University of MississippieGrove
Honors Theses Honors College (Sally McDonnell BarksdaleHonors College)
2016
Patient Experiences with Small-Scale PharmacyCompoundingMorgan CawthonUniversity of Mississippi. Sally McDonnell Barksdale Honors College
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Recommended CitationCawthon, Morgan, "Patient Experiences with Small-Scale Pharmacy Compounding" (2016). Honors Theses. 718.https://egrove.olemiss.edu/hon_thesis/718
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©2016
MorganCawthon
ALLRIGHTSRESERVED
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ACKNOWLEDGEMENTS
Firstandforemost,IwouldliketoacknowledgeDr.ErinHolmes.Withoutherguidanceandhelp,Iwouldhavebeenlostthroughoutthewholeprocess.Iamveryappreciativeofhersupportforthisproject,aswellasallofmyotheracademicendeavorsoverthepastfewyears.IappreciateDr.ShermanandDr.West-Strumforbeingmysecondandthirdreaders,respectively.Dr.Shermanwasagreatresourceindecidingfromwhatanglestoanalyzemydata.IwouldliketoacknowledgethecustomersofCandCDrugsthatchosetoparticipateintheprojectbycompletingthesurvey.Theirwillingnesstohelpmadeallthedifferenceinthesuccessofthisproject.Withouttheirinput,theprojectwouldnothavebeenpossibleandtheiropinionsaregreatlyvalued.IwouldalsoliketothankcompoundingpharmacistsScottValleeandDarrellPestafortheirtime,byallowingmetoconductinterviewstogaintheirperspectivesonpharmacycompoundingandpatientperceptions.Yourresponsesallowedmetoconsiderhowperceptionsmaychangeasgeographiclocationofthepatientdiffers.IwouldliketoacknowledgetheUniversityofMississippiSchoolofPharmacyandSallyMcDonnellBarksdaleHonorsCollege.Theacademicchallengesandopportunitiesofferedtobethroughoutthepastfouryearshaveallowedmetopursuethisresearchopportunity.Iamveryappreciativeoftheendlesssupportfrommyfamilyandfriendsoverthecourseofthisproject,aswellasineveryacademicendeavorIdecidetotackle.
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ABSTRACT
MORGANALEXISCAWTHON:PatientExperienceswithSmall-ScalePharmacy
Compounding
Investigatorsexaminedpatients’use,knowledgeandperceptionsof
pharmacycompoundingatanindependentcompoundingpharmacyinMandeville,
Louisiana.Datawerecollectedusingaself-administeredsurveythatpatientscould
completeinhard-copyinthepharmacyorathome,oronlineusingQualtrics.
Investigatorsfoundthat,insomeinstances,patientswhousecompounded
medications,orhaveamemberoftheirhouseholdwhousescompounded
medications,maybemoreknowledgeableorhavemorepositiveperceptionsof
compoundedmedications.However,patientswhodidnothaveexperiencewith
compoundswerenotunknowledgeableaboutthepracticeanddidnotreportany
negativeperceptionsofcompounding.Theseoverallpositiveperceptionsandhigh
levelofknowledgeaboutcompoundedmedicationsmaybeaproductofthisspecific
pharmacy,andtheculturethatthecompoundingpharmacisthascreatedthere,but
further,in-depth,longitudinal,quantitative,andqualitativeresearchisneededto
confirmthesefindings.Furthermore,researchisneededtodetermineifthistrendis
seeninothercompoundingpharmacies,andforotherpharmacyservices.Future
confirmationofthesefindingshassignificantimplicationsforpharmacists,andhow
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theculturetheycreateintheirpharmacycanleadtoenhancedknowledge,positive
perceptions,andincreasedsatisfactionamongpatients.
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TABLEOFCONTENTS
LISTOFTABLES…………………………………………………………………………………………………vii
LISTOFFIGURES………………………………………………………………………………………………viii
LISTOFABBREVIATIONS…………………………………………………………………………………….iv
INTRODUCTION…………………………………………………………………………………………………...1
BACKGROUND……………………………………………………………………………………………………..4
METHODS………………………………………………………………………………………………………….15
RESULTS……………………………………………………………………………………………………………19
DISCUSSION…………………………………………………………………………………………………….…37
REFERENCES……………………………………………………………………………………………………..42
APPENDICES……………………………………………………………………………………………………...45
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LISTOFTABLES
Table1: DemographicCharacteristics
Table2: RecipientsofCompounds
Table3: NumberofCompoundsReceivedinthePastYear
Table4: TypesofCompoundsReceived
Table5: RespondentReasonsforUsingCompounds
Table6: LegallyAcceptableUsesforCompoundedMedications
Table7: RespondentSatisfactionwithCompoundedMedication
Table8: RespondentAgreementwithStatements
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LISTOFFIGURES
Figure1: LegallyAcceptableCompoundUsePerceptions
Figure2: FamiliaritywithNECCOutbreak
Figure3: FamiliaritywithPharmacyCompounding
Figure4: FamiliaritywithPharmacyCompoundingamongCompoundUsers
Figure5: FamiliaritywithPharmacyCompoundingamongCompoundNon-
Users
Figure6: SupportforPharmacyCompounds(AllRespondents)
Figure7: SupportforPharmacyCompoundsbyCompoundUsers
Figure8: SupportforPharmacyCompoundsbyCompoundNon-Users
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LISTOFABBREVIATIONS
FDA FoodandDrugAdministration
BHRT BioidenticalHormoneReplacementTherapy
NECC NewEnglandCompoundingCenter
ASHP AmericanSocietyofHealth-SystemPharmacists
FDAMA FoodandDrugAdministrationModernizationAct
USP UnitedStatesPharmacopeia
USPC UnitedStatesPharmacopeialConvention
FDCA Food,DrugandCosmeticAct
TPN TotalParenteralNutrition
CPG CompliancePolicyGuide
ACOG AmericanCollegeofObstetriciansandGynecologists
PPI PatientPackageInsert
DQSA DrugQualityandSecurityAct
IRB InstitutionalReviewBoard
MTM MedicationTherapyManagement
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INTRODUCTION
AccordingtotheFoodandDrugAdministration(FDA),prescription
compoundingisdefinedas“apracticeinwhichalicensedpharmacist,or…aperson
underthesupervisionofalicensedpharmacist,combines,mixes,oralters
ingredientsofadrugtocreateamedicationtailoredtotheneedsofanindividual
patient”(FoodandDrugAdministration,2013).TheDrugQualityandSecurityAct
definescompoundingas“thecombining,admixing,mixing,diluting,pooling,
reconstituting,orotherwisealteringofadrugorbulkdrugsubstancetocreatea
drug”(PharmaceuticalCompoundingQualityandAccountabilityAct,2013).Darrell
Pesta,apharmacistintheBostonareadescribesitas“makingstuffthatdoesn’t
exist,”andScottVallee,apharmacistinsouthernLouisianadescribeditas“theart
andscienceofcreatingpersonalizedmedicationbasedonprescriptionsfrom
practitioners”(personalcommunications,December16,2014,March20,2015).
Prescriptioncompoundingisawideandvariedfieldthathasgrowninpopularityin
recentyears,andmanyofitsaspectsarenotasconcreteandwellknownasmore
traditionalprescriptiondispensing,asshownbythemultipledefinitionsthatcanbe
usedtodescribethepracticeofcompounding.
Inthe1800s,compoundingwascommonpracticeforapharmacist,ifnotthe
mainportionofhisjob.Then,intheearly1900s,theindustrialrevolutionhit,and
medicationsbegantobeproducedinlargequantitiesinmultiplestrengthsand
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doses(Peterson,2014).Thisleftthepharmacistwithlittlecompoundingtodo,as
therewasnotmuchneedforindividualmedicinepreparationsforindividual
patients.Asaresult,prescriptioncompoundingdecreasedinpopularityand
prevalenceuntilaboutthe1990s.Atthatpoint,interestincompoundingwas
rekindledwiththegrowingdemandforveterinarypreparationsaswellas
“BioidenticalHormoneReplacementTherapy,”alsoknownasBHRT,forthe
treatmentofmenopauseinwomen.Bothofthesehaveremainedasmajormarkets
forcompoundedmedicationstothisday,with“upwardsoftwomillionwomenin
theUS[usingcompoundedhormones]onadailybasisforreliefofsymptoms
associatedwithmenopauseandperimenopause”(Benda,2006).Aswomen,along
withmanyotherdemographicgroups,andpetsbenefittedforyearsfromthefact
thattheirmedicationscouldbetailoredtotheirneeds,misfortunestruckthe
compoundingindustryin2012withthefungalmeningitisoutbreakfromtheNew
EnglandCompoundingCenter(NECC).BetweenMayandOctoberofthatyear,vials
ofcompoundedmethylprednisoloneinjectionswereinadvertentlycontaminated
withthefungusanddistributedtootherstates(Peterson,2014).Thiswasnotthe
firstcontaminationeventtooccurinthefieldofcompounding,butitcertainlygot
themostpressandmediaattention.Asaresult,thereactiontocompoundingbythe
publicwasnotagoodone.Eventoday,morethantwoyearsafterthecases
occurred,manypatientsarewaryofcompoundingandcompoundedmedications.
