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 institution and networks

Institutions

ANSM France, The Norwegian Medicines Agency Norway

Contact details

Daniel Nogueras Zondag

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Start date of data analysis

Planned:
Actual:

Date of interim report, if expected

Actual:

Date of final study report

Planned:
Actual:
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