A Medical Device Daily

Ten years ago the Institute of Medicine (IOM; Washington) estimated that as many as 98,000 Americans die every year from preventable medical errors. Now, Consumers Union (Austin, Texas), the nonprofit publisher of Consumer Reports, has issued a report, "To Err is Human – To Delay is Deadly," detailing the lack of progress that has been made in the past decade to improve patient safety. The report appears to be a follow-up to the IOM's 1999 report "To Err is Human" which prompted a rush of congressional hearings and promises of reform – promises which were never followed through on, according to Consumers Union.

The organization's report is quite timely, considering the current focus on healthcare reform. Consumers Union believes that reducing medical harm – including hospital-acquired infections and medication errors – would not only improve patient care but also provide significant costs savings to help make expanded access to health coverage possible.

"There is little evidence to suggest that the number of people dying from medical harm has dropped since the IOM first warned about these deadly mistakes a decade ago," said Lisa McGiffert, director of Consumers Union's Safe Patient Project (www.SafePatientProject.org). "That means a million lives and billions of dollars have been lost over the past ten years because our healthcare system failed to adopt key reforms recommended by the IOM to protect patients. As the debate over healthcare heats up in Washington, Congress should make sure that improving patient safety is a central part of any reform legislation it adopts."

The IOM's 1999 report estimated that medical errors cost the U.S. $17-29 billion a year, and recommended sweeping changes to the healthcare system to improve patient safety. According to Consumers Union, the IOM called for a measurable improvement in patient safety, stating it would be "irresponsible to expect anything less than a 50% reduction in errors over five years." The report prompted a flurry of activity in Washington, including seven high profile hearings in Congress and the introduction of five medical error bills, Consumers Union noted. But none of those bills were adopted and progress in implementing a number of the IOM's key recommendations has been "frustratingly slow," the organization said.

"One decade later, we can't say whether we are any better off today than when the IOM first sounded the alarm about medical errors in 1999," said Arthur Levin, director of the Center for Medical Consumers and member of the IOM's Committee on the Quality of Health Care in America, which issued the 'To Err is Human' report. "We can't wait another decade to take the steps needed to protect patients from deadly and costly medical errors. The time to act is now. Too many lives and healthcare dollars are at stake." Levin assisted Consumers Union with its report.

Consumers Union's report reviewed four key IOM recommendations to make healthcare safer:

• Implement safe medication practices: According to the IOM, at least 1.5 million preventable medication errors cause harm in the U.S. and cost $3.5 billion each year. Medication errors include administering or prescribing the wrong drug, providing the wrong dose, or using the wrong route to administer drugs to patients. The IOM recommended stronger FDA oversight to address safety issues connected with drug packaging and labeling, similar name drugs, and post marketing surveillance by doctors and pharmacists. Unfortunately, according to the new report, progress on reducing medication errors has fallen short of the IOM's vision. The FDA reviews new drug names for potential confusion that could lead to mistakes, but few existing names are changed. In addition, a 2008 American Hospital Association (Chicago) survey revealed that only 17% of hospitals were using Computerized Physician Order Entry (CPOE) systems, which could help reduce medication errors significantly. The survey found that 45% had no plans to implement CPOE systems. Finally, no reliable national medication error system that publicly discloses errors by facility is in place, the report notes.

• Create Accountability Through Transparency: The IOM recommended two national reporting systems to help reduce errors: a mandatory and public reporting system designed to encourage accountability, and a voluntary and confidential reporting system to help healthcare providers learn from their mistakes. According to the new report, the progress that has been made on reporting since 1999 has been made mostly on voluntary, confidential systems that do not create external pressure for change.

Twenty-four states do not have any medical error reporting requirements in place and most states that require error reporting do not disclose facility-specific information to the public about mistakes, a key incentive for improving patient safety, the report notes. Consumers Union recommends facility-specific reporting of medical harm that is mandatory, validated, and public.

• Measure the Problem: In its 1999 report, the IOM noted that there was no cohesive effort to improve healthcare and called for the creation of a Center for Patient Safety within the federal Agency for Healthcare Research and Quality (AHRQ) to coordinate and monitor improvements. "Ten years later, we still have no national entity comprehensively tracking patient safety and are unable to tell if we are any better off than we were a decade ago," says Consumers Union. "AHRQ is attempting to do this, but its efforts are hamstrung by the lack of reliable medical error reporting." According to the AHRQ's May report, patient safety actually declined by almost 1% a year over the six years after the IOM report was issued in 1999 and "[d]ata remain incomplete for a comprehensive national assessment on patient safety," the agency said.

• Raise Standards for Competency in Patient Safety: The IOM recommended a greater focus on patient safety by regulators, accreditors, and purchasers and called for periodic examinations of doctors and nurses to assess "both competence and knowledge of safety practices." Over the past ten years, many initiatives to improve competency in patient safety standards have come from the private sector. While these efforts are "laudable," according to the new report, "the results have been fragmented and no process exists to promote and measure national improvement."