Almost all children on intensive care units given ‘off-label’ drugs

Oct 23 2012

By Helen Albert, Senior medwireNews Reporter

Study results show that a very high proportion of children admitted to intensive care units (ICUs) are treated with "off-label" drugs that have not been tested for the specific age or condition of the patient.

The researchers found that 96% of 490 children (aged 4 days to 17 years) in the ICU of a US urban children's hospital were given off-label medication. The proportion was even higher in older children (aged 13-17 years), all of whom were given at least one off-label drug.

Presenting the research at the American Academy of Pediatrics National Conference and Exhibition in New Orleans, USA, Susan Sorenson (Primary Children's Medical Center, Salt Lake City, Utah, USA) told the press: "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.

"Everyone does the best they can to find suggested doses and do the right thing, however, it is better medicine to dose or recommend doses based on evidence."

To assess the prevalence of off-label drug use in children, Sorenson and team collected information on drugs given to all patients admitted to the Primary Children's Medical Center ICU between October 2002 and February 2003.

Drug use was considered off-label when the drug was prescribed for a child whose age was not listed on the drug label, no pharmacokinetic data was provided in packaging, and if the indication the drug was used for was not approved by the US Food and Drug Administration.

The 490 patients received 335 different drugs in total, with each patient receiving an average of 14 drugs while in hospital. Of the drugs prescribed, 74 were used off-label 10 times or more.

The results of the survey carried out by Sorenson and team show that off-label prescribing is the rule rather than the exception in the pediatric ICU.

"More studies need to be conducted so that prescribing in our youngest and sickest patients can be done based on evidence," emphasized Sorenson.

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