A crucial element in the delivery of high-quality health care is patient safety. The rate of adverse events among hospital patients is an indication of patient safety. A systematic review of in-hospital adverse events revealed the median incidence of adverse events as 9.2%; 7.4% were lethal and 43.5% preventable. All the studies in the systemic review were from developed countries, as research is lacking from developing countries. In 2012, data from 10 developing countries reported adverse events ranging from 2.5 to 18.4% per country; 30% were lethal and 83% preventable. This study places patient safety as one of the major concerns of the health policy agenda in developing countries. Human resources for health deficits in developing countries constitute a major structural constraint for ensuring patient safety. The key to reducing adverse events in health care is system-based interventions rather than clinical interventions or technologies. Patient safety skills training, effective communication, and good team work are essential in improving patient safety in developing countries. Research on patient safety is needed to address the knowledge gap in developing countries.
Introduction
Health care, albeit mostly lifesaving, is not always without risk to the patient. Adverse events can occur as a result of a faulty health system, a clinical decision or clinical procedure, or problems inherent within products. Since the publication of the results of the Harvard Medical Practice study in 1991, adverse events have been reported more frequently in health care. Adverse events can be defined as unintended injuries or complications that are caused by healthcare management, rather than by the patient’s underlying disease, that lead to death, disability at the time of discharge, or prolonged hospital stays. The rate of adverse events among hospital patients is an indication of patient safety. Therefore, patient safety can be defined as the process of ensuring the non-occurrence of adverse events in health care. Patient safety has now become a public health issue. The reported incidence of adverse events in developed countries ranges from 3.8% in USA, 7.5% in Canada, 9.0% in Denmark, 10.6% in Australia to 11.7% in UK.
A systematic review of in-hospital adverse events among a total of 74,485 patients revealed the median overall incidence of hospital adverse events as 9.2%; 7.4% of the events were lethal. It further revealed that 43.5% of adverse events were preventable, and more than 56.3% of patients experienced no or minor disabilities. All the studies in the systemic review were from developed countries, as research is lacking for developing countries. In 2012, an estimate was made of the extent of harm caused by health care in some selected hospital in resource-poor countries data. Collaborating countries and agencies included the ministries of health in Egypt, Jordan, Kenya, Morocco, Tunisia, South Africa, Sudan and Yemen, and the World Health Organization (WHO) Eastern Mediterranean and African Regions in conjunction with WHO World Alliance for Patient Safety. A total of 15,548 hospital records were reviewed, out of which at least one adverse event occurred in 8.2%, with a range of 2.5–18.4% per country. As high as 30% of the cases were associated with the death of a patient. Over three-quarters (83%) were judged to be preventable. This study places patient safety as one of the major concerns of the health-policy agenda in developing countries. It also shows that the mortality and preventability of adverse events in developing countries are considerably higher than in developed countries.
Aside from direct harm to the patient, adverse events are a considerable financial burden to the healthcare system. In 1999, it was estimated that the total costs of preventable adverse events in the USA were between $17 billion and $29 billion annually. In the UK, consequent additional hospital stays alone cost about £2000 million a year, and paid litigation claims cost the National Health Service around £400 million annually, in addition to an estimated potential liability of £2400 million for existing and expected claims. In addition to these costs is the erosion of trust, confidence, and satisfaction among the public and healthcare providers. All studies on the financial burden of adverse events to the healthcare system, however, have been conducted in developed countries, with none conducted in developing countries.
Patient safety in the global agenda
The issue of patient safety made it onto the global agenda at the 55th World Health Assembly (WHA), when resolution WHA55. 18 was adopted in May 2002. At the Assembly, Member States were urged to pay the closest possible attention to the problem of patient safety, and to establish and strengthen science-based systems necessary for improving patient safety and the quality of health care, including the monitoring of drugs, medical equipment and technology. It further requested the Director-General to develop mechanisms to recognise excellence in patient safety internationally; to develop global norms and standards; to promote the framing of evidence-based policies; to encourage research on the subject; and to support Member States in several key areas. At the 57th WHA in May 2006, the Member States noted progress in the implementation of the resolution WHA55.18, and approved the creation of an international alliance for improving patient safety (World Alliance for Patient Safety) as a global initiative. The World Alliance for Patient Safety has identified six action areas : (1) Global Patient Safety Challenge 2005–2006; (2) patient and consumer involvement; (3) developing a patient safety taxonomy; (4) research in the field of patient safety; (5) solutions to reduce the risk of health care and improve its safety; and (6) reporting and learning to improve patient safety. These are discussed below.
