Clinical Resources LLUMC Investigational Drug Service Desiree Wallace

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 Pharmacy. Trial Center

IDS Overview » Activities centralized in UH Central Hospital Pharmacy, 2 nd floor » IDS Coverage M-F 8 -4: 30 (1 FT Pharmacist & 1 FT tech), Pharmacist Supervisor on duty after hours & weekends » Assist Coordinator (s) and Site Investigator(s) with conducting an ID protocol » In. Patient: all study drugs administer in UH, CH, SH, EC must be processed through the IDS Pharmacy » Out. Patient: as requested by sponsor/investigator » Any Type of Study: Open-Label, Randomized, Placebo-Controlled, Single/Double. Blind, Investigator Initiated » Adhere to Regulations/Policies: § E 6 (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 -R 2, R 1, Q 29) § 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. 57 c: 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, CPh. T, 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@my 2 way. com Fax (909)558 -0323 email: dwallace@llu. edu » Backup: Norm Hamada, Pharm. D, RPh-Director of Clinical Pharmacy Services; x 47386