Managing T3 Access throughout Your Organization: DSCSA Answers for Dispensers
You may run a standalone corner pharmacy, or a hospital with several primary locations plus dozens of clinics. Regardless of the complexity and breadth of your organization, DSCSA compliance documentation will be needed across multiple processes, by different people, and potentially across many locations. It is critical to insure appropriate access throughout your business. Here are five things to consider as you think through who needs access, where, for what reasons, and how you can best provide it.
1 – Compliance documentation will touch multiple processes
DSCSA compliance documentation will impact many parts of your operations, including:
- Product receipt – Whether you are thoroughly comparing compliance documentation against product before you accept the shipment or doing a spot check afterwards, staff will need access to compliance documentation during the receiving process.
- Product trading or reselling – If you exchange product with another dispenser that is not part of your larger organization - and is not being sent to fill a prescription for a specified patient - you will need to retrieve the correct compliance documentation for that product and add the required information to the outbound T3 before you ship the product out.
- Product verifications or inspections – a government official may query your business, either to verify product involved in a suspect product inquiry or to inspect your overall compliance with the law. In either case, they might ask to see T3 (Transaction History, Statement, and Information) for a specific product; for all products from a given supplier; for all products received during a stated time period, or for some other scenario.
Depending on how your business is configured, these tasks may take place under the same roof or in multiple locations, and they may be managed by 2, 20, or 200 different staff.
2 – The law does not mandate that compliance documentation follow the physical product
Unlike some of the pedigree laws it replaces, DSCSA focuses on change of ownership, not change of possession. Your company may have a central receiving facility where both compliance documentation and product arrive from your suppliers. Down the line, though, you will ship product to different pharmacy locations, clinics, or physician offices. Or you may share product between two like locations. Either way, by DSCSA regulations, you are not required to send its T3 with the product as long as the facility to which it is going is either owned by you or under the same larger ownership umbrella. Given this, you may very well end up with T3 that lives in one place and product that lives in another.
Requirements aside, there are numerous business reasons to have access to T3 where the product is located. An inspector could show up to inspect drugs in inventory against their compliance documentation. How can you provide compliance documentation access to staff at the product’s new location? You could require the first location to find the physical T3 and include it with the shipment. Or you could provide a system that offers both central access and the ability to notate and update product location.
3 – Whether they are under the same roof or far afield, your staff will benefit from individual access to T3
Even when all operations are happening under the same roof, T3 data may not be received or stored in the same spot where relevant business operations and compliance activities take place. In a storefront pharmacy, paper T3 may come in at the receiving dock but whoever is in charge of responding to regulatory inquiries may sit in another part of the building. If that person needs access to T3, do you want them to ask the receiving staff to look it up for them, or enable them to do it themselves?
4 - Giving your staff access to T3 documentation is about more than simply making it available
In its raw format, T3 information is not easily interpretable. Your receiving person may be a pharmacy technician, while the expertise of your outbound staff is shipping procedures. Providing them with a login to look at raw EDI documents will have limited utility.
A compliance system that sits on top of the raw data can provide access in a meaningful way, to help your staff make the decisions they need to make. For instance, when your receiving person is processing a shipment, they will need to figure out if they can take the product into inventory. A good compliance system is built to understand both the regulations and the business context. It can help guide them through each process, prompting them for what information they need to check and removing the burden of having to master all DSCSA compliance details.
5 – Choose a solution that allows your staff to retain their focus on patients, not documentation
A system that can capture compliance data for any product that comes in to any of your locations—and that provides subsequent, flexible access to that T3 anywhere within your organization—can help minimize the business impact of DSCSA. You hired your staff to serve patients. You don’t want them to spend time figuring out where the T3 is—you just want them to know that it exists and to be able to quickly find it when they need it. That’s what will allow them to do the job you need them to do—taking care of patients – while allowing your organization to be confidently compliant.
If you missed part one in our series of DSCSA answers for dispensers, learn now whether you need to enter a lot number. And if you have questions about 340B product and compliance, catch up on part two.