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

Yes

Study countries

Belgium
Estonia
Finland
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

Ongoing
Research institution and networks

Institutions

University of Tartu
Estonia
First published:
01/02/2024
Institution
Educational Institution
Estonian Biobank Estonia, Clinical Data Warehouse of Bordeaux University Hospital (CHUBX) France, Auria Clinical Informatics VARHA (ACI Varha) Finland

Networks

Contact details

Annika Jodicke

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Study protocol
Initial protocol

Study Protocol P2 C1-002 Version 2.1 final

English (1.78 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable