Class Notes for Pharmacology Connections to Nursing Practice, 2nd Edition

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd EditionCHAPTER1INTRODUCTIONTOPHARMACOLOGY:CONCEPTSANDCONNECTIONSLEARNINGOUTCOME1Identifykeyeventsinthehistoryofpharmacology.ConceptsforLecture1.Over3.6billionprescriptionsaredispensedeachyearintheUnitedStates,withthenumberrapidlyincreasing.2.Pharmacologyhasevolvedoverthecenturiesandisakeyaspectofnursingcare.3.Pharmacologystartedwithearlymanusingplantsandherbstorelievediseasesymptoms.4.One of the oldest forms of health care, herbal medicine has been practiced in virtually every culturedating to antiquity.5.Manyearlyremedieswereaccidentaldiscoveries.6.Firstprescriptionswrittenintheyear3,000BCbytheBabylonians.TheChinesehavethefirstrecordedvolumeofplantremediesintheyear2,700BC.7.PharmacologywasprobablyreviewedasmagicandsuperstitionduringtheDarkAges.ThereisverylittlerecordeddatafromtheDarkAges.8.Firstbegantobepracticedasascienceinthe17thcenturyandthefirsttextwiththewordpharmacologywaspublishedin1693.9.Inthe19thcentury,chemistswereabletomakeremarkableprogressinseparatingspecificsubstancesandthefirstactiveagentssuchasmorphine,colchicines,curare,cocaine,andotherearlydrugswerediscoveredfromtheirnaturalplantproducts.10.Earlypharmacologistsstudiedtheeffectsonbothanimalsaswellasthemselves.11.FirstrecognizedasadisciplineinEstoniain1847.IntheUnitedStates,thefirstpharmacologydepartmentwasattheUniversityofMichiganin1890.12.The20thcenturysawgreatprogressanddevelopmentofnewdrugs.Wearenowabletosynthesizedrugsfrom“scratch”inthelaboratory.13.Thecurrentpracticeofpharmacologyiscomplex,buttheapplicationhasnotchanged.Thegoalofpharmacologyistorelievehumansuffering.LEARNINGOUTCOME2Compareandcontrastthetermsdrug,pharmacology,andpharmacotherapy.ConceptsforLecture1.Thedefinitionofadrugisdifficultbutimportanttothenurse.

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd Edition2.Adrugisanysubstancethatistakentoprevent,cure,orreducesymptomsofamedicalcondition.3.Usingexamplesdiscussedintext,discusshowwater,vitaminC,cola,ornaturalhormonescanbeadrug.4.ThewordpharmacologycamefromtheGreekpharmakon,whichmeans“medicine”or“drugs”andlogos,whichmeans“study.”5.Pharmacotherapyorpharmacotherapeuticsistheapplicationofdrugsforthepurposeofdiseasepreventionandtreatment.6.Thesubjectofpharmacologyisanexpansivesubjectthatinvolvesunderstandingwhatadrugisgivenfor,howitisadministered,whereittravelsinthebody,theactualresponseitproduces,andhowitiseliminated.7.Drugsareoneformofmedicalinterventioninwhichthenurseplaysamajorrole.a.Thenursedesignsinterventionsfordesiredhealthgoals.b.Pharmacotherapyisacriticalintervention.8.Thereareover11,000brand,generic,andcombinationagents,eachwithitsownapplication,interactions,sideeffects,andactions.9.Manydrugshavemorethanoneuse.Theymaybeprescribedformorethanonediseaseandmanyproducemultipleeffectsinthebody.10.Drugresponsescandifferinindividualpatients.11.Patientfactorsthatcancausedrugstoelicitadifferentresponseareage,gender,race,bodymass,healthstatus,andgenetics.12.Newdrugsareintroducedeachyear.13.Stayingcurrentandup-to-datewithnewdrugsiscriticalforthepatientandhealthcareprovider.Properapplicationofadrugcanimprovequalityoflifewhileanimproperlyapplieddrugcancausedisabilityorevendeath.LEARNINGOUTCOME3Explain the importance of pharmacotherapy to clinical nursing practice.ConceptsforLecture1.Manypeoplebelievethatthereareperfectdrugsandthattheperfectdrugshouldandcanalwaysbeselectedforthepatient.2.Characteristicsoftheperfectoridealdrug:a.Effectiveb.Givenatlowdosesc.Worksquickly

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd Editiond.Nosideeffectse.Convenientf.Givenonceadayg.Inexpensiveh.Easilyeliminatedi.Nointeractions3.Thereisnosuchthingasaperfectdrug,butmostprescriptionmedicationsdohaveadegreeofeffectiveness.4.Conditionsforwhichdrugsareapprovedarecalledindications.Allprescriptiondrugshaveatleastoneindicationandsomehavemultipleindications.5.Somedrugsareusedforconditionsforwhichtheydonothaveanapprovedindication;thisiscalledanunlabeledoroff-labeluse.6.Drugsthatareusedmostoftenareonesthatareclosetotheperfectdrugprofile.Drugsthathaveaprofilethatstraysfurthestfromtheperfectdrugprofileareusedinfrequently.7.Mostdrugsmaybeeasilyusedathomebythepatient,butsomedrugsmaybeonlyadministeredintheclinicalsetting.LEARNINGOUTCOME4Using specific examples, explain the difference between the pharmacological and therapeutic methods ofclassifying drugs.ConceptsforLecture1.Nursesneedtounderstandhowadrugworksboththerapeuticallyaswellaspharmacologically.2.Drugtherapyisalargepartofnursingcare.3.Understandinghowpatientvariablesaffectdrugtherapyisacriticalpartofunderstandingdrugtherapy.4.Stayup-to-dateonchangesindrugindicationsaswellasnewdrugsispartofongoingnursingeducation.LEARNINGOUTCOME5Identify the advantages of using prototype drugs to study pharmacology.ConceptsforLecture1.TheFoodandDrugAdministration(FDA)publishesadocumentcalledthe“ApprovedTherapeuticEquivalenceEvaluation,”whichisalsocalledthe“OrangeBook.”Thisdocumentcurrentlylistsover11,000approveddrugs.Thelistincludesbothprescriptionandnonprescriptiondrugs.

