DARWIN EU® Drug Utilisation Study of prescription opioids

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, 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:
  All

  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.