WHO-HIS-SDS-2017.6-eng

Medication Without Harm WHO Global Patient Safety Challenge

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Foreword In the last decade, the WHO Patient Safety Programme has raised awareness across the world of the key concepts and strategies in patient safety. It has inspired passion for the universal cause of making health care safer. It has secured commitment at the highest level among health ministers and health leaders in Member States of WHO. It has provided standards, evidence-based guidance and practical tools to support those involved in the design of patient safety programmes within countries’ health care systems. It has championed the use of the stories of patients and families who have been the victims of unsafe care. More than 10 years ago, with colleagues Significant portions of the Programme’s initial in the World Health Organization (WHO), work have been delivered and a new direction I was involved in establishing the foundation and new priorities are now required for the programme of a global patient safety initiative next phase in this programme. Moreover, that was the first of its kind. It was wide- the global context of patient safety as a ranging and led to the launching of two Global science has evolved considerably since Patient Safety Challenges. It also created the creation of the Programme. At the time, a programme led by patients and families there were few, if any, national agencies who had suffered avoidable harm from health with a recognized mandate to work on patient care, and it set a clear agenda for research safety and virtually no training and education and development, among many other areas programmes in patient safety globally. of work aimed at improving safety globally. Currently, many Member States have active safety and quality programmes, campaigns and agencies, although some still ask the World Health Organization to provide implementation assistance. The WHO Patient Safety Team has received strong feedback from major stakeholders and 1 Global Patient Safety Challenge | MEDICATION WITHOUT HARM

experts that a third global patient safety and leading world experts and stakeholders challenge should be the first of these new have given invaluable advice and support. priorities and would be greatly welcomed. In participating in the work to create this third The Global Patient Safety Challenge is Global Patient Safety Challenge, I have been essentially a programme of change aimed driven and inspired by three things. Firstly, at improvement and risk reduction. The an awareness of studies in the 1960s that programme blends evidence-based identified sources of medication error that can, interventions with multi-modal implementation and do, kill and harm patients in hospitals strategies. They seek to achieve widespread around the world today, nearly sixty years on. engagement and commitment. They span Secondly, that there are many individuals and the needs of all countries. They are most groups in the fields of pharmacy, medicine, impressive when they develop the features nursing, and other professions, who have been of a social movement, as the first and second fighting for decades to see the day when challenges managed to do. medication safety would become a global priority; their passion has always been to save I was delighted and honoured, two years ago, lives from this long-standing intractable type of when Assistant Director-General, Dr Marie- avoidable harm. Thirdly, over the years, I have Paule Kieny, asked me to advise on the design spoken to many people who have lost loved of a third Global Patient Safety Challenge ones to medication-related harm; their stories, on medication safety. Dr Kieny and WHO’s their quiet dignity and their acceptance of Director-General, Dr Margaret Chan have situations that should never have arisen have given me, as well as the world’s patient safety moved me deeply. It is to the memories of all community, unfailing support in continuing those who have died due to incidents of unsafe to pursue the goal of safer care as a core care that this Challenge should be dedicated. component of universal health coverage. In the hard work of bringing this historic Sir Liam Donaldson Challenge to life, the WHO Secretariat WHO Envoy for Patient Safety MEDICATION WITHOUT HARM | Global Patient Safety Challenge 2

Global Patient Safety Challenges Global Patient Safety Challenges identify a The scale and speed of implementation patient safety burden that poses a significant of these Challenges remains unprecedented. risk to health, then develop frontline They secured strong and rapid commitment interventions and partner with countries to from health ministers, professional bodies, disseminate and implement the interventions. regulators, health system leaders, civil society Each Challenge focuses on a topic that poses and health care practitioners. Their success a major and significant risk to patient health resulted from the following solid basis and and safety. WHO provides leadership and achievements: guidance in collaboration with Member States, stakeholders and experts, to develop and • an evidence-based analysis of the key implement interventions and tools to reduce problems and proposed solutions; risk, improve safety and facilitate beneficial change. • an invitation to Member States and other relevant parties to pledge, or sign up, Previous Global Patient Safety to address the aims of the Challenge; Challenges • high-profile actions to generate passion Beginning in 2004, the World Health and enthusiasm; Organization (WHO) working in partnership with the (then) World Alliance for Patient Safety, • facilitation of implementation by the WHO initiated the two previous Global Patient Safety Secretariat and associated experts and Challenges: Clean Care is Safer Care, followed advisers; a few years later by Safe Surgery Saves Lives. Both aimed to gain worldwide commitment • strong leadership and extensive internal and spark action to reduce health care infection and external communication. and risk associated with surgery, respectively. 3 Global Patient Safety Challenge | MEDICATION WITHOUT HARM