Global Patient Safety Challenge 2005–2006
The Global Patient Safety Challenge 2005–2006 is the core element of The World Alliance for Patient Safety. It was agreed that healthcare-associated infection will be the focus. Healthcare-associated infection, also called ‘nosocomial infection’, is a major issue in patient safety, especially in developing countries. It can lead to a patient becoming more seriously ill, prolonged hospital stay, and long-term disabilities. In fact, for some, it can lead to death. Multiple factors are responsible for the occurrence of healthcare-associated infections. It can be caused by human behaviour, health-system factors, and the process of providing care.
Five action areas have been identified as key in improving safety and reducing the risk of healthcare associated infections : (1) clean environment; (2) clean equipment; (3) clean hands; (4) clean products; and (5) clean practices.
These are especially important in resource-poor countries where hospitals have unclean and untidy environments. Equipment are usually inadequate, non-functional or poorly maintained. A study conducted in Uganda revealed that almost all healthcare workers interviewed ( n = 183) knew to wash their hands; however, nurses and support staff especially were less likely to perceive that their hands could be a vector of disease transmission. Also, in the same study, it was found that healthcare workers perceived hand washing as a means of self-protection from infection rather than as a means of preventing patient to patient transmission of infection. Some of the challenges of hand washing identified were lack of availability of sinks and soap at sinks. Resource availability, occupational safety, and local understanding and attitudes about infection control must be addressed if infection control practices are to change in developing countries.
Patient and consumer involvement
The need for involving patients, relatives, or both, is crucial in issues of patient safety. They need to be fully informed when things go wrong in a healthcare setting, as they are usually the victims of the harm induced. They can also assist the healthcare system in identifying risk factors of adverse events and suggesting ways of improving patient safety. In developed countries, organisations and movements have been created that focus on patient safety, such as ‘Consumers Advancing Patient Safety’ in the USA and ‘Action against Medical Accidents’ in the UK. This is not the case in developing countries, however, where such organisations are yet to be established. The World Alliance for Patient Safety now provides the opportunity for interested countries to establish and empower patients and their relatives to be at the centre of improving patient safety.
Developing a patient safety taxonomy
A patient safety taxonomy needs to be developed. This implies the need to create clarity, consistency, and standardisation in patient safety. This will go a long way in facilitating global monitoring and reporting of adverse events and near misses. The developed standards will ensure uniform collection, coding, and classification of adverse events and near misses. It will also provide research opportunities. This taxonomy will be named the International Patient Safety Taxonomy (IPST), and will be a common information infrastructure for the World Health Oganization to support initiatives to reduce adverse events and improve delivery of high quality and safe care.
Research in patient safety
Many investigators have estimated the prevalence of adverse events in health care and also the financial consequences of the adverse events. Most studies, however, have been conducted in developed countries rather than developing countries. More pressing are research priorities on patient safety. These include (1) epidemiology of adverse events, types and rates of such events in different healthcare settings; (2) knowledge of interventions for improving patient safety practices; (3) infrastructure and organisational structure required for improving patient safety; and (4) the right information system required for monitoring and evaluating the success of patient safety practices.
The issue of research is even more crucial in developing and transitional countries, as little has been documented on the extent of patient safety problems in those countries. Therefore, The World Alliance for Patient Safety is supporting developing countries to conduct baseline surveys using high-quality research methodologies.
