Medication Errors – a characterisation of spontaneously reported cases in EudraVigilance

Study type

• Study topic:
  Other
• Study topic, other:
  Medication errors
• Study type:
  Not applicable
• If ‘Not applicable’, further details on the study type:
  Database characterisation
• If ‘other’, further details on the scope of the study:
  Characterisation of cases in database

Population studied

• Short description of the study population:
  Spontaneous case reports in the EudraVigilance Post-Authorisation Module were used. Valid case reports include, at a minimum, an identifiable reporter, an identifiable patient, and at least one drug and one adverse drug reaction.
• 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)
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  This study aims to characterise spontaneously reported cases of medication errors in EudraVigilance over the period 2002-2015 before the release of European Union good practice guidance.
• Data analysis plan:
  Cases reports were identified through the adverse reaction section where a MedDRA® term is reported and included in the Standardised MedDRA® Query (SMQ) for medication errors. These case reports were further categorised by MedDRA® terms, geographical region, patient age group and Anatomical Therapeutic Chemical classification system of suspect medicinal product(s).