Archive 2011
PSI disseminating IMB advice on cough and cold medicines in children
September 20, 2011
On the 19th of September, the Irish Medicines Board issued a letter to all healthcare professionals, following its review of the safety and efficacy of non-prescription cough and cold medicines authorised for use in children. Please click here to view letter.
The key recommendations from the review include the following:
- Cough and cold medicines containing certain active ingredients should no longer be used in children under six years
- Many cough and cold medicines can continue to be considered for children aged six to 12 years, where necessary
- Cough and cold medicines containing certain active ingredients which continue to be available for use in children aged between 6 and 12 years will now be only available in pharmacies, where parents and members of the public can avail of a pharmacist’s expertise and advice
The attached letter from the IMB contains a list of non-prescription products involved in the review which are no longer recommended for use in children under six years, which should be helpful to pharmacists implementing the new recommendations.
The letter also outlines the measures being taken to update the product information and labelling for affected medicines; please note that a recall or immediate withdrawal of products with older labelling is not considered necessary at this time.
Pharmacists, particularly superintendent and supervising pharmacists, are therefore requested to immediately implement the recommendations contained in the IMB letter, including reviewing and updating all relevant policies and procedures relating to the supply and patient counselling for these medicines, and arranging any necessary additional training or education of relevant staff.
Pharmacists should also be prepared to deal with queries from members of the public with regard to these changes in the availability and use of these medicines in children, including concerns around the safety of the use of these medicines in children.
Your co-operation with the effective implementation of these recommendations is appreciated.
PSI – the pharmacy regulator
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