Solutions to reduce the risk of health care and improve its safety
The fifth action area in the World Alliance for Patient Safety is finding solutions for reducing the risk of adverse events in health care and therefore improving patient safety. The Alliance will achieve this by documenting interventions and practices that reduce the risk of health care, and also by disseminating and making solutions accessible to patient safety issues. The Alliance also hopes to advocate these solutions to major stakeholders that can assist in the implementation of these solutions to patient safety.
Reporting and learning to improve patient safety
The sixth action area in The Word Alliance for Patient Safety is reporting on adverse events, errors and near misses. The reporting serves as a source of learning and is essential in improving patient safety. Such reports should be investigated and the responses to these results geared towards improving the healthcare system to prevent recurrence of adverse events and errors in health care. The sixth theme is reporting and learning. The Alliance will develop guidelines on best practice to improve patient safety, and they will facilitate the development of new reporting systems and improvement of existing reporting systems. The core principles underlying the guideline development will be (1) reporting must be safe; (2) reporting is only of value if it leads to a constructive response; (3) reporting systems should enhance safety by learning from failures; and (4) reporting requires expertise and other human and financial resources.
The Alliance will also support governments and agencies to establish reporting systems. They will facilitate the interpretation and sharing of data to ensure that solutions can be developed.
The resource-poor countries now have the opportunity to partner with the World Alliance for Patient Safety to establish all the six action areas mentioned above as a step to protecting patient safety within their healthcare systems.
Factors contributing to unsafe care
One crucial component of delivering high-quality health care is patient safety. The research priority working group of the World Alliance for Patient Safety have identified 23 key factors that contribute to unsafe care, which are further categorised into structural factors, process, and outcome. A recent review conducted by another expert group of the same Alliance concluded that studies are limited in scope and number, and that they have been carried out to assess and measure structure, process and outcome of adverse events that are associated with health care in developing and emerging countries. This knowledge gap makes it difficult to propose solutions on patient safety issues in developing and transitional countries.
Structural factors
A major contributor to unsafe care is the breakdown of a healthcare system’s organisational structure. The fact that the healthcare system is complex and involves many interdependent organisations (e.g. administrators, professional bodies, legislators and manufacturers) further complicates a breakdown and is a major cause of unsafe care. This breakdown may occur at different levels of the system. The expert group of the Alliance identified inadequate number of qualified healthcare providers worldwide as a key structural factor affecting patient safety. A deficit of 24 million doctors, nurses and midwives has been estimated globally in about 57 countries. This is a huge challenge and an even greater challenge in developing countries. An assessment in 47 countries of sub-Saharan Africa revealed a critical shortage of healthcare workers, the deficit amounting to 2.4 million doctors and nurses. For every 10,000 population, two doctors and 11 nursing or midwifery personnel were reported compared with 19 doctors and 49 nursing and midwifery personnel per 10,000 for the Americas, and 32 doctors and 78 nursing and midwifery personnel per 10,000 for Europe. In high-income countries, 28 doctors and 87 nurses and midwifery personnel per 10,000 were reported for high-income regions of the world; in low-income countries, only five doctors and 11 nurses and midwifery personnel were reported per 10,000 in low-income regions. Undoubtedly, this human resource for health deficit in developing countries constitute a major constraint for ensuring patient safety in these low-resource countries.
Another related factor is the over-stretching of the healthcare system beyond what it can provide, mitigating the provision of optimal care. Other structural factors identified are communication breakdown, ‘burn-out’ among healthcare workers, lack of organisational patient safety culture, and lack of human ability to use technology effectively. As stated above, although most of the issues identified have been drawn from data on developed countries, the same can be said for developing countries.
Process factors
The process factors identified are misdiagnosis, lack of adequate follow up of tests with appropriate treatment in a timely manner, counterfeit and substandard drugs, and unsafe injection practices. If as high as 10–15% of diagnoses are incorrect in developed countries with sophisticated technology, it is safe to assume that the percentage of misdiagnosis will be higher in developing countries. Delay or lack of adequate follow up of tests is not just particular to developed countries, where up to 50% of critical laboratory tests are not followed up with appropriate treatment. Studies in developing countries have also shown suboptimal follow up of tests. World health organization figures estimate that up to 77% of reports of counterfeit and substandard drugs are from the developing countries. Counterfeit and substandard drugs are defined as missing or wrong active ingredients and mislabelled drugs. Use of these drugs can lead to serious adverse events, such as treatment failure, drug resistance or even death. World Health Assembly continues to express great concern about the quality, safety and efficacy of medicines, particularly those products imported or produced in developing countries.
