USP<800>
andWhatChangesWillMean
forOncologyPractices
November 2, 2016
State Society Education Series
WillisC.Triplett,Pharm.D.
Comply797&Comply800
LearningObjectives
1. UnderstandUSP’spurportedrole,scope,and
authority;
2. UnderstandthepurposeofGeneralChapter
<800>- “HazardousDrugs– Handlingin
HealthCareSettings”anditsimplicationsfor
OncologyPractice;and
3. Understandthetimelineforimplementation
of<800>
UnitedStatesPharmacopeial
Convention(USP)
• Recognizedinfederallaw(FDCA)asthenational
compendiumofdrugs
• FoundedinWashington,D.C.in1820toseta
systemofstandardsforstrength,quality,purity,
packaging,andlabelingofdrugsandanational
formulary
• Globalreach– 140nationsaroundtheworld
• Standards(3-digit GCs)havebeendeemed
enforceable byfederallaw
USPandProfessionalPractice
• For195years,USPlimiteditspurviewto
substances– drugs,excipients,additives,etc.
• Early“2000s”– USPpublishednewsetsof
nationalpracticestandardsregarding
compoundeddrugs(<795>,<797>)
• May-June,2015– revised<800>publishedin
PharmacopeialForumtobecomeofficially
implementedonJuly1,2018(whichgave
entities>2yearstoprepare)
Purpose- <797>vs.<800>
• <800>doesnotreplace<797>
• <797>existstoprotectpatientsfromreceiving
tainted,contaminated,ordegradedsteriledrugs
• <800>existstoprotecthealthcareworkers
frombeingexposedtopossiblehealthrisks
inherentinhandlingHazardousDrugs
• Manytopicsofoverlapbetweenthetwo
chaptersrequire“harmonization.”
USPSterileCompounding
OverlappingAbbreviations&Jargon
• CSP– “compoundedsterilepreparation”
• PEC– “primaryengineeringcontrol”
– LAFW– “laminarairflowworkstation”
– BSC– “biologicalsafetycabinet”
– CAI– “compoundingasepticisolator”(“glovebox”)
– CACI– “compoundingasepticcontainment isolator”
• BUD– “beyond-usedate”
• SOP– “standardoperatingprocedures”
USPAbbreviations&Jargon
ISOairqualityclassifications
• Both<797>and<800>haverequirementsfor
QualifiedAir.
• QualifiedAir– ISOclassifications– logscales
ISO-5
ISO-6
ISO-7
GeneralChapter<797>- Scope
(Officialsince2004– Revised2008)
• Titleis,“PharmaceuticalCompounding–
Sterile Preparations”
• “…thischapterprovidesminimumpractice
andqualitystandardsforCSPsofdrugsand
nutrients…”
• Appliesto,“…allpersonswhoprepareCSPs
andallplaceswhereCSPsareprepared.”
• Suchpersons,“…includepharmacists,nurses,
pharmacytechnicians,andphysicians.”
GeneralChapter<800>- Scope
(BecomesOfficialon7/1/2018)
• Titleis“HazardousDrugs– Handlingin
HealthcareSettings”
• “…appliestoallhealthcarepersonnelwhohandle
HDpreparationsandallentitiesthatstore,prepare,
transport,oradministerHDs.”
– (e.g.,pharmacies,hospitals,andotherhealthcareinstitutions,
patienttreatmentclinics,physicians’practicefacilities,or
veterinarians’offices.)
– “…pharmacists,pharmacytechnicians,nurses,physicians,PAs,
homehealthcareworkers,veterinariansandveterinary
technicians.”
USP- ShouldversusShall/Must
• Evenwithina3-digitChapter,therewillbe
both“shoulds”and“shalls”
• InUSPlanguage,“Should”isa
recommendation
• Asentencethatuses“Shall”or“Must”isa
mandatedrequirement
Why<800>?
• MustardGaswasusedasaweaponintheWorld
Wars
• Amongmanyeffects,itdroppedWBCcount
• Chemotherapy– Goodman&Gilman– 1946
– MustardGas->NitrogenMustard(stable)
– Effectivelyshranklymphoma,althoughtheeffect
wasshort-lived
• SydneyFarbertestedfolateantagonistsagainstAcute
LymphocyticLeukemiaandfounditeffective(1948)
Why<800>?
• Initially,allofthefocuswasonthepatient
• Later,therewasarealizationthatdrugswhich
affectDNAandcellreproductioncouldbe
harmfultohealthcareworkers
• Seriesofstudiesdemonstratedexposure
– MeasurablecyclophosphamidefromLAFW
– Measurableantineoplasticsintheurineof
healthcareworkers
• Long-termeffects?Stillnotclear.
<800>- BigSpotlighttoSpeed
Progress
• OSHA’sControllingOccupationalExposureto
HazardousDrugs– evolvedsince1986
• ASHP’sGuidelinesonHandlingHazardous
Drugs- evolvedsince1988
• ASCO/ONS’ChemotherapyAdministration
SafetyStandardsIncludingStandardsforthe
SafeAdministrationandManagementofOral
Chemotherapy– evolvedsince2009
<800>broaderthan<797>
• <800>scopeismuchbroaderthan<797>’s:
– Receipt,Handling,Storage,Disposal,Presence
– Appliestoeveryone inthegreaterenvironment
(nurses,receptionists,billingstaff,executives,
patients,waitingroom,couriers,cleaningcrew,
etc.)
– includesstaffwhoreceive andunpack drugs
– Applytonon-sterile(i.e.oral,topical,etc.)drug
forms
Chapter<800>Impact
• “MotherhoodandApplePie”
• Massivecost– Uncertainbenefits
• Costswillinclude:
– Increasedenergyconsumption&CO2production
– Increaseddrivetoconsolidate– onlymega-entitiescan
affordtoconstructandoperatetherequiredfacilities
– Limitationofpatientaccess
– Acceleratedshifttoautomatedapproaches
– LegalandRiskManagement
Chapter<800>Impact
• UnfundedMandate– <800>maybringanew
areaofcomplianceandenforcement,butwith
nonewrevenue tooffsetit.
• Enforcement?
– Unpredictable
• Penalties?
– Unpredictable
• StateorFederal
Chapter<800>Impact
ImpactAreas:
– PhysicalFacilitiesandEquipment(&energy)
• requiresnegative-pressurePECsventedtotheoutside
• negative-pressureSEC,hardwalls,door,12or30ACPH
– SOPsandQualityAssuranceProgram
– Training- requiredforallstaffmembers
– Disposablesupplies– gowns,garb,gloves,etc.
– Surveillance
• Environment
• MedicalConditionsofyourPersonnel(includingfuture)
PhysicalEnvironment
TypicalCurrentState
– Haswoodencounters,drawers,shelves
– Containspaper,cardboard,carpet,drapes,etc.
– TheC-PECisaBSCrestingonacounter
– Containscompressor-stylerefrigerator(s)
– Opentounrestrictedtraffic
– Walls,flooring,ceilingsareofinappropriate
surfaceandnotmaintainedbyprotocol
– CompoundingperformedbyseasonedR.N.– main
focusisonclinicalaspectsofthedrug-patient
combination– NOTonsterility/stabilityofCSP
<800>ImpactPhysicalEnvironment
Tocomply,choosebetweentwostrategies:
ISO-7CleanRoomComplex
Versus
ContainmentSegregatedCompoundingArea
(C-SCA)
<800>ImpactPhysicalEnvironment
C-SECfeatures:
• “…shallbevoidofactivitiesandmaterialsthat
areextraneoustosterilecompounding.”
