Although the United States spends more per capita on health care than any other country, as many as 98,000 Americans die each year from preventable medical errors during hospitalization, according to a 1999 report by the National Academy of Sciences’ Institute of Medicine. In 2002, a study by the Harvard School of Public Health and the Kaiser Family Foundation found that 35 percent of physicians and 42 percent of the public said they had experienced errors in their own or in a family member’s care.
Beyond the serious societal toll of medical mistakes, there are far-reaching consequences for the American economy and corporations. The price associated with these errors in lost income, disability, and health-care expense is as much as $29 billion annually, according to the Institute of Medicine. Preventable medication errors alone are estimated to increase hospital costs by about $2 billion nationwide.
Medical errors have become so alarming to companies that the Leapfrog Group, a coalition of more than 100 large U.S. employers and insurers, representing about 33 million health-care consumers, is supporting federal legislation to lower health-care mistakes by requiring hospitals and physicians to report errors in patient care to a centralized database.
In a related development, the U.S. Food and Drug Administration (FDA) announced in March 2003 that it will require bar codes on all medications, allowing health-care workers in hospitals to closely track the medications they administer to patients. The supermarket-style bar-coding system can also significantly reduce prescription and transcribing errors.
Although the federal legislation supported by Leapfrog never made it out of committee in either the Senate or the House in the last Congress, it has strong backing from influential lawmakers. If it passes, a model used today by the FDA shows how such a patient-safety databank can be implemented.
Known as the Adverse Event Reporting System (AERS), this national database was developed for the FDA in 1998 by Booz Allen Hamilton. It is the centerpiece of the FDA’s safety surveillance program for drugs and therapeutic products. Prior to the creation of AERS, the FDA primarily used paper records to keep track of adverse drug reactions reported by pharmaceutical companies, health-care providers, or consumers. Because the data wasn’t automated, it was virtually impossible for the FDA to analyze and correlate the information.
AERS automatically codes adverse reaction terms using an international coding schema; critical adverse event reports are routed directly to the appropriate FDA staff’s electronic inboxes; flexible query tools let the agency identify potential drug risks and explore various drug safety hypotheses online; and tools, screens, tables, and reports present adverse event data in summarized or detailed formats. The output from AERS may lead to further epidemiological studies, regulatory action to improve product safety, correspondence with health-care professionals alerting them to the proper use of the drug, or the reevaluation of an approval decision.
There are many ways that the existing AERS framework could be expanded to support a patient safety reporting system. Literature pertaining to medical conditions, and collaboration with medical associations that are establishing treatment protocols in their fields, can help a governing organization set guidelines for standards of care. These guidelines can then be coded in a database that is continually updated with information from health-care providers and hospitals describing their actions — and the results — during patient encounters. (Patients’ names would be withheld to protect confidentiality.) The databank could automatically modify standard treatment guidelines when certain protocols proved to be more successful. Errors would be highlighted and analyzed; data would then be available to health-care providers via computer.
Patient safety has become such a high-priority issue that companies are not waiting for legislation or the development of a national database to do something about it. To eliminate medical errors, the General Motors Corporation, the largest private purchaser of health care in the U.S., is providing physicians with Palm PDAs that have a preinstalled drug database and prescription-writing program. Physicians can access current information about thousands of drugs and receive alerts about drug interactions. And drug giant Pfizer Inc. has launched a program to print bar codes on packaged pills that identify the medicine, its dosage, its lot number, and its expiration date. The main purpose is to ensure that patients get the right medicine in the right strength.