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd Edition2.Drugsarecategorizedtwoways:atherapeuticclassificationandapharmacologicclassification.3.Thetherapeuticclassificationishowthedrugisusedintreatingaspecificdisease;manydrugshavedifferenttypesoftherapeuticclasses.Thekeytotherapeuticclassificationsiswhichconditiontheparticulardrugistreating.Forexample,onedrugmaylowerbloodpressureandalsorelievechestpain.4.Thepharmacologicalclassificationisthemechanismofdrugactionorhowthedrugproducesitseffectsinthebody.Differentdrugscanalltreatthesameconditionbuttheymaydoitdifferently.Thisclassificationisconsideredmorespecificthanthetherapeuticclassification.Again,manydrugshavemultiplepharmacologicalclassifications.Thepharmacologicalclassificationmayusethedrug’schemicalname.5.Drugsmayalsohavemultipletherapeuticandpharmacologicalclassificationsthataredependentontheclinicaluseofthedrug;thestudentmustunderstandalloftheseclassifications.LEARNINGOUTCOME6Classify drugs by their chemical, generic, and trade names.ConceptsforLecture1.Theprototypedrugisusuallythefirstandbestunderstooddruginitsclass.2.Sometimestheprototypemaybeaneworclinicallymoreusefuldrug.3.Bylearningtheprototypedrug,nursescanunderstandthedepth,actions,andadverseeffectsofotherdrugsinthesameclass.4.Studyingbyprototypehelpsthenursetounderstandaclassificationofdrugtherapybystudyingasingledrug.5.Prototypesareeasilyidentifiedinthetextbook,whichgivesthetherapeuticeffects,mechanismofaction,adverseeffects,andnursingresponsibilitiesforeachprototype.LEARNINGOUTCOME7Compare the advantages and disadvantages of a pharmaceutical company being granted exclusivity for thedevelopment of a new drug.ConceptsforLecture1.Drugsareidentifiedbymultiplenames,whichcanbeconfusingtoboththepatientandhealthcareprovider.2.ChemicalnamesareassignedbyusingstandardnomenclatureestablishedbytheInternationalUnionofPureandAppliedChemistry(IUPAC).Eachdrughasonlyonechemicalname.3.Drugscanbenamedandclassifiedbyaportionoftheirchemicalstructure,knownasthechemicalgroupname.4.GenericnamesareassignedbytheU.S.AdoptedNameCouncil.Genericnamesareusuallylesscomplicatedandareeasiertorememberthanchemicalnames.Eachdrughasonlyonegenericname.

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd Edition5.Tradenamesarealsocalledproprietary,product,orbrandnames.Thetradenameisassignedbythepharmaceuticalcompany.6.Tradesnamesareusuallyshortandeasytoremember.7.ThetermproprietarysuggestsownershipandintheUnitedStates,theFDAgrantsthepharmaceuticalcompaniesexclusiverightsfornamingandmarketingadrugforafixednumberofyearsafterthenewdrugapplicationisapproved.8.Thisprocessallowsthedrugcompanytorecoupthecostofresearchanddevelopmentofthedrug.9.Whenthispatentexpires,competingcompaniesmaysellagenericequivalentdrug.Theymaygiveitadifferenttradename,whichtheFDAmustapprove.10.Tradenamesmaybedifficulttolearn,becausemanyproductswithdifferentnamesmaycontainthesamedrug.11.Combinationdrugsaredrugswithmorethanoneactivegenericingredient.12.Becauseofthepotentialconfusionwithtradenames,itisimportantthatthenurseidentifiesdrugsbytheirtradenames.LEARNINGOUTCOME8Analyze possible differencesbetween generic drugs and their brand-name equivalents.ConceptsforLecture1.Pharmaceuticalcompaniesmarkettheirbrandofdrug.Theexclusivityformarketingandsellingthedrugunderitstradenameislimitedforacertainperiodoftime.2.Whenthisperiodoftimeorpatentexpiresothercompaniesmaymarketthedrugunderitsgenericnameorcreateanewbrandnameforthedrug.3.Pharmaceuticalcompaniesoftenlobbyaggressivelyagainstlawsthatmightrestricttheroutineuseofcertainbrandnamedrugs.Theyclaimthatthereisadifferencebetweenatradenamedruganditsgenericequivalentandthatswitchingtoagenericmaybeharmfultothepatient.4.Consumeradvocatesarguethatgenericsubstitutionsshouldalwaysbepermittedbecausetheyprovidecostsavingstothepatient.5.SomestatesintheUnitedStatesallowthepharmacisttoroutinelysubstituteagenericdrugwhentheprescriptioncallsforabrandnamedrug.Inotherstates,pharmacistsmustdispenseaswrittenorobtainapprovalbeforeprovidingagenericsubstitution.Manypharmaciesprovidelistsofgenericdrugs.LEARNINGOUTCOME9Assess the responsibilities of the nurse in drug administration.ConceptsforLecture1.Genericdrugsmayhaveidenticaldoses,buttheirformulationsorinertingredientsmaydiffer.

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd Edition2.Thisdifferencemaychangethebioavailabilityofthedrug.3.BioavailabilityisdefinedbytheFederalFood,Drug,andCosmeticAct(seeChapter2),astherateandextenttowhichtheactiveingredientisabsorbedfromthedrugproductandthenbecomesavailableatthesiteofthedrugactiontoproducethedesiredeffects.4.Bioavailabilitymaybeaffectedbyformulation,inertingredients,andtabletcompression.Allofthesefactorscanaffecttheabsorptionand/ordistributionofthedrug.5.Bioavailabilityismeasuredbythetimeittakesforthedrugtoexertitseffect;itisalsoknownasonsettime.6.Bioavailabilitymaydifferbetweentradeandgenericdrugs.Thisdifferencecouldbeimportantwithdrugswithcriticalcareusesandthosewithanarrowsafetymargin.However,formostotherdrugsthegenericequivalentmaybesafelysubstituted.7.Internetsitesmayallowpatienttopurchasedrugsatsubstantialsavings.However,thedangerofthisisthatthedrugsmaybesoldfromothercountriesandthesecountriesmaynothavethesamequalitycontrolstandardsastheUnitedStates.Thesedrugsmaybeharmfulornoteffective.Thenursemusthelppatientsunderstandthedifferencesandthepotentialdangers.GENERALCHAPTERCONSIDERATIONS1.Havestudentsstudyandlearnkeytermslistedatbeginningofchapter.2.HavestudentscompleteendofchapterexerciseseitherintheirbookoronthePearson NursingStudent Resourceswebsite.MarginalNotesPOWERPOINTSLIDES5–12SUGGESTIONFORCLASSROOMACTIVITIES•Makeatimelinewithstudentstodemonstratehowthescienceofpharmacologyhashadgreatprogressinthelasttwohundredyears.Discusswhatthefuturemighthold.REFERENCE•TheAmericanChemicalSocietywebsite:http://pubs.acs.org/subscribe/journals/mdd/v04/i05/html/05timeline.htmlPOWERPOINTSLIDES13–18Figure1.1RationaleforPharmacotherapySUGGESTIONFORCLASSROOMACTIVITIES•Usingtheexamplesofwater,vitaminC,andnaturalhormones,discusshowapatientmaybeconfusedaboutthedifferencebetweenasubstanceforeverydayuseoronethatnaturallyoccursinthebody,andhowthesechangewhenusedindrugtherapy.POWERPOINTSLIDES19–25

