FDA initiative targets drug errors

By Lyndsey Layton
Washington Post Staff Writer
Wednesday, November 4, 2009; 4:49 PM

The Food and Drug Administration wants to reduce the misuse of medications, saying that at least 50,000 hospitalizations a year could be prevented if physicians, pharmacists, patients and parents used greater care in dispensing and taking drugs.

"When I first started looking at this, I was stunned at the scope of the problem," FDA commissioner Margaret A. Hamburg said Wednesday as she announced the new "Safe Use" program.

The Institute of Medicine estimates that at least 1.5 million preventable injuries and deaths result each year from overdosing, mix-ups and unintended exposure to prescription drugs. Children are often the victims -- one study found that, between 2003 and 2006, more than 9,000 children were accidentally exposed to prescription drugs such as codeine and morphine.

The cost of these preventable injuries is estimated at about $4 billion annually by the Institute of Medicine.

The amount of preventable harm from over-the-counter medications is not known, according to the FDA.

Hamburg said her agency intends to work with physicians, pharmacists, insurers, drug companies, patients and parents to develop a list of specific problems, a strategy for addressing them, and ways to measure success. Some measures may call for voluntary action on the part of the drug industry and medical community, and some may require new FDA regulations, she said.

FDA officials said some steps may be as simple as providing better information to consumers, improving the dispensing devices that accompany drugs and urging caregivers and patients to follow the directions of the drug maker.

"Even if we have a dosing device attached to the bottle, some parents will still reach for the household teaspoon, and we know those teaspoons come in all sizes," said Janet Woodcock, a physician who directs the FDA's Center for Drug Evaluation and Research.

Another area of concern is alcohol-based surgical swabs, which are flammable and have caused an estimated 600 fires in operating rooms each year, Hamburg said. The FDA is considering procedures that could eliminate such preventable fires, Hamburg said.

The agency will also look for ways to reduce intentional misuse, drug abuse and self-harm, Hamburg said.

The effort is an expansion of the FDA's traditional regulatory role, in which the agency has been largely concerned with determining whether a drug is safe and effective for its intended use, Woodcock said.

"Simply putting out a warning label [on a medication] does not insure safe and effective use in the real world," Woodcock said. "We can't overlook this and say, 'These guys are not using this right and that's not our problem.' "


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