# Presentation: 733489

## Drug Distribution

**Patricia R. Schettino, R.Ph., M.S.**
**Associate Chief**
- Pharmaceutical Management Branch
- Cancer Therapy Evaluation Program
- Division of Cancer Treatment and Diagnosis
- National Cancer Institute

**Notes:**
Opening remarks are appropriate here.

## Drug Distribution

**WE’RE THE GOVERNMENT AND WE’RE**
**HERE TO HELP**
- For PMB this really is a true statement
- From expediting shipments, to offering advice, to helping work out solutions for unique problems—we are available and interested in helping

## Drug Distribution

**WARM UP:  DRUG ACCOUNTABILITY**
**BASICS**
- These hints are all applicable, regardless of the
- DARF required or the sponsor of the protocol
- Be neat from the get-go
- All entries should be timely
- Always take the time up front to make accurate and complete entries.  It really does save time to do it right the first time.

## Drug Distribution

**WARM UP:  DRUG ACCOUNTABILITY**
**BASICS (continued)**
- If an error is made, correction should be with a single line-through that is initialed.  **NO CORRECTION FLUID**
- Don’t re-write DARFs just to improve neatness.  In extreme cases, DARFs can be re-written but any rewrite introduces opportunities to make errors.  If rewritten, the original must be attached to the rewrite with a brief explanation as to why a rewrite was done.

## Drug Distribution

**GETTING STARTED:  CONSIDER THE**
**SOURCE**
- CCOPs participate in trials from a large number of
- different sponsors (CTEP/NCI, DCP/NCI, CCOP,
- Cooperative Group, company), each of which may
- have their own requirements
- 1572 filing differences
- Form differences even among programs at NCI (CDR, Return Drug List)

## Drug Distribution

**GETTING STARTED:  CONSIDER THE**
**SOURCE (continued)**
- Record keeping differences
- Protocol differences, even if only formatting
- Resource differences
- BOTTOM LINE  ??

## Drug Distribution

**HAVE A PLAN**
- Make your plan before trial initiation—and stick
- to it.  But part of your plan should be when to
- regularly re-evaluate it and how to change it if
- necessary.  You’ll want to have both a general
- plan for clinical trial participation and a
- protocol-specific plan.

## Drug Distribution

**TRICKY SUBJECT:  TRANSPORTATION OF**
**AGENTS**
- Reshipment vs. transportation
- Post 9-11—enhanced scrutiny
- Safety concerns (container/method validation, accountability, increasingly temperature labile products, dangerous goods)
- Sponsor obligations
- PMB’s (or any sponsor’s) ability to get emergency information to the place where the drug actually is

## Drug Distribution

**ONCOLOGY COMMUNITY GOAL:**
**STANDARDIZATION**
- The more protocols, language, forms, and
- procedures can be standardized, the more time
- we’ll have for patient care and research—and
- there will be fewer errors and better, cleaner,
- and faster clinical trials results.

## Drug Distribution

**RESOURCES**
- Protocol
- Web
- Investigational Drug Handling (IDH) slideshow
- Telephone numbers
- Email addresses
- PMB Newsletter
- PMB FAQs

## Drug Distribution

**RESOURCES (continued)**
*Protocol*
- Title page (contact information, sponsor)
- Pharmaceutical section (supplier of agents)
- Appendices often have a wealth of information, particularly for Group sponsored phase 3 trials.

## Drug Distribution

**RESOURCES (continued)**
*Web*
- Each Group website has a wealth of information
- CTEP Home page _[http://ctep.cancer.gov](http://ctep.cancer.gov/)_
-   _[http://ctep.cancer.gov/forms/index.html](http://ctep.cancer.gov/forms/index.html)__ _
-   _[http://ctep.cancer.gov/monitoring/2006_ctmb_guidelines.pdf](http://ctep.cancer.gov/monitoring/2006_ctmb_guidelines.pdf)_
- CTSU Home page _[https://www.ctsu.org/](https://www.ctsu.org/)_
-   https://members.ctsu.org

## Drug Distribution

**RESOURCES (continued)**
- An *Investigational Drug Handling (IDH)*
- Slideshow has been created by PMB and a
- similar one has been created by SWOG.  One
- of them is scheduled to be available before the
- end of the year.

