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

Funding text 1 Funding: This review is supported by the National Health and Medical Research Council (NHMRC) Centre of Research Excellence in Medicines Intelligence (GNT1196900); H.Z. is supported by a UNSW Scientia Fellowship; E.K. is supported by an NHMRC Emerging Leader Fellowship (APP1172978); C.B. is supported by an Australian Government Research Training Program Scholarship. Funding text 2 Conflicts of Interest: C.E.B. is a member of the Pharmaceutical Benefits Advisory Committee (PBAC); S.P., N.P., T.L. and C.E.B. are members of the Drug-Utilization Sub-Committee of the PBAC; T.L. is a member of the Economics Sub-Committee of the PBAC; M.I. is a member of the Economics Sub-Committee of the MSAC; S.P. is a member of the National Data Advisory Council; C.M.V. is Deputy Chair of the NSW Population Health Service Research Ethics Committee; D.P. is a member of the Sax Institute Board. The views of authors expressed in this review article are their own and do not represent those of the aforementioned bodies. In 2020, the Centre for Big Data Research in Health received funding from AbbVie Australia to conduct post-market surveillance research. AbbVie did not have any knowledge of, or involvement in, this manuscript. Publisher Copyright: © 2021 by the authors. Li-censee MDPI, Basel, Switzerland.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.Peer reviewe