Inordertoexplorepatientperspectivesofcompoundedmedications,
searchesweredoneinanefforttoidentifypreviousstudiesofpatients’experiences
withcompounding—specificallysmall-scalecompoundingdoneforindividual
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patientsincommunitypharmacies.Nostudieswereidentifiedfromthepatient’s
perspective,sotheliteraturereviewedforthisstudyfocusedonthehistoryof
compoundingandthecompoundingregulationsthathavebeenleviedoverthe
years.Theobjectivesofthisstudyare:
1. Todescribetheprevalenceofcompoundedmedicationusebyrespondents
inalocalcommunitypharmacy.
2. Todeterminethetypesofcompoundsrespondentsuse,aswellaswhy
respondentsusecompounds.
3. Toexaminepatientknowledgeandfamiliarityofsmall-scale,personal
compoundingdoneinalocalcommunitypharmacy.
4. Toexaminepatientsatisfactionandperceptionsofsmall-scale,personal
compoundingdoneinalocalcommunitypharmacy.
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BACKGROUND
DefiningCompounding
Compoundingisafieldthatisnotverywellunderstood,muchlesseasyto
define.Thereappearstobeafinelinebetweencompoundingandmanufacturingof
prescriptions,aswellasquestionsaboutwhethersomethingassimpleas
reconstitutingaretailantibioticsuspensionisconsideredtobe“compounding.”
AccordingtotheAmericanSocietyofHealth-SystemPharmacists(ASHP),
compoundingisaprocesswhere“amedicinehastobecreatedbecausethestrength,
concentration,ordosageformthatisneededforaspecificpatientisnot
commerciallyavailable,”andisunderthesupervisionofstateboardsofpharmacy,
ratherthanthefederalgovernment(Flaker,2012).Withthisdefinition,simple
processeslikereconstitutinganantibioticormixingaMagicMouthwasharenota
formofcompoundingbecausethemedicationsarecommerciallyavailable
preparations.Manufacturing,astermedbyASHP,is“thepreparationoflarge
quantitiesofmedicationwithaprocessthatisapprovedandregulatedbytheU.S.
FoodandDrugAdministration(FDA).Underthisprocess,manufacturersmust
complywithfederalqualityandsafetystandards”(Flaker,2012).
Evenwhenmakingamedicationspecificforapatient,therearecertain
criteriathatmustbemet.Thecompoundmustbemadeforanethical,approveduse,
onlyapprovedingredientsmaybeused,andonlycertainamountsmaybemadeina
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singlesitting(Allen,2003).Medicationscanonlybecompoundedforapatientifthe
medicationthatthepatientrequiresisnotalreadycommerciallyavailable,orif
whatiscommerciallyavailableisnotsuitableforthepatient.Allergiesoradverse
reactionstoinactiveingredientslikedyes,preservatives,orfillersareacceptable
usesforcompounding.Itcanalsobeusedifaspecificdosagestrengthordosage
routeisnotcommerciallyavailable,orifthephysicianprescribesamedicationin
whichmultiplecommerciallyavailableproductsarecombinedintoasinglecapsule
orcream,tobeadministeredtogether(personalcommunication,March20,2015).
Therearealsomedicationsthathavemultipleclinicaluses,butonlyoneuseisFDA
approvedasanindication.Inthiscase,acompoundcanonlybemadeforthe
indicateduse.Forexample,domperidonehasaFDA-approveduseisasa
gastrointestinalaidtoincreaseGImovementandpreventnauseaandvomiting,but
therearestudiesthatshowthatitcanbeusedtoincreaselactationinwomen.This
howeverwasfoundtocausedangerousheartproblemsinnursingwomen,sothe
FDAremoveditasanacceptablemedicationforwomenwhoarenursing(Foodand
DrugAdministration,2013).Asaresult,onlyprescriptionsfordomperidonefrom
gastroenterologistsareacceptedasanappropriateordertocompoundthe
medication.Compoundsmustalsoconsistentirelyofapprovedingredients.TheFDA
ModernizationActof1997(FDAMA)legislatedthat“compoundingmustbedone
usingingredientsthathadUSPharmacopeia/NationalFormulary(USP/NF)
monographs,werecomponentsofcommercialproducts,orappearedonalistof
approvedbulkdrugsubstancesthatwastobedevelopedbytheFDA”(Allen,2003).
Estriol,anestrogenproductusedinthetreatmentofmenopause,isaningredient
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affectedbythislaw.TheFDAstatesthatonlypharmacieswithvalidinvestigational
newdrugapplicationsmaycompoundmedicationscontainingtheestrogen
substance(2013).Ingredientsthatprovetobedifficultorpotentiallydangerousto
compoundarealsonotapproved.Compoundingpharmacistsarealsolimitedtothe
amountofacompoundtheycanmakeatonetime.Legally,thequantityofthe
compoundedmedicationmadeisonlytobesufficientfortheindividualpatient
prescriptionforwhichthephysicianwrote.Theserestrictionsarealsooutlinedby
theFDAMA,statingthatapharmacistcouldnotcompounddrugproductsthatwere,
forintentsandpurposes,copiesofcommerciallyavailableproducts,drugsthat
couldpresent“demonstrabledifficultiesforcompounding,”andmaynotusean
ingredientthatisonalistofingredientsthathasbeenremovedfromthemarketfor
efficacyorsafetyreasons(Allen,2003).Forthisreason,compoundsmustbemade
insmall,patient-specificbatches,withnoexcesstobesavedforuseatalaterdate.
HistoryofCompoundingRegulation
Thehistoryofcompoundingregulationismuchmoreextensivethan
determiningappropriateingredients,uses,andquantities.Thepracticeof
compoundinghasbeenaroundsincethemedievaltimes,whenmedicationswere
madeoffatsandherbsinindividualdoses,onlywhenrequestedbyadoctor,fora
singlepatient.Thelate1700sandearly1800sbroughtwithittheIndustrial
Revolution,whichputcompoundinglargelyonhold.TheIndustrialRevolutionsaw
theriseofdrugmanufacturingcompanies,churningoutcopiousamountsofdrugs
offeredinonlyoneortwostrengths,makingtheprocessofprovidingmedication
morestandardizedandeconomicalthanpreparingindividualizedcompounds
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(Petersen,2014).In1820,theUnitedStatesPharmacopoeia(USP)wasestablished
withtheintentofsetting“standards(forquality,strength,purity)fordrugproducts
thatwereprescribedbyphysiciansandprepared(compounded)bypharmacists”
(Allen,2003).TheUSPwasuseduntiltheearly1900sasthestandardfor
pharmaceuticalcompoundingintheUnitedStates,mainlywithregardtonatural
ingredients.AnofficialsetofqualityandpuritystandardswassetfortheUnited
Statesin1906withtheUSPharmacopeialConvention(USPC),andisstillineffect
today,supplementedbymorerecentlegislation.Chapters795,797,1075,and1160
oftheUSPCpertaindirectlytocompoundingingredientsandpracticesforsterile
andnon-sterilecompounding(Allen,2003).ThePureFoodandDrugActwasalso
passedin1906,andwasdesignedtoregulatetheshiftthatthepharmaceutical
industrywasexperiencingfromsmall-scalecompoundingofmedicationstolarge
scalemanufacturingpractices(Petersen,2014).
In1938,thePureFoodandDrugActwasreplacedbytheFood,Drugand
CosmeticAct(FDCA),whichplayedalargeroleinsettingupthecurrentUSFood
andDrugAdministration,orFDA(Pergolizziet.al,2013).Thisallowed
compoundingtobeusedasawayfordoctorsto“specialorder”medicationsthat
werenotcommerciallyavailableforapatient,inorderforthepatienttoreceive
optimaldosing.Pergolizzistatesthatthisiswhenpediatricmedicationincreasedin
popularity,becausedoctorswerenolongertiedtothepill-formdosagesthatwere
toostrongforinfants(2013).Theycouldhavethedosagescut,orthemedication
madeintoaliquid,inordertofacilitatetheneedsofthechild.TheFDCAalsostated
thatcompoundingpharmacies,unlikedrugmanufacturers,werenotunderthe
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regulationsoftheFDA,becausetheywerenotactuallymanufacturingdrugs,dueto
thesmallbatchsizes.Instead,compoundingpharmaciesweredeemedtobe
regulatedbystateboardsofpharmacy,unlessamanufacturing-typeoffensewere
committed,whichwouldallowtheFDAtointervene(Pergolizziet.al,2013).
