Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Drug utilisation

Data collection methods

Secondary use of data
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

CODEINE

Medical condition to be studied

Upper-airway cough syndrome
Population studied

Short description of the study population

Children and adolescents with cough and cold who have been prescribed Codeine.

Age groups

  • Paediatric Population (< 18 years)
    • Neonate
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)

Special population of interest

Other

Special population of interest, other

Cough and cold patients

Estimated number of subjects

3700000
Study design details

Main study objective

The present analyses primarily concern the utilisation of codeine in children. practice in Germany, general practice in France) will be performed. In addition, available on-line Nordic prescription registries will be queried. The study will also analyse the incidence of death occurring within a short time span of a codeine prescription.

Outcomes

The utilisation of codeine in children. practice in Germany, general practice in France) will be performed. The study will also analyse the incidence of death occurring within a short time span of a codeine prescription.

Data analysis plan

Descriptive drug utilisation study using the EMA’s in-house electronic health record (EHR) databases (IMS Germany, IMS France and THIN UK). In addition available on-line data on prescriptions dispensed from pharmacies in the three Nordic Countries have been used (Norway, Sweden and Denmark).