'Off-Label' Use of Meds Routine in Pediatric ICU
But not enough is known about their safety and effectiveness in children, researcher says
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Tuesday, October 23, 2012
Off-label refers to the use of drugs that do not have U.S. Food and Drug Administration approval for treatment of certain patients or conditions. For example, some drugs are approved for use in adults but used off-label in children.
"Treatment with off-label medications is the rule rather than the exception in the [pediatric intensive-care unit]," said study author Susan Sorenson, a doctor of pharmacy. "Numerous problems emanate from the lack of drug data in children, including uncertainty about whether a drug is effective in children for a particular disease, questions about the side effect profile, and lack of dosing information."
The study looked at off-label drug use among nearly 500 children, ranging in age from newborn to 17 years, in the pediatric intensive-care unit at Primary Children's Medical Center in Salt Lake City.
A total of 335 drugs were prescribed to the children and 96 percent of them received at least one off-label drug, including all patients aged 13 to 17, according to the study, which was presented Sunday at the American Academy of Pediatrics' national conference in New Orleans.
Sorenson added that it "is very difficult when you stand at the bedside and want to treat a sick child with a drug and you don't know if the dose or drug you have chosen or recommended will harm the child or help the child."
This study attempted to determine the drugs used most frequently in the sickest pediatric patients that lack dosing information, "with the intent that studies of dosing, safety and efficacy will be carried out on those drugs," Sorenson explained in an academy news release.
"More studies need to be conducted so that prescribing in our youngest and sickest patients can be done based on evidence," she added.
Data and conclusions presented at meetings should be considered preliminary until published in a peer-reviewed medical journal.
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