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drivenmorebyresistancepatternsinpathogenscoveredbytheclassthanthepotentialriskofarthropathy
tothepatient.
Cardiovascularsafetyandadversepsychiatriceffectsareaconcernwiththeuseofpsychostimulantsin
thetreatmentofattentiondeficithyperactivitydisorder(ADHD).Averysmallnumberofcasereportsof
suddencardiacdeathhavebeenreportedinchildrenprescribedpsychostimulantsforADHD.Theriskhas
beenfoundtobegreaterinpatientswithunderlyingcardiacstructuralabnormalities.However,theriskis
similar to thatof strenuousexercise inthis population, andthe useinthegeneral populationdoes not
necessitateadditionaltestingbeyondnormalscreening.Thereisalsoasmallriskofpsychosisandmaniatype reactions in children. As a result, the FDA requires the pharmaceutical industry to provide
medication guides to patients and prescribers explaining the risks of ADHD drug treatments and
informationontheirpotentialsideeffects.
Another widely used drug class with specific safety concerns in the pediatric population is
antidepressants. There is a very slight increase in suicide risk in patients started on antidepressants,
whichlikelyreflectsthecurrentdepressedstateandothercomorbidities.TheFDAhasincludedablack
box warning for increased suicidality for children and adolescents initiating all classes of
antidepressants. Although this is a statistically significant increased risk compared to the normal
population,theriskofsuicideinuntreateddepressedpatientsismuchhigher.
Long-TermEffects
Drugsadministeredtopediatricpatientsmaytakealongertimetoproduceadverseeffectsthaninadults.
Certain adverse effects may not be detected until decades after treatment. For example, secondary
cancers,growthretardation,hypogonadism,andsterilityhaveall beenreportedas lateadverseeffects
associated with certain antineoplastic therapies. Inhaled and intranasal corticosteroids may decrease
growthvelocity,whichisa meansofcomparinggrowthrates amongchildrenofthesameage.Studies
withinhaledsteroidsshowedanapproximately1-cm/yreductioningrowthvelocity.TheFDAsuggests
that the reduction is related to dose and how long the child takes the drug (U.S. Food and Drug
Administration,1998b).LoneandPederson(2000)evaluatedthelong-termeffectongrowthofinhaledor
intranasal budesonide in pediatric asthma patients. At the end of this 10-year study, the researchers
concluded that normal adult height was achieved in patients receiving these corticosteroids. More
recently, theChildhoodAsthmaManagementProgram(CAMP) ResearchGroupshoweda reductionof
1.2cminadultheightintheinhaledbudesonideversusplacebogroup(Kellyetal.,2012).
Potentiallong-termeffectsofmedicationsusedinchildrencreateaconcern.The5-yearsurvivalrates
ofmostpediatricmalignanciesareexceeding80%inmosthighincomecountries.Thishasledtoafocus
on the late effects of therapy and the quality of life in this growing population of childhood cancer
survivors (Erdmannetal.,2020).Nearlytwo thirdsofallchildhoodcancersurvivors will experience
somephysicalorpsychologicoutcomethatdevelopsorpersistsbeyond5yearsfromtheinitialdiagnosis
(Shankaretal.,2008). Othermedicationsusedinpediatricsmayalsocarryrisksfor long-termeffects.
Unfortunately,theseeffectsmaynotbeseenforyearsafterthemedicationisstopped,andtherearelikely
otherfactorsthatcouldcauseoratleastcontributetotheeffect.Studiesthatevaluatethelong-termeffect
ofamedicationareverydifficulttoperformandoftenyieldconflictingresults.
DosageFormulation
Commerciallyavailabledosageformulationsoftenlimitthedrugsthatcanbeprescribedtochildrenand
arenotalwayschildfriendly.Manydrugsare availableonlyasanoral tablet,capsule,or intravenous
dilutioninadultdosagestrengths.Prescribinga drugasa tablet or capsule fora pediatric patienthas
several drawbacks. The pediatric patient may have difficulty swallowing a whole or intact tablet or
capsuleandattemptingtobreakatabletintosmallerpiecesoremptyingpartofacapsuletoprovidean
appropriatedose leads toquestionable accuracyofthe administereddose.Itisimportanttoprovidea
dosageformthatcanbe administered easily,accurately,andsafelytoapediatric patient.Amethodto
improveadministrationisviaextemporaneousformulations,especiallyifaproductisnotcommercially
availableasanelixir,solution,suspension,orsyrup.However,theseoralliquidformulationsalsohave
drawbacks, such as an unfavorable taste. Other alternatives to oral liquid formulations include tablet
dispersion,powderedpapers,andrepackedcapsules.Combinationproductsareavailabletoreducepill
burdenandimprovemedicationadherence.However,theseagentscontainfixeddosageformsintablets
orcapsules,makingitdifficultforachildlessthanage5toswallow.
Ideally, a practitioner who is prescribing a dosage formulation not commercially available for a
pediatricpatientoughttoworkwithapharmacistwhoiswillingandabletocompoundaccuratepediatric
drugdosages and formulas. Practitioners can familiarizethemselves with additional drugs thatcan be
extemporaneouslycompounded foruse inpediatrics bya pharmacistinsuchpublicationsas Pediatric
DrugFormulations(Nahata&Pai,2018);TeddyBearBook:PediatricInjectableDrugs(Phelps,2018);
Pediatric Dosage Handbook (Taketomo et al., 2019); Extemporaneous Formulations for Pediatric,
Geriatric, and Special Needs Patients (Jew et al., 2016); or Trissel’s Stability of Compounded
Formulations(Trisseletal.,2018). AMedlinesearchshouldbe conductedfor drugsnotcontainedin
thesepublications.
Dosage
Inadultdrugtherapy,onestandarddoseofadrugcanbeusedforalmostalladults,buttheoppositeis
trueinpediatricdrugtherapy:Apediatricdrugdosechangesfordifferentillnessesorasthepatientgrows
ordevelopsandrequiresage-dependentadjustments.
When writing or assessing a pediatric medication order, the following process is recommended to
ensuresafeandeffectivepharmaceuticalcare:
1.Determinethepatienttype(i.e.,neonate,pediatric,adolescent).
2.Assesstheappropriatenessofthedrugtherapyselectedinthispatienttype,patientpopulation,and/or
diseasestate.
3. Establish the appropriate dose, route, formulation, and frequency based on the recommended
referencesdescribedintheparagraphbelow.
4.Ifallresourceshavebeenexhaustedorfurtherinformationisneededregardingthepediatricdosage,
contactapharmacist.Itisimportanttoensurethatthedoseisappropriateorreasonablebasedonthe
pharmacist’sknowledgeofpediatricpharmacokineticsandavailableresources.
Manydrugs currentlyinuse inpediatrics have established dosing recommendations based onbody
weight, BSA, concurrent drug therapy, and stage of development or physiologic function (age). Body
weight–baseddosingisthemostcommonmethodforpediatricdosing.Atotaldailydose,milligramsper
kilogram per day (mg/kg/d), is divided by the dosing interval to calculate each individual dose.
Analgesics,antipyretics,andemergencydrugsareoftenadministeredonadose-by-dosemethod;assuch,
the recommended pediatric dose is reported as milligrams per kilogram per dose (mg/kg/dose). The
starting or maximum doses for pediatric intravenous infusions areusuallyreportedasmicrogramsper
kilogramperminute(mcg/kg/min)ormicrogramsperkilogramperhour(mcg/kg/h).Drugdosagesbased
onapatient’sBSAareusuallyreservedforantineoplasticagentsorcriticallyillpatients.BSAcorrelates
closely with many factors that influence drug elimination, including cardiac output, respiratory
metabolism,bloodvolume,extracellularwatervolume,GFR,andrenalbloodflow.Dosagesofseveral
drugs,includingdocusate(Colace)andmontelukast(Singulair),arebasedonage.
