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Drug approval processes in Australian Paediatric Hospitals
  1. Y K Sinha1,
  2. J C Craig1,2,
  3. P Barclay3,
  4. J Taitz4,
  5. M South5,6,
  6. K Coulthard7,
  7. C Pearson8,
  8. S Erickson9,
  9. J E Brien10,11
  1. 1Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, University of Sydney, New South Wales, Australia
  2. 2School of Public Health, University of Sydney, New South Wales, Australia
  3. 3The Children's Hospital at Westmead, Westmead, New South Wales, Australia
  4. 4Sydney Children's Hospital, Randwick, New South Wales, Australia
  5. 5Department of General Medicine, Royal Children's Hospital, University of Melbourne, Parkville, Victoria, Australia
  6. 6Murdoch Children's Research Institute, Parkville, Victoria, Australia
  7. 7Division of Pharmacy, Women's and Children's Hospital, Children, Youth and Women's Health Service, North Adelaide, South Australia, Australia
  8. 8Department of General Medicine, Women's and Children's Hospital, Children, Youth and Women's Health Service, North Adelaide, South Australia, Australia
  9. 9Princess Margaret Hospital, Subiaco, Western Australia, Australia
  10. 10St Vincent's Hospital, Darlinghurst, University of Sydney, New South Wales, Australia
  11. 11University of New South Wales, New South Wales, Australia
  1. Correspondence to Dr Yashwant Sinha, Centre for Kidney Research, The Children's Hospital at Westmead, Locked Bag 4001, Westmead 2145, Australia; yashwans{at}chw.edu.au

Abstract

Objective To describe and evaluate the decision-making processes for drug approval in Australian paediatric hospitals.

Design Multicentre descriptive study involving face-to-face interviews of drug and therapeutics committee chairs and secretaries, review of committee documents and drug submissions for all Australian paediatric hospital drug and therapeutics committees over a 1-year period.

Setting All eight paediatric hospitals in Australia.

Participants Eight committee chairs and seven secretaries or delegates.

Main outcome measures Total drug expenditure, number of formulary submissions, individual-patient use approvals and approval rates for each hospital from 1 July 2006 to 30 June 2007, stratified by therapeutic class. Qualitative description of the approval processes.

Results Total drug expenditure varied from $A1.7 million (US$1.5 million) to $A11.1million (US$9.8 million) per hospital. The number of formulary submissions also varied, from 7 to 21, but approval rate was high (76%–100%) and not significantly different among hospitals (p=0.17). Several committees approved identical submissions for five drugs. The number of individual-patient use applications varied considerably, ranging from 10 to 456 per hospital. Where estimable, individual-patient use approval was 76%–100% and variable (p=0.03). Quality of evidence relating to safety and efficacy of drugs being considered was regarded as the most important factors influencing decision making, with the cost less important. Most committees had poor infrastructural support for approval processes. No committee formally included a pharmaco-economic evaluation.

Conclusions Most drug submissions in tertiary paediatric hospitals are approved; however, workload, drug expenditure and individual-patient use schemes vary considerably. Duplication of effort occurs, and few committees are resourced sufficiently given their terms of reference.

  • Accepted 31 March 2010

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  • Accepted 31 March 2010
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Footnotes

  • Funding YKS receives funding from a National Health and Medical Research Council postgraduate scholarship in Public Health and the Faculty of Pharmacy, University of Sydney. Travel expenses for the study were reimbursed by the Faculty of Pharmacy, University of Sydney.

  • Competing interests None.

  • Ethics approval This study was conducted with the approval of The Children's Hospital at Westmead and the University of Sydney.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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