title: Paediatric adverse drug reactions reported to the Spanish Pharmacovigilance System from 2004 to 2009.
abstract: OBJECTIVE
  This study was conducted to evaluate relevant new information about ADRs reported in the Spanish paediatric population over a 6-year period.
  
  
  METHODS
  Adverse drug reactions (ADRs) for individuals aged 0-17 years reported to the Spanish Pharmacovigilance System from 2004 to 2009 were analysed with respect to time, age and sex, category of ADR [System Organ Class (SOC)], seriousness, suspected medicines [level 2 of the Anatomical Therapeutic Chemical (ATC) Classification System] and type of reporter.
  
  
  RESULTS
  In total, 4,279 ADR reports corresponding to 8,196 ADRs were analysed, approximately two ADRs per report. The rate of paediatric ADR reports in 2009 was 165 per million, of which nearly half (46 %) were for children (age group 2-11 years). Similar total numbers of ADRs were reported for boys and girls. The most frequent ADRs reported were from the following SOCs: general disorders and administration site conditions (34 %); skin and subcutaneous tissue disorders (15 %); nervous system disorders (14 %). Reports encompassed medicines from various ATC groups: vaccines and anti-infectives for systemic use (67 %); nervous system (9 %); respiratory system (9 %). On average, 37 % of ADRs were classified as serious. There were 33 fatal ADRs, and 35 % of the paediatric population associated with the ADR notifications required hospitalization or extended hospital stay.
  
  
  CONCLUSIONS
  In Spain, ADR reporting rate in the paediatric population has increased since 2004. The proportion of suspected ADR reports related to vaccines was predominant, which highlights the important role played by nurses. ADR notification of congenital malformations in newborn infants highlights the need for joint action between the Spanish System of Pharmacovigilance of Medicines for Human Use (SEFV-H) and paediatricians, obstetricians and gynaecologists. The publication of safety reports by regulatory agencies is determinant for the increased number of ADR notifications.
authors.affiliation: Unidad Central de Investigación Clínica y Ensayos Clínicos, Hospital Universitario de Canarias, Ofra, s/n. La Cuesta, 38320, San Cristóbal de Laguna, Santa Cruz de Tenerife, Spain. a.aldea@gmail.com
authors.forename: A
authors.initials: A
authors.lastname: Aldea
authors.forename: M
authors.initials: M
authors.lastname: García Sánchez-Colomer
authors.forename: E
authors.initials: E
authors.lastname: Fernández Quintana
authors.forename: M
authors.initials: M
authors.lastname: García Sáiz
mesh_terms: D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D017677:Age Distribution; D002648:Child; D002675:Child, Preschool; D004358:Drug Therapy / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D010372:Pediatrics / Q000706:statistics & numerical data*; D060735:Pharmacovigilance; D012111:Residence Characteristics; D012189:Retrospective Studies; D017678:Sex Distribution; D013030:Spain; D013997:Time Factors