GeneralpediatricdrugreferencessuchasthePediatricDosageHandbook(Taketomoetal.,2019)and
Micromedex (MICROMEDEX Solutions, 2020) provide comprehensive drug monographs, including
dosageformulations,adverseevents,pharmacology,andpharmacokinetics.TheHarrietLaneHandbook
(Hughes&Kahl,2017)providesdrugmonographsbasedontheJohnsHopkinsHospital formularyand
specialdrugtopics.AspecialtypediatricreferencesuchastheRedBook(Kimberlinetal.,2018)covers
onlyantimicrobialagentsandvaccines;Neofax(Neofax,2020)providesinformationaboutdrugdosingin
neonates.
Obesity
Obesity, defined in children as a body mass index (BMI) at or above the 95th percentile for age, is
considered a public health crisis in the United States (Ogdenet al., 2010). Nearly 1 in 5 school-age
childrenandyoungpeopleareobeseintheUnitedStates(Halesetal.,2017).ChildrenwithaBMIator
abovethe85thpercentileareconsidered“atriskforoverweight,”andnearly32%ofU.S.childrenages2
to 19 fall into this category (Ogden et al., 2010). While it is known that there is an overall lack of
informationondosagesregardingmostmedicationsinchildren,thereisfar lessinformationonproper
medicationdosingintheoverweightchild.Obesitycanaffectthepharmacokinetics,dosing,half-life,and
metabolismofamedication.Medicationsoriginallyintendedforadultusearenowbeingutilizedtotreat
hypertension, hyperlipidemia, and type 2 diabetes as these diseases are on the rise secondary to the
increaseinobesity(Kennedyetal.,2013).Thereisagreaterriskofdosingerrorsinoverweightchildren,
specifically for underdosing and overdosing of antimicrobials (Matson et al., 2017). The Pediatric
PharmacyAdvocacyGrouprecommendsthatweight-baseddosingbe utilizedfor allchildrenlessthan
age18andweighinglessthan88lbs(40kg).Forchildrenwhoweighover40kg,weight-baseddosing
shouldbe used,unlessthepatient’sdose or dose perdayexceedstherecommendedadultdose forthe
specificindication(Matsonetal.,2017).
RoutesofAdministration
Oral
Whenprescribingoradministeringoraldrugsforpediatricpatients,thecaregiverneedstoconsidernot
only the drug’s flavor and ease of delivery but the frequency of administration, dosage form, and
“inactive”ingredients,suchasalcoholandsugar.Aliquiddosageformispreferred formostpediatric
patients.
Toensuretheaccuracyofeachdoseadministered,thedrugshouldbemeasuredandthenadministered
withanoralsyringeoracalibrateddrugcup,withthebaseofthemeniscusviewedateyelevel.Ifthe
drugisavailableonlyintabletformandthetabletcanbebroken,thetabletmaybecrushedandmixedin
compatible syrup. However, mixing a crushed or whole tablet with food should be done cautiously
becausemanyfoodsinterferewithdrugabsorption.
Ifthepatientisaninfant,theheadshouldberaisedtopreventaspirationofthedrug.Applyinggentle
downwardpressureonthechinwithathumbhelpsopenthepatient’smouth.Ifasyringeisused,thetipof
thesyringeshouldbeplacedinthepocketbetweenthepatient’scheekandgumandthedrugadministered
slowlyandsteadilytoreducetheriskofaspiration.
Forbottle-fedinfants,thedrugcanbeplacedinanipple andtheinfantallowedtosuckthecontents.
However,adrugshouldneverbemixedwiththecontentsofababy’sbottlebecausethecorrectdosewill
notbereceivediftheinfantdoesnotconsumethefullcontentsofthebottle.Inaddition,adrug–nutrient
interaction may occur if a drug is mixed with formula feeds. A classic example of a drug–nutrient
interactionisthesignificantreductionoforalphenytoinabsorptionafterconcurrentadministrationwithan
enteralfeedingformula(Sacks&Brown,1994).
Rectal
Toddlers beingtoilettrained,especiallychildrenexperiencingstressordifficulty,oftenresisttherectal
administrationofdrugs.Older childrenmayperceivetheprocedureasaninvasionofprivacyandmay
react withembarrassmentoranger andhostility. Thebestapproachto reducinganxietyandincreasing
cooperationistospendtimeexplainingtheprocedureandtoreassurethechildthatgivingdrugsbythis
routewillnothurt.Itmaybenecessary,afterplacingasuppository,toholdthechild’sbuttockstogether
forafewminutestopreventexpulsionofthedrug.
Parenteral
Establishing venous access, venipuncture for blood samples, and intramuscular injections are a great
source ofdistressandpain for children. Several local anesthetic agents havebeendeveloped tohelp
managethepainandanxietybroughtonbytheseprocedures.Theidealproductwouldhaveneedle-freeor
topical administration,a rapid onsetof anesthetic, andnodermal orsystemicadverse effects,andthe
productwouldhavenoimpactonthesuccessrateoftheprocedure.Nocommerciallyavailableproduct
hasallthesequalities.Thethreegeneraldeliverymethodsusedtobypassthestratumcorneumlayerare
directinjectionoflocalanesthetics,passivediffusionfromtopicallyappliedgelsorcreams,andseveral
needle-freemethodsthathastentherateofdrugpassagethroughtheskinandspeedthetimetoonsetof
action. Table 4.6 lists the methods of drug delivery, the available agents, and the advantages and
disadvantagesofeach(Zempsky,2008).
TABLE4.6
TopicalAnesthetics
Method Product(s) Medication(s) OnsetofTopical
Anesthesia
AdverseReactions
Injectionoflocal
anesthetics
Lidocaine,Lidocaine
bufferedwithsodium
bicarbonate
Lidocaine <1min Painassociatedwith
initialneedlestickfor
injectionofmedication
Lidocaineneedle-free
injection
J-Tip® Lidocaine <1min “Poppingnoise”with
administration(may
frightensomechildren)
Passivediffusionwith EMLA®,generic Lidocaine,2.5%; 30min(minimum), Skinblanching,rare
topicalcreamsorgels prilocaine,2.5% 60minformore
completeeffect
methemoglobinemiain
infants
LMX4® Liposomal
lidocaine,4%
30min Erythema,blanching
Needle-freestrategiesto
accelerateonset
Synera® Lidocaine/tetracaine 10min Localreactions
(erythema,71%;
blanching;andedema)
Lidocaineiontophoresis NumbyStuff® Lidocaine 10-15min Intolerabletingling,
itching,burning
sensation,discomfort,
potentialforburn
LidocaineHCl
monohydratepowder
intradermalinjection
system
Zingo® LidocaineHCl
monohydrate
1-3min Localreactions
(erythema,62%;
petechiae,52.8%)and
edema
Vapocoolantsprays PainEase® Liquidrefrigerant
(ethylchloride)
Immediate(may
requiretwo
providersaseffect
lasts11min)
Someskinpigmentation
changes(temporary)
J-Tip,EMLA,LMX4,Synera,NumbyStuff,Zingo,andPainEase
Pulmonary
Nebulizers,pressurizedmetered-doseinhalers(pMDIs),anddrypowderinhalers(DPIs)canbeusedto
deliver bronchodilators and corticosteroids in the treatment of asthma. Nebulized drugs require
connectinganairoroxygentubetothenebulizermachineandareoftenusedininfantsandyoungchildren.
pMDIsrequirecoordinationbetweenactuationandinhalation;thisisdifficultinanyagegroup,soatube
spacerisrecommendedforchildrenofallages(GlobalInitiativeforAsthma,2019).Spacerdeviceshave
expandedtheuseof metered-dose inhalerseventotheneonatal population.ADPIsuchasbudesonide
powder(PulmicortTurbuhaler) involves coordinationwiththepatient’sinspiratoryflow;therefore,the
delivery mechanism is not recommended in children less than age 4. Table 4.7 summarizes the
recommendedpopulationforaerosoldeliverydevices(GlobalInitiativeforAsthma,2019).