• Sealed– airmovementcontrolled/monitored
• Floors/walls/ceilings/fixtures/cartssmooth,
impervious,easilycleanedanddisinfected
• Jointscovedandsmooth,ceilingtilessealed
toframe(s)
<800>ImpactPhysicalEnvironment
TomakeCSPswithBUDs> 12hours:
– C-PECmustbelocatedinanISO-7BufferRoom
•
•
•
•
•
Musthavefixedwalls
MustmaintainISO-7underdynamicconditions
Mustbe-0.01to-0.03inchWCfromadjacentareas
Mustmaintain≥30ACPH
Mustbeventedtotheoutside
– EnterBufferRoomonlyviaanISO-7AnteRoom
• DynamicISO-7,fixedwalls,30ACPHasabove
• ≥+0.02inchWCcomparedtoalladjacentareas
<800>ImpactPhysicalEnvironment
• ContainmentSegregatedCompoundingArea
– AcceptableforCSPswithBUDs≤ 12hours
– C-SCArequires:
C-PECventedtotheoutside
TheairoftheC-SCAmustalsoventtotheoutside
SolidwallsanddoormustenclosetheC-PEC
Negativepressurevs.adjacentspacesmaintainedin
therange-0.01to-0.03inchWC
• Minimumof12ACPH
• NocompoundingofMedium- orHigh-RiskCSPs
•
•
•
•
<800>ImpactPhysicalEnvironment
AirConditioning:
– TheairdeliveredtotheC-SEC(BufferroomorCSCA)needstobechilledtoabout65°Ftooffset
heatfromC-PECsandbodyheatfromworkers
– C-PECandC-SECmustbothventtotheoutside
– DependingontheC-SECmodalitychosen:
• ISO7C-SECmustachieve≥30ACPHwhilemaintaining-0.01to
-0.03inchWC
• C-SCAmustachieve≥12ACPHand-0.01to-0.03inchWC
– Thousandsofdollarsinenergycostsperyear
<800>ImpactSOPsandQualityProgram
• IfyouhavewrittenSOPs,you’remilesahead
• Evenifyouhavenotformallywrittenthem
down,youdo haveSOPs
• Whetherwrittenornot,<800>compliance
willdrasticallyalterthewayyoudobusiness
• “QualityAssuranceProgram”=“amechanism
formonitoring,evaluating,correcting,and
improvingtheactivitiesandprocesses
described”intheChapters
<800>ImpactSOPs
DeveloporAdoptSOPs,thoughtfullyandoneatatime,
rankedby(1)impactand(2)difficulty– “Lowhangingfruit”
<800>ImpactSOPs
• “HazardCommunication”Requirement
• Mandatedsince1994 (29CFR1910.1200)(OSHA)
• Pharmaciesandphysiciansexemptfromlabeling
aspects
• Requires employerstotransmithazardinformationto
employees
• Entitymustcollectandstoreretrievableproof that
employeeswerewarned(signatures)
• SDS(formerlyMSDS)(MaterialSafetyDataSheets)
mustbe“easilyaccessible”foreachandevery
hazardousagent
<800>ImpactSOPs
• OccupationalSafetyProgram
– Entity’slistofHDs(toincludeNIOSHList- 2016)
– FacilityandEngineeringControls
– SafeWorkPractices
– ProperuseofPPE
– PoliciesforHDwastesegregationanddisposal
<800>ImpactSOPs
• Receipt/Unpacking/StorageofHD
• Unpackingcannot beperformed:
– inpositivepressurearea(s)
– Insterilecompoundingarea(s)
• HDsmustbestoredtopreventbreakageifcontainerfalls
• HDscannotbestoredonthefloor
• AntineoplasticHDsmustbestored inexternallyvented,
negativepressureroomwith≥12ACPH
• RefrigeratedHDsmustbestoredinadedicated refrigerator
locatedinanegative-pressureroom,≥12ACPH
<800>ImpactSOPs
• Compounding
•
•
•
•
•
•
•
•
•
Allrequirementsof<797>mustalsobefollowed
C-PECmustoperatecontinuously
Lossofpower=immediatesuspensionofallC-PECactivities
Powerreturned– mustdecontaminate,clean,&disinfect
Handwashingsinkmustbeavailable
Eyewashstationmustbereadilyavailable
WatersourcesanddrainsmustnotdegradeISOqualification
Watersourcesanddrainslocated≥1meterfromC-PEC
NeitherLAFWnorCAIareacceptableforHDcompounding
<800>ImpactSOPs
