NUR 615 Pharm Exam 1 General review
WhatzdoeszthezFDAzdo?z-
zANSWERzThezU.S.zFoodzandzDrugzAdministrationzregulates:zThezofficialzlabelingzforzallzprescriptionzan
dzover-the-counterzdrugs
WhatziszphasezIVzclinicalztrialszinzthezUnitedzStateszalsozknownzas?z-zANSWERzPostmarketingzresearch
Whatziszoffzlabelzprescribing?z-zANSWERzOff-
labelzuseziszthezusezofzpharmaceuticalzdrugszforzanzunapprovedzindicationzorzanzunapprovedzagezgroup
,zdosagezorzroutezofzadministration.zBothzprescriptionzdrugszandzover-the-
zcounterzdrugszcanzbezusedzinzoff-labelzways,zalthoughzmostzstudieszofzoff-
labelzusezfocuszonzprescriptionzdrugs.
Insurancezmayznotzpayzforzoff-labelzuse.zi.e.zWellbutrinzforzsmokingzcessation.
Iszoffzlabelzprescribingzlegal?z-zANSWERzOff-
labelzuseziszgenerallyzlegalzunlesszitzviolateszethicalzguidelineszforzsafetyzregulations.zitziszcommonlyzus
edztozgoodzeffectzbyzphysicianszandznursezpractitionerszbecausezwezunderstandzhowztozusezitzcorrectly
.zHowever,zitzcanzentailzhealthzriskszandzdifferenceszandzlegalzliability.
WhenzshouldzanzinvestigationalznewzdrugzbezfiledzwithzthezFDAz-
zANSWERzPriorztozanyzhumanztestingzofzanyznewzdrugzentity.
WhatzneedszFDAzapprovalzpriorztozbeingzputzinzthezmarketzforzsale?z-
zANSWERzMedicalzdeviceszincludingzartificialzjoints.
, WhenzshouldzbezFDAzMedWatchzsystemzbezactivated?z-
zANSWERzWhenzanzadversezeffectzorzseriouszproblemzoccurszwithzazmedicationzthatzisznotzalreadyzide
ntifiedzonzthezlabel.
UnderznewzU.S.zFoodzandzDrugzAdministrationzlabeling,zPregnancyzCategorieszwillzbez-
zANSWERzChangedztozincorporatezazpregnancyzriskzsummaryzandzclinicalzconsiderationszonzthezdrugzla
bel
Whatziszpharmacodynamics?z-zANSWERzThezstudyzofzwhatzazmedicationzdoesztozthezbody
Whatziszpharmacokinetics?z-zANSWERzThezstudyzofzdrugzmovementzthroughoutzthezbody
Whatziszpharmacotherapeutics?z-
zANSWERzPharmacotherapeuticsziszthezclinicalzpurposezorzindicationzforzgivingzazdrug
Whatziszazdrug'szhalf-life?z-zANSWERzTheztimezperiodzoverzwhichzconcentrationzwillzdecreasezbyzhalf
Whatziszazdrug'szonsetzofzaction?z-
zANSWERzThezdurationzofztimezitztakeszforzazdrugztozstartztakingzeffect.zDependszonzroutezofzadministr
ation.
Whatziszpeakzofzaction?z-zANSWERzTheztimezitztakeszforzazdrugztozbezatzitszstrongestzinzthezbody.
Whatziszthezdurationzofzaction?z-zANSWERzThezlengthzofztimezazdrugziszeffectivezinzthezbody.
Whatziszfirstzpasszmetabolism?z-zANSWERzAlthoughzazfirst-
passzeffectzcanzoccurzinzazvarietyzofztissues,zincludingzthezintestineszandzuterus,zitziszmostzobservedzwit
hzthezliver.zDrugzabsorbedzfromzthezgastrointestinalztractztravelszimmediatelyztozthezliverzthroughzthez
hepaticzportalzvein.zHepaticzfirstzpasszoccurszwhenzthezdrugzabsorbedzfromzthezgastrointestinalztractzis
WhatzdoeszthezFDAzdo?z-
zANSWERzThezU.S.zFoodzandzDrugzAdministrationzregulates:zThezofficialzlabelingzforzallzprescriptionzan
dzover-the-counterzdrugs
WhatziszphasezIVzclinicalztrialszinzthezUnitedzStateszalsozknownzas?z-zANSWERzPostmarketingzresearch
Whatziszoffzlabelzprescribing?z-zANSWERzOff-
labelzuseziszthezusezofzpharmaceuticalzdrugszforzanzunapprovedzindicationzorzanzunapprovedzagezgroup
,zdosagezorzroutezofzadministration.zBothzprescriptionzdrugszandzover-the-
zcounterzdrugszcanzbezusedzinzoff-labelzways,zalthoughzmostzstudieszofzoff-
labelzusezfocuszonzprescriptionzdrugs.
Insurancezmayznotzpayzforzoff-labelzuse.zi.e.zWellbutrinzforzsmokingzcessation.
Iszoffzlabelzprescribingzlegal?z-zANSWERzOff-
labelzuseziszgenerallyzlegalzunlesszitzviolateszethicalzguidelineszforzsafetyzregulations.zitziszcommonlyzus
edztozgoodzeffectzbyzphysicianszandznursezpractitionerszbecausezwezunderstandzhowztozusezitzcorrectly
.zHowever,zitzcanzentailzhealthzriskszandzdifferenceszandzlegalzliability.
WhenzshouldzanzinvestigationalznewzdrugzbezfiledzwithzthezFDAz-
zANSWERzPriorztozanyzhumanztestingzofzanyznewzdrugzentity.
WhatzneedszFDAzapprovalzpriorztozbeingzputzinzthezmarketzforzsale?z-
zANSWERzMedicalzdeviceszincludingzartificialzjoints.
, WhenzshouldzbezFDAzMedWatchzsystemzbezactivated?z-
zANSWERzWhenzanzadversezeffectzorzseriouszproblemzoccurszwithzazmedicationzthatzisznotzalreadyzide
ntifiedzonzthezlabel.
UnderznewzU.S.zFoodzandzDrugzAdministrationzlabeling,zPregnancyzCategorieszwillzbez-
zANSWERzChangedztozincorporatezazpregnancyzriskzsummaryzandzclinicalzconsiderationszonzthezdrugzla
bel
Whatziszpharmacodynamics?z-zANSWERzThezstudyzofzwhatzazmedicationzdoesztozthezbody
Whatziszpharmacokinetics?z-zANSWERzThezstudyzofzdrugzmovementzthroughoutzthezbody
Whatziszpharmacotherapeutics?z-
zANSWERzPharmacotherapeuticsziszthezclinicalzpurposezorzindicationzforzgivingzazdrug
Whatziszazdrug'szhalf-life?z-zANSWERzTheztimezperiodzoverzwhichzconcentrationzwillzdecreasezbyzhalf
Whatziszazdrug'szonsetzofzaction?z-
zANSWERzThezdurationzofztimezitztakeszforzazdrugztozstartztakingzeffect.zDependszonzroutezofzadministr
ation.
Whatziszpeakzofzaction?z-zANSWERzTheztimezitztakeszforzazdrugztozbezatzitszstrongestzinzthezbody.
Whatziszthezdurationzofzaction?z-zANSWERzThezlengthzofztimezazdrugziszeffectivezinzthezbody.
Whatziszfirstzpasszmetabolism?z-zANSWERzAlthoughzazfirst-
passzeffectzcanzoccurzinzazvarietyzofztissues,zincludingzthezintestineszandzuterus,zitziszmostzobservedzwit
hzthezliver.zDrugzabsorbedzfromzthezgastrointestinalztractztravelszimmediatelyztozthezliverzthroughzthez
hepaticzportalzvein.zHepaticzfirstzpasszoccurszwhenzthezdrugzabsorbedzfromzthezgastrointestinalztractzis
