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