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PRC Inventory Management (10.5)

PRC Inventory Management (10.5) - Policies, Clinical, UWHC Clinical, Department Specific, Pharmacy, Pharmaceutical Research Center

10.5

POLICY & PROCEDURE





Effective Date:

August 2002
 Pharmacy Policy Manual
Chapter: Pharmaceutical
Research Center
Operations Procedure Manual
Chapter:

Policy #: 10.5

Original
 Revision
09/14
Page 1
of 9
Title: PHARMACEUTICAL RESEARCH
CENTER INVENTORY
MANAGEMENT


I. PURPOSE: To establish a procedure for the receipt, accountability, distribution and inventory
management of research drugs/supplies handled by the Pharmaceutical Research Center (PRC).

II. POLICY: The PRC will follow applicable standards, regulations and sponsor stipulations in the
receipt and cradle-to-grave accountability of research drugs/supplies received by PRC and will
assure appropriate inventory levels are maintained for uninterrupted clinical research care

III. PROCEDURE: Protocol-specific ordering, distribution and accountability procedures will be
detailed in the PRC’s Protocol Summary document and other supportive instructions and forms.
PRC personnel will observe appropriate safe handling procedures when handling investigational
drugs and/or returns as indicated in the PRC protocol summary and/or reflected in applicable
departmental policies and PRC procedures
A. Mechanism for ordering investigational/study drugs
1. Ordering instructions for each protocol are detailed in the “ordering” section
of the PRC protocol file located in the PRC office
2. All medications ordered from the NCI will be ordered per NCI
Pharmaceutical Management Branch electronic ordering system and ;
documentation of order will be retained
3. Medications ordered for non-NCI protocols will be placed via facsimile,
phone, electronically, interactive voice response service, etc; documentation
of order will be retained.
4. All shipments will be addressed to the Pharmaceutical Research Center:
B. Once the order has been placed the individual placing the order will:
1. Enter the order on the PRC Investigational Drug Order/Receipt Form
a. The Investigational Drug Order/Receipt Form will be checked daily by
the PRC staff to monitor outstanding order requests.
b. Shipments that fail to be received by the date requested will be addressed
as a high priority action item until the shipment is received and/or new
shipment date established
2. Place the order form in the pending order file
a. In the event the item being ordered does not have a corresponding
sponsor order form (phone orders, electronic/email orders etc), the
individual who placed the order will generate documentation reflecting
the content of the order and applicable protocol identification information
and place in the pending order file

POLICY & PROCEDURE





Effective Date:

August 2002
 Pharmacy Policy Manual
Chapter: Pharmaceutical
Research Center
Operations Procedure Manual
Chapter:

Policy #: 10.5

Original
 Revision
09/14
Page 2
of 9
Title: PHARMACEUTICAL RESEARCH
CENTER INVENTORY
MANAGEMENT

b. In the event the item being ordered is being ordered through the
pharmacy stock room, a copy of the order should be printed and placed in
the pending orders file with a copy submitted to the Business Operations
Specialist.
C. Upon receipt of the order
1. The PRC Technician will:
a. Verify if special storage requirements are immediately needed
(refrigerator or freezer). Facilitate quick transfer to required
storage area until such time as shipment can be completely
processed
b. Verify if a temptale or other type of monitoring system must be
deactivated and then forwarded to the Research Specialist.
c. Inspect the contents of the shipment (bottle/vial size, strength, lot
number, expiration date, and amount sent) and verify content
labeling against the information on the package slip.
d. Record the shipment on a PRC Shipment Receipt Invoice Form
noting the date received, protocol number, lot number, quantity
received, strength received, bottle/vial size, expiration date,
initials of PRC staff receiving the shipment and other information
as prompted on the form
i. Any discrepancies or informational notes should be
documented on the PRC Shipment Receipt Invoice Form
for communication back to the PRC Pharmacist
ii. Clip the package slip (if applicable) and the PRC
Shipment Receipt Invoice Form together and place in the
Completed Packing Slip Bin in the PRC Office.
e. Locate the order entry on the PRC Investigational Drug
Order/Receipt Form and record the receipt of the shipment noting
any discrepancies in quantity, bottle/vial size or strength ordered
2. The PRC Research Specialist will:
a. Inspect the Completed Packing Slip Bin on a daily basis
(minimum) and complete the processing and filing of shipment
documents by:
i. Combining/marrying the original PRC order request form
(pending orders bin) with the PRC Shipment Receipt
Invoice Form/Package Slip.

