11 February 2013 EMA/65632/2013/ Drug utilisation of codeine in children: EMA analyses of The Health Improvement Network and of the IMS Health German databases 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8613 E -mail
[email protected] Website www.ema.europa.eu An agency of the European Union 1. PASS information Title Drug utilisation of codeine in children: EMA analyses of The Health Improvement Network and of the IMS Health German databases Protocol version identifier 1.0 Date of last version of the protocol 18 January 2013 EU PAS Register No: Study not registered Active substance Codeine ATC code: R05DA04, N02AA59, N02AA79 Medicinal product(s): Product reference: Procedure number: Study initiator EMA Research question and objectives On 3 October 2012, the European Medicines Agency started a review of codeine-containing medicines under Article 31 of Directive 2001/83/EC. Recent concerns have arisen over an increased risk of morphine toxicity when codeine is given to children after surgery. In particular, cases have been reported of fatal or life-threatening respiratory depression in children who are ultra-rapid metabolisers and were given codeine after surgical removal of the tonsils. On 31 October 2012 the scope of the review was extended from post-surgery pain relief in children to pain relief in children. This study seeks to determine the extent to which codeine is prescribed or dispensed to children and the incidence of death occurring within this population. Analyses are done in the THIN database (UK general practice) and IMS database (German general and specialists practice).