Research Pharmacy COVID-19 Updates

Shipping Investigational Products to Study Participants

In response to queries related to the shipment of investigational product (IP), the Research Pharmacy has developed a new process for shipping IP to study participants that is effective immediately.

Investigational product being studied under an IND is eligible for interstate shipment without restriction. If a drug is not being studied under an IND application (such as a commercially available drug) but is being shipped to an address in Michigan, the drug may be eligible for shipment. Drugs not being studied under an IND application usually cannot be shipped out of state per Michigan and other state boards of pharmacy laws. Exceptions will require Research Pharmacy Manager approval (kredic@med.umich.edu).

Study teams will be responsible for obtaining all necessary approvals from the PI and sponsor to ship to the patient. After approval is granted, Research Pharmacy will dispense and ship in temperature certified shippers, arrange overnight shipping with signature required through UPS, and provide tracking information to the study team. The study team must assume responsibility for assuring the patient has received the package. Research Pharmacy will charge the study shortcode for the cost of shipment and shipping materials (minimum of $70 for most shipments).

Of note, sponsors CANNOT ship IP supply to patients directly UNLESS they are in compliance with Michigan Board of Pharmacy requirements to do so (i.e. they will dispense and label according to state requirements), and have been vetted through the appropriate Michigan Medicine process as an approved outside pharmacy, so this option should be strongly discouraged in favor of the process we have for shipping outlined below.

PROCESS:

1. Upon decision by the study team and PI to ship to the participant, the sponsor should be contacted for permission to ship per the Research Pharmacy procedure. The SOP/Procedure* and FAQ* should be included. OF IMPORTANCE: The Research Pharmacy is prepared to support shipping using the SOP, which includes the necessary chain of custody and certified shippers to retain required temperatures in transit. We are not able to accommodate exceptions to this process, such as sponsor-provided shippers, temperature monitoring devices, or special courier arrangements or forms. Please indicate clearly that the request is to ship per the SOP when contacting the sponsor. Click here* for the patient shipping enclosure form. 
2. Once sponsor and PI approval is obtained, please complete the Shipping Request INTAKE form*, and send it to Research Pharmacy as indicated, along with the signed prescription. 
3. The Research Pharmacy will be responsible for all of the items noted on the form, including the inclusion of a ziplock bag for old study supply (which participant should retain until next in-person visit) and the standard enclosure attached. Any exceptions to this should be noted on the INTAKE form.

*All documents can also be found on the Research Pharmacy website in the COVID-19 Resources Folder. 

NEW! Email In-basket Instead of FAX

In light of more study team members working remotely, reliability issues with our fax process, and increased requests to ship investigational products to patients, Research Pharmacy is modifying the workflow for receiving patient care-related correspondence and requests.

Effective IMMEDIATELY, please STOP using the Research Pharmacy FAX line to send documents related to patient care. Instead, please BEGIN USING Pharm-IDS-RxBasket@med.umich.edu for the following requests:

1. Signed paper prescriptions
2. Requests to ship IP to patients
3. IVRS and other treatment assignments

Kindly follow preferred formatting below to ensure your request is complete and triaged appropriately:

View the In-basket End User Guide. 

The new inbox will be consistently monitored during our normal business hours (Monday through Friday, 8:00 AM - 4:30 PM). You will receive an email response from us to confirm receipt of your submission. We will continue to keep the fax in service and monitor transmissions, but ask that you transition to this new process as soon as feasible. In addition, the current group emails for Research Pharmacists (Pharm-IDS-RPH) and Technicians (Pharm-IDS-Tech) will now be reserved for internal use. We will forward any emails that are received via these groups to the new RxBasket address as needed. 

Please see the below table for a variety of scenarios and the best way to contact us.