FDA to Fight Avoidable Harm from Medicines

November 5, 2009

U.S. health officials unveiled plans to fight avoidable injuries from medication errors or misuse, a problem that harms hundreds of thousands of people each year and can be deadly.

The Food and Drug Administration said on Wednesday that a more coordinated effort was needed across the nation’s healthcare system, and with patients and manufacturers, to reduce unnecessary complications from misuse, dosing errors, drug interactions or abuse.

The agency said it will work with doctors, nurses, patient groups and others to identify medicines linked to preventable complications and develop strategies to prevent them.

Manufacturers may be required to take steps to help minimize risks from specific medicines, FDA officials said. Some problems could be addressed through voluntary efforts such as education campaigns.

“Too many people suffer unnecessary injuries and some die as a result of errors or misuse that could have been prevented,” the FDA said in a report.

Many problems “can be addressed only through coordinated interventions across all sectors,” the agency added.

The Institute of Medicine estimates 400,000 hospital patients experience a preventable drug side effect each year. The number rises to 1.5 million when nursing homes and other outpatient settings are included.

FDA Commissioner Margaret Hamburg said it was estimated that “up to half of all medication related injuries could be prevented using currently available knowledge.”

“We really do have a proactive responsibility to help make sure that important information to promote and protect safety will get to the people that need it,” she said at a news conference at the agency’s headquarters in suburban Maryland.

Improper use is one area FDA officials want to tackle. Even one dose of an opioid painkiller, for example, can kill if taken by someone other than the intended patient, the FDA said.

One problem that may be targeted through the program is inadvertent overexposure to acetaminophen, the active ingredient in Johnson & Johnson’s Tylenol and other over-the-counter pain relievers, the FDA report said. Too much acetaminophen can damage the liver, and the agency and manufacturers have been working for years to find ways to prevent accidental overdoses.

“Much will need to be done, in collaboration with various healthcare stakeholders, to improve communication about inadvertent overexposure and discourage intentional overdose,” the FDA report said.

Officials also want to develop safeguards against surgical room fires caused by alcohol-based prepping solutions applied to the skin to reduce infection risk, the report said. An estimated 100 to 600 fires occur each year in surgical settings and “would be entirely preventable if procedures were in place and followed,” the agency said.

Dr. Janet Woodcock, head of the agency’s drugs division, said the effort was a shift for FDA. “We are going beyond our traditional role as regulator of the industry and reaching out to make sure we are impacting the real problems out there.”

Ken Johnson, spokesman for the Pharmaceutical Research and Manufacturers of America, an industry group known as PhRMA, said the measures “fit in with PhRMA’s goals of ensuring that patients receive the right medicine and the right dose at the right time.”

Also Wednesday, the FDA released guidelines for manufacturers who make cups, droppers, syringes and spoons to measure over-the-counter medicines. Many accidental overdoses stem from confusion about how much of a drug to take, and better measuring devices may help with proper dosing, especially for children, the FDA said.

(Reporting by Lisa Richwine; Editing by Tim Dobbyn)

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