title: Reported paediatric adverse drug reactions in the UK 2000-2009.
abstract: OBJECTIVE
  The UK Medicines and Healthcare products Regulatory Agency (MHRA) runs a national spontaneous reporting system (Yellow Card Scheme) to collect 'suspected' adverse drug reaction (ADR) data. MHRA advice is to report all suspected ADRs in paediatric (<17 years) patients.
  
  
  METHODS
  Data on all ADRs reported to the MHRA in patients <17 years from the years 2000-9 were supplied in two datasets, inclusive and exclusive of vaccines.
  
  
  RESULTS
  Of 222 755 ADR reports received by the MHRA from 2000-9, 31726 (14.2%) were in children <17 years. The number of reports in 2000 was greater than in subsequent years (12035) due to a national vaccination programme (Meningococcal Serogroup C conjugate vaccine). The median number of ADR reports per annum (2001-2009) for children was 2146 (95% CI 1801, 2575). Vaccines were included in 22102 (66.5%) paediatric ADR reports, with Meningococcal Serogroup C conjugate vaccine reported most frequently (12106 reports) and headache the commonest symptom (3163). Excluding vaccines, methylphenidate (653 reports) and atomoxetine (491) were the most commonly reported medications, and the most commonly reported symptom was vomiting (374). Reporting by nurses increased from 396 in 2001 to 1295 in 2009 (41.8% of all reports); reporting by doctors stayed constant. Reports from patients, parents or carers more than doubled but remained infrequent (1.5% in 2005, 4.0% in 2009).
  
  
  CONCLUSIONS
  Although under-reporting is probably common, the Yellow Card Scheme in the UK receives more than 2000 reports per year on patients <17 years. Nurses now report more suspected ADRs in children than any other healthcare professional.
authors: Division of Developmental and Reproductive Medicine, University of Liverpool, Liverpool Northwick Park Hospital, Watford Road, Harrow, London Alder Hey Children's Hospital, Liverpool Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.
authors: Daniel B
authors: DB
authors: Hawcutt
authors: Pramod
authors: P
authors: Mainie
authors: Andrew
authors: A
authors: Riordan
authors: Rosalind L
authors: RL
authors: Smyth
authors: Munir
authors: M
authors: Pirmohamed
mesh_terms: D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D006282:Health Personnel / Q000706:statistics & numerical data; D006801:Humans; D007223:Infant; D006113:United Kingdom / Q000453:epidemiology; D014611:Vaccination / Q000009:adverse effects*