Generating real-world evidence on the quality use, benefits and safety of medicines in Australia: History, challenges and a roadmap for the future

Sallie Anne Pearson*, Nicole Pratt, Juliana de Oliveira Costa, Helga Zoega, Tracey Lea Laba, Christopher Etherton-Beer, Frank M. Sanfilippo, Alice Morgan, Lisa Kalisch Ellett, Claudia Bruno, Erin Kelty, Maarten Ijzerman, David B. Preen, Claire M. Vajdic, David Henry

*Corresponding author for this work

Research output: Contribution to journalReview articleResearchpeer-review

2 Citations (Scopus)
7 Downloads (Pure)

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 Aus-tralia’s limited capacity to contribute to the global effort in real-world studies of vaccine and dis-ease-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.

Original languageEnglish
Article number13345
Number of pages20
JournalInternational Journal of Environmental Research and Public Health
Volume18
Issue number24
DOIs
Publication statusPublished - 18 Dec 2021

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