International Primary Care Respiratory Group
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News
IPCRG and EFA submit comments to EMEA consultation for medicines used in children
On 19 January 2006, IPCRG International Primary Care Respiratory Group and EFA European Federation of Allergy and Airway Diseases Patients' Associations submitted comments to the European Medicines Agency (EMEA) draft "Guideline on conduct of pharmacovigilance for medicines used by the paediatric population".
This is the first guideline to focus exclusively on the issues of safety of medicines in children. The guideline is designed as preparatory work for the implementation of the proposed EU paediatric regulation once it comes into force, since this also contains a number of provisions on pharmacovigilance.
IPCRG and EFA fully support the thrust and importance of these proposals.
According to the European Commission many medicines taken by children may not have been tested in that age group. In addition, the child population itself is quite diverse, ranging from newborns to teenagers. This has led to the widespread use of unlicensed medicines in children ('off-label' use of medicines), which is potentially dangerous, as proper treatment and control cannot be ensured. Treating children simply as small adults is clearly not the solution as their medical treatment needs differ.
IPCRG and EFA are particularly concerned about the small number of thorough dose-ranging studies in children with asthma of inhaled medicines, in allergic rhinitis and atopic eczema. For example recent evidence presented at the British Thoracic Society in December 2005 showed that almost one in ten children prescribed inhaled steroids are prescribed both high and unlicensed doses. Appropriate pharmacovigilance should ensure that this does not happen in the future.
Both organisations look forward to receiving feedback from the EMEA on their comments and learning about next steps as regards the finalisation of the guideline.
For further information please contact:
Prof David Price, Chair of the IPCRG Research Committee
Department of General Practice & Primary Care
University of Aberdeen
Foresterhill Health Centre Westburn Road
Aberdeen AB25 2AY
Tel: +44 (0) 1224 553972 Fax: +44 (0) 1224 550683
Email: d.price@abdn.ac.uk
MD PhD Paediatric Allergist Erkka Valovirta, EFA Medical Advisor
EFA Central Office
Avenue Louise 327, 1050 Brussels, Belgium
Tel : +32 (0)2 646 9945 Fax : +32 (0)2 646 1641
E-mail : efaoffice@skynet.be
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