Drug Distribution

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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

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Drug Distribution

• WERE THE GOVERNMENT AND WERE
• HERE TO HELP
• For PMB this really is a true statement
• From expediting shipments, to offering advice, to
  helping work out solutions for unique problemswe
  are available and interested in helping

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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.

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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
• Dont 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.

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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)

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Drug Distribution

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

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Drug Distribution

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

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Drug Distribution

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

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Drug Distribution

• ONCOLOGY COMMUNITY GOAL
• STANDARDIZATION
• The more protocols, language, forms, and
• procedures can be standardized, the more time
• well have for patient care and researchand
• there will be fewer errors and better, cleaner,
• and faster clinical trials results.

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Drug Distribution

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

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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.

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Drug Distribution

• RESOURCES (continued)
• Web
• Each Group website has a wealth of information
• CTEP Home page http//ctep.cancer.gov
• http//ctep.cancer.gov/forms/index.html
• http//ctep.cancer.gov/monitoring/2006_ctmb_guid
  elines.pdf
• CTSU Home page https//www.ctsu.org/
• https//members.ctsu.org

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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.

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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

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Drug Distribution

• RESOURCES (continued)
• Email addresses
• PMB pmbafterhours_at_mail.nih.gov
• IB Coordinator ibcoordinator_at_mail.nih.gov
• Investigator registration PMBRegPend_at_ctep.nci.ni
  h.gov
• Associate Registration ctepreghelp_at_ctep.nci.nih.
  gov
• CTSU Help Desk CTSUContact_at_westat.com

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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
• 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.

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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
• arent posted on the web as we want to determine
• first exactly what your issue is (since sometimes
  the
• first question isnt the real question!), but
  they can
• provide good documentation for your call.

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Drug Distribution

• FAQ My actual drug inventory doesnt 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?

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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 youve conducted your investigation, youve
  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)

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Drug Distribution

• TAKE HOME MESSAGE
• Contact PMB with any questions or concerns by
  phone
• 301-496-5725 (Monday through Friday 830 am to
  430
• pm ET) or email PMBAfterHours_at_mail.nih.gov
• (anytime). Wed 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!

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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 [phone]
• Fax [phone]
• Email SchettinoP_at_mail.nih.gov