Ashley Gibbons Ellek, Pharm.D.
Ashley Gibbons Ellek, Pharm.D.

The next implementation stage of the Drug Supply Chain Security Act (DSCSA), also known as the track-and-trace law, begins on Nov. 27, 2019. After this date, wholesalers are required to receive and distribute only serialized prescription drug products. Serialization refers to the assignment of a globally unique identifier on each saleable unit and case pack. The identifier is affixed on product packaging in the form of a two-dimensional barcode that is encoded with the GTIN (global trade item number), serial number, expiration date, and lot number. Distributors and dispensers must be prepared with the appropriate devices to read 2D barcoded products. This information is intended to secure the supply chain by allowing electronic tracking and verification of products at each point of sale. Wholesalers will be required to verify saleable returned drugs before they can re-enter the market. Although this deadline specifically targets requirements for wholesalers, both manufacturers and pharmacies should consider the impact this requirement will have on their operations.

Serialization at the Wholesaler Level

The DSCSA was enacted on Nov. 27, 2013, with the goal to provide unit-level traceability by Nov. 27, 2023. Earlier steps in the process included requirements for pharmaceutical manufacturers and repackagers to serialize products. Serialization requires unique product identifiers on all packaging, consisting of a 2D barcode and human readable text format containing the product’s GTIN, serial number, expiration date, and lot number. GS1 is a global information standards organization best known for creating a variety of barcode standards. These standards aim to improve business processes and support regulatory requirements. GS1 assigns a GTIN to products once the manufacturer is registered with the organization. For U.S.-based products, the NDC (national drug code)  can be converted into a GTIN-14 to be incorporated into the barcode matrix. For human-readable text format, the standard NDC formatting may be used. While the GTIN will not be found in drug compendia databases, it is searchable through the GS1 database.

Now that these serialization implementations have occurred, wholesale distributors will be required to verify serialized product identifiers before products can be restocked and resold. This also involves verification of transaction information, transaction statement, and transaction history (T3) with the returned product. This will help ensure that the product was originally purchased from a wholesaler to identify and prevent illegitimate or unsafe products from re-entering the supply chain. With an implementation date of Nov. 27, 2020, serialization identification requirements at the pharmacy are also fast approaching. Now is the time to ask your pharmacy management system provider what its plans are to meet this deadline.

Verification Routing Service

The DSCSA saleable returns verification requirement will involve additional effort from both the wholesaler and the manufacturer. Wholesalers will need to verify the four key data elements with manufacturers, who then must respond within 24 hours. Currently, wholesalers are mainly positioned to handle data transactions with manufacturers in one direction. It is possible that wholesalers have all the data they need for verification internally. First, they can verify if a product was sold to the customer through original invoices. They may also have data pushed from the manufacturer when the product was purchased. If manufacturer data is not available, the wholesaler will need to submit a verification request to the manufacturer. Ideally, the response will be instantaneous, rather than the 24 hours that the act gives manufacturers to respond.

Using an open verification router service (VRS) has become the industry standard. An automated system has the ability to quickly route and return information needed in the verification process. The Healthcare Distribution Alliance developed the VRS Request and Response Messaging Standard, approving version 1.0 in April 2018 before passing it on to GS1 to complete the standard. GS1 then released the v1.0.2 Lightweight Messaging Standard for Verification of Product Identifiers in January 2019 to be used as part of U.S. requirements for verification requests and responses. This standard provides a framework allowing multiple VRS systems to work with all stakeholders. Verification router services are currently marketed by multiple supply chain software companies.

When a wholesaler scans the 2D barcode containing relevant identification information or manually enters the four key data elements, the VRS routes the request to the appropriate location where manufacturer data is stored and returns a response. If a proper response is not returned, the wholesaler must investigate if the product has been recalled or obtained from an illegitimate source. Until the issue is reconciled, the product should not be restocked and resold. If a product is suspected to be illegitimate, the wholesaler should quarantine the product in a physically separate area and investigate along with the manufacturer to validate transaction information and transaction history. The wholesaler will either return an illegitimate product to the dispenser who sent it, or have it destroyed based on the manufacturers instructions. Documentation should be retained for all products, including suspect products and those that were deemed illegitimate. Both manufacturers and wholesalers will need to move toward this system to ensure the success of the upcoming saleable returns verification requirement for wholesalers.

Once the DSCSA requirements are complete, the movement of drugs should be traceable across the supply chain. These changes will allow for faster dissemination of information on FDA-recalled products and more efficient detection of illegitimate products if they are introduced into the supply chain. The ideal scenario will be a supply chain that is secured through the use of electronic systems for unit-level traceability.

Pharmacy Call to Action

First, pharmacies need to be aware of these upcoming requirements for wholesalers and plan accordingly. Use the months ahead of the November implementation date to review and clean up inventory within the pharmacy and make the necessary returns to the wholesaler. Then, pharmacies should work with their pharmacy management system vendor on gaining the necessary technology and processes in advance of the 2020 deadline. On Nov. 27, 2020, transactions can only be made for serialized products. Necessary steps may include purchasing new scanning technology to read 2D barcodes and implementing software to interpret data within the barcode. Pharmacies will need to monitor packaging for the proper 2D barcode for products packaged after Nov. 27, 2018. Pharmacies should be aware of specific requirements for investigating suspected illegitimate products. This includes verifying the product’s lot number, transaction history and transaction information, followed by communications with the manufacturer and FDA. Products found to be illegitimate will need to be destroyed.

The final phase of the DSCSA will be implemented in November 2023. Once the DSCSA requirements are complete, the movement of drugs should be traceable across the supply chain. These changes will allow for faster dissemination of information on FDA-recalled products and more efficient detection of illegitimate products if they are introduced into the supply chain. The ideal scenario will be a supply chain that is secured through the use of electronic systems for unit-level traceability. CT

Ashley Gibbons Ellek, Pharm.D., joined Pharmacy Healthcare Solutions Inc., as a pharmacist consultant in 2011. She has experience in retail pharmacy, managed care, specialty, and hospital pharmacy at various institutions. Ashley works on a variety of projects, with a particular focus in MAC pricing, pharmacy reimbursement, and generic drug forecasting. She can be reached at aellek@phsirx.com.