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FDA set to review prescription drug errors, misuse
Andrew Zajac - Tribune Washington BureauIssue date: 11/5/09 Section: Real News
WASHINGTON - 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 an effort to identify the greatest threats and find ways to avoid them.
Some 1.5 million so-called adverse drug events occur in the United States every year, according to a 2007 study by the Institute of Medicine, 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 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 news conference with Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and 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 health care 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 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 nonprofit consumer advocacy group.
"About 99 1/2 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.
Some 1.5 million so-called adverse drug events occur in the United States every year, according to a 2007 study by the Institute of Medicine, 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 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 news conference with Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and 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 health care 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 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 nonprofit consumer advocacy group.
"About 99 1/2 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.
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