MEDICAL MISTAKES: Exact Number of Drug Errors Unknown
While some experts believe that prescription drug errors are the most common medical mistakes -- attributed to one in every five mistakes -- the General Accounting Office told the Senate Health and Education Committee yesterday that it "is not clear" how often those errors occur "because the problem has not been studied closely enough," the Philadelphia Inquirer reports. The FDA also told senators that it lacked resources to completely monitor drugs' effects on patients after approval. Janet Heinrich, associate director of health financing and public health issues for the GAO, said, "Although it is clear that a wide range of commonly used drugs causes adverse drug events with potentially serious consequences for patients, relatively little is known about their incidence or cost." She added, "We just don't understand the magnitude of the problem. We have no way of knowing if we're getting better or worse."
System Upgrade Needed
One study revealed that five to seven out of 1,000 patients in New York, Colorado and Utah hospitals suffered injuries from drug treatment, while another study indicated that drug errors affect 6% of hospitalized patients, costing a total of $12.2 billion annually in additional expenses and causing more than 7,000 deaths each year. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said that if the FDA upgraded its current system, the agency could gather more information about drugs' use after approval. Such an upgrade would cost between $11 million and $14 million. But Richard Platt, a Harvard Medical School professor and director of research at Harvard Pilgrim Healthcare, said that the FDA would need closer to $50 million to monitor drugs' safety. Woodcock said computer software could be developed to compare new drug names to existing drug names before granting approval. Confusion over similar drug names has contributed to medical errors (Gerlin, 2/2). Other solutions, according to a GAO report, might include computerized systems to help physicians select medications and more effective surveillance systems (Rovner, CongressDaily, 2/1). Sen. Edward Kennedy (D-Mass.), the committee's ranking minority member, called for a "beefing up in resources," saying, "I hope that we come up with some solutions that will address the whole package, not just piecemeal." Kennedy is developing bipartisan legislation with Sens. Bill Frist (R-Tenn.) and Christopher Dodd (D-Conn.).
Voluntary Reporting System
Witnesses testifying before the committee also advocated a voluntary system of reporting error. Michael Cohen, president of the Pennsylvania-based Institute for Safe Medical Practices, said, "We believe that voluntary, non-punitive reporting does the best job for learning. We have to decide whether we want a report card or a learning system, and a learning system will come from voluntary reporting" (Philadelphia Inquirer, 2/2). Woodcock added that if health care workers are going to be motivated enough to report adverse events, they "need to believe their reports are going to make a difference" (CongressDaily, 2/1).