Calls for drug mon­i­tor­ing to tighten

The Weekend Australian - Travel - - Health - Adam Cress­well

DRUG safety ex­perts have called on the fed­eral Gov­ern­ment to tighten mon­i­tor­ing pro­ce­dures that can de­tect harm­ful drug side-ef­fects, say­ing ex­ist­ing meth­ods re­main rel­a­tively in­ef­fec­tual.

More rig­or­ous clin­i­cal stud­ies and im­proved sys­tems for pick­ing up prob­lems that only emerge af­ter a new drug has ap­peared on the mar­ket should all be con­sid­ered, they say amid claims that a re­cent con­tro­versy over a well-known brand of sleep­ing pill has ex­posed flaws in the cur­rent sys­tems.

The crit­i­cism comes de­spite a move by the fed­eral Gov­ern­ment this week to in­ter­vene and save from clo­sure a con­sumer medicines hot­line which pro­vides peo­ple with a means to re­port in­stances of sus­pected ad­verse events while tak­ing drugs.

The Bris­bane-based Ad­verse Medicine Events Line was to close at the end of this month when fund­ing by its cur­rent spon­sor, the phar­macy um­brella group the Phar­macy Guild, was to run out.

The hot­line was mainly re­spon­si­ble for alert­ing Aus­tralia’s medicines reg­u­la­tor, the Ther­a­peu­tic Goods Ad­min­is­tra­tion, to the full ex­tent of the dis­turb­ing re­ac­tions to the sleep­ing pill Stil­nox.

The TGA’s ad­verse events mon­i­tor­ing body, the Ad­verse Drug Re­ac­tions Ad­vi­sory Com­mit­tee, had put out a bul­letin in 2002 say­ing it had re­ceived 72 re­ports of strange psy­chi­atric ef­fects in peo­ple tak­ing the drug in the two years since its Aus­tralian re­lease.

But it wasn’t un­til Fe­bru­ary this year that ADRAC warned of bizarre sleep-re­lated ef­fects’’ linked to Stil­nox, prompted by 24 re­ports of such cases, many of them through the hot­line.

The cases re­ported in the Fe­bru­ary bul­letin — which pre­ceded sim­i­lar warn­ings in the US — in­clud­ing cases of pa­tients eat­ing from the fridge or driv­ing cars while asleep. One pa­tient put on 23 kilo­grams over seven months, and her be­mused fam­ily only dis­cov­ered why when she was found eat­ing in front of an open re­frig­er­a­tor while asleep. An­other pa­tient woke with a paint­brush in her hand af­ter paint­ing the front door while asleep.

In this week’s an­nounce­ment the Gov­ern­ment said it had agreed to keep the ser­vice run­ning for an­other 12 months, dur­ing which time longer-term fund­ing op­tions to keep it go­ing in­def­i­nitely will be ex­plored. The cost of the 12-month ex­ten­sion is not yet known.

In a state­ment, health min­is­ter Tony Ab­bott said the fund­ing would ‘‘ en­sure Con­tin­ued inside, page 21

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