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Overview of how TGA manages adverse event reports

28 August 2012

The TGA receives adverse event reports from consumers, health professionals and members of the therapeutic goods industry. Once the TGA has received an adverse event report about a medicine, it is:

• acknowledged
• coded by the TGA with the relevant terms from the Medical Dictionary for Regulatory Activities (MedDRA)
• given a case number
• entered into the internal TGA database
• analysed and checked 
• relevant information copied from the internal TGA database to the publically accessible Database of Adverse Event Notifications after a three-month time lag for new cases.

The majority of reports are submitted voluntarily. However, medicine sponsors are required under the Therapeutic Goods Act 1989 to report serious adverse events suspected of being related to one of their products.

Entry into the database

All reports that contain the minimum data requirements are entered into the database. The minimum data requirements are:

• a means of identifying the patient. This is the patient's initials or a patient ID number, not the patient's full name
• a description of the adverse event
• the name of the medicine or medicines that are thought to be related to the adverse event
• contact details of the reporter.

Data analysis

The information in the internal TGA database is analysed by the TGA for patterns of adverse events that may indicate a safety issue (signal detection). The detected safety signal is then assessed and appropriate actions are taken to manage the risks.

In some cases, the TGA requests further information from the reporter if it could assist in assessing the possible role of the medicine, including vaccines, in the reported event, or if the report is of an event of special interest to the TGA.

As part of the process, the possible link between the medicine and the adverse event is examined and classed as being 'suspected', 'not suspected' or 'interaction'. If there is no suspected link between any medicine and the adverse event, that report will not be included in data analysis.

The TGA works with the National Centre for Immunisation Research & Surveillance (NCIRS) on adverse events relating to immunisation including the preparation of regular national AEFI (adverse events following immunisation) surveillance reports. These annual reports have been published in Communicable Diseases Intelligence since 2003.