UNITEK HAYWARD PHARMACOLOGY | QUIZ 1 | CHAPTERS 1, 2, 3 | LATEST|2024 Which bbdescription bbbest bbdefines bba bbmedication? A) bbChemical bbsubstance bbthat bbrequires bba bbprescription bbby bba bbhealth bbprofessional B) bbDrug bbused bbfor bba bbtherapeutic bbeffect bbto bbtreat bbor bbprevent bban bbillness C) bbPharmacologic bbpreparation bbused bbto bbreverse bbdisease D) bbPlant, bbanimal, bbor bbmineral bbsubstance bbthat bbprevents bbdisease bb- bbcorrect bbanswer's bbB) bbDrug bbused bbfor bba bbtherapeutic bbeffect bbto bbtreat bbor bbprevent bban bbillness Medications bbare bbdrugs bbused bbfor bbtheir bbtherapeutic bbeffec ts. bbA bbtherapeutic bbeffect bbcan bbbe bbthe bbprevention bbor bbtreatment bbof bbdisease. bbAll bbmedications bbdo bbnot bbrequire bba bbprescription. bbSpecifying bba bbcertain bbaction bbis bbnot bbthe bbbest bbdefinition bbof bba bbmedication bbbecause bbit bbis bbincomplete. What bbis bbthe bbtrade bbname bbof bba bbdrug? A) bbThe bbproprietary bbname bbof bbthe bbdrug bbgiven bbby bba bbmanufacturer. B) bbThe bbchemical bbname bbof bbthe bbdrug bbgiven bbby bbits bbdeveloper. C) bbThe bbname bbgiven bbto bbthe bbdrug bbby bbthe bbU.S. bbFood bband bbDrug bbAdministration bb(FDA). D) bbThe bbname bbunder bbwhich bbthe bbdrug bbis bblisted bbin bbthe bbU.S. bbPharmacope ia. bb- bbcorrect bbanswer's bbA) bbThe bbproprietary bbname bbof bbthe bbdrug bbgiven bbby bba bbmanufacturer. The bbtrade bbor bbbrand bbname bbis bbthe bbproprietary bbname bbgiven bbto bbthe bbdrug bbby bbits bbmanufacturer. bbThe bbsame bbdrug bbproduced bbby bbdifferent bbcompanies bbhas bbone bbgeneric bbname bbbut bbmay bbhave bbmany bbtrade bbnames. bbThe bbtrade bbname bbis bbtrademark bbprotected bband bbcan bbbe bbused bbonly bbby bbits bbmanufacturer. bbThe bbdrug bbmay bbbe bblisted bbunder bbmore bbthan bbone bbname bbin bbthe bbPharmacopeia. bbThe bbbook bbis bbused bbto bbprovide bbstandards bbfor bbidentity, bbquality, bbstrength, bband bbpurity bbof bbsubstance s bbused bbin bbhealthcare bbpractice. bbThe bbtrade bbname bbis bbnot bbgiven bbto bba bbdrug bbby bbthe bbFDA. bbThe bbchemical bbname bbis bbthe bbexact bbchemical bbconstitution bbof bbthe bbdrug bband bbthe bbexact bbplacing bbof bbits bbatoms bbor bbmolecular bbgroupings. What bbis bbthe bbMedWatch bbform bbused bbfor? A) bbTracking bbnumbers bbof bbprescriptions bbwritten bbfor bba bbspecific bbdrug B) bbAssessing bbthe bbacceptability bbof bbthe bbdrug bbto bbindividual bbpatients C) bbDetermining bbthe bbtherapeutic bbeffectiveness bbof bbthe bbdrug D) bbIdentifying bbadverse bbeffects bbof bba bbdrug bbin bbthe bbgeneral bbpopulation bb- bbcorrect bbanswe r's bbD) bbIdentifying bbadverse bbeffects bbof bba bbdrug bbin bbthe bbgeneral bbpopulation Healthcare bbpractitioners bbmake bba bbsignificant bbcontribution bbto bbthe bbknowledge bbof bbdrug bbsafety bbby bbreporting bbadverse bbeffects bbto bbthe bbFDA bbusing bbthe bbMedWatch bbprogram bbfor bbthe bbvoluntary bbreporting bbof bbadverse bbevents bband bbproduct bbproblems. bbThis bbmethod bbof bbidentifying bbadverse bbeffects bbof bba bbdrug bbin bbthe bbgeneral bbpopulation bbis bbpart bbof bbthe bbpostmarketing bbsurveillance bbphase bbof bbdrug bbdevelopment. bbMore bbthan bb200,000 bbMedWatch bbforms bbare bbfiled bbwith bbthe bbFDA bbannually. bbMedWatch bbis bbnot bbdesigned bbto bbtrack bbthe bbnumbers bbof bbprescriptions bbwritten bbfor bba bbspecific bbdrug; bbis bbnot bba bbprogram bbinvolved bbin bbdetermining bbthe bbtherapeutic bbeffectiveness bbof bba bbdrug; bband bbis bbnot bbinvolved bbin bbassessing bbthe bbacceptability bbof bba bbdrug bbto bbindividual bbpatients. Which bbstatement bbabout bbdrug bbnames bbis bbcorrect? A) bbDrugs bbare bblisted bbby bbtheir bbchemical bbnames bbin bbthe bbU.S. bbPharmacopeia. B) bbA bbdrug bbmay bbhave bbmultiple bbproprietary bbnames. C) bbThe bbgeneric bbname bbis bba bbtrademarked bbname. D) bbThe bbofficial bbname bbmust bbbe bbused bbon bball bbprescript ions. bb- bbcorrect bbanswer's bbB) bbA bbdrug bbmay bbhave bbmultiple bbproprietary bbnames. The bbproprietary bbname bbof bba bbdrug bbis bba bbtrade bbor bbbrand bbname bband bbis bbfollowed bbby bbthe bbsymbol bb®. bbEach bbmanufacturer bbof bba bbdrug bbcan bbregister bba bbproprietary bbname bbthat bbcan bbbe bbused bbonly bbby bbthat bbcompa ny. bbThus bba bbdrug bbproduced bbby bbmore bbthan bbone bbmanufacturer bbcan bbhave bbmultiple bbproprietary bbnames bbbut bbonly bbone bbgeneric bbname. bbDrugs bbare bblisted bbby bbtheir bbofficial bbnames bbin bbthe bbU.S. bbPharmacopeia. bbGeneric bbnames bbare bbnot bbtrademarked. bbPrescriptions bbcan bbbe bbwritten bbusing bbgeneric bbor bbtrade bbnames. How bbdo bbSchedule bbII bbdrugs bbdiffer bbfrom bbSchedule bbV bbdrugs? A) bbSchedule bbV bbdrugs bbhave bbgreater bbrisk bbfor bbtoxicity. B) bbSchedule bbII bbdrugs bbhave bbless bbpotential bbfor bbabuse. C) bbSchedule bbV bbdrugs bblack bbaccepted bbsafety bbmeasures bbfor bbuse. D) bbSchedule bbII bbdrugs bbare bbmore bblikely bbto bbcause bbdependence. bb- bbcorrect bbanswer's bbD) bbSchedule bbII bbdrugs bbare bbmore bblikely bbto bbcause bbdependence. Schedule bbII bbdrugs bbhave bba bbhigh bbpotential bbfor bbabuse bbthat bbmay bblead bbto bbsevere bbpsychological bbor bbphysical bbdependence. bbSchedule bbII bbdrugs bbhave bbmore, bbnot bbless, bbpotential bbfor bbabuse bbthan bbSchedule bbV bbdrugs. bbSchedule bbII bband bbSchedule bbV bbdrugs bbhave bbaccepted bbguidelines bbfor bbsafe bbuse. bbDrugs bbin bbboth bbschedules bbare bbnot bbdifferentiated bbbased bbon bbtoxicity. bbThere bbmay bbbe bbdrugs bbin bbeach bbschedule bbthat bbhave bbhigh bbor bblow bbtoxicity. Which bblegislation bbwas bbwritten bbto bbrequire bbcompanies bbto bbdetermine bbthe bbsafety bbof bbmedications bbbefore bbmarketing? A) bbThe bbFederal bbFood, bbDrug, bband bbCosmetic bbAct bbof bb1938 B) bbDurham bbHumphrey bbAmendment bbof bb1952 C) bbThe bbKefauver bbHarris bbDrug bbAmendme nt bbof bb1962 D) bbControlled bbSubstance bbAct bbof bb1970 bb- bbcorrect bbanswer's bbA) bbThe bbFederal bbFood, bbDrug, bband bbCosmetic bbAct bbof bb1938 The bbFederal bbFood, bbDrug, bband bbCosmetic bbAct bbof bb1938 bb(passed bbon bbJune bb25, bb1938, bband bbamended bbin bb1952 bband bb1962) bbrequires bbthe bbFDA bbto bbdetermine bbthe bbsafety bbof bbdrugs bbbefore bbmarketing bband bbto bbensure bbthat bbcertain bblabeling bbspecifications bband bbstandards bbin bbadvertising bbare bbmet bbin bbthe bbmarketing bbof bbproducts. bbManufacturers bbare bbrequired bbto bbsubmit bbnew bbdrug bbapplications bbto bbthe bbFDA bbfor bbreview bbof bbsafety bbstudies bbbefor e bbproducts bbcan bbbe bbreleased. bbThe bbDurham bbHumphrey bbAmendment bbof bb1952 bbwas bbpassed bbto bbtighten bbcontrol bbover bbprescription bbdrugs bbby bbrestricting bbthe bbrefilling bbof bbprescriptions. bbThe bbKefauver bbHarris bbDrug bbAmendment bbof bb1962 bbwas bbbrought bbabout bbby bbthe bbthalidomide bbtragedy. bbThe bbamendment bbprovides bbgreater bbcontrol bband bbsurveillance bbof bbthe bbdistribution bband bbclinical bbtesting bbof bbinvestigational bbdrugs, bband bbrequires bbthat bba bbproduct bbbe bbproven bbsafe bband bbeffective bbbefore bbrelease bbfor bbsale. bbThe bbControlled bbSubstance bbAct bbof bb1970 bbwas bbpassed bbby bbCongress bbto bbimprove bbthe bbadministration bband bbregulation bbof bbmanufacturing, bbdistributing, bband bbdispensing bbof bbdrugs bbthat bbhave bbbeen bbfound bbnecessary bbto bbbe bbcontrolled. Which bblegislation bbwas bbenacted bbto bbstimulate bbdevelopment bband bbavailability bbof bbdrugs bbto bbtreat bbrare bbdiseases? A) bbThe bbOrphan bbDrug bbAct B) bbThe bbFast bbTracking bbrules C) bbThe bbControlled bbDrugs bband bbSubstance bbAct bbof bb1997 D) bbThe bbFood bband bbDrug bbAct bbof bb1979 bb- bbcorrect bbanswer's bbA) bbThe bbOrphan bbDrug bbAct The bbmedicines bbthat bbare bbdeveloped bbfor bbrare bbconditions bbare bbknown bbas bborphan bbdrugs, bbbecause bbthe bbmanufacturers bbhave bbbeen bbunable bbto bbrecover bbthe bbcosts bbof bbthe bbresearch bbdue bbto bbthe bbvery bblimited bbuse bbof bbthe bbfinal bbproduct. bbBecause bbno bbcompanies bbwere bbwilling bbto bb"adopt" bbthe bbdisease bbto bbcomplete bbextensive bbresearch bbto bbdevelop bbproducts bbfor bbtreatm ent, bbthe bbdiseases bbbecame bbknown bbas bbhealth bborphans. bbIn bb1983, bbCongress bbpassed bbthe bbOrphan bbDrug bbAct bbto bbstimulate bbthe bbdevelopment bband bbmarket bbavailability bbof bbproducts bbthat bbare bbused bbfor bbthe bbtreatment bbof bbrare bbdiseases. bbThe bbOrphan bbDrug bbAct bbprovides bbresearch bbgrants, bbprotocol bbdevelopment bbassistance bbby bbthe bbFDA, bbspecial bbtax bbcredits bbfor bbthe bbcost bbof bbclinical bbtrials, bband bb7 bbyears bbof bbexclusive bbmarketing bbrights bbafter bbthe bbproduct bbhas bbbeen bbapproved. bbThe bbFood bband bbDrug bbAct bbof bb1979 bbempowered bbHealth bbCanada bbto bbprotect bbthe bbpublic bbfrom bbforeseeable bbrisks bbrelating bbto bbthe bbmanufacture bband bbsale bbof bbdrugs. bbThe bbFast bbTracking bbrules bballow bbinvestigational bbdrugs bbto bbreceive bbhighest bbpriority bbfor bbreview bbwith bbthe bbFDA. bbThe bbControlled bbDrugs bband bbSubstance bbAct bbof bb1997 bbestablished bbthe bbrequirements bbfor bbcontr ol bband bbsale bbof bbnarcotics bband bbsubstances bbof bbabuse bbin bbCanada. Which bbstage bbof bbnew bbdrug bbdevelopment bbinvolves bbgiving bbthe bbmedication bbto bblarge bbnumbers bbof bbindividuals bbwith bbthe bbdisorder bbthat bbthe bbmedication bbintends bbto bbtreat? A) bbDevelopmental bbstage—Phase bb2 B) bbPostma rketing bbsurveillance bbstage C) bbDevelopmental bbstage—Phase bb1 D) bbDevelopmental bbstage—Phase bb3 bb- bbcorrect bbanswer's bbD) bbDevelopmental bbstage—
Phase bb3 If bbphase bb1 bbtrials bbare bbsuccessful, bbthe bbdrug bbis bbmoved bbto bbphase bb2, bbwhich bbinvolves bba bbsmaller bbpopulation bbof bbpatients bbwho bbhave bbthe bbcondition bbthat bbthe bbdrug bbis bbdesigned bbto bbtreat. bbStudies bbat bbvarious bbdosages bbare bbconducted bbto bbdetermine bbthe bbsuccess bbrate bband bbsafety bbof bba bbdrug bbfor bbits bbintended bbuse. bbIf bbsuccessful, bbthe bbdrug bbis bbadvanced bbto bbphase bb3 bbtrials, bbin bbwhich bblarger bbpatient bbpopulatio ns bbare bbused bbto bbensure bbthe bbstatistical bbsignificance bbof bbthe bbresults. bbStudies bbin bbthis bbphase bbalso
Phase bb3 If bbphase bb1 bbtrials bbare bbsuccessful, bbthe bbdrug bbis bbmoved bbto bbphase bb2, bbwhich bbinvolves bba bbsmaller bbpopulation bbof bbpatients bbwho bbhave bbthe bbcondition bbthat bbthe bbdrug bbis bbdesigned bbto bbtreat. bbStudies bbat bbvarious bbdosages bbare bbconducted bbto bbdetermine bbthe bbsuccess bbrate bband bbsafety bbof bba bbdrug bbfor bbits bbintended bbuse. bbIf bbsuccessful, bbthe bbdrug bbis bbadvanced bbto bbphase bb3 bbtrials, bbin bbwhich bblarger bbpatient bbpopulatio ns bbare bbused bbto bbensure bbthe bbstatistical bbsignificance bbof bbthe bbresults. bbStudies bbin bbthis bbphase bbalso
