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PRC Distribution of Research Drugs/Supplies (10.4)

PRC Distribution of Research Drugs/Supplies (10.4) - Policies, Clinical, UWHC Clinical, Department Specific, Pharmacy, Pharmaceutical Research Center

10.4

POLICY & PROCEDURE





Effective Date:

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

Policy #: 10.4

Original
Revision
09/14
Page 1
of 4
Title: PHARMACEUTICAL RESEARCH
CENTER DISTRIBUTION OF
RESEARCH DRUGS/SUPPLIES
THROUGH THE MEDICATION USE
SYSTEM


I. PURPOSE: To establish a procedure for processing research drugs (regardless of investigational
or commercial status) and supplies through the UWHC medication use system.

II. POLICY: The Pharmaceutical Research Center (PRC) will coordinate the distribution
procedures of all investigational and/or research medications throughout UWHC

III. PROCEDURE: Distribution procedures will be outlined in the PRC Protocol Summary
document with key distribution instructions duplicated within physician orders, prescriptions
and/or order form(s)
A. General requirements
1. PRC will review all clinical drug protocols under consideration at UWHC and
establish appropriate drug handling/distribution procedures
2. PRC will verify Health Sciences Institutional Review Board approval prior to first
subject enrollment in clinical drug research protocols
3. All inpatient and Clinical Research Unit (CRU) subject (regardless of
inpatient/outpatient status) investigational/research medication orders will be
processed through the pharmacy’s/PRC’s medication distribution system
4. All outpatient investigational/research medication orders will be processed
through the pharmacy’s/PRC’s medication distribution system unless the protocol
and location of the study justifies alternate distribution mechanisms (see
Secondary - Clinic Delegated procedures below)
5. All requests for investigational/research medications distributed through the
pharmacy/PRC medication distribution system will be accompanied by physician
order, prescription and/or protocol specific order form reflecting at minimum the
unique protocol identifier number, subject name and identifier number and other
information as required by the protocol.
6. All investigational drugs distributed will be labeled for “Investigational Use
Only”
B. Storage and removal of investigational/research medications stored by Pharmacy/PRC
1. All investigational/research medications distributed through the Pharmacy/PRC
medication distribution system will be stored in the PRC Control drug storage area
with sub-supplies located in designated pharmacy satellite areas as appropriate and
determined by PRC
2. Removal of drug from the PRC drug storage area for drug preparation or sub-supply
inventory will be performed by PRC Monday-Friday 0700-1700 or by SPA
Pharmacist after PRC hours and holidays

POLICY & PROCEDURE





Effective Date:

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

Policy #: 10.4

Original
Revision
09/14
Page 2
of 4
Title: PHARMACEUTICAL RESEARCH
CENTER DISTRIBUTION OF
RESEARCH DRUGS/SUPPLIES
THROUGH THE MEDICATION USE
SYSTEM

3. All removal of drug/supplies from the PRC Control drug storage areas will be
documented on the PRC Daily Pull List for subsequent tracking of returns,
minimum level assessment and review by the PRC Pharmacist
4. See policy 10.5 for additional information
C. Inpatient orders
1. Parenteral investigational/research medications
a. Will be prepared by pharmacy/PRC per protocol instructions and in
compliance with institutional and regulatory standards
b. Will have protocol specific/drug specific preparation instructions created
by PRC that will accompany each investigational/research medication
product to the pharmacy preparation area (if applicable)
c. Unless otherwise noted in the protocol summary, the following should be
observed in preparing investigational/research medications:
i. Investigational/research medication vials are to be considered as
single use vials; do NOT use as multi-dose vial
ii. Investigational/research medication vials are NOT to be shared
between patients/subjects (example: if only 1 vial needed to
prepare doses for two patients on the same protocol, being
prepared at the same time – two (2) separate vials must be used;
one vial for each patient/subject)
iii. All investigational/research vials are to be saved for return to the
PRC unless otherwise instructed by PRC
d. Will have appropriate source documentation (e.g., pharmacy computerized
systems, medication administration records, preparation logs, drug
accountability records) so as to confirm drug preparation, administration
and/or distribution
2. Oral investigational/research medications
a. Will be distributed through an outpatient pharmacy or through PRC
medication distribution system
b. Investigational/research medications will NOT be unit dosed nor delivered
through the cart system
c. Subsequent to outpatient pharmacies/PRC’s processing of the
investigational/research medication, orders for oral investigation/research
medications will be processed on the inpatient unit as “Patient’s Own”.
d. Will have appropriate source documentation (e.g., pharmacy computerized
systems, medication administration records, drug accountability records)
so as to confirm drug distribution and administration