The1960sand70sopenedupdoorstonewtypesofcompounding.As
technologyadvanced,thepossibilityformedicationstobeofferedinsingle-dose
vialsandsyringesaroseandbecameverypopular.Byonlyusingasyringeorvial
once,thesterilityofthedrugcouldbebetterguaranteedthanthatofamulti-use
vial.Thisideawonfavoramongdoctors,nurses,andpatients,andthecompounding
ofTPNs,andrepackagingofmedicationintosingle-useadministrationsbecame
moreofacommonpractice(Pergolizziet.al,2013).Inthe1990s,veterinary
compoundsandBioidenticalHormoneReplacementTherapies(BHRT)becamea
hotnewtopicinthecompoundingindustry.Veterinarianshadtheabilitytowrite
prescriptionsforananimal,usinghumanmedicationswithaltereddosages,fillers,
orflavorings.Studiesshowthatthe1990sarealsowhenpeoplebegantospend
moremoneyontheirpetswithfancyoutfitsandtoys,specialtyveterinarians,as
wellasmedicationsbettertailoredtotheiranimals(Petersen,2014).Petersenalso
sharesthatcompoundedhormonetherapyalsobecamemorepopularinthe90s,as
itofferedwomen,aswellasmen,manymorehormoneoptionsthantheselectfew
thatwerecommerciallyavailable,andphysicianscouldmorespecificallytargetthe
causesorsymptomsofthepatient’shormoneimbalances(2014).
1992broughtthenextroundofcompoundingregulations,withtheFDA
publishingitsfirstCompliancePolicyGuide,orCPG.Becauseitwaspublishedbythe
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FDA,wholegallydidnothavejurisdictionovercompoundingpharmacies,theguide
wasnotenforceable,butprovidedverydetailedguidelinesonexpectedprocedures
andpracticesinacompoundingpharmacy(Allen,2003).AllenstatesthattheCPG
explainedthecriteriathatwouldclassifyapharmacyasamanufacturerversusa
compoundingpharmacy,andwouldthereforemaketheestablishmentsubjectto
regulationbytheFDA,ratherthanthestateboardofpharmacy(2003).In1997,
officiallegislation,bythenameoftheFoodandDrugAdministrationModernization
Act(FDAMA),waspassedandallowedtheFDAtohaveabiggerroleinthe
regulationofcompounding,declaringittheofficialregulatoryboard,ratherthanthe
stateboardsofpharmacy(Petersen,2014).Withtheirnewauthority,theFDAbegan
toinvestigatepharmaciesthattheyfeltwere“manufacturingundertheguiseof
compounding”(Allen,2003).Thiswasamajorchangeforcompoundingpharmacies,
andmanyofthemchallengedtherestrictions,withafewcasesmakingittotheUS
SupremeCourt(Petersen,2014).ThepassageoftheFDAMAwashelpfulto
compoundingpharmacieswithregardtoNewDrugApplications,however.TheAct
declaredthatifthenewprescriptionisbeingcompoundedbasedoffofaphysician’s
orders,forasinglepatient,thenthenewdrugrequirementsdonotapplytothat
drug(Allen,2003).
Thepracticeofcompoundinghasdealtwithmorethanthepassageofafew
lawsovertheyearsandhashaditsshareofoutbreaksandmediaattentionaswell.
Thefirstwasin2002,withafungalmeningitisoutbreakfollowingthe
administrationofinjectionsthatwerefoundtobecontaminatedwithExophiala
dermatitidisfromacompoundingpharmacyinNorthCarolina,killing6patients
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(Pergolizziet.al,2013).TheFDAhasalsodealtwithcomplaintsfromthedrug
manufacturers,inregardstocompounding.WyethPharmaceuticals,the
manufacturersofthecommerciallyavailablehormonereplacementdrugsPremarin
andPrempro,putpressureontheFDAtodelvedeeperintotheregulationsinplace
regardingpharmacistsmakingBHRTdrugs.Themanufacturerarguedthatwas
stealingasignificantportionoftheirFDA-regulatedbusiness,partlybecausethose
pharmaciesdidnothavetoanswertoFDAregulation(Benda,2008).Atthecenter
ofthedisputewastheterm“bioidentical,”whichcompoundingpharmaciesusedto
describetheirhormonereplacementtherapies.TheEndocrineSocietydefines
“bioidentical”pertainingtohormonecompoundsas“compoundsthathaveexactly
thesamechemicalandmolecularstructureashormonesthatareproducedinthe
humanbody”(Fileset.al,2011).Similarly,theAmericanCollegeofObstetricians
andGynecologists(ACOG)statesthat:
Bioidenticalhormonesareplant-derivedhormonesthatare
chemicallysimilarorstructurallyidenticaltothoseproducedbythe
body.Bioidenticalhormonesincludecommerciallyavailableproducts
approvedbytheU.S.FoodandDrugAdministration(FDA),suchas
micron-izedprogesteroneandestradiol,aswellascompounded
preparationsthatarenotregulatedbytheFDA(2012).
Wyethwasarguingthatcompoundingpharmaciesthatwereofferingoradvertising
“bioidentical”hormonetherapiesweretakingalargeportionoftheirbusiness,
falselyadvertisingthebenefitsofcompoundedhormonesversusmanufactured
ones,andbecausetheywerenotregulatedbytheFDA,weregettingawaywithit
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(Benda,2008).InOctoberof2005,WyethPharmaceuticalssubmittedacitizen’s
petitiontotheFDA,askingtheFDA,amongotherthings,toclassifycompounded
BHRTproductsas“newdrugs,”makingthemsubjecttoallofthesameFDAcriteria
thatWyethwassubjectto(Benda,2008).Inhisarticle,WilliamBendastatesthat
thepetitionaskedforenforcementagainstpharmaciststhatwerecompoundingor
advertisingBHRTproductsandwereinviolationoftheFDCA,forinvestigationinto
whethercompoundingpharmaciesweredispensingPPIsandfactsandrisk
informationwiththeircompounds,forcompoundingpharmaciststoberequiredto
disclosecertainthingsontheirBHRTlabels,andforanotherCPGtobeissued
discussingtheconcernsassociatedwithBHRTmedications(2008).Thepetition
madeitallthewaytotheSupremeCourt,wherealloftherequestsmadebyWyeth
Pharmaceuticalsweredenied,particularlytheonerequestingthatcompounded
BHRTsbesubjecttonewdrugtesting.Thecourt’srulingwasthat“itwouldnot
makesensetorequirecompoundeddrugscreatedtomeettheuniqueneedsof
individualpatientstoundergothetestingrequiredforthenewdrugapproval
process…requiringsuchtestingwouldforcepharmaciststostopproviding
compoundeddrugs”(Benda,2008).Furthermore,Bendastatesthatmanypatients
andphysiciansweredocumentedasbeingonthesideofthecompoundedBHRT
prescriptions,ratherthanthecommerciallyavailableones,likethosemanufactured
byWyeth,amongothers(2008).
Thecompoundingindustryremainedoutbreak-freeuntil2011,when
multiplecasesofSerratia,causedbythebacteriaSerratiamarcescens,were
determinedtohavebeenlinkedtocontaminatedtotalparenteralnutrition(TPN)
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bagsthatwerecompoundedbyapharmacyinAlabamaanddistributedinthe
surroundingareas(Pergolizziet.al,2013).In2012,therewasamulti-state
outbreakofendopthalmitis,tracedbacktocontaminatedvialsofintraocular
injectionsofbevacizumab,alongwiththewell-knownfungalmeningitisoutbreak
tracedbacktotheNewEnglandCompoundingCenter(NECC)(Pergolizziet.al,
2013).TheNECCcontaminationeventisthemostinfluentialoftheseoutbreaks,due
tothelargeamountofmediaattentionthatitgot,andthevastareathatthe
infectionscovered.BecausetheNECCisamanufacturerofcompounded
medications,likethemethylprednisolonevialsthatwereaffected,itsproductswere
shippedoutsidethestatesborders,puttingmorethanjustthecustomersof
Massachusettsatriskofinfection.TheNECCoutbreakreceivedsuchasignificant
amountofmediaattentionduetothelargenumberofdeathsandhospitalizations
caused.Theinjections,contaminatedwiththeExserohiliumrostratumfungi,were
administeredinthespinalcordsofpatients,givingthefungusaccesstothe
meninges,causingfungalmeningitis,whichisverydifficulttotreat(Centersfor
DiseaseControl,2013).Becauseofthegeographicalspreadoftheinfectedvials,and
theprolonged,intensemediaexposurethatthesituationreceived,havocbrokeout
intheUnitedStatesformultiplemonthsasnewcasespoppedupacrossthenation.
