Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000534

EU PAS number

EUPAS1000000534

Study ID

1000000534

Official title and acronym

DARWIN EU® - Monitoring prescription of essential medicines administered in ICU

DARWIN EU® study

Yes

Study countries

Finland
France
Greece
Hungary
Portugal
Spain

Study description

The European Medicines Agency (EMA) recently expanded its mandate to include crisis preparedness and management of medicinal products and medical devices, particularly focusing on monitoring and reporting shortages during public health emergencies (PHE).
This extended responsibility encompasses coordinating responses to shortages of critical medical devices and in-vitro diagnostics across European Union (EU) and European Economic Area (EEA) countries.
Recognising the importance of robust scientific and commercial data, there is a growing emphasis on analysing prescriptions of critical medicines in hospital settings, particularly Intensive Care Units (ICUs), to provide valuable insights into usage patterns.
This systematic analysis enhances EMA's ability to proactively monitor and respond quicker to potential public health emergencies, ensuring continued access to essential healthcare resources during crises.
This is a routine repeated study of a population- and patient-level drug utilisation study previously performed within DARWIN EU® (EUPAS1000000089) to report the annual prescription rate of selected medicines of importance for public health emergencies, specifically used in ICU.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Guido van Leeuwen

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
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable