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

• Study drug International non-proprietary name (INN) or common name:
  PARACETAMOL
• Anatomical Therapeutic Chemical (ATC) code:
  (N02BE01) paracetamol

  paracetamol

Population studied

• Short description of the study population:
  For objective 1 and 2, the study population will comprise all individuals present in the database at any time from 1st January 2010 to 31st of December 2023 (or the latest year with complete observation). For objective 3, the study will comprise of individuals with paracetamol overdose for the first time in their patient history during the study period.; ; For incidence calculations (objective 1 and 2), individuals with a record of the outcome will re-enter the study after a certain amount of time (i.e. washout period) so further occurrences of the outcome can be captured. This washout period will be defined as 60 days following the end of the prescribed treatment for paracetamol prescribing and 365 days for paracetamol overdose. For objective 3, individuals with a prior history of paracetamol overdose any time prior to index date will be excluded. ; ; A year of observation history prior to index date will be required for all individuals within selected databases except CDWBordeaux. Individuals aged less than 1 year of observation history will be excluded.

Study design details

• Study design:
  1. Population-level drug utilisation study to assess incidence and prevalence of paracetamol prescribing (objective 1) 2. Population-level descriptive epidemiology study to estimate the incidence of paracetamol overdose (objective 2) ; 3. Patient-level characterisation study
• Main study objective:
  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.
• Setting:
  This study will be conducted using routinely collected data from 8 databases in 7 European countries selected from the DARWIN EU® Database Catalogue. All databases were previously mapped to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM).

Documents

Study report

DARWIN EU_Report_P3-C1-007_Paracetamol_V2.pdf