Changes in availability of paediatric medicines in Australia between 1998 and 2002

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Abstract
Aims: To determine changes in the availability of medicines for children in Australia and to determine the status of newly introduced chemical entities by age category.Methods: Using the Australian Prescription Products Guide and the Schedule of Pharmaceutical Benefits, licensed medicines available in Australia in the calendar years 1998 and 2002 were examined.Results: The total number of medicines licensed in Australia increased from 1544 to 1903, the number of licensed paediatric items increased from 579 (37.5%) to 725 (38.1%), and those both licensed for paediatric use and subsidized increased from 356 (23.1%) to 441 (23.2%). The number of medicines with formulations suitable for paediatric use increased from 861 (55.7%) to 967 (50.8%), and of these 382 (24.7%) and 466 (24.5%) were licensed for paediatric use. Of the 90 new orally available chemical entities licensed for adults only 12 (13%) were licensed for children. Three (3%) were licensed for the 0–28 days and 28 days to 23 months age groups, eight (9%) for 2–11 years and 12 (13%) for 12–18 years. An additional 14 orally available chemical entities previously only licensed for adults, were licensed for children by 2002.Conclusions: There have been some improvements in medicines licensing for older children, but not for children under the age of two years.