Download KCCOP Guidelines for Investigational Drug Management

NCORP-KC Guidelines for
Investigational Drug Management
Adapted from the PMB through CTEP
2008
(revised 09/2014)
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.
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SOPs
Corrective Action Plans for errors
Proper 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 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
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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:
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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 Completion
 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”).
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.)
Top of Satellite DARF
Patient initials and
Study ID number
Should
always be a
satellite
record
This is always
NCORP-KC
Dispensing area is
YOUR location
Bottom of Satellite DARF
Please complete the DARF EXACTLY as you see below!!
You MUST put
a full date!!
First
dispensed
to the
patient
Fill out pt
initials, ID, and
total dose
Inventory
count
First entry made by
NCORP-KC staff
Full lot
numbers!
Pharmacist
initials on
each entry
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
record
This 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
First entry made by
NCORP-KC staff
Inventory count
Full lot
numbers!
Pharmacist
initials on
each entry
Date
Patient
returned
Expiration
date
Recorders
initials
Quantity
returned
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 completion
 Maintaining originals in the NCORP-KC study file
 Requesting 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
Questions?
Please contact us anytime!!!
913-948-5588
Thank you!
Your NCORP-KC staff