Single-patient expanded access/compassionate use

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Anjali Todd
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Single-patient expanded access/compassionate use

Does anyone have hospital, pharmacy or IRB policies or SOPs related to single-patient expanded access programs (formerly compassionate use)? We are wanting to outline our process to assist physicians who need access to a drug (or device) through one of these programs. Looking for examples to assist with writing a new policy.

Thanks in advance for your assistance!
Anjali

Anjali Todd, PharmD
Pharmacist Specialist, Medication Safety
The University of Tennessee Medical Center
Knoxville, TN