audit pharmacy review - alliance - home...alliance for clinical trials in oncology, chicago office...
TRANSCRIPT
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Audit Pharmacy Review
Rosalyn D. WilliamsAlliance for Clinical Trials in Oncology, Chicago Office
Audit Workshop, November 3, 2016
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• Solet’strytohelpsortthisout…
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PresentationObjectives
•Pharmacysecurityisimportant.Aresupplieddrugstoredunderproperconditions?AretheNCIDARFsbeingusedandcorrectlymaintained?Whataretheexpectationatthetimeoftheaudit?
• Isstorageofdrugappropriate?•DARFs~DrugAccountabilityRecordForm
• StandardDARF• OralDARF• eDARF
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Security•AccesstoPharmacy
• Whohasaccess?• PharmacyStaff• ResearchStaff
• Istheunitlocked?• BadgeAccess• Key• AbelltogetintothePharmacy
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AuthorizedPrescribers
• WhoaretheauthorizedPrescribers?•AreallInvestigatorsCTEPregistered?• Isthereaprocessinplacetobesureeachinvestigatorremainscompliant?
•OnlyPhysicianscanbeCTEPregisteredtoorderanddispenseinvestigationaldrug.NursePractitioners,PAandNPcannotordersupplydrugunlesstheorderiscosignedbyaCTEPregisteredPhysician
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Stability
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Storage
• Istheretemperaturemonitoring?
• IsthereanAlarm• Shelfstorage
• Isthestudydrugstoredseparately fromcommercialdrug?
• Isthereturneddrugstoredseparately?
• Howarepatientdrugsreturned?
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DARFs
•DrugAccountabilityRecordForm• StandardDARF•OralDARF• eDARF• TheseDARF’sareusedtotrackthedispositionofinvestigationalagentsusedforNCIclinicaltrials
• DARFformscanbefoundonCTEPwebsite:http://ctep.cancer.gov/forms
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StandardDARF
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OralDARFs
•MustbeusedforallNCIstudiesusinganoralagent•Allheadersmustbecompleted• Youmustusethecorrectdispensingrowtodocumentpatientdrugreturnbycompletingthedatereturnsandthequantityreturns
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OralDARF
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DARF- Headers
•Commonauditerrors orMissinginformation• Protocoltitle• Dispensing Area• Control/Satellite checkbox• Pagenumber(s)• Doseformandstrength
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DARF
•Commonauditentryerrors• Entryofthedrugreceived fromtheNCI• Patientinitialsnotlisted• Balancetotalsnotcompleted• Correctpatientdose
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ExampleofanincompleteDARF
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ExampleofanincompleteDARF
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CompletedOralDARF
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eDARF’s
• IfaPharmacyaccountabilitysoftware isused,apapercopymustprintedfortheauditthatisidenticaltoanNCIDARF
• TheNCI/PMBdoesnotendorseanypharmacysoftwarepackage
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DARF’sshippingreceiptsStudyspecificvs.Patientspecific
• Howisdrugsupplied?
• IstheDARFstudyspecific(openlabel)?
• IstheDARFpatientspecific(double-blinded)?
The key is to check the drug receipt
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DARFDrugReturns
• Returns• Followprotocolforreturnordestruction• Ifpossible transferdrugtoanotherstudy,theywillneedtofollowPMBguidelines.
• Returnsshouldbedonewithin90daysperCTMBguidelines (thisisnotpharma)
• Alldocumentation ofreturnordestruction ofdrugshouldbemaintained
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Pharmacyauditresults• Pharmacyreviewcategoriesareeithercompliantornon-compliant• IfthePharmacysectionhastoomanynon-compliantissuesanunacceptableratingwillbeassigned.
• Anunacceptablewillrequireare-auditwithin12months• Re-auditcanbeforthepharmacysectiononlyorafullre-audit
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• PMBinformation• http://ctep.cancer.gov/branches/pmb/
•Newsletters• PharmacytrainingVideos
• CTMBguidelines• Section5.3ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring
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Questions
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2016FallGroupMeetingNovember3-5/Chicago,IL