Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000479

EU PAS number

EUPAS1000000479

Study ID

1000000479

Official title and acronym

DARWIN EU® Drug Utilisation Study of prescription opioids

DARWIN EU® study

Yes

Study countries

Belgium
Denmark
Estonia
France
Netherlands
Norway
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.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Amy Lam

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Study protocol
Initial protocol

DARWIN EU Protocol_P3-C2-002_DUS Opioids_V3.pdf

English (862.45 KB - 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