Adverse drug reactions: what happens to a report

All reports are assessed by a health professional and entered into the Australian Adverse Drug Reactions System (ADRS). All reports of serious reactions, reports for vaccines (serious and non-serious), and reports for complementary medicines (serious and non-serious) are forwarded to the Adverse Drug Reactions Advisory Committee (ADRAC) <http://www.tga.gov.au/adr/adrac.htm> for further assessment. ADRAC is composed of independent medical experts who have expertise in areas of importance to the evaluation of medicine safety.

ADRAC may make any of several decisions for a report:

• no further action as this is a well-known non-serious reaction
• no further action unless or until additional similar reports are received
• request for additional information from the reporter
• analysis of the ADRS database reports to investigate potential safety signals
• request for information from the drug Sponsor or Manufacturer
• publication in the Australian Adverse Drug Reactions Bulletin <http://www.tga.gov.au/adr/aadrb.htm> or medical journals to raise awareness of the reaction
• referral to other areas of the TGA for further investigation
• discussion of the reaction with international medicines regulatory agencies
• recommendation to amend the medicine's product information
• recommendation to restrict the availability of the medicine
• recommendation to remove the medicine from the market