Question Number: 266
PDR Number: SQ22-000637
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 152 The assertion that it is “so hard to lodge an adverse event report” is inconsistent with the fact that almost 140,000 reports have been lodged since early 2021. The Therapeutic Goods Administration (TGA) has multiple channels available for reporters to submit an adverse event report. Consumers and health professionals can report to the TGA via email, through the TGA website and even by mail and fax. In addition, consumers can call the Adverse Medicines Event telephone line which is staffed by pharmacists who assist consumers in reporting adverse events to the TGA. Consumers can also report to the TGA via their health professional, such as their pharmacist or GP. For an adverse event report to be valid, only four data elements are required: information about the (i) patient; (ii) medicine or vaccine; (iii) adverse event experiences and (iv) the reporter of the event. Using this approach, many simple email enquiries received by the TGA are entered as adverse event reports. To assist health professionals in reporting adverse events, the TGA has made templates available for GPs to integrate into some prescribing software, reducing the time to report as information is transferred from their system into the form. The TGA continues to work on solutions to further streamline the reporting of adverse event reports for health professionals. Question 153 The TGA’s function is to analyse adverse event report data to look for potential conditions or adverse effects which may be linked to vaccination. It is quite unrealistic to expect that each of the 140,000 reports submitted would receive individual detailed tailored replies, although acknowledgment letters are sent to members of the public who submit reports. When an adverse event report is received by the TGA it is entered into the Adverse Event Management System and an acknowledgement letter is sent to the reporter. This letter includes the TGA identifier for their report, which can be used by reporters if they wish to provide further information about their event. Reporters are not routinely given feedback about their adverse event report beyond the acknowledgement letter. However, in some cases reporters are contacted if further information is required to either complete or assess the adverse event report.