• HandhygieneandPPE
• DisposablePPEmustnotbereused
• Gowns,head,hair,shoecoversandtwopairsof
chemotherapyglovestocompoundHDs
• Twopairsofchemotherapyglovesrequiredtoadminister
antineoplasticHDs
• Gownsmusthavedemonstratedpermeabilityresistance
• ChemotherapyGloves
– MustmeetASTMStandardD6978(orsuccessor)[readthebox]
– Mustbepowder-free
<800>ImpactSOPs
• HandhygieneandPPE
– Glovesmustbephysicallyinspectedfordefects
– Glovesmusthavenopinholesorweakspots
– Ifsterilecompounding,glovesmustbesterile
– Glovesmustbechanged≤30minutes
– Gownsmustcloseatbackandnotbecloth
– GownsmustnothaveHD-permeableseams
– Potentiallycontaminatedclothingisnevertaken
home
<800>ImpactSOPs
• HandhygieneandPPE
– GownsworninareasofHDhandlingmustnever
bewornintootherareas
– Head/hair/beard/moustachecoversrequired
– Secondpairofshoecoversrequiredwhen
enteringC-SECandremoveduponexiting
– EyeandfacecoversrequiredwhenriskofHD
spills/splashes(e.g.,administrationinO.R.,
hangingHDCSPsaboveeyelevel,spillcleaning)
<800>ImpactSOPs
• HandhygieneandPPE
– Full-facepiecerespiratorprotectseyes/face
– Gogglesrequiredwheneyeprotectionneeded
– Faceshieldsalonedonotprotecteyesfromsplash
– Faceshields+goggles=fulleye/faceprotection
– UnpackingHDrequireselastomerichalf-maskwith
amulti-gascartridgeandP100filteruntil
ascertainedthattherewasnoleakage/spill
– Surgicalmasks= inadequaterespiratoryprotection
<800>ImpactSOPs
• HandhygieneandPPE
– SurgicalN95respiratorprovidesN95respiratory
protection+barriertosplashesorsprays
– Fit-testedN95respiratorsprotectagainstairborne
particles,butnoprotectionforgasses/vaporsand
littleprotectionagainstliquidsplashes
– FullfacepieceorPAPRwhenatrisk,including:
• AttendingtoanHDspill
• Deactivating,decontaminatingandcleaningbelowC-PEC
• Knownorsuspectedairbornepowdersorvapors
<800>ImpactSOPs
• Deactivation/Decontamination/Cleaning
– AllareaswhereHDarehandledandanyreusable
equipmenttheytouchmustbedeactivated,
decontaminated,andcleaned
– Sterilecompoundingareasanddevicesmustalso
bedisinfected
– Theproceduresandtheagentsused,dilutions,
frequencyanddocumentationrequirements
– Proceduresincludeeye,faceandrespiratory
protectionasrequired
<800>ImpactSOPs
• DrugAdministration
– HDsmustbeadministeredusingprotectivedevicesand
techniques(needle-less,closedsystems)
– AppropriatePPEmustbewornwhenadministeringHDs
– UsedPPEmustbedisposedofinawastecontainer
approvedfortrace-contaminatedHD
– Equipmentandpackagingmaterialsdisposedlikewise
– CSTDsmustbeusedtoadministerantineoplasticHDs
wheneverthedosageformallows
<800>ImpactSOPs
• PersonnelTraining
– PersonnelwhohandleHDmustbetrainedbasedon
theirjobfunctions
– Trainingmustoccurbeforeemployeeindependently
handlesHDs
– Effectivenessoftrainingmustbedemonstratedfor
eachemployee
– Competencyreassessedevery12months
– EachemployeetrainedforallnewHDandeverynew
oralteredSOP
<800>ImpactPersonnelTraining/Competency
• Notenoughtotrainyourstaff,youmust
demonstratethatyoudid
• Mustdemonstratethattrainingwaseffective
• Notenoughtotraininitially,
• Youmustdemonstratethatyou’vereiterated
trainingregularlyandthatstaffknowwhat
theyneedtoknowtoprotectthemselvesand
othersfromHDexposure
<800>Impact–
Disposablesupplies
• PPE(asnoted)(gloves,gowns,booties,etc.)
• Cleanroomsuppliesandancillaries
– Tackymats
– Sterile,non-sheddingwipes
– Sterilealcohol(liquidandwaterlessfoamers)
– Steelorplasticshelvingandcarts
– Deactivating/Decontaminating/Disinfectionliquids
– Dedicateddisposablemops/buckets/scrubbers
<800>ImpactSurveillance- Environment
• Surfacewipesamplingshouldinclude:
InterioroftheC-PECandequipmentcontainedinit
Pass-throughchambers
SurfacesinstagingorworkareasneartheC-PEC
AreasadjacenttoC-PECs(e.g.,floorsdirectlyunderCPEC,staging,anddispensingarea)
– AreasimmediatelyoutsidetheHDbufferroomorthe
C-SCA
– Patientadministrationareas
–
–
–
–
<800>ImpactSurveillance- Environment
• Surfacewipesampling:
– Example=cyclophosphamide
– Notmanyvendors
– Expensive
– Payingforthetestisstep1.
– CosttotrytoeliminateHDisstep2.
– Payingtodemonstrateeliminationwaseffectiveis
step3.
<800>ImpactSurveillance- Medical
• HealthcareworkerswhohandleHDsasaregularpartoftheir
jobassignmentshould beenrolledinamedicalsurveillance
program.
• Medicalsurveillanceprogramsinvolveassessmentand
documentationofsymptomcomplaints,physicalfindings,and
laboratoryvalues(suchasabloodcount)todetermine
whetherthereisdeviationfromtheexpectednorms.
• Trackingpersonnelthroughmedicalsurveillanceallowsthe
comparisonofhealthvariablesovertimeinindividual
workers,whichmayfacilitateearlydetectionofachangeina
laboratoryvalueorhealthcondition.
<800>ImpactSurveillance- Medical
• Medicalsurveillanceprogramsalsolookfortrendsin
populationsofworkers.
• Examininggroupeddatacomparedwithdatafromunexposed
workersmayrevealasmallalterationorincreaseinthe
frequencyofahealtheffectthatwouldbeobscuredif
individualworkers'resultsalonewereconsidered.
• Medicalsurveillanceevaluatestheprotectionaffordedby
engineeringcontrols,otheradministrativecontrols,safework
processes,PPE,andworkereducationaboutthehazardsof
thematerialstheyworkwithinthecourseoftheirduties.
<800>ImpactSurveillance- Medical
• WhydidUSPprescribesuchacostly,ineffective,
inefficient,anddisastrousprocessas“Medical
Surveillance?”
• Becausewehadthedataatourfingertips,butwe
neverdidthestudy…
– Weknewwhohandledandwhowereexposedtothesedrugs
– Thesimplestcase-controlepidemiologicalstudyever
– Contrastratesofmalignancyandspecific“candidate”diseases
betweencohortsoforthopedicsurgicalworkersvs.E.D.workers
vs.El-Edteachersvs.us+ourstaffanddetermineRelativeRisk
– Noincreaseinriskobviatesanyneedfor“MedicalSurveillance”
Whowrote<800>
• ExpertCommitteeonCompoundingformedanExpert
Panel
• Therewere9members:
– Chair– apharmacist/executivefromCardinalHealth
– Pharmacists(2)– neitherstillpracticing
– Airflow/HVACexpert/CleanroomConsultant(1)
– NursingProfessor(1)
– NIOSHPh.D.s(2)
– Physician(1)– aworkplaceepidemiologist
Whowereconspicuouslyabsent
fromwriting<800>?
