Incidence and outcome of paracetamol poisoning

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology
• 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
• Medical condition to be studied:
  Poisoning deliberate

  Accidental poisoning

  Liver disorder

  Death

Population studied

• Short description of the study population:
  Patients admitted to hospitals in Sweden for paracetamol poisoning identified from hospital discharge diagnoses and cause of death in national health-care databases.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired
• Estimated number of subjects:
  50000

Study design details

• Main study objective:
  Estimate incidence and outcome of paracetamol poisoning
• Outcomes:
  - Impact of intervention on monthly count of poisoning events (interrupted time series analysis), - Health care utilisation- Liver failure- Liver transplant- Death
• Data analysis plan:
  - Incidence estimation- Time series analysis

Documents

Study results

Gedeborg_et_al-2017-Pharmacoepidemiology_and_Drug_Safety