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd EditionSUGGESTIONFORCLASSROOMACTIVITIES•Havestudentslookatcurrentmediamarketingforprescriptiondrugs—television,print,andradioaresuggestions.Discusswhatpartsoftheadattempttomakethedrugappeartobethe“perfect”drugforthatcondition.POWERPOINTSLIDE26SUGGESTIONSFORCLASSROOMACTIVITIES•Havestudentsdiscussvariouswaysoffindingup-to-datedrugtherapyinformation.Suggestionsincludereferencebooks,evidence-basedInternetsites,ongoingclinicaleducation,andpharmacists.•Suggestedsourcesincludethedruginformationhandbookassignedforthecourse,plusthefollowingwebsites:www.ptcommunity.comwww.nlm.nih.gov/medlineplus/druginformation.htmlwww.drugs.comPOWERPOINTSLIDES26–33Table1.1TherapeuticClassificationsTable1.2PharmacologicClassificationSUGGESTIONFORCLASSROOMACTIVITIES•GototheFDAOrangeBookwebsite:http://www.fda.gov/cder/ob/.Engagestudentsinusingthewebsitetosearchforvariousdrugs.UsetheFAQlinktodemonstratehowtostayupdatedonnewdrugs.SUGGESTIONFORCLINICALACTIVITIES•Havethestudentscompareandcontrastmedicationtherapyusedforpatientswhohavethesamediseasestate,butarebeingtreatedwithdifferentdrugs.Comparethedrug’spharmacologicalandtherapeuticclassifications.POWERPOINTSLIDES34–35SUGGESTIONFORCLASSROOMACTIVITIES•Havethestudentsusethetextbooktolocateaprototypedrug.Discusshowitiseasilyidentifiableandwhatimportantnursingconsiderationsarelistedforeachprototype.SUGGESTIONFORCLINICALACTIVITIES•Havestudentslookatamedicationadministrationrecordforanassignedpatient.Comparewhichdrugsareprototypesandwhicharenot.Studentscouldalsodiscusshowdifferentorsimilarthedrugistotheprototype.POWERPOINTSLIDES36–42

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd EditionTable1.3BrandNamesSUGGESTIONFORCLASSROOMACTIVITIES•Havestudentslookatpopulargenericssuchasacetaminophen,aspirin,oribuprofen.Havethemidentifypossibletradenamesthatarepopularforthesedrugs.Thenlookatwhichproductsmayrepresentacombinationofdrugs.SUGGESTIONFORCLINICALACTIVITIES•Havestudentstakeadrughistoryfromapatient.Discussifthepatientsidentifytheirmedicationsbygenericortradenames.Havestudentsdiscusshowthiscouldleadtopossiblemedicationerrors.SUGGESTIONFORCLASSROOMACTIVITIES•UsingInternetpharmacysites,compareandcontrastthedifferencesbetweenpricesfortradeandgenericdrugs.Examplesitesinclude:http://www.pharmacychecker.com/http://www.drugstore.comhttp://drx.comSUGGESTIONFORCLINICALACTIVITIES•Havethestudentsinterviewahospitalorneighborpharmacisttofindoutwhatthelawintheirstateisregardingsubstitutionofgenericdrugs.POWERPOINTSLIDES43-48SUGGESTIONSFORCLASSROOMACTIVITIES•Giveexamplesofdrugsthatmaybeavailabletothepatientinbothtradeandgenericnames.Suggestionscouldbeibuprofen,loratadine,andpseudoephedrine.Discusswhatcouldchangethebioavailabilityofthedrug.•Havethestudentrole-playascenewhereapatientasksthenurseifgenericsubstitutionsaresafe,andhowthenursewouldrespond.Role-playanotherscenewherethepatientasksthenurseaboutusinganoverseasInternetpharmacy.POWERPOINTSLIDES49–52SUGGESTIONSFORCLASSROOMACTIVITIES•Thestudentsshouldtakethecoreresponsibilitiesforsafedrugadministrationanddiscusshoweachconceptcanpreventmedicationerrors.•Havethestudentsworkinsmallgroupsandintervieweachother.Havethemidentifydifferencesintheirowndemographicsthatwouldinfluencesafedrugtherapy.SUGGESTIONFORCLINICALACTIVITIES•Havethestudentshadowanurseinthehospitalorclinicsettingwhoisassignedtoadministermedications.Havethestudentobservehowthenursecheckstomakesurethemedicationsarecorrectforthatpatient,ifthedrugsaredispensedintradeorgenericnames,whatchecksthenursecompletes

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd Editionbeforedispensingthemedication,andwhatteachingthenurseoffersthepatientaboutthemedication.PEARSONNURSINGSTUDENT RESOURCES(WWW.NURSING.PEARSONHIGHERED.COM)•WebLinks•NCLEX®-style reviewquestions•Casestudies•MakingthePatientConnection•Mechanism of Action AnimationsMYNURSINGLAB(WWW.MYNURSINGLAB.COM)•KnowledgeQuickCheck•Pre/Posttests•Customizedstudyplans•SeparatepurchasePRENTICEHALLNURSE’SDRUGGUIDE•SeparatepurchasePEARSONETEXT•Studentscansearch,highlight,takenotes,andmoreallinelectronicformat.•SeparatepurchaseMYTEST

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd EditionCHAPTER2DRUGREGULATIONSLEARNINGOUTCOME1Explaintheroleofpatentmedicinesinthehistoryofpharmacologyandthelegislationofdrugs.ConceptsforLecture1.In theUnitedStatesandCanadalawsgovernallaspectsofdrugapproval,labelling,manufacturing,marketing,anddistribution.2.Consumersexpectthatthedrugtheyaretakingiseffectiveandthatthelabelisclearandaccurate.3.Consumersexpectthatthedrugtheyaretakingissafe.4.Itisonlysincethe20thcenturythatstandardsandregulationsexisttoprotecttheconsumer.5.InearlyAmerica,patentmedicinewaswidelyusedandavailable.6.Therewerenolawstoregulatethesemedicinesandproductscouldmakeanyclaimtohealthorcure.7.Manypatentmedicinescontainaddictiveandattimesdangerousadditives,suchasmorphineandcocaine.Suchaddictiveadditivesguaranteedrepeatsales.8.Severalearlypatentmedicineshavegonethroughdrugregulationandchangeandarestillavailabletoday.LEARNINGOUTCOME2OutlinethekeyU.S.drugregulationsandexplainhoweachhascontributed tothesafetyandeffectivenessofthemedications.ConceptsforLecture1.Druglegislationbeganinthe1900stomakedrugssaferandmoreeffective.2.ThefirstnationallawwastheDrugImportationActpassedin1848.3.Thiswasspurredondeathsofchildrenin1901whoweregivenacontaminatedantitoxin.4.TheBiologicsControlActwaspassedin1902toregulateera,antitoxins,andblood-relatedproducts.5.ThePureFoodandDrugAct(PFDA)waspassedin1906tocontrollabellingofmedicines.6.ThePFDArequiredaccuracyindruglabeling.7.In1912theSherleyAmendmenttothePFDAaddressesfalsetherapeuticclaimsondruglabels.8.TheSherleyAmendmentdidnotaddresstheissueofprovingthatthedrugcompanyknewthattheirfalseclaimwasintentional.9.TheHarrisonNarcoticActof1914requiredprescriptionsforhigherdosesofnarcoticdrugs.

