Study identification

PURI

https://redirect.ema.europa.eu/resource/107398

EU PAS number

EUPAS106954

Study ID

107398

Official title and acronym

Incidence, prevalence, and characterisation of medicines with suggested drug shortages in Europe

DARWIN EU® study

No

Study countries

Belgium
Bulgaria
Denmark
Estonia
Finland
France
Germany
Italy
Montenegro
Netherlands
Portugal
Serbia
Spain
Türkiye
United Kingdom

Study description

This study aims to characterise the incidence and prevalence of medicines with (suggested) shortages and their alternatives for the period 2010-2023, stratified by healthcare setting and time period in each database. Furthermore, we aim to describe incident and prevalent patients receiving a prescription / dispensation of a medicine with (suggested) shortages for the period 2010-2023, stratified by year in each database, including information on potential indication, treatment duration, and dosage.

Study status

Planned
Research institution and networks

Institutions

Networks

Contact details

Daniel Prieto-Alhambra

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

EHDEN
Study protocol
Initial protocol

EHDENMegaStudy_drugshortage v1.0_FINAL

English (950.09 KB - PDF)View document
Updated protocol

EHDENMegaStudy_drugshortage v2.0_FINAL

English (950.92 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable