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MANAGED CARE April 2007. ©MediMedia USA

The Formulary Files

80 percent of hospitalized kids prescribed off-label drugs

Nearly 4 out of 5 hospitalized children receive medications that have been tested and approved only in adults, according to a study in the Archives of Pediatric and Adolescent Medicine. Pediatric Health Information Systems Research Group performed the study in 31 tertiary hospitals. The adult-approved drugs most prescribed for children were central or autonomic nervous system drugs (specifically morphine), anti-infective agents, and fluids and electrolytes, says the principal investigator, Anthony D. Slonim, MD, of Children's National Medical Center in Washington D.C. "If 80 percent of hospitalized kids at academic pediatric hospitals use drugs off label, then that's a significant amount," says Slonim. Much more study is needed, researchers add.

Medications most often prescribed off-label to children

Morphine

Midazolam

Nystatin

Bacitracin

Dopamine

Nitroprusside

Potassium chloride

Fat emulsions

Methylprednisolone

Fluticasone propionate

Human albumin

Thrombin

Diphenhydramine

Ipratropium bromide

Spironolactone

Povidine-iodine

Central and autonomic central nervous system drugs

Anti-infective agents

Cardiac and adrenergic agents

Fluids, nutrients, and GI agents

Endocrine and metabolic agents

Hematologic, biologic, and immunologic agents

Respiratory tract, and eye, ear, nose, and throat agents

Other agents

Percentage of discharged patients who received the drug

Percentage of patients who received the drug off label

Source: Shah SS, et al. Off-label drug use in hospitalized children. Arch Pediatr Adolesc Med. 2007;161:282–290.