The Children’s Healthcare of Atlanta Investigational Drug Service (IDS) Pharmacy is a joint venture of the Children’s Department of Pharmacy and the Department of Clinical Research. The IDS pharmacy manages the investigational medications for over 140 clinical trials conducted on the various campuses in the Children’s system. The IDS pharmacy is staffed by two full time pharmacists and one full time pharmacy technician/assistant. The hours of operation are 8:00 am - 4:30 pm, Monday-Friday. The services and staff of the main hospital pharmacies are utilized to support trials requiring off-hours support. Various services provided by the IDS pharmacy include protocol review, budget preparation, staff education, receipt of study medications, IWRS system documentation, inventory maintenance, dose preparation, medication dispensing, subject randomization, subject and family education, invoice preparation and billing, periodic meetings with study monitors, final disposition of study medications, preparation and shipping of study medications, transfer of study medications among the various campuses, and compounding services (see below a detailed list of services provided by the IDS pharmacy).
|Services provided by the Children’s Healthcare of Atlanta Investigational Drug Service (IDS) Pharmacy|
|Study Initiation||Review protocol Prepare budget Receive and process initial shipment of study drug Prepare study fact sheet for staff In-service staff (as needed) Work with pharmacy IT staff to create drug build in Epic Prepare preprinted labels (as needed)|
|Study Maintenance||Maintain appropriate inventory storage Maintain study records Meet with study monitors Order and receive inventory Process expired inventory Process patient returns Store patient returns for monitor Process drugs for onsite destruction Periodic study billing|
|Study Closeout||Process study drug for return to sponsor / onsite destruction Process study records to archive Meet with study monitor for closeout visit Final billing|
|Dose Preparation||Retrieve and sign out inventory Calculate dose/volume (as needed) Order entry / verification in computer Prepare dose Dose labeling|
|Prescription Dispensing||Retrieve and sign out inventory Order entry into computer Prepare prescription Prescription labeling Patient/family education IVRS documentation (when required) Prepare for shipping (as needed)|