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Medication Errors: Congress Gets to the Root of the Problem


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Feb. 1, 2000 (Washington) -- Almost half of America's drug-related adverse events could be prevented if health care professionals were to move beyond a "culture of blame," under which more emphasis is placed on fault than practicing good medicine, a panel of experts testified Tuesday before the U.S. Senate Committee on Health, Education, Labor, and Pensions.

The Senate committee was meeting to discuss a General Accounting Office (GAO) report on the risks and costs associated with adverse drug events (ADEs) in the American health care system. An ADE can be caused by a number of factors, including a drug's unknown side effects. But in the report, the GAO concluded that although a number of medication-related adverse events are unavoidable, prescribing errors and administration errors result in an estimated 25-50% of all adverse drug events among hospital patients. In total, the GAO report added, ADEs could be costing the American health care system upward of $100 billion a year.

Contributing to these ADEs, testified FDA's Director of Drug Evaluation and Research Janet Woodcock, MD, is the fact that many drugs are not used properly. Although the FDA can control what goes on a drug's label, "when we approve a drug, we are relying on the health care system to use it properly," she said. But at the present, health care professionals do not always follow the precautions on the label or take the time to discuss those precautions with their patients. In fact, the FDA has had to withdraw several drugs over the last few years because they were not used properly.

"There needs to be a new emphasis on the patient," says William Ellis, RPH, MS, executive director of the American Pharmaceutical Association Foundation. Pharmacists could play a critical role in helping patients understand their medications. However, he tells WebMD, there is still little value placed on the services provided by pharmacists under the current system. "Pharmacists still represent an underutilized resource."

Nevertheless, there is no need for additional federal controls over physicians or for a mandatory reporting system to record drug-related adverse events, testified Michael Cohen, MS, FASHP. What is needed, said Cohen, president of the Institute for Safe Medication Practices, is additional quality controls, as well as physician review of drug labels, more patient education, and increasing emphasis of the use of information technology. Increasing the use of information technology to catch drug-to-drug related interactions alone "could decrease prescribing errors by 55%."

The underreporting of adverse events is only a problem when the FDA does not "get any reports about a certain problem," says Woodcock. "It is a question of quality." If the FDA were to receive additional funds to set up satellite reporting centers at various health care settings, that could increase the reporting of adverse events by about fifteenfold, she tells WebMD. But the key to preventing unknown side effects is to catch them early. And in terms of known side effects, the FDA is prepared to take a different approach. "We even might not approve the drug if improper prescribing of that drug could cause death."

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