Educational Paper: Aspects of clinical pharmacology in children--pharmacovigilance and safety

Eur J Pediatr. 2013 May;172(5):577-80. doi: 10.1007/s00431-012-1871-9. Epub 2012 Oct 31.


Adverse drug reactions (ADRs) are a significant problem in children, affecting one in ten children in hospital. Within the community, one in 500 children will experience an adverse drug reaction each year. Pharmacovigilance has been useful in detecting suspected ADRs. However, most ADRs are unreported and often not suspected. Education of health professionals in relation to drug toxicity improves the reporting rate of suspected ADRs. Clinical trials are useful to evaluate the efficacy of drugs. They are, however, not the best way of looking at ADRs where surveillance following the widespread use of a drug is more appropriate. Alongside work by the regulatory agencies, independent investigators have helped collate data. This information has been useful in developing guidelines to prevent further cases of drug toxicity. Greater awareness and understanding of drug toxicity in children should result in more rational prescribing.

Publication types

  • Review

MeSH terms

  • Adverse Drug Reaction Reporting Systems*
  • Child
  • Humans
  • Patient Safety*
  • Pharmacology, Clinical*
  • Pharmacovigilance*