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Clinical Resources: LLUMC Investigational Drug Service

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.

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Clinical Resources: LLUMC Investigational Drug Service

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  1. 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

  2. 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/Double-Blind, 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

  3. 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 @ room-temperature, 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

  4. 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

  5. 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)

  6. 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.

  7. Questions?

  8. 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 dwallace@my2way.com Fax (909)558-0323 email: dwallace@llu.edu • Backup: Norm Hamada, PharmD, RPh-Director of Clinical Pharmacy Services; x47386

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