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UAB Hospital Investigational Drug Service
The Pharmacy and Therapeutics Committee has deemed the Hospital Department of Pharmacy as responsible for the proper storage and distribution of investigational drugs prescribed for patients hospitalized at UAB Hospital. Commercially available drugs may be considered investigational if the drug is obtained by the investigator outside of the normal hospital purchasing process.
The investigational drug pharmacist can assist investigators in planning and executing clinical trials using investigational drugs. The pharmacist can also assist in the randomization and “blinding” process.
Investigators are strongly encouraged to meet with the investigational drug pharmacist prior to enrolling subjects in order to develop study-specific orders and review drug dispensing processes. Fees to assist investigators are negotiable; however, this should be done before the study is ready to be implemented. Investigators should contact the UAB Hospital Department of Pharmacy at 205-934-7191 for additional information.
Investigators are required to submit protocols to the Pharmacy Department at the time the study is submitted to the IRB. A completed “Release of Drugs for Human Research Use” Form must accompany the protocol. The current version of this form is available on the
. Completing this simple form provides needed budgetary and logistical information, not always contained in a protocol.
Appointments are required for tours and audits.
We provide limited access, locked ambient refrigerator and freezer storage for investigational drugs within the Central, Storeroom, and Research Pharmacy areas of North Pavilion.
We utilize the appropriate workspaces within the Central Pharmacy 797 clean room for the preparation of injectable doses.
The Alabama State Board of Pharmacy laws are followed regarding space, storage, and labeling.
Ambient temperature is thermostatically controlled to allow for a temperature range of 68F (20C) to 77F (25C). If noted that the ambient temperature is out of the allowed range, the maintenance department will be contacted immediately to determine and correct the problem. If the temperature exceeds 86F (30C), documentation will be provided in drug accountability records. Study sponsors will be contacted if necessary. Limited space is available for storing drugs at 2-8 C, -20 C, and -80 C. Within range documentation is provided daily. UAB Central Plant & Utilities electronically monitors these units. Refrigerators and freezers are on emergency power circuits and UAB Hospital Maintenance is available 24 hours a day to respond to problems. A pharmacist is paged if the unit temperature is “out of range.” Study sponsors will be notified if necessary.
Shipment Address for Investigational Drugs managed by UAB Hospital Department of Pharmacy:
North Pavilion, Room 3470
1802 6th Avenue South
Birmingham, AL 35249
Phone: 205-934-7191 Fax: 205-975-6647
In order to ensure that drug supplies are available at the time a subject is enrolled, the investigator or the designee must contact the investigational drug pharmacist when screening candidates for a study.
Drug Handling Activities
Prior to dispensing, the pharmacist(s) must be notified in writing of the patient's enrollment and will be provided a written “order.” Drug storage, inventory maintenance, preparation, and dispensing activities are protocol-specific. Documentation of dispensing will be maintained in the pharmacy until after the study is closed.
Records will be transferred to the investigator after the completion of the study.
Destruction of Drugs
Immediately after a dose or a prescription is prepared and dispensed, supplies used in the preparation are handled as hazardous waste. Hazardous wastes at UAB are incinerated by the UAB Incinerator. The incinerator location is 221 14th Street South, Birmingham, AL 35294. Hazardous wastes will not be stored or saved for an audit. Unused drug supplies may be destroyed at the UAB Incinerator. A destruction fee will be assessed.
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The UAB CCTS is supported through the
National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program
, grant UL1 TR000165.The CTSA program is led by the NIH’s
National Center for Advancing Translational Sciences (NCATS)
. The content of this website is solely the responsibility of UAB and does not necessarily represent the official views of the NIH.