collaborate with low- and middle-income staffing shortages, staff redeployment to unfamiliar roles, countries to reduce the risk of avoidable patient and “workarounds”, all disrupted existing care processes harm; in most health systems worldwide. In addition, the World Patient Safety Day, established by World indirect effects of the virus on access to unrelated areas Health Assembly resolution WHA72.6, the first of of care emerged as another form of serious harm. Delays which was held on 17 September 2019; the 2020 arose from patients not seeking care due to fear, people event was dedicated to health worker safety and unable to go to health facilities because of lockdowns, launched a landmark charter Health worker safety: a those with complex chronic conditions not receiving priority for patient safety, among other advocacy and their routine ambulatory or preventive care due to health technical products; system overload, or COVID-19 admissions being given priority. In addition, patients experienced new types of Publication of patient safety normative guidance diagnostic errors, some related to the virus and others and tools, including the Technical Series on Safer not as much (18). Primary Care, the Safe Childbirth Checklist and accompanying implementation guide, the Minimal Despite these negative effects and risks, the COVID- Information Model for Patient Safety Incident 19 pandemic has provided some short-term benefits Reporting and Learning Systems (technical report in key areas that could be a catalyst for subsequent and guidance), and technical reports on medication improvement strategies. Shared commitment and safety, among other WHO guidance and tools; responsibility have united health care stakeholders Africa Patient Safety Initiative, a high-level forum as never before. Many have spontaneously adopted jointly organized with key partners for working with key safety attributes such as transparency, active countries in Africa to improve patient safety; communication, collaboration and rapid adoption of patient safety practices. This may only be temporary WHO Flagship Initiative “A Decade of Patient and in selected settings and countries, but it illustrates Safety 2021–2030” launched to guide and support how traditional silos and clinical territories can rapidly strategic action on patient safety at the global, dissolve in the interest of fighting a common enemy. regional and national levels. The flagship initiative’s core work involves formulation of the Global Patient It is sobering to realize that the chronic and widespread Safety Action Plan and supporting its implementation public health crisis of avoidable patient and workforce at all levels through advocacy, normative guidance harm will remain as much of a challenge as before when and tools, strategic partnerships, campaigns, the COVID-19 pandemic is over. The next five years will collaboration, patient and family engagement, be a time for the global patient safety movement to learn knowledge sharing and technical work on building from both the negative and positive effects of COVID-19. and strengthening patient safety systems and It will be a time to build safer health care systems that practices. minimize harm to patients and to health workers. This global action plan is built from a deep understanding 1.1.4 Coronavirus disease of the nature of avoidable harm in health care and the way in which it threatens patient safety in diverse and (COVID-19): a broader concept complex settings across the globe. Thinking through how of avoidable harm COVID-19 adds to this context will help to harvest patient safety lessons from both pandemic failures and pandemic In 2020, the toll of the COVID-19 global pandemic transformations. This is all part of the urgent need to brought increased recognition of risks to patients. The “build back better” and “hardwire” positive changes, to ongoing impact on health care delivery systems around promote the spread of safety strategies and innovations, the world will become clearer and fully quantified over and to make health care systems more resilient to the time. However, important patient safety implications impact of harm than ever before. have emerged, giving heightened impetus to efforts that promote safer care at every level. Growing clinical familiarity with the SARS-CoV-2 virus and its 1.2 Mandate manifestations began to reduce uncertainty, but with the new disease and its novel treatments came the greater The Global Patient Safety Action Plan 2021–2030 draws risk of avoidable harm. The physical and psychological its mandate from World Health Assembly resolution safety of health workers was widely compromised, WHA72.6 on “Global action on patient safety”. The Overview of the Global Patient Safety Action Plan 2021–2030 | 5 resolution requested the Director-General of WHO World Health Assembly in May 2021 deliberated and “to formulate a global patient safety action plan in decided to adopt the Global Patient Safety Action Plan consultation with Member States and all relevant 2021-2030. The World Health Assembly also requested stakeholders, including in the private sector”. The plan the Director-General to report back on progress in the must be submitted to the Seventy-fourth World Health implementation of the global action plan to the Seventy- Assembly in 2021 through the 148th session of the WHO sixth World Health Assembly in 2023 and thereafter Executive Board. The operating paragraphs of resolution every two years until 2031. WHA72.6 delineate the strategic and operational boundaries of this action plan (19, 20). 