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 UAMS Institutional Review Board approval.
IND / IDE
Generally, the emergency use of a test article requires either an investigational new drug application (IND) — for unapproved drugs and biologics — or an investigational device exemption (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.
Arkansas Children’s Hospital 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 Arkansas Children’s Hospital 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 Clinical Research Administration (CLARA).
Emergency Use Five Day Follow-up Report
A follow-up report must be submitted to the UAMS Institutional Review Board within five working days of the initial emergency use of the test article. If the follow-up report is not submitted within five working days, this will result in a finding of non-compliance and institutional officials will be notified in accordance with Institutional Review Board Policies.
Emergency INDs versus Single Patient INDs — Are They the Same Thing?
Emergency investigational new drug applications (IND) and single patient INDs are not the same thing. See this table for an overview of the differences between the two.