Abstract

Patient safety is a global imperative. It has extensive implications for all WHO Member States, for all health-care workers--and for all of us when we become patients. We already know that about 10% of people who receive health care in industrialized countries will suffer because of preventable harm and adverse events (1-5). By 2006 we expect to have a greater understanding of the nature and scale of the problem in developing countries and countries in economic transition. Early indications from a pilot study being carried out suggest that the figure will be significantly higher. Recent WHO data suggest that developing countries account for around 77% of all reported cases of counterfeit or substandard drugs (6). It is also reported that at least half of all medical equipment in many of these countries is unusable or only partly usable, resulting in an increased risk of harm to patients and health workers (7). Adverse events occur in all settings where health care is provided. Most of the current evidence comes from hospitals because risks associated with hospital treatment are higher but many such events occur in other health-care settings such as physicians' offices, nursing homes, pharmacies, community clinics and patients' homes. Every point in the process of caregiving contains an inherent lack of safety. Adverse events may therefore be the result of problems in practice, products, procedures or systems. Current conceptual thinking on the safety of patients places the prime responsibility for adverse events on deficiencies in system design, organization and operation rather than on individual practitioners or products. For those who work on systems, adverse events are shaped and provoked by "upstream" systemic factors, which include the particular organization's strategy, culture, working practices, approach to quality management, risk prevention and capacity for learning from failures. Countermeasures based on changes in the system are, therefore, more productive than those that target the behaviour of individuals and their propensity to commit errors. In 2002 WHO acknowledged that, to tackle patient safety internationally, a comprehensive, multifaceted approach involving cultural change, system development and technical expertise was necessary. The Fifty-fifth World Health Assembly called upon all Member States to take action in relation to patient safety (8), following which WHO established a number of work programmes tackling systemic issues such as taxonomy, estimating hazards and the development of reporting and learning systems. The Organization also brought together its technical experts dealing with the safety of blood, injections, vaccines, drugs and medicines, pregnancy procedures and medical devices so that their individual expertise could be harnessed to find global solutions. …

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