The third Global Patient Safety Challenge Medication Without Harm WHO is initiating the third Global Patient Every person around the world will, at some Safety Challenge with the theme of medication point in their life, take medicines to prevent safety. It is set within the philosophy of patient or treat illness. Medicine has forever altered safety previously developed by WHO, namely our ability to live with disease and generally that errors are inevitable and provoked in increased the duration of our lives. However, large part by weak health systems, and so medicines do sometimes cause serious harm the challenge is to reduce their frequency if taken incorrectly, monitored insufficiently and impact. The Challenge was launched or as the result of an error, accident or in March 2017, at the Global Ministerial communication problem. Summit on Patient Safety in Bonn, Germany. By seeking the commitment of high-level Experience from other high-risk industries, delegates, ministers of health and experts, and WHO’s longstanding work with experts the launch created an opportunity for leaders in health care safety, demonstrate that human to drive change and work together to make beings make mistakes rarely through neglect, real difference to the lives of patients, but instead because the systems, processes families and health workers at the frontline. and procedures that they work with are often This Challenge will draw on the experience flawed or dysfunctional. This inevitably gives accumulated during the previous Challenges rise to errors and medication harm is no and will drive a process of change to reduce exception to this rule. All medication errors patient harm generated by unsafe medication are potentially avoidable. They can thus be practices and medication errors. greatly reduced or even prevented by MEDICATION WITHOUT HARM | Global Patient Safety Challenge 4

improving the systems and practices of which can then result in severe harm, medication, including ordering, prescription, disability and even death. preparation, dispensing, administration and • Errors occur most frequently during monitoring. Given that the subject is so vast, administration, however there are risks the approach of this third Challenge aims at different stages of the medication to save lives and reduce the medication- process. related harm caused by unsafe practices and errors, by specifically addressing Overall goal the weaknesses of service delivery and developing more effective health care systems. The Global Patient Safety Challenge on Medication Safety focuses on improving Severity of the problem medication safety by strengthening the systems for reducing medication errors • Unsafe medication practices and medication and avoidable medication-related harm. errors are a leading cause of avoidable harm in health care systems across the world. Reduce the level of severe, avoidable harm related to • The scale and nature of this harm differs medications by 50% over between low-, middle- and high-income 5 years, globally countries. Globally, the cost associated with medication errors has been estimated The goal of the third Global Patient Safety at US$ 42 billion annually. Challenge on Medication Safety is to gain worldwide commitment and action to reduce • Patients living in low-income countries severe, avoidable medication-related harm experience twice as many disability-adjusted by 50% in the next five years, specifically life years lost due to medication-related by addressing harm resulting from errors harm than those in high-income countries. or unsafe practices due to weaknesses in health systems. The Challenge aims to make • Medication errors occur when weak improvements at each stage of the medication medication systems and/or human factors process, including prescribing, dispensing, such as fatigue, poor environmental administering, monitoring and use. conditions or staff shortages affect prescribing, transcribing, dispensing, administration and monitoring practices, 5 Global Patient Safety Challenge | MEDICATION WITHOUT HARM

Objectives of the Global Challenge on Medication Safety The Global Patient Safety Challenge on dispensing, administration and monitoring Medication Safety will facilitate a strength- practices, which can be adopted and ening of systems and practices that can adapted by Member States. initiate corrective action within countries to improve patient safety and decrease 3. DEVELOP guidance, materials, avoidable harm related to medications. technologies and tools to support the setting up of safer medication use systems In order to achieve this, the Challenge for reducing medication errors. will adopt five specific objectives. 4. ENGAGE key stakeholders, partners and 1. ASSESS the scope and nature of industry to raise awareness of the problem avoidable harm and strengthen the and actively pursue efforts to improve monitoring systems to detect and track medication safety. this harm. 5. EMPOWER patients, families and their 2. CREATE a framework for action aimed carers to become actively involved and at patients, health professionals and engaged in treatment or care decisions, Member States, to facilitate improvements ask questions, spot errors and effectively in ordering, prescribing, preparation, manage their medications. MEDICATION WITHOUT HARM | Global Patient Safety Challenge 6