InresponsetothechaosandworrythatwascausedbytheNECCevent,the
FDAissuedtheDrugQualityandSecurityAct(DQSA)in2013.Thelegislation
distinguishesbetweenacompoundingpharmacyandcompoundingmanufacturers,
“whichmakesterileproductswithoutorinadvanceofaprescriptionandsellthose
productsacrossstatelines”(FoodandDrugAdministration,2013).TheActis
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dividedintotwosections.Thefirstsection,theCompoundingQualityActsetsupa
compliancesysteminwhichcompoundingpharmaciescanvoluntarilydeem
themselvesas“outsourcingfacilities”andbesubjecttothesamesupervisionbythe
FDAaspharmaceuticalmanufacturers(Looser,2013).Onceregisteredasan
outsourcingfacility,thecompoundingpharmacymustpayfeestotheFDA,ensure
thatthelabelsontheircompoundedmedicationsclearlyindicatethatthedrugis
compounded,alongwithmanyotherpiecesofinformationforthepatient,andbe
subjecttorisk-basedinspections,initiatedbythecontentsoftheadverseevent
reportsthattheoutsourcingfacilitiesarerequiredtosubmit(McGuire-Woods,
2013).TheActalsostatesthattheFDAwasintheprocessofdevelopinganewlistof
drugsthatmaynotbeusedincompounds,aswellasbulkingredientsthatwillbe
permitted.ThesecondsectionoftheDQSAistheDrugSupplyChainSecurityAct,
whichrequiresthatallmanufacturersputbarcodesontheirproductsfromthevery
beginningofmanufacturing.Thebarcodecanbeusedtotrackproductsthrough
everystepofthemanufacturingprocess,aswellasthroughthedistributingand
dispensingsteps(FoodandDrugAdministration,2013).
Becauseofalloftheeventsthathaveoccurredrecently,thereisan
understandablepossibilitythatconsumerandpublicopinionsofcompoundinghave
beenaffected.Betweenthenewscoverageandthetalkofnewlegislationasaresult
ofawidespreadcompoundingmanufacturingcontaminationerror,thegeneral
public,alongwithanyhealthcareprofessionalnotfamiliarwithcompounding
practices,receivedaverybiasedanddramatizedrepresentationofthe
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compoundingindustry.Thelastingeffectofthisrepresentationhasyettobe
studied.
15
METHODS
Design
Thisstudywasconductedusinganobservational,cross-sectional,
descriptive,non-experimentalsurveydesign.Across-sectionalstudyisamethodof
datacollection,inwhichalldataaregatheredatonepointintime,ratherthan
multipletimesoveranextendedperiodoftime.
Sample
Thesampleframeforthisstudyconsistedofanypatients,age18orolder,of
CandCDrugsVitalCare,anindependentretailpharmacyinMandeville,Louisiana.
Thissettingwaschosenforthisstudybecause,unliketheotherchainor
independentpharmaciesinthearea,itofferscompoundedmedications.Avarietyof
patientsusethesecompoundedmedications,includingchildren,animals,men,
women,andelderlypatients.Atotalof175papersurveysand1300linkstothe
electronicversionofthesurveyweremadeavailabletopatientsofthepharmacy.
DataCollection
Beforeanysurveyswereadministered,anapplicationforexemptstatuswas
submittedtotheUniversityofMississippiInstitutionalReviewBoard(IRB).The
UniversityofMississippiIRBindeeddesignatedthestudyasexempt,andsurveys
werethenallowedtobedistributedanddatatobecollected.Thestudyofferedtwo
waysinwhichtocompletethesurvey:apapercopythatcouldbefilledoutwhilein
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thepharmacyortakenhomeandbroughtbackatthepatient’sconvenience,anda
websiteaddressthatlinkedtothesurvey,generatedusingQualtrics.Referto
AppendixAforthesurveyquestionsthatwereadministered.Eachformofthe
surveygivenincludedacoverletterexplainingthestudy,andinstructionsonhowto
completeit.RefertoAppendicesBandCfortheseletters.
Thefirstfewquestionsinthesurveywerebasicdemographicquestions,such
asgender,age,ethnicity,education,employmentstatus,andhouseholdincome.The
surveyalsocontainedquestionsaboutpatients’use,knowledgeandperceptionsof
thesmall-scalepharmacycompoundingthatwasdoneatCandCDrugsVitalCare,
thepharmacywheretheygettheirmedicationsfilled.Patientswhohadreceived
compoundedmedications,eitherforthemselves,arelative,achild,orpetwere
promptedtoanswermoredetailedquestionsaboutthekindsofcompoundsthey
received,whattheyunderstoodcompoundedmedicationstobefor,andtheir
opinionsonthecompoundedmedicationstheyhadreceived.Thesurveythenasked
allparticipantsabouttheirperceptionsofthekindofsmall-scalepharmacy
compoundingdoneatCandCDrugsVitalCare,andoftheNewEngland
CompoundingCenterfungalmeningitisoutbreak.Levelsofagreementwereusedin
multiplequestionstodescribelevelsoffamiliarity
DataManagement
Afterclosingdatacollection,surveyscompletedinQualtricswere
downloadedtoanExcel2013spreadsheet.Onthisspreadsheet,investigators
entereddatafromthepapersurveys.Anadditionalfieldwasaddedtothe
spreadsheettoindicatesurveynumbers.Numbersonthespreadsheetmatched
17
numbersthatwereplacedonthepapersurveyinordertoallowtheinvestigatorsto
cross-referencepaperssurveyswiththedatasetasnecessary.Afterallpapersurvey
datawereentered,thedatawasuploadedintoIBMSPSSStatistics22fordata
analysis.
Analysis
SampleDescription.Asampledescriptionwasgeneratedbycalculating
means,frequenciesandpercentagesasappropriateforeachdemographic
characteristicmeasuredamongparticipants.
PrevalenceofCompoundUse.Frequenciesandpercentageswereusedto
describetheprevalenceofcompounduseamongrespondents.
TypesofCompoundsUsed/ReasonsforUse.Frequenciesandpercentageswere
usedtodescribethetypesofcompoundsusedamongrespondentsaswellaswhy
respondentsusecompounds.AChi-SquaretestofIndependencewasconductedto
determineifthetypeofcompoundusedvariedaccordingtopatientage.
KnowledgeandFamiliarity.Patientknowledgeandfamiliaritywereanalyzed
usingfrequencies,percentages,andPearsonChiSquaretestsofIndependence.
Frequenciesandpercentageswereusedtoanalyzequestionsaboutawarenessof
availabilityofcompoundingatCandCDrugsVitalCare,legalusesforcompounding,
andfamiliaritywithcompoundingingeneral,aswellastheNewEngland
CompoundingCenter(NECC)event.ChiSquareanalyseswereconductedtotestfor
differencesinknowledgebetweenrespondentswhoreceivedcompoundsandthose
whodidnotreceivecompoundstodeterminewhetherthedifferencesintheir
knowledgewerestatisticallysignificant.
18
SatisfactionandPerceptions.Patientperceptionswereanalyzedusing
frequenciesandmeans,alongwithChiSquareteststodeterminestatistically
significantdifferencesbetweengroups.Meanswerecalculatedtoestablishan
averagesatisfactionoragreementscoreonquestionsregardingreceiptofa
compoundandpatient-pharmacistrelationshipsrelatedtocompounding.Chi
Squareanalysiswasusedtoexaminestatisticallysignificantdifferencesbetween
thosewhodidanddidnotreceivecompoundswithregardtohowsupportivethey
wereofpharmacycompounding.
19
RESULTS
ResponseRate
Althoughthenumberofpapersurveysandsurveylinksavailableisknown
(175and1300,respectively),itispossiblethatindividualpatientsmayhave
receivedthesurveyorlinkmultipletimesasaresultofmultiplevisitstothe
pharmacy.Therefore,aresponseratewasnotabletobecalculated.Atthe
conclusionofdatacollection,81electronicand60papersurveyswerereceived.Of
the141totalsurveysreceived,7werenotincludedindataanalysisduetothe
surveysbeingincomplete.Therefore,aresulting134totalsurveyswereusedfor
dataanalysis.
SampleDescription
Inordertobetterunderstandsomeofthecharacteristicsofrespondents,
multipledemographicquestionswereasked.Ofthe134completedsurveys,27
(20.1%)werecompletedbymales,and107(79.9%)werecompletedbyfemales.
Theminimumagetocompletethesurveywas18yearsold.Participantagesranged
from18to80yearsofage,withameanageofabout50(49.59)years.Themajority
ofrespondentsreportedtheirraceasCaucasian,with129of134(96.3%)
respondentsdesignatingitastheirnationality.Respondents’highestlevelsof
educationweremorevaried,withBachelor’sdegreeandsomecollegecompleted
beingthemostcommonresponsesat32.1%and23.9%,respectively.Intermsof
20
employmentstatus,47.8%ofrespondentshadfull-timejobs.Whenaskedabout
theirtotalhouseholdincome,only129ofthe134respondentschosetoanswerthe
question.Mostoftherespondentsreportedatotalhouseholdincomeof$80,000per
yearormore.AdditionalsamplecharacteristicscanbefoundinTable1.
Table1:DemographicCharacteristics
Nationality NumberofRespondents(%)African-AmericaAmericanIndian/AlaskaNativeAsian/AsianIndianCaucasian(white)HispanicNativeHawaiian/PacificIslanderOther
2(1.5)0(0)1(0.7)129(96.3)2(1.5)0(0)0(0)
HighestLevelofEducation NumberofRespondents(%)SomegradeschoolSomehighschoolHighschooldiplomaorGEDSomecollegeVocationaldegreeAssociate’sdegreeBachelor’sdegreeMaster’sdegreeDoctoraldegreeProfessionaldegree(MD,etc.)
0(0)3(2.2)26(19.4)32(23.9)4(3.0)5(3.7)43(32.1)11(8.2)5(3.7)5(3.7)
EmploymentStatus NumberofRespondents(%)Full-timePart-timeUnemployedStudentRetiredDisabled
64(47.8)20(14.9)11(8.2)9(6.7)24(17.9)6(4.5)
TotalHouseholdIncome* NumberofRespondents(%)Lessthan$10,000$10,000to$19,999
4(3.0)9(6.7)
21
$20,000to$29,999$30,000to$39,999$40,000to$49,999$50,000to$59,999$60,000to$69,999$70,000to$79,999$80,000to$89,999$90,000to$99,999$100,000to$149,999$150,000ormore
6(4.5)7(5.2)7(5.2)6(4.5)9(6.7)5(3.7)11(8.2)10(7.5)30(22.4)25(18.7)
*Totalnumberofrespondents=129
PrevalenceofCompoundUse
Respondentswereaskedtoindicateiftheythemselves,aspouseor
significantother,achild,apet,ornooneintheirhouseholdhadeverreceiveda
compoundedmedication.Respondentswereaskedtoselectallanswersthat
applied.Themostcommonresponseswere“myself”and“noone,”withfrequencies
of60and50responses,respectively.Therewereatotalof83surveysthatindicated
thattheyeitherreceivedacompoundthemselves,orhadahouseholdmemberthat
gotone,and51respondentsindicatednooneintheirhouseholdhadeverreceiveda
compoundedmedication.Otherdatapertainingtothedistributionofassociation
withcompoundscanbefoundinTable2.
Therespondentsthatreportedhavingahouseholdassociationwith
compoundedmedicationswerethenaskedtocompleteanadditionalsetof
questions.Thesamplesizeforthesequestionswas83(representingthenumberof
respondentsindicatingthatsomeoneintheirhouseholdhasusedacompound),
ratherthan134,usedinpreviousquestions.Theywereaskedtowriteinthe
22
numberofdifferentcompoundsreceivedinthelastyear,notincludingrefills.
Responsesvariedfromzerototen.Aresponseofzeroindicatedthattheyhadgotten
compoundsbefore,justnotinthelastyear.Themajorityofparticipantsreceived
oneortwocompoundsinthelastyear,withthosepercentagesbeing24.6%and
17.9%ofthe83-respondentsamplesize,respectively.Additionaldataonthe
numberorprescriptionspickedupinthelastyearbythosepatientsthatgot
compoundedmedicationscanbefoundinTable3.
Table2:RecipientsofCompounds
CompoundRecipient NumberofRespondents(%)MyselfSpouseorsignificantotherChildPetNoone
60(44.8)17(12.7)15(11.2)17(12.7)50(37.3)
Table3:NumberofCompoundsReceivedinthePastYear
NumberofCompounds NumberofRespondents(%)012345678910
15(18.1)33(39.8)24(28.9)6(7.2)3(3.6)1(1.2)0(0)0(0)0(0)0(0)1(1.2)
23
Patientswhousedcompoundsintheirhouseholdwerealsoaskedtoindicate
howmanyoftheircompoundedmedicationsarecoveredbyinsurance(inother
words,notrunfora“cashprice”).Tencompoundusers(12%)indicatedthatthey
didnothaveinsurancewhile37(46%)indicatedthatnoneoftheircompounds
werecoveredbyinsurance.Twenty-onerespondents(26%)indicatedthatallof
theircompoundswerecoveredbyinsurance.Asmallnumberofrespondents(13)
indicatedthatsomeoftheircompoundsarecoveredbyinsurance.
TypesofCompoundsUsed/ReasonsforUse
Question12askedthoseparticipantsthatgotcompoundsintheirhousehold,
whatkindsofcompoundstheyget,orwhattheindicationsareforthem.Ofthe83
whogotcompounds,33.7%indicatedthattheyorsomeoneintheirhouseholdgota
compoundthatwasabioidenticalhormonecreamorgel,followedby21.7%
respondentshavingboughtacompoundedmedicationfortheirpet.Other
dermatologicoranestheticcreamswerealsocommon,with16.9and15.7%,
respondentsreportinguse,respectively.Additionaldataonwhatkindsof
compoundsrespondentsreportedreceivingcanbefoundinTable4.
Furtheranalysis,usingtheChiSquaretestofIndependencewasperformedto
determineforeachtypeofcompoundlistedinTable4,iftherewasadifferencein
frequencyofusagebasedonage.Toconducttheanalysis,agerangeswereused.
Basedontheirreportedage,respondentswerecategorizedintofouragegroupsas
utilizedbytheCensusBureau(18-24,24-44,45-64,and65+).Notsurprisingly,
24
respondentsinthe45-64agegroupreportedusingmorebioidenticalhormone
creamsthanrespondentsinanyotheragegroup,X2(3,N=134)=18.4,p<.05.
Table4:TypesofCompoundsReceived
KindsofCompoundsReceived NumberofRespondents(%)BioidenticalhormonecapsulesBioidenticalhormonecreams/gelsNasalspraysorirrigationsInfusibleantibioticsorTPNsAnesthetic(painrelief/numbing)Lipbalms(coldsores)DermatologiccreamsGastroenterological(domperidone)MagicMouthwashPetmedicationsTrimixVancomycinTrochesorlollipopsSuppositoriesEyeoreardrops
11(13.3)28(33.7)5(6)4(4.8)13(15.7)4(4.8)14(16.9)5(6)5(6)18(21.7)1(1.2)2(2.4)0(0)2(2.4)3(3.6)
Thosepatientswhohadreceivedcompoundedmedicationsthemselvesorin
theirhouseholdwereaskedtoindicatewhytheyreceivedacompounded
medication.Asindicatedbytheinformationabove,themostcommonreasonsfor
usingcompoundswere“individualizedhormonecombinations”and“drugnot
availableforpharmacytoorder,”with34.9%and30.1%ofrespondentsindicating
thoseastheirreasonsforgettingcompounds,respectively.Anothercommonreason
wastogetthedrugproductintherightdosageform,chosenby26.5%of
respondents.Morethanonereasoncouldbechosen,andsomemayberelatedtothe
25
samecompoundedmedicationusedbythepatient.Additionaldatacanbefoundin
Table5.
Table5:RespondentReasonsforUsingCompounds
ReasonsforUsingCompounds NumberofRespondents(%)IndividualizedhormonecombinationsIndividualizeddosagesforachildIndividualizeddosagesforapetDrugnotavailableforpharmacytoorderProperdosage/strengthnotavailabletoorderMorepersonalpatient-pharmacistrelationshipAllergiestocommerciallyavailabledrugsCombinemultiplemedicationsintoasingledoseAvoidunwantedingredientsDosageformneeds(creamvstablet)PersonalpreferenceInsurancereasonsAdditionofflavoring
29(34.9)10(12.0)17(20.5)25(30.1)12(14.5)5(6.0)4(4.8)16(19.3)13(15.7)22(26.5)9(10.8)2(2.4)4(4.8)
KnowledgeandFamiliarity
ParticipantswereaskediftheywereawarethatCandCDrugsVitalCare
offeredcompoundedmedications.Ofthe134respondents,118respondents,or
88.1%wereawarethatcompoundedprescriptionswereanoption.Ofthese118
respondentsawareofcompoundedprescriptionsatthepharmacy,81ofthose
respondents,or68.6%,hadusedcompoundsintheirhousehold.Thiswas
significantlyhigherthanrespondentswhodidnotusecompoundsintheir
householdtobeawareofcompoundsbeingmadeatthepharmacy,X2(1,N=134)=
15.0,p<.05.
26
Allrespondentswereaskedtoindicate,fromalistofoptions,whatthey
thoughtwerelegallyacceptableusesforcompoundedmedications.Participants
couldselectasmanyofthetenoptionsthattheythoughtwerelegallyacceptable
reasonsforgettingmedicationscompounded.Themostcommonlyselectedreasons
were“dosageformneeds”andto“combinemedicationsintoasingledose,”with90
and79peoplechoosingtheoptions,respectively.Furtherinformationon
frequenciesforeachoftheoptionscanbefoundinTable6.Additionally,Table6
outlineswhichoftheusesarelegallyacceptable,andwhicharenot.
Thefrequenciesforeachoptionwerethensplitintothosewhoreported
themselves,orsomeoneelseintheirhousegettingacompoundedmedication,and
thosewhohadnooneintheirhouseholdreceiveacompoundedmedication.The
frequencybreakdownofthetenoptionsbetweenthosewhogotcompounds,and
thosewhodidnotcanbefoundinFigure1.Therewasastatisticallysignificant
differencebetweenthosewhoreceivedcompoundsandthosewhodidnotfor“drug
notavailableforpharmacytoorder”(X2(1,N=134)=5.4,p<.05)and“proper
dosagenotavailableforpharmacytoorder”(X2(1,N=134)=5.6,p<.05).Among
these,thosewhousedcompoundedmedicationsintheirhouseholdthoughtthe
reasonsmentionedabovewerelegallyacceptableusesmorefrequentlythanthose
whohadnotgottenacompound.
27
Table6:LegallyAcceptableUsesforCompoundedMedications
PotentialUses NumberofRespondents(%)
LegalUse?
DrugnotavailableforpharmacytoorderProperdosagenotavailabletoorderAllergytocommerciallyavailableversionCombinemedicationsintoasingledoseAvoidunwantedingredientsPersonalpreferenceChildren’sdosingneedsDrugshortagesDosageformneeds(creamvs.tablet)Additionofflavoring
63(47)66(49.3)61(45.5)79(59)70(52.2)41(30.6)71(53)31(23.1)90(67.2)53(39.6)
NoYesYesYesYesNoYesYesYesYes
Figure1:LegallyAcceptableCompoundUsePerceptions
Allrespondentsweretoindicatetheirlevelofknowledgeabouttheoutbreak
offungalmeningitisthatwastracedbacktotheNewEnglandCompoundingCenter
010203040506070
Frequency
LegallyAcceptableCompoundUsesamongThoseWhoUseCompoundsin
TheirHouseholdsandThoseWhoDoNot
GetsCompounds
DoesNotGetCompounds
28
(NECC).Theanswerchoicesrangedfrom“extremelyfamiliar”to“notatallfamiliar.”
Themajorityofrespondentsreportedbeing“notatallfamiliar,”with78%choosing
thisoption.AsummaryofresponsescanbefoundinFigure2.
Figure2:FamiliaritywithNECCOutbreak
Allrespondentswereaskedabouttheirfamiliaritywithpharmacy
compounding,from“extremelyfamiliar”to“notatallfamiliar.”WhileCandCDrugs
VitalCaredispensesalargeamountofcompoundedmedications,about37%of
respondentsreportedbeingmoderatelyfamiliarandalmost30%reportedbeing
onlyslightlyfamiliarwithcompounding.Asummaryofresponsescanbefoundin
Figure3.
Extremely2%
Very,7,5%
Moderately,9,7%Slightly,11,
8%
NotatAll78%
HOWFAMILIARAREYOUWITHTHENEWENGLANDCOMPOUNDINGCENTERFUNGAL
MENINGITISOUTBREAK?
29
Additionalanalysiswasdonetodetermineifthefamiliaritywith
compoundedmedicationschangedwiththepersonalorhouseholduseofa
compound,andthenfurthertodetermineiftherelationtothepersonthatreceived
thecompoundchangedpeoples’familiaritywiththetopic.Whenrespondentswere
dividedintoonlytwogroups,onehavingnotreceivedacompoundedmedication
withintheirhouseholdandtheotherincludingallrespondentsthateitherhada
householdmemberreceiveacompoundedmedication,ortheypersonallyhad
gottenacompound,aPearsonChiSquaretestofIndependencewasperformedto
examinewhetherornottherewasadifferenceinfamiliaritybetweenthetwo
groups.Therewasfoundtobeastatisticalsignificantdifferencebetweenthetwo
groups,withthegroupwhohadatleastreceivedahouseholdcompoundsbeing
morefamiliarwithcompoundedmedications,X2(4,N=134)=35.3,p<.05.Ofthe
“receivescompounds”group,70%ofthoseincludedinthegroupwere“moderately
familiar”ormorewithcompoundedmedications.Inthegroupthatdidnotget
compounds,76%ofrespondentsreportedbeing“notatall,”oronly“slightly”
familiarwithcompounding.AdditionaldatacanbefoundinFigures4and5.
Athirdanalysiswasdonetoexaminewhetherfamiliaritychangeddepending
ontheparticularpersonthatreceivedthecompound.Respondentsweresplitinto
threegroups:thosewhoclaimednocontactwithcompoundedprescriptions,those
whosaidtheyhadahouseholdmemberwhoreceivedacompoundedmedication,
andthosewhopersonallyreceivedcompoundedmedications,andmayhavean
additionalhouseholdmemberreceivethemaswell.APearsonChiSquaretestof
Independencewasperformedonthethreegroupsandastatisticallysignificant
30
differenceinfamiliaritywasfoundbetweenthethreegroups,X2(8,N=134)=39.8,
p<.05.Higherlevelsoffamiliarityweremoreoftenfoundinthegroupwith
personalreceiptofacompound,andlowestfamiliarityinthosewhohadno
connectiontocompoundedmedications.
Figure3:FamiliaritywithPharmacyCompounding
Extremely6% Very
10%
Moderately37%
Slightly30%
NotatAll17%
HOWFAMILIARAREYOUWITHPHARMACYCOMPOUNDING?
31
Figure4:FamiliaritywithPharmacyCompoundingamongCompoundUsers
Figure5:FamiliaritywithPharmacyCompoundingamongCompoundNon-Users
Extremely7%
Very14%
Moderately49%
Slightly25%
NotatAll5%
HOWFAMILIARAREYOUWITHPHARMACYCOMPOUNDING?(GETS
COMPOUNDS)
Extremely4% Very
2%Moderately
18%
Slightly38%
NotatAll38%
HOWFAMILIARAREYOUWITHPHARMACYCOMPOUNDING?(DOESNOT
GETCOMPOUNDS)
32
SatisfactionandPerceptions
Respondentswhoreceivedcompoundswereaskedaseriesofquestions
regardingtheirsatisfactionwithcompoundedmedications.Thisfirstsetof
questionswasproduct-focused.Theywereaskedtoratetheirsatisfactionona
linearnumericscale,with“1”being“notatallsatisfied,”and“5”being“very
satisfied.”Theaverageanswerstothequestionswerehigh,withthehighestbeing
4.68outof5forthesafetyandquality,andthelowestbeing4.10outofapossible5
forthecostofthecompounds.Additionaldataonpatientsatisfactionwith
compoundscanbefoundinTable7.
Otherquestionswereaskedtoassesshowrespondentsthatreceived
compoundedmedicationsfeltaboutmoresubjectivematters,likerelationshipswith
theirpharmacist.ThesequestionsusedaLikertscalewith“1”being“strongly
disagree,”andascoreof“5”being“stronglyagree.”Averagescoreswerenotashigh
asthesatisfactionquestionsaskedinthesectionbefore,butstillcomparativelyhigh,
rangingfrom3.53to3.90,outofapossible5.AdditionaldatacanbefoundinTable
8.
33
Table7:RespondentSatisfactionwithCompoundedMedications*
Frequency(%) Average(SD)
1 2 3 4 5 Howsatisfiedareyou,ingeneral,withyourcompound?
2(2.5)
0(0)
3(3.8)
13(16.5)
61(77.2)
4.66(0.783)
Howsatisfiedareyouwiththecostofyourcompound?
3(3.8)
4(5.1)
13(16.5)
21(26.6)
38(48.1)
4.10(1.093)
Howsatisfiedareyouwiththequalityofyourcompound?
1(1.3)
2(0)
4(5.1)
13(16.5)
61(77.2)
4.68(0.690)
Howsatisfiedareyouwiththeeaseofuseofyourcompound?
0(0)
2(2.5)
6(7.6)
13(16.5)
58(73.4)
4.61(0.741)
Howsatisfiedareyouwiththesafetyofyourcompound?
0(0)
1(1.3)
4(5.1)
14(17.9)
59(75.6)
4.68(0.634)
Howsatisfiedareyouwiththeappearanceofyourcompound?
1(1.3)
0(0)
4(5.1)
14(17.7)
60(75.9)
4.67(0.693)
Howsatisfiedareyouwiththepackagingofyourcompound?
0(0)
0(0)
4(5.1)
19(24.1)
56(70.9)
4.66(0.575)
Howsatisfiedareyouwiththeconvenienceofhavingacompound?
1(1.3)
0(0)
6(7.6)
13(16.5)
59(74.7)
4.63(0.737)
Howsatisfiedareyouwiththeperformanceofyourcompound?
1(1.3)
0(0)
6(7.6)
13(16.5)
59(74.7)
4.63(0.737)
*1=notatallsatisfiedand5=verysatisfied
34
Table8:RespondentAgreementwithStatements*
Frequency(%) Average(SD)
1 2 3 4 5 Iprefercompoundedmedicationsovermanufactured,commerciallyavailablemedications
0(0)
6(7.2)
46(55.4)
12(14.5)
19(22.9)
3.53(0.928)
Gettingcompoundedmedicationsleadstoadeeperandmorepersonalrelationshipwithmypharmacist
3(3.6)
5(6.0)
32(38.6)
25(30.1)
18(21.7)
3.60(1.011)
Gettingcompoundedmedicationsleadstoamorepatient-centered,ratherthandrug-centeredrelationshipwithmypharmacist.
1(1.7)
4(4.8)
25(30.1)
25(30.1)
28(33.7)
3.90(0.970)
*1=stronglydisagreeand5=stronglyagree
Respondentswerealsoaskedabouttheirsupportforcompounded
medications.Answerchoiceswerethesameasthequestionbeforeitthatasked
aboutfamiliarity,rangingfrom“extremelysupportive”to“notatallsupportive.”
Therewasalsoasixthoption,“Idon’tknow;Ihaveneverheardaboutpharmacy
compoundingbeforetakingthissurvey.”Themajorityofrespondentswere
supportiveofcompounds,with36%ofrespondentsbeing“verysupportive,”and
34%being“extremelysupportive.”AdditionaldatacanbefoundinFigure6.
Additionalanalysiswasdonetodetermineifthosewhohadreceiveda
compoundwithinthefamilyweremoresupportiveofcompoundedmedications
35
thanthosewhohadnot.Therespondentsweresplitintotwogroups:thosewhohad
compounduseinthehousehold,andthosewhohadnoconnectiontocompounded
medications.Astatisticallysignificantdifferencewasfoundbetweenthetwogroups,
withthosehavingahouseholdconnectiontocompoundedmedicationsbeingmore
supportiveofcompoundedmedications,X2(4,N=134)=34.4,p<.05Thegroup
thatdidnotgetcompoundsreportedmore“Idon’tknow”and“moderately
supportive”answersthanthegroupthatreceivedcompounds.Noparticipantin
eithergroupreportedbeingunsupportiveofcompoundedmedications.Further
dataonthedifferencesinanswersbetweenthetwogroupscanbefoundinFigures
7and8.
Figure6:SupportforPharmacyCompounds(AllRespondents)
Extremely34%
Very36%
Moderately16%
Slightly4%
IDon'tKnow10%
HOWSUPPORTIVEAREYOUOFCOMPOUNDEDMEDICATIONS?
36
Figure7:SupportforPharmacyCompoundsbyCompoundUsers
Figure8:SupportforPharmacyCompoundsbyCompoundNon-Users
Extremely43%
Very44%
Moderately11%
Slightly1%
IDon'tKnow1%
HOWSUPPORTIVEAREYOUOFCOMPOUNDEDMEDICATIONS?(GETS
COMPOUNDS)
Extremely18%
Very24%
Moderately26%
Slightly8%
IDon'tKnow24%
HOWSUPPORTIVEAREYOUOFCOMPOUNDEDMEDICATIONS?(DOES
NOTGETCOMPOUNDS)
37
DISCUSSION
DiscussionofFindings
Thisstudyaimedtomeasurepatients’use,knowledgeandperceptionsof
small-scalepharmacycompoundingatanindependentcompoundingpharmacyin
Mandeville,Louisiana,CandCDrugsVitalCare.About20%,ofthepharmacy’s
businessiscomprisedofcompoundedmedications,andthereforetheyarewidely
usedinthestore’spatientpopulation,withsomepatientsusingmorethanone
uniquecompound.Anecdotally,manyofthepatientshavegottentoknowthe
compoundingpharmacistandtendtobeverysupportiveofhim,whethertheyget
compoundsornot.Specifically,positiveword-of-mouth,isthoughttobeareason
thatnewpatientscometoCandCDrugsVitalCare.Manyofthefindingsinthis
studymaybeexplainedbythesupportforthecompoundingpharmacistandhis
practice,butfurther,in-depth,longitudinal,quantitative,andqualitativeresearchis
neededtoconfirmthesefindings.
Forexample,allrespondentswereaskedtoreporttheirfamiliaritywith,and
supportivenessof,pharmacycompounding.Whilethereweresignificantdifferences
infamiliarityandsupportbetweenthosewhodidanddidnothaveaconnectionto
compoundedmedications,eventhosewhodidnotgetcompoundedmedications
werestillfamiliarwithorsupportiveofthepractice.Indeed,commentsprovidedby
38
someoftherespondentsattheendofthesurveyreiteratedthesefindings.For
example,onerespondentnoted:
“My38yeardaughterhasmanymedicalproblems,andcompoundingmedsis
extremelyvaluabletoherduetomanyallergiestomanyingredientsthatare
used,althoughinsmallamounts,inmanydrugs,causingterriblesideeffects.
Cangetjustaneffectivemedthrucompounding.”
Anotherrespondentlessfamiliarwithcompoundingnoted:
“Iknowverylittleaboutpharmaceuticalcompounding.Iassumethatitwas
morecommonpriortothemassproductionofmedicationsinrecenttimes.
Dependingonthecircumstances,Iwouldthinkthatthereisstillandwill
continuetobeaneedtopharmaceuticaltobetterservepatients.”
Inlightofthesefindings,thecharacteristicsofthestudysampleshouldnot
beignored.Thevastmajorityoftherespondentsdescribedthemselvesas
Caucasian,highlyeducated,andmakinghighincomes.Perhapsthissampleisa
reflectionofthelocalpopulation,oritcouldbeaself-selectionphenomenon.In
otherwords,thispharmacymayattractthistypeofpatientpopulationbecauseit
doesmakecompoundsthatmaybemoreexpensiveandsometimesnotcoveredby
insurance,orthistypeofpopulationmaybemoredesiringofcompounded
39
products.Thatsaid,therewasstillconcernexpressedbyarespondentinher
commentaboutthecostofcompoundedmedications:
“Whyisitsoexpensive?Iusedtogetmycompoundingcreamfor$35and
nowit'sover$200,thereforeInolongergetitbecauseIcan'taffordit,
althoughitislike"magic"creamformypain.Itreallyhelpsmypain
conditiongreatly.”
Indeed,nearly56%ofthe83respondentsreportednothavinginsuranceor
insurancenotcoveringanyoftheirmedications.
Interestingly,thosethatreportedusingacompoundedmedicationintheir
householdmoreoftenreportedthata“drugnotavailableforthepharmacytoorder”
and“properdosagenotavailableforthepharmacytoorder”werelegallyacceptable
reasonstomakeacompoundedmedications.Whileaproperdosagenotbeing
availableisalegitimatereasontocompoundamedication,amedicationnotbeing
availableforthepharmacytoorderisnot.Additionally,41ofthe134total
respondents(approximately31%)indicatedthattheybelievedpersonalpreference
wasalegallyacceptableuseforacompoundedmedication.Whilenotstatistically
significant,itwasfoundthatmorerespondentswhodidnotusecompoundsintheir
householdthoughtpersonalpreferencewaslegallyacceptablethandidrespondents
whodidusecompoundedmedicationsintheirhousehold.Ingeneral,thissuggests
thatpatienteducationonappropriatereasonsformakingcompoundedmedications
40
maybeworthwhile.However,respondents’interpretationofthequestionsshould
betakingintoconsiderationwhenexploringthesefindings.
AnotherinterestingfindingwasthelackofknowledgeoftheNECCeventthat
happenedonlyafewyearsago.Thereportedoutcomemayhavebeenafunctionof
howthequestionwasasked.Manypatientsmayhaverememberedhearingabout
themanycasesofdeadlyfungalmeningitisthatwerecontractedfromaninjection,
buttheymaynothaveknownthattheNECCwastheorganizationresponsiblefor
compoundingthosetaintedmedications.
