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

Follow this and additional works at: https://egrove.olemiss.edu/hon_thesisPart of the Pharmacy and Pharmaceutical Sciences Commons

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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.

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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,feelfreetocontactmeatmacawtho@go.olemiss.edu,ormyadvisor,Dr.ErinHolmes,aterholmes@olemiss.edu,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,feelfreetocontactmeatmacawtho@go.olemiss.edu,ormyadvisor,Dr.ErinHolmes,aterholmes@olemiss.edu,or(662)915-5914.Thankyouinadvanceforyourparticipation.Sincerely,AlixCawthon