DARWIN EU® - Drug utilisation study on antibiotics in the ‘Access’ category of the WHO AWaRe classification of antibiotics for evaluation and monitoring of use

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  All antibiotics listed under the WHO AWaRe ‘Access’ category 2023

Population studied

• Short description of the study population:
  The study domain includes all persons present in the data sources in the study period: 01/01/2012 to 31/12/2024 (or the latest available date) with at least 365 days observation time. This will be used as the denominator population for calculating incidence rates.

Study design details

• Study design:
  • Population level cohort study (Objective 1, Population-level drug utilisation study on ‘Access’ category antibiotics) ; • New drug user cohort study (Objectives 2 and 3, Patient-level drug utilisation analysis with regard to duration and indication of antibiotics use)
• Main study objective:
  1. To investigate the incidence of prescription of individual antibiotics and antibiotics class (from the WHO AWaRe ‘Access’ category), stratified by age, sex, calendar year/month during the study period 2012-2024. ; 2. To characterise individual antibiotics and antibiotics class (WHO AWaRe ‘Access’ category 2023) use by duration of use over the study period 2012-2024. ; 3. To characterise individual antibiotic and antibiotics class (WHO AWaRe ‘Access’ category 2023) use by indication of use stratified by calendar year over the period 2012-2024.
• Setting:
  Inpatient and/or outpatient setting