Prescribing of codeine for the treatment of pain in children. Drug utilisation study using IMS electronic health records in Germany and France.

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

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Descriptive study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  CODEINE
• Medical condition to be studied:
  Pain

Population studied

• Short description of the study population:
  The study participants were children who has been prescribed codeine for the treatment of non-acute pain or pain in Germany and France.; Inclusion criteria: ; • children below the age of 12 years ; • children between 12-18 years of age with non-acute pain or pain that is less than moderate in severity that can be relieved by other analgesics such as paracetamol or ibuprofen alone; • children undergoing tonsillectomy, adenoidectomy or combined tonsillectomy/adenoidectomy for obstructive sleep apnoea
• Age groups:
  • 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:
  Patients with non-acute pain
• Estimated number of subjects:
  50000

Study design details

• Main study objective:
  The aim of this study is to investigate the impact of risk minimisation measures on prescribing of codeine for pain in children in the IMS France and Germany databases. Impact measures by age group (0-11 and 12-18 years) and gender include 3- or 6-monthly prevalences of codeine prescriptions, and before and after RMM the following measures: Prevalences by 1-year age groups, doses, durations...
• Outcomes:
  Prescribing of codeine in children before and after introduced risk minimisation measures.
• Data analysis plan:
  Descriptive drug utilisation study using the EMA’s in-house electronic health record (EHR) databases (IMS Germany, IMS France)