DARWIN EU® - RR2 Drug utilisation study of prescription opioids

Study type

• Study topic:
  Human medicinal product
• Study topic, other:
  Opioids
• 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

• Anatomical Therapeutic Chemical (ATC) code:
  (N01AH) Opioid anesthetics

  Opioid anesthetics

  (N02A) OPIOIDS

  OPIOIDS

  (R05DA) Opium alkaloids and derivatives

  Opium alkaloids and derivatives

Population studied

• Short description of the study population:
  The study cohort will comprise all individuals present in the database during the study period (2012-2024) and with at least 365 days of data availability (not applicable to hospital databases) before the day they become eligible for study inclusion.
• Age groups:
  • In utero
  • Paediatric Population (< 18 years)

    • Neonate

      • 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)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Study design details

• Study design:
  A cohort study will be conducted using routinely-collected health data from 7 databases.
• Main study objective:
  This study aims to assess the incidence and prevalence of prescription opioids for the period 2012-2024, stratified by history of cancer/no history of cancer and age, sex, calendar year and country, as well as characterisation of new users, indications and treatment duration overall and in people with history of cancer/no history of cancer stratified by calendar year and country