POLICY & PROCEDURE





Effective Date:

August 2002
 Pharmacy Policy Manual
Chapter: Pharmaceutical
Research Center
Operations Procedure Manual
Chapter:

Policy #: 10.5

Original
 Revision
09/14
Page 3
of 9
Title: PHARMACEUTICAL RESEARCH
CENTER INVENTORY
MANAGEMENT

ii. Enter expiration date(s), if applicable, in the PRC
Expiration Database and initial activity completion on the
PRC Shipment Receipt Invoice Form
iii. All information entered in the PRC Expiration Database
will be verified by a second Research Specialist and
documented appropriately.
iv. Determine and complete any special shipment receipt
instructions (examples: IVRS entry or study coordinator
notification, temptale processing, shipping material return
to sponsor) by inspecting the Special Shipment
Instructions Form located on top of the receipt/shipment
section of the protocol file
v. Document receipt on the sponsor’s package slip (if
applicable), obtain PRC Pharmacist review and signature
(if required), and complete receipt confirmation as
stipulated by the sponsor.
vi. File order/receipt documents in the receipt/shipment
section of the PRC protocol file in order of: PRC
Shipment Receipt Invoice (top), sponsor package slip,
PRC order request document (bottom).
3. Transfer receipt documentation:
a. In the event drug or supplies are received via transfer, the PRC
will generate a PRC Shipment Receipt Invoice noting the
protocol where drug/supply was transferred FROM and the
protocol where drug/supply is transferred TO in addition to
completion of all other standard information as prompted by the
form with copies of this form placed in the receipt/shipment
section of BOTH the transferred FROM protocol and transferred
TO protocol.
i. In the event the transfer is for an NCI sponsor study
 The NCI transfer form must also be completed,
submitted to the NCI and approved by the NCI
prior to PRC transferring and utilization of
drug/supplies
 The NCI transfer form should be attached to the
PRC Shipment Receipt Invoice with copies

POLICY & PROCEDURE





Effective Date:

August 2002
 Pharmacy Policy Manual
Chapter: Pharmaceutical
Research Center
Operations Procedure Manual
Chapter:

Policy #: 10.5

Original
 Revision
09/14
Page 4
of 9
Title: PHARMACEUTICAL RESEARCH
CENTER INVENTORY
MANAGEMENT

placed in all of the affected protocol files (i.e. the
transferred FROM and transferred TO files)
D. Maintenance on Minimum Inventory Levels
1. The PRC will establish systems to assure continuous access to the
study medication/supplies and minimize therapeutic interruption
when such avoidance is within PRC control
2. Minimum levels will be declared for research medications and
critical supplies and are to be reflected on the control drug
accountability record
3. PRC Technicians will record the current inventory level and the
declared minimum level for each item pulled on the Daily Pull List.
a. PRC Pharmacist will review the Daily Pull List on a daily
basis (no later than by the morning of the next business day)
and assess if additional research drug/supplies are needed
4. Studies where declaration of minimum levels alone may not be
sufficient to manage inventory needs (examples: dose escalation
studies; fluctuating subject accrual; fluctuation duration of treatment),
will additionally be tracked on the Misc Count List or Phase I
Inventory List with weekly assessments of inventory needs
a. PRC Technicians will perform counts of all items on list,
assess current subject accrual and study status and suggest
inventory ordering needs
b. PRC Pharmacist will review each weekly assessment and
approve ordering activities
c. PRC Technician will proceed with ordering (exception are
products ordered via OrderRx)
E. Drug Accountability Records
1. When generated:
a. Accountability Records (Control, Satellite, Patient
Returns as applicable) will be generated at time of
activation for all drug/supplies received by sponsors
b. Accountability Records (Control, Satellite, and Patient
Returns as applicable) may also be generated at time of
activation for ancillary supplies at the activating
pharmacist’s discretion.
2. Format:

