Pre­scrip­tion safe­guards fail­ing chil­dren

The Weekend Australian - Travel - - Career One -

From Health cover ex­cep­tion, it is clearly un­ac­cept­able when it be­comes the norm.’’

While she de­fends the right of doc­tors to pre­scribe off-la­bel, and says re­strict­ing this right would im­pose too great a limit on clin­i­cal free­dom, Gazar­ian thinks it is overused and should be lim­ited to cir­cum­stances where it can be jus­ti­fied by pre-spec­i­fied cri­te­ria, as this will re­duce in­ap­pro­pri­ate use and ex­po­sure to un­nec­es­sary risk.

A sep­a­rate pa­per, pub­lished in the Med­i­cal Jour­nal of Aus­tralia last year, of which she was lead au­thor, found the level of off-la­bel pre­scrib­ing was also com­mon in adults — be­tween 7.5 and 40 per cent of the to­tal.

That pa­per pro­posed three sce­nar­ios where off-la­bel use was ap­pro­pri­ate: when such use was jus­ti­fied by high-qual­ity re­search ev­i­dence, within the con­text of a for­mal trial or re­search project, and in ex­cep­tional cir­cum­stances, where such use was jus­ti­fied by in­di­vid­ual clin­i­cal cir­cum­stances.

The Aus­tralian Health Min­is­ters Ad­vi­sory Coun­cil has al­ready com­mis­sioned a work­ing group to re­view the is­sue and con­sider how the safety of pae­di­atric pre­scrib­ing can be im­proved.

To close the ev­i­dence gaps, Gazar­ian ar­gues for a ‘‘ co-or­di­nated and well­re­sourced na­tional approach’’ — in­clud­ing the com­mit­ment of pub­lic funds — to con­duct stud­ies on chil­dren. She also says there should be a na­tional ev­i­dence-based pre­scrib­ing in­for­ma­tion re­source, to give doc­tors, phar­ma­cists, nurses and oth­ers the latest ev­i­dence on what drugs work best.

And she calls for US-style in­cen­tives for phar­ma­ceu­ti­cal com­pa­nies to con­duct stud­ies, and for drug li­cences to be up­dated when new re­search data shows a par­tic­u­lar use for a drug is safe and ef­fec­tive. At the mo­ment, li­cence pro­vi­sions are only ex­tended if a man­u­fac­turer makes an ap­pli­ca­tion to the TGA — some­thing they cur­rently have lit­tle in­cen­tive to do.

A spokesman for the drug man­u­fac­tur­ers’ um­brella body Medicines Aus­tralia said it ‘‘ ac­knowl­edges the need for eth­i­cally con­ducted, ev­i­dence-based re­search for the ben­e­fit of all chil­dren who may need medicines which haven’t been specif­i­cally de­signed for them.

‘‘ One of the ques­tions that needs to be con­sid­ered is how best to es­tab­lish a regime which can pro­vide ap­pro­pri­ate in­cen­tives to en­cour­age re­search that will pro­vide chil­dren with li­censed medicines,’’ he said.

A spokes­woman for the TGA said the reg­u­la­tor was ‘‘ very keen to progress bet­ter pae­di­atric in­for­ma­tion about drugs’’ and the AHMAC ini­tia­tive was key to achiev­ing that.

‘‘ The TGA is very keen to see in­creased pae­di­atric data, bear­ing in mind the eth­i­cal con­sid­er­a­tions, and to find so­lu­tions that would en­cour­age com­pa­nies to pro­duce bet­ter pae­di­atric ev­i­dence,’’ she said. Due to space con­straints, Body Parts does not ap­pear this week

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