As hospital and retail pharmacies—collectively known as “dispensers” under the Drug Supply Chain Security Act (DSCSA)—prepare the final 2023 DSCSA deadline, they can expect to realize many benefits by adopting 2D barcode scanning sooner rather than later. For starters, they’ll reduce time-consuming and error-prone manual record-keeping processes, such as reconciling receipts and recording lot and expiry information. Pharmacies that scan 2D barcodes will also have the means to quickly verify the authenticity and recall status of orders upon delivery. And by populating a serialized product data repository from these scans, pharmacies can create opportunities to improve supply chain efficiency and reduce costs through reporting and analytics.
Most importantly, scanning helps ensure higher levels of patient safety by preventing recalled or diverted product from reaching the patient. Given all the benefits, the path forward is clear: The time to start thinking about 2D barcode scanning is now.
3 Stages of DSCSA Compliance
DSCSA was enacted in 2013 to protect the public from drugs that may be counterfeit, contaminated, or harmful in some other way. The law, when fully implemented in 2023, calls for drug manufacturers, distributors, and pharmacies to build a digitalized and interoperable system to track and trace pharmaceuticals as they move through the supply chain. Three key stages of the rollout affect pharmacies directly, including:
- Stage 1: Lot-level traceability
Pharmacies should be aware of the first wave of DSCSA requirements, which became law in 2015. Stage 1 ushered in lot-level traceability requirements and mandated that pharmacies only do business with authorized trading partners. It also states that pharmacies can only accept covered prescription products if they’re accompanied by tracing documentation known as a T3—transaction history, transaction information, and transaction statements. All pharmacies should be doing these things now.
- Stage 2: Transition to serialization and 2D barcodes
Stage 2 became law in November 2020. Since then, all pharmacies are required to receive only serialized products from their suppliers. This means that each unit of purchase must include a Global Trade Item Number (GTIN), a serial number, a lot number, an expiration date, and a 2D data matrix barcode, which enables these data fields to be easily scanned. Additionally, stage 2 includes new verification requirements for serialized product. If there is an inquiry related to suspect products, pharmacies will be required to launch an investigation and verify unique product identifiers with the manufacturer, as well as T3 information for those products. Pharmacies that implement 2D scanning solutions will be able to gather and share this information quickly and easily.
- Stage 3: Full supply chain digitalization
The final phase of DSCSA, which goes into effect in 2023, requires electronic data exchange across the entire supply chain, including retail and hospital pharmacies. They will be required to implement a system for storing and sharing electronic transaction information and transaction statements. They’ll also have to maintain this data and be able to provide it on request for at least six years.
Scan for compliance
Despite the upcoming mandate that all prescription products include 2D barcodes at the unit of purchase, most pharmacies today lack the ability to electronically scan and store 2D barcode information. Failure to implement 2D scanning means those pharmacies will be forced to carry out cumbersome visual inspections and follow lengthy T3 paper trails to meet verification requirements during suspect product investigations.
Forward-thinking pharmacies that make a commitment to scanning 2D barcodes upon delivery will gain quicker access to this information. They can also easily record serial numbers for all incoming products, providing the ability to immediately demonstrate compliance with the law when a regulatory inquiry occurs.
Scan for business value
Scanning 2D barcodes can lead to much more than simplified and automated DSCSA compliance. It also means operational improvements and financial opportunities for hospitals and pharmacies that capitalize on the technology.
On the operational front, 2D scanning enables easier physical product reconciliation and eliminates manual data entry. It also simplifies the process of collaborating and sharing products across business units. That’s because scanning helps enable full synchronization between physical product movement and digital information. Finally, scanning makes it easier to identify and remove products when they reach expiration dates.
Scanning can help pharmacies reduce costs and increase revenue through decreased leakage and inventory loss, better financial reconciliation processes, and improved data-based decision making. With 2D scanning, pharmacies can enhance inventory management processes, reduce the amount of money spent on unused drugs, and generally improve supply chain efficiency.
Scan for patient safety
The most compelling reason to adopt 2D scanning is all about increasing patient safety. With 2D scanning, pharmacies can easily identify recalled products, ensure product authenticity, and do a better job of managing drug shortages. Collectively, these things can help lead to more effective care and better patient outcomes.
The most innovative pharmacies and hospitals are already moving toward full serialization and digitalization with 2D scanning—because these digital pioneers recognize that the many benefits of scanning are far too great to ignore.
Future-proof your supply chain with TraceLink
TraceLink helps hospital and retail pharmacies digitalize their supply chains and maximize the value of 2D scanning data. TraceLink’s solutions for the healthcare industry support both full and partial product scanning strategies and provide users with a data repository for compliance, analysis, and reporting. Additionally, TraceLink offers a full set of capabilities designed to generate new business value and support the compliance needs of pharmacies going into 2023 and beyond. These include:
- Store information connected to every drug received
- Consolidate multiple sources of compliance data
- Receive real time product master data updates
- Instantly receive verification responses
- Provide visibility for the entire enterprise
- Quickly identify recalled products for removal from inventory
TraceLink is the world's largest integrated supply network, enabling digitalization and compliance strategies across the life sciences supply chain, from manufacturers to distributors to hospitals and pharmacies. TraceLink's network includes more than 269,000 hospital and pharmacy trading partners and includes more than 280 hospital and more than 50 retail pharmacy customers.
Article originally published August 2019. Updated June 2021.