University of Florida Health Investigational Drug Service
Position Statement – Shipping of Investigational Drugs
April 2, 2020
The University of Florida Investigational Drug Service (IDS) Pharmacy receives, stores, and dispenses investigational product (IP) to facilitate drug related research at UF. In the event that a participant is unable to travel to the UF for a clinic visit, it may become necessary for IP to ship to the home of the participant. In general, IDS Pharmacy does not ship prepared prescriptions to research participants.
There is no standardized process for shipping IP to the participant’s home address because each individual sponsor will have a specific set of instructions for the shipment of IP based upon the physical characteristics of the IP, storage requirements, temperature monitoring device requirements, transfer forms, and other sponsor-specific requirements for shipping.
If it becomes necessary to ship IP to a research participant, the study coordinator should reach out to the sponsor to request IP-specific shipping instructions. Sponsors may provide validated shippers and temperature monitoring devices to facilitate the transfer. Sponsors may also provide third party billing numbers for contracted couriers (e.g. Fed Ex, UPS, World Courier, etc).
In the event a sponsor does not have specific instructions as noted above, there are some general considerations for study staff to consider when shipping to study participants.
- Always confirm the participants mailing address and phone number.
- Use a courier that can provide tracking numbers and text or email notification to confirm delivery of the IP shipment.
- Complete a Note To File to document the details of the transfer.
- It is recommended that packages containing IP ship with the most efficient shipping method. In all cases, refrigerated items should ship for overnight delivery.
- IDS Pharmacy may be able to provide recycled Styrofoam coolers with gel packs for shipping, though these are not stock items and subject to availability based on incoming shipments of IP. Gel packs may be room temperature, refrigerated, or frozen based on need. Please call IDS Pharmacy to check on cooler or gel pack availability.
- IDS Pharmacy does not stock temperature-monitoring devices. There are multiple vendors. One common vendor is Sensitech which offers some of the following devices:
- TagAlert: Single use items, need to be ordered in batches of #500. These must be programmed by Sensitech for a specific temp range. In other words, one would need to order #500 for 2-8°C, #500 for 15-30°C, etc.
- TempTale Single Use: Minimum order of #10 @ $42 each. Must be programmed by Sensitech for an entire batch. In other words, one would need to order #10 ($420) for 2-8°C, #10 for 15-30°C, etc.
- TempTale Reusable: $106 each. Programming can occur at site with Sensitech proprietary software. Would need a mechanism to condition, send, and retrieve from patient. Would need to purchase enough to send out any additional shipments while awaiting device return to IDS.
- Inform IDS Pharmacy staff of any scheduled courier pick-ups directly from IDS Pharmacy. Any direct courier pick-up from IDS Pharmacy must occur between 8 am and 2pm Monday-Friday.
Susan Beltz, PharmD | Coordinator, UF Health Investigational Drug Services
(352) 294-5894 | email@example.com