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