Preventable Adverse Drug Reactions reported to the Croatian Agency for Medicinal Products and Medical Devices (PREVENTABLE)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Descriptive 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:
  1000

Study design details

• Main study objective:
  The objective of the study is to identify, evaluate and describe preventable adverse drug reactions among the spontaneously reported ADRs to the Croatian Agency for Medicinal Products and Medical Devices (HALMED).
• Outcomes:
  To identify the proportion of preventable adverse drug reactions (ADRs) among the spontaneously reported ADRs.To describe the preventable ADRs in terms of seriousness, pertaining SOC, ATC classification, number of drugs used, setting in which ADR occurred, indication for use of suspected drug, and category according to p-method. To identify risk factors contributing to preventable ADR occurrence
• Data analysis plan:
  Descriptive study. The previously validated “P-method” will be employed to systematically detect preventable ADRs in individual case safety reports (ICSR) sent to the Croatian pharmacovigilance centre (PVC) at HALMED.