FDA Takes Steps to Curb Medication Errors

We are a medication-taking society. In any given week, four out of five Americans use at least one prescription medicine and nearly one-third of adults take five or more different medications. With over 4 billion prescriptions being filled every year, it’s not surprising that things go wrong. Some adverse drug events, as injuries from medication are generally called, are unavoidable and reflect the risk associated with treatment, such as a life-threatening allergic reaction to a drug when the person had no known allergies to it. But many times, the harm is caused by error, such as a patient receiving an antibiotic to which they are known to be allergic, going into anaphylactic shock and dying. This represents a preventable adverse event.

According to a 2007 study by the Institute of Medicine (IOM), more than 1.7 million preventable adverse drug events occur in the U.S. every year—400,000 in hospitals, another 800,000 in long-term care settings, and roughly 530,000 among Medicare recipients in outpatient clinics. Errors are common at every stage, from prescription and administration of a drug to monitoring of the patient’s response, the study found. Aside from the obvious harm to the patient’s health, these errors cost our nation approximately $4 billion annually; which doesn’t include lost wages and worker productivity or any compensation for pain and suffering.

“When I started to look at some of the research, I was fairly stunned at the scope of the problem,” Food and Drug Administration (FDA) Commissioner Dr. Margaret A. Hamburg said in a news conference on Wednesday. “Up to half of all medication-related injuries could be prevented using currently available knowledge,” she said. The agency also unveiled its Safe Use Initiative, which Hamburg says is designed to enlist stakeholders across the nation to develop targeted solutions for reducing these injuries.

Dr. Janet Woodstock, director of the FDA’s Center for Drug Evaluation and Research, said the agency will hold public hearings to gather information from healthcare providers and consumers about drugs and circumstances that may be particularly problematic. One issue that has already been identified is the overuse of acetaminophen, a pain reliever found in Tylenol and in other over-the-counter medications, including cold remedies. When taken in excess, the drug can cause liver damage.
Another issue the FDA wants to address is developing safeguards against surgical room fires caused by alcohol-based prepping solutions applied to the skin to reduce infection risk. Each year, an estimated 100 to 600 fires occur in surgical settings and “would be entirely preventable if procedures were in place and followed,” agency officials said.

Also on Wednesday, the agency released new guidelines for companies that manufacture or distribute liquid over-the-counter medications that come with spoons, cups or droppers that calibrate proper dosage. “This new drug dosage guidance document is an example of steps that can be taken to ensure safer medication use,” said Woodcock. “Many accidental overdoses result from confusion about exactly how much of a drug to take. Better measuring devices will help patients, parents and other caregivers use the right amount of these medications—the safest and most effective dose—especially for children.”

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

The FDA also plans to scrutinize information such as package inserts, labels and instructions that pharmacists provide patients when dispensing prescriptions. Dr. Sidney Wolfe, director of the health research arm of Public Citizen, a nonprofit consumer advocacy group, said such an examination is long overdue. “About 99.5 percent of pamphlets are completely unregulated,” Wolfe said. “They are missing critical information.”

Woodstock said the initiative is an expansion of the FDA’s traditional regulatory role, in which the agency has been primarily concerned with determining whether a drug is safe and effective for its intended use. However, “simply putting out a warning label 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.’”