Outcomes of unsafe health care
Outcomes of unsafe health care identified by the working group of the Alliance of patient safety include the following: (1) adverse drug events; (2) adverse medical device events; (3) surgical adverse events; (4) nosocomial infections; (5) unsafe blood transfusion leading to blood borne infections such as HIV, Hepatitis B and C, syphilis, and malaria.
In developed countries, between 7.5% and 10.4% of hospitalised patients experience adverse drug events, with an estimated 140,000 deaths in the USA alone and 28–56% of adverse drug events said to be preventable. Studies conducted by the World Health Organization in developing countries suggest that patients are placed in great danger of medical device adverse events owing to poorly maintained or improperly replaced medical equipment. In a large multicentre, retrospective patient record review in developing and transitional countries published in 2012, one of the most common types of adverse events was peri-operative. It revealed that about 18% of people who had undergone surgery suffered adverse events, with a range from 7–47% across different countries.
An estimated 25–40% of hospitalised patients develop hospital-acquired infections in developing countries. Factors that increase the risks of nosocomial infections are intensive care admission, prolonged catheterisation, prolonged immobilisation, and surgical procedures. Unsafe blood transmission account for an unacceptable 5–15% of HIV transmission in developing countries.
Quality assurance in maternal health
One of the major adverse events in health care, particularly in developing countries, is maternal death. Following the same factors as above, quality assurance in maternal health was assessed in Northern Nigeria in 2010 in 10 hospitals. The assessment revealed that all the three parameters of quality of structure, quality of process and quality of outcome are interrelated. Similarly, the three parameters are needed if improvement of quality care in maternal health (MDG5) and child health (MDG4) is to be achieved, especially in developing countries. We were able to show that, using the score criteria for assessing the quality of structure in terms of infrastructure, equipment conditions, and hygiene conditions of the theatre, delivery room, neonatal unit, and perinatal clinic, hospitals with the lowest score of 20–40 had the lowest maternal mortality rate of about 500 maternal deaths per 100,000 births; hospitals with the highest score of 45–50 had the highest maternal mortality rate of 2000 maternal deaths per 100,000 births ( Figs. 1 and 2 ). This clearly shows that hospitals with a better quality structure had a better maternal mortality rate, and those with a poor quality structure had a poorer maternal mortality rate. This study further shows that, without improvements in the quality of the infrastructure of health facilities (e.g. hygiene and equipment), all maternal health interventions will a have minimal effect on maternal health statistics. Unfortunately, most healthcare facilities in developing countries are faced with the challenge of poorly maintained equipment, or even non-functioning equipment, poor hygiene, and general lack of adequate infrastructure. We can, therefore, conclude that improving patient safety in maternal healthcare services in developing countries demand improvement in quality of structure, quality of process and quality of outcome of our health facilities.
Adverse drug events
Another major patient safety issue is adverse drug events. Adverse drug reactions (ADR) contribute considerably to increased morbidity and mortality in the health system. Although little has been reported on adverse drug reaction in developing countries, many studies have reported prevalence of ADR in hospital admissions in developed countries. A meta-analysis of studies in the USA revealed the prevalence of ADR as 6.7% of hospital admissions. Similarly, in the UK, a prevalence of ADR of 6.5% of hospital admission was reported, with median bed stay of 8 days and overall fatality as 0.15%. The financial burden was reported as fairly high, and and most (70%) adverse drug reactions were said to be preventable. What is also disappointing is that the prevalence of ADR has not reduced in the past 20 years. The situation may be worse in developing countries, as their health system is faced with challenges of fake, counterfeit or substandard drugs.