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd Edition10.Statesandthefederalgovernmenthavepassedadditionallawsregulatingdrugsofabuse.ThisiscoveredinChapter8.11.Twoissueswithearlyregulationswerethatthedrugcompaniesdidnothavetoprovethatthedrugwaseffectiveanddidnotrequiretestingbeforemarketing.12.Afterdeathsin1937duetoacontaminateddrug,theFood,Drug,andCosmeticAct(FDCA)waspassedbyCongressin1938.13.TheFDCArequiredthatdrugsbetestedforsafetybeforemarketinganddruglabelstocontaininstructionsforuse.14.TheFDCAdidnotdefinewhatwasconsideredaprescriptiondrug.15.In1951theDurham-HumphreyAmendmenttotheFDCAdefinedthedifferencebetweenprescriptiondrugsandover-the-counter(OTC)drugs.16.Inthelate1950s,therewasahighnumberofbirthdefectsfromthedrugthalidomide,whichwasprescribedtopregnantwomenbytheirphysicians.BecausethesephysiciansreceivedthedrugfromthemanufacturerwithFDAapproval,theKefauver-HarrisAmendmenttotheFDCAwaspassedin1962.17.TheKefauver-HarrisAmendmentrequiredthatmanufacturersprovetheirdrugssafeandeffectivebyconductionofadequateandcontrolledstudies.18.TheKefauver-HarrisAmendmentalsorequiredadverseeffectsbereportedtotheFDAandincludedinliteraturegiventohealthcareproviders.19.TheKefauver-HarrisAmendmentalsorequiredinformedconsentofthosepatientsparticipatingindrugresearch.20.In1966,theFDAbeganevaluatingtheeffectivenessofpreviouslyapproveddrugs.21.In,1972theFDAbeganreviewingover-the-counterdrugsforsafetyandeffectiveness.22.In1983,theOrphanDrugActbecamelawtoassistwithdevelopmentofdrugsforserious,butrare,diseases.23.ThePrescriptionDrugUserFeeAct(PDUFA)of1992assessedfeesfrommanufacturerstoreducedrugreviewtime.24.The1997passageoftheFoodandDrugAdministrationModernizationActreviewedmedicaldevicesandhealthclaimsforfood.25.TheDietarySupplementHealthandEducationActof1994aimedtocontrolclaimsofdietarysupplements.26.TheMedicarePrescriptionDrugImprovementandModernizationActof2003aimedtoassistpatientswithprescriptiondrugcosts.LEARNINGOUTCOME3DescribehowtheUnitedStatesPharmacopeia-National Formulary(USP-NF)controlsdrugpurityandstandards.

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd EditionConceptsforLecture1.Whendrugswerepreparedfromplants,purityandstrengthvariedduetotheingredientsandpreparer.2.Pharmacistsbeganusingformulariestolistproductsandrecipes.3.In1820theU.S.Pharmacopeia(USP)wasestablished.4.Forover100years,theUSPandtheNationalFormulary(NF)maintaineddrugstandardsintheUnitedStatesbysettingstandardsfordrugpurityandstrength.5.TheUSPcovereddrugproductsandtheNFcoverednondrugingredients.6.In1975theyweremergedintotheUSP-NF,whichispublishedannually.7.TheUSPlabelisfoundonmanymedications.8.DrugsmarketedintheUnitedStatesmustconformtoUSP-NFstandards.LEARNINGOUTCOME4EvaluatetheroleoftheU.S.FoodandDrugAdministrationinthedrugapprovalprocess.ConceptsforLecture1.TheFoodandDrugAdministration(FDA)isresponsibleforensuringthesafetyofdrugsandmedicaldevices.2.TheFDAstartedin1906,makingittheoldestdrugregulatoryagencyintheworld.Ithaseightbranches.3.TheCenterforDrugEvaluationandResearch(CDER)coversdrugsafety.4.TheCenterforBiologicsEvaluationandResearch(CBER)regulatesbiologicsafety.5.TheCenterforFoodSafetyandAppliedNutrition(CFSAN)overseesherbalproducts,dietarysupplements,andcosmetics,butdoesnotrequiretestingofherbalsanddietarysupplementsbeforemarketing.6.CFSANregulatescosmeticsthatarenotconsidereddrugs.LEARNINGOUTCOME5Categorizethefourstagesofnewdrugapproval.ConceptsforLecture1.ThedrugapprovalprocessintheUnitedStateswasestablishedbytheFDA.2.ThedrugapprovalprocessensuresdrugssoldintheUnitedStatesaresafeandeffective.3.Therearefourstagestonewdrugapproval.4.Thefirststageispreclinicalinvestigational.Thisislaboratoryresearchbythepharmaceutical

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd Editioncompany.5.TheFDAdoesnotregulatethepreclinicalinvestigation.6.Ifthepreclinicalinvestigationispositive,thecompanymaysubmitanInvestigationalNewDrug(IND)applicationtotheFDA.7.OnceapprovedbytheFDA,thedrugcanstartclinicalphasetrials.8.Phase1involvestestingon20to80healthyvolunteers.9.Phase2involvestestingseveralhundredpatientswiththeparticulardiseaseforthedrug.10.Phase3involvesalargenumberofpatientswiththediseaseforpatientvariability.11.Iftheclinicalphasetrialsarepositive,thecompanywillsubmitaNewDrugApplication(NDA)totheFDA.12.TheFDAwillthenapproveornotapproveadrug.13.Ifapproved,thedrugcanbeginpostmarketingsurveillance,whichisstage4.14.Stage4looksforharmfuldrugeffectsinalargepopulation.15.PostmarketingsurveillancehelpstheFDAdiscoveranyseriousproblems.TheAdverseEventReportingSystemandFDApublicmeetingsallowpatientsandhealthcareproviderstoreportproblems.16.Althoughmorediversepopulationsareusedtotestdrugs,mostdrugsarenottestedinchildrenandpregnantwomen,asthesepopulationsarenotusedindrugtesting.17.Off-labeluseiswhenadrugisdiscoveredtobeusefulforanindicationthatwasnotapprovedbytheFDA.18.TheFDAdoesnotregulateoff-labeluse.About20%ofprescriptiondrugsareusedoff-label.LEARNINGOUTCOME6Explaintheroleofaplaceboinnewdrugtesting.ConceptsforLecture1.Aplaceboorinertsubstanceisusedinphase2ofclinicaldrugtrials.2.Theplaceboservesasacontrolornontreatmentgroup.LEARNINGOUTCOME7Discusshowrecentchangestotheapprovalprocesshaveincreasedthespeedatwhichnewdrugsreachconsumers.ConceptsforLecture1.Theprocessofdevelopingandtestinganewdrugcantakemanyyears.