Topical
Thetopicaldeliveryofmedicationsiscommoninthepediatricpopulationwithdiseasessuchaseczema
and acne as well as other skin disorders that appear during childhood. Caution is warranted in this
populationduetoseveralfactorsthatmaylead toa higher rateofdrugabsorption.Whencompared to
adults,infantsandchildrenhaveahigherratioofskinsurfacetobodyweight.Thisincreasestheriskof
accumulatingsignificantserumdruglevels(Metry&Herbert,2000).Itisespeciallytrueinthenewborn
andinfantbecausethebarrierfunctionoftheirskinisimmature.Parentsmustbecautionedtofollowthe
directions for administration of all topical medications to prevent toxic drug levels. A fatal case of
diphenhydramine toxicity has been reported in the literature, largely due to excessive application
followingabathinachildwitheczema(Turner,2009).
TABLE4.7
RecommendedAgeGroupsforAerosolDeliveryDevices
Device Age
Nebulizer •Anyage
pMDI •Anyage(withvalvedspacer)
•>8yold
Breath-actuatedpMDI •>7yold
Drypowderinhaler •>5yold
pMDI,pressurizedmetered-doseinhaler.
MEDICATIONSAFETY
Ensuringeffectiveandsafedeliveryofdrugstofetusesandpediatricpatientsinvolvesunderstandingthe
physiologicchangesthatoccurthroughoutchildhoodandpregnancy.SincethestartoftheInstituteforSafe
Medication Practices in 1994, pediatric medication safety movements have progressed over time. In
2004,theInstituteof Healthcare Improvement(IHI) introducedthe100,000Lives Campaigntoprotect
patients from medical harm. Two years later, the IHIlaunched the 5 Million Lives Campaign with a
pediatricnitiative toreduce adverse drug events anddecrease harmfrom high-alert medications (i.e.,
anticoagulants, sedatives, opioids, insulin) (Institute of Healthcare Improvement, 2006). The Joint
CommissionSentinelEventAlertstatedthatharmcausedbymedicationerrorsisthreetimesgreaterin
pediatricpatientsthanadults(TheJointCommission,2008).Asaresult,TheJointCommissionIssue39
recommendsinitiativestopreventmedicationerrorsandsuggestsriskreductionstrategies.Box4.1gives
some recommendations to assist health care professionals in reducing medication errors (American
AcademyofPediatrics,2003;TheJointCommission,2008).Inthefuture,pediatricpharmacotherapywill
evolvewithadditionallegislationandsafetymovements.
Box4.1 PreventingPediatricMedicationErrors
AmericanAcademyofPediatricsTheJointCommission
•Maintainanup-to-datepatientallergyprofile.
•Confirmthevalidityofapatient’sweightformedicationsthataredosedbybodyweight(orBSAfor
medicationsdosedbyBSA).
•Statespecificdosagestrengthsorformulation.
•Donotuseabbreviationsfordrugnamesorpatientinstructions.
•Avoidusingabbreviationsfordosageunits.
•Useazerobeforeadecimalpoint.
•Avoidazeroafteradecimalpoint.
•Standardizeconcentrationsofhigh-alertmedications(i.e.,heparin,insulin,ornarcotics).
•Utilizeoralsyringestoadministerliquidformulations.
•Createdrugorderpathwaysforprotocols.
•Collaborateandeducateallhealthcaremembersinvolvedwiththepatients’care.
•Usetechnologysuchasautomateddispensingcabinets,smartinfusionpumps,barcoding.
BSA,bodysurfacearea.
CONCLUSION
Insummary,pediatric, pregnancy,andlactationpharmacotherapyposes a uniquechallenge.Thelackof
medications approved by the FDA, insufficient literature resources, pharmacokinetic parameters
comparedtoadultsandnon-pregnantwomen,individualdrugdosingcalculations,lackofdosageforms,
andinappropriatedrugdeliverysystemsare a few examples(Levineetal., 2001).Althoughthehealth
benefitsofbreast-feedingare established,there remainafewmedicationsthatareunsafetouseduring
breast-feeding. As with medication use during pregnancy,the risk–benefit ratio needs to be assessed.
Choice of the best medication totreatthematernal condition needstobe balanced against the risk of
adverse effects to the infant. Furthermore, ensuring medication safety practices and legislations will
allowforsafeandeffectivemedicationtherapytothisvulnerablemedicalpopulation.
