Drug mon­i­tor­ing un­der fire

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that con­sumers are pro­vided with a way to seek help with, or re­port, ad­verse re­ac­tions to medicines’’.

Hot­line man­ager and clin­i­cal phar­ma­cist doc­tor Geral­dine Moses said the hot­line had prob­a­bly re­ceived about 900 calls about Stil­nox over a four-month pe­riod this year.

She said she was ‘‘ very grate­ful and very ex­cited’’ at the ex­tra fund­ing. Al­though ne­go­ti­a­tions on the cost were still un­der way, the hot­line had asked for $400,000 to fund the 12 months of op­er­a­tion, she said.

‘‘ It’s a short-term so­lu­tion,’’ Moses said. ‘‘ We are go­ing to be en­ter­ing ne­go­ti­a­tions with the Na­tional Pre­scrib­ing Ser­vice and the Ther­a­peu­tic Goods Ad­min­is­tra­tion to see if we can come up with some sort of long-term so­lu­tion. This gives us some breath­ingspace.’’

How­ever, drug ex­perts said Aus­tralia’s sys­tems for de­tect­ing prob­lems with drugs would re­main sadly lack­ing, even af­ter the hot­line’s wel­come re­prieve.

Ken Har­vey, Ad­junct Se­nior Re­search Fel­low in the School of Pub­lic Health at La Trobe Univer­sity, said much more rig­or­ous sur­veil­lance of drugs was re­quired af­ter they were put on sale, in­clud­ing mea­sures to force drug gi­ants to con­duct ef­fec­tive large-scale stud­ies. ‘‘ It’s good the Gov­ern­ment’s do­ing it (sav­ing the hot­line), but more needs to be done,’’ Har­vey said. ‘‘ I cer­tainly sup­port what Geral­dine Moses is do­ing. But you are still left with (a sys­tem of) spon­ta­neous re­port­ing, and we know that’s not good enough.

‘‘ There’s a move go­ing on glob­ally to get a much more rig­or­ous post-mar­ket­ing sur­veil­lance of drugs. Drug com­pa­nies should be en­cour­aged to do bet­ter stud­ies, and to get good data, and you re­ally need good pop­u­la­tion stud­ies.’’

The Fe­bru­ary bul­letin re­port­ing the bizarre ef­fects of Stil­nox at­tracted mas­sive me­dia pub­lic­ity, and fur­ther re­ports to the hot­line spiked as a re­sult. The TGA says that up un­til May 25 ADRAC had re­ceived 727 re­ports about Stil­nox, with 208 re­ports con­cern­ing ‘‘ ab­nor­mal sleep-re­lated event, sleep walk­ing, and/or sleep talk­ing’’ — with all but 24 of the lat­ter cat­e­gory com­ing in af­ter the Fe­bru­ary bul­letin.

‘‘ This rapid in­crease in re­ported side­ef­fects fol­low­ing me­dia at­ten­tion on the is­sue of Stil­nox is a phe­nom­e­non known as ‘ stim­u­lated re­port­ing’,’’ says a re­port on the TGA’s web­site. ‘‘ Reg­u­la­tors must in­ter­pret the re­sults of stim­u­lated re­port­ing with great care as the ef­fect of me­dia at­ten­tion may be to over­es­ti­mate the num­ber of ad­verse re­ac­tions re­lated to a medicine.

‘‘ This in turn may re­sult in an over­es­ti­mate of the risk side of any risk-ben­e­fit anal­y­sis con­ducted by the reg­u­la­tor.’’

A spokesman for the drug in­dus­try um­brella group Medicines Aus­tralia said com­pa­nies al­ready had an obli­ga­tion to re­port ad­verse eff­fects to the TGA.

‘‘ If the TGA had a con­cern they would work with the com­pany to con­duct post­mar­ket­ing sur­veil­lance, and that process can be ini­ti­ated by the com­pany or by the TGA,’’ he said.

‘‘ Be­fore medicines are al­lowed to be sold in Aus­tralia they have to have been through rig­or­ous clin­i­cal tri­als to make sure the ben­e­fit out­weighs the risk. Th­ese tri­als won’t nec­es­sar­ily pick up one-in-a-mil­lion side­ef­fects, but that’s why com­pa­nies and the TGA con­tinue to mon­i­tor medicines’ safety once medicines are in gen­eral use.

‘‘ The TGA is cer­tainly mov­ing to­wards re­quir­ing com­pa­nies to have riskman­age­ment plans for new medicines when they eval­u­ate th­ese new medicines, and that’s be­ing in­tro­duced now.’’

Point of sale: Keep­ing watch on side-ef­fects should not end here, say au­thor­i­ties

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