Patient Safety: "Do No Harm"

by Sir Liam Donaldson

The maxim "First, do no harm" is attributed to Hippocrates. Scholars debate whether he actually said it, but it endures as an elegantly simple expression of what should be the cardinal rule in health care: We health care providers are called to improve patients' health, not to make it worse by our errors.

Yet in fact, medical errors and other adverse events in health care are major contributors to the global burden of disease and death. A 1999 study by the Institute of Medicine in the United States found that medical errors cause as many as 98,000 U.S. deaths annually—more than the number of deaths due to breast cancer, car accidents or AIDS. Studies in the United Kingdom indicate that one in 10 patients suffers an adverse event while hospitalized. Similar rates are found in New Zealand and Canada, and in Australia, the rate is 16.6 percent.

Data are more difficult to come by in developing countries. But according to the World Health Organization (WHO), half or more of medical equipment in those countries is unsafe, and 77 percent of all reported cases of counterfeit and substandard drugs are in poorer countries. There's little doubt that millions of adults and children in the developing world suffer prolonged illnesses, permanent disabilities or death because of unsafe vaccinations and blood, poor-quality drugs, unsafe equipment, inadequate infection control, and generally unreliable practices performed in ill-equipped settings.

Failures in patient safety exact an enormous human toll, but they have an important economic impact as well. Studies have shown that individual countries lose between $6 billion and $29 billion a year as a result of prolonged hospitalizations, litigation claims, lost income, disability and medical expenses.

Human error is only part of the problem of lapses in patient safety. Although a more conscientious approach by medical staff would prevent many medical errors, there are also chronic problems with medical systems and procedures. For example, thousands of patients every year are given the wrong drugs—sometimes with fatal results—because of hand-written prescriptions and hospital orders that are difficult to read. Yet electronic reporting and medical recording are widely available, though not yet standard.

New alliance
The issue of patient safety has been a growing public concern in recent years, and a growing number of medical practitioners, public health experts and patient advocates have been working to address it. In October 2004 at the headquarters of the Pan American Health Organization, WHO launched a new World Alliance for Patient Safety in the presence of ministers of health, senior officials, academics and patients groups from around the world. The goal of the new alliance is to galvanize and coordinate global and national efforts to improve patient safety around the world.

What needs to be done?
First, we need more research on the nature and scope of the problem. What exactly is happening, to whom, where and why? In developed countries, considerable research has already been done in this area, but more is needed. In the developing world, we need to start by carrying out baseline studies on the prevalence and nature of adverse events.


Second, to aid both research and the search for solutions, we need a taxonomy on patient safety issues, that is, a common set of concepts, principles and norms for reporting and analysis. We also need to create and coordinate reporting systems that can track adverse events and "near misses," to facilitate learning and to serve as the basis for preventive action.

In addition, we must develop guidelines based on best practices and facilitate early learning from information as it becomes available.

And we need to begin to deliver solutions, promoting interventions that have already been shown to be effective and coordinating our activities internationally to ensure that new interventions are widely disseminated.

We also need to involve patients and patients' organizations in all this work, so that we can learn lessons from their firsthand experiences and capitalize on their energy and motivation to find solutions.

One of the first initiatives of the new World Alliance for Patient Safety is a Global Patient Safety Challenge for 2005–06, whose theme is "Clean Care Is Safer Care." This campaign will focus on nosocomial infections. These hospital-acquired infections result in prolonged or aggravated illnesses, extended hospital stays, and even long-term disability and death for millions of patients worldwide. Research in the United States has found that U.S. hospitals lose from $583 to $4,886 for every nosocomial infection. A study in Thailand found that hospital-acquired infections consume up to 10 percent of some hospitals' total budgets. The campaign will promote five action areas: clean hands, clean practices, clean products, clean environment and clean equipment.

The focus of the first Global Patient Safety Challenge was chosen in part because it presents all the main characteristics of a patient safety problem: It affects large numbers of patients worldwide; it has multiple causes, relating to systems and procedures as well as human error; there are proven ways to reduce it, yet many health care institutions have not yet adopted the proven practices; and it offers a clear agenda for research and for monitoring and evaluation of the effectiveness of remedial actions.

We are inviting countries around the world to join in our efforts to document the scale and nature of health care–associated infections, analyze their root causes and develop solutions to reduce the risk of these infections as a first step toward improving patient safety overall. We hope that ministries of health, other government agencies, nongovernmental organizations, and patient and consumer groups will join in this challenge.

Patient and consumer groups are particularly critical to the success of not only the Global Patient Safety Challenge but also all our future efforts. Patients and their families are the ones who suffer when things go wrong. Yet in the past, health care providers have tended to resist their involvement in corrective efforts. It is essential that patients and their families take an active role, and that we in the health professions listen to what they have to say. Their natural concerns—to find out what happened, to hold someone accountable, and to see to it that similar errors don't happen again—should be our concerns as well.

The biggest challenge for patient safety is not to place blame or to punish, but to prevent errors—both human and systemic—from occurring. That requires both greater transparency in health care systems and greater willingness on the part of health professionals to confront our failings. To err, after all, is human. But to cover up is unforgivable, and to fail to learn is simply inexcusable. We all make mistakes, but it is our duty to learn from them and find ways to make sure they never again cause harm.

Sir Liam Donaldson is chief medical officer of the United Kingdom and chair of the new World Alliance for Patient Safety, launched at Pan American Health Organization headquarters in October 2004.