Last year, the American Academy of Pediatrics (AAP) released a statement on the off-label use of drugs in pediatric patients. As the AAP pointed out, changes in the federal regulations and incentives for pediatric drug research over the last decade have led the Food and Drug Administration (FDA) and pharmaceutical companies to add pediatric guidance to the prescribing labels for more than 500 medications.
Yet, the topic of off-label prescriptions remains highly important in pediatrics and public health, because many medications prescribed for children in the U.S. today have never been studied in children.
“While the rate can vary greatly depending on the specialty and environment, in general, less than 50 percent of medication labels have any guidance for providers on a drug’s use in children,” says Florence Bourgeois, MD, MPH, an emergency physician at Boston Children’s Hospital who studies pediatric drug development practices. “At an academic medical center, that rate might even be as high as 60 to 80 percent for the medications used among hospitalized patients.” …Read More