Implementation of new pharmacovigilance legislation concerning the new adverse drug reactions definition (IMAGINATION)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Policy assessment (The extent of implementation of the new legislation)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  After before study

Population studied

• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  1500

Study design details

• Main study objective:
  To investigate the level of implementation of pharmacovigilance legislation concerning ADRs which arise from the use outside the terms of the marketing authorisation, including overdose, off-label use, misuse, abuse and medication errors.
• Outcomes:
  To evaluate and compare the number of individual case safety reports (ICSRs) concerning ADRs which arise from the use outside the terms of the marketing authorisation, including overdose, off-label use, misuse, abuse and medication errors before and after the change in pharmacovigilance legislation, To identify, evaluate and describe ICSR in which suspected medicinal product was used outside the terms of the marketing authorisation, but did not result in harm.
• Data analysis plan:
  The primary endpoint of the study, difference in number of ICSR in which suspected medicinal product was used outside the terms of the marketing authorisation before and after the implementation of the change in pharmacovigilance legislation