Dosing information for paediatric patients: are they really "therapeutic orphans"?

Abstract

Objectives: To review the approved product information (PI) of prescription medicines to determine the extent and nature of information available on paediatric dosing and the availability of paediatric dosage formulations in Australia.

Methods: The PIs for all prescription medicines listed in the Australian Monthly Index of Medical Specialties (MIMS) were reviewed. Dosing information for each PI was categorised according to age groupings. PIs claiming suitability for use in paediatric patients were reviewed for information on the availability of paediatric dosage forms.

Main outcome measures: Proportion of PIs providing paediatric dosing information; availability of dosage forms suitable for children.

Results: A total of 1497 PIs were reviewed. The proportions, for each age group, of PIs with inadequate paediatric dosing information were: < 1 month (80.5%), 1-3 months (79.1%), 3 months-2 years (77.5%), 2-6 years (73.2%), and 6-12 years (71.6%). The proportions, for each age group, of PIs that gave specific paediatric dosing information but did not provide a paediatric dosage form were: < 1 month (26.5%), 1-3 months (25.1%), 3 months-2 years (23.3%), 2-6 years (21.9%), and 6-12 years (24.0%).

Conclusions: The PIs for many prescription products listed in MIMS do not adequately detail paediatric doses. Many medicines for which specific paediatric dosing information is given are not available in dosage forms appropriate for children.