DARWIN EU® Drug utilization study of prescription opioids

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/106383
• EU PAS number:
  EUPAS105641
• Study ID:
  106383
• Official title and acronym:
  DARWIN EU® Drug utilization study of prescription opioids
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Estonia

  France

  Germany

  Netherlands

  Spain
• Study description:
  Prescription opioids, while effective for managing severe pain, have led to a public health crisis due to misuse, addiction, and overdose, particularly in the US. Recently, concerns have been growing in Europe due to increasing opioid use and related mortality. Factors such as chronic pain, mental health disorders, and advanced age can exacerbate misuse and the development of dependence. Given the potential for global spread of this issue, enhanced surveillance and in-depth research into opioid utilization patterns are imperative. A drug utilization study using a Common Data Model (CDM) is a promising approach to supplement European opioid monitoring systems, providing more granular data to inform evidence-based decisions on this complex topic. The European Medicines Agency commissioned this DARWIN EU© CC study to: (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 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.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Actual: 30/03/2023

Study start date

Actual: 01/01/2012

Date of final study report

Actual: 06/11/2023

Study protocol

Initial protocol

Study Protocol P2 C1-002 Version 2.1 final

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable