Investigational Drug Services
Georgetown Research Pharmacy Services manages investigational agents for a wide variety of research protocols, including those of Oncology, Memory Disorder, Pediatrics, and Infectious Disease. Consistent with hospital policy pertaining to investigational drugs, the Department of Pharmacy assumes direct oversight responsibility for the storage, handling, preparation, dispensing, disposal and coordination of all investigational drugs intended for human use within the Medical Center.
- Investigational drug ordering
- Procurement, storage and perpetual inventory control
- Drug supply, return and destruction
- Preparation of investigational products
- Inpatient and outpatient study drug dispensing
- Blinding investigational drug
- Clinical checking
- Patient counseling
- Staff education and training
- Dose adjustments and dose calculations
- Drug interaction checking
- Assistance with protocol development
- Billing services
- Institutional Review Board (IRB) participation
- Treatment randomization
- Participation in Initial, Follow-Up and Close-Out sponsor visits
To ensure the safe storage of investigational and commercially available drugs, the Research Pharmacy has implemented procedures for temperature monitoring including refrigerators (2-8°C), freezers (-20°C), deep freezer (-70°C) and room temperature (20-25°C).
The Research Pharmacy uses the ELPRO temperature data logger to document storage conditions of pharmaceutical products. The data logger allows for efficient evaluation of logged data in graph or table format. In the event any monitored temperature excursions, the system notifies the hospital Main Pharmacy, on-call pharmacist and Research Pharmacy Manager in sequence.
Aware Point is another temperature monitoring program that is used hospital-wide including the Research Pharmacy. It provides automated temperature collection and sends alerts for out-of-range temperatures.
Paper reports are produced monthly with daily temperatures recorded manually by pharmacy personnel and stored in a file for fast reproducibility.
Disposition of study drugs will be handled according to specific instructions from the sponsor. The Research Pharmacy has the capacity to destroy study drug in accordance with GUH SOP Policy Number MM 12-06.
Investigational agents are dispensed by a registered pharmacist with training and background in the area of clinical research.
Research Pharmacy pharmacists are graduates of accredited colleges of pharmacy with training that emphsizes on hospital setting and are licensed to practice in the District of Columbia by the Board of Pharmacy. Certified pharmacy technicians work under the direct supervision of a pharmacist. They assist in pharmacy activities that do not require the professional judgment of a pharmacist. All pharmacy personnel participate in competency testing on an annual basis.
The Research Pharmacy Manager is a member of the Georgetown University IRB. Under the direction of the Director of Pharmacy, the Research Pharmacy Manager has the overall responsibility of the investigational drug services.
The Research Pharmacy regular business hours are 7:30am to 5:00pm Monday through Friday. A research/oncology pharmacist is on call 24 hours a day, 7 days a week, including holidays.
The Research Pharmacy is located on the 7th floor of the hospital’s Main Building and has double locked controlled access. Access to the pharmacy is restricted to pharmacy personnel only.
Georgetown University Hospital
Research Pharmacy Services
3800 Reservoir Road, NW
M7103, Main Hospital
Washington, DC 20007