Codeine is used to treat pain, cough, and diarrhoea. Respiratory depression, a decreased rate of breathing, is a rare side effect associated with codeine and therefore it is not recommended for use in children in whom breathing might already be compromised.
A review of the risk of life-threatening/fatal respiratory depression in children taking codeine for pain concluded that in order to balance this risk against the benefits of treatment there was a need to restrict the use of codeine-containing medicines recommended for the treatment of pain to those aged 12+ years with acute moderate pain that cannot be relieved by other pain relievers and then only at the lowest effective dose for the shortest time. It was also agreed that codeine should be contraindicated in all children having their tonsils or adenoids removed to relieve obstructive sleep apnoea (disorder characterised by pauses in, or shallow/infrequent, breathing during sleep caused by obstruction in the upper airway), in known CYP2D6 ultra-rapid metabolisers (an enzyme responsible for the metabolism of many medicines), and in women who are breastfeeding.
This drug utilisation study will explore to what extent these new measures are being followed in routine care and inform the need for further communications or actions.
Codeine is an opium alkaloid converted in the body into morphine. The main risk associated with morphine toxicity is respiratory depression, which may be fatal.
In 2012/13, the EU Pharmacovigilance Risk Assessment Committee (PRAC) undertook an Article 31 review of the risk of life-threatening or fatal respiratory depression in children after taking codeine for the treatment of pain and agreed risk-minimisation measures restricting use in order to maintain a positive benefit risk balance. Changes were made to the Summaries of Product Characteristics to reflect these variations in the licences and information was also communicated directly to healthcare professionals on an EU and National basis.
This descriptive study will examine the patterns of prescribing of codeine-containing products with an indication for the treatment of pain in children in the period 2010-2015 in the UK in relation to these risk minimisation measures. The results will inform the PRAC on the impact of the new measures and the effectiveness of the communication strategy and is being performed as part of a wider collaborative study in which a common protocol will be used to examine electronic healthcare record data from four EU countries (UK, France, Germany, and Spain). Summary statistics only will be used.
Katherine Donegan - Chief Investigator - MHRA
Katherine Donegan - Corresponding Applicant - MHRA
HES Admitted Patient Care