1.3 Development process References: Chapter 1 1. Mannion R, Braithwaite J. False dawns and new horizons in This global action plan was co-developed through a patient safety research and practice. Int J Health Policy Manag. participative process with the contribution of leading 2017;6:685–9 (https://dx.doi.org/10.15171%2Fijhpm.2017.115, international experts on patient safety. The draft went accessed 16 July 2021). through multiple rounds of stakeholder consultations 2. Institute of Medicine. Crossing the quality chasm: a new including Member States, international organizations, health system for the 21st century. Washington (DC): National academic institutions, patient groups, intergovernmental Academies Press; 2001 (https://www.nap.edu/read/10027, organizations, and WHO global, regional and country accessed 16 July 2021). offices. The initial outline and development pathway 3. Kohn LT, Corrigan JM, Donaldson MS, editors. Institute of of the action plan was developed by the Patient Safety Medicine. To err is human: building a safer health system. Flagship secretariat at WHO headquarters in Geneva, with Washington (DC): National Academies Press; 2000 the guidance and support of WHO Patient Safety Envoy, (https://www.nap.edu/read/9728/chapter/1, accessed 16 July and in consultation with relevant technical programmes, 2021). units and departments within the WHO system. A WHO 4. Department of Health. An organisation with a memory: global consultation was convened in February 2020 at report of an expert group on learning from adverse events WHO headquarters in Geneva to synthesize the first in the NHS chaired by the Chief Medical Officer. London: The Stationery Office; 2000 (https://qi.elft.nhs.uk/wp-content/ draft of the action plan. Leading patient safety experts uploads/2014/08/r_02-an-organisation-with-a-memory-l- and practitioners from 44 countries provided invaluable donaldson.pdf, accessed 16 July 2021). concrete recommendations on what should be the 5. World Health Organization, Organisation for Economic future course of global action on patient safety. Co-operation and Development & International Bank for Additional inputs were received from experts and Reconstruction and Development. Delivering quality stakeholders through the WHO Global Patient Safety health services: a global imperative for universal health Network. coverage. Geneva: World Health Organization; 2018 (https:// apps.who.int/iris/handle/10665/272465, accessed 16 July A drafting and review task force was constituted with 2021). the mandate to take forward the recommendations 6. Slawomirski L, Auraaen A, Klazinga N. The economics of from these consultations and prepare the draft action patient safety: strengthening a value-based approach to plan. The first draft was further discussed with Member reducing patient harm at national level. OECD Health Working States through regional committees and consultations. Papers No. 96. Paris: Organisation for Economic Co-operation Additional technical briefings were organized with and Development; 2017 (https://doi.org/10.1787/5a9858cd-en, permanent country missions in Geneva. The draft accessed 16 July 2021). action plan was made available online for public 7. National Academies of Sciences, Engineering, and Medicine; consultation on the WHO website for a period of one Health and Medicine Division; Board on Health Care Services; month. Feedback, comments and technical input Board on Global Health; Committee on Improving the Quality of Health Care Globally. Crossing the global quality chasm: from Member States and from the outcome of the improving health care worldwide. Washington (DC): National public consultation were reviewed and appropriately Academies Press; 2018 (https://doi.org/10.17226/25152, addressed by the drafting and review task force. An accessed 16 July 2021). advanced draft of the action plan was submitted to the 8. Kruk ME, Gage AD, Arsenault C, Jordan K, Leslie HH, 148th session of the Executive Board in January 2021 Roder-DeWan S et al. High-quality health systems in the for review, discussion and approval. At its 148th session Sustainable Development Goals era: time for a revolution. the Executive Board adapted a decision to recommend Lancet Glob Health. 2018;6(11):e1196-e1252. the global action plan for approval. The Seventy-fourth https://doi.org/10.1016/S2214-109X(18)30386-3 6 | Global Patient Safety Action Plan 2021–2030 9. Woods D, Thomas EJ, Holl JL, Weiss KB, Brennan TA. 15. World Alliance for Patient Safety. Global Patient Safety Ambulatory care adverse events and preventable Challenge 2005–2006. Clean Care is Safer Care. Geneva: adverse events leading to a hospital admission. Qual World Health Organization; 2005 (https://www.who.int/ Saf Health Care. 2007;16:127–31. news/item/13-10-2005-launch-of-the-global-patient-safety- http://dx.doi.org/10.1136/qshc.2006.021147 challenge-clean-care-is-safer-care, accessed 16 July 2021). 