By Cathy Clark, APR - May 07, 2019
Tucked away on the ground floor of the Magnolia campus, the Investigational Drug Services (IDS) pharmacy manages the drugs needed for approximately 300 various early-phase clinical trials administered in Moffitt’s Clinical Research Unit (CRU). These are the life-saving, cutting-edge therapies that offer hope to patients without other treatment options.
"The Investigational Drug Services pharmacy manages investigator-initiated, National Cancer Institute and industry-sponsored trials," said Anay Moscu, PharmD, who manages the IDS pharmacy. In addition to servicing the CRU, the IDS pharmacy manages dispensing of drugs for inpatients and the BMT treatment center.
The IDS team of seven pharmacists and four technicians develops all treatment order sets, which are approved by the principal investigator for each clinical research study. Considering there are more than 120,000 drugs or biologics-based registered studies worldwide, the work of this team to keep up with the drugs required for patients undergoing trials is quite an undertaking.
"Each study has specific clinical guidelines, compounding, documentation and administration instructions that are verified before each dispense," said Moscu. Additionally, regulatory requirements involve approximately 450 monitor visits annually to inspect inventory, account for drugs and maintain the sites are ready for audit. Expansion plans underway include updating the IDS and relocating it closer to the CRU.
Some of the services provided by IDS include:
- Phase 1-3 studies
- Virus-based and vaccine-based therapies
- Combination tumor-infiltrating lymphocyte (TIL)-cell regimens