Andersons pediatric cardiology 2114
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al.DesignandtestingofanEHR-integrated,busulfanpharmacokinetic
decisionsupporttoolforthepoint-of-careclinician.FrontPharmacol.
2016;7:65.).
Conclusion
ThepassageoftheBestPharmaceuticalsforChildrenAct(BPCA)123and
PediatricResearchEquityAct(PREA)124hascontributedtoasignificant
increaseinpediatricdrugstudies,resultinginmorethan500druglabel
changes.125Despitethissignificantworkandprogress,off-label
pharmacotherapyinchildrenstilloccursformorethan50%ofdrugagents.126In
fact,arecentreviewdescribesthatasignificantnumberofchildrenreceiveat
leastoneoff-labeldrug(~18%to65%)orunapproveddrug(~7%to48%)
duringahospitalization.127Concerningtoourcommunityisthatasignificant
proportionofoff-labeldruguseshaveoccurredwithcardiovascular
pharmacologicagents.IntheUnitedStates78%ofhospitalizedcardiovascular
patientsreceivedatleastoneoff-labelmedicationand31%receivedatleast
threeoff-labelmedications.128SimilartrendshavebeenseeninEurope,where
76%ofhospitalizedpatientsonpediatriccardiologywardsreceivedatleastone
ormoreoff-labeland/orunlicensedprescriptions.129Thetraditionalmodelof
clinicaldrugdevelopmentistoinvestigateeffectofdrugsinpopulationsand
thenapplythedatatotreatindividualpatients.Forpediatriccardiology,the
problemisfurthercomplicatedwhenthepopulationexperienceisinadultsand
theinformationistobeappliedtopatientsofdifferentagesandstagesof
development.Thereforethereisaneedtoconductstudiesthatidentifyand
quantifysourcesofinterindividualvariabilityindrugdispositionandresponse
forthemanagementofpediatriccardiovasculardisease.Thechallengeforthe
futureistoaddresseachoftheknowledgedeficitstobettercharacterizethe
dose-exposure-responserelationshipinchildrenandadolescentswithacquiredor
congenitalheartdiseasesuchthatthedesignoffutureclinicaltrialswillbebetter
informed,thusincreasingtheprobabilityofchangetothedruglabelsand
circumventingthemistakesofthepast.130
AnnotatedReferences
HinesRN.Theontogenyofdrugmetabolism
enzymesandimplicationsforadversedrug
events.PharmacolTher.2008;118(2):250–267.
Theauthorisaworldauthorityondevelopmental
pharmacology.Thiscomprehensivereview
collatesalltheknowntheontogeny
(developmental)patternsformajordrug
metabolizingenzymes..
NevilleKA,BeckerML,GoldmanJL,KearnsGL.
Developmentalpharmacogenomics.Paediatr
Anaesth.2011;21(3):255–265.
Theauthorsarewell-knownexpertsin
developmentalpharmacologyand
pharmacogenomics.Thiscomprehensivereview
providesanoverviewofdevelopmental
pharmacogenomicsanditsfuturerolefor
individualizedpharmacotherapy..
WagnerJ,LeederJS.Pediatricpharmacogenomics:
asystematicassessmentofontogenyandgenetic
variationtoguidethedesignofstatinstudiesin
children.PediatrClinNorthAm.
2012;59(5):1017–1037.
Theauthorsareexpertsinpediatric
pharmacogenomicsanditsrelevanceinclinical
