NAPSRX STUDY GUIDE
Pharmaceuticalsvg-vganswer--
Medicinesvgandvgvaccinesvgforvghumanvgandvganimalvguse.vgProductsvgmayvghavevgavgtrad
emarkvg(brand)vgnamevgorvgbevggeneric;vgandvgtheyvgmayvgbevgprescriptionvgorvgover-
thevgcounter.
Diagnosticvg-vganswer--
Equipmentvgandvgsuppliesvgusedvginvgscreening,vgdetecting,vgandvgmonitoringvgdisease.vg
Canvgrangevgfromvgsimplevghomevgtestingvgkitsvgtovgsophisticatedvgdiagnosticvgimagingvgte
chnologies.
MedicalvgDevicesvg-vganswer--
Advancedvginstrumentationvgandvgappliancesvgusedvgforvgmedicalvgtherapy,vgsuchvgasvgjoi
ntvgreplacements,vgimplantablevgdefibrillators,vgandvgpacemakers.vgAlsovgincludesvgdrugv
gdeliveryvgdevicesvgsuchvgasvgsyringes,vginfusionvgpumps,vgmetered-
dosevginhalers,vgandvgtransdermalvgpatches.
MedicalvgSuppliesvg-vganswer--Commodity,vghigh-
volumevgsuppliesvgsuchvgasvgsurgicalvggownsvgandvggloves.
DurablevgMedicalvgEquipmentvg-vganswer--Reusablevgproductsvgforvghealth-
relatedvgusevginvgthevghome,vgsuchvgasvgwalkers,vgwheelchairs,vgoxygenvgequipment,vgpro
stheticsvgandvghospitalvgbeds.
Whatvgcountriesvgarevgpharmaceuticalvgsalesvgthevghighest?vg-vganswer--
UnitedvgStates,vgWesternvgEurope,vgandvgJapan.
ThevgU.S.vgaccountsvgforvgroughlyvg__________vgofvgthevgworld'svgpharmaceuticalvgreven
ues.vg-vganswer--50%
Twovgfactorsvghavevgsignificantlyvgcontributedvgtovgrecentvggrowthvginvgthevgpharmaceutic
alvgindustryvgare?vg-vganswer--Populationvggrowthvgandvgincreasingvglifevgexpectancies.
Whatvgisvgthevgpredictedvgrelationshipvgbetweenvgpharmaceuticalvgcompaniesvgandvggen
omicvgresearchvgfacilities?vg-vganswer--
Partnershipsvgbetweenvgpharmaceuticalvgcompaniesvgandvggenomicvgresearchvgfacilitie
svgwillvgnotvgprovevgimmediatelyvgprofitable.
Prescriptionvgdrugvgtherapyvgisvgcostvgeffectivevgforvginsurancevgcompaniesvgandvghealthvg
carevgproviders.vgTruevgorvgFalse?vg-vganswer--True
Thevghighvgpricevgofvghealthvgcarevgisvgexplainedvgbyvgthevghighvgpricevgofvgmedicines.vgTru
evgorvgFalse?vg-vganswer--False
,OnevgofvgthevgoldestvgandvgleastvgeffectivevgpharmaceuticalvgmarketingvgtechniquesvgisvgD
TCvg(direct-to-consumer)vgadvertising.vgTruevgorvgFalse?vg-vganswer--False
Whatvginfluencesvgthevgnumbervgofvgdistrictsvginvgavgregion?vg-vganswer--
Thevgregion'svgpopulation.
Whatvgisvganvgexamplevgofvgthevgregionalizationvgofvghealthcarevgdeliveryvgsystems?vg-
vganswer--
CaliforniavgandvgFloridavghavevgdifferentvgprescriptionvgreimbursementvgpolicies.
Whatvgisvgthevgheartvgofvgavgpharmaceuticalvgsalesvgteam?vg-vganswer--DistrictvgManager.
Howvgmanyvgterritoriesvgarevginvgavgtypicalvgdistrict?vg-vganswer--8-12
Whatvgisvgthevgmostvgeffectivevgmethodvgforvggrabbingvgmarketvgshare?vg-vganswer--
Comparativevgselling.
Thevgaveragevgreviewvgtimevgforvgavgnewvgdrugvgisvg18vgmonths,vgdownvgfromvgalmostvg3vgy
earsvginvg1996.vgTruevgorvgFalse?vg-vganswer--True
Whatvgarevgsomevgquestionsvgrepsvgshouldvgaskvgavgphysician?vg-vganswer--
Whyvgdovgyouvgprefervgthevgcompetitor'svgdrugvgtovgours?
vgWhatvgdovgtheyvglikevgandvgdislikevgaboutvgit?
vgWhichvgpatientvgtypesvgisvgthevgdrugvgbeingvgusedvgfor?
vgWhatvgarevgthevgresultsvgandvgsidevgeffects,vgifvgany?vg
Note:vgCarefulvgquestioningvgandvglisteningvgenablesvgrepsvgtovgcraftvgeffectivevgmessage
svgbasedvgonvgeachvgphysician'svgspecificvgneeds.
Pharmaceuticalvgrepsvgmainlyvgvisitvgpharmacies.vgTruevgorvgFalse?vg-vganswer--
False.vgPharmaceuticalvgrepsvgmainlyvgvisit/targetvgphysicians.
Itvgusuallyvgtakesvgonlyvg1-
2vgcallsvgonvgavgphysicianvgbeforevghevgorvgshevgprescribesvgyourvgproduct.vgTruevgorvgFals
e?vg-vganswer--
False.vgYourvgsuccessvgultimatelyvgdependsvgonvgyourvgrelationshipvgwithvgthevgphysician.
vgThisvgtakesvgtime.vgPersistencevgisvgkey.
Thevgpharmacistvgmayvgdispensevgavgproductvgothervgthanvgwhatvgthevgphysicianvgprescri
bed.vgTruevgorvgFalse?vg-vganswer--
True.vgThevgpharmacistvgcanvgeithervg(1)vgdispensevgavggeneric;vg(2)vgThevgpharmacistvgc
allsvgthevgdoctorvgandvgrequestsvgpermissionvgtovgdispensevgavgdifferentvgmedication.
Accordingvgtovgchaptervg2vgofvgyourvgmanualvgwhichvgofvgthevgfollowingvgclassifiesvgasvgpay
ers?vg
(a)vgemployers
(b)vgpatientsvg
(c)vgpharmacists
(d)vgphysiciansvg-vganswer--(a)vgemployersvg
, Somevgthirdvgpartyvgpayersvgincludevgthevginsurancevgcompany,vgthevgemployer,vgmanag
edvgcarevgorganization,vgorvgthevgU.S.vggovernmentvg(Medicare/Medicaid).
Whatvgdefinesvgethicalvgpharmaceuticalvgcompanies?vg-vganswer--
Pharmaceuticalvgcompaniesvgthatvgresearchvgandvgdevelopvgnovelvgdrugs.
ThanksvgtovgmodernvgmedicinevghowvglongvgarevgpeoplevgnewlyvgdiagnosedvgwithvgHIVvge
xpectedvgtovglive?vg-vganswer--Anothervg50vgyears.
HowvgmuchvghasvgthevgaveragevgAmericanvglifespanvgincreasedvgsincevg1890?vg-
vganswer--30vgyears
Whatvgisvgavgtreatmentvggroup?vg-vganswer--
Avggroupvgofvgpatientsvgassignedvgtovgreceivevgspecificvgtreatment.
Whatvgisvgthevgmainvgdifferencevgbetweenvgavgblindedvgandvgdouble-blindedvgstudy?vg-
vganswer--
Invgavgdoublevgblindedvgstudy,vgneithervgthevgstaffvgnorvgthevgstudyvgparticipantsvgknowvgwh
ichvgsubjectsvgarevginvgthevgexperimentalvggroupvgandvgwhichvgsubjectsvgarevginvgthevgcontr
olvggroup.
Whatvgdoesvgasymptomaticvgmean?vg-vganswer--
Withoutvgsignsvgorvgsymptomsvgofvgdisease.
Whatvgisvganvgapprovablevgletter?vg-vganswer--
LettersvgsentvgbyvgthevgFDAvgtovgthevgapplicantvgindicatingvgwhethervgthevgnewvgdrugvgappl
icationvg(NDA)vgorvgabbreviatedvgnewvgdrugvgapplicationvg(ANDA)vgforvgavgproductvgmeets
vgthevgnecessaryvgrequirementsvgandvgwhethervgorvgnotvgthevgagencyvgbelievesvgthatvgitvgc
anvgapprovevgthevgapplicationvgorvgabbreviatedvgapplicationvgifvgspecificvgadditionalvginfor
mationvgorvgmaterialvgisvgsubmittedvgorvgspecificvgconditionsvg(e.g.,vgcertainvgchangesvginvg
labeling)vgarevgagreedvgtovgbyvgthevgapplicant.
Whatvgisvgavgblindedvgorvgmaskedvgstudy?vg-vganswer--
Avgstudyvginvgwhichvgparticipantsvgdovgnotvgknowvgwhethervgtheyvgarevginvgthevgexperiment
alvgorvgcontrolvggroupvgofvgavgresearchvgstudy.vgThosevginvgthevgexperimentalvggroupvggetvgt
hevgmedicationsvgorvgtreatmentsvgbeingvgtested,vgwhilevgthosevginvgthevgcontrolvggroupvgge
tvgstandardvgtreatmentvgorvgnovgtreatment.
Whatvgisvgavgcontrolvgorvgcontrolvggroup?vg-vganswer--
Thevgstandardvgbyvgwhichvgexperimentalvgobservationsvgarevgevaluated.vgInvgmanyvgclinic
alvgtrials,vgonevggroupvgofvgpatientsvgwillvgbevggivenvganvgexperimentalvgdrugvgorvgtreatment
,vgwhilevgthevgcontrolvggroupvgisvggivenvgeithervgavgstandardvgtreatmentvgforvgthevgillnessvgor
vgavgplacebo.
Whatvgisvgavgdouble-blindvgorvgdouble-maskedvgstudy?vg-vganswer--
Avgstudyvginvgwhichvgneithervgthevgparticipantsvgnorvgthevgstudyvgstaffvgknowvgwhichvgpartici
pantsvgarevgreceivingvgthevgexperimentalvgtreatmentvgandvgwhichvgpatientsvgarevginvgthevgc
ontrolvggroup.vgThesevgstudiesvgarevgperformedvgsovgneithervgthevgpatientvgnorvgdoctorvgex
pectationsvgaboutvgthevgexperimentalvgdrugvgcanvginfluencevgthevgoutcome.
Pharmaceuticalsvg-vganswer--
Medicinesvgandvgvaccinesvgforvghumanvgandvganimalvguse.vgProductsvgmayvghavevgavgtrad
emarkvg(brand)vgnamevgorvgbevggeneric;vgandvgtheyvgmayvgbevgprescriptionvgorvgover-
thevgcounter.
Diagnosticvg-vganswer--
Equipmentvgandvgsuppliesvgusedvginvgscreening,vgdetecting,vgandvgmonitoringvgdisease.vg
Canvgrangevgfromvgsimplevghomevgtestingvgkitsvgtovgsophisticatedvgdiagnosticvgimagingvgte
chnologies.
MedicalvgDevicesvg-vganswer--
Advancedvginstrumentationvgandvgappliancesvgusedvgforvgmedicalvgtherapy,vgsuchvgasvgjoi
ntvgreplacements,vgimplantablevgdefibrillators,vgandvgpacemakers.vgAlsovgincludesvgdrugv
gdeliveryvgdevicesvgsuchvgasvgsyringes,vginfusionvgpumps,vgmetered-
dosevginhalers,vgandvgtransdermalvgpatches.
MedicalvgSuppliesvg-vganswer--Commodity,vghigh-
volumevgsuppliesvgsuchvgasvgsurgicalvggownsvgandvggloves.
DurablevgMedicalvgEquipmentvg-vganswer--Reusablevgproductsvgforvghealth-
relatedvgusevginvgthevghome,vgsuchvgasvgwalkers,vgwheelchairs,vgoxygenvgequipment,vgpro
stheticsvgandvghospitalvgbeds.
Whatvgcountriesvgarevgpharmaceuticalvgsalesvgthevghighest?vg-vganswer--
UnitedvgStates,vgWesternvgEurope,vgandvgJapan.
ThevgU.S.vgaccountsvgforvgroughlyvg__________vgofvgthevgworld'svgpharmaceuticalvgreven
ues.vg-vganswer--50%
Twovgfactorsvghavevgsignificantlyvgcontributedvgtovgrecentvggrowthvginvgthevgpharmaceutic
alvgindustryvgare?vg-vganswer--Populationvggrowthvgandvgincreasingvglifevgexpectancies.
Whatvgisvgthevgpredictedvgrelationshipvgbetweenvgpharmaceuticalvgcompaniesvgandvggen
omicvgresearchvgfacilities?vg-vganswer--
Partnershipsvgbetweenvgpharmaceuticalvgcompaniesvgandvggenomicvgresearchvgfacilitie
svgwillvgnotvgprovevgimmediatelyvgprofitable.
Prescriptionvgdrugvgtherapyvgisvgcostvgeffectivevgforvginsurancevgcompaniesvgandvghealthvg
carevgproviders.vgTruevgorvgFalse?vg-vganswer--True
Thevghighvgpricevgofvghealthvgcarevgisvgexplainedvgbyvgthevghighvgpricevgofvgmedicines.vgTru
evgorvgFalse?vg-vganswer--False
,OnevgofvgthevgoldestvgandvgleastvgeffectivevgpharmaceuticalvgmarketingvgtechniquesvgisvgD
TCvg(direct-to-consumer)vgadvertising.vgTruevgorvgFalse?vg-vganswer--False
Whatvginfluencesvgthevgnumbervgofvgdistrictsvginvgavgregion?vg-vganswer--
Thevgregion'svgpopulation.
Whatvgisvganvgexamplevgofvgthevgregionalizationvgofvghealthcarevgdeliveryvgsystems?vg-
vganswer--
CaliforniavgandvgFloridavghavevgdifferentvgprescriptionvgreimbursementvgpolicies.
Whatvgisvgthevgheartvgofvgavgpharmaceuticalvgsalesvgteam?vg-vganswer--DistrictvgManager.
Howvgmanyvgterritoriesvgarevginvgavgtypicalvgdistrict?vg-vganswer--8-12
Whatvgisvgthevgmostvgeffectivevgmethodvgforvggrabbingvgmarketvgshare?vg-vganswer--
Comparativevgselling.
Thevgaveragevgreviewvgtimevgforvgavgnewvgdrugvgisvg18vgmonths,vgdownvgfromvgalmostvg3vgy
earsvginvg1996.vgTruevgorvgFalse?vg-vganswer--True
Whatvgarevgsomevgquestionsvgrepsvgshouldvgaskvgavgphysician?vg-vganswer--
Whyvgdovgyouvgprefervgthevgcompetitor'svgdrugvgtovgours?
vgWhatvgdovgtheyvglikevgandvgdislikevgaboutvgit?
vgWhichvgpatientvgtypesvgisvgthevgdrugvgbeingvgusedvgfor?
vgWhatvgarevgthevgresultsvgandvgsidevgeffects,vgifvgany?vg
Note:vgCarefulvgquestioningvgandvglisteningvgenablesvgrepsvgtovgcraftvgeffectivevgmessage
svgbasedvgonvgeachvgphysician'svgspecificvgneeds.
Pharmaceuticalvgrepsvgmainlyvgvisitvgpharmacies.vgTruevgorvgFalse?vg-vganswer--
False.vgPharmaceuticalvgrepsvgmainlyvgvisit/targetvgphysicians.
Itvgusuallyvgtakesvgonlyvg1-
2vgcallsvgonvgavgphysicianvgbeforevghevgorvgshevgprescribesvgyourvgproduct.vgTruevgorvgFals
e?vg-vganswer--
False.vgYourvgsuccessvgultimatelyvgdependsvgonvgyourvgrelationshipvgwithvgthevgphysician.
vgThisvgtakesvgtime.vgPersistencevgisvgkey.
Thevgpharmacistvgmayvgdispensevgavgproductvgothervgthanvgwhatvgthevgphysicianvgprescri
bed.vgTruevgorvgFalse?vg-vganswer--
True.vgThevgpharmacistvgcanvgeithervg(1)vgdispensevgavggeneric;vg(2)vgThevgpharmacistvgc
allsvgthevgdoctorvgandvgrequestsvgpermissionvgtovgdispensevgavgdifferentvgmedication.
Accordingvgtovgchaptervg2vgofvgyourvgmanualvgwhichvgofvgthevgfollowingvgclassifiesvgasvgpay
ers?vg
(a)vgemployers
(b)vgpatientsvg
(c)vgpharmacists
(d)vgphysiciansvg-vganswer--(a)vgemployersvg
, Somevgthirdvgpartyvgpayersvgincludevgthevginsurancevgcompany,vgthevgemployer,vgmanag
edvgcarevgorganization,vgorvgthevgU.S.vggovernmentvg(Medicare/Medicaid).
Whatvgdefinesvgethicalvgpharmaceuticalvgcompanies?vg-vganswer--
Pharmaceuticalvgcompaniesvgthatvgresearchvgandvgdevelopvgnovelvgdrugs.
ThanksvgtovgmodernvgmedicinevghowvglongvgarevgpeoplevgnewlyvgdiagnosedvgwithvgHIVvge
xpectedvgtovglive?vg-vganswer--Anothervg50vgyears.
HowvgmuchvghasvgthevgaveragevgAmericanvglifespanvgincreasedvgsincevg1890?vg-
vganswer--30vgyears
Whatvgisvgavgtreatmentvggroup?vg-vganswer--
Avggroupvgofvgpatientsvgassignedvgtovgreceivevgspecificvgtreatment.
Whatvgisvgthevgmainvgdifferencevgbetweenvgavgblindedvgandvgdouble-blindedvgstudy?vg-
vganswer--
Invgavgdoublevgblindedvgstudy,vgneithervgthevgstaffvgnorvgthevgstudyvgparticipantsvgknowvgwh
ichvgsubjectsvgarevginvgthevgexperimentalvggroupvgandvgwhichvgsubjectsvgarevginvgthevgcontr
olvggroup.
Whatvgdoesvgasymptomaticvgmean?vg-vganswer--
Withoutvgsignsvgorvgsymptomsvgofvgdisease.
Whatvgisvganvgapprovablevgletter?vg-vganswer--
LettersvgsentvgbyvgthevgFDAvgtovgthevgapplicantvgindicatingvgwhethervgthevgnewvgdrugvgappl
icationvg(NDA)vgorvgabbreviatedvgnewvgdrugvgapplicationvg(ANDA)vgforvgavgproductvgmeets
vgthevgnecessaryvgrequirementsvgandvgwhethervgorvgnotvgthevgagencyvgbelievesvgthatvgitvgc
anvgapprovevgthevgapplicationvgorvgabbreviatedvgapplicationvgifvgspecificvgadditionalvginfor
mationvgorvgmaterialvgisvgsubmittedvgorvgspecificvgconditionsvg(e.g.,vgcertainvgchangesvginvg
labeling)vgarevgagreedvgtovgbyvgthevgapplicant.
Whatvgisvgavgblindedvgorvgmaskedvgstudy?vg-vganswer--
Avgstudyvginvgwhichvgparticipantsvgdovgnotvgknowvgwhethervgtheyvgarevginvgthevgexperiment
alvgorvgcontrolvggroupvgofvgavgresearchvgstudy.vgThosevginvgthevgexperimentalvggroupvggetvgt
hevgmedicationsvgorvgtreatmentsvgbeingvgtested,vgwhilevgthosevginvgthevgcontrolvggroupvgge
tvgstandardvgtreatmentvgorvgnovgtreatment.
Whatvgisvgavgcontrolvgorvgcontrolvggroup?vg-vganswer--
Thevgstandardvgbyvgwhichvgexperimentalvgobservationsvgarevgevaluated.vgInvgmanyvgclinic
alvgtrials,vgonevggroupvgofvgpatientsvgwillvgbevggivenvganvgexperimentalvgdrugvgorvgtreatment
,vgwhilevgthevgcontrolvggroupvgisvggivenvgeithervgavgstandardvgtreatmentvgforvgthevgillnessvgor
vgavgplacebo.
Whatvgisvgavgdouble-blindvgorvgdouble-maskedvgstudy?vg-vganswer--
Avgstudyvginvgwhichvgneithervgthevgparticipantsvgnorvgthevgstudyvgstaffvgknowvgwhichvgpartici
pantsvgarevgreceivingvgthevgexperimentalvgtreatmentvgandvgwhichvgpatientsvgarevginvgthevgc
ontrolvggroup.vgThesevgstudiesvgarevgperformedvgsovgneithervgthevgpatientvgnorvgdoctorvgex
pectationsvgaboutvgthevgexperimentalvgdrugvgcanvginfluencevgthevgoutcome.
