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FDA Initiative Seeks to Reduce Accidental Overdoses

Posted on 11/04/2009, 16:00
By Amanda Gardner, HealthDay Reporter

The program will enlist health-care workers, drug makers, consumers, patients

WEDNESDAY, Nov. 4 (HealthDay News) -- U.S. health authorities unveiled Wednesday an initiative designed to reduce preventable injuries and deaths caused by misuse of medications.

The Safe Use Initiative will focus on preventable injuries and deaths caused by "medication errors such as unintentional exposures, misuse, abuse and attempts at self- harm," Dr. Janet Woodcock, director of the U.S. Food and Drug Administration's Center for Drug Evaluation and Research, said at a press conference.

"Many errors are also caused by lack of information needed by prescribers at the point of care, or by patients or consumers at the point of use, as well as by procedural and process errors -- for example, dispensing the wrong drug or wrong strength of drug," she said. "This must be better managed because preventable injuries and deaths cause significant harm to patients and enormous costs to the health-care system and significant cost to society as a whole."

Dr. Margaret A. Hamburg, head of the U.S. Food and Drug Administration, added: "We have a collective obligation to address this."

The announcement coincided with the release of a report titled FDA's Safe Use Initiative -- Collaborating to Reduce Preventable Harm from Medicines.

"When I started to look at some of the research, I was fairly stunned at the scope of the problem," Hamburg said, adding that four million visits to "emergency departments, doctors' offices and outpatient-care facilities are due to medication misuse or overdose."

Misuse of prescription drugs also results in 100,000 hospitalizations each year. And an estimated 1.5 million preventable drug-related injuries occur in health-care settings alone, Hamburg said.

"Up to half of all medication-related injuries could be prevented using currently available knowledge," she said.

Hamburg said the FDA plans to "enlist stakeholders across the nation to develop interventions," meaning patients, consumers, health-care practitioners, pharmacists, insurers, drug manufacturers as well as other government agencies.

The officials did not give specifics of planned programs because remedies will likely be very specific to specific problems, such as when patients catch on fire from flammable drugs used during preparation for surgery. This happens about 600 times a year, Hamburg said.

Health-care providers will also look for better ways to provide information to consumers, such as trying to get people who are taking acetaminophen-containing narcotic prescription drugs not to add over-the-counter acetaminophen products to the mix, Hamburg said. Overexposure to acetaminophen, which is the active ingredient in Tylenol and other over-the-counter pain relievers, can cause liver damage.

The FDA also released on Wednesday new industry guidelines for over-the-counter liquid medications, such as treatments for colds, for children. These guidelines are intended to make the dosing directions for cups, droppers and other measuring devices clearer.

More information

The Institute of Medicine has a fact sheet on preventing medication errors.

SOURCES: Nov. 4, 2009, teleconference with Margaret A. Hamburg, M.D., commissioner, U.S. Food and Drug Administration, and Janet Woodcock, M.D., director, U.S. Food and Drug Administration's Center for Drug Evaluation and Research

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