## Drug Distribution

**RESOURCES (continued)**
*Telephone numbers*
- PMB:  301-496-5725  (all issues)
- CTEP PIO:  301-496-1367
- CTSU Help Desk:  1-888-823-5923
- Associate Registration:  703-738-9171

## Drug Distribution

**RESOURCES (continued)**
*Email addresses*
- PMB:  pmbafterhours@mail.nih.gov
- IB Coordinator:  ibcoordinator@mail.nih.gov
- Investigator registration:  PMBRegPend@ctep.nci.nih.gov
- Associate Registration:  ctepreghelp@ctep.nci.nih.gov
- CTSU Help Desk: CTSUContact@westat.com

## Drug Distribution

**RESOURCES (continued)**
- PMB publishes a quarterly *Newsletter* that can
- be found on the CTEP website at _[http://ctep.cancer.gov/about/insidepmb.html](http://ctep.cancer.gov/about/insidepmb.html)_
-  “Inside PMB” offers a less formal, more
- entertaining format to pass on interesting
- information and insider heads up.  It also
- always includes helpful contact numbers and
- mail addresses.

## Drug Distribution

**RESOURCES (continued)**
- PMB has prepared a number of *FAQs* in pdf format
- that can be emailed to a caller when they have one
- of the questions that we routinely receive.  They
- aren’t posted on the web as we want to determine
- first exactly what your issue is (since sometimes the
- first question isn’t the real question!), but they can
- provide good documentation for your call.

## Drug Distribution

**FAQ: My actual drug inventory doesn’t match the quantities reflected**
**on the Drug Accountability Record Form. What should I do?**
- Investigate this problem much like you would investigate a controlled
- substance ledger error:
- (1)	Check your math. Often, people add or subtract incorrectly, leading to discrepancies. Remember that when you correct errors, you should line through with a single line, and initial all changes. Do not use correction fluid, or obscure the entry with blobs of ink.
- (2) Missing investigational agent?
- Check all potential storage areas. Is it possible some of the missing agent was slipped into a bag belonging to a drug with a sound-alike or look-alike name?
- Check charts of patients who are on the study. Did staff forget to record the dose given to a patient recently?

## Drug Distribution

- (3) Too much investigational agent?
- Did staff log out investigational agent for a patient who failed to appear or was turned away because of low blood counts? Did they return it to stock but forget to change the balance?
- Did they log out the right investigational agent, and then use commercial drug accidentally?
- Is another agent short the same amount? Did they log out the right investigational agent, and then use the wrong investigational agent?
- Stamp your feet and yell, “Hooray!” or “DOGGONE IT!”
- Once you’ve conducted your investigation, you’ve either found the agent or
- written an incident report. In the latter case, make an entry on the Drug
- Accountability Record Form (DARF; NIH 2564) indicating that you are
- correcting the balance, and referring to your internal incident report. Keep
- a copy in a readily retrievable place.
- (December 13, 2004)

## Drug Distribution

**TAKE HOME MESSAGE**
- Contact PMB with any questions or concerns by phone
- 301-496-5725 (Monday through Friday 8:30 am to 4:30
- pm ET) or email _[PMBAfterHours@mail.nih.gov](mailto:PMBAfterHours@mail.nih.gov)_
- (anytime).  We’d much rather help you do things right
- the first time than have to help you clean up after an on
- going problem.  We take any and all questions.
- We really are here to help and collectively we have a lot
- of experience at it!

## Drug Distribution

_**Contact Information**_
- Patricia R. Schettino, R.Ph., M.S.
- Associate Chief
- Pharmaceutical Management Branch, CTEP, NCI
- 6130 Executive Boulevard - Room 7149
- Rockville, MD  20852
- Phone:  301-496-5725
- Fax:  301-402-0429
- Email:  SchettinoP@mail.nih.gov