Study type

Study type

Non-interventional study

Scope of the study

Drug utilisation
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

BUPRENORPHINE
NALOXONE HYDROCHLORIDE DIHYDRATE
OXYCODONE
PENTAZOCINE
TILIDINE

Anatomical Therapeutic Chemical (ATC) code

(N01AH) Opioid anesthetics
Opioid anesthetics
(N02AX) Other opioids
Other opioids
(R05DA) Opium alkaloids and derivatives
Opium alkaloids and derivatives
Population studied

Age groups

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

19000000
Study design details

Main study objective

(i) To investigate the annual incidence and annual period prevalence of use of opioids stratified by calendar year, age, sex and country/database during the study period 2012-2022.
(ii) To determine duration of prescription opioid use, as well as characteristics of new users and indication for opioid prescribing/dispensing, all stratified by calendar year and country/database.

Data analysis plan

Population-level opioid use: Annual period prevalence of opioid use and annual incidence rates per 100,000 person years will be estimated.
Patient-level opioid use: Large-scale patient-level characterization will be conducted at index date, including patient demographics, and history of comorbidities and comedication.
Frequency of indication at index date, and in the immediate time before will be calculated.
Cumulative treatment duration will be estimated for the first treatment era and the minimum, p25, median, p75, and maximum will be provided.
For all analyses a minimum cell count of 5 will be used when reporting results, with any smaller counts will be noted as <5.
Documents
Study report

DARWIN_EU_StudyReport_P2_C1_002_Opioids_V3_final_EUPAS.pdf

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