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PRC Quality Assurance/Statistics (10.7)

PRC Quality Assurance/Statistics (10.7) - Policies, Clinical, UWHC Clinical, Department Specific, Pharmacy, Pharmaceutical Research Center

10.7

POLICY & PROCEDURE





Effective Date:

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

Policy #: 10.7

Original
 Revision 9/14
Page 1
of 3
Title: PHARMACEUTICAL RESEARCH
CENTER QUALITY
ASSURANCE/STATISTICS


I. PURPOSE: To establish procedures for auditing of research drug/supply usage, storage and
recording of protocols handled by the Pharmaceutical Research Center (PRC) and to document
such auditing in a manner that conforms to Food and Drug Administration (FDA), sponsor,
institutional and applicable regulatory requirements and guidelines. This policy will also
describe the monthly statistics to be maintained by the PRC program.
A. For quality assurance auditing associated with investigator-handled protocols, refer to
Policy and Procedure 10.8

II. POLICY: The PRC Manager, Pharmacist(s), Business Operations Specialist, Research
Specialist(s), and Pharmacy Technicians will perform and document regular audits of all stored and
dispensed research drugs and related supplies

III. PROCEDURE:
A. Mechanism for assuring the accuracy of research drug/supply accountability records:
1. The PRC technician will perform daily comprehensive audits for all research
drugs and supplies dispensed for the previous day. These audits will consist of:
a. Verifying completeness of information in the Control Drug
Accountability Records (i.e.: patient initials, MR number, dose,
quantity dispensed, lot number used and balance remaining).
b. Verifying completeness of information on the Drug Accountability
Records for those Satellite Pharmacies that are on site (Oncology
Clinic Pharmacy, AFCH Pharmacy)
2. The PRC technician will perform monthly audits of the Drug Accountability
Records for Control, and biweekly audits for all off-site satellite areas. Completion
of the Inventory Count Audit form will be done for each area per audit. These
audits will consist of:
a. Conducting an actual count of quantity and lot numbers versus drug
accountability record count of quantity and lot numbers.
b. Verifying accuracy of math for each line entry from last inventory
count.
c. Verifying all line entries from last inventory count for completeness
and accuracy (i.e., quantity used corresponds with dose and strength).
d. Verifying minimum inventory documented on Drug Accountability
Records (when applicable)
e. Immediate notification to Research Specialists or On Line PRC
Pharmacist of any of the following occurrences
A. Expired/Expiring inventory
B. Inventories with no activity for at least 6 months

POLICY & PROCEDURE





Effective Date:

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

Policy #: 10.7

Original
 Revision 9/14
Page 2
of 3
Title: PHARMACEUTICAL RESEARCH
CENTER QUALITY
ASSURANCE/STATISTICS

C. Any inventory error or discrepancy
B. Mechanism for assuring proper storage of investigational/study drugs:
1. The PRC Technician will perform and record daily temperature readings for all PRC
drug storage areas, including room temperature readings, all PRC refrigerators and
PRC freezers, during business hours Monday through Friday. On weekends and
holidays, SPA personnel will perform and record the temperature readings.
a. In the event the daily recording is noted to be outside of the
acceptable standard range for the area being monitored notification
will be immediately made to the PRC Pharmacist for assessment and
follow up. If needed, a Temperature Deviation Form will be
initiated and a notation will also be made on the temperature log
indicating that action was taken.
i. The PRC Pharmacist will follow the steps noted on the
Temperature Deviation Form and determine if any product
requires relocation to an alternate PRC storage unit
ii. Temperature Deviation Forms will be filed in the
Temperature Notebook and if applicable in involved
protocol files
b. The PRC refrigerators and freezers are equipped with audible alarms
in the event temperatures fall out of calibrated range.
c. Additionally, PRC refrigerators and freezers are connected to the
Plant Engineering Metasys system., if temperatures fall out of the
established parameters, Plant Engineering will page the PRC
Pharmacist (pager 2717) for further direction 24 hours per day/7 days
per week

2. When performing monthly audits for Control and biweekly audits for on-site
Satellite Pharmacies as required, the PRC technician will:

a. Check the general appearance of the storage areas.
b. Check for expired drugs and note these on the Inventory Count Audit
form (Appendix A).
c. Verify each drug in stock has an appropriate shelf label, traveling
inventory card and preparation instruction sheet if applicable.

C. Mechanism for recording and resolving drug/supply accountability discrepancies:
1. The PRC technician will notify the Research Specialists of any discrepancy
found during daily comprehensive and monthly/biweekly drug accountability
audits. Information will include:

POLICY & PROCEDURE





Effective Date:

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

Policy #: 10.7

Original
 Revision 9/14
Page 3
of 3
Title: PHARMACEUTICAL RESEARCH
CENTER QUALITY
ASSURANCE/STATISTICS

a. Location of discrepancy
b. Drug, form, and strength
c. Protocol
d. adjustment made
2. The PRC Pharmacist or Research Specialist will review discrepancy and list any
systems modifications that are appropriate. PRC will meet with the appropriate
area manager to discuss any systems modifications. Systems modifications may
also be relayed to the appropriate area manager via e-mail.
3. Research Specialist will document the event and all steps taken in a
comprehensive Note to File. This documentation will be retained in the PRC
protocol file folder. Reporting as required by protocol will be undertaken.

D. Mechanism for reporting monthly statistics:
1. The PRC Business Operations Specialist will compile monthly statistics and
submit to the Director of Pharmacy. Monthly statistics to include:
a. Protocols added (primary, secondary formulary, secondary clinic
delegated)
b. Protocols deleted (primary, secondary formulary, secondary clinic
delegated)
c. Protocols maintained (primary, secondary formulary, secondary clinic
delegated)
d. Budget estimates
e. Pre-qualification visits
f. Health Sciences IRB Reviews
g. Number of hours spent at administrative, research and educational related
meetings
h. Externally mandated activities
i. PRC Product preparation/dispensing units



Approved By: ____________________________
Director of Pharmacy Services

Date: ____________