The changing face of Australian data reforms: Impact on pharmacoepidemiology research

Abstract

ObjectiveA wealth of data is generated through Australia’s universal health care arrangements. However, use of these data has been hampered by different federal and state legislation, privacy concerns and challenges in linking data across jurisdictions. A series of data reforms have been touted to increase population health research capacity in Australia, including pharmacoepidemiology research. Here we catalogued research leveraging Australia’s Pharmaceutical Benefits Scheme (PBS) data (2014–2018) and discussed these outputs in the context of previously implemented and new data reforms. MethodsWe conducted a systematic review of population-based studies using PBS dispensing claims. Independent reviewers screened abstracts of 4,996 articles and 310 full-text manuscripts. We characterised publications according to study population, analytical approach, data sources used, aims and medicines focus. ResultsWe identified 180 studies; 133 used individual-level data, 70 linked PBS dispensing claims with other health data (66 across jurisdictions). Studies using individual-level data focussed on Australians receiving government benefits (87 studies) rather than all PBS-eligible persons. 63 studies examined clinician or patient practices and 33 examined exposure-outcome relationships (27 evaluated medicines safety, 6 evaluated effectiveness). Medicines acting on the nervous and cardiovascular system account for the greatest volume of PBS medicines dispensed and were the most commonly studied (67 and 40 studies, respectively). Antineoplastic and immunomodulating agents account for approximately one third of PBS expenditure but represented only 10% of studies in this review. ConclusionsThe studies in this review represent more than a third of all population-based pharmacoepidemiology research published in the last three decades in Australia. Recent data reforms have contributed to this escalating output. However, studies are concentrated among specific subpopulations and medicines classes, and there remains a limited understanding of population benefits and harms derived from medicines use. The current draft Data Availability and Transparency legislation should further bolster efforts in population health research.

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

“…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]. However, recent reforms around data availability and use are paving the way for population-based, public health data to be combined on a scale never before seen in Australia [34][35][36].…”

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

“…PBS records have been shown to accurately reflect prescribed medicine use compared to self-reported use and for medicines prescribed and administered in hospital outpatient settings [18,19]. PBS data have proven an invaluable source of information to quantify population-level medicine use and associated outcomes [7,20]. Notwithstanding the strengths and insights that can be generated from data of this kind, they were not established for research purposes and the gaps in, and limitations of, these data to support QUM research must be acknowledged and addressed.…”

“…Our systematic reviews [7,20] cataloguing peer-reviewed publications using PBS claims in the period 1987-2018 demonstrate that the vast majority of Australian pharmacoepidemiology research has used aggregate, unliked individual-level PBS, or RPBS data for utilisation studies or to investigate prescriber practice (guideline concordant) or patient behaviour (adherence to treatment) [42][43][44][45][46][47][48]. These studies typically investigated medicines acting on the nervous system (opioids, psychotropics) or for treating cardiovascular disease (statins, antihypertensives, and antithrombotics).…”

“…However, studies using the entire PBS-eligible population have increased with the availability of under co-payment data in the PBS collections since 2012. Moreover, the number of studies using individual-level PBS data has accelerated in the last decade due to the availability, to the research community, of a standardised, de-identified data collection of person-level dispensing claims for a 10% sample of PBS eligible people ("PBS 10%") [7].…”

“…During the last 20 years, the capacity to generate real-world data on quality use, benefits and safety of prescribed medicines has expanded greatly. 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.…”