Research Pharmacy

Specialized Pharmacy Services for Research Excellence

The Research Pharmacy at Beth Israel Deaconess Medical Center (BIDMC) plays a crucial role in supporting drug clinical trials at BIDMC-licensed locations. Reporting to the Department of Pharmacy, the Research Pharmacy ensures the ethical, scientific, and operational integrity of investigational drug protocols. This comprehensive approach aligns with federal regulations and Good Clinical Practice (GCP) standards. The Research Pharmacy's responsibilities extend across various areas including protocol review, inventory control, drug accountability, and proper storage conditions. 

Protocol Review & Adherence

The Pharmacy evaluates protocols for ethical and scientific merit, as well as feasibility from an operational standpoint and cost potential to the medical center. It reviews protocol for adherence to federal regulations for investigational drugs. 

Preparation & Dispensing Guidelines

The Pharmacy establishes 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 verifies 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

Using a perpetual inventory system used to document all receipts and distribution of investigational agents, The Pharmacy retains 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.

Restricted, Proper Storage

Stored in a restricted access area, The Pharmacy provides proper storage conditions for study medications, including product segregation and controlled environmental conditions (including both refrigerated, 2-8C, and frozen, -20C, conditions).