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GAO says more data needed on adverse drug events
Posted
2-7-2000 Washington. A 2-year study has concluded that adverse drug events (ADEs)-complications or deaths due to mistakes in the prescribing or usage of drugs-are a serious problem, but are impossible to quantify because of a lack of data. "The existing research on adverse drug events makes it clear that many patients experience negative outcomes from drug therapy," said Janet Heinrich of the General Accounting Office (GAO) in testimony to the Senate Health, Education, Labor, and Pensions Committee last week. "However, there is little precise information about the rate at which ADEs occur and their costs. Most of what is known on incidence and costs is highly fragmentary, relating to specific drugs or specific institutions. Information on ADEs outside hospitals or nursing homes is especially sparse." Heinrich noted that with so many drugs being prescribed-2.7 billion prescriptions were filled in the United States in 1998-and with so many new drugs on the market, "even a very low rate of ADEs can result in a large number of serious injuries and deaths." One impediment to quantifying the problem is the lack of standardization of what constitutes an adverse drug event. Some definitions include both medication errors-such as prescribing or administering the wrong drug or wrong dosage-and adverse reactions from known side effects. But some studies, Heinrich testified, estimate that between a quarter and half of all ADEs among hospital patients result from medication errors that presumably could have been prevented. The GAO report cited several ways to address the problem, including mandating packaging changes to prevent drugs from being mistaken for one another and to regulate dosing; having physicians enter prescriptions on a computer; and using a single name for drugs rather than generic and brand designations. In response to the GAO report, Janet Woodcock, director of the Food and Drug Administration's Center for Drug Evaluation and Research, warned the committee not to try to legislate solutions before acting to better quantify the problem. "We need better data before we try to devise solutions," she said. Without it "there's no way to measure the impact" of changes. Woodcock also said that while the FDA already has authority to implement some changes, "we don't have adequate resources for better post-market surveillance."
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