Drug Distribution

1. 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

2. 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

3. 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.

4. 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.

5. 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)

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

7. 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.

8. 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

9. 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.

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

11. 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.

12. 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_guidelines.pdf CTSU Home page https://www.ctsu.org/ https://members.ctsu.org

13. 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.

14. 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

15. 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

16. 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.

17. 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.

18. 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?

19. 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)

20. 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 (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!

21. 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