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Quality of care: patient safety

by Rasika S. Jayasekara, Coordinator, Nursing Research Foundation, Sri Lanka

Health care interventions are intended to benefit patients, but they can also cause harm. The complex combination of processes, technologies and human interactions that constitute the modern health care delivery system can bring significant benefits.

However, it also involves an inevitable risk of adverse events.

The problem of adverse events in health care is not new. Studies as early as the 1950s and 1960s reported on adverse events, but the subject remained largely neglected.

A body of evidence started to emerge in the early 1990s with the publication of the results of the Harvard Medical Practice Study in 1991. Subsequent research in Australia, the United Kingdom of Great Britain and Northern Ireland and the United States of America in particular, the 1999 publication 'To err is human: building a safer health system' by the Institute of Medicine in the United States of America provided further data and brought the subject to the top of the policy agenda and the forefront of the public debate worldwide.

Extend of adverse events

Today more countries, including Canada, Denmark, the Netherlands, Sweden and other member countries of OECD are taking a serious look at the problem.

New Zealand has carried out a feasibility study on research into adverse events in public hospitals. Sri Lanka Health Service should consider this trend to protect patients as well as improving the quality of care.

Various studies have investigated the extent of adverse events. The Harvard study found that 4% of patients suffer some kind of harm in hospital; 70% of the adverse events result in short-lived disability, but 14% of the incidents lead to death.

The Institute of Medicine report estimated that 'medical errors' cause between 44,000 and 98,000 deaths annually in hospitals in the United States of America - more than car accidents, breast cancer or AIDS.

The United Kingdom Department of Health, in its 2000 report, An organization with a memory, estimated that adverse events occur in around 10% of hospital admissions, or about 850,000 adverse events a year.

The Quality in Australian Health Care Study (QAHCS) released in 1995 found an adverse-event rate of 16.6% among hospital patients. The hospitals for Europe's Working Party on Quality Care in Hospitals estimated in 2000 that every tenth patient in hospitals in Europe suffers from preventable harm and adverse effects related to his or her care (WHO 2001).

Adverse events exact a high toll in financial loss as well. The total national cost of preventable adverse medical events in the United States of America, including lost income, disability and medical expenses, is estimated at between US$ 17,000 million and US$ 29,000 million annually.

Added to these costs is the erosion of trust, confidence and satisfaction among the public and health care providers. The situation in developing countries and countries in economic transition merits particular attention.

The poor state of infrastructure and equipment, unreliable supply and quality of drugs, shortcomings in waste management and infection control, poor performance of personnel because of low motivation or insufficient technical skills, and severe under financing of essential operating costs of health services make the probability of adverse events much higher than in industrialized nations.

Despite of highest health status, most Sri Lankan people experience this situation everyday, however reporting and analyzing of adverse event are in the lower level. WHO figures suggest that developing countries account for around 77% of all reported cases of counterfeit and substandard drugs.

It is also reported that at least 50% of all medical equipment in most of these countries are unusable, or only partly usable, at any given time, resulting in neglect of patients or increased risk of harm to them and to health workers. In the Newly Independent States, about 40% of hospital beds are located in structures originally build for other purposes. This makes facilities for radiation protection and infection control extremely difficult to incorporate, with the result that such facilities are often either substandard or absent.

Where and why adverse events occur

WHO studies reveal that most of the current evidence on adverse events comes from hospitals, because the risks associated with hospital care are high, strategies for improvement are better documented, and the importance of patient trust is paramount.

But many adverse events occur in other health care settings, such as Dispensaries, nursing homes, pharmacies and patients' homes.

Every point in the process of care-giving contains a certain degree of inherent unsafety: side-effects of drugs or drug combinations, hazards posed by a medical device, substandard or faulty products entering the health service, human shortcomings, or system (latent) failures.

Adverse events may therefore result from problems in practice, products, procedures or systems. Immunization, which is given to healthy individuals, poses a particular challenge. With the decline in prevalence of vaccine-preventable diseases, concern about potential adverse events following immunization may have a negative impact on national immunization programmes and preventive health care in general.

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 providers or individual products.

Adverse drug events in the Utah-Colorado Study in the United States of America provide a dramatic example, 75% of them being attributable to system failures. Similarly, most adverse events are not the result of negligence or lack of training, but rather occur because of latent causes within systems.

For those who work on systems, adverse events are shaped and provoked by 'upstream' systemic factors, which include the particular organization's strategy, its culture, its approach towards quality management and risk prevention, and its capacity for learning from failures.

Safety is a fundamental principle of patient care and a critical component of quality management.

Strategies to enhance the safety of patients

Its improvement demands a complex system-wide effort, involving a wide range of actions in performance improvement, environmental safety and risk management, including infection control, safe use of medicines, equipment safety, safe clinical practice and safe environment of care.

It embraces nearly all health care disciplines and actors, and thus requires a comprehensive multifaceted approach to identifying and managing actual and potential risks to patient safety in individual services and finding broad long-term solutions for the system as a whole.

Thinking in terms of systems offers the greatest promise of definitive risk-reduction solutions, which place the appropriate emphasis on every component of patient safety, as opposed to solutions driven by narrower and more specific aspects of the problem, which tend to underestimate the importance of other perspectives.

WHO recommends several strategies for enhancing the safety of patients includes three complementary actions: preventing adverse events; making them visible; and mitigating their effects when they occur.

This requires: (a) increased ability to learn from mistakes, through better reporting systems, skilful investigation of incidents and responsible sharing of data; (b) greater capacity to anticipate mistakes and probe systemic weaknesses that might lead to an adverse event; (c) identifying existing knowledge resources, within and outside the health sector; (d) improvements in the health care delivery system itself, so that structures are reconfigured, incentives are realigned, and quality is placed at the core of the system. In general, national programmes should built around these principles.

Despite growing interest in the safety of patients, there is still widespread lack of awareness of the problem of adverse events. Capacity for reporting, analyzing and learning from experience is still seriously hampered by lack of methodological uniformity in identification and measurement, inadequate adverse event reporting schemes, undue concerns over breaches in confidentiality of data, the fear of professional liability, and weak information systems.

Understanding and knowledge of the epidemiology of adverse events - frequency of occurrence, causes, determinants and impact on patient outcomes, and of effective methods for preventing them - are still limited. Although there are examples of successful initiatives for reducing the incidence of adverse events, none has been scaled up to embrace an entire health system.

Practices relating to quality management in health care differ from one country and culture to another. There is a need for international standardization of terminology in definition, common methods for measurement, and compatible reporting of adverse events. These could be achieved by building on WHO's experience in the methodology of intercountry comparisons.

(The writer is Co-ordinator, Nursing Research Foundation)

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