Australia's regulatory agency for medicines has a system for monitoring side effects of medicines that are used in Australia. It is a voluntary system that relies on reports of suspected side effects from health professionals and consumers. In order to gain a comprehensive safety profile of a medicine, a continuous post-marketing monitoring system is essential.
Reports of suspected adverse reactions are reviewed by the Adverse Drug Reactions Advisory Committee (ADRAC), a group of independent medical experts who provide advice regarding issues relating to the safety of medicines. All reports are individually reviewed by medical and professional staff and entered into the national adverse reaction database. The data is then analysed to identify potential safety issues that require further evaluation.
If you suspect that your patient has experienced an adverse reaction to a medicine, you can report it directly to ADRAC at http://www.tga.gov.au/problem/index.htm using a "blue card" available from the web site or by completing the report electronically. Consumers are also encouraged to ask you to report suspected adverse reactions on their behalf.
