"Off-label" refers to a medication being used to address a different condition than it was approved to treat by the FDA. An example of an off-label med prescription for a child would be a doctor recommending anti-depressant medication for ADHD symptoms.
The research team were alarmed by their findings, and believe this study illustrates a glaring need for improved oversight and regulation when it comes to ensuring that children are prescribed safe, and effective, medication.
Data collected between 2006-2015 by the CDC and Prevention's National Ambulatory Medical Care Surveys was analyzed for the study. More specifically, researchers looked at information on doctor's office visits all over the United States, and investigated the frequency, trends, and reasons why doctors prescribed off-label meds for individuals under the age of 18.
In many ways, this study is incredibly overdue - it is the first in a decade to look at trends among non-hospital doctors prescribing off-label medicine to children. Researchers focused specifically on systemic drugs, or drugs that work throughout the body but also carry a greater chance of toxicity.
According to researchers, many of the off-label drugs being prescribed to children by doctors all over the country haven't even been properly tested among adolescent populations.
"Off-label medications - meaning medications used in a manner not specified in the FDA's approved packaging label - are legal. We found that they are common and increasing in children rather than decreasing," comments senior author Daniel Horton, assistant professor of pediatrics and a pediatric rheumatologist at Rutgers Robert Wood Johnson Medical School, in a release. "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 research team studied an estimated two billion adolescent visits to a physician, and found that in about 19% of those visits the doctor ordered one or more off-label systemic drugs. Most of the time, these drugs were intended to treat a common problem, such as asthma or a respiratory infection. Among visits that resulted in at least one prescription, off-label drugs were ordered in 83% of newborn visits, 49% of infant visits, and about 40% of visits among other adolescent ages.
The study also noted that prescription of off-label meds has increased over time; among visits that resulted in at least one prescription, off-label rates increased from 42% in 2005 to 47% by 2015.
Interestingly, girls and children with chronic conditions seemed to be prescribed off-label meds more often than other patients. Furthermore, doctors practicing medicine in southern U.S. states exhibited higher instances of off-label drug orders than doctors from other areas of the country. Doctors focusing on a specific medical field, commonly referred to as specialists, also ordered off-label meds more often than general practitioners.
The most common off-label drugs prescribed by doctors included antihistamines for respiratory infections, anti-depressants for ADHD, and numerous types of antibiotics for respiratory infections.
"Despite the laws in this country and Europe that encourage and require research on medications for children, we found that physicians are increasingly ordering certain medications off-label for children," Horton says. "Use of some off-label drugs is supported by high-quality evidence. For example, drugs approved to prevent vomiting caused by chemotherapy also work quite well in treating more common causes of vomiting in children, such as from viruses. We need this kind of evidence to determine the appropriateness of use of many other drugs currently used off-label to treat a wide range of conditions in children."
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