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd Edition2.TheFDAreviewprocesscantakeseveralyears.3.Theestimatedcosttobringanewdrugtomarketcanbeover$802millionU.S.dollars.4.Pharmaceuticalcompaniesareanxioustorecoupthehighexpenses.5.Thepublicisalsoanxiousfornewmedications,especiallyfordiseaseswithahighmortalityrate.6.In1992thePDUFAwaspassed,whichprovidedyearlyproductuserfees.7.ThisincomeallowedtheFDAtorestructureandhiremoreemployees.8.Thisrestructuringdecreasedtheirviewprocessbyhalf.9.Prioritydrugsnowreceiveacceleratedapproval.10.Theseprioritydrugsareforseriousandlife-threateningconditions.LEARNINGOUTCOME8Compareandcontrastprescriptionandover-the-counterdrugs.ConceptsforLecture1.TheDurham-HumphreyAmendmentof1951establishedthedifferencebetweenprescriptionsandover-the-counter(OTC)drugs.2.Apatientmusthaveauthorization,a“prescription”toreceiveaprescriptiondrug.3.Prescriptiondrugsareconsideredtobepotentiallyaddictiveortooharmfulforself-administration.Prescriptiondrugsrequireskilltoadministercorrectly.4.Prescriptiondrugsallowthepatienttobeexaminedandproperlydiagnosed.5.Prescriptiondrugsallowforpatientteachinganddiseasemonitoring.Prescriptiondrugstreatcomplexconditions.6.OTCdrugsdonotrequireaprescriptionforahealthcareprovider.7.OTCdrugsaresafeifthepatientcarefullyfollowstheinstructions.8.OTCdrugsareeasiertoobtain.9.ChoosingthecorrectOTCdrugcanbeaproblemforthepatient.10.Patientsmaynotbeawareoffood,drug,andherbalinteractionswithOTCdrugs.11.Self-treatmentwithOTCdrugscanbeineffective.12.PrescriptiondrugscanundergoareviewprocessbytheFDAwhichcanreclassifyaprescriptiondrugtobeanOTCdrug.InorderforaprescriptiondrugtobereclassifiedasanOTCdrug,ahighmarginofsafetymustexist.13.Herbalanddietarysupplementsareavailableoverthecounter.

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd Edition14.Herbalanddietarysupplementsarenotconsidereddrugs.Theyarenotsubjectedtothesameregulatoryprocessasprescriptiondrugs.15.TheFDAdoesnottestherbalanddietarysupplementsforsafety.Theseproductscancausesideeffectsandinteractwithmedications.LEARNINGOUTCOME9Explainhowscheduleddrugsareclassifiedandregulated.ConceptsforLecture1.Somedrugshaveahighpotentialfordependence.2.Somedrugsarefrequentlyabused.3.Thesaleanddistributionofthesedrugsarehighlyrestricted.4.Drugswithahighpotentialforabusearecalledscheduleddrugs.5.Thesedrugsareplacedintooneoffivecategoriescalledschedules.6.DependenciesanddrugschedulesarediscussedinChapter8.7.TheComprehensiveDrugAbusePreventionandControlActof1970restrictsthesecontrolledsubstances.8.TheDrugEnforcementAdministration(DEA)requireshospitalsandpharmaciestouseregistrationnumberstopurchasethesedrugs.9.Completerecordsmustbemaintainedofqualitiespurchasedandsold.10.Drugswiththehighestabusepotentialhaveadditionalrestrictions.11.Theserestrictionsmayincludespecialorderforms,notelephoneorders,andnorefills.12.Therearestrictpenaltiesfornotfollowingthelaws.LEARNINGOUTCOME10DescribetheCanadiandrugapprovalprocessandidentifysimilaritiestothe drug approval processintheUnitedStates.ConceptsforLecture1.TherearemanysimilaritiesbetweenU.S.andCanadianregulationsfordrugs.2.HealthCanadaisthefederaldepartmentandtheHealthProductsandFoodBranch(HPFB)ofHealthCanadaistheregulatorybodyforhealthproductsandfoodsafety.3.TheHPFBregulatestheuseoftherapeuticproductsbydirectorates.4.TheTherapeuticProductsDirectorate(TPD)authorizesmarketingofdrugsandmedicaldevices.5.TheBiologicsandGeneticTherapiesDirectorate(BGTD)regulatebiologicaldrugsandradio

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd Editionpharmaceuticals.6.TheNaturalHealthProductsDirectorate(NHPD)regulatesnaturalproducts.7.TheCanadianFoodandDrugsActsisaregulatorydocumentthatspecifiesthatdrugscannotbemarketedwithoutaNoticeofCompliance(NOC)andDrugIdentificationNumber(DIN)fromHealthCanada.8.IfadrugdoesnotcomplywithstandardssetintheUnitedStates,Europe,Britain,orFrance,theycannotbesold,labeled,packaged,orsoldinCanada.GENERALCHAPTERCONSIDERATIONS1.Havestudentsstudyandlearnkeytermslistedatbeginningofchapter.2.HavestudentscompleteendofchapterexerciseseitherintheirbookoronthePearson NursingStudent Resourceswebsite.MarginalNotesPOWERPOINTSLIDES6–11Figure2.1PatentMedicinesContainedaNameBrandThatClearlyIdentifiedtheProductandClaimedtoCureJustaboutAnySymptomorDiseaseFigure2.1PatentMedicinesSUGGESTIONFORCLASSROOMACTIVITIES•Discusswithstudentshowpatentmedicineshave“survived”overalongperiodoftime.UseexamplesgiveninthetextbooksuchasSmithCoughDrops,Fletcher’sCastoria,Doan’sPills,Vick’sVapoRub,andPhillip’sMilkofMagnesia.Whyaretheseproductsstillpopularandwidelyused?Whatcouldbesomeofthereasonsthattheysurvivedregulations?POWERPOINTSLIDES12–18Table2.1HistoricalTimeLineofRegulatoryActs,Standards,andOrganizationFigure2.2USPLabelsSUGGESTIONFORCLASSROOMACTIVITIES•UsingthetimelineinTable2.1,havethestudentsaddanyfutureregulationstheybelieveareneededorforthcoming.SUGGESTIONFORCLINICALACTIVITIES•HavestudentsteachassignedpatientsintheclinicalsettingwhatU.S.regulationsensurethesafetyandeffectivenessoftheirdrugtherapy.POWERPOINTSLIDES19-20SUGGESTIONFORCLASSROOMACTIVITIES

