Our medicines safety research focuses on detecting and understanding problems with medicines. Our researchers are world leaders in the study of medicine safety, also known as pharmacovigilance. They are experts in using large scale data sets to detect signals of adverse medicine events. Their research quantifies harms from medicines suitable for informing clinical practice and regulation of medicines.

Our report for the Pharmaceutical Society of Australia shows that medication-related problems are responsible for 250,000 admissions per year in Australia, and up to 50 per cent of these harms are preventable.

Our research centre has more than 20 years’ experience in identifying problems with medicines use and promoting behaviour change to optimise medicine use.

Large scale evidence generation for the utilisation and safety of biologic medicines

This research utilises our global research data networks to monitor the safety of biologic medicines in populations large enough to detect rare outcomes if they exist. This research will profile trends and treatment patterns of biologic medicines around the world and investigate how these treatment patterns contribute to harm. Clinical evidence will be generated on the risks and extent of harm of biologic medicines in real-world practice, including estimates of numbers needed to harm suitable for clinical use. This research will not only detect adverse event risk associated with biologic medicines but will generate new knowledge regarding the identification of characteristics that make patients more vulnerable to adverse effects to aid in clinical treatment decision making.  This research is required as biologic medicines are a comparatively new class of medicines used to treat cancers and immune-mediated diseases including rheumatoid arthritis and inflammatory bowel disease. Created using bioengineering processes, the principal advantage of these protein-based biologics is their unique specificity of action, targeting molecular processes to improve health. Biologic medicines are one of the fastest evolving treatment options and currently account for 25 per cent of the Pharmaceutical Benefits Scheme (PBS) expenditure. While biologics have demonstrated benefits as therapeutic alternatives for difficult-to-treat diseases, there is limited knowledge of their adverse effects. Pre-market clinical trials often have limited samples, short-term follow-up and exclude patients with co-morbidities, meaning rare adverse reactions and delayed reactions can be missed and outcomes in complex patients are unknown. Examples of serious life-threatening adverse reactions that only came to light in the real world setting, or were more prevalent in the real world setting than predicted in clinical trials, highlight the need for an active safety surveillance monitoring system.

Distributed networks for signal detection allowing simultaneous comparison of medicine safety issues in multiple countries - OHDSI and AsPEN

The Asian Pharmacoepidemiology Network, or AsPEN, is a multi-national research network incorporating Japan, Taiwan, Hong Kong, the Republic of Korea and Australia which was formed to provide a mechanism to support the conduct of medicine safety (pharmaco-epidemiological) research and to facilitate the prompt identification and validation of emerging safety issues among the Asia-Pacific countries. Researchers use a distributed network model which has been tested using fit-for-purpose code written by the lead organisation and run across the databases of each collaborating centre. Our research across this network has shown the need for global research by demonstrating where side effects from medicines are consistent across countries, and importantly, how side effects from medicines may differ by ethnicity, demonstrating the need for both global and local safety monitoring. Because the network enables medicine safety studies to be run across data sets involving hundreds of millions of people, the network also offers the opportunity to study rare side effects such as the cardiac safety of medicines used in children for attention deficit hyperactivity disorder.

The Observational Health Data Sciences and Informatics program (or OHDSI, pronounced ‘Odyssey’) is a multi-stakeholder, interdisciplinary collaborative involving multiple countries showing the value of health data through large-scale analytics. Solutions are open-source. OHDSI has established an international network of researchers and observational health databases with a central coordinating centre housed at Columbia University.  This high-tech network enables comparative assessment of medicine safety and effectiveness. Recently, this research demonstrated the comparative safety and effectiveness of almost all anti-hypertensives medicines available globally.

Enhancing joint replacement outcomes through national data linkage

This study involves the analysis of a new and unique national dataset to enhance outcomes of hip, knee and shoulder replacement surgery. It builds on the recognised success of the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). The AOANJRR has been successful in improving the outcome of joint replacement surgery in Australia, but is currently only able to report on two outcomes: revision and mortality. There is a much wider range of complications that can occur following joint replacement that contribute to significant ongoing morbidity and cost. This new data set of over a million patients combines the entire AOANJRR data set (1999-2015) through case level linkage to Medicare and PBS data, and state hospital databases. Through the analysis of this data, we will be able to identify national regional and hospital incidence, trends and variations in a range of complications. We plan to determine the effects of patient, surgical implant, surgeon, hospital, pharmacological and disease-related factors on a range of complications. Understanding the relative importance and interaction of these factors and how the effects can be modified in particular patient populations is critical in identifying and implementing best practice. In addition, this study will define and describe the use of rehabilitation, as well as the frequency of rehospitalisation and emergency room encounters post-surgery to more completely assess the extent of health resource utilisation associated with joint replacement surgery.

Medicine safety in dementia

Several studies have shown an association between use of anticholinergic or sedative medicines and increased risk of dementia. Questions remain about whether these medicines cause dementia (or are just used by people already at risk), whether or not cognitive function improves if the medicines are stopped or if the dose is reduced, and the characteristics of patients most likely to use these medicines. This program of research aims to answer these questions using pharmacoepidemiologic methods.

Medicine and Device Surveillance Centre of Research Excellence (past project)

Prescription medicines and therapeutic devices when used appropriately offer significant benefit to patients and their health care, however, medicines and medical devices are also associated with significant levels of harm. The Medicine and Device Surveillance CRE (funded by the National Health and Medical Research Council 2012-2017) was formed with the goals of building capacity in the field of pharmacoepidemiology, developing better mechanisms for detecting medicine and device safety signals, quantifying the level of risk from medicines and devices and identifying those at most risk of harm and practice.

Among the achievements of this CRE are:

  • Identification of potential systemic safety issues with metal on metal hip prostheses that led to the TGA issuing a national alert
  • Identification of a cardiac safety issue with methylphenidate in children, which resulted in an editorial in the British Medical Journal
  • Validation of a rapid assessment signal safety tool for detection of adverse events that is now being piloted by Australia’s TGA, has been used by Health Canada, Korea Institute of Drug Safety, and being considered by the USA FDA
  • Development and conduct of national training programs to improve use of administrative claims data for policy evaluation and research
  • Development and testing of a distributive network model for medication safety signal detection involving 9 countries and involving over 200 million persons demonstrating global surveillance was possible
  • Co-establishment of the Asian Pharmacoepidemiology Network (AsPEN); including leading the first four multinational studies and establishing successful cross-cultural collaboration and governance structures;
  • Partnering with the Observational Health Data Science Informatics OHDSI group (a 13 country member network) with 2 multinational studies now complete.
UniSA Video

Improving Medication Safety

Better patient outcomes with better medicine management: Professor Libby Roughead and speaks about the Veterans’ Medicines Advice and Therapeutics Education Services (MATES) program

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