Impact of Off Label Medication Use in Pediatric Readmissions

Abstract

Objectives: The specific aims of this study were: 1) describe the frequency of off-label medication use in pediatric discharge medication regimens, 2) compare the frequency of FDA-approved and off-label medication use in pediatric discharge medication regimens, and 3) identify potential patient-specific risk factors, including use off-label use of medications, associated with 90-day readmission. Methods: This was a retrospective chart review of pediatric patients admitted to a tertiary academic medical center during a 6-month period. Inclusion criteria included age less than 18 years of age and admission between January 1, 2014 and June 30, 2014. Exclusion criteria included admission for oncology chemotherapy, admitted < 24 hours, admission to NICU only and patient expiration prior to discharge. Data collection included patient demographics, types and number of medications, and FDA approved and off-label indication of medications. Data analyses were completed on STATA 11.0 (College Station, TX) including student t-test/Mann Whitney U and Chi square/Fisher Exact test with a priori of α= 0.05. Results: A total of 706 admissions were included in the study. There were no significant differences in demographic characteristics between groups (readmitted within 90 days of discharge vs. not readmitted within 90 days of discharge) except sex (males vs. females, 56.3% vs. 44.2%, p=0.034). Length of hospital stay was significantly higher in subjects readmitted within 90 days of discharge compared to those who were not (8.55 ± 12.5 vs. 3.79 ± 4.43 days, p<0.001). Number of medications at discharge (7.31 ± 5.92 vs. 2.91 ± 2.93, p<0.001) and total number of non-FDA approved medications (3.16 ± 3.81 vs. 1.12 ± 1.44, p<0.001) were all significantly higher in subjects readmitted within 90 days of discharge compared to those who were not. The percentages of patients taking medications related to cardiovascular (6.1% vs. 2.4%, p=0.002), electrolytes and nutrition (12.2% vs. 8.5%, p=0.007), and gastrointestinal (19.2% vs. 14.3%, p=0.004) disorders were significantly higher in the subjects readmitted within 90 days of discharge compared to those who were not. Additonally, subjects readmitted within 90 days of discharge (versus those not readmitted within 90 days) demonstrated less use of medications related to neurology (17.7% vs. 25.8%, p<0.001) and respiratory (16.4% vs. 21.4%, p=0.008) disorders. A significantly higher percentage of subjects whose third party payor was Medicaid, were readmitted within 90-days of discharge (69.7% vs. 58.3, p=0.045). Conclusions: In comparing several characteristics of pediatric patients readmitted to a tertiary medical center within 90 days of discharge versus those who were not, it was noted that several factors may be associated with readmission, including: sex, length of initial hospital stay, third-party payor, and the number of medications as well as the types of medication a patient takes. Future research may be warranted to further investigate these potential patient-specific factors in helping identify children at increased risk for readmission and develop more effective approaches to patient education, discharge planning, and continuity of care to reduce preventable readmission.