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd Edition•HavethestudentsexploretheUSPwebsite(www.usp.org).Havethestudentslookatwhattypeofinformationisavailablesuchasreferencestandards,healthcarequalityandinformation,seminars,workshops,anddrugsafetyreview.Discusshowtheycouldusethisinformationinclinicalpractice.POWERPOINTSLIDES21–23Figure2.3U.S.FoodandDrugAdministrationSUGGESTIONSFORCLASSROOMACTIVITIES•HavethestudentslogontotheFDAwebsite(http://fda.com).Then,havethestudents exploretheconsumerlinksandresources. Assignadifferentlinkorresourcetoeachstudent;havethemgiveabriefsummaryiftheythoughttheresourcewouldbehelpfultothegeneralpatientpopulation.StudentscanchooseanFDAindustrylinktoexplore.Breakstudentsintogroupsandassignoneofthefollowingtoeachgroup:CDER,CBER,CFSAN,MedWatch,HealthCareProfessional,FoodNutritionIndustry,andCosmeticIndustry.Havethestudentsreportbacktothegroupwhatinformationisavailable.SUGGESTIONFORCLINICALACTIVITIES•HavethestudentsexplaintotheirassignedpatientshowtheFDAoverseesdrugproductsintheUnitedStates.IfInternetaccessisavailable,thestudentcandemonstratetheconsumerlinksontheFDAwebsite(http://fda.com).POWERPOINTSLIDES24–29Figure2.4DrugDevelopmentTimeLineSUGGESTIONFORCLASSROOMACTIVITIES•Breakthestudentsintogroups,giveeachgrouponeofthethreephasesoftheclinicaldrugtrial,havethemdevelopapatientteachingtooltoprovideteachingtothepatientinvolvedinthatphaseofthetrial.Howwouldtheyexplainsafety,adverseeffects,andpatientvariables?SUGGESTIONFORCLINICALACTIVITIES•Ifpossibleinyourclinicalsetting,havethestudentsintervieweitherahealthcareprofessionalorpatientinvolvedinaclinicaldrugtrial.Theyshouldaskquestionsaboutstagesandphasesofthetrial,preclinicalinvestigation,goalofthetrial,possibleadverseeffects,andpatientconsentsandcompensations.Havethemreportbacktotheirclinicalgroupwhattheylearnedintheirinterview.Diditchangetheirthoughtsaboutclinicaldrugtrials?Whyorwhynot?SUGGESTIONFORCLASSROOMACTIVITIES•BuildofftheactivityforLearningOutcome5andcontinuetodiscussclinicaldrugtrials.Whydosomepatientsreceivetheplacebo?Isthereariskwithplacebos?Howwouldthepatientfeelaboutgettingtheplaceboifthedrugwasveryeffective?Discussthemoralissuesregardingcontrolleddrugtrials.POWERPOINTSLIDES30–32SUGGESTIONFORCLASSROOMACTIVITIES•Discusswiththeclasswhichdiseasestatescouldrequireprioritydrugapproval.Makealistontheclassroomblackboard.Askthestudentsthentoprioritizetheirlist.Discusshowdifficultitistodecide

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd Editionwhichdiseaseis“moreimportant.”Discussifthelistwouldbedifferentinanotherpartofthecountryorworld.POWERPOINTSLIDES19–39SUGGESTIONFORCLASSROOMACTIVITIES•Discusssomeoftherecentdrugsthathavebeenreclassifiedfromprescriptiontooverthecounter,suchasloratadine(Claritin),cetirizine(Zyrtec),Omeprazole(Prilosec),famotidine(Pepcid),naproxensodium(Aleve),andcromolynsodiumnasalspray(Nasalcrom).Discussthepotentialforuseandmisusebytheconsumer.Whyarethesedrugssaferthanotherdrugsinthesamecategorythatarestillprescriptiondrugs?Doestheirclassificationhelporharmtheconsumer?SUGGESTIONFORCLINICALACTIVITIES•Assignthestudentstoapatientwhoisprescribedadrugthatisavailableoverthecounter.Havethestudentsdevelopapatientteachingplanthatwillteachthepatienthowtousethedrugsafelyandhowtofollowtheguidelines.SUGGESTIONSFORCLASSROOMACTIVITIES•Providethestudentswithalistofsomecontrolledsubstancemedications.Havethestudentpickonedrugandinvestigateitsuseandsafety.Havethemreportbacktotheclassiftheythinktheassignedscheduleisappropriateornot.Discusstheargumentspresentedinclass.•RefertotheDEAwebsiteforalistof controlledsubstances:http://www.usdoj.gov/dea/pubs/scheduling.htmlSUGGESTIONSFORCLINICALACTIVITIES•Havethestudentsshadowanurseorpharmacistwhopreparescontrolledsubstancemedications.Havethestudentnotetheregulationsinthatclinicalsettingforrecordinganddispensingthedrugs.Havethestudentsreportiftheythinktheregulationsareappropriateornot.Whatwouldtheychange,ifanything?•RefertotheDEAwebsiteaboutthecontrolledsubstanceact:http://www.usdoj.gov/dea/pubs/scheduling.htmlPOWERPOINTSLIDES40–46Table2.2StepsforApprovalforDrugsMarketedWithinCanadaSUGGESTIONSFORCLASSROOMACTIVITIES•ExploretheHealthCanadawebsitewiththestudents:http://www.hc-sc.gc.ca/index-eng.php•CompareandcontrastinformationfoundonthatsiteagainstU.S.sites,suchastheFDA(www.fda.gov)ortheCentersforDiseaseControl(www.cdc.gov).•Whatinformationisprovidedonthewebsitesforhealthcareprofessionals?Whatinformationisprovidedfortheconsumer?•Discussifinformationiseasytofindandtounderstand.Focusondrugstandardsandsafety.

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd EditionPEARSONNURSINGSTUDENT RESOURCES(WWW.NURSING.PEARSONHIGHERED.COM)•WEBLINKS•NCLEX®-STYLE REVIEWQUESTIONS•CASE STUDIES•MAKING THEPATIENTCONNECTION•MECHANISM OFACTIONANIMATIONSMYNURSINGLAB(WWW.MYNURSINGLAB.COM)•KnowledgeQuickCheck•Pre/Posttests•Customizedstudyplans•SeparatepurchasePRENTICEHALLNURSE’SDRUGGUIDE•SeparatepurchasePEARSONETEXT•Studentscansearch,highlight,takenotes,andmoreallinelectronicformat•SeparatepurchaseMYTEST

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd EditionCHAPTER3PRINCIPLESOFDRUGADMINISTRATIONLEARNINGOUTCOME1Outlineaplanforimprovingpatientadherencetothemedicalregimen.ConceptsforLecture1.Medicationadherenceinvolvesdeterminingwhetherthepatientistakingthemedicationcorrectly.2.Patientnonadherencetomedicationuseisamajorproblemcausingsignificantproblemsandevendeath.Factorsinfluencingnonadherenceinclude:a.Forgettingdosesofdrugsb.Expensec.Sideeffectsd.Self-adjustmentofdosagese.Discontinuesusewhenfeelingbetter3.Thenurseplaysasignificantroleindeterminingpatientadherencetodruguse,including:a.Allmedicationistakenb.Medicationistakenatcorrecttimec.Correctdoseofmedicationistaken4.Thenurseneedstoformulateacareplanwhichinvolvesthepatient,andisdesignedtoimproveadherencewithmedicationuse.Elementsofthepersonalizedplanofcareincludesuchessentialinformationas:a.Nameofmedicationb.Reasonforusec.Expecteddrugactiond.Sideeffectse.Significantinteractionswithmedications,food,andherbalsupplementsf.Assessabilityforself-administrationLEARNINGOUTCOME2Describehowthestorageofdrugscanaffecttheireffectiveness.ConceptsforLecture

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd Edition1.Properstorageofmedicationsisneededtoprotectmedicationsfromdeterioration.2.Nursesneedtocheckthatmedicationsareproperlystoredandcheckforexpirationdatesbeforeadministering.3.Donotuseanymedicationsthatarepastexpirationdate;disposeofthemproperly.4.Exposuretolightandmoisturecanbedamagingtosomedrugs.5.Medicationstorageprinciplesinclude:a.Storeatrecommendedtemperatureb.Highhumidityenhancesdeteriorationc.Scheduledrugshaverestrictedaccessd.Checkdrugsforunusualcolorortextures6.Accesstoscheduleddrugsisrestrictedandrequiresadherencetoinstitutionpolicy.LEARNINGOUTCOME3Describethecomponentsofalegalprescriptionandtheabbreviationsassociatedwithdrugorders.ConceptsforLecture1.Prescriptionsmaybewrittenindifferentformats,butallmustincludethethreeelementsofheading,body,andclosing.2.Theheadingmustinclude:a.Dateb.Patient’snamec.Prescriber’sname,address,phonenumber3.Theclosingmustinclude:a.Prescriber’ssignatureb.Refillamount,ifapplicablec.Genericequivalentsubstitution4.Statesdifferonthespecificrequirementstobeincludedinaprescription.5.Certainabbreviationscanleadtoerrorsandmustbeavoided.6.PrescriptionsforcontrolledsubstancesrequireaDrugEnforcementAdministration(DEA)number.LEARNINGOUTCOME4Relatetheimportanceofdosingschedulestosuccessfulpharmacotherapeuticoutcomes.