CASESTUDY1
M.T.isan18-month-old,20-kgmalewhopresentstotheemergencydepartmentinstatusepilepticus,
whichhascontinuedforapproximately20minutes.Hewasbroughttotheemergencydepartmentfrom
asmallcommunityviaafamilyvehicle.Hehasnotreceivedanycareatthispoint.Thenursingstaffs
haveattemptedseveralintravenouslineinsertionsbutwereunabletogainaccess.M.T.continuesto
convulsewithoutinterruption(LearningObjective1).
1.Discusstheadvantagesanddisadvantagesofthedifferentroutesofadministrationsofmedications
availabletotreatM.T.
Answer: Available options includerectal administration, which offers a relativelyfastonsetof
actionbutwithsomevariabilityinabsorption.Alternatively,theintranasalrouteallowscomplete
absorptionwithaquickonsetofaction.
2. Youprescribe arescuemedicationforM.T.'smom touseathomeintheeventM.T.hasanother
seizure. Discuss some advantages of utilizing the mucosal route of administration for at home
administration.
Answer:Somemedicationshaveverygoodabsorptionandsystemiceffectwhenadministeredby
nasalspray.Nasal(mucosal)administrationavoidsthetraumaofintravenouslineplacement.Nasal
administrationofmedicationis typically less expensive than intravenous administration.This is
alsoeasierforparentstouseratherthantherectalroute,whichcanbetraumatic.
3.Duringthefollow-upclinicvisitafter hishospital admission,MomexplainsthatM.T.has been
havingrashesalloverhisbody.Youevaluatetherashanddeterminethatitiseczemaandwantto
prescribe a topical steroid. Discuss some considerations regarding the absorption of topical
medicationsinpediatricpatients.
Answer: The absorption of compounds is inversely related to the thickness of the skin. The
absorption of compounds is related to the hydration of the skin. Body surface area(BSA) is
increased,relativetobodymass,intheinfantandyoungchildwhencomparedwitholderchildren
andadults.Allthesefactorsleadtoahigheramountoftopicalmedicationbeingabsorbed.
CASESTUDY2
K.F.isa33-year-oldfemalewhohasarecenthistoryofdeepveinthrombosis(DVT)andreflux.She
is on enoxaparin for treatment of her DVT, and she also occasionally takes famotidine for reflux.
Duringhermostrecentvisittoherprimarymedicaldoctor,shefoundoutshewaspregnant.Duetoher
recentDVThistoryandincreasedriskofDVTinpregnancy,herprimarymedicaldoctorwouldliketo
continuetheenoxaparinthroughoutherentirepregnancy(LearningObjectives4and5).
1.Whataresomepharmacokineticchangestoconsiderwiththeuseofenoxaparininpregnancy?
Answer:Evaluatethelabelingforpregnancy.Itdoesnotcrosstheplacenta,soitissafetousein
pregnancy. Enoxaparin has demonstrated increased clearance, so therapeutic monitoring may be
recommendedtoensurecontinuedefficacy.
2.K.F.isnow4dayspostpartum, experiencingseverepainfromherC-sectionandunresponsiveto
acetaminophenandibuprofen.Shementionsthatshewould liketotrytramadol forstrongerpain
control. She wishes to continue breast-feeding her baby. What are the recommendations for
tramadol’scompatibilitywithbreast-feeding?
Answer:Tramadolisnotrecommendedwithbreast-feedingduetoriskofadverseeffectsinbreastfedinfants,suchassleepinessandbreathingproblemsthatcouldresultindeath.
3.K.F.isnow2monthspostpartumandissuccessfullyexclusivelybreast-feedingherbaby.Sheplans
to continue breast-feeding but is diagnosed with acute bacterial sinusitis. She is prescribed
amoxicillin and is concerned that this will negatively affect her baby. What are the
recommendationstominimizetheconcentrationofamoxicillininherbreastmilk?
Answer:Determinethepeakofamoxicillininbreastmilkabout4to5 hoursafterthedose and
schedule administration right after breast-feeding to minimize the dose to the infant by
circumventingpeakbreastmilklevels.
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