10. NHS Resolution presses ahead with mediation as litigation 16. World Alliance for Patient Safety. The second WHO Global decreases but claims costs continue to rise. London: Patient Safety Challenge: Safe Surgery Saves Lives. Geneva: NHS Resolution; 12th July 2018 (https://resolution.nhs. World Health Organization; 2008 (https://apps.who.int/iris/ uk/2018/07/12/nhs-resolution-presses-ahead-with-mediation- bitstream/handle/10665/70080/WHO_IER_PSP_2008.07_ as-litigation-decreases-but-claims-costs-continue-to-rise/, eng.pdf?sequence=1&isAllowed=y, accessed 16 July 2021). accessed 16 July 2021). 17. WHO global consultation: setting priorities for global 11. Aitken M, Gorokhovich L. Advancing the responsible use of patient safety. Executive summary. Geneva: World Health medicines: applying levers for change. Parsippany (NJ), United Organization; 2016 (https://www.who.int/news-room/events/ States of America: IMS Institute for Healthcare Informatics; detail/2016/09/26/default-calendar/expert-consultation-on- 2012 (https://papers.ssrn.com/sol3/papers.cfm?abstract_ setting-priorities-for-global-patient-safety, accessed id=2222541, accessed 16 July 2021). 16 July 2021). 12. Slawomirski L, Auraaen A, Klazinga N. The economics of 18. Ensuring a safe environment for patients and staff in COVID-19 patient safety in primary and ambulatory care: flying blind. health-care facilities. Geneva: World Health Organization; 2020 OECD Health Working Papers No. 106. Paris: Organisation for (https://www.who.int/publications/i/item/WHO-2019-nCoV- Economic Co-operation and Development; 2018 (https://doi. HCF_assessment-Safe_environment-2020.1, accessed 16 July org/10.1787/baf425ad-en, accessed 16 July 2021). 2021). 13. Slawomirski L, Klazinga N. Economics of patient safety: from 19. Resolution WHA72.6. Global action on patient safety. In: analysis to action. Paris: Organisation for Economic Co- Seventy-second World Health Assembly, Geneva, 20–24 May operation and Development; 2020 (http://www.oecd.org/ 2019. Geneva: World Health Organization; 2019 health/health-systems/Economics-of-Patient-Safety-October- (https://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_R6-en.pdf, 2020.pdf, accessed 16 July 2021). accessed 16 July 2021). 14. World Alliance for Patient Safety: forward programme. 20. Patient safety: global action on patient safety: report by the Geneva: World Health Organization; 2004 (http://apps.who.int/ Director-General. In: Seventy-second World Health Assembly, iris/handle/10665/70460, accessed 16 July 2021). Geneva, 20–24 May 2019. Geneva: World Health Organization; 2019 (https://apps.who.int/iris/handle/10665/327526, accessed 16 July 2021). Overview of the Global Patient Safety Action Plan 2021–2030 | 7 2. Vision, Mission and Goal Vision A world in which no one is harmed in health care and every patient receives safe and respectful care, every time, everywhere Mission Drive forward policies, strategies and actions based on science, patient experience, system design and partnerships to eliminate all sources of avoidable risk and harm to patients and health workers Goal Achieve the maximum possible reduction in avoidable harm due to unsafe health care globally 8 | Global Patient Safety Action Plan 2021–2030 3. Guiding principles C reating a system for progressing towards universal health coverage in which patients are safer than they are today, especially at the point they receive care 3.2 Achieve results through collaborative working anywhere in the world, is a major challenge. It is this With A Decade of Patient Safety 2021–2030 initiative challenge that is addressed in the Global Patient Safety as a global mandate, WHO will provide policy guidance Action Plan 2021–2030. The following seven guiding and implementation tools to countries to make health principles establish an underpinning set of values to care safer at the point of delivery. There will inevitably guide the development and implementation of the be disruptive innovations and newer models of safer framework for action proposed in the global action care evolving at local level. They should feed into global plan. The framework includes seven strategic objectives learning systems to redesign the policy architecture and and 35 strategies that are the foundation of the global promote global discourse on patient safety. Rather than action plan. a unidirectional flow of interventions, there is a need for a collaborative ecosystem whereby everybody (from 3.1 Engage patients and global policy-makers to front-line service providers) contributes, shares and learns. All patient safety families as partners in interventions will need to be carefully designed and safe care tailored to meet countries’ and communities’ priorities, as well as their specific implementation needs. WHO will Safe health care should be seen as a basic human drive harm reduction impact in every country through right. As health care is predominantly a service, it is