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Title: Off-Label Medication Use Common in Critically Ill Children: Presented at AAP
URL: http://www.pslgroup.com/dg/22ECA2.htm
Doctor's Guide
October 14, 2008


By Martha Kerr, BSN

BOSTON -- October 14, 2008 -- Use of medications that are not labelled for paediatric use is common in paediatric intensive care units (ICUs), researchers reported here at American Academy of Pediatrics (AAP) 2008 National Conference & Exhibition.

Pharmaceutical companies frequently do not conduct drug studies in paediatric populations, so many medications lack indications specific to children, said presenter Benson S. Hsu, MD, Department of Pediatrics, University of Wisconsin, Madison, Wisconsin.

To assess the prevalence of off-label use of medications in their institution's paediatric ICU, Dr. Hsu and colleagues reviewed prescriptions for 677 children and adolescents admitted to their paediatric ICU during 2005.

The investigators assessed the drugs and drug classes most commonly prescribed in each age category. They then evaluated the guidelines approved by the US Food and Drug Administration (FDA) for each medication, looking in particular for paediatric indications.

The 3 drug classes with highest exposure rates were analgesics (42%), anaesthetics (39%), and antiemetics (33.8%).

The 5 medications administered most commonly were acetaminophen (70.2%), ranitidine (51.7%), morphine (46.1%), fentanyl (39.3%), and propofol (39.1%).

"Of the top 5 medications, only acetaminophen had FDA-approved prescribing guidelines in all age categories," Dr. Hsu reported on October 12. "FDA-approved prescribing guidelines existed in less than 35% of commonly prescribed medications for all ages."

"The Best Pharmaceuticals for Children Act (BPCA) in 2002 aimed to encourage paediatric drug studies," Dr. Hsu noted. "However, the medication classes currently specified for further testing does not reflect the critical care population."


[Presentation title: Off-Label Medication Use in an Academic Pediatric Critical Care Unit. Abstract 1022]

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