Changes in alternative treatments for pain and cough in children after introduction of risk minimisation measures for codeine (Alternatives to codeine)

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:
  CODEINE

  DEXTROMETHORPHAN

  DIHYDROCODEINE

  ETHYLMORPHINE

  HYDROMORPHONE

  METAMIZOLE

  MORPHINE

  OXYCODONE

  PHOLCODINE

  TRAMADOL

Population studied

• Short description of the study population:
  The patient population consisted in all patients under the age of 18 years, with a particular focus on children below 12 eligible to be exposed to codeine or any of the alternative analgesics or antitussives of interest included in our study.
• 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)
• Estimated number of subjects:
  750

Study design details

• Main study objective:
  To assess whether the codeine referrals for the treatment of pain and cough or cold in patients below 18 years of age were temporally associated with statistically significant changes in prescribing of alternative analgesics, antitussives or cold medicines in this patient population.
• Data analysis plan:
  Interrupted time series analysis

Documents

Study results

Annex A - Tables and Figure

Annex B - Medicines use in children 12 to 18 years of age

Final Report