Download all study drug must be reconcilable Inventory

Clinical Resources:
LLUMC Investigational Drug Service
»Desiree Wallace, Pharm.D.
»Objectives:
• To describe the availability of the IDS for research on
campus
• To discuss how one can collaborate and access the
IDS to enhance research activities
2016 Research Affairs Symposium
October 21, 2016
LLUMC Department of PharmacyTrial
Center
IDS Overview
» Activities centralized in UH Central Hospital Pharmacy, 2nd floor
» IDS Coverage M-F 8-4:30 (1FT Pharmacist & 1FT tech), Pharmacist Supervisor on
duty after hours & weekends
» Assist Coordinator (s) and Site Investigator(s) with conducting an ID protocol
» InPatient: all study drugs administer in UH, CH, SH, EC must be processed through
the IDS Pharmacy
» OutPatient: as requested by sponsor/investigator
» Any Type of Study: Open-Label, Randomized, Placebo-Controlled, Single/DoubleBlind, Investigator Initiated
» Adhere to Regulations/Policies:
 E6 (ICH)-Good Clinical Practice
 Food & Drug Administration (FDA): Title 21 CFR Part 50, 56, 210 & 312
DHHS Title 45 CFR Part 46
 State of CA Requirements
CA Board of Pharmacy Law
 Institutional Policies & Procedures (421-R2, R1, Q29)
 LLU IRB Board Member
IDS
 Protocol Evaluation: review feasibility of IDS participation, budget, letter of
agreement, EPIC requirements, staff education
 Routes of Administration: intravenous, oral, topical, hazardous/chemotherapy,
controlled substances
 Storage: in Separate area from commercially available drugs, Secured Location with
Limited Access
 Temperature Monitoring: daily with certified calibrated device @ roomtemperature, refrigerated, frozen, excursion reporting; preferably continuous with
excursion alarms & procedures established
 Storage Equipment: refrigerator/freezer maintained/inspected by clinical
engineering
 Transport: Chain of Custody/Cold Chain documentation & temperature
monitoring during transport
 Packaging/Labeling: OL or Blinded; per CA Rx Law (“Caution: New Drug—Limited
by Federal law to investigational use.”); special precautions; child proof
 Preparation: non-aseptic, aseptic in ISO class 5 (hazardous/chemo) or laminar flow
hood in USP 797 compliant facility
IDS
 Randomization: experience with many IVRS/IWRS systems, manually, Rx
generated lists
 Dispensing: Inpatient/Outpt EPIC/Willow/BEACON formulary build requests or
treatment plan build
 Drug Accountability: manual paper forms or electronically; all study drug must be
reconcilable
 Inventory: ordering, receipt, transfer, returns/compliance by subject, expiration
dating
 Disposal: on site per SOP T-9 or return to sponsor
 Regulatory: maintain current Protocol/IB, IRB approval, ICD, amendments,
investigator/sub-I’s, billing
 Monitoring, Audits and Closeout (Sponsor/CRO, FDA, DEA)
 Record Retention: 21 CFR 312.57c: 2 yrs after the date of approval for the
indication (NDA) being investigated or not approved
IDS Collaboration
» Investigator may contact IDS directly for ?’s (see contact info)
» CTC feasibility analysis: will help determine the need for IDS ancillary
department
» IDS works with CTC on LOA to Participate & Financial support
» IDS will determine feasibility based on information provided by the
investigator from the Sponsor & SEV (Protocol, IB, Pharmacy Manual,
Operating Manual, IWRS/EDC)
Conclusion
»IDS resource is available to help the PI with the
responsibility of Managing Investigational Drugs
»IDS will collaborate with CTC, the Investigator,
Coordinator & Sponsor to assure that the protocol,
regulations, laws & P&P’s are followed to ensure the
safety of human subjects.
»IDS will ensure that all Investigational Drugs are fully
managed and accounted for.
Questions?
Contact Information:
» Desiree Wallace, Pharm.D.,RPh, Investigational Drug Pharmacist
» Mayra L. Gonzalez, CPhT, IDS Pharmacy Technician
» SHIPPING ADDRESS:
Loma Linda University Medical Center
Investigational Drug Service, Department of Pharmacy
11223 Campus Street, DOCK B
Loma Linda, CA 92354
» Office: LLU School of Pharmacy, Shyrock Hall Rm 228
(909) 558-4000, ext.83773
Pager (909)558-1717,1505 or [email protected]
Fax (909)558-0323
email: [email protected]
» Backup: Norm Hamada, PharmD, RPh-Director of Clinical Pharmacy Services;
x47386