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

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  PARACETAMOL

Population studied

• Short description of the study population:
  The source population will comprise all individuals present in the database at any time during the period from 1st of January 2010 to 31st of December 2023 (or last year with complete observation). All patients will need to have at least 365 days of data visibility prior to index date. Therefore, children aged <1 year will be excluded.

Study design details

• Study design:
  Retrospective cohort studies will be conducted using routinely collected health data from 8 databases.
• Main study objective:
  The aim of the study is to provide an overview of paracetamol prescribing and paracetamol overdose in the 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. ;