1 / 15

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

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*

seth-mendez
Download Presentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. CCOP, MBCCOP & Research BasePrincipal Investigator and Administrator MeetingBreakout Session: Drug Distribution Mimi Passarello, M.B.A. NSABP, Pittsburgh, PA

  2. NSABP Trials – Resources for Protocol-Specific Drug Accountability • Protocol* • Protocol-Related Documents • Fact Sheet* • Nurse/CRA Guidelines

  3. 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

  4. 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

  5. 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)

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

  7. “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

  8. “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

  9. 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

  10. 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

  11. 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

  12. 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 Groups(PowerPoint) 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)

More Related