The WHO World Alliance for Patient Safety: towards the years of living less dangerously

In May 2004, the 57th World Health Assembly supported the creation of an international alliance to improve patient safety as a global initiative. The World Alliance for Patient Safety was launched in October 2004. The Alliance brings together a broad range of partners — ministries of health, safety experts, national agencies on patient safety, health care professional associations and consumers — to achieve improvements in patient safety worldwide. Here, we provide an overview of the major priorities of the Alliance and identify some of the main challenges facing the patient safety agenda internationally.

A body of research evidence stretching back 25 years points to unsafe care as a significant source of patient morbidity and mortality.1-4 Publications such as To err is human: building a safer health system by the US Institute of Medicine and An organisation with a memory by the Chief Medical Officer in the United Kingdom have made patient safety much more visible on the policy agenda for many countries, accompanied by growing public debate on matters of health care safety.5,6 Studies of adverse events have been published recently in New Zealand, Canada and Denmark,7-9 and are under way in a number of other countries, including Spain and Brazil.

The creation of the World Alliance for Patient Safety underlines the fact that the safety of patient care is now recognised as a global issue. Even just 10 years ago, patient safety was not viewed as a core concern by most policy makers. Australia was one of the first countries to develop a comprehensive, national program of action on patient safety and has been at the forefront of international efforts. The Quality in Australian Health Care Study is widely regarded as seminal in its efforts to quantify and characterise patient safety problems on a large scale.3 A number of those involved in patient safety initiatives in Australia have stepped up to play important leadership roles internationally. Specific safety initiatives are also highly regarded. This includes long established work on incident reporting through the Australian Patient Safety Foundation and the pioneering work of the Australian Council for Safety and Quality in Health Care in areas such as open disclosure.10,11

Differences between countries inevitably mean that approaches to patient safety must be adapted to ensure their local relevance. However, there are also many common challenges for countries seeking to establish patient safety programs and initiatives. All health systems coming to grips with patient safety must address:12

• how to prevent patients being harmed during health care;

• ways of quickly detecting patient harm and unsafe care;

• strategies to ameliorate the effects of any such harm on patients, their families and health care providers; and

• ways of ensuring system-wide learning which prevents harm to future patients from similar sources of risk.

The forward program for 2005 of the World Alliance for Patient Safety sets out an important and comprehensive international program within six main action areas:12

• Patients for Patient Safety;

• Reporting and Learning;

• Taxonomy for Patient Safety;

• Solutions for Patient Safety;

• Research for Patient Safety; and

• Global Patient Safety Challenge.

Consumers of health care are at the heart of patient safety. When things go wrong, they and their families suffer from any harm caused.12 Such harm is often made worse by the defensive and secretive way that many health care organisations respond in the aftermath of a serious event.

Around the world, health care organisations that are most successful in improving patient safety are those that encourage close cooperation with patients and their families.13 Patients and their families have a unique perspective on their experience of health care and may provide information and insights that health care workers may not otherwise have known.14

The World Alliance is developing an international network of patients and patient organisations. This initiative, known as Patients for Patient Safety, will ensure that patient perspectives are an integral part of the international patient safety movement. A major strategy is to develop a cohort of patient champions drawn from different countries around the world (Box 1). Although Australia has a long tradition of consumer involvement in patient safety, in many other countries this is a new concept. A major challenge for Patients for Patient Safety is to identify the right starting point for action in varied cultural contexts across the world and in situations where a tradition of active patient involvement in health care provision may be much less established.

A central foundation for building well targeted safety initiatives is to better understand the nature of the safety problems that occur and the factors that contribute to them. Common sources of risk may otherwise go unnoticed if not reported and analysed.6

Adverse event reporting systems are emerging as a major area of interest for many countries.12 The World Alliance has worked closely with Professor Lucian Leape of the Harvard School of Public Health to produce draft World Health Organization guidelines on adverse event reporting and learning systems to help countries develop or improve these systems.16 These guidelines will be further refined with experience. Box 2 outlines important design principles for reporting systems derived from these draft guidelines.

While a growing interest in better methods of detecting patient safety problems is welcomed, the World Alliance recognises that reporting systems must be seen in their wider context. A particular need is to ensure that developments in systems of reporting are matched by developments in systems of response to what is reported.16 For example, expert analysis of reported events and timely feedback of identified risks and hazards are required.

There is a continued need to address barriers to more open reporting by health care professionals. Fear of punishment, blame, lack of feedback and inadequate organisational support emerge as common challenges across many countries.

