TGA AE anal­y­sis

Pharmacy Daily - - News -

THE Ther­a­peu­tic Goods Ad­min­is­tra­tion (TGA) has re­leased its lat­est anal­y­sis of ad­verse event (AE) re­ports, cov­er­ing about 18,600 in­ci­dents dur­ing 2017.

The ma­jor­ity of re­ports made last year were by spon­sors, at a new high of 9,998 or 54%.

The pre­vi­ous high­est re­ported num­ber was in 2013 (9,563) while its low­est point for this five-year pe­riod was in 2014 (8,359).

Of the to­tal ad­verse event re­ports, 18% (3,441) were from state and ter­ri­tory health de­part­ments (re­ports of ad­verse events fol­low­ing im­mu­ni­sa­tion); 10% (1,879) came from hos­pi­tals and hos­pi­tal phar­ma­cists; 7% (1,201) from con­sumers; 6% (1,170) from com­mu­nity phar­ma­cists; 3% (579) from gen­eral prac­ti­tion­ers and 2% (359) from other sources.

Com­pared to pre­vi­ous years, the big­gest in­creases in re­ports of ad­verse events were from spon­sors and state and ter­ri­tory health de­part­ments.

The TGA said the in­crease in re­ports from health de­part­ments may re­late in part, to the con­tin­u­a­tion of en­hanced sur­veil­lance for two ad­di­tions to the Na­tional Im­mu­ni­sa­tion Pro­gram in 2016, namely the 18-month diph­the­ria, tetanus and acel­lu­lar per­tus­sis-con­tain­ing vac­cine and Zostavax.

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