Your hospital and pharmacy has mastered Drug Supply Chain Security Act (DSCSA) lot-level mandates, but that’s just the beginning: within the next five years, two additional—and much more demanding—phases of DSCSA requirements take effect. Beginning in 2020, dispensers can only buy and sell prescription (Rx) medications that display a unique, serialized product identifier. And in 2023, all product transaction and verification data must be in electronic format.
What, exactly, do each of those requirements mean for your organization, and how do you need to prepare for them as part of your long-term serialization strategy?
2020 Requirements: Buy and sell serialized product
By 2020, all Rx products covered under DSCSA must be serialized, and all transactions can only involve serialized product. At this point, verification requirements for the different supply chain entities will be in place. For hospitals and pharmacies—referred to as dispensers under the law—this means:
- In the event of an inquiry, the dispenser must begin an investigation for suspect or illegitimate product. The dispenser will be required to verify the unique product identifier back to the manufacturer of at least 3 package or 10% of the suspect product, whichever is greater, and provide the transaction history and transaction information for those products.
As a continuation of the requirements that began in 2015, hospitals and pharmacies must still receive a T3 (TH/TI/TS) from its immediate supplier for all received Rx product. The dispenser must maintain and be able to access this T3 data upon request for a minimum of six years.
2023 Requirements: Electronic-only data exchange
The final phase of DSCSA is focused on "enhanced drug distribution security" by implementing electronic-only data exchange across the entire supply chain, including hospitals and pharmacies. As a result, only the Transaction Information and Transaction Statement will accompany Rx products and dispensers must:
- Receive a secure, electronic T2 (TI/TS) from its immediate supplier for all received Rx product.
- Maintain this electronic T2 data and be able to provide it on request for a minimum of six years.
- Have a system for providing and storing electronic T2 documentation to their customer when sending product to another company.
- Respond to a documentation request electronically as a result of an investigation or inquiry.
While the requirements for responding to an inquiry and assisting with an investigation into suspect product remain largely unchanged from 2020, the requirement that product information be transmitted and stored in “a secure, interoperable, electronic manner” will have a profound effect on how most hospitals and pharmacies address their serialization strategies.
How can you prepare now for serialization?
In order to be ready for the upcoming DSCSA regulations and to minimize any disruption to day-to-day business operations, dispensers should review the technology and processes necessary to prepare to only receive serialized product in 2020 and be ready to manage all-electronic documentation in 2023. Using a phased approach, hospitals and pharmacies should:
- Work with suppliers to ensure they’re not only sending serialized product by 2020, but that they will also be able provide electronic documentation by 2023.
- Implement standard operating procedures (SOPs) to verify that incoming products are serialized and to be able respond to an investigation request by 2020.
- Develop and test solutions to verify that every order that comes after 2023 is accompanied by the correct documentation in the proper electronic format and that you are able to access and transmit the required documentation in the case of an investigation.
How TraceLink helps
The TraceLink information sharing network is the only digital supply chain platform that allows hospitals and pharmacies to link every part of their supply ecosystem and access and share product information with wholesale distributors and manufacturers with just a single connection. Every day, thousands of hospital and pharmacy locations rely on the TraceLink network to exchange and validate transaction documentation, protect patients from counterfeit drugs, and adhere to legal requirements.