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Off-label drug use in a single-center pediatric cardiac intensive care unit
Lily A Maltz1, Darren Klugman, Michael C Spaeder
1Department of Cardiology, Children's National Medical Center, Washington, DC, USA.
Insights
Off-label drug use is common in pediatric cardiac intensive care units (CICUs), with most patients receiving at least one such medication. Higher use correlated with longer hospital stays and increased ventilator days.
Area of Science:
- Pediatric Cardiology
- Clinical Pharmacology
- Intensive Care Medicine
Background:
- Off-label drug use in pediatric cardiac intensive care units (CICUs) is prevalent but understudied.
- The association between off-label prescribing and patient outcomes in this critical care setting remains unclear.
Purpose of the Study:
- To investigate the frequency of off-label medication use in pediatric CICU patients.
- To explore the relationship between off-label drug administration and patient morbidity.
Main Methods:
- Retrospective analysis of patients under 18 admitted to the CICU from June to August 2008.
- Off-label use defined by age-inappropriate indications per Micromedex and electronic Physician's Desk Reference.
- Demographic and clinical data collected for 30 days or until discharge.
Main Results:
- Of 82 patients, 94% received at least one off-label drug; 36% of all prescribed drugs were off-label.
- Younger patients received more off-label medications (median four), experiencing longer CICU stays and more ventilator days.
- Common diagnoses included shunt and single-ventricle lesions, with an overall mortality of 2.4%.
Conclusions:
- Off-label drug use is a frequent occurrence in the CICU, potentially linked to patient illness severity.
- Further research into the safety and efficacy of these medications is crucial for optimizing pediatric cardiac patient care.
Background:
The frequency of off-label drug use and its association with morbidity and mortality in the cardiac intensive care unit (CICU) has not been previously studied.
Methods:
Patients less than 18 years of age admitted to the CICU from June to August 2008 were retrospectively identified. Patient demographics were collected for 30 days or until CICU discharge. Off-label drug use was defined as the prescription of a medication that lacked a labeled indication based on patient's age as reported in the Micromedex drug database and electronic Physician's Desk Reference.
Results:
Eighty-two patients were admitted to the CICU during the study period. In all, 40 (46%) patients were male; the median age was 10.6 months. Common diagnoses were left-to-right shunt lesions (20.7%) and single-ventricle lesions (20.7%), with an overall mortality of 2.4%. Of all drugs prescribed, 36% were off-label. In all, 94% of the patients received ≥1 drug off-label. The median number of drugs prescribed off-label was four. Patients receiving more than four off-label medications were younger, had longer CICU lengths of stay (median 9.5 vs 2 days, P < .001), and increased ventilator days (median two vs one day, P < .001).
Conclusions:
Off-label drug use in the CICU is common. Frequency of use is likely higher in patients with a higher severity of illness. Further safety, efficacy, and pharmaceutical trials are warranted to optimize the use of these drugs to improve outcomes.
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