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Chapter2

DrugRegulations

LearningOutcome1

Explaintheroleofpatentmedicinesinthehistoryofpharmacologyandthelegislationofdrugs.

ConceptsforLecture

  1. IntheUnitedStatesandCanadalawsgovernallaspectsofdrugapproval,labeling,manufacturing,marketing,anddistribution.
  2. Consumersexpectthatthedrugtheyaretakingiseffectiveandthatthelabelisclearandaccurate.
  3. Consumersexpectthatthedrugtheyaretakingissafe.
  4. Itisonlysincethe20thcenturythatstandardsandregulationsexisttoprotecttheconsumer.
  5. InearlyAmerica,patentmedicinewaswidelyusedandavailable.
  6. Therewerenolawstoregulatethesemedicinesandproductscouldmakeanyclaimtohealthorcure.
  7. Manypatentmedicinescontainaddictiveandattimesdangerousadditives,suchasmorphineandcocaine.Suchaddictiveadditivesguaranteedrepeatsales.
  8. Severalearlypatentmedicineshavegonethroughdrugregulationandchangeandarestillavailabletoday.

LearningOutcome2

OutlinethekeyU.S.drugregulationsandexplainhoweachhasensuredthesafetyandeffectivenessofthemedications.

ConceptsforLecture

  1. Druglegislationbeganinthe1900stomakedrugssaferandmoreeffective.
  2. ThefirstnationallawwastheDrugImportationActpassedin1848.
  3. Thiswasspurredondeathsofchildrenin1901whoweregivenacontaminatedantitoxin.
  4. TheBiologicsControlActwaspassedin1902toregulatesera,antitoxins,andblood-relatedproducts.
  5. ThePureFoodandDrugAct(PFDA)waspassedin1906tocontrollabelingofmedicines.
  6. ThePFDArequiredaccuracyindruglabeling.
  7. In1912theSherleyAmendmenttothePFDAaddressesfalsetherapeuticclaimsondruglabels.
  8. TheSherleyAmendmentdidnotaddresstheissueofprovingthatthedrugcompanyknewthattheirfalseclaimwasintentional.
  9. TheHarrisonNarcoticActof1914requiredprescriptionsforhigherdosesofnarcoticdrugs.
  10. 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.

LearningOutcome3

DescribehowtheU.SPharmacopeia-NationalFormulary(USP-NF)controlsdrugpurityandstandards.

ConceptsforLecture

  1. 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.

LearningOutcome4

EvaluatetheroleoftheU.S.FoodandDrugAdministrationinthedrugapprovalprocess.

ConceptsforLecture

  1. TheFoodandDrugAdministration(FDA)isresponsibleforensuringthesafetyofdrugsandmedicaldevices.
  2. TheFDAstartedin1906,makingittheoldestdrugregulatoryagencyintheworld.Ithaseightbranches.
  3. TheCenterforDrugEvaluationandResearch(CDER)coversdrugsafety.
  4. TheCenterforBiologicsEvaluationandResearch(CBER)regulatesbiologicsafety.
  5. TheCenterforFoodSafetyandAppliedNutrition(CFSAN)overseesherbalproducts,dietarysupplements,andcosmetics,butdoesnotrequiretestingofherbalsanddietarysupplementsbeforemarketing.
  6. CFSANregulatescosmeticsthatarenotconsidereddrugs.

LearningOutcome5

Categorizethefourstagesofnewdrugapproval.

ConceptsforLecture

  1. ThedrugapprovalprocessintheUnitedStateswasestablishedbytheFDA.
  2. ThedrugapprovalprocessensuresdrugssoldintheUnitedStatesaresafeandeffective.
  3. Therearefourstagestonewdrugapproval.
  4. Thefirststageispreclinicalinvestigational.Thisislaboratoryresearchbythepharmaceuticalcompany.
  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.

LearningOutcome6

Explaintheroleofaplaceboinnewdrugtesting.

ConceptsforLecture

  1. Aplaceboorinertsubstanceisusedinphase2ofclinicaldrugtrials.
  2. Theplaceboservesasacontrolornontreatmentgroup.

LearningOutcome7

Discusshowrecentchangestotheapprovalprocesshaveincreasedthespeedatwhichnewdrugsreachconsumers.

ConceptsforLecture

  1. Theprocessofdevelopingandtestinganewdrugcantakemanyyears.
  2. TheFDAreviewprocesscantakeseveralyears.
  3. Theestimatedcosttobringanewdrugtomarketcanbeover$802millionU.S.dollars.
  4. Pharmaceuticalcompaniesareanxioustorecoupthehighexpenses.
  5. Thepublicisalsoanxiousfornewmedications,especiallyfordiseaseswithahighmortalityrate.
  6. In1992thePDUFAwaspassed,whichprovidedyearlyproductuserfees.
  7. ThisincomeallowedtheFDAtorestructureandhiremoreemployees.
  8. Thisrestructuringdecreasedthereviewprocessbyhalf.
  9. Prioritydrugsnowreceiveacceleratedapproval.
  10. Theseprioritydrugsareforseriousandlife-threateningconditions.