Finally, reporting on its own will never provide a complete picture of all that may have gone wrong and all that may be important to know. Multifaceted approaches to learning are needed, incorporating a variety of methods, such as clinical audit, pooled analysis of the findings of incident investigations, and proactive identification of risks.16

Closely linked to developments in reporting systems is the potential for more systematic sharing of data and information about patient safety problems across countries. Currently, a wide range of definitions and terms are used to measure and report on patient safety problems.17 For example, in the field of medication safety, a recent Australian study showed that more than 25 different terms were in use, with 119 associated definitions.18 Such variation makes it almost impossible to usefully compare data within and across countries.

The World Alliance is working to develop an internationally acceptable framework for defining and classifying adverse events and near misses. The action area, Taxonomy for Patient Safety, seeks to define, harmonise and group patient safety concepts into a classification that will elicit, capture and analyse factors relevant to patient safety. The final product will be known as the International Patient Safety Event Classification. It is planned that this will be ready for field testing by early 2007.

Safety solutions are interventions and actions which prevent recurrence of patient safety problems and reduce risks to patients. No patient safety knowledge is more important than how to prevent harm to patients. A wide range of solutions to safety problems are already in use in a number of countries (Box 3). As a first step, the World Alliance wants to ensure that these tried and tested solutions are made widely available.

The Alliance aims to increase international collaboration to spread existing solutions and better coordinate efforts to develop future solutions. This will require input from a range of stakeholders to identify priorities relevant to diverse country needs. To spearhead this program, WHO has designated the Joint Commission on Accreditation of Healthcare Organizations and Joint Commission International as a WHO Collaborating Centre on Patient Safety Solutions.

Timely implementation of risk-reduction strategies and safety interventions remains a major stumbling block for patient safety internationally. The same errors and system failures are often repeated. Action to reduce known risks is often too slow. This is illustrated by an audit of progress in implementing action on alerts on the safe administration of intrathecal (spinal) chemotherapy within the National Health Service in England.22 Progress was slow despite the serious and high profile nature of the event to be prevented. The same audit showed worrying delays in implementation of other patient safety alerts.

Case studies such as this reveal much about the safety culture of health care. It is not yet clearly focused or organised enough to reduce potentially fatal risks to patients sufficiently rapidly. Diffusion of safer practice may follow the same trajectory as the adoption of good practice on the spread of innovation.23 Consultation with countries and experts through the World Alliance suggests the challenge is not unique to any one country.

Work on safety solutions is complemented by the action area Research for Patient Safety, which is initiating work to develop an agreed international research agenda for patient safety. This will address priorities for research in areas such as the effectiveness of safety interventions, research methodologies and the implementation of changes in safety practices. The World Alliance is also commissioning a multi-country research project to better understand sources of patient harm in a cross-section of developing and transitional countries, where far less is known about the nature of patient safety problems.

A flagship initiative of the World Alliance is the formulation of a Global Patient Safety Challenge over a 2-year cycle of action. The purpose of the Challenge is to galvanise global commitment and action on a specific patient safety topic which addresses a significant area of risk relevant to all WHO member states.12

The topic chosen for the first Global Challenge is health care-associated infection, focusing over 2005–2006 on the theme Clean care is safer care.24 Health care-associated infection is a growing threat to the safety of patient care. At any given time, more than 1.4 million people worldwide are estimated to have an infection acquired in a health care facility.24

The Clean care is safer care Challenge was launched internationally in October 2005. Australia, along with nine other countries, actively participated in the launch. The Challenge brings together the expertise of leading specialists in infection prevention and patient safety to catalyse worldwide commitment by policy makers, health care workers and patients to make Clean care is safer care an everyday reality in all WHO member states.

A key action within the Global Challenge is to promote hand hygiene in health care. Poor hand hygiene among health care providers is a worldwide problem. To provide the best scientific evidence and recommendations to health care workers, hospital managers and health authorities to improve practices, WHO has developed new Guidelines on hand hygiene in health care (advanced draft).25

The World Alliance for Patient Safety is an important vehicle for collaborative action on patient safety across the world. However, growing interest in the safety of patients among policy makers and clinical leaders must also be matched by action.

There is a continued need to build and maintain strong political will and commitment to comprehensive and sustained action. As exemplified by other high-risk industries, such as aviation, commitment is needed over the long term.

Engagement of front-line health care workers is also vital in building a more open safety culture. A key factor is the need to balance individual and organisational responsibilities for patient safety. Patient safety requires well designed processes and structures of health care delivery. Competent, conscientious and risk aware health care providers are also essential at the “sharp end”.

Australia has played a vital role in helping to establish an international agenda for patient safety. The World Alliance for Patient Safety looks to Australia to continue to play a leadership role in meeting the future challenges of the patient safety agenda internationally. Australian health care leaders and consumers are now needed in the global movement for patient safety to ensure the years ahead are years of living less dangerously.