Symbols for paediatric medicines too risky, says EMEA

The paediatric committee of the European Medicines Agency (EMEA) has spoken out against using a specific symbol on paediatric medicine packaging, believing it would present more risks than benefits.

European Regulation EC No 1901/2006 on paediatric medicines adopted in 2006 plans for medicines with an approved paediatric indication to bear a symbol to make their identification easier.

After a risk-benefit analysis the paediatric committee declared it was "unable to recommend to the European Commission any symbol for which the benefits would outweigh the risks identified and dominated by potentially fatal medication errors". Eighteen members of the committee voted against use of a symbol while only four voted in favour.

In the opinion, the paediatric committee considers such a symbol "would mostly be a marketing advantage for the products displaying it."

The Committee said it was not convinced that the symbol would encourage carers and patients to read the package leaflet where they would find the explanation for the symbol. It considered the main risk incurred would be that of incorrectly interpreting such a symbol, especially since it would be printed on all products with a paediatric indication, whatever the dosage or formulation.

Moreover, the symbol would appear on presentations not to be administered to children and this would make matters difficult for carers and parents.

The Committee views the risk as "major and certainly unacceptable where a single unit dose (of a medicinal product which has a paediatric indication) can kill a child (paracetamol, colchicine, digoxine, chloroquine, etc.)".

Furthermore, the Committee considers that "the complexity of the message on safe use of a medicinal product in the various subsets, and weight ranges of the paediatric population could not be covered by a single symbol.