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NEW BRUNSWICK, N.J. – American children are already prescribed various types of medications at extremely high rates, but a new study conducted at Rutgers University found that the frequency of non-compliant drug orders for children was also increasing.
"Non-label" means a drug used to treat a different diagnosis or symptoms for which it has been approved by the FDA. An example of a medical prescription not indicated on the label of a child would be a doctor who recommends an antidepressant to treat the symptoms of ADHD.
The members of the research team were alarmed by their findings and are convinced that this study illustrates the dire need for improved surveillance and regulation to ensure that children receive safe and effective medications.
Data collected between 2006 and 2015 by the CDC and Prevention's National Outpatient Care surveys were analyzed. Specifically, the researchers reviewed information on physician visits throughout the United States and examined the frequency, trends, and reasons why physicians prescribed non-drug medications to persons under the age of majority. 18 years old.
In many ways, this study is incredibly expected – this is the first time in 10 years that trends in non-hospital physicians prescribing untagged drugs to children have been examined. The researchers focused on systemic drugs, or drugs that work throughout the body, but also have an increased risk of toxicity.
According to the researchers, many of the drugs that do not comply with the guidelines prescribed to children by doctors across the country have not even been properly tested in adolescents.
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"Non-labeled drugs, that is, drugs that are used in a manner not specified on FDA-approved packaging, are legal. We found that they are common and that they increase in children rather than decrease, "says author Daniel Horton, assistant professor of pediatrics and pediatric rheumatologist at Rutgers Robert Wood Johnson Medical School in a statement. "However, we do not always understand how non-labeled medications will affect children, who do not always respond to drugs like adults. They may not respond as desired to these drugs and could be adversely affected. "
The research team studied about two billion teen visits to a doctor and discovered that in about 19% of these visits, the doctor had ordered one or more non-compliant systemic medications. Most of the time, these drugs were meant to treat a common problem, such as asthma or a respiratory infection. Of the visits that resulted in at least one prescription, noncompliant medications were ordered in 83% of newborn visits, 49% of infant visits and approximately 40% of visits of other ages.
The study also noted that the prescription of off-label drugs has increased over time; among the visits that resulted in at least one prescription, non-indication rates increased from 42% in 2005 to 47% in 2015.
Interestingly, girls and children with chronic conditions appeared to be prescribed non-compliant medications more often than other patients. In addition, physicians practicing medicine in the southern US had more orders for non-label drugs than doctors in other parts of the country. Physicians specialized in a specific medical field, commonly referred to as specialists, also ordered more non-label drugs than general practitioners.
The most common non-compliant medications prescribed by doctors included antihistamines for respiratory infections, antidepressants for ADHD and many types of antibiotics for respiratory infections.
"Despite laws in this country and in Europe that encourage and mandate research on children's medicines, we found that doctors are increasingly ordering some substandard drugs for their children," said Horton. "The use of certain drugs not indicated on the label is supported by high quality evidence. For example, drugs approved to prevent chemotherapy-induced vomiting are also very effective at treating the most common causes of vomiting in children, such as viruses. We need this type of evidence to determine the appropriateness of using many other drugs not currently used for the treatment of many conditions in children. "
The study is published in the scientific journal Pediatrics.
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