Protocol Review and 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.
- Arranges for the safe and accurate handling of investigational drugs, in accordance to protocol guidelines, Good Clinical Practice (GCP), federal, state and JCAHO requirements.
- Insures proper licensure (DEA and State) in place to store and dispense agents for IND use only.
- Assists in the ordering, receipt, and return of study medications, in cooperation with the investigator/study coordinator and sponsor.
Preparation and 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.
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).