policy dialogue, strategic support, technical assistance always co-produced with the users. Achieving safe for safer service delivery. Global action can help, but care requires that patients be informed, involved and the strength of the plan will lie in the passion and treated as full partners in their own care. In many commitment for patient safety shown at the national, parts of the world, this happens much less than it subnational and local levels. should. Patients, families and caregivers have a keen interest in their own health and that of their communities. Patient safety depends on their full 3.3 Analyse and share data involvement as the users of the health care system to generate learning and the people who are most familiar with the entire patient journey. Patients and families should Reporting systems that gather data about adverse events be involved at every level of health care, ranging and incidents from the point of care are widespread from policy-making and planning, to performance throughout the world. In 2020, WHO produced the oversight, to fully informed consent and shared document Patient safety incident reporting and learning decision-making at the point of care. Patients, systems: technical report and guidance. There are other families and communities have essential sources of such data, including malpractice claims, contributions to make in patient safety. patient-reported experience and outcome measures, clinical care audits, medical record reviews, surveys, Guiding principles | 9 significant event audits, and safety surveillance data for settings can be of value to those running programmes in blood products, medicines, vaccines and medical devices. well-resourced health care systems, as well as the usually Gathering data from these various sources provides a rich favoured “North–South” route for advocating best practice. opportunity to gain greater understanding of why safety incidents occur and to devise solutions to prevent them. However, too often, great volumes of data are collected 3.6 Use both scientific and most of the available time and resources are spent expertise and patient storing them. Less time is spent on analysing and sharing experience to improve data in a way that is usable for learning and can reliably and consistently contribute to improving patient safety. safety There are also issues of data quality and reliability, which Today, developing safe services for patients does not could best be addressed through building a culture of only involve the skills of planning, design and strategic trust in reporting. Whilst it is always of interest to use such investment, it also involves advocacy, awareness data to provide information on patterns and trends in the raising, political commitment, persuasion and localism. types of harm that occur, the emphasis must be firmly on Traditionally, the scientific and technical expertise their capability to make future care safer. comes from the policy-makers, health system leaders, health care professionals, academics and managers, whilst the passion comes from the citizens, civil society 3.4 Translate evidence organizations and patient advocates. Formulating into actionable and and delivering a plan requires scientific and technical measurable improvement expertise, but it also must have the buy-in and positive emotional drive of those who remember that too many An area of weakness in many parts of health care, past patients and families have suffered loss and serious including patient safety, is the slow translation of harm as a result of flawed health care. If these two evidence of effectiveness into routine practice: what elements – science and personal experience – are always is sometimes called the “knowing–doing” gap. There brought together in improvement, it will be a winning is also a wealth of provider and patient experience combination. and tactical knowledge available for designing and testing solutions to improve patient safety. During the process of framing actions to improve patient safety, it is 3.7 Instil a safety culture in important to fully understand the process of change the design and delivery and utilize the established body of knowledge on of health care improvement science to achieve the desired outcome. This also means working closely with leaders, managers, Developing a culture of safety is cardinal to any professional staff and patient representatives in health sustainable efforts towards patient safety improvement. Policy and legislative interventions can provide a facilities and clinical services. It is also important to conducive environment for a flourishing safety culture. nurture centres of excellence, learn from them, and scale Ultimately, though, a culture of safety has to percolate up proven best practices. into the attitudes, beliefs, values, skills and practices of health workers, managers and leaders of health care 3.5 Base policies and action organizations. The safety culture must intertwine with on the nature of the care the overall organizational philosophy and culture. Countries and organizations can identify their own setting optimal ways of achieving a culture