title: Use of Antibiotics in Pediatrics: 8-Years Survey in Italian Hospitals.
abstract: OBJECTIVE
  To evaluate antibiotic consumption in the pediatric wards of Emilia-Romagna Region, from 2004 to 2011, with a focus on the antibiotics reserved to the most serious infections, and to analyse the ADRs reported for antibiotics by the pediatric wards of Emilia-Romagna hospitals.
  
  
  METHODS
  Reference population was represented by all the patients (0-14 years old) admitted to the pediatric wards of all the hospitals of Emilia-Romagna Region. Drug consumption was expressed as number of DDDs per 100 Bed-Days (BD) and data were analysed by active substance, by therapeutic subgroups or by ward type. The time trends of antibiotic consumption were statistically analysed by linear regression. All the suspected ADR reports associated with antibiotics, reported between January 2004 and December 2011 were drawn by the Italian Spontaneous Reporting Database.
  
  
  RESULTS
  Overall antibiotic consumption showed only a slight increase (p = 0.224). Among the pediatric wards, pediatric surgery showed the highest increase from 2004 to 2011 (p = 0.011). Penicillins and β-lactamase inhibitors was the first therapeutic group with a statistically significant increase over years (p = 0.038), whereas penicillins with extended spectrum presented a statistically significant reduction (p = 0.008). Moreover, only 5 drugs out of the 8 antibiotics reserved to the most serious infections were used. Pharmacovigilance data showed 27 spontaneous ADR reports associated to ATC J01 drugs. Amoxicillin/clavulanic acid had the highest number of ADR reports (n = 7).
  
  
  CONCLUSIONS
  The steadily increasing consumption in penicillins and β-lactamase inhibitors, in association with a considerable decrease of plain penicillins, raises a serious concern. Pharmacovigilance reports seem to suggest a safe use of antibiotics in the hospital setting of Emilia-Romagna. Further studies to investigate the reason for prescribing antibiotics in children inpatients are needed.
authors.affiliation: Unit of Pharmacology, Department of Medical and Surgical Sciences, University of Bologna, Via Irnerio 48, 40126, Bologna, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Buccellato
authors.affiliation: Unit of Pharmacology, Department of Medical and Surgical Sciences, University of Bologna, Via Irnerio 48, 40126, Bologna, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Melis
authors.affiliation: Unit of Pharmacology, Department of Medical and Surgical Sciences, University of Bologna, Via Irnerio 48, 40126, Bologna, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Biagi
authors.affiliation: Unit of Pharmacology, Department of Medical and Surgical Sciences, University of Bologna, Via Irnerio 48, 40126, Bologna, Italy.
authors.forename: Monia
authors.initials: M
authors.lastname: Donati
authors.affiliation: Unit of Pharmacology, Department of Medical and Surgical Sciences, University of Bologna, Via Irnerio 48, 40126, Bologna, Italy.
authors.forename: Domenico
authors.initials: D
authors.lastname: Motola
authors.affiliation: Unit of Pharmacology, Department of Medical and Surgical Sciences, University of Bologna, Via Irnerio 48, 40126, Bologna, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Vaccheri
mesh_terms: D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D004363:Drug Utilization / Q000706:statistics & numerical data*; D006776:Hospitals, Pediatric / Q000706:statistics & numerical data*; D006801:Humans; D007223:Infant; D007558:Italy
chemical_list: D000900:Anti-Bacterial Agents