PDL com­pound­ing con­cern

Pharmacy Daily - - FRONT PAGE -

PHAR­MA­CEU­TI­CAL De­fence Lim­ited has high­lighted the on­go­ing evo­lu­tion of com­pound­ing in Aus­tralia as rep­re­sent­ing “a par­tic­u­larly high reg­u­la­tory con­cern at the present time”.

In a post pub­lished on the PDL web­site this week, Kel­lie Dell’ Oro and Tamir Katz from Merid­ian Lawyers urged phar­ma­cists to make sure they are fa­mil­iar with the Phar­macy Board of Aus­tralia’s (PBA’s) Guide­lines on the Com­pound­ing of Medicines, which ap­ply to both sim­ple and com­plex com­pound­ing.

“Re­cent reg­u­la­tory ac­tions, both State and Fed­eral, have high­lighted the im­por­tance for com­pound­ing phar­ma­cists to be aware of spe­cific clauses in the PBA’s com­pound­ing guide­lines,” the lawyers said, in par­tic­u­lar sec­tions which state that a com­pounded medicine should only be pre­pared when an ap­pro­pri­ate com­mer­cial prod­uct is un­avail­able, where a com­mer­cial prod­uct is un­suit­able (such as where a pa­tient was al­ler­gic to an ex­cip­i­ent in the com­mer­cial item) or when un­der­tak­ing sanc­tioned re­search.

The com­pound­ing of a medicine that would be a close for­mu­la­tion to an avail­able and suit­able com­mer­cial prod­uct “should not take place,” they warned, not­ing com­plaints made to to AHPRA alleging un­pro­fes­sional con­duct where phar­ma­cists have ei­ther been un­aware of newly avail­able com­mer­cial prod­ucts or have com­pounded items where there has been only a slight dif­fer­ence be­tween the com­pounded prod­uct and an equiv­a­lent com­mer­cially avail­able prod­uct.

Re­cent cases have in­volved com­pound­ing of a testos­terone cream sim­i­lar to the com­mer­cially avail­able An­dro-Forte 5, as well as lit­i­ga­tion and reg­u­la­tory ac­tion around com­pounded med­i­ca­tions con­tain­ing phen­ter­mine, which is also com­mer­cially avail­able as Duromine.

Vari­a­tions across states and ter­ri­to­ries should also be borne in mind, the au­thors added - see www.pdl.org.au.

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