Limitations
Thetopicofpharmaceuticalcompoundsandtheirperceptionbythe
surroundingpatientpopulationcanbegreatlyaffectedbythesetting,whichisthe
mainlimitationofthisstudy.Thesurveywasonlyadministeredatasingle
pharmacy,makingitaconveniencesample,ratherthanonethatistruly
representativeofthewholestateorcountry.Communityperceptionsmaydifferin
NewEngland,astheNECCoutbreakwasacloserthreatandmayhaveturnedmany
patientsoffofcompounding,orinacitythatdoesnothaveapharmacythatoffers
compoundedmedications,inwhichcasethereisalackofknowledgeofthem.By
usingonlyonecommunitytodrawdatafrom,andbychoosingapharmacythatwas
veryinvolvedinthepracticeofpharmacycompounding,thestudyisnot
generalizabletotherestoftheUnitedStatesorallpatientpopulations.
Themotivationofpatientswithinthesamplemayalsoaffectthe
generalizability.Participationwasvoluntary,soitcanbeexpectedthatself-selection
biasmayresultinamuchhigherratioofpatientswhogetcompoundedmedications
41
participating.Theresultswerenotadverselyswayedinthisstudy,buttherewasa
verylargepercentageofresponsesthatwerefrompatientswithaconnectionto
compoundedmedications.Pharmacypatientsmayhavealsofeltmoreinclinedto
completethesurveywhentheysawthattheirparticipationwouldbenefitoneofthe
employees,someonetheyknewpersonally,ratherthanasurveythatwasconducted
bysomeonetheydidnotknow.
ConclusionsandImplications
Overall,bothgroupsofparticipants,thosewhogotcompoundsthemselvesor
hadahouseholdmemberwhoreceivedacompound,andthosewhohadnotiesto
compounds,hadpositiveperceptionsofcompoundedmedications,andwere
familiarwiththepractice.Eventhosewhodidnothaveanyconnectionto
compoundedmedicationsappearedfamiliarwiththepracticeofcompounding
medications.Again,thismaybeduetothecultureofCandCDrugsVitalCareand
theeffortsbythecompoundingpharmacisttocreateanatmosphereandbusiness
thatpromotespharmacycompoundingandpositiveperceptionsofitbythe
patients.However,further,in-depth,longitudinal,quantitative,andqualitative
researchisneededtoconfirmthesefindings.Futureconfirmationofthesefindings
hassignificantimplicationsforpharmacists,andhowtheculturetheycreateintheir
pharmacycanleadtoenhancedknowledge,positiveperceptions,andincreased
satisfactionamongpatients.Thistypeofworkcouldbetranslatedtoother
compoundingpracticesoranyotherpatient-orientedpharmacyservicesuchas
medicationtherapymanagement(MTM).
42
REFERENCES
43
Allen,L.J.(2003).Contemporarypharmaceuticalcompounding.TheAnnalsof
Pharmacotherapy,37(10),1526-1528.Doi:10.1345/aph.1C508.
Benda,W.(2008,May1).CompoundFractures:TheBattlebetweenWyeth
PharmaceuticalsandtheCompoundingIndustryoverBioidentical
Hormones.(GuestEditorial).TownsendLetter,100-102.
CommitteeonGynecologicPracticeandtheAmericanSocietyforReproductive
MedicinePracticeCommittee.(2012,August).CompoundedBioidentical
MenopausalHormoneTherapy.CommitteeOpinionNo.532.American
CollegeofObstetriciansandGynecologists.RetrievedFebruary7,2015.
http://www.acog.org/Resources-And-Publications/Committee-
Opinions/Committee-on-Gynecologic-Practice/Compounded-Bioidentical-
Menopausal-Hormone-Therapy.
Files,J.,Ko,M.G.,Pruthi,S.(2011,July).BioidenticalHormoneTherapy.MayoClinic
Proceedings,86(7),673-680.Doi:10.4065/mcp.2010.0714.
Flaker,S.(2012,December1).WhyDoPatientsNeedAccesstoCompounded
Medicines.RetrievedJuly19,2015.
http://www.safemedication.com/safemed/PharmacistsJournal/Access-to-
Compounded-Medicines.
FoodandDrugAdministration.(2013,December16).CompoundedMenopausal
HormoneTherapyQuestionsandAnswers.RetrievedNovember13,2014.
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Ph
armacyCompounding/ucm183088.htm.
44
Looser,B.J.,Kennan,S.A.(2013,December4).DrugQualityandSecurityAct:What
YouNeedtoKnow.McGuire-Woods.RetrievedNovember12,2014.
https://www.mcguirewoods.com/Client-Resources/Alerts/2013/12/Drug-
Quality-and-Security-Act.aspx.
Pergolizzi,J.V.,Labhsetwar,S.,&LeQuang,J.A.(2013).CompoundingPharmacies:
WhoisinCharge?PainPractice,13(3),253-257.Doi:10.1111/papr.12033.
Petersen,C.(2014,August1).TheArtandScienceofCompounding:WhereWeAre
Now,andHowDidWeGetHere?TownsendLetter,18-22.
PharmaceuticalCompoundingQualityandAccountabilityAct:Summaryofthe
BipartisanSenateLegislation.(n.d.).1-3.RetrievedJuly19,2015,from
http://www.help.senate.gov/imo/media/Section-by-Section_PCQA.pdf.
45
APPENDICES
AppendixA:SurveyQuestions
AppendixB:CoverLetterforPaperSurvey
AppendixC:CoverLetterforElectronicSurvey
46
AppendixA:SurveyQuestions
47
48
49
AppendixB:CoverLetterforPaperSurvey
DearPatient,MynameisAlixCawthon,andIamapharmacystudentatOleMiss.Thissummerandfall,IamconductingaresearchsurveythroughtheSallyMcDonnellBarksdaleHonorsCollege,andIamaskingforyourparticipation.Thissurveyshouldtakenomorethan7or8minutesofyourtime.Itincludesvariousdemographicquestions,butmainlyfocusesonyourknowledgeandperceptionsofpharmacycompounding,suchasthekinddoneatCandCDrugsVitalCare.Weareinvitingallcustomerstoparticipate,whetheryougetcompoundedmedicationsornot.Yourwillingnesstoparticipateinthisresearchwillhelpmebetterunderstandpatients’understandingandattitudetowardsmall-scalepharmaceuticalcompounding.Pleasekeepinmindthatyourparticipationinthissurveyisentirelyvoluntary.Yourcompletionofthissurveydoesnotaffectyourpatronageatthispharmacy,orwithanyofitsemployees.Yourresponseswillremaincompletelyanonymousandwillbeexaminedalongwithotherrespondents’surveys.ThisstudyhasbeenreviewedbytheUniversityofMississippi’sInstitutionalReviewBoard(IRB).TheIRBhasdeterminedthatthisstudyfulfillsthehumanresearchsubjectprotectionsobligationsrequiredbythestateandfederallawandUniversitypolicies.Ifyouhaveanyquestions,pleasecontacttheIRBat(662)915-7482.Ifyouhaveanyquestionsabouttheresearchprojectspecifically,[email protected],ormyadvisor,Dr.ErinHolmes,[email protected],or(662)915-5914.Thankyouinadvanceforyourparticipation.Sincerely,AlixCawthon
50
AppendixC:CoverLetterforElectronicSurveyDearPatient,MynameisAlixCawthon,andIamapharmacystudentatOleMiss.Thissummerandfall,IamconductingaresearchsurveythroughtheSallyMcDonnellBarksdaleHonorsCollege,andIamaskingforyourparticipation.Thissurveyshouldtakenomorethan7or8minutesofyourtime.Itincludesvariousdemographicquestions,butmainlyfocusesonyourknowledgeandperceptionsofpharmacycompounding,suchasthekinddoneatCandCDrugsVitalCare.Weareinvitingallcustomerstoparticipate,whetheryougetcompoundedmedicationsornot.Yourwillingnesstoparticipateinthisresearchwillhelpmebetterunderstandpatients’understandingandattitudetowardsmall-scalepharmaceuticalcompounding.Youcanaccessthesurveybytypingthelinkbelowintoyourinternetbrowser:http://tinyurl.com/n7nj89lPleasekeepinmindthatyourparticipationinthissurveyisentirelyvoluntary.Yourcompletionofthissurveydoesnotaffectyourpatronageatthispharmacy,orwithanyofitsemployees.Yourresponseswillremaincompletelyanonymousandwillbeexaminedalongwithotherrespondents’surveys.ThisstudyhasbeenreviewedbytheUniversityofMississippi’sInstitutionalReviewBoard(IRB).TheIRBhasdeterminedthatthisstudyfulfillsthehumanresearchsubjectprotectionsobligationsrequiredbythestateandfederallawandUniversitypolicies.Ifyouhaveanyquestions,pleasecontacttheIRBat(662)915-7482.Ifyouhaveanyquestionsabouttheresearchprojectspecifically,[email protected],ormyadvisor,Dr.ErinHolmes,[email protected],or(662)915-5914.Thankyouinadvanceforyourparticipation.Sincerely,AlixCawthon
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