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd EditionConceptsforLecture1.Dosageschedulingandintervalsaredeterminedbythehealthcareproviderbasedonthechemicalcharacteristicsofadrug,purposeandactionofthedrug,andfrequencywithwhichitshouldbetaken.2.Theusualdosingis1–4times/day.Manydrugdosingschedulesaredeterminedbyagencyprotocol.3.Theadministrationtimeshouldenhancetherapeuticeffectiveness.Patientsmustavoidskippingdosesordoubledosing.4.Somedrugshaveanirregularschedule,suchasdrugsorderedtobegivenSTATandprn.LEARNINGOUTCOME5Compareandcontrastthethreesystemsofmeasurementusedinpharmacology.ConceptsforLecture1.Dosagesarelabeledbyweightandvolume.2.Measuringsystemsusedinpharmacologyincludemetric,apothecary,andhousehold.3.Themetricsystemisthemostcommon.4.Metricvolume=liter(L)ormilliliter(mL).5.Metricweightsareasfollows:a.Kilogramb.Milligramc.Microgram6.Inthehouseholdsystem,thetablespoon,teaspoon,andcuparethemostcommonmeasurements.7.Conversionsbetweenhouseholdandmetricareasfollows:a.240mL=8ouncesb.5mL=1tsp8.Theapothecarysystemisthemostinfrequentlyusedsystem:a.Basicunitisthegrain(gr)b.Unitdosingiscommonc.Knowledgeofdosagecalculationimportant9.Althoughmanydrugsaredispensedinunitdosesfromthepharmacy,itisstillimportantforthenursetohaveaworkingknowledgeofdosagecalculations.10.Thevolumeofadrugisexpresseddifferentlyineachofthemeasuringsystems.

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd EditionLEARNINGOUTCOME6Explaintheimportanceofproperlydocumentingmedicationadministration.ConceptsforLecture1.Properdocumentationofdrugadministrationbythenurseisessential.Thisincludesrecordinginitials/signatureafterthemedicationisgiven.2.Documentationofadrugisdoneonthemedicationadministrationrecord(MAR).3.Documentationofmedicationadministrationisdoneafterthedrugisgiventothepatient.4.Documentationalsoincludespatientrefusals,concerns,andanyadverseeffects.LEARNINGOUTCOME7Compareandcontrastenteral,topical,andparenteraldrugadministration.ConceptsforLecture1.Drugsareadministeredviadifferentroutes:parenteral,topical,andenteral.2.Oraldrugsareoftenentericcoatedanddesignedforabsorptioninthesmallintestine.3.Extendedreleasetabletsprovidealongerdurationofactionandallowfortheconvenienceofonce-ortwice-dailydosing.a.Mostareabsorbedinsmallintestineb.Commonendings:XR,X.,LA,SR,-durc.Allowforlongerdurationofactiond.Donotcrush,open,orchewe.Exposuretostomachaciddestroysmedicationf.Somecoatedtomaskatasteorpreventstaining4.Sublingualandbuccalmedications:a.Extensivecapillariesprovideexcellentabsorptionb.Preventsexposuretostomachacidsc.Donotundergohepaticfirst-passmetabolismd.Sublingualprovidesrapidonset:i.Administerafterothermedicationsii.Avoideatingordrinkinguntildrugisdissolved5.Nasogastric(NG)andgastrostomymedicationadministration:

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd Editiona.Usedforlong-termtreatmentb.NGrouteusedforshort-termtreatmentc.Liquiddrugformulationisbesttoused.Avoidcrushingslowrelease(SR)tabletse.Flushtubestomaintainpatencyf.Maycrushanddissolvesometablets6.Topicalmedicationscanbeappliedforlocalandsystemiceffects.7.Topicalmedicationsincludetransdermalpatchesandcreams/lotions,andophthalmic,otic,vaginal,andrectalroutes.8.Topicalroutes:a.Dermatologicaltopicalmedicationsareappliedtoskinb.Instillationsandirrigationsareplacedinbodycavitiesandorificesc.Inhalationsareappliedtorespiratorytract:i.Inhalationsii.Nebulizersiii.Positivepressurebreathingmachine9.Topicaldrugs:a.Canproducealocalorsystemiceffectb.Examples:i.Localeffects:nasalsteroidsii.Systemiceffects:nitroglycerinpatchc.Identifydesiredeffectofdrugd.Avoidapplicationtoabradedoropenskin10.Transdermaldeliverysystems:a.Deliverspecificamountofdrugthroughskinb.Rotatesiteofapplicationc.Checkthatpreviouspatchisremovedd.Disposeofusedpatchesproperly11.Othertopicalroutes:

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd Editiona.Ophthalmicb.Oticc.Nasald.Vaginale.Rectal12.Enteralroute:a.DruggiventhroughtheGItractb.Thesafestroutec.Considerpatients’abilitytoswallowd.Oraldrugforms:i.Tabletii.Capsuleiii.Entericcoatedtablets13.Parenteraladministrationrequirestheuseofaneedletoinjectmedicationsintotheintradermal,subcutaneous,intramuscular,orintravenoussite.14.Parenteralroutes:a.Administersdrugintoskinlayers:i.Intradermalii.Subcutaneousiii.Intramusculariv.Intravenousb.Moreinvasivec.Specializedequipmentandtechniquesneededd.Avoidsdigestiveenzymesandfirst-passeffect15.Intradermalandsubcutaneousroutes:a.Dermismaycontainbloodvesselsb.Intradermalroutemostlyusedforallergytestingi.Injectioncontainsonly0.1to0.2mLc.Subcutaneoussiteiseasilyaccessible:

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd Editioni.Deliversdrugtodeepestskinlayerii.Injectionvolumesrangefrom0.5to1.0mL16.Intramuscularroute:a.Drugisdeliveredintomuscleb.Morerapidresponsethanoralorsubcutaneousc.Selectsiteawayfrombone,nerves,andlargebloodvesselsd.Injectionvolumeshouldnotexceed3mL:i.Deltoidsiteislimitedto1mL17.Intravenousroute:a.Drugisdelivereddirectlyintobloodstreamb.Rapidonsetofdrugactionc.Mostdangerousrouted.Threebasictypes:i.Largevolumeinfusionii.Intermittentinfusioniii.BolusadministrationGENERALCHAPTERCONSIDERATIONS1.Havestudentsstudyandlearnkeytermslistedatbeginningofchapter.2.HavestudentscompleteendofchapterexerciseseitherintheirbookoronthePearson NursingStudent Resourceswebsite.MarginalNotesPOWERPOINTSLIDES4–10SUGGESTIONFORCLASSROOMACTIVITIES•Discussthenecessaryelementstoincludewhendevelopinganindividualizedteachingplanandwaystoincludethepatientandfamily.SUGGESTIONFORCLINICALACTIVITIES•Havestudentsdevelopapersonalizedmedicationteachingplanforapatienttheyhavehadinclinical.REALNURSINGSKILLSMedicationAdministrationVideos.

