U.S. physicians are increasingly ordering medications for children for conditions that are not approved by the FDA, according to a Rutgers study published in Pediatrics. The findings highlight the need for more education, research, and policies addressing effective, safe pediatric drug prescribing.
The study analyzed data collected from 2006 to 2015 in the Centers for Disease Control and Prevention’s National Ambulatory Medical Care Surveys, which provide information on U.S. doctor office visits. The researchers analyzed the frequency, trends, and reasons why doctors ordered unapproved medications for children under 18.
This is the first study in a decade to look at how U.S. doctors outside of hospitals order a broad range of medicines off-label to children. This study focused on systemic drugs, which work throughout the body and have a greater potential for toxicity.
Many drugs prescribed for children have not been rigorously tested in children, according to the FDA. “Off-label medications—meaning medications used in a manner not specified in the FDA’s approved packaging label—are legal,” says senior author Daniel Horton, Assistant Professor of Pediatrics and a pediatric rheumatologist at Rutgers Robert Wood Johnson Medical School. “However, we don't always understand how off-label medications will affect children, who don’t always respond to medications as adults do. They may not respond as desired to these drugs and could experience harmful effects.”
The study found that, for about 19% of the estimated two billion office visits for children studied, doctors ordered one or more off-label systemic drugs, often for common conditions such as respiratory infections, asthma, or mental health disorders. In visits with at least one drug order, doctors ordered drugs off-label in about 83% of newborn visits, 49% of infant visits, and about 40% of visits for other ages. The study also found that, among visits with at least one ordered drug, the rates of ordering off-label increased from 42% in 2006 to 47% by 2015.
Rates of off-label drug orders were higher for girls, for children with chronic conditions, in the South compared with other regions, and among specialists compared with general practitioners. The most frequently ordered off-label drugs were antihistamines for respiratory infections, several classes of antibiotics for respiratory infections, and antidepressants for attention-deficit/hyperactivity disorder.
Source: Rutgers, September 16, 2019