Pharmacovigilance is the process by which the use of medicines is monitored; providing information to assess the risks and benefits of medicines and to improve the safety and effectiveness of their use.

Most new medicines are studied in a relatively small number of people in clinical trials before licensing (1,500 on average) and clinical trails are conducted under very strict conditions which means that clinical trials will identify common side effects of medicines but rarer side effects may only be seen once the medicine is used in much larger numbers of patients. This is why post-marketing surveillance of licensed medicines is so important.

Pharmacovigilance of medicines used in the treatment of children is particularly important because:

  • medicines may have different effects in children than in adults
  • medicines are less intensively tested in children
  • many medicines are not specifically licensed for use in children and are used off-label
  • suitable formulations may not be available to allow precise dosing for children
  • the nature and course of illnesses and ADRs may differ between adults and children