title: Adverse drug reactions in Ghanaian children: review of reports from 2000 to 2012 in VigiBase.
abstract: OBJECTIVE
  The aim of this article is to describe adverse drug reactions (ADRs) reported for children aged 0 - 17 years in Ghana.
  
  
  METHODS
  Paediatric reports submitted by the Ghana National Centre for Pharmacovigilance to the World Health Organisation (WHO) Global ADR database, VigiBase up to December 2012 were extracted. The data were analysed for number of reports per year, types of reporters and suspected ADRs and drugs.
  
  
  RESULTS
  A total of 343 reports for children were received during the period. The drug classes most frequently reported were vaccines (115, 31%), antimalarials (106, 28%) and antibiotics (57, 15%). Of the top 20 individual drugs, 19 were anti-infectives. The most frequently reported ADRs were injection site infection, fever and rash. There were 23 deaths reported, and antimalarials were implicated in 12 cases.
  
  
  CONCLUSIONS
  Vaccines, antimalarials and antibiotics are the leading medicines reported to cause ADRs in Ghanaian children. There was a high mortality rate, with many of the deaths due to causes explained in the individual case safety reports.
authors.affiliation: a 1 The University of Nottingham, Derbyshire Children's Hospital, Academic Division of Child Health , Derby, UK mzxkoc@nottingham.ac.uk.
authors.forename: Kennedy Obebi
authors.initials: KO
authors.lastname: Cliff-Eribo
authors.affiliation: a 1 The University of Nottingham, Derbyshire Children's Hospital, Academic Division of Child Health , Derby, UK mzxkoc@nottingham.ac.uk.
authors.forename: Imti
authors.initials: I
authors.lastname: Choonara
authors.affiliation: b 2 University of Ghana, School of Medicine and Dentistry, WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance , Accra, Ghana.
authors.forename: Alex
authors.initials: A
authors.lastname: Dodoo
authors.affiliation: c 3 Food and Drugs Authority, National Pharmacovigilance Centre , Accra, Ghana.
authors.forename: Delese M
authors.initials: DM
authors.lastname: Darko
authors.affiliation: a 1 The University of Nottingham, Derbyshire Children's Hospital, Academic Division of Child Health , Derby, UK mzxkoc@nottingham.ac.uk.
authors.forename: Helen
authors.initials: H
authors.lastname: Sammons
mesh_terms: D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems; D000900:Anti-Bacterial Agents / Q000009:adverse effects; D000962:Antimalarials / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000209:etiology / Q000401:mortality; D005260:Female; D005869:Ghana / Q000453:epidemiology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D060735:Pharmacovigilance; D014612:Vaccines / Q000009:adverse effects
chemical_list: D000900:Anti-Bacterial Agents; D000962:Antimalarials; D014612:Vaccines
keywords: adverse drug reactions; children; drug safety; pharmacovigilance; spontaneous reporting system