FDA Institutes Changes to End Drug Label Confusion
The FDA has ordered pharmaceutical companies to make some "eye-catching changes" to drug labels to help address confusion over "look-alike or sound-alike" treatment names, which have become a "major source" of medication errors, the AP/Pittsburgh Post-Gazette reports. The agency has ordered drug makers to list the names of more than 30 medications in a "mix of upper- and lower-case and different-colored letters." For example, the new label for the epilepsy drug Lamictal will highlight the "-ictal" part of the name in red italics in order to distinguish the drug from Lamisil, an anti-fungal drug. Although the FDA has issued repeated warnings in the past about "drug mix-ups," the agency "only very rarely" forced a company to rename a drug on the market. FDA employees have also recently begun to test for "potential confusion" about the names of new drugs before they reach the market, which has prompted the agency to reject about one-third of the brand names that manufacturers have proposed for their treatments. Drug safety expects described the new policies as "long overdue." Michael Cohen of the not-for-profit Institute for Safe Medication Practices said, "They're getting away from blaming pharmacists, nurses, doctors and patients from not reading the names properly and making it easier for them to read it properly." More than 1,000 drugs sold in the United States have names "so similar that health workers can get them confused," the AP/Post-Gazette reports, and some studies have attributed 30% of medication errors that result in injuries to patients to "name confusion." Also, a new FDA study of 400 deaths that resulted from medication errors blames "name mix-ups" for 16% of the deaths (Neergaard, AP/Pittsburgh Post-Gazette, 1/2).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.