Study identification

PURI

https://redirect.ema.europa.eu/resource/199005

EU PAS number

EUPAS107932

Study ID

199005

Official title and acronym

DARWIN EU® Monitoring prescription of medicines for public health emergencies at risk of shortages

DARWIN EU® study

Yes

Study countries

Belgium
Germany
Spain
United Kingdom

Study description

The extended mandate of EMA reinforcing the role of the Agency in crisis preparedness and management of medicinal products and medical devices became applicable on 1st March 2022 (Regulation on EMA’s extended mandate becomes applicable, European Medicines Agency). EMA is now responsible for monitoring medicine shortages that might lead to a crisis situation, as well as reporting shortages of critical medicines during public health emergencies (PHE). Such shortages would make it difficult or impossible to meet the treatment needs of individual patients or populations. The Agency has also the mandate to coordinate responses of EU, EEA countries to shortages of critical medical devices and in vitro diagnostics in crisis situations. Scientific and commercial data on monthly prescriptions of medicines that may be critical in PHE can help understanding trends and seasonal variations. In conjunction with time series and forecasting models, as well as data on medicines supply, such data will contribute to the ongoing efforts of the Agency to better monitor and coordinate its response to shortages of critical medicines. This study aims at generating monthly prescription rates of selected medicines over the last 10 years and to fit Autoregressive Integrated Moving Average (ARIMA) prediction models to such data.

Study status

Ongoing
Research institutions and networks

Institutions

University of Oxford, PSMAR

Networks

Contact details

Marta Pineda Moncusi

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_P2_C1_012_V4.1.pdf

English (651.28 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