FDA seeks to reduce drug dosage errors

In an attempt to reduce the deaths and serious health problems caused by misuse of medication, the Food and Drug Administration is trying to identify the most serious threats and find ways to avoid them.

About 1.5 million preventable “adverse drug events” occur in the United States every year, according to a 2007 study by the Institute of Medicine, part of the National Academy of Sciences. Aside from the toll on health, the errors cost an estimated $4 billion a year, the study found.

“I was frankly stunned at the scope of the problem,” FDA Commissioner Margaret Hamburg said at a news conference Wednesday. The plan, dubbed the Safe Use Initiative, “is something that doesn’t require a new scientific discovery or a budget appropriation.”

The FDA called on doctors, other healthcare professionals and consumers to help identify drugs and circumstances that may be particular problems. The agency will hold public hearings to gather information, said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.


Among the issues the agency has identified is the overuse of acetaminophen, a pain reliever that can cause liver damage when taken to excess.

The drug is the primary ingredient in Tylenol and is included in several other over-the-counter medications, so it can be difficult for consumers to judge how much they’ve consumed.

The FDA also will scrutinize the information provided to patients, such as package inserts, labels and instructions that pharmacists give when dispensing prescriptions.

Such an examination is long overdue, said Dr. Sidney Wolfe, director of the health research arm of Public Citizen, a nonprofit consumer advocacy group.


“About 99.5% of pamphlets are completely unregulated,” Wolfe said. “They are missing critical information.”

The FDA also recommended ways to reduce dosage errors in liquid medications, such as including a spoon or cup to properly calibrate dosage.

Agency officials acknowledged that 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 the wrong medication or the wrong dosage, abuse of medication and drug-quality defects.

Medication errors do not include common side effects, such as nausea associated with some anti-cancer medications.


“Everybody is measuring something at a different level,” said Shawn Becker, director of healthcare quality standards for the U.S. Pharmacopeia, a nonprofit 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.”