Adapted from the PMB through CTEP2008

(revised 09/2014)

NCORP-KC Guidelines for Investigational Drug

Management

IntroductionPhysician 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.

SOPsCorrective Action Plans for errorsProper entry and maintenance on all Satellite drug

logs

NCORP-KC provides a link to the PMB slide show on our website.

Satellite Locations PMB defines a “Satellite Location” as a remote location

away from the control area or primary storage area. The NCORP-KC 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 (e.g., NCORP-KC 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 to send drug to patients unless

there are extenuating circumstances. Documentation will need to be in place for special circumstances.

NCORP-KC ProcessDrug 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 will be brought over.We will attempt to give an approximate timeframe of when we

will be there, but this is not always possible. We will try to contact people accordingly.

Drug is delivered (generally) in clear plastic bags with a NCORP-KC sticker containing the patient’s name, study, drug name, and date delivered.

CRAs also 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.

Drug Accountability For studies that have provided drug, there are three forms you need to

be aware of: Satellite DARF for Study Drugs that are administered, Satellite DARF for Oral Agents, and Drug Delivery Form. The details on how to correctly document drug accountability for the Satellite DARF for Study Drugs that are administered and the Satellite DARF for Oral Agents are included in these slides.

Please be advised that a new Oral DARF was introduced in 2014 and will be used going forward for all patients enrolled in 2014 and onward. The older DARF version should still be used for previously enrolled patients and for those studies where Study Drugs are administered (I.V. meds).

The Satellite DARF form for Oral Agents and Study Drug that is administered are required by NCI for accurate drug accounting and must be filled out completely and correctly. The Drug Delivery Form was created by the NCORP-KC as an internal edit check system, and its accuracy is also important.

Sites document drug delivery, dispensing to patient, and any return on the NCORP-KC 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 NCORP-KC. Current documents will be faxed to NCORP-KC monthly for review and correction.

Each time drug is delivered, you’ll sign a drug delivery form that comes back with the NCORP-KC employee. Please be consistent in documenting the “Lot Number” listed on this form when receiving and returning study drug as these numbers HAVE to be the same on the Satellite DARF and the Control DARF so that it can be reconciled properly.

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.

Satellite DARF CompletionYou will need to complete initial entry when we

deliver drug. 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 (e.g.,

entry would read “Rec’d from NCORP-KC”).

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 NCORP-KC 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.• Make sure the lot number documented matches the lot number on the Drug

Delivery Form (this will ensure your site is using the correct number).• If multiple bottles with different lot numbers are returned, a separate entry for

each lot number should be made. (Please see example 1-page 21.)• It is the responsibility of Satellite locations to fax their Satellite DARFS to

NCORP-KC 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.)

Patient initials and Study ID

number

Should always be a

satellite record

Dispensing area is YOUR

location

This is always NCORP-

KC

Top of Satellite DARF

Bottom of Satellite DARF

You MUST put a full

date!!

First entry made by

NCORP-KC staff

First dispensed to

the patient

Please complete the DARF EXACTLY as you see below!!

Full lot numbers!

Pharmacist

initials on each

entry

Fill out pt initials, ID, and total

dose

Inventory count

Special Entries

For a broken vial, document as above. You

must remove that vial from your inventory and contact

us to bring additional supply

Satellite DARF Completion For Oral Agents

You will need to complete initial entry when we deliver drug. 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 (e.g.,

entry would read “Rec’d from NCORP-KC”).

Satellite DARF Completion For Oral Agents(continued)

When a patient returns remaining study drug, the nurse will return it to the Pharmacy and the Pharmacist will record the date of expiration, the date it was returned, the quantity that was returned, and initial it on the correct dispensing row. o If no expiration date is provided or if the date is the manufacture date,

leave that field blank. Record full or partial containers as the quantity returned for oral

suspensions or solutions. If multiple containers from a single dispensing are returned on the same

date, record the total quantity returned (i.e., total number of tablets/capsules counted). If lot numbers are the same, one entry can be made. If there are different lot numbers, a separate entry must be made for each lot number indicating the exact count for each lot number.o If additional containers are returned on a different date, record the

return on a new line and reference the dispensing row (i.e., page number, line number, date).

If study drug is not returned to the dispensing area/pharmacy, DO NOT record in the return column on the Oral DARF. o If no study drug is going to be returned the nurse will email the CRA

and Drug Specialist and give an explanation as to why the remaining study drug will not be returned. The Drug Specialist will attach a Note to File to the Satellite DARF explaining the blank field.

