Drug reaction breakthrough

Nov 8 2004

New research to reduce the incidents of adverse drug reactions in the community is being pioneered by the University of Ballarat.

The ‘data mining’ research maximises the information extracted from existing drug safety data by cross-referencing much of the existing information on adverse drug reactions.

Spearheaded by University researchers Gary Saunders, Simon Barty and Michelle O’Brien, the study is one of many projects undertaken by the University’s School of Information Technology and Mathematical Sciences.

The study also was featured in the University’s Research Conference on 3 November.

Simon Barty said his research was aimed at determining which drugs were most likely to be associated with an adverse drug reaction (ADR) in patients.

“The Therapeutic Goods Administration (TGA), an industry partner in this project and provider of the data, is responsible for the monitoring of pre- and post-market monitoring of drugs and medications, and may be able to use this methodology to assist in determining if a drug is associated with an ADR,” Mr Barty said.

“This research is aimed at assisting in determining more clearly when a drug has an association with an ADR and determining this association at the earliest moment.

“The Statistical algorithm called STATFILE (Statistical Filtering) will also enable the communication of statistical analyses on ADRs predominantly to the medical and pharmacy professions so that they can better pass on this information to patients and laypersons.”

Gary Saunders said the project examines new approaches to “post-marketing surveillance” of drug safety data, which is concerned with the early detection of adverse reactions to drugs.

“Most detection methods currently employ disproportionality analysis, which is not ideally suited to the type of data generated by the spontaneous reporting that has been used for adverse reaction data collection,” Mr Saunders said.

“I also examine the utilisation of classification systems for both reactions and drugs to better structure the data to facilitate the optimization of adverse reaction detection methods.”

Mr Saunders said the main interest for improving these early detection methods has been with regulatory bodies such as the Therapeutic Goods Administration (TGA) in Australia, The Food and Drug Administration (FDA) in the USA, and the Upsala Monitoring Centre (UMC) in Europe.

“However, there is growing interest in the improvement of these methods from the pharmaceutical industry as the risk of litigation increases.”