•
•
•
•
•
•
•
PracticingOncologists
PracticingPharmacists
HospitalAdministrators
OncologyProfessionalAssociations
BusinessOwners(personsmakingapayroll)
StateBoardauthorities
Payersofanytype
<797>and<800>
HowtoImplement?
• Stratifyactions– Rankforimpactand
difficulty
• Startwithactionsthat(1)havethebiggest
impactand(2)areeasiesttoimplement
• Changeminds:
– Changeyourownmindfirst– informyourself
– Liveandbreathethenewpriorities
– Changethemindsofyourpersonnel
<797>and<800>
HowtoPushBack?
•
•
•
•
•
Articulateasaneposition
Deploythatsanepositiontoalloncologists
Unitedfronttodeploytheoncologymessage
Educate/Inform/Persuade– Beatthedrum
Pileconsequencesontheotherside:
– FDA
– PhRMA
– MonolithicVendors(Cardinal,McKesson,etc.)
Dialogue
• Questions?
• Comments?
WillisCTriplett,Pharm.D.
• Beste-mail:
[email protected]
• Cellulartelephone:317-626-6973
• Pleasedonothesitatetoreachout!
BackgroundReading
•
•
•
•
•
•
•
•
•
•
PurchaseUSPCompoundingCompendium
USPFAQson<800>
NIOSHList- 2016
ControllingOccupationalExposuretoHazardousDrugs-OSHA
ASCO/ONSSafetyStandards-2013
ASCO/ONSSafetyStandards– Menuof2003+2011+2013versions
ASHPGuidelinesonHandlingHazardousDrugs
NewJerseyAssemblyBillNo.837– 2016Session
FDAGuidanceonProcessValidation
SterileDrugProcessInspections-FDA
Off-LabelUseDisclosure(s)
Idonotintend todiscussanyoff-labeluseofanydrugproduct
duringthisactivity
FinancialDisclosure(s)
Icurrentlyhaveorhavehad thefollowingrelevantfinancial
relationshipstodisclose:
– Idonothavefinancial,consulting,andadvisoryrelationshipswithany
pharmaceuticalcompaniesotherthan“formerconsultant.”
– Idohavebusinessrelationshipswithseveralcompaniesthatprovideproducts
orservicesinthesterileproductcompoundingarena,includingcleanroom
builders,consultingcompanies,accreditationbodies,softwareproviders,
professionalorganizations,cGMPvalidationfirms,certificationcompanies,
andcommerciallaboratories.Idonotintendtomentionanyofthoseby
nameduringthispresentation.
LoydAllen’sEditorial
AuthorityforEstablishingProfessionalPracticeStandards
TheIJSPdoesnotappeartohavebeengrantedtheauthoritytorestablishing"OFFICIAL"professionalpracticestandards
torpharmacy,medicine,nursing,etc.Theactualauthorityforestablishingprofessionalpracticestandardsgenerally
resideswiththeindividualstates,especiallythestateboardsofpharmacy,medicine,nursing,etc.TheindividualBoards
caneitherpreparethestandards,usemodelstandardsfromothersources(e.g.,NABPinthecaseofpharmacy),orsome
otherentity,etc.Insummary,toviewtheUSPprofessionalpracticestandardspublishedas"official"and"enforceable"
doesnotseemtobeappropriateandseemstobewithoutfoundation.
IrecallbackwhenwewrotethefirstpracticestandardsattherequestoftheCEOofUSP,Dr.RogerWilliams;he
explainedthathewantedtoestablishaseriesofprofessionalpracticestandardstortheUSP,includingthosefor
nonsterilecompounding,sterilecompounding,hazardousdrugscompounding,etc.AfterthePharmacyCompounding
ExpertCommitteewroteUSP<795>,thequestionof'WheredoweputitintheUSP?"wasasked.Thechaptersdidn't
really"fit"anywhere,butitwasdecidedbyUSPpersonneltoinserttheminthePhysicalTestssectionoftheGeneral
Chapters.ThiswasfollowedbyUSP<797>,etc.
Atthetime,theexpertcommitteewasgivenataskbytheUSPCEOanddidn'treallyconsiderthequestionofthe
authoritytodothistask.TherewasalotofpressurefromtheFDA,anditwasdiscussedatthattimethatthesechapters
mayaidinkeepingtheFDAatbay...butweknowthathasnotbeenthecase.Insummary,itdoesnotseemthatthere
waseverany"legalauthority"providedtotheIJSPtoestablish"official"professionalpracticewassimplydone.Ifthisis
thecase,theyarenot"official"andshouldberemovedfromtheLISP,andtheresponsibilityfordevelopmentof
professionalpracticestandardsbeplacedonthestateboardsofpharmacy.
LoydVAllen,Jr.,PhD,RPh
Editor-in-Chief
InternationalJournalofPharmaceuticalCompounding
Remington- TheScienceandPracticeofPharmacy Twenty-secondedition
Historyof<797>Enforcement
Historyof<797>Enforcement
in“PharmacyWorld”
• USP<797>- 2004– ApprehensionandNear
PanicinPharmacy– butnoenforcement
• Updatedin2008– Anxiety,but“wait-and-see”
approach– again,noenforcement
• FungalMeningitisOutbreakin2012
• DrugQualityandSecurityActof2013
• Markedshiftinenforcementbystateand
federalauthoritiesmassiveenforcement
HistoryofEnforcement
• StatePharmacyBoardsshouldhaveenforced
acceptablesterilecompoundingpractices
forever,butlackedtherequisitecompetencies
• FDAcouldn’tlegallyenterpharmaciesuntil
unleashedbyDQSA
• 503A“Traditionalpharmacies”vs.503BROFs
• “CompoundinginAdvance”;“Office-Use”
• FDA-citationsissuedto215 503Apharmacies
USPandFDA
Borrowacupofsugar?
<797>EnforcementinMedicine
• Hasbeennon-existentinprivatepractices
• MostPharmacyBoardshaveinspectors,but
mostBoardsofMedicinedonot
• Wherewill“inspection”comefrom,if and
when itcomes?
– ResearchConsortia(MSKexample)
– AccreditationBodies(JCAHO,FACT,etc.)
– StateGovernment(ProfessionalBoards)
– FederalGovernment(FDA,OSHA)
<797>EnforcementinMedicine
• Hasbeennon-existentinprivatepractices
• MostPharmacyBoardshaveinspectors,but
mostBoardsofMedicinedonot
• Wherewill“inspection”comefrom,if and
when itcomes?
– ResearchConsortia(MSKexample)
– AccreditationBodies(JCAHO,FACT,etc.)
– StateGovernment(ProfessionalBoards)
– FederalGovernment(FDA,OSHA)
• The above appeared on the web on Wed, June 22
• FDA appeared at the physician’s practice on Tues, June 28
• FDA said to have a team of web search experts working M-F.
Whatdoes<797>prescribe?
ResponsibilitiesofCompoundingPersonnel
CSP“RiskLevels”– Low,Medium,orHigh
PersonnelTrainingandEvaluation
SpecialconditionsforcompoundingHD,
Radiopharmaceuticals,&AllergenExtracts
• Verification- CompoundingAccuracy/Sterility
• EnvironmentalQualityandControl
• SuggestedSOPs
•
•
•
•
Whatdoes<797>prescribe?
•
•
•
•
•
•
•
FinishedPreparationReleaseChecks/Tests
StorageandBeyondUseDating
Sterility,Purity,andStabilityofDispensedCSP
PatientandCaregiverTraining
PatientMonitoringandA.E.reporting
QualityAssurance(QA)Program
Manyothertechnicalaspects
<797>ComplianceinMedicine
• Complianceinoncologypracticesislacking
• Gainingcompliancewillrequiremassive,
sustainedeffort;AProcess not anEvent
• CostsandBenefitsofcurrentstate=unknown
• MedicalOncologypracticestypically:
– Lackstandardoperatingproceduresforsterile
compounding(SOPs);
– Lackformal,standardizedtraining/tracking
processfornewhiresandexistingstaff
<797>ComplianceinMedicine
– Lack<797>-compliantenvironments;
– Lackcompliantreleasechecking;
– LackstoragecomplianceandBUDlabeling;
– DonotVerifyCompoundingAccuracyandSterility
– Lackcompliancewith“HazardousDrugsasCSPs”
– LackAdverseDrugEventsreportingprocess
– LackaneffectiveandfunctionalContinuous
QualityImprovementprocess(CQI)
Motivationsfor<797>Compliance
• Governmentalenforcement?What’sthe
penalty?
• Publicityandmedia?
• Expulsionfromresearchnetwork(s)?
• Moral/Ethicalmotivation?(rightthingtodo)
<797>HurdlestoAdoption
• Arcanenomenclature/jargon/terminology
• Lackofexperienceintraditional“clean”space
• Excessattentiontoqualifiedairenvironment,
insufficientattentiontoDCA,“FirstAir,”
“CriticalSite,”andtouchcontamination
• Inertiaamongstaff– Organizationalculture:
– “We’vealwaysdoneitthisway…”
– “Ifitain’t broke,don’tfixit…”
– Unlearningbadhabitsisverydifficult
<797>HurdlestoAdoption
• Arcanenomenclature/jargon/terminology
• Lackofexperienceintraditional“clean”space
• Excessattentiontoqualifiedairenvironment,
insufficientattentiontoDCA,“FirstAir,”
“CriticalSite,”andtouchcontamination
• Inertiaamongstaff– Organizationalculture:
– “We’vealwaysdoneitthisway…”
– “Ifitain’t broke,don’tfixit…”
– Unlearningbadhabitsisverydifficult
<797>HurdlestoAdoption
• Arcanenomenclature/jargon/terminology
• Lackofexperienceintraditional“clean”space
• Excessattentiontoqualifiedairenvironment,
insufficientattentiontoDCA,“FirstAir,”
“CriticalSite,”andtouch contamination
• Inertiaamongstaff– Organizationalculture:
– “We’vealwaysdoneitthisway…”
– “Ifitain’t broke,don’tfixit…”
– Unlearningbadhabitsisverydifficult
<797>HurdlestoAdoption
• Arcanenomenclature/jargon/terminology
• Lackofexperienceintraditional“clean”space
• Excessattentiontoqualifiedairenvironment,
insufficientattentiontoDCA,“FirstAir,”
“CriticalSite,”andtouchcontamination
• Inertiaamongstaff– Organizationalculture:
– “We’vealwaysdoneitthisway…”
– “Ifitain’t broke,don’tfixit…”
– Unlearningbadhabitsisverydifficult
<797>ComplianceRoadmap
•
•
•
•
Researchdeeplyandplancarefully
Beginbyreadingandcomprehending<797>
Performapainstaking“GapAnalysis”
DeveloporAdoptSOPs,oneatatime
– Trainingandeducation=biggestbangforbuck
– ISO-7environmentalcompliance=large$$$
• Restricttraffic,eliminateparticles,improvegowning,
garbing,gloving,andcleaning/disinfection
• PlantomovefromBSCtoCACIassoonasfeasible