DSCSA for Hospitals: Managing T3 from Multiple Suppliers

For any dispenser, the advent of DSCSA requirements poses a risk to their operational efficiency. But for hospitals - whose organizations are generally much larger and more complex than your average pharmacy’s – those challenges are magnified. If you represent a hospital, what business hurdles should you anticipate, and how can the right DSCSA compliance approach potentially mitigate the impact?

In this first segment of a 3-part series on DSCSA hospital considerations, let’s look at the DSCSA implications of having a long and diverse supplier list. 

More than one source of products – and compliance documentation

One of the challenges hospitals face is that they almost never obtain product from one single source. You likely have a primary supplier from whom you get 70-90% of your medications, and then anywhere from 5 to 20 secondary suppliers for unique products. Hospitals also receive drop shipments directly from manufacturers if there is an upcoming procedure or other immediate need that regular suppliers cannot meet.

In a DSCSA regulated world that means your hospital is receiving Transaction History, Information, and Statement (T3) documentation from multiple sources.

Managing compliance documentation from multiple suppliers

How do you manage all of this regulated data from various suppliers? Your wholesale distributor partners are likely offering you portal access to view T3 for the product you purchase from them. With more than one supplier, that will quickly become an untenable solution requiring the management of multiple logins, user interfaces, and applications. All of that creates a fair amount of complexity – especially if you are in the midst of an inspection with only one business day to respond, or have many staff who will need to master all of these systems.

And that doesn’t factor in drop shipments, where you often won’t have a direct purchasing or trading relationship with the manufacturer. How will you get compliance documentation from them? If you don’t receive it, you can’t legally take the product into inventory.

The optimal solution: a single, central repository for all your T3

If all of your compliance documentation is consolidated in one place, you only have one system to manage, train staff on, and navigate when you are under a tight investigatory deadline. As you evaluate third party solutions, ask potential partners if their systems accommodate T3 from any source, and allow you to run queries on the full repository. Would you be able to create electronic versions of any paper T3 you receive, and have the capability to accept compliance documentation for emergency drop shipments? Having a single repository where your hospital can receive, store, and view all of your T3 in one system will lessen the operational impact of DSCSA.

Check back next week, when we'll look at how to manage T3 access control across multiple facility and physician locations.