NEW BRUNSWICK, NJ – Different types of drugs are already prescribed to American children at extremely high rates, but a new study conducted at Rutgers University finds that the frequency of unmarked drug orders is for children
"Excluded label" refers to a drug used to treat a different diagnosis or symptoms that have been approved for FDA treatment. An example of an over-the-counter prescription for a child would be a doctor recommending antidepressant medications for the symptoms of ADHD.
The research team was concerned about their findings and felt that this study showed a clear need for improved supervision and regulation when it came to ensuring that children were prescribed safe and effective medications.
Data collected between 2006-201
In many respects, this study is incredibly overdue – this is the first in a decade to look at trends among non-hospital doctors who prescribe off-label drugs. Researchers focused specifically on systemic drugs or drugs that act throughout the body but also have a greater chance of toxicity.
According to researchers, many of the unlabelled drugs prescribed to children by physicians across the country have not even been properly tested in adolescent populations.
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"Non-labeled medicines – means medicines used in a way that is not listed on the FDA's approved packaging label – are legal. We found that they are common and increasing in children, not decreasing, "said senior author Daniel Horton, a pediatric assistant and pediatric rheumatologist at Rutgers Medical Center Robert Wood Johnson, in a message. "However, we do not always understand how unlabelled medicines will affect children who do not always respond to medicines as adults. They may not respond as desired to these drugs and may experience adverse effects. ”
The research team examined approximately two billion adolescent visits to a doctor and found that in about 19% of those visits, the doctor had ordered one or more discounted systemic medicines. Most of the time, these drugs have been used to treat a common problem, such as asthma or respiratory infection. Among the visits that led to at least one prescription, unlabelled medications were prescribed in 83% of newborn visits, 49% of newborn visits and about 40% of visits among other adolescents.
The study also notes that the prescription of unlabelled drugs has increased over time; among visits that led to at least one prescription, unlabelled percentages increased from 42% in 2005 to 47% by 2015.
Interestingly, girls and children with chronic conditions seem to be prescribed more often than they are other patients. , In addition, physicians practicing medicine in the southern United States showed higher cases of labeled drug orders than physicians in other areas of the country. Physicians focusing on a specific medical field, commonly referred to as specialists, also prescribe unlabelled medicines more often than general practitioners.
The most common over-the-counter drugs prescribed by physicians include antihistamines for respiratory infections, antidepressants for ADHD, and numerous antibiotics for respiratory infections.
"Despite laws in this country and Europe that encourage and require research into medicines for children, we have found that doctors are increasingly ordering certain unlabelled medicines for children," says Horton, "The use of some unlabelled medicines supported by high quality evidence. For example, drugs approved for the prevention of vomiting caused by chemotherapy also work quite well in treating more common causes of vomiting in children, such as viruses. We need this type of evidence to determine the appropriateness of using many other medicines currently used without labels for the treatment of a wide range of conditions in children. "
The study was published in the scientific journal Pediatrics.