AHRQ Launches Patient-Safety Initiatives

by Peggy Eastman

Washington, DC -- As major users of medical services and prescription drugs, elderly patients stand to be the prime beneficiaries of new US public and private efforts designed to reduce medical errors and improve patient safety. But culture change and cooperation within the medical system are necessary for these new programs to be effective, according to health experts (also see Medical Error Disclosure: Easier Said than Done, in this issue).

At a news briefing here sponsored by the Agency for Healthcare Research and Quality, AHRQ Director Carolyn Clancy, MD, said the new patient-safety initiatives represent an evolution in thinking about how to address medical errors." The public thinks of disciplining an individual physician "when an error occurs, said Dr. Clancy. "But we need to move away from a culture of name, blame, and shame. We need an emphasis on systems and systems thinking," she emphasized, adding that "the only thing worse than screwing up is not learning from it."

At the briefing, Victoria Fraser, MD, Professor of Medicine at Washington University School of Medicine in St. Louis and an AHRQ grantee, explained how a systems-oriented, no-fault method of reporting medical errors can improve patient safety. She said there has been a 10-fold increase in reporting preventable errors under this system--in use at all BJC Healthcare System hospitals--which can lead to a new understanding of how to prevent such errors in the future. Analyzing the incident-reporting system at BJC hospitals, Dr. Fraser found that over a 22-month period, the most frequent types of adverse medication events were wrong dose (18.3%), wrong drug (16.8%), setting the wrong infusion rate (15.7%), and extra dose (14.7%).

To encourage the no-fault reporting of medical errors, and the process of learning from them, AHRQ has launched an online journal and forum on patient safety and health care quality patterned after US hospitals' Morbidity and Mortality (M&M) conferences, where cases that raise questions about medical errors and quality improvement are discussed, and potential solutions are offered. This Web-based, peer-reviewed journal, Web M&M (http://webmm.ahrq.gov), presents cases related to medical errors and patient safety and offers slides that can be downloaded for educational purposes.

Cases are submitted from all over the world anonymously to protect privacy, but those whose cases are selected for posting are contacted so they can receive an honorarium. One example of an M&M case is that of an elderly man with delusions and progressive neurological symptoms, initially attributed to psychosis, who was found to have metastatic cancer." This is the only environment in which health care professionals are comfortable talking about medical errors; it's internal," said Robert M. Wachter, MD, a co-editor of the new AHRQ site and Professor and Associate Chairman of the Department of Medicine at the University of California, San Francisco. And, he noted, "doctors and nurses learn better when they're presented with a case embedded with a lesson."

FDA also on Board

The AHRQ briefing was held shortly before the announcement of two major steps proposed by the US Food and Drug Administration to improve patient safety: drug bar coding and a revamping of the medical-error reporting system. In announcing these initiatives, Health and Human Services Secretary Tommy G. Thompson said, "medication errors are a serious public health problem, but the good thing is we can do something about it." Speaking at the 5th Annual National Patient Safety Foundation (NPSF) Congress here, Secretary Thompson said the expected annual benefit from preventing medication errors, in addition to alleviating the emotional cost of human suffering, is about $3.9 billion.

Secretary Thompson's announcement coincided with the passage of the bipartisan Patient Safety and Quality Improvement Act (HR 663) by the House of Representatives, a bill that would create a voluntary database to track medication errors. Under this legislation, Patient Safety Organizations (PSOs) would analyze reported problems, identify potential solutions, and provide feedback to prevent similar errors in the future. The American Medical Association strongly supports this bill. "Future errors can be prevented as we learn from them," said AMA President Yank D. Coble, Jr., MD.

The first FDA-proposed rule announced by Secretary Thompson would require a standardized bar code on all prescription drug products, including biologicals and vaccines (excluding physician samples), and over-the-counter drugs commonly used in hospitals. The bar codes would be required for prescription drug products dispensed in retail pharmacies as well as those dispensed in hospitals.

The required linear bar code, which would be part of a drug label, would contain the National Drug Code number and identifying information about the drug. FDA Commissioner Mark B. McClellan, MD, PhD, believes that when used with bar-code scanners and computerized patient information systems, bar-code technology can prevent many potential medication errors including: administering the wrong drug, a drug to a patient with a known allergy to that drug, the wrong dose, administering the drug at the wrong time, or using the wrong route of administration.

Michael R. Cohen, RPh, DSc, President of the Institute for Safe Medication Practices, has praised bar-code technology for drugs as an effective way of saving lives and money while increasing staff efficiency. In the foreword to a review of bar-code technology for pharmaceuticals, he said that bar codes "provide a safeguard against error at the most vulnerable stage in the medication-use process--during administration."

The second step announced by Secretary Thompson at the NPSF Congress is the proposed revamping of medication and blood-product safety reporting requirements. This proposed rule would: require reports on important potential medication errors, referred to as "near misses"; require submission of all suspected serious reactions to blood and blood products on the market; improve the quality of safety reports submitted to the FDA ; and enhance the consistency of safety reporting globally by requiring the use of internationally agreed-on definitions and reporting formats.

The proposed revamping of safety-reporting rules would require blood centers to submit to FDA reports of all suspected serious reactions--not just deaths, as is currently the case. Pharmaceutical companies would be required to submit to the FDA within 15 days all reports they receive of "near-miss" errors as well as actual medication errors occurring in the United States. As an example of a near miss, HHS officials cited a hypothetical case in which the pharmacist selects the wrong medication because of a similar drug name, but catches the error before dispensing the medication. If the pharmacist reports the near miss to the manufacturer of the drug, then that company would be required to report it to the FDA. The FDA could then work with the company to make changes so that such name mixups would not occur again.

IHI Web Site

In addition to the AHRQ M&M Web site, the not-for-profit Institute for Healthcare Improvement (IHI) has launched a free online resource to help health professionals reduce medication errors. By going to www.QualityHealthCare.org, a health professional can find patient-safety improvement ideas, connect with experts on medical errors and other professionals who are dealing with the same challenges at other sites, and track progress in improving patient safety over time.

The online patient safety host for the new IHI Web site is Lucian Leape, MD, Adjunct Professor of Health Policy at the Harvard School of Public Health and a leading authority on the prevention of medical errors. Dr. Leape is a member of the Institute of Medicine's Quality of Care in America Committee, which authored the landmark report, To Err is Human: Building a Safer Health System. The report was at least in part responsible for the allocation to AHRQ in 2001 of more than $50 million to launch its patient-safety initiatives, including the M&M site.

"The Internet is the number one preferred source of education," noted IHI President and CEO Donald Berwick, MD. "We have tens of thousands, hundreds of thousands of people, who want to get involved in patient safety. The Internet allows for democratization of knowledge." Dr. Berwick said health officials in England plan to use the new IHI Web site for the National Health Service as part of a systematic approach to reducing medical errors in that country.

While the patient-safety movement has matured since the late 1990s, said speakers, there is still a ways to go to change medical culture into one of exchanging finger-pointing blame for no-fault disclosure and professional education. "There's no question that communication makes a big difference," said Dr. Clancy. "The message that 'it's the system' hasn't really taken root yet, either with health professionals or the public."

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