When there is a contamination scare, wouldn’t it be great if the people taking a certain drug could be quickly notified? Wouldn’t it be wonderful if a drug sold on street could be traced back through its distribution channel to know how it got there? I’m guessing law enforcement officials would give a collective nod.
The Drug Supply Chain Security Act (DSCSA, enacted by Congress in 2014, requires manufacturers, packagers, wholesale distributors, dispensers and third-party logistics providers to create systems that can trace prescription drugs from any point in the chain of custody, from the creator to the user. Due to the complexity of the drug supply chain, DSCSA is designed for staged implementation through 2023, but some participants in the process are facing mandatory changes now.
The Healthcare Distribution and Management Association has been a strong advocate for this type of legislation and its mission to support information exchange standardization for drugs passing through the supply chain. While it has some concerns about the effectiveness of DSCSA’s requirements as they are written, the organization is generally supportive.
For wholesale distributors, warehouse managers and others affected by DSCSA, new IT systems may be needed to meet the guidelines of monitoring pharmaceutical logistics. Requirements have already been established to have lot level management systems in place, and by 2023 serialized item level traceability must be enacted so that a drug can be traced from the manufacturer to the consumer.
There’s no question that warehouses will need more specific IT capabilities, which translates to a greater dollar investment in infrastructure. There is an upside, particularly for distributors and suppliers that have already instituted a warehouse management system. Instead of focusing on the fines and sanctions that may be imposed by the government for infractions to DSCSA, warehouses can often look to their existing WMS for the corresponding cost savings that will be gleaned from business process improvements.
WMS platforms are already designed to offer accurate receiving and inventory tracking, reduced picking errors, faster order fulfillment times, shipping manifests and more. While DSCSA will require organizations to securely transfer digital information about pharmaceutical inventories and shipping to governing bodies, suppliers and partners. The good news is, many WMS platform providers are now working to increase data accessibility within the application to help customers meet upcoming DSCSA requirements. There also may be the option for manufacturers, packagers and distributors to turn on a customer portal within their own websites that provides information about things like order status and shipment times.
What’s next? Keeping drugs real
Again, the first phase of the DSCSA mandate has already been enacted. By now warehouses have instituted lot level management systems to meet these new requirements. The next phase, product serialization, is scheduled to begin November 27, 2019.
What exactly is this, and why should we care? With the explosion of pharmaceuticals sold through the internet and the corresponding lax security requirements accompanying the sales, the marketplace is being flooded with adulterated or fake drugs - not to mention the increase in illegal pharmaceuticals. New tactics are required to monitor, eliminate or control them.
The links in the supply chain continue to grow and each step offers more opportunity for counterfeiters and drug contamination. Pharmaceutical companies quickly realized that the product serialization proposed by DSCSA would be a straightforward way to stem the rising influx of illegal drugs in the U.S.
In the simplest terms, serialization will identify each product with a unique number. This number enables any drug to be tracked from the manufacturer to the user/patient. Warehouses and distributors with a WMS in place can already meet the need to record, track and manage these numbered products to provide visibility within the supply chain. Some modification may be required due to the data sharing nuances, but most vendors are already geared up for the task.
Here are just a few of the many changes within the pharmaceutical supply chain that will happen in 2019, thanks to DSCSA:
- No drug can be returned and then resold without accurate documentation.
- All drug shipments will need verification of the right barcode and the correct serial number, in addition to other supporting documentation (such as quantity). If the quantity is off, the drug cannot be used until the problem is resolved.
- Master data must be held in a central repository.
These new mandates will require work and modification, but a WMS can do a lot of the heavy lifting. With new processes will come more efficiencies and a nice return to the bottom line.
It’s easy to see that warehouse management systems will play a key role in facilitating the success of DSCSA. We stand ready to participate.