Healthcare-acquired infection
Nosocomial infection, also known as healthcare-acquired infection (HAI), is defined as an infection acquired by a patient on admission to a healthcare facility or appearing immediately after discharge that was not manifesting or incubating at the time of admission. Nosocomial infection is a major global patient safety concern. In developed countries, the burden of HAI, has been frequently reported, with a prevalence of 5–15% of patients on admission in regular wards, and as high as 50% or more in patients admitted to intensive care units. Although not much has been documented on the magnitude of HAI in developing countries, evidence shows that its magnitude is higher than in developed countries. A recent meta-analysis of studies conducted in Africa on HAI revealed a prevalence of between 2.5% and 14.8% in total hospital admissions, and the prevalence in surgical wards ranged from 5.7% to 45.8%. Catheter-related urinary tract infection, surgical site infection, and hospital-acquired pneumonia are the three most common HAI in developing and developed countries, with blood-stream infection as the fourth most common HAI in developed countries. As stated previously, the burden of HAI on the health system is high, and has been documented for developed countries; however, even a meta-analysis conducted in Africa found no studies where the cost of HAI was estimated. Prolonged hospital stay, however, is one of the consequences of HAI. In a study in Burkino Faso hospital stay of 10 days longer in patients with HAI was reported. With lack of adequate infrastructure in most of the health facilities in developing countries, prolonged hospital stay will further increase burden on the already compromised healthcare system.
Some of the measures used in preventing HAI in developing countries include establishment of hospital infection control committees, training of healthcare workers on infection control, and development of policies on hand hygiene. Others include policies on antibiotic use in hospitals and policies on medical waste management. As stated earlier, the World Alliance for Patient Safety have identified five key areas for improving patient safety, which includes clean hands, clean environment, clean practices, clean equipment, and clean products. The World Health Organization African Regional Office, in collaboration with World Health Organization Patient Safety, have also developed a technical paper on patient safety, detailing 12 key action areas, including the reduction of HAIs. It has been endorsed by all 46 African Member States. The effort of the World Health Organizaztion and other organisations will no doubt go a long way towards addressing the burden of HAIs in Africa.
Surgical adverse events
One of the common sites for adverse events in health care is the operating theatre. A review of surgical records across 11 hospitals revealed 14.6% surgical adverse events, with 8.7% of the events resulting in permanent harm or even death. The review also showed that the common causes of these surgical adverse events are surgery-related injuries, bleeding related to the surgery, and wound infections. One of the key factors identified as responsible for most of these surgical adverse events are lack of effective communication and good team work. A common cause of inadvertent patient harm is communication failure. The operating theatre and the aviation industry have been described similarly as high risk and a stressful environment. In both industries, professionals work with high technology with challenges from various environmental sources. The aviation industry has greatly reduced errors by introducing crew resource management, which has standardised teamwork and communication ; however the operating theatre has not been achieved this. Against a background of a poor patient safety record in the operating theatre, the World Health Organization developed a surgical safety checklist in 2008. Pre-surgical briefings using checklists are designed to prepare teams to counter threats and minimise potential errors. Studies have shown that pre-surgery briefings reduce communication errors. Team communication and cohesion is also improved with briefings. Despite this knowledge, pre-surgical briefings are not routine in many operating theatres, especially in developing countries. It has been stated that a unidirectional change in attitude is essential to create a safety climate in the operating theatre, and that briefings will continue to be difficult to establish without team-based, patient-safety education. The need to establish checklists and pre-surgical briefings in the operating theatre in developing countries cannot be over emphasised. This will lead to effective communication and good team work, with resultant improved patient safety.
