Respiratory drugs frequently used off-label in children
Over a third of children's prescriptions for respiratory medicines are for drugs not licensed for paediatric use or for drugs being used outside their licensed indications (off-label), a Dutch study has shown.
For infants aged between one month and two years, the level is higher,
with around 65 per cent receiving prescriptions for drugs used outside
their licence status.
Researchers reviewed prescriptions issued to 2,502 patients in the Netherlands,
but say that their findings are relevant to the rest of Europe. Of 5,253
prescriptions for respiratory drugs issued to children, 882 prescriptions
were for medicines not licensed for use in children and 1,065 were prescribed
off-label. The most frequently prescribed unlicensed and off-label drugs
included salbutamol, fluticasone, terbutaline and sodium cromoglicate.
“The current shortage of formulations and dosage forms appropriate
for infants and toddlers, especially, has to be resolved, and research
on
new and older drugs should include safety and efficacy studies in all
appropriate paediatric age groups,” say the researchers.
The study is published in the February issue of the European Respiratory Journal (2004;23:310). |
The
Pharmaceutical Journal