Adverse drug reaction reporting goes online
Adverse drug reactions are typically reported to the TGA advisory committee on the safety of medicines (ACSOM) by TGA Blue Cards, by phone reporting, or by contacting the TGA directly.
Now, when the report is submitted through MIMS it will be emailed to the TGA. MIMS said that each report received by the TGA is entered into the national adverse reaction database, typically within two working days of receipt, and a letter of acknowledgement is sent to the reporter.
Australia has a voluntary or “spontaneous” reporting system that allows consumers as well as health professionals and pharmaceutical companies to report adverse drug reactions. This allows reporting on adverse reactions from over-the- counter and complementary medicines as well as prescribed drugs.
The TGA receives more than 12,000 reports of suspected adverse reactions to medicines each year. About 40 per cent come via pharmaceutical companies and the rest directly from general practitioners (around 15 per cent), hospitals (20 per cent), specialists, community pharmacists, state and territory health departments and consumers.
MIMS has also released its May monthly medicines update, including new product information on Cayston (aztreonam), a monobactam antibiotic for inhalation that is indicated for the control of gram-negative bacteria, particularly Pseudomonas aeruginosa, in the respiratory tract of adults and paediatric patients six years of age and older with cystic fibrosis.
New products also include Incivo (telaprevir), an inhibitor of the hepatitis C virus NS3 4A serine protease, an enzyme that is essential for HCV replication. Incivo, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis C in adult patients. Incivo is available as 375 mg tablets in bottles of 42s.
Posted in Australian eHealth