Chief Investigators

Professor Libby Roughead
Quality Use of Medicines and Pharmacy Research Centre


Professor Phil Ryan
Fellow, Faculty of Public Health Medicine,
University of Adelaide


Professor Stephen Graves
Flinders University


Dr Nicole Pratt
Quality Use of Medicines and Pharmacy Research Centre


Dr Sepehr Shakib
Director of Clinical Pharmacology,
Royal Adelaide Hospital


Dr Gillian Caughey
Quality Use of Medicines and Pharmacy Research Centre

Dr Nancy Huang


Dr Anna Kemp
Assistant Professor
The University of Western Australia

Medicine and Device Surveillance CRE

Medicine and Device Surveillance CRE

A  Centre of Research Excellence funded by the National Health and Medical Research Council

The CRE’s program of research focuses on improving the safety of medicines and medical devices. We are developing novel methods for early identification of potential adverse events from medicines and devices. We are undertaking studies to quantify the risk associated with adverse events and to identify those people who are most at risk. We are also monitoring the use of medicines and medical devices in practice to assist in optimising their use and minimising harm. This work supports improvements in health care in Australia. We are also building capacity within Australia for medicine and device surveillance as well as developing pharmacoepidemiological and prosthetic epidemiological research capacity.

The CRE brings together a multidisciplinary team of experts in the fields of clinical medicine, clinical pharmacology, clinical pharmacy, pharmacoepidemiology, medical device safety, public health, biostatistics, data linkage and research translation to develop a program of research to systematically generate information on the safety and effectiveness of medicines and medical devices to enhance patient safety in Australia.

The CRE’s research collaboration focuses on three key research themes:

  1. Early detection of potential problems
  2. Quantifying Problems and Risks
  3. Monitoring Practice

Medicines are a significant component of Australia’s health care costs, with expenditure on subsidised pharmaceuticals over $8 billion in 2007/08.  The medical device industry is worth over $4.6 billion annually in Australia, with more than 25,000 devices available. When used appropriately, medicines and medical devices offer significant benefit to healthcare; however, they are also associated with significant levels of harm. Ten percent of Australians (approx. 2 million people) have experienced an adverse reaction to medicines in the previous six months, at significant cost to the health care system. Much of this harm can be avoided. This program of research will make a major contribution to reducing this harm.

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  • Inacio, M. C. S., et al. (2014). Using Medications for Prediction of Revision after Total Joint Arthroplasty. Journal of Arthroplasty.        
  • Inacio, M. C. S., et al. (2015). Predicting Infections After Total Joint Arthroplasty Using a Prescription Based Comorbidity Measure. Journal of Arthroplasty 30(10): 1692-1698.
  • Lai, E. C. C., et al. (2015). Databases in the Asia-pacific region: The potential for a distributed network approach. Epidemiology 26(6): 815-820.            
  • Nguyen, T. A., et al. (2015). Hospitalization for drug-induced hepatotoxicity: Linking Y-codes with pharmaceutical claims data to identify implicated medicines. J Clin Pharm Ther 40(2): 213-219.        
  • Pratt, N., et al. (2015). Prescription sequence symmetry analysis: Assessing risk, temporality, and consistency for adverse drug reactions across datasets in five countries. Pharmacoepidemiology and Drug Safety 24(8): 858-864.              
  • Pratt, N. L., et al. (2015). Association between ophthalmic timolol and hospitalisation for bradycardia. Journal of Ophthalmology 2015.               
  • Roughead, E. (2015). Data informs debate. Australian Prescriber 38(2): 38-39.             
  • Roughead, E. E., et al. (2015). Variation in Association Between Thiazolidinediones and Heart Failure Across Ethnic Groups: Retrospective analysis of Large Healthcare Claims Databases in Six Countries. Drug Safety 38(9): 823-831.              
  • Roughead, E. E. and N. L. Pratt (2015). Impact on Drug Safety of Variation in Adherence: The Need for Routinely Reporting Measures of Dose Intensity in Medication Safety Studies Using Electronic Health Data. Drug Safety.
  • McDonald CJ, Kalisch Ellett LM, Barratt JD, Caughey GE, A Cross-Country Comparison of Rivaroxaban Spontaneous Adverse Event Reports and Concomitant Medicine Use with the Potential to Increase the Risk of Harm, Drug Safety 2014; [epub ahead of print]
  • Pratt NL, Ramsay EN, Kemp A, Kalisch-Ellett LM, Shakib S, Caughey GE, Ryan P, Graves S, Roughead EE. Ranibizumab and Risk of Hospitalisation for Ischaemic Stroke and Myocardial Infarction in Patients with Age-Related Macular Degeneration: A Self-Controlled Case-Series Analysis. Drug Saf. 2014 Sep 27. [Epub ahead of print]
  • Pratt NL, Ilomaki J, Raymond C, Roughead EE. Validation of prescription sequence symmetry analysis as a tool for active post-market surveillance of newly marketed medicines: a simulation study. BMC Medical Research Methodology 2014; 14:66
  • McDonald CJ, Kalisch Ellett LM, Barratt JD, Caughey GE (2014) An international comparison of spontaneous event reports and potentially inappropriate medicine use associated with dabigatran. Pharmacoepidemiology and Drug Safety. Doi 10.1002/pds3648.
  • Roughead EE, Lhazeem K, Socialine E, Bahri S, Park BJ, Holloway K. Monitoring medicines use to support national medicines policy development and implementation in the Asia Pacific region. WHO South East Asia Journal of Public Health 2013; 2(2):113-117.
  • A Wahab I, Pratt NL, Kalisch LM, Roughead EE. Comparing Time to Adverse Drug Reaction Signals in a Spontaneous Reporting Database and a Claims Database: A Case Study of Rofecoxib-Induced Myocardial Infarction and Rosiglitazone-Induced Heart Failure Signals in Australia. Drug Saf. 2013 Nov 16. [Epub ahead of print]
  • A Wahab I, Pratt NL, Kalisch LM, Roughead EE.The Detection of Adverse Events in Randomized Clinical Trials: Can we really say new medicines are safe?Curr Drug Saf. 2013 May 17. [Epub ahead of print].
  • A Wahab I, N. L. Pratt, et al. (2013). "The validity of sequence symmetry analysis (SSA) for adverse drug reaction signal detection." Pharmacoepidemiology and Drug Safety 22(5): 496-502.
  • Pratt, N, M. Andersen, et al. (2013). "Multi-country rapid adverse drug event assessment: The Asian Pharmacoepidemiology Network (AsPEN) antipsychotic and acute hyperglycaemia study." Pharmacoepidemiology and Drug Safety 22(9): 915-924
  • Andersen, M., U. Bergman, N Pratt, E Roughead et al. (2013). "The Asian Pharmacoepidemiology Network (AsPEN): Promoting multi-national collaboration for pharmacoepidemiologic research in Asia." Pharmacoepidemiology and Drug Safety 22(7): 700-704.
  • A Wahab I, Pratt NL, Kalisch LM, Roughead EE. Sequence Symmetry Analysis and Disproportionality Analyses: What Percentage of Adverse Drug Reaction do they Signal? Adv Pharmacoepidem Drug Safety 2013; 2:140. doi: 10.4172/2167-1052.1000140.

Areas of study and research

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