POLICY & PROCEDURE





Effective Date:

August 2002
 Pharmacy Policy Manual
Chapter: Pharmaceutical
Research Center
Operations Procedure Manual
Chapter:

Policy #: 10.5

Original
 Revision
09/14
Page 5
of 9
Title: PHARMACEUTICAL RESEARCH
CENTER INVENTORY
MANAGEMENT

a. NCI Drug Accountability Record forms will be used for
NCI sponsored studies (different versions for oral and
Injectable agents)
b. UWHC/PRC Drug Accountability Record format will be
used for all non-NCI sponsored studies with column and
design modification to meet the accountability demands
of the protocol and entity being tracked
c. Sponsor Drug Accountability Records may be used in
conjunction with UWHC/PRC Drug Accountability
Records if mandated.
d. Sponsor Drug Accountability Records may be used in
lieu of UWHC/PRC Drug Accountability Records at the
discretion of the activating pharmacist and in consultation
with the PRC Manager.
3. Entries/corrections:
a. All entries are to be recorded legibly and in black ink
b. No white-out is permitted anywhere on the drug
accountability record
c. Corrections are to be single-lined through, dated and
initialed; no write-overs
d. Entries for drug/supply removal or addition:
i. Must be based on the product handled and not
assumed to the same as the information written on
the drug accountability record. For example, lot
number should be recorded from the product
container and then compared to the lot number
reflected in the balance on the DAR – NOT
simply from the DAR alone (this action will help
prevent errors associated with stock being placed
in wrong inventory)
ii. The resulting inventory from any activity must be
physically checked and confirmed against the
balance on the drug accountability record
4. Inventory count verifications:
a. In addition to count verifications performed with drug
removal and dispensation, monthly (Control) and bi-

POLICY & PROCEDURE





Effective Date:

August 2002
 Pharmacy Policy Manual
Chapter: Pharmaceutical
Research Center
Operations Procedure Manual
Chapter:

Policy #: 10.5

Original
 Revision
09/14
Page 6
of 9
Title: PHARMACEUTICAL RESEARCH
CENTER INVENTORY
MANAGEMENT

weekly (all satellite areas) will be conducted (see policy
10.9 for more description of quality assurance activities)
F. Storage of research drugs/supplies
1. PRC Control
a. Provides controlled, locked access for room temperature,
refrigerated, frozen (-10/-20°C) and ultra frozen (-70/-80C)
products
b. Access is limited to PRC staff and Sterile Products Area (SPA)
Pharmacist staff and SPA specified technicians for weekend
temperature checks
c. Space within the PRC Control storage area is also available for
controlled substances with access limited.
d. For information regarding temperature monitoring/control, refer to
applicable pharmacy refrigeration/freezer policies
2. PRC Satellites
a. On a protocol per protocol basis, PRC will determine the
appropriateness of maintaining sub-supplies in a PRC Satellite
area (examples include but are not limited to: Oncology Clinic
Pharmacy, West Clinic Pharmacy, VA Pharmacy, 1 S. Park
Pharmacy)
b. PRC Technicians will supplement satellite supplies during weekly
inventory count checks or as needed upon receipt of a page for
additional supplies.
c. Supplies required during non-PRC hours will be removed by the
SPA Pharmacists who will document off hour removal on the
sign out sheets in the PRC Control rooms
d. All movement of drug from Control to Satellite will be
accompanied by appropriate entries on both the Control and
Satellite drug accountability records
3. Temporary storage for SPA Preparation
a. Non-stat/non-24/7 items:
i. Research drugs/supplies prepared by the SPA will be
stored in the PRC until one business day prior to
anticipated preparation (unless on a weekend or Monday
AM)

POLICY & PROCEDURE





Effective Date:

August 2002
 Pharmacy Policy Manual
Chapter: Pharmaceutical
Research Center
Operations Procedure Manual
Chapter:

