Chui Jocelyn, Tordoff June, Reith David
School of Pharmacy, University of Otago, New Zealand.
Br J Clin Pharmacol. 2005 Jun;59(6):736-42. doi: 10.1111/j.1365-2125.2004.02211.x.
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.
确定澳大利亚儿童用药的可及性变化，并按年龄类别确定新引入化学实体的状况。
利用《澳大利亚处方产品指南》和《药品福利清单》，对1998年和2002年澳大利亚日历年度内的获许可药品进行审查。
澳大利亚获许可药品总数从1544种增至1903种，获许可的儿科药品数量从579种（37.5%）增至725种（38.1%），获儿科使用许可且得到补贴的药品从356种（23.1%）增至441种（23.2%）。有适合儿科使用剂型的药品数量从861种（55.7%）增至967种（50.8%），其中382种（24.7%）和466种（24.5%）获儿科使用许可。在仅获成人使用许可的90种新口服化学实体中，仅12种（13%）获儿童使用许可。3种（3%）获0至28天及28天至23个月年龄组使用许可，8种（9%）获2至11岁使用许可，12种（13%）获12至18岁使用许可。另外14种先前仅获成人使用许可的口服化学实体到2002年获儿童使用许可。
大龄儿童用药许可方面有一些改善，但两岁以下儿童用药许可方面没有改善。