of safety, though certain elements remain indispensable. Leadership Most of the attention and research endeavour in patient commitment, transparency, open and respectful safety has focused on the experience of high-resourced communication, learning from errors and best practices, health care systems and large hospital groups. Yet, a great and a judicious balance between a no blame policy deal of good work has been taking place in low-resource and accountability are indispensable components of settings. First, it has become clear that patient safety safety culture. A strong safety culture is not only core to policies and solutions must be adapted to the local context. reducing patient harm, it is also critical for providing a They do not simply translate from one setting to another, safe working environment for health workers. This especially where the culture, traditions, health care system includes creating a psychologically safe work design and level of infrastructure can be very different. environment, whereby health workers can speak up Second, learning is not just a one-way flow. The experience regarding patient safety and other concerns without fear of finding patient safety solutions in resource-limited of negative consequences. 10 | Global Patient Safety Action Plan 2021–2030 4. Partners in action C omprehensive action on patient safety across all countries worldwide is a complex endeavour and requires the collective efforts of numerous stakeholders, ranging from policy-makers to health workers. To achieve the goal and strategic objectives of the Global Patient Safety Action Plan 2021– 2030, it is important that partnerships develop at both the strategic and the operational levels. Collaboration in this way will add particular value to patient safety endeavours and strengthen the efforts of individual organizations. By working together to achieve the vision of the action plan and improve the safety of care for all, partners can also accelerate progress to achieve their own respective goals. As shown below, four broad categories of partners have been identified to support implementation of the global action plan. The action plan also envisages patients, families and communities as key partners at all levels of action. 4.1 Governments National and subnational governments Parliament and subnational legislative bodies Ministries of health National and subnational specialized agencies and adjunct bodies, for example, national patient safety and quality institutes, centres or agencies, including planning agencies, scheme implementation bodies, public health institutions, and occupational health agencies Other ministries directly or indirectly involved in health, including ministries of education, finance, labour and 4.2 Health care facilities social affairs, consumer affairs, justice and territorial administration and services Tertiary and secondary care facilities and health care National and subnational regulatory bodies, including organizations standard setting, licensing and accreditation agencies, Primary care facilities and service providers and health care safety investigative bodies Long-term care facilities and service providers Palliative care service providers Mental health facilities and service providers Pre-hospital care service providers Specialized clinics and diagnostic service providers Substance use disorder facilities and dementia care facilities Outreach health care service providers Community-based and home-based health care service providers Subnational and district health service management teams Partners in action | 11 4.3 Stakeholders Intergovernmental organizations, for example, European Commission, OECD International and national nongovernmental organizations International development organizations International and independent standard setting bodies and accreditation agencies International and national professional bodies and scientific associations and societies Universities, academic institutions, educational centres and other international and national training and capacity-building institutions Research institutions International and national consortiums and associations of health service providers Trade unions and other labour organizations representing health workers International and national civil society organizations, including patient organizations Community groups and organizations Media, including print, electronic and social media United Nations and other multilateral organizations Development partners, donors and funding agencies Pharmaceutical and medical devices industry Health care information technology industry Private sector entities, including commercial businesses (industry) and health service provider organizations Health insurance and maintenance organizations 4.4 The WHO Secretariat WHO at all levels – country offices, regional offices and headquarters WHO geographically dispersed offices 12 | Global Patient Safety Action Plan 2021–2030 5. Framework for action The framework includes seven strategic objectives, which can Make zero avoidable harm to 1 be achieved through 35 specific patients a state of mind and a rule of engagement