Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000329

EU PAS number

EUPAS1000000329

Study ID

1000000329

Official title and acronym

DARWIN EU® – Paracetamol prescribing and paracetamol overdose in Europe: a descriptive analysis of trends and patient characteristics

DARWIN EU® study

Yes

Study countries

Croatia
Denmark
France
Germany
Portugal
Spain
United Kingdom

Study description

Paracetamol (acetaminophen) is one of the most widely used medicines worldwide and is available over the counter in the European Union. It is one of the most common causes of drug poisonings and can result in severe hepatic failure. Different regulatory interventions at national level have occurred to reduce the incidence of paracetamol overdose, but it is uncertain how paracetamol is prescribed across Europe and to what extent prescription may be involved in poisonings.

Research question and objectives
The aim of the study is to provide an overview of paracetamol prescribing and paracetamol overdose trends in selected European databases, and to characterise patients presenting with paracetamol overdose.

The specific objectives of the study are:
1. To examine the incidence/prevalence of paracetamol prescribing (overall, and by age, sex, formulation and country/database).
2. To examine the incidence of paracetamol overdose (overall, and by age, sex, country/database).
3. To characterise patients with paracetamol overdose, in terms of comorbidities, co-prescribed medications, prior paracetamol prescription, and incidence of short-term complications and mortality.

Study status

Ongoing
Research institution and networks

Institutions

Networks

Contact details

Berta Raventos

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-C1-007_Paracetamol_V2.pdf

English (724.56 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