Patient- safety skills and competences
Essential to patient safety is the healthcare system itself; however, the people working in the healthcare facilities are crucial to attainment of safe health care. Quality of care in terms of patient safety is now being integrated into the medical training prgrammes. Being conscientious, disciplined, honest, and humble are some of the qualities of a safe healthcare provider. Patients safety, especially in complex health systems, requires much more than that. Resilience, flexibility, anticipation, preparedness, and awareness of hazards are some of the qualities identified for highly-reliable organisations. It is important that these qualities are affected by clinicians in training; therefore, patient safety is now being in incorporated into the curriculum of both undergraduate and postgraduate trainings. Most curricula, however, contain issues related to the role of the health system in avoidance of adverse events and do not particularly contain qualities of the healthcare provider that ensures patient safety. A study conducted in a clinical safety research unit, in conjunction with an NHS trust, identified 73 patient safety skills in 18 categories. The most important being technical skills, crisis management, honesty, and the least important being patient awareness, empathy, humility and open-mindedness. Most qualities are felt to be trainable, with the most trainable being technical skills, organisational skills, efficiency, anticipation, and preparedness. The least trainable are conscientiousness, humility, and open-mindedness. These skills identified can be further refined and developed into a formal taxonomy for qualities and skills of a safe healthcare provider. Hopefully, incorporating these safety skills into training curricula can be the catalyst to creating safe clinicians today and for the future. These safety skills identified, however, were from studies in developed countries. Hence, studies need to be conducted in developing countries to identify patient safety skills that assist healthcare providers to provide safe health care. Education and training of healthcare professionals in developing countries on patient safety skills will go a long way in ensuring patient safety in the health system. It has been reported that, even a half day training on safety skills, achieves positive educational outcome, which can help maintain the momentum of patient safety once integrated into the training curriculum of healthcare professionals. Being a new area of education, patient safety competences need to be assessed as part of the educational process. This is, however, a challenging task, as no reliable and valid assessment tool is available for patient safety competences. Of all the assessment tools identified, no single tool covers all the safety competency levels.
Patient safety researches in developing and transition countries
One of the major limitations to conducting patient safety research in developing and transitional countries is the shortage of trained patient safety researchers. Therefore, a surgical patient safety training programme has been developed to provide the foundation of the core competences necessary to conduct robust patient safety research in developing and transition countries as defined by the World Health Organization competences framework.
Data collection for patient safety research in developing and transition countries
Most studies carried out in patient safety in developed countries are based on use of retrospective review of medical records, although other methods used are incident reporting, routine hospital data, claims and complaints analysis, central, national, or regional audits, or enquiries. In developing and transition countries, most data are not routinely collected. The quality and detail of information recorded in the patient’s case note in those data collected are insufficient to support any meaningful retrospective review. Therefore, patient safety studies in developing countries can only be conducted in major hospitals with good record keeping. Where data are incorrect, incomplete or inaccessible, other methodologies will have to be used. That was why the World Health Organization Patient safety expert advisory working group on advancing methods and measures developed a methodological guide for data-poor hospitals. The group identified the following as possible methodologies for data collection in patient-safety studies in data-poor hospitals.
Retrospective record review
The retrospective record review is a commonly used method of data collection and uses readily available information from archived patient’s record. It is based on a two-phased data collection by external reviewers. Its major disadvantage is that it relies on the information recorded in patients’ records, and therefore it cannot be used in smaller health facilities with poor health records.
Record review of current inpatients
A record review of current inpatients is a cross-sectional survey that estimates the point prevalence of adverse events using the records of current patients on admission into hospital. It therefore assesses the adverse events on that particular day. This method is more efficient, less time-consuming, and easier to perform than the retrospective record review. It also has the advantage of identifying current trends and problems in care rather than past problems. Healthcare professionals can also provide additional information if required.
Direct observation and related interviews
Direct observation and related views is based on interviews with hospital staff instead of review of patients record. It also measures the point prevalence of adverse events and the factors that contribute to such events. This method can be used in healthcare facilities that have poor record keeping, hence its advantage in developing countries.
Daily, regular nominal group meetings
Daily, regular nominal group meetings use structured interviews with key informants to gather information about a given issue. This method relies on participants’ subjective perception of harm, and does not aim to measure the extent of patient harm. It does not require extensive training and can be implemented quite rapidly, usually carried out by a person with local knowledge of the facility.
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