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

Study identification

• EU PAS number:
  EUPAS17093
• Study ID:
  49537
• Official title and acronym:
  Prescribing of codeine for the treatment of pain in children. Drug utilisation study using IMS electronic health records in Germany and France.
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany
• Study description:
  In June 2013, the EU introduced risk minimisation measures (RMM) to the use of codeine for treatment of pain in children that included a contraindication in children below the age of 12 years, in children 0-18 years who undergo tonsillectomy or adenoidectomy (TA) for obstructive sleep apnoea, and in ultrarapid metabolisers of CYP2D6. Prescribers should use the lowest possible dose of codeine for the shortest possible time, and only prescribe codeine if other analgesics, e.g. ibuprofen or paracetamol, are insufficient.The aim of this study is to investigate the impact of RMM 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, amounts, prescribing of analgesics before codeine, and prescribing of codeine in children undergoing TA.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned:24/02/2015

Actual:24/02/2015

Study start date

Planned:10/11/2015

Actual:10/11/2015

Data analysis start date

Planned:11/11/2015

Actual:11/11/2015

Date of final study report

Planned:31/01/2017

Actual:23/04/2019

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable