# Presentation: 678623

## CCOP, MBCCOP & Research BasePrincipal Investigator and Administrator MeetingBreakout Session:  Drug Distribution

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

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## Slide 3

## Slide 4

## 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 ResultsJune 1, 2006 – May 31, 2007

|  | Acceptable | Acceptable Needs F/up | Unacceptable |
| --- | --- | --- | --- |
| All Sites | 73 / 135 = 54% | 56 / 135 = 42% | 5 / 135 = 4% |
| CCOPs | 8 / 21 = 38% | 12 / 21 = 57% | 1 / 21 = 5% |

## “Major” Drug Accountability IssuesNSABP 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**

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

## 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 
	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)

**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)**