LearningOutcome8

Compareandcontrastprescriptionandover-the-counter(OTC)drugs.

ConceptsforLecture

  1. 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.
  14. Herbalanddietarysupplementsarenotconsidereddrugs.Theyarenotsubjectedtothesameregulatoryprocessasprescriptiondrugs.
  15. TheFDAdoesnottestherbalanddietarysupplementsforsafety.Theseproductscancausesideeffectsandinteractwithmedications.

LearningOutcome9

Explainhowscheduleddrugsareclassifiedandregulated.

ConceptsforLecture

  1. 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.

LearningOutcome10

DescribetheCanadiandrugapprovalprocessandidentifysimilaritiestohowdrugsareapprovedintheUnitedStates.

ConceptsforLecture

  1. TherearemanysimilaritiesbetweenU.S.andCanadianregulationsfordrugs.
  2. HealthCanadaisthefederaldepartmentandtheHealthProductsandFoodBranch(HPFB)ofHealthCanadaistheregulatorybodyforhealthproductsandfoodsafety.
  3. TheHPFBregulatestheuseoftherapeuticproductsbydirectorates.
  4. TheTherapeuticProductsDirectorate(TPD)authorizesmarketingofdrugsandmedicaldevices.
  5. TheBiologicsandGeneticTherapiesDirectorate(BGTD)regulatebiologicaldrugsandradiopharmaceuticals.
  6. TheNaturalHealthProductsDirectorate(NHPD)regulatesnaturalproducts.
  7. TheCanadianFoodandDrugsActsisaregulatorydocumentthatspecifiesthatdrugscannotbemarketedwithoutaNoticeofCompliance(NOC)andDrugIdentificationNumber(DIN)fromHealthCanada.
  8. IfadrugdoesnotcomplywithstandardssetintheUnitedStates,Europe,Britain,orFrance,theycannotbesold,labeled,packaged,orsoldinCanada.

GeneralChapterConsiderations

  1. Havestudentsstudyandlearnkeytermslistedatbeginningofchapter.
  2. HavestudentscompleteendofchapterexerciseseitherintheirbookorontheMyNursingKitwebsite.
  3. UsetheClassroomResponseQuestionsprovidedinPowerPointtoassessstudentspriortolecture.

MarginalNotes

PowerPointSlides24–29

Figure2.1PatentMedicinesContainedaNameBrandThatClearlyIdentifiedtheProductandClaimedtoCureJustaboutAnySymptomorDisease

Figure2.1PatentMedicines

SuggestionforClassroomActivities

  • Discusswithstudentshowpatentmedicineshave“survived”overalongperiodoftime.UseexamplesgiveninthetextbooksuchasSmithCoughDrops,Fletcher’sCastoria,Doan’sPills,Vick’sVapoRub,andPhillip’sMilkofMagnesia.Whyaretheseproductsstillpopularandwidelyused?Whatcouldbesomeofthereasonsthattheysurvivedregulations?

PowerPointSlides30–34

Table2.1HistoricalTimeLineofRegulatoryActs,Standards,andOrganization

SuggestionforClassroomActivities

  • UsingthetimelineinTable2.1,havethestudentsaddanyfutureregulationstheybelieveareneededorforthcoming.

SuggestionforClinicalActivities

  • HavestudentsteachassignedpatientsintheclinicalsettingwhatU.S.regulationsensurethesafetyandeffectivenessoftheirdrugtherapy.

PowerPointSlides35–37

Figure2.2USPLabels

SuggestionforClassroomActivities

  • HavethestudentsexploretheUSPwebsite(Havethestudentslookatwhattypeofinformationisavailablesuchasreferencestandards,healthcarequalityandinformation,seminars,workshops,anddrugsafetyreview.Discusshowtheycouldusethisinformationinclinicalpractice.

PowerPointSlides38–40

Figure2.3U.S.FoodandDrugAdministration

SuggestionsforClassroomActivities

  • HavethestudentslogontotheFDAwebsite(Then,havethestudentsexploretheconsumerlinksandresources.Assignadifferentlinkorresourcetoeachstudent;havethemgiveabriefsummaryiftheythoughttheresourcewouldbehelpfultothegeneralpatientpopulation.

StudentscanchooseanFDAindustrylinktoexplore.Breakstudentsintogroupsandassignoneofthefollowingtoeachgroup:CDER,CBER,CFSAN,Medwatch,HealthCareProfessional,FoodNutritionIndustry,andCosmeticIndustry.Havethestudentsreportbacktothegroupwhatinformationisavailable.

