KCCOP Guidelines for Investigational Drug Management

1. KCCOP Guidelines for Investigational Drug Management Adapted from the PMB through CTEP 2008 (revised 05/2012)

2. Introduction • Physician is ultimately responsible for all drug, however, they may delegate handling to other individuals (nurses, pharmacists) • Site is responsible for implementing procedures for safe handling and dispensing in accordance with NCI guidelines. • SOPs • Corrective Action Plans for errors • Proper entry and maintenance on all Satellite drug logs • KCCOP provides a link to the PMB slide show on our website.

3. Satellite Locations • PMB defines a “Satellite Location” as a remote location away from the control area or primary storage area. The KCCOP serves as the Control for all members, and for all drugs. • Transportation of the investigational agent between the control location and satellite location must remain in the immediate control of the institution. (ex: KCCOP office straight to SLCI pharmacy) • If delivery of an agent requires the use of a secondary carrier (e.g. US postal service, Fed-EX, UPS), the remote location is not a satellite and delivery is prohibited. • We cannot send drug to you by mail or otherwise. • It is HIGHLY discouraged in sending drug to patients unless there are extenuating circumstances. Documentation will need to be in place for special circumstances.

4. KCCOP Process • Drug will be delivered prior to the start date (if possible). • The nurses receive a fax or email indicating who the CRA is and the date drug is to be brought over. • We will attempt to give a window of when we will be there, but this is not always possible. We will try to page people accordingly. • Drug is delivered (generally) in clear plastic bags with a KCCOP sticker containing the patient’s name, study, drug name, and date delivered. • CRAs also make a note on the sticker if the drug needs to be refrigerated. • Each CRA, as well as the Drug Specialist have tracking mechanisms in place to anticipate when the next drug will be due. These records are compared to listings received from the satellite site to attempt to ensure drug supplies are available when needed. • Once drug is delivered to your site, you are responsible for ensuring it is delivered to the clinic or floor as appropriate.

5. Drug Accountability • For studies that have provided drug, there are 2 forms you need to be aware of: Satellite DARF and Drug Delivery Form. • The Satellite DARF form is required by NCI for accurate drug accounting and must be filled out completely and correctly. The Drug Delivery Form was created by the KCCOP as an internal edit check system, and its accuracy is also important. • Sites document drug delivery, dispensing to patient, and any return on the KCCOP Satellite DARF that remains on site. This is an original document that should be kept according to your SOPs. A copy is always returned to KCCOP. Current documents will be faxed to KCCOP monthly for review and correction. • Each time drug is delivered, you’ll sign a drug delivery form that comes back with the KCCOP employee. • Once a patient goes off study, we will retrieve any remaining drug and the Satellite DARF. The DARF must reflect a zero balance of study drug at your site at the time of this transaction.

6. Satellite DARF Completion • We complete initial entry, for your convenience, when we deliver drug. However, YOUR initials should be on the first line indicating your have received the drug and it is properly logged via your SOPs. • One DARF for Each patient, Each drug and Each dosage. • You may have more than 1 DARF for a patient (i.e. Patient is on IMC-A12 and Erlotinib or patient is on 100 mg of Erlotinib and has a dose reduction to 50 mg of Erlotinib) • One entry for each dispensing of drug. • Enter another line when more drug is supplied. • (example: Entry would read Rec’d from KCCOP)

7. Top of Satellite DARF Patient initials and Study ID number Should always be a satellite record This is always KCCOP Dispensing area is YOUR location

8. Bottom of Satellite DARF Please complete the DARF EXACTLY as you see below!! Fill out pt initials, ID, and total dose You MUST put a full date!! First entry made by KCCOP staff First dispensed to the patient Pharmacist initials on each entry Inventory count Full lot numbers! IV meds require wasting. Approximate mL or mg

9. Special Entries For a broken vial, document as above. You must remove that vial from your inventory and contact us to bring additional supply

10. End of Treatment DARF entry • At EOT, if any drug is remaining, KCCOP will retrieve. Make an entry indicating drug is returned to KCCOP to leave your balance at 0. Strikethrough the rest of the empty log lines on that page and initial and date. This verifies that the form cannot be changed once it leaves your possession. • Make a copy of the DARF for your records and please give us the original. • For oral medications already dispensed to the patient: Have the patient return the drug to the research nurses, NOT the pharmacy!! Do NOT log drug back into the pharmacy. We will retrieve from the nurses to be destroyed. The Satellite log will indicate returned drug on one entry line, and return to KCCOP for destruction on a separate entry line. • For non-blinded oral drug, we do NOT need empty bottles back. • For blinded oral drug, empty bottles MUST BE RETURNED TO US!

11. Additional Dispensing and EOT Additional drug received from KCCOP should be logged in by a designee the day it is delivered. All remaining drug at end of treatment is returned to KCCOP. Your balance should be 0.

12. Oral Medications No need to document wasting. Dispense in whole bottles.

13. Transferring Locations Sample DARF for SLCI clinic receiving drug from SLH SLH DARF would have an entry of 12/1/10 Transferred to SLCI (pt initials and study ID) with the quantity and lot number.

14. Tips for Filling out DARFs • Don’t use crayon, pencil, or correction fluid! • If you make an error, make a single line through and initial and date the error. Overwriting is prohibited. • Do not obscure the entry with blots or black magic marker or scribble. • Always call KCCOP with questions about how to correctly document something • Make sure entries are in date order, on the date occurred. Late entries get us a “ding” during audit. • It is the responsibility of Satellite locations to fax their Satellite DARFS to KCCOP monthly. At that time they will be audited for accuracy and you will be contacted to fix all problem entries. (Please be advised the more thorough you are, the less likely corrections will need made.)

15. Transfer of Drug • Drug cannot be transferred between studies. • For example, bevacizumab for B40 cannot be used for C40502 • Transfer of NCI supplied agents for commercial use is both prohibited and illegal. • For example, Zometa for R0517 cannot be used for a patient on S0702 or a non-study patient • Replacement of NCI supplied agents with commercial agents is also prohibited and illegal. • For example, commercial Vidaza cannot be used in place of supplied Vidaza on S0703 A CORRECTIVE ACTION PLAN will have to be issued in this case. For the above issues, PMB is requesting you document on the DARF the error.

16. Drug Errors • CAPs must be comprehensive and are expected to be implemented immediately for errors. Writing the CAP, but not implementing the new procedures will result in serious audit findings. • Sites with continual errors can possibly be prevented by NCI from dispensing further study drug. Not only is this dangerous for patients, it causes MAJOR violations at the time of audit. • For patients who receive commercial drug instead of supplied drug • You CANNOT charge the patient the cost of the drug • You CANNOT replace your commercial supply with the study supplied drug

17. KCCOP Responsibility • Maintaining a secure pharmacy in our office, including adequate drug supply for various studies • Control DARF and Drug Delivery Form management • Tracking accuracy and accountability on Satellite DARFs • Monthly checks via Fax to ensure accuracy and completion • Maintaining originals in the KCCOP study file • Requesting corrections to forms as the need arises • Temperature control of fridges @ KCCOP • Assisting pharmacy, nursing, and research staff as needed • Monitoring drug compliance among patients receiving study drug (pill counts, calendars, verifying dosing/reductions) • Ensuring drug is delivered to your location prior to patient start

18. Questions? Please contact us anytime!! 913-948-5588 Thank you! Your KCCOP staff