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Off-label medication use in an academic hospital pediatric critical care unit
1Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, WI 53792-4108, USA. bhsu@uwhealth.org
Insights
Pediatric intensive care units frequently use medications without FDA approval for children. This study highlights critical medication gaps, emphasizing the need for more pediatric drug trials to improve patient safety.
Area of Science:
- Pediatric Critical Care Medicine
- Pharmacology and Therapeutics
- Drug Development and Regulation
Background:
- Off-label medication use is common in pediatric intensive care units (PICUs).
- Limited Food and Drug Administration (FDA)-approved prescribing guidelines exist for pediatric medications.
- The Best Pharmaceuticals for Children Act (BPCA) aims to encourage pediatric drug studies.
Purpose of the Study:
- To analyze medication use in a PICU over one year.
- To identify medications and classes most prevalent in different pediatric age groups.
- To determine which medications would benefit most from pediatric drug trials.
Main Methods:
- Retrospective analysis of 677 pediatric patients (<18 years) admitted to a PICU from January 1, 2005, to December 31, 2005.
- Assessment of medication and medication class prevalence.
- Comparison of prevalent medications against FDA approval status and prescribing guidelines (PDR, Lexi-Comp).
Main Results:
- Top medications included acetaminophen, ranitidine, morphine, fentanyl, and propofol.
- Leading medication classes were analgesics, anesthetics, and antiemetics.
- Only acetaminophen had FDA-approved guidelines across all pediatric age categories; less than 35% of commonly prescribed medications did.
Conclusions:
- Off-label medication use remains a significant issue in pediatric critical care.
- Current pediatric drug study initiatives may not adequately address the needs of the critical care population.
- Further research is essential to identify and prioritize medications requiring pediatric-specific studies.
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.
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