SuggestionforClinicalActivities

  • HavethestudentsexplaintotheirassignedpatientshowtheFDAoverseesdrugproductsintheUnitedStates.IfInternetaccessisavailable,thestudentcandemonstratetheconsumerlinksontheFDAwebsite(

PowerPointSlides41–44

Figure2.4DrugDevelopmentTimeLine

SuggestionforClassroomActivities

  • Breakthestudentsintogroups,giveeachgrouponeofthethreephasesoftheclinicaldrugtrial,havethemdevelopapatientteachingtooltoprovideteachingtothepatientinvolvedinthatphaseofthetrial.Howwouldtheyexplainsafety,adverseeffects,andpatientvariables?

SuggestionforClinicalActivities

  • Ifpossibleinyourclinicalsetting,havethestudentsintervieweitherahealthcareprofessionalorpatientinvolvedinaclinicaldrugtrial.Theyshouldaskquestionsaboutstagesandphasesofthetrial,preclinicalinvestigation,goalofthetrial,possibleadverseeffects,andpatientconsentsandcompensations.Havethemreportbacktotheirclinicalgroupwhattheylearnedintheirinterview.Diditchangetheirthoughtsaboutclinicaldrugtrials?Whyorwhynot?

PowerPointSlide45

SuggestionforClassroomActivities

  • BuildofftheactivityforLearningOutcome5andcontinuetodiscussclinicaldrugtrials.Whydosomepatientsreceivetheplacebo?Isthereariskwithplacebos?Howwouldthepatientfeelaboutgettingtheplaceboifthedrugwasveryeffective?Discussthemoralissuesregardingcontrolleddrugtrials.

PowerPointSlides46–49

SuggestionforClassroomActivities

  • Discusswiththeclasswhichdiseasestatescouldrequireprioritydrugapproval.Makealistontheclassroomblackboard.Askthestudentsthentoprioritizetheirlist.Discusshowdifficultitistodecidewhichdiseaseis“moreimportant.”Discussifthelistwouldbedifferentinanotherpartofthecountryorworld.

PowerPointSlides50–56

SuggestionforClassroomActivities

  • Discusssomeoftherecentdrugsthathavebeenreclassifiedfromprescriptiontooverthecounter,suchasloratadine(Claritin),cetirizine(Zyrtec),Omeprazole(Prilosec),famotidine(Pepcid),naproxensodium(Aleve),andcromolynsodiumnasalspray(Nasalcrom).Discussthepotentialforuseandmisusebytheconsumer.Whyarethesedrugssaferthanotherdrugsinthesamecategorythatarestillprescriptiondrugs?Doesthereclassificationhelporharmtheconsumer?

SuggestionforClinicalActivities

  • Assignthestudentstoapatientwhoisprescribedadrugthatisavailableoverthecounter.Havethestudentsdevelopapatientteachingplanthatwillteachthepatienthowtousethedrugsafelyandhowtofollowtheguidelines.

PowerPointSlide57

SuggestionsforClassroomActivities

  • Providethestudentswithalistofsomecontrolledsubstancemedications.Havethestudentpickonedrugandinvestigateitsuseandsafety.Havethemreportbacktotheclassiftheythinktheassignedscheduleisappropriateornot.Discusstheargumentspresentedinclass.
  • RefertotheDEAwebsiteforalistofcontrolledsubstances:

SuggestionsforClinicalActivities

  • Havethestudentsshadowanurseorpharmacistwhopreparescontrolledsubstancemedications.Havethestudentnotetheregulationsinthatclinicalsettingforrecordinganddispensingthedrugs.Havethestudentsreportiftheythinktheregulationsareappropriateornot.Whatwouldtheychange,ifanything?
  • RefertotheDEAwebsiteaboutthecontrolledsubstanceact:

PowerPointSlides58–63

Table2.2StepsforApprovalforDrugsMarketedWithinCanada

SuggestionsforClassroomActivities

  • ExploretheHealthCanadawebsitewiththestudents:
  • CompareandcontrastinformationfoundonthatsiteagainstU.S.sites,suchastheFDA(ortheCentersforDiseaseControl(
  • Whatinformationisprovidedonthewebsitesforhealthcareprofessionals?Whatinformationisprovidedfortheconsumer?
  • Discussifinformationiseasytofindandtounderstand.Focusondrugstandardsandsafety.

MyNursingKit(

  • Websites
  • NCLEX®questions
  • Casestudies
  • MakingthePatientConnection

MyNursingLab(

  • KnowledgeQuickCheck
  • Pre/Posttests
  • Customizedstudyplans
  • Separatepurchase

StudentWorkbookandResourceGuide

  • Chapter2activities
  • Separatepurchase

PrenticeHallNurse’sDrugGuide

  • Separatepurchase

PearsoneText

  • Studentscansearch,highlight,takenotes,andmoreallinelectronicformat
  • Separatepurchase

ClassroomResponseQuestionPowerPoints

Testbank

AdamsCh02-1