in the strategies: planning and delivery of health care everywhere Build high-reliability health systems and health organizations that protect patients daily 2 Assure the safety of every clinical from harm 3 process 4 Engage and empower Inspire, educate, patients and families skill and protect to help and support health workers to the journey to safer 5 contribute to the health care design and delivery of safe care systems Ensure a constant flow 6 of information and Develop and sustain knowledge to drive multisectoral and the mitigation of risk, multinational a reduction in levels of synergy, partnership avoidable harm, and improvements in the safety of care 7 and solidarity to improve patient safety and quality of care Framework for action | 13 Framework for Action - The 7x5 Matrix 1.1 1.4 1.5 Policies to Patient safety 1.2 1.3 1 Safety World Patient eliminate policy, strategy Resource Protective standards, Safety Day and avoidable harm and mobilization and legislative regulation and Global Patient in health care implementation allocation measures accreditation Safety Challenges framework 2.3 2.4 2.2 2.5 2.1 Leadership Human 2 Good Patient safety High-reliability Transparency, capacity for factors/ governance in emergencies systems openness and clinical ergonomics for for the health and settings of No blame culture and managerial health systems care system extreme adversity functions resilience 3.3 3.4 3.2 3.5 3.1 Infection Safety of 3 Global Patient Patient safety Safety of clinical Safety of prevention and medical devices, Safety Challenge: in primary care processes risk-prone clinical control & medicines, Medication and transitions procedures antimicrobial blood and Without Harm of care resistance vaccines 4.1 4.2 4.4 4.5 4.3 4 Co-development Learning from Patient safety Information and Patient and family Patient advocates of policies and patient experience incident education to engagement and patient safety programmes with for safety disclosure to patients champions patients improvement victims and families 5.2 5.1 5.3 5.4 Health worker Centres of 5.5 5 Patient safety Patient safety Linking patient education, skills excellence for Safe working in professional competencies as safety with and safety patient safety environment for education and regulatory appraisal system education health workers training requirements of health workers and training 6.1 Information, 6.2 6.3 6.4 6.5 6 Patient safety research and risk incident reporting Patient safety Patient safety Patient safety Digital management information surveillance research technology and learning systems systems programmes for patient safety systems 7.2 7.4 7.5 Synergy, 7.3 7 7.1 Common Cross geographical Alignment with partnership Patient safety Stakeholders understanding and multisectoral technical and solidarity networks and engagement and shared initiatives for programmes collaboration commitment patient safety and initiatives 14 | Global Patient Safety Action Plan 2021–2030 Strategic objectives and articulated so that it is entirely permissible within their scope to formulate programmes of action that fit with implementation strategies local needs and priorities and that are shaped by the Few large organizations in any sector across the world specific context. They do this precisely because they are intended to empower and not to constrain. So, for operate effectively without a clear, simple set of objectives example, Objective 2 has meaning whether “high that govern strategic and operational activities and are reliability” is being developed in a teaching hospital understood and owned by all staff. Establishing these in Western Europe or in a rural health centre in a poor at high-level for a system helps to focus all existing country in West Africa. Each will be aiming to do the very policies and activities of the health care system towards a best they possibly can within their operating context and common purpose. If few in number, and appropriately resource availability. formulated, they can enable progress to be reviewed at strategic level and also at the level of the clinical team. In turn, Objective 3, which deals with the important The objectives should not create an extra burden, area of designing and operating safe care processes and nor replace existing measures of performance within pathways, is equally applicable to a high technology countries, nor in their systems and facilities. Instead, they maternity service in a large Canadian city as it is to a should serve to unify the work of the leadership, the service in a remote part of Sierra Leone trying to reduce endeavours of managers and the care of doctors, nurses maternal deaths from post-partum haemorrhage. and other health workers. They should provide a test of everything from everyday clinical work to big strategic The strategic objectives are also intended to be easily decisions about the design of health care systems. understood and envisioned, readily communicated, and They should also provide a simple public accountability have an uplifting and inspiring tone as well as being few framework.

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