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Write byline ANDREW ZAJAC Reporting from Washington
Write body In an effort to reduce the annual toll of deaths and serious problems caused by mistakes and misuse of prescription drugs and over-the-counter medications, the Food and Drug Administration is launching a new effort to identify the most serious threats and find ways to avoid them. Some 1.5 million so-called "adverse drug events" in the United States every year, according to a 2007 study by the Institute of Medicine study, at least half of them considered avoidable. In addition to the toll on individuals, the errors impose an estimated $ 4 billion in financial costs annually. "I was frankly stunned at the scope of the problem," FDA Commissioner Margaret Hamburg said in announcing the agency's new effort. "This is something that doesn't require a new scientific discovery or a budget appropriation," said Hamburg, who unveiled the plan, dubbed the Safe Use Initiative, at a press conference with Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation Research. In addition to zeroing in on particular medicines that are most frequently involved in problems, the agency will take a fresh look at information provided to drug users, including labeling and instructions given by pharmacists when dispensing prescriptions. As a first step, the FDA called on doctors, other healthcare professionals and consumers to help the agency identify particular drugs and circumstances that may be at the center of the problem. The agency will also hold public hearings to gather more information, Woodcock said. The agency already has identified a handful of issues, including the overuse of acetaminophen, a pain reliever that can cause liver damage when taken to excess. The FDA is also considering whether information given to consumers about their medications should be presented in a brief, standardized leaflet, as is the practice in some other countries. The move to examine instructions given to consumers is long overdue, said Dr. Sidney Wolfe, director of the health research group for Public Citizen, a non-profit consumer advocacy group. "About 99 and ½ percent of pamphlets are completely unregulated," Wolfe said. "They are missing critical information." The FDA also made a series of recommendations Wednesday to makers and distributors of liquid drugs aimed at reducing dosage errors. It advised, for example, that a dosage delivery device, such as a spoon or cup, marked with same units of measure specified in the instructions, be included with all liquid drugs. FDA officials acknowledged they don't have hard figures about how many people die or suffer serious injury from medication misuse. That's partly because "preventable harm" covers a range of poorly tracked activities including accidental overdoses, dispensing of the wrong medication or the wrong dosage, abuse of medication and drug quality defects. "Everybody is measuring something at a different level," said Shawn Becker, Director of Healthcare Quality Standards for the U.S. Pharmacopeia, a non-profit organization that sets standards for strength, quality and purity of drugs. "People have been looking at safe medication use issues for a long time. It certainly is a problem." Woodcock said the FDA will work with the Centers for Disease Control to try to compile more reliable medication error statistics. Medication errors do not include the side-effects of drugs, such as nausea associated with some anti-cancer medications. 30
Write mm_summary
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Write byline ANDREW ZAJAC Reporting from Washington
Write body In an effort to reduce the annual toll of deaths and serious problems caused by mistakes and misuse of prescription drugs and over-the-counter medications, the Food and Drug Administration is launching a new effort to identify the most serious threats and find ways to avoid them. Some 1.5 million so-called "adverse drug events" in the United States every year, according to a 2007 study by the Institute of Medicine study, at least half of them considered avoidable. In addition to the toll on individuals, the errors impose an estimated $ 4 billion in financial costs annually. "I was frankly stunned at the scope of the problem," FDA Commissioner Margaret Hamburg said in announcing the agency's new effort. "This is something that doesn't require a new scientific discovery or a budget appropriation," said Hamburg, who unveiled the plan, dubbed the Safe Use Initiative, at a press conference with Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation Research. In addition to zeroing in on particular medicines that are most frequently involved in problems, the agency will take a fresh look at information provided to drug users, including labeling and instructions given by pharmacists when dispensing prescriptions. As a first step, the FDA called on doctors, other healthcare professionals and consumers to help the agency identify particular drugs and circumstances that may be at the center of the problem. The agency will also hold public hearings to gather more information, Woodcock said. The agency already has identified a handful of issues, including the overuse of acetaminophen, a pain reliever that can cause liver damage when taken to excess. The FDA is also considering whether information given to consumers about their medications should be presented in a brief, standardized leaflet, as is the practice in some other countries. The move to examine instructions given to consumers is long overdue, said Dr. Sidney Wolfe, director of the health research group for Public Citizen, a non-profit consumer advocacy group. "About 99 and ½ percent of pamphlets are completely unregulated," Wolfe said. "They are missing critical information." The FDA also made a series of recommendations Wednesday to makers and distributors of liquid drugs aimed at reducing dosage errors. It advised, for example, that a dosage delivery device, such as a spoon or cup, marked with same units of measure specified in the instructions, be included with all liquid drugs. FDA officials acknowledged they don't have hard figures about how many people die or suffer serious injury from medication misuse. That's partly because "preventable harm" covers a range of poorly tracked activities including accidental overdoses, dispensing of the wrong medication or the wrong dosage, abuse of medication and drug quality defects. "Everybody is measuring something at a different level," said Shawn Becker, Director of Healthcare Quality Standards for the U.S. Pharmacopeia, a non-profit organization that sets standards for strength, quality and purity of drugs. "People have been looking at safe medication use issues for a long time. It certainly is a problem." Woodcock said the FDA will work with the Centers for Disease Control to try to compile more reliable medication error statistics. Medication errors do not include the side-effects of drugs, such as nausea associated with some anti-cancer medications. 30
