A European multicentre drug utilisation study of the impact of regulatory measures on prescribing of codeine for pain in children.

ABSTRACT:

Purpose

In June 2013, following recommendations from the World Health Organization (WHO) and Food and Drug Administration (FDA), the European Medicines Agency agreed updates to the codeine product information regarding use for pain in children younger than 12 years and children undergoing tonsillectomy or adenoidectomy (TA) for obstructive sleep apnoea. This study was conducted to (a) assess effectiveness of these measures on codeine prescribing in the "real-world" setting and (b) test feasibility of a study using a common protocol by regulators with access to databases.

Methods

The study was performed using BIFAP (Spain), CPRD (UK), and IMS® Disease Analyzer (France and Germany) databases. Prescribers included general practitioners (GPs) (France and UK), GPs and paediatrici

SUBMITTER: Hedenmalm K 

PROVIDER: S-EPMC6771637 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature