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

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.

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.

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.

There have been some improvements in medicines licensing for older children, but not for children under the age of two years.