Shaping the Challenge – the Strategic information. Confusing ‘look-alike sound- Framework alike’ medicines names and/or labelling and packaging are frequent sources of error The lessons for success drawn from earlier and medication-related harm that can be Global Patient Safety Challenges include addressed. high visibility, political and professional commitment, multileveled ‘spearheading’ • Health care professionals sometimes interventions and WHO’s ability to lead prescribe and administer medicines in ways and mobilize the global community to reach and circumstances that increase the risk the proposed goals. The Strategic Framework of harm to patients. for this Challenge should galvanize commitment to reduce medication errors • Systems and practices of medication and medication-related harm and strengthen are complex and often dysfunctional, and measurement and safety monitoring can be made more resilient to risk and harm systems. if they are well understood and designed. Four fundamental problems lay the ground The actions planned in this Challenge are for the strategic framework: based on four domains of work, one for each fundamental problem identified. These are: • Patients and the public are not always • patients and the public medication-wise. They are too often made • medicines to be passive recipients of medicines • health care professionals and not informed and empowered to play • systems and practices of medication. their part in making the process of medication safer. In each of these domains, there are many ways in which using medications can cause • Medicines are sometimes complex and avoidable harm. There are many ways, too, can be puzzling in their names, or packaging in which care could be made safer. and sometimes lack sufficient or clear 7 Global Patient Safety Challenge | MEDICATION WITHOUT HARM

Key action areas The actions embraced by the Challenge fall into three categories: Early priority actions. Ask countries and key stakeholders to make strong commitments, prioritize and take early action, and effectively manage three key areas to protect patients from harm, namely: • high-risk situations • polypharmacy • transitions of care Developmental programmes. Ask countries to convene experts, health care professionals and leaders, key stakeholders and patient representatives to design targeted programmes of change and take action to improve safety in each of the four domains of the Challenge framework: 1) patients and the public; 2) medicines; 3) health care professionals; and 4) systems and practices of medication. Global action. WHO aims: a) to provide guidance and develop strategies, plans and tools to ensure that the medication process has the safety of patients at its core, in all health care settings; b) to strengthen human resource capacity through leadership development and skill-building; c) to strengthen the quality of monitoring data; d) to promote and support research in this area as part of the overall agenda of patient safety research; e) to continue engaging with regulatory agencies and international actors and continuously improve medication safety through improved packaging and labelling; and f) to develop mechanisms for the engagement and empowerment of patients to safely manage their own medications. MEDICATION WITHOUT HARM | Global Patient Safety Challenge 8

A mother’s call for medication without harm My oldest daughter, Martha went to study our daughter had suffered a fatal cardiac nursing with a strong desire of caring for arrhythmia. the sick. But she had some health concerns of her own. She had chronic hypokalemia Although a tragic series of medical errors or low potassium that required and the adverse medication reaction took supplementation from time to time and her Martha’s life, no reporting took place and EKG’s were always abnormal. Even when her death was simply identified as ‘natural’. further cardiac tests were done, the It took six years of great effort, extensive abnormal results were seen as normal for media coverage, and two further death her and the results were simply filed away, reviews to finalize Martha’s death and Martha and I remained unaware of her investigation and create meaningful changes heart condition. Later, she developed mood to help prevent similar fatalities. So as swings that were seen as symptoms of patients and families, what can we do bipolar affective disorder and she was to help avoid medication-related harm? prescribed lithium which helped to regulate There are two things that stand out: her moods. We read the information sheet 1) We can encourage reporting and can together and looked up the drug online, even report an adverse medication event but we were not aware of a warning in her ourselves; and 2) We can take an active medical file specifically advising against role in the patient’s own medical care prescribing lithium and we were not told and medication management. of severe adverse reactions to look for. Even though her heart began to race at Let’s honour those like Martha who have times, the lithium dosage was increased. been harmed, not by covering up what Then 13 days later, her father went to wake happened, but by demanding transparency her up one morning, and found Martha on and centralized reporting so these tragic her bedroom floor where she had died. events can lead to improved medication She had not been able to get to the door safety for everyone. to call for help. At just twenty-two years old, 9 Global Patient Safety Challenge | MEDICATION WITHOUT HARM

