title: Adverse Events in Pediatric Patients Receiving Long-Term Outpatient Antimicrobials.
abstract: BACKGROUND
  Although long treatment courses of outpatient antimicrobials are often used in pediatric patients, few data exist regarding the frequency of adverse events (AEs) associated with these medications.
  
  
  METHODS
  We performed a retrospective cohort study of all patients seen in the Infectious Diseases clinic at a tertiary referral children's hospital from August 1, 2009 to August 1, 2011. We included patients who received ≥14 days of oral or intravenous antibiotic, antiviral, or antifungal medications. Patients receiving only prophylactic medications or human immunodeficiency virus treatment were excluded.
  
  
  RESULTS
  Three hundred thirty-five subjects met inclusion criteria, with a median age of 7.4 years at start of therapy. The cohort was predominantly male (60%), white (54%), and previously healthy (59%). A majority (88.4%) of subjects were treated for bacterial infections. β-Lactam agents were the most commonly used antimicrobial class (210 subjects; 62.7%), followed by clindamycin (86; 25.7%), rifampin (76; 22.7%), and vancomycin (62; 18.5%). Overall, 107 (31.9%) subjects experienced 151 distinct AEs. The most common individual AE noted was diarrhea (44; 29.1% of all AEs). Serious AEs developed in 42 (12.5%) subjects, including allergic reactions (15; 11.3% of all AEs), venous catheter-related complications (14; 13.0% of those with catheters), neutropenia (9; 3.0%), renal insufficiency (7; 2.5%), and hepatotoxicity (3; 1.1%). Rates of AEs were similar between those on oral and intravenous antimicrobials.
  
  
  CONCLUSIONS
  In our study population, patients on prolonged oral or intravenous outpatient antimicrobials experienced AEs frequently. These findings support the need for close monitoring of pediatric patients on prolonged antimicrobial therapy and vigilance for unwanted effects of these medications.
authors.affiliation: Department of Pediatrics Division of Infectious Diseases, University of Washington, Seattle.
authors.forename: Scott C
authors.initials: SC
authors.lastname: Olson
authors.affiliation: Department of Pediatrics Division of Infectious Diseases, University of Washington, Seattle Center for Clinical and Translational Research.
authors.forename: Sherilyn
authors.initials: S
authors.lastname: Smith
authors.affiliation: Department of Pediatrics Division of Infectious Diseases, University of Washington, Seattle Center for Global Infectious Disease Research, Seattle Children's Hospital Research Institute, Washington.
authors.forename: Scott J
authors.initials: SJ
authors.lastname: Weissman
authors.affiliation: Department of Pediatrics Division of Infectious Diseases, University of Washington, Seattle Center for Clinical and Translational Research.
authors.forename: Matthew P
authors.initials: MP
authors.lastname: Kronman
mesh_terms: D015746:Abdominal Pain / Q000139:chemically induced; D061605:Administration, Intravenous / Q000009:adverse effects / Q000706:statistics & numerical data; D000284:Administration, Oral; D000293:Adolescent; D000553:Ambulatory Care / Q000706:statistics & numerical data*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects*; D000935:Antifungal Agents / Q000008:administration & dosage / Q000009:adverse effects*; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects*; D057785:Catheters / Q000009:adverse effects; D056486:Chemical and Drug Induced Liver Injury; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D003967:Diarrhea / Q000139:chemically induced; D004342:Drug Hypersensitivity / Q000209:etiology; D005260:Female; D006801:Humans; D007239:Infections / Q000150:complications* / Q000188:drug therapy*; D008297:Male; D009325:Nausea / Q000139:chemically induced; D009503:Neutropenia / Q000139:chemically induced; D051437:Renal Insufficiency / Q000139:chemically induced; D012189:Retrospective Studies; D062606:Tertiary Care Centers / Q000706:statistics & numerical data; D014839:Vomiting / Q000139:chemically induced
chemical_list: D000900:Anti-Bacterial Agents; D000935:Antifungal Agents; D000998:Antiviral Agents
keywords: adverse events; antimicrobial stewardship; antimicrobials; outpatient; pediatrics