RevPaulPediatr.2016;34(4):393---394
REVISTA
PAULISTA
DE
PEDIATRIA
www.rpped.com.br
EDITORIAL
Adverse
drug
events
in
pediatric
intensive
care
are
common,
but
improvement
strategies
exist
and
are
effective
Eventos
adversos
a
medicamentos
em
terapia
intensiva
pediátrica
são
comuns,
mas
estratégias
de
melhoria
existem
e
são
eficazes
Karel
Allegaert
a,baIntensiveCareandDepartmentofSurgery,ErasmusMC-SophiaChildren’sHospital,Rotterdam,TheNetherlands bDepartmentofDevelopmentandRegeneration,KatholiekeUniversiteitLeuven,Belgium
Received8May2016
Off
label
use
is
associated
with
adverse
drug
events
Pharmacotherapyisapowerfultooltoimproveoutcomein children,butthereisstillanobviousneed toreduce drug relatedproblemsthroughadversedrugevent(ADE) preven-tionand management.1 An ADE can hereby be definedas ‘anyharmfulandunintendedeventresultingfromtheuse ofadrug intendedfor diagnosisortherapy’.SuchanADE definitionisirrespectiveofthedosebutmoreappropriate forchildren,sincethesepatientsstillcommonlyreceiveoff labeldrugsusingdosesextrapolatedfromadults.Besidesthe absenceoflabeling,(poly)pharmacy,inappropriate formu-lations,variabilityindosingpractices,difficultiestoassess pharmacodynamics effects (e.g. sedation, pain), immatu-rityandorgandysfunctionfurtherraisetheriskforADEsin criticallyillchildren.2,3Inpediatricandneonatalintensive careunits(ICU),offlabeluseofdrugsisupto80---90%,so significantlyhigherthantherecentlyreported30%ina pri-marypediatriccaresettinginBrazil.4Unfortunately,these offlabelpracticesareassociatedbysignificanthigherrisks to develop ADE. Duet al. recently quantified this risk in
E-mail:karel.allegaert@uzleuven.be
acohortof697 consecutivePICUadmissions.5 The overall riskwas13.1%,withanevenhigherriskaftercardiovascular surgery,duringinfancy(<1yearofage),orinthesettingof polypharmacy(≥6drugs) or higherdisease severity (Pedi-atricRiskofMortalityscoreuponadmission).5
Can
we
reduce
the
burden
of
adverse
drug
events?
Consequently, we need strategies to recognize and pre-vent ADEs in these populations, and a clinical pharmacy service (CPS) may be a very effective tool to do so. In thisjournal,Okumura etal.reportedontheir experience followingintroductionofaCPSintoasingle,12bed pedi-atric ICU.6 Already in a small sample of patients (n=53), theimpactoftheCPSonthedetectionofpreventableADE (n=141 events in 53 cases) was relevant. The most com-moninterventionsrelatedtoincompatibilityofintravenous solutions(21%), or inadequate doses (17%)and---similar to otherobservations1,2,5---antimicrobialagents were overrep-resented(5ofthetop10drugs)intheinterventiongroup.
Thisalsomeansthatsuchobservationsshouldguide sec-ondary prevention programs to improve practices: avoid theavoidance,andlearnfromyourcurrentpractices.CPS teamsofclinicalpharmacistsshouldbeanintegratedpart
http://dx.doi.org/10.1016/j.rppede.2016.07.002
394 AllegaertK
ofmultidisciplinaryteamsinadditiontophysicians,nurses andotherhealthcareproviders.Clinicalpharmacistsshould providebesidesupportintheprescription(dose,frequency) and the administration of drugs (e.g. incompatibilities). BecauseofthehighADEincidence,theICUenvironmentis anobviouschoice.6
Multidisciplinary
teams
to
close
the
knowledge
gap
As mentioned earlier, the currently still too limited knowledge on pharmacotherapy in ICU children is linked to a still too high incidence of ADEs. Multidisciplinary approaches---includingclinicalpharmacists---areveryhelpful toreducepreventableADE.However,weshouldnot under-estimatethedynamicsofsuchmultidisciplinaryteamsonce implemented.These groups can also generate new infor-mationon olddrugs (off label use should not remainoff knowledge)andtheycandevelopandvalidatebestpractices andnewdosingregimens,duetotheirexpertiseto collabo-ratebedsideinthedailypracticeonpharmacotherapy:let’s makethingsbetter.
Funding
The clinicalresearchof KAllegaert wassupported bythe FundforScientificResearch,Flanders(fundamentalclinical investigatorship1800214N)andarefurtherfacilitatedbythe
agencyforinnovationbyScienceandTechnologyinFlanders (SAFEPEDRUG,IWT/SBO130033).
Conflicts
of
interest
Theauthordeclaresnoconflictsofinterest.
References
1.Fabiano V, Mameli C, Zuccotti GV. Adverse drug reactions in newborns, infants and toddlers: pediatric pharmacovigi-lance between present and future. Expert Opin Drug Saf. 2012;11:95---105.
2.Allegaert K, Van den Anker J. Neonatal drug therapy: the firstfrontieroftherapeuticsforchildren.ClinPharmacolTher. 2015;98:288---97.
3.AllegaertK,VandenAnkerJN.Adversedrugreactionsinneonates andinfants:apopulation-tailoredapproachisneeded.BrJClin Pharmacol.2015;80:788---95.
4.Gonc¸alves MG, Heineck I. Frequency of prescriptions of off-labeldrugsanddrugsnotapprovedforpediatricuseinprimary healthcareinasouthernmunicipalityofBrazil.RevPaulPediat. 2016;34:11---7.
5.Du W, Tutag Lehr V, Caverly M, Kelm L, Reeves J, Lieh-Lai M.Incidenceand costsofadversedrugreactionsin atertiary carepediatric intensive careunit.JClinPharmacol.2013;53: 567---73.
