Ad­verse events in­crease

Pharmacy Daily - - News -

THE to­tal num­ber of medicine and vac­cine ad­verse event re­ports to the Ther­a­peu­tic Goods Ad­min­is­tra­tion (TGA) rose by 1,882 from 2016-17, rep­re­sent­ing a 9.5% in­crease, ac­cord­ing to the agency’s an­nual per­for­mance re­port.

The mean num­ber of re­ports re­ceived weekly rose from 380 to 416 and the pro­por­tion of re­ports re­ceived from each cat­e­gory of re­porter broadly matched 2016-17.

Other el­e­ments of the TGA per­for­mance for the year 201718 in­clude the work load around new and vari­a­tion ap­pli­ca­tions for bi­o­log­i­cals, which the TGA says has sta­bilised back to “ex­pected lev­els” fol­low­ing the prior pe­riod spike.

The num­ber of new listed medicines on the Aus­tralian Reg­is­ter of Ther­a­peu­tic Goods (ARTG) in­creased by 211 in 2017-18, partly at­trib­ut­able to the in­tro­duc­tion of per­mit­ted in­di­ca­tions in Mar 2018.

The num­ber of post-mar­ket com­pli­ance re­views com­pleted de­creased in 2017-18 “due to a large and com­plex tar­geted re­view project of listed sun­screens hav­ing been un­der­taken over the course of the year”.

In­ves­ti­ga­tions, which arise from com­plaints from the pub­lic, in­dus­try re­fer­rals and ad­verse event re­port­ing, de­creased.

The num­ber of new over-the­counter medicine ap­pli­ca­tions re­ceived sub­stan­tially in­creased over the prior year, largely due to com­pli­ance with the new la­belling or­der, while ap­proval times for “all new medicine ap­pli­ca­tion types were shorter than in 2016-17”.

See the full anal­y­sis at

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