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.
Highlights
Prescribing medicines is the most common health intervention globally [1]
The Pharmaceutical Benefits Advisory Committee (PBAC), formed in the early 1950s, is an independent expert body appointed by the Australian Government recommending new medicines for Pharmaceutical Benefits Scheme (PBS)-listing based on clinical efficacy, safety and cost-effectiveness (‘value for money’) relative to other available treatments, a process underpinned by RCT evidence
There is no doubt that this has resulted in significant health gains for individuals and populations, but it has been accompanied by substantial harm and health care costs
Summary
Prescribing medicines is the most common health intervention globally [1]. Modern medicines have changed the course of major diseases including coronary atherosclerosis, heart failure, stroke, HIV/AIDS and several cancers. The field of pharmacoepidemiology has developed from a primary interest in drug utilisation and ecological exposure-outcome studies to contemporary use of large databases of multiple linked routinely collected, real-world data to estimate the balance between the benefits and harms of medicines [7,8]. These analyses have become increasingly important in decision making. To generate insights and enhance our understanding of the real-world use, benefits and safety of medicines in Australia In this context, we refer to ‘medication data’ as an allencompassing term that includes prescription, dispensing, sales and self-report data about medicine use. Discuss Australian medicines policies and detail the available medication data that can be leveraged to estimate real-world medicine use; Describe how medication data have been used for population-level monitoring, evaluation and research on quality use, effectiveness and safety of medicines, including a COVID-19 case study; Highlight the key barriers to delivering a comprehensive research program quantifying real-world use, effectiveness and safety of medicines in Australia; and Outline a roadmap to bolster Australia’s capacity to accelerate evidence development about effectiveness, safety and quality use of medicines in routine clinical care
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