Top of Satellite DARF for Oral Agents

Patient initials and Study ID

number

Should always be a

satellite recordThis is

always NCORP-

KC

Bottle Size(e.g., #

tablets/bottle)

Bottom of Satellite DARF for Oral Agents

You MUST put a full

date!!

First dispensed to

the patient

Inventory count

First entry made by

NCORP-KC staff

Full lot number

s!

Pharmacist

initials on each

entry

Expiration date

Date Patient returne

d

Quantity

returned

Recorders

initials

End of Treatment DARF entry At EOT if any drug is remaining, NCORP-KC will retrieve. Make an

entry indicating drug is returned to NCORP-KC 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 NCORP-KC 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!

Additional Dispensing and EOT

Additional drug received from NCORP-KC should be logged in by a designee the day it is delivered.

All remaining drug at end of treatment is returned to

NCORP-KC. Your balance should be 0.

Oral Medications

No need to document wasting.

Dispense in whole

bottles.

Transferring Locations

Sample DARF for SLCI clinic receiving drug from SLH

SLH’s DARF would have an entry of 12/1/10 Transferred to SLCI (pt initials and study ID) with the quantity and lot

number.

Tips for Filling out New Oral 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 NCORP-KC 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. Make sure the lot number documented matches the lot number on the

Drug Delivery Form (this will ensure your site is using the correct number)

If multiple bottles with different lot numbers are returned, a separate entry for each lot number should be made. (Please see example 1.)

Do NOT add study drug returned from patient back into inventory on the left hand side of the Oral Drug DARF. These should be documented on the right hand side on the same line of the date/lot number that it was initially dispensed. (Please see example 2.)

It is the responsibility of Satellite locations to fax their Satellite DARFs to NCORP-KC 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.)

Special Notes Regarding all DARFs

* The NEW Oral DARF includes a section to reflect “bottle size (e.g. #tablets/bottle). This may refer to bottles, capsules, kits, etc. When documenting the amount received on all DARFs you must be consistent on how this is entered. If you have a bottle with 90 tablets and are dispensing a partial amount of each bottle this should be entered as “90 tabs” vs “1 bottle”. So the remaining balance would reflect the correct amount. If a full bottle is dispensed then it should be entered as “1 bottle”.

Example 1

Example 2

Patient Drug Returns• Patient returns remaining study drug to the clinic.• Research nurse receiving the study drug must document the date received and

do a pill count.• Research nurse will take the remaining study drug to the pharmacy.• The Pharmacy must do a pill count to ensure the correct amount was

documented. • Once the number of pills/tablets have been confirmed the pharmacy will

document this on the Satellite DARF on the RIGHT HAND SIDE and the date the patient returned it (not the date they received it if different). They are not to enter a line “returned to NCORP-KC” as they have in the past.

• This entry MUST be on the line that corresponds to that particular lot number that is indicated on the bottle. If different lot numbers there should be two line entries.

• The CRA assistant will generally retrieve drug in a timely fashion. They will bring the drug and a copy of the Satellite DARF back to the office and give it to the CRA. The CRA makes a copy to include in the patient’s chart, counting the pills to ensure the correct amount is documented and then gives the Drug Specialist the drug and copy of the DARF. The Drug Specialist will count the pills and document drug received on the Drug Destruction log.

Patient Drug Return (con’t.)• No drug goes back to inventory UNLESS it is a FULL BOTTLE that has never

left the pharmacy, and has never been in the hands of a patient. In these instances when drug is returned to NCORP-KC, it is documented on the Satellite DARF as “returned to NCORP-KC” and the amount is deducted from the balance.

• Drug returned to NCORP-KC will be logged back into the Control log if it can be dispensed to another patient. If has been returned due to expiration or is patient specific and cannot be used for another patient it will be logged on the “Drug Destruction Log” and returned or destroyed accordingly.

• All drug return must be returned and/or destroyed within 90 days. Drug is destroyed exclusively via the Research Medical Center Pharmacy.

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 requests you document the error on the DARF.

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.

NCORP-KC Responsibilities 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 completionMaintaining originals in the NCORP-KC study fileRequesting corrections to forms as the need arises

Temperature control of fridges at NCORP-KC 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

Please contact us anytime!!!913-948-5588

Thank you!Your NCORP-KC staff

Questions?