DARWIN EU® - RR1 Drug Utilisation Study of prescription opioids

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:
  Opioids (substances listed in ATC classes N01AH, N02A and R05DA), namely:; acetyldihydrocodeine, alfentanil, anileridine, bezitramide, butorphanol, buprenorphine, codeine, dezocine, dimemorfan, dextromethorphan, dextromoramide, dextropropoxyphene, dihydrocodeine, ethylmorphine, fentanyl, hydrocodone, hydromorphone, ketobemidone, meptazinol, meperidine (pethidine), methadone, morphine, nicomorphine, normethadone, nalbuphine, noscapine, oliceridine, opium, oxycodone, oxymorphone, papaveretum, pentazocine, phenazocine, phenoperidine, pholcodine, pirinitramide, propoxyphene, remifentanil, sufentanil, tapentadol, thebacon, tilidine, tramadol; naloxone; buprenorphine/naloxone, oxycodone/naloxone,pentazocine/naloxone, tilidine/naloxone;
• Study drug International non-proprietary name (INN) or common name:
  BUTORPHANOL

  BUPRENORPHINE

  CODEINE

  DEXTROMETHORPHAN

  DIHYDROCODEINE

  ETHYLMORPHINE

  FENTANYL

  HYDROMORPHONE

  METHADONE

  MORPHINE

  OXYCODONE

  PENTAZOCINE

  PHOLCODINE

  SUFENTANIL

  TAPENTADOL

  TILIDINE

  TRAMADOL

  NALOXONE
• 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 before the day they become eligible for study inclusion. Therefore, children aged <1 year will be excluded.
• Age groups:
  • Paediatric Population (< 18 years)

    • 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 8 databases.
• Main study objective:
  The objectives of this study are ; (i) To investigate the annual incidence and annual period prevalence of use of opioids (overall, active drug substance, strength (weak/strong opioids) and route (oral, transdermal or parenteral), stratified by history of cancer/no history of cancer and for calendar year, age, sex and country/database during the study period. ; (ii) To determine duration of prescription opioid use, as well as characteristics of new users and indication for opioid prescribing/dispensing overall and in people with history of cancer/no history of cancer, all stratified by calendar year and country/database.
• Summary results:
  CONCLUSION ; An increasing trend in overall opioid use was observed in EBB and IMASIS, while a decreasing trend was observed in DK-DHR and IPCI. Most of the opioid prescriptions were not prescribed to people with a history of cancer, which suggests they were prescribed for non-cancer related indications. There was a decrease in opioid prescriptions during the early COVID-19 period (2020-2021), in particular prescriptions of weak opioid and opioid with non-cancer related indications. However, rates of opioid prescriptions returned to the pre-COVID-19 level or even higher from 2022 onwards.