POLICY & PROCEDURE





Effective Date:

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

Policy #: 10.4

Original
Revision
09/14
Page 3
of 4
Title: PHARMACEUTICAL RESEARCH
CENTER DISTRIBUTION OF
RESEARCH DRUGS/SUPPLIES
THROUGH THE MEDICATION USE
SYSTEM

3. Other investigational/research medications
a. Will be distributed through an appropriate pharmacy/PRC medication
distribution system or double check system in the event the agent’s
preparation and/or delivery require processing and administration outside
of the institution’s standard medication distribution system (e.g., cellular
gene therapy product made in laboratory setting and handled by the stem
cell lab).
b. Will have processing, distribution and double-check instructions created by
PRC.
D. Outpatient Orders Processed through Pharmacy/PRC (parenteral, oral and other)
1. PRC will create detailed distribution, packaging, labeling and accountability
instructions for each protocol and each investigational/research medication to be
distributed within the protocol
2. Prescriptions will be entered into the pharmacy’s computerized patient profile record
whenever such computerization exists
3. The PRC Protocol Summary and physician orders (paper or electronic) will indicate
if investigational/research medication to be repackaged into standard amber child-
resistant prescription vials to be distributed in the sponsor’s original container
4. Prescription labels will contain appropriate standard information and Investigational
Use Only language if investigational. If attaching a prescription label to a sponsor’s
original container, the attachment must avoid coverage of sponsor label information
unless otherwise instructed (“flagging” of prescription label may be necessary)
5. The Pharmacy/PRC will document distribution of the investigational/research
medication to the study subject on the appropriate drug accountability record
E. Outpatient orders processed by the investigator (PRC Secondary Protocol - “Clinic
Delegated” category; see policy 10.9 for additional information)
1. The investigational/research group will be responsible for the receipt, storage,
distribution and final disposition of research drug/supplies as stipulated by PRC
2. Investigational/research group will be responsible for handling sponsor monitoring
visits, maintaining changes of protocol and regulatory documents.
3. Research groups handling study drug are subject to PRC inspection at any time

POLICY & PROCEDURE





Effective Date:

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

Policy #: 10.4

Original
Revision
09/14
Page 4
of 4
Title: PHARMACEUTICAL RESEARCH
CENTER DISTRIBUTION OF
RESEARCH DRUGS/SUPPLIES
THROUGH THE MEDICATION USE
SYSTEM


F. Clinical research protocols utilizing only pharmacy formulary inventory (PRC Secondary
Protocol – “Formulary Protocols”)
1. PRC will assist in generation of preprinted physician orders (paper or electronic) as
needed in compliance with applicable institutional policy
2. PRC will monitor changes of protocol and potential impact on reimbursement,
distribution procedures and preprinted physician orders (paper or electronic).
G. Subject return of investigational/research medication
1. Subjects will be instructed to return all empty, partial and full containers of research
supplies at each study visit or as instructed by the investigator/study coordinator
(exceptions to be determined by PRC Pharmacist and per protocol criteria)
2. The investigator/study coordinator will document compliance as required by the
study sponsor and forward all containers to PRC (see policy 10.5 section 7 for more
information)
3. PRC staff will count subject returns and document on the PRC return drug
accountability records as outlined by the PRC Protocol Summary
H. Contact the PRC on-call pager (#2717; available 24/7) for any questions that arise during
the investigational/research medication distribution process.


Approved By: ____________________________
Director of Pharmacy Services

Date: ____________