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CCOP, MBCCOP & Research Base Principal Investigator and Administrator Meeting Breakout Session: Drug Distribution. Mimi Passarello, M.B.A. NSABP, Pittsburgh, PA. NSABP Trials – Resources for Protocol-Specific Drug Accountability. Protocol* Protocol-Related Documents Fact Sheet*

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Mimi Passarello, M.B.A. NSABP, Pittsburgh, PA

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CCOP, MBCCOP & Research BasePrincipal Investigator and Administrator MeetingBreakout Session: Drug Distribution

Mimi Passarello, M.B.A.

NSABP, Pittsburgh, PA

NSABP Trials – Resources for Protocol-Specific Drug Accountability

  • Protocol*

  • Protocol-Related Documents

    • Fact Sheet*

    • Nurse/CRA Guidelines

What Auditors Review

Drug Accountability Record Form (DARF)

  • DARFs (or NCI-approved logs) are present for all investigational agents

  • Logs are completely and correctly filled out

  • Separate form for each agent / protocol / dosage form / dosage strength

  • Logs for all satellites

What Auditors Review(con’t)

Storage and Stability

  • Balance on the DARF matches the physical inventory and/or discrepancies are accounted for

  • All study drugs are stored securely in a separate, limited-access area (at appropriate temperatures)

  • Expired drugs are disposed of or returned

  • Unused drug on closed studies has been transferred properly to open protocols or has been returned

What Auditors Review(con’t)

Tracking and Disposition

  • Shipping receipts, transfer forms and drug return forms for each drug are on file

  • Destruction records are on file

  • Able to follow drug from shipment to patient (including dates)

NSABP Pharmacy/Drug Accountability Audit ResultsJune 1, 2006 – May 31, 2007

“Major” Drug Accountability IssuesNSABP Sees on Audit

  • Use of commercial agent when agent is supplied

    • Patient / insurance charged in error

    • Cost to site

    • Do not replace commercial agent with investigational

  • Shipping of agents between sites

  • NCI logs not in use for PMB-supplied agents and/or use specified in protocol; particularly problematic for double-blind trials

  • No log for small offices

“Lesser” Drug Accountability Issues NSABP sees on Audit:

  • “Write-overs”, changes not initialed

  • Math errors corrected during audit

  • Late return of drug

  • Blanks, incomplete headings

Some NSABP Protocols allow shipment to patient(double blind, tamoxifen)

  • Oral agents, stable at room temperature

  • Patients on long-term treatment

  • Intensive, frequent on-site follow-up not required

  • Patient-specific labeling on bottles

  • Controlled ordering through NSABP Biostatistical Center

Newer Issues

  • Double blind studies only – patient returns of IND agents are recorded on log

  • Master logs highly recommended by NSABP for double blind studies

Avoiding Problems

  • Conduct periodic audits of pharmacies

  • Communication with pharmacist regarding study-specific information

  • Read protocol and protocol-related documents

  • Avoid re-writing messy drug logs

Audit Program

CTMB Guidelines Presentation and Audit Deficiencies, provided by the Clinical

Trials Monitoring Branch 3/07

  • CTMB Audit Deficiency Examples

  • Guidelines for Monitoring of Clinical Trials for Cooperative


    Site Visit Audit News(01/11/2007)

    Audit Program Description (07/17/2007)

    Examples of Audit Deficiencies (06/19/2007)

    Sample of Notification Letter (Treatment) (07/17/2007)

    Sample of Notification Letter (Prevention) (07/17/2007)

    Sample of Final Report (Treatment)

    Sample of Final Report (Prevention)

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