Research Pharmacy

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PROJECT SUMMARY/ABSTRACT The Research Pharmacy (Investigational Drug Service-IDS) Shared Resource (SR) was established to support inpatient and outpatient clinical research conducted by investigators at the Sidney Kimmel Comprehensive Cancer Center (SKCCC). The Research Pharmacy staff work in close collaboration with the SKCCC Clinical Research Office, disease groups, individual investigators and the Weinberg Oncology Pharmacy clinical staff to coordinate and facilitate the development, implementation and maintenance of clinical trial protocols. Services provided by the Research Pharmacy include protocol consultation, clinical data monitoring, investigational product management, participation in the electronic order set development process, monitoring patient investigational product adherence, providing quality assurance activities, providing drug information and drug-drug interaction reviews, IRB membership and resources to disease groups, and other services to support the study teams. This SR is fully integrated within the SKCCC Oncology Pharmacy and is an integral part of the SKCCC's research efforts. This integration allows for additional support to research participants by incorporating pharmacy clinical specialists' expertise and collaboration with Oncology Pharmacy staff and technology to support production. The SR staff include a Pharmacy Division Director, an Operations Manager, four Clinical Research Pharmacists, one Clinical Decision Support Pharmacist, two Certified Pharmacy Technicians and one Certified Pharmacy Technician/Inventory Specialist. Pharmacy support is available to investigators and the research teams for patient care services 24/7. The Research Pharmacy is compliant with Maryland Board of Pharmacy regulations, United States Pharmacopeia (USP) Chapter 797, pharmaceutical sterile compounding regulations, and with state, federal and Johns Hopkins Medicine Institutional Review Board regulations for the conduct of research. Compliance with USP Chapter <800> will be fully instituted at the completion of upcoming pharmacy renovations planned for fall 2021. Current areas of focus to improve services and provide exceptional care to oncology study participants include medication safety initiatives, exploring new technology and innovative practices, implementing clinical pharmacy services within the Developmental Therapeutics Clinical Research Group (Phase I), supporting research expansion initiatives, and facilitating residency training of a nationally accredited pharmacy residency program for investigational drugs and research. SKCCC Managed Shared Resource Reporting Period: January 1, 2020 to December 31, 2020