Phase two is underway & bringing changes with it
Medications make their way from the manufacturer to the distributor to the dispenser (generally a pharmacy), and from there, they go to the patient’s bedside or home. The Food and Drug Administration (FDA) wants to ensure that only legitimate drugs get to the patient, without tampering, and are serialized at the package level. The FDA wants them electronically tracked by Nov. 27, 2023.
Welcome to the Drug Supply Chain Security Act (DSCSA). Authorized in 2013, the act is entering phase two, with this current phase mandating that trading partners (e.g., manufacturers, repackagers, wholesalers and dispensers) use interoperable exchange data standards when sharing tracking information. Paper-based product-tracing methods will no longer be acceptable. The FDA is also mandating more granular serialization and lot numbers for medications at the package level, and interoperable verification of these products.
Complying with the legislation means a potential overhaul in how all trading partners, including health system pharmacies, monitor these prescription products, and will most likely also require implementing new workflows and software.
DSCSA legislation “is meant to ensure that the product, from the point of manufacturing to the point where it’s dispensed, is legitimate. It is meant to address those potential gaps that could allow for the introduction of counterfeit products into the supply chain,” says Carlon King, RPh, MBA, Senior Director of Pharmacy Operations for Community Health Systems, headquartered in Franklin, Tennessee.
Currently, any time a product is transferred from one party to the next, the transaction information, transaction history and transaction statement (or T3 data) is generated. It allows the dispenser to trace the product to the manufacturer, says King, but this is a paper process. The government requires the dispenser to keep those statements on file for six years and to make them available in 48 hours if a regulatory agency requests them.
The DSCSA implementation has been rolled out over the past decade. “Each stakeholder has had different layers to comply with throughout the course of the implementation,” says Chris French, PharmD, MBA, Senior Director of Pharmacy Operations for HealthTrust. “The final piece is the harder one—the interoperable electronic transfer of data.” The data standard used to transfer the information is the Electronic Product Code Information Services (EPCIS). “The level of product verification in the legislation is new for hospitals to manage,” explains King. They will now need to verify the data received from the interoperable electronic exchange of information at the dispenser level.
Implementing a solution
A recent HealthTrust provider survey showed that around 30% to 40% of member hospitals do not yet have an electronic solution to manage this process, and the November deadline for implementation is fast approaching.
“But not to worry,” French adds. “There are several large technology suppliers that can help. HealthTrust has had an electronic solution on contract since 2019: RxTransparent by Inmar Intelligence. The solution is available to all HealthTrust members with exclusive contracting tiers.
Dispensers should consider several things when implementing a solution, assuming they already have a vendor identified or in place. First, they need to obtain a global notification number (GLN). Each facility or dispenser will need this 13-character identification. GLNs are overseen by the third-party nonprofit group, Global Standard 1 (GS1).
Along with HealthTrust, the DSCSA pharmacy compliance software solution provider, distributor partners and GS1 can help determine which sites need GLNs and verify existing numbers. The compliance solution provider can assist in training the staff on the tool and working with the facility to develop and implement new process workflows.
What the process looks like for health systems
The dispenser or health system will need to create a standard operating procedure (SOP) for best practices and auditing to verify the products received in order to show the organization is following the plan. DSCSA is not prescriptive for how to manage the process, but a process must be in place and followed, says French. The plan will help the organization audit the data to ensure the products physically received match the data in their system. These verification efforts include managing exception reporting. Exceptions might be for missing drugs or if an unexpected tote with products arrives. “That’s why it’s an interoperable system,” French explains. The dispenser must be able to communicate with the distributor, the FDA and the manufacturer if situations such as this arise.
Facilities can be audited during state inspections for licensing. “Not complying with the regulations will likely result in some form of penalty, but how this will be managed at the state level is unknown at this time,” says French. Health system leaders should ensure they only work with manufacturers and distributors compliant with the DSCSA regulations.
While this phase of implementation was delayed during the pandemic, further delays are not expected. The scope of this final phase is daunting. “It sounds simple—moving from paper to electronic—but there are a lot of pieces required to make this work effectively,” adds King. He encourages health systems to break down the steps when tackling this phase of the legislation.
Questions about the switch? Contact your HealthTrust Account Manager, or email firstname.lastname@example.org to request assistance.Share Email