High-risk situations the medicines are appropriately prescribed and administered, to ensure that they The impact of medication errors is greater produce direct and measurable benefits in certain clinical circumstances, such as with with minimal side effects. The standardization inpatients in hospital, rather than in ambulatory of policies, procedures and protocols care. This may be related to the more acute is critical to polypharmacy. This applies or serious clinical situations in these settings from initial prescribing practices, to regular and the use of more complex medication medication reviews. regimes. Young children and the elderly are more susceptible to adverse outcomes, Patients can play a vital part if provided as well as those with concomitant kidney with the right information, tools and resources or liver disease. Medication errors in these to make informed decisions about their circumstances often involve the administration medicines. Technology can also serve of the wrong dose, use of the wrong route, as a useful aid. and a failure to follow treatment regimens. Understanding the situations where the Transitions of care evidence shows there is higher risk of harm from particular medicines, is key to this Transitions of care occur when a patient Challenge. Tools and technologies may help moves between facilities, sectors and staff health care professionals using high-alert members; for example: a transfer from the medications (those that are associated with emergency room to the intensive care unit, a high risk of severe harm if used improperly), from a nursing home to a hospital, from and also enhance patient knowledge and a primary care doctor to a specialist, or from understanding of these medications. one nurse to another during a shift change. Transitions of care increase the possibility Polypharmacy of communication errors, which can lead to serious medication errors. Patients are Polypharmacy is the routine use of four or at increased risk during transitions of care more over-the-counter, prescription and/or and so serious mistakes can and do occur traditional medications at the same time at these times, in particular. by a patient. Polypharmacy has increased dramatically with greater life expectancy Good communication is vital, including and as older people live with several chronic a formal comparison of medicines pre- diseases. Polypharmacy increases the and post-care, so-called medication likelihood of side effects, as well as the risk reconciliation. Patients can be valuable of interactions between medications, and and active participants in this process may make adherence more difficult. If a by maintaining a current medicine list patient requires many medicines, they must that is updated when any medicine changes be utilized in an optimal manner, so that occur. MEDICATION WITHOUT HARM | Global Patient Safety Challenge 10

Political leadership, commitment and support The third Global Patient Safety Challenge on Medication Safety invites WHO Member States to prioritize medication safety at the national level. Demonstrable commitment and leader- ship are needed to significantly reduce the level of severe, avoidable harm related to medications in their countries over a period of five years. The emphasis is on countries working out their own priorities and action programmes using the Challenge framework to support their work. A five-point plan has been developed to facilitate adoption: 1. Take early action to protect patients from harm arising from: high-risk situations; polypharmacy; and transitions of care. 2. Convene national experts, health system leaders and practitioners to produce guidance and action plans for each of the targeted domains. 3. Put mechanisms in place, including the use of tools and technologies, to enhance patient awareness and knowledge about medicines and medication use process, and patients’ role in managing their own medications safely. 4. Designate a national coordinator to spear- head the Global Patient Safety Challenge on Medication Safety. 5. Assess progress regularly. The success of the Challenge will depend on the high prioritization of medication safety within health care systems, achieving wide- spread buy-in by stakeholders, a shift to the mainstream of care provision activities and taking concrete action to prevent harm. 11 Global Patient Safety Challenge | MEDICATION WITHOUT HARM

WHO action 10. Mobilize resources to enable full and successful implementation of In driving forward the Global Patient Safety the Challenge. Challenge on Medication Safety, WHO will provide support in 10 key areas: Throughout the implementation process, WHO will also seek to develop a much greater 1. Lead the process of change and take understanding of the special problems global action to make progress on the of medication-related harm in low- and domains of the Challenge framework. middle-income countries and to reshape the Challenge to meet needs in diverse settings. 2. Facilitate the development and implementation of country programmes. Collaboration and partnerships 3. Commission expert reports to provide Working with international experts, partners a starting point for in-country work and interested stakeholders, WHO will develop to develop guidance and action plans the guidelines, tools, technologies and in each of the domains of the Challenge. materials needed, and work in close collaboration with countries to implement 4. Develop strategies, guidelines, plans the Challenge. and tools to ensure safety of medication practices. Who should act as a catalyst for change? Ministries of health and health system leaders 5. Publish a strategy setting out research Educational and research institutions priorities and mobilize resources for an Regulatory authorities international research study on hospital Health care professional societies admissions due to medication effects. Patient advocacy groups Donors and development partners 6. Hold regional launch events in each WHO Pharmaceutical industry region following on from the global launch. In addressing the overall goal and action areas of the Challenge, WHO will work with a wide 7. Create and implement a communications range of stakeholders including: ministries of and advocacy strategy and a global health, national coordinators or programme campaign, and produce promotional managers for medication safety, health system and educational materials. leaders, experts, educational institutions, researchers, safe medication practice centres, 8. As part of the WHO Patients for Patient regulatory agencies, patient representative Safety programme, ensure that patients bodies and professional societies and industry. and families are closely involved in all aspects of the Challenge and develop a tool to help patients protect themselves from harm. 9. Monitor and evaluate impact of the Challenge. MEDICATION WITHOUT HARM | Global Patient Safety Challenge 12



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