Generating Real-World Evidence on the Quality Use, Benefits and Safety of Medicines in Australia: History, Challenges and a Roadmap for the Future.

Pearson, S-A; Pratt, N; de Oliveira Costa, J; Zoega, H; Laba, T-L; Etherton-Beer, C; Sanfilippo, FM; Morgan, A; Kalisch Ellett, L; Bruno, C; Kelty, E; IJzerman, M; Preen, DB; Vajdic, CM; Henry, D

Generating Real-World Evidence on the Quality Use, Benefits and Safety of Medicines in Australia: History, Challenges and a Roadmap for the Future.

Pearson, S-A Pratt, N de Oliveira Costa, J Zoega, H Laba, T-L Etherton-Beer, C Sanfilippo, FM Morgan, A Kalisch Ellett, L Bruno, C Kelty, E IJzerman, M Preen, DB Vajdic, CM Henry, D

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Publisher:: MDPI AG
Publication Type:: Journal Article
Citation:: International Journal of Environmental Research and Public Health, 2021, 18, (24), pp. 1-20
Issue Date:: 2021-12-18

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Field	Value	Language
dc.contributor.author	Pearson, S-A
dc.contributor.author	Pratt, N
dc.contributor.author	de Oliveira Costa, J
dc.contributor.author	Zoega, H
dc.contributor.author	Laba, T-L
dc.contributor.author	Etherton-Beer, C
dc.contributor.author	Sanfilippo, FM
dc.contributor.author	Morgan, A
dc.contributor.author	Kalisch Ellett, L
dc.contributor.author	Bruno, C
dc.contributor.author	Kelty, E
dc.contributor.author	IJzerman, M
dc.contributor.author	Preen, DB
dc.contributor.author	Vajdic, CM
dc.contributor.author	Henry, D
dc.date.accessioned	2022-01-21T01:48:06Z
dc.date.available	2021-12-14
dc.date.available	2022-01-21T01:48:06Z
dc.date.issued	2021-12-18
dc.identifier.citation	International Journal of Environmental Research and Public Health, 2021, 18, (24), pp. 1-20
dc.identifier.issn	1660-4601
dc.identifier.issn	1660-4601
dc.identifier.uri	http://hdl.handle.net/10453/153399
dc.description.abstract	Australia spends more than $20 billion annually on medicines, delivering significant health benefits for the population. However, inappropriate prescribing and medicine use also result in harm to individuals and populations, and waste of precious health resources. Medication data linked with other routine collections enable evidence generation in pharmacoepidemiology; the science of quantifying the use, effectiveness and safety of medicines in real-world clinical practice. This review details the history of medicines policy and data access in Australia, the strengths of existing data sources, and the infrastructure and governance enabling and impeding evidence generation in the field. Currently, substantial gaps persist with respect to cohesive, contemporary linked data sources supporting quality use of medicines, effectiveness and safety research; exemplified by Australia's limited capacity to contribute to the global effort in real-world studies of vaccine and disease-modifying treatments for COVID-19. We propose a roadmap to bolster the discipline, and population health more broadly, underpinned by a distinct capability governing and streamlining access to linked data assets for accredited researchers. Robust real-world evidence generation requires current data roadblocks to be remedied as a matter of urgency to deliver efficient and equitable health care and improve the health and well-being of all Australians.
dc.format	Electronic
dc.language	eng
dc.publisher	MDPI AG
dc.relation.ispartof	International Journal of Environmental Research and Public Health
dc.relation.isbasedon	10.3390/ijerph182413345
dc.rights	info:eu-repo/semantics/openAccess
dc.subject.classification	Toxicology
dc.subject.mesh	Australia
dc.subject.mesh	COVID-19
dc.subject.mesh	Forecasting
dc.subject.mesh	Humans
dc.subject.mesh	Pharmacoepidemiology
dc.subject.mesh	SARS-CoV-2
dc.subject.mesh	Australia
dc.subject.mesh	COVID-19
dc.subject.mesh	Forecasting
dc.subject.mesh	Humans
dc.subject.mesh	Pharmacoepidemiology
dc.subject.mesh	SARS-CoV-2
dc.subject.mesh	Humans
dc.subject.mesh	Pharmacoepidemiology
dc.subject.mesh	Forecasting
dc.subject.mesh	Australia
dc.subject.mesh	COVID-19
dc.subject.mesh	SARS-CoV-2
dc.title	Generating Real-World Evidence on the Quality Use, Benefits and Safety of Medicines in Australia: History, Challenges and a Roadmap for the Future.
dc.type	Journal Article
utslib.citation.volume	18
utslib.location.activity	Switzerland
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Strength - CHERE - Centre for Health Economics Research and Evaluation
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/Centre for Health Economics Research and Evaluation
utslib.copyright.status	open_access	*
pubs.consider-herdc	false
dc.date.updated	2022-01-21T01:48:04Z
pubs.issue	24
pubs.publication-status	Published
pubs.volume	18
utslib.citation.issue	24

Abstract:

Australia spends more than $20 billion annually on medicines, delivering significant health benefits for the population. However, inappropriate prescribing and medicine use also result in harm to individuals and populations, and waste of precious health resources. Medication data linked with other routine collections enable evidence generation in pharmacoepidemiology; the science of quantifying the use, effectiveness and safety of medicines in real-world clinical practice. This review details the history of medicines policy and data access in Australia, the strengths of existing data sources, and the infrastructure and governance enabling and impeding evidence generation in the field. Currently, substantial gaps persist with respect to cohesive, contemporary linked data sources supporting quality use of medicines, effectiveness and safety research; exemplified by Australia's limited capacity to contribute to the global effort in real-world studies of vaccine and disease-modifying treatments for COVID-19. We propose a roadmap to bolster the discipline, and population health more broadly, underpinned by a distinct capability governing and streamlining access to linked data assets for accredited researchers. Robust real-world evidence generation requires current data roadblocks to be remedied as a matter of urgency to deliver efficient and equitable health care and improve the health and well-being of all Australians.

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http://hdl.handle.net/10453/153399