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(originally published by Booz & Company)


Patient Safety: A Data-Driven Prescription

Medical mistakes kill almost 100,000 Americans each year and cost the country as much as $29 billion annually. The right prescription could be a nationwide information system modeled on the FDA’s adverse drug reaction network.

Medical mistakes are a persistent blight on the U.S. health-care system. Although the United States spends more per capita on health care than any other country in the world, as many as 98,000 Americans die each year from preventable medical errors during hospitalization, according to a 1999 report by the Institute of Medicine. And a 2002 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.

Hospitals and physicians operate in a litigious culture in which mistakes are not addressed openly or shared for their learning value.”
Beyond the obvious societal toll of medical mistakes, there are also serious and far-reaching consequences for the American economy and corporations. The cost associated with these errors in lost income, disability, and health-care expenses is as much as $29 billion annually, according to the National Academy of Sciences Institute of Medicine. Preventable medication errors alone are estimated to increase hospital costs by about $2 billion nationwide.

In fact, the costs of medical errors have become so alarming to companies that more than 120 large U.S. employers and insurers, representing about 33 million health-care consumers, have formed a collective called the Leapfrog Group to tackle the problem. Among a wide set of initiatives, including a plan that would attempt to assign patients to hospitals that specialize in their specific conditions, Leapfrog is supporting federal legislation to decrease health-care mistakes by requiring hospitals and physicians to report errors in patient care to a centralized database. Under the proposed law, the job of monitoring and analyzing this computerized information would go to the Center for Quality Improvement and Patient Safety, a new agency yet to be created within the Department of Health and Human Services. This agency would identify national trends, provide feedback to health-care providers about safe and efficacious treatments as well as alternatives that should be avoided, and, overall, encourage best practices in the medical profession.

Although it has much of corporate America on its side, and backing from influential lawmakers like Senators Edward Kennedy (D-Massachusetts), William Frist (R-Tennessee), and James Jeffords (I-Vermont), this bill’s future is far from certain. In the last Congress, it never made it out of committee in either the Senate or the House.

A Database Template
If patient safety legislation does pass, a model already exists for how it can be implemented. It’s called the Adverse Event Reporting System (AERS), developed in 1998 by Booz Allen Hamilton for the Food and Drug Administration (FDA). This is a national database that has become the centerpiece of the FDA’s safety surveillance program for drugs and therapeutic products. Prior to 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. That, in turn, made it difficult to uncover, for instance, regional or condition-specific drug-reaction phenomena. Also, the FDA was frustrated by the haphazard way that the information was provided. Officials wanted a more standardized process for drug safety reporting and information sharing among health authorities and pharmaceutical companies worldwide.

A patient safety database could be a credible repository of treatment options for people bewildered by the array of good and bad medical information on the Web.”
Designed to fulfill these needs, AERS automatically codes adverse reaction terms using a new 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 is evaluated by clinical reviewers in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The results may lead to further epidemiological studies; regulatory action to improve product safety, such as updated labeling; regular correspondence with health-care professionals alerting them to the proper use of the drug; or the reevaluation of an approval decision.

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  1. “Health Care’s New Electronic Marketplace,” by J. Philip Lathrop, Gary Ahlquist, and David G. Knott, s+b, 2Q 2000. Click here.
  2. “HMO’s  “R” Us: A Prescription for the Future,” by Philip Lathrop and David C. Carlebach, s+b, 4Q 1998. Click here.
  3. “Vertical Integration: 80’s Fad or Health Care’s Future?,” by David G. Knott, s+b, 3Q 1997. Click here.
  4. “A Trillion-Dollar Opportunity,” by Gary Ahlquist, David G. Knott, and J. Philip Lathrop, s+b, 4Q 2001. Click here.
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