Study identification

EU PAS number

EUPAS1000000678

Study ID

1000000678

Official title and acronym

DARWIN EU® – Trends in utilisation of Attention-Deficit Hyperactivity Disorder (ADHD) Medications

DARWIN EU® study

Yes

Study countries

Denmark
Germany
Spain
Sweden

Study description

A first OTS study (EUPAS1000000219) has been performed in 2024 at the request of the SPOC Working Party (responsible for monitoring and reporting events that could affect the supply of medicines in the EU) that has been monitoring shortages of different medicines to treat Attention-Deficit Hyperactivity Disorder (ADHD), mainly due to an increased demand in multiple markets, production constraints related to raw material availability, new regulatory approvals for some medicines, and changes in the competitive landscape.
The main products under monitoring are lisdexamfetamine and methylphenidate, but three more have the indication in Europe (atomoxetine, dexamphetamine, and guanfacine). Currently, the situation has improved slightly in the EU and there are no critical shortages. However, it is anticipated that constraints in the supply will continue throughout 2025.
The initial study was conducted to better anticipate potential shortages and its impact on appropriate patient management, as it is important to assess the evolution of prescriptions over time and get an overview of how these ADHD medicines are used across Europe.
The Spanish Regulatory Authority (AEMPS), after having seen the results of the initial study, has asked the EMA if we could repeat the study with additional data partners, especially Spanish ones, as only one Spanish data partner was finally included in the first study, as reported (https://catalogues.ema.europa.eu/system/files/2025-03/DARWIN%20EU_Report_P3-C1-004_ADHD_V5.pdf).
This study is now being repeated to include additional data sources with more recent data.
In addition, since all ADHD medications are approved only for individuals aged six and older, their use in children under six years of age is considered off-label.
Therefore, in the current study, we will add a stratum of young child aged below five years old to assess potential off-label use of these medications.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Xintong Li

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