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd EditionPOWERPOINTSLIDES11–12SUGGESTIONSFORCLASSROOMACTIVITIES•Discusstheeffectthatheatandhumidityhaveonthestorageofmedications.•Relatetheeffectofmedicationstoragetoshelflife.SUGGESTIONFORCLINICALACTIVITIES•Havestudentscheckwheredifferentmedicationsarestoredattheclinicalsite.REFERENCE•ProperDisposalofPrescriptionDrugs:FederalGuidelines.(n.d.).DrugFacts:OfficeofNationalDrugControlPolicyGuidelines.RetrievedApril18,2008fromwww.whitehouse.gov/ondcpPOWERPOINTSLIDES13–16Figure3.1SamplePrescriptionSUGGESTIONFORCLASSROOMACTIVITIES•Havestudentspracticewritingasampleprescriptionwithalltherequiredcomponents.SUGGESTIONFORCLINICALACTIVITIES•Havestudentschoosearecentlywrittenprescriptiononapatientchart;identifyanddetermineifalltherequiredcomponentsarepresent.Ifanycomponentismissingorincorrect,discusswhatactionshouldbetakenbythenurse.REALNURSINGSKILLSMedicationAdministrationVideos.REFERENCE•TheISMP’sListofError-ProneAbbreviations,Symbols,andDoseDesignations.(2006).RetrievedApril18,2008fromwww.ismp.org/tools/errorproneabbreviations.pdfPOWERPOINTSLIDES17–19SUGGESTIONFORCLASSROOMACTIVITIES•Discussthenurse’sresponsibilitywhenapatientinapparentpainrefusestotakeaprnpainmedication.Anotherscenariocouldinvolveapatientwhohasanelevatedtemperatureandrefusestotaketheprnacetaminophen.Discusshowthenursecanbesthandlethesetypesofsituations.SUGGESTIONFORCLINICALACTIVITIES•Chooseapatientassignedtooneofthestudentsandexaminetherationaleforthedosingscheduleoftheirprescribedmedications.POWERPOINTSLIDES20–24

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd EditionSUGGESTIONFORCLASSROOMACTIVITIES•Havestudentspracticeconvertingsomecommondrugsfromonesystemtoanother,suchasmetrictohouseholdormetrictoapothecary.SUGGESTIONFORCLINICALACTIVITIES•Lookforexamplesofdrugsthatmaycomepackagedinadifferentsystemofmeasurementthanwasorderedbythehealthcareprovider,suchaslevothyroxineornitroglycerin,andillustratetheseexamples.POWERPOINTSLIDES25–26SUGGESTIONFORCLASSROOMACTIVITIES•Discusssomeofthepossibleconsequencesthatcanoccurwhenmedicationsarenotproperlycharted,suchasapatientreceivingadoubledoseofmedication.SUGGESTIONFORCLINICALACTIVITIES•Havestudentsidentifywhatismostimportanttodocumentfollowingamedicationthattheyhavejustadministered.Discussanysignificantinformationorassessmentdatathatneedstobeincluded,suchasvitalsignsorapatientcomplaint.POWERPOINTSLIDES27–43Figure3.2SublingualMedicationAdministrationFigure3.3TransdermalPatchAdministrationFigure3.4OphthalmicAdministrationFigure3.5VaginalMedicationAdministrationFigure3.6IntradermalDrugAdministrationFigure3.7SubcutaneousDrugAdministrationFigure3.8IntramuscularDrugAdministrationSUGGESTIONSFORCLASSROOMACTIVITIES•Giveanexampleofadrug,suchasmorphine,thatcanbeadministeredbythesubcutaneous,intramuscular,andintravenousroutes.Discusswheneachsitewouldbethemoreappropriatechoice.•Discussthedifferencesinsublingualandbuccalmedications.DemonstrateproperplacementusingOTClozengesorcandy.SUGGESTIONFORCLINICALACTIVITIES•Assigneachstudentaparenteralmedication,checkingthatitispreparedinthecorrectsizesyringewithcorrectneedlelengthandgauge.Discusswhythesizeandgaugeoftheneedleisappropriatefortheparticularmedicationandthespecificpatient.

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd EditionPEARSONNURSINGSTUDENTRESOURCES(WWW.NURSING.PEARSONHIGHERED.COM)•WebLinks•NCLEX®-style reviewquestions•Casestudies•MakingthePatientConnection•Mechanism of Action AnimationsMYNURSINGLAB(WWW.MYNURSINGLAB.COM)•KnowledgeQuickCheck•Pre/Posttests•Customizedstudyplans•SeparatepurchasePRENTICEHALLNURSE’SDRUGGUIDE•SeparatepurchasePEARSONETEXT•Studentscansearch,highlight,takenotes,andmoreallinelectronicformat•SeparatepurchaseMYTEST

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Adams/Urban,Instructor’s Resource ManualforPharmacology: Connections to Nursing Practice, 2nd EditionCHAPTER4PHARMACOKINETICSLEARNINGOUTCOME1Identifythefourprimaryprocessesofpharmacokinetics.ConceptsforLecture1.Pharmacokineticsiswhatthebodydoestodrugs.Pharmacomeans“medicines,”andkineticsmeans“movement.”2.Thefourphasesofpharmacokineticsare:absorption,distribution,metabolism,andexcretion.3.Adrugmustgothroughallphasesbeforebeingeliminatedbythebody.LEARNINGOUTCOME2Explainmechanismsbywhichdrugscrossplasmamembranes.ConceptsforLecture1.Variousmechanismsareusedbydrugstoreachtargettissues.Thesecaninvolvepassivediffusion,activetransport,andfacilitateddiffusion.2.Passivediffusioninvolvesmovementfromanareaofhighconcentrationtooneoflowconcentration.3.Facilitateddiffusioninvolvesutilizationofacarrierprotein.4.Activetransportinvolvesmovementagainstaconcentrationgradient,whichrequiresenergy.LEARNINGOUTCOME3Discussfactorsaffectingdrugabsorption.ConceptsforLecture1.Thefirstphaseofpharmacokinetics,absorption,isaffectedbymanydifferentfactors.2.Factorsaffectingabsorption:a.Oralmedsmustundergodissolutionb.Topicaldrugscanhavesloworrapidabsorptionc.Drugconcentration/dosed.PhysicalandchemicalconditionofGItract:i.Motilityii.Presenceoffood/fatinstomach

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