Off-label medication use in an academic hospital pediatric critical care unit.
OBJECTIVE: The objective of this study was to analyze medication use in a medium-sized academic hospital pediatric intensive care unit over a 1-year period and identify medications, medication classes, and age categories that would benefit most from pediatric drug trials. METHODS: The patient population included all pediatric patients < 18 years of age (n = 677) admitted to the pediatric intensive care unit from January 1, 2005 to December 31, 2005. The main outcomes assessed were medications and classes of medications most prevalent in each age category in comparison to currently available prescribing guidelines based on Food and drug Administration (FDA) approval as shown in the PDR and research as shown by Lexi-Comp. RESULTS: The 5 medications with highest exposure rates were acetaminophen (70.2%), ranitidine (51.7%), morphine (46.1%), fentanyl (39.3%), and propofol (39.1%). The medication classes with highest exposure rates were analgesics (42%), anesthetics (39%), and antiemetics (33.8%). Of the top 5 medications, only acetaminophen had FDA-approved prescribing guidelines in all age categories. FDA-approved prescribing guidelines were available for less than 35% of commonly prescribed medications in all age categories. CONCLUSION: Pediatric off-label medication use continues to be prevalent. In the pediatric critical care population, most medications are not properly tested for pediatric use. The federal government passed the Best Pharmaceuticals for Children Act (BPCA) in 2002 to encourage pediatric drug studies. However, the medication classes specified for further testing do not reflect the critical care population. Further studies are necessary to delineate the medications and medication classes that need study the most. (+info)
Outcome reporting in industry-sponsored trials of gabapentin for off-label use.