Investigational Drug Services (IDS) The Investigational Drug Service (IDS) Pharmacy was established at the University of Pittsburgh Cancer Institute (UPCI) in 1986 to coordinate all pharmacy procedures associated with oncology clinical research protocols.
The specific aims of IDS are to 1) Review protocols (pre-approval process), assist with protocol implementation, and coordinate drug management and investigational drug supply; 2) Make clinical recommendations for drug therapy, provide dose calculations and monitoring plans, and manage adverse events; 3) Assist in writing medication administration and delivery section of protocols; and 4) Provide experiential education opportunities for clinical pharmacists in training at the University of Pittsburgh and Duquesne University. The goal of the IDS is to ensure that the procurement, receipt, storage, accountability, preparation, dispensing, labeling, and shipping of investigational agents are performed in accordance with all state and federal laws. Clinical recommendations for drug therapy, monitoring plans for a treatment regimen, managing adverse events, and dose calculations are performed with respect to the treatment of patients who have agreed to participate in a clinical research protocol. Moreover, the IDS works with physicians, nurses, and other clinical research personnel in order to provide optimal care for patients with cancer. The IDS pharmacy employs two pharmacists and one pharmacy technician. In addition to the IDS personnel, the UPMC Shadyside-Hillman Cancer Center Clinic Pharmacy works with the IDS and has ten full-time pharmacy technicians, twelve full-time pharmacists, and 2 part-time pharmacists. These individuals assist in treating patients enrolled in protocol treatments mainly through checking eligibility for the trials and treatments, entering chemotherapy orders, and mixing chemotherapy. The IDS reviews all approved IRB protocols, standard chemotherapy and protocol regimens, supportive care regimens (antiemetics and other premedications), and investigational drug policies and procedures. The IDS pharmacy prepares, labels, and dispenses all investigational medications and maintains accurate and complete drug accountability records for all investigational agents. For oral agents, an IDS pharmacist counsels each patient receiving an investigational drug dispensed for home administration at the Hillman Cancer Center. This process occurs with the first dispense, along with any dose changes (dose reduction or dose escalation). Throughout the entire network, the IDS provides oversight and monitoring for all clinical trial related activities. In the current project period members of six UPCI Research Programs used IDS.
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