UAMS.EDU

Emergency Use

UAMS IRB Policy 18.3

Emergency Use definition: The use of a test article (unapproved drug, biologic, or device) in a life-threatening situation where no standard acceptable treatment is available and there is not sufficient time to obtain IRB approval.

IND/IDE: Generally, the emergency use of a test article requires either an IND (for unapproved drugs and biologics) or an IDE (for unapproved devices).  Physicians/Investigators wishing to use a test article in an emergency use situation should work with the drug/biologic/device manufacturer and the FDA to obtain the appropriate approval.

Pharmacy Notification:  If the emergency use involves an investigational drug or biologic, you must comply with institutional policies regarding the receipt, storage, and dispensation of the investigational drug/biologic.

ACH Use: Please contact the Arkansas Children’s Research Institute Pharmacy at (501) 364-2596 and ask to speak with a Research Pharmacist.

If a situation arises after normal business hours or on weekends and must be addressed immediately before the next business day, call the ACH Inpatient Pharmacy at (501) 364-4822 and ask to speak to a pharmacist. Please explain the situation, provide contact information, and request that a Research Pharmacist be notified.

UAMS Use:  Please contact the UAMS Medical Center Research Pharmacy at (501) 686-6246 and ask to speak with a Research Pharmacist.

If a situation arises after normal business hours or on weekends and must be addressed immediately before the next business day, call the UAMS Medical Center Inpatient Pharmacy at (501) 686-6221 and ask to speak to a pharmacist.  Please explain the situation, provide contact information, and request that a Research Pharmacist be notified.

(See UAMS Pharmacy Investigational Drugs Policy 5:16)

Notification of Intent to Use: When possible, the physician/investigator should submit an “Intended Emergency Use” form through CLARA.

Emergency Use 5 Day Follow-up Report:  A follow-up report must be submitted to the IRB within 5 working days of the initial emergency use of the test article. If the follow-up report is not submitted within 5 working days, this will result in a finding of non-compliance and institutional officials will be notified in accordance with IRB Policies.