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More consistency needed in approval of children’s drugs, Australia

A national, standardised approach to -based drug evaluation could reduce overlap and improve decision making for drugs used in ’s paediatric . Internationally, many medicines for children are used despite lack of reliable information about their safety and efficacy. According to research published in the Medical Journal of Australia, selection and approval processes for formulary applications could be made more consistent and resource-efficient through a coordinated formal national process to share evidence and approval decisions.

Researchers led by Dr , at The Children’s Hospital, Westmead’s Centre for Kidney Research in Sydney, found that approval processes for inclusion of medicines in hospital formularies across all eight tertiary paediatric hospitals varied considerably. There was duplicated effort, lack of reliable evidence to assist decisions and inconsistent recording of decisions made between institutions.

“Our findings suggest that standardisation of formulary application processes among Australian paediatric hospitals may improve the quality and consistency of formulary decisions.

“This could be facilitated through formal agreements for sharing of evidence and approval outcomes. More resources and training for personnel involved in evaluating submissions may improve this process” Dr Sinha and her coauthors wrote.

In Australia, medicines for public hospital inpatients are largely funded by the hospitals themselves under agreements among the states, territories and the Commonwealth government, “without direct costs to patients”, they wrote.

The drug and therapeutics committee of each hospital decides which drugs it should fund from the hospital’s allocated budget.

“While most hospital-based formulary decisions are made independently of other hospitals, four states [Queensland, Western Australia, South Australia and Tasmania] currently have state-based formularies.

“In Australia, the collating and sharing of drug and therapeutics committee decisions through state-based therapeutic advisory groups has been a step towards a more unified process however; for paediatric hospitals who have few or no state-based peers there would be benefit from creating a formal sharing process at a national level.”


A national study of the processes and outcomes of paediatric formulary applications in Australia, Yashwant K Sinha, Jonathan C Craig, Peter G Barclay, Hugh Miller, Sean C Turner, Joseph P Whitehouse, Jo-anne E Brie, Medical Journal of Australia, DOI: 10.5694/mja13.11138, published 19 May 2014.