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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44757
• EU PAS number:
  EUPAS32021
• Study ID:
  44757
• Official title and acronym:
  Changes in alternative treatments for pain and cough in children after introduction of risk minimisation measures for codeine (Alternatives to codeine)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Spain

  United Kingdom
• Study description:
  Europe-wide risk minimisation measures (RMMs) were introduced for the use of codeine for the treatment of pain relief in children in June 2013 to minimise the risk of serious adverse events. In April 2015, similar RMMs were also introduced for the use of codeine in the treatment of cough or cold in paediatric patients. This is a drug utilisation study in a cohort of patients under 18 years of age. The study has the following objectives: 1. 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. 2. To describe prescribing trends for codeine and alternative analgesics and antitussives over time in patients below 18 years of age by evaluating the total number of children with a prescription and the total number of prescriptions of codeine and selected alternative analgesics and antitussives per time period: 2.1. In relation to all children in the database during the same time period. 2.2. Stratified by age group (0-11 years and 12-17 years) and gender.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Agencia Española de Medicamentos y Productos Sanitarios (Spanish Agency for Medicines and Medical Devices, AEMPS)

Spain

ANSM France, The Norwegian Medicines Agency Norway

Study timelines

Date when funding contract was signed

Planned: 15/01/2019

Actual: 01/01/2020

Study start date

Planned: 01/10/2019

Actual: 01/06/2020

Data analysis start date

Planned: 01/11/2019

Actual: 01/09/2020

Date of interim report, if expected

Actual: 31/01/2021

Date of final study report

Planned: 01/02/2019

Actual: 31/07/2021

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable