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MPJE – Michigan Exam Questions and Answers
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MPJE – Michigan Exam Questions and Answers
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MPJE – Michigan Exam Questions andAnswers
Misbranding ii- iiAnswers ii-Drugs iiwhich iiare iisold, iidispensed iior iidistributed iiin iiviolation
iiof iilabeling iirequirements iiof iiFDCA
Adulterated iior iiMisbranded?:
False/misleading iilabeling ii- iiAnswers ii-Misbranded
Adulterated iior iiMisbranded?:
Packaging iifails iito iiidentify iiname ii& iiaddress iiof iimanufacturer, iipackager iiof
iidistributor, iiand iiquantity iiof iidrug ii- iiAnswers ii-Misbranded
Adulterated iior iiMisbranded?:
Any iiword iior iistatement iirequired iion iilabel iiis iinot iiprominent, iiconspicuous iiand
iireadable ii- iiAnswers ii-Misbranded
Adulterated iior iiMisbranded?:
Drug iihas iihabit-forming iisubstance iiand iilabel iifails iito iilist iiname iiand iiproportion iiof
iisubstance iiand ii"Warning—may iibe iihabit iiforming" ii- iiAnswers ii-Misbranded
Adulterated iior iiMisbranded?:
If iiestablished iiname iior iimutli-ingredient iiproducts iidon't iiidentify iieach iiactive iiingredient
ii- iiAnswers ii-Misbranded
Adulterated iior iiMisbranded?:
Drug iiis iiliable iito iideterioration iiand iilabel iidoesn't iiwarn iito iithat iieffect ii- iiAnswers ii-
Misbranded
Adulterated iior iiMisbranded?:
Misleading iicontainer, iiimitates iianother iidrug iior iioffered iifor iisale iiunder iithe iiname iiof
iianother iidrug ii- iiAnswers ii-Misbranded
Adulterated iior iiMisbranded?:
Dosage, iifrequency, iiduration iior iiroute iiof iiadmin iisuggested iiin iithe iilabeling iiis
iidangerous ii- iiAnswers ii-Misbranded
Adulterated iior iiMisbranded?:
Pharmacist iidispensed iia iimedication iiwithout iia iirefill iior iiprescription ii- iiAnswers ii-
Misbranded
,Adulteration ii- iiAnswers ii-Failure iiof iidrug iior iidevice iito iisatisfy iiFDA iipurity iistandards
Adulterated iior iiMisbranded?:
Consists iiin iiwhole iior iiin iipart iiof iifilthy, iiputrid iior iidecomposed iisubstance ii- iiAnswers ii-
Adulterated
Adulterated iior iiMisbranded?:
Prepared, iipackaged iior iiheld iiunder iiunsanitary iiconditions, iiwhereby iiit iiMAY iihave
iibecome iicontaminated iiw/ iifilth iior iiMAY iihave iibeen iirendered iiinjurious iito iihealth
ii(don't iihave iito iiprove, iijust iisay iiit iiMAY iihave) ii- iiAnswers ii-Adulterated
Adulterated iior iiMisbranded?:
Drug iiis iimanufactured iiin iifacility iiin iiviolation iiof iicGMPs ii- iiAnswers ii-Adulterated
Adulterated iior iiMisbranded?:
Container iiis iicomposed iiof iipoisonous iior iideleterious iisubstance iithat iimay iirender
iicontains iiinjurious iito iihealth ii- iiAnswers ii-Adulterated
Adulterated iior iiMisbranded?:
Bears iiunsafe iicolor iiadditive iifor iipurposes iiof iicoloring iionly ii- iiAnswers ii-Adulterated
Adulterated iior iiMisbranded?:
Drug iilabeled iiin iiofficial iicompendium iibut iistrength iidiffers iifrom iior iiquality iior iipurity
iifalls iibelow iicompendium iistandards ii- iiAnswers ii-Adulterated
Adulterated iior iiMisbranded?:
Drug iinot iilisted iiin iiofficial iicompendium iiand iiits iistrength iidiffers iifrom iior iiits iiquality iior
iipurity iifalls iibelow iiwhat iiis iirepresented iion iilabel ii- iiAnswers ii-Adulterated
Adulterated iior iiMisbranded?:
Any iisubstance iimixed iiw/ iithe iidrug iito iireduce iistrength, iior iiany iisubstance iithat iihas
iibeen iisubstituted iifor iithe iidrug ii- iiAnswers ii-Adulterated
Adulterated iior iiMisbranded?:
Pharmacist iidispenses iiexpired iiproducts ii- iiAnswers ii-Adulterated
Labeling ii- iiAnswers ii-Anything iiaccompanying iithe iiproduct ii(ex: iipackage iiinsert, iimed
iiguide, iiadvertisements, iiphysician's iidesk iireference, iiside iieffects iistatement,
iipromotional iimaterial, iithe iiactual iilabel, iietc.)
OTC iiLabeling ii- iiminimum iifont iisize? ii- iiAnswers ii-Size ii6
Federal iiFood iiDrug ii& iiCosmetic ii(FDC) iiAct ii- iiAnswers ii--Required iinew iidrugs iito iibe
iishown iisafe iibefore iimarketing
-Authorized iifactory iiinspections
,Prescription iiDrug iiMarketing iiAct ii- iiAnswers ii--Bans iithe iisale iiof iisamples
-Requires iidrug iiwholesalers iito iibe iilicensed iiby iithe iistates
-Restricts iireimportation iifrom iiother iicountries
Michigan iiBoard iiof iiPharmacy iiMembers ii- iiAnswers ii-11 iimembers ii- ii6 iiRPh iiand ii5
iiPublic
Michigan iiBoard iiof iiPharmacy iiDisciplinary iiSubcommittee ii- iiAnswers ii--2 iipublic iiand
ii3 iiprofessional iimembers
-Vote iion iidisciplinary iiactions
-Must iihave ii1 iipublic iimember iito iivote iialong iiwith iithe iimajority iifor iia iidecision iito iibe
iimade ii(gives iithe iipublic iimembers iia ii"super iivote")
Package iiInsert ii- iiAnswers ii--Contains iiessential iiinformation iifor iisafe iiand iieffective
iiuse iiof iithe iidrug ii(Ex. iiBlack iiBox iiWarnings)
-Can iigive iito iithe iipatient
Patient iiPackage iiInsert ii- iiAnswers ii--Community iior iioutpatient iipharmacies iimust iigive
iiwith iievery iidispensing ii
-Institutional iilaw: iimust iibe iigiven iibefore iithe iifirst iiadministration iiand iievery ii30 iidays
-Physician iicanNOT iiopt iiout iifor iia iipatient
-It iiis iiconsidered iimisbranded iiif iinot iigiven
Medication iiGuide ii- iiAnswers ii--Required iiby iiFDA iion iicertain iiproducts iithat iicause ii"a
iiserious iiand iisignificant iipublic iihealth iiconcern" ii
-Required iiin iithe iicommunity iisetting iiwith iiEVERY iidispensing ii(misbranded iiif iinot
iigiven)
-Physician iiCAN iirequest iithe iipatient iidoes iinot iireceive iione iibut iipatient iican iioverride
iithis iirequest
-Institutional iisetting: iiit's iiunnecessary iito iidispense iib/c iithere's iia iiprofessional
iiavailable iiat iiall iitimes iito iianswer iiquestions.
Consumer iiMedication iiInformation ii- iiAnswers ii--Not iia iirequirement
-It's iiprinted iiconsumer iimedication iiinformation iiprovided iito iipatients iiat iithe iitime iia
iinew iiRx iiis iifilled
HIPAA iiPrivacy iiPolicy ii- iiAnswers ii--Notice iigiven iito iievery iiindividual
-Good iifaith iieffort iito iiobtain iithe iipatient's iiwritten iiacknowledgment iiof iithe iireceipt iiof
iithe iinotice
OBRA ii90 iiand iithe iiMichigan ii"counseling iirule" ii- iiAnswers ii--OBRA ii90: iiRequires
iipharmacists iito iioffer iito iicounsel iiALL iiMedicaid iipatients iior iicaregiver iion iithe iifirst iifill
iiof iia iinew iimedication ii(and iion iirefills iiif iideemed iinecessary)
-Counseling iiRule: iiMichigan iirequires iithe iiALL iipatients iior iicaregiver ii(regardless iiof
iiinsurance iicarrier) iibeing iicounseled iion iithe iifirst iifill iiof iia iinew iimedication.
, -NOTE: iiInfo iishall iibe iiprovided iiif iirequested iifor iiany iiRx iiby iithe iipatient iior iipatient's
iicaregiver iior iiagent
OBRA ii90: iiItems iito iidiscuss iiwith iipatient ii- iiAnswers ii--Name iiand iidescription iiof iithe
iimedication
-Route, iidosage iiform, iidosage, iiand iiduration iiof iidrug iitherapy
-Special iidirections iiand iiprecautions
-Common, iisevere iiside iieffects iior iidrug iiinteractions
-Techniques iifor iiself-monitoring iidrug iitherapy iiand iiactions iirequired
-Proper iistorage
-Prescription iirefill iiinformation
-Action iito iibe iitaken iiin iithe iievent iiof iia iimissed iidose
OBRA ii90: iiItems iineeded iifor iimaintaining iirecords ii- iiAnswers ii--Name, iiaddress,
iiphone iinumber, iiDOB ii(or iiage), iigender
-RPh iicomments iirelevant iito iithe iiclient's iidrug iitherapy
-Patient iihistory iiwhen iisignificant, iidisease iistates, iiknown iiallergies, iiand iidrug
iireactions
-Comprehensive iilist iiof iimedications iiand iirelevant iidevices
-Offer iito iicounsel iithe iipatient—they iican iiaccept iior iireject iithe iioffer
Drugs iiExempt iifrom iiChildproof iiPackaging ii- iiAnswers ii-Sublingual iiNitroglycerin,
iiPotassium iisupplements, iiIsosorbide iidinitrate ii10mg iior iiless ii(SL iior iichewable),
iiErythromycin, iiAnhydrous iicholestyramine ii(powder), iiSodium iiFluoride,
iiBetamethasone, iiMebendazole, iiCholestipol, iiPrednisone, iiNorethindrone iiacetate,
iiMedroxyprogesterone, iiSucrase, iiMethylprednisone, iiPancrelipase, iiOral
iicontraceptives ii/ iiEstrogen iireplacement iitherapy ii(HRT)
NDC iiNumber iiRequirements ii- iiAnswers ii-Required iion iiall iiRx iiand iiOTC iiproducts
When iican iinon-child iiresistant iipackaging iibe iiused? ii- iiAnswers ii--Dispensing iito
iipatients iiin iia iinursing iihome/hospital
-Drugs iito iibe iiadministered iiby iiinstitutional iipersonnel
-Samples, iiStarter iipacks
-Topical iiapplication
-Dosage iiform iinot iiintended iifor iioral iiadministration
-Bulk iicontainers iireceived iiby iithe iipharmacy
-Unit iidose iipackaging ii(birth iicontrol)
-Patient, iiphysician, iior iicaregiver iican iirequest iiexemption
Adulterated iior iiMisbranded?:
Re-selling iia iirepackaged iimedication ii- iiAnswers ii-Misbranded
Unit iidose iipackaging iiexpiration iidates ii- iiAnswers ii-6 iimonths, iior ii25% iiof iithe
iiremaining iitime iibetween iithe iidate iiof iirepackaging iiand iithe iioriginal iiexpiration iidate....
iiwhichever iicomes iifirst
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