Most Hospitalized Children Prescribed Drugs Off-Label

Nearly four-fifths receive at least one drug outside terms of product license

THURSDAY, March 8 (HealthDay News) -- Almost 80 percent of hospitalized children are prescribed at least one drug off-label, yet there is no mechanism to assess their safety and efficacy, according to study findings published in the March issue of the Archives of Pediatrics & Adolescent Medicine.

Samir S. Shah, M.D., of Children's Hospital of Philadelphia, and colleagues analyzed data from 355,409 patients who were hospitalized in 31 tertiary care pediatric hospitals across the United States in 2004.

In 297,592 (78.7 percent) of cases, patients were prescribed at least one drug off-label, accounting for over $270 million of total spending for the medications concerned. The most commonly used off-label drugs included agents affecting the central or autonomic nervous system, fluids or nutrients and gastrointestinal tract agents.

The patients most likely to receive these drugs were those undergoing surgery, those over 28 days old, and those with more severe illness. All-cause in-hospital mortality was also positively associated with greater likelihood of off-label drug use.

"Despite the frequent off-label use of drugs, using an administrative database, we cannot determine which of these treatments are unsafe or ineffective and which treatments result on substantial benefit to the patient," the authors conclude.

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