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

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.

Health Statistics in Australia: What We Know and Do Not Know

“…The use of these data for pharmaco-epidemiological purposes is described by Pearson et al [36] in this issue. Increasingly, medicines data are linked to other national datasets (see Section 15, Data Linkage, below).…”

The Medicines Intelligence Centre of Research Excellence: Co-creating real-world evidence to support the evidentiary needs of Australian regulators and payers.

“…However, Australia's federated health system also means these data are under the custodianship of different agencies and held across different jurisdictional boundaries. To undertake pharmacoepidemiologic research on medicine use and outcomes, medicines exposure data held by the Commonwealth must be linked with outcomes data, such as hospitalisations, held by the States and Territories [30]. This has traditionally been a significant barrier to generating timely and contemporary research output [31][32][33].…”

“…They relate to populations defined by jurisdiction (e.g., residents of New South Wales and Western Australia), service use (e.g., people dispensed opioids or other drugs of dependence, clients of the Department of Veterans' Affairs), and health events (e.g., women who gave birth, people with cancer, or people who experienced poisonings or substance misuse). A comprehensive review of Australian data collections that can be leveraged for whole-ofpopulation medicines use and outcome studies is detailed in our recently published review [30] Table 1 also describes two of the key data platforms that will underpin MI-CRE's evidence generation. These platforms were funded by a Research Infrastructure Grant from MI-CRE's lead institution and were developed to generate evidence and drive improvements in the health and wellbeing across the life course.…”

Patient Selection for Spinal Cord Stimulation in Treatment of Pain: Sequential Decision-Making Model — A Narrative Review

“…Results from real-world data generate evidence on the effectiveness and safety of a therapy and may lead to real-world evidence. 18 Despite the growing interest in real-world neuromodulation data, real-world evidence concerning patient selection for SCS in treatment for chronic pain is still limited. 19–22 Within this narrative review, the aim is to provide insights into the indications of SCS for pain in combination with statistical, health-economic, and ethical aspects that may influence the selection of patients for SCS.…”