TGA Project Facilitates Health Professionals Reporting Adverse Events

The Therapeutic Goods Administration is inviting medical software vendors to participate in a pilot project to facilitate reporting  adverse events by health professionals. The project is to develop a TGA web service to assist software vendors who wish include access to reporting adverse events for health professionals in medical software. Following this pilot project, which is expected to run until April 2014, a TGA web service will be available to software vendors at no cost. Any company providing software to health professionals - such as general practitioners, hospital and community pharmacists, specialists and nurses - who submit reports of adverse events to medicines is welcome to participate. The web service will be compatible with both mobile and desktop devices. Involvement in the pilot will require vendors to develop a reporting interface within their own software program and to test transmission of reports using the web service from their software to the TGA in XML format. Reports of adverse events from health professionals are essential to the TGA’s safety monitoring activities. Feedback to the TGA indicates that the time required to report is a significant barrier to reporting by health professionals.  Providing an adverse event reporting mechanism in medical software, particularly one that allows reports to be automatically populated from clinical record data, has been suggested as a way of reducing the time required to find, complete and send reporting forms. Development of the adverse event report web service is one of a number of projects that the TGA is currently undertaking to encourage adverse event reporting by health professionals and consumers by:

• improving access to methods for reporting


• promoting the reporting system, and


• educating health professionals about how and why to report.

If you are interested in participating in the pilot, or would like more information, please email ADR Reports.