FDA launches plan to curb accidental overdoses

November 4, 2009 By MATTHEW PERRONE , AP Business Writer

(AP) -- The Food and Drug Administration is launching a program to try and prevent millions of accidental drug overdoses that occur each year due to medication errors, misuse and other problems.

Under the plan announced Wednesday, the FDA will work with physicians to identify the types of drugs that pose the greatest risks to patients.

Proposals to improve safety include: simplifying drug labeling, standardizing dosage cups for cold medicines and requiring risk-management plans of drug manufacturers.

The agency will hold several public meetings to gather comments and plans to start its first initiatives within the next 12 months.

"All participants in the health care community have a role to play in reducing the risks and preventing injuries from medication use," said Dr. Janet Woodcock, director of the FDA's drug center.

The FDA says medication errors send 4 million Americans to the emergency room each year, resulting in 117,000 hospitalizations.

Federal regulators have made numerous attempts to curb drug overdoses in the past. Earlier this year, the FDA sent letters to the makers of two dozen powerful painkillers - including morphine, codeine and methadone - ordering them to develop plans to reduce the misuse of their drugs.

But the agency said Wednesday its so-called Safe Use initiative will take "a more coordinated, systematic manner, with interventions across all sectors of the medication distribution and use system."

One problem the agency hopes to address is liver damage caused by acetaminophen, the active ingredient in Tylenol and other over-the-counter pain relievers. Those medications cause an estimated 55,000 trips to the emergency room annually, according to federal data. Other issues include preventing operating room fires started by alcohol-based surgical solutions.

"Too many people suffer unnecessary injuries from avoidable medication misuse, errors and other problems. The FDA is launching the Safe Use Initiative to develop targeted solutions for reducing these injuries," FDA Commissioner Margaret Hamburg said in a statement.

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