Policy #: 10.5

Original
 Revision
09/14
Page 7
of 9
Title: PHARMACEUTICAL RESEARCH
CENTER INVENTORY
MANAGEMENT

ii. PRC will remove drug from Control, place in ziplock bag
with a completed PRC Traveling Inventory Card and
place in the temperature appropriate area of SPA

iii. Control drug accountability record will reflect patient
specific entry information (i.e. NOT to SPA as for other
satellite situations)
b. Stat and/or 24/7 items:
i. The PRC Pharmacist will determine the desirability of
maintaining SPA satellite supplies for those studies that
request stat and/or 24/7 preparation
ii. PRC Pharmacist will determine use of Satellite and/or
Control drug accountability records in these situations
G. Return of used/unused supplies:
1. From SPA:
a. SPA preparation instructions sheets will detail the handling of
research drug/supplies after preparation
b. SPA will retain all used, partially used and unused containers and
place in the appropriate PRC return bin unless otherwise
instructed in the SPA preparation instructions sheets
c. PRC Technician will inspect SPA return bins throughout the day
to obtain used, partially used and unused containers and complete
drug accountability record transactions
d. PRC will then destroy per protocol instructions or retain for
sponsor verification in PRC Control
2. From Satellite Areas:
a. Satellite preparation/dispensing instructions will detail the
handling of research drug/supplies after preparation/dispensing
b. The Satellite area will retain all used, partially used and unused
containers and place in the appropriate PRC return bin unless
otherwise instructed in the Satellite preparation/dispensing
instruction sheets
c. PRC Technician will inspect Satellite return bins periodically
(daily for on-site; weekly for off-site) to obtain used, partially
used and unused containers and complete drug accountability
record transactions

POLICY & PROCEDURE





Effective Date:

August 2002
 Pharmacy Policy Manual
Chapter: Pharmaceutical
Research Center
Operations Procedure Manual
Chapter:

Policy #: 10.5

Original
 Revision
09/14
Page 8
of 9
Title: PHARMACEUTICAL RESEARCH
CENTER INVENTORY
MANAGEMENT

d. PRC will then destroy per protocol instructions or retain for
sponsor verification in PRC Control
3. From Study Coordinators:
a. Study coordinators are not permitted to count out hazardous study
drugs to determine compliance. Coordinators are to return
product to PRC. The receipt of patient returns will be recorded
on the PRC Return Drug Accountability Record
b. If a count is needed by the research coordinator, they will contact
PRC via the group email address to submit a request. PRC will
provide this information to the coordinators via email. If a
request is needed urgently, coordinators may page the on line
pharmacist (2717) or notify PRC in advance that drug being
returned must be counted ASAP.
H. Retention of containers for sponsor verification:
1. PRC will provide storage space for the retention of used containers for
sponsor verification when required and appropriate.
2. In the event PRC considers the act of container retention to be potentially
hazardous and/or in conflict with clean storage area requirements, PRC
will request (and expect) sponsor waiver for the requirement to retain
used/partial containers. Examples include:
a. Open ampules (broken glass/cut hazard)
b. Chemotherapy-like agents (cytotoxic agents; agents requiring a
biological safety cabinet for preparation; mutagenic/teratogenic
agents)
c. Used syringes
d. Used sharp containers (dirty item; cannot be stored in clean area)
e. IV bags and/or tubing spiked for drug administration and/or empty
bags after drug administration to subject
f. Sharps containers returned by subjects
g. Any potentially contaminated product including those for oral,
topical or rectal use.
I. Final disposition
1. All used, partial, empty, or full containers of research study drug
(regardless of investigational or commercial status) will be destroyed per
Administrative Policy 5.27 “Waste Management”; unless otherwise
stipulated in the PRC Protocol Summary

POLICY & PROCEDURE





Effective Date:

August 2002
 Pharmacy Policy Manual
Chapter: Pharmaceutical
Research Center
Operations Procedure Manual
Chapter:

Policy #: 10.5

Original
 Revision
09/14
Page 9
of 9
Title: PHARMACEUTICAL RESEARCH
CENTER INVENTORY
MANAGEMENT

2. All used, partial, empty or full containers of research study drug
(regardless of investigational or commercial status) that is to be returned
to the sponsor/sponsor-designee, will be packaged and labeled for
shipment in compliance with all applicable regulations




Approved By: ____________________________
Director of Pharmacy Services

Date: ____________