Locations:
BIDMC, East Campus
Research Pharmacy
330 Brookline Avenue, FD-B14
Boston, MA 02215
Phone: (617) 667-4249
Fax: (617) 667-4248

Research Pharmacy Services

Protocol Review: Evaluate protocols for ethical and scientific merit, as well as feasibility from an operational standpoint and cost potential to the medical center. Review protocol for adherence to federal regulations for investigational drugs.

Inventory Control: The Pharmacy will arrange for the safe and accurate handling of investigational drugs, in accordance to protocol guidelines, Good Clinical Practice (GCP), federal, state and JCAHO requirements. Insure proper licensure (DEA and State) in place to store and dispense agents for IND use only. The Pharmacy, in cooperation with the investigator/study coordinator and sponsor, will assist in the ordering, receipt, and return of study medications.

Preparation and Dispensing: The Pharmacy will establish internal preparation and dispensing guidelines. Most investigational agents are prepared and dispensed from two research pharmacies. However, it is sometimes necessary to dispense from other pharmacy satellites, such as the Oncology Pharmacy and In-patient Pharmacy, depending on the patient population being studied. The Pharmacy will verify that each patient has signed informed consent and ensure appropriate randomization/study drug assignment. Written orders/prescriptions will be obtained prior to dispensing. When applicable, pharmacists will dispense study medication directly to study patients, counsel patients, and provide study drug material. The Pharmacy will maintain patient profiles to document dispensed and returned drug; if requested, patient compliance will also be tracked.

Drug Accountability: A method to maintain all study medications will be established, with a perpetual inventory system used to document all receipts and distribution of investigational agents. The Pharmacy will retain copies of all study medication records, including order forms, receipts for transfer and returns, packing slips, inventory and accountability records in accordance with FDA guidelines.

Storage: The Pharmacy will provide proper storage conditions for study medications, including product segregation and controlled environmental conditions (including both refrigerated, 2-8C, and frozen, -20C, conditions). All study medications will be stored in a restricted access area.

Research Pharmacy Links

• Animal Medication Schedule (ARF Forms)

• Research Investigational Drug Policies