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HowSafeAreKIDS'PrescriptionDrugs?Drugsprescribedtochildrenandadolescentshavebeenmuchinthenewslately.HealthCanadahasissuedwarningsaboutsomedrugsthatbothpatientsandphysicianstrusted,andithaswithdrawnothersfromthemarket.What'sgoingon?Parentsshouldunderstandthesecomplicatedandconfusingissues.HowArePrescriptionDrugsApprovedinCanada?Whenapharmaceuticalcompanyhasanewdrug.itappliestoHealthCanadaforalicencetosellit.basedoninformationthecompanyprovides,includingtheresultsofclinicaltrials,thedrugiseitherapprovedortheapplicationisrejected.

IsThereaDifferenceintheWayDrugsAreApprovedforChildrenandAdults?Normally.drugsaretestedinadultsfirst.Dr.DenisDaneman.aclinicalinvestigatoratTheHospitalforSickChildreninToronto,says,wehavetoberemarkablycarefulbecausechildrenarephysiologicallydifferentthanadultsandareseenbyphysiciansasahighlyvulnerablegroup."WhatHappensOnceaDrugIsApproved?Onceapproved,"explainsDaneman.it'savailableonthemarketanddoctorscanprescribeitforanyindicationthey'dliketo."Evenifithasnotbeentestedspecificallyinchildren.hesays.physiciansmaystarttouseiteitherinsmalltrialsorwhatwecalloff-label(useofaprescriptiondrugtotreataconditionforwhichthedrughasnotbeenapproved)inchildren."HowCommonIsOff-labelUse?

Dr.MichaelRieder.directoroftheAdverseDrugReactionClinicattheChildren'sHospitalofWesternOntario,says,drugscommonlyusedinchildren，suchasantibiotcsandasthmadrugs,aretestedinchildren."But,hesays,thereisamisconceptionthatchildrentakeonlythosedrugs.WedidastudylookingatamillionkidsinCanadaoverayear.Itturnsouttheyusedl,400differentdrugs,ofwhich60percenthavenotbeentested,orapprovedforuseinchildren."IfaDrugIsSafeinAdults,WhyDoYouNeedtoTestItinchildren?HealthCanada'sDr.SiddikaMithanisays.childrenarenotsmalladults."Theirphysiologyisdifferent.Thatgoesforadolescents.too.Dr.EricWookltorton.anOttawa-basedfamilyphysicianwhowritesacolumnonadverseeventsfortheCanadianMedicalAssociationJournal,says,DepoProveraisaninjectablebirth-controlproductusedbywomenofallages.Noonethoughttotestitinadolescentsuntilrecently.Teenagersarelayingdownbonedensityandthisdrugdecreasedbonedensity."

AreOlderDrugsSafer?IfIweretouseamedicationoff-labelthat'sbeenaroundforsometime,I'dbelessconcernedaboutit."advisesDr.PeterNieman.aCalgarypediatrician.Butifyouuseamedicationthat'sbeingpromotedaschebestthingsinceslicedbread,andyouknowit'sfairlynewandareusingitoff-label,youareabitnervous."HowManySideEffectsAreReported?In2004HealthCanadareceived10,238reportsofadversereactionsinpeopleofallages.Thenumberofreportshasbeenincreasingsince1999,whenjustunder6,000weresentin.However.Dr.BruceCarleton.ofthepharmaceuticaloutcomesprogramattheChildren'sandWomen'sHealthCentreofBritishColumbia，says,95percentofnegativereactionsareneverreported."Wooltortonexplains:howdoyoutrackthemoreminor,long-termsideeffects,theoneswherekidsarealittlebitstuntedingrowthortheyarehavinglearningproblemsinschool.There'snoregulationandnofinancialincentivetoreportanythingatall."

ShouldWeBeMoreCarefulwithSomeDrugs?Dr.JackUetrecht,aCanadaResearchChairinadversedrugreactions,advisesextracautionwithdrugsthataffectthecentralnervoussystem.Theeffectsandlong-termoutcomesofgivingthesetypesofdrugsaren'ttotallyunderstood.Makesuretheappropriatetestsaregiventomakeasclearadiagnosisaspossible.andthattheappropriatetreatmentisgivenbasedonthatdiagnosis.Talkingtothepatientforafewminutesandprescribingadrugwouldnotbethebestmethod.Ifthereisasevereclinicalproblemandaclearclinicalbenefit,thenthebenefitisworththerisk."